20Ways WINTER Hospital 2020 by RXinsider

I M P R O V I N G PATIENT CARE &

PHARMACY COST C O N TA I N M E N T Winter 2020

Health System

•

Infusion

20 Unique Products & Services

Discover 20 products and services that will help your pharmacy improve patient care or contain costs.

CSTD (Closed-System Transfer Device) Products and Manufacturers Industry Expert Q&A, Market Leaders Buyer’s Guide, and More

8 Thought Leaders page 64

SPARx, Mission Critical Delivery Solutions, Micro Merchant Systems, and More page 36

9 Case Studies

Swisslog, GSL Solutions, Medacist, Sentry Data Systems, Charles River, and More

SpecRx

Medical Packaging Inc., ARL Bio Pharma, and TouchPoint Medical

page 79

We’ve Got You

Covered

Head-to-toe USP <797> & <800> Compliant Products

Pharma-HolTM » » » » »

Cleaners & Disinfectants Sterile & Non-Sterile Wipers Disposable Cleanroom Apparel Enviromental Controls Cleanroom Supplies

» » » »

70% IPA / 30% USP WFI cleaner Validated sterile Available in 16oz, 16oz ﬂip-top, 32oz & gallon Only disinfectant mentioned in USP <797>

In stock and available at AmerisourceBergen Cardinal McKesson Pharma-ChoiceTM is a full line of USP <797> & <800> compliant products by Acute Care Pharmaceuticals. Contact us for more information! 888.909.7700 | pharma-choice.com info@acutecareonline.com San Diego, CA

SMART THINKING.

AVAILABLE PRODUCTS Description SmartPak® provides a revolutionary delivery system for these essential drugs, offering faster, easier preparation more economically. It’s also safer. The SmartPak bag system is a convenient alternative to using multiple glass vials. No glass means no breakage during handling. SmartPak saves time and labor with less waste. SmartPak — the smart choice for your pharmacy service.

Cefazolin 100 grams Cefazolin 300 grams

Ceftriaxone 100 grams

Vancomycin 100 grams Cefepime 100 grams

NDC

List#

66288-1100-1

1100

66288-1300-1

1300

66288-6100-1

6100

66288-7100-1

7100

66288-8100-1

8100

www.samsonmt.com Toll Free (877) 418-3600 PO BOX 2730, Cherry Hill, NJ 08034 Telephone (856) 751-5051 Fax (856) 751-5044

Not Just Another

503B Outsourcing Facility

OR Anesthesia | Ophthalmics | Pain Management | Specialty Presentations

Fagron Sterile Services US (FSS) integrates state-of-the-art quality to provide a reliable supply of sterile medication to hospitals, surgery centers, clinics and the patients they serve. FSS offers industry leading automation, advanced environmental monitoring and FDA/DEA registered/ inspected facilities, along with top-tier customer service, streamlined shipping and a 24/7 mobile-friendly web shop.

FACILITIES

PROCESSING

ENVIRONMENTS

NEW

MEDICAL

INDEPENDENT

FILL RATE

7,300+

ASEPTIC

>97% SAME-DAY

TRUSTED BY

Silicone Free AvastinÂŽ Presentation, IV Bags and Sterile L.E.T. Gel

Trusted by members of

Download Product Catalog

/fagronsterile

877.405.8066

fagronsterile.com

Contents WAY

Verity Solutions – An Innovator in 340B Program Optimization

Results you can believe in.

Partner with us to simplify 340B administration, confidently optimize federal pricing benefits, and benefit from the dedication and knowledge of our expert team.

Your true partner for 340B program administration and compliance.

1.800.581.1378 info@verity340b.com www.verity340b.com

Partner with us to simplify 340B program administration, confidently optimize federal pricing benefits, and benefit from the knowledge of our expert team.

Thought Leader Video Series

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iA – Unleashing the Full Potential of Pharmacy intelligentAutomation

At warp speed with iA. Our leading-edge pharmacy automation and software solutions fill prescriptions with industry-changing speed. Let us focus on your prescription fulfillment so your pharmacists can focus on patient-facing healthcare. And as your demand grows, we can scale with you. With innovative advancements and impressive accuracy, iA is unleashing pharmacy. iARx.com | sales@iARx.com | 607.352.2146

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Rising to the Challenge of Safe and Effective Vaccine Storage With Helmer Scientific

The First Professional Medical-grade Refrigerators

With our leading-edge automation and software solutions, we partner with pharmacy providers to transform pharmacy by deepening the patient-pharmacist relationship, enhancing patient safety, and increasing operational efficiency.

There’s never been a more critical time to safeguard your vaccine inventory.

Meet existing CDC standards for safe vaccine storage

GX Solutions help you rise to the challenge.

Eliminate costly temperature excursions

Three ways GX Solutions help you safeguard your vaccine inventory.

Prepare for new NSF standards

Energy savings Quiet operation Supports sustainability initiatives

Learn more: helmerinc.com/vaccine-refrigerators

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C AS E S T U DY

Cohen Children’s Medical Center Streamlined Pharmacy Operations with the BoxPicker Automated Pharmacy Storage System to Drive Efficient Medication Management. ®

Cohen Children’s Medical Center is a member of Northwell Health System. Located in Queens, NY, the 202-bed hospital specializes in serving children from prematurity to adolescence, approximately 1.8 million in the Brooklyn, Queens, Nassau and Suffolk county areas. Recognized for excellence by U.S. News & World Report for thirteen consecutive years, Cohen Children’s is on the publication’s 2018-19 Best Children’s Hospitals list where it earned top 50 placement in nine specialty areas. Cohen Children’s partnered with Swisslog Healthcare to automate medication management by deploying BoxPicker. The labor-saving solution helps skilled staff realize more time to allocate to patient-critical, clinical tasks.

THE CHALLENGE In the past, Cohen Children’s Hospital stored pharmacy inventory in multiple locations throughout the facility, including several satellite pharmacies and inventory rooms situated in various department areas. The pharmacy staff was required to routinely walk throughout the hospital to these locations to carry out inventory and stocking tasks. This was logistically challenging, causing inefficient and time-consuming workflows. Within these satellite locations, medication was stored and managed on static shelving. This method was highly susceptible to human errors including inaccuracy in labeling bins, mis-identification of medication during manual pulls

www.swisslog-healthcare.com

page 39

Case Study: Swisslog Healthcare – Cohen Children’s Medical Center

Case Study: Retail Management Solutions

Case Study In 2013 hospitals began to experience Medicare penalties based on 30-day readmittance rates for specific medical conditions. These penalties triggered systemic changes across hospital organizations. All with the goal to improve patient compliance following discharge. Thereby improving patient outcomes and reducing readmittance rates.

Streamlined pharmacy operations with the BoxPicker® Automated Pharmacy Storage System to drive efficient medication management.

Today, the drive to reduce readmittance rates through improved patient compliance continues.

Software

Outpatient pharmacies play a major role in organizational initiatives. Both in making sure that patients leave the hospital with appropriate medications and instructions, but also in giving every patient the tools for long term compliance and wellness.

Additionally, bedside transactions capabilities must not come at the expense of patient experience and satisfaction.

Meds-to-beds programs create opportunities to meet these goals. In this article we’ll draw on years of meds-to-beds program experience. Providing not just a single use case, but a framework for successful implementation of meds-to-beds programs through 4 key areas. Software, hardware, training and long-term support.

In 2013 hospitals began to experience Medicare penalties based on 30-day readmittance rates for specific medical conditions. These penalties triggered systemic changes across hospital organizations.

Meds-to-beds programs must operate with flexibility while still adhering to rigorous pharmacy compliance standards. Challenges include signature capture, PHI and PII concerns, and secure credit card acceptance.

Software considerations for meds-to-beds programs should include; ease of use for patients and employees, continuity of care, existing or desired system integrations, alignment with both regulatory and organizational compliance mandates, robust reporting capabilities, and the convenience features that you’d like to see offered at bedside. Let’s explore each of these areas a little further: Ease of use & continuity of care –- Using the same Pharmacy POS software application for both meds-to-beds and the main outpatient pharmacy counters provides many benefits. Pharmacy team members use a single application for every transaction, no matter where they process it. Reducing the potential for errors or confusion that impact the patient experience. This also means that all transaction data for the pharmacy, whether meds-to-beds or pharmacy counter, is recorded and accessible from the same place. Software Integrations – Pharmacy POS software is a specialized offering. Meds-to-beds programs add another layer of complexity and necessary vendor expertise. Organizational requirements for specific system integrations, such as pharmacy system or credit card vendor should be taken into account. Also keep in mind future compatibility should one of those systems change. For example, if the organization changes pharmacy system providers, does the meds-to-beds program then have to be entirely re-worked to accommodate this change? Or can a software adapt to potential future changes? Compliance – Organizations should understand how pertinent data (like PII, PHI and PCI) is kept safe and secure with any software. And whether any special organizational requirements can be easily met.

Toll free: 1.877.767.1060 Email: sales@rm-solutions.com Web: www.rm-solutions.com

Reporting – Important data is gathered during any transaction, including medsto-beds transactions. Many departments within a hospital organization need access to this data. From auditing and compliance, to accounting and leadership. Pharmacies should understand how data will be accessible to all involved parties and know that the data collected meets the needs of each department.

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You provide the care. We’ll provide the protection. We have what it takes to keep hospitals safe.

ISO-MED line of medical supplies extends from reliable PPE to lab supplies and disinfectants. All products conform to the strictest clean room standards, and will keep the entire hospital staff feeling well-protected.

Get what you need to give the best care. Order now:

iso-med.com

Call for fast reordering:

800-797-1405

1220 Graphite Drive, Corona, CA 92881 USA | 800-797-1405 | sales@iso-med.com | www.iso-med.com

ISO-MED Gives Hospitals the Benefit of Their Cleanroom Expertise With the Medical Supplies Critical for Protection

As one of the leading suppliers for pharmacy cleanroom supplies, we provide an unparalleled selection of specialized medical products, globally trusted quality and service, and delivery convenience.

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Parata’s Solutions Improve Operational Efficiencies to Reduce Medication Errors and Operating Costs

Powering hospital pharmacies to help people lead healthier lives.

An established pharmacy automation leader, Parata’s adherence packaging, vial-filling, and workflow solutions reduce costs and medication errors and improve medication adherence. Explore our full portfolio of pharmacy workflow solutions designed with your business, pharmacy teams, and patients in mind at parata.com.

Adherence Packaging & Inspection

Workflow & Inventory Management

Vial-Filling Robots

Explore the technology, expertise, and people you can count on.

866.251.6171 parata.com

Secure Pick-Up Kiosks

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WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N

Dedicated to Controlled Environment Contamination Control Products Teknipure is the premier developer, manufacturer, distributor of innovative cleanroom and other controlled environments consumable contamination solutions. Our products are designed to prevent, control, and remove contamination effectively and efficiently.

We carry a complete line of products, including the following wipers, swabs, facemasks and mops:

Facemasks TM-EL-7 Facemask, 3Ply, PET, Pleated, Round Ear loops

Wipers TS1MPI70-911 / S Melt blown Polypropylene Pre-saturated Wiper 70% IPA

Mops TM-516V Microfiber Flat Mop 5â&#x20AC;?x16â&#x20AC;?, Single Use, Velcro

TS1MFI70-99 / S Non-woven Microfiber Pre-Saturated Wiper 70% IPA

TM-516V-1 Velcro Mop Hardware Collapsible Frame & Handle

TS2PUI70P-99 / S Polyester Knit Pre-Saturated Wiper 70% IPA

TM-MFP-516P Microfiber Flat Mop, Knit, 5" x 16", Single Use, Pocket Style

Swabs TS-FMD-3/5/6 Micro denier covered Foam Swab 3, 5 and 6 inches

TM-PFM-516HF Pocket Mop Blue Frame & Extendable 4'-6' Handle

Innovative Contamination Solutions

844.309.2376 Info@Teknipure.com

www.Teknipure.com

Free Sample

Pre-Saturated Wipes and Mops 9001:2015

Experts in 340B

Healthcare Technology Our extensive experience in healthcare technology and the 340B Program enables us to provide our clients with the best solutions in the industry. Split-Billing Software

• Increase Claim Capture • See Signiﬁcant Savings • Close the Loop

Advanced Referral Program • Superior Technology • Intuitive Accumulation • Optimize Purchase Orders

Exceptional Customer Service Contact Us 888-356-6225 info@340Basics.com www.340Basics.com

• Client Support • Training & Education • Growth & Optimization

Contents I N F O R M AT I O N F O R I N T E L L I G E N T P H A R M A C Y M A N A G E M E N T

WAY

Pharmaceutical Inventory Management Services by Capital Inventory Pharmaceutical Inventory Experts:

Cover (Vert).indd 1

Precise, Efficient, and Confident

9/27/06 3:00:09 PM

Why Outsource Your Inventory Needs? • • • •

Teams of experts conduct the inventory within a few hours. Teams conduct inventories daily-not annually. Minimal interruption to the pharmacy staff and operation. Teams work seamlessly around the pharmacy staff ensuring that the “snapshot” is a true representation of the inventory on-hand. • Eliminate the need for overtime or coordination of staffing to accommodate inventory. • Expert valuation and pricing of the inventory by an independent party. • Competent inventory specialist that can work with finance and/or external audit firm to validate the inventory. • Collaboration with the pharmacy to provide an accurate report in a timely manner.

Steri-Tamp® Tamper-Evident Sterile Seals by Allied Pharmacy Products, Inc.

THE MOST INNOVATIVE TAMPER-EVIDENT SEALS IN HOSPITAL PHARMACY TODAY

The nation’s leader in pharmaceutical inventory service providing inventory data that is accurate and dependable.

• Sterile & Paper Free (USP 797 Compliant).

NEW ISMP & USP 800 IV Bag Seals

IV Bag Port Seals

• Maintains a 100% sterile barrier* with 3X greater adhesion.

The only single-use, tamper-evident seal that both provides and maintains a 100% sterile barrier.

• Helps prevent contamination of drugs and provides added protection to pharmacists. • Will not fall off, even in cold storage conditions (down to -20 degrees centigrade). Vial Seals

• Patented dual-layer indicates true tamperevidence, with “OPENED” marking. • Cost-effective, allows pharmacy to recycle medication and protects patients from dosing errors. • Dispensing and application training videos available on our website to help with

Tamper-Clear Syringe Seal®

JCAHO training. • Available in major wholesalers and distributors.

Red Syringe Seal

To learn more about Capital Inventory and how we can help you with our inventory services please contact 1-800-345-0849 or Info@capitalinventory.com.

*Tested in Nelson Labs, Salt Lake City, UT

Visit our website to learn more: www.steri-tamp.com

page 47

C AS E S T U DY Pharmacists Will be Replaced by Robots: An Updated Time Study on IntelliVault™ From GSL Solutions Inc. BACKGROUND

Michael Kiso, Pharm D. RPh MBA Candidate 2020

Pharmacists have been manually tracking and reconciling physical controlled drugs to a perpetual log since 1971 at the institution of the DEA’s Title 21. The importance of tracking controlled substance inventory and dispensing history cannot be understated, but has long been hampering the full potential of pharmacy operations and demoting clinically trained pharmacists to “bookkeepers” and “gatekeepers.” GSL Solutions Inc., a company well-known for the RFID-based IntelliCab™ pharmacy willcall system found throughout military, community, and integrated-delivery network (IDN) pharmacies across the globe, has developed a new product, IntelliVault™. This product disrupts the current labor intensive and error-prone controlled-substance inventory management practices within the pharmacy. This unique product aims to replace the typical open-faced “control cabinet” with discrete drug storage featuring real-time workflow tracking to eliminate diversion and drug loss. This optimizes pharmacy operations and reduces labor costs. It achieves this through shifting time-consuming, non-clinical labor away from pharmacists to pharmacy technicians and software automation, while maintaining controlled substance accountability. While accountability was the primary objective for IntelliVault™, it has also demonstrated significant operational benefits via streamlining pharmacy workflows. More specifically, these benefits include: 1. Controlled Substance Stock Receiving Technicians can now receive controlled substances and associate stock bottles to a SmartBasket™, reducing pharmacist time in drug receiving. As controlled substances are documented by the IntelliVault™ software, the stock is automatically reconciled against the DEA 222 form, ensuring all products are accounted for. Additionally, multiple technicians can receive controlled substance stock simultaneously, allowing for reduced drug shelving time. 2. Drug Retrieval + Filling Controlled substance stock bottle retrieval, Rx filling, and back counting can now be completely shifted away from pharmacists to pharmacy technicians. The Pick-to-Light™ system of IntelliVault™ directs the technician to the SmartBasket™ with the appropriate stock bottle upon prescription label scanning. This eliminates the “gate-keeper” responsibilities of pharmacists to retrieve the stock bottle from the CII cabinet for the technician to fill. Documentation of the stock bottle’s lot and expiration date at receiving allows for the oldest stock bottle to be utilized first. Additionally, NDC verification, tracking and logging the drug pedigree is as simple as picking to the lights.

page 53 WAY

Case Study: Pharmacists Will be Replaced by Robots: An Updated Time Study on IntelliVault™

FFF Enterprises, Inc. – The Nation’s Most Trusted Specialty Distributor

Our dedication to Helping Healthcare Care® means that we provide you with the products, systems, programs, and services that give you the freedom to focus on patient care.

From GSL Solutions Inc.

www.gslcorp.com

page 48-51

20Ways MISSION To educate pharmacy management on products and services that serve to improve patient care or improve a pharmacy’s financial bottom line, while distilling and presenting this relevant information via 20 product profiles.

page 55

QUARTERLY ISSUES Winter 2020/ 2021

Fall 2020

NG I M P R O VI I M P R O V I N G PAT I E N T PCAATRI EE NT CARE & PHARMACY & P HI LAIRTMYA C Y C B OST P R O F I TA Winter 2021

C O N TA I N M E

• LTC Community • Specialty

Winter 2020

Health System

•

Fall 2020

& Services

and services Discover 20 products pharmacy improve Discover 20 products that will help your y. and services profitabilit that will help your pharmacy improve patient care or increase patient

page 46 Products and Manufacture

Industry Expert Q&A, Market

Leaders Buyer’s Guide,

4 Case Studies 9 Case Studies

Issue Focus: Retail, Specialty, & LTC Issue Frequency: Spring, Fall, & Winter Circulation Per Issue: 26,500+ 18,000+ Owners (Independents) 1,500+ Long-Term Care Pharmacies 2,500+ Retail Chain Executives 2,500+ Industry Executives 2,000+ Trade Show Handouts

Summer 2020

Health System

•

Infusion

20 Unique Products & Services

Discover 20 products and services that will help your pharmacy improve patient care or increase profitability.

Discover 20 products and services that will help your pharmacy improve patient care or contain costs.

Multi-Dose Packaging Systems and Resources

Drug Diversion & Opioid Stewardship Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 46

8 Thought Leaders

ARxIUM, Sentry Data Systems, Comprehensive Pharmacy Services, ACHC, Parata, and More

Eight Video Series Including Comprehensive Pharmacy Services – SPARx, ACHC, Micro Merchant Systems, and Parata

page 36

Issue Focus: Hospital & Infusion Issue Frequency: Summer & Winter Circulation Per Issue: 12,200+ 6,500+ Hospital Directors 2,200+ Clinical Consultants 2,500+ Industry Executives 1,000+ Trade Show Handouts

C O N TA I N M E N T

page 50

Systems, and More

2020 CIRCULATION

PHARMACY COST

Community • Specialty • LTC

8 Thought Leader Videos

page 64

page 30

IMPROVING PAT I E N T C A R E & PHARMACY P R O F I TA B I L I T Y Spring 2020

Community • Specialty • LTC

QS/1 and Temptime

SpecRx

20 Unique Products & Services

Discover 20 products and services that will help your pharmacy improve patient care or increase profitability.

Specialty Pharmacy Solutions (Technology & Software) Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 56

8 Thought Leader Videos

page 32

Eight Video Series Including Medicine Shoppe International, Inc., Comprehensive Pharmacy Services, Sentry Data Systems, and ACHC

Comprehensive Pharmacy Services, Charles River, and GSL Solutions

Medicine Shoppe International, Inc. and CPS SPARX

3 Case Studies

2 Case Studies

Swisslog, GSL Solutions, Medacist, International, Shoppe Sentry Data Systems, Care Services, Medicine and Temptime Charles River, and More Noritsu Pharmacy Automation, ARL Bio Pharma, and TouchPoint

Industry Expert Q&A, Market Leaders Buyer’s Guide, and More

and More

Parata, PharmaLink, Thought Leaders Eight Video Series Including Services SPARx, Pharmacy Consulting Broker page 20 Mission Critical Delivery Solutions, Sentry Data Systems, and Micro Merchant

Medical Packaging Inc.,

PATIENT CARE

20 Unique Products & Services

Products care or contain costs. Resources &CSTD (Closed-System Transfer Cannabidiol (CBD) Guide, and More Device) Q&A, Market Leaders Buyer’s

8 Thought Leader Videos 8

I M P R O V I N G

Infusion

20 Unique 20 Unique Products & ServicesProducts

Industry Expert

Spring 2020

Summer 2020

IMPROVING PAT I E N T C A R E & PHARMACY P R O F I TA B I L I T Y

page 30

2 Case Studies

Medical page 79

Health System • Infusion & Community • Specialty • LTC

Community • Specialty • LTC

Health System • Infusion

Community • Specialty • LTC

Visit 20Ways ONLINE at RXinsider.com/20Ways

WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N

Now Available from Amneal:

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

AP-rated equivalent to Precedex®

• • • •

Ready-to-use; no admixing required Includes vial label hangers for eﬀicient drug administration Not made with natural rubber latex Preservative free

Unit of Sale NDC

Inner NDC

Strength

Size

70121-1388-08

70121-1388-01

200 mcg/50 mL

20 x 50 mL single-dose bottles

70121-1389-07

70121-1389-01

400 mcg/100 mL

10 x 100 mL single-dose bottles

Image

Learn More at Amneal.com

Contact Us: Toll Free 866.525.7270 | CustomerRelations@amneal.com or Sales@amneal.com All trademarks are property of their respective owners. Images are for reference only; actual product may vary. © 2020 Amneal Pharmaceuticals LLC. All rights reserved. DXMAD-01 10.13.20

Helping you deliver better medicine to more people. With increasing regulatory pressure and drug shortages, access to quality medicine is more important than ever. Leiters is an FDA-registered 503B outsourcing provider of high-quality, compounded sterile preparations including: Pre-filled syringes, IV bags and vials ON-Q* Pain Relief System fill services Opioid-free surgical pain services medications Ophthalmology medications and services including FDA-compliant repackaged Avastin®

COMPOUNDING HEALTH™ www.leiters.com | 800.292.6772

ON-Q* is a registered trademark of Avanos Medical, Inc., or its affiliates. Avastin® is a registered trademark of Genentech, Inc.

Contents Case Study: Sentry Data Systems

WAY

Pharmacy & Business working together to optimize your results

Sentry Data Systems helps large children’s hospital improve 340B capture rate by 29%.

Visante – High-Performing Pharmacy is Who We Are

We're in the business of advancing pharmacy. Our consultants work with hospitals and health systems combining a wealth of expertise with personalized and comprehensive support.

No one makes pharmacy and business work together like Visante. Our consulting work with Integrated Delivery Networks, hospitals and health systems combines a wealth of expertise with personalized and comprehensive support so you can optimize your pharmacy operations and deliver better patient care.

High-performing pharmacy is who we are

successful program. Recently, one of Sentry’s long-standing customers, a large, nationally-ranked children’s hospital, sought to deepdive into its 340B capture rate to identify overlooked benefit opportunities. In doing so, they leveraged the following Sentry solutions:

• 340B Program

• Comprehensive Pharmacy Assessments

• Specialty Pharmacy • Sterile Compounding & USP Excellence

• Pharmacy Finance and Reimbursement • Pharmacy Stars TM Compliance Tools

• Drug Diversion Prevention

SenturionTM Professional Services Comprised of some of the industry’s most educated and credentialed pharmacy experts, Sentry’s elite Senturion Services teams combine over 120 years of in-depth knowledge and hands-on experience to provide dedicated

Learn more at visanteinc.com, or contact us at solutions @ visanteinc.com or (866) 388-7583.

resources who can take your 340B program to the next level.

Sentrex® eRx Eligibility Check Using your existing e-prescription data, the Sentrex eRx eligibility check module links prescriptions to the service location, reducing audit risks and rapidly optimizing financial benefit to improve patient safety and quality of care.

sentry data systems, inc. | www.sentryds.com | 800.411.4566

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Q.I. Medical, Inc.™ Your Partner in USP <797> Pharmacy Compliance

WAY

AHP Supports Pharmacy Efficiency With an Evolving Barcoded Unit-Dose Product Offering

Supporting Pharmacy Efficiency with a Growing Product Formulary

Liquid Unit Dose

from American Health Packaging American Health Packaging delivers unit-dose products supporting patient safety and pharmacy efficiency initiatives. Products come in multiple pack sizes to provide flexibility in managing local inventory. Liquid Unit Dose cups are available through partner wholesalers and GPOs. ■ Pull-tab labels promote ease of opening and product administration ■ Thick-gauge cups with excellent label seal integrity aid in avoiding costly

damage and cleanup ■ Legible labels aid in selecting correct products from the pharmacy shelf ■ Cups and storage trays are designed to optimize limited storage space ABC 8-digit #

Providing quality assurance products to hospitals and pharmacies practicing sterile compounding, with a singular focus on pharmacy compliance.

10237650 10211921 10188404

Cardinal Item #

McKesson Item #

5660352

1557057

5517206

3795689 3917226

Product Description

Unit Strength

906891 Amantadine HCl Sol 100mg/10mL

100mg/10mL

584466 Fluoxetine Oral Solution, USP

20mg/5mL

10mL 5mL

Cup Strength

Pack Size

100mg/10mL

100ct

20mg/5mL

40ct

NDC

60687-0239-56 60687-0244-77

20mg/5mL

3968229

752410 Hydrocodone Bitartrate & APAP Oral Solution CII

7.25mg/325mg/15mL

15mL

7.25mg/325mg/15mL

50ct

60687-0417-71

3901766

584557 Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

40ct

60687-0249-77

238550 Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

3775822

50ct

60687-0244-67

5mL

5552237 5517214 5430343

363275 Fluoxetine Oral Solution, USP

Cup Delivery

20mg/5mL

10228115 10211783 10183100

5465380

Morris & Dickson #

50ct

60687-0249-67

10210354

5512413

3777034

568063 Ondansetron Oral Solution, USP

4mg/5mL

5mL

4mg/5mL

30ct

60687-0252-86

10219153

5528518

3949997

603993 Oxycodone HCl Oral Solution CII, USP

5mg/5mL

5mL

5mg/5mL

40ct

60687-0406-77

10219154 10231522 10209414 10211558

5528526

3950037

5587894

2549509

5508114

3751294

5515705

3935129

604306 Oxycodone HCl Oral Solution CII, USP 822841 Phenobarbital Elixir CIV, USP*

5mg/5mL 20mg/5mL

560649 Phenytoin Oral Suspension, USP 575878 Potassium Chloride Oral Solution, USP 10%

125mg/5mL 20mEq/15mL

5mL 5mL 4mL 15mL

5mg/5mL 20mg/5mL 100mg/4mL 20mEq/15mL

50ct 50ct 50ct 30ct

60687-0406-67 60687-0448-67 60687-0275-66 60687-0341-58

10212031

5520416

3909884

584904 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

40ct

60687-0341-64

10191061

5486220

3263035

321570 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

50ct

60687-0341-71

10211557 10212749 10191066 10236851

5515713

3935137

5521521

3937786

5487574

3266467

5655030

1552645

575894 Potassium Chloride Oral Solution, USP 10% 591016 Potassium Chloride Oral Solution, USP 10% 465344 Potassium Chloride Oral Solution, USP 10% 881052

Siladryl Allergy (Diphenhydramine Hydrochloride) Antihistamine Liquid 25mg per 10mL

20mEq/15mL 20mEq/15mL 20mEq/15mL 25mg/10mL

15mL 30mL 30mL 10mL

20mEq/15mL 40mEq/30mL 40mEq/30mL 25mg/10mL

80ct 40ct 50ct 100ct

60687-0341-07 60687-0341-14 60687-0341-72 60687-0267-56

10182920

5427497

3772373

231159 Theophylline Oral Solution, USP

80mg/15mL

15mL

80mg/15mL

50ct

60687-0258-71

10231260

5583273

2080927

793638 Valproic Acid Oral Solution, USP

500mg/10mL

10mL

500mg/10mL

100ct

60687-0262-56

*Product contains 10% alcohol.

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Your One-Stop Source for All Tamper-Evident Needs – Health Care Logistics®

STERILE EMPTY VIALS

With a responsive line of barcoded unit-dose oral solutions – a growing liquid unit dose offering and now individually wrapped inhalants – AHP continues to deliver supporting pharmacy efficiency.

Case Study: Charles River – Achieving 503A+

C ASE ST U DY

Achieving 503A+ JSD Pharmacy Sets the Gold Standard for Super Sterile

JSD Pharmacy sets the gold standard for super sterile.

PRIMARY INTENDED OUTCOME

Deborah Larison, PharmD Director of Pharmacy ~ JSD Pharmacy

Find a diverse selection of USP <800> and infection prevention solutions in one convenient location.

Deborah J. Larison, Pharm.D., C.Ph. is currently the Director of Pharmacy at JSD Pharmacy in Evansville, IN. Dr. Larison has served the compounding pharmacy industry for over 20 years and obtained her QP503A™ Certification. Dr. Larison is a visionary and dynamic clinical pharmacist with broad-based experience in Pharmacotherapy, Pharmacy Practice, and Pharmacy Regulatory and Compliance matters.

The lightbulb moment happens when you realize the choice of system and methods for your compounding pharmacy enable you to become a top tier 503A facility. Deborah Larison, Director of Pharmacy at JSD Pharmacy, advocates that with the right microbial solutions and data tools, the organization can achieve – what she calls "503A+." This case study analyzes Dr. Larison's approach, motivations, and expectations in elevating a 503A compounding pharmacy. “I ask my team; do you want to be average or outstanding?” states Dr. Larison. “I consider the baseline acceptance criteria for adhering to USP guidelines as our worst-case scenario. If we are not going above and beyond the minimum high-risk USP expectations, we are not outstanding.” Dr. Larison's mantra is that a 503A compounding pharmacy should exceed regulatory requirements. Pharmacists can do this by putting patient safety at the center of everything and mitigating all risks to them. No compromises exist in her microbiological testing methods. Dr. Larison is a perfectionist, but if you ask her for a descriptor, it would be patient protector. She had a constant awareness for increased safety even before USP made it mandatory. For example, regulatory guidelines indicate that the facility should sample once every six months. This means a facility only takes two snapshots of their bioburden each year. If there are contamination events, the facility will not have enough data to precisely find and eliminate these invisible invaders. Leaders of high-risk compounding facilities need to know daily risk. Heavy emphasis on processes and monitoring will result in safer product development and improved manufacturing. Dr. Larison delivers on these goals with the help of Charles River's QC Microbial Solutions – offering Endosafe® cartridge technology for rapid endotoxin detection, Celsis® rapid microbial detection, as well as Accugenix® microbial identification and strain typing. Charles River provides the JSD team with reliable and relevant data to fuel confident decisions on product quality and bioburden control. Without this strict control, the pharmacy risks more than just its reputation; patient lives are at stake.

THE CHALLENGE Reputation isn't everything, but one pharmacy’s wrongs can have a multiplying effect. The industry still reels eight years later from one of the worst public health catastrophes when 64 people died and 753 were sickened from a fungal meningitis outbreak, which stemmed from contaminated, deficient, and deadly drugs at The New England Compounding Center.1 This horrific incident led to increased regulations for compounding pharmacies, which in turn encouraged the FDA to divide these entities into 503A and 503B facilities.2

GOHCL.COM • 1.800.848.1633 www.criver.com

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Prep-Lock™ From IMI Guards Against Drug Diversion and Misuse

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Increase pharmacy productivity and safety with economical, American-made devices designed to advance the safety and security of your drug products and ultimately your patients.

Simple, Innovative Solutions to Enhancing Drug Security Programs.

Drug diversion and misuse presents innumerable risks for the healthcare industry. The installation of drug security programs continues to rise each year. Over 80% of US Hospitals now offer educational programs or guidelines on opioids. Ensuring protocol adherence and mitigating diversion temptations are central missions for these programs. Experts agree, including tamper-evident technology in your drug security program is a simple, effective way to provide an extra security level to your compounded preparations and controlled substances. Prep-Lock™ Tamper Evident Caps are an active deterrent to potential tampering or misuse. The Prep-Lock™ line of products provides tamper-evident solutions for IV Syringes, Medication Cassettes, Oral Syringes, IV Bags, and ENFit® Syringes. IMI understands the challenges our HCP must confront. We work closely with pharmacists and compounding professionals to continuously advance our devices to serve the healthcare industry. IMI has designed American-made tamper-evident closures for drug delivery devices for over half a century. Our quality, reliability and exceptional customer care have made Prep-Lock Products an industry standard for guarding drug delivery containers.

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H E A LT H S Y S T E M • I N F U S I O N 11

Pharmaceutical Inventory Experts:

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Why Outsource Your Inventory Needs? • • • • • • • •

Teams of experts conduct the inventory within a few hours. Teams conduct inventories daily-not annually. Minimal interruption to the pharmacy staff and operation. Teams work seamlessly around the pharmacy staff ensuring that the “snapshot” is a true representation of the inventory on-hand. Eliminate the need for overtime or coordination of staffing to accommodate inventory. Expert valuation and pricing of the inventory by an independent party. Competent inventory specialist that can work with finance and/or external audit firm to validate the inventory. Collaboration with the pharmacy to provide an accurate report in a timely manner. To learn more about Capital Inventory and how we can help you with our inventory services please contact 1-800-345-0849 or Info@capitalinventory.com.

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PYROSATE

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It’s been an unprecedented time in health care, especially in the surgical suite. But now, surgery volumes are returning and it’s critical that your patients have access to reliable, safe medications throughout their surgical experience. From Pre-op relaxation to pain-free post anesthesia, patients and practitioners should have confidence in the safety of their medications. SCA Pharma is committed to meeting that need. We’ve been working during the surgical shutdown to prepare for this “new normal”. SCA Pharma has increased capacity to meet demand and enhanced our Buy-and-Ship portal to simplify ordering. We’ve also partnered with DoseID and Kit Check.™ Simply stated, you can:

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SCA Pharma is here to help hospitals and surgical centers meet today’s OR needs. COVID has been unpredictable. Treating your surgical patients doesn’t have to be.

To learn more visit us at SCAPharma.com.

Pharma Logistics.

The Reverse Distribution Experts.

What Can Pharma Logistics Do For Your Hospital? Pharma Logistics not only gets you credits for expired pharmaceuticals and keeps you compliant with all state and federal regulations, we provide solutions that help your hospital pharmacy’s overall health. All of our services come with access to our online portal, giving you the data you need to keep your entire team informed— from the technician responsible for inventory to the procurement and finance teams. Plus, with a dedicated Customer Advocate, we’re always available to help you find a solution that best fits your needs. Receive credit within 14 days.

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BENEFIT: Keep your hospital finance team happy. Upfront payments help eliminate time spent on reconciliation, chasing down credits from vendors and combing through reporting trying to figure out when and if credits will be received.

Trained and licensed representatives come onsite to check paperwork, ensure proper packaging, and prepare shipments for carrier pickup. BENEFIT: Let us handle the entire process for you so you can focus on running your pharmacy.

Manually pack and ship your own returns with prepaid labels and boxes. BENEFIT: Limit vendor interruptions and ship returns back on your own schedule.

A community medication disposal program that complies with the requirements of the DEA Secure and Responsible Drug Disposal Act. BENEFIT: Keep your community safe by helping to prevent misuse and improper disposal, which can lead to health and environmental issues.

clean

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Pharma Logistics brings efficiency and 24/7 visibility to the returns process so you can focus on patient care and the community. Call 888-729-7427 or visit www.pharmalogistics.com.

Contents SpecRx Product Guides

SpecRx

WAY

A better, greener waste solution

Comprehensive product guides from Medical Packaging, Inc., ARL Bio Pharma, and TouchPoint Medical.

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Stryker's Cactus Smart Sink and Cactus PharmaLock OR Stryker's Cactus Smart Sink System securely captures partially administered, non-hazardous controlled substances and renders them non-retrievable and unusable.

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Stryker Corporation or its divisions or other corporate afﬁliated entities own, use or have applied for the following trademarks or service marks: Pharma Lock, Smart Sink, Stryker. All other trademarks are trademarks of their respective owners or holders. © 2019 Stryker | www.stryker.com | 9100-004-677 Rev none

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Unit Dose Done Right Brightly Colored Labels Call Attention to Meds Requiring Special Handling

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Medi-Dose, Inc./ EPS, Inc. Delivers Bar Coding, Packaging, and Labeling Pharmacy Solutions

Case Study: The Evidence is in Numbers

C ASE ST U DY

The Evidence is in Numbers

Tucson Medical Center Deters Drug Diversion with RxAuditor Investigate™.

Tucson Medical Center Deters Drug Diversion With RxAuditor Investigate™ PRIMARY INTENDED OUTCOME The mission at Tucson Medical Center (TMC) states to provide exceptional health care with compassion. In 2018, the Director of Pharmacy, Claudia Koreny, PharmD, knew the pharmacy department could do even more to uphold that pledge by creating the safest environment possible.

Claudia Koreny, PharmD Director of Pharmacy Services ~ Tucson Medical Center

Improve your Solid Oral Unit Dose needs with our comprehensive Bar Coding, Packaging, and Labeling Solutions – designed by healthcare professionals, for healthcare professionals.

TMC did not have diversion analytics tools to help Koreny achieve her goal. This case study analyzes the elements involved in advancing a drug diversion program. By automating the prevention, assessments, and detection of any drug diversion, TMC could better protect patients, safeguard TMC's stellar reputation, and reduce manual labor and costs. Tucson Medical Center is a nonprofit community hospital with more than 600 licensed beds. It has served Southern Arizona as its leading provider for medical care for 75 years. In January 2018, the leadership team took a stronger approach to drug diversion. Koreny's strategy for broader safety and prevention initiatives entailed a systems and analytics approach. The existing method of diversion discovery by time-consuming manual audits was antiquated. The intensive time and labor, especially for nurse managers, took away from being with the team and patients. Yet, purchasing a multi-tiered analytics platform had to show value by quantifiable benefits over costs.

Zachary Hodges, PharmD, BCCCP Medication Safety Officer ~ Tucson Medical Center

Value was also measured by a system that can target risk areas across TMC at any level of responsibility. Koreny worked with Medication Safety Officer, Zachary Hodges, PharmD, BCCCP, to map out the requirements for a system. For Hodges, the approach to automating diversion prevention aids TMC's zero-tolerance mentality because this act is a life-threatening offense with multiple victims – from the patient who is not administered the drug, to the employees who perform additional work, and to the hospital that could lose its reputation and community trust.

THE CHALLENGE Drug diversion is one of the major threats occurring in hospitals today. The numbers tell an alarming story about the state of drug diversion in the United States. Statistics from both the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the American Nurses Association (ANA), indicate that approximately 10 percent of health care workers are abusing drugs. Hospitals are on the frontlines of the opioid crisis in trying to solve the epidemic and addressing it in their facility. Even before COVID-19, U.S. drug overdose deaths reached a record high of 70,980 in 2019, increasing 4.6% from 2018.1 The pandemic creates new risks to Americans impacted by substance use disorder.2 These statistics are worrisome to hospital leaders who know first-hand the growing prevalence of drug diversion in healthcare facilities and diverters' savviness to prevent detection. www.medacist.com

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C AS E S T U DY IntelliVault & IntelliCab Oregon Health & Transform Prescription Science University Management at OHSU Pavilion Pharmacy RFID-based technology from GSL Solutions delivers safety, efficiency, and financial benefits at health system. Michael Deam, RPh Assistant Director, Outpatient Pharmacy Service ~ Oregon Health & Science University Pavilion Pharmacy Matthew Spinar, PharmD Supervisor, Pharmacy Services ~ Oregon Health & Science University Pavilion Pharmacy

members at “Staff the pharmacy tell

me they don’t know how they’d operate without that technology.” — Michael Deam, RPh

PRIMARY INTENDED OUTCOME Safely, accurately, and efficiently dispensing medications to patients is the primary function of pharmacies. Oregon Health & Science University (OHSU) teamed up with GSL Solutions as a beta partner, utilizing its family of RFID products to physically track medications while achieving efficiency in operations, accountability, reduction of labor hours, increased compliance, and higher user and patient satisfaction. GSL Solutions IntelliCabs for filled prescriptions (Will Call) and IntelliVault for controlled substances (C2’s) stock storage are integrated in a single software for a fool-proof system. The IntelliCab Will Call storage cabinets replaced the manual “hanging bag” system, and the IntelliVault Controlled Drug storage cabinet replaced the manual biometric “steel safe” and manual perpetual log book.

THE CHALLENGE With its manual “hanging bag” will call system, OHSU was prone to long patient wait time, lost or missing prescriptions, and labor-intensive return to stock activities. Controlled drug storage and management was heavily controlled by pharmacist time and process and procedures (P&P) to maintain inventory control and reporting requirements. OHSU pharmacy rules required pharmacy technicians to have a pharmacist be the only contact with controlled substances. “Before, the process was pharmacist driven because they were the only ones with access,” says Matthew Spinar, PharmD, pharmacy supervisor of the OHSU Physicians Pavilion Outpatient Pharmacy. If technicians saw an order for a narcotic, they put it to the side because they had to wait for an available pharmacist to actually retrieve the product from their steel safe that was enabled with fingerprint technology. This workflow process caused bottlenecks and periods of long wait times for patients. OHSU also wanted to improve its inventory management, replacing the error-prone manual perpetual log with an automated and electronic log – and also providing an electronic record of all transactions and user activities of anything that is touched, discretely and in real time.

THE DECISION

www.gslcorp.com

Due to the success of the IntelliCab Will Call cabinet program at OHSU, the decision was made to install the IntelliVault Controlled Drug storage cabinet. Similar to the IntelliCab’s RFID-based random storage and “pick

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Case Study: IntelliVault and IntelliCab Transform Prescription Management at OHSU

Trade Show & Meeting Calendar

RFID-based technology from GSL Solutions delivers safety, efficiency, and financial benefits at health system.

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Temptime Temperature Intelligence® Solutions – Monitoring Devices and Integrated Solutions for Medication Shipments, Storage, and Pharmacy Facilities

TEMPERATURE INTELLIGENCE®

Monitoring solutions for central pharmacy operations Protect the stability of your temperature sensitive medication – onsite and in transit Getting medication and vaccines to your various sites within the right temperature range is critical to quality patient care. From single-use temperature indicators to reusable wireless dataloggers to facility monitoring — Temptime offers solutions to meet the needs of every central pharmacy, no matter the size or reach. Learn more about how Temptime can help you improve efficiency and reduce costs while protecting your medication inventory from start to finish: temptimecorp.com/pharmacy

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Providing the devices and information to accurately monitor temperature sensitive medications.

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DECON-SPORE 200® Plus From Veltek Associates, Inc.

THE CLEAR CHOICE FOR A SPORICIDAL PRODUCT

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DECON-SPORE 200 Plus has been designed for the hospital and healthcare industries. This EPA registered Peracetic Acid and Hydrogen Peroxide solution kills Clostridium difficile spores in three minutes while having a reduced obnoxious odor.

DECON-SPORE 200® Plus • Effective in 3 minutes against C. diff spores • Features a "0" NFPA health rating on the RTU SDS • No respiratory device needed provided there is adequate room ventilation* • Minimized odor significantly reduces the objectionable smell • Respiratory concerns from the permissible exposure limitation are virtually non-existent due to low levels of hydrogen peroxide during application*

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Veltek Associates, Inc.

*Hydrogen peroxide at 0.64% and peroxyacetic acid at 0.14% in a 3 fl. oz/gallon solution. Site specific exposure levels must be determined to ensure adequate ventilation is achieved.

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H E A LT H S Y S T E M • I N F U S I O N 17

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Contents WAY

Connecting the Medication Supply Chain Through Integrated Transport and Pharmacy Automation Solutions We live in a connected world. But inside the walls of a hospital, connections can break down, leading to delays in care. At Swisslog Healthcare, our logistics-driven approach integrates automated transport and pharmacy solutions to connect the medication supply chain. So you can connect with the people that matter most—your patients.

Discover what’s possible when you redefine medication management. Visit swisslog-healthcare.com

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BoxPicker® Automated Pharmacy Storage System From Swisslog Healthcare Creates a More Efficient Pharmacy Workflow Optimize pharmacy workflows with the market’s proven robotic storage and retrieval system to virtually eliminate picking errors, increase efficiency, and improve medication safety.

WAY

Mobile Pharmacy Compounding Cleanrooms by Mobile Cleanrooms, LLC and Cleanroom Design LLC

MOBILE PHARMACY COMPOUNDING CLEANROOMS Discover the advantages of our Mobile Cleanroom solutions. Pre-engineered and pre-manufactured mobile cleanrooms available in a fraction of the time it takes for a typical cleanroom design/build. We offer high-quality, cost-effective cleanroom solutions which are pre-built at our production facility and delivered as turn-key mobile cleanrooms operational immediately upon delivery. Our highly engineered mobile cleanrooms can be placed indoors or outdoors, and can even be relocated to a different location at a later date – offering the ultimate in flexibility and portability.

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page 105

C AS E S T U DY Facility and Engineering Control Design Under USP <800> In light of the recently published versions of USP chapters <795>, <797>, and <800>, with the intention of creating cohesive alignment between nonsterile and sterile compounding, it is essential to consider engineering controls for HD handling with these two categories of compounding. Issues such as compounding volume, production downtime during renovations, air filtration, make up air units, and exhaust methods all factor into the design considerations for creating a compliant HD compounding operation. Bryan Prince, MBA Owner and Lead Consultant ~ Red Pharmacy Consultants

DESIGN FOR THE FUTURE BUSINESS MODEL To ensure a successful HD facility design, first consider the pharmacy’s business model, with a focus on compounding volume. This is an important precursor to beginning the design process, as every design decision should be informed by the pharmacy’s business trends. Examine the previous two years of compounding business evolution, taking into account factors such as patient demand, new providers, and the current landscape of state and federal regulations. Once you have quantified the business trends of the past few years, think ahead two to five years to consider potential growth, the competitive landscape, and projected patient trends. Given that quite a few pharmacies experience space constraints, it is understandable if future expansion seems daunting; however, the best approach is not to design your pharmacy for today’s prescription volumes, but instead design with an eye towards the future, allowing room for growth.

Shawn Valandra Owner ~ SVE Industrial Air Filtration Solutions

Case Study: Facility and Engineering Control Design Under USP <800> From Nuaire

page 113

ANALYTICAL LAB GROUP AND DPS GROUP DEMONSTRATE THE POWER OF PARTNERSHIP INTRODUCTION AND INTENDED OUTCOME

When the client is pioneering immunotherapy for people with cancer, work on their behalf takes on new meaning. This magnitude is commonplace for DPS Group (DPS), as their portfolio ranges from life-saving therapeutics to industry-changing biomedicine. The team at DPS understands the significance of successful projects and the hope it brings for patients. Caroline Carmody Vice President, Technical Services Operation ~ DPS Group

MINIMIZE DOWNTIME

Case Study: Analytical Lab Group and DPS Group Demonstrate the Power of Partnership

C ASE ST U DY

From Analytical Lab Group

The specific example involves a biotechnology company that engaged DPS for its consulting and validation engineering expertise. Known for meeting timelines and ensuring quality control, DPS draws on those abilities to complete the lifecycle facility. However, the scope also called for cleanroom qualifications.

Losing production capacity during the remodeling process is a serious concern for pharmacies, so it is crucial to strategically plan the construction steps with the goal of averting downtime wherever possible. Have a frank discussion with the general contractor and the project team at the outset to help all parties understand that downtime is to be minimized. Whenever possible, it is recommended to utilize a phased approach to construction to minimize any negative impact on compounding production.

Caroline Carmody, Vice President, Technical Services Operation, DPS Group, offers insights on the need and value of partnerships. In this case, Caroline pulled in Analytical Lab Group (ALG), now part of Element, to ensure the result is an impeccable facility that accelerates the client’s mission to eradicate tumors.

FRESH AIR VS. INDOOR CONDITIONED AIR The heating, ventilation, and air conditioning (HVAC) system typically has the biggest financial impact on efforts to achieve USP <800> compliance. The chapter specifically states that the containment secondary engineering control (C-SEC) must be externally vented, meaning that the HD compounding room must have a system in place to direct air out of the building. While the chapter does not explicitly state what percentage of air from the C-SEC should be externally vented, it can be deduced that no recirculation of air from the HD room is to be introduced back into the air handler. When air is externally vented from the building, the source of the replacement air supply – which must satisfy the minimum number of air changes per hour (ACPH) – must be determined. Currently under debate is whether fresh air or indoor conditioned air should be used as the replacement air supply to satisfy the HD room’s ACPH requirement.

THE CHALLENGE

The stakes are high with getting a vaccine or biotechnology to market. Companies in the antimicrobial, pharmaceutical, and medical device space face regulatory and technologyrelated challenges every day. Failure to keep up with the latest testing, contamination control, or cleanroom advancement could result in delays and recalls. Companies deal with complex quality standards, and missing a step within those regulations may cost time and money. Product quality control is job one. Companies cannot achieve that goal without performance indicators, risk analysis, or expertise on the latest solutions or regulations.

A standard package air handling unit is not intended to consistently replace externally exhausted air. A standard package unit works on an 85% to 100% www.analyticallabgroup.com

www.nuaire.com

page 106-109 WAY Safety, Accountability, Efficiency and Compliance See what others have already discovered WITH AUTOLOG™ B Y

G S L

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INTELLIVAULT STANDS ALONE OR INTEGRATED WITH INTELLICABS • Eliminates shrink and drug loss by replacing today’s “open face / open access” controlled drug storage cabinets • Replaces today’s error-prone and manual perpetual log book • Logs all transactions and user activities automatically • Replaces pharmacist labor with technician labor for C2 filling • Maintains complete chain of custody and pedigree from stock receiving to prescription filling and patient pick up

BEFORE

AFTER

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™

B Y

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MEDS-TO-BED

S O L U T I O N S

NEW SYSTEM TO SUPPORT STREAMLINED DISPENSING OF PRESCRIPTION MEDICATIONS AT PATIENT’S BEDSIDE • Physical chain of custody is maintained from filling of prescription through receipt by the patient • Easy integration to RN notification system and dashboard when prescription is ready • Signature Capture stores the patient’s signature confirming receipt of medications from their bedside • Real-time inventory of cabinet contents • Secure storage of patient’s home medications • Patient monographs printed on demand

INTELLICAB STANDS ALONE OR INTERGRATED WITH INTELLIVAULT

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BEFORE

AFTER

• Integrates with central fill • Maintains drug pedigree, lot, and expiration date when integrated with IntelliVault

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Pharmacy Job Opportunities

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PUBLISHER RXinsider LTD RXinsider CEO: Gregory Cianfarani RPh DESIGN AND PRODUCTION Design & Layout Multimedia Marketing and Operations

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Lora Sosa Eric Simmons Jay DiNardi Samantha Pirraglia Jillian Melly

SALES AND BUSINESS DEVELOPMENT Chris Kolkhorst, Vice President chris.kolkhorst@rxinsider.com Shaun Russell shaun.russell@rxinsider.com Mike Rahme mike.rahme@rxinsider.com Matt Payne matt.payne@rxinsider.com Email sales@rxinsider.com Phone 800.972.2083 Fax 646.329.9766 Website www.RXinsider.com

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Excelera connects manufacturers, health systems and payers through integrated programs that optimize the quality and cost of complex pharmacy patient care. We are the preferred partner who delivers seamless access to a nationwide network of accredited health systems, the industryâ&#x20AC;&#x2122;s most comprehensive complex pharmacy patient data platform, a health system-centric pharmacy benefit management solution and fully integrated pharmacy care programs. Through these intentionally connected offerings, we enable health systems and payers to improve the quality of care and patient outcomes; while empowering manufacturers to improve performance at every stage of the specialty product lifecycle.

EXCELERA NATIONWIDE NETWORK

INTEGRATED CARE PROGRAMS

IMPROVE ACCESS Seamless access to complex pharmacy patients, vital medications and a nationwide network of accredited health systems.

MANUFACTURER ACCESS & OPTIMIZATION PROGRAMS

CAPTURE INSIGHTS Integrated medical, pharmacy and patient journey data to improve patient experience and outcomes.

COMPLEX PHARMACY PATIENT DATA PLATFORM

OPTIMIZE PERFORMANCE Data-driven programs and expert guidance to manage risk and reduce the total cost of care.

At Excelera, we are passionate about transforming the way integrated care is delivered in health system settings â&#x20AC;&#x201C; and creating an environment where manufacturers, health systems, payers and patients ... all win. We invite you to join us.

Visit us at www.excelerarx.com or follow us on Linkedin.

Together…

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Macro Helix: Providing Confidence, Accuracy and Peace of Mind During an Audit Medicaid Exclusion File (MEF) listings, or inaccurate 340B OPAIS database entries and diversion. Audit readiness and preparation are key but should not be limited to just auditing your 340B dispenses. Compliance activities should also include but are not limited to:

Meeting all compliance requirements is your main goal during a HRSA audit. Preparation is key to your success and execution during the audit is paramount. Macro Helix is a proven leader in 340B program management and has helped more than 350 covered entities to navigate through 340B program audits. Q. What is a HRSA audit and how can you prepare? A. When an entity enrolls in the 340B Drug

• Verifying all aspects of your covered entity’s 340B OPAIS database listing, especially Medicaid elections. • Ensuring you have all pharmacy services agreements (PSAs) match your OPAIS listing and that they are readily available. • Regularly review and update your covered entity’s policies, procedures and 340B program scope. • Establishing controls for preventing diversion and duplicate discounts for all areas that utilize 340B. • Developing a cross-functional committee to increase oversight of your 340B program.

Q. How can your 340B program management software help with program compliance?

A. The goal of a 340B program management

software is to help simplify the complexities of the 340B program through data management, qualification customization and support to help you stay compliant and audit ready. Program management software like Macro Helix’s 340B ArchitectSM offers you the ability to configure the software to meet your definition of a patient while providing an additional layer of oversight and monitoring to your existing processes. In addition to software, ongoing support is essential. A trusted partner like Macro Helix can make all the difference in ensuring you are HRSA audit ready. Throughout the year, our team of audit specialists proactively reviews all settings and configurations. We leverage our 340B audit knowledge and experience to help covered entities during a HRSA audit. We understand audits are stressful and we provide virtual or onsite assistance during the visit. We are here to support you.

Q. What happens during a HRSA audit?

A. HRSA audits are conducted onsite at the

covered entity, except in the event of a public health emergency or any other extenuating circumstances where travel may be restricted. The duration of the onsite visit varies from 1 to 2 days. The auditor will conduct a thorough “deskaudit” of all the documentation the covered entity is required to submit before the onsite visit.

Pricing Program, they are subject to program audits by HRSA to ensure the covered entity is fulfilling all compliance requirements by maintaining accurate and auditable records. HRSA audits are not intended to be punitive; however, some audits may involve manufacturer repayment. Instead, these audits are designed to be educational and help covered entities identify potential compliance gaps in their policies or processes. Nearly 60-70% of audited covered entities have at least one finding. Some of the most common findings include Medicaid-related discrepancies, such as duplicate discounts, inaccurate

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HRSA audit will be reviewed and finalized several weeks after the onsite audit and will be provided to the authorizing official.

“Together… We got this!”

Megan Burks Director of Crosswalk & Audit Services

When the auditor is onsite, they will meet with the pertinent staff involved in the covered entity’s 340B program and may request to tour an eligible location such as a clinic or outpatient pharmacy. Also, the covered entity will be required to perform audit tracers on 340B dispenses, purchases and patient billing to Medicaid to demonstrate 340B eligibility. Results of the

888.462.4526

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info@macrohelix.com

USP <800> RESOURCES Leading Pharmacy Suppliers of USP <800> Compliant Solutions These leading pharmacy suppliers offer product and service solutions to help your pharmacy and/ or cleanroom achieve USP <800> compliance. Contact these companies directly for more details on how they can help you meet the mandate of USP <800> compliance.

www.RXinsider.com/USP800

Rees Scientific

PHARMECOLOGYÂ®

Results you can believe in. Your true partner for 340B program administration and compliance.

Verity Solutions is an innovator in 340B program optimization. We drive continually improved solutions and vigilantly address regulatory changes so that our customers can dedicate fewer resources to program administration and more resources to community wellness. Partner with us to simplify 340B program administration, confidently optimize federal pricing benefits, and benefit from the knowledge of our expert team.

1.800.581.1378 info@verity340b.com www.verity340b.com

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Verity Solutions – An Innovator in 340B Program Optimization Partner with us to simplify 340B administration, confidently optimize federal pricing benefits, and benefit from the dedication and knowledge of our expert team.

CEO:

George Puckett Founded: 2015 Employees: 87 Toll-Free Phone: (800) 581-1378 Phone: (425) 947-1922 Address: 12131 113th Avenue NE, #200 Kirkland, WA 98034 Website: www.verity340b.com

Company Background Verity Solutions is an award-winning leader in software and services developed for administration of the federal 340B drug pricing program. Our mission is to make every aspect of 340B program management clear and easy to understand. We believe in optimizing program benefits through predictable automation and support so that every customer can maximize their savings. Verity Solutions is based in Kirkland, Washington, with remote employees stationed across the nation to best serve our widespread customer base. Product Overview Hundreds of integrated healthcare systems, acute-care hospitals, community health centers, federally qualified health centers, pharmacies, and other 340B-eligible covered entities throughout the United States rely on Verity 340B® software and services to successfully manage their 340B program. Our comprehensive solutions for split billing, contract pharmacy, specialty contract pharmacy, compliance management, purchase analytics, and pharmacy network management (VHUB™) all offer: • Agile Software Platform: Built and deployed with security, performance, scalability, and agility as primary goals. HITRUST certified and HIPAA compliant. • Intuitive Application: Designed with our users in mind, we maintain ongoing feedback and collaboration with our clients. This collaboration steers our continual software and services development. • Responsive Support: Designated account managers provide focused support, training, audit readiness, and regular business reviews to maximize your 340B program success and help you maintain compliance.

What Sets Verity Solutions Apart? With increasing 340B regulatory complexity and demand for audit preparedness, it is more important than ever to have the right solution for your 340B program management – and the right partner. Verity Solutions, and its powerful V340B® cloud-based software platform, is a partner your organization can rely on to ensure 340B compliance and optimized savings. Our depth of in-house technical and software development resources and our highly-skilled account management team are closely aligned to swiftly adapt as changes arise in the 340B program. n Highlights • Industry leading core functionality of our V340B® platform with optional, patent-pending add-on modules to enhance all aspects of 340B operations in challenging and unique environments. • 60- to 90-day implementation time frame for both split billing and contract pharmacy solutions upon receipt of compliant dataset. • Access to your own unique 340B program test environment – before and after implementation. Test environment runs continually in parallel to your live system. • Easy and exportable reporting functionality including detailed data for manufacturer or HRSA audits. • Transition from one electronic medical record (EMR) to another without downtime (contingent upon receipt of dispense file from the covered entity). • Multiple vendor support with controlled substances ordering system (CSOS) – efficiently place orders with both EDI (electronic data interchange) and non-EDI vendors. • Two-week sprint release cycles ensure timely software updates driven by customer feedback, regulatory changes, and user needs. • Flexible and 'winners only' contract pharmacy pricing models. No true-ups. • Verity Care Card Program – directly pass 340B savings to uninsured and underinsured patients. • Referral capture opt-in functionality to compliantly add meaningful savings lift to your 340B program. • Responsive customer service provided by our in-house staff and the ability to submit and track issues in our online customer portal. • 79% of our customer support cases resolved within two hours. 95% resolved within 24 hours.

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intelligentAutomation

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

iA – Unleashing the Full Potential of Pharmacy With our leading-edge automation and software solutions, we partner with pharmacy providers to transform pharmacy by deepening the patient-pharmacist relationship, enhancing patient safety, and increasing operational efficiency.

CEO:

Marvin Richardson Founded: 1972 Phone: (607) 352-2146 Address: 711 Innovation Way Johnson City, NY 13790 Website: iARx.com

Company Background

At the heart of iA, we are passionate about pharmacy. Everything we do is designed to allow pharmacists to make a difference in the health and well-being of their patients. By inventing and developing leadingedge pharmacy automation solutions for every type of pharmacy – from retail to mail-order and central fill – iA works with our customers to tailor our solutions to meet their needs and scale to support the growth of their pharmacy. Together, we can empower pharmacy providers and pharmacists to unleash the full potential of pharmacy.

Product Overview

iA’s pharmacy automation and software solutions enable pharmacists to focus on patient care beginning with its leading-edge suite of intelligent software solutions, iA Symphony Software. Developed to dynamically optimize prescription fulfillment from end-to-end, iA Symphony Software will manage prescription input to delivered prescription. Supported by iA’s hardware solutions, iA Symphony Software enables pharmacies to improve efficiencies and accuracy.

iA Pharmacy Automation Solutions for Retail and Health Systems Pharmacy

n iA Symphony Software Our industry-leading suite of intelligent software solutions that are central to the entire prescription fulfillment process – from one to many. The power of iA Symphony Software is its sophisticated workflow management system with checks and balances that allow it to examine every touchpoint, changing and adjusting as necessary to ensure prescriptions are on time and accurately fulfilled. iA Symphony Software can easily connect with iA robotics, connect with other hardware suppliers, and connect with any pharmacy management system software – enabling pharmacy providers to see and control their operation.

n iA Cabinet iA’s scalable solution that allows any pharmacy to grow and build its pharmacy automation solution to align with prescription volume. iA Cabinet simultaneously counts orders, auto-calibrates, and maximizes productivity in a way that aligns with your prescription volume. n iA LightWay iA’s customizable light-to-pick solution for will-call, storage and retrieval, order collation, and inventory control processes across pharmacies. Developed specifically for pharmacy, iA LightWay increases efficiency and accuracy of fulfillment. n iA Dispenser The cornerstone of iA’s pharmacy automation dispensing solutions. Each iA Dispenser is an independent smart device, powered by iA Symphony Software, that is used in conjunction with pill counting technology and that can be configured to store, count, and dispense virtually all tablet/capsule medications simultaneously within any pharmacy environment.

iA High-Volume Pharmacy Automation Solutions for Central Fill and Mail-Order Pharmacy

iA works with pharmacy providers across the country and around the world to create central fill and mail-order pharmacy solutions, working with pharmacy providers to ensure that patients are able to get their medications and therapies when and where they want them – at the store, delivered to their home, or through the mail. iA pharmacy automation solutions can scale to meet any level of central fill or mailorder pharmacy. iA High-Volume Solutions feature a range of technologies, tools, and resources that enable pharmacy providers to realize dramatic improvements across all aspects of their operation.

Learn More

To learn how our leading-edge iA pharmacy automation and software solutions can unleash the full potential of pharmacy, call (607) 352-2146 or email sales@iARx.com.

n iA SmartCabinet The starting point for retail pharmacy automation. iA SmartCabinet features the industry’s smallest footprint and brings the benefits of pharmacy automation to the retail pharmacy environment with a two-cabinet system capable of dispensing 45% of the daily volume of top-moving countable medications. Unleashing the full potential of pharmacy begins with the iA SmartCabinet. WINTER 2020

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CAS E S TU DY

Cohen Children’s Medical Center Streamlined Pharmacy Operations with the BoxPicker® Automated Pharmacy Storage System to Drive Efficient Medication Management. Cohen Children’s Medical Center is a member of Northwell Health System. Located in Queens, NY, the 202-bed hospital specializes in serving children from prematurity to adolescence, approximately 1.8 million in the Brooklyn, Queens, Nassau and Suffolk county areas. Recognized for excellence by U.S. News & World Report for thirteen consecutive years, Cohen Children’s is on the publication’s 2018-19 Best Children’s Hospitals list where it earned top 50 placement in nine specialty areas. Cohen Children’s partnered with Swisslog Healthcare to automate medication management by deploying BoxPicker. The labor-saving solution helps skilled staff realize more time to allocate to patient-critical, clinical tasks.

www.swisslog-healthcare.com

CAS E S TU DY and returns, and mispicks. Inventory counts were done by hand each day. These handwritten counts and subjective opinions were used to place medication orders with wholesalers. This high-touch process required constant management and presented

“

The inventory management, ordering and restocking process at Cohen Children’s Hospital used to take three people a full day to complete. With BoxPicker on site, one person spends one hour a day on ordering and less than one hour a day restocking the unit.”

opportunities for miscounts, which in turn led to instances of over and underordering from wholesalers. Pharmacy leadership sought to minimize inventory shrinkage, gain visibility into medication stocking and reduce the volume of expired medications. This highly manual workflow also led to medication stockouts, increasing the risk of delayed patient care.

THE SOLUTION When reviewing their operations, hospital administrators recognized the need for a medication storage and retrieval system capable of streamlining medication administration workflow to improve efficiency and patient safety. As plans emerged for the hospital to construct a new facility, a priority was placed on consolidating pharmacy operations. The BoxPicker Automated Pharmacy Storage System from Swisslog Healthcare was chosen to be the cornerstone in Cohen Children’s new inventory workflow. Administration was highly interested in the flexible, scalable nature of the solution, the opportunity to improve patient safety through secure scan in/scan out access and overall time-saving potential. A five-module, three-operator station, 10-foot dual- temperature BoxPicker was selected to replace their previously manual process. Inventory was moved from these satellite locations to be securely located and managed for pharmacy workflows.

IMPLEMENTATION At the time of implementation, Swisslog Healthcare’s Project Management Team worked closely with the Pharmacy staff to ensure a smooth transition to using the new technology in their space. The dedicated trainers used a hands-on approach onsite to train “super-users” on the machines, followed with a trainthe-trainer model so that the whole staff felt confident in the change.

www.swisslog-healthcare.com 31

CAS E S TU DY MEASURES OF SUCCESS Pharmacy management reports previously experiencing medication picking errors and issues with manual, labor-intensive medication dispense. Following implementation of BoxPicker, they have realized a greater than 50% reduction in picking errors, a greater than 30% reduction in labor and a greater than 30% increase in time saved. BoxPicker allows Cohen Children’s Hospital to streamline medication ordering. Fewer numbers of personnel are needed to complete the process now, whereas

“

Before implementing a central pharmacy model with BoxPicker, the medication storage, inventory, and ordering processes were chaotic and inefficient. Technicians had to conduct manual checks of bins and trays and counts, all very laborintensive. The BoxPicker makes it all faster and those techs can now do more rewarding work.” Wazeem Mohammed, RPh, MHA Coordinator, Inventory Management and Finance ~ Cohen Children’s Medical Center

previously three pharmacy technicians were dedicated to inventory control and ordering. Now a single reorder list is generated by BoxPicker based on PAR levels and medication usage, enabling pharmacy staff to quickly, accurately place orders before moving on to more rewarding duties. The first inventory review following implementation of the BoxPicker identified a 30% decrease in total value of inventory on hand.

ONGOING SUPPORT Swisslog Healthcare provides ongoing support for Cohen Children’s through the Field Service Technician, who spends time onsite. They are a local resource that act as an extension of the pharmacy team, learning the workflows and keeping the machine running optimally. The Customer Success Manager serves as an internal advocate, helping Cohen Children’s to navigate the Swisslog Healthcare organization as well as ensure ongoing system optimization.

CONCLUSION With the goal to minimize manual labor processes to improve efficiency and patient safety, Cohen Children’s Medical Center has found success through optimizing their pharmacy operations using the BoxPicker.

www.swisslog-healthcare.com

CAS E S TU DY MEDICATION PICKING WITH THE BOXPICKER AUTOMATED PHARMACY STORAGE SYSTEM BoxPicker is a robotic, goods-to-person picking system that supports safe, accurate medication dispensing.

A user logs into the operator station and selects an order to dispense. The option for multiple workstations enables one user to be picking while another is loading.

The user picks the correct medication from the box and scans the product barcode for verification. BoxPicker supports 100% scan-in/scan-out of medications.

BoxPicker picks only the correct medication box and places it in an access drawer at the operator station.

Once the medication has been scanned and confirmed, a label is produced and the inventory quantity is updated in the system.

Once the box arrives, a green light indicates the drawer is unlocked and can be opened. Only one drawer can be accessed at a time.

While the technician scans one product out, BoxPicker is already retrieving the next medication box to be dispensed, picking up to three orders ahead of the user.

www.swisslog-healthcare.com 33

You provide the care. Weâ&#x20AC;&#x2122;ll provide the protection. We have what it takes to keep hospitals safe.

Get what you need to give the best care. Order now:

iso-med.com

Call for fast reordering:

800-797-1405

1220 Graphite Drive, Corona, CA 92881 USA | 800-797-1405 | sales@iso-med.com | www.iso-med.com

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ISO-MED Gives Hospitals the Benefit of Their Cleanroom Expertise With the Medical Supplies Critical for Protection As one of the leading suppliers for pharmacy cleanroom supplies, we provide an unparalleled selection of specialized medical products, globally trusted quality and service, and delivery convenience for meeting USP <797> and USP <800> standards.

President:

David Lowrie Founded: 2010 Toll-Free Phone: (800) 797-1405 Fax: (951) 547-1681 Address: 1220 Graphite Drive Corona, CA 92881 Website: www.iso-med.com

Company Background Since 2011, ISO-MED, Inc., a medical supply distributor, has been supplying quality products for pharmacy cleanrooms and other medical industries in the United States. Providing highgrade supplies for cleanrooms, hospitals, laboratories, homecare, and more, we are dedicated to achieving and maintaining compliant sterile compounding environments. Product Overview ISO-MED maintains the largest and broadest portfolio on-theshelf warehouse of supplies. We offer customized supply plans, a seamless e-commerce customer experience, easy ordering with matching manufacturer, and dependable purchasing/supplier aggregation services. With one-on-one scheduled training services, we increase the efficiency of your purchasing processes, consolidate your portfolio, and link your on-site supply demand to your inventory management processes.

• Variety of Manufactures or Suppliers • Variety of Cleanliness and Sterility • All ASTM and IEST Tested Cleanroom consultation from design to build to commissioning.

Additional Product Modules n Premier Product Offerings • PPE Product Selection • HD Spill Kit • Chemotherapy Gowns and Supplies • Cleaning and Disinfection Solutions For every cleanroom or critical environment cleaning and disinfection program, several brands and ISO-MED, Inc. in formularies are offered.

Markets Served • Hospital • Compounding • Infusion • Retail Ordering Information

Contact us by phone at (800) 797-1405 or email sales@iso-med.com to gain access to our exclusive online ordering platform.

Offering value-added services, we provide consistent customer service and on-time delivery with a streamlined transaction process. We are driven to help healthcare-oriented organizations save money.

Features & Options n Personal Protection Equipment (PPE) We offer the highest cleanroom compatible materials that are tested to meet the most rigorous environments. • Sterilization: ETO, GAMMA (10-6) • Variety of Materials: SMS, SPP, MP, POLYOLF (aka. Tyvek), PE, Vinyl • Variety of Sizes: XS-7XL • Variety of Styles and Configurations

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T H O U G H T L E A D E R Video Series

THOUGHT LEADER VIDEO SERIES

SPARx

Micro Merchant Systems Join Brian J. Courtney, Pharm.D., Chief Revenue Officer, Ketan Mehta, CEO, Samir Haleem, Director of IT, Sheila Dawalt, National Sales Manager, Heba Macksoud, Pharmacy Owner, and Boris Niyazov, Pharmacist, as they discuss Micro Merchant Systems, PrimeRx™ Pharmacy Management System in a 12-part video series.

www.micromerchantsystems.com

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Join Michael Heinrichs, Senior Vice President of Business Development, Keith Cook, President, Doug Massey, Senior Vice President of Operations, and Eugene Queener, Vice President of Ambulatory & Infusion, as they discuss a specialty and ambulatory pharmacy solution designed to unleash the powerful potential inside hospitals and health systems.

www.cpspharm.com/sparx

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THOUGHT LEADER VIDEO SERIES

Verity Solutions: Your Comprehensive 340B Partner

Accreditation Commission for Health Care (ACHC)

Join George Puckett, CEO, Scott LaChute, VP, Operations, Mark Cassidy, CTO, and Todd Behrman, VP, Product Management Marketing, as they discuss Verity Solutions: Your Comprehensive 340B Partner in a 12-part video series.

www.Verity340B.com

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THOUGHT LEADER VIDEO SERIES

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H E A LT H S Y S T E M • I N F U S I O N

Join Josè Domingos, Matt Hughes, Renee White, Ralph McBride, Jon Pritchett, Megan Reed, and Greg Stowell as they discuss Accreditation Commission for Health Care (ACHC), for providers, by providers.

www.achc.org

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THOUGHT LEADER VIDEO SERIES

Advancing the Business of Pharmacy

Mission Critical Delivery Solutions: When Failure is Not an Option

Join Kristin Fox-Smith, MPA, Tammy Zukowski, MBA, and Jim Jorgenson, MS, RPh, FASHP, CEO, as they discuss Advancing the Business of Pharmacy in a 12-part video series.

Join Kyle Janssen, President & Owner of Community Pharmacy, Mackenzie Farr, Chief Operating Officer & Pharmacist at Community Pharmacy, Ted Johanson, President & CEO, Mission Critical Delivery Solutions, Inc., and John Fiene, Medical Courier, Mission Critical Delivery Solutions, Inc., as they discuss Mission Critical Delivery Solutions: “When failure is not an option.”

www.visanteinc.com

www.MissionCriticalDelivery.com

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THOUGHT LEADER VIDEO SERIES

T H O U G H T L E A D E R Video Series

THOUGHT LEADER VIDEO SERIES

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THOUGHT LEADER VIDEO SERIES

Innovative Pharmacy Solutions

Sentry Data Systems | Expect More

Join George Smith, Pharm.D., BCPS, BCSCP, Pharmacist Consultant of Sterile Compounding Automation and Craig Boyce, Director of Professional Services, as they discuss Innovative Pharmacy Solutions in a 12-part video series.

Join Lidia Rodriguez-Hupp, Joel Hennenfent, PharmD, MBA, BCPS, FASHP, Lisa Scholz, PharmD, MBA, Kenosha Chastang, JD, PRS, MBA, Lateef Durosinmi, and Bill Sander, PharmD, as they discuss Sentry Data Systems.

www.sentryds.com

www.arxium.com

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The First Professional Medical-grade Refrigerators

Thereâ&#x20AC;&#x2122;s never been a more critical time to safeguard your vaccine inventory.

Meet existing CDC standards for safe vaccine storage

GX Solutions help you rise to the challenge.

Eliminate costly temperature excursions

Prepare for new NSF standards

Energy savings Quiet operation Supports sustainability initiatives

Learn more: helmerinc.com/vaccine-refrigerators

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Rising to the Challenge of Safe and Effective Vaccine Storage With Helmer Scientific Three ways GX Solutions help you safeguard your vaccine inventory. CEO:

Bruce King

Vice President of Sales & Marketing: Lori Gabrek Founded: 1977 Employees: 300 Toll-Free Phone:

(800) 743-5637 (317) 773-9073 Address: 14400 Bergen Boulevard, Noblesville, IN 46060 Website: www.helmerinc.com Phone:

Company Background

Helmer Scientific is a manufacturer and worldwide distributor of medical-grade cold storage and laboratory processing equipment. We have over 40 years of experience in providing high-quality temperature-controlled environments, with our products used in over 130 countries throughout the world. We serve customers from our U.S.based headquarters, which also houses our R&D center and advanced FDA GMP manufacturing operation. Helmer is an industry leader for pharmacy and vaccine cold storage solutions.

Product Overview

Vaccine demand is increasing. The expected rise in influenza vaccinations along with the anticipated release of new COVID-19 vaccines are creating unprecedented demands for vaccine storage. Ensuring appropriate capacity and quality of vaccine storage is more important than ever. Failure to maintain the cold chain can result in the loss of potency of vaccines. That is why it is critical to use effective cold storage units to help ensure every vaccine dose counts. When choosing the equipment that will safeguard your vaccine inventory providers need to consider existing CDC recommendations for safe vaccine storage, which includes using purpose-built or pharmacy-grade units with forced-air circulation, microprocessor-based controls, and alarms. Additional industry standards are also emerging to further ensure appropriate temperature performance of vaccine storage units. This emerging standard, being developed by the NSF Joint Committee on Vaccine Storage, is designed to confirm temperature performance under various door open and vaccine load scenarios anticipated in provider environments. Helmer Scientific vaccine storage solutions are designed to meet current CDC guidelines as well as emerging standards to help reduce the risk of damaging vaccines due to temperature excursions. The Helmer Scientific portfolio includes a full range of cold storage products including vaccine refrigerators and freezers. GX Solutions pharmacy refrigerators are specifically designed to provide safe and effective storage in three ways:

1. GX Solutions eliminate costly temperature excursions with superior temperature uniformity, recovery, and stability. Temperature is maintained within +/-1°C throughout the unit. Offer faster recovery after prolonged door openings and create fewer deviations from the set point avoiding rapid, significant changes in temperature which could put vaccines at risk for temperature excursions. 2. GX Solutions are powered by OptiCool™ technology. The OptiCool™ cooling system pairs a variable capacity compressor (VCC) and natural refrigerants to: • Ensure optimal temperature uniformity, recovery, and stability. • Efficiently manage energy consumption (50-65% reduction over traditional medical-grade units). • Reduce noise output from the system (three times quieter than traditional medical-grade units). 3. Finally, GX Solutions supports CDC guidelines for vaccine storage and handling and new emerging standards that further define temperature performance.

Features & Options

n Professional, Medical-Grade Performance • Best-in-class temperature management, including uniformity, recovery, and stability, to safeguard medications and vaccines, regardless of where they are placed within the unit. • Avoiding rapid, significant changes in temperature to ensure that medications and vaccines are always in an optimal storage environment. • Energy management reduces operating costs and supports sustainability initiatives through a highly-efficient cooling system. n Continuous Monitoring Offers Safety and Security of Stored Product The i.C3® Information Center provides constant temperature monitoring and multiple information logs, plus security features to keep crucial refrigerator settings protected. • Information and event center records performance history of the unit as well as event. • Offers protected settings and limits refrigerator access with a key lock or optional integrated electromagnetic access control. • Offers data export of temperature, event, and access data via USB port as PDF reports or CSV files. n Medication and Vaccine Storage • Factory pre-set to 5°C for pharmacy applications. • Supports CDC guidelines for vaccine storage. • Remote lock adapter kits available for integration with automated dispensing cabinets. • Quiet operation for improved work environment (UC 42dB, Upright 47-50dB). • Standard configuration includes, ventilated pull-out pharmacy drawers and ventilated shelf. WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 39

Software

Additionally, bedside transactions capabilities must not come at the expense of patient experience and satisfaction.

Meds-to-beds programs create opportunities to meet these goals.

Ease of use & continuity of care –- Using the same Pharmacy POS software application for both meds-to-beds and the main outpatient pharmacy counters provides many benefits. Pharmacy team members use a single application for every transaction, no matter where they process it. Reducing the potential for errors or confusion that impact the patient experience. This also means that all transaction data for the pharmacy, whether meds-to-beds or pharmacy counter, is recorded and accessible from the same place.

In this article we’ll draw on years of meds-to-beds program experience. Providing not just a single use case, but a framework for successful implementation of meds-to-beds programs through 4 key areas. Software, hardware, training and long-term support.

Software Integrations – Pharmacy POS software is a specialized offering. Meds-to-beds programs add another layer of complexity and necessary vendor expertise. Organizational requirements for specific system integrations, such as pharmacy system or credit card vendor should be taken into account. Also keep in mind future compatibility should one of those systems change. For example, if the organization changes pharmacy system providers, does the meds-to-beds program then have to be entirely re-worked to accommodate this change? Or can a software adapt to potential future changes? Compliance – Organizations should understand how pertinent data (like PII, PHI and PCI) is kept safe and secure with any software. And whether any special organizational requirements can be easily met.

Toll free: 1.877.767.1060 Email: sales@rm-solutions.com Web: www.rm-solutions.com 40

Case Study Functionality â&#x20AC;&#x201C; Many meds-to-beds programs have grown beyond a basic bedside transaction. Counselling is an important part of any meds to beds initiative. Pharmacies should consider how they will complete this important step and evaluate software compatibility with that plan. Sales of often purchased OTC products, or supplement recommendations based on prescription induced nutrient depletion can also be completed in tandem with the prescription sale. Organizations may also consider functionality such as emailed receipts for improved convenience.

Hardware Meds-to-beds programs must include a hardware & technology scheme that both supports program goals and meets organizational requirements. This can be challenging so early attention to this detail will help streamline program implementation. The first determination is whether there are any organizational requirements or restrictions that will reduce options for acquiring hardware. These often range from wireless access requirements, to minimum hardware specifications, or sourcing stipulations. Hardware should also be chosen in partnership with the software provider. While it is a separate component of the program, solutions providers may have a preferred option or range of options that fit with the functionality offered while accounting for organizational requirements and program goals. Traditionally, hardware for meds-to-beds should include a method for electronic signature capture, physical receipt printing, barcode scanning, and payment acceptance. Credit card processing options will often need to allow for implementation of a validated point-to-point encryption (P2PE) solution to reduce payment card industry (PCI) compliance scope. Although payment acceptance is a function of the software, hardware components are inextricably linked to credit card processing.

Training Implementation and training are core components for long term meds-to-beds program success. For any meds-to-beds program, the desired outcome and experience should be fully considered prior to implementation. Outlining goals enables a program launch built with those goals in mind. Pharmacy and meds-to-beds teams should be prepared to train in the following areas: Program workflow and goals â&#x20AC;&#x201C; A comprehensive meds-to-beds program workflow should cover touchpoints from the time a patient is admitted, until the moment they receive their prescriptions at discharge. Each member of the patient care team should know and understand their role in the meds-to-beds initiative as well as the benefits to patients. This A to Z approach contributes to better program participation across the board. One RMS customer notes that that patients are asked during admission if they would like to use outpatient prescription dispens41

Case Study ing. Others identify participants while preparing for discharge. Yet another option takes this a step further and bills meds-to-beds as an “opt out” instead of an “opt in”. Hardware & Software – Meds-to-beds staff should be well-versed in the technology and tools they’ll be using as they deliver discharge prescriptions. Hardware and software vendors should be relied on to provide training plans and documentation.

Meds-to-Beds In 2012, RMS launched the very first pharmacy meds-to-beds products. Today, Meds-to-beds by RMS leads the way as a patient centric and innovative solution.

Contingency planning – Organizations should outline and provide training on how meds-to-beds operates in events such as a network outage, hardware issue, or other program infrastructure failure. One real world example might be that wireless communication temporarily fails, prohibiting live bedside transaction processing. In this instance, discharge prescriptions can be processed in the pharmacy, taking payment over the phone and capturing signatures with an alternate application or via hard copy. While not ideal, contingency plans keep the program running with limited patient impact.

Long Term Support Organizations should consider the support offered by their software and hardware vendors. Program operations will at some point rely on the availability and responsiveness of these partners. Prior to implementing a meds-to-beds solution, teams should review support policies and procedures, understand update processes, enhancement request management and overall service availability. Communication is key for any questions or concerns that may arise. Teams should know who to call, when they are available, and what service level expectations are in place.

About RMS In 2012, RMS launched the very first pharmacy meds-to-beds product. Today, Meds-to-beds by RMS leads the way as a patient-centric and innovative solution for hospital pharmacies looking to improve patient outcomes and reduce readmittance rates. Our software and hardware solutions are cornerstones of meds-to-beds programs across the country. Each program, like each organization, is unique so we work with our clients to meet those unique needs. Every meds-to-beds implementation is carefully managed by our team of Customer Success Managers Implementation Specialists, and Technical Support Specialists. Additionally, The RMSCare training program is focused on improving customer-centricity. A key characteristic for meds-to-beds initiatives. Last but not least, all RMS customers are supported by a team of US based 24 x7 Support Specialists. Toll free: 1.877.767.1060 Email: sales@rm-solutions.com Web: www.rm-solutions.com 42

Start building (or refreshing) your meds-to-beds program – plan your program, identify key features, and compare available solutions. Download our free meds-to-beds checklist at www.rm-solutions.com/ mtbchecklist or contact our team for more information today at 877-767-1060.

www.rm-solutions.com

Looking for ways to boost profitability and improve patient outcomes? Discover why the top pharmacies in America trust RMS as their â&#x20AC;&#x153;point-of-serviceâ&#x20AC;? solution.

Call us today at 1-877-RMS-1060 with code RMSRX to schedule your RMS CLIMB Checkup and learn how we can improve your bottom line and help you create a customer experience everyone will be talking about.

Powering hospital pharmacies to help people lead healthier lives.

An established pharmacy automation leader, Parataâ&#x20AC;&#x2122;s adherence packaging, vial-filling, and workflow solutions reduce costs and medication errors and improve medication adherence. Explore our full portfolio of pharmacy workflow solutions designed with your business, pharmacy teams, and patients in mind at parata.com.

Adherence Packaging & Inspection

Workflow & Inventory Management

Vial-Filling Robots

866.251.6171 parata.com

Secure Pick-Up Kiosks

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Parata’s Solutions Improve Operational Efficiencies to Reduce Medication Errors and Operating Costs Explore the technology, expertise, and people you can count on.

CEO:

Rob Kill Founded: 2001 Employees: 400+ Toll-Free Phone: (888) 727-2821 Address: 106 Roche Drive, Durham, NC 27703 Website: www.Parata.com

employees are no exception. Expand your reach beyond the pharmacy counter and hours of operation without the traditional overhead costs with WellSpot, our remote prescription pickup locker. Provide 24/7 prescription access for late discharge patients and all shifts of employees. Improve transition of care and help increase script capture – all without increasing your physical pharmacy store hours. Convenient Solutions: WellSpot™

Parata provides pharmacy technology solutions to reduce costs, improve health outcomes, and enhance the patient experience by offering the most comprehensive pharmacy automation portfolio with medication adherence packaging, high-speed robotic dispensing technologies, and pharmacy workflow solutions. Discover how pharmacies across all practice settings use our solutions to stay out in front at parata.com.

n Ensure Safety, Accuracy, and Efficiency You get the fastest counting technology in the market automating 5060% of oral solids and helping your team delight customers with timely service and a personal touch. We’re proud to offer the premier line of high-speed automation solutions to ensure safety, accuracy, and efficiency in every pharmacy setting. We make it – and make it better – because we’re driven to free your time so you can do what you do best – support your patients and lead your team.

Product Overview

Leading Solutions: Parata Max®, Parata Mini®, AccuCount® 2 Scale

Company Background

n Improve Medication Adherence Simplify adherence for your patients and take the guess work out of when they need to take their medications. With a medication adherence program, synchronize daily medications into med pass times improving compliance, outcomes, and readmission rates. Once patients experience the ease and efficiency of adherence packaging, vials and scattered refills are replaced with patient loyalty and long-term revenue. We’re proud to offer the most extensive adherence packaging solutions – for both pouch and blister – with inspection and workflow additions to support your growth. Stand-Out Solutions: ATP® 2, ATP® Mini, ATP® 2 Duo, InspectRx®, Parata Perl® Pouch Inspector n Drive Efficiencies to Impact Bottom Line We’re serious about pharmacy efficiency. That’s why we’ve taken best practices and real-world research – with more than a little feedback from pharmacists – to craft cost and space-saving strategies to drive efficiency and impact the bottom line. Your pharmacy’s inventory is its largest investment. Why not gain visibility and control of inventory to manage costs and offset increasing expenses of higher drug prices and specialty pharmaceuticals? Our solutions can reduce inventory carrying costs by more than 30% and expired medications by 80% – all while increasing inventory turns. The addition of our inventory management, enterprise software, light-guided high-density storage, and will call solutions allow for greater visibility and can help consolidate your pharmacy’s footprint by more than 50%. Smooth Solutions: Beacon® Inventory Management System, HD Stock™ Workstations and Shelving n Enhance Patient Experience and Access Everybody loves it when you can make things easier for them; patients and

n Optimize Your Operations Whether big or small, we’ve got ideas to help you optimize your pharmacy operations. Our experts and industrial engineers can work with you to analyze your pharmacy's specific needs and help you design a workflow using solutions and technology able to scale and grow with your business. Top-Notch Solution: Parata Centralized Filling Solutions n Count On Support Our customers love our technology, but that’s not the only reason they choose us as a partner. Our in-house experts offer a wealth of experience – and we’re with you every step of the way. When you choose Parata automation, you have our support from signing the contract through maximizing your technology to grow your business. We have more than 25 years of experience with the best industrial engineers in pharmacy, and we‘re ready to put that expertise to work by offering pharmacy design services whether it’s a new build, remodel, or optimization project. Helpful Solutions: Parata Performance Services, Parata Consulting

Testimonial

“ Beacon has allowed us, both on the quality side and on the financial side, to have a process of continual improvement. We’ve seen a reduction in dispensing errors. We have confidence in the accuracy of the products we dispense. In addition, we’ve been able to reduce our formulary size and reduce the inventory we have on hand.”

— Jeff Brinkley, Maury Regional Medical Center

Markets Served

Central Fill; Hospital – Inpatient; Hospital – Outpatient; Independent Retail; Long-Term Care; Mail Order; Nutraceuticals; Retail Chain; and Specialty. WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 45

Pharmaceutical Inventory Experts:

Cover (Vert).indd 1

Precise, Efficient, and Confident

Why Outsource Your Inventory Needs? • • • • • • • •

Teams of experts conduct the inventory within a few hours. Teams conduct inventories daily-not annually. Minimal interruption to the pharmacy staff and operation. Teams work seamlessly around the pharmacy staff ensuring that the “snapshot” is a true representation of the inventory on-hand. Eliminate the need for overtime or coordination of staffing to accommodate inventory. Expert valuation and pricing of the inventory by an independent party. Competent inventory specialist that can work with finance and/or external audit firm to validate the inventory. Collaboration with the pharmacy to provide an accurate report in a timely manner. To learn more about Capital Inventory and how we can help you with our inventory services please contact 1-800-345-0849 or Info@capitalinventory.com.

9/27/06 3:00:09 PM

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Pharmaceutical Inventory Management Services by Capital Inventory

The nation’s leader in pharmaceutical inventory service providing inventory data that is accurate and dependable. Founder:

William Straub Sr. President: Duran Dunn Founded: 1979 Employees: 80 Toll-Free Phone: (800) 345-0849 Phone: (770) 928-7202 Fax: (770) 928-2287 Address: 9725 Main Street Woodstock, GA 30188 Website: www.capitalinventory.com

Company Background

Capital Inventory, Inc. was founded by William Straub Sr. during the late 1970s in Alexandria, VA. The company relocated to Georgia in the early 1980s and serves the entire nation, including Alaska, Hawaii, Puerto Rico, Guam, and the U.S. Virgin Islands from our office in the Atlanta, GA area. Capital Inventory, Inc. has been in business for over 40 years, providing service to thousands of hospitals, university medical centers, regional medical centers, and health systems. Capital Inventory exclusively services hospital, outpatient, and infusion pharmacies. Our inventory experts are in pharmacies daily and year-round. Employees of Capital Inventory are employed full-time and receive complete benefit packages. Employees undergo extensive continuing education including pharmacy practices, drug information, HIPAA regulations, and blood borne pathogen. Feel confident and secure as all of Capital Inventory’s employees undergo an extensive background check including felony, misdemeanor, and sex offender. Employees are 12 panel drug tested regularly and at a minimum of twice a year. All testing is conducted by third party specialty companies. Additionally, employees are required to be current with all vaccinations including yearly Influenza and TB testing.

Product Overview

Our people are the difference. Our teams speak “NDC fluently”, are CPhT’s, and understand the dynamics of pharmacy operations. The physical inventory process is seamless and unobtrusive as team leaders strategically place the team in locations throughout the pharmacy to ensure accuracy and efficiency. Before completion of an inventory service, our teams actively work with finance and/or independent auditors while on-site to validate the accuracy of the inventory data collected. Beyond the physical inventory, the data is then received, analyzed, and formatted into a report that includes all pertinent information to allow for accurate and precise analysis of the inventory data. Let our team of experts provide your next inventory valuation with precision, accuracy, and confidence.

Now is the time to get to know Capital Inventory, Inc. The following will briefly explain our procedures and service capabilities. n What to Expect On Inventory Day Upon arrival, the Capital Inventory team will be introduced to the pharmacy and staff. Our team leader and a pharmacy representative will map the pharmacy and its respective areas. Team members are then assigned to the designated areas and proceed entering each NDC number and QTY into a hand-held data gathering computer. Once all areas are completed, the raw inventory data is then transmitted to an independent team for review and analysis. n What to Expect Post Inventory Day Items will be priced according to GPO/ Wholesaler Cost Data and Direct Purchase/ Secondary Wholesaler Cost Data. Upon review the data will be adjusted, compiled, and valuated. Finally, the inventory data will be delivered electronically as an Excel file. n What to Expect After Receipt of Inventory Data If it is identified that adjustments are needed, we have an easy step-by-step way to apply the indicated changes. When submitted, the adjustments can be made and returned within 24-48 hours. Unlike other companies that do not allow adjustment to the inventory data, we will make adjustments to the data as requested to ensure the final value is a true representation of the on-hand inventory.

GPO Affiliations • Premier • Vizient

• Amerinet • The Resource Group

• Health Trust

Ordering Information

To learn more about Capital Inventory and how we can help you with our inventory services, please contact us by phone at (800) 345-0849 or email us at customerservice@capitalinventory.com.

WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 47

CAS E S TU DY Pharmacists Will be Replaced by Robots: An Updated Time Study on IntelliVault™ From GSL Solutions Inc. BACKGROUND

Michael Kiso, Pharm D. RPh MBA Candidate 2020

www.gslcorp.com

CAS E S TU DY BEFORE

QUANTIFYING THE OPERATIONAL VALUE OF INTELLIVAULT™ An integrated-delivery network (IDN) hospital system in the United States conducted a time study in one of their several outpatient pharmacies to calculate the direct cost-savings and indirect benefits of utilizing IntelliVault™ for controlled substance inventory tracking. The data collectors followed the lifecycle of a prescription from start to finish and recorded the time to complete each workflow step. Time data was collected pre- and post- institution of IntelliVault™ in the pharmacy workflow. The preand post- IntelliVault™ data was then compared to determine if a time savings existed per prescription filled. Total labor cost per prescription was calculated by multiplying the time to complete a workflow step by the wage rate of each respective pharmacy employee type: “pharmacist” or “pharmacy technician.” These labor costs were then summed to calculate the total cost to dispense a single controlled substance prescription in the IntelliVault™ model.

THE RESULTS Table 1. Pharmacy Volume Data IDN Rx Volume Average Total Rx (Per week)

1,320

Control Rx volume (per week)

307

Table 2. Total Labor Savings with use of IntelliVault™ for Rx Filling and Ancillary Activities Total Labor Savings

Labor Savings Per Year ($)

Direct Rx Filling Activities

$ 38,929.14

Ancillary Activities Inventory Check-in $ 5,590.62 Discrepancy Investigation $ 4,020.00 Total $ 48,539.76

Figure 1. Pre- vs. Post- IntelliVault™: Comparison of Total Time-to-Complete Rx Filling Workflow Steps

www.gslcorp.com

CAS E S TU DY AFTER

Figure 2. Pre- vs. Post- IntelliVault™: Comparison of Total Time-to-Complete Ancillary Task Activities

DATA ANALYSIS From the above data, we can see that IntelliVault™ was found to markedly reduce the total time to fill a controlled prescription. The total time to fill a single controlled substance was reduced by 1.81 minutes. This IDN filled approximately 307 controlled substances per week, so this cost savings could be significantly larger in many retail or hospital pharmacies with larger outputs. Outside of prescription fulfillment, reductions in time to complete inventory receiving and controlled inventory reconciliations were also observed. Inventory receiving was reduced by 4.08 hours per week and inventory discrepancies were eliminated altogether. Labor savings produced by IntelliVault™ for inventory receiving and discrepancy investigations were calculated to be $5,590.62 and $4,020.00, respectively (based on this IDN’s Pharmacist and Technician hourly rates). In total, combined labor savings were calculated as $48,539.76 per year. These calculations do not take into account the value of improved customer satisfaction with reduced wait times, nor do they quantify employee satisfaction by allowing technicians and pharmacists to practice at the top of their licenses.1

CONCLUSIONS & OTHER CONSIDERATIONS

1. It should be noted that this IDN pharmacy also has the GSL IntelliCabs for will call. Adding IntelliVault to the efficiency and labor savings is not herein quantified. In broad strokes, retrieval of prescriptions from the antiquated “hanging bag” system of old to one using real-time RFID IntelliCabs saved over 55% in prescription retrieval time and a total of 34% reduction in the time a patient spends at the register. This savings is in addition to the hours gained for automating the return to stock process IntelliCabs now provides.

www.gslcorp.com

From the data collected, we can see that this pharmacy has produced significant labor savings by instituting the IntelliVault™ into their workflow. This savings is largely due to the elimination of pharmacist documentation in the manual perpetual inventory and shifting controlled drug receiving, stock bottle retrieval, prescription filling, and return-to-stock away from pharmacists to pharmacy technicians. For any pharmacist who has spent significant time reviewing a manual perpetual inventory (while questioning why they went to pharmacy school to “manage a log-book”), this is a paradigm shift. IntelliVault™ automatically monitors user access and tracks changes in the controlled substance inventory in real-time, eliminating the potential for human-driven accounting errors and diversion. The most striking finding of this study was the complete elimination of discrepancies in controlled substance inventory since the adoption of IntelliVault™. While other automated controlled drug inventory products exist, they do not share the same unique characteristic of discrete storage as used by IntelliVault™. The use of discrete storage ensures that the individual filling a controlled prescription only has access to the stock bottle that it deems appropriate, based on the scanned Rx label. Should other SmartBaskets™ with other drug product be tampered with, this is documented in the IntelliVault™ user-activity logging feature for future review. A metaphor that can be used to describe this is: if you were going to commit burglary, you would not do so in your own house. That is to say, diversion of drug is less likely to occur if a user’s activities are tracked and all drug storage containers are “hermetically sealed” until deemed appropriate by the IntelliVault™ software. This allows for true automated controlled inventory accountability and inventory management, unlike any other product that is currently available.

Safety, Accountability, Efficiency and Compliance See what others have already discovered WITH AUTOLOG™ B Y

G S L

S O L U T I O N S

BEFORE

AFTER

• Payback from labor savings in as little as 1 year

™

B Y

G S L

MEDS-TO-BED

S O L U T I O N S

INTELLICAB STANDS ALONE OR INTERGRATED WITH INTELLIVAULT

THE LEADER IN WILL-CALL STORAGE

BEFORE

AFTER

• Integrates with central fill • Maintains drug pedigree, lot, and expiration date when integrated with IntelliVault

See our full suite of products online Contact us: www.gslcorp.com |360.896.5354

THE MOST INNOVATIVE TAMPER-EVIDENT SEALS IN HOSPITAL PHARMACY TODAY NEW ISMP & USP 800 IV Bag Seals

IV Bag Port Seals

• Sterile & Paper Free (USP 797 Compliant). • Maintains a 100% sterile barrier* with 3X greater adhesion. • Helps prevent contamination of drugs and provides added protection to pharmacists. • Will not fall off, even in cold storage conditions (down to -20 degrees centigrade).

Vial Seals

• Patented dual-layer indicates true tamperevidence, with “OPENED” marking. • Cost-effective, allows pharmacy to recycle medication and protects patients from dosing errors.

Tamper-Clear Syringe Seal®

Red Syringe Seal

• Dispensing and application training videos available on our website to help with JCAHO training. • Available in major wholesalers and distributors. *Tested in Nelson Labs, Salt Lake City, UT

Visit our website to learn more: www.steri-tamp.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Steri-Tamp® Tamper-Evident Sterile Seals by Allied Pharmacy Products, Inc. The only single-use, tamper-evident seal that both provides and maintains a 100% sterile barrier. National Sales Manager: Alex Meadow Founded: 2010 Phone:

(516) 374-8862

Address: 100 Tec Street, Unit F

Hicksville, NY 11801

Website: www.steri-tamp.com Email: info@steri-tamp.com

Company Background

Allied Pharmacy Products, Inc. was founded in 2010 with the focus on improving the preparation and dispensing of intravenous medication in the hospital pharmacy and compounding settings. Steri-Tamp® was developed by a pharmacist who understood the need for better tamperevidence and sterility in IV preparation. Allied Pharmacy Products, Inc. has always been responsive to pharmacists’ requests, which continues to contribute to expanding our product line.

Product Overview

The Steri-Tamp® sterile product line is comprised of seven innovative tamper-evident seals. Steri-Tamp IV Bag Port Seals are available in blue, red, and CHEMO (yellow). The vial seals are available in 13 mm (red), 20 mm (silver), and 28 mm (blue). Steri-Tamp Belly Button Bag Seals (green) are the only seals that will adhere to the port of a Hospira/ICU Medical “belly button” bag, as well as the top of a 13 mm vial. Steri-Tamp's recently released USP 800 and ISMP specific IV Bag Port Seals help address labeling recommendations for paralytic agents or hazardous drugs in a single workflow. Unlike other seals on the market, Steri-Tamp seals provide true tamperevidence. Using dual-layer technology, the seals help to alert hospital staff if a bag or vial has been used or modified. If the top foil layer is removed, the "opened" layer is revealed and the top layer cannot be reapplied. Due to the 3X stronger adhesive, Steri-Tamp is able to provide a 100% sterile barrier.

• Protects the point of entry of IV admixture bags from contamination and accidental double dosing. • Using a simple “twist” method, the seal adheres to itself and the port ensuring no air channels. • The green Belly Button Bag Seal is the only seal specifically designed to cover the “belly button” port, which is located in the middle of the Hospira bag. The seal can also be used on a 13 mm vial top. n Steri-Tamp® Vial Seals • Designed to lay flat on the vial top preventing bacteria from entering the vial. The seal should not overlap the edges. • Helps to maintain the integrity of the medication. • Sized specifically to fit 28 mm, 20 mm, and 13 mm vial tops. A seal should only be applied to its corresponding vial size. n Steri-Tamp® Syringe Seals • Non-sterile solutions to provide tamper-evidence for syringes and other medical containers. • The new Tamper-Clear Syringe Seal® provides clear visibility to the barrel of the syringe and allows barcodes to be scanned. Perfect for sealing small oral, pediatric, and NICU syringes. n Available in 1,000 Seals Per Roll n All Seals Help to Reduce Waste, Improve Workflow, and Save You Time and Money

Testimonials

“ T hese seals have improved our workflow drastically.”

— Pharmacy Technician, LA

“ Love Tamper-Clear and dual layer nature of seals … really loved that they don't fall off in fridge.”

— Pharmacy Buyer, MI

“ We love the Tamper-Clear Syringe Seals – they don’t obscure any information.”

Steri-Tamp also offers two non-sterile syringe seals. Their increased tensile strength allows you to remove easily from the liner and manipulate over any desired container (syringes, pill bottles, inhalers, EpiPens, insulin pens, medication boxes, etc.) without the seal breaking before it is applied. Our new Tamper-Clear Syringe Seal® will now allow you to see through to the markings on the syringe and scan the barcodes on syringes, inhalers, insulin pens, etc.

Trade Shows/Meetings Attended

Features

Ordering Information

n Steri-Tamp® IV Bag Port Seals • Offers the most fool-proof, potentially life-saving way of clarifying whether or not medication has been dispensed.

— Pharmacy Inventory Supervisor, OK

ASHP Midyear, EAHP, CPC (United Kingdom), Annual Compounding Pharmacy Compliance, and various ASHP state affiliate pharmacy conferences. Available through major wholesalers and distributors. Visit our website for order information and dispensing and application training videos at www.steri-tamp.com. WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 53

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

FFF Enterprises, Inc. – The Nation’s Most Trusted Specialty Distributor Our dedication to Helping Healthcare Care® means that we provide you with the products, systems, programs, and services that give you the freedom to focus on patient care.

President & CEO: Patrick M. Schmidt Founded: 1988

Employees: 500+

combined with our perfect safety tracking record of counterfeit-free distribution since 1988, we are in a prime position to care for the nationwide needs of our clinicians and their most precious patients.

(800) 843-7477 Phone: (951) 296-2500 Fax: (800) 418-4333 Address: 44000 Winchester Road, Temecula, CA 92590 Website: www.fffenterprises.com

FFF is committed to ensuring healthcare systems are prepared with adequate supplies of essential medications, especially during times of shortage or crisis, as in the case with the COVID-19 pandemic. With several manufacturers making the decision to partner with us in place of full-line wholesale channels, we are fully equipped to provide the products you need, when you need them.

Company Background

Additional Product Lines

Toll-Free Phone:

FFF Enterprises, Inc. (FFF) was founded on our commitment to Guaranteed Channel Integrity®, our pledge to purchase product directly from the manufacturer, and ship only to a licensed healthcare professional. With a perfect safety track record of counterfeit-free product distribution since 1988, FFF continues to set the standard for patient safety, product efficacy, and fair pricing for the critical-care products that improve the quality of life for the patients we serve. Our mission of Helping Healthcare Care® is the benchmark by which we measure all our actions. We consider this not just the FFF way, but the only way.

n MyFluVaccine® Through MyFluVaccine®, our e-commerce vaccine ordering system, we provide advantages that our competitors simply cannot match: 1) Choice – comprehensive all-products portfolio from the industry’s top manufacturers, 2) Convenience – pick your preferred delivery dates, and 3) Safety – Guaranteed Channel Integrity® ensures a safe supply. With MyFluVaccine, you can take control and manage your flu vaccine inventory with ease by selecting multiple presentations from the top manufacturers, thus mitigating the inherent risks associated with purchasing flu vaccine.

Product Overview

n BioSupply® Our BioSupply® online platform makes ordering your products easy, fast, and convenient. This easy-to-use demand-based product distribution system is your online portal for ordering FFF’s full portfolio of criticalcare biopharmaceuticals, including: • Adult Vaccines • Coagulation • Oncology • Albumin • Essential Medications • Pediatric Vaccines • Ancillaries • Hyperimmune Globulin • Pharmaceuticals • Antithrombin • Immune Globulins • BioSurgical • Influenza Vaccines

FFF Enterprises is the largest and most trusted specialty distributor of blood plasma products, adult, pediatric and flu vaccines, pharmaceuticals, oncology therapies, infectious disease products, and ophthalmology treatments. Our customers, who include hospitals, physician practices, homecare companies, and other healthcare providers, receive products through our Controlled Volume Measures™ (CVM) methodology for allocation management. Additionally, we have the technology and equipment to place pharmaceuticals on-site at providers’ offices utilizing our Forward-Deployed Inventory solutions, which enable clinicians to keep products readily available for their patients’ needs. Our strength is building communities with patients and physicians by providing them with information regarding disease states and healthcare trends through our complimentary educational resources and award-winning publications.

Features & Options

n Guaranteed Channel Integrity® FFF’s commitment to Guaranteed Channel Integrity® guarantees that products are purchased only from the manufacturer and shipped only to licensed healthcare providers, with additional steps taken to safely store, handle, and ship products to ensure patient safety is never compromised. n Controlled Volume Measures FFF has aligned with our manufacturing partners to establish and promote the responsible distribution of critical and preventive care products through our Controlled Volume Measures™ (CVMs) methodology. By means of this unique approach to product allocation management, ™

n RightNow Inventory™ Product Management Solutions RightNow Inventory™ product management solutions provide on-site, ondemand, and pay-as-dispensed product availability for your practice and your patients. Our robust and unique IoT technology offers automated replenished orders, so the products you need, are already there through the: • Verified Inventory Program™ (VIPc®) • MinibarRx® • New SMART Cabinet – Coming Soon!

Ordering Information

Place an order through our Wow! Customer Care team at: P: (800) 843-7477 Emergency Ordering Available 24/7/365 F: (800) 418-4333 E: customerservice@fffenterprises.com Online ordering: BioSupplyOnline.com | OrderMyFlu.MyFluVaccine.com WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 55

Sentry Data Systems helps large children’s hospital improve 340B capture rate by 29% Sentry Data Systems, a trusted leader in 340B management and compliance, has been helping healthcare organizations establish strong 340B programs and reach more underserved patients since 2003. From innovative technology to expert knowledge and support, they are passionate about helping their customers optimize 340B benefit with powerful solutions that deliver the precision, compliance, insights and savings needed to run a successful program. Recently, one of Sentry’s long-standing customers, a large, nationally-ranked children’s hospital, sought to deepdive into its 340B capture rate to identify overlooked benefit opportunities. In doing so, they leveraged the following Sentry solutions:

sentry data systems, inc. | www.sentryds.com | 800.411.4566 56 56

case study The customer The hospital, founded in the 1980s, is now one of the largest children’s hospitals in the country, and is nationally ranked in multiple specialties, reflecting their long-standing commitment to patient care. The organization provides inpatient, outpatient, trauma and emergency care across more than 70 pediatric subspecialties and participates in the 340B Drug Pricing Program.

The challenge Lower than expected capture rates A Sentry customer for ten years, the organization realized its hospital-owned pharmacy’s 340B capture rate — the percentage of prescriptions that are eligible to be purchased through the 340B program — was very low for a lobby pharmacy, and executives believed they were missing significant savings opportunities from drugs that should have been 340B-eligible but weren’t being coded accurately. Part of the challenge stemmed from the fact that the hospital treats many seriously ill children, including those with cancer and those in need of organ transplantation. These conditions require a large percentage of compounded prescriptions — medications in which ingredients and dosage are personalized for each patient — which also happen to be very expensive. “A large percentage of our pediatric patients receive special compounded prescriptions, and we were not capturing any of those through 340B,” says the director of process optimization at the hospital.

The change Working with a trusted partner Having used Sentry solutions since 2010, the hospital chose to work with Sentry’s Senturion Services team of experts, who carefully analyzed and identified two distinct areas where 340B capture rates could be improved: Processing compounded prescriptions By working closely with the pharmacy manager, the Senturion team was able to identify the correct data elements and file formats to identify and process the individual components of compound prescriptions that would be eligible for 340B pricing. Capturing prescriptions at discharge The Senturion Services team realized that there was a high degree of variability in how physicians were writing discharge prescriptions. By leveraging Sentry’s eRx Eligibility Check application, the hospital was immediately able to increase their compliant capture of discharge prescriptions.

sentry data systems, inc. | www.sentryds.com | 800.411.4566 57

case study The results Dedication and commitment to success “We selected Sentry because of its industry reputation, our familiarity with its other quality products, and our existing vendor relationships,” says, the hospital’s manager of pharmacy business services. In turn, the Senturion Services team focused on delivering significant results. They leveraged their wealth of knowledge and experience in the areas of compounded prescriptions and discharge prescriptions — two areas of operation that are integral to a successful 340B program — and made a swift and impressive impact on the hospital’s 340B capture rate. In just six months, the hospital increased its 340B capture rate by 29%. “Sentry pulled all their resources. We had daily phone calls with them for the first few months. The Senturion Services team was very responsive. We couldn’t have gotten the results that we got without that level of dedication on both sides,” says the director of process optimization.

“ We selected Sentry because of its industry reputation, our familiarity with its other quality products, and our existing vendor relationships.” Manager of Pharmacy Business Services

sentry data systems, inc. | 800 Fairway Drive, Suite 400 | Deerfield Beach, FL 33441 | www.sentryds.com | 800.411.4566 phone © 2020 Sentry Data Systems, Inc. All rights reserved. No unauthorized reproduction.

About Sentry Data Systems, Inc. We provide technology solutions that help hospitals address their three biggest challenges: reducing costs, managing compliance and producing better outcomes. 58

expect more with Sentry Since 2003, Sentry Data Systems has been providing healthcare organizations with 340B management and compliance solutions that help you make better business decisions. We bring you MORE than just software solutions and technology — we deliver passion, expertise and partnership every step of the way. And as a company always at the forefront of innovation, it’s both our opportunity and our responsibility to pair our solutions with a strong support team that helps you navigate complex waters and continue to deliver on your mission.

sentryds.com | 1.800.411.4566

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Q.I. Medical, Inc.™ Your Partner in USP <797> Pharmacy Compliance Providing quality assurance products to hospitals and pharmacies practicing sterile compounding, with a singular focus on pharmacy compliance. Our long-standing regional distribution partners are able to provide exceptional in-person service and training. President & CEO: Brady K. Schwarz Founded: 1992 Toll-Free Phone:

(800) 837-8361 Phone: (530) 272-8700 Fax: (530) 272-8702 Address: 1415 Whispering Pines Lane, Suite 150 Grass Valley, CA 95945 Website: www.qimedical.com

Company Background Q.I. Medical, Inc. was founded in 1992 with a focus on providing the sterile compounding industry with testing kits and products to assure proper technique and quality is maintained in their facility. We have a broad network of distribution partners throughout North America, Canada, and other international markets. These distribution partners provide in-person servicing and education to accounts to comply with USP guidelines.

Additional Product Lines Additional products are available for validation of hazardous drug handling, automated compounder manipulation validation, filter integrity testing, and vial adaptors. n Support Equipment Includes: • Incubators • Sterile Filters • Vial Blocks • UV Lights

Ordering Information

To learn more about how Q.I. Medical, Inc. can help your facility, please contact us at (800) 837-8361 or email info@qimedical.com.

Product Overview Our cost-effective, disposable products are available for various needs in the compounding pharmacy. Aseptic technique validation kits are available for low, medium, and high-risk settings. We also sell multiple ala carte sizes of vials, bags, tubes, and syringes of growth media for facilities looking to create a custom media fill test that mimics their day-to-day practice. In regard to environmental monitoring/gloved fingertip sampling, our EnviroTest™ paddle is ideal for both. The rectangle shape and built in hinge allow for testing critical areas such as edges and corners of a hood and behind latch handles. Sterility testing products are available in both USP 71 approved methods of testing. For the full filtration method, the QT Micro™ and QT Junior™ systems work for both small and large volume solutions. For the direct inoculation methods, our TuffTest 2™ product is ideal. All Q.I. Medical growth media is challenged with a battery of USP specified organisms and lot specific Certificate of Analysis (CofA) are available for download. All products are sold through regional stocking distributors in order to provide fast local service and support.

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STERILE EMPTY VIALS

GOHCL.COM â&#x20AC;¢ 1.800.848.1633

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Your One-Stop Source for All Tamper-Evident Needs – Health Care Logistics® Find a diverse selection of USP <800> and infection prevention solutions in one convenient location. In addition to stock items such as cleaning tools and infection control mats, HCL can manufacture stainless steel containers and trays to help achieve your compliance goals.

President & CEO: Gary Sharpe Founded: 1978

Employees: 300+ Toll-Free Phone:

(800) 848-1633 (740) 477-3755 Address: P.O. Box 25 Circleville, OH 43113 Website: goHCL.com Phone:

Company Background

What began 40+ years ago as a garage-based business at the home of founder Gary Sharpe, now encompasses five well-equipped facilities in Central Ohio and reaches customers around the globe. Employment has also grown, with more than 300 employees now dedicated to HCL’s mission of providing unmatched customer service. Complete customer satisfaction is at the heart of everything HCL does.

Product Overview

Containing HD surface contamination is a tough job. While there’s no single solution to effectively deactivate all chemo agents, Health Care Logistics offers the RXGon® Pad HD Prep Mat to significantly simplify the process. This innovative mat combines the absorption of a standard prep mat with the power of activated carbon to form a protective barrier between HD solutions and work surfaces. RXGon Pad HD Prep Mat is proven to prevent surface contamination from common marker HDs cyclophosphamide and fluorouracil by using the activated carbon in the mat to encapsulate and absorb liquids. Likewise, the poly backing shields surfaces from leaks or “bleed through.” Efficacy data and lint test results can be found at goHCL.com. The 12"x12" low-lint mat is a versatile tool that can be used anywhere HD contamination is possible, including: • Shipping, Transport, and Storage: Studies indicate that shipping containers, transport totes, and carousel bins are a major source of HD contamination. RXGon Pad HD Prep Mat can be used to line these containers to protect staff against leaking containers and broken vials. • Compounding and Dispensing: RXGon Pad HD Prep Mat can be used to line work surfaces in the nonsterile prep area, limiting unnecessary contamination. • Administration: The RXGon Pad HD Prep Mat can line work surfaces to prevent contamination of the drug administration area. Users may also place it under the I.V. drip to catch any accidental leaks. • Home Health: Patients may be instructed to use the RXGon Pad HD Prep Mat under their medication bottles and when prepping pumps to limit contamination in the home.

HCL offers a complete inventory of infection prevention solutions to reduce the risk of contamination and help users improve the quality of patient care. Look for the RXGon Pad HD Prep Mat along with PPE, disinfectants and cleaners, surface and fingertip test kits, HD waste disposal options, hygiene stations, and more. Visit goHCL.com to see how HCL can be the single-source resource for all your pharmacy essentials.

Additional Options

In addition to stock items designed to help customers achieve USP compliance, HCL provides a variety of in-house specialty design services. Design consultations are always free, there are no minimum order requirements, and orders ship within seven days of approval. • Cabinets by Design: Cabinets, shelving, and storage units for those who want to renovate existing spaces or outfit newly constructed areas with high-quality pieces made to their exact specifications. • Metals by Design and Plastics by Design: One-of-a-kind items manufactured to match individual customer requests. Product modifications are also possible. These allow customers to work more efficiently and produce better results. • Printing and Graphics: From labels, magnets, and clings to banners, signs, and stamps, HCL’s print specialists can create solutions for any situation.

Product Specifications

HCL’s inventory includes compounding and dispensing items, infection prevention supplies, unit dose packaging materials, and much more. The company offers small package quantities, free samples, and ships most orders the same day. HCL’s hassle-free return policy allows customers to return any product, at any time, for any reason.

Additional Product Lines

Unit Dose; Storage; I.V. Accessories and Injectables; Compounding and Dispensing; Seals; Plastic Bags; Refrigerators, Freezers and Accessories; Temperature Monitoring; Infection Prevention; Carts and Accessories; Pharmacy Supplies; Crushers, Cutters, and Organizers; and Error Prevention.

Ordering Information

Health Care Logistics offers small package quantities, no minimum order requirements, free samples, and ships most orders the same day. The company’s hassle-free return policy allows customers to return any product, at any time, for any reason. HCL’s Live Chat customer service team is available from 8 a.m. to 8 p.m. EST Monday - Friday. *FDA-approved drug products include otherwise legally marketed sterile drug products in finished dosage form. Such commercially available drugs are produced in FDA-registered facilities subject to FDA inspection.

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CSTD (CLOSED-SYSTEM TRANSFER DEVICE) PRODUCTS & MANUFACTURERS Q & A

Q&A

Robert Quintana, RPh Director of Pharmacy

Campbell County Health

Q. As a director of pharmacy, what is your responsibility to your

employees and/or patients in ensuring their safety?

I am charged with ensuring the safe utilization of hazardous drugs throughout the organization. So the use of a CSTD at Cambell County Health was initiated in response to regulatory requirements and an increased need for safety for the staff, increase in use for different treatment modalities, and a desire for a safe and quality product. The CSTD system we chose addressed some deficiencies we were noticing while optimizing our ability to provide excellent care with very challenging agents. This system has literal design features built in to ensure compliance and safety for staff and our patients.

Q. What were some challenges the pharmacy faced with your

pre-existing CSTD system?

The most prevalent deficiency noticed was the lack of ensured compliance with the appropriate utilization of the product. It did not meet many of our patient care needs and often less safe workarounds were required to accomplish the treatment modality needed. Our new system has a unique Foley administration device we needed to utilize that helps provide the therapy while still providing for as much of a closed system as possible with that type of higher-risk treatment modality.

Q. What was the reasoning to look at a different CSTD system for

hazardous drug compounding?

We needed a more expansive system that provided uses in more applications and was easier to use than the system we were utilizing. We were looking for a system that could give us the following

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H E A LT H S Y S T E M â&#x20AC;˘ I N F U S I O N

Q. What role does nursing play in the selection of a CSTD? Our oncology/infusion center nurses played a huge role in helping select a CSTD. It was essential to get their perspective and buy-in as they are the ones at the end administering the product prepared by the pharmacy. We brought in the systems we thought were better options for a review and input from the nursing side. We coupled the nursing feedback with that of pharmacyâ&#x20AC;&#x2122;s research of the clinical studies, outcomes, costs, and hands-on evaluation of the systems to make our decision.

Q. Was the infamous cost issue a consideration for your review?

Absolutely! Any CSTD system utilized is an additional cost to the institution and it is necessary to evaluate costs. Fortunately, with the utilization of our GPO contracts, the transition was fairly cost neutral from one system to another.

Q. Once the decision was made to switch CSTD systems, how was

the transition?

We received incredible support including on-site training and assistance for both the pharmacy and the nursing staff. A pharmacy technician was brought in to work and train the pharmacy staff, as well as a nurse to work with and train the nursing staff. Our account representative worked extensively with us to ensure that we ordered and had the correct amount of inventory to make us successful without overstocking. The implementation side of our CSTD process was fairly straight forward and easy.

Q. What was your approach to

implementing and standardizing a CSTD within your institution? Due to incorporating our highest users of these systems into the decision process, it made the implementation process much smoother to incorporate into our practices. We only use one CSTD to ensure standardization and we made it a hard cutoff. Meaning, that once we had the product and new system, we did not use the older system. It was a balance of managing the old inventory, purchasing the new inventory, and deciding a go-live. Although it could not be a perfect, zero loss process, the staff did an excellent job to minimize losses.

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CSTD (CLOSED-SYSTEM TRANSFER DEVICE) PRODUCTS & MANUFACTURERS Q & A

advantages: ease of use, a truly closed system, and flexibility for use in certain treatment modalities that we did not have with our previous system.

H E A LT H S Y S T E M â&#x20AC;˘ I N F U S I O N 65

CSTD (CLOSED-SYSTEM TRANSFER DEVICE) PRODUCTS & MANUFACTURERS Q & A

Q. What do you feel are the advantages of your new CSTD system? Definitely the flexibility of the system to be utilized in various treatment modalities and the safety it provides the pharmacy compounding staff. The CSTD system is very intuitive and is engineered to reduce or eliminate incorrect usage. The individual products are engineered to protect compounding and administering staff. It is a simple system to use and is not overly cumbersome while ensuring safety for the staff involved in providing treatment.

Q. Are there any other considerations you have about your decision

with the CSTD system you chose?

The transition was positive for our institution, staff, and overall success. Our account representative still reaches out on a regular basis to offer both on-site (when possible) and virtual training for staff as transitions occur. We are also provided analytics to help maintain costs with utilization, which is helpful in the current environment.

BIOGRAPHY

Robert Quintana, RPh, Director of Pharmacy, Campbell County Health

Robert Quintana, RPh, is the Director of Pharmacy at Campbell County Health in Gillette, Wyoming. He has an extensive 25-year pharmacy background in institutional, critical care, clinical, and infusion/oncology center practices.

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Buyer’s Guide B. Braun Medical Inc. 824 12th Avenue Bethlehem, PA 18018 (800) 523-9676 www.bbraunusa.com

EQUASHIELD, LLC 2 Harbor Park Drive Port Washington, NY 11050 (516) 684-8200 www.equashield.com

Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 (800) 422-9837 www.baxter.com

ICU Medical 951 Calle Amanecer San Clemente, CA 92673 (800) 824-7890 www.icumed.com/closedandcompliant

BD 1 Becton Drive Franklin Lakes, NJ 07417 (201) 847-6800 www.bd.com/en-us

Yukon Medical 4021 Stirrup Creek Drive, #200 Durham, NC 27703 (919) 595-8250 yukonmedical.com

Corvida Medical 941 25th Avenue, Suite 218 Coralville, IL 52241 (800) 651-6832 Corvidamedical.com

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CSTD (CLOSED-SYSTEM TRANSFER DEVICE) PRODUCTS & MANUFACTURERS B u y e r ' s G u i d e

CSTD (CLOSED-SYSTEM TRANSFER DEVICE) PRODUCTS & MANUFACTURERS

H E A LT H S Y S T E M • I N F U S I O N 67

Pharmacy & Business working together to optimize your results No one makes pharmacy and business work together like Visante. Our consulting work with Integrated Delivery Networks, hospitals and health systems combines a wealth of expertise with personalized and comprehensive support so you can optimize your pharmacy operations and deliver better patient care.

High-performing pharmacy is who we are • 340B Program • Specialty Pharmacy • Sterile Compounding & USP Excellence • Drug Diversion Prevention

• Comprehensive Pharmacy Assessments • Pharmacy Finance and Reimbursement • Pharmacy Stars TM Compliance Tools

Learn more at visanteinc.com, or contact us at solutions @ visanteinc.com or (866) 388-7583.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Visante – High-Performing Pharmacy is Who We Are We're in the business of advancing pharmacy. Our consultants work with hospitals and health systems combining a wealth of expertise with personalized and comprehensive support to optimize your pharmacy operations and deliver better patient care. President & CEO: James Jorgenson Founded: 1999 Toll-Free Phone:

(866) 388-7583

Address: 101 E 5th Street, #2220

St. Paul, MN 55101 Website: www.visanteinc.com

Company Background

Visante is a multidisciplinary, clinician-composed consulting firm specializing in all aspects of the business of pharmacy. We believe in moving the practice of pharmacy forward through innovative solutions that deliver lasting results. Far too often we’ve seen pharmacy and medication management underutilized or under-resourced, resulting in a negative impact on finances and patient care. We’re in the business of reversing that. We’re in the business of advancing pharmacy. By diagnosing and solving complex problems, we help organizations more effectively deliver optimized and compliant medication related services. Our 60-plus consultants include experienced pharmacists, nurses, physicians, IT professionals, and business experts, all working together to ensure you get the right solutions for your unique needs. No matter what your specific challenge is, we always know what matters most – delivering safe, high-quality, cost-effective patient care so you can continue to grow.

Featured Services

n Comprehensive Pharmacy Assessment Optimizes Financial and Clinical Results

We put our extensive experience and knowledge to work to assess your current operations and help you take your pharmacy to the next level. We have the right combination of skills to evaluate all the moving parts and recommend improvements that will help you provide better patient care while improving your bottom line. We listen and work closely with you to support your objectives, delivering a personalized pharmacy plan for optimal growth, including a complete evaluation of your current program; opportunity analysis for safety, clinical, operational, and financial improvements; strategic planning support based on identified opportunities; and program enhancement design and implementation. n 340B Solutions for Total Compliance and Lasting Success Visante’s independent, external audit support continues to provide transparency to your 340B processes, allowing you to recognize compliance gaps while also focusing on new opportunities within the program. Visante provides: internal and external audit support, on-site HRSA audit support, and corrective action plan guidance in the event of HRSA audit findings; gap analysis and targeted recommendations, focusing on

long-term strategy in the mixed-use and contract pharmacy space to ensure program optimization; program implementation and development of internal oversight structure and maintenance; and split billing RFP guidance, implementation, and program re-designs. Visante’s experienced team members are all Apexus 340B University graduates, many of whom have completed the Advanced Ops Certificate. n Sterile and Non-Sterile Compounding Compliance That Drives Safe, High-Quality, Cost-Effective Care

Safely compounded medications are essential to quality patient care. Hospitals face the challenge of optimizing care while also meeting safety requirements and managing cost. We will prepare you for compliance with USP Chapters <795>, <797>, <800>, and <825>. We’ll also assist you in preparing for compounding related inspections by the CMS, FDA, DEA, and Joint Commission/DNV. Our consulting services include: USP <795>, <797>, <800>, and <825> gap assessment and facility design; 503A, 503B assessment, facility design, and implementation support; and home infusion compounding services. When it comes to pharmacy compounding, we don’t settle for basic compliance – and you shouldn’t either. Our processes are designed to assist you and your team to be successful. n Drug Diversion Prevention Protects Your Patients and Yourself Drug diversion problems continue to escalate with opioid addiction at epidemic levels. Our program takes a comprehensive multidisciplinary approach to identify drug diversion risk points in your medication use processes. Minimize risk through assessment of pharmacy operations, informatics, automation, nursing, and perioperative processes to identify and strengthen points of vulnerability. Our drug diversion experts have real-life experience in hospitals and health systems and understand the challenges hospitals face today and in the future. n Expand Your Specialty Pharmacy Services and Quality of Care A clearly defined specialty pharmacy strategy can help improve patient care and optimize your bottom line. Developing a specialty pharmacy strategy or expanding your existing services can be a complex process, but our team of experts guides you through each phase and delivers lasting ROI. Our specialty pharmacy consulting capabilities include: operational assessment and pro forma models; multi-year business and strategic plans; facility design including workflow and automation options; implementation and project management; accreditation support (URAC/ ACHC/CPPA); contract pharmacy strategy, if applicable; wraparound strategy to include consideration for site of care challenges (infusion); and home infusion and DME strategies and business planning.

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Supporting Pharmacy Efficiency with a Growing Product Formulary

Liquid Unit Dose

damage and cleanup ■ Legible labels aid in selecting correct products from the pharmacy shelf ■ Cups and storage trays are designed to optimize limited storage space ABC 8-digit #

Cardinal Item #

McKesson Item #

10237650

5660352

10211921

Morris & Dickson #

Product Description

Unit Strength

Cup Delivery

Cup Strength

Pack Size

NDC

1557057

906891 Amantadine HCl Sol 100mg/10mL

100mg/10mL

10mL

100mg/10mL

100ct

60687-0239-56

5517206

3795689

584466 Fluoxetine Oral Solution, USP

20mg/5mL

5mL

20mg/5mL

40ct

60687-0244-77

10188404

5465380

3917226

363275 Fluoxetine Oral Solution, USP

20mg/5mL

5mL

20mg/5mL

50ct

60687-0244-67

10228115

5552237

3968229

752410 Hydrocodone Bitartrate & APAP Oral Solution CII

7.25mg/325mg/15mL

15mL

7.25mg/325mg/15mL

50ct

60687-0417-71

10211783

5517214

3901766

584557 Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

40ct

60687-0249-77

10183100

5430343

3775822

238550 Levetiracetam Oral Solution, USP

100mg/mL

5mL

500mg/5mL

50ct

60687-0249-67

10210354

5512413

3777034

568063 Ondansetron Oral Solution, USP

4mg/5mL

5mL

4mg/5mL

30ct

60687-0252-86

10219153

5528518

3949997

603993 Oxycodone HCl Oral Solution CII, USP

5mg/5mL

5mL

5mg/5mL

40ct

60687-0406-77

10219154

5528526

3950037

604306 Oxycodone HCl Oral Solution CII, USP

5mg/5mL

5mL

5mg/5mL

50ct

60687-0406-67

10231522

5587894

2549509

822841 Phenobarbital Elixir CIV, USP*

20mg/5mL

5mL

20mg/5mL

50ct

60687-0448-67

10209414

5508114

3751294

560649 Phenytoin Oral Suspension, USP

125mg/5mL

4mL

100mg/4mL

50ct

60687-0275-66

10211558

5515705

3935129

575878 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

30ct

60687-0341-58

10212031

5520416

3909884

584904 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

40ct

60687-0341-64

10191061

5486220

3263035

321570 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

50ct

60687-0341-71

10211557

5515713

3935137

575894 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

15mL

20mEq/15mL

80ct

60687-0341-07

10212749

5521521

3937786

591016 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

30mL

40mEq/30mL

40ct

60687-0341-14

10191066

5487574

3266467

465344 Potassium Chloride Oral Solution, USP 10%

20mEq/15mL

30mL

40mEq/30mL

50ct

60687-0341-72

10236851

5655030

1552645

881052

25mg/10mL

10mL

25mg/10mL

100ct

60687-0267-56

10182920

5427497

3772373

231159 Theophylline Oral Solution, USP

80mg/15mL

15mL

80mg/15mL

50ct

60687-0258-71

10231260

5583273

2080927

793638 Valproic Acid Oral Solution, USP

500mg/10mL

10mL

500mg/10mL

100ct

60687-0262-56

Siladryl Allergy (Diphenhydramine Hydrochloride) Antihistamine Liquid 25mg per 10mL

*Product contains 10% alcohol.

Hitting the Mark

American Health Packaging is a leading manufacturer of serialized, barcoded unit-dose products for hospital, institutional, and long-term care pharmacy AH-100017

americanhealthpackaging.com | 800.707.4621

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

AHP Supports Pharmacy Efficiency With an Evolving Barcoded Unit-Dose Product Offering With a responsive line of barcoded unit-dose oral solutions – a growing liquid unit dose offering and now individually wrapped inhalants – AHP continues to deliver on their commitment to supporting pharmacy efficiency.

President & CEO: Bruce Bennett Toll-Free Phone:

(800) 707-4621 Columbus, OH 43217 Website: www.americanhealthpackaging.com Address:

Company Background

AHP UD supports these objectives while providing cost-savings opportunities. Sourcing pre-packaged UD allows pharmacies to obtain adequate supply while mitigating capital expenses, such as those related to repackaging equipment, bulk supply, and labor.

Benefits for Health Systems n Patient Safety

Located in Columbus, Ohio, American Health Packaging is an industry leader in manufacturing serialized, barcoded unit-dose medications provided for the healthcare marketplace. As a unit-dose manufacturer, AHP’s commercially-available unit-dose products are available to hospital, institutional, and long-term care pharmacies nationwide through partner GPOs and wholesalers.

Ensuring the right medication is given to the right patient at the right time – and in the right strength – is imperative. Pharmacies can facilitate effective execution of these “Five Rights” by providing caregivers with as many products in a pre-packaged unit dose format as possible. Removing repackaging tasks from the pharmacy eliminates a potential point of failure during the unit-dosing process as medications arrive to pharmacies ready to dispense.

AHP’s reputation for quality is supported by a 30+ year history of broad manufacturing expertise – operating a facility that is registered with the FDA, fully adherent to cGMP guidelines, and licensed by the DEA to package Schedule II-V controlled substances. Synonymous with unit dose, following years of success and leadership in the production of oral solids, AHP expanded their offering in 2017 to include liquid unit dose cups.

n Pharmacy Efficiency

Product Overview

Pharmacies strive to process orders and supply the proper medications to caregivers for their patients as quickly as possible. Adding potentiallycomplex repackaging steps to the procurement process not only harms the ability of pharmacy to supply caregivers effectively, but also removes clinicians from their core patient care competencies. In addition, prepackaged UD often allows for products to be sourced more quickly than third-party repackaging can support.

AHP is committed to supporting pharmacy efficiency through a diverse range of both high-utilization and niche treatments. Producing over 500 unit-dose oral solid SKUs for the healthcare marketplace, AHP’s broad selection of products are produced with quality components and printed with legible barcodes that facilitate effective execution of BPOC initiatives. Their wide selection of products reduces the gap between what pharmacies are forced to repackage themselves, and what is commercially available on the market – supporting health systems nationwide in their efforts to create efficiencies throughout the chain of care.

n Cost-Savings Opportunity

AHP’s tailored offering of unit-dose oral liquids provide similar efficiency, safety, and cost-savings benefits as their oral-solids products. Product features include right-sized packaging, thoughtful tray design, differentiated labelling, and accurate barcodes. AHP’s new unit-dose inhalants provide efficiency and feature individually-wrapped vials and pouches barcoded to the dose level. AHP oral solids, liquids, and inhalants include major therapeutic classes and product groups to meet unique pharmacy needs. They are continuously evolving to meet the changing demands of caregivers and staff to support more effective medication procurement strategies.

Hitting the Mark for BCMA, USP <800> Support

As facilities nationwide compete to demonstrate they provide the highest quality of care, AHP unit dose supports caregivers as they strive to promote positive outcomes for patients. Pharmacies simultaneously strive to be cost-effective as they provide necessary resources for caregivers.

Health systems that choose to package on-site must consider all direct costs, such as purchasing capital equipment for packaging areas and paying highly-trained clinical professionals to perform, manage, and support non-core work. American Health Packaging unit-dose products allow for pharmacies to avoid these costs while also shifting the potential costs associated with packaging errors. The pre-packaged format also prevents additional fees than may result from utilizing third-party repackaging services.

Effective execution of BCMA initiatives require medications that scan correctly at the bedside. With a robust oral-solids portfolio – and growing offering of unit-dose liquids – AHP UD provides reliable access to unit-dose treatments. AHP products promote safety towards BPOC and efficiency in pharmacy while freeing up internal resources. AHP UD supports pharmacies as they strive for compliance with USP General Chapter <800> guidelines. As pharmacies craft effective procurement strategies to meet the needs of their facilities, protecting patients and caregivers alike from potential harm while handling hazardous drugs is a priority. AHP’s UD portfolio supports compliance to USP <800> by featuring many relevant treatments.

WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 71

CAS E S TU DY

Achieving 503A+ JSD Pharmacy Sets the Gold Standard for Super Sterile PRIMARY INTENDED OUTCOME

Deborah Larison, PharmD Director of Pharmacy ~ JSD Pharmacy

www.criver.com

CAS E S TU DY

“

When I open the lab door for the day, I look around that room and think, what’s the risk today?” Deborah Larison, PharmD Director of Pharmacy ~ JSD Pharmacy

Googling pharmacy compounding incidents now still shows more unacceptable cases of near deaths3, loss of eyesight, and excruciating wounds.4 These recent reports reinforce Dr. Larison's commitment to performing more than minimum requirements from the state and Federal government. Charles River aids JSD Pharmacy in those efforts to never lose focus on product quality and bioburden control. Dr. Larison is a realist on many fronts, as she recognizes first that pharmacists are not microbiologists, and second that it is unreasonable that 503A pharmacies be compared to 503B regulations. But every 503A pharmacy should strive for 503 "A+." Time management, cost control, and automated reporting are practical needs that require solutions to run an efficient operation. “When I open the lab door for the day, I look around that room and think, what’s the risk today and how can we mitigate it?” Dr. Larison conveyed. “To mitigate any risk, I need a system that instills confidence.”

THE DECISION Initially, Dr. Larison looked for a provider to perform genus/species ID in a new lab. However, in working with her team and striving for outstanding, she knew that to transform her lab into "A+", she needed more than a tactical tool. Dr. Larison required strategic vision and a system for long-term gains. Detailed below are four criteria that led Dr. Larison to Accugenix® and Microbial Solutions from Charles River.

SAVE TIME, ENSURE QUALITY Before using the Accugenix® Customer Web Portal, the team at JSD Pharmacy had to manually analyze copious amounts of data for either pass or fail for every sampling event. If the possibility of a germ existed, a new system had to make a difference in uncovering the likely scenario for its presence and accelerating identification, freeing up time to focus on compounding.

CONVENIENT TESTING Charles River also provides proprietary Endosafe® FDA-licensed LAL cartridge technology for bacterial endotoxin testing that produces a 15-minute quantitative result and can be used right on the manufacturing floor.

FIND AND IDENTIFY EVERYTHING “We do most of our testing at the end of the day when the team has completed compounding medicines for the patients and all the traffic in and out of the lab has subsided and the lab is at its dirtiest,” said Dr. Larison. “Charles River makes it simple for us to submit sample requests online. Established metadata help to filter sample results and give insight into the state of control of the facility.”

DRILL DOWN ON DETAILS More than a nicety, the team needed the most environmentally relevant library in the industry to accurately identify all organisms recovered. Accugenix® provides clients various tools in the form of tracking and trending reports that assist in drilling down on specific organisms and where they came from in the facility. Charles River compares results of unknown organisms to industry-relevant databases that contain entries for bugs discovered globally. The Accugenix® team processes more than 450,000 environmental isolates every year, which enables the R&D team to know what to add to build the most robust libraries available to the industries we serve. www.criver.com

CAS E S TU DY

“

With Charles River, it’s problem solving to the nth degree and

“We receive data that allow us to take action on questions like: Do we need to reclean, change processes, check kill efficacy, or address gowning and garbing?” stated Dr. Larison. “With Charles River, it’s problem solving to the nth degree and foreseeing and determining a trend before it becomes an out of specification.”

SUPPORT STAFF From client engagement specialists who onboard clients to account managers and a customer care team, Charles River is an extension of the pharmacy. They are the microbiologists providing whiteglove service.

foreseeing and

“I knew Charles River had a strong reputation in the industry and had more than 16,000 employees to support clients. But it came down to the one-on-one with an expert microbiologist that solidified our choice,” said Dr. Larison.

determining a

THE RESULTS

trend before it becomes an out of specification.” Deborah Larison, PharmD Director of Pharmacy ~ JSD Pharmacy

For JSD Pharmacy, the outsourcing of microbial identifications coupled with tracking and trending features provided the accuracy and advancements that elevated the team’s work. By making a concerted effort to set the bar higher, JSD Pharmacy is well prepared for both internal and external audits and evaluations. They even conduct mock FDA evaluations with a third party. The push for "503A+" means an added protection level for the patient and JSD's reputation. These high standards for super sterile compounded medications help ensure safe medicines for patients with acute and chronic conditions. Charles River also receives an "A+" for delivering on the criteria; their support and tools strengthen the oath we take to protect every patient.

THE CONCLUSION Patient need for compounded medicines will grow because customized medicines make a difference in quality of life. The medical field that develops these complicated pharmaceuticals will remain highly regulated. In response, pharmacists not only require precision at every stage involving prepping, mixing, assembling, altering, packaging, and labeling, but they also must be hypervigilant about their bioburden in the controlled environment to ensure no harm to anyone. Pharmacists realize they are not microbiologists, which only adds to the need for exacting tools and subjectmatter experts who support them from start to finish. Currently, under FDA guidelines, 503B pharmacies have more requirements to meet than 503A in terms of manufacturing practice (CGMP) compliance. JSD decided that it was doable to go above the 503A standards. Today, with the help of Charles River, JSD Pharmacy stays ahead of the curve in preparation for the opportunities of tomorrow. 1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/december-13-2018-owner-and-four-formeremployees-new-england-compounding-center-convicted-following#:~:text=BOSTON%20%E2%80%93%20An%20owner%20and%20four,caused%20 by%20a%20pharmaceutical%20drug. 2. https://www.congress.gov/bill/113th-congress/house-bill/3204 3. https://www.kvue.com/article/news/investigations/defenders/54000-higher-austin-woman-almost-dies-after-pharmacys-dosage-mistake/269d1bf71e7-025b-44d4-b8ec-8a45e108b8b8 4. https://www.kvue.com/article/news/a-pharmacy-error-left-a-hole-in-a-womans-arm-the-size-of-a-golf-ball/269-03e58e22-40ca-4dfc-9888ec0548484433

www.criver.com

FIND THE Aspergillus BEFORE YOUR PATIENT DOES.

Making sure a contaminated product never reaches patients means being proactive about quality control. Trust Charles Riverâ&#x20AC;&#x2122;s portfolio of FDA-licensed, CGMP-compliant products and services to maintain control and consistency in your compounding facility. Gain peace of mind from raw materials to final product release, and prevent the avoidable when providing patients the products on which they depend.

For more information, visit us at www.criver.com/compounding

Innovation in Secure Drug Delivery

“

Simple, Innovative Solutions to Enhancing Drug Security Programs.

1.800.344.2554

IMI-501-AA-33 R1

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Prep-Lock™ From IMI Guards Against Drug Diversion and Misuse

Increase pharmacy productivity and safety with economical, American-made devices designed to advance the safety and security of your drug products and ultimately your patients. President:

Jonathan Vitello Founded: 1969 Employees: 100+ Toll-Free Phone: (800) 344-2554 Phone: (954) 917-9570 Fax: (954) 917-9244 Address: 2981 Gateway Drive Pompano Beach, FL 33069 Website: www.imiweb.com

Company Background

For over 50 Years, IMI has worked closely with pharmacist and compounding professionals to create innovative, American-made, sterile devices that meet very specialized needs. Throughout this time, IMI has established long standing partnerships with some of the biggest names in healthcare. Through these partnerships and directly, IMI is delivering the kind of high-quality and high-value products that pharmacy operations demand. All IMI products are manufactured in the USA under the strictest quality standards at their FDA registered, ISO 13485 certified facility.

Product Overview

n Prep-Lock™ Tamper-Evident Caps for I.V. Syringes Compounded sterile preparations (CSPs) are at their greatest risk when they leave the custody of your pharmacy. The Prep-Lock TamperEvident Cap greatly reduces the risk of your CSP being compromised either accidentally or intentionally. It ensures that product integrity is maintained from the time it leaves the sterile hood until it is administered by an authorized clinician. If your facility uses an outsource compounder, chances are you are already familiar with IMI’s tamper-evident cap technology. You can easily incorporate the use of this cap for your in-house preparations which will provide standardization of all syringes throughout your hospital. Installing the tamper-evident cap in your compounding operation is highly efficient. Each sterile tray of 10 caps offers the pharmacist the ability to quickly install the cap with a simple twist of the syringe. This helps to reduce the risk of touch contamination and enhances aseptic technique. Administering a syringe is very easy for the authorized clinician. Simply pull off the outer sleeve of the tamper-evident cap, unscrew the remaining luer lock cap, and discard. A choice of three different colored caps and two outer sleeve styles allows the pharmacy the ability to color code either specific drug classes or processes.

n Prep-Lock™ Tamper-Evident Caps – With Male Luer Lock for CADD Cassettes

Drugs are prepared in a variety of devices with different connector types. When those devices feature a female luer lock connector, the Prep-Lock Tamper-Evident Cap with Male Luer Lock Connector can provide all the same safety and protection benefits found in IMI’s entire family of tamper-evident products. n Prep-Lock™ Tamper-Evident Additive Port Cap The Tamper-Evident Additive Port Cap offers your IV bag preparations unparalleled protection against potential tampering or misuse. The advance design ensures a secure closer. Once the cap is applied it cannot be removed without damage to the bag. The simple one-handed installation is a preferred solution over sticky foil seals. In addition to impenetrable coverage for medication port covers, the cap also serves as an indication that medication has been added providing additional protocol assurance. The Prep-Lock Tamper-Evident Additive Port Cap is a simply solution to enhance your overall drug safety program. n Prep-Lock™ Tamper-Evident Caps – for ENFit® Syringes The ENFit® connector standard (ISO 80369-3) for enteral feeding devices is a welcomed feature for mitigating potential misconnections. IMI is pleased to offer a tamper-evident cap for ENFit syringes that further enhances patient safety. These innovative caps help guard against drug diversion and misuse from the time the syringe leaves the pharmacy until the time it is administered. The tamper-evident cap is compatible with both standard and low dose ENFit syringes.

Additional Product Lines

IMI offers a variety of sterile devices designed for the compounding pharmacist:

• Prep-Lock™: Tamper-Evident Caps for Oral Syringes • Prep-Seal™: Sterile Luer Lock Caps and Plugs • Prep-Fill™: Sterile Luer Lock Connectors • Rx-Vent™: Sterile Venting Needles • Rx-Tract™: Sterile Aspirating Needles

Trade Shows/Meetings Attended

IMI regularly participates at a variety of industry trade shows and conferences including: • American Society of Health‑System Pharmacists (ASHP) • European Association of Hospital Pharmacists (EAHP) • National Pharmacy Purchasing Association (NPPA) • International Health Facility Diversion Association (IHFDA) • Hospital Pharmacy Conference (Health Connect Partners) Visit the event website or contact IMI for dates and booth numbers. WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 77

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SpecRx INDUSTRY PRODUCT GUIDES

Medical Packaging Inc., LLC

Fluidose® Series 6 Unit Dose Packaging System The Fluidose® Series 6, an automated barcoding packaging solution for unit dose oral liquid medication, contains new design features that provide improved durability and safeguards along with the latest technology. Automatic packaging of bulk liquid medication into unit dose is more cost effective than buying oral liquids pre-packaged by the manufacturer and provides the hospital pharmacy with the ability to package in-house instead of relying solely on outsourced packaging services to provide a single barcoded, unit dose package to the bedside each and every time, ensuring patient safety.

FEATURES • Packages up to twenty-two (22) unit dose packages per minute • Standard cup sizes available: 7mL,15mL, 25mL, 35mL • Easy to use & compact footprint • Requires less input from user compared to previous models • Manufactured of stainless steel for use in clean room environments • Serialization is a standard feature in system software • Powered by Pak-EDGE™ software - optimally integrated with First DataBank® drug data, imprints and images database • Class A packaging allows for twelve month expiration from date of packaging • Capable of packaging oral liquid medication with viscosity ranges up to 1000 centistokes • All standard size cups are available in a variety of different colors: blue, red, yellow and amber. Custom colors available.

DIMENSIONS

WEIGHT

POWER

32” L x 14” W x 18” H

125 lbs.

115 VAC, 60 Hz, 400VA or 230 VAC, 50/60 Hz, 400VA

NEW FEATURES & UPDATES Improvements

Enhanced user workflow, simplified operating procedures, stronger seal head for durability and additional warnings if improperly configured

Display

Touchscreen is now larger to increase ease of operation and navigation

Functionality

Pumping parameters, including volumes and rates, for each individual product are now stored in Pak-EDGETM software and sync with the liquid packaging system

For additional information, please visit medpak.com

Medical Packaging Inc., LLC

Auto-Print® Unit Dose Packaging System For over three decades hospital pharmacies worldwide have been relying on the Auto-Print®, a complete barcoding packaging solution for oral solid medications, for their packaging and labeling needs. The semi-automated system packages tablets and capsules into a unit dose at a minimal cost per dose using our exclusive MPI-certified consumable materials. The Auto-Print® is powered by our exclusive Pak-EDGE™ UD Barcode Labeling Software, which is capable of generating and printing all linear, 2D and GS1 barcodes and offers advanced barcoding capabilities and configurations.

FEATURES • Packages up to sixty (60) unit dose packages per minute • Standard package size of 2.0”W x 1.5”L • Class A and Class B packaging materials available • Offered in stainless steel for use in clean room environments • Optional software license available to print Medi-Dose® blister pack labels • Pak-EDGE™ software is optimally integrated with First DataBank® drug data, imprints and images database • Materials offered in six (6) different colors to assist in coding expiration dates or designating controlled medications • Customizable to accommodate range of pharmaceutical canister technologies • Easy to use & compact footprint

DIMENSIONS

WEIGHT

POWER

36” L x 15” W x 14” H

65 lbs.

115 VAC 50 Hz or 230 VAC 60 Hz, 320V

OPTIONAL COMPONENTS Oral Solid Feeder Attachment

Variable Length Option

Barcode Veriﬁer Option

Adapts to Auto-Print® packaging system for oral solids allowing packaging of bulk medications into unit dose

Adds the capability to change the package length as needed. Standard available choices for variable length packages include: 1″, 1 1/8″, 1 1/4″, 1 3/8″, 1 1/2″, 1 7/8″, 2 1/4″.

Automatically scans each package as a ﬁnal check after the packaging of the unit dose container is completed to assure that the barcode can be accurately scanned at the bedside

For additional information, please visit medpak.com

Dispense Drugs Faster with Rapid Sterility Advantages of Releasing Drugs from Quarantine Earlier • Decrease costly drug waste • Decrease internal drug shortages • Improve space utilization • Gain efficiencies by increasing batch size • Detect contamination events faster

ARL’s Rapid Sterility Method • Fully validated per USP <1223> VALIDATION PARAMETER Specificity

Repeatability

Limit of Detection

Recovery of Stressed & Injured Microorganisms

Robustness

Equivalency

• Tests all sample types including solutions, oil, and suspensions • Non-Destructive allowing for identification of contaminating organisms • Objective, automated results generated by the instrument • Formulation specific method suitability required

Ruggedness

ARL Bio Pharma is a contract laboratory that provides analytical and microbiology testing services. Our laboratory’s regulatory expertise and comprehensive services supports your commitment to provide high-quality medications and excellent patient care. ARL Bio Pharma | 840 Research Parkway, Ste. 546 | Oklahoma City, OK 73104 www.arlok.com/rapid | info@arlok.com | (800) 393-1595

High or Low Security, Large or Small Items – medDispense® delivers the most flexible and adaptable dispensing system. Single Dose Control Storage Capacity

1,248 (F series) 1,440 - 2,160 (M series)

F series, M series

Single Line Item Control with Closed Compartments Storage Capacity

324 (L series)

L series

Single Line Item Control with Linear or Open Matrix Compartments Storage Capacity

800 (C series) 1,200 (CS series) 1,400 (CT series)

C series, CS series, CT series

Bulk Item Control Storage Capacity

720 (V series)

V series

No two healthcare facility workflows are the same. medDispense® is designed so you can tailor a solution that fits your unique workflow to help keep your team efficient and your patients safe.

Instantly Request a Quote or Schedule a Demo (virtual or in-person)

Unit Dose Done Right Brightly Colored Labels Call Attention to Meds Requiring Special Handling

Unit Dos e Bar Cod , ing, Pharma c Nursing y & Supply Experts !

• Cold Seal • Tamper-Evident • Moisture Resistant • Ultraviolet Inhibitant • Reduces Cross Contamination • Ideal for Meds Covered by USP 800 • 6 and 12-month Beyond-Use Dating • 1-D and 2-D Bar Coding • Flexible Label and Report Formatting • Multiple Sizes and Shapes to Fit Your Meds & Storage Needs

Scan QR Code for more information and pricing.

Simple. Reliable.

800.523.8966

MediDose.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Medi-Dose, Inc./EPS, Inc. Delivers Bar Coding, Packaging, and Labeling Pharmacy Solutions Improve your Solid Oral Unit Dose needs with our comprehensive Bar Coding, Packaging, and Labeling Solutions – designed by healthcare professionals, for healthcare professionals. President:

Robert Braverman

Founded: 1971 Employees: Private Toll-Free Phone: (800) 523-8966 Phone:

(215) 396-8600 (800) 323-8966 Address: 70 Industrial Drive Ivyland, PA 18974 Website: www.medidose.com Toll-Free Fax:

Company Background Medi-Dose/EPS was founded in 1971 when Milton Braverman, a former pharmaceutical company territory manager, saw the need for inexpensive, manual unit dose packaging allowing a hospital to convert from traditional dispensing. He developed the Medi-Dose System to package, handle, and dispense predetermined amounts of medication so they would be accessible for one regular dose. Comprehensive bar coding and labeling identification is accomplished using our innovative MILT 4 software. Because of the continued success of the MediDose System, Medi-Dose/EPS expanded its product line to include the TampAlerT System, offering tamper-evident liquid packaging without the need for heat tunnels and accessory sealing equipment, as well as a full line of supplies and disposable products designed specifically for the pharmacy and health care professional. Product Overview Medi-Dose provides Tamper-Evidence as well as UV and Moisture Resistance for one-year beyond-use dating. Our MILT® 4 software maintains packaging logs and lets you design and print your Lid-Label® Covers with color, bar codes, tall man lettering, and graphics. You can format the labels any way you want, directly from your own computer and printer! Medi-Dose works well in any pharmacy operation and can be used with all classifications of drugs (chemo meds, meds covered by USP 800, compounded drugs, controlled substances, etc.). It’s affordably priced for all pharmacy budgets. For the best in manual unit dose packaging, check out Medi-Dose!

Features & Options

n Packaging and Labeling Solutions

• Simple to use – no extensive training needed. • 1-D and 2-D bar coding – including NDC, lot numbers, and expiration dating.

• Ideal for hazardous medications and USP 800 drugs. • Tall Man Lettering and dynamic formatting options. • Built-in NDC lookup database and extensive image library. • Packaging logs and error reporting. • Six-month and one-year beyond-use dating. • UV and moisture resistance. • Tamper-Evidence. • 15 styles of blisters to accommodate virtually all meds. • No machinery or space requirements. • Inexpensive – no capital outlay required.

Product Specifications

n Accompanying Labeling Software

• MILT 4 • MILT 3.0 • MILT 2.6 • Medi-Dose 2000

Trade Shows/Meetings Attended ASHP Midyear, ASHP Summer, Joint Forces Pharmacy Seminar, National Pharmacy Purchasing Association, EAHP, IACP, and various state, regional, and pharmacy compounding conferences. Ordering Information For additional information, please contact us at (800) 523-8966, visit our website at www.medidose.com, or email us at info@medidose.com.

WINTER 2020

H E A LT H S Y S T E M • I N F U S I O N 85

CAS E S TU DY IntelliVault & IntelliCab Oregon Health & Transform Prescription Science University Management at OHSU Pavilion Pharmacy RFID-based technology from GSL Solutions delivers safety, efficiency, and financial benefits at health system. Michael Deam, RPh Assistant Director, Outpatient Pharmacy Service ~ Oregon Health & Science University Pavilion Pharmacy Matthew Spinar, PharmD Supervisor, Pharmacy Services ~ Oregon Health & Science University Pavilion Pharmacy

“

Staff members at the pharmacy tell me they don’t know how they’d operate without that technology.” — Michael Deam, RPh

THE DECISION

www.gslcorp.com

CAS E S TU DY BEFORE

to light” technology, the IntelliVault system provides discrete stock storage and prescription filling of controlled medications (C2-C5), therefore helping OHSU meet several objectives. First, because users must use their badge to open the IntelliVault and can only access the specific medication that is needed, loss is virtually impossible. Simply using the system creates an automatic log without repetitive scanning. An automated C2 log, “AutoLog”, with 100 percent user accountability and medication product tracking vastly increased efficiency and any potential for diversion. This real-time tracking capability provided the level of security that empowered OHSU management to let technicians fill C2 prescriptions, freeing pharmacists to work to their licensure and focus on skilled clinical work. Michael Deam, RPh, Assistant Director of Outpatient Pharmacy, likes that the IntelliVault system allows for tracking of every single drug movement. He also appreciates that they no longer need to spend as much time in the perpetual inventory log manually recording each prescription dispensed. He estimates savings of up to an hour a day just on the log. Installation of IntelliVault took some work but it went off without a hitch, says Spinar, thanks to thorough planning. Spinar oversaw extensive dry testing to make sure the server they set up was going to work. Closer to the transition, they integrated the system with OHSU firewalls and brought the physical piece of hardware on site. During an overnight installation, Spinar and his team, as well as a GSL Solutions crew put the new IntelliVault safe in place. “We prepared for a long time to make sure it would go as planned.” The staff had an adjustment period, he says, mostly due to the changed workflow. IntelliVault provides “full autonomy for technicians. It put pressure on the technicians at first because there’s really no excuse for them not to integrate any prescription [narcotic] into their normal workflow,” Spinar says. “We had to get them to build that into their mindset.” It only takes one time to see just how easy it is to use IntelliVault, he adds. Users simply scan the prescription label and the appropriate drawer and cell lights up. “It’s so simple. It tells you what to do next. Staff-wise, the learning curve is very, very small.”

THE RESULTS Spinar’s pharmacy is right on the hospital’s main campus and dispenses a lot of medications for post-surgical patients. While they don’t handle a large quantity of narcotics, Spinar says the volume of prescriptions is high. This means they might fill up to 100 prescriptions for 10 oxycodone pills a day, which represented a lot of pharmacist time. Shifting this workload onto technicians was meaningful, along with pharmacist time saved from eliminating the manual perpetual log and providing better user accountability. By utilizing technicians to fill C2’s, “we’ve definitely seen a lot less people waiting in the waiting room,” he says. Prescriptions are now ready for pick up by the time the patient comes down from the floor. “We didn’t imagine before the installation how much of a difference this would really make, but it’s huge.” Another benefit centers around reconciling inventory. Before partnering with GSL Solutions, Spinar says they spent more time auditing errors that were self-inflicted than actual discrepancies in that manual log. “All it takes is one prescription you forgot to log,” says Deam. “The counts are off and you’re spending [pharmacist] time trying to figure out the missing prescription so your counts balance at the end of the day. You just don’t have that with IntelliVault,” says Deam, illustrating the high intelligence of the system that enables everything to be accounted for and resolved in real time. www.gslcorp.com

CAS E S TU DY AFTER

Return to stock processes have been simplified as well, Spinar says. Only the user conducting the return to stock function can pull medications from the IntelliCabs for will call. When a prescription is pulled from will call, the user has one-time access to the IntelliVault C2 safe. The return goes into the IntelliVault, and the door closes back up for a closed loop. The system then automatically increments the correct NDC inventory. IntelliVault’s receiving process adds another layer of safety check, Spinar says. The staff now scans and links the stock to RFID-enabled SmartBaskets, and the system automatically knows the drug name, strength, and more. They also can enter in the lot and expiration date. The linked basket is returned to the IntelliVault anywhere it fits, and this worklow alleviates time spent manually logging the right NDC, doing the math, and rotating stock. “We’ve eliminated sifting through our physical inventory to find any outdated or recalled lots,” Spinar says, since they now can easily track lot and expiration dates. We do a simple electronic database search when there is a recall and mark the product for destruction or return to vendor, he says. They can even track if someone historically received a recalled medication. IntelliVault provides immediate reports of what the pharmacy has on hand. “It’s nice to have a system that’s always tracking real time what’s available in your safe to be dispensed,” says Spinar. Prior to implementing IntelliVault, OHSU saw great success with the IntelliCab Will Call solution. The system provided for more efficient and accurate prescription filling and retrieval of prescriptions ready for patient pick-up, says Spinar. IntelliCabs eliminated misfiling, picking errors, and wasted space while reducing wait times and improving patient satisfaction. Spinar also appreciates the clean, professional appearance of the system. Staff no longer rummage through dozens of bags to find the right prescription. In the past, they used clear hanging bags, which were very error prone and inefficient. People in the lobby could potentially see identifying patient information through the clear bags. Now, with IntelliCabs, randomly filed prescriptions ensure patient privacy. If a staff forgets to link a prescription to a RFID SmartBasket, the system automatically alerts to help correct the issue. The system is self-healing and self-correcting.

THE CONCLUSION It’s hard to put a specific number on the time and cost savings OHSU has experienced with GSL Solutions, Spinar says. Preventing miss-sells and bundling errors with IntelliCabs “is worth its weight in gold for patient safety.” Improvements in turnaround at the pharmacy counter are hard to measure “but I know it’s a lot faster.” Implementing IntelliVault allows OHSU to use its staff members more efficiently. “Pharmacists don’t have to mess around with the C2 safe all day,” he says. “It’s a great product,” says Deam. “We’ve definitely streamlined our workflow and become more efficient [on how we use our staff]. I would certainly recommend.” OHSU has plans to implement IntelliCab at its second busiest location on campus, which fills 400500 prescriptions a day. Spinar and Deam both say the systems have more than met their needs and goals. “Staff members at the pharmacy tell me they don’t know how they’d operate without that technology,” says Deam.

www.gslcorp.com

Safety, Accountability, Efficiency and Compliance See what others have already discovered WITH AUTOLOG™ B Y

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See our full suite of products online Contact us: www.gslcorp.com |360.896.5354

TEMPERATURE INTELLIGENCE®

zebra.com | temptimecorp.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Temptime Temperature Intelligence® Solutions – Monitoring Devices and Integrated Solutions for Medication Shipments, Storage, and Pharmacy Facilities Providing the devices and information to accurately monitor temperature sensitive medications, indicating if they have been exposed to temperature events that could impact their effectiveness in treating patients.

President:

Anders Gustafson Founded: 1987 Employees: 90 Phone: (973) 630-6000 Fax: (973) 630-6100 Address: 116 The American Road Morris Plains, NJ 07950 Website: www.temptimecorp.com

Company Background

More than 30 years ago, Temptime Corporation developed the first miniaturized technology to monitor time-temperature exposure of vials containing the oral polio vaccine. Since then the company has deepened its commitment to public health by expanding its suite of easy-to-use, patient-centric temperature monitoring solutions to include those designed for both pharmacy and patient use. In 2019 Zebra – an innovator at the edge of enterprise solutions with expertise in healthcare, among other industries – acquired Temptime.

Product Overview

Through Temptime’s manufacturing facility, Zebra offers a comprehensive range of temperature monitoring solutions to meet the cold chain needs of specialty pharmacies and their patients. Their products include: • Visual, low-cost, chemically-based heat and freeze indicators for blood products, vaccines, biologics, and other medication during storage. • Heat and freeze indicators for monitoring medication during shipment. • Sophisticated electronic, wireless temperature and humidity monitoring systems with cloud-based data storage and sharing. Zebra is striving to improve supply chain efficiency, global health, and patient care through the effective deployment of devices and solutions that identify temperature excursions and provide information so that action to be taken.

Product Specifications

n Wireless Monitoring Systems The family of wireless Bluetooth®-enabled sensors monitor and record temperature data 24/7. The W-200 is designed for facilities and warehouses, monitoring both temperature and humidity in medication storage areas to help with accreditation compliance and regulatory requirements. Data can be accessed remotely using a web-based application and customized alerts notify users instantly if any areas have exceeded temperature limits.

The M-300 and S-400 programmable dataloggers are ideal for monitoring temperatures during transport or storage, letting users: • View and share temperature data with a free mobile app. • Customize alarm limits, datalogging intervals, startup options, and more. • Store unlimited data on the cloud and generate reports with a complementary web app. n Package Performance Qualification Testing

For specialty pharmacies, Package Performance Qualification (PPQ) testing ensures that the shipment packaging is able to provide the necessary temperature range for the required period of time during transport of critical and often lifesaving medications to patients. More than that, PPQ testing is also required for certain pharmacy accreditations, such as URAC. These wireless monitoring devices help specialty pharmacies simplify PPQ testing while providing data and information to optimize packouts. Customized Third-Party PPQ Testing services also help meet the requirements of pharmacy networks that make third-party validation testing a condition of participation. n TransTracker® Shipment Indicators TransTracker® visual temperature indicators monitor medication heat and freeze events during shipment. They are simple to read and understand so patients can tell at-a-glance if medication has been handled within the appropriate temperature range. These devices instill a higher level of patient confidence so that unnecessary, costly reshipments due to suspected temperature damage can be reduced or eliminated. These cost-effective, single-use indicators also help specialty pharmacies comply with state regulations.

Testimonial

97% of medication recipients said they prefer a specialty pharmacy that uses the TransTracker® indicator in its shipments.* * Based on “Experience of Specialty Pharmacies in TransTracker Product-in-Use Patient Research” with over 8,000 patient responses.

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A better, greener waste solution Cactus controlled substance waste management systems

Cactus Pharma Lock® OR System

Cactus Smart Sink® System

For more information, please call 800 253 3210.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Stryker's Cactus Smart Sink and Cactus PharmaLock OR Stryker's Cactus Smart Sink System securely captures partially administered, nonhazardous controlled substances and renders them non-retrievable and unusable. The Cactus Smart Sink System helps reduce drug diversion and improve patient safety while also reducing the impact on the environment.

President & CEO: Kevin A. Lobo Founded: 1941

Employees: 36,000+ Stock Symbol: SYK Toll-Free Phone:

(800) 367-5690 Phone: (269) 385-2600 Fax: (269) 385-2300 Address: 2825 Airview Boulevard Kalamazoo, MI 49002 Website: www.stryker.com

Company Background

When Dr. Homer Stryker, an orthopaedic surgeon from Kalamazoo, Michigan, U.S.A., found that certain medical products were not meeting his patients’ needs, he invented new ones. As interest in these products grew, Dr. Stryker started a company in 1941 to produce them. Today, we are one of the world's leading medical technology companies. Our growth is based on a diverse array of innovative products and services in orthopaedics, medical and surgical, and neurotechnology and spine that help improve patient and hospital outcomes – which we achieve through the dedication of our more than 33,000 employees globally. We are well-positioned to continue serving the worldwide medical community for generations to come. We think Dr. Stryker would be pleased.

Product Overview

Stryker’s Cactus Smart Sink System is an easy-to-use, “green” waste solution for partially administered, non-hazardous controlled substances pharmaceuticals. It accepts unused portions or partial doses of controlled substances and provides for a secure alternative to a sink, toilet, red sharps container, or waste bin for drug waste. This innovative and compact system helps bring medical facilities into compliance by eliminating the impact to our environment while preventing unauthorized use of partially administered DEA-regulated controlled substances. The Cactus Smart Sink System automatically secures and renders controlled substance waste unusable and non-recoverable while providing a secured bridge from traditional drug disposal to proper and responsible disposal. This system utilizes two replaceable cartridges: one liquid cartridge for liquid waste and one solid cartridge for capsules, tablets, and patches. Both cartridges allow for continuous disposal over time and are designed to last up to 90 days. The system utilizes automatic timers and weight indicators providing notice when cartridges are full or have expired. The system also allows you to choose a preferred expiration date by using the built-in timer selector switch.

The Cactus Smart Sink System helps bring medical facilities into compliance by providing a secured and environmentally friendly method of disposal. • It facilitates properly witnessed wasting of narcotics in the open and near the drug dispensing systems where needed, improving safety and saving time. • It allows for up-front waste documentation and facilitates this process to be completed immediately (when controlled substances are dispensed) rather than later. • It provides for secure disposal of partially administered, nonhazardous controlled substances, as opposed to the insertion of drugs into red sharps containers. • It reduces the opportunities for drug diversion by facilitating twoperson witnessed-wasting and by keeping partially filled vials and syringes out of red sharps containers, which have become a key source for drug diversion in medical facilities.

Features & Options

n Cactus Exclusives • Patented Proprietary Mixture: This patented technology uses a combination of denaturants and deterrents to render drugs unusable and non-recoverable in accordance with the DEA standards for controlled substance disposal.

• Secure System: The Smart Sink and PharmaLock OR are fully

locking systems, complete with universal key sets. Additionally, the Smart Sink has an alarm system with both audible and visual alerts that notify the user when the lid is unlocked and when the cartridges have reached roughly 90% of their wasting capacity.

n Technology: Offers both audible and visual alerts that notify the user when the cartridges are roughly 90% full.

Product Specifications

n Cactus Smart Sink • Accepts both liquid and solid pharmaceutical waste. Solids are accepted in the form of tablets, capsules, and patches. • Liquid cartridge solidifies drugs within 15 seconds with a wasting capacity of 3.6 L. • Solids cartridge features a uniquely designed pill maze and patch slot, rendering drugs acutely non-divertible with a max wasting volume of 1.7 L (approximately 1,500 pills). • Locking lid with a universal key set for added security. • Audible and visual alarm system that alerts user when lid is locked. • Audible and visual alerts to notify user when cartridges are full. • Can be wall or countertop mounted. • Comes with antimicrobial, wipeable exterior. • Powered by either a battery or AC adaptor unit.

D0000020373 AA.1

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CAS E S TU DY

The Evidence is in Numbers Tucson Medical Center Deters Drug Diversion With RxAuditor Investigateâ&#x201E;˘ PRIMARY INTENDED OUTCOME The mission at Tucson Medical Center (TMC) states to provide exceptional health care with compassion. In 2018, the Director of Pharmacy, Claudia Koreny, PharmD, knew the pharmacy department could do even more to uphold that pledge by creating the safest environment possible.

Claudia Koreny, PharmD Director of Pharmacy Services ~ Tucson Medical Center

Zachary Hodges, PharmD, BCCCP Medication Safety Officer ~ Tucson Medical Center

Value was also measured by a system that can target risk areas across TMC at any level of responsibility. Koreny worked with Medication Safety Officer, Zachary Hodges, PharmD, BCCCP, to map out the requirements for a system. For Hodges, the approach to automating diversion prevention aids TMC's zero-tolerance mentality because this act is a life-threatening offense with multiple victims â&#x20AC;&#x201C; from the patient who is not administered the drug, to the employees who perform additional work, and to the hospital that could lose its reputation and community trust.

www.medacist.com

CAS E S TU DY

“

For 27 years, I’ve seen TMC provide exceptional care. Medications play a vital role in overall health and well-being for our patients,” said Koreny. “I feel a great sense of responsibility to ensure everything goes right for our patients when it comes to their medication needs. Integrity and accuracy must be at the center of every quality and safety initiative we undertake.” Claudia Koreny, PharmD Director of Pharmacy ~ Tucson Medical Center

Confidence and accuracy must be apparent when addressing drug diversion with an employee and mitigating any false positives. The best method to back up a claim is with insurmountable, quantifiable evidence of an event. Achieving that proof requires sifting through data. If performed manually, the job requires a significant amount of staff resources and time ranging anywhere from an added hour to days depending on the case.

THE DECISION Stopping diversion is bigger than one person. TMC's drug diversion interdisciplinary team includes representatives from risk management; human resources; security; and nursing, physician, and pharmacy leadership. Koreny presented to the team that TMC needed to go beyond automated dispensing cabinet (ADC) reporting or employee screening to an advanced monitoring, surveillance, and detection platform. The team developed the following action-oriented criteria that guided the solution to choose RxAuditor Investigate from Medacist. 1. SAVE LIVES The needs of the patient come first, and anything impeding that primary value must be addressed with swift speed. Reducing diversions prevent patients from suffering from insufficient analgesia, anesthesia, or compromised syringes stemming from impaired employees.3 Uncovering an employee diverter could help save their life. 2. DECREASE TIME AND LABOR TMC needed to reduce time spent on manually accounting for pharmaceuticals, creating reports, and investigating employees that took up staff work hours and made for long days. Previous to RxAuditor Investigate, the manual labor produced stacks of paper for each one of the medications and lists of possible diverters that required painstaking reviews. Moving to automation eliminates crowdsourcing investigations and provides accurate lists in a judicious manner, which can mean giving back an eight-hour day to management. Time saved equates to time to support hospital improvement initiatives, time for staff education, and importantly, more time spent at the patient's bedside. RxAuditor Investigate delivers this decrease by reducing the false positives associated with traditionally identified statistical outliers. The system autonomously performs previously performed manual audits, and then applies over 70 levels of weighted risk scoring metrics to curate a list of "at-risk" individuals. 3. LOWER COSTS Diversion is stealing. Hospitals bear the cost of diverted drugs, internal investigations, employee turnover, and follow-up care for affected patients that are high-cost drivers. Fines for diversion events can be in excess of $4 million for inadequate safeguards.4 The investment in the RxAuditor Investigate demonstrates a deeper responsibility to patient health and well-being. 4. APPLY ACCURATE ANALYTICS RxAuditor Investigate instills confidence when deciding to advance an investigation or rule out an employee. The algorithms weigh more than 70 variables and uncover that outlier that denotes failure to document or why a drug was wasted or not returned. The reports offer drill-down capability and links that provide more of the story. RxAuditor Investigate also interfaces with Electronic Health Record Systems (EHRs), automated dispensing cabinets (ADCs), and timekeeping (Time & Attendance) systems and other data enrichment sources for advanced quantitative inferencing. This confidence gained with RxAuditor Investigate translates into saving hours, even days, spent in unnecessary investigations. The intelligence aid leaders in informed decision-making. 5. ENSURE EASE-OF-USE

www.medacist.com

TMC wanted the ease of producing a single-glance, tell-me-what-I-need-to-know report for leadership. The curated list of "at-risk" individuals stems from a more extensive list of statistically 95

CAS E S TU DY

“

The investment in the platform represents TMC's commitment to patients," said Koreny."When we investigate ‘at-risk’ individuals, we've seen a physical reaction when they realize the thoroughness and precision of the diversion report.”

identified diversion outliers. TMC can also easily flag users with high transaction volumes for a particular class or group (e.g., all hydromorphone-containing products). The functionality of RxAuditor Investigate allowed for a 100 percent adoption rate by the interdisciplinary team. 6. OWN BEST-IN-CLASS With RxAuditor Investigate, TMC has a legacy system bundled with more than 20 years of machine learning and diversion behavior patterns from over 2000 hospitals, backed by a U.S. patent. TMC accesses a robust, centralized diversion knowledgebase (Genesis) weighing and analyzing various diversion outcomes to produce algorithms that target a diversion activity. Medacist's Genesis knowledgebase contains 10.1 petabytes of data confirmed by actual diversion events and enriched by multiple data sources. This platform delivers the highest level of diversion analytics in the industry, which differentiates Medacist from competitive solutions and quantifies RxAuditor Investigate as "best-in-class." Thousands of hospitals across the U.S. have relied on RxAuditor Investigate to ensure regulatory compliance, reduce liability, and ensure patient safety.

THE RESULTS The purchase of RxAuditor Investigate provides TMC's leadership with peace of mind and the confidence that the interdisciplinary team is doing their best to keep the patient safe. Pharmacy operations has a single source of truth that can mitigate reputational risks and patient safety concerns. The cases produced allow for centralized management with a dashboard that illuminates all aspects of the case, which streamlines work for the team. The previous need to perform time-consuming manual audits is gone. TMC now has technology that audits, evaluates scores, and ranks risk, thus reducing false positives and curating a targeted list of "at-risk" individuals. For example, with a minimum of one FTE from each discipline (pharmacy, nursing, risk management, human resources, anesthesia, and security), the reduction of FTE’s spent per month in suspected diversion equates to a minimum of 3-4 hours savings per detailed audit for reduction of a false positive statistical outlier. In addition, RxAuditor Investigate achieved the following for TMC: • • • •

Improved compliance with drug usage protocols, resulting in effective processes. Identified otherwise unknown diverters, resulting in a safer hospital. Improved diversion investigation, resulting in increased efficiencies. Decreased demand for staff dedicated to investigating diversion, resulting in time given back to patient care. • Improved the false positive rate of diversion detection, resulting in increased confidence.

THE CONCLUSION In healthcare, a case of drug diversion can be that one bad incident that can harm many. The numbers indicate the opioid crisis is still growing, but advancements in technology hasten leaders' ability to prevent it in their hospital. The quantification of benefits and cost-effectiveness advantage health systems who opt for a platform approach, such as RxAuditor Investigate, to deter diversion. Medacist offers healthcare leaders an analytics engine powering data and algorithms to identify diversion risks through pattern recognition. The bottom line, analytics offer the ability to stop a person from illegally taking drugs. 1. https://www.aacc.org/publications/cln/cln-stat/2020/august/20/when-a-substance-abuse-crisis-and-pandemic-intersect 2. https://www.cdc.gov/injury/features/prescription-drug-overdose/index.html 3. https://www.journalofhospitalmedicine.com/jhospmed/article/202732/hospital-medicine/diversion-controlled-drugs-hospitals-scoping-review 4. https://www.journalofhospitalmedicine.com/jhospmed/article/202732/hospital-medicine/diversion-controlled-drugs-hospitals-scoping-review

www.medacist.com

T R A D E S H O W & M E E T I N G E v e n t Calendar

Behind Every Good Pharmacist, is a Great Resource.

Event Calendar

Trade Shows, Meetings, & Expositions Due to COVID-19, all trade shows and meetings are subject to change. Please confirm with the individual organization for updates.

RXinsider’s Virtual Pharmacy Trade Show 24 / 7 / 365 450+ Booths, 91 Aisles www.rxinsider.com

NHIA 2021 Annual Conference February 27-March 3, 2021 Austin, TX nhia.org/conference

ASHP Midyear Clinical Meeting & Exhibition December 6-10, 2020 Virtual Event midyear.ashp.org

2021 FAH Public Policy Conference and Business Exposition March 7-9, 2021 Washington Hilton Hotel Washington, DC www.fah.org/conference/ FAH-Conference-andBusiness-Exposition

PDS Super Conference February 11-13, 2021 Disney’s Coronado Springs Resort Orlando, FL Pdsconference.com 340B Coalition Winter Conference February 16-24, 2021 Virtual Event 340bwinterconference.org American College of Apothecaries Annual Conference & Expo 2021 February 23-27, 2021 Wyndham Grand Rio Mar, Puerto Rico acainfo.org/ace

APhA 2021 March 12-15, 2021 Los Angeles, CA Aphameeting.pharmacist.com NACDS Annual Meeting April 24-27, 2021 The Breakers Palm Beach, FL Annual.nacds.org Asembia 2021 Specialty Pharmacy Summit May 2-5, 2021 Las Vegas, NV Asembiasummit.com

Continued on page 101 For listing and advertising details, please contact sales@RXinsider.com or call 800.972.2083.

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H E A LT H S Y S T E M • I N F U S I O N

With 80+ aisles, the Virtual Pharmacy Trade Show is pharmacy’s one-stop destination to research and connect with leading providers of products and services.

RXinsider.com

We provide support in addressing your 340B operational and compliance challenges Prepare for a government or manufacturer audit

Stay compliant with changes to Medicare Part B reimbursements

Compare split-billing software vendors

Connect with 340B hospitals around the country

Member Benefits Advocacy

As your voice in Washington, we encourage you to join our advocacy efforts to protect 340B, which includes creating an Impact Profile document illustrating how your savings support your safety-net mission. Our staff is ready to help your hospital engage in advocacy through the development of op-eds and social media campaigns.

Webinars

You and your staff will be invited to 340B related webinars throughout the year on topics ranging from audit prep and findings to recertification. We host over a dozen webinars each year and encourage your team to join us.

Individual Membership

Through your hospitalâ&#x20AC;&#x2122;s membership, you are eligible to join this supplemental program which provides professional development and networking opportunities.

Real-Time 340B Information

Stay in-the-know and up to date through our email alerts, members-only bi-weekly Bulletin, and the 340B Informed blog.

Technical Assistance (TA) Calls

Take advantage of this invaluable resource by speaking with a member of our legal and/or pharmacy teams. Our staff is able to answer questions on topics ranging from audit prep and diversion to adding child sites and drafting policies and procedures.

National Conferences

340B Health, along with our 340B Coalition partners, provides you unparalleled access to information and networking opportunities at our summer and winter conferences. 340B Health and 340B Coalition members receive discounts to both events.

340B Health Website

The website has sample forms, letters and P&Ps, as well as policy guides and member best practices. Miss a webinar? No problem, past webinars are housed on our website. Find our audit and compliance resource centers along with a calendar of upcoming events.

The Exchange

Access our secure online member discussion forum 24/7 for answers to your most pressing 340B related questions, hear ideas and best practices, and grow your network.

Roundtables

340B Health hosts interactive roundtables throughout the year. In 2018 alone, roundtables were conducted in nearly a dozen states. These half-day seminars provide vital 340B information, create a forum for idea generation, and are always free to attend.

Questions? Contact Shane Kelley at (202) 552-5864 or email shane.kelley@340bhealth.org.

T R A D E S H O W & M E E T I N G E v e n t Calendar

Event Calendar

Trade Shows, Meetings, & Expositions Due to COVID-19, all trade shows and meetings are subject to change. Please confirm with the individual organization for updates.

Continued from page 98

ASHP Summer Meetings and Exhibition June 5-9, 2021 Long Beach, CA www.ashp.org/Meetingsand-Events McKesson ideaShare June 23-27, 2021 San Diego, CA Mckessonideashare.com Cardinal Health RBC July 14-17, 2021 Orlando, FL Rbc.cardinalhealth.com

NACDS Total Store Expo August 21-23, 2021 Denver, CO Tse.nacds.org ECRM - Health System/ Institutional Pharmacy Program September 27-30, 2021 TBD ecrm.marketgate.com/ sessions NCPA Annual Conference October 9-12, 2021 Charlotte, NC Convention.ncpa.org

AACP Annual Meeting 2021 ASCP Annual Meeting July 17-21, 2021 & Exhibition Toronto, ON November 4-7, 2021 aacp.org/events Town and Country San Diego, CA 2021 HIMSS Global Health www.ascp.com Conference & Exhibition August 9-13, 2021 Las Vegas, NV www.himss.org/events

For listing and advertising details, please contact sales@RXinsider.com or call 800.972.2083.

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H E A LT H S Y S T E M â&#x20AC;˘ I N F U S I O N 101

THE CLEAR CHOICE FOR A SPORICIDAL PRODUCT

MINIMIZE THE SMELL • MINIMIZE RESPIRATORY CONCERN* • KEEP THE SAME 3 MINUTE C. DIFF CONTACT TIME

Make the Right Choice!

WWW.STERILE.COM

Veltek Associates, Inc.

*Hydrogen peroxide at 0.64% and peroxyacetic acid at 0.14% in a 3 fl. oz/gallon solution. Site specific exposure levels must be determined to ensure adequate ventilation is achieved.

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

DECON-SPORE 200® Plus From Veltek Associates, Inc. DECON-SPORE 200 Plus has been designed for the hospital and healthcare industries. This EPA registered Peracetic Acid and Hydrogen Peroxide solution kills Clostridium difficile spores in three minutes while having a reduced obnoxious odor.

President & CEO: Arthur Vellutato Jr. Founded: 1981 Employees: 200 Toll-Free Phone:

(888) 4-STERILE (610) 644-8335 Fax: (610) 644-8336 Address: 15 Lee Boulevard Malvern, PA 19355 USA Website: www.sterile.com Phone:

Company Background

Veltek Associates, Inc. (VAI) is the leader in contamination control for pharmaceutical, biotechnology, medical device, and USP <797> industries worldwide. We design innovative solutions to address the control of particulate and microbial contamination while striving to develop meaningful technical relationships with our clients. VAI has been an industry leader since 1981 and owns numerous U.S.A. and foreign patents. VAI’s comprehensive USP <797> contamination control program provides a guide to assuring patient protection in compounding sterile preparations. Our full-circle approach addresses the practices and conditions required by USP to maintain safe and compliant aseptic compounding. For each condition and practice required, VAI has an answer. VAI is committed to continual innovation and improvement of our products to satisfy current and future regulatory requirements. Our industry experience and corporate capabilities provide the framework for continuing our leadership in contamination control. VAI’s product lines include: environmental monitoring equipment, laboratory services including antimicrobial testing, saturated wipers, dry wipers, a USP <800> compliance wipe kit, sterile disinfectants, sterile sporicides, cleaning agents, cleaning application equipment, personnel gowning, and consulting and training services.

Product Overview

DECON-SPORE 200® Plus is an EPA registered Peracetic Acid and Hydrogen Peroxide solution that is for use as a broad-spectrum sanitizer, disinfectant, virucide, fungicide, sporicide, cleaner, and deodorizer in the hospital and healthcare industries. DECON-SPORE 200 Plus solution cleans, disinfects, and deodorizes hard, non-porous hospital/medical surfaces in one step with no rinsing required. This product quickly removes dirt, grime, blood, and other organic matter commonly found in hospitals, healthcare facilities, and on medical surfaces. When used as directed, EPA A.O.A.C. testing has demonstrated that DECON-SPORE 200 Plus kills Clostridium difficile spores in three minutes.

DECON-SPORE 200 Plus is available as a 2.3% sporicidal dilution ratio (3 oz/gallon) in a 16 oz trigger spray and one gallon container. Both 16 oz and one gallon containers are sterile and come in our one-step, ready-to-use, SimpleMix® System. Each sterile container of DECON-SPORE 200 Plus is individually double-bagged sterile in easy-tear packaging.

Product Specifications

n Quality and Manufacturing • Filled in an ISO 5 (Grade A/B, Former Class 100). • Filtered at 0.2 microns. • Components are air washed with 0.2 micron filtered air before assembly. • Aseptically filled into sterile components via gamma irradiation. • Lot sterility tested according to current USP compendium. • Completely traceable from start to finish. • Completely validated for sterility and shelf life. n Features and Benefits • Each sterile container is individually double-bagged in easy-tear packaging. • Individually labeled with lot number and expiration. • Delivered with lot specific Certificate of Analysis and Certificate of Sterility. • Available in the convenient, one-step, ready-to-use, SimpleMix® System. • Cleans, disinfects, and deodorizes hard, non-porous hospital/medical surfaces in one step with no rinsing required. • One-step hospital use germicidal disinfectant cleaner and deodorant. • Quickly removes dirt, grime, blood, and other organic matter commonly found in hospitals, in healthcare facilities, and on medical surfaces. • One-step fungicide at 3 oz per gallon of water; treated surfaces must remain wet for 10 minutes. • Designed for killing C. diff spores on pre-cleaned, hard non-porous surfaces in hospitals; kills in three minutes. • Tough on C. diff spores but easy on surfaces and designed for daily use.

Trade Shows/Meetings Attended

VAI will be attending ASHP’s Midyear 2020 Virtual Meeting where we will be discussing our DECON-SPORE 200 Plus and other USP <797> compliance products. Please come visit us at our virtual booth!

Ordering Information

Contact VAI or one of VAI’s numerous healthcare distributors for ordering information on DECON-SPORE 200 Plus or any of our other USP <797> contamination control products.

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swisslog-healthcare.com

Discover whatâ&#x20AC;&#x2122;s possible when you redefine medication management. Visit swisslog-healthcare.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

CEO:

Stephan Sonderegger President: Cory Kwarta Founded: 1915 Employees: 500-1,000 Toll-Free Phone: (800) 764-0300 Address: 11325 Main Street, Broomfield, CO 80020 Website: www.swisslog-healthcare.com

Company Background

Swisslog Healthcare connects the medication supply chain, bringing together automated transport and pharmacy automation solutions in more than 3,000 healthcare institutions worldwide. These connections are made possible through: • Proven pharmacy robotics • Enterprise medication management software • The industry’s most trusted pneumatic tube systems • Front-of-house autonomous service robots • A pharmacy-driven delivery tracking system Through an agnostic approach to integration, Swisslog Healthcare enables forward-thinking health systems to create a connected medication ecosystem. Learn more at www.swisslog-healthcare.com.

Product Overview

BoxPicker reinvents medication storage by streamlining workflow and storing medication inventory in one central and secure location. BoxPicker decreases the opportunity for picking errors by limiting accessible medication and requiring barcode scanning with any medication movement. With the ability to include refrigerated modules and multiple operator stations (including inside the ante-room), Swisslog Healthcare can configure a BoxPicker to fit any pharmacy operation. • Elevated Efficiency. Hourly productivity and picking performance are increased through multi-user, multi-tasking, automated storage, and retrieval. Multiple workstations allow simultaneous operation by several technicians. Integration with existing hospital information and cabinet vendor systems enables the BoxPicker to pick medication three picks ahead of the operator. As an option, when paired with Pharmacy Manager, medications stored outside the automation can be managed and organized to allow optimal workflow and efficiency where orders are separated, prioritized, and routed to the correct location for dispensing or stocking. • Ultimate Medication Control and Safety. BoxPicker requires scan in and scan out tracking that decreases opportunity for error, and secure access ensures inventory control and audit capabilities. BoxPicker minimizes access to the number of different medications per user, therefore reducing picking errors.

• Custom Configuration and Scalable Technology, Including

Cleanroom Access, Dual-Temp, and Fully Refrigerated Options.

The modular design and flexible operator station placement allow pharmacies to configure the solution to meet their current and future needs. Additionally, the BoxPicker offers refrigerated modules or operator stations built in the anteroom for direct medication access from the cleanroom suite. This supports USP <797> compliance by providing a secure pass-through to anterooms, and positive-pressure airflow ensures environmental integrity. High-density storage and retrieval allows for greater storage within a smaller footprint without floor reinforcement.

To learn about BoxPicker, visit: swisslog.com-healthcare.com/boxpicker

Additional Product Lines

Pharmacy Manager is a medication management software designed with growing health systems in mind. It takes the lead on incoming and outgoing orders, becoming the central point of truth for pharmacy inventory control. Pharmacy Manager can manage the inventory of all the medications within the enterprise and improve the pharmacy workflow by streamlining orders, managing expiration dates, and minimizing waste. PillPick® Automated Packaging and Dispensing System decreases human touches in bar coding, packaging, storing, dispensing, and returning unit-dose medications. The patented PickRing® delivers patientspecific medication on a single ring ready for administration, reducing the opportunity for missed medications and speeding up administration time. AutoCarousel® Semi-Automated Pharmacy Storage System transforms medication management by reducing labor, drug waste, missing medications, and picking mistakes. AutoCarousel is accurate and reliable, and the vertical design ensures maximal storage in a compact footprint, reclaiming valuable pharmacy space. AutoPack® Automated Oral Solid Packager allows pharmacies to pre-package tablets for unit dose dispense. Or, through integration with hospital information systems, orders can be filled on demand, including cabinet replenishment orders or patient-specific cart fill or STAT orders. AutoPack further minimizes human touches and maximizes productivity. Relay® is the first autonomous service robot designed to work around people in busy hospitals. Highly useful for hospitals without a pneumatic tube system or for “Do Not Tube” items, this healthcare robot handles deliveries quickly, safely, and reliably, increasing productivity by allowing staff to focus on high-value tasks, while improving their overall experience and ultimately patient outcomes.

Markets Served

• Hospitals and Health Systems • Long-Term Care • Correctional Healthcare Settings WINTER 2020

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CAS E S TU DY Facility and Engineering Control Design Under USP <800> In light of the recently published versions of USP chapters <795>, <797>, and <800>, with the intention of creating cohesive alignment between nonsterile and sterile compounding, it is essential to consider engineering controls for HD handling with these two categories of compounding. Issues such as compounding volume, production downtime during renovations, air filtration, make up air units, and exhaust methods all factor into the design considerations for creating a compliant HD compounding operation. Bryan Prince, MBA Owner and Lead Consultant ~ Red Pharmacy Consultants

Shawn Valandra Owner ~ SVE Industrial Air Filtration Solutions

MINIMIZE DOWNTIME Losing production capacity during the remodeling process is a serious concern for pharmacies, so it is crucial to strategically plan the construction steps with the goal of averting downtime wherever possible. Have a frank discussion with the general contractor and the project team at the outset to help all parties understand that downtime is to be minimized. Whenever possible, it is recommended to utilize a phased approach to construction to minimize any negative impact on compounding production.

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CAS E S TU DY recirculating model with little to no fresh air being introduced into the facility. In larger facilities, there may be an outdoor air damper on the air handler that allows for a small percentage of fresh air to be introduced into the system. In smaller facilities, it is not uncommon for fresh air to only be introduced into the building when the external building doors happen to open. Regardless of the package model type, in almost every case, the solution for replacing externally vented air is introducing a new makeup air unit (MAU) to satisfy the minimum ACPH requirement. The MAU draws in outside air, conditions it to appropriate temperature and humidity, and then supplies it to the HD compounding room. Because conditioning air from outside can be costly, some pharmacies may consider whether it is appropriate to instead draw on already conditioned air within the building. Doing so would require taking a percentage of conditioned air from the hallway, retail area, or office area and recirculating it into the dedicated MAU for introduction into the sterile or nonsterile HD compounding room. The HD compounding room would then vent that air out of the building.

“

HD cleanroom specifications and instruction should utilize the term air exhausts or low wall exhausts so that the architects, engineers, and contractors do not misinterpret the necessary direction of the air.”

There are multiple concerns with this approach; perhaps the most important is that the conditioned air from a common space may be above the temperature and humidity targets for the HD compounding room. Because of the operational simplicity of a standard commercial package/split system, an individual unit is not able to control temperature and humidity, which precludes it from being utilized to supply air to a controlled environment. A single pass of that common conditioned air through the dedicated MAU will not be enough to satisfy the HD compounding room targets, mainly because the setup makes the HD room parasitic to the space the air is being taken from. A further concern is that the local HVAC contractor likely has a

complex network of duct work, dampers, and controls to negotiate in order to determine the recirculation formula from common areas to HD compounding rooms. Most importantly, if air is redirected from any area (eg, retail, office, etc), that air then must be replaced, or the equation can cause the entire facility (or area) to become negatively pressurized, creating the potential for unhealthy interior conditions such as microbial growth and carbon dioxide buildup. Therefore, a dedicated MAU for the HD compounding rooms proves to be the most straight-forward mechanical solution. While most commercial spaces rely on the common HVAC concept of air tonnage (ie, the number of BTUs the AC unit can remove in one hour) to plan for their HVAC needs, this concept does not apply to externally vented rooms; rather, cubic feet per minute (CFM), temperature, and humidity targets are the key HVAC criteria for compounding spaces. As a general rule, one ton equals 400 CFM, but using that logic, the pharmacy would exceed tonnage trying to achieve adequate CFM coverage. Even then, there would not be sufficient cooling capacity to make a standard commercial package unit cool 100% outside air. Better logic for achieving the desired temperature and humidity in the HD compounding room is sizing a custom HVAC to the proper CFM. Pharmacies must select a mechanical engineer who understands these concepts.

ACPH: DESIGN TO A HIGHER STANDARD When engineering an air handling system for HD rooms, it is advised to avoid designing to the lowest common denominator; rather, the design should exceed the minimum ACPH as defined by the USP chapter. If the air handling unit is engineered simply to meet USP’s lowest design standard, it is likely that the air handling unit and HD room will fail to maintain design parameters for ACPH, temperature, and humidity in all situations. The minimum design requirement for a hazardous nonsterile room, or unclassified containment segregated compounding area (C-SCA), is 12 ACPH. In the hazardous sterile buffer room, the minimum requirement is 30 ACPH. Special consideration must also be given to temperature, which should be maintained below 20°C, and humidity, which should be maintained below 60% relative humidity. An effective design must also take into account the fact that people, equipment, and processes generate additional heat gain in the room. Furthermore, in certain geographic areas, temperature and humidity may be more difficult to control. Therefore, designing the air handling system to meet the required ACPH will likely require adjustments to accommodate both compounding processes and local climate. As such, it is best practice to design the nonsterile HD room with up to 18 ACPH and the sterile HD buffer room with up to 45 ACPH. While more ACPH requires more energy, which equals higher costs, the alternative of a cleanroom that fails to achieve compliance is exceedingly expensive.

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CAS E S TU DY The compounding room, whether modular or stick built, can be expected to experience some amount of air infiltration or exfiltration. For example, doors will leak air an average of 80 to 130 CFM, depending on factors such as how the door slab seats into the frame, the size of the gap between the slab and the floor, the presence of gaskets and sweeps, and the amount of room pressure. The greater the room pressure (eg, closer to .03" water column [WC]), the more air is being pulled around the door. It is recommended that the design of the negative pressure HD room stay as close to .01" of WC as possible. The greater the room pressure, the greater the rate of infiltration (for negative pressure).

CREATE A TIGHT ENVELOPE Infiltration is an important design concept, as negative pressure sterile HD compounding rooms can experience failing viable counts during environmental monitoring due to moisture and bacteria being pulled into the room. Negative pressure rooms, by nature, allow air infiltration, which has the potential to introduce bacteria, moisture, and other unwanted sources of contamination around doors, light switches, electrical outlets, or other wall penetrations. To better seal the exterior of a stick-built room, include a vapor barrier around the structure. To seal the wall penetrations, spray foam (preferably with an antimicrobial cleaning agent) can be utilized, but be cautious around electrical wiring and ensure that local building codes do not prohibit this practice. USP <797> states, “Seals and sweeps should not be installed at doors between buffer and ante-rooms.”1 The reasoning behind this is to promote ease of cleaning. Seals and sweeps are rarely cleaned in ISO-related environments and therefore may harbor bacteria. However, there is a downside to not using seals and sweeps in a negative pressure environment as this reduces the control over airflow. Nonetheless, it is more important to keep the sterile compounding environments clean and identify other means of controlling air infiltration. Inlaid ceiling panels and grids are a subtle culprit of air infiltration in negative pressure rooms. The space above the ceiling is commonly referred to as the interstitial space and can be a relatively dirty area. If the ceiling is a source of air infiltration, the recommended best practice is to caulk the ceiling grid to the perimeter walls. USP <797> states the following as further justification: “Junctures between the ceiling and the walls and between the walls and floor must be sealed to eliminate cracks and crevices where dirt can accumulate. If ceilings consist of inlaid panels, the panels must be caulked around each panel to seal them to the support frame.”1 As a best practice, it is recommended that caulking be applied after construction is complete and the HD room has been 108

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thoroughly cleaned to remove all debris and dust. It is further recommended to use a cleanroom caulk, because other sealants may absorb dust and present challenges to proper cleaning.

LOW WALL EXHAUSTS USP Chapter <800> does not detail how HD rooms are to be externally vented, but based on airflow patterns, best practice is to use a low wall exhaust. The recommended design is to supply the air from the ceiling and place the exhaust vents just above the finished floor. Because air takes the path of least resistance, circulating air will move from top to bottom, and essentially sweep the room. A low wall exhaust is typically a metal grill, square or rectangular depending on the amount of CFM, placed about 8" to 12" above the finished floor. USP <797> states, “Air returns in the cleanroom suite must be low on the wall unless a visual smoke study demonstrates an absence of stagnant airflow where particulate will accumulate.”1 It is important to understand that this direction from USP <797> applies to USP <800> cleanroom suites as well; however, the air returns terminology implies air will be returned or recirculated back into the air handler. A better term to use for the HD cleanroom specifications and instruction is air exhausts or low wall exhausts so that the architects, engineers, and contractors do not misinterpret the necessary direction of the air. Notably, there is no airflow design reference in USP Chapter <795> for nonsterile compounding. Nonetheless, nonsterile compounding rooms typically experience heavy power handling. Should technicians breach containment with contaminated gloves or instruments, micron-size powders can aerosolize and become airborne, potentially entering the HD compounding room. To counteract this risk, the use of low wall exhausts in the nonsterile room is recommended to sweep the room with air and eliminate dead zones. Theoretically, any aerosolized powder in this situation would be forced down to the floor, where it can be cleaned during the daily cleaning routine or exhausted via the low wall exhaust.

AIR FILTRATION PRIOR TO EXTERNAL EXHAUST USP Chapter <800> indicates that air exhausted from the HD compounding room should be filtered through HEPA filtration located inside the containment primary engineering controls (C-PECs). There are both sterile and nonsterile compounding room designs which include a low wall exhaust used either to supplement the exhaust CFM or to carry all the C-SEC exhaust as part of the ACPH calculations. If low wall exhausts are used as a means of externally exhausting all, or even a small percentage of, the C-SEC’s air, then they must be HEPA filtered as well. In the event of a bulk powder spill in the HD room, airborne aerosolized particulates will be generated. In this situation, if the low wall exhaust is directly ducted to the external exhaust blower without any HEPA

CAS E S TU DY filtration, this will release a potentially contaminated airstream directly to the outside atmosphere. For this reason, a HEPA filter module should be in line with the exhaust duct before the exhaust blower. It is strongly recommended that the HEPA filter module contain a “bag-in/bag-out” (BIBO) feature, which protects staff members from exposure to contamination while replacing HEPA filters.

BALANCING THE NEGATIVE PRESSURE ROOM Occurring near the end of the design project, a third party sets the supply CFMs and makes adjustments on the exhaust blower to balance the negative pressure rooms to .01" WC to .03" WC, which may prove to be a tight parameter of balance. For this reason, it is imperative that engineering solutions are available to maintain absolute control over the negative pressure room. The totality of room variables such as wall/ceiling/door infiltration, supply diffuser type, and exhaust source (ie, via the C-PEC or low wall exhaust), combine to make the test and balance process imperative. Per USP <797>, “Air supplied to the cleanroom suite must be introduced through HEPA filters that are located in the ceiling of the buffer and ante-rooms.”1 The most common way to introduce air into a cleanroom is with a fan filter unit (FFU), also known as a fan-powered HEPA. Since the tiles and ceiling grid must be caulked, the FFU should have a room-side accessible fan speed controller so that supply CFM can be accurately dialed. If the facility needs multiple FFUs, certain models can be wired together and centralized into a main control panel, allowing each FFU to be adjusted from the control panel. The goal is to simplify the process for the provider conducting the test and balance, as well as the cleanroom certification representatives, who also play a role in the balancing process. Integrating the FFU as a supply source may be a reasonable strategy in the nonsterile HD room as well, not for an intended ISO room rating, but because the fan speed and supply CFM can be accurately dialed in during the room’s test and balance process. The FFU supply strategy is more expensive than a traditional supply diffuser, but gaining absolute control over the supply CFM air is vital. A best practice in HVAC design is utilizing dampers over the supply and exhaust, especially in negative pressure rooms. Dampers installed in the ductwork allow airflow to be manipulated in and out of the room; however, one challenge associated with damper control is access after the ceiling tiles have been caulked. It has been a common practice to refrain from sealing one ceiling tile to allow for future access, but if the supply

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and exhaust ducts are spread apart, it is unlikely that one ceiling tile will be sufficient. State boards of pharmacy do not typically support this approach, so caution is advised in this area. It is possible to cut the caulk seal with a utility blade to allow access, but then tiles must be caulked again, creating extraneous labor and downtime in the compounding rooms. One unique solution we recommend as a best practice is the integration of gear drive dampers. The gear drive damper allows for room-side access to the damper for manual adjustment of supply or exhaust airflow.

CONCLUSION When updating a facility and engineering controls, it is essential to clarify the scope of the project, taking into account the many design choices, product options, and price points offered in the market. When assembling project teams that may include architect, mechanical engineer, structural engineer, electrical engineer, and various other general contractors, all parties must understand the full scope of your business model, and they should read the appropriate section in USP chapters <795>, <797>, and <800> to better conceptualize the goals of the project. Each step taken toward compliance ensures safety and productive workflow. 1. USP General Chapter <797>. Pharmaceutical Compounding - Sterile Preparations. Second Supplement to United States Pharmacopeia and National Formulary (USP 42-NF37). www.usp.org/compounding/generalchapter-797. Accessed October 3, 2019.

“

Dampers installed in the ductwork allow airflow to be manipulated in and out of the room; however, one challenge associated with damper control is access after the ceiling tiles have been caulked.”

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See our full suite of products online Contact us: www.gslcorp.com |360.896.5354

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

IntelliVault, IntelliVault MTB, IntelliCab, and IntelliStock by GSL Solutions, Inc. The full suite of GSL Solutions, Inc.’s products are integrated in a single software, IntelliSys™, which uses Radio Frequency Identification (RFID) to physically track medications while achieving efficiency in operations, reduction of labor hours, increased compliance, and higher user and patient satisfaction.

President & CEO: Shelton Louie Founded: 2000 Toll-Free Phone:

(866) 477-2682 (24-Hour Support) Sales Phone: (360) 896-5354 Fax: (360) 397-0496 Address: 2414 SE 125th Avenue Vancouver, WA 98662 Website: www.GSLcorp.com

Company Background GSL Solutions Inc’s technologies are founded by the marriage of the minds of an engineer, Steve Garrett, and a pharmacist, Shelton Louie. Both understood from the very beginning that prescriptions are physical products that need to be tracked physically. Further, they added the requirement that the technology they developed would track automatically, without repetitive scanning. These requirements led them to use RFID in their family of products, which all run on the IntelliSys platform, ensuring accountability. The system is based on real-time RFID and integrates seamlessly, allowing tracking medications from receiving through the sale. Achieve efficiency in operations through an automated C2 log, 100% user accountability, and pill tracking. Product Overview GSL Solutions offers several products to meet the needs of a multitude of pharmacy environments: IntelliVault™, IntelliVault MTB™, IntelliCab™, and IntelliStock™. Each product can stand alone, or can work together to provide a seamless workflow. n IntelliVault

The IntelliVault provides discrete stock storage and prescription filling of controlled medications (C2-C5). The user is required to use their badge to open the IntelliVault and can only access the specific medication that is needed. The physical use of the system creates the log just by using it without repetitive scanning. Efficiency in operations is achieved through an automated C2 log (AutoLog™) with 100% user accountability and medication product tracking. The system’s inventory reporting can be configured to meet any of your internal needs and pharmacy board requirements. Reports are in real-time. With the IntelliVault, technicians can fill C2 prescriptions, freeing pharmacists to focus on skilled clinical work.

n IntelliVault MTB (Meds-to-Bed)

IntelliVault MTB (Meds-to-Bed) modifies the functionality of the IntelliVault for storage of home medications and the dispensing of discharge medications at the patient’s bedside. Discrete “pick to light” access ensures safety, efficiency, and accountability. n IntelliVault RD (Remote Dispense) IntelliVault Remote Dispense uses the IntelliVault platform to provide efficient remote delivery of medications from the filling pharmacy to your patient discharge dispensing location. Discrete “Pick to Light” access ensures safety, efficiency, and accountability. n IntelliCab

The IntelliCab will-call system eliminates misfiling, picking errors, and wasted space while providing safe and HIPAA compliant will-call storage, reduced transaction times, and increased customer service. Return-to-stock is performed with the touch of a button in minutes instead of hours. The IntelliCab is easy to install without construction or disruption to your operation while saving up to 50% of will call space. One of the optional AutoFeatures, AutoNotify, will automatically notify a patient when their medication is shelved in the IntelliCab. This feature can also notify patients of recalls. When paired with the IntelliVault system, a complete chain of custody and pedigree is maintained from stock receiving to prescription filling to patient pickup. n IntelliStock

IntelliStock allows for tracking of all non-controlled medication stock with full user accountability. The system performs automatic NDC verification while identifying the right stock bottle and quantity of a drug needed to fill a prescription without repetitive scanning. The system uses the oldest drugs first automatically and will not dispense any expired or recalled medications. Inventory reports are in real-time and can be configured to your internal needs and pharmacy board requirements. The full suite of GSL Solutions products are integrated in a single software to ensure full accountability with less labor, increased compliance, reduced transaction times, and elevated customer service and patient safety.

WINTER 2020

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» USP 795, USP 797, USP 800, and 503B Compounding Pharmacies

» Airlock Entry for Added Safety » Purchase or Monthly Rentals » Large Fleet and Nationwide Coverage » Pre-built and Ready for Use Upon Delivery » Standard or Customized Layouts

Mobile Dual-Purpose USP 795, USP 797, and USP 800 or 503B Cleanrooms

Mobile Single-Purpose USP 795, USP 797, and USP 800 Pharmacy Cleanrooms

CALL FOR INFORMATION OR TO REQUEST A QUOTE (317) 333-8742 www.cleanroomdesignllc.com | www.portable-cleanroom.com

2 0WAY S TO I M P R O V E PAT I E N T C A R E & P H A R M A C Y C O S T C O N TA I N M E N T

Mobile Pharmacy Compounding Cleanrooms by Mobile Cleanrooms, LLC and Cleanroom Design LLC Premanufactured mobile cleanroom available in a fraction of the time compared to traditional design/build. Fully engineered turn-key mobile cleanrooms designed to meet a variety of applications including USP 795, USP 797, USP 800, and 503B Compounding Pharmacies.

President & CEO: Greg Mink Founded: 1987 Employees: 30 Toll-Free Phone:

(800) 456-3369 (317) 818-4477 Address: 6678 Guion Road, Indianapolis, IN 46268 Website: www.portable-cleanroom.com Phone:

President & CEO: Brian Clark Founded: 2013 Employees:

15 (844) 213-1323 Address: 4830 W Kennedy Boulevard, Ste 600 Tampa, FL 33609 Website: www.cleanroomdesignllc.com Toll-Free Phone:

Company Background

The partnership between Mobile Cleanrooms, LLC and Cleanroom Design LLC leverages our years of industry experience, combining our industry-leading modular building methods with a state-of-the-art cleanroom engineering group to create highly-engineered premanufactured mobile pharmacy compounding cleanroom solutions ready for use upon delivery. We are the only mobile cleanroom provider that offers standard and customized mobile cleanrooms which are equally suited as either short or long-term rentals or as purchased permanent additions. Discover how we’re better together at www.cleanroomdesignllc.com and www.portable-cleanroom.com.

Product Overview

We offer high-quality, cost-effective mobile cleanroom solutions which are pre-engineered and pre-built, then delivered as turnkey compounding cleanrooms ready for use immediately upon delivery. Compared to traditional design/build, our mobile cleanrooms can be built in a fraction of the time as we control the entire production at our facility – eliminating delays caused by local permit approvals, subcontractor scheduling, etc.

What sets MDI/CRD Mobile Pharmacy Cleanrooms apart?

• Pre-certified prior to delivery and guaranteed to pass third-party inspection. • 14' wide mobile cleanrooms, up to 40% larger than 8' wide trailers. • Short or long-term rentals, or as permanent additions. • Cloud-based control and monitoring system with real-time datalogging and alarms.

Product Specifications

n Safety • All rooms have hands-free interlocking doors with red and green light indicators to ensure the integrity of differential pressures. • USP compliant hazardous unpack/storage room, dedicated gowning rooms, HEPA filtered pass-throughs, and gowning room sinks deep enough for fingertip to elbow scrubbing. n Productivity • Our mobile cleanrooms are 14' wide, 6' wider with over 40% more space than other mobile cleanroom trailers (on wheels). This provides a much more functional environment for personnel and workflow. • Each compounding room comes equipped with two 4' wide biosafety cabinets and/or two 4' wide laminar flow hoods. n Flexibility • Two standard size mobile pharmacy cleanroom products. • Single purpose: Either USP 797 or USP 800. • Dual-purpose: Larger size engineered for USP 797 and USP 800. • Turnkey building and HVAC systems designed and engineered to be placed in locations anywhere in the US. • Custom HEPA-filtered pass-through designs include single- and double-door, through-the-wall pass-throughs, cart pass-throughs, and pharmacists’ checking pass-throughs. n Security • Real-time data-logging and alarming for out-of-range temperatures, humidity, and pressures. • Video recording systems and fire protection systems included.

Testimonial

" T hank you for the excellent service Cleanroom Design and MDI Mobile Cleanrooms has provided to us for the temporary pharmacy compounding cleanrooms for the Staten Island University Hospital Campus. Upon delivery the NYS Board of Pharmacy conducted an inspection and approved the unit for operation in the capacity of compounding both hazardous and traditional I.V. solutions for patients. The unit surpassed our expectations and was able to maintain the high-volume production necessary during the recent COVID-19 outbreak."

— Otto VonEilbergh, Director – Capital Projects, Corporate Facilities Services, Northwell Health

Ordering Information

To learn how our mobile cleanrooms can assist with your pharmacy upgrade or expansion, or to help meet new USP 797 or USP 800 standards, contact us by phone at (317) 333-8742 or email us at markk@modulardevices.com. WINTER 2020

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CAS E S TU DY ANALYTICAL LAB GROUP AND DPS GROUP DEMONSTRATE THE POWER OF PARTNERSHIP INTRODUCTION AND INTENDED OUTCOME

When DPS oversees a project, they are tasked with ensuring every piece of the puzzle works. Sometimes a piece may extend beyond their scope. If so, DPS goes to the client in full transparency and recommends a partner with options of working under DPSâ&#x20AC;&#x2122;s contract or on their own. This case study breaks down the criteria DPS uses to partner and what that means for the client. The specific example involves a biotechnology company that engaged DPS for its consulting and validation engineering expertise. Known for meeting timelines and ensuring quality control, DPS draws on those abilities to complete the lifecycle facility. However, the scope also called for cleanroom qualifications. Caroline Carmody, Vice President, Technical Services Operation, DPS Group, offers insights on the need and value of partnerships. In this case, Caroline pulled in Analytical Lab Group (ALG), now part of Element, to ensure the result is an impeccable facility that accelerates the clientâ&#x20AC;&#x2122;s mission to eradicate tumors.

THE CHALLENGE

www.analyticallabgroup.com

CAS E S TU DY If management contracts any work, they must require rigorous guidelines for their partners, where all parties have confidence in quality protocols and deliverables.

DECISION TO PARTNER

Caroline brings her 20-year career as a commissioning and validation professional to complex biopharmaceutical projects. With this biotechnology client, Caroline provided commissioning, qualification, and validation (CQV) consulting and front-end strategic planning to ensure successful operations. “We work in a relationship-based industry. I stay in touch with former colleagues and rely on their expertise when necessary,” said Caroline. “That is why I partner with ALG – because I’ve known and trusted them for years.” Caroline is often the client as well, which allows her to see both sides of a project. When Caroline determined that the project needed expertise in environmental monitoring, specifically prevention, sampling, and testing, she called on the ALG team again. Caroline knew that the client would assess her on this recommendation. She backed her decision on going with ALG on the following three criteria, which has always made for a strong partnership.

SERVICE AND TRANSPARENCY

Based on technical requirements, the client faced a gap that could hinder a fully functioning lab. DPS went to the client to present ALG as the vendor that could hit the ground running, fill the chasm, and maintain timelines. In the discussion, Caroline explained how the partnership would work and where DPS was the primary contractor; however, DPS would not hinder open communication between the client and ALG. This clarity immediately created a trusting environment that allowed quicker problem solving among all parties. Not adding levels with a growth-stage biotech company maintained nimbleness. ALG came to the project demonstrating superior service to both clients. Because of their rapid accomplishments, the two ALG principals receive an additional contract. Their success reaffirmed Caroline’s decision-making and management style. DPS also gained a happy client because expectations and budget were met, even during a pandemic. “ALG did everything right the first time. They didn’t lose any samples, which is rare and demonstrated their attention to detail,” said Caroline. “Pressure was on given time frames and COVID-19; ALG didn’t falter.” The secret to success was that quality and caliber reflected in ALG mirrored DPS. The partners complemented each other.

SEAMLESSNESS AND BENCH STRENGTH

DPS wanted one-stop shopping, so the client would not experience any burden with additional administrative work. DPS presented this turn-key approach under the header of commission and qualification statement of work. This unified front ensured white-glove service. ALG delivered on its environmental monitoring and cleanroom compliance services, which means a future-proof solution. www.analyticallabgroup.com

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CAS E S TU DY “ALG immediately established confidence with the client because of their competence and integrity,” Caroline said. The ALG team at the client site could rely on their colleagues based across the nation. More than 130 scientists and experts with experience in prevention and virology testing; and backgrounds in molecular cell biology, antimicrobial, pharmaceuticals, and biotechnology could offer additional support.

CLEAN AND SAFE

Developing immunotherapies requires clean, controlled rooms that regularly address any possibility of contaminants. DPS needed an experienced partner who shared the goal of contamination prevention. They received that in ALG and their demonstrated leadership in FDA- and EPA-focused laboratories and cleanroom testing. With more than 25 years of environmental monitoring in pharmaceutical manufacturing, ALG brought solutions to any vexing healthcare cleaning and disinfection challenges that arose. They considered every aspect of a cleanroom that could protect employees, patients, and the environment as a whole. ALG focuses on infection prevention, with the most comprehensive testing solutions in the pharmaceutical, medical device, biotech, and healthcare spaces. They also provide training in proper aseptic practices to develop the safest possible product. “I knew ALG could deliver for DPS,” said Caroline. “They addressed any variables that hindered the cleanroom. Moreover, they consistently added value with their knowledge of the latest safety measures, testing, and technology.”

RESULTS

The partnership is on track to complete commissioning and qualification and meeting all CQV and compliance-related projects. By the end of 2020, the client will house a fully qualified cleanroom and equipment, which can manufacture phase 1 and phase 2 vaccines. The team understood the precision necessary for the cleanrooms to pass USP <797> and <800> guidelines. Moreover, the result for the client is a project completed as promised and as budgeted. It also means the client now has the tools, testing, and processes to operate successfully and carry out their mission. For Caroline and the DPS team, success is a strong pipeline of clients based on referrals from successful projects like this one. The partnership with ALG contributes to the growth of new clients. “Our vision with each client is to up our quality, and we do that with ALG. They share our mentality as super pleasers,” Caroline stated. “Because of this mindset, ALG received more work from the client, and that makes me happy and reaffirms my decision to partner with ALG.”

CONCLUSION

Caroline’s philosophy is that you can never go wrong if your only agenda is to do right by your client. She knew pulling in ALG as a partner was the right thing to do.

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www.analyticallabgroup.com

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