20Ways SUMMER Hospital 2022

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SUMMER 2022

I M P R O V I N G PAT I E N T CARE & PHARMACY COST CONTAINMENT H E A L T H

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

Clean Air Technology & Supplies Industry Expert Q&A, Market Leaders Buyer’s Guide, and More pg. 56

New Features NSF/ANSI 456 Vaccine Storage Standard pg. 46

CSTDs (Closed System Transfer Devices) pg. 86

3 Case Studies CPS, Liberty Software, and Rees Scientific

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Follett Refrigerators are Omnicell FlexLock-Ready A 20Ways Profile by Follett

pg. 43


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At Acute Care Pharmaceuticals, we help protect the healthcare workers that care for us everyday. That’s why we are passionate about supplying exceptional USP <800> compliant products for hospital and cleanroom personnel. From gowns to gloves to chemo prep mats and spill kits, we have the essential products you need to ensure protection for your Healthcare team. Visit us for our full line of USP <797> and <800> compliant products.

For free, next-day delivery, order through your wholesaler or distributor. Products available at AmerisourceBergen, Cardinal, McKesson and Medline.

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-86°C Ultralow Temperature Freezers

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*Note: Listed feature/option is unavailable on the Blizzard NU-99100J model. © Copyright 2022. NuAire, Inc. All Rights Reserved.

©

Learn more or request a quote online at:

www.nuaire.com


Contents Verity Solutions — Your Invested Partner for 340B

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

NSF/ANSI 456 Standard Compliant Vaccine Cold Storage From Helmer Scientific

NSF/ANSI 456 Vaccine Certified GX Solutions Medical-grade Cold Storage Ensuring consistent temperature performance for safe vaccine storage

Designed for critical vaccine storage and NSF/ANSI 456 standard certified

NSF/ANSI 456 Vaccine Storage Standard promotes safety and efficacy by ensuring consistent vaccine storage conditions.

Best-in-class temperature management for uniformity, stability, and recovery ENERGY STAR® certified and 50-60% more energy efficient than conventional medical-grade refrigerators and freezers

Learn More helmerinc.com/nsf-ansi-456

© 2020-2021 Helmer Inc. All rights reserved. © 2022 Helmer Inc. All rights reserved

20Ways_TabAd-summer 2022.indd 1

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Shields Health Solutions — The Premier Specialty Pharmacy Accelerator in the Country Elevate performance where it matters most with Shields — the premier specialty pharmacy accelerator in the country.

Visit Shieldsrx.com

customized software

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MEET YOUR NEXT STAR EMPLOYEE. www.rm-solutions.com

Transform your specialty pharmacy into a powerful growth engine and elevate performance where it matters most with — Shields.

Thought Leader Video Series

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Point-of-Sale to Simplify Your Pharmacy Operations — Retail Management Solutions

Pharmacy point-of sale should work for you, not the other way around. Meet the solution that helps you improve patient outcomes, streamline operations, and use your choice of pharmacy management systems.

Visante — High-Performing Pharmacy is Who We Are

Pharmacy consulting designed for optimal growth

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.

We help you achieve extraordinary results in all areas of health system pharmacy

Strategic Planning & Implementation

Compliance that Improves Care

Financial Results

We collaborate with you to deliver innovative solutions that will elevate your organization to peak performance levels.

Our team of compliance experts will improve confidence, enhance care and ensure patient, worker and community safety.

Making the most of opportunities to manage costs and increase revenue is core to our consulting. We help you improve financial performance across your organization.

Visante consultants bring you expertise in all areas of hospital and health system pharmacy: • Comprehensive Strategic Assessments • 340B Program Solutions • Specialty Pharmacy Programs • Revenue Cycle and Drug Reimbursement Strategies

Connect with Visante today to learn how we can help you reach your goals. Visit us at visanteinc.com, or call 866-388-7583.

• Supply Chain Strategies • Drug Diversion Programs • Drug Compounding Excellence

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Transforming healthcare through pharmacy.

© Visante Consulting, LLC, 2021. All Rights Reserved.

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SUMMER 2022

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

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USP <797> Trusted Solutions

Hardy Diagnostics has the products you need to meet regulatory requirements for: Air sampling

Surface sampling

Personnel sampling

Aseptic technique verification

Check out our aseptic media fill kits here: 800.266.2222 HardyDiagnostics.com Sales@HardyDiagnostics.com

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Compliance shouldn’t be a four-letter word.

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Robotics and Other Compounding Devices

Solutions designed to keep your patients safe Increase accuracy and control with automation that helps advance patient safety and protect staff during production of hazardous and non-hazardous compounded sterile preparations.

KIRO® Oncology

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Gri-fill® 4

Semi-automated compounding for batch and patient-specific production of hazardous and non-hazardous sterile preparations.

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Contents FDA Registered | Iso Certified

Your partner in pharmacy compliance since 1992 USP <797> USP <71> USP <800> Left: GM7030 PATT2®, Personal Aseptic Technique test kit, 3mL ampules, 20mL vials, 100mL partially filled minibag. Below: ET1000 EnviroTest® TSA with Lecithin & Tween 80 growth media paddles for surface, air, or glove fingertip sampling.

Media Fill Hazardous Drug Handling Validation Surface and Fingertip Testing

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

NEW Follett Refrigerators are Omnicell FlexLock-Ready

It’s a cold, hard fact

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

Follett FlexLock-ready refrigerators facilitate durable and fast installation of Omnicell® XT FlexLocks. Laser cut holes allow the locking device to bolt to the side of the refrigerator for improved durability.

When it comes to product temperature accuracy, there is no room for error. Follett upright refrigerators and freezers feature our exclusive plenum air distribution which delivers cold air at multiple levels to ensure consistent

Sterility Testing

top‑to‑bottom temperatures, even when heavily loaded with product.

Qimedical.com

info@qimedical.com

Tel. 800.837.8361

DAYTON CHILDREN’S HOSPITAL'S COMMITMENT TO PHARMACY EXCELLENCE A Strategic, Long-Term Partnership With CPS INTRODUCTION AND INTENDED OUTCOME

Benjamin Goodstein Vice President & Chief Ambulatory Officer; President, Specialty Physicians, Inc. ~ Dayton Children’s Hospital

Dayton Children’s Hospital is one of eight children’s hospitals in Ohio. As a regional referral center, they serve patients from a 20-county area, which includes Ohio and eastern Indiana. The hospital’s more than 200 physicians include primary care pediatricians and subspecialists in over 35 areas of pediatric medicine. Working as a team with the medical staff are more than 3,500 employees and volunteers who share a commitment to quality care. This, combined with Dayton Children’s affiliation with Wright State Boonshoft School of Medicine and accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), supports their mission to provide the local patient population access to the finest pediatric care available. “We consider this access to care to be our edge in the world’s most competitive market for children’s hospitals,” says Dayton Children’s Vice President & Chief Ambulatory Officer; President, Specialty Physicians Inc., Benjamin Goodstein. “And a critical part of that is access to quality pharmaceutical care.” This commitment to quality pharmaceutical care was foundational to the growth of the hospital’s relationship with CPS, which has evolved into a rewarding strategic partnership. CPS has helped Dayton Children’s strengthen its inpatient pharmacy and build out its outpatient services with a highly successful specialty pharmacy.

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Case Study: Dayton Children’s Hospital's Commitment to Pharmacy Excellence

Acute Care Pharmaceuticals — Leader in USP <797> and <800> Compliant Products

CLEAN AIR TECHNOLOGY & SUPPLIES

C AS E S T U DY

See our full line at folletthealthcare.com or call 800.523.9361 for more information

A strategic, long-term partnership with CPS.

Your one-stop shop for USP <797> and <800> compliant PPE, wipes, disinfectants, and cleaners. We make your buying experience easy with multiple GPO contracts and products available at your contracted wholesaler.

THE ORIGINAL CHALLENGE In 2017, a JCAHO survey uncovered some compliance issues, explains Ben. “The survey flagged concerns around policies, procedures, and workflows in a range of areas — from 340B to supply chain to the way we were handling sterile compounding.”

A

COMPANY

Dayton and CPS collaborated to help address the Joint Commission issues. A leader in hospital pharmacy services, CPS was equipped to help their stakeholders overcome challenges impeding pharmacy performance excellence — such as purchasing practices, compliance, accreditation survey readiness, sterile compounding, and more. www.cps.com

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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.

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QUARTERLY ISSUES Spring 2022

Summer 2022

Winter 2021/2022

H E A L T H

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

S Y S T E M

&

I N F U S I O N

I M P R O V I N G PAT I E N T CARE & PHARMACY P R O F I TA B I L I T Y

Follett Refrigerators are Omnicell FlexLock-Ready A 20Ways Profile by Follett

C O M M U N I T Y ,

E D I T I O N

pg. 43

Clean Air Technology & Supplies

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

S P E C I A L T Y ,

&

L T C

E D I T I O N

Pharmacy Management Software Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 56

8 Thought Leaders

CPS, Micro Merchant Systems, The Compliance Team, and Surescripts

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

3 Case Studies

pg. 54

McKesson, Liberty Software, and Innovatix

New Features NSF/ANSI 456 Vaccine Storage Standard page 46

2022 CIRCULATION 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 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

Fall 2021

WINTER 2022

SPRING 2022

SUMMER 2022

I M P R O V I N G PAT I E N T CARE & PHARMACY COST CONTAINMENT

CSTDs (Closed System Transfer Devices)

IENT PAT I M P R O V I N GI M P R OCV Y A I N G PAT I E N T A RA M CARE & P HC RE & B I L I T YP H A R M A C Y P R O F I T ACOS T CON TAIN MEN T

FA L L 2 0 2 1

I M P R O V I N G PAT I E N T CARE & PHARMACY P ROF ITABILITY

WINTER 2021

I T Y , C O M M U N

T Y , S P E C I A L

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H E A L T H

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20 Unique 20 UniqueDecis & Drugion-Making Products &Products for Diversion Services Services &

I N F U S I O N

E D I T I O N

A Case Study From

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

Drug Diversion

Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 60

7 Case Studies

Waste Management, Veltek Associates, Inc., Culturelle, IMI, Azina, Modular Devices Inc., and More

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

g Adherence Packagin Market

Industry Expert Q&A, and More Leaders Buyer’s Guide, page 48

8 Thought Leaders

Micro Merchant Including Surescripts, Team, and Azina Systems, The Compliance

3 Case Studies

Temptime, Epicor, and Automation Noritsu Pharmacy

Medacist page 70

C O M M U N I T Y ,

Celebrating 10 Years RXinsider Reflects on the Past Decade With Retail Management Solutions

S P E C I A L T Y ,

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L T C

E D I T I O N

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

Long-Term Care Delivery/Back-Up Pharmacy Services

Industry Expert Q&A, Market Leaders Buyer’s Guide, and More page 56

2 Case Studies

Innovatix and Temptime

pg. 84

3 Case Studies CPS, Liberty Software, and Rees Scientific

Robert Fink, Pharm.D., MBA, FACHE, FASHP, BCNSP, BCPS Chief Pharmacy Executive ~ UofL Health, Louisville, KY

Health System • Infusion

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Contents Long before the COVID-19 pandemic, vaccine providers and program administrators faced significant challenges as they navigated the selection and purchase of effective vaccine storage equipment. Because vaccines require storage at specified temperature ranges, refrigerators and freezers play a significant role in the storage and handling process. Proper storage is critical to ensure the safety and viability of life-saving vaccines.

Dennis, please tell us about yourself and the role you played on the NSF Joint Committee. I supported the committee providing perspective from the refrigerator/freezer manufacturers. My role was Chair of the Use Group, and the committee’s responsibility was to look at developing the actual test methods that represented how the end users interact and use these units in the field. We needed to make sure that the test methods adequately challenged the performance of the refrigerator or freezer to simulate real-world field usage.

Data collected by the Advisory Committee on Immunization Practices (ACIP) and the National Institute of Standards and Technology (NIST) indicated that refrigerators and freezers used to store vaccines in clinics and hospitals were, and continue to be, a major risk point. The CDC Vaccine Storage and Handling Toolkit was initially launched in 2012 to provide guidelines and recommendations for vaccine handling and storage across the cold chain. The toolkit is updated periodically and provides guidance that improves the safety and efficiency of vaccine storage.

Why was this new NSF/ANSI 456 Vaccine Storage Standard needed? Up until the release of the NSF/ANSI 456 standard there wasn’t a good standard in North America that could be referenced for the performance of a refrigerator or freezer for the storage of vaccines or refrigerated medications. What was available, the CDC Storage and Handling Toolkit, provided guidance on how to store vaccines in refrigerators and freezers, but there were still issues in the field where providers were losing vaccines due to poor temperature performance. The providers were seeking something more that focused on performance and how these units were being used in real-world conditions. The committee was established to develop a standard that looked at overall performance of the refrigerators and freezers.

However, the toolkit does not provide clearly defined performance criteria for cold storage. Performance differences between purpose-built vaccine refrigerators may be significant but may be identified only through testing that simulates real-world use related to load conditions and door openings, as well as measuring cabinet temperature across all potential storage locations. The NSF Joint Committee for Vaccine Storage was formed in 2015 to develop a new standard. The committee was responsible for creating a standard that ensures engineering controls are in place to assist in safely storing vaccines under real-world conditions in clinical environments. The NSF/ANSI 456 Vaccine Storage Standard was finalized in May 2021, and equipment manufacturers can submit their products for independent testing and certification against the standard.

Who created the new NSF/ANSI 456 Vaccine Storage Standard, and what was the driving force? The NSF/ANSI 456 standard was developed by a committee including manufacturers of vaccines, directors from several state health departments, pediatricians and physicians, members from the Immunization Coalition,

We recently spoke with Dennis Smith, a member of the NSF Joint Committee for Vaccine Storage tasked with creating the new standard, to provide a manufacturer’s perspective on the implications of the new standard including the certification of vaccine storage units. 46

SUMMER 2022

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Vaccine providers and program administrators face significant challenges as they navigate the selection and purchase of effective vaccine storage equipment.

CLEAN AIR TECHNOLOGY & SUPPLIES

NSF/ANSI 456 Vaccine Storage Standard

NSF/ANSI 456 Vaccine Storage Standard

Medication Workflow

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Class II, Type A2 Biosafety Cabinet Protection: Product, Personnel, & Environmental

Sterile Hazardous Workflow Containment Primary Engineering Control (C-PEC)

Model: NU-543 Series Optimized for Sterile Hazardous Drug Compounding Systems IV Bar with 3 Height Locations and 6 Hooks for IV Preparation Back-Wall Cutout for Viewing Computer Monitor Interior Duplex GFCI Outlets and Cord Pass-Through Ports Motorized Auto-Rising Base Stand for Optimal Comfort Up to 12 inch (305 mm) Access Opening *Product shown with optional features

Sterile Non-Hazardous Workflow

Horizontal Laminar Airflow Workstation

Primary Engineering Control (PEC)

Protection: Product

Choose NuAire as the safer choice for your pharmacy.

Model: NU-240 Series Optimized for Sterile Non-Hazardous Compounding ErgotronTM Mount for Monitor, Keyboard, and Mouse Easy-to-Clean Stainless Steel Work Surface IV Bar with 3 Height Locations and 6 Hooks Telescoping Base Stand with Shelf Attachment Exterior Mounted Duplex GFCI Outlet Sidewall Cord Pass-Through Ports

*Product shown with optional features

Learn more or request a quote online at:

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NuAire, Inc. | 2100 Fernbrook Lane | Plymouth, MN 55447 | 763.553.1270 | www.nuaire.com © Copyright 2022. NuAire, Inc. All Rights Reserved.

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

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CLEAN AIR TECHNOLOGY & SUPPLIES

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chemo transport bags

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saljet® - Single-Dose Sterile Saline

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super tough bins and accessories

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No mess. No waste. No problem. Get maximum quality and convenience with these liquid unit dose products from American Health Packaging. Our products quickly deliver safety and efficiency in every dose without the mess or waste.

AHP unit dose products include: • Scannable bar codes • Color-coded labels • Clear “Tall Man” lettering

With access to more than 600-unit dose items, including 100+ exclusives, you’re sure to find oral liquids, oral solids, and inhalants that can help your patients and streamline your operations. Browse our extensive catalog and take advantage of these featured liquid unit dose products from AHP.

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Midazolam HCl Syrup (CIV)

2.5 mL

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10 mg /5 mL

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60687-0576-86

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5 mL

20 mg /5 mL

50 UD

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15 mL

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50 UD

The NDC shown is in the 11-digit format required for the Centers for Medicare & Medicaid Services (CMS) processing, 42 CFR § 447.502 – Definitions.

Browse our full catalog through americanhealthpackaging.com or through your preferred wholesaler today.

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Q&A Buyer’s Guide

S Q&A

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This time is Buffalo Grove, IL 60089 Remember that Larchmont, NY 10538 facility. laminar flow for your pressure times(847) room872-2500 you are (914) 833-0278 rs mandate (484) (800) 806-5887 520-3000 delay year? proves a it regulato longer and or t because testing twice is yes, USP chapters is importan bvna.com validate shorter parasolmed.com environment, not technowipe.com however, ignores guardianmed.net m answer ng of room pressure This answer, the cleanroo Inc. The short the monitori CINTAS Care Logistics of control overPolyConversions, Teknipure Environmental Health every six months. . done be required state is Boulevard yearCintas certification Box 25ing a 3202 Apollo Drive is critical. 2150 W Broadway Road maintain twice a6800 potentially affect P.O. certification room pressure these changes a specific Cincinnati, OH 45040 43113 Campaign, ILmainta 61822 in our state Suites 104-105 the real reasons because OH airflows Circleville, the seasons and degrade, to with d seals load, (888) 834-2883 (888) 893-3330 not (800) 848-1633 conditions change res are require n negative Mesa, AZ 85202 services. Filters every year does nce betwee www.cintas.com/uniformgohcl.com other building polycousa.com (844) 309-2376 Q. What pressu differe HVAC and in the same season control” and why the ? teknipure.com only once a year work-apparel/uniformof a “state of mentsCleanrooms HEMCO ProPharma of control change. Testing re require column (w.c.) the maintenance confidence in rental/cleanroom.aspx of 0.020" 711and S. Powell Roade pressu 5465 Legacy Drive,water Suite 650 negative Texwipe positiv environment. provide adequate a minimum pressure to 0.030" w.c. require compoundingCleanroom Connection Independence, MO 64056 Plano, TX 75024 0.010" sterile of chapters the1210 South Park Drive it affect USP a range over a critical is no cap on 160 Creekside Park, does Suite 202 (816) 796-2900 pressure rooms and (469) 283-1190 Kernersville, NC 27284 l” and how ding room. There for positive ation to a(800) 839-9473 compoun Spring Branch, TX 78070 “state of contro hemcocorp.com propharmacleanrooms.com for contamin a hazardous for potential Q. What is a little pressure t impacttexwipe.com there isPrudential (800) 616-5319 significan ISO Class underInfinity Laboratories Cleanroom Services ? pressure because m is to maintain There is, however, when operating our facility cleanroomsupplies.com buffer room1585positive a cleanroo South Perry Street, Suite Apressure. 1661 Alton Parkway The Baker Company positive ISO Class 7 function of cleanroom an elevated at primary pressure were ter example, room The Irvine, CA 92606to Chapter <797> 175 Gatehouse Road 0.5 microme Castle Rock, CO 80104 nce of a negative conditions. ForConnecticut Clean changes below 352,000 the performa was 2008 767-5536 level Corporation Room dynamic operating (303) on 730-7330 the (800) . This is s buffer room Sanford, ME 04073 a particle count32 Valley vacuum. After is in full operation for a hazardou in infinitylaboratories.com prudentialuniforms.com/ at too much pressure must maintain while the roomStreet the heating, ventilation, This resulted (800) 992-2537 required negative services/cleanroom cubic meter with no cap. via Bristol, CT 06010 bakerco.com passed, ISO-MED, Inc.the particles per adequate airflow 0.01" w.c. negative g at a very negative pressure in the ceiling (860) 589-0049 by delivering minimum of filters located a ished operatin was HEPA 1220 Graphite Drive QleanAir Scandinavia Veltek Associates, Inc. (VAI) simply ation accompl through or exhaust buffer rooms logical contamin through return ing system (HVAC) ctcleanroom.com hazardous drug Corona,many CA 92881 8445 Rausch Drive 15 Lee Boulevard range, most air condition remove them ioning As a result, microbio in the commiss (800) 797-1405 Containment Technologies in the room and Plain City, OHnegative 43064 pressure Malvern, PA 19355 to the ante room. the of verified particles be relative slightly dilute but low-end to It shouldInc. ante room result in adequate iso-med.com . By restricting the (614) 954-1040 (610) 644-8335 low on the wall. Group,rate negative to the will, in fact, common grilles located amount rooms are The tight range 5460 Victory Drive, Suite 300 air change qleanair.com/us_en/ sterile.com Kimberly-Clark Corporation sified areas. s drug buffer cleanliness. The the certified the non-clas room hazardou and other room process that desired IN 46203 Indianapolis, the ceiling and products/cleanrooms 1400 Holcomb Bridge Road Vileda through return/ s drug buffer to maintain to the room the hazardou amount removed (317)the 713-8200 in a positive particle removal betweenSentry resultRoswell, GA 30076 versus Air Systems imperative for 2188 Diehl Road to the room mic4.com or other openings will maintain but to FM of negative pressure ly difficult ding room of air supplied www.kimberly-clark.com 21221 529 Road Aurora, IL 60502 at the doors admitted any sterile compoun to rooms and leakage Contec, Inc. anteroom is monitored. function Cypress, of TX 77433 (630) 270-1437 exhaust grilles Lakeland continuously be negative nce. The primary (800) 799-4609 which must be525 Locust Grove room can only performa ce.vileda-professional.com Parkway, Suite 325 so a buffer room pressure ant that it 1525 Perimeter of the product, sentryair.com Spartanburg, 29303 re soSCimport is. Huntsville,isALsterility 35806 room pressu logged daily? as clean as it (864) the 503-8333 pressures Q. Why is the red, and that are at least (256) 350-3873 compounding method cal sterile our contechealthcare.com most economi cleanroom.lakeland.com rds should the must be monito pressures is the easiest and from Q. What standa d to meet? room to and removed the FDA to Monitoring the airflow delivered or returns inspected by certifie will the amount of facility be facility will be remains constant of verifying that 58 S U A 503A facility d outsourcing M M Eroom R 2 0pressure 2 2 I H E A LT H S Y S T Eour M • state INFUSION t that A 503B registere changed. If the Practices (GMPs). sion, or can be confiden room has not Manufacturing excursion, we y, the Joint Commis ing the required s current Good of pharmac value after an are maintain or to USP Chapter to the same by state boards Therefore, we own standard ion be inspected not changed. in that room. to either their of control has ent Testing Associat work being done ents of health ed Environm ss level for the ion of sterile re goes to departmand <800>. The Controll room cleanline 3) for certificat room pressu <797> on guide (CAG-00 our door, the control? of d an applicati open we state develope has Q. When we lost our for more that mean that door open neutral. Does state of control if you left your You might lose 56

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ronment trolled Envi

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American Health Packaging, Offering a Broad Portfolio of Barcoded Unit-Dose Products

With a responsive line of barcoded unit-dose oral solutions, a growing liquid unit-dose offering, as well as individually wrapped inhalants, American Health Packaging continues to deliver on their commitment to pharmacy efficiency.

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Helping you deliver better medicine to more people.

Leiters is a trusted FDA-registered 503B outsourcing provider of compounded sterile preparations committed to providing healthcare professionals and their patients with the highest-quality medications.

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.

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CLEAN AIR TECHNOLOGY & SUPPLIES

Cervey — 340B Split Bill, 340B Contract Pharmacy, Specialty Pharmacy

Industry expert Q&A, Drug Diversion Market Leaders Buyer’s Guide, and more.

Cervey’s experts employ a consultative methodology to understand our client's unique challenges, then tailor a software offering that meets their specific needs and integrates seamlessly with your EHR and pharmacy systems.

BE CERTAIN, WITH CERVEY. 340B SOLUTIONS Cervey’s 340B suite of web-based products helps 340B split bill and contract pharmacies manage the complexities of 340B. Be HRSA audit ready at the click of a button, manage multiple facilities with our Group Dashboard, empower your buyers with Split Preview, and eliminate the frustration of managing master NDCs. Our TPA team of ACE-certified experts will take a consultative approach to help streamline your 340B program and meet your needs.

Service, not just software.

SPECIALTY Cervey’s Specialty Pharmacy software is designed precisely for hospital operated specialty pharmacies – streamlining pharmacy operations and patient management. Elevate the efficiency of your pharmacy by identifying potential patients while optimizing staff workflow and data collection. Manage opportunities, customize assessment documentation, utilize benefit investigation, preadjudicate test claims and simplify using system integration.

Cervey’s customer support is always there. It’s a 100% real person, who is not outsourced, with real answers to your questions.

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our capabilities are unrivaled! Our Mission Health Care Logistics has been a veteran-owned, industry leader in the distribution and manufacture of medical supplies since 1978. We have over 22 extensive lines of medical products, which include compounding and dispensing items, infection prevention supplies and unit dose packaging materials.

Healthcare Segments Served • Chemo Clinics

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Contents C AS E S T U DY HEALTHPOINT CHOOSES LIBERTY SOFTWARE TO EMPOWER THE PHARMACY TEAM BACKGROUND With strong roots in the King County community in Washington State, HealthPoint, a level 3 patientcentered medical home, cares for more than 100,000 people at 20 primary care facilities. There are 11 pharmacies across the health system: nine traditional site pharmacies, one central fill pharmacy, and one specialty pharmacy.

Case Study: Liberty Software

Zebra Temperature Monitoring and Sensing Solutions — Monitoring Devices and Integrated Solutions for Medication Shipments, Storage, and Pharmacy Facilities

TEMPERATURE INTELLIGENCE®

Peace of mind for your patients

HealthPoint chooses Liberty Software to empower the pharmacy team.

Temperature monitoring for direct-to-patient shipments Getting medication to patients in the right temperature range is critical for reducing unnecessary reshipments. Including a TransTracker® in outgoing medication shipments can help. These inexpensive, singleuse indicators monitor temperature exposures – letting your patients know at-a-glance whether medication has gotten too hot or too cold while in transit. Learn more about how TransTracker cards, manufactured by Temptime, can help you give your patients added peace of mind while helping you save money by avoiding medication replacements. zebra.com/transtracker

This case study examines one of HealthPoint’s high-profile upgrades — a new pharmacy management solution by profiling Director of Pharmacy Services, Katya Kanevski. She shares the analysis and decision-making process that led to selecting Liberty Software to build their personalized pharmacy platform.

Katya Kanevski Director of Pharmacy Services ~ HealthPoint

INTENDED OUTCOME Robust dispensing software is about accuracy, efficiency, productivity, compliance, safety, and adaptability to meet ever-changing business and compliance needs. Kanevski wanted a low-touch system to support the delivery of high-touch pharmacy-based services for patients. “Pharmacists’ time is valuable and stretched thin. We need to free up their time with a system that allows for dispensing efficiency and technological solutions,” said Kanevski. “We can do more for our patients by spending less time on manual tasks.” Healthpoint needed a system that could clearly identify certain patient population groups, such as urgent care patients or school-based clinics, to meet unique needs for filling and distribution accurately. “Many requirements exist to meet the needs of a diverse pharmacy business,” said Kanevski. “Our goal is always to provide an enhanced level of dispensing safety, accuracy, and tools to adhere to 340B regulations.” Kanevski’s aim centered on perfecting the pharmacy customers’ experience through operational excellence. Leading the team of 75 pharmacy staff involved providing the tools needed for directly engaging in delivery of high-quality patient consultations and clinical services like immunizations and CGM placements/training.

CHANGES AND CHALLENGES “We were not as efficient as we needed to be. And we had a limited system,” said Kanevski. “We needed to position ourselves competitively against the rapidly changing pharmacy landscape.” The pain points for the pharmacy team included too much manual intervention that made processes cumbersome. Central fill had too many moving parts.

zebra.com www.libertysoftware.com

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Shred-it® Secure Information Destruction Protect your business and your patients’ PHI with secure information destruction.

Visit Stericycle.com or call 866-783-7422.

© 2022 Stericycle, Inc. All rights reserved. RXINSAD_0422

CLEAN AIR TECHNOLOGY & SUPPLIES

Breathe easy With cleanroom solutions from ISO-MED

We have just what hospitals need to maintain a clean compounding environment, giving staff confidence in their patient safety efforts, and making it easy to always have the appropriate products at hand. That’s why ISO-MED has been a trusted hospital supplier for over a decade. Let us give you one less thing to worry about. Order now at iso-med.com.

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

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Safeguard Your Organization, Community, and the Environment With Stericycle Solutions

Closed-System Transfer Devices (CSTDs)

Stericycle’s CsRx Controlled Substance Waste Service can serve as a central component to prevent drug diversion in your hospital.

Closed-System Transfer Devices (CSTDs) U.S. Centers for Disease Control and Prevention defines a closed system drug-transfer device (CSTD) as a system that “mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.” CSTDs are designed to provide protection against hazardous exposures to healthcare workers who are compounding and administering hazardous drugs. While CSTDs are not the only means of protection, they play a crucial role in hazardous drug safety measures.

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CSTDs are designed to provide protection against hazardous exposures to healthcare workers who are compounding and administering hazardous drugs.

Tell us about your role and experience at Martha’s Vineyard Hospital and how the facility is using CSTDs? I am a board-certified sterile compounding pharmacist and in my current role at Martha’s Vineyard Hospital (MVH), I serve as the lead sterile compounding operations pharmacist. Throughout the past several years, two different brands of closedsystem transfer devices (CSTDs) have been utilized at MVH pharmacy and the outpatient infusion department. The majority of hazardous compounds prepared at MVH are intravenous chemotherapy drug solutions that are administered by chemo certified nurses at the outpatient infusion department. At MVH, the use of CSTDs is the primary standard for hazardous compounding and administration with exceptions. These exceptions may include drug-device chemical incompatibilities or routes of administration that require an open system. What is your responsibility to your employees and/or patients in ensuring their safety? Reducing the risk of exposure to hazardous drugs requires a multi-faceted approach with the overall goal of lowering contamination levels to a reasonably achievable point and eliminating unnecessary human exposure. Engineering controls that create and maintain negative pressure within the compounding area, CSTDs, staff educational programs, personal protective equipment, and institutional standard operating procedures are examples of individual strategies that address different aspects of the hazardous compounding process. The combination of all these safety measures helps to guarantee hazardous contamination prevention and control.

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

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ISO-MED Lets Hospitals Breathe a Sigh of Relief

International Medical Industries — Innovation in Secure Drug Delivery

Cleanliness is critical to a hospital’s ability to safely treat patients, from the purity of the air everyone breathes to the contaminant-free surfaces in the cleanroom. You can trust ISO-MED to make your efforts more worry-free.

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.

IMI designs innovative medical devices that enhance the security of medication from pharmacy to patient. Fifty years of product design exclusively focused on the needs of the compounding pharmacist means exceptional quality, reliability and customer-driven innovation. From Tamper Evident Caps to essential sterile compounding supplies, ensure the integrity and security of your medications with solutions from the leader in secure drug delivery. Over 50 Years Serving The Industry Exceptional Quality & Reliability Enhance Your Drug Security Program Strengthen USP <797> Practices To See All Our Products and Request Samples Visit IMIWEB.COM |

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© 2022 International Medical Industries, Inc. All rights reserved. Companies and products mentioned herein may be trademarks or registered trademarks of their respective trademark owners.

IMI-501-AA-77 R1

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Case Study: Dameron Hospital's Data-Driven Temperature Monitoring Strategy

C ASE ST U DY DAMERON HOSPITAL’S DATA-DRIVEN TEMPERATURE MONITORING STRATEGY Backed by Rees Scientific

Trade Show & Meeting Calendar

Leanne Gonigan CPhT, Pharmacy Technician ~ Dameron Hospital

INTRODUCTION AND INTENDED OUTCOME

Backed by Rees Scientific.

Located in Stockton, California, Dameron Hospital is a fully accredited non-profit community hospital. With more than 200 beds, the hospital — which recently became part of Adventist Health — provides general acute, emergency, and intensive care services to the people of San Joaquin County. In addition to being a top-rated joint replacement center and the county’s leading orthopedic hospital, Dameron is also a designated STEMI (heart attack) receiving center and certified stroke center. Like all busy hospitals, Dameron’s priority is ensuring patient safety and positive outcomes. That’s why as a part of their commitment to quality care, administrators are always looking for ways to enhance their facilities and improve efficiency in all areas of the hospital. This includes the hospital pharmacy, where the staff is focused on protecting the efficacy of the temperature-sensitive medications and vaccines they dispense. When Dameron decided to automate its temperature monitoring protocols to streamline processes several years ago — they turned to Rees Scientific for help.

THE CHALLENGE Various regulatory bodies and accreditation agencies — such as the FDA, CDC, WHO, USP, and more — have requirements and guidelines for monitoring the temperatures of medication and vaccines. To comply, hospitals have long had processes in place to make sure temperatures inside refrigerators, storage areas, and operating rooms stay in range, explains CPhT, Pharmacy Technician Leanne Gonigan, who is responsible for pharmacy operations at Dameron. “For many years, we monitored temperatures manually,” she says. Couriers who delivered medication throughout the hospital were tasked with checking and recording

www.reesscientific.com

Rees Scientific

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Contents CLEAN AIR TECHNOLOGY & SUPPLIES

MOBILE PHARMACY COMPOUNDING CLEANROOMS

Whether you are planning a cleanroom renovation or building a new cleanroom, Modular Devices’ mobile cleanrooms provides an expedited option that combines a modular and prefabricated approach by delivering a ready-to-use, turnkey cleanroom that only requires utility connections upon being delivered. Our pharmacy compounding cleanrooms are available to rent or purchase! Experience unmatched quality, state-of-the-art materials and equipment, and a cleanroom that will not only exceed your expectations but USP 797/800 as well!

» Meets and Exceeds USP 797/800 » Hands-Free Interlocked Doors » Continuous Data Logging and Monitoring » 14' Wide x 48' Long » Includes 4' BSC’s and 4' LFH’s » Includes Dedicated Refrigerators » HEPA Filtered Interlocked Passthroughs » Hands-Free Scrub Sinks » Dedicated Haz and Non-Haz Gowning Rooms » USP 800 Negative Pressure Unpack / Storage Room » Hands-Free Flush Mount Intercoms » Guaranteed Environmental Control Anywhere in U.S. » Large Fleet and Nationwide Coverage » Guaranteed Certification

Full Compliance with USP 797 and USP 800 is one phone call away!

CALL FOR INFORMATION OR TO REQUEST A QUOTE (317) 489-4616 www.portable-cleanroom.com

Mobile Pharmacy Compounding Cleanrooms by Modular Devices

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Premanufactured mobile cleanroom available in a fraction of the time compared to traditional design/build projects. Fully engineered turn-key mobile cleanrooms designed to provide immediate compliance for USP 797 and USP 800.

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page 95

Capital Inventory, Inc. — The Premier Leader in Pharmacy Inventory Services Our decades of expertise, working exclusively with pharmacies, makes us uniquely qualified to provide accurate and dependable inventory valuations through a streamlined process.

page 97

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

Lora Bourque Eric Simmons Samantha Roy Alexa DiLuca Kristin Fennessey

SALES AND BUSINESS DEVELOPMENT Chris Kolkhorst, EVP chris.kolkhorst@rxinsider.com Mike Rahme mike.rahme@rxinsider.com Shaun Russell shaun.russell@rxinsider.com Jillian Melly jillian.melly@rxinsider.com Email sales@rxinsider.com Toll-Free Phone 800.972.2083 Fax 646.329.9766 Website www.RXinsider.com

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Adjuvanted to help prevent seasonal influenza in adults 65+1 Designed to strengthen, broaden, and lengthen the duration of the immune response2-4

Learn more at fluad.com For more information, please see Important Safety Information below and the Brief Summary on adjacent page.

INDICATION and IMPORTANT SAFETY INFORMATION INDICATION AND USAGE

FLUAD® QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

Do not administer FLUAD QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine.

WARNINGS AND PRECAUTIONS If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT should be based on careful consideration of the potential benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

The immune response to FLUAD QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope. Vaccination with FLUAD QUADRIVALENT may not protect all vaccine recipients against influenza disease.

ADVERSE REACTIONS The most common (≥10%) local and systemic reactions in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov. Before administration, please see the full US Prescribing Information for FLUAD QUADRIVALENT. FLUAD® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

REFERENCES: 1. FLUAD QUADRIVALENT. Package insert. Seqirus Inc; 2021. 2. O’Hagan DT, Ott GS, De Gregorio E, Seubert A. The mechanism of action of MF59—an innately attractive adjuvant formulation. Vaccine. 2012;30(29):4341-4348. doi:10.1016/j.vaccine.2011.09.061 3. O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Del Giudice G. The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines. 2013;12(1):13-30. doi:10.1586/ erv.12.140 4. Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249. doi:10.1111/j.1750-2659.2008.00059.x FLUAD QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates. Seqirus USA Inc., 25 Deforest Avenue, Summit, NJ 07901, USA ©2022 Seqirus USA Inc. January 2022 USA-aQIV-21-0065

18


FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) Injectable Emulsion for Intramuscular Use 2021-2022 Formula

b

c

BRIEF SUMMARY OF PRESCRIBING INFORMATION Consult the full US Prescribing Information for complete product information. INDICATIONS AND USAGE FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For intramuscular injection only. CONTRAINDICATIONS Do not administer FLUAD QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. WARNINGS AND PRECAUTIONS Guillain-Barré Syndrome: If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. [see Reference (1)] Evidence for a causal relationship of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. Altered Immunocompetence: The immune response to FLUAD QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope. Limitations of Vaccine Effectiveness: Vaccination with FLUAD QUADRIVALENT may not protect all vaccine recipients against influenza disease. ADVERSE REACTIONS The most common (≥10%) local and systemic reactions in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in clinical practice. The safety of FLUAD QUADRIVALENT was evaluated in two clinical studies in 4269 elderly subjects 65 years of age and older. Study 1 (NCT02587221) was a multi-center, randomized, observer-blind, non-influenza comparator-controlled efficacy and safety study conducted in 12 countries during the 2016-2017 Northern Hemisphere and 2017 Southern Hemisphere seasons. In this study, 3381 subjects received FLUAD QUADRIVALENT and 3380 subjects received a US-licensed non-influenza comparator vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Boostrix® [GlaxoSmithKline Biologicals]). The mean age of subjects at enrollment was 72 years, 62% were female, 48% White, 34% Asian, 16% Other, 2% American Indian/Alaska Native, and 18% of Hispanic/Latino ethnicity. Solicited local and systemic adverse reactions were collected for 7 days after vaccination in a subset of 665 subjects who received FLUAD QUADRIVALENT and 667 subjects who received the comparator vaccine. The percentages of subjects reporting solicited local adverse reactions are presented in Table 1a and systemic adverse reactions are presented in Table 1b. Onset usually occurred within the first 2 days after vaccination. The majority of solicited reactions resolved within 3 days. Table 1a. Percentages of Subjects Reporting Solicited Local Adverse Reactionsa in the Solicited Safety Populationb within 7 Days of Vaccination (Study 1) Local (Injection site) Reactionsc Injection site pain Erythema ≥25mm Induration ≥25mm Ecchymosis ≥25mm

FLUAD QUADRIVALENT N=595-659 16.3 3.8 4.0 0.5

Non-Influenza Comparator Vaccine N=607-664 11.2 1.8 2.6 0.7

Study 1: NCT02587221 Abbreviation: N=number of subjects with solicited safety data Non-Influenza Comparator Vaccine = combined Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Boostrix® (GlaxoSmithKline Biologicals) a All solicited local adverse events reported within 7 days of vaccination are included

Solicited Safety Population: all subjects in the exposed population who received a study vaccine and provided post-vaccination solicited safety data Severe reactions of each type were reported in 1.1% or fewer subjects receiving FLUAD QUADRIVALENT; severe reactions of each type were also reported in the comparator group at similar percentages. Severe definitions: Erythema, Induration and Ecchymosis = >100 mm diameter; Injection site pain = prevents daily activity.

Table 1b. Percentages of Subjects Reporting Solicited Systemic Adverse Reactionsa in the Solicited Safety Populationb within 7 Days of Vaccination (Study 1) Systemic Reactionsc Headache Fatigue Myalgia Arthralgia Chills Diarrhea Nausea Loss of appetite Fever ≥100.4°F (38°C) Vomiting

FLUAD QUADRIVALENT N=595-659 10.8 10.5 7.7 7.3 5.0 4.1 3.8 3.6 1.7 0.8

Non-Influenza Comparator Vaccine N=607-664 8.3 8.8 6.1 6.6 3.9 3.0 2.3 3.6 1.2 1.1

Study 1: NCT02587221 Abbreviation: N=number of subjects with solicited safety data Non-Influenza Comparator Vaccine = combined Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Boostrix® (GlaxoSmithKline Biologicals) a All solicited systemic adverse events reported within 7 days of vaccination are included b Solicited Safety Population: all subjects in the exposed population who received a study vaccine and provided post-vaccination solicited safety data c Severe reactions of each type were reported in 1.1% or fewer subjects receiving FLUAD QUADRIVALENT; severe reactions of each type were also reported in the comparator group at similar percentages. Severe definitions: Nausea, Fatigue, Myalgia, Arthralgia, Headache, and Chills = prevents daily activity; Loss of appetite = not eating at all; Vomiting = 6 or more times in 24 hours or requires intravenous hydration; Diarrhea = 6 or more loose stools in 24 hours or requires intravenous hydration; Fever = ≥102.2°F (39°C).

Unsolicited adverse events (AEs) were collected for all subjects for 21 days after vaccination. Related unsolicited AEs were reported by 303 (9.0%) and by 261 (7.7%) of the subjects for FLUAD QUADRIVALENT and Boostrix, respectively. For FLUAD QUADRIVALENT, injection site pain and influenza-like illness were the only unsolicited adverse reactions reported in ≥ 1% of subjects (1.7% and 1.5%, respectively). Serious adverse events (SAEs) and potentially immune-mediated adverse events of special interest (AESIs) were collected up to 366 days after vaccination. SAEs were reported by 238 (7.0%) FLUAD QUADRIVALENT recipients and 234 (6.9%) comparator recipients. There were no SAEs, AESIs or deaths in this study that were related to FLUAD QUADRIVALENT. Study 2 (NCT03314662) was a multicenter, randomized, double-blind, comparator-controlled study conducted during the 2017-18 Northern Hemisphere influenza season. In this study, 888 subjects received FLUAD QUADRIVALENT, 444 subjects received the licensed adjuvanted trivalent vaccine (aTIV-1 - FLUAD® (trivalent formulation)) and 444 subjects received an adjuvanted trivalent influenza vaccine with an alternate B strain (aTIV-2). The mean age of subjects at enrollment who received FLUAD QUADRIVALENT was 72.5 years. Female subjects represented 56.6% of the study population and the racial distribution of subjects was 91.6% Caucasian, 7.0% Black or African American, and ≤ 1% each for Asian, Native Hawaiian or Pacific Islander, American Indian or Alaska Native or Other. Solicited local and systemic adverse reactions reported within 7 days after vaccination were similar to those reported for Study 1. Unsolicited AEs were collected for 21 days after vaccination. Related unsolicited AEs were reported by 39 (4.4%) and by 17-19 (3.8%-4.3%) of subjects administered FLUAD QUADRIVALENT or aTIV, respectively. For FLUAD QUADRIVALENT, injection site bruising (1.0%) was the only unsolicited adverse reaction reported in ≥ 1% of subjects. Serious AEs and AESIs were collected up to 181 days after vaccination. Within 6 months after vaccination, 37 (4.2%) FLUAD QUADRIVALENT recipients and 18-28 (4.1%-6.3%) aTIV recipients experienced an SAE. There were no SAEs, AESIs or deaths in this study that were related to the study vaccine. There were no AEs leading to withdrawal from the study. Postmarketing Experience: There are no postmarketing data available for FLUAD QUADRIVALENT. However, the postmarketing experience with FLUAD (trivalent formulation) is relevant to FLUAD QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Blood and lymphatic system disorders: Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy General disorders and administration site conditions: Extensive swelling of injected limb lasting more than one week, injection site cellulitis-like reactions (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week) Immune system disorders: Allergic reactions including anaphylactic shock, anaphylaxis, and angioedema

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Musculoskeletal and connective tissue disorders: Muscular weakness

Pediatric Use

Nervous systems disorders: Encephalomyelitis, Guillain-Barré Syndrome, convulsions, neuritis, neuralgia, parasthesia, syncope, presyncope

Safety and effectiveness of FLUAD and FLUAD QUADRIVALENT (same manufacturing process and overlapping composition with FLUAD) were evaluated in clinical trials conducted in children 6 months to <72 months of age. Data from these trials are inconclusive to demonstrate the safety and effectiveness of FLUAD QUADRIVALENT in children 6 months to <72 months of age. The safety and effectiveness of FLUAD QUADRIVALENT in infants less than 6 months of age and in children older than 72 months of age have not been evaluated.

Skin and subcutaneous tissue disorders: Generalized skin reactions including erythema multiforme, urticaria, pruritus or nonspecific rash Vascular disorders: Vasculitis, renal vasculitis DRUG INTERACTIONS Concomitant Use With Other Vaccines: No clinical data on concomitant administration of FLUAD QUADRIVALENT with other vaccines is available. If FLUAD QUADRIVALENT is given at the same time as other injectable vaccine(s), the vaccine(s) should be administered at different injection sites. Do not mix FLUAD QUADRIVALENT with any other vaccine in the same syringe. Concurrent Use With Immunosuppressive Therapies: Immunosuppressive or corticosteroid therapies may reduce the immune response to FLUAD QUADRIVALENT. USE IN SPECIFIC POPULATIONS Pregnancy

Geriatric Use Safety and immunogenicity of FLUAD QUADRIVALENT have been evaluated in adults 65 years of age and older. REFERENCE 1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 19931994 influenza vaccines. N Engl J Med 1998; 339(25):1797-1802. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Risk Summary FLUAD QUADRIVALENT is not approved for use in persons < 65 years of age. There are insufficient human data to establish whether there is a vaccine-associated risk with use of FLUAD QUADRIVALENT in pregnancy. There were no developmental toxicity studies of FLUAD QUADRIVALENT performed in animals. A developmental toxicity study has been performed in female rabbits administered FLUAD (trivalent formulation) prior to mating and during gestation. A 0.5 mL dose was injected on each occasion (a single human dose is 0.5 mL).

FLUAD QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates. Seqirus USA Inc., 25 Deforest Avenue, Summit, NJ 07901, USA US License No. 2049 ©2021 Seqirus USA Inc. December 2021 USA-aQIV-21-0073

Lactation Risk Summary FLUAD QUADRIVALENT is not approved for use in persons < 65 years of age. No human or animal data are available to assess the effects of FLUAD QUADRIVALENT on the breastfed infant or on milk production/excretion.

23407_1_seqiru_21_Fluad_ROB_RxInsider_0222_RL.indd 3

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Sealed for safety Cardinal Health™ ChemoPlus™ IVA Security Seals promote safety and security of IV admixtures. These tamper-evident seals are a solution to support your facility’s USP <797> and <800> compliance practices and are available in a variety of sizes and colors for use with vials, IV bags and medication containers.

Sterile • Protects point of entry

Dual warning system • Ensures reconstituted medication is not further diluted or enhanced prior to administering to a patient • Tamper-evident seal self destructs upon attempted removal • Needle punctures are highly visible

Visual indicator • Aids in the identification of contents, routes of administration, beyond-use dates or other alerts

For more information or to order, call 800.964.5227 or visit cardinalhealth.com/chemoplus/IVASeals

© 2022 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO and CHEMOPLUS are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other marks are the property of their respective owners. Patent cardinalhealth.com/patents. Lit. No. 2 2GM22-1934108-01 (04/2022)

Made in the U.S.


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

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Verity Solutions — Your Invested Partner for 340B Partner with us to simplify 340B administration, confidently optimize federal pricing benefits, and benefit from the dedication and knowledge of our expert team. George Puckett Founded: 2015 Employees: 100 Toll-Free Phone: (800) 581-1378 Phone: (425) 947-1922 Address: 12131 113th Avenue NE, #200 Kirkland, WA 98034 Website: www.verity340b.com CEO:

Company Background

Verity Solutions is a leader in 340B program administration. Recognized as Best in KLAS: 340B Management Systems for the last five years, 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 outstanding support so that every customer can maximize their savings. We partner with integrated healthcare systems, acute-care hospitals, community health centers, federally qualified health centers, pharmacies, and other 340B-eligible covered entities throughout the United States who rely on Verity 340B® software and services to successfully manage their 340B program.

Product Overview

Our powerful V340B® cloud-based software platform provides comprehensive solutions for split billing, contract pharmacy, specialty contract pharmacy, compliance management, purchase analytics, and pharmacy network management (VHUB®). Our innovative new product, VERISAVE™, automatically selects the best priced products available for your complete order, reducing tedious manual processes and dramatically decreasing your drug spend. 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. We offer: • Agile Software Platform: Built and deployed with security, performance, scalability, and agility as primary goals. The Verity 340B platform is HITRUST certified, demonstrating robust HIPAA compliance. • 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?

We continually invest in our technology and people to ensure 340B program success for our clients. With increasing 340B regulatory complexity and demand for audit preparedness, it's more important than ever to have the right solution for your 340B program management — and the right partner.

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. • Rapid 120-day average 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 audits, HRSA audits, and UDS reporting. • 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. • F lexible 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. • 80% of our customer support cases resolved within two hours. 95% resolved within 24 hours.

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Elevate performance where it matters most with Shields — the premier specialty pharmacy accelerator in the country.

Visit Shieldsrx.com


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Shields Health Solutions — The Premier Specialty Pharmacy Accelerator in the Country Transform your specialty pharmacy into a powerful growth engine and elevate performance where it matters most — with Shields.

Lee Cooper Founded: 2012 Employees: 1,500 Phone: (781) 566-5066 Address: 100 Technology Center Drive, Suite 600 Stoughton, MA 02072 Website: www.shieldshealthsolutions.com CEO:

Company Background

At Shields, improving lives and elevating performance are at the heart of everything we do. That’s why more health system leaders trust Shields to elevate access, outcomes, and growth within specialty pharmacy — delivering value throughout the entire health system. Transform your specialty pharmacy into a powerful growth engine and elevate performance where it matters most with Shields — the premier specialty pharmacy accelerator in the country.

Product Overview

n Elevate Performance Where it Matters Most — With Shields. At Shields, improving lives and elevating performance are at the heart of everything we do. That’s why more health system leaders trust Shields to elevate access, outcomes, and growth within specialty pharmacy — delivering value throughout the entire health system. Leveraging our proven Shields Performance Platform, we help you produce the superior outcomes your patients deserve and the financial results your health system demands. We work alongside your team, scaling resources and implementing the processes required to deliver more affordable care, optimize specialty pharmacy services, improve outcomes, retain more patients, and accelerate system-wide growth. n Make Complex Care More Accessible and Affordable. It all starts by providing your health system with access to the medications, health plans, and financial support that patients with complex and chronic conditions require. That’s why we put our trade relations experts to work for you — securing access to 90% or more of the limited distribution drugs and specialty medications that patients desperately need. Simultaneously, our payer teams open the door to nine out of 10 restricted payer networks most specialty pharmacies are unable to access — expanding your eligible patient opportunity twofold. While our financial professionals work tirelessly to ensure that patients have access to affordable care and support services through your health system. n Scale Integrated Pharmacy Services and Improve Outcomes. As we are increasing access to affordable care, our clinical pharmacist, patient liaison, and support teams are also implementing the proven Shields Care Continuum to improve therapy management and care coordination

across your health system. These dedicated experts operate as integrated members of your care team — improving patient success by reducing time to therapy to 48 hours or less; optimizing the patient experience by expanding the number of critical care touchpoints four times; and enhancing outcomes by achieving 90% or greater adherence across your entire specialty pharmacy patient population. n Attract and Retain More Patients. Our Patient Workflow and Care Coordination Solution, along with our data experts also enable you to scale patient engagement and care coordination throughout the hospital. Rapidly identify patients in need and follow them throughout therapy — connecting patients with the medical providers, specialty pharmacists, patient liaisons, and financial support professionals required to deliver the best possible outcomes. This one-of-a-kind solution has proven to increase specialty pharmacy retention by 40-60%; improve patient experience Net Promoter Scores (NPS) from 20 to 80+; and reduce the total cost of care by 13% or more. n Accelerate System-Wide Growth. While we are laser-focused on helping you produce superior patient outcomes, we also understand that your health system must be financially fit. That’s why we leverage Shields Acceleration Solutions and Services to unlock economic upside as we scale your specialty pharmacy capabilities. Whether it is reducing your total cost of care by double digits, enhancing margins through 340B; increasing specialty pharmacy revenue by 30%; or generating $20M+ in incremental year-over-year net operating income — we will deliver the system-wide financial performance required to accelerate growth and optimize care. n Transform Specialty Pharmacy Into a Growth Engine. With the foremost leaders in specialty pharmacy on our team; proven success partnering with more than 70 health systems across the country; and a vested interest in delivering measurable results — we are the partner of choice for health system leaders who want to transform specialty pharmacy into a powerful growth engine and produce superior patient outcomes. Together, we will expand payer and drug access; improve therapy management and care coordination; deliver unsurpassed patient experiences; and generate the net operating income you need to accelerate growth.

Key Customers

We are the partner of choice for health system leaders who want to transform specialty pharmacy into a powerful growth engine and produce superior patient outcomes. Visit our website to see our growing list of health system partners nationwide, including leading academic medical centers, integrated delivery networks, accountable care organizations, and health systems. SUMMER 2022

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customized software

turnkey hardware

innovative training

24/7 US-based support

MEET YOUR NEXT STAR EMPLOYEE. www.rm-solutions.com


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Point-of-Sale to Simplify Your Pharmacy Operations — Retail Management Solutions Pharmacy point-of-sale should work for you, not the other way around. Meet the solution that helps you improve patient outcomes, streamline operations, and use your choice of pharmacy management systems. All while enjoying 24 seven customer support.

President & CEO: Brad Jones Founded:

1998 Toll-Free Phone: (877) 767-1060 Phone: (360) 438-8276 Fax: (360) 438-8284 Address: 4535 Lacey Boulevard SE Lacey, WA 98503 Website: www.rm-solutions.com

Company Background

Founded in 1998, with a mission to help pharmacies understand and use technology-based tools to run a successful business, Retail Management Solutions continues to lead point-of-sale innovation. Giving pharmacies access to tools and technology to improve patient outcomes, streamline operations, and improve profits. At RMS, we believe that point-of-sale should simplify pharmacy operations and management all while improving the patient experience. Our POS products are designed exclusively for pharmacies with flexibility, ease of use, and scalability in mind.

n Beyond the Basics: Improving patient outcomes and increasing customer satisfaction are goals at the heart of most organizations today. n Meds-to-Beds: Technology and support help you to align your pharmacy with organizational goals. Point-of-sale tailored for bedside interactions and full transaction processing help you work towards increasing patient compliance and reducing readmittance rates as a result. n Nutrient Depletion: Notifications at the register help you to improve patient wellness by making supplement recommendations based on prescription induced nutrient depletion. n Easy Compliance: RMS credit card processing capabilities include options for validated P2PE, allowing the potential for reduced PCI scope. Processing integrations also include options for EMV, tokenization, NFC, and FSA/HSA card acceptance. Every RMS system includes optional integration with NPLEx for Pseudoephedrine tracking as well as signatures, ID capture, and tracking for HIPAA, safety caps, prescription acknowledgment, etc.

RMS’ solutions create a more customer-centric patient experience and reduce employee workload through many different avenues.

n Headquarters and Management: Point-of-sale applications extend beyond the customer interaction to help you run your pharmacies more efficiently. Enterprise-level multi-location management unlocks powerful tools for policy, pricing, employee, and customer management. Data fed back to the headquarters saves time and resources.

n At the Register: RMS customers have freedom to choose from over 30 pharmacy system partners, all with integrations that make prescription sales fast, easy, and accurate. Signatures for HIPAA, safety caps, prescription acknowledgment, etc. are captured at the time of sale and are always easily accessible when needed for reporting and audits. Built-in date of birth verification processes and additional prescription for pickup notifications bring added patient safety and convenience to every transaction.

A host of reports, both canned and customizable, are available. From cash management and employee performance to A/R balances, and more. RMS systems give you the data you need to drive important decisions and run pharmacies efficiently.

Product Overview

Additionally, every RMS system includes built-in will-call management. Batch multiple prescriptions together into a single bag. Store according to your organizational preferences. Scan a single barcode at checkout. This easy-to-use option improves patient safety and saves time. Beyond prescription sales, OTC product sales are as simple as scanning the item barcode. Custom items can also be created for easy sale of unique products, gift items, etc. Payroll deduct can be added to any implementation for easy employee sales. Sales can be processed in many different ways to meet the unique needs of your pharmacy. Whether you need traditional retail lanes, Medsto-Beds technology, an option for drive-thru payments and signatures, curbside pickup solutions, or an easy way to track deliveries. You can mix and match to create the perfect technology scheme.

For pharmacies managing retail departments, RMS’ inventory management solutions open the door for advanced management of front-end product with wholesaler interfaces, automated purchasing and receiving, price updates, and integrated signs and labels.

n When You Need Support: RMS’ solutions are more than point-of-sale software and hardware. You won’t have to hire a team to manage your RMS system. All RMS customers are supported by a team of U.S.-based technical specialists that are available 24 hours a day, seven days a week. Certified trainers help you implement your solution in a timely manner that meets the requirements of your organization. Every RMS customer is also assigned a dedicated customer success manager to help your team stay on track with organizational goals following implementation. The RMS customer center is available at any time to request support, access the customer knowledgebase, and more.

Trade Shows/Meetings Attended

Experience RMS in person this year at one of our many pharmacy industry events. Find out where we’ll be next at www.rm-solutions.com/events. SUMMER 2022

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NSF/ANSI 456 Vaccine Certified GX Solutions Medical-grade Cold Storage Ensuring consistent temperature performance for safe vaccine storage

Designed for critical vaccine storage and NSF/ANSI 456 standard certified Best-in-class temperature management for uniformity, stability, and recovery ENERGY STAR® certified and 50-60% more energy efficient than conventional medical-grade refrigerators and freezers

Learn More helmerinc.com/nsf-ansi-456

© 2020-2021 Helmer Inc. All rights reserved. © 2022 Helmer Inc. All rights reserved


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NSF/ANSI 456 Standard Compliant Vaccine Cold Storage From Helmer Scientific NSF/ANSI 456 Vaccine Storage Standard promotes safety and efficacy by ensuring consistent vaccine storage conditions.

President:

Bruce King

Vice President of Sales & Marketing: Lori Gabrek Founded:

Employees: Toll-Free Phone: Phone: Address: Website:

1977 500 (800) 743-5637 (317) 773-9073 14400 Bergen Boulevard, Noblesville, IN 46060 www.helmerinc.com

Company Background

Helmer Scientific is a manufacturer and worldwide distributor of medicalgrade cold storage and laboratory processing equipment. We have over 45 years of experience in providing high-quality temperature-controlled environments, with our products used in over 125 countries throughout the world. Precise temperature control is essential to the successful storage of pharmaceuticals and Helmer cold storage products have been designed and developed with these principles.

Product Overview

Proper storage and handling are critical to ensure the safety and viability of life-saving vaccines. Because vaccines require storage at specified temperature ranges, cold storage plays a significant role in the storage and handling process. The NSF/ANSI 456 Vaccine Storage Standard was published in 2021 by the NSF Joint Committee on Vaccine Storage to help define temperature performance attributes for vaccine storage units. The standard was developed using real-world cases common in healthcare environments. To achieve NSF/ANSI 456 certification, several temperature performance standards must be validated by a third-party certifying body. These include short door opening tests to simulate regular daily use and long door opening tests to simulate less frequent events — such as inventory counts or cleaning. Both tests must be conducted with the unit loaded and unloaded. Additional requirements for NSF/ANSI 456 certification include: • Certified units are required to have calibration certificates as well as calibration and service schedules designed to ensure units remain in compliance. • Digital temperature displays visible with unit doors closed. • Both visual and audio high/low temperature excursion alarms. • Auto-closing doors.

Powered by OptiCool™ technology, GX Solutions pair a variable capacity compressor (VCC) and natural hydrocarbon (HC) refrigerants to offer best-in-class temperature management, including optimized uniformity, stability, and recovery. This provides confidence that vaccines and medications are stored at the precise temperature regardless of where they are placed within the unit. The new NSF/ANSI 456 Vaccine Storage Standard will set a new, higher standard for the performance of purpose-built, medical-grade vaccine refrigerators and freezers. Helmer Scientific GX Solutions are leading the way with temperature, energy, and noise management designed to safely store vaccines and ensure every dose counts.

Features & Options n Professional, Medical-Grade Performance • NSF/ANSI 456 Vaccine Standard Certified and supports CDC guidelines for vaccine storage. • Optimized temperature performance that safeguards stored product ensuring vaccines and medications remain efficacious. • Energy Star® certified and 50-60% more energy efficient than conventional medical-grade refrigerators while supporting environmental sustainability. • Three times quieter than traditional models, leading to better rest for patients and fewer distractions for healthcare personnel. 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. • Records performance history of the unit, including event acknowledgment. Includes 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.

GX Solutions Professional Medical-Grade Refrigerators from Helmer Scientific are designed for the unique needs presented by critical vaccine storage and are NSF/ANSI 456 standard certified. SUMMER 2022

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

THOUGHT LEADER VIDEO SERIES

Advancing the Business of Pharmacy

Sentry Data Systems | Expect More

Join Steve Rough, Senior Vice President, Phil Brummond, Senior Vice President, Jerame Hill, Vice President, Joe Cesarz, Vice President, and Maxie Friemel, Senior Director of Pharmacy Revenue Cycle Services, as they discuss hospitals and health systems, infusion, and pharmacy revenue cycles in a nine-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.visanteinc.com

www.sentryds.com

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THOUGHT LEADER VIDEO SERIES

THOUGHT LEADER VIDEO SERIES

The Compliance Team

Surescripts

Join Caitlin Warner, Provider Relations, Jack Haire, Director of DMEPOS & Pharmacy Services, Sandy Canally, RN, Founder & CEO, Steve Simmerman, COO, and Scott Muscarella, Vice President of Marketing, as they discuss Exemplary Provider Accreditation in a 12-part video series.

Join Melanie Marcus, Chief Marketing Officer, Cecelia Byers, Specialty Pharmacy Clinical Product Manager, and Tom Skelton, Chief Executive Officer, as they discuss the nation’s most trusted and capable health information network.

www.thecomplianceteam.org

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Azina

CPS Join Frank Segrave, Chuck Ball, Michael McCarrell, Joseph Dula, Rabiah Dys, Chris Beebe, Kelly Kolker, Paresh Patel, Keith Cook, Eric Murphy, Lars Ringger, and Tony Callander, as they discuss partnering with hospital and health system leaders to drive performance excellence.

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

www.azina.com

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THOUGHT LEADER VIDEO SERIES

THOUGHT LEADER VIDEO SERIES

The Nation’s Premier Pharmaceutical Returns Processor in the Pharmacy Market

Accreditation Commission for Health Care (ACHC)

Thierry Beckers, President & COO, Gil Kanner, Vice President, Supply Chain Logistics, Hilmer Beckers, Chairman & CEO, and Adam Bottie, Vice President, Sales & Business Development, discuss PharmaLink: The Nation’s Premier Pharmaceutical Returns Processor in a 12-part video series.

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

THOUGHT LEADER VIDEO SERIES

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.pharmalinkinc.com

www.achc.org

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SUMMER 2022

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Pharmacy consulting designed for optimal growth

We help you achieve extraordinary results in all areas of health system pharmacy

Strategic Planning & Implementation

Compliance that Improves Care

Financial Results

We collaborate with you to deliver innovative solutions that will elevate your organization to peak performance levels.

Our team of compliance experts will improve confidence, enhance care and ensure patient, worker and community safety.

Making the most of opportunities to manage costs and increase revenue is core to our consulting. We help you improve financial performance across your organization.

Visante consultants bring you expertise in all areas of hospital and health system pharmacy: • • • •

Comprehensive Strategic Assessments 340B Program Solutions Specialty Pharmacy Programs Revenue Cycle and Drug Reimbursement Strategies

Connect with Visante today to learn how we can help you reach your goals. Visit us at visanteinc.com, or call 866-388-7583. © Visante Consulting, LLC, 2021. All Rights Reserved.

• Supply Chain Strategies • Drug Diversion Programs • Drug Compounding Excellence

TM

Transforming healthcare through pharmacy.


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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 (866) 388-7583 Address: 101 East 5th Street, #2220 St. Paul, MN 55101 Website: www.visanteinc.com Toll-Free Phone:

Company Background

Visante is a specialized consulting firm focused exclusively on helping health systems accelerate strong financial and operational performance through pharmacy. Our team of professionals bring deep, contemporary expertise and innovation to optimizing all aspects of a fully integrated health system pharmacy program, driving significant value quickly. By providing customized solutions to fit the needs of our clients, we deliver sustained financial results through revenue growth, cost savings, and optimal business performance.

Featured Services n Business Strategy Optimization 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 Specialty Pharmacy Services A clearly defined specialty pharmacy strategy can help improve patient care and greatly improve 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.

n Pharmacy Revenue Cycle Sustained financial growth is one of the top challenges for even the most successful organizations in the healthcare industry. Effective pharmacy programs can increase revenue by maximizing existing opportunities, creating new programs and services, and reducing costs. Our team of experts is here to help maximize financial performance within your organization through our mastery of both pharmacy and revenue cycle operations. Our consultants bring a wide range of experience to the table to assist each of our clients in a way that best fits them and their financial goals. n Pharmacy Supply Chain Optimization Supply chain and utilization management are complex and ever-changing functions of a pharmacy enterprise. To find success in these areas, disciplined focus and alignment must be prioritized. Visante’s supply chain experts help hospitals and health systems achieve reliable, safe, and efficient drug supply chain performance while also realizing significant financial returns. n 340B Solutions 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. n Sterile and Non-Sterile Compounding Compliance 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> as well as gap assessment and facility design; 503A, 503B assessment, facility design, and implementation support; and home infusion compounding services. n Drug Diversion 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. SUMMER 2022

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FDA Registered | Iso Certified

Your partner in pharmacy compliance since 1992 USP <797> USP <71> USP <800> Left: GM7030 PATT2®, Personal Aseptic Technique test kit, 3mL ampules, 20mL vials, 100mL partially filled minibag. Below: ET1000 EnviroTest® TSA with Lecithin & Tween 80 growth media paddles for surface, air, or glove fingertip sampling.

Media Fill Hazardous Drug Handling Validation Surface and Fingertip Testing Sterility Testing Qimedical.com

info@qimedical.com

Tel. 800.837.8361


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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 (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 Toll-Free Phone:

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 à la 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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CAS E S TU DY DAYTON CHILDREN’S HOSPITAL'S COMMITMENT TO PHARMACY EXCELLENCE A Strategic, Long-Term Partnership With CPS INTRODUCTION AND INTENDED OUTCOME

Benjamin Goodstein Vice President & Chief Ambulatory Officer; President, Specialty Physicians, Inc. ~ Dayton Children’s Hospital

Dayton Children’s Hospital is one of eight children’s hospitals in Ohio. As a regional referral center, they serve patients from a 20-county area, which includes Ohio and eastern Indiana. The hospital’s more than 200 physicians include primary care pediatricians and subspecialists in over 35 areas of pediatric medicine. Working as a team with the medical staff are more than 3,500 employees and volunteers who share a commitment to quality care. This, combined with Dayton Children’s affiliation with Wright State Boonshoft School of Medicine and accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), supports their mission to provide the local patient population access to the finest pediatric care available. “We consider this access to care to be our edge in the world’s most competitive market for children’s hospitals,” says Dayton Children’s Vice President & Chief Ambulatory Officer; President, Specialty Physicians Inc., Benjamin Goodstein. “And a critical part of that is access to quality pharmaceutical care.” This commitment to quality pharmaceutical care was foundational to the growth of the hospital’s relationship with CPS, which has evolved into a rewarding strategic partnership. CPS has helped Dayton Children’s strengthen its inpatient pharmacy and build out its outpatient services with a highly successful specialty pharmacy.

THE ORIGINAL CHALLENGE In 2017, a JCAHO survey uncovered some compliance issues, explains Ben. “The survey flagged concerns around policies, procedures, and workflows in a range of areas — from 340B to supply chain to the way we were handling sterile compounding.” Dayton and CPS collaborated to help address the Joint Commission issues. A leader in hospital pharmacy services, CPS was equipped to help their stakeholders overcome challenges impeding pharmacy performance excellence — such as purchasing practices, compliance, accreditation survey readiness, sterile compounding, and more. 38

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CAS E S TU DY

INPATIENT PHARMACY SOLUTIONS

Since August of 2020, specialty pharmacy revenue has grown by 61%. In addition, volume in the first quarter of 2022 increased from 12 per day to 16.5 per day compared to the same time frame in 2021."

n Compliance Through CPS’ Pharmacy Management services, Dayton Children’s brought an expert CPS interim director of pharmacy on board. The first order of business? Establishing trust.

Benjamin Goodstein Vice President & Chief Ambulatory Officer; President, Specialty Physicians, Inc. ~ Dayton Children’s Hospital

n Clinical Initiatives The partnership with CPS has also helped Dayton Children’s bolster the clinical profile of its staff. For instance, by leveraging the company’s range of clinical services and programs — which includes access to the nation’s largest peer network of pharmacy professionals — the hospital now has more board-certified staff. They’ve also set up a successful residency program, allowing the hospital to attract and educate promising new pharmacists who can eventually help build and strengthen the pharmacy’s services.

“Within four or five months, our CPS director had turned the relationship between leadership and the inpatient pharmacy team completely around,” says Ben. “With that trust, she was able to go to work changing the culture — adjusting policies and procedures for compliance and implementing proper workflows for the emergency department and inpatient units.”

n Decentralized Pharmacy Once the inpatient pharmacy transformation was well underway, Dayton Children’s CPS director began to decentralize the pharmacy — which turned out to be a crucial and valuable course of action. The initiative focused on placing clinical pharmacists on all floors, including inside neonatal intensive care units, pediatric intensive care units, and the emergency department. “Our engagement with healthcare providers throughout the hospital skyrocketed almost immediately.” Ben and his team found that having clinical pharmacists available for rounds gave the nursing staff a greater sense of support. “The move to decentralize really changed the relationship with our pharmacy across the entire system.” Plus, having a pharmacy partner right there meant that compliance of the medications being delivered was better managed. “That was pretty powerful,” says Ben.

n Drug Diversion Program Dayton Children’s current inpatient pharmacy director was the clinical coordinator when the hospital partnered with CPS to build their Drug Diversion Program. “We didn’t have a lot of infrastructure around drug diversion from a compliance standpoint,” says Ben. Dayton Children's prioritized performance excellence within their Drug Diversion Program. Their coordinator then implemented a systematic process to help control drug diversions and make sure they are handled consistently across a wide range of perspectives — public safety, clinical, nursing, compliance, and legal.

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CAS E S TU DY

Now, 82% of all prescriptions qualify as 340B, which leads to lower overall drug spend." Benjamin Goodstein Vice President & Chief Ambulatory Officer; President, Specialty Physicians, Inc. ~ Dayton Children’s Hospital

n Sterile Compounding The inpatient pharmacy director and ambulatory pharmacy services director rebuilt the entire sterile compounding program in about a year and a half. Their goal from the start was to maintain compliance with USP 797 while implementing a compliance plan to satisfy USP 800, which provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare workers, patients, and the environment. This approach positions Dayton Children's to pivot as needed as the final rules for satisfying USP 800 become more clear. To do that, they worked with nursing, environmental services, and employee health stakeholders to establish hazardous handling policies. They also engaged with facilities, quality, and infectious disease teams in the hospital to ensure the infrastructure was correct. Now, Dayton Children’s has a supervisor of sterile compounding who is also a pharmacist, and techs are trained regularly on policies that go above and beyond USP 800. They also ensure compliance with new regulations, installing the correct hoods for hazardous compounding, for instance, which became the rule in 2021.

OUTPATIENT PHARMACY SOLUTIONS “From early on in our relationship, CPS’ specialty division, Azina, System VP of Pharmacy Services, John Petts, had been talking to me about elevating our pharmacy manager to lead the outpatient pharmacy,” says Ben. They ultimately took the recommendation, and today that person works for CPS — serving as Dayton Children’s ambulatory pharmacy services director, overseeing the outpatient, specialty, and home care pharmacies.

n Specialty Pharmacy With all these successes, the ambulatory pharmacy services director recommended having CPS Azina manage Dayton Children’s Specialty Pharmacy. “We had been wanting to build out a specialty pharmacy, but at the time, CPS’ program wasn’t quite what I was looking for,” Ben explains. When they circled back around to discuss it again later, however, he found that CPS had added some world-class leadership, and the program fit their needs much better. “I’m a metrics person. I want to see the data — and that’s exactly what they showed me.” As a result of the partnership with CPS, the hospital’s specialty pharmacy ended up being highly profitable during its first year. This was partly due to its achieving dual

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CAS E S TU DY

For [CPS] to be successful, they've got to hit my metrics — which they've done, time and time again." Benjamin Goodstein Vice President & Chief Ambulatory Officer; President, Specialty Physicians, Inc. ~ Dayton Children’s Hospital

accreditation, which gave them increased access to specialty networks. Since August 2020, specialty pharmacy revenue has grown by 61%. In addition, volume in the first quarter of 2022 increased from 12 per day to 16.5 per day compared to the same time frame in 2021.

n 340B Compliance Once the specialty pharmacy was built, the ambulatory pharmacy services director started working on 340B compliance. This involved bringing on a 340B compliance specialist and expanding contract pharmacy agreements. Now, 82% of their prescriptions qualify as 340B, which leads to lower overall drug spend. CPS’ annual Comprehensive Pharmacy Assessment, a proprietary tool consisting of a 450+ point audit of pharmacy operations health, verified that overall compliance oversight of the 340B program has improved.

THE RESULT — A STRATEGIC PARTNER DAYTON CHILDREN’S CAN COUNT ON “I expect the people in leadership positions to understand the ‘why’ behind what Dayton Children’s does and how the pharmacy relationship relates to our mission — the relentless pursuit of optimal health for every child within our reach,” says Ben. That means keeping teams engaged and making sure they are aligned and feel supported, he adds. He expects the same from CPS. That’s because Ben doesn’t see CPS as a vendor. “They’re part of the team — they have to be in order for our pharmacy to be successful,” he says. “And for them to be successful, they’ve got to hit my metrics — which they’ve done, time and time again.” The promise CPS made from the beginning was that Dayton Children’s would earn back the fee they pay for services in revenue every year. That has held. “I don’t think there’s been a project or a program we’ve done with CPS that hasn’t been successful,” says Ben. “It’s fantastic to have a partner who understands we’re not just a small children’s hospital wedged in Ohio and that we’re fiercely independent.” It’s not just the local leadership from past and present directors, but the senior leadership who also understands the importance of Dayton Children’s in the market.

CONCLUSION Today, Dayton Children’s has the most engaged, reliable, quality-focused pharmacy the hospital has ever had. As a result, the pharmacy program is the second-highest revenue source for the entire hospital.

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It’s a cold, hard fact

When it comes to product temperature accuracy, there is no room for error. Follett upright refrigerators and freezers feature our exclusive plenum air distribution which delivers cold air at multiple levels to ensure consistent top‑to‑bottom temperatures, even when heavily loaded with product.

See our full line at folletthealthcare.com or call 800.523.9361 for more information


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NEW Follett Refrigerators are Omnicell FlexLock-Ready Follett FlexLock-ready refrigerators facilitate durable and fast installation of Omnicell® XT FlexLocks. Laser cut holes allow the locking device to bolt to the side of the refrigerator for improved durability. Installation time is less than 15 minutes, and the unit is ready for service immediately.

General Manager: Michael Raycher Founded:

1948 Employees: 500+ Toll-Free Phone: (800) 523-9361 Phone: (610) 252-7301 Fax: (610) 250-0169 Address: 801 Church Lane Easton, PA 18040 Website: www.follettpharmacy.com

Company Background

Follett Products LLC is a leading manufacturer of innovative equipment for the healthcare market, including medical-grade refrigerators and freezers, ice and water dispensing equipment, and ice machines. Our focus on 100% customer satisfaction results in equipment that provides outstanding innovation and design excellence to meet the specific needs of each healthcare facility.

Product Line Overview

Follett medical-grade pharmacy refrigerators and freezers maintain precise and consistent temperatures for your valuable medications and vaccines. Powerful forced air refrigeration enables quick recovery after door openings, ensuring medications are stored at specified temperatures and reducing the risk of lost product. Designed in partnership with Omnicell, Follett’s NEW FlexLock-ready refrigerators facilitate durable and fast installation of XT FlexLocks. Laser cut holes in the refrigerator allow the locking device to be bolted to the side of the refrigerator for improved durability. Installation can be performed in less than 15 minutes, and the unit is ready for service immediately. n Follett upright refrigerators and freezers feature a powerful topmounted refrigeration module and innovative back plenum air distribution system for superior temperature consistency.

n Choice of superior storage options. • Industry-exclusive “floating” basket system on -PH models. • Six full extension, epoxy-coated “floating” baskets move with a gentle push or pull. •B askets and slide assemblies lift out without tools for full cleaning access. • Four heavy-duty epoxy-coated shelves, adjustable in ½" (1 cm) increments are standard on -LB models. n Follett’s innovative single module refrigeration system provides outstanding serviceability. • Top-mounted modular design allows the entire refrigeration system to be removed as one unit without cutting refrigerant lines. If needed, a spare system can slide into place, virtually eliminating downtime. n High-performance countertop refrigerators and freezers offer superior temperature performance in space-saving configurations. • 1 and 2 cu ft models fit on standard 24" deep counters. • Forced-air cooling provides cabinet-wide temperature consistency and quick recovery after door openings. • External digital temperature display in user-selectable F or C with integral high/low alarming and display sleep mode. • Keyless entry via keypad and electronic lock option. n Powerful undercounter refrigerators and freezers are designed for use below standard and lower ADA-compatible counters. • Heavy-duty forced air cooling for quick recovery after door openings. • External digital temperature display in user-selectable F or C with integral high/low alarming and display sleep mode. • Keyless entry via keypad and electronic lock option.

Contact information

For more information, contact Follett Products LLC at (800) 523-9361 or visit www.follettpharmacy.com.

• Industry-exclusive ducted air distribution delivers cold air at six different levels for top-to-bottom temperature uniformity, allowing full utilization of the storage space. • Modular refrigeration system with microprocessor controller provides a ±1⁰C temperature consistency throughout the storage cabinet, ensuring all product is stored within the proper range. • Intuitive full-color touchscreen user interface features enhanced data management, providing the ultimate in user convenience. n Full stainless-steel cabinet and high-quality components designed with the user in mind. • Heavy-duty, self-closing doors provide important energy savings and lock open at 90 degrees to allow easy product loading.

Follett and Follett Healthcare are registered trademarks of Follett Products LLC, registered in the U.S. Omnicell and the Omnicell brand mark are registered trademarks of Omnicell Inc. in the United States and internationally. ©2021 All rights reserved.

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A

COMPANY


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

Acute Care Pharmaceuticals — Leader in USP <797> and <800> Compliant Products Your one-stop shop for USP <797> and <800> compliant PPE, wipes, disinfectants, and cleaners. We make your buying experience easy with multiple GPO contracts and products available at your contracted wholesaler.

President & CEO: Tom Friedl Founded:

1992 17 Toll-Free Phone: (888) 909-7700 Address: 12195 Dearborn Place Poway, CA 92064 Website: www.pharma-choice.com Employees:

Company Background

For decades, Acute Care Pharmaceuticals has been the pharmacy cleanroom supplier of choice, delivering exceptional products and service to healthcare providers nationwide. We have been pioneers in the industry long before the guidelines became requirements. This has put us at the forefront of the pharmacy compounding market and true experts in the day-to-day, real-world requirements of USP <797> and <800> regulations. We offer an unparalleled range of USP <797> and <800> compliant disposable products that are manufactured under the highest standards. This unique dedication to compliance, coupled with our decadeslong commitment to partner with hospital pharmacies and critical environments, has helped make Acute Care a market leader. As part of the Hospeco Brands Group, Acute Care Pharmaceuticals has access to the entire Hospeco family of cleaning and safety products making us even better equipped to satisfy your facilities critical environment needs. This new broader range of products has given us the ability to be the supplier of choice to a wide range of healthcare related entities, including independent (non-hospital) pharmacies, labs, veterinary pharmacies, nursing homes, aerospace manufacturing, food processing, medical device manufacturing, and more.

Product Overview

Our broad range of products and services affords us the opportunity to supply your facility with all your most important safety and cleaning needs. With 20 GPO and IDN contracts in place, our goal is to make your buying experience simple and easy. Our Pharma-Choice™ brand of products are stocked at a variety of national distribution partners including, AmerisourceBergen, Cardinal, McKesson, and Medline where you can receive your special discounted contract pricing. We supply: • Sterile Alcohol • Non-Linting Wipes (Dry and Pre-Saturated) • Disinfectants • Media Test Kits • Gloves

• Disposable Apparel • Personal Protective Equipment • Cleaning Equipment • Spill Kits • Crash Cart Kits • Disposable Mopping Systems

Key Business Partners • AmerisourceBergen • AvMedical • Cardinal

• McKesson • Medline

Markets Served

• Inpatient Pharmacies • Compounding Centers • Hospital/Acute • Clinic • HMO

• Home Health Care (HHC) • Home Infusion • Surgery Centers • Retail • Long-Term Care

Trade Shows/Meetings Attended • MHA Business Summit • Vizient Reverse Trade Show • ONS Congress • Premier’s Breakthrough Conference • HealthTrust University Conference • CSHP Market Show • ASHP Clinical Meeting and Exhibition • NPPA Conference • HCP Hospital Supply Chain

GPO Affiliations • APCI • Ascension (The Resource Group) • Asembia • Fairview Pharmacy Services • GeriMed

• HealthTrust (HPG) • MHA • Northside Hospital System • Premier • Vizient

Ordering Information

For free, next-day delivery, order through your wholesaler or distributor. To order our full line of USP <797> and <800> compliant products, visit www.pharma-choice.com or speak directly to a product and contract order expert at (888) 909-7700.

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NSF/ANSI 456 Vaccine Storage Standard Long before the COVID-19 pandemic, vaccine providers and program administrators faced significant challenges as they navigated the selection and purchase of effective vaccine storage equipment. Because vaccines require storage at specified temperature ranges, refrigerators and freezers play a significant role in the storage and handling process. Proper storage is critical to ensure the safety and viability of life-saving vaccines. Data collected by the Advisory Committee on Immunization Practices (ACIP) and the National Institute of Standards and Technology (NIST) indicated that refrigerators and freezers used to store vaccines in clinics and hospitals were, and continue to be, a major risk point. The CDC Vaccine Storage and Handling Toolkit was initially launched in 2012 to provide guidelines and recommendations for vaccine handling and storage across the cold chain. The toolkit is updated periodically and provides guidance that improves the safety and efficiency of vaccine storage. However, the toolkit does not provide clearly defined performance criteria for cold storage. Performance differences between purpose-built vaccine refrigerators may be significant but may be identified only through testing that simulates real-world use related to load conditions and door openings, as well as measuring cabinet temperature across all potential storage locations. The NSF Joint Committee for Vaccine Storage was formed in 2015 to develop a new standard. The committee was responsible for creating a standard that ensures engineering controls are in place to assist in safely storing vaccines under real-world conditions in clinical environments. The NSF/ANSI 456 Vaccine Storage Standard was finalized in May 2021, and equipment manufacturers can submit their products for independent testing and certification against the standard. We recently spoke with Dennis Smith, a member of the NSF Joint Committee for Vaccine Storage tasked with creating the new standard, to provide a manufacturer’s perspective on the implications of the new standard including the certification of vaccine storage units. 46

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Dennis, please tell us about yourself and the role you played on the NSF Joint Committee. I supported the committee providing perspective from the refrigerator/freezer manufacturers. My role was chair of the use group, and the committee’s responsibility was to look at developing the actual test methods that represented how the end users interact and use these units in the field. We needed to make sure that the test methods adequately challenged the performance of the refrigerator or freezer to simulate real-world field usage. Why was this new NSF/ANSI 456 Vaccine Storage Standard needed? Up until the release of the NSF/ANSI 456 Standard there wasn’t a good standard in North America that could be referenced for the performance of a refrigerator or freezer for the storage of vaccines or refrigerated medications. What was available, the CDC Storage and Handling Toolkit, provided guidance on how to store vaccines in refrigerators and freezers, but there were still issues in the field where providers were losing vaccines due to poor temperature performance. The providers were seeking something more that focused on performance and how these units were being used in real-world conditions. The committee was established to develop a standard that looked at overall performance of the refrigerators and freezers. Who created the new NSF/ANSI 456 Vaccine Storage Standard, and what was the driving force? The NSF/ANSI 456 Standard was developed by a committee including manufacturers of vaccines, directors from several state health departments, pediatricians and physicians, members from the Immunization Coalition, National Association of County and City Health Officials


(NACCHO), National Institute of Standards and Technology (NIST), and the CDC, as well as multiple equipment manufacturers. It was a very cross-functional group. The decisions on what requirements were needed in the standard were driven by public health members and end users. The key aspects of the requirements were driven by research and data collected from healthcare facilities throughout the U.S. Health clinics were visited, and usage data collected to understand how these units were being used. The test methods in the standard were developed to provide confidence that the vaccines would maintain their temperature requirements and stay in compliance during these real-world use cases. Can you explain the basics of the standard? The standard follows the standard format for an ANSI certified standard. The standard is written to address both refrigerators and freezers and covers design and construction, test methods, performance requirements, and guidance on performing the actual temperature measurements including construction of a vaccine simulation device. NIST provided a significant amount of support for the development of the test methodologies and how to perform the temperature measurements that were written into the standard. The standard itself includes some minimum refrigerator and freezer performance requirements throughout the testing protocols. The test method portion of the standard is focused on maintaining temperature performance through frequent door openings and door openings related to loading of the cabinet, as well as how many vaccines are stored in the unit. We looked at two storage scenarios to develop the requirements, which were a totally empty cabinet and a totally full cabinet. We simulated the full cabinet by filling the units with standard size boxes to make sure we filled a large percentage of total volume inside. Many storage units are packed very full when they first receive their vaccine shipments, so we wanted to make sure that the performance of the unit was the same whether empty or full. In addition to testing the unit with two different storage scenarios the units are tested with multiple and frequent door openings in these storage scenarios. The refrigerators or freezers must maintain a temperature that is specific to the product that would be stored in that particular device during the duration of the test.

The door openings are a critical piece of the requirements. When we were out in the field, we observed two typical use cases. During the daytime there were many short openings when they were getting in and out of the refrigerator to pull vaccines for injection. The other use case was a very long door opening. This is when they’re refilling or restocking the refrigerator and we found that to average around three minutes. So, the protocol was written to address both cases, a large number of short, sequential door openings and then a long door opening. These protocols are tested on both an empty and a full cabinet. What were the major challenges/surprises that the committee faced? I think there were two main challenges. First was to develop what we call a vaccine simulation device (VSD) which is a way to measure the performance of the actual unit. There was a significant amount of time spent to develop this device to make sure that it accurately represented a typical single-dose vaccine vial in a steady state temperature condition and in a dynamic temperature changing condition like a door opening.

Did the COVID-19 pandemic have any impact on the committee’s efforts on this new standard? The pandemic was additional confirmation that we needed a standard out there to support the storage of vaccines. What are the implications of the new standard for vaccine refrigerator and freezer manufacturers? The new standard will set a new, higher standard for the performance of purpose-built, medicalgrade vaccine refrigerators and freezers. From the manufacturer standpoint, they’re going to have to review their portfolio and address or redesign products to be compliant with this standard. What is next for the committee? Will the standard evolve or change over time? The standard is considered a living standard. The committee continues to meet to work on continually improving the standard. Anyone can offer recommendations for changes or additions to present to the NSF committee.

Second was to address the layout of how the temperatures would be measured within the cabinet. There was a lot of work done to identify what the worst-case conditions would be in the field. Multiple VSDs were then used within the cabinet to map the temperature distribution during steady state and door openings. Additionally, we had to ensure that the measurement was scalable to all different cabinet sizes to reflect the different refrigerator and freezer units that are available. The test methods had to be able to work on any size equipment. How is the new standard going to improve public health and safety? The biggest benefit is that if a vaccine provider purchases a vaccine storage unit that is certified to the NSF standard, they will be confident in the performance of that unit, and that with normal usage, the vaccines will be stored safely within the temperature range specified by the manufacturers of the vaccines. Having an NSF certified unit should lead to less temperature excursions for the provider and improved vaccination effectiveness for the public. Long term, we are hoping to see a higher rate of effective vaccinations across the U.S.

Between the CDC Vaccine Storage and Handling Toolkit which makes important recommendation to help protect the safety and efficacy of vaccines, and the new NSF/ANSI 456 Vaccine Storage Standard which further defines appropriate temperature performance for vaccine storage equipment, significant progress has been made to improve the safety and viability of vaccines. Ongoing efforts to further protect public health via safe and effective vaccine storage will continue to support effective immunization.

BIOGRAPHY Dennis Smith Chair of the Use Group NSF Joint Committee for Vaccine Storage

Dennis Smith serves as chair of the use group on the NSF Joint Committee for Vaccine Storage. He joined the committee at its inception in 2015 and continues his duties as they work on continuous improvement of the standard. Dennis has been designing equipment for cold chain storage for over 30 years and is currently vice president of research and development at Helmer Scientific.

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NSF/ANSI 456 Vaccine Certified GX Solutions Medical-grade Cold Storage Ensuring consistent temperature performance for safe vaccine storage

Designed for critical vaccine storage and NSF/ANSI 456 standard certified Best-in-class temperature management for uniformity, stability, and recovery ENERGY STAR® certified and 50-60% more energy efficient than conventional medical-grade refrigerators and freezers

Learn More helmerinc.com/nsf-ansi-456

© 2020-2021 Helmer Inc. All rights reserved. © 2022 Helmer Inc. All rights reserved


Behind Every Good Pharmacist, is a Great Resource. Pharmacy Case Studies take an in-depth look at specific products and services that help pharmacies improve patient care, profitability, and cost containment. Available in our digital library and within each issue of 20Ways.

RXinsider.com


K IN STOC NOWINE

1 to 46 cu.ft.

C FOR VACAGE STOR

Advanced Temperature Control

Intelligent microprocessor controls with a 2-8ºC range & +/-1ºC variation

Fast Temperature Recovery Optimized forced air cooling

Built-In Display

Multiple Alarms

Trusted Security

Antimicrobial Handles

EcoFriendly

Digital display of the current & high/low temperature with a buffered temperature probe

Audible alerts for temperature spikes, door open, & power failure

Keyed or keyless locks

Flexible Interior

DDLReady

ADA Height Option

Ventilated drawers, interior lockers, or adjustable shelves

Access port & remote contacts allow easy connection to external logging systems

32” high choices for use under lower ADA compliant counters

Silver ion coating to reduce the spread of germs

Uses environmentally-friendly hydrocarbons for a greener footprint

Accucold products are available through a host of high quality dealers To discuss your storage needs, contact our product specialists: Ike Goldstein 1.888.4.MEDLAB ext. 204 ikeg@accucold.com

Christian Geddes 1.888.4.MEDLAB ext. 268 christiang@acccucold.com ACCUCOLD DIVISION FELIX STORCH, INC. ISO 9001:2015 CERTIFIED 770 Garrison Avenue, Bronx, NY 10474 USA • TEL 1.888.4-MEDLAB FAX 844.478.8799 • info@accucold.com • accucold.com


Behind Every Good Pharmacist, is a Great Resource. Known as the “Yellow Pages of Pharmacy,” the Pharmacy Platinum Pages is published annually and serves the profession as a high-quality and relevant buyer’s guide featuring more than 450 company profiles and enhanced company sponsorships. Available in print and digital formats.

RXinsider.com


9HCL WAYS ®

1

4 7

Tamper-evident tip caps

tamper-resistant tape

chemo transport bags

2

5 8

GoHCL.com

pull-tight seals

BD™ needles

chemosafety™ waste containers

3

low-lint wipes

6

saljet® - Single-Dose Sterile Saline

9

super tough bins and accessories

Health Care Logistics, Inc. 06/2022

©

1.800.848.1633


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Health Care Logistics® — Storage and Drug Handling Solutions Put Safety First We’re committed to helping you achieve cleaner, more efficient medication management processes and improve patient safety every day. Shop thousands of solutions from one convenient location.

President & CEO: Gary Sharpe Founded:

1978 (800) 848-1633 Phone: (740) 477-3755 Address: P.O. Box 25 Circleville, OH 43113 Website: goHCL.com Toll-Free Phone:

Company Background Unique and hard-to-find products are the lifeblood of our business. That includes manufactured solutions made by skilled technicians in our central Ohio facilities. By Design is where our manufacturing talent converts customer ideas into highquality cabinet, metal, plastic, or print products made to their exact specifications. Best of all, we deliver those made-to-order solutions in five working days or less. Product Overview Our goal is firm ­— create functional products to improve everyday workflow — there are no limits to our design capabilities. We can turn virtually any idea into reality without outrageous upcharges or extended shipping schedules. Start with a no-obligation, no-cost digital proof for a cabinet, metal, plastic, or print project today! Product Specifications n 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. The process starts with our free 3D Design Service, which provides a virtual layout of the targeted space paired with unique solutions that showcase specific design goals. We can create performancerich products in multiple sizes, styles, and colors that make it easier than ever to achieve a customized brand. Cabinets by Design offers the quickest, easiest, and most affordable way to maximize organization and efficiency. All units ship in five working days or less so customers can get the look they want without the wait.

n Metals by Design and Plastics by Design One-of-a-kind items manufactured to match individual customer requests. Modifications to stock products are also available. These allow customers to work more efficiently and produce better results. From stainless steel storage containers, lock boxes, and utility trays to specially sized plastic lock boxes and dividers, we have the engineering and manufacturing capabilities to design and modify products or create affordable replacements that meet the everyday needs of our customers. We can create and modify functional products using stainless steel, aluminum, acrylic, PETG, polycarbonate, polystyrene, HDPE, and PVC. There are no limits to our design capabilities. Whether customers want to simplify USP compliance or better manage changing trends, we can design a solution and deliver it quickly. n Printing and Graphics by Design From labels, magnets, and clings to banners, signs, and stamps, our print specialists can create solutions for any situation. Prevent the confusion that results from the unknown by communicating a consistent message for all products across all departments. Choose the size, color, and style of your message and our print team will create it. Kicking off a marketing campaign? We can help with an assortment of fun promotional materials. Our print experts can hot stamp a customer logo, message, or facility information on a variety of products. Our process ensures a professional finish with lasting results. We can print as few as 50 or as many as 1,000+ — and quick!

Ordering Information

It’s easy for customers to begin their design journey. Complete a cabinets, metal, or plastics options request form, view our Print By Design options, or call our product specialists at (800) 848-1633 to discuss options.

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No mess. No waste. No problem. Get maximum quality and convenience with these liquid unit dose products from American Health Packaging. Our products quickly deliver safety and efficiency in every dose without the mess or waste.

AHP unit dose products include: • Scannable bar codes • Color-coded labels • Clear “Tall Man” lettering

With access to more than 600-unit dose items, including 100+ exclusives, you’re sure to find oral liquids, oral solids, and inhalants that can help your patients and streamline your operations. Browse our extensive catalog and take advantage of these featured liquid unit dose products from AHP.

• Extended shelf life

Product description

Cup delivery

Cup strength

Diphenhydramine HCl Liquid

10 mL

25 mg / 10 mL

100 UD

60687-0267-56

Diphenhydramine HCl Liquid

10 mL

25 mg / 10 mL

30 UD

60687-0267-08

Hydrocodone Bitartrate & APAP Oral Solution (CII)

15 mL

7.25 mg / 325 mg / 15 mL

50 UD

60687-0417-71

Hydromorphone HCl Oral Solution (CII)

5 mL

5 mg / 5 mL

30 UD

60687-0566-86

Midazolam HCl Syrup (CIV)

2.5 mL

5 mg / 2.5 mL

30 UD

60687-0576-10

Midazolam HCl Syrup (CIV)

5 mL

10 mg /5 mL

30 UD

60687-0576-86

Phenobarbital Elixir (CIV)*

5 mL

20 mg /5 mL

50 UD

60687-0448-67

Theophylline Oral Solution

15 mL

80 mg / 15 mL

50 UD

60687-0258-71

The NDC shown is in the 11-digit format required for the Centers for Medicare & Medicaid Services (CMS) processing, 42 CFR § 447.502 – Definitions.

Browse our full catalog through americanhealthpackaging.com or through your preferred wholesaler today.

UD size (cups/case)

NDC

*Product contains alcohol

AD202204-0134


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

American Health Packaging, Offering a Broad Portfolio of Barcoded Unit-Dose Products With a responsive line of barcoded unit-dose oral solutions, a growing liquid unitdose offering, as well as individually wrapped inhalants, American Health Packaging continues to deliver on their commitment to supporting pharmacy efficiency.

Bruce Bennett Toll-Free Phone: (800) 707-4621 Address: Columbus, OH 43217 Website: americanhealthpackaging.com President:

Company Background

Located in Columbus, Ohio, American Health Packaging (AHP) is an industry leader in manufacturing serialized, barcoded unit-dose (UD) medications provided for the healthcare marketplace. As a UD manufacturer, AHP’s commercially-available UD products are available to hospital, institutional, and long-term care pharmacies nationwide through partner GPOs and wholesalers. 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 and inhalants in 2019.

Product Overview

AHP is committed to supporting pharmacy efficiency through a diverse range of both high-utilization and niche treatments. Producing nearly 600 UD 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. AHP’s tailored offering of UD 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 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. As facilities nationwide compete to demonstrate they provide the highest quality of care, AHP UD 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.

Additional Product Modules

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: 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 “rights” by providing caregivers with as many products in a pre-packaged UD format as possible. Removing repackaging tasks from the pharmacy eliminates a potential point of failure during the UD process as medications arrive to pharmacies ready to dispense. n Pharmacy Efficiency: Pharmacies strive to process orders and supply the proper medications to caregivers for their patients as quickly as possible. Adding potentially-complex 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, pre-packaged UD often allows for products to be sourced more quickly than third-party repackaging can support.

n Cost-Savings Opportunity: 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. AHP UD 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 that may result from utilizing thirdparty repackaging services. n Liability Management: Pharmacy repackaging operations can be subject to distractions from a variety of sources. An active pharmacy environment can encourage lapses in concentration and present opportunities for staff error. Since these errors may vary in gravity and place liability on the facility and caregivers, mitigation of risk is key. Unit dose from American Health Packaging can help shift liability burden away from staff.

Hitting the Mark for BCMA, USP <800> Support

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 UD 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 has a number of NIOSH/USP <800> products already packaged for bedside dispensing which supports compliance to USP <800> handling procedures. SUMMER 2022

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CLEAN AIR TECHNOLOGY & SUPPLIES Q&A

Q&A

Jim Wagner, President Controlled Environment Consulting (CEC)

Q. We find ourselves spending a significant amount

of money every year to certify our cleanrooms and laminar flow devices. Is it necessary to do this testing twice a year?

The short answer is yes, USP chapters and regulators mandate certification be done every six months. This answer, however, ignores the real reasons certification twice a year is required. Environmental conditions change with the seasons and these changes potentially affect HVAC and other building services. Filters load, seals degrade, airflows change. Testing only once a year in the same season every year does not provide adequate confidence in the maintenance of a “state of control” over a critical sterile compounding environment.

Q. What is a “state of control” and how does it affect

our facility?

The primary function of a cleanroom is to maintain ISO Class under dynamic operating conditions. For example, an ISO Class 7 buffer room must maintain a particle count level below 352,000 0.5 micrometer particles per cubic meter while the room is in full operation. This is accomplished by delivering adequate airflow via the heating, ventilation, air conditioning system (HVAC) through HEPA filters located in the ceiling to dilute particles in the room and remove them through return or exhaust grilles located low on the wall. It should be verified in the commissioning process that the certified air change rate will, in fact, result in adequate particle removal to maintain the desired room cleanliness. The amount of air supplied to the room versus the amount removed through return/ exhaust grilles and leakage at the doors or other openings will result in a room pressure which must be continuously monitored.

Q. Why is the room pressure so important that it must be monitored, and the pressures logged daily?

Monitoring the room pressures is the easiest and most economical method of verifying that the amount of airflow delivered to and removed from the room has not changed. If the room pressure remains constant or returns to the same value after an excursion, we can be confident that our state of control has not changed. Therefore, we are maintaining the required room cleanliness level for the work being done in that room.

Q. When we open our door, the room pressure goes to neutral. Does that mean we lost our state of control?

You might lose your state of control if you left that door open for more

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

than the few seconds it takes to walk through it. However, you can prove that the room maintains ISO class during the time the door is open for people and materials to be transferred by conducting particle count testing under dynamic conditions. The amount of time the door is open during this testing should be used to set the alarm delay function on the room pressure monitor. This time is typically 45 seconds, but you can validate shorter or longer delay times for your facility. Remember that the monitoring of room pressure is important because it proves you are maintaining a state of control over the cleanroom environment, not because a specific room pressure is critical.

Q. What pressures are required to maintain our state of control and why the difference between negative and positive pressure requirements?

USP chapters require a minimum pressure of 0.020" water column (w.c.) for positive pressure rooms and a range of 0.010" to 0.030" w.c. negative pressure for a hazardous compounding room. There is no cap on the positive pressure because there is little potential for contamination to a room at elevated positive pressure. There is, however, significant impact on the performance of a negative pressure cleanroom when operating at too much vacuum. After the 2008 changes to Chapter <797> were passed, the required negative pressure for a hazardous buffer room was simply a minimum of 0.01" w.c. negative with no cap. This resulted in many hazardous drug buffer rooms operating at a very negative pressure relative to the ante room. As a result, microbiological contamination was common. By restricting the low-end of the negative pressure range, most hazardous drug buffer rooms are negative to the ante room but slightly positive to the ceiling and other non-classified areas. The tight range of negative pressure between the hazardous drug buffer room and the anteroom is admittedly difficult to maintain but imperative for room performance. The primary function of any sterile compounding room is sterility of the product, so a buffer room can only be negative to rooms that are at least as clean as it is.

Q. What standards should our sterile compounding facility be certified to meet?

A 503B registered outsourcing facility will be inspected by the FDA to current Good Manufacturing Practices (GMPs). A 503A facility will be inspected by state boards of pharmacy, the Joint Commission, or departments of health to either their own standard or to USP Chapters <797> and <800>. The Controlled Environment Testing Association has developed an application guide (CAG-003) for certification of sterile


Q. How can we get more out of the certification process?

Certification for compliance to USP Chapters <797> and <800> has become an interactive process between the compounding personnel and the certification team. The certifier can no longer provide a compliant certification without interacting with the compounding team. The dynamic particle count surveys, smoke studies, and environmental monitoring all are required to be done under dynamic conditions, which is “the actual compounding staff performing actual compounding processes using surrogate materials.” The compounding staff must work with the certifier to make this happen. Often, like most other industries, compounding operations are short-staffed, so giving up a trained compounding technician even for a few minutes for this regulatory required testing is looked at as a burden and is treated as a timewasting task. This deprives the compounding team of a tremendous training tool for the proper use of “first air” in developing good aseptic technique. The dynamic tests should be looked at as an opportunity to better understand your facility and to train your personnel. For example, we often see the same person perform all aseptic operations during the dynamic smoke studies every certification cycle. Ideally, a different compounding technician should participate or even multiple technicians for different devices and for different test cycles. A dynamic smoke study can be the best aseptic technique training tool you have if you plan for it. If you rush through it or go into it with an attitude that it’s a waste of your time, it will be. If you use it as a valuable training tool, it will be that too. You must do it so you might as well embrace it and allow it to be a beneficial tool.

Q. My certifier says that there are no

accommodations for leak testing the HEPA filters. Can they certify the room?

USP Chapter <797> (2019) Section 5 establishes the minimum requirements for the certification of ISO classified areas. Section 5 references the Controlled Environment Testing Association’s (CETA) certification guide for sterile compounding facilities for specific procedures. Section 5 also lists HEPA filter integrity testing as one of the specific tests that MUST be conducted at every certification (six-month intervals). Historically, this is one test that was not always completed as part of certification by every certification provider.

The reason given was often “our facility was not designed to accommodate filter leak testing.” While this may be true, it never was an acceptable justification to not do this important test. Any time a HEPA filter is relied upon as a part of the critical facility state of control, that filter MUST be proven to be leak free. It is ultimately the designated persons responsibility to ensure that certification is done correctly. In this case, that means ensuring that accommodations are provided for integrity testing every HEPA filter. There are several remote-challenge systems available on-line if accommodations are not already provided. They can be installed by your certifier or by an HVAC contractor.

Q. Are there any specific tests required for the initial

certification after new construction?

After the construction phase is complete, consider functional testing by “commissioning” the rooms. Commissioning can be carried out by your certification vendor or a commissioning engineer. It should be performed before operational compounding can begin. Commissioning verifies that the cleanroom suite is operating according to the facility design requirements as well as meeting regulatory requirements. The commissioning report is similar to a certification report but is intended to ensure the mechanical systems are performing to the specific facility design, not general guidance provided in USP chapters. A certification report is intended to prove the facility meets regulatory requirements. Both are important but the commissioning report is more valuable for ensuring you got what you paid for from the installer.

CLEAN AIR TECHNOLOGY & SUPPLIES Q&A

compounding facilities. This application guide was developed to outline the certification process for compliance with USP chapters, but it can also be followed when testing a 503B facility.

More testing may be required for a commissioning project than routine certification. The acceptance criteria should be based on the facility design parameters, not necessarily the minimum criteria found in USP chapters. For example, if a negative pressure hazardous buffer room was designed to have 60 air changes per hour (ACPH), it must have 60 ACPH when it is commissioned to design, but if it was certified to USP minimum values, it could be certified to 30 ACPH. Additionally, if the design for that same facility’s non-hazardous buffer room was for 1,000 CFM through the HVAC system and the room is commissioned to be delivering 1,050 CFM which results in a room pressure of 0.050" w.c., the room pressure monitor should be set to alarm at approximately 0.040" w.c., not 0.020" w.c. (the USP minimum). The state of control point for that room will have been commissioned to a meaningful and relevant number for that room. The acceptance criteria used in the commissioning process should then become the state of control based certification parameters for future certifications. The commissioning agent should be contracted directly to the owner, not the contractor.

BIOGRAPHY Jim Wagner, President Controlled Environment Consulting (CEC) Jim Wagner, the president of Controlled Environment Consulting (CEC), has been involved in the controlled environment performance evaluation industry since 1979. His consulting includes design and evaluation of sterile compounding facilities, containment facilities, and other engineering controls. Jim conducts international training on cleanroom and containment device design and certification. Prior to founding CEC, Jim was the president of Micro-Clean, a certification and validation company. Jim led the Controlled Environment Testing Association’s (CETA) efforts to develop guidance documents for

compliance with USP Chapter <797>. Jim was a member of the USP Compounding Expert Committee (2005-2010, 2015-2020). Jim is a steering committee member for NSF/ANSI standard 49 Biosafety Cabinetry: Design, Construction, Performance, and Field Certification. Jim was a two-time president of the Controlled Environment Testing Association including being CETA’s first president in 1991-92. Jim was awarded CETA’s Mel First award for outstanding contributions to the advancement of certification and testing of controlled environments.

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CLEAN AIR TECHNOLOGY & SUPPLIES Buyer's Guide 58

CLEAN AIR TECHNOLOGY & SUPPLIES Buyer’s Guide Acute Care Pharmaceuticals 12195 Dearborn Place Poway, CA 92064 (888) 909-7700 pharma-choice.com American Cleanroom Systems 23221 Arroyo Vista Rancho Santa Margarita, CA 92688 (949) 589-5656 americancleanrooms.com Berkshire 21 River Street Great Barrington, MA 01230 (800) 242-7000 berkshire.com Bureau Veritas 95 Oakwood Road Lake Zurich, IL 60047 (800) 806-5887 bvna.com CINTAS 6800 Cintas Boulevard Cincinnati, OH 45040 (888) 834-2883 www.cintas.com/uniformwork-apparel/uniformrental/cleanroom.aspx Cleanroom Connection 160 Creekside Park, Suite 202 Spring Branch, TX 78070 (800) 616-5319 cleanroomsupplies.com Connecticut Clean Room Corporation 32 Valley Street Bristol, CT 06010 (860) 589-0049 ctcleanroom.com Containment Technologies Group, Inc. 5460 Victory Drive, Suite 300 Indianapolis, IN 46203 (317) 713-8200 mic4.com Contec, Inc. 525 Locust Grove Spartanburg, SC 29303 (864) 503-8333 contechealthcare.com SUMMER 2022

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ESCO 903 Sheehy Drive, Suite F Horsham, PA 19044 (215) 441-9661 www.escolifesciences.com FG Clean Wipes 2255 Westover Road Chicopee, MA 01022 (413) 598-8344 saturix.com Germfree 4 Sunshine Boulevard Ormond Beach, FL 32174 (386) 265-4300 germfree.com Guardian Medical Systems 409 Edgewood Drive Exton, PA 19341 (484) 872-2500 guardianmed.net Health Care Logistics P.O. Box 25 Circleville, OH 43113 (800) 848-1633 gohcl.com HEMCO 711 S. Powell Road Independence, MO 64056 (816) 796-2900 hemcocorp.com Infinity Laboratories 1585 South Perry Street, Suite A Castle Rock, CO 80104 (303) 730-7330 infinitylaboratories.com ISO-MED, Inc. 1220 Graphite Drive Corona, CA 92881 (800) 797-1405 iso-med.com Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076 www.kimberly-clark.com Lakeland 1525 Perimeter Parkway, Suite 325 Huntsville, AL 35806 (256) 350-3873 cleanroom.lakeland.com

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

Modular Cleanrooms, Inc. 3740 Paris Street Denver, CO 80239 (800) 496-7666 modularcleanrooms.com Modular Devices 6678 Guion Road Indianapolis, IN 46268 (800) 456-3369 portable-cleanroom.com NuAire 2100 Fernbrook Lane Plymouth, MN 55447 (763) 553-1270 www.nuaire.com Parasol Medical 1602 Barclay Boulevard Buffalo Grove, IL 60089 (847) 520-3000 parasolmed.com PolyConversions, Inc. 3202 Apollo Drive Campaign, IL 61822 (888) 893-3330 polycousa.com ProPharma Cleanrooms 5465 Legacy Drive, Suite 650 Plano, TX 75024 (469) 283-1190 propharmacleanrooms.com Prudential Cleanroom Services 1661 Alton Parkway Irvine, CA 92606 (800) 767-5536 prudentialuniforms.com/ services/cleanroom QleanAir Scandinavia 8445 Rausch Drive Plain City, OH 43064 (614) 954-1040 qleanair.com/us_en/ products/cleanrooms Sentry Air Systems 21221 FM 529 Road Cypress, TX 77433 (800) 799-4609 sentryair.com

Spotcheck 816 Foster Avenue Bensenville, IL 60106 (630) 422-3181 spotcheckinc.com SteraMist by TOMI 8430 Spires Way, Suite N Frederick, MD 21701 (800) 525-1698 tomimist.com Superior Laboratory Services, Inc. 1710 Preston Road, #A Pasadena, TX 77503 (713) 477-9247 slsi.net Technowipe Lint Free Wipes 283 Murray Avenue Larchmont, NY 10538 (914) 833-0278 technowipe.com Teknipure 2150 W Broadway Road Suites 104-105 Mesa, AZ 85202 (844) 309-2376 teknipure.com Texwipe 1210 South Park Drive Kernersville, NC 27284 (800) 839-9473 texwipe.com The Baker Company 175 Gatehouse Road Sanford, ME 04073 (800) 992-2537 bakerco.com Veltek Associates, Inc. (VAI) 15 Lee Boulevard Malvern, PA 19355 (610) 644-8335 sterile.com Vileda 2188 Diehl Road Aurora, IL 60502 (630) 270-1437 ce.vileda-professional.com


Clean Air Technology & Supplies www.RXinsider.com

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CLEAN AIR TECHNOLOGY & SUPPLIES Market Leaders

Visit RXinsider’s Virtual Trade Show to Research the Leaders in

H E A LT H S Y S T E M • I N F U S I O N 59


Medication Workflow

Class II, Type A2 Biosafety Cabinet Protection: Product, Personnel, & Environmental

Sterile Hazardous Workflow Containment Primary Engineering Control (C-PEC)

Model: NU-543 Series Optimized for Sterile Hazardous Drug Compounding Systems IV Bar with 3 Height Locations and 6 Hooks for IV Preparation Back-Wall Cutout for Viewing Computer Monitor Interior Duplex GFCI Outlets and Cord Pass-Through Ports Motorized Auto-Rising Base Stand for Optimal Comfort Up to 12 inch (305 mm) Access Opening *Product shown with optional features

Sterile Non-Hazardous Workflow

Horizontal Laminar Airflow Workstation

Primary Engineering Control (PEC)

Protection: Product

Model: NU-240 Series Optimized for Sterile Non-Hazardous Compounding ErgotronTM Mount for Monitor, Keyboard, and Mouse Easy-to-Clean Stainless Steel Work Surface IV Bar with 3 Height Locations and 6 Hooks Telescoping Base Stand with Shelf Attachment Exterior Mounted Duplex GFCI Outlet Sidewall Cord Pass-Through Ports

*Product shown with optional features

Learn more or request a quote online at:

www.nuaire.com

NuAire, Inc. | 2100 Fernbrook Lane | Plymouth, MN 55447 | 763.553.1270 | www.nuaire.com © Copyright 2022. NuAire, Inc. All Rights Reserved.


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

NuAire Quality Containment Primary Engineering Controls (C-PECs) for Your Pharmacy Choose NuAire as the safer choice for your pharmacy.

President & CEO: Bill Peters Founded:

1971 Employees: 250-300 Toll-Free Phone: (800) 328-3352 Phone: (763) 553-1270 Address: 2100 Fernbrook Lane Plymouth, MN 55447 Website: www.nuaire.com

Company Background For over 50 years, NuAire has provided a wide range of primary engineering controls that meet USP <797> and <800> standards for hazardous and non-hazardous sterile drug compounding. NuAire's [C]-PECs options include compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), biological safety cabinets (BSC), laminar airflow workstations (LAFW), containment ventilated enclosures (CVE), and custom robotic enclosures for automation. All equipment can be fully customized to meet your pharmacy’s specific needs. We create our premium-quality products with your success in mind; if you purchase a piece of laboratory equipment from us, we want you to be completely happy while using it. We'll help you work through any issues or difficulties until you are 100% satisfied for the entirety of your equipment’s lifespan. We succeed only when you succeed.

Product Overview I.V. workflow systems that utilize barcoding and gravimetric technology enable real-time error detection during the medication compounding process. All airflow products come fitted with unique HEPEX™ plenum technology for a more balanced airflow and quiet operation. All [C]-PECs are equipped with an ultra-efficient DC-ECM motor and an optimally determined forward facing blower. NuAire has developed pharmacy equipment configured to maximize safety and protection along with improving workflow efficiency and ergonomics.

• Interior Duplex Outlet Options • Sidewall Pass-Through Ports (NSF Approved) • Optional Backwall Viewing Window for Monitor • Optional Ergonomic Support Arm for Keyboard and Monitor • Auto-Rising Adjustable Base Stand Options

Additional Product Lines n Blizzard™ -86°C Ultralow Temperature Freezers Complete your pharmacy with NuAire’s line of ultralow temperature (ULT) freezers. Every ULT model utilizes environmentally friendly, energy-efficient hydrocarbon (HC) refrigerants. All units provide quick pull-down times, precise temperature uniformity (±5°C), and optional redundant backup systems in the case of a power outage. • Available Capacities: 100-828 Liters • Temperature Range: -40 to -86°C • Temperature Accuracy: ±1°C

Trade Shows/Meetings Attended ASHP Midyear 2022, December 5-7, 2022, Las Vegas, NV GPO Affiliations • Vizient • HealthTrust • Premier • Intalere • Managed Health Care Associates Ordering Information

To learn more or request a free quote online, scan QR code or visit www2.nuaire.com/20ways-2022/med-workflow.

Features & Options • Smooth Interior Option for Easy Cleanability • Optional I.V. Bar with Six SST Hooks • Up to 12" (305 mm) Access Opening on Select Models • Prop-Up Work Tray for Easy Cleanability SUMMER 2022

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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


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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. Robert Braverman 1971 Employees: Private Toll-Free Phone: (800) 523-8966 Phone: (215) 396-8600 Toll-Free Fax: (800) 323-8966 Address: 70 Industrial Drive Ivyland, PA 18974 Website: www.medidose.com President: Founded:

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.

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Get a handle on hazardous drug containment.

When you’re ready to get a handle on hazardous drug containment, HALO® CSTD is your complete solution for drug preparation and administration. • Airtight and leak-proof1 • Ergonomically designed for hand comfort2 • Strong and secure attachment3 • No internal filter to maximize vial extraction4 Make the HALO system your standard of care for enhanced protection of patients and caregivers. To request a demonstration or to order the HALO System, call 1-888-386-1300 or visit us at www.HALO-CSTD.com.

HALO® is a registered trademark of Corvida Medical, Inc.

1. Health and Human Services, Federal Drug Administration, 510(k) Clearance Letter, July 24, 2015. 2. Ergonomics: The Study of Work. U.S. Department of Labor Occupational Safety and Health Administration. OSHA 3125 2000 (Revised). 3. Internal study, data on file. 4. Internal study, data on file.

©2022 Fresenius Kabi USA, LLC. All Rights Reserved. 2392-HALO-05-01/22


Medication preparation

Medication delivery

Sharps disposal

Cardinal Health™ Monoject™ SmarTip™ Vial Access Cannulas

No needle means no needlestick Protect your staff and patients from needlesticks with Monoject™ SmarTip™ needleless medication preparation technology from Cardinal Health. Patient and clinician safety starts with smart design Preventing needlestick injuries is key to maintaining your facility’s sharps safety protocol. In fact, Occupational Safety and Health Administration (OSHA) guidelines recommend avoiding the use of needles altogether where safe and effective alternatives are available.1

Dual eyelets Gray cap

Choose Monoject™ SmarTip™ Vial Access Cannulas Developed to replace a variety of medication preparation needles in your sharps line with little training, the SmarTip™ Cannula is the needle-free solution that’s superior by design.

Needleless

Anti-coring

Efficient

for clinician safety Plastic cannula engineered to help prevent accidental needlesticks

for patient safety Piercing, not puncturing, helps eliminate coring and particulate2

medication draws 16-gauge equivalent flow rate and dual eyelets draw up even the most viscous medication from a vial easily and completely

For more information or to sample product, visit cardinalhealth.com/monoject/smartip or call 800.964.5227 References: 1. NIOSH. Alert: preventing needlestick injuries in health care settings. Cincinnati, OH: US Dept of Health and Human Services; 1999. https://www.cdc.gov/niosh/docs/2000-108/pdfs/2000-108.pdf. 2. 2016 Cardinal Health data on file © 2021 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, MONOJECT and SMARTIP are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other trademarks are the property of their respective owners. Patent cardinalhealth.com/patents. Lit. No. 2 2GM22-1934108-02 (04/2022)

Plastic cannula Standard luer connection

Features: • Soft pack packaging • Not manufactured with DEHP or natural rubber latex • Sterile, single use and individually packaged


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.


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Leiters. We Are Compounding Health™ Leiters is a trusted FDA-registered 503B outsourcing provider of compounded sterile preparations committed to providing healthcare professionals and their patients with the highest-quality medications.

President & CEO: Robin Smith Hoke Founded:

1926 Employees: 215 Toll-Free Phone: (800) 292-6772 Phone: (720) 697-5140 Fax: (408) 288-8252 Address: 13796 Compark Boulevard, Englewood, CO 80112 Website: www.leiters.com

Company Background

Leiters, founded in 1926, is an FDA-registered 503B outsourcing provider of high-quality compounded sterile preparations and pharmacy services. Leiters has a long history of evolving and innovating to meet the latest regulatory requirements and market needs. All sterile preparations are produced under Section 503B of the FD&C Act (503B Guidance), follow Current Good Manufacturing Practices (cGMP) and USP <797>. The Leiters facility consistently upholds all standards based on the audits conducted by the FDA, states of California and Florida Boards of Pharmacy, multiple health systems, group purchasing organizations, and other independent accreditation organizations. The Leiters team of experts in sterile pharmaceutical manufacturing, repackaging, and compounding provide a sophisticated understanding of what it takes to elevate the quality and consistency of supply in pharmaceutical outsourcing. Leiters combines a highly experienced team, with robust processes, in a new state-of-the-art outsourcing facility to ensure delivery of the highest quality products and services.

Product Overview

Leiters provides ready-to-use compounded sterile preparations and pharmacy services across the continuum of healthcare, including hospitals, surgery centers, physician offices, and clinics. n Hospital Products • Prefilled operating room syringes and I.V. bags. • PCA (patient-controlled analgesia) prefilled syringes. • Surgical Pain Services portfolio including opioid free medications. n Ophthalmology Products • Prefilled syringes, vials, and dropper bottles including: injections, antibiotics, dilating agents, and topical anesthetics. • FDA-Compliant† Repackaged Avastin® Service. n ON-Q* Pump Fill Service • Pharmacy fill service for the Avanos Medical opioid sparing ON-Q* Pain Relief System. • Prefill pump services offered for both Bupivacaine HCl and Ropivacaine HCl.

Additional Information

We combine our team, robust processes, and state-of-the-art outsourcing facility to ensure the highest-quality medications for healthcare professionals and their patients. Through three key pillars: people, place, and product, we are elevating the standards in pharmaceutical outsourcing.

Key Business Partners

Leiters is partnered with many market leading innovative healthcare companies that compliment what we do. The products and services offered by these companies may provide additional value to your organization. Our business partners include: Avanos Medical, Besse Medical, Cardinal Health OptiFreight®, CPS Solutions, LLC, Eye Connect International, Hibernation Therapeutics, Kit Check, and Prodigy Health.

Trade Shows/Meetings Attended

Leiters supports and attends a variety of regional and national industry trade shows and conferences. Please visit www.leiters.com to view a list of 2022 events we’ll be attending.

GPO Affiliations

Leiters provides its products and services to many leading health systems, community hospitals, clinics, and physician offices. In addition, we currently have national contracts with: HealthTrust, Intalere, JDJ Consulting, Kaiser, Premier, The Resource Group, US Retina, and Vizient. Please contact us for additional information regarding our contracts.

Ordering Information

Leiters offers four convenient ways to place your order. 1. 2. 3. 4.

Toll-Free Phone: (800) 292-6772 Fax: (408) 288-8252 Email: orders@leiters.com Visit the Leiters Online Ordering Portal: orders.leiters.com

Site Visits

We don’t want to simply tell you about what we do, we want to show you! We invite you to visit our facility to better understand the cGMP regulations, sterile manufacturing processes, and automation we use to elevate the quality of our products and services. Come join the growing list of organizations who have visited our facilities. To schedule a site visit or learn more about how Leiters is Compounding Health™, please visit www.leiters.com. COMPOUNDING HEALTH™ is a registered trademark of Leiters. Avastin® is a registered trademark of Genentech, Inc. ON-Q* is a registered trademark of Avanos Medical, Inc., or its affiliates. 1BUD is from date compounded. † Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application Guidance for Industry https://www.fda.gov/downloads/drugs/guidances/ucm434176.pdf

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BE CERTAIN, WITH CERVEY. 340B SOLUTIONS Cervey’s 340B suite of web-based products helps 340B split bill and contract pharmacies manage the complexities of 340B. Be HRSA audit ready at the click of a button, manage multiple facilities with our Group Dashboard, empower your buyers with Split Preview, and eliminate the frustration of managing master NDCs. Our TPA team of ACE-certified experts will take a consultative approach to help streamline your 340B program and meet your needs.

Service, not just software.

SPECIALTY Cervey’s Specialty Pharmacy software is designed precisely for hospital operated specialty pharmacies – streamlining pharmacy operations and patient management. Elevate the efficiency of your pharmacy by identifying potential patients while optimizing staff workflow and data collection. Manage opportunities, customize assessment documentation, utilize benefit investigation, preadjudicate test claims and simplify using system integration.

Cervey’s customer support is always there. It’s a 100% real person, who is not outsourced, with real answers to your questions.


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Cervey — 340B Split Bill, 340B Contract Pharmacy, Specialty Pharmacy Cervey’s experts employ a consultative methodology to understand our client's unique challenges, then tailor a software offering that meets their specific needs and integrates seamlessly with your EHR and pharmacy systems. And we offer peerless, personalized service, and support.

President & CEO: Chad Runeberg Founded:

1983 44 Toll-Free Phone: (888) 376-7409 Address: 410 Kay Lane Shreveport, LA 71115 Website: cervey.com Employees:

Company Background Cervey was founded in 1983 by the fourth largest wholesaler in the U.S. Our pharmacy operations expertise provided valuable insight into operations and workflow. We built our software to address the challenges our customers were facing and have continued to evolve based on their needs. Our knowledge is what sets us apart. Product Overview n 340B Split Bill Software Cervey’s 340B Split Bill solution is tailored to fit your unique challenges. Prepare for a HRSA audit with the click of a button using our Compliance Module, stay on top of multiple facilities with our Group Dashboard, empower your buyers with Split Preview, increase savings by capturing all items within a compound drug, and eliminate the frustration of managing master NDCs. n 340B Contract Pharmacy Software Cervey’s 340B Contract Pharmacy solution helps covered entities ensure compliance while optimizing financial performance. Conveniently access transaction data with our user-friendly drill down tools. Eliminate 99% of true-ups with our “pro-rated” replenishment model, streamline ordering with our order split feature, eliminate inventory swells and automatically send claims to 340B ESP with our new data transmission service. n Specialty Pharmacy Software Cervey’s Specialty Pharmacy software is specifically designed for hospital-based specialty pharmacies. Our EHR interface elevates the efficiency of your pharmacy and helps grow revenue by identifying potential patients before they leave the hospital. Streamline operations and patient management with custom assessment documentation, benefit investigation, pre-adjudicated test claims, and automated refill reminders.

Testimonial “ Cervey has exceptional customer service to their clients. Their knowledge of 340B is first class which serves their clients well in proper software setup and needs. The contract pharmacy tool is user friendly and Cervey is open to suggestions for future enhancements to support their clients. I feel that we have a true partnership with Cervey to meet our 340B regulatory requirements and reporting needs to assist us in managing a compliant program.” — Mike Loftus, RPh, MBA, 340B Ace, Director — Pharmacy Services 340B/Mercy

Newly Released 340B Features n Compliance Module that produces all the documentation and reports required for a HRSA audit at the click of a button. It stores covered entity documents including policy and procedures, Medicare cost report, and other files such as 340B Universe and/or employee roles. The crosswalk management tool allows users to create crosswalks of locations and purchasing accounts from usage data/accounts to Medicare cost reports to HRSA registration identification number (340B ID). n Group Dashboard that provides a financial and operational view across your health system all in one page — including 340B savings tracking, WAC losses, financial trends, and maintenance statistics.

Additional Product Lines • Patient Assistance • DQSA Track and Trace • PBM Claims Management Trade Shows/Meetings Attended Join us August 1st-3rd at the Summer 340B Coalition Conference in National Harbor! Stop by our booth for specialty coffee, experience and enter to win an Oculus virtual reality headset and get to know our team! We are hosting an event Tuesday, August 2nd at The Walrus Oyster & Ale House from 7-10 p.m. Join us for cocktails and ales, oysters, and more. We would love to see you there!

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CAS E S TU DY HEALTHPOINT CHOOSES LIBERTY SOFTWARE TO EMPOWER THE PHARMACY TEAM BACKGROUND With strong roots in the King County community in Washington State, HealthPoint, a level 3 patientcentered medical home, cares for more than 100,000 people at 20 primary care facilities. There are 11 pharmacies across the health system: nine traditional site pharmacies, one central fill pharmacy, and one specialty pharmacy.

Katya Kanevski Director of Pharmacy Services ~ HealthPoint

This case study examines one of HealthPoint’s high-profile upgrades — a new pharmacy management solution by profiling Director of Pharmacy Services, Katya Kanevski. She shares the analysis and decision-making process that led to selecting Liberty Software to build their personalized pharmacy platform.

INTENDED OUTCOME Robust dispensing software is about accuracy, efficiency, productivity, compliance, safety, and adaptability to meet ever-changing business and compliance needs. Kanevski wanted a low-touch system to support the delivery of high-touch pharmacy-based services for patients. “Pharmacists’ time is valuable and stretched thin. We need to free up their time with a system that allows for dispensing efficiency and technological solutions,” said Kanevski. “We can do more for our patients by spending less time on manual tasks.” Healthpoint needed a system that could clearly identify certain patient population groups, such as urgent care patients or school-based clinics, to meet unique needs for filling and distribution accurately. “Many requirements exist to meet the needs of a diverse pharmacy business,” said Kanevski. “Our goal is always to provide an enhanced level of dispensing safety, accuracy, and tools to adhere to 340B regulations.” Kanevski’s aim centered on perfecting the pharmacy customers’ experience through operational excellence. Leading the team of 75 pharmacy staff involved providing the tools needed for directly engaging in delivery of high-quality patient consultations and clinical services like immunizations and CGM placements/training.

CHANGES AND CHALLENGES “We were not as efficient as we needed to be. And we had a limited system,” said Kanevski. “We needed to position ourselves competitively against the rapidly changing pharmacy landscape.” The pain points for the pharmacy team included too much manual intervention that made processes cumbersome. Central fill had too many moving parts.

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CAS E S TU DY Criteria for Vendor Selection • Offer an increased level of patient safety and overall security. • Streamline and customize workflows and improve dispensing efficiency. • Support growth plans. • Deliver a true central fill model. • Meet regulatory requirements. • Provide hassle-free inventory control and reporting. • Enhance patient communication features.

The pharmacy department needed to tighten operations and gain dispensing efficiencies by reallocating pharmacists’ time to pharmacy-based services. “We were looking for a vendor that could grow with us in every way: support our growing locations as well as changing pharmacy and patient needs,” said Kanevski.

THE DECISION TO PARTNER WITH LIBERTY SOFTWARE The pharmacy team conducted a SWOT, which produced the following primary requirements that guided the choice for a new system (see side-bar). The pharmacy leadership team assessed numerous vendors and narrowed the field to three front runners. Then other departments and the rest of the pharmacy team conducted a final review where they selected the Liberty Software Pharmacy Platform as the system that best addressed their requirements. The team’s decision has been validated time and again because Liberty has excelled on delivering on the following areas:

n A Smooth Transition “Liberty is a phenomenal partner,” said Kanevski. “We received a tremendous amount of support led by a strong implementation manager that oversees everything.” Liberty brought in two support members for each clinic pharmacy, one for the specialty pharmacy, and five for central fill. The support team stayed on-site for three days after go-live to ensure a smooth transition. “This was expected to be a very challenging experience. However, looking back, it was an easy installation,” said Kanevski. “When you see workflows come together and staff acknowledging the ease, you know it was a successful transition.”

n Workflow Efficiencies “Our 11 pharmacies talk to each other like never before,” said Kanevski. “We can do central fill and handle the complex workflow.” The platform’s ease stems from the specially designed embedded workflow technology that includes data entry, RPH check, count, and verify. The system also accommodates remote working, which is valuable for HealthPoint’s pharmacy operations. “The pandemic showed us that not everyone has to or can do work from a certain place. The platform allows for remote work, which is critical with the current labor shortage,” said Kanevski.

n 340B Liberty offers many solutions for HealthPoint. One that stands out is the many features to support the 340B pharmacy program. The platform allows the team to work more confidently due to the system’s tools to support compliance requirements. “The essence of why Liberty is great for our 340B program is its ability to track documentation required for program compliance by HRSA,” said Kanevski. Liberty allows for a robust way to enter and track notes if documentation is missing. It also features an easy way to mark prescribers and patients as eligible for the 340B program so medications will not get filled outside the program boundaries.

www.libertysoftware.com

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CAS E S TU DY

n Patient Communications

Liberty is a phenomenal partner, we received a tremendous amount of support led by a strong implementation manager that oversees everything.” Katya Kanevski Director of Pharmacy Services ~ HealthPoint

“When reviewing Liberty, their outbound messaging capabilities were far superior. Liberty’s other unique features made automation flexible and superior to anything we reviewed,” said Kanevski. Liberty has built-in translations for labels for Spanish and Vietnamese and can integrate 18 more languages based on patient population needs.

n Patient Refill Options A key feature of the platform, MedSync, synchronizes filling medications simultaneously. Patients can be signed up to auto refill their chronic medications every month, which aids in adherence and streamlines workflow even more for predictive refills. Liberty’s software includes an online app that patients can use to order refills. It also includes an online scheduling tool allowing patients to schedule appointments for clinical services. These features are added benefits that came built in with the system, which saved HealthPoint the expense of hiring additional third party vendors.

n Support “Liberty’s technical support is unbeatable. When a staff member or any one of the system administrators need help, Liberty is there for us, providing great support by phone, chat, or email,” said Kanevski.

RESULTS The Liberty Software Pharmacy Platform integrated a central dispensing function, shipping, and outbound engagement, resulting in increased in-house and remote productivity. “A pharmacy management system should enable staff to provide better service. Liberty did this for us,” said Kanevski. “We went from an inefficient system that required numerous clicks and workarounds to a modern system that improves productivity through customized workflows.” The differentiation that stood out was that Liberty assigned a success manager for the first six weeks after installation to troubleshoot and answer questions. And after six weeks, they provide a permanent account manager to provide upgrades and support. “If a feature didn’t exist, Liberty’s agility allowed them to build it for us,” said Kanevski. “They don’t sit on a request. It is a problem-solving organization.” The bottom line, HealthPoint can quantify the efficiencies, and operations are smooth and tied together more than ever before amongst all pharmacy facilities.

CONCLUSION “Liberty delivered on what Liberty promised,” said Kanevski. “The platform does so much more than what we had.” The technology redefined their operations to increase accountability and assure regulatory compliance. Liberty Software helped HealthPoint increase patient safety, enhance customer service, and improve workflow efficiencies.

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PHARMACY IS COMPLICATED. YOUR SOFTWARE SHOULDN’T BE.

Pharmacy software that works with your pharmacy’s Liberty Software is dedicated to helping community pharmacies enhance patient care, increase patient

PHARMACY SOFTWARE FOR

PHARMACY SUCCESS View a demo now at www.libertysoftware.com or call us at 800-480-9603


PHARMACEUTICAL WASTE SOLUTIONS

Comprehensive Waste Solutions Tailored to Your Pharmacy’s Needs Join over 1 million organizations who trust Stericycle to provide safe, compliant and eco-conscious healthcare waste management.

CsRx™ Controlled Substance Waste Service Advance your drug diversion program with the industry-leading controlled substance waste program.

SafeDrop™ Sharps Mail Back Containers Improve your immunization program with our cost effective and convenient mail back sharps container service.

MedDrop™ Drug Collection Kiosks Provide your patients with safe medication disposal via our award-winning drug take back kiosk.

Seal&Send™ Medication Envelopes Provide your patients with safe medication disposal via our mail back envelopes.

Shred-it® Secure Information Destruction Protect your business and your patients’ PHI with secure information destruction.

Visit Stericycle.com or call 866-783-7422.

© 2022 Stericycle, Inc. All rights reserved. RXINSAD_0422


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Safeguard Your Organization, Community, and the Environment With Stericycle Solutions Stericycle’s CsRx Controlled Substance Waste Service can serve as a central component to prevent drug diversion in your hospital. Stericycle’s Safe Community Solutions provide your patients with safe and convenient disposal of sharps waste and unused medications.

President & CEO: Cindy J. Miller Founded:

1989 Employees: 15,000+ Stock Symbol: SRCL Toll-Free Phone: (866) 783-9816 Phone: (844) 752-6211 Address: 2355 Waukegan Road Bannockburn, IL 60015 Website: www.stericycle.com

Company Background Stericycle supports the leading role that pharmacists hold as healthcare providers in our communities. For over three decades, Stericycle has introduced innovative products and services for regulated medical waste management and is a pioneer in offering pharmaceutical waste solutions that help drive safety, regulatory compliance, and environmental sustainability. Product Overview n Increase Efficiency, Safety, and Your Organization’s Community Stewardship

Stericycle’s Safe Community Solutions increase your patient engagement by offering convenient disposal of unused consumer medication and sharps waste generated by home injectable therapies. CsRx Controlled Substance Waste Service helps mitigate drug diversion within your healthcare organization. • MedDrop™ Drug Collection Kiosks help prevent prescription drug abuse in your community and reduce the environmental risk that results from improper disposal. Customers and patients appreciate the convenience and anonymity of returning unused medications to the same place they received them. Add additional value to retain customers and promote brand loyalty with Stericycle’s MedDrop medication collection kiosks.

• SafeDrop™ Sharps Mail Back Kits include everything needed to properly collect and safely dispose of sharps. With a convenient auto-replenishment option, Stericycle makes it easy to manage container inventory. SafeDrop provides efficient and compliant disposal of sharps waste generated at your facility and serves as a driving component of successful COVID-19, influenza, and other immunization programs. Additionally, your patients can use the SafeDrop Mail Back program to safely store and dispose of sharps waste generated through their injectable therapies at home. • CsRx® Controlled Substance Waste Service supports your organization’s internal diversion prevention efforts. CsRx is a solution for safely disposing controlled substance wastage immediately after patient administration, to mitigate drug diversion and protect the environment.

Stericycle: Your Trusted Partner

Stericycle has partnered with thousands of pharmacies of all sizes to provide easy-to-use regulated waste disposal services that help:

• Keep employees safe and healthy and protect your brand — by safeguarding your staff, community, and organization through compliant disposal solutions.

• Add customer value in store — by driving foot traffic and brand loyalty through safe in-store disposal solutions.

• Extend customer satisfaction at home — by prolonging

enhanced customer experience and extending your brand’s reach through secure in-home disposal solutions.

To learn more, visit www.stericycle.com/en-us/solutions/specialtyservices/consumer-take-back-solutions today. Protect your employees, customers, and community.

• Seal&Send™ Medication Mail Back Envelopes allow consumers to package and mail their unwanted or expired medications to Stericycle in secure, anonymous, prepaid envelopes via USPS. Seal&Send envelopes are particularly useful for rural and homecare patients to safely and sustainably dispose of unused medications simply by placing in a mailbox. SUMMER 2022

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Breathe easy

With cleanroom solutions from ISO-MED

We have just what hospitals need to maintain a clean compounding environment, giving staff confidence in their patient safety efforts, and making it easy to always have the appropriate products at hand. That’s why ISO-MED has been a trusted hospital supplier for over a decade. Let us give you one less thing to worry about. Order now at iso-med.com.

sales@iso-med.com | 800-797-1405 | www.iso-med.com


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ISO-MED Lets Hospitals Breathe a Sigh of Relief Cleanliness is critical to a hospital’s ability to safely treat patients, from the purity of the air everyone breathes to the contaminant-free surfaces in the cleanroom. You can trust ISO-MED to make your efforts more worry-free, with a full range of products that not only maintain a sterile cleanroom, but test for compliance with a clean compounding environment.

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 President:

Company Background Since 2011, ISO-MED, INC., a medical supply distributor, has been a trusted hospital supplier with a solid combination of quality, selection, service, and convenience. We supply quality products for pharmacy cleanrooms and other medical industries in the United States. We provide high-grade supplies for cleanrooms, laboratories, home-care, and more. We strive to achieve and maintain compliant sterile compounding environments.

Product Overview ISO-MED maintains the largest and broadest portfolio of on-theshelf warehouse 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. 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 ISO-MED not only has products that help a hospital conform to cleanroom standards, but we also offer the following products for testing cleanliness. n ICR Plus TSA LT Contact Plates Environmental monitoring for isolators and cleanrooms (surface and air monitoring). n Tryptic Soy Agar Added measure to assure sterility in your environmental monitoring program! Hardy Diagnostics contact plates are recommended for use in the cultivation of microorganisms from environmental surfaces.

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, ISO-MED offers several brands and ISO-MED, INC. formularies.

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.

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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

RXinsider.com

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, 89 Aisles www.rxinsider.com

McKesson ideaShare July 7-10, 2022 National Harbor Washington, DC Mckessonideashare.com

ACVP Veterinary Pharmacy Conference 2022 June 10-11, 2022 Marriott Center City Raleigh, NC vetmeds.org/vpc

Cardinal Health RBC July 13-16, 2022 Mandalay Bay Las Vegas, NV Rbc.cardinalhealth.com

2022 ASHP Summer Meetings June 11-15, 2022 Phoenix, AZ Summer.ashp.org ECRM Health System/ Institutional Pharmacy Program June 13-16, 2022 Charlotte, NC ecrm.marketgate.com/ sessions Compounding Pharmacy Compliance June 21-22, 2022 Hybrid Event Washington, DC informaconnect.com/ compounding-pharmacycompliance

2022 TPA Conference & Expo July 15-17, 2022 Austin, TX www.texaspharmacy.org/ page/CONFEXPO AACP Pharmacy Education 2022 July 23-27, 2022 Grapevine, TX www.aacp.org/pharmed22 340B Coalition Summer Conference August 1-3, 2022 Washington, DC 340bcoalition.org/events NACDS Total Store Expo August 27-29, 2022 Boston, MA Tse.nacds.org

Continued on page 83 For listing and advertising details, please contact sales@RXinsider.com or call 800.972.2083.

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Pharmacy Case Studies take an in-depth look at specific products and services that help pharmacies improve patient care, profitability, and cost containment.

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Behind Every Good Pharmacist, is a Great Resource. Subscribe to RXinsider’s 411 Email Alerts and receive up-to-date announcements on pharmacy employment opportunities, new products and services, continuing education, surveys, and more.

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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.

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.

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.

Individual Membership

National Conferences

Through your hospital’s membership, you are eligible to join this supplemental program which provides professional development and networking opportunities.

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.

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


Bringing the Right Buyers & Suppliers Together ECRM’s Pharmacy & Medical Programs set you up for success with pre-scheduled, private, one-on-one meetings with partners that matter to your business.

Contact our SVP of Pharmacy & Medical Markets, Michael Castillo to learn how you can take advantage of virtual and in-person opportunities at 440-528-0441 or mcastillo@ecrm.marketgate.com


P H A R M A C I S T S W H O WA N T

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Behind Every Good Pharmacist, is a Great Resource. The Pharmacy Market BUZZ is a daily news feed, designed to keep the pharmacy community informed on the latest industry news, products, services, and trends that impact both patient care and the bottom line of a pharmacy.

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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 78

Compounders on Capitol Hill September 14-15, 2022 Hilton National Mall Washington, DC a4pc.org/cch NASP 2022 Annual Meeting & Expo September 19-22, 2022 Gaylord Palms Resort & Convention Center Orlando, FL naspnet.org/annual-meeting NCPA Annual Conference October 1-4, 2022 Kansas City, MO Convention.ncpa.org

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

ECRM – Pharmacy Technology, Services, Supplies, and Automation Program November 7-9, 2022 Santa Ana Pueblo, NM ecrm.marketgate.com/ sessions

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.

ASHP Midyear Clinical Meeting and Exhibition December 4-8, 2022 Las Vegas, NV www.ashp.org/Meetingsand-Conferences/MidyearClinical-Meeting-andExhibition

ASCP Annual Meeting & Exhibition November 3-6, 2022 JW Marriott San Antonio Hill Country Resort & Spa San Antonio, TX www.ascp.com

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

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TEMPERATURE INTELLIGENCE®

Peace of mind for your patients Temperature monitoring for direct-to-patient shipments Getting medication to patients in the right temperature range is critical for reducing unnecessary reshipments. Including a TransTracker® in outgoing medication shipments can help. These inexpensive, singleuse indicators monitor temperature exposures – letting your patients know at-a-glance whether medication has gotten too hot or too cold while in transit. Learn more about how TransTracker cards, manufactured by Temptime, can help you give your patients added peace of mind while helping you save money by avoiding medication replacements. zebra.com/transtracker

zebra.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

Zebra Temperature Monitoring and Sensing 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.

Anders Gustafson Founded: 1969 Employees: 8,800 Phone: (847) 634-6700 Fax: (847) 913-8766 Address: 3 Overlook Point Lincolnshire, IL 60069 Website: www.zebra.com CEO:

Company Background

Zebra empowers organizations to thrive in the on-demand economy by making every front-line worker and asset at the edge visible, connected and fully optimized. With an ecosystem of more than 10,000 partners across more than 100 countries, Zebra serves customers of all sizes — including 94% of the Fortune 100 — with an award-winning portfolio of hardware, software, services, and solutions that digitize and automate workflows. Supply chains are more dynamic, customers and patients are better served, and workers are more engaged when they utilize Zebra innovations that help them sense, analyze, and act in real time. In 2021, Zebra expanded its industrial automation portfolio with its Fetch Robotics acquisition and increased its machine vision and AI software capabilities with the acquisitions of Adaptive Vision and antuit.ai.

Product Overview

Zebra’s portfolio of solutions includes: specialty printing and supplies, barcode scanning, mobile computing and rugged tablets, RFID and real-time location systems (RTLS), intelligent workforce management and execution solutions, data services and prescriptive analytics, support, managed and professional services, intelligent automation systems, and temperature monitoring and sensing solutions. Our comprehensive temperature monitoring and sensing portfolio, manufactured by Temptime, meets the cold chain needs of specialty pharmacies and their patients. This portfolio includes: • 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 can be taken.

Product Specifications n Wireless Monitoring Systems The family of wireless Bluetooth®-enabled sensors monitor and record temperature data 24 hours a day, seven days a week. 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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Closed-System Transfer Devices (CSTDs) U.S. Centers for Disease Control and Prevention defines a closed system drug-transfer device (CSTD) as a system that “mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.” CSTDs are designed to provide protection against hazardous exposures to healthcare workers who are compounding and administering hazardous drugs. While CSTDs are not the only means of protection, they play a crucial role in hazardous drug safety measures.

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Tell us about your role and experience at Martha’s Vineyard Hospital and how the facility is using CSTDs? I am a board-certified sterile compounding pharmacist and in my current role at Martha’s Vineyard Hospital (MVH), I serve as the lead sterile compounding operations pharmacist. Throughout the past several years, two different brands of closedsystem transfer devices (CSTDs) have been utilized at MVH pharmacy and the outpatient infusion department. The majority of hazardous compounds prepared at MVH are intravenous chemotherapy drug solutions that are administered by chemo certified nurses at the outpatient infusion department. At MVH, the use of CSTDs is the primary standard for hazardous compounding and administration with exceptions. These exceptions may include drug-device chemical incompatibilities or routes of administration that require an open system. What is your responsibility to your employees and/or patients in ensuring their safety? Reducing the risk of exposure to hazardous drugs requires a multi-faceted approach with the overall goal of lowering contamination levels to a reasonably achievable point and eliminating unnecessary human exposure. Engineering controls that create and maintain negative pressure within the compounding area, CSTDs, staff educational programs, personal protective equipment, and institutional standard operating procedures are examples of individual strategies that address different aspects of the hazardous compounding process. The combination of all these safety measures helps to guarantee hazardous contamination prevention and control.


I work with pharmacy leadership, engineering control certifiers, pharmacy compounding technicians, pharmacists, nursing staff, environmental monitoring labs, and hospital environmental services to ensure proper functioning of engineering controls, safe compounding practices, and effective decontamination procedures. My other responsibilities are staff education, hazardous drug risk assessment, development of hazardous compounding policies and procedures, and keeping up to date with the latest technologies and regulations. In light of recent PPE shortages due to the pandemic, I work with pharmacy buyers to ensure an uninterrupted supply of appropriate personal protective equipment and their availability to hazardous compounding staff. Who should be involved in the process when selecting a CSTD for an organization, and when should an in-house test be done? I think the discussion surrounding the selection of a CSTD must include representatives from multiple disciplines such as manufacturer, pharmacy, nursing, administration, contracting, and supply chain. Personnel directly involved with hazardous compounding and administration (i.e., the end-users), are an integral part of these discussions and their opinion is enormously valuable when it comes to details that matter the most. For in-house testing, enough time should be allowed between testing and go-live in order to ensure staff training and SOP development. What features and benefits should be considered when selecting a CSTD for the pharmacy staff? When selecting a CSTD, the most important feature that should be considered is simply the efficacy. This is the ability of the system to form and maintain closed drug pathways, dry connections between the components and an impenetrable pressure equalization mechanism that contains contaminated air while maintaining the product sterility through it all. Unfortunately, evaluating clinical efficacy of CSTDs is not always straight forward. A universal and standardized protocol for evaluation of these systems is yet to be established. However, the draft NIOSH test

protocol and growing number of research and review articles published on testing and comparison of these systems are available and can be cautiously referenced. It is important to note that while NIOSH acknowledges the existence of research and advertisements that report their CSTD performance based on its draft protocol, it reiterates the fact that the protocol has not been finalized and its many key components are under construction. Ergonomic design factors to consider include the amount of force required for assembly, the potential for injury due to long-term repetitive motions, the number of pieces required, and the ease of unwrapping the components. The issue of reduced user dexterity due to double gloving should be kept in mind during this evaluation. Factors that help narrow the choices include: clear proof of locking completion and system activation, the user’s unobstructed view of the drug product, the mechanism in which inadvertent disengagement or dislodgement of the pieces is prevented, chemical compatibility with drugs, physical compatibility with various medical instruments, devices and drug containers, ability of the system to deliver drugs through desired routes of administration, dead space and delivery of small volumes, disposal and its impact on the waste management process, packaging, manufacturer/supplier ongoing support, and of course, overall cost. What features and benefits should be considered when selecting a CSTD for the nursing staff of an organization? In addition to the features mentioned above, it is beneficial for nursing staff to consider size and bulkiness of the components when it comes to patient comfort during extended infusions particularly when they carry portable infusion pumps while performing daily activities. Security of the connections and risk of accidental CSTD dislodgment or disengagement during patient ambulation should also be considered. Challenges? The most frequently reported challenges faced by compounding staff are risk of inadvertent unscrewing of the syringe from the CSTD at the time of de-accessing the vial or bag

adaptor, difficulty in aligning and connecting the pieces, and arm/shoulder fatigue. Another issue is the inability to use the MVH designated standard CSTD for filling and priming portable pump cassettes due to the size of the components and reported patient discomfort during infusion. Trending chemo wipe testing data has shown that most of the contamination detected on tested surfaces are related to drugs that are administered via portable infusion pumps. We have tackled this issue by implementing a second line of CSTDs that are smaller in size and create less discomfort for patients. When it comes to cost and storage space limitation, it is preferable to have a “one-size-fits-all” system. MVH pharmacy is in the process of reviewing an updated version of the currently used CSTDs. The goal is to eliminate the existing challenges while benefiting from updated design and added features. What do you feel are the advantages of your CSTD system? The overall experience working with CSTD at MVH has been positive and reassuring. Among many advantages, reliable pressure equalization method, dry connection mechanism, needle safety, useful design updates by the manufacturer, FDA clearance, customer support, and availability of credible research done on system’s hazard containment and product sterility preservation, are the most significant.

BIOGRAPHY

Orchid Motahari, Pharm.D. BCSCP Martha’s Vineyard Hospital Sterile Compounding Oversight As a new foreign graduate pharmacist, I started my career in the U.S. working as a long-term care, home infusion, and later on hospital pharmacist in Las Vegas, Nevada. I moved to Massachusetts a few years later and since 2013, I’ve had the pleasure of working at Martha’s Vineyard Hospital (MVH) as the lead sterile compounding operations pharmacist. Recently, I became board-certified in the sterile compounding field and these days I am mostly involved in the MVH hazardous and non-hazardous cleanroom construction project.

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IMI designs innovative medical devices that enhance the security of medication from pharmacy to patient. Fifty years of product design exclusively focused on the needs of the compounding pharmacist means exceptional quality, reliability and customer-driven innovation. From Tamper Evident Caps to essential sterile compounding supplies, ensure the integrity and security of your medications with solutions from the leader in secure drug delivery. Over 50 Years Serving The Industry Exceptional Quality & Reliability Enhance Your Drug Security Program Strengthen USP <797> Practices To See All Our Products and Request Samples Visit IMIWEB.COM |

1.800.344.2554

© 2022 International Medical Industries, Inc. All rights reserved. Companies and products mentioned herein may be trademarks or registered trademarks of their respective trademark owners.

MADE IN THE USA

IMI-501-AA-77 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

International Medical Industries — Innovation in Secure Drug Delivery 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. 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 President:

Company Background

visibility down to NDC and lot. Recognizing the advantages that RFID technology presents IMI joined industry consortium DoseID to help increase interoperability, quality, and performance of RFID tagged products. Tamper Evident Caps with RFID provide a labor-reducing solution to incorporating RFID into your drug doses. With a simple twist of a syringe, your CSPs are equipped with renowned tamper evident protection and powerful analytic automation capabilities. These two powerful technologies in combination enhance workflow efficiencies, eliminate time-consuming manual inventory control processes, provide assistance with growing regulatory demand, and supply a comprehensive strategy to prevent, detect, and resolve drug diversion events. In addition, by incorporating RFID technology into IMI’s Industry-leading Tamper Evident Caps, facilities can significantly reduce their cost of RFID implementation with little time-to-live and minimal staff investment, procedural changes, or capital investments.

Founded in 1967 and exclusively devoted to the needs of the compounding pharmacist, at IMI creating products for the compounding pharmacist is our sole focus. As a result, our customers experience the quality, service, and value that only a specialized partner can offer. Through our partnerships with compounding professionals, we continue to advance our devices to serve the healthcare community. From new product developments to customized packaging configurations IMI’s customer-focused ethos and superior engineering capabilities allow us to be responsive to the needs of our partners and customers. Our capabilities and highly trained teams are the reasons we have remained the industry standard for tamper evident cap technology and how we continue to deliver customer-focused products to enhance pharmacy productivity, safety, and security. All IMI products are manufactured in the United States at our FDA-registered, ISO 13485-certified facility under the strictest quality standards.

n Prep-Lock Tamper Evident Additive Port Caps The Tamper Evident Additive Port Cap provides remarkable protection, and protocol assurance to the medication ports of Baxter, B.Braun, and Fresenius Kabi I.V. bags. The simple one-handed installation and considerable contributions to the integrity of I.V. compounds have gained acclaim with pharmacists and healthcare professionals. “I find their products to be the best on the market in terms of the device itself, the functionality, and the securement,” says Neil Colby RPh, director of infusion pharmacy services CDRX infusion. These products extend the intention of USP <797> from pharmacy to patient by providing last mile security that strengthens pharmacist and HCP confidence and reduces risk of contamination and diversion.

Product Overview

Testimonial

n Prep-Lock Tamper Evident Caps Compounded preparations are at their greatest risk when they leave the custody of your pharmacy. The benefits of tamper-evident products to address this risk have been recognized within the standards and guidelines of multiple influential organizations including the American Society of Health-System Pharmacists and the FDA. Tamper Evident products increase overall accountability in the chain of custody of mediation, maintain sterility, prevent leakage, ensure patients receive the full intended dose and reduce the risk of contamination. Experts agree that the use of tamper evident products increases the confidence of pharmacies, health care workers, and patients. IMI’s Prep-Lock™ Line of products provide high-value, high-quality, tamper-evident closures devices for a variety of drug delivery containers, including I.V., enteral and oral syringes, medication cassettes, and I.V. bags. ™

n Prep-Lock Tamper Evident Caps Featuring RFID RFID Technology continues to garner adherents in hospital pharmacy systems. The technology enables real-time scanning that optimizes inventory management, efficiency, and medication safety while creating quantifiable pharmaceutical supply chain benefits by providing item level inventory

“ I find their [Tamper Evident] products to be the best on the market in terms of the device itself, the functionality, and the securement.” — Neil Colby RPh, Director of Infusion Pharmacy Services CDRX Infusion

Additional Product Lines

IMI manufactures a variety of high-quality devices for the compounding pharmacist including: Prep-Lock™ Tamper Evident Caps, Prep-Seal™ Caps and Plugs, Prep-Fill™ Sterile Connectors, Rx-Vent™ Filtered Venting Needles, Rx-Tract™ 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. SUMMER 2022

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CAS E S TU DY DAMERON HOSPITAL’S DATA-DRIVEN TEMPERATURE MONITORING STRATEGY Backed by Rees Scientific

Leanne Gonigan CPhT, Pharmacy Technician ~ Dameron Hospital

INTRODUCTION AND INTENDED OUTCOME Located in Stockton, California, Dameron Hospital is a fully accredited non-profit community hospital. With more than 200 beds, the hospital — which recently became part of Adventist Health — provides general acute, emergency, and intensive care services to the people of San Joaquin County. In addition to being a top-rated joint replacement center and the county’s leading orthopedic hospital, Dameron is also a designated STEMI (heart attack) receiving center and certified stroke center. Like all busy hospitals, Dameron’s priority is ensuring patient safety and positive outcomes. That’s why as a part of their commitment to quality care, administrators are always looking for ways to enhance their facilities and improve efficiency in all areas of the hospital. This includes the hospital pharmacy, where the staff is focused on protecting the efficacy of the temperature-sensitive medications and vaccines they dispense. When Dameron decided to automate its temperature monitoring protocols to streamline processes several years ago — they turned to Rees Scientific for help.

THE CHALLENGE Various regulatory bodies and accreditation agencies — such as the FDA, CDC, WHO, USP, and more — have requirements and guidelines for monitoring the temperatures of medication and vaccines. To comply, hospitals have long had processes in place to make sure temperatures inside refrigerators, storage areas, and operating rooms stay in range, explains CPhT, Pharmacy Technician Leanne Gonigan, who is responsible for pharmacy operations at Dameron. “For many years, we monitored temperatures manually,” she says. Couriers who delivered medication throughout the hospital were tasked with checking and recording

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Rees Scientific


CAS E S TU DY ZIGBEE WIRELESS & WIFI TEMPERATURE MONITORING

temperatures four times a day. This process became more and more time-consuming as the regulatory environment around storing and monitoring pharmaceuticals was evolving to be increasingly stringent. “If a regulatory body came in and wanted historical temperature monitoring information about a specific refrigerator or an OR, for example, I would have to look through the manual records to find the information they wanted,” Leanne says. “It wasn’t efficient for anyone — the regulators or me.” The manual nature of the process also lacked consistency, which meant a higher risk of human error.

• Fully GxP, FDA, CDC, and WHO compliant

Then one day, nearly ten years ago, a refrigerator stopped working and the hospital lost thousands of dollars’ worth of vaccines. That’s when Dameron administrators knew they needed a more reliable, systematic process to monitor medication and vaccine temperatures hospital-wide. “We did two things then,” says Leanne. “We increased the number of refrigerators throughout the hospital and clinics, and we implemented the Rees Monitoring System more broadly.”

• Instant alarm notification

THE SOLUTION

• Automated daily printouts

Dameron opted to expand its use of the Zigbee Wireless and WiFi continuous monitoring solution, which monitors both refrigerated and ambient temperatures 24 hours a day, seven days a week, 365 days a year. The system, which can easily be configured to meet a hospital pharmacy’s specific needs, provides instant notification of equipment failures and temperature excursions. This is combined with a robust Rees Software, which displays the status of each data logging device in use.

Benefits At-a-Glance

• Ad hoc report • Audit trails • Data encryption

“The first thing I do when I come in every morning is bring up the Rees Board (software) on my computer,” says Leanne. “That way, I know right away if there’s anything I need to address.” Dameron also has a Rees Board (software) up in the pharmacy itself that gives real-time readings on close to 200 inputs across refrigerators, operating rooms, medication rooms, and dispensing machines throughout the hospital, as well as remote storage facilities. “That means everyone in the pharmacy can see when there’s an alarm,” she adds. In addition to visual cues on the Rees Board (software), real-time text and email notifications are also sent to key personnel when there’s an event — so even if they aren’t in the pharmacy, they can still respond instantly.

REGULATORY COMPLIANCE What Leanne says she appreciates most about the Rees Monitoring System is how simple it is to access data. “There’s nothing more worrisome than having a governing body walk in and say they need reporting on this OR or that refrigerator and feel like I’m scrambling to pull it together.” Now, she says she never feels that way because the Rees Monitoring System is always on and collecting data. “I run daily reports on all vaccine refrigerators and keep these in binders for easy access,” Leanne explains. That way, if any regulatory body were to come in, she has the most critical information on hand. However, if they ask for information she doesn’t have at her fingertips — she can generate a report right on the spot. “It’s just a little added peace of mind for me because I can always give regulators exactly what they want quickly.”

www.reesscientific.com

Rees Scientific

91


CAS E S TU DY

DATA-DRIVEN DECISIONS

The first thing I do when I come in every morning is bring up the Rees Board (software) on my computer. That way, I know right away if there’s anything I need to address.” Leanne Gonigan CPhT, Pharmacy Technician ~ Dameron Hospital

Our service manager is very responsive. If I call, he calls me right back and walks me through solutions, so I can resolve issues on my own if possible.”

Leanne says they’ve found the Rees Monitoring System is vital for Installation Qualification (IQ) and Operational Qualification (OQ) as well. “We need to be able to collect data to not only monitor the temperatures of medication and vaccines — but also to ensure our refrigerators are operating as they should be.” Right now, for instance, she says Dameron is in the process of evaluating hospital equipment. “We’ve had to repair some of our refrigerators recently, and the plant operations and maintenance director is using the information we’ve compiled to analyze whether it is more cost-effective to replace refrigerators entirely or continue to maintain them.”

ONGOING SERVICE AND VALIDATION All systems will require occasional maintenance. That's when Leanne says the IT and support staff at Rees really provide a value-based service. “Our service manager is very responsive. If I call, he calls me right back and walks me through solutions, so that if it’s possible — I can resolve issues on my own.” If not, Rees’ unique regional service model ensures sales and engineers can be on-site quickly. Rees also conducts an annual validation of the system. The objective behind this is to ensure the Rees Monitoring System is operating at an optimum level. As a result of the 2021 validation, for instance, Dameron upgraded to Z3 wireless, which is designed to provide even greater security and flexibility.

Leanne Gonigan CPhT, Pharmacy Technician ~ Dameron Hospital

92

www.reesscientific.com

Rees Scientific


TEMPERATURE

Rees Scientific

DIFFERENTIAL PRESSURE

HUMIDITY

PARTICLE COUNTS

COMPLIANT VACCINE MONITORING SOLUTIONS

Monitor temperature of any cold storage (refrigerators, freezers, ultra-low freezers) from +1300 to -196 °C Continuous, real time monitoring rate exceeds requirements of CDC Regional Sales and Service teams for superior support Receive alarm notification via interactive phone, texts and e-mail Meet compliance for FDA, WHO, USP <797>, USP <800>, VFC, GxP & more

Min 2.0 °C Max 8.0 °C

Exceeds data logger capabilities Local audio and visual (LED) alarm available

609.530.1055 www.reesscientific.com

View sensor min/max conditions with the LCD display module


MOBILE PHARMACY COMPOUNDING CLEANROOMS

Whether you are planning a cleanroom renovation or building a new cleanroom, Modular Devices’ mobile cleanrooms provides an expedited option that combines a modular and prefabricated approach by delivering a ready-to-use, turnkey cleanroom that only requires utility connections upon being delivered. Our pharmacy compounding cleanrooms are available to rent or purchase! Experience unmatched quality, state-of-the-art materials and equipment, and a cleanroom that will not only exceed your expectations but USP 797/800 as well!

» Meets and Exceeds USP 797/800 » Hands-Free Interlocked Doors » Continuous Data Logging and Monitoring » 14' Wide x 48' Long » Includes 4' BSC’s and 4' LFH’s » Includes Dedicated Refrigerators » HEPA Filtered Interlocked Passthroughs » Hands-Free Scrub Sinks » Dedicated Haz and Non-Haz Gowning Rooms » USP 800 Negative Pressure Unpack / Storage Room » Hands-Free Flush Mount Intercoms » Guaranteed Environmental Control Anywhere in U.S. » Large Fleet and Nationwide Coverage » Guaranteed Certification

Full Compliance with USP 797 and USP 800 is one phone call away!

CALL FOR INFORMATION OR TO REQUEST A QUOTE (317) 489-4616 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 Modular Devices Premanufactured mobile cleanroom available in a fraction of the time compared to traditional design/build projects. Fully engineered turn-key mobile cleanrooms designed to provide immediate compliance for USP 797 and USP 800. Rent one today as an interim solution, or purchase one as your new permanent, state-ofthe-art cleanroom. We make compliance as simple as a phone call.

President & CEO: Greg Mink Founded:

1987 Toll-Free Phone: (800) 456-3369 Phone: (317) 489-4616 Address: 6678 Guion Road Indianapolis, IN 46268 Website: www.portable-cleanroom.com

Company Background

Modular Devices is based in Indianapolis, IN and offers short and long-term mobile cleanroom solutions for any industry or application that requires controlled environments throughout the USA and North America. Every cleanroom that we offer meets our high-quality standard commitment, has the most state-of-the-art materials and equipment, and includes unmatched customer service. We have all the required expertise under one roof. This includes architects, engineers, construction disciplines, and cleanroom experts that can guide you through the entire project. As the race continues to become compliant with USP 797 and USP 800, our primary focus as a company is to provide solutions for our clients by solving problems. We are a company that puts your needs first, and that takes care of the many complexities of building a compliant cleanroom so that you can focus on what is most important to you, your patients and staff!

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 and wasted capital, and providing immediate compliance and peace of mind.

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 data-logging 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 U.S. • 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 Modular Devices 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) 489-4616 or visit our website for a free quote, www.portable-cleanroom.com. SUMMER 2022

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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

Capital Inventory, Inc. — The Premier Leader in Pharmacy Inventory Services Our decades of expertise, working exclusively with pharmacies, makes us uniquely qualified to provide accurate and dependable inventory valuations through a streamlined process. Our clients can trust that we will be transparent, supportive, and reliable in every interaction.

William Straub Sr. President: Shannon McArthur Founded: 1979 Employees: 75 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 Founder:

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, Guam, Hawaii, Puerto Rico, and the U.S. Virgin Islands from its office in the Atlanta, GA area. Capital Inventory, Inc. has been in business for over 43 years, providing inventory services to thousands of hospitals, university medical centers, regional medical centers, and health systems. Capital Inventory exclusively services hospital, outpatient, specialty, and infusion pharmacies. Our expert on-site inventory teams conduct pharmacy inventories daily and are employed year-round. Employees of Capital Inventory are employed full-time and receive complete benefit packages. Employees undergo extensive and continuing education including pharmacy practices, drug information, and HIPAA regulations. You can be confident and secure as all of Capital Inventory’s employees undergo a thorough background check including felony, misdemeanor, and sex offender. Our employees are 12-panel drug tested regularly and at a minimum of twice a year. Third-party specialty companies conduct all testing. Additionally, our 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” 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.

Benefits

n Expertise: Our expert inventory teams consist of inventory specialists who speak ‘NDC’ fluently and are accustomed to working with finance and/or external auditors for validation. Our processes are streamlined for minimal interruption to the pharmacy staff and operations. n Analysis: Our expert analysis team of data specialists average over 15 years of experience, working in pharmacies and with pharmacy ADM data. All client data is analyzed and adjusted as needed to ensure the most accurate representation and valuation of your inventory. n Reporting: Final inventory data is provided in a clear, concise format across multiple mediums, all designed for maximum inventory management. Our secure online client portal allows you to access, view your data, and create customized reports and graphs. n Client Care: We provide friendly and personal experiences with highly knowledgeable and professional customer service-oriented personnel. Our pharmacies can trust that Capital Inventory will be transparent, supportive, and reliable every step of the way.

Why choose Capital Inventory for your inventory needs? • Pharmacies are our natural environment. Our expert on-site inventory teams specialize in conducting pharmacy inventories only and within a few hours. • Our on-site inventory teams work seamlessly around your pharmacy staff ensuring that the “snapshot” is a true and accurate representation of the inventory on-hand. • Eliminate the need for overtime, or coordination of staffing, to accommodate the inventory process with minimal interruption to the pharmacy staff and operations. • Our inventory specialists have the expertise and knowledge to work with finance and/or external audit firms to validate the inventory. • Our expert data processing team collaborates with the pharmacy to provide an accurate report in a timely manner. • Receive expert valuation and pricing of the inventory by an independent party.

GPO Affiliations

Premier, The Resource Group, HealthTrust

More Information

To learn more about Capital Inventory and how we can help meet your pharmacy’s objectives with our inventory services, please contact us at (800) 345-0849 or info@capitalinventory.com.

SUMMER 2022

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The Most Innovative Tamper-Evident Seals In Hospital Pharmacy Today 28mm

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• Sterile & Paper Free (USP 797 Compliant). • Maintains a 100% sterile barrier* with 3X greater adhesion. *Tested in Nelson Labs, Salt Lake City, UT • 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).

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Pharmacy Design and Modular Casework that help your pharmacy perform at its best!

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With over 7,500 completed installations, we have the experience to make your pharmacy project a complete success! PHARMACY SPACE PLANNING · MODULAR PHARMACY CASEWORK (FURNITURE) · PROFESSIONAL INSTALLATION

Call us today toll-free, 1 (800) 747-7648.

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Behind Every Good Pharmacist, is a Great Resource. The Pharmacy Market BUZZ is a daily news feed, designed to keep the pharmacy community informed on the latest industry news, products, services, and trends that impact both patient care and the bottom line of a pharmacy.

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Behind Every Good Pharmacist, is a Great Resource. RXinsider’s Thought Leader Video Series are informative videos comprised of multiple interviews with thought leaders throughout the pharmacy profession. Explore niche subject matter and gain insight through hundreds of thought leader videos.

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PraxiJect ™ SF 0.9% NaCl Prelled Syringes

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INNOVATING FOR HEALTH

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Who is reviewing controlled substance transactions at your facility? An estimated 10-15% of healthcare professionals will have a substance abuse problem at some point in their careers. Meeting this crisis with an effective drug diversion prevention and monitoring program is imperative, both for the healthcare worker and for patient safety. We are here to help! Rxpert Solutions’ Diversion Monitoring Operations Center (DMOC) will centralize your diversion monitoring — whether you are an independent hospital or a large healthcare system — so you can dedicate your staff to patient care. We perform audits and analyze results to meet regulatory requirements and improve the quality of the program and diversion findings. Our experts will help you maximize your investment in diversion monitoring software, and assist your facility in putting together an effective prevention and monitoring program from start to finish. Get started on your assessment by contacting us today!

www.rxpert.solutions (760) 705-4078 | tvidals@rxpert.solutions

THERESA VIDALS, B.S. PHARM F O U N D E R O F R X P E RT S O L U T I O N S


AVA I L A B L E F R O M

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Easy ordering and turnaround time You get fast access to affordable medicines. You can also view and manage your orders online. Visit DrReddysDirect.com today or contact your Sales Rep for more information.

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©2022 Dr. Reddy’s Laboratories Inc. RDY-0821-364


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