Special Advertising Section
American Health Packaging AmerisourceBergen Technology Group Amneal lnstitutional APP Clinical and Laboratory Standards Institute CSL Behring CutisPharma, Inc. Grifols ICU Medical, Inc. Medi-Dose/EPS Pacira Pharmaceuticals, Inc.
The profiles in this section were submitted by the advertisers.
American Health Packaging Prepackaged Unit Dose Provides Many Benefits for Health Systems
AT A GLANCE Address American Health Packaging 2550-A John Glenn Ave Columbus, OH 43217 Phone: (800) 707-4621 Fax: (614) 492-0448 Website: www. americanhealthpackaging.com
Patient safety is a critical issue for health systems. As a result, many health systems seek bar-coded medications to dispense to patients. Bar-coded product, used in conjunction with bar code medication administration systems, automate the “five rights.” American Health Packaging is dedicated to supporting this health care initiative with its growing line of prepackaged unit-dose products.
Products Bar-coded unit-dose generics, unit-of-use bottles, complianceprompting packaging
Vice President/ General Manager Rick Knight
Vice President, Sales & Marketing Brian McMillan
There are many benefits to American Health Packaging prepackaged unit-dose products: Safety. Companies that specialize in pharmaceutical packaging are highly regulated and inspected by the FDA. Current Good Manufacturing Practices (cGMP) compliance ensures that products are packaged in a regulated and safe environment. Packaging professionals are adept at ensuring that the product’s lot number, National Drug Code and expiration date are recorded correctly and legibly. Pharmacy Efficiency. Pharmacies are concerned with timely processing of orders that supply the proper medication to the patient at the appropriate time. Adding a multitude of steps to packaging and checking commercially available products in-house not only slows down this process, it also takes clinicians away from their core competency, patient care. Liability Management. Packaging products within health-system pharmacies can involve various distractions in terms of quality systems and process controls. Errors that ensue can place the liability on the hospital as well as the caregiver. Purchasing medications from a highly regulated, cGMP-compliant company such as American Health Packaging can help to mitigate risk by shifting some burden of responsibility from the health system. Cost Savings. In addition to shifting the potential cost of errors, health systems that choose on-site packaging must consider other direct costs, such as establishing the packaging infrastructure as
Find us at the intersection of patient safety and pharmacy efficiency.
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Corporate Profile 2013
well as paying the highly trained professional staff to perform, manage and support non-core work. Safety in Every Dose. Bar coded to the dose level, American Health Packaging’s unit-dose line has grown substantially in recent years. The line now contains close to 400 SKUs and nearly one-third of those are industry-exclusive items. The unit-dose products are bar coded to the dose level, many already converted to Global Trade Item Number and feature an extended shelf life. Additionally, color-coded labels with “tall man” lettering provide an extra safety feature to more easily differentiate similar cartons on the pharmacy shelf.
Our bar-coded unit dose supports health system patient safety efforts.
About American Health Packaging American Health Packaging is a subsidiary of AmerisourceBergen. Its manufacturing facility is registered with the FDA and fully adheres to cGMP. Industry veterans with nearly 100 years of collective experience lead the quality and manufacturing departments. American Health Packaging is licensed by the Drug Enforcement Administration to package Schedule II to V controlled substances.
New unit dose launches include tretinoin capsules, misoprostol tablets, modafinil tablets, nifedipine capsules, zafirlukast tablets, oxandrolone tablets, montelukast chew tablets
Special Advertising Section Pharmacy Practice News
RxWorks™ From AmerisourceBergen Technology Group (ABTG) AT A GLANCE A platform designed to provide true integration of inventory, workflow, bar coding, packaging and carousel solutions, RxWorks is optimal for facilities that want greater inventory control, reduced medication errors and advanced unit-dose packaging, while best using limited space. RxWorks is a scalable platform, designed to expand as you expand. Company Background AmerisourceBergen Technology Group (ABTG) is a business of AmerisourceBergen Drug Corporation and has been a leader in the pharmacy automation industry for nearly 20 years. From small community pharmacies dispensing a few dozen prescriptions per shift to multifacility health systems supporting thousands of lives, ABTG has technology solutions that will help improve patient safety, streamline medication management processes and control costs. The ultimate goal is to provide its business partners with safer and smarter ways to care for their patients, customers and communities.
Product Overview RxWorks™ from AmerisourceBergen Technology Group (ABTG) is the platform on which many of ABTG’s inpatient pharmacy solutions are integrated. Features include: • A single database to manage and connect all of these components. • Modularity that enables reporting consistency. • A single point of entry for medications and users. Beyond integration, RxWorks is an open system, which means that ABTG designed the platform to have interfacing capabilities with virtually any vendor or device.
340B offers a compreAddress hensive approach to track, report and replenAmerisourceBergen Technology ish 340B inventory, while Group 1400 Busch Parkway improving the overall Buffalo Grove, IL efficiency of the pharToll-free Phone: (877) 781-ABTG macy’s supply chain. (2284) Implementing this soluWebsite: www.abtg.com tion provides the pharmacy with the assurance Vice President/ that its 340B savings will General Manager be maximized, and time spent ordering medicaTony Guarino tions will be minimized. FastFind ® UniverEmployees sal. The carousel allows 250+ technicians to retrieve medications from a single location, and its ergonomic design minimizes technicians’ bending and reaching by picking from the waist height. Driven by the RxWorks platform, the FastFind Universal employs complete inventory management for all items stored in the carousel. That includes the ability to generate purchase orders directly from the carousel when inventory is running low. FastPak® EXP. ABTG’s premier packaging solution, the FastPak EXP consists of packaging subunits that can be easily switched between standard or narrow widths: standard for traditional unit-dose and multidose solutions, narrow for automated dispensing cabinets or 30-day boxes. Innovative Smart Canisters are optional and can be interchanged quickly, enabling the automation of limitless oral solids. Barcoding Station. The Barcoding Station allows bar codes to be added to products that are either not bar coded by the manufacturer or inadequately coded/unreadable by a barcode medication administration scanner. Through extensive market research and customer feedback, ABTG updates and launches new technology solutions routinely. Look for more cutting-edge introductions from ABTG coming soon!
Features and Options RxWorks Inventory. This powerful inventory management software module integrates pharmacy, automation, materials, finance, nursing and purchasing systems. With the ability to provide a perpetual inventory system for any number of locations, RxWorks Inventory helps facilities save time and money through better management of drugs and materials processes. RxWorks Workflow. This integrated software solution is developed to address pharmacy needs for safer, more efficient workflow management. RxWorks Workflow easily integrates into the pharmacy environment and interfaces with the pharmacy information management system. Easy to learn and use, RxWorks Workflow is a comprehensive software solution that improves safety and workflow by efficiently guiding staff to the appropriate pick locations (automated and manual), and more importantly, ensuring the right drug is picked, in the right dose, for the right patient. RxWorks 340B. Also integrated on the RxWorks platforms, RxWorks
Special Advertising Section Pharmacy Practice News
Corporate Profile 2013
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Amneal Institutional™ AT A GLANCE Address Amneal Institutional 118 Beaver Trail Glasgow, KY 42141 Phone: (866) 525-7270 Email: Sales@amnealinstitutional.com
Specialized Products and Packaging Unit-Dose Packaged Oral Solids • Both existing and future Amneal products • Customer-defined, automationready packs Injectables (syringes, vials, bags) • Partner-developed and produced • Internal development with vertically integrated and finished product capabilities Distribution • Orders ship within 36 hours • Single, central Amneal distribution center in Glasgow, Ky.
In less than six years, Amneal Pharmaceuticals has become the seventh largest generic pharmaceutical manufacturer in the United States. The company has been recognized with awards, seen more than 118 million of its prescription drugs dispensed per year, built its infrastructure to a 35 billionunit annual capacity and has nearly 240 Abbreviated New Drug Applications filed or in development. Despite its phenomenal growth, this award-winning company remains passionate about continued expansion across its current business segments as well as into new products, dosage forms and markets, all while maintaining its total commitment to quality and superior customer value and relationships.
Amneal recently extended its philosophy further into the institutional market with the creation of Amneal Institutional (AI)—a business unit dedicated to generic products and packaging designed to meet the specific needs of health systems, clinics and physician offices. With an average of more than 25 years in the The Amneal Institutional pharmaceutical industry, AI’s account manageValue ment team has extensive experience serving the Proactive, fully immersed into institutional market, widely defined as hospitals segment and other acute care facilities, outpatient surgi• Dedicated and committed cal and radiology services, oncology centers, experienced team and superb home infusion service providers, long-term care customer support centers, correctional facilities, specialty pharmaProven performance cies and group purchasing organizations. • Superior supply, quality and With a distinct product selection that includes integrity specialty injectables (prefilled syringes, singleOrganizational relationships dose vials, pharmacy bulk packaging and premix • Transparent, collaborative and bags) and unit-dose packaging, Amneal is now customer-focused well positioned to fill the unique needs of these markets. Some of the near-term launches—products from a partnership with Agila Specialties— are on the FDA Drug Shortage List and should help address current market supply issues. Several other product launches are planned through year-end as well as a robust pipeline for 2014 and beyond. The new dosage forms join the same proven bulk oral solids, topicals and large-quantity oral liquid medications on which Amneal’s reputation was built, offering institutional pharmacies a broader selection of superb-quality generics.
A Move Into Biologics and Biosimilars Understanding the strategic direction of the industry, Amneal began moving into biologics in 2009 and expanded into biosimilars with the early 2012 acquisition of Therapeutic Proteins International (TPI), a biosimilars development firm in Chicago. TPI’s management team offers extensive, industry-wide experience in this rapidly evolving area of pharmaceuticals, in both the domestic and inter-
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national markets. The company’s revolutionary patented disposable bioreactor-based manufacturing technology radically alters biologic production paradigms, enabling accelerated time to market. With 40-plus tests—five of which are patented—per product, TPI delivers the same superior quality and extraordinary consistency for which Amneal goods are known. Amneal anticipates the first FDA approval of its TPI biosimilar product in 2014. Beyond stellar products, Amneal offers a unique collaborative business style to the institutional area. A dedicated and committed account management team boasts extensive experience from a variety of injectable manufacturers. This highly focused sales leadership group—together with Amneal’s transparent and responsive way of doing business—promises to deliver industry-recognized customer focus bolstered by unrelenting quality, development of non-price value and a consistent supply of essential products to meet the institutional pharmacy’s needs and help improve the health of its patients.
Special Advertising Section Pharmacy Practice News
The APP Brand of Specialty Injectable Products From AT A GLANCE Fresenius Kabi USA Address
Fresenius Kabi is a leading global health care company that focuses on medicines and medical devices for critically and chronically ill patients inside and outside the hospital. Its APP brand of specialty injectable products is well known to hospitals and other health care providers in the United States. Fresenius Kabi provides a full line of critical care, anesthesia/analgesia, oncology and antiinfective products under the APP brand.
Table. APP Injectable Drug Products
Today, providing reliable access to quality specialty injectable products is more important than ever before. As part of a global company, Fresenius Kabi USA is positioned to provide high-quality products to its customers based on the following capabilities: • Access to multiple U.S.-based and global manufacturing locations • Redundant production lines that can be used when needed • Well-established relationships with suppliers • A secure global distribution network
Number of Product Families
Number of Products
Analgesia and anesthesia
16
124
Antiinfectives
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79
Critical care
54
139
Oncology
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63
Therapeutic Area
APP products are produced at multiple FDA-registered facilities located throughout the United States, Europe and Asia. To help further ensure that the company can reliably meet the needs of its customers, the global manufacturing capabilities of Fresenius Kabi have been utilized in times of great customer need. What this ultimately means to health care providers and the patients they serve is that Fresenius Kabi USA has the commitment and resources to provide specialty injectable products that meet the highest quality standards.
Well Prepared To Serve Customer and Patient Needs
Fresenius Kabi USA Three Corporate Drive Lake Zurich, IL 60047 Phone: (847) 550-2300 Toll-Free: (888) 391-6300 www.fresenius-kabi.us
Customer Service (Ordering) Toll-Free: (888) 386-1300 FAX: (800) 743-7082
Medical Affairs Toll-Free: (800) 551-7176 FAX: (847) 413-8571
Products
Together, these capabilities define what customers and patients expect and rely on from a leader focused on supporting the care of critically and chronically ill patients inside and outside the hospital.
A leading supplier of multisource and branded injectable pharmaceutical products, primarily focused on the anesthesia/analgesia, anti-infective, critical care and oncology markets.
A Growing Portfolio of Quality Products In 2012, Fresenius Kabi USA was the second largest supplier of multisource products based on the number of units sold in the United States and Canada.1 The company ranks first in terms of the number of injectable drugs offered across four key therapeutic areas (Table). There is a commitment to continually expand its already broad portfolio. Recently, Fresenius Kabi added Meropenem for Injection, USP (IV) and Imipenem and Cilastatin Injection, USP (IV) to its antiinfective portfolio; Acetylcysteine Injection, Tranexamic Acid Injection, Benztropine Mesylate Injection and Levetiracetam Injection to its critical care product line; and Oxaliplatin Injection, USP to its oncology portfolio.
Commitment in Action Fresenius Kabi USA has the resources to maintain its commitment to providing quality essential medicines. The comprocesses, production capabilities and people pany’s demonstrate its commitment in action on a daily basis.
Reference 1.
Special Advertising Section Pharmacy Practice News
IMS Health, September 2012.
Corporate Profile 2013
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Clinical and Laboratory Standards Institute AT A GLANCE Address Clinical and Laboratory Standards Institute 950 W. Valley Road, Suite 2500 Wayne, PA 19087 Phone: (610) 688-0100 Fax: (610) 688-0700 Email: customerservice@clsi.org Website: www.clsi.org
Products Standards, companion products, webinars, workshops, certificate programs, document competency quizzes, symposia, training
Chief Executive Officer Glen Fine, MS, MBS, CAE
Senior Vice President, Operations Luann Ochs, MS
The Clinical and Laboratory Standards Institute (CLSI) is setting the standard for quality in clinical laboratory testing around the world. A not-forprofit membership organization, CLSI brings together the global laboratory community for advancement of a common cause: fostering excellence in laboratory medicine. For over 40 years, our members, volunteers and customers have made CLSI a respected, transformative leader in the development and implementation of clinical laboratory testing standards. Through our unified efforts, we will continue to set and uphold the standards that drive quality test results, enhance patient care delivery and improve health care around the world. CLSI distributes more than 75,000 standards worldwide each year. Vision: Quality practices for better health. Mission: Develop clinical and laboratory practices and promote their use worldwide.
Why Use CLSI Consensus Standards? We have an array of standards that span nine main subject areas. By using CLSI standards, you save time and costs while improving process quality, speeding the development of standard operating procedures and implementing safer practices with greater ease and efficiency. CLSI Companion Products related to the standards are available to improve the ease of use of standards. CLSI has a hierarchy of committees that oversee the development of our consensus standards. What’s unique about CLSI is that all of our committees have a balanced consensus body, which means that each of the three constituencies— government, industry and professional representatives—has an equal say when approving documents for publication.
Pharmacists—eM100 comes in a version just for you!
eM100™ is an easy-to-use interactive, searchable database for drug selection, interpretation and quality control procedures.
Why Volunteer With CLSI? Take part in developing standards that apply to the work you do each day. By donating your time and talents to improve the standards that affect your own work, you will play an active role in improving health care across the globe. Gain recognition from CLSI, your organization, your colleagues and your community by enriching your career and resumé through your contributions.
Clear Guidance on How To Improve Laboratory Practices Through CLSI’s educational resources, one can learn directly from the experts who developed the standards to implement those technical documents in his or her laboratory and improve quality. Enhance comprehension and use of CLSI standards and earn P.A.C.E.® continuing education credits along the way. Educational opportunities include webinars, document competency quizzes and certificate programs. Participate in webinars related to AST standards, quality management and upcoming CLSI standards. All our educational offerings can be found on our website at www.clsi.org/education-programs.
Why Join CLSI?
eM100 is an interactive, searchable database for drug selection, interpretation and quality control procedures. It is based on CLSI’s widely recognized AST standard M100-S23—Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Informational Supplement. The database can help you work more efficiently by providing the latest recommendations for detecting emerging resistance in an easy-to-use format. You’ll find only the information you need to make informed patient recommendations. Membership discounts apply. If you already own M100-S23, you will receive an additional 50% off your member price for your 2013 eM100 subscription!
CLSI members have access to a network of more than 2,000 influential organizations across the global laboratory community. Members can receive up to 70% off the cost of CLSI documents, educational programs and companion products. Along with our revised membership levels and categories, this year we have introduced individual memberships! If you are interested in learning more about CLSI membership, email us at membership@clsi.org.
Raise your standards for excellence with the help of CLSI.
CLSI’s widely recognized standard M100-S23— Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Third Informational Supplement.
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Corporate Profile 2013
Special Advertising Section Pharmacy Practice News
CSL Behring Biotherapies for Life CSL Behring is a global leader in the plasma protein therapeutics industry. Committed to saving and improving the lives of people with rare and serious medical disorders, we research, develop, manufacture and market plasma-derived and recombinant biotherapies. Our products are used around the world to treat coagulation disorders such as hemophilia and von Willebrand disease (VWD), primary immune deficiencies, hereditary angioedema and inherited respiratory disease, as well as neurological disorders in certain markets. We also manufacture products that are used in cardiac surgery, organ transplantation, burn treatment and to treat acquired bleeding and prevent hemolytic disease of the newborn.
CSL Behring maintains state-of-the-art manufacturing facilities that we have been expanding to keep pace with the growing demand for immunoglobulin and albumin.
Customer Focus At CSL Behring we are committed to the people who rely on our products. We never forget that our therapies are essential to the life and well-being of every patient. Each of us brings that sense of purpose to work every day. Our Core Values—customer focus,
innovation, integrity, collaboration and superior performance—underscore our purpose and our commitment to provide the best possible therapies and services.
AT A GLANCE Address
Innovation We continually leverage our medical and scientific expertise to develop new therapies, create new applications and innovative enhancements for our products, and identify underserved markets. We invest in emerging technologies to develop new products and improve existing therapies. We continue to increase our investment, growing the R&D project portfolio and enhancing and expanding global capabilities where they can add the most value. CSL Behring has more than 1,000 R&D employees who serve on various global project teams to maximize individual expertise while leveraging core capabilities at each site. We strive to ensure our manufacturing processes and facilities are state-of-the-art and can meet a growing demand for immunoglobulin and albumin. Our facilities combine advanced industrial-scale filtration technology, highly efficient separation processes and advanced formulation to generate our innovative plasma therapies.
CSL Behring 1020 First Avenue King of Prussia, PA 19406 Corporate Inquiries: Chris Florentz - (610) 878-4316 Product Inquiries: Sheila Burke – (610) 878-4209 Fax: (610) 878-4009 Website: www.cslbehring-us.com
Products CSL Behring is a global leader in the plasma-protein biotherapeutics industry, providing life-saving treatments that include recombinant biotherapies for a range of rare and serious medical disorders. CSL Behring also operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia.
Access to Care
Employees
Even the most innovative therapies are meaningless if people are not able to obtain them. CSL Behring offers a broad range of programs and services to assist patients and physicians with reimbursement support and ways to ensure access to their therapies. We also partner with patient associations to advocate for legislation that protects patient and physician choice of therapy, appropriate standards of care, appropriate reimbursement and other topics that impact the rare disease communities we serve.
10,500+ employees in 30 countries
Recognition
Manufacturing Facilities Marburg, Germany Bern, Switzerland Kankakee, Illinois, United States Broadmeadows, Australia
CSL Plasma Headquartered in Boca Raton, Florida, United States Testing laboratories in Knoxville, Tennessee, United States; and Göttingen, Germany 75+ collection centers in the United States and eight in Germany
CSL Behring has been recognized by patient groups and the industry for its innovative lifesaving therapies. The European Organization for Rare Disorders presented its EURORDIS Award to CSL Behring for “pioneering work in developing and manufacturing therapies used to treat rare and serious medical conditions.” The National Organization for Rare Disorders recognized CSL Behring for developing and marketing the first treatment in the United States for acute bleeding episodes in patients with congenital fibrinogen deficiency. Forbes has included CSL Behring in its Top 50 List of the world’s most innovative companies.
CSL Behring global headquarters in King of Prussia, Pennsylvania
Special Advertising Section Pharmacy Practice News
Corporate Profile 2013
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CutisPharma, Inc. AT A GLANCE Address CutisPharma, Inc. 68 Cummings Park Woburn, MA 01801 Contact: Jim Nagle, Vice President–Business Development Phone: (781) 935-8141 ext. 120 Email: JNagle@cutispharma.com Website: www.cutispharma.com
CutisPharma, Inc., brings innovation and value to the prescription-compounding sector of hospital and health-system pharmacies. Patient-specific – Compounding Kits simplify the entire process by quickening preparation and helping facilitate reimbursements. What typically takes compounders up to 15 minutes to do now takes just minutes.
FIRST® – Omeprazole and FIRST® – Lansoprazole Suspension Unitof-Use Compounding Kits in 3, 5 and 10 oz sizes.
more easily through nasogastric (NG) tubes, with minimal clogging compared to current practice. Also, our three different sizes of packaging, 3 oz., 5 oz. and 10 oz., provide considerable prescribing flexibility.”
Compounding Kits for Often-Filled ‘Magic Mouthwashes’
CutisPharma, Inc., offers convenient kits that make dispensing some Greater efficiencies in the compounding process of the most commonly prescribed suspensions a simple, easy process. bring multiple financial and clinical gains to hospiCommonly known as ‘Magic Mouthwashes,’ the products include: Patient-Specific Prescription tal and health-system pharmacies. By using pre• FIRST® – Mouthwash BLM (Benadryl®, lidocaine and Maalox®) in Compounding Kits measured, pre-weighed unit-of-use prescription three sizes ® ® kits, pharmacies and nurses save • FIRST – Mouthwash BXN (diphenhydramine, lidocaine and compounding FIRST – Omeprazole Suspension: significant staff time in preparation, help lower the nystatin) 3, 5, 10 oz. • FIRST® – Duke’s Mouthwash (diphenhydramine, hydrocortisone and total costs of compounding, and refine their justFIRST® – Lansoprazole Suspension: 3, 5, 10 oz. in-time inventories to ensure ingredients are on nystatin) FIRST® – Mouthwash BLM: 4, 6, 8 oz. hand when needed and ready to use over longer • FIRST® – Mary’s Mouthwash (diphenhydramine, hydrocortisone, FIRST® – BXN Mouthwash periods of shelf life. All dispensing containers are nystatin and tetracycline) FIRST® – Duke’s Mouthwash bar-coded for convenient bedside scanning. Each FIRST® Kit has everything needed to compound one prescripFIRST® – Mary’s Mouthwash Clinically, the packaged reagents help deliver tion from one prescriber for one patient. They include pre-weighed FIRST® – 10% Hydrocortisone in powders and a pre-measured suspension. The pharmacist needs only consistent accuracy of the compound admixtures Ultrasound Gel and speed medication delivery to patients, if to add the powders to the liquid suspension, shake and dispense. FIRST® – Progesterone Vaginal “The company now has a wide range of FIRST® ‘Magic Mouthwash’ compounded according to instructions, because Suppository USP: 25, 50, 100, formulations to choose from, particularly for the most commonly prethey’re easier and quicker to use than the typical 200, 400 mg laborious processes. These benefits, in turn, may scribed and used,” Dr. Muni said. FIRST® – Testosterone MC: lead to better patient health outcomes. The kits FIRST® products save dispensing time and can be compounded by 2% Testosterone in White also help facilitate compliance with USP <795>. the pharmacist while the patient waits, thus increasing customer satMoisturizing Cream Base “Industry-wide savings can be vast. [The] FDA isfaction. Using FIRST® Mouthwash kits, the pharmacist can compound FIRST® – Testosterone: 2% estimates 30 million a prescription faster than those prepared in the Testosterone in White Petrolatum hospital-outpatient conventional way. and retail compound– 10% Hydrocortisone ing prescriptions are In Ultrasound Gel Compounding Kit filled per year. Inpatient figures are also significant, yet harder Primarily prescribed for physical therapy patients, the FIRST® – 10% Hydrocortisone in to pinpoint because they lack a single NDC number,” said Jim Nagle, Vice President– Ultrasound Gel Compounding Kit contains 6 Business Development at CutisPharma. g of micronized hydrocortisone USP in a 24-g The NDC number imprinted on each suspension with propylene glycol USP and end-use container in every CutisPharma simethicone USP. It also includes 36 g of ultrasound gel for topical use. The kit has a twoFIRST® – Kit facilitates third-party reimbursement for health systems. The single year shelf life prior to compounding. There are approximately 350,000 10% HydroNDC number for the entire kit may also improve patient safety, because of minicortisone in Ultrasound Gel prescriptions writmized dispensing errors, suiting the growten annually. A CutisPharma cost comparison The FIRST® – Magic Mouthwash line contains FIRST® – ing number of inpatient and outpatient Mouthwash BLM (4, 6 and 8 oz sizes), BXN, Duke’s and shows that FIRST® – 10% Hydrocortisone Kit Mary’s versions. pharmacies that bar-code prescriptions can yield a profit of over $9 for a compounding from point of dispensing to point of care. pharmacy versus a loss of over $16 when the admixture is compounded conventionally. Also, preparation time is cut Compounding Kits for Widely Used PPIs to two minutes from well over 15 minutes. CutisPharma, Inc., also offers FIRST® – Omeprazole and FIRST® – LanGrowing Portfolio Serves Compounding Needs soprazole Patient Specific Oral Suspension Compounding Kits. These kits will help pharmacists quickly dispense these compounded preThe CutisPharma Kit portfolio is growing to meet pharmacy’s increasing reliance on compounding. To meet the need for efficiencies, safety scriptions containing widely used proton pump inhibitors (PPIs). Traditionally, compounded omeprazole and lansoprazole oral suspensions and convenience, all FIRST® Patient-Specific Compounding Kits follow can take up to several hours to prepare and have an unpleasant taste. the simple rule of “one prescription from one prescriber for one patient.” With FIRST® – Omeprazole and FIRST® – Lansoprazole, pharmacists CutisPharma, Inc., now has 20 proprietary prescription compoundneed only add the liquid suspension to the powder, shake, and then ing kits on the market: five progesterone suppository compounding kits, two testosterone kits, one hydrocortisone kit, six Magic Mouthwithin minutes can dispense to the patient with improved flavoring. “We invested a lot of time to develop these new suspension kits. wash kits, three omeprazole suspension kits and three lansoprazole The results are a pleasant-tasting strawberry-flavored medication with suspension kits. Several more compounding kits, including a grapeadequate stability once compounded,” said Dr. Indu Muni, founder, flavored Vancomycin Suspension, are in the planning stages. chairman and CEO of CutisPharma, Inc. “These products offer another advantage for hospital use: Since the suspensions are made using powders and not pellets, our new compounded suspensions should flow
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Corporate Profile 2013
Special Advertising Section Pharmacy Practice News
Grifols Grifols is a global health care company headquartered in Barcelona, Spain. The company produces and markets plasma-derived medicines as well as hospital pharmacy products, compounded IV solutions, and in vitro diagnostic products for clinical laboratories. Grifols employs more than 8,000 people in the United States and 11,200 people worldwide, and its products are sold in more than 90 countries.
AT A GLANCE Address Grifols 2410 Lillyvale Ave. Los Angeles, CA 90032 Phone: (888) GRIFOLS (474-3657) Website: www.grifols.com
A Legacy of Innovation At Grifols, a history of innovation defines our modern-day approach to medicine. More than 70 years ago, a Spanish hematologist named Dr. Jose Antonio Grifols Roig pursued a line of research that would set the stage for contemporary use of human plasma to treat disease. Together with his sons, he founded Laboratorios Grifols in 1940. Among their pioneering achievements, they obtained a patent in Spain for the process of plasma lyophilization, or freeze-drying of human plasma, along with the devices needed to inject plasma into patients who required its therapeutic properties. Shortly thereafter, in 1951, Dr. Jose Antonio Grifols Lucas published the first large-scale clinical data describing the plasmapheresis technique of extracting plasma from donors while returning their red blood cells. Combined with the work of Edwin Cohn, Grifols paved the way for the birth of the plasma fractionation industry as we know it today.
Expanding To Meet the Demand From these auspicious beginnings, Grifols has evolved into an industry leader in the collection, manufacture and marketing of plasma-derived therapies. Through recent acquisitions, Grifols is now the third largest global producer of plasma-derived medicines. Grifols operates the world’s largest plasma collection platform, with 150 source plasma donation centers across the United States. Grifols currently has the world’s highest plasma protein fractionation capacity of more than 8 million liters of plasma per year. To accommodate the growing global demand for plasma-derived medicines, Grifols is significantly expanding its three manufacturing sites in Clayton, N.C., Los Angeles, Calif., and Barcelona, Spain— the company’s global headquarters. The expansions include a
Divisions Edwin J. Cohn & Jose Antonio Grifols at the 4th International Congress of Blood Transfusion, Lisbon 1951.
new, 185,000-square-foot fractionation facility in Clayton and a new facility in Los Angeles dedicated to the production of immune globulin therapies. The new manufacturing facilities will increase the company’s capacity to fractionate plasma to 12 million liters by 2015. In addition, this year, Grifols opened a new, state-of-the-art plasma testing laboratory in San Marcos, Texas, where every plasma donation undergoes rigorous scientific analysis prior to being approved for use in manufacturing. The 72,000-square-foot facility houses the latest technology for conducting sophisticated viral testing, including transcription-mediated amplification to rapidly detect minute levels of viral material in plasma samples. The San Marcos laboratory, together with an existing plasma testing laboratory in Austin, will analyze millions of plasma samples annually. Grifols is firmly committed to giving patients and health care providers broad access to our products. As Grifols grows, it continues to pursue its mission of improving the health and well-being of people around the world.
Bioscience: Specializes in the research, development, production and commercialization of high-quality plasma therapies. Hospital: Specializes in operational solutions for compounding areas in pharmacy. Diagnostic: Specializes in diagnostic instrumentation, reagents, software and related products for the clinical laboratory.
Products Albumin (Human), marketed as Albutein® 5%, Albutein® 25% and Plasbumin® _ 5 and Plasbumin® _ 25 Alpha1-Proteinase Inhibitor (Human), marketed as Prolastin®-C Antihemophilic Factor/von Willebrand Factor Complex (Human), marketed as Alphanate® Antithrombin III (Human), marketed as Thrombate III® Coagulation Factor IX (Human), marketed as AlphaNine® SD Factor IX Complex, marketed as Profilnine® SD Hyperimmune Globulin Therapy Products: • Rabies Immune Globulin (Human) • Tetanus Immune Globulin (Human) • Rho (D) Immune Globulin (Human) • Hepatitis B Immune Globulin (Human) Immune Globulin Intravenous (Human) or IVIG Immune Globulin Injection (Human) Gri-fill® System 3.0 for compounding sterile preparations Misterium® modular clean room solution Grifols-SencorpWhite inventory management system solutions Phocus® Rx: remote pharmacist validation system for compounding IV preparations Grifols Triturus® Fully Automated EIA Analyzer
IVIG manufacturing plant in Barcelona, Spain, designed by Grifols Engineering.
Interlab G26 Clinical Agarose Gel Electrophoresis Systems A focused selection of reagents for infectious serology, autoimmunity, oncology, and celiac disease CO23-0612
Special Advertising Section Pharmacy Practice News
Corporate Profile 2013
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ICU Medical, Inc. ICU Medical connects patients and caregivers through safe, life-saving, lifeenhancing medical devices, providing clinicians around the world with innovaAddress tive and cost-effective patient care soluICU Medical, Inc. tions for unmet clinical needs. Since the 951 Calle Amanecer 1970s, the unsafe handling of hazardSan Clemente, CA 92673 Phone: (866) 829-9025 ous drugs used to treat many forms of Fax: (949) 366-2183 cancer has been recognized as a signifiWebsite: www.icumed.com cant health hazard to health care workers, including oncology pharmacists. Chairman of the Board, President and CEO In response to these well-documented George A. Lopez, MD risks, ICU Medical has developed the ChemoClave™ system, including the world’s only needlefree closed system transfer devices for the safe handling of hazardous drugs, and the Diana™ hazardous drug compounding system, an automated sterile compounding system for the accurate, safe and efficient preparation of hazardous drugs.
AT A GLANCE
The Diana System The Diana system is the world’s first needlefree, user-controlled automated sterile compounding system for the safe preparation and reconstitution of hazardous drugs. The Diana system takes the variation out of manual drug preparation practice and lets clinicians create a repeatable sterile preparation and safe-handling process. The Diana system is designed to facilitate both low-volume and highvolume preparation of drugs, fits inside the pharmacy’s biological safety cabinet and complements existing pharmacy workflows. The system also provides automated checks and reminders to improve workflow efficiency and safety.
User-Controlled Automated Sterile Compounding For Maximum Accuracy and Safety Unlike automated technologies that require huge investments and do not fit into existing workflows, the Diana system cost-effectively keeps pharmacists and technicians in control of the compounding process from beginning to end. The mechanically and microbiologically closed design of the Diana system is accomplished through a series of innovative, needlefree components that attach to all con-
The affordable, easy-to-use ChemoClave system includes the world’s only needlefree closed system transfer devices for the safe handling of hazardous drugs.
tainers that are dispensing or receiving a drug in the compounding process, to protect the preparation from exposure to environmental contaminants while also protecting the clinician from both exposure to the drug and accidental needlesticks.
Reduces Risk for Repetitive Stress Injuries And Increases Efficiencies The Diana system helps free pharmacists and technicians from many of the repetitive motions required during drug preparation and reconstitution, and helps reduce the stresses and injuries that can occur as a result. Also, by helping clinicians improve the efficiency of high-volume compounding, the Diana system can deliver workflow efficiencies while reducing drug waste by extracting every drop of drug from every container. The Diana system’s proprietary enabling technology includes pre-packaged preparation sets and ICU Medical’s clinically proven simple, safe and secure ChemoClave™ needlefree closed devices to help enhance health care worker safety and comply with OSHA, NIOSH, ASHP, ISOPP, ONS, APHON and USP <797>.
The ChemoClave System ICU Medical’s ChemoClave system, designed to keep clinicians safe from dangerous exposure to hazardous drugs, provides clinicians with a variety of needlefree vial access devices, a selection of needlefree bag spikes, and primary add-on and administration sets featuring the Spiros® CSTD Male Luer. These devices work together to create and maintain a mechanically and microbiologically closed system throughout the preparation, transportation, administration and disposal of hazardous drugs.
Commitment to the Safety of Oncology Pharmacists Treating cancer patients takes compassion. It shouldn’t take your life. With limited federal regulation for devices that reduce exposure to hazardous drugs, ICU Medical has taken on the responsibility of increasing clinical awareness of the dangers of exposure to these chemicals and improving safety throughout the oncology drug–handling process. ICU Medical is committed to providing easy-to-use needlefree solutions that generate less biohazardous waste and lower costs, while helping keep clinicians and patients safe. For more information on how to improve the accuracy, safety and efficiency of the hazardous drug–compounding process, visit us at www.icumed.com/oncology or call (866) 829-9025.
The Diana hazardous drug compounding system is the new standard in accuracy, safety, and efficiency for the automated sterile compounding of hazardous drugs.
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Corporate Profile 2013
Special Advertising Section Pharmacy Practice News
Medi-Dose/EPS For more than 40 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unitdose medications. Working with pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and bar-code your inventory. Inexpensive, Easy and Flexible: Because of its unique Cold-Seal technology, the Medi-Dose System is simple to use and requires no special in-service training or additional space. Medi-Cup blisters are available in a variety of sizes and styles to accommodate virtually any medication or storage system. Ultraviolet-inhibitant blisters provide additional protection from light. Plus, a combina-
tion of special blister plastics with aggressive tamper-evident label adhesives provide either six-month or one-year beyond-use dating for all your unit-dose packaging needs. Adapts to Your Needs: With our MILT 3.0 software, you can design your labels any way you want. In addition to being able to use graphics, special fonts, tall man lettering, shapes—even logos and symbols—to better identify your medications, MILT 3.0 has been designed to easily create bar codes with the information your bar code–enabled point-of-care and bar code medication administration systems require. Popular one-dimensional and two-dimensional bar code formats can be created with National Drug Code numbers, expiration dates, lot numbers and special codes. • Sealed units can be left in sheets or easily torn down to individual doses. • Medi-Cup Blisters are available in five sizes to accommodate the largest medications or the smallest storage spaces. • Lid-Label Covers are available in 8 1/2˝ × 11˝ laser sheets of 25 doses or 4˝ × 6 1/4˝ direct thermal sheets of five doses. • Laser Lid-Label Cover Sheets are available in 12 colors to facilitate color-coding of medications. • New Oval Blisters and Lid-Label Covers have been designed to fit your dispensing machines and storage cabinets. • All Medi-Cup Blisters and Lid-Label Covers work with our MILT 3.0 software, which can be used for all your bar-coding and labeling needs.
AT A GLANCE Address Medi-Dose/EPS 70 Industrial Drive Ivyland, PA 18974 Phone: (800) 523-8966 Fax: (800) 323-8966 Email: info@medidose.com Website: www.medidose.com
Products Medi-Dose® (Solid) and TampAlerT® (Liquid) Oral Unit-Dose Packaging Medi-Cup® PLUS packaging for extended beyond-use dating MILT® by Medi-Dose unit-dose and bar-coding software LiquiDose® labeling, IV additive and filtration products Nultraviolet® ultraviolet light inhibitant bags Steri-Dropper sterile ophthalmic dropper bottles High Alert and IV Line Tracing Labels Resealable bags, bottles and other pharmacy supplies and disposables
To get started, all you’ll need is: 1. Medi-Cup Blisters: 13 styles to suit your packaging needs. 2. Lid-Label Covers: Laser or Direct Thermal labels to seal the blisters. 3. MILT 3.0 software: Design and manage Lid-Label Cover printing. 4. Fil-Form and Roll-E-ZY: Aligns Lid-Label Covers to the Medi-Cup Blisters and ensures positive seal between labels and blisters. Inexpensive. Flexible. Tamper-Evident. If you are looking for a system to handle any or all of your unit-dose or bar-coding needs, then the Medi-Dose System is a perfect fit for you!
Special Advertising Section Pharmacy Practice News
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Pacira Pharmaceuticals, Inc. AT A GLANCE Address Pacira Pharmaceuticals, Inc. 5 Sylvan Way Parsippany, NJ 07054 Phone: (973) 254-3560 Fax: (973) 267-0060 Website: www.Pacira.com For more information on EXPAREL, visit www.EXPAREL.com For medical inquiries related to EXPAREL, contact Medical Information at medinfo@pacira. com or 1-855-RX-EXPAREL (1-855-793-9727)
Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products to address the needs of acute care practitioners and their patients. Pacira is driven by a dynamic workforce committed to optimizing patient care and satisfaction in the acute care setting, with a special focus on improving outcomes in postsurgical pain management. A Proprietary Drug Delivery Platform
The cornerstone of the Pacira product portfolio is DepoFoam®, a proprietary drug delivery platform designed to extend a medication’s duration of action without altering its molecular structure. The DepoFoam carrier matrix is made up of multivesicular liposomes that encapsulate a drug. Each chamber is separated by lipid membranes that naturally erode to release the drug over a desired period of time.
A First of Its Kind Single-Dose Local Analgesic In 2012, Pacira successfully launched EXPAREL® (bupivacaine liposome injectable suspension), the first and only DepoFoam-based local analgesic. Indicated for administration into the surgical site to produce postsurgical analgesia, a single dose of EXPAREL provides non-opioid pain control with reduced opioid requirements for up to 72 hours* without the need for catheters or pumps.1
Shifting the Postsurgical Pain Management Paradigm The launch of EXPAREL is bolstered by a robust Phase 4 clinical program, which builds a compelling case for EXPAREL as the foundation of an opioid-sparing multimodal postsurgical pain management regimen. Recently published national and regional retrospective analyses2,3 of more than 400,000 postsurgical patients receiving opioids concluded that patients who experienced opioid-related adverse events had both longer lengths of hospital stay and higher hospitalization costs. The company’s efforts are buoyed by a groundswell movement led by governmental and independent health care organizations to mitigate potentially fatal side effects related to the use of opioids by recommending a shift toward opioid-sparing pain regimens, especially in high-risk postsurgical patients.
Pacira recently presented data supporting the administration of EXPAREL via infiltration into the transversus abdominis plane to produce up to 72 hours of postsurgical analgesia. The company is also advancing its Phase 3 nerve block program studying the safety and efficacy of EXPAREL administered as a femoral or intercostal nerve block.
The Pacira Advantage Discovery, innovation and proprietary expertise are the hallmarks of the Pacira competitive advantage. The company not only holds the exclusive rights and expertise to DepoFoam, but owns the unique distinction of being the only company in the world with the ability to manufacture DepoFoam-based products, such as EXPAREL, on a large commercial scale. With steadily increasing demand and a growing list of potential clinical applications, Pacira and EXPAREL are poised to become vital fixtures in the postsurgical pain management arena. For more information about Pacira Pharmaceuticals Inc., visit www.pacira.com.
Important Safety Information for EXPAREL EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs, should occur during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk for developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following the administration of EXPAREL were nausea, constipation and vomiting. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy and hemorrhoidectomy procedures.
References 1. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Dis Colon Rectum. 2011;54:1552-1559.
Clinical Utility Across a Broad Range of Potential Applications
2. Oderda GM, Gan TJ, Johnson BH, Robinson SB. J Pain Palliat Care Pharmacother. 2013;27:62-70.
EXPAREL has broad applications across multiple surgical specialties, as well as in the anesthesiology arena.
3. Kessler ER, Shah M, Gruschkus SK, Raju A. Pharmacotherapy. 2013;33:383-391.
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Corporate Profile 2013
Special Advertising Section Pharmacy Practice News