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American Health Packaging American Regent, Division of Luitpold Pharmaceuticals, Inc. Baxalta BD CETYLITE Corporation Claris Lifesciences Inc. CutisPharma, Inc. Eagle Pharmaceuticals Equashield Follett Corporation ICU Medical, Inc. Medi-Dose/EPS Pacira Pharmaceuticals, Inc. Par Sterile Products, LLC Pharmacy Practice News Specialty Pharmacy Continuum West-Ward Pharmaceuticals Corp The profiles in this section were submitted and/or reviewed by the advertisers.
American Health Packaging Hospital pharmacies juggle many critical tasks. Patient safety is always a top priority. Operational efficiency is important, too, as pharmacies seek to provide barcoded med2550-A John Glenn A Ave. ications to support barcode medication Columbus, OH 43207 administration (BCMA) in the most efficient Phone: (800) 707-46 621 manner possible. American Health PackagWebsite: www.americanhealthpackaging.com ing (AHP) knows that in-house packaging is not typically a hospital’s core competency. Our industry-leading unit-dose (UD) line can help you to support bedside scanning in the most efficient manner.
AT A GLANCE
There are many benefits to utilizing AHP’s prepackaged UD items: Safety. AHP is a Current Good Manufacturing Practices (cGMP) facility, which ensures regulatory compliance. Our leadership and support staff are adept at manufacturing processes to ensure our products are packaged correctly and will scan accurately as intended. Efficiency. Hospitals are in the business of providing excellent patient care and are not typically as well suited to manage packaging operations. Buying AHP’s prepackaged UD items allows you to save time in receiving, managing and dispensing the medications your patients require to better focus your staff on other core patient care duties.
Aripiprazole tablets are new in unit dose and exclusively available from American Health Packaging.
Savings. Purchasing prepackaged UD items oftentimes provides a cost savings over in-house packaging when all infrastructure, technology and staff costs are considered. Liability Management. Packaging in the hospital setting shifts the legal burden of accuracy in packaging and dispensing to hospital associates and dispensing caregivers. Prepackaged product, however, maintains a legal burden to be correct as delivered to the hospital.
And New From AHP – Unit Dose Plus! Our customers gave us feedback that in addition to the higher-volume UD items typically available in the healthcare marketplace, they also require barcodes on the lowervolume products that hospitals dispense. In addition, smaller hospitals oftentimes prefer lower-count carton sizes for these types of items to better match utilization. To meet this need, AHP recently launched Unit Dose Plus! These select products will help to avoid burdensome in-house packaging in the same way our core line does. In addition, lower-count packaging sizes (e.g., 30UD) aid you to avoid both waste and returns. AHP is the only company offering a unique line of lower-volume UD items of this type.
Unit Dose Plus is a new line of difficult-to-find unit dose items recently launched by AHP.
AHP unit dose items support patient safety and operational efficiency in the hospital pharmacy.
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Special Advertising Section Pharmacy Practice News
American Regent, Division Of Luitpold Pharmaceuticals, Inc. Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo company, has experienced tremendous growth in the past few years with the addition of a new manufacturing facility to increase our manufacturing capacity. Our company consists of three divisions: American Regent, Animal Health and Osteohealth. We are pleased to offer innovative solutions to our customers’ needs. Our commitment to quality has helped us become a pioneer in both development and marketing of a wide variety of specialty drugs and medical devices.
Our Corporate Culture At Luitpold Pharmaceuticals, Inc., our culture plays an integral role in how we conduct our business. Our guiding principles are based on living a culture of QUALITY: Q – Quality U – Understanding/Urgency A – Accountability/Accuracy L – Leadership/Learning I – Integrity/Initiative T – Teamwork/Transparency Y – You!
AT A GLANCE One Luitpold Driv ve PO Box 9001 Shirley, NY 11967 Customer Service:: (800) 645-1706 Drug Information: (800) 645-1706 Mary Jane Helene ek President and CEO O
Our QUALITY culture represents shared beliefs, expectations and values. To our customers and business partners, QUALITY represents how we strive to understand their needs, deliver on commitments and be a trusted, value-added resource. Most importantly, QUALITY highlights that we know and value the fact that each individual employee, business partner and customer makes a significant contribution to the success of our company. QUALITY is evident in the commitment that we make, which continues long after we deliver products to our customers. We offer ongoing assistance and support, 24-hour drug information services, reimbursement and patient assistance programs for selected products, and a field force of highly trained sales representatives and clinical specialists who can help with any of your needs.
Our Mission The home of our newest manufacturing facility in New Albany, Ohio.
About American Regent
We are committed to bringing the healthcare community the highest-quality products and service. Our expanding product portfolio and continually increasing manufacturing capacity are designed to keep pace with the growing demands of the healthcare community.
American Regent, Inc. (American Regent) manufactures branded and generic specialty injectable products. Since 1967, American Regent has been dedicated to distributing parenteral products to hospitals, pharmacies, clinics and dialysis centers. American Regent offers a diverse portfolio of specialty injectable products, including IV iron, electrolytes and IV additives.
Luitpold Pharmaceuticals corporate headquarters in Shirley, N.Y.
Special Advertising Section Pharmacy Practice News
Corporate Profiles 2015
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Now Available! Our brand-new iPad app Scan here to download
BD Since our founding in 1897, BD has sought to make healthcare more effective, efficient and safer through innovation in areas that leverage the company’s clinical knowledge and expertise. Our focus on Pharmacy builds on the company’s legacy and commitment to supporting safety and efficiency. Our expanded portfolio, including solutions from the recent acquisition of CareFusion, allows our customers to manage quality improvements, compounding legislation changes and drug shortages with cost-reduction expectations. BD’s comprehensive portfolio of medication management and preparation products as well as pharmacy disposal solutions is specifically designed to enhance patient and healthcare worker safety, improve efficiencies and help facilitate compliance to existing guidelines and standards.
Patient Safety Despite best efforts, patient safety can be compromised during medication preparation and delivery. BD’s broad, innovative portfolio can help. BD Cato™ Medication Workflow Solutions is an innovative gravimetric-based, barcode verification-enabled workflow solution that enhances safety and workflow efficiency of preparation of IV medications by detecting wrong drug and dose errors in real time. BD Simplist™ Ready-to-Administer, Prefilled Injectables, supplied by BD Rx from its state-of-the-art pharmaceutical plant, are designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence,1 reducing the potential risk of medication error.
Healthcare Worker Safety OSHA reports that more workers are injured in healthcare than any other sector.2 BD offers solutions designed to prevent occupational exposure. BD PhaSeal™ Closed System Drug Transfer Device (CSTD) is an airtight and leak-proof CSTD that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, minimizing individual and environmental exposure to drug vapor aerosols and spills. The BD PhaSeal System has been clinically demonstrated to reduce healthcare workers’ exposure to hazardous parenteral medications from preparation to administration to disposal.3 SmartSite® VialShield Chemo System is an intuitive needle-free system indicated for reconstitution or dispensing of medications, including chemotherapy agents. BD Disposal Solutions include collectors in a variety of colors and size specifically designed to safely contain Sharps, Non-hazardous Pharmaceutical, Chemotherapy and Hazardous RCRA waste.
Workflow Efficiency and Cost Containment As healthcare evolves, there will be increasing demand for better outcomes, while still controlling costs. Workflow efficiency will play a critical role in your success—and BD can help you get there, today. BD Cato™ Medication Workflow Solutions help improve efficiency and contain cost by standardizing the medication preparation workflow, automating documentation and optimizing drug utilization to reduce drug waste. BD PhaSeal™ CSTDs prevent microbial ingress for up to 168 hours (within an ISO Class V environment following aseptic technique),4-8 thus protecting the sterility of drugs, which may enable drug vial optimization.9 Costly drugs that are still chemically stable may not have to be discarded after partial use, potentially leading to better drug utilization, lower overall cost of operations and reduced waste. The Chemo Safety System provides hospitals with a cost-effective solution to help protect healthcare workers from exposure to hazardous drugs. The system’s bonded Texium syringes and IV administration sets with no component assembly required, help to streamline workflow throughout the continuum of care. BD Simplist™ (see above).
Special Advertising Section Pharmacy Practice News
AT A GLANCE 1 Becton Drive Franklin Lakes, NJ J 07417 Phone: (201) 847-6800 Website: www.bd..com
Products Medical supplies, devices, laboratory instruments, antib bodies, reagents and diagnostic pro oducts
Vincent A. Forle enza
About BD
Chairman, Chief Executive Officer and President
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes.
About BD Rx Inc. BD Rx Inc. is a wholly-owned subsidiary of BD (Becton, Dickinson and Company). Based on a strategic decision and long-term investment in the acute care generic injectables category BD applied its expertise in manufacturing excellence, high-quality products and service delivery to the manufacturing of high-demand generic pharmaceuticals. This is a logical extension of BD’s demonstrated 12-year history of continuous, reliable supply of our Flush platform and existing leadership position in glass prefillable syringe manufacturing and should be seen as an addition to our current pharmaceutical offerings, as it will enable us to offer a broader range of treatment options for customers. With the BD Simplist™ ready-to-administer, prefilled injectables, BD Rx is aiming to redefine injectable drug administration practice. We envision safe patient care and efficient clinical applications and believe this is the future of injectables. For more information, please visit www.bdrxinc.com. BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. ©2015 BD. 07/15 MSS0649-1 BDRx0166-1
References 1.
Potter P, Perry A, Stockert P, Hall A. Vial & Syringe Injection Steps. Basic Nursing, 7th ed. (St. Louis, MO: Mosby, 2010) 442-447.
2. United States Department of Labor. Occupational Safety and Health Administration (OSHA). “Safety and Health Topics.” https://www.osha.gov/SLTC/healthcarefacilities. 3. Wick C, Slawson MH, Jorgenson JA, et al. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J HealthSyst Pharm. 2003;60(22):2314-2320. 4. McMichael D, Jefferson D, Carey E, et al. Utility of the PhaSeal closed system drug transfer device. Am J Pharm Benefits. 2011;3(1):9-16. 5. Carey ET, Forrey RA, Haughs D, et al. Second look at utilization of a closedsystem transfer device (BD PhaSeal). Am J Pharm Benefits. 2011;3(6):311-318. 6. Sanchez-Rubio J, Vargas B, Sanchez-Rubio L, et al. CSTDs and microbiological stability of cytostatics. Hosp Pharm Eur. 2013;69, July/August. 7. Wickham Laboratories Limited. Hampshire, UK. August 2013. Prevention of Microbial Ingress Into Vials and IV Bags Using the PhaSeal System. 8. Wickham Laboratories Limited. Hampshire, UK. Sept 2013. Microbial Integrity Testing (Whole Immersion) of BD PhaSeal Protectors. 9. Edwards MS, Solimando DA, Grollman FR, et al. Cost savings realized by use of the PhaSeal® closed-system transfer device for preparation of antineoplastic agents. J Oncol Pharm Pract. 2013;19(4):338-347.
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CETYLITE Corporation Aging and rising obesity rates in the United States mean more patients with difficult airways to intubate arrive in hospitals each year. Obese patients, as well as elderly and chronically ill patients, challenge health care teams to clear and keep their airways open so procedures can begin. Cetacaine Topical Anesthetic Spray enables gastroenterologists, anesthesiologists, nurses and emergency department physicians to control gagging and pain, and successfully manage airways, by spraying the anesthetic directly into the throat. The anesthetic— effective on mucous membranes (except the eyes)—helps prepare patients for procedures such as endoscopies, bronchoscopies and transesophageal echocardiograms. Due to Cetacaine’s rapid onset of 30 seconds, efficacy and usefulness in a wide variety of procedures, it has become a must-have product for hospitals.
Cetacaine: The Gold Standard in Topical Anesthetics The Cetacaine legacy began more than 50 years ago, when the brand’s breakthrough combination of Benzocaine 14.0%, Butamben 2.0% and Tetracaine HCl 2.0% pioneered in the anesthetics field to achieve new levels of patient comfort and safety. Dr. Robert A. Berman, the creator of several ubiquitous Berman airways, “provided input into the development of Cetacaine Spray to adequately suppress the gag reflex for use with his inventions,” said Anthony Moreira, Business Development Manager and National Account Manager, Cetylite Industries, in Pennsauken, N.J. This unique mixture of three ingredients was clinically proven to be more effective than any single topical or combination of two ingredients, reported an Anesthesiology Review w study.1 Cetacaine produced the most intense anesthetic activity that lasted the longest time, and had the most patients experiencing a total blockade. Moreover, Mr. Moreira added, Cetacaine does not cause hypotension or respiratory depression like some other topical anesthetics, and has a long history of safety when used as directed. Another unique element of Cetacaine spray is the malleable stainless steel cannula, which precisely aims the spray. Readily available replacement cannulas help reduce the risk for cross-contamination. Because of its low price, many hospitals use it as a disposable that they simply replace. The cannula can also be put in an autoclave to be sanitized and disinfected. This flagship product of Cetylite Industries is available in three forms: spray, for hospital and dental applications; liquid, for dental scaling and root planing procedures below the gum line; and gel, for
anal or vaginal procedures, or for needle-phobic dental patients.
Raising the Care Bar Today When Cetacaine is used in conjunction with propofol or other drugs in that class, “it allows the anesthesiologist to use less of that anesthetic, and it requires less sedation. Therefore, we see an uptick in its use today for these purposes,” Mr. Moreira explained. “This leads in turn to increased patient safety, an overall more pleasant experience, and potentially higher patient satisfaction scores, which can benefit the hospital too.”
AT A GLANCE 9051 River Road Pennsauken, NJ 08110 Phone: (856) 665--6111 Fax: (856) 665-54 408 Website: www.cetylite.com
Products Cetacaine Topical Anesthetic Spray Cetacaine Topical Anesthetic Liquid Clinical Kit Cetacaine Topical Anesthetic Gel
A ‘Patient-First’ Culture of Innovation Continues Cetacaine is the flagship brand of Cetylite Industries, which has specialized in the manufacturing of sprays, liquids and gels for over 60 years that are widely distributed to the wholesale drug, medical and dental fields. Cetacaine is manufactured in the U.S.A. at Cetylite’s corporate headquarters in Pennsauken, N.J. Besides the prescription topical anesthetic, the company’s brands include concentrated infection prevention products, plus complementary dental and medical products. As health care evolves, Cetylite continues to innovate. The company has active contact with doctors, dentists, pharmacists and PhDs to keep it on the cusp of medical and pharmaceutical advances. “Patient safety and comfort is at the forefront of what we do—that is, to perform to high standards and earn the trust of health care professionals, while being open to internal and external new ideas to innovate and evolve our brands,” Mr. Moreira said.
Reference 1.
Adriani J, Mehta D, Naraghi M. Mixtures of local anesthetics: the effectiveness of combinations of benzocaine, butamben, and tetracaine topically. Anesthesiology Review. 1981;12:15-19.
The family of Cetacaine topical anesthetic products.
Special Advertising Section Pharmacy Practice News
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Claris Lifesciences Inc. A Pure Play Injectables Company Committed to bring world-class injectables that cater to the needs of hospital markets in the United States.
AT A GLANCE 1445 US HIGHWAY 130 North Brusnwick, NJ J 08902 Tel: (732) 422-9100 Website: www.us.clarrislifesciences.com Email: Kunal.Shah@ us.clarislifesciences.c com
Claris Lifesciences Inc. is a pure play injectables company involved in the marketing and distribution of generic injectables in the United States. The company is a wholly-owned subsidiary of Claris Lifesciences Ltd., India, engaged in manufacturing and marketing its products worldwide.
The company, headquartered in North Brunswick, N.J., caters to the growing and unmet demands of hospital and medical professionals for injectable products. Claris Lifesciences Inc. aims to become one of the most respected and reliable injectables companies in the United States, through our focus on bringing a large portfolio of high-end quality and technologicallycomplex injectable products to market. Our deep knowledge of regulatory issues, combined with an engaged sales and marketing team, ensures seamless product availability and after-sales services to our esteemed customers. Moreover, we have established relationships with top-notch and experienced channel partners to ascertain customer needs and guarantee their satisfaction at every step of the value chain. We are one of a few players to have launched technologically advanced, complex-to-manufacture products in premix bags, using both non-PVC and PVC materials. Our other technological platforms include glass vials and ampules. Having established a strong team to address customer needs personally and provide prompt and satisfactory services, we place a major emphasis on the quality of our products. As such, our products are manufactured at Current Good Manufacturing Practices (cGMP)-compliant facilities and are inspected and approved by the FDA in the United States, the Medicines & Healthcare products Regulatory Agency (MHRA) in the U.K., the Therapeutic Goods Administration (TGA) in Australia and the Gulf Cooperation Council (GCC) in Saudi Arabia, U.A.E. and other countries in the Middle East.
State-of-the-art manufacturing facility in India capable of innovating and producing high-end, complex products. Our commitment to quality is manifested through unique products developed by our competent research and development team, which strives to introduce innovative generic injectable products and valueadded delivery systems. Novel Drug Delivery System (NDDS) remains a primary focus for Claris, where we demonstrate our expertise in developing niche injectable technologies across multiple delivery systems. Relying on our experienced workforce to manage product development has been instrumental in our growth. Our world-class manufacturing facility in India is designed to produce complex and niche aqueous and lipid-based products in glass containers and non-PVC/PVC bags. Having received India Manufacturing and Quality Excellence Awards from Frost & Sullivan and the Indian Drug Manufacturers’ Association, respectively, for several years testifies to our focus on quality and excellence.
Possessing a broad portfolio of injectables in the United States and growing with time. Our products are manufactured and marketed across various high-end technological platforms, especially in premix bags, making us one of the few companies to offer such niche products. We are committed to bringing a large product line to help counteract the acute shortage of injectables in the current market. A growing portfolio of injectables—13 Abbreviated New Drug Applications (ANDAs) approved and 26 under approval (as of May 2015)— underscores our dedication to saving human lives through product innovation.
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Our products include Ciprofloxacin Injection - USP, Fluconazole Injection - USP, Furosemide Injection - USP, Levofloxacin Injection, Metoprolol - USP, Metronidazole Injection - USP, Norepinephrine
Bitartrate Injection - USP, Ondansetron Injection - USP and Levofloxacin - Premix Bag. We are planning to launch Fluconazole Injection - 50 mL PVC bag, and we are the only supplier with this product in a Premix bag delivery system.
Ensuring a stringent, compliant environment in line with U.S. FDA requirements, and assuring customer services at all times. Our considerable regulatory capabilities are in line with the requirements of the FDA, and we follow strict procedures on product testing and management to ensure global compliance. Our established sales, marketing and distribution network enables us to reach a large number of customers, doctors, medical institutions and hospitals. The strength of the sales and marketing team at Claris lies in trained and committed manpower to reach a large customer base. We ensure sufficient inventory to address shortages and meet unplanned customer needs. We reach a wider audience through active participation in conferences and seminars, enabling us to stay abreast of latest industry trends, gain competitor insights, build key industry contacts and strengthen relationships with customers.
Committed to continuously scale up efforts and resources in bringing innovative and affordable medical care products to patients in the United States.
Special Advertising Section Pharmacy Practice News
CutisPharma, Inc. CutisPharma, Inc. is a specialty pharmaceutical company whose mission, in its 17 years of operation, has been to improve the quality, safety and convenience of compounded pharmaceutical products. CutisPharma’s product line, FIRST® Unit-of-Use Compounding Kits, is designed to improve accuracy and quality for pharmacists who need to compound a prescription for drugs for which there is no FDA-approved, commercially available alternative.
CutisPharma Upholds the Highest Standards of Manufacturing Quality and Facilitates Pharmacist Compliance With Regulations Governing Compounding • All CutisPharma products are manufactured in compliance with cGMP regulations. Our facility, like those of each of our pharmaceutical contract manufacturers, is subject to regular FDA inspections, in addition to rigorous third-party audits on a recurring basis. • FIRST® Compounding Kits allow pharmacists to comply with the requirements for compounding under Section 503A and the USP <795> guidelines for nonsterile compounded preparations. All APIs used in FIRST® Kits are sourced from FDA-registered facilities, and API Certificates of Analysis are independently verified by our own analytical testing for release. Beyond-use dates are established by stability testing, conducted by independent analytical laboratories commissioned by CutisPharma, to verify potency and purity. • Adverse events and product complaints received by CutisPharma or its affiliated parties are actively tracked and monitored, and MedWatch safety reporting is performed in accordance with FDA regulations.
Using CutisPharma’s FIRST® Compounding Kits Complements Managed-Care Efforts To Restrict Utilization of Compounded Medications to Those Patients Who Truly Need a Compounded Product • CutisPharma FIRST® Compounding Kits focus on a small cohort of patients who cannot take and/or are not well served by existing, commercially available therapies and have the need for a quality compounded product. • The single NDC number for each FIRST® Kit facilitates implementation of controls to track spending and utilization, and reduces the likelihood of variability in claims. • Claims data show that FIRST® Kit average pricing is the same as that of many generic products, and in some cases lower than billed claims for comparable, extemporaneously compounded prescriptions.
Our Product Portfolio Vancomycin Oral Solution Prescription Compounding Kits FIRST® – Vancomycin Compounding Kits make pharmacy compounding easier. With FIRST® – Vancomycin, the oral solution is compounded within a minute by adding the pre-measured white grape-flavored solution to the pre-weighed vancomycin hydrochloride powder bottle and shaking it. The pleasant white grape flavor helps mask the typical bitterness of vancomycin hydrochloride. These compounding kits are provided in two concentrations: 25 mg/mL (5 and 10 oz. sizes), and 50 mg/mL (5, 7 and 10 oz. sizes).
Omeprazole/Lansoprazole PPI Compounding Kits CutisPharma, Inc. also offers FIRST® – Omeprazole and FIRST® – Lansoprazole Oral Suspension Compounding Kits. These kits help pharmacists quickly dispense compounded prescriptions containing widely used proton pump inhibitors (PPIs). Traditionally, compounded omeprazole and lansoprazole oral suspensions can take up to several hours to prepare and have an unpleasant 841 Woburn Street taste. With FIRST® – Omeprazole and FIRST®– Wilmington, MA 01887 Lansoprazole, pharmacists need only add the Contact: Les Swarrtz, Director, Trade liquid suspension to the powder, shake and then Relations within minutes can dispense to the patient with Phone: (781) 935-8 8141 ext. 125 improved flavoring.
AT A GLANCE
Compounding Kits for Often-Filled ‘Magic Mouthwashes’ CutisPharma, Inc. offers convenient kits that make dispensing some of the most commonly prescribed suspensions a simple, easy process. Commonly known as ‘Magic Mouthwashes,’ the products include: • FIRST® – Mouthwash BLM (Benadryl®, lidocaine and Maalox®) in two sizes • FIRST® – Mouthwash BXN (diphenhydramine, lidocaine and nystatin) • FIRST® – Duke’s Mouthwash (diphenhydramine, hydrocortisone and nystatin) • FIRST® – Mary’s Mouthwash (diphenhydramine, hydrocortisone, nystatin and tetracycline) Each FIRST® Kit has everything needed to compound individual prescriptions quickly and easily. Each kit includes pre-weighed powders and a pre-measured suspension; pharmacists need only to add the powders to the liquid suspension, shake and dispense. FIRST® products save dispensing time and can be compounded by the pharmacist while the patient waits, thus increasing customer satisfaction. Using FIRST® Mouthwash kits, the pharmacist can compound a prescription faster than those prepared in the conventional way.
Email: lswartz@cu utispharma.com Website: www.cuttispharma.com
FIRST® Unit-of-U Use Compounding Kits FIRST® – Vancomy ycin 25 mg Solution: 5, 10 oz. FIRST® – Vancomy ycin 50 mg Solution: 5, 7, 10 oz. FIRST® – Omepraz zole Suspension: 3, 5, 10 oz. FIRST® – Lansopra azole Suspension: 3, 5, 10 oz. FIRST® – Mouthwa ash BLM: 4, 8 oz. FIRST® – BXN Mou uthwash FIRST® – Duke’s Mouthwash FIRST® – Mary’s Mouthwash FIRST® – 10% Hydrrocortisone in Ultrasound Gel FIRST® – Progeste erone Vaginal Suppository USP: 25, 50, 100, 200, 400 mg FIRST® – Testosterrone MC: 2% Testosterone in White e Moisturizing Cream Base FIRST® – Testosterrone: 2%
Growing Portfolio Will Further Serve Compounding Needs The CutisPharma Kit portfolio is growing to meet marketplace needs for better quality and more convenience in compounding. Complementing our current product line of 24 different marketed prescription compounding kits, CutisPharma is aggressively investing in R&D to bring additional products in its pipeline to market. For further details about CutisPharma and its product portfolio, please visit www.cutispharma.com. For more information regarding product enhancements, events and the latest news, be sure to follow CutisPharma on social media! www.facebook.com/CutisPharma www.twitter.com/CutisPharma www.youtube.com/CutisPharma
FIRST® – Omeprazole and FIRST® – Lansoprazole Suspension Unit-of-Use Compounding Kits in 3, 5 and 10 oz. sizes.
Special Advertising Section Pharmacy Practice News
Corporate Profiles 2015
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Eagle Pharmaceuticals Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable therapeutics, primarily in the areas of critical care, 50 Tice Boulevard, Suite S 315 orphan diseases and oncology. Our goal Woodcliff Lake, NJ 0 07677 is to improve the lives of customers and patients with optimized formulations Website through the 505(b)(2) regulatory http://eagleus.com pathway. We develop proprietary enhancements to FDA-approved drugs while adhering to the principles of innovation, quality, integrity and leadership.
AT A GLANCE
Making Improvements for Patients and Health Care Professionals We recognize that many injectable products used in acute care settings have suboptimal characteristics. These products may not fully meet the needs of patients and health care professionals. That’s why we work diligently to create enhanced formulations that address these issues. For instance, some drug formulations have inherent inefficiencies when it comes to preparation. These can include requiring multistep preparation (labor- and time-intensive), the need for a large volume of diluent and the use of numerous vials in an emergency situation.
Our Products At Eagle, we believe that our products have the potential to create a new standard for treatment. Our optimized reformulations of injectable drugs aim to: • Enable faster reconstitution and administration in most cases • Reduce the fluid volume infused into patients, which may reduce the potential for complications relating to fluid-volume overload • Reduce drug infusion time • Optimize dose regimen
Improving Malignant Hyperthermia Treatment A prime example of how Eagle has improved an area of treatment is RYANODEX® (dantrolene sodium) for injectable suspension. Our novel formulation of dantrolene sodium is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures.1,2 A major issue with conventional dantrolene sodium products is that they are often time-consuming to reconstitute and administer.3,4 Usually several members of the operating room staff are employed in the reconstitution process.2 That’s because a full initial dose for a 100-kg patient may require the reconstitution of 12 or more vials of the conventional dantrolene sodium product.3,4 This can pose a serious problem as the risk for complications increases by over 30% for every 20-minute delay in treatment.5 That’s where RYANODEX® is different: It is formulated to be fast to reconstitute and administer a loading dose.2 RYANODEX® is unlike conventional dantrolene sodium products; one vial provides a full loading dose (2.5 mg/kg) for most patients.1,6 It can be reconstituted and administered by just one health care professional in less than one minute.1,2 This creates the potential to reduce complications resulting from treatment delays.1,2,5,7
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Indication RYANODEX® is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures and for prevention of malignant hyperthermia in patients at high risk.
Important Safety Information RYANODEX® (dantrolene sodium) for injectable suspension is not a substitute for appropriate supportive measures in the treatment of malignant hyperthermia, including: • Discontinuing triggering anesthetic agents • Increasing oxygen • Managing metabolic acidosis • Instituting cooling when necessary • Administering diuretics to prevent late kidney injury due to myoglobinuria (the amount of mannitol in RYANODEX® is insufficient to maintain diuresis) Precautions should be taken when administering RYANODEX® preoperatively for the prevention of malignant hyperthermia, including monitoring vital signs, avoiding known triggering agents, and monitoring for early clinical and metabolic signs of malignant hyperthermia that may indicate additional treatment is needed. The administration of dantrolene sodium is associated with loss of grip strength and weakness in the legs, as well as drowsiness, dizziness, dysphagia, dyspnea and decreased inspiratory capacity. Patients should not be permitted to ambulate without assistance until they have normal strength and balance. Care must be taken to prevent extravasation of RYANODEX® into the surrounding tissue due to the high pH of the reconstituted RYANODEX® suspension and potential for tissue necrosis. This is not a complete list of potential adverse events associated with RYANODEX® for injectable suspension. Please see full Prescribing Information for a complete list. To report negative side effects associated with RYANODEX®, please call (855) 318-2170. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/ medwatch or call (800) FDA-1088. For more information about Eagle Pharmaceuticals, visit Eagleus.com. To see the RYANODEX® difference, visit Ryanodex.com.
References 1.
RYANODEX [package insert]. Woodcliff Lake, NJ: Eagle Pharmaceuticals, Inc.; 2014.
2. Data on file. Eagle Pharmaceuticals, Inc. 3. Dantrium Intravenous [package insert]. Rochester, MI: JHP Pharmaceuticals, LLC; 2008. 4. Revonto [package insert]. Louisville, KY: US WorldMeds, LLC; 2011. 5. Riazi S, Larach MG, Hu C, et al. Malignant hyperthermia in Canada: characteristics of index anesthetics in 129 malignant hyperthermia susceptible probands. Anesth Analg. 2014;118(2):381-387. 6. Managing an MH crisis. Malignant Hyperthermia Association of the United States website. http://www.mhaus.org/healthcareprofessionals/managing-acrisis. Accessed June 10, 2015. 7. Brandom BW. Cases from the North American MH Registry/MHAUS [1992 through 2012].
Special Advertising Section Pharmacy Practice News
Equashield Hazardous drugs, such as chemotherapy antineoplastic agents, present an occupational hazard to those who handle them. Occupational exposure to hazardous drugs can lead to both acute and chronic effects, ranging from skin irritation to more serious reproductive complications and even some forms of cancer. The Centers for Disease Control and Prevention’s (CDC’s) National Institute for Occupational Safety and Health (NIOSH), the US Pharmacopeia (USP) Chapter <797>, the recently added USP Chapter <800>, the American Society of Health-System Pharmacists (ASHP), the International Society of Oncology Pharmacy Practitioners (ISOPP) and the Oncology Nursing Society (ONS) have all recognized and made recommendations to take additional measures based on the potential health risks associated with occupational exposure to hazardous drugs. While the dangers are often invisible to the naked eye, common practice when handling hazardous drugs creates multiple routes of exposure that can lead to contamination of the environment despite the use of standard personal protective equipment (PPE), Biological Safety Cabinets and associated handling procedures. Since hazardous drugs have adhesive characteristics, traces can often be carried out of the workspace, and are often found on unlikely surfaces such as keyboards, doorknobs and elevator buttons, outside of the designated areas for drug compounding and administration. NIOSH defines closed system transfer devices (CSTDs) as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system,” and the FDA recently created the ONB category that clears devices as “closed antineoplastic and hazardous drug reconstitution and transfer system.” CSTDs, which typically encapsulate the syringe and vial into one closed system, provide a vital layer of protection against hazardous drug exposure. In fact, studies have shown that using a CSTD has significantly reduced the levels of surface contamination in labs, pharmacies and hospitals.1
However, not every CSTD provides the same level of protection, and not every CSTD is equally effective at closing off the major routes of exposure. Equashield’s closed systems are among the 99 Seaview Blvd. only CSTDs in the world cleared under the Port Washington, NY 11050 FDA’s ONB code, confirming that they meet the Phone: (516) 684-8200 Website: www.equ uashield.com requirements of a truly closed system. Equashield’s first- and second-generation systems are also the first to be substantiated to Products FDA and defined in FDA-cleared labeling as preEQUASHIELD® II - Closed System venting microbial ingress up to 7 days. Transfer Device Equashield’s system was created with a simpliFor medical inquirries related to fied, elegant design that provides ease of use, Equashield, contac ct Tammy Balzer, and covers more routes of exposure to hazardDirector of Clinica al Services USA ous drugs. tammyb@equashield.com One of the major routes of exposure, the syringe plunger, is uniquely covered by Equashield’s system. Studies show that a typical standard syringe plunger is contaminated many times after a drug transfer when it is drawn back out. When pharmacists use standard syringes, and even when they use standard syringes that are found in other closed systems, they can be exposed to hazardous drugs due to plunger contamination, and they risk major spills, as these plastic syringes can be pulled out of the barrel completely. Equashield’s flagship CSTD, EQUASHIELD® II, introduced in late 2013, uses a metal plunger instead of a standard plastic plunger. The metal rod runs through the center of the barrel, and is fully encapsulated and sealed in. This design prevents plunger contamination and it cannot be removed from the barrel, so it also prevents potential spills. The metal rod plunger cannot come in contact with the inner walls of the barrel, and therefore, remains uncontaminated by the barrel sides. In this way, Equashield’s CSTD is the only CSTD to cover this major route of exposure by minimizing plunger contamination to undetectable levels.2 Equashield developed its fully encapsulated syringe system with an internal, self-contained pressure equalizer and sterile air chamber found within the syringe barrel. This feature allows for a more streamlined design that is intuitive for those using it in the compounding, transferring and administration of hazardous drugs. Equashield’s CSTD design also innovates with its connection mechanism. Whether connecting the syringe to a vial adapter, infusion bag or infusion tubing, each Equashield adapter and syringe are designed for safe and easy connections made in one smooth motion. Committed to protecting healthcare professionals, Equashield’s devices are qualified to the highest industry standards. Equashield’s CSTD is simple, with an elegant design and ease of use, which make it the CSTD of choice by hundreds of healthcare facilities in North America, Europe, Asia-Pacific, and the Middle East. Equashield is a privately held medical device company with more than 140 employees. With offices located in Port Washington, N.Y., and its manufacturing facilities located internationally, the company has a growing global footprint, and is committed to continuing to protect healthcare professionals from exposure to hazardous drugs.
AT A GLANCE
References 1.
www.ncbi.nlm.nih.gov/pubmed/19965949.
2. http://opp.sagepub.com/content/early/2014/03/05/1078155214526428.full. pdf+html.
Special Advertising Section Pharmacy Practice News
Corporate Profiles 2015
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Follett Corporation AT A GLANCE 801 Church Lane Easton, PA 18040 Phone: (800) 523-93 361 or (610) 252-7301 Website: www.folletttice.com
Products Follett Upright Medical-Grade Laboratory and Pharrmacy Refrigerator Follett Upright Medical-Grade Laboratory and Pharrmacy Freezers Follett Performance Plus Undercounter Medic cal-Grade Refrigerators and Freezers Follett Countertop M Medical-Grade Refrigerators and Freezers
To ensure temperature integrity for pharmaceuticals, hospitals are using medicalgrade refrigerators and freezers in central pharmacy and at key points of care. The CDC urges the use of medical-grade refrigeration for vaccines, and The Joint Commission and pharmacy directors nationwide advocate the move to highperformance units to better protect medication efficacy and enhance patient safety. Moreover, hospital pharmacies can have as much as $500,000 of medication inventory on hand that requires maintaining consistently cold temperatures within a narrow range. Medicalgrade refrigerators and freezers from Follett are essential to safeguard not only these medications, but also irreplaceable substances that go beyond dollar value, such as blood products, mothers’ milk and investigational drugs.
Superior Medical-Grade Refrigerators And Freezers Follett medical-grade refrigerators and freezers are distinctive in maintaining precise temperature control. Heavyduty compressors with forced-air refrigeration deliver consistent, cabinet-wide temperatures and quick recovery after door openings. Audible and visual temperature alarms provide the highest safeguards for valuable stored products, and all Follett refrigerators and freezers are compatible with third-party medication-dispensing electronic locking systems. A dedicated third-party probe port allows pharmacies to easily connect to their facility’s central monitoring system. For greater accuracy in measuring product temperature, Follett places its refrigerator temperature probes in glycerin and water solutions to replicate actual temperatures inside medications, and that temperature is displayed digitally on the outside of doors. The upright refrigerators and freezers feature an industry-exclusive back plenum air distribution system that flows cold air directly to six different levels of the cabinet, wherever shelves or drawers are. This powerful air distribution system provides a ±1° centigrade performance throughout the storage area. Heavy-duty glass doors
High-performance refrigerators and freezers save workspace and add convenience.
provide full view and are energy efficient; their low-E coating cuts energy loss by 30% to 50%. A top-mounted modular refrigeration system makes servicing easy. All Follett refrigerators and freezers are constructed of stainless steel inside and out for durability and easy cleaning. They are equipped with magnetic gaskets and self-closing doors to ensure proper seals and heavy-duty hinges to ensure long life. “These technological benefits help compensate for the fast-paced real-life working conditions of health-system pharmacists and healthcare professionals, who have more to do than they can possibly get done,” says Cindy Fitton, Product Marketing Manager-Healthcare, Follett Corporation, Easton, Pa. Follett’s medical-grade refrigeration portfolio includes undercounter, upright, and countertop refrigerators and freezers (a new countertop freezer was recently launched) for use in hospital and health-system pharmacies, on patient floors, in the NICU and in remote settings such as ambulatory centers.
Portfolio Expands With New Countertop Freezer The new Follett countertop freezer is the only true forced-air medical-grade countertop freezer in the market today. Available in one- and two-cubic foot models, the freezer fits easily on standard 24-inch deep counters. Shallow shelf depth gives superior visibility and easy reach to stored products. The freezer is an ideal space-saving solution for hospitals wanting to store vaccines and other frozen medications near patient-care areas.
Educational Leadership and Dedication To Outstanding Support After the Sale Follett displays educational leadership by running extensive service seminars at no charge around the United States to train hospital technicians on refrigerators, freezers and other Follett equipment. The company also has training modules online, and live tech support 12 hours a day, seven days a week. “Follett lives by its mission to deliver on what matters most to pharmacists—consistent cabinet-wide temperatures and quick recovery after door openings. The company has innovated for 67 years and continues to raise the performance bar,” Ms. Fitton added.
Comprehensive line of medical-grade refrigerators and freezers are designed to meet critical demands of hospitals and health systems.
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Corporate Profiles 2015
Special Advertising Section Pharmacy Practice News
ICU Medical, Inc. ICU Medical helps you maximize clinician and patient safety with easy-to-use needlefree technology designed to minimize exposure to hazardous drugs and maintain drug sterility. These needlefree solutions include the world’s first needlefree closed system transfer device (CSTD) FDA 510(k) cleared for both pharmacy compounding (ONB) and patient administration (FPA) applications, as well as a CSTD with the lowest implementation cost of any other on the market.
Minimize Exposure to Hazardous Drugs While Maximizing Medication Safety Keep yourself safe from exposure to hazardous drugs and maintain drug sterility with our complete line of needlefree safehandling solutions. These convenient, needlefree CSTDs and automated drug compounding systems maintain mechanically and microbiologically closed systems to help you stay safe and in compliance with recommended guidelines during the sterile preparation of IV medications.
The Most Cost-Effective Way To Start Protecting Yourself Today
AT A GLANCE
With the lowest implementation cost, ICU 951 Calle Amanece er Medical’s ChemoClave® CSTD makes the deciSan Clemente, CA A 92673 sion to start improving IV medication safety a Phone: (800) 824-7890 whole lot easier. The easy-to-use ChemoClave Fax: (949) 366-83 368 CSTD is comprised of a selection of vial adaptWebsite: www.icumed.com ers that mechanically prohibit the transfer and escape of environmental contaminants, as well as a selection of needlefree bag spikes and primary add-on and administration sets. ChemoClave also generates less biohazardous waste than competing systems and helps keep you and your patients safe during every step of the hazardous drug handling process.
Enhance Your Pharmacy Workflow Efficiency should not have to come at the expense of clinician and patient safety. That’s why we developed a full line of safe handling solutions that complement your workflow, not complicate it. Our needlefree CSTDs help speed preparation times by eliminating the need to assemble multiple components, and user-controlled automated compounding systems with integrated barcode scanning help increase the accuracy and speed of data entry while improving workflow traceability.
Setting a Whole New Standard for Hazardous Drug Safety With the ChemoLock™ needlefree CSTD, it has never been easier to keep yourself safe from exposure to hazardous drugs. ChemoLock’s intuitive and easy-to-use system locks with a single motion and an audible click, ensuring a safe and secure connection to minimize exposure to hazardous drugs and protect the patient preparation from contamination. ChemoLock is also the first needle-free CSTD to receive FDA 510(k) clearance under the ONB product code, keeping you and the drugs you mix safer while ensuring safe-handling compliance.
With the lowest cost to implement of any CSTD, ChemoClave makes the decision to start improving IV medication safety easier.
Automate Your Sterile Drug Compounding Process The Diana™ hazardous drug compounding system lets you reduce the risk for exposure to hazardous drugs while maintaining drug sterility and minimizing physical stress to pharmacists and technicians. Using many of ICU Medical’s proven ChemoClave closed system components, Diana fits under the hood of your existing biologic safety cabinet to protect clinicians from exposure to hazardous drugs and accidental needlesticks.
Commitment to the Safety of Oncology Pharmacists Bringing new and innovative technologies to oncology pharmacists and technicians is at the core of who we are and what we do. We are committed to providing easy-to-use needlefree solutions that generate less biohazardous waste and lower costs while helping keep clinicians and patients safe. Only ICU Medical gives you simple, safe, and secure needlefree closed systems; CSTDs; and automated drug compounding systems to help enhance health care worker safety and comply with OSHA, NIOSH, ASHP, ISOPP, ONS, APHON and USP <797>. Contact us today to learn how we can help you improve your IV medication safe handling process by calling (800) 824-7890 or by visiting www.icumed.com. With ChemoLock, one click is all it takes to minimize exposure to hazardous drugs and maximize medication safety.
Special Advertising Section Pharmacy Practice News
Corporate Profiles 2015
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Medi-Dose/EPS AT A GLANCE 70 Industrial Drive Ivyland, PA 18974 Phone: (800) 523-89 966 Fax: (800) 323-8966 6 Email: info@medidos se.com Website: www.medid dose.com
For more than 40 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory.
Medi-Dose began in 1971, when Milton BraverProducts man, a former pharmaceutical company territory manager, formed his own company. Robert Medi-Dose® (Solid) a and Braverman, President and Director of Market® TampAlerT (Liquid)) Oral ing, remembers, “My dad was acutely aware Unit-Dose Packaging g of the requirements of hospital pharmacy. He Medi-Cup® PLUS pac ckaging for saw the need for inexpensive, manual unit-dose extended beyond-usse dating packaging allowing hospitals to convert from ® traditional dispensing. He developed systems to MILT by Medi-Dose unit-dose and package, handle and dispense predetermined bar-coding software e amounts of medication so they would be accesLiquiDose® labeling, IV additive and sible for one regular dose.” filtration products Although familiar today, launching the idea of Nultraviolet® ultravio olet light unit dose was a huge problem the new company inhibitant bags faced. “We were one of the pioneers, the innovators promoting unit dose in hospitals,” Robert Steri-Dropper sterile e ophthalmic Braverman recalled. “Due in part to Medi-Dose’s dropper bottles educational efforts, pharmacists and nurses High Alert and IV Lin ne Tracing Labels accepted the validity of unit dose.” Inexpensive, Easy and Flexible: Because of Resealable bags, botttles and other its unique Cold-Seal technology, the Medi-Dose pharmacy supplies and a disposables System is simple to use and requires no special in-service training or additional space. MediCup 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 combination of special blister plastics with aggressive tamper-evident label adhesives provides either six-month or one-year beyond-use dating for all your unit-dose packaging needs. • 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.
Using our MILT 4 software, you can label and identify all your medication, complete with graphics and a bar code.
• 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 4 software, which can be used for all your barcoding and labeling needs. Adapts to Your Needs: With our new 64 bit–compatible MILT 4 software, you can design your labels any way you want (for solids, liquids, syringes, ampules, IVs—even equipment and supplies). In addition to the ability to use graphics, special fonts, tall man lettering, shapes—even logos and symbols—to better identify your medications, MILT 4 has been designed to easily create barcodes with the information that your barcode-enabled point-of-care and barcode medication administration systems require. Popular 1-D and 2-D barcode formats can be created with National Drug Code numbers, expiration dates, lot numbers and special codes.
To get started, all you will 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 4 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 a 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 barcoding needs, then the Medi-Dose System is a perfect fit for you!
NEW 64 bit–compatible MILT4 software. Medi-Dose is simple to use and requires no special in-service training.
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Corporate Profiles 2015
Special Advertising Section Pharmacy Practice News
Pacira Pharmaceuticals, Inc. 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.
The Pacira Advantage Discovery, innovation and proprietary expertise are the hallmarks of the Pacira competitive advantage. The company not only holds the exclusive rights to and expertise in 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. Fo r m o re i n f o r m a t i o n a b o u t P a c i ra Pharmaceuticals Inc., visit www.pacira.com.
AT A GLANCE 5 Sylvan Way Parsippany, NJ 07 7054 (973) 254-3560 www.Pacira.com For more informattion on EXPAREL, visit www.EXPARE EL.com. For medical inquirries related to EXPAREL, conta act Medical Information at medinfo@pacira.co om or (855) RX-EXPAREL (855-793-9727).
*Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing hemorrhoidectomy and bunionectomy procedures.
Important Safety Information for EXPAREL
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 single-dose administration into the surgical site to produce postsurgical analgesia, EXPAREL provides long-lasting pain control that reduces opioid requirements without the need for catheters or pumps.
Shifting the Postsurgical Pain Management Paradigm With 99% of patients receiving postsurgical opioids1 and one in 15 of those patients going on to long-term use, the burden of opioids has reached epidemic proportions.2,3 The use of opioids for postsurgical pain has opened the floodgates, adding a cascade of new users to the 5.1 million Americans who already abuse prescription painkillers every day.4 Pacira is committed to working to address this growing societal burden by providing clinicians with a nonopioid option to control pain and reduce opioid requirements in the immediate postsurgical setting, when effective, consistent analgesia is most critical. The company’s efforts are buoyed by a groundswell movement led by government and independent health care organizations that are recommending a shift to opioid-sparing pain management regimens in order to mitigate patient exposure to unwanted and potentially severe side effects, including abuse, addiction and overdose.
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 after administration of EXPAREL. Monitoring of cardiovascular and neurologic status as well as vital signs should be performed 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 EXPAREL administration were nausea, constipation and vomiting. In the hemorrhoidectomy study, there was a cumulative decrease in opioid consumption over the 72-hour study period, the clinical benefit of which was not demonstrated.
References 1. Kessler ER, et al. Pharmacotherapy. 2013;33(4):383-391. 2. Carroll I, et al. Anesth Analg. 2012;115(3):694-702. 3. Alam A, et al. Arch Intern Med. 2012;172(5):425-430. 4. National Institutes of Health. Popping pills: prescription drug abuse in America. http://www.drugabuse.gov/related-topics/ trends-statistics/infographics/popping-pills-prescription-drugabuse-in-america. Updated January 2014. Accessed June 15, 2015.
PP-EX-US-0927
Special Advertising Section Pharmacy Practice News
Corporate Profiles 2015
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Par Sterile Products, LLC “Providing patients and customers with uncompromising quality and value.” Quality You Can Depend On
AT A GLANCE
The legacy of Par Sterile Products reaches back to the birth of the American pharmaceutical industry at the turn of the 20th century. Our One Ram Ridge Road Rochester, Mich., location represents one of the Chestnut Ridge, NY 10977 landmark manufacturing facilities in the history www.parsterileprodu ucts.com of our industry. Our iconic brands such as Aplisol® and Adrenalin® have been relied upon CUSTOMER SERVIICE by physicians and patients for decades. While proud of our heritage, we are even prouder of (800) 828-9393 Opttion 5, Option 2 the great things we are accomplishing today. In an injectables world frequently plagued by DRUG SAFETY/ME EDICAL compliance issues and product shortages, Par INFORMATION Sterile Products stands as a highly regarded (800) 828-9393 Opttion 3 partner with exemplary trade service levels and an impeccable record of regulatory compliance. CHIEF EXECUTIVE E OFFICER Every week in America, more than 1 million Paul Campanelli Par prescriptions are dispensed, including Par Sterile Products. In return for the trust that is placed in us, we are committed to providing products of uncompromising quality. In fulfilling this mission, we deliver value to our customers and the physicians and patients who rely on us.
Partners for Health Care Excellence Par Sterile Products, LLC, a subsidiary of Par Pharmaceutical, Inc., is at the forefront of developing, manufacturing, marketing and distributing safe, innovative and cost-effective branded and generic aseptic injectable pharmaceuticals that help improve patient quality of life. We also provide contract manufacturing services to our partners in the biopharmaceutical and pharmaceutical industry. Today, our company’s sales place it among the top five largest generic pharmaceutical companies in the United States. At Par Sterile Products, our most important resource is the talent and dedication of our nearly 500 employees, each of whom is part of a culture that values integrity, customer focus, teamwork and performance.
Pitocin® and dexmedetomidine. Since 2012, Par Sterile Products has launched 12 new products. We possess one of the most promising new product pipelines in the injectable space, having developed a pipeline of 34 products, 12 of which have been submitted for FDA approval. We expect at least a half-dozen ANDA filings annually, fueled by our commitment to investment in research and development. At Par Sterile Products, we are large enough to maintain a significant trade presence, yet agile enough to provide maximum attention to our customers, and we remain poised to continue our impressive track record of success. For more information, please visit www.parsterileproducts.com.
PAR—People Achieving Results!
Promising Product Pipeline Par Sterile Products currently markets a portfolio of 16 specialty injectable products, including Vasostrict®, Brevital®, Dantrium®,
PSPM01 0715
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Corporate Profiles 2015
Special Advertising Section Pharmacy Practice News
Pharmacy Practice News
AT A GLANCE
Launched 35 years ago, Pharmacy Practice Newss remains loyal to an editorial mission that has kept the magazine perennially ranked No. 1 in key readership categories. Our primary focus is to give health-system pharmacists the information they need to provide high-quality patient care, as well as the tools to demonstrate the value of that care to colleagues and administrators.
545 W. 45th Stree et, 8th Floor New York, NY 100 036 Phone: (212) 957-5 5300 Fax: (212) 957-723 30 Website: www.pharmacypra acticenews.com
Editorial Directo or David Bronstein davidb@mcmahon nmed.com
Meeting Coverage To achieve those goals, our editors follow the latest developments in hospital practice. Much of our content comes from attending meetings convened by the major pharmacy groups, such as the American Society of Health-System Pharmacists. But we also attend smaller, more focused conferences to keep our readers abreast of the latest trends in patient care and pharmacy operations. For example, we recently completed a four-part series on strategies for optimizing nutrition, based on reporting from the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N) annual conference. We also cover webinars throughout the year by the Institute for Safe Medication Practices, and most recently, added biosimilars to the mix by attending several conferences on the topic in Washington, D.C.
Peer-to-Peer Content The magazine also welcomes contributions from readers to facilitate a peer-to-peer exchange of best practices in health-system pharmacy. Contributions can be in the form of Practice Pearls, such as the one on page 22 submitted by a team of experts at the Hospital Sisters Health System in Belleville, Ill. The article details how the team used a home-grown electronic scorecard to boost compliance with barcode medication administration. The health system achieved a nearly 96% compliance rate as a result of the initiative and documented almost $4 million in cost avoidance in three months of observation. We also continue to feature regular contributions from thought leaders in pharmacy, including Ernie Anderson Jr., MS, RPh, author of the “Leadership in Action” column, and Bonnie Kirschenbaum, MS, FASHP, who pens the bimonthly “Reimbursement Matters” column (p. 12).
Spotlight On... We continue to feature our special “Spotlight” sections focusing on important clinical and operational areas of pharmacy practice. Our latest Spotlight theme, on Pharmacy Technology,
Publication Dire ector Dave Kaplan dkaplan@mcmaho onmed.com
Senior Editor appeared in the June 2015 issue and featured articles about making “smart” programmable infusion pump alarms more discerning, as well as high-tech solutions for thwarting drug diversion.
Educational Reviews
Marie Rosenthal mrosenthal@mcm mahonmed.com
Sales Account Manager Lillie Onday Londay@mcmahonmed.com
One of the core editorial features of Pharmacy Practice News is our educational reviews. Written by pharmacists with specialized clinical training and experience, the reviews offer comprehensive summaries of stateof-the-art clinical care. Topics this year included how to maximize the cost-effectiveness of IVIG therapy; glucose management in the ICU; strategies for optimizing the effectiveness of the new novel oral anticoagulants; and a perennial favorite, the ISMP’s “Medication Errors: a Year in Review.” Many of these reviews are featured in Pharmacy Practice News Special Edition, our annual print compendium that mails in October.
Website Initiatives Each month, print articles are posted to pharmacypracticenews. com and can be shared via Facebook, Twitter, Google+ and other social and business networking sites. Additionally, web-only, breaking news stories are posted daily. Twice a week, our opt-in e-newsletter features a mix of print and web-only content. Video interviews with the nation’s top health-system pharmacy experts are a new addition to the website. One recent example is a discussion between Cindy O’Bryant, PharmD, BCOP, associate professor, Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado, Denver, and Niesha Griffith, RPh, MS, FASHP, director of pharmacy and infusion services at the Ohio State Comprehensive Cancer Center, Columbus. In a wide-ranging Q&A, these experts addressed the patient access and operational challenges posed by limited distribution networks for oral cancer medications that don’t include health systems as participants. We also launched an iPad app for Pharmacy Practice News, so that tablet users can access content on demand.
Supplements Pharmacy Practice News publishes educational supplements such as Special Reports and Literature Reviews bound inside the newspapers. These supplements are produced by our Special Projects division and can be accessed via the “Medical Education” tab on our website.
We’re No. 1 Judging by an independent readership survey by Kantar Media, this editorial formula is working: Pharmacy Practice News continues to be the No. 1–read publication in its field, with top rankings in at least 10 key readership categories (Table). Many thanks for your continued support and readership!
Special Advertising Section Pharmacy Practice News
Corporate Profiles 2015
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Specialty Pharmacy Continuum AT A GLANCE 545 W. 45th Street, 8th Floor New York, NY 10036 6 Phone: (212) 957-530 00 Fax: (212) 957-7230 Website: www.specia altypharmacycontinuum.com
Specialty Pharmacy Continuum (SPC) is a dynamic addition to the Pharmacy Practice News editorial franchise, featuring essential clinical and business information for specialty pharmacies, home infusion providers, insurers and group purchasing organizations.
Meeting Coverage
Sales Account Man nager
Specialty Pharmacy is undergoing explosive, double-digit growth, and for the past four years, SPC C has been tracking this trend and its effect on patients and providers. Typical topics covered over the course of our print issues include biosimilars, site-of-care optimization strategies, drug adherence aids, best practices in home infusion and nutrition, and the use of cutting-edge technology to improve patient care. Our coverage also reflects the growing role that specialty pharmacists are playing in transitions of care; hence our focus on the entire patient-care continuum—from the hospital to the home and other community-based care settings.
Lillie Onday Londay@mcmahonm med.com
Features
Editorial Director David Bronstein davidb@mcmahonm med.com
Publication Directtor Dave Kaplan dkaplan@mcmahonm med.com
Senior Editor Marie Rosenthal mrosenthal@mcmah honmed.com
SPC C includes a number of recurring features to meet the informational needs of our readers: Ask the Experts. Top-notch thought leaders answer common questions on clinical and business operations. One recent installment featured an interview with Terri Smith Moore, PhD, RPh, of URAC, who offered her views on the value of specialty pharmacy accreditation. Disease State Spotlight. Specialty pharmacists detail their approach to managing a specific therapeutic area. Recent topics include oral chemotherapy; multiple sclerosis and other inflammatory conditions; pulmonary arterial hypertension; and hepatitis C virus. Practice Profiles. This feature includes in-depth examples of “best
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practices” in home infusion therapy, specialty pharmacy and other key patient care settings. Technology Watch. Smart IV pumps, remote patient monitoring and other high-tech tools for enhancing patient safety are covered. Policy Update. Health care reform, REMS (Risk Evaluation and Mitigation Strategies), and Joint Commission compliance and accreditation are among the topics we track as needed.
Corporate Profiles 2015
To ensure SPC C covers the latest developments in specialty pharmacy, our editors and writers attend a wide range of conferences throughout the year, including the Armada Specialty Pharmacy Summit, MHA Annual Business Summit, National Association of Specialty Pharmacy’s Annual Meeting & Expo, and annual meetings of the National Home Infusion Association and Academy of Managed Care Pharmacy. These meetings primarily target established specialty pharmacy providers and thus forsm the basis of our conference coverage. However, we also help readers stay abreast of relatively new, nontraditional competitors in specialty pharmacy. Health systems are a prime example: Many of these entities are adding millions of dollars in new revenue annually by expanding their specialty pharmacy offerings. Although some limited distribution networks remain closed to such providers, they nevertheless are changing the landscape of specialty pharmacy and are on our radar for editorial coverage. (The American Society of Health-System Pharmacists’ recent Summer Meeting had several strong sessions on specialty pharmacy that yielded content for SPC.) We also welcome contributed articles, so if you are a clinical expert or operational whiz—regardless of which specialty pharmacy segment you represent—we’d like to hear from you. Send your topic ideas to davidb@mcmahonmed.com, and we will help you share your insights and lessons learned.
Special Advertising Section Pharmacy Practice News
West-Ward Pharmaceuticals Corp. West-Ward Pharmaceuticals Corp. is a wholly owned U.S. subsidiary of Hikma Pharmaceuticals PLC, based in Amman, Jordan, and headquartered in London, England. Hikma (HIK.L) develops, manufactures and markets a broad range of pharmaceutical products spanning 45 countries across the United States, Europe, Middle East and North Africa. The business is conducted through three segments— branded, injectables and generics—with 27 manufacturing facilities worldwide. Hikma’s revenues for the year 2014 were nearly $1.5 billion globally. West-Ward is the U.S. operations arm of Hikma, and is responsible for marketing, planning and distributing products in both the injectable and non-injectable business units. West-Ward is supported by six FDA-approved manufacturing facilities across the globe, with two based in the United States. West-Ward has grown at a rate faster than that of the consolidated company, increasing the importance of the U.S. market to Hikma. In 2014, West-Ward represented 51% of Hikma’s group sales.
‘Our expanded capacity and site transferring of products optimizes our outputs and increases production for flexible manufacturing.’ —Spiro Gavaris West-Ward was established in 1946 as a generic orals manufacturing company. With more than 60 years of experience, West-Ward has a long-standing presence in the U.S. oral solid generics market, with a focus on quality manufacturing and high service levels. West-Ward has a broad product portfolio comprising 41 oral products in 103 dosage forms. Some of the products for the non-injectable product line
Special Advertising Section Pharmacy Practice News
include Doxycycline, Amoxicillin and Prednisone. West-Ward became the second largest injectable supplier by volume in the United States after the acquisition of Baxter’s Multi-Source 401 Industrial Way y West Injectables (MSI) division in 2011. Continuing Eatontown, NJ 07724-2206 the growth of the injectables business, in 2014, Phone: (800) 631--2174 Hikma/West-Ward announced the acquisition Website: www.wesst-ward.com of certain assets of Bedford Laboratories (the generic sterile injectables division of Boehringer Products Ingelheim), thereby adding to its injectable product portfolio. In combination with the existOral Solid and Inje ectable ing injectables portfolio and FDA manufacturing Pharmaceuticals facilities in Portugal and Germany, these acquiMichael Raya sitions solidified the portfolio and reinforced President & Chief Executive Officer West-Ward as a full-service generics manufacturer. West-Ward’s injectable product portfolio includes 65 products in 184 dosage forms and strengths, including controlled substances. Some of the injectable products include Fentanyl, Morphine, Phenylephrine, Glycopyrrolate and Argatroban. Spiro Gavaris, West-Ward’s Vice President, Sales and Marketing, believes that on the heels of the Bedford transaction, West-Ward has optimized the potential of its combined product portfolio, building stronger customer relationships, and increasing new product launches and product acquisitions with the expanded operating capacity. West-Ward is focused on maintaining a continuous supply of products, given the span of the global market shortages across the industry. With the acquisition of manufacturing facilities in Portugal, Jordan, Saudi Arabia and Germany, Hikma/West-Ward has expanded its capacity to produce quality pharmaceuticals.
AT A GLANCE
Corporate Profiles 2015
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Editorial Highlights: Automated Drug Cabinets: Several studies show ADCs can boost patient safetyâ&#x20AC;&#x201D;but only if the implementation is spot-on. ISMPâ&#x20AC;&#x2122;s Matt Grissinger offers tips for maximizing safety benefits. The Internet of Things (IoT): It sounds weird, but IoT is a serious tool that hospitals are using to improve smart pump functionality, reduce drug diversion and boost supply chain safety. The Safety Connection: A new federal report touts the safety benefits of Clinical Decision Support (CDS), Computerized Prescriber Order Entry (CPOE) and Electronic Health Records (EHRs). PTR profiles hospitals that successfully rolled out these technologies and documented improvements in patient safety. Telepharmacy. A Connecticut hospital uses a cutting-edge telepharmacy system to provide direct pharmacist supervision of chemotherapy in its nine new community cancer clinics. CPOE: A JAMA study says CPOE remains the No. 1 challenge for hospitals trying to meet meaningful use requirements. PTR profiles hospitals that have overcome the main roadblocks to e-prescribing. Big Data. A Massachusetts health system mines a huge data set to identify heart-failure patients who are at risk for hospital readmission.