NABP e-News February 21, 2008

NABP to Launch Pharmacy Curriculum Outcomes Assessment Program
NABP will launch its Pharmacy Curriculum Outcomes Assessment™ (PCOA®) mechanism in April 2008 for use by colleges of pharmacy in evaluating their curricula. NABP is currently inviting colleges of pharmacy to participate in the 2008 administration of the PCOA, scheduled for April 7-18. There will be no fee for participation in this first year of administration. Those colleges of pharmacy that participate in the April 2008 administration will receive detailed score reports for their students that sit for the assessment, as well as national comparative data. NABP developed the PCOA at the request of colleges of pharmacy and accreditation stakeholders that have expressed a need for a national assessment that is psychometrically validated to assist with measuring curriculum development and student performance. More information is available by contacting NABP Customer Service at custserv@nabp.net. Details will be posted on the NABP Web site in the near future.

FDA Proposes Guidance for Disseminating Information on Unapproved Uses of Medical Products
Food and Drug Administration (FDA) has issued a draft guidance, Good Reprint Practices, for industry regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. The guidance recommends principles manufacturers should follow when they distribute these materials, such as ensuring that the articles are published by an organization that has an editorial board and that discloses any conflicts of interest; that they are peer-reviewed and published according to specific procedures; that they are not funded by the manufacturer of the product in the article; and that they are supported by credible medical evidence. FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or causes a product to be considered misbranded or adulterated under the Federal Food, Drug and Cosmetic Act. FDA is accepting public comments on the draft guidance through April 21, 2008. More information is available in the Federal Register (Docket No. FDA-2008-D-0053) at www.fda.gov/OHRMS/DOCKETS/98fr/08-746.pdf.

ASCP Issues Guidelines for Making Important Medical Information Available to the Blind
Through a collaborative project with the American Foundation for the Blind, the American Society of Consultant Pharmacists (ASCP) Foundation has issued Guidelines for Prescription Labeling and Consumer Medication Information for People with Vision Loss. These guidelines provide pharmacists and pharmacies with specific recommendations for making important medication information accessible for patients with vision loss. The guidelines also serve as a resource for individuals with vision loss and organizations serving this population. The document is available on the ASCP Web site at www.ascpfoundation.org/downloads/Vision_GLs.pdf.

Manufacturer Recalls Fentanyl Pain Patches Due to Overdose Risk from Cut Edge
PriCara and Sandoz Inc has announced a nationwide recall of all lots of 25 mcg/hr Duragesic® (fentanyl transdermal system) patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication, and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation. More information is available on the FDA MedWatch site at www.fda.gov/medwatch/safety/2008/safety08.htm#Duragesic.

London Court Blocks Eli Lilly’s Attempt to Stop Re-importation of its Drugs
London’s High Court rejected an attempt by Eli Lilly to stop a British pharmacy from buying supplies of its drugs in Turkey and selling them to Internet pharmacies in Canada, according to a Reuters report (www.reuters.com/article/companyNews/idUSL0583032020080205). Eli Lilly won a temporary injunction in November 2007 preventing UK pharmacy 8PM Chemists from shipping drugs from Turkey and then sending them to US patients via Canada, Reuters reports. The pharmacy reportedly appealed the case, however, and persuaded the court to overturn that decision, stating that the drugs were shipped in plain brown boxes and never released by customs in Britain. Thus, the trademarks Eli Lilly was seeking to protect were never seen by the public in Britain. The court agreed with the pharmacy and determined Eli Lilly's European trademarks were not jeopardized by the trade.

Three Additional Facilities Awarded VAWD Accreditation
NABP recently accredited three new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 246 as of February 15, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • B. Braun Medical Inc is a division of B. Braun of America, Inc, based in Bethlehem, PA. The company received accreditation for two of its four B. Braun facilities:
    • The B. Braun Medical facility in Atlanta, GA distributes intravenous solutions and accessories to hospitals and other device supply distributors primarily in 10 southeastern states. It is licensed in 37 states.
    • The B. Braun Medical facility in Breinigsville, PA distributes medical delivery devices, including intravenous products and epidermal procedure kits. The company distributes its own product line as well as those of other medical product manufacturers. It is licensed in all states that require licensure.
  • Fresenius USA Manufacturing, Inc, dba Fresenius Medical Care North America, distributes a variety of dialysis products and equipment to clinics and home patients in regional states. An internal pharmacy assists in facilitating the delivery of patient-specific prescription drugs to patients. The company received accreditation for its Charlotte, NC facility.

News Topics

Archives