NABP e-News: June 12, 2008

Study Results Fuel Concerns over Safety, Efficacy of Foreign Drugs Purchased Online
According to study results published in the May 2008 issue of Annals of Pharmacotherapy, many prescription medications purchased from foreign pharmacies through Internet drug outlets differ significantly from the versions approved by the US Food and Drug Administration. "These findings have implications for safety and effectiveness that should be considered by clinicians to potentially safeguard patients who choose to purchase foreign-manufactured drugs via the Internet," the study authors say. The study evaluated 20 simvastatin tablets and capsules, including the US innovator product and 19 generic samples obtained from international Internet drug outlets. Tablet samples were tested according to US Pharmacopeial (USP) guidelines where applicable, using high-performance liquid chromatography, disintegration, dissolution, weight variation, hardness, and assessment of physical characteristics. Several international samples analyzed were not comparable to the US product in one or more aspects of quality assurance testing, and significant variability was found among foreign-made tablets themselves. Five samples failed to meet USP standards for dissolution, and two for content uniformity. Among all samples, variability was observed in hardness, weight, and physical characterization.

NABP List of ‘Not Recommended’ Internet Drug Outlets Continues to Grow
As NABP continues to review and verify its findings on Internet drug outlets selling prescription medications, the Association continues to identify sites that appear to be out of compliance with state and federal laws and NABP patient safety and pharmacy practice standards. NABP recently listed an additional 43 such sites as “not recommended” in the new Internet Pharmacies section of the NABP Web site, bringing the total to 182 as of June 6, 2008. NABP launched its new Internet Drug Outlet Identification program on May 16 to educate patients on the potential dangers of buying medicine online and to empower them to make informed choices. Program criteria, patient information, and a full listing of “not recommended” Internet drug outlets are available under Internet Pharmacies on the NABP Web site, www.nabp.net.

Resolutions Passed at NABP 104th Annual Meeting Now Available Online
Delegates from the member boards of pharmacy adopted eight resolutions during the NABP 104th Annual Meeting, held May 17-20, 2008, in Baltimore, MD. The resolutions addressed such issues as prescription labeling requirements, registration for pharmacy interns, education and training requirements for the registration or licensure of pharmacy technicians, medication collection and disposal programs, establishment of a behind-the-counter class of drugs, and the abuse of medications by teens. In addition, one recognition resolution was passed. The complete text of the resolutions is available under Newsroom on the NABP Web site, and will also be published in the forthcoming special Annual Meeting issue of the NABP Newsletter.

Five Additional Facilities Awarded VAWD Accreditation
NABP recently accredited five new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 273 as of June 6, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • Bound Tree Medical, LLC distributes over-the-counter products, controlled substances and other legend drugs, medical devices, and a large variety of supplies that are used by emergency first responders to 16 regional states. The company received accreditation for its Tempe, AZ facility.
  • Cardinal Health 200, Inc dba Cardinal Health’s Georgia facility is part of the Medical Products Distribution infrastructure of the company’s Supply Chain Services Division. Cardinal Georgia mainly sells non-drug medical products to hospitals and surgery centers, primarily in Georgia, Tennessee, Virginia, Alabama, Florida, and North Carolina. The company received accreditation for its Buford, GA facility.
  • Fisher Clinical Services, Inc provides clinical trial supplies and services, ancillary supplies, labeling, manufacturing, bio-specimen management, shipper qualification services, and global logistics. The company received accreditation for its Allentown, PA facility.
  • MWI Veterinary Supply Company provides veterinary prescription products to veterinarians and veterinary hospitals in Wisconsin, Minnesota, North Dakota, South Dakota, Iowa, and Illinois. The company received accreditation for its Clear Lake, WI facility.
  • Richie Pharmacal Company distributes generic pharmaceutical products to include Schedule III-V controlled substances to retail pharmacies, physicians, hospitals, and other small distributors throughout the United States. The company received accreditation for its Glasgow, KY facility.