NABP e-News February 21, 2007

February 21, 2007 12:00 am

FDA Alerts Consumers to Unsafe, Misrepresented Drugs Purchased Over the Internet
The Food and Drug Administration (FDA) reported that a number of Americans who ordered specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan) instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug. Reports show several consumers in the United States sought emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms, and muscle stiffness after ingesting the suspect product. Haloperidol can cause muscle stiffness and spasms, agitation, and sedation. The origin of these tablets is unknown, but the packages were postmarked in Greece. Consumers should notify their health care provider and report suspected products to FDA.

NABP Referenced in Parade Magazine Cover Story on Counterfeit Drugs
NABP is cited in a February 18, 2007 Parade Magazine cover story on counterfeit drugs. The article, “Is Your Medicine Dangerous to Your Health?” by Tom Zoellner, discusses the widespread problem of counterfeit prescription medications infiltrating the US drug supply chain, where the fake drugs are coming from, what the effects are, and what’s being done to stop it.

HHS Drafts Regulations to Implement New Reporting Requirements for NPDB
The United States Department of Health and Human Services (HHS) is drafting regulations to implement new reporting requirements for the National Practitioner Data Bank (NPDB). NPDB currently requires reporting of adverse actions by medical malpractice payers, medical and dental state licensing boards, hospitals, and other health care entities, professional societies with formal peer review, Office of the Inspector General, and US Drug Enforcement Administration. The new requirements, found in Section 1921 of the Social Security Act, will soon require all state health care practitioner licensing and certification authorities, state health care entity licensing and certification authorities, peer review organizations, and private accreditation organizations to report adverse actions to the NPDB. Section 1921 also would allow a wider audience to query the data bank, including hospitals and other health care entities, as well as State and Federal agencies. NABP is evaluating the potential effects of the new requirements the on state boards of pharmacy and NABP. Updates will be forthcoming as the information becomes available.

Ohio Senator Would Hold Board of Pharmacy Responsible for Technician Training
Ohio Senator Tim Grendell reportedly plans to introduce a bill that would require pharmacy technicians to complete a two-year training program or internship, pass a state or national exam, and be licensed through the Ohio State Board of Pharmacy. The proposal would limit the number of technicians working under one pharmacist to three. It would also hold the Board of Pharmacy responsible for overseeing testing, certification, and school curriculum for pharmacy technicians. Ohio is one of 22 states with no formally established requirements or oversight for pharmacy technicians. In addition, US Representative Steve LaTourette is reportedly working on a bill that would establish federal standards for pharmacy technician training and registration by the states. These legislative efforts follow the death of a 2-year-old girl in February 2006 after a pharmacy technician incorrectly prepared her intravenous treatment. The technician was fired, and her supervising pharmacist will face a disciplinary hearing before the Board of Pharmacy.

Fifteen Facilities Awarded VAWD Accreditation
NABP recently accredited 15 new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 63. A full listing of VAWD facilities is available in the VAWD section of the NABP Web site, http://www.nabp.net.

• Apotex Corp provides manufacturing, biotechnology research, and distribution technologies to meet the needs of the US generic pharmaceutical market. The company received accreditation for its Indianapolis, IN facility.
• ASD Specialty Healthcare, Inc is a distributor of specialty products. The company received accreditation for its Reno, NV facility.
• Community Blood Center is a provider of blood components, laboratory services, transfusion medicine, and therapeutic blood. The company received accreditation for its Dayton, OH facility.
• Cutis Pharma, Inc provides pharmacists with pre-assembled reagents in kit form for certain standardized compounding prescriptions. The company received accreditation for its Beverly, MA facility.
• CVS Pharmacy, Inc has received accreditation for three of its facilities. The Smithfield, RI facility, which is one of the CVS corporate headquarters; and the Knoxville, TN and Vero Beach, FL facilities, which distribute to the CVS/Pharmacies in their respective areas.
• Dik Drug Company is a regional wholesaler of pharmaceuticals and medical equipment. The company received accreditation for its Burr Ridge, IL facility.
• Dixon Shane, LLC dba R&S Northeast, LLC is a supplier of brand and generic pharmaceuticals and various health care products. The company received accreditation for its Philadelphia, PA facility.
• Emergency Medical Products, Inc is a pre-hospital distributor of emergency medical supplies, equipment, and pharmaceuticals. The company received accreditation for its Waukesha, WI facility.
• Gulf South Medical Supply, Inc is a distributor of over 20,000 medical supply products. The company received accreditation for its Gahanna, OH facility.
• H.D. Smith Wholesale Drug Company is a national supplier of health care products and services. The company received accreditation for its distribution center in Wood Dale, IL.
• Health Coalition, Inc is a provider of biopharmaceutical products. The company received accreditation for its Miami, FL facility.
• QK Healthcare, Inc provides branded and generic pharmaceutical and other medical products to retailers, pharmacy benefit programs, and other distributors. The company received accreditation for its Ronkonkoma, NY facility.
• Qualitest Pharmaceuticals, Inc manufactures and distributes liquid- and solid-dose prescription drugs to wholesaler drug distributors and retail outlets throughout the United States and Puerto Rico. The company received accreditation for its Huntsville, AL facility.