NABP e-News: February 18, 2009

February 18, 2009 12:00 AM

FDA to Meet with Drug Companies about REMS for Certain Opioids
Food and Drug Administration (FDA) will require manufacturers of certain opioid drugs to develop a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. The affected opioids include brand name and generic products formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. In an effort to balance appropriate access and risk mitigation, FDA will seek input from industry, patient advocacy groups, the pain and addiction treatment communities, the general public, and other stakeholders. In the first of a series of meetings with stakeholders, FDA has invited companies that market the affected opioids to a meeting on March 3 to discuss REMS development. FDA is planning a public meeting later this year to allow for broader public input and participation.

USP Sets New Standards to Protect Patients from Counterfeit, Adulterated Medications
With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the US Pharmacopeial (USP) Convention announced on February 4, 2009, new standards for two widely used drug products, the blood thinner heparin and the sweetener glycerin, that have been involved in episodes of adulteration resulting in patient deaths. More information is available in the USP news release.

Rx Response Map Shows Open Pharmacies in Disaster Areas
Rx Response, a program to help support the continued delivery of medicines during a severe public health emergency, has a new feature on its Web site that provides pharmacy status information to the public and emergency response personnel during widespread disasters. The interactive map currently displays pharmacies in Kentucky counties recently affected by winter storms and that have had electronic prescription billing activity in the previous 24 hours.

Additional information, including a small situation report and a downloadable list of the pharmacies shown on the map, is accessible in the InfoCenter section of the Rx Response Web site, www.RxResponse.org. Boards of pharmacy and others can gain access to the InfoCenter by filling out the "Request access to RxResponse.org InfoCenter" form on the InfoCenter Login page.

Five Additional Facilities Awarded VAWD Accreditation
NABP recently accredited five additional facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 311 as of February 13, 2009. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

• Cardinal Health 110, Inc primarily packages pharmaceuticals for shipment to Cardinal distribution hubs from which they are then distributed to customers. The company received accreditation for its Lakeland, FL facility.
• Gulf South Medical Supply, Inc distributes prescription and over-the-counter (OTC) products to long-term and adult care facilities located in nine upper-Midwestern states. The company received accreditation for its Omaha, NE facili ty.
• McKesson Corporation, dba McKesson Drug Company, distributes OTC products, medical supplies, prescription drugs, and controlled substances to pharmacies and hospitals primarily on the Hawaiian Islands. The company received accreditation for its Honolulu, HI facility.
• TEVA Pharmaceuticals USA, Inc is a generic pharmaceutical company that markets and distributes prescription and OTC products in a wide range of therapeutic areas including analgesic, anti-infective, cardiovascular, oncology, central nervous system, dermatological, and anti-inflammatory. The company received accreditation for the following two facilities:
  • Chalfont, PA
  • North Wales, PA