The National Association of Boards of Pharmacy®’s (NABP®) National Drug Advisory Coalition (NDAC) convened its inaugural meeting in early September and then concluded with formal recommendations in early October 2004. The NDAC was commissioned by NABP to develop criteria for determining which prescription drugs should be included on NABP’s “National Specified List of Susceptible Products” because of counterfeiting or susceptibility to counterfeiting as well as to evaluate and revise NABP’s “National Specified List of Susceptible Products” as needed. In this capacity, the Coalition will serve as an advisory resource to the NABP Executive Committee, which will review the Coalition’s final recommendations.
On February 20, 2004, NABP released the updated Model Rules for the Licensure of Wholesale Distributors. The updated Model Rules, part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, were provided to assist state boards of pharmacy in maintaining the integrity of the United States medication distribution system through the regulation of wholesale distributors. In addition to stricter licensing requirements such as criminal background checks and due diligence procedures prior to wholesale distribution transactions, the Model Rules mandate specific pedigree requirements for products that are particularly prone to adulteration, counterfeiting, or diversion. These products, as defined in the updated Model Rules, are designated as the “National Specified List of Susceptible Products.” NABP hopes that states will adopt NABP’s “National Specified List of Susceptible Products” as wholesale distributor regulations are revised.
The NDAC, appointed by the NABP Executive Committee, consists of representation from the state boards of pharmacy, American Medical Association, American Society of Health-System Pharmacists, Healthcare Distribution Management Association, National Association of Chain Drug Stores, Pharmaceutical Distributors Association, Pharmaceutical Research and Manufacturers of America, and United States Pharmacopeia. Ex-officio members, who serve as resources for the Coalition, include Food and Drug Administration, an independent counterfeit expert, and representation from the wholesale distribution and pharmaceutical manufacturing industries.
Following presentations on the NABP Model Rules for the Licensure of Wholesale Distributors (Charisse Johnson, NABP), Florida Prescription Drug Protection Act (Jerry Hill, bureau chief of Pharmaceutical Services, Florida Department of Health), and an Overview of Counterfeiting (Lewis Kontnik, Lew Kontnik Associates), the Coalition discussed the development of criteria for determining prescription drug products to be included on the NABP “National Specified List of Susceptible Products.” Pfizer US Pharmaceuticals representative Peggy Staver discussed Pfizer’s efforts to address counterfeit drugs via enhanced business practices, regulatory and legislative action, industry initiatives, and various technologic solutions.
After evaluating a number of resources and recommendations including Florida’s Specified Drug List criteria the Coalition developed criteria to serve as a guideline for determining which prescription drugs should be listed. Suggestions recommended by the Coalition include:
- The addition of Viagra® to the NABP “National Specified List of Susceptible Products”;
- The exclusion of veterinary prescription drugs and devices from the scope of the Coalition and NABP’s “National Specified List of Susceptible Products”; and
- The inclusion of prescription drug products that are noted to be in limited supply due to a national shortage for significant periods of time.
The recommendations of the Coalition have been forwarded to the NABP Executive Committee for review and final approval. The Executive Committee will release its final decisions regarding the criteria and the “National Specified List of Susceptible Products” in the upcoming weeks.