Editor's Note: Ensuring the Integrity of Purchased Pharmaceuticals

MAY 01, 2008
James C. McAllister III, MS, FASHP

Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.

Questioning the quality of purchased pharmaceuticals is not a new issue. Many years ago, the proliferation of generic manufacturers resulted in the distribution of generic drugs that were not bioequivalent to the market standard. Efforts such as regulatory reform by the FDA, educating pharmacists in assessing bioequivalence before making source selections, buyers switching sources to ensure quality, and generic industry self-reform improved the quality and reliability of drug supplies.

More recently, the integrity of the drug supply was compromised when intermediaries in the ?grey market? adulterated high-cost injectables by dilution to reap huge profits. This was followed by the proliferation of counterfeit oral and injectable drugs of questionable quality that became available via the Internet, often from foreign sources. Purchasers became more savvy, and pressure was brought to bear on wholesalers and distributors to ensure the quality of their sources of drugs.

Pharmacists, professional associations, the FDA, and manufacturers collaborated to promulgate requirements for radio frequency identification (RFID) technology to help ensure the quality of selected drugs while they are in the supply chain pipeline. I suspect that these measures have helped ensure the quality of selected drugs, but widespread application of RFID technology has not yet been realized. Many state boards of pharmacy have responded to this issue with a variety of strategies to minimize if not eliminate counterfeit and adulterated drugs. The California Board of Pharmacy enacted very aggressive requirements to combat this issue but recently announced a second 2-year delay in requiring compliance for a variety of reasons, predominantly because manufacturers and distributors claim that complete compliance is currently unrealistic.

Over the past several months, the quality of injectable heparin has come under scrutiny, with over a dozen deaths being attributed to adulterated product manufactured in China. Nationwide recalls have resulted, and the availability of heparin injection has been compromised. A recent article in the New York Times (March 30, 2008) released a shocking expos? on this topic, including a picture that sent shivers up my spine. I realized that it is possible that other drugs manufactured outside the United States are similarly compromised in terms of quality. It is interesting, however, that Hospira avoided recall of its heparin products; although the company obtained product from the same supplier that made the recalled heparin and produced other products using raw materials from China, the company requested product that was produced using raw materials from only the United States and Canada.

Solving this dilemma will be challenging. Collaboration of pharmacists, manufacturers, wholesalers, and distributors, as well as regulatory agencies at the state and national level, should begin expeditiously. As reformers consider strategies to ensure quality and integrity, I suggest that the following be considered:

  • Manufacturers should bear all costs of the recall to hospitals and pharmacies by an established formula
  • The FDA should create and maintain a comprehensive and readily accessible list of recalls for those making source selection decisions
  • Manufacturers, rather than the FDA, should be held financially accountable for the quality and integrity of drugs or chemicals used to manufacture its drugs not produced in the United States
  • The FDA should be empowered to levy substantial economic sanctions for substandard drugs sold

In the interim, decision makers in pharmacy should use all their expertise and experience in source selection of the drugs they buy and, to the extent possible, hold manufacturers and distributors accountable for drug quality in every way possible.

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