Is there a new role for R.Ph.s in postmarket surveillance?

A key drug safety researcher says the electronic systems that pharmacists use to talk to one another may be a powerful tool for postmarket safety surveillance. The organizations he works with are doing pilot studies to explore that possibility.

Raymond L. Woosley, M.D., Ph.D., who heads both the Critical Path Insti-tute (C-Path) and the University of Arizona Center for Education and Research on Therapeutics (CERT), asked, "If you wanted to have your finger on the pulse of drug use, what electronic system is there out there that is already established?" Neither hospitals nor doctors talk to one another electronically, he said, but pharmacists do. "Could that system be utilized and could pharmacists, who are highly trusted by the public, be part of an active surveillance system?"

Pilot feasibility studies on the idea, expected to be completed in about six months, include research with pharmacists in Arizona, testing the possibility of pharmacists or pharmacy technicians talking to patients to get information at different points. They will, for example, survey patients before they take a medication to find out what else they are taking. They will also talk to patients later to ask whether they took the medicine (since one-third of patients don't) and what happened.

Woosley presented the "Community Pharmacy Safety Network" plans at a wide-ranging discussion sponsored by the FDA in June, at the offices the agency has in Rockville, Md.

If the project moves forward, Woosley also foresees the development of a curriculum for pharmacists and pharmacy technicians. It could possibly be available on the Internet, to focus on potential adverse reactions, and would include elements akin to the information available at poison control centers.

According to Woosley, everyone agrees that the nation needs a new mechanism to get "the data that we need, urgently, on new products." His group, he said, is exploring this network as one possibility. Although the nation can learn a lot about adverse reactions from other types of databases, he said, "My belief is that we also need an active surveillance system looking for problems."

And those actual conversations with the patients are vital, he asserted. At Arizona CERT, he said, "we have found over and over that looking at electronic records and then talking to people, you find out something very different." He thinks pharmacists and pharmacy technicians are qualified to get this information at far less cost than large clinical trials.

The safety network idea is one of the initial projects of the novel C-Path, recently formed in Tucson to tackle the rising costs of medical products, as well as the need to speed their development and ensure their safety. Funded by commitments of more than $10 million from private interests, the city, the county, and the state, C-Path is designed as neutral ground where industry, the FDA, and academic professionals can cooperate. Woosley said no industry funds of any kind are part of the C-Path seed money.

Plans for testing such a network foresee the Arizona CERT, C-Path, and the FDA identifying target drugs and CERT and the FDA developing survey instruments. After a Web-based network in pharmacies is developed, CERT would conduct a pilot study with evaluation of outcomes and the FDA Office of Drug Safety would monitor new drug data.

The Arizona CERT is one of seven CERTs around the country funded by the federal Agency for Health Research and Quality for research and education on therapeutics use. Woosley indicated active postmarket surveillance would help ensure safety and "help everybody accelerate drug development." However, he emphasized that, ideally, postmarket surveillance would be just one tool to identify adverse reactions.

Asked about recent problems with approved drugs that were uncovered only because the medications were being studied for other indications, Woosley replied, "I think that there are additional cases where we are going to have to do randomized trials," adding that such trials are very expensive. He went on to say that "when we find problems, we need to know more about them so that we can have a better chance of preventing them. Taking the drug off the market is not always the best thing to do."