PR View by Kate Cronin

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In the wake of the Vioxx litigations, the media and public are in a frenzy questioning the safety of widely used pharmaceutical drugs and the US Food and Drug Administration's role in ensuring that safety. But one drug-safety issue no one seems to be talking about—let alone heard of—is the practice of pharmacy compounding.

Compounding can range from crushing pills and adding liquids to make them easier to administer, to preparing complex sterile drugs in a hospital pharmacy. The end product is always the same: an unapproved drug manufactured without regulatory oversight and supporting safety data. Every year, the pharmaceutical industry spends countless resources researching drug safety, following strict standards established by the FDA. Altering the product could potentially affect the efficacy or safety profile that has been established in pre-approval clinical trials.

When prescriptions are filled at the pharmacy or dispensed in the hospitals, we expect those drugs are safe. Under certain circumstances, pharmacy-prepared drugs can fill a need, such as when there are no approved medicines available. But in cases where therapeutic options exist, the risk of injury or death may be too great.

As a consumer, I want to know that my medicines have been extensively tested. As a parent, I want to know that my son is getting the approved product for his asthma.

As communicators, we need to be more vocal about this practice, encouraging the pharmaceutical companies we represent to get more involved in the debate. The industry has too much at stake—in financial investments in research and development and in its reputation—not to take a leadership position on the issue of safety, particularly pharmacy compounding.

Kate Cronin is the head of the Global Healthcare Practice at Ogilvy Public Relations Worldwide

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