Are OTC Statins a Danger to Patients?

The benefits and risks of OTC statins are debated again as Pfizer weighs a new future for its top-selling cholesterol drug Lipitor.

Faced with a looming patent expiration for its blockbuster cholesterol drug, Pfizer is looking to seek FDA approval for an OTC version of Lipitor, the Wall Street Journal reported last week.

The news, which came to WSJ via anonymous sources close to the subject, incited debate among health professionals. Many believe switching statins from prescription-only to OTC status would seriously compromise patient safety. Their concern stems not from the drugs themselves, but from questions about patients’ ability to use them safely without a prescriber’s recommendation.

“Most physicians are against the move,” said blogger Kevin Pho, MD, of KevinMD.com. He cited earlier attempts by Merck to market its statin, Mevacor, over the counter—requests the FDA roundly rejected on 3 separate occasions. Officials who reviewed the evidence on consumer use and understanding of Mevacor in 2008 determined that patients are not equipped to decide for themselves if statin therapy is appropriate.

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At the time, Mary Tinetti, MD, chair of FDA’s Nonprescription Drugs Advisory Committee (NDAC), said that although statins are generally considered safe, the agency’s concerns were “whether consumers could make an informed decision.” Will the right patients get the treatment they need at the correct dose? Further, who will monitor possible side effects, drug interactions, and adherence to OTC statins once the patient leaves the pharmacy?

Leave it to the experts

The same questions apply to Lipitor’s hypothetical crossover, and there are no easy answers.

When Mevacor was last on deck for an Rx-to-OTC switch, the American Pharmacists Association (APhA) came forward with a solution that has been practiced in the United Kingdom—let pharmacists handle it. In a statement submitted to NDAC, APhA presented a compelling case for offering statins only in pharmacies, where pharmacists could help patients select and manage self-treatment appropriately.

As trained medication experts, pharmacists are already doing the legwork, the group argued. Pharmacists administer point-of-care cholesterol screenings, refer patients to physicians as needed, monitor drug interactions and side effects involving statins, and recommend lifestyle changes to help patients achieve therapeutic goals, APhA noted. And research suggests pharmacist care boosts adherence—a key factor in clinical outcomes for statins.

Not all pharmacists are on board with the idea, however. Many in the profession share concerns voiced by FDA panels and physician groups about statins and patient behavior. And even the best-case scenario—in which pharmacists provide thorough testing, counseling, and follow-up for each patient—would pose considerable challenges to retail pharmacists already struggling with heavy workloads and high prescription volume.

Despite these practical obstacles, drug makers continue to pursue OTC status for statins as a way to ward off the inevitable profit loss due to generic competition. Lipitor’s patent protection ends in November 2011, which explains Pfizer’s timing; however, no one is predicting OTC status for the drug as soon as that, given the significant regulatory hurdles involved.

Meanwhile, Pfizer has remained tight-lipped about the possibility of Lipitor going OTC. When asked to comment on the subject, Pfizer spokesperson Raymond Kerins, Jr. told the New York Times, “We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time.”

For other articles in this issue, see:

• The High Cost of Kids' Asthma
• Making Sense of Health Insurance Lingo