Statin Down the Hatches: OTC Statins- More Questions than Answers

OTC statins. Not a new conversation, but certainly a timely one as we continue to face not just Hyperlipidemia – but medication adherence (and particularly for chronic, asymptomatic conditions).

Are statins “safe enough” to be available without a prescription? Well, with the appropriate caveat that no drug is 100% safe, it’s pretty fair to say that their safety profile is excellent – for Rx products. But is the same true if they were available OTC?

Can a patient self-diagnose and self-dose?  Do symptoms hide another, potentially more serious, underlying condition?  And what of safety concerns? 

Per a New England Journal of Medicine written by the chair of the FDA advisory committee, “Some docs argue that increasing access to statins could prevent heart attacks and strokes, which in turn would lower health care costs. Overall, a study of an OTC Mevacor (Merck’s statin) showed 30 percent of patients who thought they should take the drug actually had less than a 5 percent risk of a heart attack or other cardiovascular event in the next 10 years, and were therefore unlikely to benefit.”

Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.

This is an important debate as well as a “teaching moment” for American pharmacists to communicate the crucial role they play in 21st century American health care.

Here are some questions should be asked when it comes to the OTC statin debate:

* Should any chronic medications be available OTC? (This is a very big “beyond statins” questions that hasn’t been widely discussed … yet.) Most Rx-to-OTC switches have been for the treatment of acute, transient symptoms of allergies, heartburn, etc.

* Isn’t this a de facto BTC play? After all, the pharmacist will have to advise, test, and dispense. Isn’t that beyond the scope of FDA’s existing regulatory authority?

* Is an OTC “Drug Facts” label up to the task of properly communicating the most important benefit/risk information about statins (or, for that matter, about any OTC product)?

* What about the financial burden on the consumer? Rx products are reimbursed. OTC products are not.

* And, to that point, when there is an increased financial burden on the patient (i.e., raised co-pays) – adherence declines. Would OTC statins further exacerbate the problems with statin adherence?

* If OTC designation is granted for one statin and then others follow suit (a pretty safe supposition), how are patients supposed to choose which statin is “best for them” minus a physicians “clinical experience?”

All this to say that it’ll make for an interesting debate.

Peter J. Pitts is a former FDA Associate Commissioner, and is President of the Center for Medicine in the Public Interest.

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