Are OTC Statins a Danger to Patients?

Published Online: Tuesday, August 9th, 2011
Laura Enderle, Associate Editor

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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:

Bonnie August 9th, 2011 02:08:4002:40:29 PM

why not put the drugs OTC ? Insurance companies are always turning you down on brand drugs or the copay is so high you cannot afford it so you cannot take what your dr. wants you to take anyway. you may as well buy it over the coter and screw the insurance company !!!!!!!

Stephan Wilcox August 9th, 2011 02:08:5702:57:22 PM

Okay. Let's go ahead & make 'em non-prescription. If they're OTC, the only one who benefits is Walmart. Behind the counter, we end up doing a lot of counseling and chasing lab values and getting paid NOTHING for it. I'm all for the best for the patient, but as an owner, I have to get paid something for my time, or I close my doors. KEEP THEM PRESCRIPTION ONLY !!! As much as I hate dealing with the PBM's, it shows the patient that we are their advocates.

Beverly Pralguske August 9th, 2011 03:08:1303:13:08 PM

For years I have been telling friends to quit taking statins. With exercise & diet changes they have all lowered their cholesterol more than when they were on statins. Another drug that is grossly over prescribed.

Frank J. Berry August 9th, 2011 05:08:2505:25:03 PM

While improving diet and exercise is definitely the preferred methods of controlling cholesterol, in many patients it is does not lower cholesterol enough. Also, many cannot or will not change their lifestyles. It is for these patients that statins are quite beneficial. However, due to the possible serious side effects, and the potential for drug interactions, physicians and pharmacists should still control access to statins.

Norm Jacobs August 9th, 2011 05:08:5605:56:10 PM

Great idea otc 30 packs with warning=IF YOU HAVE ANY QUESTIONS PLEASE ASK THE PERSON ON ISLE 9 HOSING DOWN THE LETTUCE. How absurd.

Barbara May August 9th, 2011 06:08:5406:54:27 PM

Many people have what could be termed familial high cholesterol, which typically is unaffected by diet or exercise. For those patients, statins are a reasonable choice, but the statins do not belong OTC, or for that matter behind the counter. As a previous person stated, we would be chasing lab values and counseling without payment for that service. KEEP THEM RX!!

robert mccarty August 10th, 2011 07:08:0707:07:44 AM

what these companies will do to try and keep the money coming in. otc lipitor would not only be unsafe for self medication but with no insurance coverage the cost would be out of reach for lots of people.

Vincent Gaver August 10th, 2011 09:08:1209:12:50 AM

Why not just put HCTZ, ACE-inhibitors, all cholesterol meds, all diabetes meds...what the heck, put them all OTC. Close the pharmacy. Then wait. Physicians, the only healthcare provider group with any tangible power, will have them all back in the pharmacy in about 2 weeks.

Christina Brewster August 10th, 2011 01:08:5401:54:12 PM

WHAT!!! This is ridiculous. I suppose if our goal was population control, sure. Lets do it. So many people could harm themselves if these drugs go OTC. Also, Robert Mccarty is right. The cost of Lipitor without insurance is so high that no one could afford it. Look at Allegra that just went OTC, Prevacid, Prilosec... all of them are still way cheaper as an RX filled under insurance. There is no way that cholesterol and BP meds will go OTC. Drugs are regulated for a really good reason. Do you know how many meds interact with statins? Are patients supposed to know this?

loida rodriguez August 18th, 2011 03:08:2803:28:51 PM

Keep them rx only! The patient need to be screen by a doctor, make blood test to ensure is a good candidate to use statin. Not only having high cholesterol make you a candidate for statins. Also patients need to use the correct dose for each individual situation. Also need to be counsel and by a pharmacist for interactions with other drugs, rx or otc. Women need special advice before using this drug. I work at arl retail pharmacy and i am sure the most part of the patients do not read the advice on the medications. PBMs should make lower the copays and the pharmaceuticals low the cost. Keep them behind the counter with prescription only!!

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