The FDA is deciding whether to allow patients to purchase prescription medications over the counter for many common ailments.

This idea is controversial.

On one hand, deregulation would remove one of the largest barriers to receiving treatment for some conditions – the doctor’s visit. If no doctor’s visit is necessary to receive necessary blood pressure medications or diabetes medications, then patients don’t have to wait for an appointment and the patient/government doesn’t have to pay for the doctor’s visit. The move would also purportedly cost patients more money for their prescriptions because insurance companies (including Medicaid) don’t pay for over the counter medications. Therefore the costs for medications that go over the counter would be shifted to the patients who purchase the medications.

But on the other side, I’m sure that patients will Bing what medications they think they need, and the proposed plan would require patients to answer questions online or at a kiosk and then get input from a pharmacist before the prescriptions could be purchased. So there really isn’t unfettered access to the selected prescription medications.

According to the article, the American Pharmacists Association is embracing the concept while many doctors’ groups are opposing to the idea. Pharmacists believe that their increasing role in a patient’s medical care will be a good thing while physicians see many of their “bread and butter” patients skipping appointments and instead going to the pharmacy kiosk.

Some of the conjectures about such a policy should be addressed.

Will prescription costs for patients go up? If patients have to pay out-of-pocket, then perhaps they would be paying more money for prescriptions, but I doubt that the amount of money would be much more than the copay they were previously paying. I imagine that most of the medications considered for over the counter use would be generic medications from the notorious “$4 list,” so the financial burden on a vast majority of patients would not be great.

However, there are certain medications that have no alternatives. Consider colchicine, vancomycin, and Plavix. Medications similar to these would continue to command a higher price. If patients need such medications or desire name brand medications, then they will keep going to the doctor in order to get their designer medications for a $20 co-pay.

However, medications that do have a generic or over the counter equivalent will see downward pressure on their pricing. Who in their right mind would buy a $300/month name brand medication when the $4 generics (or a combination of $4 generics) work just as well? So pharmaceutical manufacturers would have to justify the price of their expensive medications or would have to lower the price until patients felt that the price justified the benefits over generic medications. That’s free market at work.

Will the public be in imminent danger if they are allowed to self-prescribe? I doubt it. The Angry Pharmacist has a different take on the matter (read the post from behind a blast shield because it is rife with F-bombs). He believes that patients who take some medications need to be medically monitored for adverse effects from the medications. For example, patients who take ACE inhibitors may have deterioration in their kidney function from the medication and may even develop renal failure. If patients are worried about the effects on their kidneys, they can see their doctors for such testing. There are also some online labs that will provide direct-to-patient testing. But if we consider the renal function example, we can also look at Mexico where patients can purchase many medications over the counter. The rates of chronic kidney disease are no higher in Mexico where people can purchase ACE inhibitors over the counter than they are in the US where people cannot purchase ACE inhibitors over the counter. Maybe the adverse effects of medications are balanced by fewer people developing hypertension-related kidney disease because they are controlling their blood pressure. Lots of potential explanations, but we won’t know the real cause and effect without specifically studying the issues. Perhaps this isn’t the most accurate indicator of adverse effects from medications, but comparing health issues in the two countries may show that some of the health concerns raised against this policy are overblown.

Will pharmacists be happy with this policy? Decidedly not. If patients are allowed to purchase prescription medications over the counter, pharmacists all over the country are going to have another very significant and time-consuming task added to their laundry list of things to do while simultaneously being expected by their employers to fill prescriptions at the rate of no less than two per minute. Consider the intent of this policy. What the government is trying to do is shift patients from a paid physician service to an unpaid pharmacist service. Pharmacists are going to be doing a lot of extra work for which they will receive no extra compensation.

And if the patient does develop a serious side effect from over the counter medications provided at a pharmacist’s advice, then the patient (or the family of the dead patient) will have only the pharmacist or the pharmacy to blame because no physician was involved in prescribing the medication. Pharmacy malpractice insurance premiums are about to go up. The Angry Pharmacist notes that there is no one to sue in Mexico if there is a bad reaction to a drug. Do pharmacists really want the target painted on their backs?

This is a case in which I think pharmacists should be careful about what they ask for.

So what’s the right answer?

Deregulation. We shouldn’t stop with medications, either. We also need to deregulate radiologic testing, lab testing, and many medical devices as well.

There shouldn’t be any input required from medical providers before patients purchase a medication, either. If patients want to ask about a medication, that’s fine. Patients don’t need pharmacist input to purchase vitamins, ibuprofen, Tylenol, Prilosec, or Claritin, so why should patients pharmacist input to purchase blood pressure medications? Just as with current over the counter medications, the onus should be on patients to research the side effects and interactions of medications before taking them. For that matter, why should we need a doctor’s permission to get a CBC, have our cholesterol checked, or get an x-ray of an injured ankle? All that the regulations are doing is causing a barrier to access. Very few people are refused x-rays if they go to a doctor and really want them.

There should be some limits on what can be purchased over the counter, though. Controlled substances and antibiotics are a couple of examples of things that should still be off limits to the general public. In fact, so many physicians inappropriately prescribe antibiotics that I think antibiotics should be a controlled substance and that physicians should lose their ability to prescribe antibiotics if they demonstrate a disregard for proper prescribing practices. Coughs, runny noses, and simple toothaches do not require antibiotics. We need to practice 21st century medicine.

So let patients purchase most medications over the counter. Yes, medical providers are still going to have to be Vicodin police and Z-pak police. For the rest of the medications, have at it. There will inevitably be some adverse outcomes and even deaths from wrong doses and from medication reactions. When these adverse outcomes occur, patients will gradually begin to see the value in the services that pharmacists and physicians provide.

We’re there to try to watch out for your interests, we’re not there to keep you from getting care and treatment that you truly need.

If you don’t believe me, you should be able to go and purchase medications yourself, knowing that you alone are responsible for any adverse outcomes that come from using the medications you purchase.

I think that is a fair trade-off.

“WhiteCoat” is an emergency physician who blogs at WhiteCoat’s Call Room at Emergency Physicians Monthly.

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