Fda Announces Efforts To Waive Rxs For Several Diseases: What Will This Mean?

The Food and Drug Administration in March 2012 announced it is thinking about waiving

prescription requirements for medications used to address illnesses including diabetes, asthma, and migraines. I strongly support the elimination of prescription requirements for the statin class of drugs as well as blood pressure medicines, and other classes of comparatively safe drugs. I favored this policy years ago and wrote a short article describing the inefficiencies associated with vesting monopoly power to write prescriptions in physicians. We cannot have meaningful health care reform if patients have to make doctor's appointments and pay for those visits just to obtain periodic refills of their chronic medications. I also favor an expanded role for pharmacists. The FDA is contemplating putting some of these drugs directly on the shelves of stores similar to the way they are available and purchased in Mexico with little or none of the overdose problems doctors use as a ruse to try to persuade regulators against broadening OTC access. For other drugs, such as blood pressure medications, the consumer would ask the pharmacist for a particular drug, and the pharmacist would ask about other conditions before getting it. Hopefully, for most patients who have been using the same medications for years, the pharmacist chats would be short and perfunctory -- in fact accounts could be noted that the pharmacist already had a consult and does not need to repeat it.

My only concern is that the FDA will drag its heels and take years to implement this necessary change. I would like to see these drugs become available without prescription immediately. Patients who need guidance from their doctors can still get it, even written prescriptions that would not be necessary, But for those of us smart enough to regulate and monitor cholesterol and liver enzymes and BP on our own, we should have the freedom to purchase these drugs when needed -- not merely when a doctor gives us permission once again to take them one more year at a time. A CBC/CMP test checking liver enzymes and lipid levels and all metabolites as well as blood cell count can be purchased for $26 online. That is cheaper than the cost of a doctor's visit -- even with a copay.

I look forward to the groundswell of popular opinion demanding change and reform in prescription drug policy and enabling consumers to get their non-narcotic medicines over the counter. The comments in this thread contain an element of hysteria about all the problems that might occur with direct consumer access. Of course, not one of the negative commentators can point to any such problem occurring in countries such as Mexico with much more open access.

Three days ago, I bought an electronic blood pressure kit from Walmart. The pharmacist came out to show me which of the different models for sale she bought for herself and said it was reliable. I then check Consumer Reports and found the model I intended to purchase was listed as "Consumer Best Buy" based on reliability. I am very pleased with my purchase and have been able to optimize my BP medicine -- all without paying any doctor for a consult to describe my prior BP test results. The machine even keeps track of the last 30 readings, so that will be nice to share with my doctor when I see him again next year.

If patients select their own medications (after consulting with a doctor or pharmacist if they are unsure), those patients are proactively managing their own health. That is one of the hallmarks of the Affordable Care Act: (1) patient empowerment, and (2) being responsible for one's own health. So the idea that doctors have to practice defensive medicine should be alleviated somewhat by individuals assuming responsibility for the drugs they take.

Drugs are expensive -- whether over the counter or prescription. People are not just going to throw money at drugs and randomly pick them of the shelf willy nilly. They don't do that with their grocery purchases and won't do that with meds either. The courts are not going to allow people to sue manufacturers or pharmacies for actions that stem from the people's own decisions. The comparative fault concept in tort theory will eliminate most consumer litigation based on their own ill-founded choices for medications. If there is false advertising, then that is a different matter -- but it has nothing to do with making drugs available without prescriptions. The mere fact that a doctor writes a prescription does not eliminate false advertising.

The hysteria element in the FDA commentary concerns unfounded fears of dire consequences without evidence backing it up. Guess what? We have plenty of drug overdoses (fatal and nonfatal) right now with our highly regulated prescription drug regime. There will be overdoses in the future, whether consumers buy their medications OTC or we continue with the restrictive regime we have now. BUT, and this is the most important point, we consumers are being denied basic freedom to manage our own health. Giving consumers access to a wide variety of medicines OTC is no more dangerous than giving consumers access to liquor, which is a drug. Yes, some people abuse the privilege of buying alcohol and will also abuse the privilege of buying medicines, but that is no reason to deny freedom to the vast majority of people who will exercise that freedom responsibly.

We have already seen antihistamines become available OTC, and there will be growing consumer pressure -- particularly when huge cost overruns occur in health insurance in 2014 -- to trim down the number of doctor visits by eliminating the need for appointments just to get routine prescriptions renewed.

By the same measure, patients want and deserve access to their medicines without having to wait hours to see a physician. the reality of the 20th and 21st centuries reflects a clear trend towards deregulation of industries -- across the board. The reason: economics. Lower prices. Easier access. Consumer choices. The same will be true of the pharmaceutical industry: the trend will overtake that industry as well.

by: Michael A. S. Guth

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