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FDA Announces Efforts to Waive Prescriptions for Certain Drug Classes

April 12, 2012 | Comments: 0 | Views: 94

The FDA in March 2012 announced it is considering waiving prescription requirements for drugs used to address certain diseases or medical conditions including diabetes, hypertension, hyperlipidemia, asthma, and migraines. The move is part of several efforts to increase access to approved drugs and promote greater patient compliance.

I strongly support the elimination of prescription requirements for the statin class of drugs, blood pressure (BP) 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 over the counter (OTC). Mexico has not experienced the kind of overdose problems that critics charge would occur with broader 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.

We need a 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 commentary in the media contains 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.

I recently bought an electronic blood pressure kit from Wal-Mart. 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 checked Consumer Reports and found the model I intended to purchase was listed as a "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 modify my dose. The machine even keeps track of the last 30 readings, so that information 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 proactive management is an intended goal of the Affordable Care Act. The Affordable Care Act endorses (1) patient empowerment, and (2) being responsible for one's own health. So the "defensive medicine" practice by some doctors should be alleviated somewhat by individuals assuming personal responsibility for the drugs they take.

Drugs are expensive - whether over the counter or prescription. People will not throw money at drugs and randomly pick them off the shelf. They don't do that with their grocery purchases and will not do that with medications 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 media 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 to trim down the number of doctor visits by eliminating the need for appointments just to get routine prescriptions renewed.

The HIPAA law was passed in part to curb abusive powers by health care professionals to prevent patients from getting access to their own medical records. By the same measure, patients want and deserve access to their medicines without having to wait hours to see a physician. The twentieth and twenty-first centuries reveal a clear trend towards deregulation of industries - across the board. The reason is based on economics: lower prices, easier access, and more consumer choices. The same will be true of the pharmaceutical industry: the trend to cut regulations on prescriptions will overtake that industry as well.

For more information on this topic, please go to

Michael A. S. Guth, Ph.D., J.D., directs Health Economics & Outcomes Research (HEOR) at Risk Management Consulting, a contract research organization based in Oak Ridge, Tennessee, where he has successfully managed the HEOR consulting business for the past ten years. He is also a licensed attorney at law with an active practice of more than 200 clients and has developed expertise on the Affordable Care Act and its implementing regulations.

Dr. Guth's principal research focus has been preventing the onset of age-related diseases known collectively as the metabolic syndrome. In the area of diabetes, he is familiar with all of the drugs used to treat the disease and their potential drawbacks. Low thyroid hormones (T3 and T4) may represent one of the most unrecognized and under-treated causes of prediabetes status affecting some 75 million Americans.

His current research comprises the optimal design of health care insurance and total health/wellness programs including preventive health strategies and employee health engagement and resiliency. Working as part of a global benefits team, he creates an integrated wellness-benefits strategy and executes programs aimed at changing mid- and high-risk behaviors. He positions wellness and disease-prevention as part of a larger strategy for medical cost containment, and contributes innovative ideas for achieving this desired result. He demonstrates thinking "outside the box" to rein in health care spending costs and reform patient utilization of medical services.

A second area of current research is the use of Clomiphene in men for hormone modulation to prevent cardiovascular disease and other consequences of the metabolic syndrome. He is Principal Investigator of a clinical study that compares use of Clomiphene with external sources of testosterone given to men; the study includes safety, efficacy, cost, and value comparisons.

Source: EzineArticles
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