Should we abandon the prescription medication system?

In part I of this debate (which was in turn prompted by the FDA’s rejection of OTC Mevacor) I questioned the libertarian position that personal freedom is more important than a beneficial, paternal, medical prescription system. One commenter made the point that if consumers are aware of the risks of medications then they should be allowed the freedom to take such risks. Reader jb added the following analogy.

“Let’s make an analogy between health care and electricity. Both are useful, both can kill if not used properly. I’m pretty handy with tools, and I am willing and so far able to do what I consider minor electric-type tasks around the house- rewire a lamp, replace a switch or outlet. Some may not be comfortable with even this level of involvement, and they are free to call the local electrician for these tasks. When I have a higher level electric problem, involving 220 volts or main house wiring, I call an electrician. I have no doubt that I am “smarter” than my electrician, but he knows a lot more about the subject at hand, and I know enough not to endanger myself by getting in over my head. Those who support the current system would not want me to change my own switch. I knowingly accept the risk of a shock or fire because I like to take care of my stuff myself as much as possible.”

Analogies can be problematic when used in an argument. The problem with your electrical repair analogy is one of risk awareness. While the repair of home electrical wiring may appear complex on the surface (to most home owners) the risks of electrocution, fire, and inadvertent damage to the wiring are fairly basic and straightforward. Almost every child who has grown up in a modern home is aware of the risk of electrocution if domestic wiring or electrical products are not used correctly. These risks are easy to understand and widely known.

Contrast this with the complicated risk profiles of most prescription medications. Statins are some of the safer prescription medications and their use is still very complicated and beyond the experience of most consumers. Most people have never heard of rhabdomyolysis nor associated it with cholesterol lowering medications. One source (Cheitlin et. al. Circulation 1999) lists over 50 medications that have the potential to interact with the CYP3A4 liver metabolic pathway and increase the risk of muscle damage including such common substances as Tylenol and grapefruit juice when used concurrently with a statin! Combine this with several medical conditions that also increase the risk of adverse events and it becomes a very complicated decision tree. How complicated? Let’s consider several hypothetical patient examples and their questions on whether or not they should take an over the counter statin medication.

The one thing that all these examples have in common is that they include questions that need to be addressed to a doctor (someone trained to understand the complexities of medical diseases and treatments including pharmacotherapy). Without any expert guidance every single one of these hypothetical patients are doing the equivalent of groping around in the dark and risk either harming themselves or a family member if they make the wrong decision.

It is also clear from these examples that patient education of the risks and indications for taking an OTC statin via the package insert would need to be overtly long and complex (in order to address the majority of patient questions) and would be very easy to either ignore or misinterpret as is evident in many of the above examples.

Unlike the complexities inherent in performing electrical repairs in the home, the activity of using OTC medications is not at all complex. Simply go to the pharmacy, purchase the drug, and take it the number of times a day according to the directions (only once a day for statins). Where the complexity of medication treatment comes from is in its indications and contraindications (both relative and absolute), risk-benefit analysis, side-effects profile, associated comorbidities, monitoring requirements, interactions with other medications and food, and the fact that no two patients are clinically identical making expert guidance essential in custom designing each patient’s medication regimen.

It is also clear from these examples that many patients would be taking an OTC statin for incorrect indications and placing themselves at risk (or in the very least, wasting money) and that many would use the convenience of an OTC medication to justify not going to a doctor. Hence they would misdiagnose themselves and inappropriately concentrate on an elevated cholesterol level. They would lull themselves into a false sense of security by believing that treatment with a new fancy OTC medication is enough while ignoring signs and symptoms of serious disease until it is too late. Trust me. I see many of these patients day in and day out. It’s sad but true.

And all of this is just about statins. Most prescription medications are even more complex and have much bigger side effect profiles. Some people advocate not just for OTC statins but for OTC everything! What about it? Should we get rid of the prescription medication system?

Ironically I have first hand experience with a system where a prescription is not needed to purchase medications and patients are allowed to self diagnose and self treat their medical conditions. In Mexico it is (unofficially) relatively easy to purchase medication over the counter without a prescription. Recently I treated a patient who almost killed himself by self-medicating without a doctor’s expert guidance. He was a middle-aged patient from an area in west Texas that was so remote, a physician’s visit involved several hours of driving. The patient had rheumatoid arthritis that was steadily getting worse but because it was so inconvenient for him to go see his doctor he decided to make the much shorter trip into Mexico and go to a local pharmacy there.

Based partly on advice from the pharmacist and partly on what he remembered about past treatments his doctor had given him, this patient purchased Prednisone and Indomethacin. He started taking both these medications at relatively high doses and almost immediately his arthritic pain was much improved! Concerned that his pain would return if he lowered the doses of these medications he continued to take high doses. After a while however, he started having problems with his stomach. At first it was just some reflux but then he started having fairly bad stomach pain and heartburn. He became increasingly nauseated, his bowel movements turned black, and he was unable to eat. He started loosing weight and became so tired that he was unable to work. His family members noticed that he had become very pale.

When one of his family members remembered reading somewhere that steroids cause stomach problems the patient abruptly stopped taking his Prednisone and over the next 24 hours he became severely ill with nausea, vomiting, and extreme lethargy. Finally the family called EMS and the patient was transported emergently to the hospital where I work. On arrival he was found to have a blood pressure in the 60’s and he required aggressive fluid resuscitation and medications to elevate his blood pressure. Initially it was thought that the patient’s blood pressure was low because he was having a large gastrointestinal bleed. However his blood counts, though moderately low, remained stable and it was only after repeated questioning of the family did we find out that the patient had been taking large amounts of the above medications without a physician’s guidance.

Both Prednisone and Indomethacin are potent prescription anti-inflammatory medications that can be very effective in the treatment of arthritic pain however both have very destructive effects on the lining of the stomach. In this patient’s case both these medications combined to cause severe stomach ulcers and erosive gastritis that caused the initial symptoms and lead to blood loss. In addition, abruptly stopping the Prednisone lead to an adrenal insufficiency crisis resulting in the rapid worsening of the patient’s condition.

Had this patient been under the care of a doctor his condition would very likely never have gotten this bad. The patient would have been monitored closely for potential side effects of these medications and there would have been many opportunities to intervene and start the patient on gastric protective medications and obtain a referral to a gastroenterologist for an endoscopy. In the very least this patient would not have been started on high doses of both these medications concurrently or would have been instructed to taper the doses as soon as the arthritic pain was under control. He would have been instructed NOT to completely stop his Prednisone dosing. But the patient didn’t know any of this because he chose to treat his condition without a doctor’s guidance and he almost died.

The health care system may not be perfect but it is clearly better than the “go-it-alone” system that many advocate for. Besides, other than the “it is self evident that paternalism in medicine is bad because it is a restriction on liberty” argument, no one yet has given me a rational explanation as to why in practical terms the requirement of a doctor’s prescription before buying medication is an undue burden on liberty or as a corollary argument why the liberty to purchase medication without restriction trumps the benefits of physician guidance in the management of complex and chronic medical conditions.