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12/23/2015

A Suggestion To Make Prescription Medicine Behind-the-Counter

by Craig Klugman, Ph.D.

I recently returned from a vacation to Central America. Besides having some adventures, I also noticed that the local towns had a large number of pharmacies—far more than would be expected of towns with small populations. When I walked into these pharmacies I saw the walls covered with boxes and bottles of medications—drugs that in the U.S. would only have been available with a doctor’s prescription. Some of them were drugs that at home were available over-the-counter in small doses but here one could purchase the prescription dose. Others were antibiotics, erectile dysfunction drugs, anti-depressants, cardiac meds, blood pressure medications, anabolic steroids, and medications for end-stage kidney disease, contraceptive pills and even some pain relievers with small doses of codeine. Most narcotics (opioids) still required a prescription but since many pharmacies were in physician offices, that process was quick and inexpensive as well. The prices were also lower than one pays in the U.S.

The United States has led the world with high prescription drug prices for a long time. We have a stringent drug classification system that requires many drugs such as antibiotics, narcotics, anti-depressants and more to only be available with a physician prescription. Then you take that order to the pharmacy where a pharmacist sells you the drugs. In a system that is highly expensive and facing shortages of health care workers, it would make sense to make most prescription drugs available without a prescription.

In the U.S., there are three levels of pharmaceuticals. (1) Over-the-counter drugs (OTC) are considered safe enough for a person to purchase and use on their own Often these are medications that have been on the market for 3 to 6 years with a good safety profile. For example, allergy medications like cetirizine and proton-pump inhibitors like lansoprazole used to only be available with a prescription. But now, they are available OTC since (a) their patents have expired and generics are on the market, (b) they are safe to use with low chance for abuse, and (c) the OTC package doses are often lower than prescription strength (for lansoprazole, OTC is 15mg but prescription is available also in 30mg tablets).

(2) Prescription medications. These are drugs with proven medical use but because of the risk of addiction, their complication of use, or that the company never applied for OTC status are only available via a doctor’s prescription that can be filled by a pharmacist. (3) Behind-the-counter (BTC) medications are those that are available to patients without a prescription but that are restricted because of their potential for abuse or moral implications. For example, sinus medications with pseudoephedrine are BTC because that chemical is an ingredient in crystal meth. The war on drugs thus limits the amount one can purchase per month. Plan B is also BTC as a moral compromise surrounding the controversies of emergency contraception.

Part of the need for control is the “prescription drug abuse epidemic” according to the Centers for Disease Control & Prevention (CDC). There is reportedly an increase in prescriptions written, increases of driving on drugs, and increased unintentional deaths due to prescription drug abuse. In the United States, about 10.2% of people have used illicit drugs. Of those 2.5% of people over the age of 12 have abused prescription drugs. Compare this to the 25.8% of the population who uses tobacco products or the 6.2% who are “heavy alcohol users” and perhaps prescription drug abuse is far from being an epidemic (Substance Abuse and Mental Health Services Administration, Department of Health & Human Services).

In other North American Countries, drug abuse levels are lower: Canada overall rate is 7.9% (with prescription drug abuse around 2.3%) and Mexico’s overall 4.2% (United Nations Office on Drugs & Crime). While Canada has a similar prescription drug system as the U.S., Mexico’s is vastly different where it is possible to buy most prescription drugs OTC. The lower rate of abuse in Mexico may be do to a lack of reporting, but consider that Mexico’s reported overall rate is closer to the U.S.’s prescription abuse rate (not total). If the goal of stricter prescription requirements is to decrease people abusing such drugs, then the effort has failed—the countries with the higher rates of abuse have stricter control. And in the U.S., prescription drug abuse increased the beginning of this century. The rise is attributed to the growth of online pharmacies, which may be less scrupulous about requiring prescriptions, as well as the development of more powerful drugs and increased advertising.

If patients had free reign over their choice of drugs, would the epidemic be worse? Would people take drug combinations that were dangerous or that had harmful side effects? Would the antibiotic resistance problem be worse? Might they just look up their symptoms online and buy drugs even if they did not have that disease? The last already happens: Patients will “doctor shop” to find a physician who gives them what they want. They’ll borrow unused courses of medications from friends and families. Or they will buy pills from someone who has a legal prescription. Most of the other questions can only be answered once prescription deregulation occurs or by looking at other countries, where such approaches have been successful and with far lower levels of abuse.

The risk of these problems could be further mitigated by not making drugs available OTC, but rather adopting the middle ground of BTC. Thus, a patient would be advised by a licensed pharmacist who could monitor and track patient drug purchases. Afterall, with electronic medical records—a patient’s purchases could appear in both the pharmacist’s and the physician’s systems. The pharmacist could offer appropriate drugs to patients with minor and ordinary conditions or for situations where a patient is on a medication long-term but needs to have regular doctor’s visits in order to get the prescription renewed. For example, prior to my trip I wanted to have an antibiotic along with me (not knowing how drugs were sold there) in case we had a particularly vengeful digestive issue. This required contacting the physician, having him send a prescription to the pharmacy, the pharmacy letting me know the prescription was received and filled, and me picking it up. Instead, what if I had gone to the pharmacy, told the pharmacist what I needed and he handed it to me? Much more efficient in terms of time and cost.  This proposal has the benefit of saving health care dollars and the time of professionals and patients. For most people with chronic conditions or needing an antibiotic, being able to get them in the same place makes sense.

Most prescription medications (schedule 2, 3, 4, and 5–though in some states schedule 5 drugs are sold as OTC) should be available behind-the-counter. Patients are better informed today in earlier eras, the costs of maintaining the status quo is too high, and technology can be used to monitor the situation (such as tracking drug purchases and regular check-ins via computer instead of visits).

This entry was posted in Featured Posts, Health Regulation & Law, Pharmaceuticals. Posted by Craig Klugman. Bookmark the permalink.

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