Here’s the latest installment of Ask Pharmie, where our guide Pharmie answers your questions on all things pharmaceutical.

At my local drugstore, I see drugs that are available Over-the-Counter (without a prescription) that I used to need a prescription for. How do drugs go from being prescription-only to being available Over-the-Counter?

Drugs that you can buy without a prescription are called Over-the-Counter (OTC) drugs. There are hundreds of different drugs that are OTC – cough and cold medications, pain relievers (aspirin, ibuprofen, etc), heartburn drugs, and many others. Many of these drugs have been available for a very long time, and have long track records for safety. Others are newer, and often started out as prescription drugs.

Some drugs that have made the switch in the past few years are the heartburn drugs Zantac, Pepcid, and Prilosec OTC, and the allergy drug Claritin.

Why would a drug company want to switch its drug from prescription-only to Over-the-Counter?

There are a number of reasons. Since it’s easier for a patient to get an OTC drug (you don’t have to visit the doctor and get a prescription), it’s likely that more people will buy it. So switching a drug to OTC can increase a company’s sales. Many people also have the impression that Over-the-Counter drugs are “safer” than prescription drugs, even though this is not necessarily the case. So switching a drug from prescription to OTC can convince people who might worry about the drug’s safety to buy it.

But sometimes drug companies make this switch as part of a larger strategy to protect and increase their profits. This usually happens when a prescription drug’s patent is about to expire. A company that discovers a new drug gets a patent that prohibits anyone else from selling that drug for a certain number of years. When that patent expires, the company’s profits on that drug drop, as competitors start selling generic versions of it. Brand-name drug companies have used a variety of questionable schemes to protect their sales when this happens. Sometimes they introduce an “extended release” version of the drug (that lasts, say, 12 hours instead of 6); or they introduce a “new” brand-name drug that’s really a minor tweak of the old drug.

Sometimes, as part of this, the brand-name drug company will try to get the FDA to switch the drug from prescription-only to Over-the-Counter. When Prilosec’s patent expired, the manufacturer petitioned the FDA to make it over the counter, while at the same time introducing a “new” prescription drug, Nexium. Claritin’s manufacturer did the same thing when its patent expired, while introducing Clarinex, a “new” prescription allergy drug.

Making this switch has a couple of effects:

  • It can hurt the sales of the generic versions of the prescription drug, since it’s easier for consumers to just buy the OTC drug than go to the doctor and get a prescription. There are already numerous obstacles to generic drug companies making cheaper prescription generics available to consumers. This tactic just adds to those obstacles, potentially hurting consumers in the long run as fewer generics come onto the market.
  • Health plans usually will not cover the OTC version, but often will cover the “new” brand-name prescription drug. Health plan co-payments for drugs are often lower than even the cost of the OTC drug, meaning that it’s often actually cheaper for the consumer to pay the co-payment for an expensive brand-name prescription drug than the full-price of the OTC version. But the overall cost to the health care system, and thus to all of us, is higher because of the higher price of the brand-name prescription drug.
  • The manufacturer usually starts a splashy advertising campaign to convince consumers that the “new” drug is a major breakthrough that makes it worth the high pricetag. They may also run ads for the OTC version. When Nexium came on to the market, AstraZeneca spent huge amounts on ads focusing on its treatment for “gastric reflux disease,” a serious sounding disease, while ads for Prilosec OTC (essentially the same drug) focused on heartburn, a reasonably-harmless sounding symptom.
  • If the company does new studies (clinical trials) as part of its request to the FDA to allow the switch, it gets to be the only OTC version on the market for three years. It can then aggressively market the OTC version and preserve a good-size chunk of its profits on the drug.

Who decides if a drug should be made Over-the-Counter?

The FDA regulates OTC drugs, just as it regulates prescription drugs. The FDA decides whether to allow a drug to make the switch from prescription to OTC. To approve a drug as an Over-the-Counter drug, the FDA must find that:

  • Its benefits outweigh its risks: In other words, the improvements to your health from taking the drug are more important then any negative side effects.
  • Its potential for misuse and abuse is low: That is, the drug should not be habit forming and shouldn’t cause a cheap “high” that would encourage people to overuse it.
  • The consumer can use it for self-diagnosed conditions: The drug isn’t for something that needs testing or a doctor’s diagnosis, like high cholesterol. Instead, the drug treats a symptom that’s obvious to the average consumer, like a headache or allergy.
  • The drug can be adequately labeled: The warnings and instructions for use are clear and easy to understand without any training.
  • The drug does not need a doctor’s supervision: The drug is easy to use. For example, the drug doesn’t need a doctor to monitor and change the dosage.

Is there anything wrong with switching drugs from prescription-only to Over-the-Counter?

For many, if not most, of the OTC drugs that are at your local pharmacy, there is no problem with them being available without a prescription: their risks or side effects are low, how to use them is clear, they treat things that patients can easily recognize, they give the consumer greater choices, etc.

But not every drug should be “self-prescribed” nor should every condition be “self-medicated.” Many diseases and conditions require a physician to diagnose them in the first place, and then to monitor them and select the right medication. For many complicated diseases, a doctor needs to occasionally change the dosage of a drug or even what drug is given, and to monitor for side effects or complications. Conditions like high cholesterol, diabetes, high blood pressure and asthma are not good candidates for making the drugs to treat them available Over-the-Counter. There are also lifestyle changes (such as diet and exercise) that are an important part of treating conditions like these, and doctors play a vital role in encouraging patients to make those changes.

Isn’t there a middle-ground between prescription-only and OTC? Can’t we have consumers get some medications from behind the pharmacy counter, so at least the pharmacist can make sure the patient understands what it’s for and how to use it?

In the US, prescription-only and OTC are really the only two ways drugs are dispensed. There are a handful of exceptions. Recently, the federal government required that cold and sinus medications with pseudoephedrine (such as Sudafed) be kept behind the counter (BTC), to prevent people from stealing or buying large quantities to make illegal drugs. Plan B, an Emergency Contraceptive, is kept behind the counter, because the FDA only allowed it to be sold OTC to patients aged 18 years and older. This allows the pharmacist to check a customer’s age before the drug is sold to them.

But many other countries give greater leeway to keep OTC drugs “behind-the-counter.” In some countries (like Australia, England, France, and Germany), some drugs that can be bought without a prescription must be requested directly from a pharmacist. This allows pharmacists to act as an intermediary and to advise consumers on whether they need an OTC drug and which one to choose.

As dozens of blockbuster drugs begin to lose their patents in the next few years, we can expect to see more switches from prescription-only to OTC. It’s not clear that these switches are always in the best interests of patients, but sometimes are designed primarily for the drug company’s bottom line.

Ask Pharmie answers readers’ questions about the pharmaceutical industry, drug marketing, drug pricing, and the like. He does not answer medical or treatment questions, or render medical advice. We encourage readers to send their questions to Pharmie.