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Over-the-Counter versus Prescription Drugs

December 14, 2011 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: Navitus Clinical Journal – December 2011

Hundreds of drugs are available over the counter, including, but not limited to, cough and cold medications, pain relievers (aspirin, ibuprofen) and heartburn drugs. Over-the-Counter (OTC) drugs are drugs that you can buy without a prescription. 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 become available as OTC in the past few years include heartburn drugs – Zantac, Pepcid, Prilosec OTC – and the allergy drug Claritin.

Why do drugs become OTC?
Drug manufacturers have an incentive to make their product(s) available OTC, since it is easier for patients to purchase a drug over the counter rather than via a prescription from their doctors. Because of the availability of OTCs, switching a drug to OTC can increase the drug manufacturer’s sales.

Drug manufacturers may also want to have their product available OTC 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. For example, when Prilosec’s patent expired, the manufacturer petitioned the Food & Drug Administration (FDA) to make it available over the counter, while at the same time introducing a “new,” chemically similar prescription drug, Nexium.

Regulation and safety of OTCs
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 the patient’s health from taking the drug are more valuable than any negative side effects.
  • Its potential for misuse and abuse is low. The drug should not be habit-forming and should not encourage people to overuse it.
  • Consumers can use the drug for self-diagnosed conditions. The drug is not intended for a condition that needs testing or a doctor’s diagnosis, such as high cholesterol. Instead, the drug treats a symptom that is obvious to the average consumer, such as 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, and the drug is easy to use. For example, the drug does not need a doctor to monitor and change the dosage.

In general, the risks or side effects of OTCs are low, how to use them is clear, they treat conditions that patients can easily recognize, and they give consumers greater choices.

Are OTC’s less expensive than prescriptions?
It depends. OTCs may be covered by your plan sponsor. If that is the case, you may only need to pay a copay for these drugs. Depending on your plan sponsor’s plan design, the copay may be less expensive than the cost of the OTC. Alternatively, your plan sponsor may not cover the OTC you need, but it may cover a generic version of that drug. In this case, the generic version is likely less expensive than the OTC.

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.

The myth of the perfect drug

June 28, 2010 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News

www.Medtipster.com Source: The Boston Globe – Christoph Westphal, 6/28/2010

If we focus too much on side effects, we might forfeit important new medications

WHEN IT comes to prescription drugs, patients expect benefits but appear intolerant of risks. What would happen in a world that accepts no risks in its pharmaceuticals? We would have very empty medicine cabinets.

Every June, 200 biotech and pharmaceutical CEOs gather in Boston. This year, the deputy commissioner of the Food and Drug Administration spoke to the group on the evolving risk-benefit analysis regarding prescription drugs. Much of the ensuing dialogue with the CEOs centered on society’s changing views of drug benefits and risks.

The first “wonder drug,” aspirin, was synthesized by Bayer in 1897 and marketed in 1899. This extremely rapid path from initial experiments to market is impossible to imagine in today’s world. Now, aspirin has some wonderful properties – it reduces inflammation, prevents blood from clotting, lowers fever, and lessens pain. Millions of Americans take aspirin every year, without a doctor’s prescription. However, side effects kill roughly 10 out of 100,000 men taking aspirin. In fact, it is possible that aspirin would not be approved today by the FDA, so dramatic is the shift in society’s risk-benefit views regarding pharmaceutical products.

That shift spelled the doom a few years ago of another drug with significant benefit, but some risk, namely Vioxx. Merck had shown beneficial effects of Vioxx in severe arthritis in thousands of patients, and the drug was approved. After Vioxx reached the market, however, the risk of death from heart attack, estimated by independent academics to be on the order of 20 to 30 out of 100,000 patients taking the drug, led Merck to remove Vioxx from the market. There are likely patients with severe arthritis who would accept the risk of side effects, in order to benefit from this effective medicine. But these patients no longer are able to make their own risk-benefit calculations. Instead, society has determined on their behalf that this therapeutic option should no longer be available to them.

How dangerous, in comparison to taking aspirin or Vioxx, is driving a car? According to the National Safety Council, the risk of dying in a car accident during one year is about 155 out of 100,000. The death rate of car usage actually appears a good deal higher than the likelihood of death caused by taking Vioxx or aspirin. Nevertheless, no one is arguing that cars should be taken off the market. Instead, society has decided that the benefits of cars outweigh their risks.

As society has shifted to a view that medications should have virtually no risks, the inevitable effect has been to reduce the flow of important new drugs. It is certainly fair to rigorously test any new medication prior to approval. In addition, any new drugs should be monitored for safety and efficacy after they have reached the market.

But society must be careful to weigh the benefits of effective new drugs for diseases that until now have been poorly treated, versus the added risks of the new medications. If we focus too much on the risks of drugs, and do not balance those risks against the benefits, fewer drugs will be approved and reach patients in need. That is a risk in and of itself.

On your next drive, remember that it may be riskier to get in your car than to take the drug Vioxx, which was shown to be highly beneficial to patients with severe arthritis, but has been removed from the market.

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