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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.

Unexpected Abuse of OTC Medications

November 18, 2010 By: PharmaSueAnn Category: Medtipster

“Skittles” not to be mistaken for the sweet, fruit flavored candy, is one of the street names for dextromethorphan also known as “poor man’s PCP” .  Dextromethorphan can be found in many cough and cold medications and are being taken in higher than recommended doses.   High doses of cold products can be fatal.

“OTC Methadone”  people are taking high doses of Loperamide, an OTC drug used to treat diarrhea, is being used for opiate withdrawal.  This has the potential to cause CNS depression and intestinal blockage

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