David L. Girouard, MPH, R.Ph. [February 03 2011]
Questions surrounding use of generic medications are very common for the pharmacist. It's a good sign that individuals are concerned about medications they use. Some individuals may believe that because generic medications are inexpensive compared to brand name that they must somehow be of inferior quality. To understand the cost difference we need to understand how drugs come to market.
When a pharmaceutical company patents a new medication, it has 20 years to market exclusively that drug. However, it takes a lot of time to satisfy FDA requirements for bringing a novel medication to market and in the end, pharmaceutical companies typically have about 12 years of marketing exclusivity. During this time, they need to make back the expense of development and marketing, and of course, make a profit. Once a medication's patent expires, other manufacturers are free to develop and market generic versions of the brand name medication. The generic versions are less expensive since the manufacturer does not have to recoup costs borne by the brand name product's maker. Competition also plays a role in minimizing costs, as there may be several generic version producers.
The FDA closely regulates all medications' production, including generic medications. The FDA requires strict testing of proposed generic medications and manufacturers must prove these drugs are bioequivalent to the brand name product. Bioequivalence means that the active ingredient is delivered to the patient's blood stream to the same extent as the brand name medication. Large studies have shown that most generic medications have bioequivalence very close (within 5 percent) to the brand name product. Pharmacists may only substitute generic medications the FDA deems as bioequivalent.
Nonetheless, users of generic medications should be alert to any differences they may experience when switching from a brand name product. While a generic medication's active ingredient is exactly the same as the brand name product, the generic version may have different ingredients like fillers, binders and dyes. Of special concern is when a person is switched from brand to generic version of a drug that requires close monitoring of blood levels. For some drugs, certain blood levels must be maintained to achieve the medication's desired effect while minimizing side effects. It's generally acceptable to switch from brand to generic for these medications but your doctor may require you to have blood level checks.
If your doctor is concerned about risk of converting to a particular generic product he/she may indicate on the prescription that the brand name is medically necessary. The pharmacist should make you aware anytime the medication you are given has been changed in any way. Patients should always be on the lookout for changes in medications and should not assume a different looking medication is really just another generic version of their medication (mistakes do happen!).
I think generic medications should be thought of as “inexpensive” vs. “cheap.” FDA-approved generic medications are of good quality and provide a better value to the consumer.
Pharmacist David L. Girouard is director of Pharmacy at The Hospital of Central Connecticut (HCC).