How Community Pharmacists Can Debunk Generic Medication Myths
Commonly, patients have read on the Internet that a generic medication may be anywhere from 25% more potent to 20% less potent than its brand-name equivalent.
As a practicing community pharmacist in an outpatient pharmacy for a local hospital, a day doesn’t go by without discussing generic medications with a patient.
In my experience, patients are not initially excited to discuss their barriers to adherence or their health literacy. When it comes to generic medications, however, it seems as though everyone has a strong opinion they are more than willing to share.
For what I believe are deep-seated cultural and anecdotal reasons, many individuals feel they are being offered substandard therapy when a generic medication is substituted for a brand-name product. When patients request the brand name, it is my store's practice standard to initially ask whether they previously had an allergic reaction to a generic version of this specific medication.
If no allergy has been present, then we will take some time to explain what a generic medication is. We describe how a medication that has been approved by the FDA for generic substitution has met rigorous standards regarding bioequivalence, strength, quality, potency, identity, and purity.
Commonly, patients have read on the Internet that a generic medication may be anywhere from 25% more potent to 20% less potent than its brand-name equivalent. This is a common misinterpretation of how medications are tested for FDA approval.
According to the FDA, a generic drug is considered bioequivalent to its associated brand-name medication if the 90% confidence interval of the mean of the area under the curve compared with the concentration curve and maximum concentration of the generic product is within 80% to 125% of the brand-name product.1
After reading this statement, anyone may conclude that a 45% variance in generic medications is possible. While this is not the time to define confidence interval testing, pharmacists can confidently tell a patient that this type of variation in generic medications does not exist.
In fact, the FDA retrospectively studied its generic drug testing data from 1996 to 2007 and found no more than a 3.5% difference, on average, between the brand-name medication and its generic equivalent. It is important to note this 3.5% difference remained the same when the brand-name medication was tested against another batch of the same brand-name product.2
When a patient requests a brand-name product, it is important to decipher specifically why they do not want to take a generic version. This creates an opportunity to educate the patient regarding the FDA testing process and generic equivalence standards. Rarely will a patient present with a true allergy to the inactive ingredients in the generic medication.
Quite often, it just comes down to some deeply ingrained theory that generic medications are somehow lesser therapy than brand-name ones. Some patients are convinced that if they use a generic drug, they will not have an appropriate therapeutic response
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or worse, experience a negative side effect.
The mind is a powerful tool, so if patients are convinced a medication will not work for them, chances are they will be able to find some sort of uncomfortable side effect from that particular treatment.
As a practicing community pharmacist, taking time to provide authentic education may help a patient understand the generic process. Presenting the education through a trusted relationship may allow the patient to accept the generic medication with an open mind and increase the potential for a positive health outcome.
References:
1. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf
