Generic drugs are an essential part of our healthcare system. Approximately 80 percent of prescription medications are generic, and a large percentage are produced overseas. Although generic drugs help control healthcare costs, they raise other complex and often overlooked issues. These complexities, some of which are identified below, underscore the importance that consumers are informed and aware of the drugs they are prescribed.
How are generic drugs different from their branded counterparts?
- Generic drugs are not required to contain the same ingredients in the same proportions.
- The process by which generic drugs are made may be different.
- Generic drugs are not subject to the same level of testing.
- Generic drugs may have a different shelf life.
- A generic drug may be 20% weaker or 25% stronger than its branded counterpart and still be considered bioequivalent. This means the average patient may absorb into their blood stream as little as 80% or as much as 125% of the active ingredient compared to the branded drug.
In most cases, a generic drug is not “identical” to its branded counterpart. Approximately 90% of generic substitution occurs at the pharmacy, according to the Department of Health and Human Services. As such, a consumer must evaluate his or her medication independently of the branded counterpart. Here are some ways to do this:
- Educate yourself about your medication.
o What are its expected side effects?
o Were there any recalls?
o Ask your Pharmacist who made the medication, where it was made, and whether he or she is aware of any manufacturing problems.
o Ask your Pharmacist if there are alternative manufacturers. Frequently, there are multiple generic manufacturers for each drug.
- Visit FDA’s website. FDA compiles safety and other useful information about drugs, such as potential side effects, past recalls, and known quality problems.
- Report quality issues, side effects and adverse events to FDA, the manufacturer, and your physician. This allows FDA to detect quality issues.
An informed patient is an empowered consumer. The more you know about your medications, the better choices you will make about your health.