It is a situation that pharmacists see on a routine basis – patients asking for generic drugs or some other less expensive alternative to the name brand drug their physician has prescribed.
If patients have any questions about generics, pharmacists should explain to them that generics offer the same quality and the same result as name brand drugs. The U.S. Food and Drug Administration (FDA) rigorously tests generics. The generic form of the drug must have the same medicine with the same active ingredient, strength and dosage as the name brand it is substituting for. Generics can save a patient between 30 to 80 percent of the cost of the name brand drug.
Federal and state governments give pharmacists a good deal of discretion in substituting generic drugs for name brand pharmaceuticals to help control the cost of medications. Pharmacy organizations encourage pharmacists to substitute when possible to control costs. So knowing when and when not to make a substitution are important for the pharmacist to know.
Fortunately, pharmacists can rely on a publication of the FDA called the Orange Book, which explains what drugs can be substituted for other drugs. The book does not cover all of the drugs sold in the United States, but drugs not included can still be substituted if the pertinent criteria are met.
The regulations governing generic substitutes vary by state, so pharmacists need to have knowledge of the different laws applicable in each state.
Most pharmacists already know that the Orange Book shows whether generic forms of a drug are in fact considered to be equivalent to a brand name drug. But pharmacists also need to be aware that the Orange Book is not totally comprehensive. The only drugs listed in the book are those that have been labeled by the FDA as new drugs. Drugs that have not been approved are not listed.
There are some drugs still on the market – Phenobarbital, for example – that have not received this new drug approval from the FDA. That’s because they came on the market before the Federal Food, Drug and Cosmetic Act was passed in 1938.
The government allowed these drugs to stay on the market without requiring the makers of the drugs to provide evidence of their safety. Pharmacists also need to be aware that the Orange Book does not contain any drugs made between 1938 and 1962. These drugs are considered safe, but during this time period, makers were not yet required to prove the drugs were effective for their intended use.
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