What’s in a name? If we’re talking about cars, toilet paper or athletic shoes, a brand name might mean the difference between a really great and just so-so — or even downright terrible — experience.
However, when it comes to prescription drugs, there may not be as much a difference between the highly marketed, brand-name and generic products as you’d think. In fact, other than cost, there may not be any difference at all.
“A generic drug is a medication that is the same as an already marketed, brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use,” says Aravinda Thatte, PhD, a pharmacist with Sharp Rees-Stealy. “In other words, a generic drug has to demonstrate bioequivalence, which means it works the same way and provides the same benefit as its brand-name version.”
According to Thatte, the U.S. Food and Drug Administration (FDA) conducts rigorous reviews before approving generic drugs to ensure that they perform the same way as their corresponding brand-name drugs. Any differences between the two are medically insignificant, and regulated by the FDA.
“Sometimes, patients may be confused when they find that a generic medication looks different from the brand name they had before,” Thatte says. “The obvious questions that follow are whether it is the same and will it work the same way, without unwanted side effects.”
To receive FDA approval, the active ingredient — what makes the drug effective — should be the same in the generic drug as the brand drug. The generic drug manufacturers also need to present evidence to show that they work the same way inside the human body to produce the same clinical effect as the brand drug.
When to stick with the brand-name drug
Certain medications have a narrow therapeutic index, which means that small changes in dosage or potency may harm the patient. Other medications may need very fine dosage adjustment over a period of time to produce the desired clinical benefit.
In these cases, changing out a brand-name drug to a generic drug might lead to undesirable outcomes. Your pharmacist can help decide whether it is prudent to continue the brand medication or safe to switch to a generic alternative.
“Pharmacists are the most accessible health care professionals who have all the necessary information about drugs and their active ingredients,” Dr. Thatte says. “Patients should always reach out to their pharmacists with questions regarding their prescription and even nonprescription medications to make sure that they are receiving what is intended for their therapy.”