Saturday, July 13, 2024

What’s the difference between branded and generic medicines

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Q: When one of my medicines became available as a generic, my insurance plan forced me to switch. Ever since I haven’t felt the same. My doctor insists that it is the exact same medicine, but if that’s so, why doesn’t it work as well?

Generic medicines are considered equivalent to their brand-name counterparts but are not identical. Although the Food and Drug Administration (FDA) requires all generic drugs to meet the same standards as brand name products, they DON’T have to match them in every way.

Before they can sell a generic version of a medication, their manufacturer must show the FDA that their product contains the same amount of active ingredients at each strength that the brand name comes in. Generic medicines must also match the form and route of administration of the original or “innovator” medicine, whether it’s a tablet, capsule, liquid, or injection.

In addition, the manufacturing processes, quality control, and testing for generics must meet the same standards as branded medicines. Some generics are even made in the same facility as the branded version.

Generic drug manufacturers must prove to the FDA that their generic is equivalent to the original branded medicine. They do this by testing human volunteers' blood after taking each version. If the blood levels from the generic and brand are similar, the FDA assumes that the generic medicine will work the same as the branded one.

The active ingredients of generics must be equivalent, but the inactive ingredients don’t have to be. Sometimes those differences change the way you absorb your medicine. Just like meatballs contain more than just meat, tablets and capsules can contain more than just their active ingredient.

When a medication's dose is a tiny bit of powder, more volume will be needed to create a tablet or capsule. The added powder is called a filler or diluent. Lactose, sucrose, kaolin, powdered starches, and cellulose are examples of fillers.

Food coloring can be added to medicines, causing reactions in people sensitive to dyes. An adhesive compound called a “binder” is usually added to help the powdered medicine press into a tablet. Binders work similarly to the raw egg in a meatball recipe: by assisting the meat and rice to form into a ball.

Generic manufacturers use less expensive versions of fillers, dyes, and binders, allowable by the FDA as long as the active ingredient is the same concentration as the original medicine. Making generic versions of extended-release or long-acting forms is more complex than duplicating a simple tablet. It's trickier to get the generic versions of these to act the same as the original.

With most generics made overseas, the COVID pandemic disrupted the supply chain of generic medicines. Many pharmacies couldn’t get medication from the generic manufacturer they typically used before COVID. Rather than run entirely out, pharmacies had to order drugs from unfamiliar manufacturers. Most generic medicines are made outside the country, where there is little control over the product's source or manufacturing quality.

4 Tips on Taking Generic Medicines:

1.           Check your pills BEFORE you leave the pharmacy.

Don't assume a different shape or color is "just another generic." Because generic medicines don't have to match the appearance of the branded version, the color or form can change whenever your pharmacy uses a different manufacturer. Check for and challenge any changes in your medicine's shape or color to ensure you have the correct medication in your pill bottle.

2.           Double-check with Google.

When getting medications by mail, you can double-check their identity at home. In a Google search box, type the shape (round or oblong), color, and any markings you see on the pill. If there is a line across the tablet, add the word “scored." You will get names, doses, and color images that you can use to match up to your mystery pills. If you are still unsure, call your pharmacy to double-check what should be there.

3.           Ask your doctor.

Let your doctor know if you have a poor experience after switching to a generic medication. If your doctor documents the problem, you may qualify for an exception from your insurance company. Many insurance companies will let you return to your original branded medication with appropriate documentation. However, sometimes they will charge you a higher copayment.

4.           Report it.

If you notice a difference when switching from a brand name medicine to the generic version, ask your doctor to report it to the FDA. The FDA’s MedWatch program tracks any adverse events caused by medicines.

Dr. Louise Achey, Doctor of Pharmacy, is a 43-year veteran of pharmacology and the author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Get clear answers to your medication questions at her website and blog, TheMedicationInsider.com.

Ó2022 Louise Achey

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