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Try it nowMegan has a master's degree in nursing and is a board certified Women's Health Nurse Practitioner. Her area of clinical focus is the impact of infectious disease on pregnancy. She has experience teaching college allied health classes. She is also a certified EMT and holds a certificate of added qualification in electronic fetal monitoring.
Your head is pounding and the nurse from your doctor's office has suggested you try a pain reliever, so you walk into the drug store. You make your way to the pain reliever aisle and you're confronted with row after row of options. Why are there so many brands? What's the difference between Tylenol® with an active ingredient of acetaminophen and the store brand acetaminophen?
According to the U.S. Food and Drug Administration (FDA), two medicines that have the same clinical effect and safety profile are said to have therapeutic equivalence. These two drugs, each from a different manufacturer, are known to have nearly identical properties and can be interchanged as needed.
These medicines are sometimes referred to as brand name medications and generic medications. According to the FDA, there should be no clinical difference between them, although patients often notice a difference in cost. This is what you're most likely to notice while you're in the pharmacy trying to find something to stop your headache.
The purpose of establishing if two medications are therapeutic equivalents is to allow the generic drug to go through a shorter, more cost-effective, approval process while still protecting public safety.
For a drug to be approved as a therapeutic equivalent it must:
Testing can be performed in vitro or in vivo. In vitro refers to when a test is done outside the living environment, sometimes referred to as test tube studies. In vivo refers to when a test is done on the entire living organism, such as when a drug trial is conducted on human participants.
Of note, these drugs do not need to have the same:
Sometimes, one of these will be of particular importance to a patient, and a physician may prescribe a brand-specific product.
The most important part of this is that the drugs have the same active ingredient. So, therefore, both Tylenol® and the store brand drug must contain acetaminophen, even though they will be produced by different companies. While acetaminophen and ibuprofen can both be used to treat your headache, because they are different medications they would never be considered therapeutic equivalents.
The FDA keeps a list (known as the Orange Book) of every approved therapeutic equivalent.
One prescription example would be combined oral contraception, also known as the birth control pill. While there are many formulations of oral contraception, the combination of desogestrel 0.15mg and ethinyl estradiol 0.03mg is available under the following names from different companies:
These various brands may come in different colors and packaging. But the expectation is that they can be substituted for one another with little difficulty.
Another example is the oral diazepam tablets (brand name Valium), often used for muscle spasms and anxiety. The tablets are available from the following companies:
As you can notice, not every company produces every approved dosage. The only requirement for therapeutic equivalence is that the dosages are the same as the original approved medication.
Several examples apply to treating your pounding headache. If you wanted an over-the-counter medication (OTC), meaning an option available without prescription, here are a few choices:
All right, let's take a moment to review what we've learned. While looking to treat your pounding head you notice the option to buy either a brand name medication or a generic medication. While these medications may have minor differences in their cosmetic features (such as their color, taste, packaging, preservatives, or release mechanisms), they must be equally safe and perform the same way clinically.
We learned that according to the U.S. Food and Drug Administration (FDA), two medicines that have the same clinical effect and safety profile are said to have therapeutic equivalence. Similar clinical performance means that they must have the same active ingredient, have the same amount of active ingredient, be taken via the same route, meet the same quality standards, and be bioequivalent (meaning the body is able to process it in the same way that the original drug was processed). They also must have been tested both in vitro, or when a test is done outside the living environment, and in vivo, or when a test is done on the entire living organism. They should also be labeled correctly and be made in a safe manner.
Examples of therapeutically equivalent medications are widespread and include both prescription and over-the-counter (OTC) medications, which are options available without the need for prescriptions. Commonly, medications are available from many different manufacturers and may be available under different names, as seen with different birth control brands. Other examples, such as with diazepam, are generally only known by their generic name but are still produced by different companies.
OTC options, such as we saw with headache medications, are also common. Options extend well beyond headache remedies and include members of nearly every class of medication, including treatments for allergies, stomach complaints, coughs, skin issues, and more.
Medications made by separate manufacturers but containing the same active ingredients are expected to behave in the same way. However, patients and prescribers can choose which medication they feel is right in any given circumstance. So use your best judgment when you pick your headache remedy.
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Introduction to Pharmacology29 chapters | 250 lessons
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