How to Discuss Brand vs. Generic Drugs With Your Patients
All of us who’ve been in practice for a while have taken care of patients who insist on either a branded product or a specific generic manufacturer for at least one of their medications. As pharmacists, it’s important not only to be on top of the differences and similarities between these, but also to communicate this information to patients in an effective way. Let’s explore ways we can discuss branded and generic products with our patients.
What is a generic drug?
The FDA requires generic drugs to be approved through an Abbreviated New Drug Application (ANDA) and to be therapeutically equivalent to the branded product. “Therapeutically equivalent” means it can be expected to have the same clinical effect and safety profile as the prescribed product, and so generic drugs must contain the same active ingredients, dosage form, strength, and route of administration.
Inactive ingredients, however, do not have to be the same with generic products. Authorized generics do have the exact same components, including inactive ingredients, as the branded product, and are either manufactured by the same company that manufactures the branded product or by a company that licenses the formula from the manufacturer of the branded product.
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Generics play a key role in ensuring medication access, having saved $313 billion in 2019 and accounting for 90% of prescriptions filled in 2018. However, there is some evidence generic drugs might not always act the same way as their branded counterparts. A 2017 study, for example, found a higher rate of adverse events among patients taking generic versions of three different blood pressure medicines, although earlier studies have not found a difference between brand and generic medications.
As most of us know, the FDA’s Orange Book contains the full list of generic products and their branded counterparts. To define therapeutic equivalence, the FDA uses therapeutic equivalence codes. Many of us probably hear and use the phrase “AB-rated” a lot, but there are quite a few more codes than that.
The FDA defines the codes as:
AA, AN, AO, AP, and AT: There are no known or suspected bioequivalence problems.
AB: Actual or potential bioequivalence problems have been resolved with adequate in vivo or in vitro testing.
Codes starting with “B”: These are drug products the FDA considers not to be therapeutically equivalent, because actual or potential bioequivalence problems have not been resolved with adequate in vivo or in vitro testing.
Are there differences in efficacy or side effects between brand and generic drugs?
The vast majority of people do well on brand and generic drugs. However, there are notable differences that should be taken into account when discussing these products with your patients.
First, many states have negative formularies that require the pharmacist to dispense the prescribed product, unless certain conditions are met. This is especially common for medications like levothyroxine or warfarin, where even switching from brand to generic, or between generic drug manufacturers can affect some patients. Still other patients might have an allergy or intolerance to an inactive ingredient in a branded or generic drug, and will require a specific manufacturer that does not include that ingredient.
Finally, there are many patients that feel a generic drug did not work for them or have concerns about their safety. Given the recent news of lack of oversight, lack of transparency, and numerous high-profile recalls (like the string of recalls involving contamination with NMDA from manufacturers that changed processes without a full evaluation), it’s no surprise we have patients hesitant to take generic drugs.
Caring for your patients
When patients are hesitant to take generic drugs or have had a bad experience with a generic drug, I find the following tips to be helpful.
Find out their primary concern
Some patients might have heard bad things about generics, others might have had a bad experience, and others might have concerns completely unrelated to generic substitution.
I once spoke with a patient who insisted we had made a mistake because her last bottle was filled with amlodipine, but her new bottle was filled with “amlodipine besylate.” On the surface, it just appeared to need explanation, but when I dug deeper I learned that the patient was worried about the medicine not working. However, she was not resting before taking her blood pressure and using an incorrect measurement technique.
After discovering her real concern, it was easier to help the patient work through it. I took that opportunity to also encourage her to tell her provider everything she told me.
Consider authorized generics
If insurance will not pay for a branded product or it is too expensive, but the patient will not take or is very concerned about taking a generic product, consider discussing the authorized generic with them. Because the formula is exactly the same, it might allow them to feel at ease while also saving money.
Let them know the price of the brand
It’s our role to empower patients and give them the information they need to take care of their health. Saying a drug is “too expensive” is shortsighted. For some patients, just $5 might be more than they can afford, but others may be willing and able to easily spend hundreds of dollars per month. Run the claim through their insurance so they know what their cost difference will be.
Order the manufacturer they want, as allowed
While some companies restrict ordering noncontracted generics, it is best to order the manufacturer the patient is comfortable with, if possible. This will help adherence and outcomes, while also helping the pharmacy with sales.
Many patients might only want a specific manufacturer of one medication, but are willing to get everything else filled at the pharmacy that will accommodate that request.
On the other hand, be sure to avoid the following:
Dismissing their concerns: That not only erodes their trust in you as their pharmacist, but for the reasons described above, there are some legitimate concerns patients might have about generic drugs. Ultimately, the decision to take a branded or generic drug is the patient’s, not ours.
Oversimplifying: Patients might ask you if the “generic works the same as the brand.” Giving them the whole picture will build trust and can help them stay on a generic product, knowing they can go to you with their questions. I often advise patients that generics are required to have the same active ingredients, but are allowed to have different inactive ingredients. I also tell them most people do very well on generics, but that I have occasional patients who feel it does not work for them.
The bottom line
Generic drugs play an important role in lowering costs and improving access to medications. When patients are concerned about generic drugs, understanding their entire story and following these guidelines will help you gain patients’ trust and keep them adherent, whether they choose a brand or generic drug.
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