Generic vs Branded Psychiatric Medications: Is There a Difference?

Jane Lowers; Robert H. Howland, MD

Disclosures

April 25, 2012

In This Article

What to Tell Patients

Medscape: Taking personal bias out of it, what can clinicians reasonably tell patients who are concerned about branded vs generic agents?

Dr. Howland: For products that have been classified by the FDA as being bioequivalent, in the absence of strong evidence suggesting that a generic product truly is different, I think a physician really has to assume that the generic will work as well as the brand-name agent.

If you are practicing medicine on the basis of case reports and anecdotal science, I think that's rather limiting in terms of what you would expect of a treatment. Anecdotal reports that get published are on things that are necessarily very negative or extraordinarily positive. A physician has to accept that the standards by which drugs are evaluated and classified as generics are based on solid science. And, unless there's strong scientific evidence otherwise, clinicians should try to convey to patients that trying a generic medication is perfectly fine -- that you personally don't see a problem in using it and you've had experience in using it -- and to try and convey that to patients, to take a very positive approach.

Obviously, where a patient might be fearful, try to be reassuring about the change. It's also prudent when you go from one product to another to have a phone call or contact with the patient to check up on them, just to reassure them.

For some medications, such as anticoagulant treatments, where there might be a bit more of a safety concern, clinicians should perhaps monitor a patient a little bit more closely if there is a switch from one product to another. But for most products, and certainly in psychiatry, I don't think that any patient or physician should be genuinely concerned that switching from a brand-name to a generic drug is really going to lead to a loss of effect or a significant adverse effect.

Medscape: Do questions arise about the inert ingredients in a generic formulation?

Dr. Howland: According to FDA guidelines, generic products have to look different than the brand-name product. It's possible that the inert ingredients used in formulating a generic drug will affect its bioavailability, but that's why the bioequivalence studies are conducted. When a company is developing a generic drug, they have information about the active ingredient of the brand-name product, but they have to formulate it on their own. They don't get assistance from the brand-name manufacturer of the original innovator drug formulation because it is proprietary information.

Another concern, obviously, is that sometimes the formulation might contain dyes or something that a person might be allergic to. That is a more genuine concern about differences in pill formulations -- if a person has some type of a sensitivity to one of the ingredients that's usually used to create a tablet, such as the coloring.

I've seen patients who switched formulations and developed what appeared to be an allergic hypersensitivity reaction. In that case, they need to go back to the formulation that they seemingly had tolerated.

Medscape: Another factor that has been discussed as a reason for changes in response is adherence. This is always a concern with medication for chronic conditions, such as depression.

Dr. Howland: Not taking medication reliably is a common reason for relapses, but it is difficult to quantify how often this happens and how quickly it might happen. For most drugs and most people, changes in levels of depression are probably more gradual rather than abrupt. But there are some patients whom I've seen who have stopped taking a given medication and have very rapid, profound mood changes. When you restart the medication, they feel better.

For most people, though, it's more of a gradual process. My guess is that it's probably not too different than what you would think of in terms of epilepsy. Not all patients with epilepsy who stop taking their anticonvulsant will immediately have a seizure. Some patients will, but for others, it may be a long period.

So, medication may be totally suppressing the risk for some event, but you don't really understand or know what the time course of that event is, whether it's relapsing into depression, becoming manic, becoming psychotic, or having a seizure.

In terms of adherence and how that may influence whether a patient does well with the medication, cost is always a consideration, too. There's some evidence to support the observation that patients taking very expensive medications or having high co-pays are more likely to skip doses or to miss doses, or to miss refills, than patients who are taking a medication that's very inexpensive, where they don't really have to worry about the cost. On the basis of this, the availability of relatively less expensive generic drugs will increase adherence to treatment.

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