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 Dr. Schachter, can you tell us the difference between a generic drug and a brand name?
The primary difference between a generic and a brand name drug is in the materials that are used to make it into a pill or a capsule. The active ingredient is identical. It's how that active ingredient is packaged with the different kinds of materials that are used to make pills and capsules.
It's those differences that change how that active ingredient is applied into the body and results in its effectiveness.
What is bioequivalence?
When you swallow a pill, it needs to get absorbed through the stomach or the intestines. It then goes through the liver where it might be changed or broken down to some extent and eventually gets into the brain. But the amount that gets into the brain versus the amount that was swallowed.
The extent of that difference might be different between a generic and a brand name medication. So we refer to the amount of medication that's in the body versus from one preparation to another as the equivalent or the bioequivalence. And the FDA will allow that difference to be within a certain range between a brand name drug and a generic drug. But the difference between one generic drug and another generic drug of a brand name could be substantial.
The Foundation's current position is opposing mandatory substitution of medication. Can you talk a little bit about that?
The Foundation advocates on behalf of people with epilepsy. It takes a position that is most consistent with seizure freedom without side effects and also empowering individuals to know exactly what it is that they're taking.
I think the communication lines would be open if one or the other party initiates the conversation. The problem I see is that physicians are not as aware of the laws in their state as they need to be. They think when they write “no substitution,” the patient is getting the brand name. That may not be the case.
And because there's the possibility that switching from one generic to another generic version of a brand name medication or from the brand name to a generic or generic to brand name because there's a potential in that switch of either a break through seizure or side effects, the Foundation's position is that such substitution at the pharmacy or by the drug supply company should be with the full knowledge and approval of the patient as well as their physician.
What are the factors a patient and a doctor should consider when switching from a brand name to a generic drug?
If the decision is made to substitute a generic version of a brand name medication, depending on what specific medication is involved, there may need to be the possibility for blood tests to determine if the dose of the generic form needs to be adjusted.
This same consideration will be true the next time the patient fills a prescription if they get a different generic version of that same drug. So the discussion between the patient and the physician should include the possibility of side effects occurring if the level of the drug rises in that patient or seizures as the level decreases.
They should also discuss blood tests. Whether not only the medication that was switched needs to be checked in terms of a blood test, but if the patient's on another seizure medication, that may need to be checked as well because of the possibility of drug/drug interaction.
So switching between brand name and generic or generic and brand name can result in changes that need to be anticipated, discussed, weighed in terms of the risks versus the benefits. And then what monitoring or what additional moderations might be necessary just to be sure everything's okay.
Are there special considerations for someone with epilepsy switching from brand to generic?
Well, generic seizure medications are cheaper than brand name medications. So that advantage of generic medications holds for seizure medications as well. However, the problem is in the difference between different generic versions of brand name medications, how much the body absorbs and how much gets in the brain.
The difference between two different generic versions can be substantial. That difference in another therapeutic area may not have any potentially serious health consequence. If your cholesterol level rises five points that isn't necessarily as serious to that person as the possibility of a break through seizure if somebody's crossing the street and then gets hit by a car.
We want to be as sure as possible about exactly what our patient is taking, have measured the concentration of that in the patient's blood, and know exactly how much of the medication they're getting. Now, if you change to a different version of that same medication, everything needs to be rechecked. It potentially puts that patient at risk.
Again, the risk is not of their cholesterol level going up five points, but the possibility of a side effect where they may fall down and break a hip or a seizure that could be potentially serious if not fatal depending on the circumstances when it occurs.
So what's unique about epilepsy is the potential severity of the consequences of under treatment or over treatment as opposed to some other health conditions.
If people with epilepsy are concerned about the possibility of their medication being switched, what should they do?
The patients need to know what the law is in their particular state. What flexibility does the pharmacy have to substitute a generic if the physician writes brand name only, no substitution? If they are prescribed the generic, then they need to know that. I've had several patients who thought they were getting a brand name medication, only to come home from the pharmacy with a generic version.
And if it's at all possible for them once switched to a generic to stay on that same company's generic version, month after month, that would be ideal. But if the pharmacy switches to a different manufacturer's version of that same generic, they need to know that. Because that might result again in the blood level of that drug going up or down, potentially leading to serious consequences.
Do you find that communication channels are open most of the time – between doctor and patient and pharmacist?
I think the communication lines would be open if one or the other party initiates the conversation. The problem I see is that physicians are not as aware of the laws in their state as they need to be. They think when they write “no substitution,” the patient is getting the brand name. That may not be the case.
On the other hand, the patient who has taken pills for months if not years, sometimes thinks that they're getting the same thing month in and month out. And so what I find is that oftentimes neither the patient nor the physician asks exactly what was dispensed, assuming what was dispensed is what they thought that they were getting or what they thought they were prescribing. And many times that's not the case.
Patients need to ask. They need to ask the pharmacist. Move over to the consulting area in the pharmacy and ask is this the same medication I've been getting all along? Is it from the same manufacturer? If the answer's no, then they need to contact their physician and be sure it's okay for them to take that medication.
And ask if they should come in for a blood test? And if so, when? Or what symptoms should they be on the look out for. Ask questions. Assume nothing. Assume that you need to learn and check every time you pick up a new bottle of medication. What is the relation of this to what you were just taking before?
The Epilepsy Foundation is taking a fresh look at all of this. Why? And what direction is the Foundation planning to take?
The Foundation wants to understand the scope of this problem. They want to know if this continue to be a problem for people with epilepsy. Has it caused health consequences? Are there more side effects? More seizures? Are there ways to know in advance who is at particular risk of this occurring?
How knowledgeable are people about generic medications and about the differences between different versions of the generic of a same brand name? It's not an easy topic to understand. And it does take some discussion. The Foundation is going to be conducting a survey to better gage the knowledge level of people who take seizure medications about all these issues.
On that basis, the Foundation will determine what further education needs to be put out there. So that patients with epilepsy are educated consumers and knowledgeable about the potential risks and benefits of the medication they're taking.
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