Generic drugs may save you money, but are they really the same as brand medications?
It’s a question many people ask, especially when they have to be on long-term medication for chronic conditions.
Some groups have raised questions about the government’s requirements for proving a generic drug acts in the same way as the brand-name drug.
Learn more about the safety and efficiency of generic drugs from medication specialist Laura Balsamini, Director of Pharmacy Services at Summit Medical Group.
Balsamini is an expert in managing medications and advises physicians about drug use and control and will share her insights about brand drugs versus medications on a special SMG radio podcast.
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Generic Vs Brand Name Medications: Is There a Difference?
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Learn more about Laura Balsamini
Laura Balsamini, Pharm D., BCPS
Laura Balsamini, PharmD, BCPS, specializes in medication therapy management, drug use and drug safety review, and continuing pharmacotherapy education for physicians. As Director of Pharmacy Services for Summit Medical Group, Dr. Balsamini advises physicians about drug use and control. She also develops and evaluates clinical guidelines for medication protocols. Dr. Balsamini teaches patients about the benefits and side effects of their medications as well as the importance of taking medications as prescribed.Learn more about Laura Balsamini
Transcription:
Generic Vs Brand Name Medications: Is There a Difference?
Melanie Cole (Host): Generic drugs may save you money but are they really the same as brand medications? It’s a question many people ask, especially when they have to be on long-term medication for chronic conditions. My guest today is Laura Balsamini. She’s the Director of Pharmacy Services for Summit Medical Group. Welcome to the show, Laura. So, tell us a little bit about the inclination of generic drugs or how they came about in the first place.
Laura Balsamini (Guest): Sure. Well, thanks for having me on today, Melanie. Generic medications really came into the spotlight back in 1984 via the Hatch-Waxman Act which was signed into law and really created greater access for patients to have generic drugs enter the market and greatly expanded access to important lifesaving drugs, making it more affordable. It’s generated more than $1.2 trillion dollars in savings to the healthcare system when we look at just a 10-year period between 2003 and 2012. It’s benefitted the health and well-being of innumerable lives since that 1984 law.
Melanie: Wow. That’s a lot of money saved. So, why are they cheaper?
Laura: Okay. So, that’s a great question. They’re cheaper because generic drugs do not have to undergo the same animal and human clinical studies that brand name drugs have to go through. In addition, generic medications are not subject to all of the expensive marketing and promotion that we see with brand named drugs. That saves a lot of money in their coming to market and allows them to be priced at 80-85% less than brand name medication, making it much more affordable.
Melanie: So, are they the same quality? And I think this is the question everybody wants to know. Is there a difference in the products that are used to make them? Is it the same quality? Or are they really different?
Laura: That’s an excellent question and I know that’s the burning question on so many patients’ minds. As a pharmacist, I’ve had so many patients come to me and ask, “Laura, it’s a copy. Is it really the same? Is it the same quality?” And my answer is always to them that, thankfully, we have our food and drug administration which requires generic drugs to have that same quality and performance as a brand name drug. So, when a generic drug product is approved and it does go through a rigorous process having to show that it is the same identity, the same strength, quality, purity and potency as a brand named drug. However, there might be some variability that occurs during manufacturing but that also occurs for brand name manufacturing as well. When a drug, whether it be generic or brand, is mass produced, we’re going to see some variations in purity, in size, in strength and other parameters as permitted. But again, generic drugs are required to have the same active ingredients, the same strength, the same dosage form, the same route of administration as the brand named products. The only difference here, though, is they do not need to contain the same inactive ingredients as the brand named products. But, otherwise, they have the same efficacy, safety and quality based on this testing process.
Melanie: Great answer, Laura. Are there any situations that would require special consideration? Are there any people who you would just say, “You know what? I don’t want you on the generic drug because you have a certain condition or disease?”
Laura: Well, there are few medications that fall into what we call a narrow therapeutic index category and for these medications, we would consider that potentially changing a patient from the brand to the generic may actually impact the therapeutic effect. So, really it’s just maybe five medications that fall into that category. Other than that, we always recommend to patients if a generic is available that we would certainly want them to try it. The benefit being that, again, it would be 85% less and save the patient a lot of money because there are so many healthcare costs out of pocket for the patient as it is. So, this is a great opportunity for them to save money and at the same time, have the same effect from a generic medication as they would from a brand name medication.
Melanie: As you said, the inactive ingredients are what seem to differ but the active ingredients are pretty much the same. So, why do they look so different sometimes? Is it because the fillers, preservatives, things that they do to the medications a little bit differently?
Laura: Again, yes. So, within the manufacturing process those inactive ingredients, again, may contribute to the dye and the coloring of the tablet. The manufacturing plants use different machinery and, therefore, may create a different tablet that has a different shape. That’s a question that comes up often from patients and I always encourage them, if the medication looks different then always ask so that we can confirm and verify that you do have the correct medication because they may be round verses oval or tan verses white. There will be those variations but they can be assured that, especially asking the pharmacist, is this the same medication? They can count on getting an accurate answer to that.
Melanie: What happens when a brand name goes generic? So, if something that we’ve been used to, Cipro or something along those lines, you know, you’ve been hearing it and now all of a sudden your pharmacist gives you the generic of that. Do you feel confident that now it’s gone through whatever it had to go through to become generic now?
Laura: Yes. Again, any generic that is available to us here in the United States is only available to us because it has gone through the FDA approval process. When a brand name medication comes off the patent, there is generally one generic manufacturer that releases products first and for the first 6 months, that will be the only generic available. So, again, because of market competition that pricing being that it’s just one generic manufacturer, will not be that much lower than the brand named drug. It also gives that first 6 months’ time to introduce it to patients, that they become aware that there is a generic available for it. Then, after that 6 months exclusivity of that one generic manufacturer, we’ll see increased competition which further drives the price down and that’s where patients may start to see a different tablet size or shape. Here, again, the market competition is key to driving the prices down to the healthcare system and the patient’s pocket.
Melanie: Is that true for over-the-counter drugs as well?
Laura: Over-the-counter drugs are also subject to the USFDA standards as well and here the generics that are available over-the-counter are also under the scrutiny of the FDA, so patients can be assured that they are meeting quality standards through their manufacturing plants by the manufacturers themselves as well.
Melanie: So, Laura, why do some people say, “I can’t take the generic because it doesn’t have the same effect on me,” or “It doesn’t work as well.” And I know that for some medications, seizures or arrhythmias, some of those blood thinners, maybe, that there are certain reasons that you stick with the brand unless you talk to your doctor, but why do we hear some people say, “Oh, I wouldn’t take the generic. It doesn’t work as well,” or “I have a bad reaction to it”?
Laura: Yes, we hear that often. Here, again, I have to go back to explaining to patients that these generics, when they are undergoing testing, they do bioequivalency testing. So, what is meant by that is, they have to show that the medication has no more than a variability within a window of 10% either way. That’s no different for brand name medications. These medications, if they cannot prove that they are bioequivalent--So again, taking the medication, gets into the bloodstream, is absorbed and then hits a certain concentration, if the generic medication is not proving that as being equivalent to the brand name, it would not be available to us. So again, it’s just really an educational point for patients, that once you start explaining to them these details that they become more comfortable to try the generic medications. I have to say, in this past decade especially, patients have embraced them more and more because of the increased cost out of their pocket for spending on healthcare in general. I also suggest to them not only to speak with their pharmacist to have these conversations but to their physician as well. So, that also provides them with peace of mind to know that, you know what? I can try this and it is safe. Then, naturally, if there are some instances where the patient does have a different response on a generic, then absolutely we would revert them back over to the brand name product.
Melanie: Well, I know I’ve been shocked before when I’ve gone through the drive through to collect something and it’s been so expensive and they’ve said, “Well, that one’s not available in generic,” and I go, “Well, then why did my doctor prescribe that?”
Laura: Right. Right. Yes.
Melanie: You know, it’s a question we all say to ourselves. So, in the last few minutes, Laura, if you would, give listeners really what you’ve been screaming to tell them about generic versus brand that you wish you could tell everybody standing in line and get them to understand about these differences.
Laura: Yes. Here, I would say, number one, that we have to have trust in the fact that these generic medications have undergone rigorous testing and have proven to be equivalent to brand name products; that there is no need to have this fear of trying them. I, myself, have my dad taking generic everything. He’s super happy because he’s saving a lot of money out of pocket and there’s the benefit of that to be able to have those extra dollars for other expenses such as co-pays when they go to the physician or their premiums on their healthcare plans as well. I would also enforce and suggest to patients that they have the conversations with their pharmacist because the pharmacist is a plethora of information on generic medication. They know, for example, if something is not available generically, what an alternative might be and I know patients feel very comfortable speaking with the pharmacist and then from that point, they can bring that information back to their physician and engage in that conversation; to say, “You know what? My pharmacist told me I could try this generic instead of this brand name product. Is that something that we can explore together?” So, it’s just getting into those conversations and raising awareness and, again, it’s the savings piece. I mean, the healthcare industry in this country cannot sustain the pricing of brand name medications when there are generics available that are up to 85% less. I mean, if there’s a medication that’s $8 a tablet verses 20 cents a tablet and it has the same equivalency and outcome, it’s a no brainer, really. So, I just offer to patients those suggestions and examples and I think that overall we have a lot of opportunity to continue to educate our patients and engage them to take control of their spending and this is a prime area.
Melanie: Absolutely great advice. Thank you so much, Laura. You’re listening to SMG Radio for more information you can go to SummitMedicalGroup.com. That’s SummitMedicalGroup.com. This is Melanie Cole. Thanks so much for listening.
Generic Vs Brand Name Medications: Is There a Difference?
Melanie Cole (Host): Generic drugs may save you money but are they really the same as brand medications? It’s a question many people ask, especially when they have to be on long-term medication for chronic conditions. My guest today is Laura Balsamini. She’s the Director of Pharmacy Services for Summit Medical Group. Welcome to the show, Laura. So, tell us a little bit about the inclination of generic drugs or how they came about in the first place.
Laura Balsamini (Guest): Sure. Well, thanks for having me on today, Melanie. Generic medications really came into the spotlight back in 1984 via the Hatch-Waxman Act which was signed into law and really created greater access for patients to have generic drugs enter the market and greatly expanded access to important lifesaving drugs, making it more affordable. It’s generated more than $1.2 trillion dollars in savings to the healthcare system when we look at just a 10-year period between 2003 and 2012. It’s benefitted the health and well-being of innumerable lives since that 1984 law.
Melanie: Wow. That’s a lot of money saved. So, why are they cheaper?
Laura: Okay. So, that’s a great question. They’re cheaper because generic drugs do not have to undergo the same animal and human clinical studies that brand name drugs have to go through. In addition, generic medications are not subject to all of the expensive marketing and promotion that we see with brand named drugs. That saves a lot of money in their coming to market and allows them to be priced at 80-85% less than brand name medication, making it much more affordable.
Melanie: So, are they the same quality? And I think this is the question everybody wants to know. Is there a difference in the products that are used to make them? Is it the same quality? Or are they really different?
Laura: That’s an excellent question and I know that’s the burning question on so many patients’ minds. As a pharmacist, I’ve had so many patients come to me and ask, “Laura, it’s a copy. Is it really the same? Is it the same quality?” And my answer is always to them that, thankfully, we have our food and drug administration which requires generic drugs to have that same quality and performance as a brand name drug. So, when a generic drug product is approved and it does go through a rigorous process having to show that it is the same identity, the same strength, quality, purity and potency as a brand named drug. However, there might be some variability that occurs during manufacturing but that also occurs for brand name manufacturing as well. When a drug, whether it be generic or brand, is mass produced, we’re going to see some variations in purity, in size, in strength and other parameters as permitted. But again, generic drugs are required to have the same active ingredients, the same strength, the same dosage form, the same route of administration as the brand named products. The only difference here, though, is they do not need to contain the same inactive ingredients as the brand named products. But, otherwise, they have the same efficacy, safety and quality based on this testing process.
Melanie: Great answer, Laura. Are there any situations that would require special consideration? Are there any people who you would just say, “You know what? I don’t want you on the generic drug because you have a certain condition or disease?”
Laura: Well, there are few medications that fall into what we call a narrow therapeutic index category and for these medications, we would consider that potentially changing a patient from the brand to the generic may actually impact the therapeutic effect. So, really it’s just maybe five medications that fall into that category. Other than that, we always recommend to patients if a generic is available that we would certainly want them to try it. The benefit being that, again, it would be 85% less and save the patient a lot of money because there are so many healthcare costs out of pocket for the patient as it is. So, this is a great opportunity for them to save money and at the same time, have the same effect from a generic medication as they would from a brand name medication.
Melanie: As you said, the inactive ingredients are what seem to differ but the active ingredients are pretty much the same. So, why do they look so different sometimes? Is it because the fillers, preservatives, things that they do to the medications a little bit differently?
Laura: Again, yes. So, within the manufacturing process those inactive ingredients, again, may contribute to the dye and the coloring of the tablet. The manufacturing plants use different machinery and, therefore, may create a different tablet that has a different shape. That’s a question that comes up often from patients and I always encourage them, if the medication looks different then always ask so that we can confirm and verify that you do have the correct medication because they may be round verses oval or tan verses white. There will be those variations but they can be assured that, especially asking the pharmacist, is this the same medication? They can count on getting an accurate answer to that.
Melanie: What happens when a brand name goes generic? So, if something that we’ve been used to, Cipro or something along those lines, you know, you’ve been hearing it and now all of a sudden your pharmacist gives you the generic of that. Do you feel confident that now it’s gone through whatever it had to go through to become generic now?
Laura: Yes. Again, any generic that is available to us here in the United States is only available to us because it has gone through the FDA approval process. When a brand name medication comes off the patent, there is generally one generic manufacturer that releases products first and for the first 6 months, that will be the only generic available. So, again, because of market competition that pricing being that it’s just one generic manufacturer, will not be that much lower than the brand named drug. It also gives that first 6 months’ time to introduce it to patients, that they become aware that there is a generic available for it. Then, after that 6 months exclusivity of that one generic manufacturer, we’ll see increased competition which further drives the price down and that’s where patients may start to see a different tablet size or shape. Here, again, the market competition is key to driving the prices down to the healthcare system and the patient’s pocket.
Melanie: Is that true for over-the-counter drugs as well?
Laura: Over-the-counter drugs are also subject to the USFDA standards as well and here the generics that are available over-the-counter are also under the scrutiny of the FDA, so patients can be assured that they are meeting quality standards through their manufacturing plants by the manufacturers themselves as well.
Melanie: So, Laura, why do some people say, “I can’t take the generic because it doesn’t have the same effect on me,” or “It doesn’t work as well.” And I know that for some medications, seizures or arrhythmias, some of those blood thinners, maybe, that there are certain reasons that you stick with the brand unless you talk to your doctor, but why do we hear some people say, “Oh, I wouldn’t take the generic. It doesn’t work as well,” or “I have a bad reaction to it”?
Laura: Yes, we hear that often. Here, again, I have to go back to explaining to patients that these generics, when they are undergoing testing, they do bioequivalency testing. So, what is meant by that is, they have to show that the medication has no more than a variability within a window of 10% either way. That’s no different for brand name medications. These medications, if they cannot prove that they are bioequivalent--So again, taking the medication, gets into the bloodstream, is absorbed and then hits a certain concentration, if the generic medication is not proving that as being equivalent to the brand name, it would not be available to us. So again, it’s just really an educational point for patients, that once you start explaining to them these details that they become more comfortable to try the generic medications. I have to say, in this past decade especially, patients have embraced them more and more because of the increased cost out of their pocket for spending on healthcare in general. I also suggest to them not only to speak with their pharmacist to have these conversations but to their physician as well. So, that also provides them with peace of mind to know that, you know what? I can try this and it is safe. Then, naturally, if there are some instances where the patient does have a different response on a generic, then absolutely we would revert them back over to the brand name product.
Melanie: Well, I know I’ve been shocked before when I’ve gone through the drive through to collect something and it’s been so expensive and they’ve said, “Well, that one’s not available in generic,” and I go, “Well, then why did my doctor prescribe that?”
Laura: Right. Right. Yes.
Melanie: You know, it’s a question we all say to ourselves. So, in the last few minutes, Laura, if you would, give listeners really what you’ve been screaming to tell them about generic versus brand that you wish you could tell everybody standing in line and get them to understand about these differences.
Laura: Yes. Here, I would say, number one, that we have to have trust in the fact that these generic medications have undergone rigorous testing and have proven to be equivalent to brand name products; that there is no need to have this fear of trying them. I, myself, have my dad taking generic everything. He’s super happy because he’s saving a lot of money out of pocket and there’s the benefit of that to be able to have those extra dollars for other expenses such as co-pays when they go to the physician or their premiums on their healthcare plans as well. I would also enforce and suggest to patients that they have the conversations with their pharmacist because the pharmacist is a plethora of information on generic medication. They know, for example, if something is not available generically, what an alternative might be and I know patients feel very comfortable speaking with the pharmacist and then from that point, they can bring that information back to their physician and engage in that conversation; to say, “You know what? My pharmacist told me I could try this generic instead of this brand name product. Is that something that we can explore together?” So, it’s just getting into those conversations and raising awareness and, again, it’s the savings piece. I mean, the healthcare industry in this country cannot sustain the pricing of brand name medications when there are generics available that are up to 85% less. I mean, if there’s a medication that’s $8 a tablet verses 20 cents a tablet and it has the same equivalency and outcome, it’s a no brainer, really. So, I just offer to patients those suggestions and examples and I think that overall we have a lot of opportunity to continue to educate our patients and engage them to take control of their spending and this is a prime area.
Melanie: Absolutely great advice. Thank you so much, Laura. You’re listening to SMG Radio for more information you can go to SummitMedicalGroup.com. That’s SummitMedicalGroup.com. This is Melanie Cole. Thanks so much for listening.