The proportion of prescribed medications that are dispensed as generics has increased over the years. In 2018, 90% of dispensed prescriptions in the US were generics (Association for Accessible Medicines, 2019).
The cost of medications
Some people think that if a brand name medication is approved by the patient’s insurance, the money comes out of the insurance company’s profits. I don’t think that is the case. I think the costs eventually get passed on to the patients covered by that health insurance. As I like to say: Somebody is paying. Please remember that. There are no free lunches.
So, when prescribing, we should consider the cost of the medication as one of the factors in deciding which medication to prescribe. I’m not saying cost should be the main consideration; I’m just saying that when prescribing medications, we should not be blind to cost.
Generics lead to HUGE savings
Generic medications lead to massive savings on both a macro and micro scale. Here are some facts related to this.
– In the Medicare and Medicaid programs, using generic preparations saved US taxpayers more than $137 billion in 2018 (Association for Accessible Medicines, 2019).
– For the individual patient, the average co-pay for a brand name medication is about 7 times more than for its corresponding generic (Association for Accessible Medicines, 2019).
– You may be surprised to know that, in 2018, generic medications for Mental Health led to more savings than for any other class of medications (Association for Accessible Medicines, 2019).
– In 2018, of the top 10 generic medications in the US (based on the money saved by prescribing the generic rather than the brand name), two were psychotropic medications—aripiprazole at number 6 and quetiapine at number 10 (Association for Accessible Medicines, 2019).
Of course, if switching to the generic leads to worsening of medication adherence and/or destabilization of the patient, the cost savings from using the generic could theoretically be offset by increased costs of healthcare (Treur et al., 2009).
Concerns about generics
OK. So, generics lead to huge savings for society as a whole and for individual patients. But, there is a persistent uncertainty in the minds of patients and clinicians about whether the brand name and generic version of a medication are really equivalent. This uncertainty is present due to several different reasons:
1. Both of the following statements are true.
a) In the vast majority of cases, generic medications are just fine.
b) There are many published reports of patients having loss of efficacy or increased side effects after changing from a brand name product to a generic equivalent.
Since all prescription medications in the US are first introduced as brand name only and later generics become available, patients and clinicians go through this transition from brand name to generic all the time.
We should also note that, under blinded conditions, individual patients sometimes also complain of greater problems when switched to a brand name preparation (Kharasch et al., 2019).
2. Once in a while, we see a report that the FDA found a problem with some specific generic preparation (e.g., bupropion extended-release 300 mg tablets). Psychologically, that tends to reduce our confidence in all generics, even those for which the FDA did not find any problem.
But, if we look into the particular generic for which a problem was found, we may see that the problem occurred not because all generics are problematic but due to very specific reasons that applied to that case but do not apply to the vast majority of other generics. Do you know what specific, uncommon circumstances led to the problem with one particular manufacturer’s bupropion XL 300 mg tablets? It is helpful to read that story at the link under Related Pages below.
3. When patients have a relapse or flare-up of their illness and had been recently changed from a brand name medication to a generic version, it is understandable that both patients and clinicians may conclude that the worsening was due to switching to the generic. This may or may not be true. There are also many other possible reasons why a patient may get worse.
4. Pharmaceutical company sales personnel sometimes tell clinicians that they have anecdotally heard from other clinicians that the generic version of their branded medication does not work as well.
When should we be more concerned?
Are there some circumstances in which we may be particularly concerned about taking a generic medication? We may need to take a closer look at the quality of specific generic preparations under the following circumstances:
1. When the patient is on a medication that has a narrow therapeutic window or potentially dangerous side effects. Sometimes, these same medications are monitored by using serum levels. For example, though clozapine and lithium have narrow therapeutic windows, thankfully, their levels are routinely checked. So, if the patient is switched to a new generic preparation or there are concerns about efficacy or side effects, we should check the serum level.
2. If an individual patient reports feeling either a loss of effect or more side effects after switching to a generic medication and doing better after being switched back to the brand name preparation, we should try to keep an open mind. There may be a problem with that generic or it may be due to how the patient perceives the generic.
But, when many patients all report problems with a specific generic, this, obviously, has to be taken even more seriously. For example, in the past, large numbers of reports kept coming in about a specific generic preparation of bupropion extended-release—mainly the 300 mg tablets rather than the 150 mg tablets, and mainly the 300 mg tablets marketing by a particular company (Teva Pharmaceuticals). See Related Pages below.
1. Due to the massive differences in cost, it is hard to recommend that patients should ONLY take brand name medications. That is why my family and I routinely take generic medications.
For example, as of March 2020, 90 tablets of generic clozapine 100 mg cost $51, while 90 tablets of brand name Clozaril 100 mg cost over $1300 (source: goodrx.com). That’s a huge difference in cost. Similarly, 30 tablets of generic lamotrigine 100 mg cost $9, while 30 tablets of brand name Lamictal 100 mg cost $453 (source: goodrx.com).
When is more monitoring needed?
2. If the patient is on a medication that has a narrow therapeutic window or potentially dangerous side effects— e.g., lithium, clozapine–we should encourage the patient to check which generic they are getting and to request, whenever possible, that they get the same generic each time.
3. If the patient is changed from brand name to generic or one generic to another, we should look out for any decrease in efficacy or increase in side effects.
4. If a patient has an unexplained decrease in efficacy of the medication or an increase in side effects, we should check if they were changed from a generic medication from one manufacturer to a generic of the same medication but from another manufacturer (Bhat and Margolese, 2017). In such situations, going back to the previous generic may solve the problem (Bhat and Margolese, 2017).
How to monitor
5. In addition to monitoring clinically, when possible, we can check serum levels to see if the change to a generic preparation has led to any change in the serum level of the medication.
6. The FDA does not require the inactive ingredients (also called “incipients”) in generic medications to be the same as in the brand name medication. Occasionally, it may be relevant to see if the inactive ingredients in the generic are a problem for the patient, e.g., lactose in a lactose-intolerant patient.
7. When looking for information about generics for a particular medication, we should look for is systematic studies of a particular generic (whenever available) rather than anecdotes about individual patients.
Simple and Practical Medical Education (SPME) will research and identify for you which generic preparations have been found to be problematic in systematic studies. See Related Pages below.
Next, for a closer look at the generics for one medication, bupropion, please see the following article:
Association for Accessible Medicines (AAM). The Case for Competition. 2019 Generic Drug & Biosimilars Access & Savings in the U.S. Report. Available at: https://accessiblemeds.org/sites/default/files/2019-09/AAM-2019-Generic-Biosimilars-Access-and-Savings-US-Report-WEB.pdf. Accessed on March 26, 2020.
Bhat V, Margolese HC. Generic formulations of psychotropic medications and treatment response. J Psychiatry Neurosci. 2017 Mar;42(2):E3-E4. PubMed PMID: 28245178; PubMed Central PMCID: PMC5373707.
Carbon M, Correll CU. Rational use of generic psychotropic drugs. CNS Drugs. 2013 May;27(5):353-65. doi: 10.1007/s40263-013-0045-2. Review. PubMed PMID: 23620145.
Desmarais JE, Beauclair L, Margolese HC. Switching from brand-name to generic psychotropic medications: a literature review. CNS Neurosci Ther. 2011 Dec;17(6):750-60. doi: 10.1111/j.1755-5949.2010.00210.x. Epub 2010 Nov 30. Review. PubMed PMID: 21114789; PubMed Central PMCID: PMC6493853.
Food and Drug Administration (FDA). Approved drug products with therapeutic equivalence evaluations. 40th edition. Available at: https://www.fda.gov/media/71474/download. Accessed March 26, 2020.\
Kharasch ED, Neiner A, Kraus K, Blood J, Stevens A, Schweiger J, Miller JP, Lenze EJ. Bioequivalence and Therapeutic Equivalence of Generic and Brand Bupropion in Adults With Major Depression: A Randomized Clinical Trial. Clin Pharmacol Ther. 2019 May;105(5):1164-1174. doi: 10.1002/cpt.1309. Epub 2019 Jan 18. PubMed PMID: 30460996; PubMed Central PMCID: PMC6465131.
Meyer MC. United States Food and Drug Administration requirements for approval of generic drug products. J Clin Psychiatry. 2001;62 Suppl 5:4-9; discussion 23-4. Review. PubMed PMID: 11305846.
Treur M, Heeg B, Möller HJ, Schmeding A, van Hout B. A pharmaco-economic analysis of patients with schizophrenia switching to generic risperidone involving a possible compliance loss. BMC Health Serv Res. 2009 Feb 18;9:32. doi: 10.1186/1472-6963-9-32. PubMed PMID: 19226465; PubMed Central PMCID: PMC2652458.
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