a pharmacist at work behind the counter of a pharmacy

Most (but not all) pharmacists routinely tell patients that generic drugs are identical to brand name medications. That is hardly surprising. This is what pharmacy students are told during their education process. It is also what the FDA states on its website:

“A generic drug is identical–or bioequivalent–to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.”

Now we don’t know about you, but when we see the word identical we assume that means exactly the same as. Here is how Dictionary.com defines the word identical:

1. Similar or alike in every way
2. being the very same
3. agreeing exactly
Related Words for: identical
Indistinguishable, one and the same, selfsame
Medical Dictionary
1. Exactly equal and alike
2. Of or relating to a twin or twins developed from the same fertilized ovum and having the same genetic makeup and closely similar appearance; monozygotic.

In our opinion, the FDA’s use of the word identical, when describing generic drugs, is misleading. First, the inactive ingredients (colors, binders, fillers, etc) do not have to be “alike in every way” to the brand name product. In fact, they are often quite different. These so-called inactive ingredients or “excipients” may influence how the product affects patients. For example, a patient who is allergic to a particular color may develop a rash when switched to a generic product.
The formulation may also differ dramatically from the brand name. Many pharmacists may be unaware that the physical characteristics or release properties of a brand name drug often stay under patent even after the active ingredient becomes available generically. This is especially problematic for slow-release or long-acting medications. Generic manufacturers may have to come up with different technologies to deliver the active ingredients. This means that the products are not always “indistinguishable or one and the same.”
To see this for yourself, visit the FDA’s website and report on the antidepressant bupropion XL.
If you look at the graph the FDA provides you will discover that the mean plasma concentration of the two drugs is certainly NOT identical! The generic formulation (which uses a matrix technology to release the active ingredients) produced peak blood levels in 1.5 to 2.5 hours, whereas the brand name product (using a membrane technology) produced peak blood levels around 5 hours. This kind of information for other generic formulations is not always easy to access.
Here is something else a pharmacist might not realize. According to the FDA, 80 percent of the active and inactive ingredients in our pharmaceuticals come from abroad. It is estimated that 40 percent of the finished pills come from abroad including countries such as India, China, Brazil and Mexico. It is also very clear that the FDA does not have the resources to inspect all or even many of the manufacturing plants producing either the raw materials or finished products millions of Americans take every day. That means that there is no verification system that the pills are exactly what they say they are.
We have seen manufacturing problems with some of the most prestigious drug companies in the U.S. (Johnson & Johnson and GSK). These problems occurred at plants where the FDA visits on a regular basis. Do we really believe that chemical companies in China that are not inspected are producing perfectly identical generic drugs at cutthroat prices?
Perhaps it is time for pharmacists to acknowledge that there are no guarantees when it comes to generic drugs. Pharmacists must be the patients’ allies and advocates. When patients experience problems with certain generic formulations, pharmacists should offer a sympathetic ear and report the problems directly to the FDA’s website (MedWatch). Perhaps if pharmacists insisted that the FDA do a better job both approving and monitoring generic drugs, patients would have more confidence in these money-saving pills.

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  1. Bruce

    An adverse reaction to any medication, brand or generic should be reported to the manufacturer. The generic market has changed over several years as around 50% of the generic manufacturers are now owned by a major brand name manufacturer.

    One of the concerns expressed today has to do with obtaining raw materials. More and more raw materials are coming from outside of the US. How well are the raw materials being screened or tested? Shortages in raw materials have caused back-orders in the final products.

    In recent years it was stated that most of the plants making generic products were more modern than the older brand name plants. More than one study has shown that the actual variance in generic vs brand is only about 4%. Of course there are exceptions especially in those products that are delay release or time release in nature. Though the active ingredients are shown to be the same other non-active ingredients being used in make up of the product can vary. Adverse reactions can be shown to be caused by dyes and fillers.

    Stabilizing a patient on a medication whether it is generic or brand should be of great importance especially in those medications that require monitoring with lab tests. If there is a problem report it to the manufacturer and your pharmacist should be able to tell you which manufacturer’s generic is being used.

    In over 40 years in this profession I have seen a lot of changes however profit was not the most important motive. Getting to know and talking with patients about their own personal situations has always been of utmost importance. Also important was seeing that patients could obtain and properly use their medications.

    In my experience these two situations are starting to disappear in pharmacy today. Profit and volume have taken the place of patient care. Too many times patients are being told that their insurance will not pay for a medication and they are not given any suggestions or options-just pay for it or go without. The pressure today is placed on the patient to resolve the problem like “talk to your doctor” as if he is going to know what formulary options or restriction overrides may be available. I know because I do not dispense medications anymore. I instead work with patients on a daily basis as an advocate in dealing with these and other issues.

  2. Michelle
    United States

    The CVS Pharmacist by my house treated me like I was an idiot when I asked what brand they could get. Of course he also threatened to report me for getting prescriptions from my PCP and my specialist because he stated it was illegal to get different prescriptions from two different doctors. Go back to school asshole is what I say!

  3. Susana

    My son was recently diagnosed with epilepsy and was put on Keppra XR. I had to ask the doctor to please allow him to take the generic, otherwise I have to pay almost $400 for a month’s supply. This is something he will be taking for a LONG time and I can’t afford the brand name. I just keep my fingers crossed that the generic will do the job. Thanks pharmaceutical companies for making your brand name prescriptions so expensive that the average middle class family can’t afford them.

  4. Stacy

    I want to ask why my pharmacy continues to change my prescriptions. With mental problems this is a problem. I get one generic (Sandoz) for 6months and they change to another.
    The first generic is long lasting with a hard coating on it. The 7th month, they give me the generic from ( Mallinckrodt ph ). This generic does not have any coating, and looks like they were homemade. I took them for 5 days and returned them to pharmacy, they told me Sandoz was on back order, so I finished out the 30 days. I was a horrible person to my children by screaming and crying all day every day. I could not function. The next two months I got the Sandoz. Now they have told me they are on back order and cannot get the Sandoz generic. I refuse to take the other generic, I will be depressed and suicidal with or without the low budget generic, which I have no idea where it comes from. It is obvious to me and should be to them that it is not made in a safe environment.

  5. Lyn

    I am on Norvasc for Blood Pressure and have been for over 20 years. I had trouble finding a product that worked for me without side effects and I will continue to use it. My concern here, is when I put a prescription in to be filled at the pharmacy, I am often given the generic brand, WITHOUT prior consultation. I always refuse it and they have to give me the one on the prescription. They will get away with it if they can. I am told it is their “policy” not to ask anymore. Well, excuse me! This is something I am putting in my body and I therefore deserve to be given the choice. I wonder WHY they don’t ask. I do know of a few who do ask and in the future I will be shopping at those pharmacies instead. Generic is NOT an identical product. Identical drug maybe, but not identical recipe.

    • Pharmacy Tech

      Well, I work in a pharmacy. When the doctor writes out the prescription, they will state whether or not the generic may be substituted (its a dispensing DAW code). In your case, I am assuming that the doctor did allow it. Most cases, the doctor will put a DAW 0, meaning that the drug may be substituted with the generic.

      If you wish to only receive the brand, let your doctor know and they can specifically write that the patient requests the brand. A pharmacy can only fill what the doctor allows, but at the same time, they want to help you save money. So, most times the generic will be switched out IF the doctor approves. Also, I would let your pharmacy know that you do not wish to get the generic. They would be more than happy to give you what you want. They can even leave a note in your profile for the future, so this does not keep happening.

    • Brad

      The bonus is on the patient to ask for the brand name product. Over 99% of patients respond well to generics and it saves them money as well. Hence, they are given the generic without consultation.

  6. BL

    “IDENTICAL” is a correct word, but it is true that we have to be very careful about patients being allergic to the non-active ingredients, as they may be the one causing the problem.

    So if you are comfortable taking generics, go for it, as it will not do any harm to you.
    But if you are allergic to, or have history of being allergic to particular agents in the product, you must stick with what you take.

    P.S. Panadeine forte in Australia is made in India where its generics are also made in, such as Comfarol Forte or Paracetamol/Codeine GH tablets. So talking about the country where the drugs are manufactured in would lose some persuasion in this context.

  7. a l

    My insurance has referred to chemically different antibiotics as “generics” – in other words, an older drug which is used for the same infection, which is NOT the same drug. How can they do this? That’s like calling aspirin a generic for ibuprofen.

  8. JW

    It is true with the drug Dilantin, my doctor requires I only take the brand name. He wrote a letter to my insurance company to have them pay for the band name, but they didn’t approve it. So I have to pay more but it’s worth a piece of mind.
    Dilantin is an old drug but the extended tabs probably all work the same. He even said the generics differ from name to name. If I were to get the generic brand all the time it would be ok. But you get all different names.
    So definitely ask for the brand name from your doctor and insist for the brand name.
    Good Luck, I wish your family the best!

    • J. Berk
      York, PA

      JW… I also “unfortunately” have been taking “brand” name Dilantin for nearly twelve (12) years now. “Expensive”
      My neurologist and I have attempted numerous times over the years to switch me over to the generic. It always ends up in severe seizure. I am extremely thankful this medication exists. However, it is certainly true that not all “generics” are the same as their brand counterparts. Even more alarming is that pharmacies will “often” change manufacturers from which they purchase their generics at any given and many times due to their price. On the surface this may seem fine, but when one truly realizes that not all generics function the same in one’s body and may in fact have up to an 80% leeway. In my opinion, it’s not responsible. I’m fortunate, I guess, that I can often tell of a change in medication. (outwardly ending in a seizure)
      However, just think of how often a pharmacy may change the manufacturer of a “generic” blood pressure, asthma, cholesterol, etc…(the list goes on) medication and that person does not realize any change until it’s too late!
      The solution is simple. An 80% leeway from brand is simply not acceptable. I believe, if attending school or college, a grade of 80% is a C or C-? Is that acceptable?
      Generic medications should function within a 99% tolerance of brand at worse or else not be approved by the FDA. In addition, individual pharmacies should self-impose their own strict testing and compliance along with FDA standards to assist. This only makes sense and creates safety within the industry. Anything less is careless, dangerous and deadly.

  9. MM

    I take Ef….r it is costly. I tried a generic equivalent for two weeks because the pharmacist claimed it was the same, but I felt very different, dizzy, not well; I went back to Ef….r brand. I feel sorry for people who can’t afford the original brand medication. The generic medication should have to go through the very same research protocol as the branded original medication before going to the market, otherwise the patients are the lab-rats of the generic pharmaceuticals company.
    Is there a committee where those who suffered bad effects of a generic medication can send a summary of their case? If several people react poorly using a specific generic product, some changes could be done to improve the generic formula.

  10. MWJ

    I have been on the name brand of Cymbalta for 5 years now. Suddenly, my insurance company has decided that because there is now a generic for Cymbalta that I now have to take it instead.
    I have tried 4 different kinds from different manufacturing companies, and NONE have worked. Only the BRAND Name Cymbalta works on me!
    After months of fighting with my insurance company and with my wonderful Drs help and constantly writing on the Rx for “Brand Name Medically Necessary ,” my insurance company still will not pay for my Cymbalta anymore! I have even had blood work done while on each generic, proving that it wasnt working or even showing in my system!
    That is all….

  11. Cpmt

    Generics from China and India…2. I know I only can use non generic, only brands with some of my meds.

  12. SallySue

    It is unbelievable the people posting that generics are identical is not misleading. IT IS! Identical is as it says, identical. Not a copy, not close too, but identical. As in many other areas of manufacturing when products come out of the same line, say Air Conditioners, and the only difference is the label at the end, one says Carrier, the other Bryant. Yes, they are identical. This is NOT how non-authorized generics are created. To expect Americans to settle for trickery is what has made millions for those producing inferior products. My stance is if I can’t sue the generic manufacturer for a faulty drug, how stupid am I to take it? If you allowed the slightest accountability for wrong doing, including jail time, we might actually be protected. Instead, you take self reporting from the conflict of interested manufacturer of the medication for face value and do not require independent testing to verify it is correct. Crazy. Why don’t you allow students to grade their own SAT’s while your at it? Same thing. Thank God it’s coming to light that while not all Generics are inferior, the checks and balances is so far off of protecting consumers we should boycott generics until the FDA actually lifts a finger in advance and tests whats already out there, brand too, and whats coming in the future. It is insane that they do not test after the product comes out too.

    • Cheri G.

      Well said. Thank you for summing it up so perfectly!

    • Mike

      You’d crap yourself if you saw the 4 different companies that manufactured the four doses of your IV antibiotic in your hospital– of course, when you don’t see the bottle or drug, you don’t know any different– we can monitor blood levels and do for most serious antibiotics (ie vancomycin) and they are all equivalent. There is something called science, ya know.

  13. ak

    Generic drugs = brand name drugs. Generic drug PRODUCTS are not the same as brand name drug PRODUCTS.
    Drugs are the same. Products are not. Remember that RPhs dispense drug PRODUCTS not drugs. This is how we can say generic DRUGS are identical, but we can’t say drug PRODUCTS are identical. The title of this article should be “…. generic drug products”.

    • David

      The FDA does check after the drug comes out. Usually given to four major companies and tested vigorously. However, it then drops to 2 visits a year, and as for foreign they only manage 1 every 9 years and cannot hit them all.

      If your pharmacy chain wont order a generic that works for you, switch. Some phentermine causes my rosacea. Red nose with a rash around it. I found one that doesn’t do that, I special order from Rite Aid with a 24 hour turn around and no extra expense. When I forget to remind them back comes the red nose and rash.

      This article scratches the surface. Check for the plants that just get shut down after manufacturing inferior meds and another one opens. When people say “My medication doesn’t seem to be working, their could be a very good reason.

  14. RB

    People’s Pharmacy please respond.
    The article argues an important point about the role of pharmacists in advocating for better drug safety reporting and ensuring the best possible treatment for patients. However, the article does not really provide any clear answer on its original point and the point brought up by many of the comments which is “What should a pharmacist say when a patient asks if the generic is ok?”
    My answer is customarily “The active ingredient in this generic is equivalent to the brand name product as per the FDA. There are differences in the inactive ingredients and the effects of these inactive ingredients can vary with each person.” Of course, this has to be varied so that the person getting the medication understands what I am saying, but the gist remains the same.
    If a customer calls to complain about a side effect they developed from a generic that they did not get from the brand, I inform the prescriber and the manufacturer (calling their drug safety department). If the patient is okay with talking to the company directly, I also pass along the patient’s contact information (only after explicitly getting permission from the patient). If the medication is not working, I try my best to find something else for the patient and also start the drug safety report with the company. I consider this an appropriate response. I hope that all pharmacists follow these basic steps and the pharmacists I know do follow these steps because this is what we studied 6 years to do.
    However, the article and following comments miss 2 major points in this discussion:
    1. Incorrect Incentives
    In the current healthcare system, the pharmacist salary is based on prescriptions sold. The legal and ethical expectations placed on pharmacists to counsel, ensure optimal therapy, and be the patient’s advocate is not reimbursed by insurance companies or any other entity to the pharmacy organization. Pharmacies make money almost entirely moving product-just like t-shirts. The amount of time I spend looking into any questions or issues with medicines patients have directly reduce my productivity because in those periods I make the organization $0.00 per hour. Consider the sheer stupidity of that point. I studied in school for 5 years and spent a year working for free to be able to help people make the most of their drug therapy. I am expected to do get people their medications, make sure they use it right, make sure doctors do not write for interacting medications, and watch out for abusers. All that is for not reimbursed. BUT, the insurance company will pay me to be a glorified vending machine.
    2. Patient/Citizen Responsibility
    This applies more to the responses I read after the article. Since all of you are well-informed enough to read people’s pharmacy and motivated enough to reply to this article, have you also filed a report with the manufacturer in question? The companies have entire departments (called Drug Safety, Pharmacovigilance, etc) dedicated to getting your phone calls. Major adverse effects reported are by law required to be processed in within 2 weeks. A quick google search will bring up the company’s corporate phone numbers.
    Also, I read a lot of complaints about foreign manufacturing (which, on a side note, brand manufacturers do as well). Why not write to your Congressman or Senator? Ask them to increase funding for the FDA rather than cutting its budget. Ask them to change the law that requires pharmacies to dispense generic unless specifically instructed by the patient or the doctor. In fact, ask them to stop imports of drugs from out of the country. Congress members will actually listen to you especially if you write a letter or show up at their office.
    As a pharmacist, I try my best to do right by my patients. I come to work every day to help them. If I wanted to cut corners and hurt people to make some more money, I would have become a Wall Street banker. However, I am also subject to the financial pressures of the time. Ordering brand medications and dispensing them at a financial loss is a great way to become unemployed. Generic medications have been a blessing to a lot of people who may not have been able to afford medication 40 years ago. Clearly there is room for improvement at every level of the system. Pegging pharmacists with the job to “tell the FDA” to regulate generics more is not helpful.

  15. RB

    The reason why you have trouble finding brand name medications is because too few people are willing to buy the product like you are. The pharmacy is not going to order a bottle of 100 tablets a brand medication which will likely cost them 10x the cost of the generic medication they have on the shelf only to dispense 7-14 tablets to you and the remainder of the 100 tablets sit on their shelf until it expires and they have to throw it out. It would be a huge financial loss and therefore probably would not be ok in any corporation.

  16. Marte Keller

    Will someone (hopefully People’s Pharmacy) please tell us how to find out where a drug -generic or brand name- is manufactured? There must be some way of getting this information. Remember too that many of us don’t get our medications from a pharmacist rather they are mail order per our insurance’s requirement.

  17. Sheryl

    I was told by my endocrineologist that he wanted me on brand. He said (unless you’re looking for change in your sofa, go with brand) He & his administration have told me (Big Pharma, ins. Co’s & pharmacies make more $$ off generics. He has been head of endocrine for 25 yrs. I do have problems with generics & would like advice on the ones that I am on. Thank You

  18. Lynn M.

    I am taking 3 generics all made by Ranbaxy. I would like to take generics made in the United States like Mylan, which makes all 3 of my generics. My pharmacist says she can not change, how can I gen U.S. made generics?

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