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Generic vs. Branded Drugs

Generic drugs are as safe as their brand name equivalents, according to Catherine Tom-Revzon, PharmD, clinical pharmacy manager, Pediatrics, Montefiore Medical Center.

1) In your opinion, are generic drugs as safe and as effective as the brand name equivalents?

Yes, I truly believe that generic drugs are as safe and effective as the brand name equivalents. Generic drugs are considered identical in dosage, strength, route given, safety, efficacy, and intended use to the brand name drugs even if they have a different color or shape than the brand name drug. This applies to both over-the-counter and prescription medicines.

2) Even if you answered yes to question #1, are there instances or specific conditions where you think the brand name drug is better for a patient than the generic version? Do you ever request the patient be prescribed the brand drug even when a generic is available?

Without research proving that a specific generic drug is NOT as effective as the brand name drug, there is no reason to believe that the brand name drug is better for a patient than the generic version for any class of drug or for any disease state. Instances when the brand name drug is better for a patient than the generic version should be determined on a case-by-case basis with documented evidence showing that the generic is not working as well as the brand. Whenever possible, blood levels of a drug or other laboratory tests, like a cholesterol level, should be used to determine safety and efficacy while the patient is taking the generic drug. If the blood levels are less than the known therapeutic level, or if the patient is having signs and symptoms of the disease, then the doctor can consider switching the patient back to a brand name drug and continue to monitor the blood work. Before making the switch, other factors that can affect the drug’s absorption, distribution, metabolism (breakdown), and elimination should be evaluated also. The patient’s diet needs to be consistent. Finally, it is also important to make sure that the patient is taking his/her medications consistently as prescribed and that all drug-drug or drug-food interactions have been considered.

Patients who have never taken the brand name version of the drug should be started on the generic drug and maintained on the generic. There is no reason to start the patient on a brand name drug or switch back if the patient is doing fine clinically. Generics work.

I have once requested that the patient get the brand name liquid suspension of a medicine for seizures instead of the generic one, even though the generic was available. A patient had an increased number of seizures despite having had the dose of the generic drug increased and the caregiver’s assurance of adherence to the regimen. The patient was admitted to the Children’s Hospital at Montefiore Medical Center and our laboratory found that the generic liquid formulation did not contain the right amount of medicine and that the patients had blood levels of the drug that were below the therapeutic level. While in the hospital, the patient achieved appropriate blood levels while on the brand name product. Six months later, a second patient came in with a similar scenario, so I recommended the brand name product for the second patient upon discharge. The pharmacist was instructed to make sure the suspension is shaken prior to transferring the liquid into a smaller bottle from the stock bottle. The caregiver was instructed to shake the bottle well prior to measuring out the dose.

Reports to the generic drug company and the FDA’s MedWatch were also made to make them aware of these incidences. I would encourage all healthcare practitioners and patients to make these reports if this occurs so that further investigation into a specific product can be made, if necessary.

3) When it comes to the OTC medications, is the pharmacy brand of a product like aspirin or ibuprofen just as good as the brand name?

Yes, when it comes to OTC medicines, the pharmacy brand of a product is just as good as the brand name. I recommend them all the time and I use them myself.

4) Does the FDA provide quality control on generic drugs? Would generic drug manufacturers ever cut corners in terms of ingredients, etc, in order to lower costs, thereby manufacturing a product that is similar to but not interchangeable with the brand name version?

Generic drugs must have the same active ingredient as the brand name drug and they must undergo the same scientific review and testing for safety and effectiveness before the product can be approved for sale. Even after approval, the FDA will inspect the manufacturing plant periodically and continue to monitor the quality of the drug. The costs for a generic drug to be manufactured are much lower than those for the brand name drugs to begin with. Generic companies do not have to deal with the cost of research and development and marketing; both can cost millions of dollars alone. Even if a generic drug manufacturer decides to use different inactive ingredients than the brand name drug manufacturers did to lower the cost of producing the drug, the end product still has to meet FDA standards and deliver the right amount of medication to the body at the right time. Furthermore, the inactive ingredients that affect taste, color, etc. do not affect the performance, safety, and effectiveness of the generic drug. Unless otherwise proven with clinical trials, all generic drugs, with the exception of biotech drugs, are interchangeable with the brand name version. One trial showing that generic Warfarin products are interchangeable with the brand name drug, Coumadin was published by Pereira JA et al. in 2005 [Are brand-name and generic Warfarin interchangeable? Multiple n-of-1 randomized crossover trials. Annals of Pharmacotherapy 2005;39(7):1188-1193.]

5) Can consumers and patients feel confident that when they buy that store brand OTC medication, or when they switch to the generic equivalent of their prescription, that they are taking a drug that is just as safe and just as effective as the more expensive name brand version?

Consumers and patients should feel confident that when they buy the store brand OTC medication, or when they switch to the generic equivalent of their prescription, that they are taking a drug that is just as safe and just as effective as the more expensive brand name version because all generic drugs meet the same FDA standards for safety, strength, purity and effectiveness as brand-name drugs. Generic drugs are bio-equivalent and therapeutically equivalent to the brand name drugs.

Source: http://www.fda.gov/cder/ogd/index.htm

Consumers should take their medicines at the same time every day. It is also very important for consumers to ask their pharmacist about the proper ways to store and prepare the medicines, especially if it is a liquid suspension that requires shaking.