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Ohio News: A Generic Equivalent May be a Brand Name Drug
Published in the August 2006 Ohio State Board of Pharmacy Newsletter
Frequently, pharmacists or patients call with questions about substitution on a prescription. A common misconception is that the “generic” must be a product with no brand name attached to it. Using over-the-counter products as an example, the mistaken belief is that a prescription written for Advil® could only be filled with Advil or a product labeled ibuprofen, but not with Motrin® IB.
A review of our substitution laws (§4729.38 Ohio Revised Code (ORC) and the definition of generically equivalent drug in §3715.01 ORC) will show that this is incorrect. In Ohio, instead of using “generic” the correct term is “generically equivalent drug.” What is required is that the products contain identical amounts of the identical active ingredients, meet the same compendial standards, and are not listed as having “proven bioequivalence problems” by the federal government (ie, listed as bioinequivalent in the “Orange Book”). In the example above, either the product labeled “ibuprofen” or the product labeled “Motrin IB” could be dispensed instead of the prescribed Advil as long as the rest of the substitution requirements were met.
Of course, no substitution may occur if the prescriber has indicated “Dispense as written” or “DAW” on the prescription unless the prescriber is contacted and gives permission for the substitution. Please make note of that last statement. If the doctor has properly indicated “Dispense as written” or “DAW” on the prescription, the product may not be changed by the pharmacist, the patient, or the insurance company. The pharmacist must dispense the product ordered unless the prescriber agrees to the change, even if the patient has to pay a higher co-pay or a higher price.
If a substitution does occur, there are several other requirements that must be met. The patient must be notified of the availability of a generically equivalent drug at a lower or equal cost and of the patient’s right to refuse. There must be an indication on either the bottle or the label that a substitution has occurred. Please review your own pharmacy’s process in this regard. We have had several instances of patients receiving generically equivalent drugs with no discussion by anyone in the pharmacy and with no labels or notices of any kind. When that happens on a refill, where the drug looks completely different than it did the last time the prescription was filled, it can cause problems and confusion on the part of the patient. They may be so concerned that they do not take the medications until speaking with the pharmacist or the doctor. Obviously, this can lead to compliance problems. Alternatively, they may be so accustomed to the pharmacy switching products without telling them that they do not worry at all and just take the medication given to them. When the drugs are different due to a dispensing error rather than just improper procedure, then patient harm can occur. We have had numerous examples of both situations.
One of the advantages of Ohio’s substitution law is that it places a great amount of trust and responsibility on the pharmacist. Unlike many states that require a product to have an AB rating in the “Orange Book” before it can be substituted, Ohio allows the pharmacist to use judgment and substitute products that are not listed as well as those that are. With that trust, however, also comes responsibility. The pharmacist’s first duty should be to the patient. Before substituting a product just to comply with the pharmacy’s policy or the insurance company’s requirement, the pharmacist should review the possible effects on the patient.
Bioequivalency studies are usually done on large groups of people and only the averages are reported. Needless to say, there are patient-to-patient variations and sometimes drugs that are generally bioequivalent are not so in an individual patient. This can be especially true in drugs whose activity is related to the blood level such as some drugs used in treating seizure disorders, asthma, cardiac problems, etc. With those drugs, where a variation in blood level could cause problems for the patient, it would not be in the best interests of the patient to change products without at least notifying the patient and the prescriber so that appropriate monitoring can occur during the transition. We have already been approached by some people who want to introduce legislation to mandate that the pharmacist “get permission” from the prescriber prior to substituting drugs in certain disease states because patient problems have been caused by pharmacists blindly following policy instead of acting in the patient’s best interests.
Please do not take shortcuts when substituting one drug product for another. Think of the patient’s best interests first.
