Generic v. Brand-name Medications Under the Virginia Workers’ Compensation Act

Written by Jessica Gorman, Esq.

Edited by Rachel Riordan, Esq.

Under the Virginia Workers’ Compensation Act, § 65.2-603, an Employer is required to provide all necessary medical attention to an injured worker as a result of a compensable accident.  But to what extent is the Employer responsible for payment of costly prescription medications when an injured worker demands brand name medications over a generic medication and what can we do to limit the costs of those medications?

The purpose of the Workers’ Compensation Act is to provide an injured worker with free treatment and to restore the injured worker’s good health so that the injured worker can return to gainful employment as soon as possible.  Richmond Memorial Hospital v. Allen, 3 Va. App. 314, 349 S.E.2d 419 (1986).  As a part of an injured workers’ treatment, most often prescription medications are prescribed for pain control or other symptoms of their injury.

§ 65.2-603.1(B) provides that a pharmacist shall dispense a prescription using the generic version of the medication where available unless: unless (1) a generically equivalent drug does not exist or the usual and customary retail price for it is higher than that of the prescribed name-brand drug; or (2) the prescriber specifies on the prescription “brand medically necessary” based upon a medical reason why the injured worker should not have the generic equivalent.  A physician may provide verbal instructions to a pharmacy requiring that a medication is brand specific – it does not need to be in writing.

So what does this mean for your claim?  Rather than waiting to try to minimize the cost of medications and obtaining an opinion from the treating physician that a brand medication should not be used, it would be worthwhile to instruct the pharmacy to generically fill any prescription for medication and only fill a brand name prescription upon specific instruction by the physician that it is medically necessary.    If an injured worker asserts a generic mediation is not as effective as the brand name medications, thereby causing the treating physician to write a prescription for the brand name – we would recommend obtaining another medical opinion addressing that issue as more often than not, generic medications are just as effective as the brand name medications.

All drug products sold in the U.S. are approved by the Federal Food and Drug Administration (FDA) whether they are manufactured under a brand or generic name.  In general, manufacturers who bring a new drug to market (as a brand name) have a period of time (often referred to as patent protection) when no generic brands can be sold.  During this time, the price of brand name drugs is often high, subject to demand, to help defray the costs of research and development. Once a drug’s patent expires, other manufacturers can bring the same drug to market, either with unique brand names or simply labeled with the drug’s generic names.  When this occurs, the original manufacturer may or may not adjust their prices, again depending on demand and competition.

For a generic drug to gain FDA approval, it must be deemed bioequivalent in therapeutically equivalent to the brand name version.  Bioequivalence is measured by the rate and extent a drug reaches the bloodstream after a dose.  To meet these standards, generic drug manufacturers must fully document the drugs chemical formula, manufacturing steps and quality control measures.  Both brand and generic manufacturers must assure the FDA that the raw materials and finished product meet standards established by the U.S. Pharmacopoeia.  Once on the market generic drugs, like brand name drugs, must continue to meet stability requirements.  Thus the only real difference between any approved brand of a drug, whether brand name of generic, if any, are likely the inactive ingredients and process of finishing the final product into its dosage form (i.e., tablet, capsule, elixir, suspension, etc.). In other words, brand and generic drugs must meet the same requirements for identity, strength, purity and quality.

Brand name and generic medications may differ in size, shape, color and/or the use of inactive ingredients, which may include binders or fillers used to create the tablet or other final product. It is possible that some patients may have an interaction or allergy to a filler in one particular brand.  However, it is extraordinarily unlikely that any person would not tolerate ANY generic brand while tolerating ONLY the brand name.

There are very few examples in our experience where generic drugs should not be substituted for brand name medications.  Those involve drugs with specific coatings or complicated sustained release forms, or drugs with narrow therapeutic windows, in which therapeutic levels are very close to toxic levels.  Examples identified by our expert include Digoxin (brand of lanoxin), Dilantin (brand of phenytoin) and some other anticonvulsants, and most types of thyroid hormone.

Unfortunately, some patients or injured workers may believe that drugs which cost more must be better, so it is up to healthcare providers to provide education and reinforce the safety and efficacy of approved generic drugs.  If a patient or injured worker does experience an adverse effect to one generic brand, then the physician/pharmacist should work with the injured worker to find another manufacturer.

By having the pharmacies utilize the generic medications rather than the brand name medications, the injured workers are still obtaining necessary medical treatment.  However, by changing a simple brand name medication to that of a generic can save thousands of dollars over the life of a claim.

For questions over the medications currently being filled on your claim, consider consulting the pharmacy to determine if a generic substitute may be available.  Furthermore, if a pharmacy HAS been prescribing a brand name medication without specific directive from the physician for the same, we recommend you send a letter to the injured worker advising them that their medication is being changed to a generic in the next 30 days so that they have time to consult the physician or pharmacist to ensure that there will be no withdrawal or complications from the change of medication.  But moving forward with any new medications prescribed, we would recommend advising the pharmacy of the requirements under the Act to fill for a generic medication absent any physician directive.


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