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Louisiana News: Generic Substitution Procedures
Are You Sure You Know the Law? (09-04-319)
Published in the April 2009 Louisiana Board of Pharmacy Newsletter
We continue to receive a number of complaints against pharmacists alleging improper generic substitution. In particular, some of these complaints involve documented patient injury attributed to improper substitution of narrow therapeutic index drugs, specifically drugs used to treat epilepsy or other seizure disorders.
When a prescriber initiates a prescription order for a multi-source product and the prescriber prohibits generic substitution by marking the box labeled “Dispense as Written” (or “DAW”), then the pharmacist may only dispense the product prescribed. Certain third-party payors, including Medicaid, may have more stringent rules about the method of instruction to the pharmacist, eg, handwritten words. Pharmacists dispensing prescriptions reimbursable by third parties should comply with those more stringent requirements. When a prescriber has properly prohibited generic substitution, then the pharmacist shall not dispense any other product – if the patient wishes to obtain a generic product, then the pharmacist shall contact the prescriber and obtain a new order that permits generic substitution.
In the process of selecting a generic substitute, please remember that not all generic drugs are approved for substitution. If you wish to substitute a generic drug for another drug prescribed, you may only do so if the federal Food and Drug Administration (FDA) has rated the proposed generic substitute as therapeutically equivalent to the product prescribed. Where do you find the information about the equivalency ratings for generic substitutes? FDA publishes the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) in both paper and electronic formats. You may order the annual paper edition from the US Government Printing Office (http://bookstore.gpo.gov; toll free at 866/512-1800). You may perform online queries – free of charge – at www
.fda.gov/cder/ob/default.htm. If the product intended as a substitute is not rated by FDA as equivalent to the product prescribed, then the pharmacist shall not dispense that product as a substitute to the product prescribed.
When a prescriber initiates a prescription order for a multi-source product and the prescriber has not prohibited generic substitution, then the pharmacist may select a generic substitute, but only if the patient is aware of – and consents to – the proposed cost-saving substitution. There should never be a “surprise” at the prescription counter or beyond. If the patient does not consent to the proposed cost-saving substitution, then the pharmacist shall not dispense a substitute for the product prescribed. Based on the complaints we are receiving, it appears that some pharmacists are not informing patients or obtaining their consent prior to dispensing a substitute medication.
The Board has instructed the office to collaborate with prescriber organizations to ensure their understanding of the correct way to prohibit generic substitution. In addition, we will collaborate with consumer organizations to inform patients of the generic substitution laws as well as how to file complaints against pharmacists. Our compliance officers are mandated to investigate consumer complaints and to enforce the generic substitution law.
Improper generic substitution is a violation of the Louisiana Pharmacy Practice Act. As a reminder, the Board has several options to discipline a pharmacist’s license. They may issue a Letter of Warning or a Letter of Reprimand. For more severe infractions, the Board may place a license on probation (for any length of time) or suspension (for any length of time). The Board may also revoke a license. In addition, the Board may levy a fine. The amount of the fine is purely within the discretion of the Board but may not exceed $5,000 – per violation, per day. Finally, the Board is authorized to recover all of its administrative and investigative costs.
