January 01, 2001

 

 Disposing of expired drugs: a matter of policy - January 1, 2001

Posted Dec. 15, 2000 

NOTE: As of July 2009, the AVMA has specific Best Management Practices for Pharmaceutical Disposal (see http://www.avma.org/issues/policy/pharmaceutical_disposal.asp)

Answer the following question honestly: do you take the expiration dates on pharmaceuticals and biologics seriously?

Not all clinics have a known, consistent policy for disposing of outdated pharmaceuticals. Without a policy, clinic personnel can find it tempting to give expired pharmaceuticals away or even sell them. If expired pharmaceuticals are not disposed of properly, clinic personnel might even dispense them mistakenly. Your staff should be made aware that dispensing expired medications is a violation of the Federal Food, Drug, and Cosmetic Act and/or the Drug Enforcement Administration (DEA) requirements.

Consumers and professionals alike sometimes ignore expiration dates, thinking they are assigned arbitrarily. When asked whether expired drugs are harmful or ineffective, Dr. Jay R. Brown, director, Large Animal Veterinary Professional Service, Merial, responded, "Usually the use of a pharmaceutical after the expiration date does not pose any harm to the target animal, but one must remember the level of active drug may be below the labeled specifications and, therefore, will not give the desired result in the patient. Therefore, it is recommended that animal owners discard expired pharmaceuticals and see their veterinarian for 'proper-dated' medication, if needed. Veterinarians are asked to contact their sales representatives or customer service to arrange for return of the short-dated or expired medicine.

"Although it is very rare, there are some pharmaceuticals for which by-products of the natural degradation process can become toxic to the target animal after the expiration date. In these few products, the expiration date is listed not only because of the degradation of the active drug below a labeled specification, but also because future degradation may lead to a toxic buildup of the by-products of that degradation.

"Modified-live biologics are handled in a similar manner as pharmaceuticals. Again, expiration dates are listed to indicate that past that date, the immune response generated in the target animal may not be as great as previous to that date, due to loss of viral antigen mass."

You may think that, because an expired drug is likely still effective in its treatment, the patient will be properly medicated and all will be well; however, imagine the following scenario. You dispense recently expired medicine to a client. The client administers the medication and the animal has an anaphylactic reaction and dies. The client assumes it is because the drugs were expired. He files suit, alleging that you failed to meet the standard of care. Will the plaintiff's lawyers and the jury understand?

Make sure your clinic has a known, consistent policy for disposal of expired medicine. Depending on the material and the services available, the distributor may allow the product to be returned. Another option is the hazardous waste disposal service that picks up the clinic's biological waste. Consider obtaining written instructions from the hazardous waste disposal service on the proper method of disposal.

You are required to maintain an inventory of discarded controlled substances. Individuals registered with the DEA are required to complete the necessary forms and to communicate the disposal of the drugs as directed by the DEA.* In addition to meeting the federal DEA requirements, contact your state controlled substance authority to ensure that you are meeting your state's requirements as well.

Consider a similar inventory for other drugs, noting the type, quantity, method, and date of disposal.