Should We Use Expired Drugs When Necessary?

Abstract

Background: Medication shortages commonly occur in resource-poor settings. The relatively short expiry dates on many medications exacerbate these shortages, often requiring clinicians to choose between providing needed medications to the patient and violating rules governing drug dispensing.

Case report: A patient presented to an emergency department in a resource-poor setting with an acute anterior myocardial infarction. Standard of care required using thrombolytics due to the unavailability of percutaneous coronary intervention. The only available thrombolytic, streptokinase, was 2 weeks past its labeled expiration date. The physicians faced the ethical dilemma of violating regulations and using the medication vs. failing to provide the patient with the best available therapy.

Discussion: The physicians in this case needed to weigh their obligation to improve the patient's health against the professional danger to themselves, their colleagues, and their institution for violating a health care regulation. The information they needed to make this decision and to provide the patient with factual informed consent requires an understanding of the myths, regulations, and science surrounding drug expiry dates. Two myths about medications pervade both the professional and lay communities-that they are uniformly effective and that medications taken past their expiry dates may be ineffective or even harmful. Scientific studies have demonstrated that both are false.

Conclusions: Ethically, physicians have a duty to place their patient's welfare above their own self-interest. In a time of increasing medication shortages around the globe, clinicians need to push rule makers to synchronize drug expiry dates with scientific findings.

Keywords: drug expiry date; drug safety and stability; food and Drug administration; informed consent; patient welfare.