Author Affiliations: California Poison Control System, San Diego Division, San Diego (Dr Cantrell); University of California, Irvine Medical Center, Orange (Dr Suchard); and San Francisco General Hospital, University of California, San Francisco (Dr Gerona).
We appreciate the insightful comments provided by Madden and colleagues. The simple goal of our study1 was to determine if long-outdated medications retained active pharmaceutical ingredients within range of their labeled quantities. We correlated this to the term potency because it is applied in one of the most long-respected texts concerning the science and practice of pharmacy2 as well as the US Pharmacopeial Convention (written communication; Technical Services Manager, Department of Standards Development, US Pharmacopeia; February 6, 2013). Our study was not designed to measure or compare drug delivery characteristics such as dissolution rate, degradation, bioequivalency, or efficacy, although neither our data nor the comments by Madden et al disprove that some or all of these measures remained intact. Thus, we did not conclude that it is safe or effective for individuals to consume expired medications. What we were comfortable in concluding was given that the active pharmaceutical ingredients for the medications tested were within an acceptable concentration for the majority tested, the concept of more longitudinal product testing by manufacturers or others may prove that many medications can remain safe and effective longer than current practices predict.
Cantrell L, Suchard J, Gerona R. Comment Regarding the Stability of Active Ingredients in Long-Expired Prescription Medications—Reply. JAMA Intern Med. 2013;173(11):1034-1035. doi:10.1001/jamainternmed.2013.832