Using expired supply in times of drug shortage

Abstract

Using expired supply in times of drug shortageShortages of oncology drugs pose a serious and growing dilemma in North America. In 2011 alone, our institution had experienced difficulties in obtaining 11 antineoplastic agents. Although various national and professional initiatives are in progress, there is no simple answer to this problem and the list of drugs in short supply will continue to grow in the foreseeable future. Health professionals have been forced to take different approaches as each shortage arises. Fortunately in some cases, an agent from a similar drug class or a similarly effective agent may be used. However, for some medications, there are simply no therapeutic alternatives.We would like to share our recent experience in dealing with a national shortage of alemtuzumab (Campath Õ , MabCampath Õ ). The stock on hand was expected to expire before the manufacturer (Genzyme Canada Inc.) could provide a new supply. Once it was established that there was no alternative agent, we were forced to assess the likelihood of toxicity if the existing stock was used beyond the expiry date. We were less concerned with the potential loss of efficacy because these patients would otherwise not have received any therapy at all.After confirming from the manufacturer that the original vial was stable for 36 months from the time of manufacturing to expiry, several assumptions were made to support using the vials for 14 days beyond expiration.

Evidence-based practice in times of drug shortage

“…There are numerous randomized comparisons of intramuscular vs. oral vitamin B12 for the management of vitamin B12 deficiency, [2][3][4][5][6][7][8] but not in the prevention of pemetrexed toxicities. After one month of therapy, none of these regimens are associated with the 6.9 mmol/L homocysteine level associated with reduction in toxicities.…”

“…We have previously shown that, during a shortage crisis, it is possible to make a recommendation on the use of an expired supply of alemtuzumab based on a reasonable estimate of its safety and efficacy. 8 Here, we would like to share further examples on how to deduce potential therapeutic alternatives based on pharmacokinetic and pharmacodynamic principles in the absence of direct clinical evidence in the literature.…”