Drug shortages: Implications for medical toxicology

Abstract

Context. Drug shortages have significantly increased over the past decade. There are limited data describing how shortages impact medical toxicology of drugs. Objective. To characterize drug shortages affecting the management of poisoned patients. Materials and Methods. Drug shortage data from January 2001 to December 2013 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, reason for shortage, shortage duration, marketing, and whether the drug was available from a single source was collected. The availability of a substitute therapy and whether substitutes were in shortage during the study period were also investigated. Results. Of 1,751 shortages, 141 (8.1%) impacted drugs used to treat poisoned patients, and as of December 2013, 21 (14.9%) remained unresolved. New toxicology shortages increased steadily from the mid-2000s, reaching a high of 26 in 2011. Median shortage duration was 164 days (interquartile range: 76–434). Generic drugs were involved in 85.1% of shortages and 41.1% were single-source products. Parenteral formulations were often involved in shortages (89.4%). The most common medications in shortage were sedative/hypnotics (15.6%). An alternative agent was available for 121 (85.8%) drugs; however, 88 (72.7%) alternatives were also affected by shortages at some point during the study period. When present, the most common reasons reported were manufacturing delays (22.0%) and supply/demand issues (17.0%). Shortage reason was not reported for 48.2% of drugs. Discussion. Toxicology drug shortages are becoming increasingly prevalent, which can result in both suboptimal treatment and medication errors from using less familiar alternatives. Conclusion. Drug shortages affected a substantial number of critical agents used in the management of poisoned patients. Shortages were often of long duration and for drugs without alternatives. Providers caring for poisoned patients should be aware of current shortages and implement mitigation strategies to safeguard patient care.

Keywords:

• Drug shortages
• Antidotes
• Medical toxicology

Funding support

None.

Declarations of interest

Dr. Mazer-Amirshahi, Ms. Hawley, Mr. Zocchi, and Dr. Nelson do not have any conflicts of interest related to this project to report.

Dr. Pines serves as a consultant for Medtronic and receives grant funding from Abbott Point of Care and Brooking Institution and receives support for educational programs from QuantiaMD; however, they are unrelated to this project.

The University of Utah Health Care Drug Information Service receives some funding from Novation, LLC for providing information on drug shortages.

Erin R. Fox reports receiving partial travel support for speaking on drug shortages from the following organizations: American Association of Clinical Endocrinologists, American Bar Association, American College of Clinical Pharmacy, American Medical Association, American Pharmacists Association, American Society of Health System Pharmacists, American Society for Pharmacy Law, California Society of Health System Pharmacists, Child Health Corporation of America, Healthcare Supply Chain Association, International Federation of Pharmacists, National Association of State EMS Officials, National Comprehensive Cancer Network, National Surgical Adjuvant Breast and Bowel Project, New Mexico Society of Health System Pharmacists, Premier Oncology/Hematology Management Society, St. Jude's Hospital, St. Josephs/Candler, Texas Society of Health System Pharmacists, University of Illinois Great Lakes cGMP & Regulatory Science Forum, and VHA Corporation.

Supplementary material available online

Supplementary Appendix to be found online at http://informahealthcare.com/doi/abs/10.3109/15563650.2015.1043441.