May 1, 2013
Volume 77, Number 5
Medication Shortages: Ongoing Activity for an Ongoing Problem
Richard P. Dutton, M.D. , M.B.A., Executive Director Anesthesia Quality Institute
Lisa Pearlstein, J.D. ASA Pain Medicine and Regulatory Lobbyist
In the past five years, inability to obtain specific injectable medications has become a daily occurrence in anesthesia practice. Almost every medication we use in anesthesiology has been affected – from propofol to fentanyl to succinylcholine. “What are we missing today?” has become a daily question in the operating room. As the masters of improvisation, we have learned how to substitute the drug we can find for the drug we desire, but there is an obvious risk to our patients.
Sometimes the indicated drug is demonstrably faster, safer or otherwise more efficacious – succinylcholine for rapid-sequence induction in a trauma patient, for example – and the consequence to the patient is a small, but finite, increase in risk for a complication (e.g., aspiration of gastric contents) or a delay in some aspect of care (e.g., subsequent neurologic examination). In other cases, such as substituting dexmedetomidine for propofol in ICU sedation, the clinical result is the same, but the adverse outcome is an increase in the cost of care. Subtle dangers can also accumulate when the anesthesiologist is using an unfamiliar agent. The January 2012 ASA NEWSLETTER reported on a case in which a serious medication error resulted from a change in packaging necessitated by inability to obtain the usual medication from the usual company. That we have not been deluged with such events is a tribute to the flexibility of anesthesiologists and our vigilance in preventing errors from reaching the patient. At the same time, it is our responsibility to speak up about this risk and to seek ways to mitigate it.
There are many causes of medication shortages at many levels of the supply chain. Some of these are intrinsic to the pharmaceutical industry and will be hard to affect, but others are much more solvable. This past summer, at the urging of ASA and other drug shortage stakeholders, Congress took action to address drug shortages by passing, on an overwhelming bipartisan basis, the Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA is a legislative package of important FDA provisions that includes a section dedicated solely to preventing and mitigating national drug shortages.
FDASIA requires manufacturers to report to the FDA a permanent discontinuance or interruption of the manufacture of a wide array of drugs, including those used by anesthesiologists in emergency medical care or during surgery and by physicians who treat patients with chronic pain. The law permits the FDA to expedite reviews of drug applications and inspections of manufacturing facilities if such actions could help alleviate pending drug shortages. The law also requires the FDA to:
Determine if a drug in shortage is a controlled substance, and if necessary, request that the Drug Enforcement Administration (DEA) increase the aggregate and individual production quotas for that drug;
Submit an annual report on drug shortages to Congress;
Establish a task force to develop and implement a strategic plan for enhancing the agency’s response to drug shortages; and
Maintain an up-to-date list of drugs in shortage.
Importantly, FDASIA requires the Government Accountability Office (GAO) to conduct a study to examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate shortages. The study is expected to be released in January 2014. Among other questions, GAO will evaluate the root causes of drug shortages and consider whether there are systemic high-risk factors – such as drug pricing structure, Medicare payments or the number of manufacturers producing a drug – that have led to shortages of products such as generic, sterile injectables.
The bipartisan passage of FDASIA was an important step in helping to prevent and mitigate drug shortages, but critical drugs are still in shortage. According to the University of Utah Drug Information Service, there were fewer new shortages in 2012 than 2011, at 204 and 267 shortages, respectively. However, there were 299 active shortages in the last quarter of 2012, which is the highest quarterly total to date and an indication that many of the ongoing shortages have not been resolved.
ASA will continue to urge lawmakers and regulators to support drug shortage relief and highlight the significant impact drug shortages have on our members and the patients they treat. Most recently in March 2013, ASA presented recommendations to the FDA regarding a strategic plan that will be developed and implemented by the FDA Drug Shortages Task Force. ASA is also leading efforts with stakeholders to develop next steps to address drug shortages, and we look forward to the GAO investigation that will make recommendations on preventing and mitigating drug shortages.
At the request of ASA and numerous other stakeholders, the Anesthesia Quality Institute (AQI) is collecting incident reports related to drug shortages. While we can never measure the full impact of shortages on patient care, we can at least take note of how they are changing our practice. Real-life clinical stories are of enormous value when ASA’s advocates in Washington talk to legislators and regulators, and they put a human face on the patient safety risks created when we are forced to work around what would otherwise be our preferred practice. AQI built a module in the Anesthesia Incident Reporting System that solicits complications, adverse outcomes and near-misses related to missing medications. The module collects data on what drug was desired, what was substituted and the consequences to the patient. All case reports are collected and maintained in strictest confidence, but important lessons and aggregate information are shared with ASA leaders using de-identified data. Every anesthesiologist can help ASA address the drug shortage issue by submitting his or her stories to AIRS. Together, we can make this better.
Visit the ASA website to learn more about ASA advocacy on drug shortages: www.asahq.org/For-Members/Advocacy/Federal-Legislative-and-Regulatory-Activities/Drug-Shortages.aspx.
Visit the AQI website to learn more about the AIRS system and to report adverse events arising from a drug shortage:
Richard P. Dutton, M.D., M.B.A. is a
Clinical Associate Anesthesiologist at
the University of Chicago.
Lisa Pearlstein, J.D. is Pain Medicine and Regulatory Lobbyist for ASA in its Washington, D.C. office.
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