Drug Shortages: An Ongoing Public Health & Safety Concern

Tricia Meyers, MS, PharmD, FASHP, FTSHP

Drug shortages have become an ongoing serious public health and safety concern. The severity of annual drug shortages reached a critical level in 2011 and subsequently have slightly declined from 2011.1 Unexpectedly, in 2017/2018, the shortage of intravenous fluids caused by Hurricane Maria left clinicians across the United States experiencing another serious shortage crisis. The manufacturing facilities were in Puerto Rico, and the hurricane caused a major supply disruption of parenteral solutions. In fact, The Food and Drug Administration (FDA) reported pharmaceutical products manufactured in Puerto Rico account for 10% of all drugs used by Americans.2 Therefore, drug shortages continue to be a major issue that require urgent solutions. This article will review some of the complex issues as they relate to present-day drug shortages.

Injectable generic medications which are widely used in hospitals, particularly in the operating room, critical care, emergency care, and procedural areas constitute most drug shortages. Unfortunately, there is a limited number of pharmaceutical manufacturers who are involved in the majority of all injectable drug productions. Only one to two producers make the vast majority of injectables.3,4 Quality problems that occur during the manufacturing process account for the majority of shortages over the last six years.5 The Government Accounting Office (GAO) reported that 46–55% of sterile injectable anti-infective, and cardiovascular drug shortages between the years of 2012 to 2014 were from manufacturing facilities that had received a FDA warning letter because they failed to comply with manufacturing standards.6 Examples of quality manufacturing issues are non-sterility (resulting in bacterial or fungal contamination), retained particulate matter (glass, metal, or fiber in vials), crystallization, precipitation, impurities, degradants (leading to less effective drug), and equipment failures.

The unpredictability of shipments adds to the difficulty of managing drug shortages. For example, hospitals can receive products in very limited supply one week and then may not have any additional supply for weeks until they receive another shipment.

Another problem is secondary shortages. This occurs when a drug is on shortage and hospitals purchase alternative drugs in the same pharmacologic category and the new demand for the alternate agent causes another shortage.3

Additionally, once a shortage occurs, it does not necessarily occur at the same time or rate across the country. This is due to the varied distribution of the available drug. For instance, one hospital may receive supplies and another hospital may not be able to obtain that same supply. Although a drug may have a supply disruption, it may be available in a variety of strengths, packages, and/or concentrations. An increased risk of medication errors can result when using different drug presentations due to clinician unfamiliarity.3

The Institute for Safe Medication Practices (ISMP), a global leader in medication safety, surveyed patient safety officers, pharmacy leaders, and purchasing agents from August to October 2017 on their opinions regarding drug shortages.7 Although shortages were occurring across all treatment categories, emergency care was the area that respondents noted had the most drug shortages, and anesthesia care was noted as the second most prevalent area to experience drug shortages. The respondents overwhelmingly felt that care of patients has been compromised due to the shortages. Seventy-one percent of those surveyed were unable to provide patients with the recommended drug or treatment and approximately half of respondents commented that patients received a less effective drug.7

Hospitals, pharmacies, and professional organizations have developed strategies and guidelines to manage the limited supplies of medications during drug shortages. Multiple strategies are used for each drug that has a supply disruption. Resource intensive actions by pharmacy are listed in Table 1 and may be used regularly or daily, depending on the drug, to mitigate the shortages.7

Table 1. Resource Intensive Actions7

  • Ration drugs
  • Establish criteria for use
  • Search literature to determine whether lower doses or shorter duration may have desired clinical effect
  • Contact suppliers repetitively
  • Review manufacturer/wholesaler ordering sites daily
  • Communicate information on shortages/respond to numerous questions from clinicians
  • Change par levels on automated dispensing cabinets (ADCs)
  • Remove/re-add inventory to ADCs
  • Purchase more expensive products
  • Borrow or purchase from another health system
  • Purchase different strengths/concentrations
  • Compound unavailable products in-house

Government and National Organizations Recognize Drug Shortage Crisis

When a drug is in shortage, it has an impact on all health care delivery systems from public and private hospitals to VA hospitals and the United States military.5 At the 2018 American Medical Association Annual Meeting, new wording was added to policy declaring that drug shortages are now an urgent public health concern. The AMA will be asking the Department of Health and Human Services and the Department of Homeland Security to examine the problem as a national security initiative, and to consider vital pharmaceutical production sites as critical infrastructure. The AMA is responding to the ongoing national drug shortages that threaten patient care and safety.8

On September 20, 2018, Drug Shortages as a Matter of National Security: Improving the Resilience of the Nation’s Health Care Critical Infrastructure Summit was held in Washington DC. The summit was hosted by the American Society of Health-System Pharmacists, American Hospital Association, American Society of Anesthesiologists, American Society of Clinical Oncology, and Institute for Safe Medication Practices. The groups discussed solutions to the persistent shortages of critical lifesaving medications that dangerously hinder patient care. The participants’ plan was to develop actionable solutions to safeguard patients by having a secure and stable supply of medications. One of the participants at the summit, then ASA President James Grant, MD, stated that 98% of anesthesiologists across the country have experienced drug shortages.9 The attendees developed 19 recommendations. See list at:

https://www.ashp.org/-/media/assets/advocacy-issues/docs/Recommendations-Drug-Shortages-as-Matter-of-Natl-security.ashx

At the 2018 APSF-sponsored Stoelting Conference in Scottsdale, AZ, speaker Erin Fox, PharmD, BCPS, FASHP, senior director of Drug Information & Support Services at the University of Utah Health, stated the rate of new shortages is increasing and long-term active/ongoing shortages are not resolving.10 Health care organizations have developed and implemented recommendations and expended significant efforts to prevent shortages from causing medication errors. However, many of these recommendations may not address the pervasive manufacturing quality problem. Dr. Alice Romie’s and Dr. John Beard’s articles (pages 87 and 89, respectively) in this issue present views on solutions from the manufacturer’s perspective.

Drug shortages can affect patients and providers on a daily basis. The impact on the nation’s health care system continues to be significant.

 

Tricia A Meyer, MS, PharmD, is currently regional director of Pharmacy at Baylor Scott & White Medical Center-Temple and associate professor of anesthesiology at Texas A&M College of Medicine. She also serves on the APSF editorial board.


She has served on the advisory board of Neumentum.


References

  1. American Society for Health Systems Pharmacist. Drug shortages. Drug shortage statistics. https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics. Accessed October 30, 2018.
  2. U.S. Food and Drug Administration. FDA statement. Statement from FDA commissioner Scott Gottlieb, MD, on FDA’s continued assistance following the natural disaster in Puerto Rico. October 6, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579493.htm. Accessed November 1, 2018.
  3. Fox E, Burganda S, Jensen V. Drug Shortages: A complex health care crisis. Mayo Clin Proc. 2014: 89;361–373.
  4. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. 2013; 93:170–6.
  5. Drug shortages roundtable: minimizing the impact on patient care. Am J Health-Syst Pharm. 2018;76:816–20.
  6. U.S. Government Accountability Office. Drug shortages: certain factors are strongly associated with this persistent public health challenge (GAO-16-595, July 2016). www.gao.gov/assets/680/678281.pdf. Accessed November 2018.
  7. Institute for Safe Medication Practices. Drug shortages continue to compromise patient care (January 11, 2018). https://www.ismp.org/resources/drug-shortages-continue-compromise-patient-care. Accessed November 9, 2018.
  8. American Medical Association. Press Release. New AMA Policy reflects frustration over ongoing drug shortages. June 12, 2018; https://www.ama-assn.org/new-ama-policy-reflects-frustration-over-ongoing-drug-shortages. Accessed September 8, 2018.
  9. American Society of Health-System Pharmacists. Press release. Summit on drug shortages to examine impact on national security and health care infrastructure. Sept. 20, 2018; https://www.ashp.org/news/2018/09/19/summit-on-drug-shortages-to-examine-impact-on-national-security-and-health-care-infrastructure. Accessed November 21, 2018.
  10. Fox E. Drug Shortages. APSF Stoelting Conference. Sept. 2018. Phoenix, AZ. https://www.apsf.org/presentation/drug-shortages/. Accessed November 21, 2018.