The United States Food and Drug Administration defines a drug shortage as “a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.”a There is evidence that drug shortages are associated with patient harm, including death.1
In 2011, we examined the implications of drug shortages to the practice of anesthesiology and patient safety.2 Although our article was well received during the peer-review process, one of the reviewers was not convinced of the relevance of the topic. The reviewer thought that “the drug shortage problem is likely to be resolved by the time the manuscript is published.” This comment was particularly difficult to address because it likely required us to perform a complex model of economic forecasting for each drug.3 In addition, the decision to discontinue manufacturing a particular medication represents a strategic business decision by the pharmaceutical company using a process analogous to Porter’s Five Forces.4 Business strategic analyses frequently go beyond principles of supply and demand often used by health care economists.5
Our reviewer was wrong. From March 2014 through February 2015, several perioperative injectable medications were included on the national drug shortage list (Table 1).6 Drug shortages have yet to be resolved for the majority of perioperative injectable drugs. Despite significant advocacy by the American Society of Anesthesiologists and an executive order signed by President Obama in October 2011 to mitigate drug shortages,7 the current number of injectable drugs on a national shortage list is larger than in 2010.2 Drug shortages are an ongoing reality in the practice of anesthesiology for the foreseeable future.
It is obvious that as a member of the perioperative team we need to inform and educate other anesthesiologists, resident physicians, nurse anesthetists, and our perioperative colleagues, including the surgeons, nurses, and health care administrators about the implications of a drug shortage on anesthesia practice and patient safety. The importance and implications of informing the most important stakeholder, the patient, about practice alterations because of drug shortages is less obvious, perhaps because it is so acutely uncomfortable.
In this issue of the Anesthesia & Analgesia, Hsia et al.8 studied patients’ desire to be informed about drug shortages before undergoing elective cholecystectomies. Motivated by a national shortage of neostigmine, the authors performed a survey to identify patients’ desire to be informed about drug shortages. The majority of patients (60.9%) wanted to be informed about the drug shortage, even if the use of the substitute represented only slight differences in potential side effects compared with the unavailable drug. The authors explained to patients that this slight difference in side effects would be analogous to treating a headache with acetaminophen instead of aspirin. On the basis of their findings, we can conclude that most patients want to be informed about and engaged in decisions with potential minor consequences to their health care.
Increased patient engagement has been shown to result in better care, outcomes, and (maybe) decreased costs in other clinical scenarios.9 Better care with lower costs is sometimes thought to involve conflicting goals for health care systems. However, initial studies have pointed toward patient engagement as a viable pathway to achieve both outcomes.10 Nonetheless, not all patients are able to engage in their own care given the complexities of our health care system. In addition, patients with poor health literacy (approximately 36% of adults in the United States) are unable to process even basic health information and lack a true understanding of their medical condition.11
There are additional barriers to patient engagement. On the patient side, reluctance to consider costs, cultural differences, and cognitive issues may preclude effective engagement.12 On the health care provider side, time restrictions, lack of training, and lack of incentives are significant obstacles.12 Effective strategies to inform patients is the first step. However, effective patient engagement is more difficult than merely informing patients.
One of the most beneficial aspects of patient engagement is the development of a shared decision-making model. This model can be used in patients who have “preference-sensitive” treatment options such as the elective cholecystectomy presented in the current study.13 In the event of a drug shortage, patients would balance their risk of having a substitute drug versus postponing their elective procedure. Interestingly, Hsia et al. found that a large proportion of patients (33.6%) would postpone surgery even if the difference in a substituted drug’s side effects was small. This finding may have liability implications if patients undergoing elective procedures are not fully informed of the risks incurred by substituting drugs considered even slightly less safe than the unavailable drug.
One major limitation in the study by Hsia et al. is the low response rate obtained in their survey. The authors attempted to address this problem by externally validating their results in a second group of patients from Canada. Readers can interpret the associations presented in the study as valid but the overall descriptive statistics as less reliable because of the potential effect of response bias. Nevertheless, we believe that the associations presented are more important because the overall descriptive statistics are likely to vary according to different health care systems, patients’ degree of health literacy, and overall perception of surgical risk by patients.
Like the drought in the American Southwest, shortages of perioperative injectable drugs are our new reality for the foreseeable future. The study by Hsia et al. tells us that patients want to know about shortages of drugs used during anesthesia so that they can make informed health care decisions. We must engage our patients in these discussions, ideally before the day of surgery, to respect their rights to make informed decisions. In addition, by fully informing patients, they can become our partners in seeking health care policies that reduce the incidence of drug shortages in the future.
Name: Gildasio S. De Oliveira, Jr., MD, MSCI.
Contribution: This author contributed to manuscript preparation.
Attestation: Gildasio S. De Oliveira, Jr., approved the final manuscript and attests to the integrity of the analysis reported in this manuscript.
Name: Robert J. McCarthy, PharmD.
Contribution: This author contributed to manuscript preparation.
Attestation: Robert J. McCarthy approved the final manuscript and attests to the integrity of the analysis reported in this manuscript.
This manuscript was handled by: Steven L. Shafer, MD.
a See http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm277745.htm. Accessed April 2, 2015.
1. McLaughlin M, Kotis D, Thomson K, Harrison M, Fennessy G, Postelnick M, Scheetz MH. Effects on patient care caused by drug shortages: a survey. J Manag Care Pharm. 2013;19:783–8
2. De Oliveira GS Jr, Theilken LS, McCarthy RJ. Shortage of perioperative drugs: implications for anesthesia practice and patient safety. Anesth Analg. 2011;113:1429–35
3. Elliott G, Timmermann A. Economic forecasting. J Econ Lit. 2008;46:3–56
4. Scurlock C, Dexter F, Reich DL, Galati M. Needs assessment for business strategies of anesthesiology groups’ practices. Anesth Analg. 2011;113:170–4
5. Fuchs VR. Major concepts of health care economics. Ann Intern Med. 2015;162:380–3
8. Hsia IKH, Dexter F, Logvinov I, Tankosic N, Ramakrishna H, Brull SJ. Survey of the national drug shortage effect on anesthesia and patient safety: a patient perspective. Anesth Analg. 2015;121:502–6
9. Greene J, Hibbard JH, Sacks R, Overton V, Parrotta CD. When patient activation levels change, health outcomes and costs change, too. Health Aff (Millwood). 2015;34:431–7
10. O’Hare AM, Armistead N, Schrag WL, Diamond L, Moss AH. Patient-centered care: an opportunity to accomplish the “Three Aims” of the National Quality Strategy in the Medicare ESRD program. Clin J Am Soc Nephrol. 2014;9:2189–94
11. Wolf MS, Wilson EA, Rapp DN, Waite KR, Bocchini MV, Davis TC, Rudd RE. Literacy and learning in health care. Pediatrics. 2009;124(suppl 3):S275–81
12. Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, Sweeney J. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff (Millwood). 2013;32:223–31
13. Veroff D, Marr A, Wennberg DE. Enhanced support for shared decision making reduced costs of care for patients with preference-sensitive conditions. Health Aff (Millwood). 2013;32:285–93