O T H E R F E AT U R E S Managing Drug Shortages During my visits to regional healthcare facilities, I often ask the facility patient safety officers what challenges they face. One common frustration they mention is managing drug shortages. Drug shortages affect patient care. Not only are there clinical implica- tions to drug shortages, such as having to use a less optimal medication or rescheduling procedures, there is a financial impact, and resources are required to manage the short- age. The patient safety aspect of drug shortages is not to be underestimated, either, as evidenced by these events reported to the Pennsylvania Patient Safety Authority. Michelle Bell, RN, BSN, FISMP Patient Safety Liaison, Southeast Region— The pharmacist was working on an order for a brand new bag of D10/0.2%NS, as the Delaware Valley North premade bottles were on back order. The pharmacist had to start from scratch to prepare Pennsylvania Patient Safety Authority the solution. The pharmacist did his calculations and noted that he came up with some- thing different than the pharmacist did the previous day. The pharmacist believed that the previous pharmacist had miscalculated and was low by a factor of ten of the sodium chloride. When the other pharmacist came into work on this day, this pharmacist dis- cussed the miscalculation together. It was learned that the order from the previous day was correct, and the miscalculation for today resulted in the sodium chloride content of the IV [intravenous bag] to be ten times higher than what was ordered. A patient [presented] to the ED [emergency department] for rabies vaccine; the phar- macy informed the ED that the vaccine was not available due to back order. A patient required 71 mg tissue plasminogen activator (t-PA). [The patient] received 50 mg t-PA related to pharmacy shortage. DRUG SHORTAGES AND PATIENT SAFETY Results of a 2010 Institute for Safe Medication Practices (ISMP) survey of pharmacists and other healthcare providers1 indicated that drug shortages present a clear patient safety threat. More than 1,800 respondents from across the country participated in the survey. Thirty-five percent of respondents indicated they experienced a near-miss event because of a drug shortage. One in four reported an error occurred that reached a patient, and one in five reported an adverse patient outcome occurred due to a drug shortage. Many error examples included in the ISMP article discussing the survey results involve high-alert medications, which are medications that are more likely to cause harm when used in error. In one case, propofol was unavailable, and an alternative medica- tion was not prescribed, leaving a paralyzed and ventilated patient with no sedation. Another patient received 10 mg of morphine instead of the 1 mg that was ordered. Another report indicated that a shortage of prefilled EPINEPHrine syringes may have contributed to a patient death during a code situation because healthcare providers were unable to keep up with the demand for EPINEPHrine when each ampul had to be diluted. WHY DRUG SHORTAGES OCCUR Drug shortages occur for many reasons.2 Raw materials used in manufacturing may be unavailable. Manufacturing disruptions could occur due to a change in formulation, manufacturer mergers, product discontinuation, or moving production to a new facil- ity. Production line downtime due to maintenance, changes, or regulatory shutdowns will also adversely affect supply. A manufacturer may choose to eliminate a product due to small market size or unprofitability. Recalls may decrease a drug’s availability. Natural disasters may disrupt production or increase demand. Drug demand may also increase because of a new indication, new guideline, a shift in clinical practice, or a dis- ease outbreak. Hoarding of drugs can prematurely increase a shortage’s impact or lead Vol. 8, No. 4—December 2011 Pennsylvania Patient Safety Advisory Page 117 ©2011 Pennsylvania Patient Safety Authority O T H E R F E AT U R E S to secondary shortages; for example, if stock? How is the drug used and in what EFFORTS TO DECREASE morphine is in short supply, more people population? How long is the shortage SHORTAGES may be purchasing HYDROmorphone, expected to last? Increasing attention has been paid to the leading to shortage of HYDROmorphone After the impact has been assessed, impact of drug shortages. In November as well. facilities can begin to prepare to mitigate 2010, ISMP, ASHP, the American Society the effects of the shortage. This requires of Anesthesiologists, the American Society MANAGING DRUG SHORTAGES evaluating what concentrations, alternate of Clinical Oncology, and representatives The American Society of Health-System packaging, or therapeutic alternatives from other professional organizations, Pharmacists (ASHP) identifies three main are available. Therapeutic alternatives manufacturers, and healthcare facilities steps in managing a drug shortage in a are rarely optimal choices, or they would convened a summit to discuss the healthcare facility:2 be in use already. It is important to impact of drug shortages and create consider how the alternatives work. For recommendations.3 1. Identification and assessment example, are they appropriate for the In February 2011, the Preserving Access 2. Preparation population? Or, what are the dosing to Life-Saving Medications Act was 3. Contingency and prescribing parameters? There will introduced to the U.S. Senate and The first step in managing a drug short- likely be differences in the amount and referred to committee.4 This bill would age is to identify that there is a shortage. frequency of dosing, side effects, and require a drug manufacturer to notify the Often, a shortage is discovered when the onset and duration of the drug’s Secretary of Health and Human Services attempts are made to order a medication. effectiveness. Preparation, storage, of a “discontinuance, interruption, or How much medication is in stock will and administration requirements are other adjustment of the manufacture determine how much time a facility has also important to examine. Certain of the drug that would likely result in to address the issue. ASHP and the U.S. populations may not be appropriate for a shortage of such drug” six months Food and Drug Administration (FDA) use of these alternatives. Education and before a discontinuance or planned have both created webpages to notify drug information about the alternatives is disruption, or “as soon as practicable” if healthcare professionals when a drug to be easily accessible to all staff. Facilities the disruption is unplanned. shortage has been identified or is likely to can also review the potential for look-alike occur. The FDA webpage (http://www. or sound-alike confusion to arise whether CONCLUSION fda.gov/drugs/drugsafety/drugshortages/ utilizing an alternative drug or a different default.htm) lists only medically necessary concentration of the drug in short supply. Drug shortages can affect patient care drugs, while the ASHP webpage (http:// and patient safety. While they are not The contingency step may involve www.ashp.org/menu/PracticePolicy/ preventable, they can be managed in a the facility risk management or ethics ResourceCenters/DrugShortages.aspx) is way that will decrease the likelihood of departments if there is reason to believe more comprehensive, with 199 medica- negative outcomes. This management that patient care could be delayed or tions listed in September. includes identifying which drugs are compromised due to the shortage. likely to be unavailable or in short supply, Once a drug shortage has been identified, Communication with staff and patients is assessing the utilization of those drugs in facilities need to assess the impact of the also a component of this step. the healthcare facility, preparing for the shortage on their practice. For example, shortage, and having clear policies for how much of the drug is currently in controversies that may arise. NOTES 1. Institute for Safe Medication Practices 3. American Society of Health-System 4. S. 296—112th Congress: Preserving (ISMP). Drug shortages: national sur- Pharmacists, American Society of Access to Life-Saving Medications vey reveals high level of frustration, low Anesthesiologists, American Society Act. (2011). In GovTrack.us [database level of safety. ISMP Med Saf Alert 2010 of Clinical Oncology, et al. Drug of federal legislation]. [cited 2011 Jul Sep 23;15(19):1-6. shortages summit summary report, 27]. Available from Internet: http:// 2. Fox ER, Birt A, James KB, et al. ASHP November 5, 2010 [online]. [cited 2011 www.govtrack.us/congress/bill. guidelines on managing drug product Jul 27]. Available from Internet: http:// xpd?bill=s112-296. shortages in hospitals and health sys- www.ashp.org/drugshortages/ tems. Am J Health Syst Pharm 2009 Aug summitreport. 1;66(15):1399-406. Page 118 Pennsylvania Patient Safety Advisory Vol. 8, No. 4—December 2011 ©2011 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 8, No. 4—December 2011. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2011 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s An Independent Agency of the Commonwealth of Pennsylvania website at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and indepen- dence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions. Scan this code with your mobile device’s QR reader to subscribe to receive the Advisory for free.