Patient Safety

Drug Shortages: A Patient Safety Crisis

Leaders must plan ahead to address this critical issue.

Hospitals and healthcare providers in the United States are facing an unexpected challenge to their patient safety efforts: a critical shortage of prescription drugs. According to the American Society of Health-System Pharmacists (ASHP), 148 drugs were in short supply in 2010 and 157 in 2009. In 2006, the number was fewer than 50. In addition, there were 211 newly reported drug shortages in 2010, which is almost three times as many as in 2006, according to the University of Utah Drug Information Service. Short supplies affect treatment modalities the U.S. Food and Drug Administration deem medically necessary such as oncology, anesthetics, analgesic agents and electrolytes used in preparing nutritional formulas. Drugs for treating cancer appear to be hardest hit. Reasons for the shortages include manufacturing problems at pharmaceutical plants, shortage of raw ingredients or decisions by drug companies to discontinue a medication due to mergers and acquisitions within the drug industry that lead to new business strategies and priorities. Clinical Consequences The drug shortage is a crisis that has real consequences. A national survey of more than 1,800 health providers

published by the Institute for Safe Medication Practices (ISMP) identified at least 1,000 errors and adverse patient outcomes due to drug shortages during a one-year period leading up to the survey in September 2010. The errors and harm that result from drug shortages can manifest themselves in many ways. Hospitals that have developed standard protocols and templates for computerized medication prescribing must now spend time revising and updating the information when a different medication is substituted. Physicians arent always familiar with the alternative options for certain medications, and pharmacists and nurses have to make adjustments to dosing and monitoring requirements. The drug formulary that every hospitals pharmacy and therapeutics committee works on is under pressure, too. The purpose of the committee is to identify medications deemed to be safe and effective and cost-effective for the hospital. Based on the committees findings, the pharmacy prepares drug monographs; sets parameters for drug listings in various forms of information technology, such as smart infusion pumps and computer order processing systems; trains nurses on the proper administration and

monitoring of the medication; and reviews prescribing. Occasionally there is a need for a nonformulary medication when the medications on the formulary are deemed inappropriate for a particular patient. However, these instances are the exceptions. Imagine being in nonformulary mode every day. That is the kind of impact the drug shortage crisis is having on hospitals and patient care.

The drug shortage is a crisis that has real consequences.

In the 2010 ISMP survey approximately one in three (35 percent) respondents (including doctors, pharmacists and nurses) reported their facilities had experienced a near miss during the past year due to a drug shortage. About one in four (25 percent) reported actual errors, and one in five (20 percent) reported adverse patient outcomes during the past year due to drug shortages. Hospitals that try to work around the situation by purchasing and prescribing alternative remedies are confronting another problem: increased costs because the alternatives arent part of a group purchasing contract. Premier, the group

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Patient Safety

purchasing organization based in charlotte, N.c., has estimated that buying alternative medications or turning to other therapies can cost providers at least $200 million extra per year. Organizations like ISMP, ASHP, the American Society of clinical Oncology, the American Society of Anesthesiologists and the American Hospital Association have formed working committees that meet regularly to lead industry and government advocacy efforts and support healthcare providers who must deal with drug shortages. At the government level there are proposals for legislation that would force drug companies to provide

early warning of drugs that may be in short supply. In the meantime, healthcare leaders need to stay tuned in to the latest developments and consider how they can support their medical staff members, who are increasingly called on to improvise without jeopardizing patient safety. Some hospitals now begin their week by examining the shortages and looking for alternatives. Depending on the specific medication needs matched against availability, this work can eat up considerable timetime that has generally not been budgeted for. This, in turn, can cause delays with other services.

Managing Drug Shortages What should hospitals do? Hospital leaders should be aware of the extent of the problem. As with any other crisis, hospitals also should develop a management plan to ensure that safety and effectiveness of the medications in use are maintained and patients are not harmed. ISMP and ASHP suggest the following be included in a plan to manage medication shortages: Assign pharmacists to be the point persons to evaluate the impact of the drug shortage on clinical and operational issues

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 Ensure all staff members who may be affected are informed of drug shortages and the hospitals plans to address them Assess the quantity of medication on hand to understand available supply Identify and understand the best dosing for the medication supply available In addition to finding medication alternatives, develop drug information sheets and dosing guidelines Reduce medication waste and locate all supplies in one area Identify therapeutic alternatives as early as possible Prioritize which patients should receive the limited supply Place limitations on usage Assess the potential hazards to patients and to the organization Determine how to best manage the risk of errors in harm that may result from the alternative medication Ongoing Preparation Anticipating medication shortages will be an ongoing effort for all involved. Healthcare leaders should be doing the following to prepare: Engage the ethics committee and risk management staff as appropriate when restricting medication supplies

Proactively monitor the impact of drug shortages on patients to determine if any are being harmed Be prepared to respond to questions from patients and providers outside your organization (Patients may be discharged on medications that may be in short supply in the outpatient setting. Local pharmacies may call hospital drug information centers to determine what alternatives are available and how they should be dosed.) Proper planning will help your organization better manage the current drug shortage. Until other activities address the factors that contribute to the shortages, hospital leaders must make plans to ensure patients receive safe and effective care, and that staff have the resources necessary to effectively manage the shortages. Organizations that can be helpful with plans and that are monitoring latest developments include ISMP (ISMP.org), ASHP (ASHP.org) and the University of Utahs University Health care Drug Information Service (http:// healthcare.utah.edu/pharmacy/ rxweblinks/rxlink07.htm). s Frank A. Federico is executive director of strategic partners at the Institute for Healthcare Improvement. He can be reached at ffederico@ihi.org. Bona Benjamin is director of medication-use quality improvement at the American Society of Health-System Pharmacists. She can be reached at bbenjamin@ashp.org. Michael Cohen is president of the Institute for Safe Medication Practices. He can be reached at mcohen@ismp.org.
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