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National Survey on Drug Shortages Reveals High Level of Frustration, Low Regard for Safety



From the March 21, 2001 issue

An exhaustive account of frustrations and problems rang out loud and clear from the 344 pharmacists who returned our survey on national drug shortages. By far, respondents were most frequently alarmed by the lack of suitable alternative drugs, the use of less desirable and unfamiliar substitutes if available, the potential for poor patient outcomes, and the lack of an advanced warning system to alert providers to impending shortages. High on the list of frustrations was the inevitable "scrambles" to learn about drug shortages, locate drugs in short supply, select alternatives if needed, and inform necessary staff about shortages and alternatives. Many also reported a financial impact due to purchasing drugs off contract or through secondary markets, costly alternative drugs, same day shipping costs, reactive overstocking practices, and precious clinical hours lost to such time-consuming activities.

Not all respondents were aware of some of the more recent critical drug shortages: 3% were unaware of the fentanyl shortage and 13-16% were unaware of isoproterenol, flumazenil, and hyaluronidase shortages. Nevertheless, respondents collectively reported about 35 additional products in critical short supply. Very few learned about shortages from professional literature (4%) or the FDA web site (2%), which lists shortages for some "medically necessary" drugs (defined as those used to treat or prevent a serious condition and without an alternative source or adequate substitute). No respondents had learned about shortages from the ASHP web site (www.ashp.org), which now offers a Drug Shortage Management Resource Center listing selected products in short supply, implications for patient care, and alternative agents (information provided by the University of Utah). The wholesaler (56%), manufacturer/distributor (22%), and buying groups (14%) were the most common sources of information about drug shortages. Yet many respondents told us that the wholesaler's failure to deliver the product was often the first warning of a shortage, which then prompted calls to the manufacturer to determine the reason. As one respondent noted, "We rarely find out about shortages from the manufacturer and find them unwilling to supply letters to answer physicians' questions about the projected length and rationale for the shortage. The current system is unsafe and shows little regard for patient safety."

Respondents made it clear that there is little or no information available about the causes of drug shortages and the anticipated duration. They find it difficult or impossible to determine if the shortage stems from FDA regulatory activities, underestimation of demands due to increased use patterns or disease outbreak, a shortage of raw materials, or marketing decisions to stop production of an older drug to accommodate a newer (and more profitable) drug. Several respondents felt that the FDA should play a stronger role in this regard. While it's the FDA's policy to evaluate reported drug shortages and assess their impact on public health, agency intervention is unlikely unless the drug is considered "medically necessary." For example, if a drug shortage may result from regulatory action, the agency may allow correction of the infraction without supply disruption, or seek alternative sources of the drug outside the US. However, if a marketing decision (or FDA regulatory action) causes a manufacturer to halt production of a drug permanently, FDA intervention is unlikely if a suitable substitute exists or alternative sources are available. This is true even if current demand cannot be met temporarily. In any case, FDA currently has no regulatory responsibility or authority to compel production of critical drugs or require pharmaceutical companies to tell them about marketing decisions to halt production - unless the company is sole producer of the drug. Further, even if known, confidentiality often prohibits FDA from divulging the reason for a drug shortage.

Respondents described the significant impact that drug shortages have had on their patients. Many gave examples of less than optimal patient outcomes, such as postponing eye surgery during the hyaluronidase shortage and, more recently, delayed administration of influenza vaccine. Over 90% of respondents told us about perceived threats to safety during the fentanyl shortage. Most often, they cited the possibility of dosing errors due to unfamiliarity with substitute products; adverse drug reactions with higher potency opiates; ineffective pain control; and issues with contamination and drug diversion if using multiple-dose vials (or reusing single-dose vials to prevent waste). But there's ample evidence that these are more than hypothetical concerns. In our February 7, 2001 issue, we mentioned several serious dosing errors when sufentanil was used as a substitute for fentanyl. Late last year, there were two published reports of administering sufentanil in the dose prescribed for fentanyl due to look-alike packaging and nurses' mistaken belief that sufentanil and fentanyl were the same product.1 Furthermore, 10% of respondents reported actual adverse events related to the use of various fentanyl alternatives, including 6 reports of oversedation/overdoses (three of which required cardiopulmonary resuscitation), 2 reports each of phlebitis, hypotension, itching, and hallucinations, and 14 reports of an overall increase in patients' recovery time, length of stay, and nausea and vomiting.

About three-quarters of respondents revealed that drug shortages have affected the relationship between the pharmacy and other healthcare professionals. The sentiments of several respondents tell the full story: "There are always hard feelings between pharmacy and physicians when they must change their practices because we can't get a drug. Nurses feel caught in the middle and are upset about using alternative drugs with which they are unfamiliar." "Physicians question why the hospital across the street can get the drug, while we can't. They lack trust and confidence in the pharmacy and believe this is the result of poor management, not a national shortage." Interestingly, those who did not report adversarial relationships between pharmacy and other providers were less likely to have experienced significant drug shortages or more likely to have a formal process in place for handling them.

The past five years of ever-increasing drug shortages and continued globalization of pharmaceutical markets (resulting in only one or two providers worldwide) have surely taught us that drug shortages are a serious dilemma requiring our immediate attention. More effective FDA oversight, a comprehensive early warning system, and patient outcomes placed ahead of pharmaceutical company profit margins may be too much to hope for in the near future. Still, it's clear that organizations can better manage drug shortages if they have a standardized, rational process in place. In our next issue, we will provide guidelines for handling drug shortages and reveal how some of our respondents have been tackling this very difficult issue.

Reference 1: Chisholm CD, Klanduch F. Inadvertent administration of sufentanil instead of fentanyl during sedation/analgesia in a community hospital emergency department: a report of two cases. Academic Emergency Medicine. 2000;7:1282-4.

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