Empty Shelves, Full of Frustration: Consequences of Drug Shortages and the Need for Action

Drug shortages have been a topic of concern for health care institutions since the early 2000s and have recently reached a critical level. The US Food and Drug Administration (FDA) has reported that the majority of shortages involve generic, injectable agents and the most common reason cited for a shortage involves manufacturing problems.¹ There has been research regarding the trends and reasons for shortages,^{2, 3} and there is evidence regarding the effect of these shortages on patients, including patient harms.⁴

Patient harms that may be associated with the unavailability of medications include medication errors, adverse events, delayed or cancelled care, inconsistency of dose potency, and sterility of injectable medications. The Institute for Safe Medication Practices (ISMP) has reported several instances of patient harm associated with drug shortages.⁴ In one case, a patient death was associated with the unavailability of amikacin. Patient harms may occur due to medication errors or adverse events. An example of a shortage that may have resulted in medication errors is the furosemide shortage. A therapeutic alternative agent was bumetanide. If administration of this alternative agent is not managed and performed with complete accuracy (due to a 40-fold difference in dosing), patients are vulnerable to high-risk medication errors. Increased toxicities with therapeutic alternatives used during a drug shortage can lead to adverse events. Due to the injectable fentanyl shortage, hydromorphone was substituted as sedation for surgical procedures. Hydromorphone has a longer half life than fentanyl, and this may have resulted in longer patient recovery times and increased patient sedation.^5,6 Delays in administering care may be associated with poor patient outcomes, and treatment failure may occur because alternative agents may not be therapeutically equivalent. The liposomal doxorubicin shortage resulted in the delay of many chemotherapy courses and potentially the loss of the ability to cure the patients’ cancer. If medications such as protamine and heparin are not available, organ transplantations and open heart surgeries may be cancelled. Inconsistency of dose potency and sterility of injectable medications from secondary vendors may lead to patient harms. When medications are not available from primary sources, institutions may need to purchase them from compounding pharmacies and secondary markets. If quality measures at these vendors fail, patients may receive contaminated or ineffective products.^7-9 A recent example of this issue is the closure of the New England Compounding Company (NECC), which is now under criminal and FDA investigation.⁹ Many, health care institutions were forced to buy from this compounding company instead of their usual suppliers in order to treat patients. Injectable products such as sodium bicarbonate, potassium chloride, and nalbuphine were not available from traditional manufacturers. There is controversy surrounding the federal oversight of the NECC,¹⁰ but if drug shortages continue to disrupt medication supplies, providers and institutions will continue to seek alternative agents to care for their patients.

The unintended consequences and potential for patient harm during a drug shortage need to be quantified and education should be provided regarding these special circumstances. Issues regarding patient harm should be further examined to provide support for the allocation of resources to research and manage shortages to avoid possible adverse events and medication errors. Clinicians are encouraged to report any patient harms associated with drug shortages to the MedWatch program of the FDA or ISMP. Antimicrobial shortages leading to patient harm may be reported to our data collection site (www.surveymonkey.com/s/antimicrobialshortages), which has been approved by the Institutional Review Board at Midwestern University.¹¹

The question surrounding drug shortages is what can health care providers do now to help this situation? Clinicians should be aware of issues resulting from drug shortages and formulate plans for avoiding patient harm. The FDA and ASHP Web sites should be consulted for information and updates to continuing shortages.^12,13 Communication about possible consequences of shortages and prospective management plans may help decrease patient harm.^14,15 These processes should use a multidisciplinary approach and include the Pharmacy & Therapeutics Committee. Once a therapeutic alternative is approved, consideration should be given to the formulation. If the medication is available in a different formulation or package size, actions should be taken to avoid medication errors. This is of critical importance at the patient bedside with all downstream systems such as the electronic health record, infusion pumps, barcode medication administration, and automated dispensing equipment synchronized with all health care technologies. All medications in shortage should be considered as high-risk medications for the duration of the shortage. Communications should include safety information regarding potential errors and monitoring parameters for adverse events. Face-to-face meetings known as “safety huddles” with clinicians should be conducted to provide education about the shortages.

A long-term solution to drug shortages is not yet within reach, and health care institution resources should be dedicated to all aspects of medication management. After an alternative medication is procured, the potential for patient harm does not end. Shortage management must extend through the medication process to avoid patient harm that may be caused by unfamiliar products or dosage forms. Drug shortages are at a crisis level and medication security has been lost in the United States. Further regulations are needed to ensure that these medically necessary drugs are in proper supply; otherwise, our patients are truly at risk for harm.