Safeguarding Against Scarcity: The Impact of Drug Shortages on Patient Care

• Fox Chase, like every other hospital in the United States, faces daily challenges caused by the ongoing nationwide shortage of vital medications.

  What was once an occasional headache has become a constant threat to safe and cost-effective patient care. In this blog, I will discuss the ongoing challenges the drug-shortage problem poses and describe some of the steps Fox Chase is taking to mitigate it and ensure that patients receive the best care possible. 

  

  Over the past decade, we have seen annual escalations in the length and severity of drug shortages across the United States. The problem is nationwide in scope and is not limited to a particular disease or therapy, but with just a few notable exceptions, it has been limited to sterile, injectable generic medications, a category of drug vital to the care of severely ill cancer patients. Far more so than the tablets or capsules that may be more familiar, these injectable medications require extremely complicated manufacturing and sterility control processes to ensure safe intravenous administration. Despite the complexity and cost of manufacturing these drugs, they typically cost just a few dollars per dose—sometimes even less. Perhaps not surprisingly, given the difficulty of producing them, such medications constitute the bulk of those prone to scarcity.

  During each of the three years from 2010 to 2012, the FDA tracked more than 200 acute drug shortages. Most recently, the “Drug Shortages” page on the FDA website listed acute shortages in 120 medications, and the Fox Chase pharmacy department was monitoring or had mitigation steps in place to deal with more than 50 shortages with the immediate potential to affect Fox Chase patients.

  There isn’t a single cause underlying the scarcity; rather, the causes are multiple and variable. Contributing factors include an increasingly global supply chain for active pharmaceutical ingredients, or APIs—the drugs’ raw ingredients—which leads to unpredictable supply consistency; challenges for end-product manufacturers including plant de-certifications by the FDA that lead to production and supply disruptions; mergers within the generic manufacturing sector that decrease the number of companies in the generic marketplace; and government-imposed restraints on price adjustments that can make it difficult for manufacturers to maintain or improve their plants. Medication “hoarding” by people in the “grey market” (think of ticket scalpers, but life-saving medications are involved instead of concert tickets) also can exacerbate shortages.

  The Fox Chase pharmacy department is devoted to maintaining patient care and invests tremendous time and effort in procuring sufficient supplies of the vital medications needed by our patients. The department’s drug shortage team can spend hours per day monitoring drug availability, communicating with drug companies, developing contingency plans, and working with Fox Chase physicians.

  

  The pharmacy department works with patient care teams to ensure that patients get the medications they need. If supplies of a particular drug are nearing a critical point, the department, in consultation with the multidisciplinary Pharmacy and Therapeutics Committee, advises the physicians whose patients would be affected. In a worst-case scenario—for example, during the national shortage of liposomal doxorubicin (known by the trade name Doxil®)—the pharmacy department and the committee worked with physician leaders to ration the drug so that the patients with the greatest need were able to receive doses from the extremely limited supply. The Doxil shortage also represented the only time, to date, that Fox Chase was forced to suspend accrual of patients to a clinical trial, due to a nationwide shortage of a medication.

  Within the Temple University Health System, Fox Chase, neighboring Jeanes Hospital, and Temple University Hospital work together to meet patients’ needs, sometimes sharing scarce medication supplies. The department of pharmacy also has worked for many years with regional hospitals outside of TUHS. It was especially heartwarming for us when we were able to loan cytarabine, a medication with an 80 to 90 percent cure rate for pediatric leukemia, to a nationally known pediatric hospital when it was on the brink of cancelling treatments. That hospital subsequently was able to loan us enough cisplatin—a drug used to treat a variety of cancers—that we were able to avoid suspending accrual to several clinical trials.

  Fox Chase also has worked for many years with outside organizations such as the Institute for Safe Medication Practices, a national organization dedicated to patient safety, and since 2011 has served as a resource for the staff of Sen. Robert Casey of Pennsylvania. Casey co-authored, with Sen. Amy Klobuchar of Minnesota, a bill designed to give greater authority to the FDA to mitigate the number and severity of medication shortages by increasing its ability to forecast supply problems. Data available so far in 2013 suggest that the availability of medications is gradually and modestly improving, but the Fox Chase pharmacy department and others across the country continue to face the daily challenge of drug shortages and potential shortages as we work to ensure the safety and well-being of our patients.