The Other Opioid Crisis: Just Another Drug Shortage?

Abstract

The cause of drug shortages is a complex issue. This commentary highlights the shortage of intravenous opioid medications for cancer patients, in light of the opioid overdose epidemic.

Four to six weeks. This was the answer to my question of how long our intravenous opioid supply would last at a recent meeting to discuss our hospital's shortage of these vital medications. Shocking to say the least. My follow‐up question, which I did not ask aloud for fear of sounding naive: how could something like this happen?

Drug shortages are certainly not a new problem in hospital medicine. It seems there is always some burden we are shouldering in trying to manage the symptoms of our admitted patients, and indeed, coincident with the lack of opioids is a shortage of the intravenous drugs we use to manage nausea.

As an inpatient oncologist, the lack of these medications affects me and my patients acutely. Many of the patients I treat would otherwise be managed as outpatients were it not for the severity of the symptoms caused by their cancer or their cancer treatments. I recently admitted a young man with newly diagnosed lung cancer, widely metastatic to his spine and pelvic bones. He remained admitted for over 2 months because his disease grew explosively and we could barely keep up with his pain requirements. My colleagues in radiation oncology and palliative care worked with our team tirelessly to come up with solutions—could we radiate another area to help control the pain? Could an epidural spinal nerve block help? Ultimately, the only thing that worked for Johnny (a fictitious name) was a constant infusion of intravenous opioid medication. At one point in his hospitalization, we ran out of the Dilaudid (hydromorphone hydrochloride) that had been working well for him and had to switch to fentanyl. Although we tried to do this as meticulously as possible, the Dilaudid supply ran out sooner than we had anticipated, and he was in an unrelenting pain crisis for 10 hours of an overnight shift. This episode was incredibly distressful on the part of the patient, his family, and the many care providers involved in his case. Ultimately, Johnny died in the hospital and was thankfully comfortable on a continued infusion of opioid medication.

It is with such patients in mind that I cringe at the shortage of intravenous opioid medications. I treat patients with bone metastases, irrevocable gnawing abdominal pain from metastatic pancreatic cancer, and end‐of‐life needs on a daily basis. I live in constant fear of running out a medication that I know can help in these challenging situations.

Drug shortages are a complex issue. Generic injectable drugs, such as antibiotics, pain medications, electrolyte products, and chemotherapeutics, fall into shortage when drug companies stop or interrupt production because of financial or quality control issues [1]. Because Medicare legislation sets reimbursement for injectable generics at a maximum of 6% above the average sales price, manufacturers of these medications are not in any particular hurry to fix problems with production as they arise. Several other factors contribute: the scarcity of companies producing generic drugs leads to incredible vulnerability to the failure of a single production facility. As one journalist has pointed out time and again, a small number of group purchasing organizations, or GPOs, control the purchasing of the supplies and medications used by the majority of acute care hospitals in the U.S. [2]. This has led to a system without natural market competition with resulting limited profit margins for the generic manufacturers and inevitable supply breakdowns. Although appalling that the fate of my suffering patients is involuntarily bound to the vagaries of the generic drug market, this is a fact that I have come to recognize. Until the federal government can come up with more effective ways to get drug manufacturers to preempt dangerous shortages, we will be left with this broken system.

The opioid shortage is occurring in the context of a second and larger opioid crisis, the opioid overdose epidemic. This public health crisis is claiming tens of thousands of American lives each year and getting worse despite widespread awareness [3]. In response, the federal government has set restrictions on the amount of opioids drug companies can produce each year, further fueling the shortage. Although these mandated reductions in opioid production have done little to decrease opioid overdose‐related deaths in the U.S., they have had the unintended consequence of limiting availability of intravenous opioids for patients who need them.

Although desperate pleas from medical professional associations have led to the Drug Enforcement Administration relaxing this year's quotas and allowing for raw materials to be redistributed from Pfizer to other drug manufacturers [4], the shortage will not reverse quickly. There has been an impressive multidisciplinary response to the opioid shortage at our hospital, and we have successfully limited the use of intravenous opioids to the patient populations who need them most. Our pharmacists have been a constant, up‐to‐date resource regarding which intravenous opioids are available to providers and in what format. They have had to communicate in real time to clinicians who are using a medication whose supply will soon be exhausted and offer strategies for substitution. An approach to opioid conservation strategies was authored by our palliative care group, shared institution‐wide, and is summarized in Figure 1. A weekly meeting between oncology, palliative care, nursing, and pharmacy has been successful in keeping all parties up to date about which specific agents are in shortage and which are in supply. These meetings have allowed us to troubleshoot specific cases or recurring issues and to review any errors or near misses that have resulted from the shortage.

Figure 1.

Summary of opioid conservation strategies.

Abbreviations: IV, intravenous; GI, gastrointestinal; NPO, nothing by mouth; NSAID, nonsteroidal anti‐inflammatory drugs.

Although the problem of drug shortages is longstanding, the frequency with which they are occurring is increasing and the negative impact they have on our patients’ quality of care is undeniable. The U.S. claims to have the best health care in the world, but if we are unable to provide generic injectable medications to patients admitted to acute care hospitals, how can we hope to maintain the quality of our care? Now is the time to take a cooperative approach among industry, medical professionals, and the federal government to make a thoughtful plan that will provide adequate supplies and avoid further shortages.

Disclosures

Mihir M. Kamdar: Amorsa Therapeutics (SAB). The other authors indicated no financial relationships.

(C/A) Consulting/advisory relationship; (RF) Research funding; (E) Employment; (ET) Expert testimony; (H) Honoraria received; (OI) Ownership interests; (IP) Intellectual property rights/inventor/patent holder; (SAB) Scientific advisory board