Drug Rationing Common for Shortages, Patient Disclosure Rare

Roxanne Nelson RN, BSN

March 26, 2019

Drug shortages of all types have slowly become the new normal in US healthcare, affecting supplies of everything from sterile saline solution to essential oncologic agents. But while these shortages continue to be highlighted in the media, a new study now shows that the method of addressing the issue is by rationing drugs — and often without the knowledge of the patient.

In a survey that included over 700 pharmacy practice managers and/or pharmacy leaders (PPM), more than one third of respondents reported that there had been an episode of rationing at their facility during the past year.

Rationing was particularly prevalent in large hospitals and academic or academically affiliated hospitals, and decisions to ration drugs were made primarily by the care team without the involvement of hospital committees or ethicists.

Patients were also not generally informed about rationing, with only a bit more than a third made aware that their care included rationing, according to the respondents.

The study was published online March 25 in JAMA Internal Medicine.

Medication shortages have been associated with decreased quality and/or quantity of life, the authors note, and switching to other drugs can cause harm to patients. In instances of severe shortages, clinicians may have to ration drugs and decide which patients receive needed medications and which do not.

Decision to Ration

In the current study, Andrew Hantel, MD, from the MacLean Center for Clinical Medical Ethics, The University of Chicago in Illinois, and colleagues conducted a national survey of hospital pharmacy managers to investigate current drug allocation and rationing practices during shortages in US medical facilities.

Their survey revealed that the decision to ration drugs was made without an ethicist in most cases, and without the patient's knowledge, but Hantel told Medscape Medical News that "we were not able to capture the specific patient consequences from individual respondents, which would vary widely based on the needed medication and situation."

"Medications can be rationed without patient knowledge by substituting with inferior drugs or delaying treatment," he said. "Patients may not know that a medication is 'best' for them but is unavailable and replaced with something that may cause more/different side effects or not work as well."

Survey respondents did not provide details on rationing, such as how these decisions were made and why patients were involved or not informed, or about which drugs were included in rationing.

Hantel explained that, as reported in their survey, one common mechanism by which hospitals are dealing with shortages is restricting medications to particular patient populations and/or indications, and more than 80% of respondents mentioned that this occurs at their institution.

"While this was not the specific type of rationing that we asked about, this is definitely a form of allocation that prioritizes particular groups over others," he said. "For some reason, many do not see this as rationing — possibly because it is imposed broadly and physicians are not 'choosing' individuals for treatment — but restrictions are by definition rationing and should be recognized as such."

"That is not to say that restrictions are either unnecessary or the wrong way to manage shortages, but that these are serious problems that hospital pharmacies are struggling with," Hantel added.

Substitutions are also common in these situations, and patients are unlikely to recognize that the hospital has had to conserve supplies of certain drugs and is using an alternative. "It's up to the medical team to tell them but they may either be too busy or not think that patients should know — these are ongoing questions that our group is actively investigating," he said.

Survey Details

A 19-item survey was sent over a 6-week period (February 6 - March 20, 2018) to nine health system PPMs who were members of the American Society of Health-System Pharmacists. Of this group, 719 responded to the survey.

A total of 453 (63.0%) reported practicing in community hospitals, 143 (19.9%) were in academic institutions, and 123 (17.1%) worked in academically affiliated hospitals.

The breakdown by hospital size was: 100 beds (109 [15.2%]), 101 to 199 (139 [19.3%]), 200 to 299 (111 [15.4%]), 300 to 399 (115 [15.9%]), or 400 or more  (245 [34.0%]).

All respondents reported that their facility had experienced drug shortages in the preceding year and 498 (69.2%) reported that there had been more than 50 shortages.

In addition, almost all respondents (664 [92.4%]) stated that, on average, there was less than 1 month from notification to active shortage, and 250 (34.9%) PPMs said that there was no administrative mechanism in place to respond to shortages.

A smaller number of respondents (96 [13.3%]) reported that a standing committee was in place that included physicians, and 20 (2.8%) had one that included an ethicist.

The strategies used to mitigate and manage shortage varied, but of note, medication hoarding was reported by 584 respondents (81.3%), while one third (247 [34.4%]) stated that an episode of rationing had taken place within the past year.

Their survey also showed that rationing was more likely to occur at academic hospitals (47.7% vs 25.5%; P = .01) and academically affiliated hospitals (45.4% vs 25.5%; P = .02) versus community hospitals, and also in large facilities with over 300 beds as compared with those with fewer beds (46.1% vs 19.7%; P < .01).

During rationing, about half (128; 51.8%) reported that the allocation methods were decided by the care team alone, while slightly under half (119; 48.2%) used committees, and a much smaller number (12; 4.9%) included an ethicist.

Patient involvement was limited, as only 89 patients (36.0%) were informed that their care included drug rationing.

The ongoing drug shortages are critical issues, Hantel emphasized. "Congress recently recognized this and convened the Drug Shortages Task Force in order to tackle some of these problems," he said. "Right now there are no guarantees for many essential medications in the United States and the pharmaceutical industry has not been able to address these problems on its own. And, while solutions are being considered, rationing continues, management is heterogeneous, and communication is poor."

Status Quo Remains

Yoram Unguru, MD, MS, MA, a pediatric hematologist/oncologist with joint faculty appointments at The Herman and Walter Samuelson Children's Hospital at Sinai and The Johns Hopkins Berman Institute of Bioethics, Baltimore, Maryland, explained to Medscape Medical News that, with shortages of life-saving normal saline, antibiotics, essential electrolytes and minerals, critical care medications, and chemotherapy, no area within medicine or the patient population is spared the effect of US drug shortages. 

"Moreover, despite numerous reports by expert panels and working groups that have offered meaningful recommendations to ameliorate the shortages, nothing seems to have changed. If anything, over the past 1-2 years, the shortages have worsened," he said.

Unguru noted that the current study contributes to the "sobering data" on US drug shortages. "Given their finding that 100% of respondents to their national survey of pharmacy professionals reported experiencing drug shortages within the past year … like death and taxes, US drug shortages are seemingly guaranteed," he said. 

According to Unguru, these data highlight the fact that, during the past decade, despite recommendations by multiple experts and working groups, many of the study's findings demonstrate, among other aspects, a lack of guidance for how to respond to shortages and the health systems' and providers' seeming unwillingness to inform and disclose to patients about the shortages.

"Equally concerning, experts have previously recommended that hospitals create drug shortage committees to ethically manage the dilemmas created by the shortages," he said. "These committees are to be staffed by a diverse group of stakeholders, including clinicians, bioethicists, and patient advocates."

However, he noted that the fact that a minority of respondents in the study (less than 14%) reported that their hospital had such a committee with less than 3% including an ethicist gives pause. "That over half of the respondents reported allocation decisions are made by the treating team without outside consultation is especially troubling," Unguru said. "Unfortunately, this is not a surprising finding. As appreciated by our group and others, bedside decision-making should be avoided as such decisions are ineffective, prone to subjective preferences (idiosyncratic), and unjust to individual patients."

The other pressing issue is transparency. "Hospitals must do more as patients deserve to know about drug shortages," he said, adding that commentators have appropriately called for hospitals to publicly post information about drugs in short supply. 

"Not only will such an approach inform patients, it has the ability to raise public awareness, promote engagement, and potentially, initiate reform," he explained. "Patients have skin in the game and as such, deserve to be included in rationing decisions. When patients are kept in the dark as reported by Hantel et al and supported by existing research, it erodes trust in individual physicians and the health care system in general."

Unguru added that lessons from history should be heeded, pointing out that allocation decisions regarding shortages of insulin in the 1920s and penicillin in the 1940s "were made without public comment and were met with derision by the community."

"Until shortages can be avoided altogether, we should learn from our past and heed recommendations for ethical allocation of scarce medicines," he said.

Findings Similar to Previous Research

Allen J. Vaida, BSc, PharmD, FASHP, executive vice president for the Institute for Safe Medication Practices, noted that the findings of this study reflect those in surveys conducted by his own organization.

The first survey was conducted in 2010, and then a second one in 2017, he told Medscape Medical News. "The main difference between the surveys was that in 2010 hospitals often didn't get any notice that a drug was in short supply," he said. "In 2017, they at least got some notice as the [US Food and Drug Administration] has become stricter with that. But it doesn't mean that they were given 3-4 months notice. It was often short as reported in this survey."

Vaida explained that their surveys did not include a great deal of detail about rationing, although in 2017, 94% of respondents reported rationing or restricting drugs in short supply. "But one thing that did stand out was in the JAMA survey, in that most places did not have a committee to look at the rationing that was being done," he said. "In our survey, most reported that they did have a group to make those decisions."

Their surveys didn't ask about patient involvement or knowledge, but he noted that "from our experience it is not common to let patients know."

"That usually only happens for a delay in elective surgery, where you have to tell the patient, or more often in oncology," he said. "There isn't a lot of patient disclosure, and sometimes it's to avoid the patient experiencing more angst than they already are."

However, Vaida does believe that it is now becoming more common for patients to ask about and question treatment, such as asking if the antibiotic they are getting is the one that's optimal for their infection. "There is more transparency now in healthcare, but disclosure for drug shortages still is uncommon unless the patient asks," he said.

Hantel has reported no relevant financial relationships. Coauthor Marc Siegler has reported receiving personal fees as a member of the board of directors for the Ross University School of Veterinary Medicine. Unguru has reported no relevant financial relationships.

JAMA Internal Medicine. Published online March 25, 2019. Abstract

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