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Surveys Confirm Drug Shortages Are a Persistent Problem

TOP - October 2013 VOL 6, NO 4

Recent surveys of oncologists and hematologists show that drug shortages persist, that practitioners are adapting in ways that often raise the cost of cancer care, and that most have no guidance to aid in decision making in the face of these shortages.

A survey of 250 physicians, by investigators at the University of Pennsylvania, Philadelphia, showed that 83% encountered shortages of curative and palliative chemotherapy agents between March and September of 2012. Many reported that shortages affected the quality and cost of patient care, as they were forced to substitute more expensive drugs for cheaper generics.

“Drug shortages are affecting the treatment of curable malignancies. We don’t know the extent to which adaptations forced by these shortages led to adverse clinical outcomes for patients,” said Keerthi Gogineni, MD, of the Abramson Cancer Center in Philadelphia, at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO).1

Shortages have also interfered with patient participation in clinical trials, slowing the pace of research progress, she added.

“We were surprised by the large number of oncologists who had to make changes in how they care for patients due to drug shortages,” she said at a press briefing at ASCO. “Unfortunately, cancer drug shortages are likely to persist, but doctors are adapting to this new reality as best they can. We need more uniform guidance to ensure that the modifications in treatment are being made in the most educated and ethical way.”

Gogineni and colleagues distributed the survey to 454 oncologists and hematologists in the United States randomly selected from the ASCO membership; 250 responded and 214 surveys were analyzed. About two-thirds practiced in community-based private settings while one-third practiced in academic settings. The data reflect drug shortage experiences from March 2012 to March 2013.

Shortages were most commonly re- ported for leucovorin, liposomal doxorubicin, 5-fluorouracil (5-FU), bleomycin, and cytarabine.

More Than 80% of Patients Had Treatment Altered

The respondents were asked about the impact of drug shortages over the previous 6 months. In response, 94% reported that their patients’ treatment had been affected and for 83% they were unable to provide standard chemotherapy. About 13% said that shortages had prevented enrollment in clinical trials or had suspended participation in them.

The physicians adapted to shortages in various ways, including changing the treatment regimen (78%), substituting drugs partway through therapy (77%), delaying treatment (43%), “rationing” treatment to certain patients (37%), omitting doses (29%), reducing doses (20%), and referring patients to other practices (17%).

Most providers (70%) indicated that they lacked institutional guidelines or committees to advise them in these difficult treatment decisions; academic physicians had more help. Clinical trial participation was affected in some way 11% of the time.

Costly Substitutions

Nearly 60% of physicians substituted more expensive agents when cheaper generics were not available. This included levoleucovorin for leucovorin, capecitabine for 5-FU, and nab-paclitaxel for paclitaxel. “This is adding to healthcare costs,” Gogineni emphasized.

Levoleucovorin costs about 30 times more than leucovorin and capecitabine costs about 140 times more than 5-FU for 1 cycle of colon cancer treatment.

There are also “hidden costs” in terms of additional hours spent by staff trying to manage these shortages, she said.

ASCO Survey: Only Small Improvements Seen

ASCO also surveyed its members in October and November 2012 (n = 390) and again in March and April 2013 (n = 462) to assess the impact of shortages over those 6 months and to determine whether recent legislative and regulatory efforts to address the problem are working.

Results of the second survey suggested that chemotherapy drug shortages have eased slightly, but oncologists still need to substitute drugs. Moreover, respondents expressed growing concern over the shortage of drugs used in supportive care, such as antiemetics, pain medications, and basic intravenous fluids and electrolytes, reported Richard L. Schilsky, MD, chief medical officer of ASCO.2

The most commonly reported substitutions were levoleucovorin for leucovorin (cited by 38% of respondents giving examples) and capecitabine for 5-FU (12%), comparable to what Gogineni reported from her survey. “The cost implications of these are significant,” Schilsky agreed.

In addition to critical chemotherapy substitutions, other substitutions include oral formulations for intravenous agents in nearly a dozen drugs. In supportive care, a few of the substitutions used are ganciclovir for acyclovir, Lomotil for atropine, and methylprednisolone and prednisone for dexamethasone.

The second survey also found:

  • 59% of respondents were aware of ongoing drug substitutions in their community in 2013, versus 70% in 2012
  • 17% said the situation is worse now, while 16% said the situation is unchanged, and 9% said some shortages improved but others worsened
  • More than one-third (37%) in both surveys had no institutional policy for drug allocation during a shortage

The Cancer and Leukemia Group B (CALGB) clinical trials group reported that 23 study protocols have been affected by drug shortages, he said. CALGB is delaying registration of new patients, borrowing drugs from neighboring institutions, substituting alternative drugs, and omitting drugs in short supply.

According to Schilsky, while the US Food and Drug Administration has stop-gap measures in place to ease the situation, “Permanent solutions will require enhancing the business model of generic drug manufacturing.”

1. Emanuel EJ, Shuman K, Chinn D, et al. Impact of oncology drug shortages. J Clin Oncol. 2013;31(suppl):Abstract CRA6510. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.
2. Schilsky RL. Improvising when standard therapy is not available. Presented at: 2013 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2013; Chicago, IL.

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