Chicago, IL—Recent surveys of hematologists/oncologists show that drug shortages persist, that oncologists are adapting in ways that often raise the cost of cancer care, and that most oncologists have no guidance to aid their decision-making.
A survey of 250 physicians showed that 83% of physicians encountered shortages of curative and palliative chemotherapy agents between March and September 2012. Many physicians reported that shortages affected the quality and cost of patient care, because physicians 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, MSHP, Medical Oncologist, Abramson Cancer Center, University of Pennsylvania, Philadelphia, at ASCO 2013.
Shortages have also interfered with patient participation in clinical trials, Dr Gogineni 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. “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.”
The survey was distributed to 455 US oncologists and hematologists; 250 members responded, and 214 surveys were analyzed.
Approximately 66% of respondents practiced in community-based private settings, and 33% practiced in academic settings. The data reflect drug shortage experiences from March 2012 to March 2013.
Shortages were most frequently reported for leucovorin, liposomal doxorubicin, 5-fluorouracil (5-FU), bleomycin, and cytarabine.
Treatment Altered in More than 80% of Patients
The respondents were asked about the impact of drug shortages over the previous 6 months. In response, 94% reported that their patients’ treatments had been affected, and 83% were unable to provide standard chemotherapy for their patients. Approximately 13% of respondents said that shortages had prevented patient enrollment in clinical trials or had suspended participation.
The physicians adapted to shortages in various ways, including changing the treatment regimen (78%), substituting drugs partially 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 (70%) providers indicated that they lacked institutional guidelines or committees to advise them on these difficult treatment decisions; academic physicians had more help. Clinical trial participation was somehow affected in 11% of instances.
Costly Substitutions
Nearly 60% of physicians substituted more expensive agents when cheaper generics were not available. This included substituting levoleucovorin (Fusilev) for leucovorin, capecitabine (Xeloda) for 5-FU, and nab-paclitaxel (Abraxane) for paclitaxel (Taxol). “This is adding to healthcare costs,” Dr Gogineni emphasized.
Levoleucovorin costs approximately 30 times more than leucovorin, and capecitabine costs approximately 140 times more than 5-FU for a 1-cycle treatment for colon cancer. There are also the “hidden costs” in terms of additional hours spent by staff trying to manage these shortages, she said.
Oncologists’ Survey: Only Small Improvements Reported
The American Society of Clinical Oncology (ASCO) also surveyed its members in October 2012 (N = 390), and again in April 2013 (N = 462), to assess the impact of shortages during those 6 months and to determine whether recent legislative and regulatory efforts to address the problem are working.
The results of the second survey suggest that chemotherapy drug shortages eased slightly, but oncologists still needed to substitute drugs. Moreover, respondents expressed a growing concern regarding 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.
The most frequently reported substitutions are levoleucovorin for leucovorin (cited by 38% of respondents giving examples) and capecitabine for 5-FU (reported by 12% of respondents), similar to what Dr Gogenini found in her survey. “The cost implications of these [substitutions] are significant,” Dr Schilsky noted.
In addition to critical chemotherapy substitutions, other substitutions included oral formulations for intravenous drugs in nearly 12 drugs. In supportive care, the substitutions included ganciclovir for acyclovir, diphenoxylate/atropine for atropine, and methylprednisolone and prednisone for dexamethasone.
The 2013 survey also showed that:
- 59% of the respondents were aware of ongoing drug shortages in their community versus 70% of respondents in the October 2012 survey
- More than 40% of respondents said that drug shortages have not been resolved
- 17% of respondents said the situation is worse now, 16% said the situation is unchanged, and 9% said some shortages improved and others worsened
- Of respondents in both surveys, 37% 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, Dr Schilsky said. The CALGB is delaying registration of new patients, borrowing drugs from neighboring institutions, substituting alternative drugs, and omitting drugs that are currently in short supply.
Dr Schilsky said that although the US Food and Drug Administration has stopgap measures in place to ease the situation, “permanent solutions will require enhancing the business model of generic drug manufacturing.”