This is the first ACCCBuzz post reporting on Critical Conversations: Navigating Drug Shortages and Empowering Oncology Pharmacists, a virtual webinar held by HOPA in partnership with ACCC and AVAHO.
Around 130 AD, Aelius Galenus, a Roman physician, implemented compounding in healthcare—a pioneering innovation involving mixing 2 or more drugs together to meet patients’ unique health-related needs. In doing so, Galenus laid the foundation for modern day pharmacy and although pharmacy and medicine would not be officially separated until 1240 AD, the patient-centered ethos that inspired Galenus’ innovation has remained in both disciplines—constituting the very foundation of the former. Now, an unprecedented drug shortage threatens the ability of oncology pharmacists to continue that mission.
On November 22, 2022, the US Food and Drug Administration (FDA) conducted an inspection of an Intas Pharmaceuticals Limited plant in Gujarat, India. This inspection lasted 9 days, and it revealed a “cascade in failure” in quality assurance. As a result, this plant which accounts for nearly 50% of the cisplatin and carboplatin (generic chemotherapy drugs used to treat up to 500,000 new patients with cancer each year) supply in the United States, was shut down.
In response to this shortage, The National Comprehensive Cancer Network (NCCN) recently surveyed 27 of its member institutions; 93% revealed they were experiencing a shortage of carboplatin while 70% were low on cisplatin. “We are not aware of any past shortages of anti-cancer medications that approach the current scale seen with cisplatin and carboplatin,” said Robert W. Carlson, MD, the CEO at NCCN. To combat this shortage, the FDA temporarily approved the importation of cisplatin with non-US labelling from China.
Recognizing the need to develop strategies that mitigate the effects of this shortage, Hematology/Oncology Pharmacy Association (HOPA) partnered with the Association of Community Cancer Centers (ACCC) and Association of VA Hematology/Oncology (AVAHO) to lead a virtual round table for oncology pharmacists, healthcare professionals, and stakeholders. This webinar titled, "Critical Conversations: Navigating Drug Shortages and Empowering Oncology Pharmacists," allowed experienced oncology pharmacists to share their insights, perspectives, and practical strategies healthcare organizations around the country can adopt to manage the current drug shortage.
The incident at Intas Pharmaceuticals Ltd. was merely a symptom of a much larger problem within the US drug manufacturing supply chain. To begin the webinar, Sol Atienza, PharmD, BCOP, clinical oncology pharmacy specialist at Advocate Aurora Health and HOPA Board Member, detailed some of the problems that currently exist. “Over the past 2 decades, it has become apparent that we have become reliant on a global pharmaceutical supply chain,” Dr Atienza said. “This includes even the active pharmaceutical ingredients from abroad.”
According to the FDA, as of August 2019, only 28% of the facilities manufacturing active pharmaceutical ingredients for the US market were domestically located. According to Dr Atienza, the US drug market’s growing reliance on foreign manufacturers is due in part to the stringent regulatory safeguards companies must adhere to in the US. “This forces drug manufacturers to shut down their manufacturing plants, delay their manufacturing process or move it overseas,” Dr Atienza explained. Further, Dr Atienza asserts that the low profit margins with generic drugs like cisplatin and carboplatin make them more susceptible to shortages. “In that first quarter of 2023, there were 47 new drugs that went into shortage—chemotherapy was one of the top 5 in those drug shortages,” Dr Atienza said. “This problem is very apparent in the oncology setting.”
The current drug shortage creates significant challenges to patients with cancer. According to Dr Atienza, patients could face delays in treatment, experience disruptions in chemotherapy doses, and even regimen alterations as a result. “Patients may have to transfer to other institutions where the drug is more available, and even unfortunately, patients may have to miss some doses of chemotherapy,” she said. Dr Atienza believes this creates anxiety and distress for patients with cancer, while increasing the burden on healthcare providers.
“In a recent HOPA survey, 29 respondents revealed there was at least 1,000 or more in personal hours that were dedicated to the current drug shortage,” Dr Atienza said, adding that, “of those respondents, only 92% of them received any additional FTE [full-time equivalent] hours.” According to Mahta Mahmoudieh, PharmD, hematology/oncology pharmacy clinical specialist at Inova Schar Cancer Institute-Fair Oaks, this burden is exacerbated by the current workforce shortages that healthcare systems around the country are experiencing. Thus, developing strategies to empower oncology pharmacists as they tackle this dilemma, is more important than ever.
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