ASCO Resources Related to Drug Shortages
*Please see @ASCO on Twitter for the most rapid updates on the availability of cisplatin and carboplatin.
The medical community is currently experiencing ongoing, and in some cases, worsening shortages of critical drugs. Key information is provided below.
Drug Shortages Updates
June 2, 2023, Cisplatin Availability Update: The FDA has worked with Qilu Pharmaceuticals and Apotex Corp. to temporarily import cisplatin to help meet patient needs during the shortage. The FDA has assessed the product to ensure it is safe for US patients. See the prescribing information here. The FDA will continue all efforts with the approved manufacturers in addition to any potential importation efforts to meet all patient needs.
May 24, 2023, Carboplatin Availability Update: Teva has a limited and available supply of the following for Carboplatin: 50 mg/5mL, 150mg/15mL, 450mg/45mL, and 600mg/60 mL multi-dose vials (the previous update of Teva's cisplatin supply remains the same with the 1 mg/mL 50 and 100 mL MDVs).
May 19, 2023, Cisplatin & Carboplatin Availability Update: Accord will release on-hold supply of cisplatin. It will release carboplatin too. This will help fill the supply gap until other manufacturers have releases. The FDA continues to explore all avenues to meet demand, including temporary importation.
May 17, 2023, Cisplatin Availability Update: Teva has a limited supply of the smaller 50mL vials of cisplatin and availability of the 100mL, with recovery to regular supply levels expected in Q4 and Q3, respectively. Call 800-545-8800 for details.
May 12, 2023, Cisplatin Availability Update: Accord released an additional cisplatin supply which should be available to order in the coming days. Accord also plans releases soon for carboplatin and methotrexate. FDA continues to work with all companies on increased supply, as well as pursuing importation.
Drug Shortage Listings
The FDA maintains a list of drugs in shortage with information on expected duration of shortage and alternative suppliers, when available.
The American Society of Health-System Pharmacists (ASHP) also maintains a list of drugs in shortage with information on the expected duration of shortage and alternative suppliers, when available. This list differs from the FDA’s list as ASHP lists every drug shortage reported through their online report form as soon as it is investigated and confirmed, usually within 24-72 hours, whereas the FDA site focuses only on shortages of medically necessary drugs, as these have the potential to impact public health.
ASCO strongly encourages all members to report drug shortages directly to FDA so that they understand the volume and scope of the problem and can best direct their attention.
General Clinical Guidance
ASCO established a Drug Shortages Advisory Group to assist in the development of the below clinical guidance. View Advisory Group membership and disclosures here.
The statements below reflect the American Society of Clinical Oncology’s position on the prioritization of antineoplastic agents in limited supply for first intervention; decisions should be based on specific goals of the therapy where evidence-based medicine has shown survival outcome and life-extending benefit in both early and advanced stages.
Effective immediately, ASCO recommends the following:
- Re-prioritize non-essential use of antineoplastic agents in limited supply. If an alternative agent, intervention or sequence with comparable efficacy and safety is available, then the limited agent should not be ordered.
- Increase the interval between cycles and/or reduce the total treatment dose when clinically acceptable. Where nationally recognized guidelines (e.g., ASCO, NCCN, etc.) state a range for cycle duration, default to the longer end of that range (e.g., if platinum is recommended every 3 to 4 weeks, default to every 4). Where guidelines indicate a range of dosing, default to the lowest therapeutically proper dose.
- Minimize or omit the limited agent for recurrent agent-resistant cancers.
- Minimize waste by optimizing vial size, dose rounding, and using multi-use vials.
- Institutions should establish a working multidisciplinary utilization committee to monitor drug shortages, provide and communicate internal policies on utilization, and act as an independent arbiter to promote equitable use of drugs in short supply.
- Select an evidence-based alternative regimen if adequate supplies are unavailable and consider a second opinion consultation with oncology/hematology colleagues to discuss disease site-specific options.
- Providers should offer counseling referrals (if available) to patients affected by shortage-related distress.
This guidance was adapted from the Society of Gynecologic Oncology (SGO) communique on cisplatin and carboplatin shortages and reviewed by SGO representatives.
Disease Site Specific Guidance
Clinical Guidance for Gastrointestinal Cancers
Clinical Guidance for Gynecologic Cancers
ASCO endorses the Society of Gynecologic Oncology's recommendations on treatment for gynecologic cancers during drug shortages. Clinical guidance can be found at the links below.
- SGO, FWC, and GOG-F Comminque: Shortages and Treating Cervical, Vulvar, and Vaginal Cancers
- SGO, FWC, and GOG-F Communique: Considerations When Treating Gestational Trophoblastic Neoplasia in the Setting of a Methotrexate Shortage
- SGO, FWC, and GOG-F Comminque: Considerations when Treating Patients with Gynecologic Cancers on Clinical Trials in the Setting of Chemotherapy Shortages
- SGO, FWC, and GOG-F Communique: Considerations When Treating Person with Ovarian, Fallopian Tube, and Peritoneal Cancers in the Setting of Cisplatin and Carboplatin Shortages
Additional site-specific guidance is forthcoming.
Drug Shortages Policy Recommendations
- 2018 Summit on Drug Shortages to Examine Impact on National Security and Health Care Infrastructure
- Recommendations from 2018 Summit
- 2017 Drug Shortages Roundtable
- 2017 Drug Shortages Roundtable Report
Association for Clinical Oncology Activities
- May 11, 2023: ASCO Statement for the Record for the House Energy and Commerce Committee, Oversight and Investigations Subcommittee Drug Shortages Hearing
- May 11, 2023: ASCO Statement for the Record for the House Energy and Commerce Committee PAHPA Hearing
- April 10, 2023: ASCO Testimony to the House Appropriations Committee Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee
- March 29, 2023: ASCO Response to Senate Health, Education, Labor and Pensions Committee Pandemics All-Hazard Preparedness Act (PAHPA) Request for Information (RFI)
- March 22, 2023: ASCO Statement for the Record for Senate Homeland Security and Government Affairs Committee Hearing
- 2021: Health Groups Recommendations to Improve Supply Chain Resiliency
- April 12, 2021: Letter to Biden Administration in Response to Supply Chain Executive Order (Executive Order 14017)
- June 25, 2020: Letter to Congressional Leadership on Oncology Drug Shortages During COVID-19
- White House “100 Day” Report: Supply Chain Review (including pharmaceuticals), June 2021
- FDA: Drug Shortages: Root Causes and Potential Solutions (published 2019, updated 2021)
- FDA: Report to Congress: Drug Shortages for Calendar Year 2021 (required annual report)
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