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.

Reporting Shortages

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:

  1. 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.
  2. 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.
  3. Minimize or omit the limited agent for recurrent agent-resistant cancers.
  4. Minimize waste by optimizing vial size, dose rounding, and using multi-use vials.
  5. 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.
  6. 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.
  7. 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.

Additional site-specific guidance is forthcoming.

Drug Shortages Policy Recommendations

Association for Clinical Oncology Activities 

Additional Resources

Association Members: Take Action Through the ASCO ACT Network.

Visit ASCO in Action for additional updates.

Answers to questions about oncology drug shortages published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) for voluntary, informational use by providers in the rapidly evolving drug shortage crisis. This information does not constitute medical or legal advice, is not intended for use in the diagnosis or treatment of individual conditions, does not endorse products or therapies, recommend or mandate any particular course of medical care, and is not a statement of the standard of care. New evidence may emerge between the time information is developed and when it is published or read. The information is not comprehensive or continually updated. This information is not intended to substitute for the independent professional judgment of the treating provider in the context of treating the individual patient. ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions. Use of the information is subject to the complete ASCO website Terms of Use.