NYSDOH Advisory on Recommendations for BCG Live Single-Use Vials During Shortage

To address the shortage of Bacillus Calmette-Guerin (BCG) Live, a drug used in treatment of bladder cancer, the New York State Department of Health (NYSDOH) has issued interim infection control guidance permitting providers to treat multiple patients from the same single-use vial of BCG. This represents an exception to NYSDOH norms and to Centers for Disease Control’s Safe Injection Practices.

According to a July 5 advisory, sent to hospitals in New York, NYSDOH has concluded that during the shortage “the risk of infection related to sharing single-use vials is outweighed by the benefit of providing this treatment if effective controls are in place to ensure aseptic technique during reconstitution, administration and disposal.” Merck announced the shortage in January 2019, resulting in updated clinical guidance from urological and cancer associations allowing use of single-use vials on multiple patients during the shortage.

NYSDOH recommends the following actions, which are quoted directly from the advisory:

  1. Ensure that written protocols are readily available for all staff who will be involved in the reconstitution, administration and disposal of BCG and related equipment. Ensure that these written protocols are based on the manufacturer’s instructions and the CDC’s safe injection guidelines except for the restriction on reuse of single-use vials.
  2. Ensure that all staff who prepare and administer BCG are doing so within the scope of their professional practice and are supervised by a physician.
  3. Ensure that this interim practice of sharing single-use vials of BCG is not allowed for any other medication and ensure that this interim practice does not continue after the shortage is resolved.
  4. Ensure that other issues surrounding the practice of using a single-use vial for more than one patient, such as billing/insurance issues, have been adequately addressed.

MLMIC encourages all providers to remain vigilant in the use of safe injections practices, and in particular, when using a single-dose vial for multiple injections to prevent cross-contamination and infection.  For more information on safe injection practices, please see The One and Only Campaign.