December 2, 2015
Stephen Ostroff, M.D. Acting Commissioner
Food and Drug Administration
Department of Health and Human Services
10903 New Hampshire Avenue
Silver Spring, MD 20993
Submitted electronically via www.regulations.gov
Dear Dr. Ostroff,
ASHP is pleased to submit comments to the Food and Drug Administration (FDA) on the agency’s draft guidance announced in the Federal Register on October 22, 2015, regarding definitions and terms for single-dose and multiple-dose containers (draft guidance).1 ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s more than 43,000 members include pharmacists, student pharmacists, and pharmacy technicians. For over 70 years, ASHP has been on the forefront of efforts to improve medication use and enhance patient safety.
ASHP and its members support actions that reduce or prevent the transmission of blood-borne pathogens caused by unsafe injection practices. We worked closely with the Centers for Disease Control and Prevention (CDC) during a period of acute drug shortages in 2012-2013 to communicate and reinforce CDC’s guidance on safe handling of single-dose injectable medications and we promote its One and Only Campaign to our members.2 In collaboration with the CDC, we developed a crosswalk to guide members on the various requirements for single- and multiple-dose injectable drugs.3 As our members handle these items daily when compounding sterile preparations, precise definitions of injectable package types are essential to assuring these containers are used in the intended manner.
ASHP agrees that a different package descriptor is needed for injectable drug containers that contain many doses but are intended for use on a sole patient. The U.S. Pharmacopeia is the official source for drug standards that guide much of pharmacy practice. As such, we strongly recommend that FDA proactively collaborate with USP to harmonize and standardize the draft guidance, including new packaging terms and definitions, in order to avoid conflicting definitions or requirements that may confuse practitioners.
We commend the Agency for addressing the need for a discard statement to be included in product labeling for single-patient-use and single-dose containers, as well as on the container label if possible. For single-dose containers, we suggest that a more specific discard statement would be “Remove one dose and discard remainder” or similar.
Finally, we advise the FDA to be mindful in replacing the term “single-use” with “single-patient-use,” that the latter term also applies to a “single-dose” container. This concept isn’t reflected in the flow chart beginning line 143 of the draft guidance.
Practitioners may assume that single-patient-use is required for only the new package type and no longer applicable to single-dose containers, despite the apparently clear intent of that term. This misperception may be facilitated by the number of mmercially available single-dose containers that potentially contain several doses. Unfortunately, there may not be space on many container labels for a more specific term that indicates that only one dose may be removed for a single patient. We recommend that FDA collaborate with CDC to explore other terms or visual cues, such as symbols or pictograms, to communicate the appropriate use of the container to the bedside care provider. We also suggest that FDA encourage container labeling that permits sufficient pace to include the package type.
ASHP appreciates the opportunity to comment on the FDA’s draft guidance. Please contact me if you have any questions or wish to discuss our comments further. I can be reached by telephone at 301-664-8806, or by e-mail at [email protected].
1Federal Register, Volume 80, No. 186. Pages 58,014–58,092
2 Protect Patients Against Preventable Harm from Improper Use of Single–Dose/Single–Use Vials
3 Guidances and Standards for Managing Single (SDV) and Multi-Dose Vials (MDV)