Guidance on access to and storage of pentobarbital
The Veterinary Practitioners Registration Board of Victoria (the Vet Board) has received information from the Coroners Court of Victoria relating to access to and storage of pentobarbital. This news item summarises that information and provides the Vet Board’s recommendations on these matters.
CONTEXT AND RESOURCES
Background: deaths by pentobarbital in Victoria
Between 1 January 2000 and 31 December 2021, there were 115 suspected or coroner-determined suicides in Victoria in which pentobarbital (referred to by the Coronors Court as pentobarbitone) was a contributing drug. In 15 of these deaths, the deceased person had been working as either a veterinary practitioner or veterinary nurse and they accessed the pentobarbital through their workplace. There was an additional death where pentobarbital was taken from a veterinary practitioner’s car.
A recent coronial finding into the death of a veterinary nurse by self-administration of pentobarbital found that the veterinary nurse had access to the locked pharmacy cupboard in which the Schedule 4 poison was stored. At the time, the key to the pharmacy cupboard was kept in a drawer in the common staff area of the clinic and all veterinary nurses working at the clinic had access to that key. The coroner found that the veterinary nurse was able to access pentobarbital in the ordinary course of her duties, outside the scope of her work duties, and without hindrance outside of clinic hours.
The coroner found that the clinic’s storage of pentobarbital and its practice of permitting veterinary nurses to access the drug were in breach of regulations made by the Therapeutic Goods Administration (TGA) in October 2020.
The coroner recognised that the clinic where the nurse had been working subsequently took measures to comply with regulations on the safe handling and storage of pentobarbital. The clinic ensured that only veterinary practitioners held a key to the locked pentobarbital storage container, and no keys (including any spare key) could be accessed by unauthorised persons. The coroner also acknowledged a commitment by the clinic to focussing on the mental health and wellbeing of its employees.
Scheduling and classification of pentobarbital
Pentobarbital is a Schedule 4 poison under the Standard for the Uniform Scheduling of Drugs and Poisons (SUSMP), also known as the Poisons Standard, administered by the TGA. Given the unique risk pentobarbital poses to human health and safety, Schedule 4 Appendix D of the SUSMP places an additional control on its storage (see below). As a barbiturate, pentobarbital is also classified as a drug of dependence under the Drugs, Poisons and Controlled Substances Act 1981 (DPCS Act). These classifications have an impact on how the poison is to be stored and who may lawfully access, possess and supply pentobarbital.
Links to legislation and further background
Storage of pentobarbital
At all times, pentobarbital must be stored in accordance with the Drugs, Poisons and Controlled Substances Regulations 2017 (DPCS Regs) and the SUSMP to prevent unauthorised access, i.e., by persons who are not authorised under the DPCS Act:
- The DPCS Regs require veterinary practitioners, authorised persons under the DPCS Regs, to store Schedule 4 poisons in a lockable storage facility. Veterinary practitioners must take all reasonable steps to ensure that the storage facility remains locked and secured, except when it is necessary to open it to carry out an essential operation in connection with the poisons stored in it.
- The SUSMP requires pentobarbital (as an injectable preparation) to be stored [secured] in a locked container.
“Secured” means secured from unauthorised access. This means that the keys or combination to the pentobarbital storage facility or container must not be accessible to unauthorised persons, including veterinary nurses.
Storage with other Schedule 4 poisons
While the requirements of the DPCS Regs and SUSMP may be met by storing pentobarbital in a locked lockable storage facility with other Schedule 4 poisons, in many clinics this storage facility would be frequently opened and accessed.
Given the very real possibility that the lockable area may inadvertently be left unlocked or unsupervised by a veterinary practitioner from time to time, it is recommended that pentobarbital (whether injectable or in other form) which is stored with other Schedule 4 poisons in a lockable storage facility should also be stored in a separate locked container to which only authorised persons (registered veterinary practitioners) have access.
Pentobarbital may be stored in a clinic’s dispensing area, pharmacy department or treatment room when a veterinary practitioner is present. However, it must additionally be stored in a locked container to prevent unauthorised access.
Storage with Schedule 8 poisons
As a drug of dependence, pentobarbital can be stored with Schedule 8 poisons, which have more rigorous storage requirements. Storage of pentobarbital in a Schedule 8 drug safe that is kept locked and secured in accordance with the DPCS Regs will meet the requirement that it be stored in a locked container.
More resources on access, possession and storage
The Medicines and Poisons Regulation (MPR) Branch of the Victorian Department of Health has published additional information about legislative requirements relating to access, possession and storage of Schedule 4 and 8 poisons, and legislative requirements for veterinary practitioners:
VET BOARD RECOMMENDATIONS
Given the particular risk posed by pentobarbital, the Vet Board’s view is that:
- Pentobarbital in all forms (injectable or otherwise) which is stored with other Schedule 4 poisons in a lockable storage facility should additionally be stored in a separate locked container to which only authorised persons (registered veterinary practitioners) have access.
Pentobarbital may be stored within a locked Schedule 8 drug safe accessible only to registered veterinary practitioners.
The Vet Board's minimum expectation is that pentobarbital be stored in a locked container, separate from other Schedule 4 poisons, with access restricted to veterinary practitioners. Although it is not mandated and goes beyond the Vet Board’s minimum expectation, veterinary practitioners may elect to manage access to pentobarbital in a manner that is consistent with the regulations for Schedule 8 poisons (i.e., with tighter controls and record keeping), given the risks inherent in access to the poison.
- A veterinary practitioner should not supply pentobarbital for later administration by a veterinary nurse or an animal’s owner or client.
- A veterinary practitioner should not send pentobarbital via mail or courier, e.g., using Australia Post or other providers or couriers.
- When pentobarbital is stored by a veterinary practitioner in a vehicle:
- pentobarbital must be stored in a locked container (best practice would be to store it in a storage facility / safe in the vehicle that satisfies the requirements for storage of Schedule 8 poisons)
- the veterinary practitioner must:
- only carry the smallest quantity needed
- try to park in secure parking
- keep the vehicle secured
- not leave the key to the container / facility / safe in the vehicle when the vehicle is unattended
- take all reasonable steps to ensure that the storage container / facility / safe in the vehicle remains locked and secured, except when it needs to be opened to carry out an essential procedure with the poisons stored in it
- at the end of a shift in which pentobarbital has been stored in a vehicle, remove the poison from the vehicle and store it as per point 1 above.
- Clinic owners, employers and managers of veterinary staff must ensure that:
- all staff are educated about expectations for the safe access, storage and monitoring of pentobarbital
- systems and escalation processes are in place to identify deviations from expected practice around access to, storage of and monitoring of pentobarbital, and all staff are educated about these systems and processes.
Promoting, protecting and supporting veterinary team health and wellbeing
In providing this guidance, the Vet Board compassionately acknowledges the relationship between mental health problems or illness and the deaths involving pentobarbital that have been the subject of coronial findings.
Various mental health support resources are provided on the Vet Board’s website. We also encourage all members of veterinary teams to review the Vet Board’s Guideline 8: Veterinary practitioner and veterinary team wellbeing. This guideline promotes personal and workplace practices which support and protect mental health, including:
- Physical and mental wellbeing is supported by self-awareness, ongoing monitoring of personal health and undertaking self-guided steps to achieve a sustainable integration of work and non-work life.
- A veterinary practitioner’s personal strategies to maintain wellbeing are supported by appropriate workplace leadership and management practices. Development, promotion and modelling by workplace leadership of strategies, systems and processes, policies and behaviours that support the physical and mental wellbeing of all members are encouraged.
- A veterinary practitioner collaborates in maintaining the wellbeing of their veterinary team by acknowledging the demands of the work environment, demonstrating care and respect for team members, and encouraging colleagues to seek support where appropriate.
Issued: 14 August 2023
Dr John Harte
Veterinary Practitioners Registration Board of Victoria