GMO Medicines and hospital pharmacy practice: a review

Abstract

Research into gene therapy and genetically modified organism (GMO) medicines is intensifying. Whilst there are only a small number of GMO medicines which have successfully reached registration, Australian hospital pharmacy departments may find themselves in a position where they are required to handle, prepare and dispense this emerging class of therapy in a clinical trial setting. This article explores current literature concerning the management of GMO medicines in a hospital setting. Currently, the bulk of GMO medicines employ the use of viral vectors to deliver therapeutic genetic material into patients. The use of biohazardous agents such as viral vectors presents a new set of safety risks to both patients and pharmacy staff. Pharmacists need to be aware of the safety risks surrounding the use of GMO medicines and implement procedures to handle these medicines safely. Further, pharmacists will need to be familiar with the Gene Technology Act 2000 in addition to the state and federal regulations governing the use of medicines in Australia.

European Association of Hospital Pharmacists (EAHP) Guidance on the Pharmacy Handling of <em>In Vivo</em> Gene Therapy Medicinal Products

“…Experts from the USA and Australia have also produced opinion and review articles providing guidance on the handling of GTMPs in a hospital pharmacy setting (1,(19)(20)(21)(22)(23)(24). Common recommendations across documents include limiting access to GTMPs to trained personnel, using appropriate biosafety containment equipment and personal protective equipment (PPE), using appropriate containers for transport, developing institutional procedures and policies, and ensuring appropriate decontamination and waste management (19)(20)(21)(22)(23)(24).…”

“…Experts from the USA and Australia have also produced opinion and review articles providing guidance on the handling of GTMPs in a hospital pharmacy setting (1,(19)(20)(21)(22)(23)(24). Common recommendations across documents include limiting access to GTMPs to trained personnel, using appropriate biosafety containment equipment and personal protective equipment (PPE), using appropriate containers for transport, developing institutional procedures and policies, and ensuring appropriate decontamination and waste management (19)(20)(21)(22)(23)(24). Additional recommendations include adding GTMPs to the institutional hazardous drugs list, following contact precautions with patient material post-administration, instating a clinical biosafety committee, caregiver training, providing appropriate personnel training/education and storage of the GTMPs in a dedicated area (20)(21)(22)(23)(24)(25).…”

“…In general, available guidelines and recommendations agree that GTMPs should only be handled by trained personnel in a manner appropriate for the biosafety level of the agent, following established procedures (6,(19)(20)(21)(22)26).…”

“…The GMTP's Summary of Product Characteristics or clinical trial documentation should also always be consulted. (20,26) All GTMPs should be added to the institutional hazardous drugs list (22) As required by local legislation a Protective clothing is required to minimise the risk of microbiological contamination of the therapeutic agent during reconstitution, as well as to protect the person preparing the agent. b Unless there is solid evidence that the vector is not being shed, disposable clothing/laundry is advised.…”