MAINTAINING the integrity and safety of clinical trials conducted in Australia is critical in the race to deliver a viable and sustainable COVID-19 vaccine, the Society of Hospital Pharmacists of Australia (SHPA) believes.
Releasing the SHPA's Standard of practice in clinical trials for pharmacy services, the Society's Clinical Trials Chair, Peter Slobodian, said the revised document was designed to support best practice.
"Pharmacists are essential to clinical trials, not only to meet regulatory requirements related to the storage, dispensing and supply of investigational products but also to ensure their safe and ethical use -- this has never been more important as safety and efficacy must remain central to the push toward coronavirus vaccination," he said.
"To meet trial requirements, clinical trials pharmacists are sometimes involved in the importation of unregistered medicines and the SHPA Clinical Trials Leadership Committee has provided detail on available permit options to ensure cutting-edge treatments can be safely secured for use in Australian hospitals.
"To support best practice regarding access and security, the 2020 standard highlights consideration around the role of interactive voice/web response system (IxRS) software and electronic accountability records for the first time."
SHPA CEO, Kristin Michaels, said the new Standard's guidance on reseach involvement is timely given recently announced Federal Government investment.
"The Clinical Trials Standard's advice on research involvement provides further guidance for pharmacists seeking to have a greater impact on patient care through this important practice domain," she said.
"Following the establishment of the $25 million Quality, Safety and Effectiveness of Medicine Use and Medicine Intervention by Pharmacists fund, as announced in the 2020 Federal Budget, SHPA members and their hospital colleagues are ideally positioned to maximise these opportunities to improve safe patient care."
The Standard has been published in the Journal of Pharmacy Practice and Research.
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