Setting the pharmacy standard in clinical trials
The critically important clinical trials setting is the latest area of focus for the Society of Hospital Pharmacists of Australia (SHPA)’s expanding suite of Standards of Practice, wholly revised to factor in new electronic systems, global medication supply chains and the increasing participation of pharmacy practitioners at a time of immense global attention.
SHPA’s Standard of practice in clinical trials for pharmacy services appears in the latest issue of the Journal of Pharmacy Practice and Research (JPPR), released this week, as the race for a viable, sustainable COVID-19 vaccine dominates international scientific research.
SHPA Clinical Trials Chair Peter Slobodian says upholding the integrity and safety of clinical trials conducted in Australia was a driving principle of the revisions.
‘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.
‘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.’
The Clinical Trials Standard of Practice also provides guidance on temperature excursions (storage outside specified temperature range) and the handling of quarantined investigational products.
SHPA Chief Executive Kristin Michaels says the Standard’s guidance on research involvement is timely given recently announced Federal Government investment.
‘Hospital pharmacists are leaders in innovation, undertaking the vast majority of pharmacy research, supported by JPPR and SHPA’s recently established Research Specialty Practice stream.
‘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.
‘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.’