Background
Medicine shortages adversely impact patients, healthcare professionals and health systems. Whilst not a new challenge, it has recently been exacerbated by global events. Currently, there are 424 medicine shortages with 40 considered critical. The Therapeutic Goods Administration (TGA) has implemented a number of improvements, such as legislative amendments, prioritisation guidance, data sharing and alternative product approvals. Access to benzylbenzathine penicillin (Bicillin LA®) premix syringes during a global shortage was mitigated by the TGA approved overseas alternative (Brancaster®) which differed in concentration and form. Implementing alternatives into practice require clinical guidelines for safe and effective use.
Objective(s)
Proactively develop national consensus guidance, including; dosing, administration, and key patient messages to align the use of Brancaster® with Australian Guidelines.
Method(s)
Real world reconstitution testing of Brancaster® was conducted independently by two pharmacists matching volumes to ascertain an average. The draft guidance was developed by pharmacists including key messages for clinician-patient discussions for informed consent. Clinical experts, national groups and key stakeholders were identified and consulted with multiple rounds of feedback for consensus.
Evaluation
National consensus guidance for the use of Brancaster® in key therapeutic conditions was reached. Simplified dosing volumes and reconstitution instructions was achieved by real world testing. The guidance was approved and co-branded by clinical experts and peak national organisations and shared nationally. This guidance was subsequently published by the Australian Injectable Drug Handbook prior to the Brancaster® being available for use.
Discussion
Despite improvements in the coordination of medicines shortages, there is a gap in coordination of clinical guidance to ensure appropriate and safe use of an alternative for standardised practice. This gap results in duplication of effort and increased burden on clinicians with each jurisdiction developing their own. This coordinated process could be replicated for future shortages and pharmacists are well placed to lead this national work.