Hospital pharmacy group shares concerns about community pharmacy environment over downscheduling medicines – but the Guild says most pharmacies are properly equipped
The Society of Hospital Pharmacists of Australia (SHPA) has reiterated concerns to the TGA around what it describes as “the suitability of the retail environment of community pharmacies and their practices, to support appropriate supply and quality use of medicines”.
Its concerns were shared as part of a submission to the TGA’s consultation on proposed criteria for Appendix M to support rescheduling of medicines from Schedule 4 (S4) to Schedule 3 (S3).
Appendix M is intended to include substances that have formerly been scheduled as S4, but if rescheduled to S3 could be dispensed by a pharmacist with specific controls in place to guide appropriate use.
The PSA provided the TGA with a list of suggested priority substances for re-scheduling, after surveying which medicines its members believed were appropriate to consider for Appendix M.
These medicines included triptans, melatonin, ondansetron, oral contraceptive pills, trimethoprim, adapalene and sildenafil.
However SHPA said: “Given these medicines are currently S4 in recognition of their risk to the public if misused and the seriousness of the conditions which they treat, the community pharmacy environment needs to be meet consumer expectations of health service requirements to support the quality use of medicines.
“Many retail pharmacies do not have private consultation rooms, which are essential given some of the medicines presented to the TGA for pro-active down-scheduling are for urinary tract infections (UTIs) and erectile dysfunction (ED).”
The Pharmacy Guild responded that retail pharmacies are appropriately equipped to provide medicines such as those for UTIs and ED through the S3 Appendix M framework.
“Most modern Australian pharmacies have consultation rooms or private areas for any interaction with patients that require a more private environment,” said a spokesperson for the Guild.
“We believe around 60% of pharmacies currently have separate consultation rooms or areas, and this number is growing all the time.”
SHPA added that supply of certain Appendix M medicines could lead to potential equity issues.
“If the supply of certain Appendix M medicines hinges on the pharmacist undergoing specific training, issues around equity of access to trained pharmacists may arise,” it said.
“It would be important to consider the expectation of patients regarding access to these medicines from community pharmacies, particularly in rural and regional areas where some inequities in medicines access already exist.”
However the TGA responded that it is beyond the powers of the Poisons Standard to require all pharmacists to supply S3 Appendix M substances and thus complete training.
“It is expected that, as part of their initial deliberations, sponsors seeking to downschedule S4 goods to S3 with Appendix M conditions will conduct preliminary discussions with the pharmacy profession to gauge interest in the supply of these medicines as OTC products,” said the TGA.
“It is common for substances to be listed in more than one schedule in different forms, and this will remain an available option if a pharmacy did not have pharmacists trained in the supply of a class of S3 Appendix M medicines.”