Leading government health agency and SHPA add voices to GP groups in opposing antibiotic downscheduling, citing fears about antimicrobial resistance
The Australian Commission on Safety and Quality in Heath Care has written to the TGA’s consultation on proposed criteria for Appendix M with concerns about downscheduling antibiotics.
Specific provisions should be included in the Appendix M criteria to exclude antimicrobials from rescheduling from Schedule 4 (S4) to Schedule 3 (S3), the Commission suggested.
“This advice is consistent with a specific recommendation of the World Health Organization that over-the-counter dispensing of antimicrobials for human and animal health not be permitted, with the aim of reducing the risk of contributing to the development of antimicrobial resistance,” it said in its submission.
“It is acknowledged that over-the-counter provision of medications is a core competency and activity of community pharmacists. However, there is no comprehensive framework to support pharmacists in the appropriate use of antimicrobials.”
PSA recently suggested that the TGA should reschedule trimethoprim from S4 to S3 to treat uncomplicated urinary tract infection in women, citing a “very favourable consumer benefit” alongside clinical pathways or protocols to guide use.
However the Commission said UTIs are not necessarily easy to diagnose and manage, and it is “well known” that countries that allow over-the-counter sales of antibiotics have higher rates of antimicrobial resistance.
The submission sees the Commission wade into an ongoing debate after a Queensland trial was announced that will see pharmacists prescribing antibiotics for acute UTIs.
In its submission to the TGA’s consultation, the RACGP also recommended against the downscheduling of antibiotics “in the interests of antimicrobial stewardship and appropriate use of medicines”.
“The proposed policy has potential to contribute to an increase in the overuse and unnecessary use of medicines,” it said, adding that diagnosis of UTIs by clinical criteria alone has been demonstrated to have an error rate of 33%.
The Society of Hospital Pharmacists of Australia (SHPA) agreed with both the Commission and the RACGP.
“Antimicrobials (including trimethoprim) should be deemed as unsuitable for Appendix M given the impact of antimicrobial use at a public health level, in addition to that at the individual patient level,” said the SHPA in its submission to the TGA.
“Reducing the incidence of antimicrobial resistance is a national and global health priority and loosening access controls to these vital medicines can undermine actions to preserve the efficacy of antimicrobials.
“Australia already faces challenges for the treatment of urinary tract infections due to the increasing incidence of resistant strains of E. coli., the most common cause of urinary tract infections. SHPA firmly believes that antimicrobials such as trimethoprim should not be down-scheduled and have an Appendix M entry.”
‘Training of pharmacists significantly under recognised’
PSA told the AJP that pharmacists could safely dispense antibiotics under the Appendix M schedule with appropriate safeguards in place.
“It’s worth understanding the nuance of the WHO recommendations,” said PSA interim chief executive Shane Jackson.
“The WHO recommendations extend from some countries where they don’t have a pharmacist supplying over-the-counter antibiotics – you can get it in a store that is in not manned by a pharmacist.
“There’s a whole spectrum of OTC provision of antibiotics internationally.
“The PSA holds the same concerns as medical groups and the Commission on antimicrobial resistance. It’s a worldwide problem and it’s a problem in Australia. We believe with appropriate safeguards that pharmacists could dispense antibiotics if appropriate under Appendix M schedule.”
Dr Jackson said these safeguards need to be worked through with the relevant bodies, which would occur through an Appendix M structure.
“The Advisory Committee on Medicines Scheduling would decide what safeguards would be appropriate. Those protocols would be worked through with the appropriate bodies including the Commission and doctors’ groups.”
Dr Jackson pointed out that pharmacists are “well aware” of the issues surrounding antimicrobial resistance.
“Pharmacists are often the ones that are leading antimicrobial stewardship programs in the healthcare setting. They are well aware of the issues and are very judicious of their use.
“The training and expertise of pharmacists is significantly under recognised by the medical groups. Scheduling through Appendix M allows appropriate framework to support access to medicines that is deemed to be appropriate – where pharmacists have the skills and training to make a clinical assessment within their scope of practice.”
‘Out of scope’
In its response to submissions on proposed criteria for Appendix M, the TGA said that the stated concerns were out of the scope of the current consultation.
“Several submissions raised concerns or objected to the downscheduling of antimicrobial substances, in particular trimethoprim,” it said.
“However consideration of the merits of specific substances for downscheduling is not in scope for this consultation.”
The TGA also pointed out that the existence of Appendix M itself is not up for debate.
“Generally speaking, medical groups oppose the use of Appendix M while pharmacy bodies, academia, consumer groups and industry are favourable, although there remain points of concern,” the TGA said in its response.
“The establishment of Appendix M is existing policy (approved by the Australian Health Ministers Advisory Council) and law (contained within a Commonwealth legislative instrument).
“The consultation was not about the existence of Appendix M or otherwise, but rather on the guidance for Appendix M.”
The TGA said based on the submissions provided, medicines could be downscheduled from S4 to S3 under the Appendix M framework, with pharmacists supplying these in accordance with specific professional practice standards including additional training.
Sponsors will work with pharmacy bodies to develop suitable training packages as part of their applications to downschedule a substance.