THE Australian Self-Medication Industry (ASMI) is seeking clarity over concerns the introduction of Appendix M may lead to pharmacist prescribing as an alternative to down-scheduling products.
The proposed introduction of Appendix M by the Therapeutic Goods Administration (TGA), could pave the way for some prescription medicines including the contraceptive pill, sildenafil and triptans, to be reclassified as pharmacist-only.
In its submission to the TGA, ASMI said, "there should be clear policy advice that pharmacist prescribing and emergency prescribing are different and these are not a substitute for Schedule 4 (S4) to S3 down-scheduling".
"ASMI supports Appendix M and welcomes the development of guidance to assist applicants," the industry group said.
"We note that pharmacists already play an important role in assessment of suitability for supply of S3 medicines, as well as provision of counselling and advice to consumers and we believe that Appendix M will strengthen these activities.
"However, ASMI is also concerned that Appendix M may fuel some existing negative attitudes and perceptions regarding S4 to S3 rescheduling, which may make it difficult for Appendix M entries to be developed and accepted.
"A proposal to include an Appendix M entry with a rescheduling application should not be perceived as an admission that the scheduling factors for S3 cannot be met or that rescheduling is not appropriate.
"The intent of Appendix M should be to mitigate risk, that it enhances safety and appropriate provision of certain newly down-scheduled medicines, as well as facilitating innovation; Appendix M should not be perceived as an obstacle to rescheduling."
The full submission can be viewed at asmi.com.au.
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