Medicines scheduling committee knocks back attempts to allow advertising for a number of Pharmacist Only medications
The Therapeutic Goods Administration has rejected proposed amendments to current medicine schedules that would have allowed the direct-to-consumer advertising of a number of Pharmacist Only medicines.
The TGA this week released the interim decisions from the March meeting of the Advisory Committee on Medicines Scheduling (ACMS). Among the committee’s decisions were rejections of Appendix H inclusions for metoclopramide, chloramphenicol and prochlorperazine.
Inclusion in Appendix H of the Poisons Standard allow direct-to-consumer advertising of pharmacist only medicines containing these substances.
The TGA delegate accepted the ACMS advice not to amend the scheduling of metoclopramide in the current Poisons Standard.
“I find that the evidence presented by the applicant is insufficient to overturn the 2018 decision not to include metoclopramide in Appendix H. The same arguments continue to apply regarding the sedating properties of metoclopramide, the potential for misuse and increased pressure on pharmacists to supply metoclopramide off-label,” the delegate said.
“I have considered arguments from the applicant and those written public submissions supportive of direct to consumer advertising, that metoclopramide does not possess inherent sedative properties. While not inherently sedating, metoclopramide’s sedating effects are additive to those of alcohol, hypnotics, narcotics, tranquilisers and sedative medications.
I find that the sedating potential of metoclopramide requires increased patient education to ensure its continuing safe use and that there is potential for inappropriate use that may be exacerbated by advertising.”
“Taking into account the potential for serious adverse effects from use of metoclopramide, even at therapeutic doses, I find that direct consumer advertising of this substance is not in the interest of protecting public health.”
The delegate reached a similar decision for chloramphenicol, “the most common first-line antibiotic prescribed for bacterial conjunctivitis, otherwise known as ‘red eye’”.
“Pharmacists can supply chloramphenicol as a Schedule 3 medicine only for the treatment of bacterial conjunctivitis for patients aged 2 years and older. Most eye infections are not bacteria and there are inherent difficulties in differentiating viral, bacterial and allergic conjunctivitis.
“It follows that pharmacist advice is necessary before chloramphenicol can be safety supplied to consumers.”
The delegate noted they had “not identified, and the applicant has not provided, sufficient evidence to suggest that the benefits of greater consumer awareness through advertising outweigh the delegate’s concerns, raised in 2018, on the potential for promoting antibiotic resistance and the inherent difficulties
in differentiating viral and bacterial conjunctivitis without professional medical advice.
“I consider that advertising could promote inappropriate self-diagnosis by consumers, and result
in selection bias from consumers attending community pharmacies and compromise the process
of professional clinical consultation by community pharmacists.”
Both the Pharmaceutical Society of Australia and the Pharmacy Guild had opposed the proposed amendment in their submissions, the delegate added.
The delegate also found that the current scheduling of prochlorperazine was appropriate, saying “I have not identified, and the applicant has not provided, sufficient evidence to adequately mitigate the delegate’s concerns, raised in 2018, on the potential negative impact on public health related to possible misuse, abuse or diversion”.
Again, the delegate noted that peak bodies, including the PSA and Pharmacy Guild had opposed the amendment in their submissions.
“On the balance of evidence, I find that the need for pharmacist oversight to manage the known safety risks outweigh the benefits of greater consumer awareness through advertising,” the delegate said.
“It is my view that advertising may result in selection bias from consumers attending community pharmacies and this may undermine the process of professional clinical consultation insofar as the appropriate management of nausea associated with migraines.”