Clash over S4 to S3 downscheduling


Doctors’s group disagrees with expansion of downscheduling S4 medicines with controls, citing patient safety concerns

The Australian Medical Association (AMA) has again taken aim at pharmacy, this time over the TGA’s proposals to introduce new controls for medicines downscheduled to S3 status.

In its submission to the consultation on the review of the Scheduling Policy Framework, the AMA states it is “apprehensive that the availability of these apparent ‘controls’ will give false assurance that it is therefore safe to downschedule S4 medicines to S3”.

It refers to the two recent applications for S4 medicines to be downscheduled – oral contraceptives and vardenafil – saying such a move would cause missed opportunities for further screening by GPs.

For example, it argues that prescribing the combined oral contraceptive pill provides GPs with the opportunity to: consider the benefits of changing contraception; offer opportunistic screening for STIs or cervical cancer; measure blood pressure; and provide further unrelated health prevention activities.

Prescription of vardenafil would also provide an opportunity for GPs to screen for diabetes and STIs, and well as provide further unrelated health prevention activity.

The AMA uses the codeine example to argue that pharmacists were not effective at reducing dependency and overdose.

“Relying on pharmacists to control the use of low-dose codeine products did not stem the increase in codeine-related deaths post 2010,” it says.

PSA says the current limitations to downscheduling are based on a misunderstanding of pharmacists’ expertise, saying that downscheduling could be expanded based on the following:

  • That pharmacists are qualified medicines and medication management experts who practise within relevant ‘mandatory’ frameworks including various legislation and a nationally endorsed competency standards framework; and
  • Pharmacists are supported by various professional practice resources such as training for any expanded areas of practice, professional guidelines, professional practice standards and implementation support tools.

PSA says that when a substance is rescheduled from S4 to S3, PSA will generally develop a guidance document.

“In our view, the strength or validity of a rescheduling application should not be dependent on the inclusion of a professional guidance document,” it says.

“PSA is best placed to develop all professional resources for pharmacists once a positive scheduling decision is confirmed.

“PSA’s S3 guidance documents (often referred to as a ‘supply protocol’) describe a series of recommended steps for pharmacists to follow.

“Pharmacists are also required to meet legislative requirements and importantly ‘are expected to exercise professional judgement in adapting the information provided [in S3 guidance documents] to specific presenting circumstances.”

The Pharmacy Guild of Australia also argues in its submission to the review that the Poisons Standard could be more flexible to allow great patient access, while ensuring medicines are supplied safely and appropriately.

It says that other comparable countries such as New Zealand have enabled several prescription-only medicines to be supplied OTC by a pharmacist, subject to a series of controls that are additional to the standard supply regulations for Pharmacist Only medicines.

These controls include:

  • Additional patient criteria, for example:
  • Patient must be within a certain age range; or
  • Patient has been previously diagnosed with the condition the medicine is intended to treat.
  • Limits on dosage strength and/or pack size;
  • A screening tool/questionnaire;
  • Mandatory training for pharmacists; and
  • A requirement to inform the individual patient’s doctor regarding supply (subject to the consent of the patient).

The Guild emphasises that not all of these controls are applicable to all medicines in this context.

However such controls are not good enough, says the AMA.

“The AMA still strongly opposes the downscheduling of these medicines on the basis that it would both risk patient safety and contravene quality use of medicine principles, even if extra ‘controls’ and ‘requirements’ were available to impose on pharmacists at the point of supply.”

Except-when model

PSA says it “strongly believes” the alternative ‘except when’ model merits consideration in the Australian context.

It refers to an arrangement implemented in New Zealand where, for example, meningococcal vaccine is classified as a prescription medicine “except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.”

The Pharmacy Guild has also thrown its support behind the ‘except-when’ model, which it hopes will be implemented when codeine-containing OTCs are upscheduled next year.

The model would see continued non-prescription dispensing of these preparations under certain circumstances: such as severe toothache where a dentist’s surgery is not open, after hours or in rural areas without services.

The Guild is working with the PSA and other stakeholders to develop a protocol around this model and the training pharmacists would need were it implemented.

Doctors unsurprisingly condemned the idea.

“We are extremely concerned at recent reports of some groups endeavouring to influence or coerce State governments to change, delay, or dilute the impact of the TGA decision,” said AMA President Dr Michael Gannon on reports that the Guild was meeting with government representatives regarding the ‘except-when’ model.

“At this stage, we do not want to see the peddling of alternative models, dressed up as ‘patient concern’, which undermine the TGA position,” he said last month.

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