‘Significant concerns’: PSR the latest to question pharmacy prescribing pilot

The Professional Services Review (PSR) has become the latest member of the medical community to criticise a proposed pharmacy prescribing trial in north Queensland.
 
The Commonwealth agency, which aims to protect patients and the community from ‘the risks associated with inappropriate practice’, raised compliance and regulatory concerns regarding the pilot program with the Department of Health (DoH) as early as February, according to its most recent quarterly update.
 
PSR Director Professor Julie Quinlivan reportedly noted that the proposed pharmacy prescribing pilot ‘appears to have no external independent regulatory or compliance oversight’ and is ‘inconsistent with Commonwealth legislation’.
 
Speaking with newsGP, Professor Quinlivan pointed out that there is currently no legislative basis to provide external regulatory oversight for pharmacists prescribing PBS medications, meaning there is no pathway by which inappropriate prescribing that causes patient harm can be reviewed.
 
She cited the overuse of antibiotics, which pharmacists would be able to prescribe under the pilot, as a potential source of patient harm that needs oversight, and also raised questions around the lack of record keeping that would be required under the scheme.
 
‘[The pilot] does not include a requirement that pharmacists implement a recognised system of medical record keeping so that consultation records are able to be retained for statutory periods and able to be independently reviewed by an external regulator to ensure that prescribing was appropriate,’ Professor Quinlivan said.
 
‘All other professions have a requirement that patient records must be kept that enable another practitioner to read the records and safely provide ongoing patient care.
 
‘If records are created in the trial, how will other practitioners involved in patient care access them? How will one pharmacist share records with another? How long will records be retained?
 
‘Who can access the records? Will record systems be able to be updated and will full patient histories be maintained including all previous medical history, medications, allergies and social situations? These are questions a regulator would ask.’
 
Professor Quinlivan also pointed out that practitioners who do currently prescribe under the Pharmaceutical Benefits Scheme (PBS) have independent external regulatory review through the compliance division within the DoH or the PSR to ensure patient safety is maintained.
 
‘All PBS prescriptions are recorded and prescribing patterns of concern can be identified and evaluated after review of medical records,’ she said.
 
‘This external regulatory oversight is missing in the pharmacy trial.’
 
Should the pilot proceed, it will allow pharmacists to prescribe a number of Schedule 4 (S4) medicines, which are currently only indicated to be prescribed under the guidance of a doctor.
 
For Professor Quinlivan, this is a major issue as it would mean the pilot is inconsistent with Commonwealth legislation, which identifies the clinicians that may prescribe medications and does not include pharmacists.
 
‘It is a concern because current Commonwealth legislation states who may prescribe PBS prescription medication and pharmacists are not listed as being able to do this,’ she said.
 
‘Further, the TGA [Therapeutic Goods Administration] carefully evaluates whether a medication is a prescription medication or an “over-the-counter” medication after careful literature review and consideration of patient safety and calls for submissions.
 
‘It is a concern that the TGA might perform such a comprehensive task, find that a medication should remain a prescription medication, and then a trial can ignore this finding.
 
‘For example, the TGA recently reviewed the contraceptive pill and after reviewing patient safety data concluded it should remain a prescription medication. Yet this trial plans to ignore the TGA conclusion and enable the contraceptive pill to be prescribed without prescription.’
 
RACGP Vice-President and Queensland Chair Dr Bruce Willett has also previously categorised the pilot as an ‘an obvious attempt’ by the Pharmacy Guild of Australia to circumvent existing legislation.
 
‘The S4s have been deemed by the regulatory authorities as not being appropriate to be pharmacy only, whereas this is shown to use alternative backdoor legislation to enable pharmacists to do it,’ he said.
 
‘It’s clearly putting patients at risk.’
 
Plans for the North Queensland Pharmacy Scope of Practice Trial, originally leaked to Australian Doctor, show it is slated to commence in June and run for 18 months as part of a deal signed by the Queensland Government, Pharmacy Guild and Pharmaceutical Society of Australia to allow pharmacists to practise at their ‘full scope’.
 
Aside from the PSR, the RACGP, AMA, Australian College of Rural and Remote Medicine, and National Council of Primary Care Doctors have called for it to be scrapped, while the DoH has also said the pilot is ‘not consistent with Commonwealth medicines policy’.
 
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