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

Matt Woodley

22/04/2022 5:02:18 PM

A lack of independent oversight and the bypassing of Commonwealth legislation have been highlighted as threats to patient safety.

Pharmacist offering customer 2 types of medication
A lack of regulatory oversight is an ongoing concern related to a proposed pharmacy prescribing pilot in north Queensland.

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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Dr Stewart James Jackson   23/04/2022 7:49:00 AM

It is no good whinging if pharmacists take over some of our roles when we aren’t there to treat patients. I am in despair where future workforce is coming from despite massive increase in graduates. We have ourselves to blame!

Dr Shamim Siddiqui   23/04/2022 9:27:20 AM

Patients take more than 20min tome for long appointments, it is not exactly 20 mins, especially those who are new eith multiple issues and complicated history

Dr Ayanthi Sonali Rodrigo Goonewardene   23/04/2022 9:27:33 AM

Can a comprehensive patient history be taken in a busy pharmacy? Without record keeping/ compliance system … it’s impossible to know any potential drug interactions or adverse events!!

Inappropriate prescribing & antibiotic overuse would be the norm!!! A patient won’t understand why their GP won’t prescribe an antibiotic for a common cold but a pharmacist would happily dispense!! … A tragic breakdown in patient care!!!

Dr Ayanthi Sonali Rodrigo Goonewardene   23/04/2022 9:38:26 AM

Ie: if a patient complaints of UTI symptoms, would a urine sample be sent off to pathology for MCS prior to prescribing antibiotics? Would there be a recall system if MCS shows resistance to the dispensed antibiotics?? Or would they just give the medication & ask the patient to follow up with GP ? … at which point sending off a sample for MCS would delay appropriate treatment! … Fragmentation of care risks patient safety!!

Dr Anjum Ahmed Shaikh   23/04/2022 10:17:13 AM

I am concerned about development of antibiotic resistance and multi drug resistant uti. Antibiotic resistance is one of the leading cause of death worldwide.

Dr Abdul Ahad Khan   23/04/2022 1:04:39 PM

To be competent enough to make a CLINICAL DIAGNOSIS, you need a Basic MBBS Degree + Hospital Internships / GP Registrar Training. Only after all of these are obtained, dies our RACGP / ACRRM feel that you are SAFE to let loose in the Community.

Dr Robert Paul Brown   23/04/2022 10:26:36 PM

As a GP , I'm appaled that other medical practitioners are blind sided by the Queensland Government and the Pharmacy Guild.
GPs are not lax in reviewing and treating their patients. Gps are quite rightly regulated, and they pay for the privilege, as well as keep medical records, maintain their registration and professionalism, liaise with other medical specialists, with hospitals and with local pharmasists, and work long hours to correctly and legally to service their patients.
Shame on the Queensland government and the Pharmacy guild for trying to belittle General Practice, and put our patients at risk with this so called "trial".

Dr Abdul Ahad Khan   24/04/2022 10:42:07 PM

To be able to PRESCRIBE, you need to be a Clinical Diagnostician
To be a Clinical Diagnostician, you need a MBBS Degree.
Our College of GPs feels that a MBBS degree is not sufficient.
You need to then do Hospital Internships.
Even then our College of GPs feels, you need to then do a GP Registrar Training.
It is only when you have done all of the above, our College of GPs feels that you are SAFE to let loose on the Community UNSUPEREVISED.
There is a Saying : ' Half a Physician is a DANGER to the Community. '
Our Innocent Populace deserves the Best of Primary Care .

Dr Angelo Joseph Mazzaferro   25/04/2022 11:06:32 PM

Why bother teaching medical students and new graduates in Queensland of the importance of taking and documenting a good medical history, medication history and allergy history before prescribing a medication. This is on the same level as Dr. Google Medicine. The danger of Antibiotic inappropriate overprescribing and the development of antibiotic resistance is no longer important or considered in Queensland? I think not!