‘Untold distress to patients.’

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Independent pharmacist prescribers based in UK general practices have been linked to a number of serious incidents and cases where patient deaths have been reported

Inappropriate prescribing or poor advice given by general practice-based pharmacists has been associated with serious incidents including cases where patient deaths have been reported, the Pharmacists’ Defence Association (PDA) in the UK has reported this week.

PDA has raised concerns in a member alert after noticing a number of incidents of unsafe practice emerging as the number of independent prescribers working in GP practices has risen.

“We have seen a number of serious incidents recently and are currently in the early stages of dealing with cases where patient deaths have been reported,” says the PDA in its alert.

“We raise as a root cause, the issue of competency once more – serious harm to patients causes untold distress to patients, their families and to the pharmacists involved.

“Some of these recent cases are linked in some way to pharmacists prescribing inappropriately or offering poor advice, often underpinned by an assumption of competence which was ill-founded.

“We cannot impress upon members strongly enough the importance of seriously considering their levels of experience and skill at all times BEFORE making a clinical decision and issuing a prescription.”

The PDA warns pharmacists that should use significant levels of caution if they are about to prescribe a medicine for the first time, “even if you have routinely supplied that medicine previously in a community pharmacy setting – the two settings or activities should not be conflated, or experience in one assumed to automatically confer expertise in the other”.

It describes the following high-risk scenarios:

  • Undertaking prescribing or providing clinical advice for patients who are not physically present.
  • Undertaking prescribing for patients without reference to their clinical records.
  • Undertaking prescribing for walk-in patients where a diagnosis may be required.
  • Prescribing alternative medicines due to shortages (particularly where the medicine to be replaced is a member of a high-risk group such as opiates and/or you are unfamiliar with the use of your chosen replacement). PDA suggests checking with a GP or a colleague with relevant specialist experience and ensuring any online or print reference sources that are relied upon are both appropriate for the scenario in which you are prescribing and that pharmacists keep a note of those they relied upon.

“In the event of a critical incident, any subsequent investigation (for example a coroner’s inquest, police or regulatory investigation) will not only examine the conduct of the pharmacist to establish if it caused harm, but also whether the pharmacist was acting within or outside of their competence,” says PDA.

It adds that pharmacists will be judged on whether they have properly assessed their competence prior to engaging in a particular prescribing episode or clinical service, “therefore not working as a maverick in a professional vacuum but as a considered professional”.

Three models of pharmacist prescribing were recently considered by the Pharmacy Board of Australia: prescribing via a structured prescribing arrangement; prescribing under supervision; and autonomous (or independent) prescribing.

In its position statement, the Pharmacy Board concluded that under the National Law, there are no regulatory barriers in place for pharmacists to prescribe via a structured prescribing arrangement or under supervision within a collaborative healthcare environment.

It said successful implementation of these pathways would require an appropriate clinical governance framework to ensure patient safety.

However the Board’s view is that autonomous prescribing by pharmacists would require additional regulation via an endorsement for scheduled medicines.

“An application could only occur after completion of preparatory work to develop a case proposing the need for an endorsement … The Board is not making an application for approval of endorsement for scheduled medicines at this time,” it said.

Online pharmacies under scrutiny

There has also been a “significant proliferation” of online pharmacies offering a choice of prescription-only medicines (POMs) for sale, says PDA.

It warns about risks associated with prescribing under these circumstances since the prescriber cannot see the patient or examine them directly, and usually do not have access to the patient’s clinical notes.

“In some cases we are aware that employers in online pharmacies may place expectations upon their pharmacist employees to prescribe high-risk POMs, such as controlled drugs or medicines for conditions that require regular monitoring, without any communication with the patient’s GP, either to check that a medicine has been prescribed before or to advise the GP of the supply made,” says PDA.

“We would regard this as unsafe and unacceptable practice.”

PDA says targeted inspections of online pharmacies are underway with enforcement action being taken against those businesses which do not meet the standards.

It warns that online pharmacy practice is “manifestly much more risk-laden for the pharmacist because of the extraordinarily high risks of patient harm due to the lack of proximity situation and also because of the business models that are sometimes operated”.

“Consequently, the regulators are taking extraordinary measures by way of a proactive additional inspection regime even though nothing wrong may even have yet occurred.

“During this process, the clinical competence of pharmacists associated with those pharmacies is also placed under scrutiny,” says PDA.

“A number of prescribing pharmacists are now on their way to Fitness to Practise hearings as a result of these inspections.”

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