NEWS
Rebalancing medicines legislation and Regulation
Pharmacy bodies have welcomed a long-awaited formal consultation on decriminalising dispensing errors.
T
he four Departments of Health have launched a consultation, ‘Rebalancing Medicines
Legislation and Pharmacy Regulation’ into the proposals. It will run until 14 May 2015 and proposes to “redress ‘imbalances’ between legislation and regulation.”
It will “bring pharmacists and pharmacy technicians, who inadvertently make dispensing errors, more in line with the handling of errors made by other healthcare professionals,” says the DoH.
“By removing the fear of criminal prosecution, pharmacists, pharmacy technicians and pharmacy teams will be encouraged to report more dispensing errors, so the Health Service can learn from when things go wrong, and stop them happening again.
“In the unlikely event that a pharmacy professional deliberately sets out to harm patients, they would continue to face the full force of criminal law.”
The Department of Health in Scotland has been fully involved in the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board. They are also consulting on changes to the regulation of pharmacy premises. The views of all pharmacy professionals, patients, the public and stakeholders are critically important, they say in urging all local pharmacists to voice their opinions.
These changes are crucial to driving high quality patient care and improving patient safety, developing pharmacy practice and enabling innovation.
The proposals are UK-wide and have been developed by a multi-disciplinary Board with representatives from the 4 countries of the UK.
Campbell Shimmins, of Woodside Pharmacy, Doune, Perthshire, says the consultation does not go far enough. “Current legislation stems from the
10 - SCOTTISH PHARMACIST
intent to prevent pharmaceutical preparations for human use being altered in such a way as thy may cause harm.
Harm or death of a patient as a result of a dispensing error is a pharmacist's most awful nightmare. That an error, slip or lapse and subsequent prosecution could lead to the jailing of a pharmacist is counterintuitive where such an incident, though horrendous, had no such intent.
“I would say the focus of the legal framework should encourage reporting, learning from and prevention of such incidents. Not simply having the effect of seeking to blame a professional in the chain. This discourages openness and aforesaid learnings and prevention.
“The review and two suggested statutory instruments do little to foster this approach and don't go far enough. That the complexities of changing the act itself and the impact of the devolved powers in each home nation are cited as barriers, is, to my mind an unsatisfactory response to those working in our profession.
“While I welcomed the review the suggestions don't nearly go far enough not do they address the fundamental problems.”
Ash Soni of the Royal Pharmaceutical Society told us the threat of criminal prosecution for reporting dispensing errors “has weighed heavy on the profession for too long.
“The knock on effect has been a reduction in the potential reporting, sharing and learning from errors that will ultimately improve safety for patients and the public.” The proposals and programme outlined in the DoH announcement could “improve this situation substantially.”
It is anticipated that the proposals will take longer to put in place for hospital pharmacy compared to the community sector. However, Mr Soni added, “We
are confident that exactly the same provisions will be made for pharmacists working in hospitals, ending the automatic criminalisation of dispensing errors made by hospital pharmacists.”
To help pharmacists understand the changes proposed RPS Scotland have published a briefing for members that may help you respond to this consultation.
The document states that, ‘This consultation is also seeking changes to legislation which will remove the requirement for the GPhC to set standards for registered pharmacy premises in legislative rules. This allows more flexibility (as changes to the standards will not need legislative change) and enables the regulator to deal with any breaches in standards through regulatory processes rather than enforcement notices (which could
campbell shimmins
“The review and two suggested statutory instruments do little to foster this approach and don't go far enough. That the complexities of changing the act itself and the impact of the devolved powers in each home nation are cited as barriers, is, to my mind an unsatisfactory response to those working in our profession”
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