‘It is vital that we change the criminal aspect of the case against pharmacy. the recent Pharmacy forum nI set of professional standards for community pharmacists is indeed evidence of our willingness to embrace the issues surrounding public safety and our working methods. Community pharmacists have always reviewed their working practices, but we need to be able to do so without the threat of criminal proceedings.’

In raising this issue, Cliff McElhinney was reiterating what pharmacy leaders and professionals have been saying for years, ie, that there should be decriminalisation of pharmacists for single dispensing errors: a point that was also raised by the Pharmacy forum nI, which also highlighted the fact that, behind this issue, lies a human tragedy.

‘the Pharmacy forum (PfnI) conveys deepest sympathies to the family of Mrs Ethna Walsh who died as a result of taking propranolol tablets, dispensed in error against a prescription for prednisolone in 2014,’ the PfnI said in a statement. ‘the Board of the Pharmacy forum nI expresses its disappointment at the criminal prosecution of northern Ireland pharmacist Martin White following a dispensing error which tragically resulted in the death of a patient.

Had a gP, dentist, social worker or community nurse made a mistake with similar consequences – as with this case – they would not have been held criminally liable unless it could be proved they were guilty of gross negligence manslaughter.

'for a pharmacist a dispensing error is an absolute offence and he or she automatically becomes a criminal.'

‘Martin White is not a criminal. He made a terrible error for which he will pay a high price professionally and personally.

‘the simple fact is that it is time the law was changed. Pharmacists work under intense pressure and a culture of reporting errors and near misses needs to be integral in our practice to improve good practice. this needs to be done without the very real threat of criminal proceedings against us when, inadvertently, the process fails.

‘However, the Pharmacy forum Board believes this prosecution is a blow to the profession; in as much as it out of step with the very positive changes, which are being made to promote a safe learning culture in relation to dispensing errors. the forum believes that these changes are in the interest of the public and the profession.

‘Currently, medicines legislation is such that pharmacists are at risk of being criminally prosecuted for single dispensing errors, as in the case of Mr White. However, there has long been an appetite to address this and review current legislation to align sanctions and penalties for errors made by pharmacists with other healthcare professionals.

‘Since 2013 the Pharmacy forum has participated in the Department of Health (DH’s) Board for Rebalancing Medicines legislation and Pharmacy Regulation; set up to assure patient and public safety whilst also removing barriers to the development of pharmacy practice.’

HoW DoES tHE goVERnMEnt PlAn to CHAngE tHE lAW? A pharmacy professional or unregistered member of staff should have a defence against a criminal sanction for an inadvertent dispensing error if they meet ‘strict conditions’. these include showing they had acted ‘in the course of [their] profession’, had made a supply on the back of a prescription or patient group directive, and ‘promptly’ informed the patient about the error once discovered.

Criminal sanctions should only apply if there is proof ‘beyond reasonable doubt’ that the pharmacist either misused their professional skills ‘for an improper purpose’ or showed ‘a deliberate disregard for patient safety’. failing to follow the pharmacy's procedures would not constitute grounds for criminal proceedings on its own. Source: DH consultation, February 2015

the PfnI was, however, quick to highlight the sense of anxiety and fear that exists among the province’s community pharmacists.

‘As pharmacists, the Board of the forum understands the fear amongst the profession of making dispensing errors and causing inadvertent harm to patients or members of the public as a result of human error. the forum also acknowledges the negative impact that this fear can have on the reporting of errors and near misses to learn from mistakes.

‘the forum’s sadness at this particular case is three-fold: sadness for the bereaved family, sadness for our pharmacist colleague who has faced great personal turmoil, and sadness that, in light of the recent consultation on decriminalising dispensing errors and the ongoing work to change medicines legislation in the near future, this prosecution has occurred.

‘Changes to the law have been delayed thus far by factors outside the control of the Rebalancing Programme Board which is typical of endeavours to change legislation. However, the Pharmacy forum Board remains fully committed to supporting DH’s programme of change to medicines legislation and pharmacy regulation. the forum believes it is of utmost importance for

the entire profession and for the public that these changes are made.’

REBAlAnCIng MEDICInES lEgISlAtIon AnD PHARMACY REgUlAtIon the DH’s work in Rebalancing Medicines legislation and Pharmacy Regulation to which PfnI refers is based on a consultation document, which was published in february 2015. the consultation focused on decriminalising dispensing errors by providing pharmacists with a defence against criminal sanctions for dispensing errors made ‘inadvertently’. As a result, the DH – through the Rebalancing Programme Board - sought views on a series of proposals in two draft orders:

• the Pharmacy (Preparation and Dispensing Errors) order

• the Pharmacy (Premises Standards, Information obligations, etc.) order

While the Rebalancing Programme Board, under the auspices of Ken Jarrold, DID publish a report detailing the responses to the consultation in february last year, it also stated that a ‘separate report’ would be published on the responses to the consultation questions on the Pharmacy (Preparation and Dispensing Errors) order 2016, but gave no indication of when this would happen. to date, it has not been forthcoming.


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