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Enforcing duty of candour would discourage ‘culture of openness’

A requirement to report all errors would contravene privilege against self-incrimination as set out in the European Convention on Human Rights, RPS English Pharmacy Board member Ash Soni has argued

Government plans to enforce a duty of candour among health professionals could have the opposite effect unless dispensing errors are decriminalised, pharmacy bodies have warned.

The planned regulations, which would require health professionals to report all errors and apologise to patients, would discourage a "culture of openness" if they came into force, Pharmacy Voice said yesterday (April 29) in its response to a Department of Health consultation.

The regulations would breach pharmacists' human rights by forcing them to risk prosecution by admitting to dispensing errors, which are still a criminal offence, the Royal Pharmaceutical Society (RPS) said In its response to the consultation, which ran between March and April.

Until dispensing errors are decriminalised it would be "inappropriate" for pharmacists to follow these standards, says RPS English Pharmacy Board member Ash Soni

More on decriminalisation

Decriminalisation consultation delayed

Government to consult public on decriminalisation

Berwick review highlights anomaly of dispensing error law

Although the new regulations would only affect organisations registered with the Care Quality Commission, which does not include the General Pharmaceutical Council (GPhC), RPS English Pharmacy Board vice-chair Ash Soni said the GPhC would be "obliged" to establish similar standards if the regulations became part of the NHS Constitution.

It would be "inappropriate" for pharmacists to follow these standards until dispensing errors were decriminalised, Mr Soni told C+D.

By forcing pharmacists to report all breaches of the Medicines Act, the regulations contravene the right to silence and privilege against self-incrimination as set out in the European Convention on Human Rights, the RPS said.

"The offences identified under [the Medicines Act] are absolute offences and therefore any admission by a professional under a duty of candour could be considered an admission of guilt," it said.

Mr Soni said the RPS would continue to push for the decriminalisation of dispensing errors and expected changes to the law "within the year".

Pharmacy Voice agreed the regulations would expose clinicians to an "increased risk of litigious action" unless dispensing errors were decriminalised.

The rules would dissuade pharmacists from "actively reporting incidents" and could also put a financial strain on contractors, it said.

"The costs associated with training and supporting staff to deliver the duty of candour, as well as the requirement for specific leads within organisations, will be a challenge for many," it added.

The GPhC told C+D that it continues to review its regulatory standards, ensuring that concerns about pharmacy services can be "raised without fear".

In March, C+D learned that a public consultation on the decriminalisation of dispensing errors had been delayed, although a board set up to oversee changes to medicines legislation still hoped the law would be changed by the end of the year.

Are you confident that the decriminalisation of dispensing errors will be achieved within this parliament?
We want to hear your views, but please express them in the spirit of a constructive, professional debate. For more information about what this means, please click here to see our community principles and information

Khaled Miah, Other healthcare profession

What ingredients does adult movicol contain and what potential harm can it do to a child of 10.5 years old? I sent email reports of OxyContin and advagraf error (dated 2011) to PCT, during my time in Boots. If I wanted to hide the movicol error then I would have just not told any of the staff around me in 2011 about my error and would have quietly gone to patient's house to collect incorrect movicol. I named individuals I told during my hearing.

I'm only reinforcing what I said to GPhC already. I hope my case are amongst those that PSA audit in future.

Yesterday's headline is today's policy with this Govt. I'm happy to have enforced candour just as soon as politicians are also obliged to behave in the same way. If Messrs Lansley and Hunt were duty bound to confess how they've screwed up healthcare in this country it would be a good start!

M Yang, Community pharmacist

Once again, this country's government has conveniently forgotten that EU human rights legislation exists.

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