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Decriminalisation of dispensing errors finds legislative solution for 2014

By News team

A Government board set up to examine pharmacy legislation is proposing a secondary legislative instrument — known as a Section 60 Order — to create an exemption to the criminal offences for dispensing errors, The Journal has learnt.

However, the changes, which are not expected to come into force until the end of 2014, are likely to apply only to pharmacists and pharmacy technicians working in the community sector, because the board is still working on a solution for hospital pharmacists, senior Department of Health officials told The Journal.

Ken Jarrold, chairman of the rebalancing medicines and pharmacy regulation programme board, said exemptions from criminal sanction would apply if certain conditions were met (see Panel).

Jeannette Howe, head of pharmacy at the DoH, explained that the board is seeking to exempt registered pharmacists and registered pharmacy technicians from the criminal sanction when they make an “inadvertent error”. However, it would not be appropriate for that exemption to extend to when a pharmacist or pharmacy technician uses their professional skills for an improper purpose, deliberately, such that there is risk of harm to patients, she added. An example might be if a pharmacist or pharmacy technician deliberately switched tablets in the pack supplied, she explained.

Pharmacists would be subject to professional regulation

Pharmacists or pharmacy technicians making a dispensing error would be subject to professional regulation, and depending on the circumstances (if there were aggravating factors) could be subject to fitness-to-practise procedures, and, ultimately, be removed from the Register, she said. General criminal law would also continue to apply —for example, gross negligence manslaughter.

Asked whether the proposal might be seen as substituting a criminal sanction with the possibility of a pharmacist losing his or her livelihood, Ms Howe said: “Reporting of a complaint and possible removal from the Register is the current situation. What we are doing is removing the criminal sanction alongside that. Healthcare professionals must have accountability for their actions.”

Keith Ridge, chief pharmaceutical officer for England, said: “It is a privilege to be a professional and serve the public, so certain basic standards have to be met. If a healthcare professional makes a mistake, then [he or she] must be prepared to face the regulator. This would encourage reporting and right systems in place to minimise risk; it is part of the deal.”

Mr Jarrold added: “We are trying to create a safer service … and hope people will report errors. We can’t remove that proper process of the regulator.”

Asked whether 2014 was too long a timeline for the change to come into force, Ms Howe said that a number of steps need to occur first. The draft Order needs to be scrutinised, there will be a three-month consultation, and a report needs to be published, as well as the necessary debate in the two Parliamentary houses.

Mr Jarrold said: “There is a need to balance speed against the need for a thorough consultation with the profession. We need to explore this approach.”

The next stage involves putting forward the proposal to a partners forum, which comprises a cross section of pharmacy groups, patients and the public. “If the partners forum were unhappy, we would reconsider the approach. We would be pleased to debate it with the partners forum,” said Mr Jarrold. The board will consult on its proposals in due course.

The board has representatives from the Royal Pharmaceutical Society, the General Pharmaceutical Council, the Medicines and Healthcare products Regulatory Agency and the community and hospital pharmacy sectors. “That is why we are pleased after three meetings [of the board] they have agreed [to this Order]. There is also strong endorsement from the Berwick report,” added Mr Jarrold.

Berwick report: criminal sanctions should be rare

The Berwick report on patient safety, published earlier this month (PJ Online 7 August 2013), said that recourse to criminal sanctions should be extremely rare, and should function primarily as a deterrent to wilful or reckless neglect or mistreatment. The report said: “We considered very carefully the balance that must be achieved to support staff and organisations to learn from error and improve their practice with the need to assure accountability to the patient for egregious acts or omissions that cause death or serious harm. These two approaches are not mutually exclusive but unintended errors must be handled very differently from severe misconduct.

Proposed conditions for the exemption

Under the proposal, pharmacists and pharmacy technicians would be exempt from the criminal offence for dispensing errors — it would apply to section 64 (the supply of a medicine not of the quality or nature demanded) and section 63 (adulteration of medicines) of the Medicines Act 1968 — provided certain conditions are met. Those conditions might include that:

  • The medicine was sold or supplied by a registered pharmacist or registered pharmacy technician;

  • The sale or supply was in pursuance of a prescription; and

  • The registered pharmacist or registered pharmacy technician was acting in the course of their profession. 

Source: Department of Health

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11124633

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