The Department of Health and Social Care (DHSC) has conceded that changes to supervision legislation could pose a potential risk to patient safety.

But it said that the regulation of pharmacy technicians, a proposed transition period for the legislation to come into effect, and professional guidance were intended to mitigate this risk.

The DHSC’s impact assessment on proposed supervision changes also revealed alternative options that were considered by ministers, with the final wording of the consultation intended to be ‘enabling’ and many of the details of the changes to be left up to the profession.

The document was published alongside the department’s public consultation on proposals to change supervision legislation to:

  • enable pharmacists to authorise pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, sale and supply of medicines,
  • and to enable pharmacists to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist.

Detail for professional leadership bodies and regulators to decide

One option considered by the DHSC was to set out in legislation which members of the pharmacy team could carry out certain parts of the dispensing process.

But the eventual proposed legislation ‘leaves it to a pharmacist to decide on who is the most suitable person(s) to undertake the different stages of the preparation, assembly, dispensing, sale and supply of medicines’.

And while the sector broadly wished the ability to authorise delegation to be limited to the Responsible Pharmacist (RP), the proposed changes leave this potential limitation to be set out by professional leadership bodies and regulators, rather than legislation.

Documents published yesterday also revealed that the DHSC believes that the changes may impact patient safety and ‘could increase the number of errors made’.

However, because the proposed approach ‘maintains that there must be a pharmacist responsible for every pharmacy premises and a registered pharmacy professional responsible for the dispensing of medicines’, the DHSC considered the risk of increased errors to be ‘extremely low’, the impact assessment stated.

It added that the DHSC ‘considered and discounted the option of changing legislation to state that preparation, assembly, dispensing, sale and supply could be conducted by a pharmacist or pharmacy technician, or under the supervision of a pharmacist or pharmacy technician’.

It explained: ‘Pharmacist training is five years at Master's level (national level seven) and pharmacy technician training is two years part-time, interspersed with work, at national level three. This means that pharmacy technicians can work autonomously but with reference to a pharmacist where necessary – our proposals reflect this.’

Instead, the proposals ‘will enable a pharmacist to authorise a registered pharmacy technician to either carry out tasks relating to the preparation, assembly, dispensing and sale or supply of medicines; or with the authorisation of the pharmacist, to supervise others to carrying out these tasks’.

It added: ‘Limiting these forms of “authorisation” to pharmacy technicians is a patient safety measure designed to ensure that the legislation starts from the premise that a registered pharmacy professional, who is accountable for their practice to the regulator, is going to be doing or supervising the preparation, assembly, dispensing and sale and supply of medicine.’

The documents also stress that the proposals are not a move to remote supervision.

‘Enabling pharmacists to remotely supervise multiple retail pharmacy businesses was never considered an option,’ the impact assessment said.

‘Important to make best use of skills mix’

Commenting on the proposals, Gordon Hockey, director of legal at Community Pharmacy England (CPE), said that the negotiator welcomed the public consultation.

‘As the clinical skills of community pharmacists are put to greater use through services such as Pharmacy First, it is important to ensure that pharmacies can make best use of skill mix across the whole team,’ he said, adding that CPE would consider the proposals and respond to the consultation.

And Nick Kaye, chair of the National Pharmacy Association (NPA), said: ‘Modernisation of the regulations is well overdue, for example the ability to delegate to any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist.’

He added that the NPA would ‘examine the consultation document thoroughly, to check for any unintended consequences that could reduce access to pharmacists’.

‘Any changes to legislation or regulations should maintain or improve, not diminish, the public’s access to a pharmacist in a community pharmacy,’ added Mr Kaye.

‘As pharmacies deliver more and more clinical services, it becomes ever more important to have the clinical skills of the pharmacist readily available.’