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Supervision proposals may pose patient safety risk, says DHSC

The UK‘s Department of Health and Social Care (DHSC) has conceded that there is a potential risk to patient safety with its proposed changes to supervision legislation, which are currently under public consultation.

But it said that a proposed transition period for the legislation to come into effect and the development of professional guidance were intended to mitigate any increased risk of errors.

In addition, the fact that pharmacy technicians are a registered and regulated profession means that they also hold accountability for maintaining patient safety.

As 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 DHSC’s impact assessment on proposed supervision changes was published alongside its 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
  • enable pharmacists to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist
  • allow pharmacy technicians to take primary responsibility for the preparation, assembly and dispensing of medicinal products in hospital aseptic facilities.

The impact assessment highlighted that while legislative change around supervision was deemed essential, many of the details of the changes are to be considered and written into guidance by the profession.

This will ensure ’good governance supports the implementation of this legislation in practice’, the DHSC said.

It also revealed a number of alternative options that were considered by ministers, with the final wording of the consultation intended to be ‘enabling’ while retaining necessary patient safety measures.

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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’.

The DHSC also considered 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.

This option was discounted due to the difference in training levels between the two professions – national level seven for pharmacists and national level three for pharmacy technicians.

’The exception to this is aseptic facilities, where the extensive post-registration training carried out by parts of the pharmacy technician workforce makes them equally as qualified as some pharmacists to supervise these facilities,’ the document said.

Aside from aseptics, the supervision 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.’

A version of this article was originally published by our sister publication The Pharmacist.






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