The Government has laid out plans to ‘modernise’ pharmacy supervision rules, after the proposed changes to aseptic services divided opinion.
Proposed amendments to the Medicines Act 1968 and The Human Medicines Regulations 2012 are intended to free up pharmacist time by allowing registered pharmacy technicians to take on more responsibility in different pharmacy settings.
The changes, developed following consultation with pharmacy professionals and stakeholders in 2023, are expected to come into effect by the end of 2025, with a one-year transition period for the bulk of the measures to allow for the development of professional standards and guidance.
The Government said the full draft legislation would be published shortly, but the legislation will enable:
- Trained team members to hand out checked and bagged prescriptions, bringing legislation in line with current practices such as home delivery and lock box services
- Pharmacists to authorise registered pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, sale and supply of medicines
- Pharmacy technicians to supervise the preparation, assembly and dispensing of medicines in hospital aseptic facilities.
Pharmacy minister Stephen Kinnock said the changes will allow pharmacists to ‘spend more time providing clinical care, while qualified pharmacy technicians can take greater responsibility for routine tasks’.
He added: ‘This will improve patient experience and help avoid delays in accessing medicines when the pharmacist is not available.
‘These are simple, common-sense changes that will help pharmacies run better, saving staff and patient time.’
Supervision in hospital aseptic facilities
The third proposal outlined in the legislation will enable suitably qualified and experienced pharmacy technicians to be responsible for a hospital aseptic facility without having to act under the supervision or authorisation of a pharmacist.
The aim of this would be to maximise the productivity of these aseptic facilities, bringing health benefits to patients.
The four UK chief pharmaceutical officers said this was the proposal that ‘split views’ most in the consultation responses, adding that this was largely ’among stakeholders working in aseptic services’.
They said: ‘The main point referenced by those who supported this proposal was that there are some suitably qualified and experienced pharmacy technicians ideally positioned for these roles who should not be blocked by law from supervising these facilities.’
Alleviating workforce pressures facing hospital aseptic services, opportunities for development of the pharmacy technician profession and benefits for the ‘often seriously ill patients who rely on these services’, were also cited.
Concerns included whether pharmacy technicians have appropriate training, who would have accountability if something goes wrong, and confusion over how the changes to supervision would be implemented in practice.
However, the CPhOs highlighted that constructive engagement with stakeholders has taken place since the consultation closed, which has resulted in this proposal being included in the draft legislation.
The CPhOs added: ‘Our understanding is that these groups support the overall objectives of the proposed legislative changes, and we will progress further work to ensure the legislative changes are supported by appropriate regulatory standards, education and training and professional guidance to secure their safe implementation.’
They also reiterated that the proposed legislative changes are enabling, but do not mandate changes to practice, and individuals’ professional responsibility to work within their competence regardless of permissions given in legislation remains.
New supervision regulatory standards in development
The General Pharmaceutical Council (GPhC) has announced it will develop and introduce new regulatory standards for superintendent pharmacists and responsible pharmacists, and rules for responsible pharmacists, to support the implementation of the new legislation on supervision.
A public consultation will be held by the GPhC on its proposed new standards and rules, once the final legislation comes into effect later this year.
Duncan Rudkin, GPhC chief executive, said: ‘These reforms will maximise the use of the skills of pharmacists and pharmacy technicians, and make sure all members of the pharmacy team are empowered to contribute fully to patient care.’
He added: ‘We are committed to making sure that the changes are implemented responsibly and are done in a way that protects patient safety. We will also make sure that the changes are proportionate, so any burdens for businesses and their employees introduced by the new rules and standards are the minimum necessary to secure the benefits expected to result from them.’
‘A more collaborative, team-based approach to pharmacy’
Professor Claire Anderson, Royal Pharmaceutical Society (RPS) president, welcomed the ‘overall direction of travel’ set out in the draft supervision legislation and said it reflected ‘a more collaborative, team-based approach to pharmacy that will help pharmacists focus on patient-facing clinical care while ensuring safety remains paramount’.
The RPS said it will be collaborating with the DHSC, GPhC, Association of Pharmacy Technicians, Pharmaceutical Society NI and Pharmacy Forum of Northern Ireland in the move towards implementation.
This involves the development of guidance to support the implementation of the GPhC’s new standards and rules on supervision for the pharmacy professions and pharmacy teams on handing out pre-checked medicine bags, along with safe and effective models of authorisation of pharmacy technicians.
The RPS has also announced work with the NHS Quality Assurance committee, Association of Pharmacy Technicians UK (APTUK) and regulators of aseptic services to update its 2016 standards for the quality assurance of aseptic preparation services, to be ready by the end of 2026.
‘We will continue to work with the regulator and partners across the pharmacy professions to shape a future where all members of the pharmacy team are empowered to contribute fully to patient care,’ Professor Anderson added.
The RPS had urged legislators to act on supervision ‘as soon as possible’ after submitting its response to the Government consultation before the last election.
Supervision to ‘unlock’ full pharmacy workforce potential
APTUK vice-president Amy Laflin said: ‘We are delighted by the outcome of the supervision consultation, this is a positive step forward for the pharmacy technician profession in modernising pharmacy practices to demonstrate and recognise the pivotal and essential role of pharmacy technicians. The legislation will unlock the full potential of the pharmacy workforce and enhance accessibility, safety and efficiency for the supply of medicines for patients across all settings.
‘We look forward to working with our colleagues to support successful implementation and development of robust guidance that reflects the evolving role of pharmacy technicians in the UK.’
An impact assessment carried out by DHSC in 2023 predicted the supervision changes could free up time for between 29% and 40% of pharmacists.
