The government has been urged to bring forward legislative change on pharmacy supervision ‘as soon as possible’ as a general election looms.

This comes as both the Royal Pharmaceutical Society (RPS) and the Pharmacists’ Defence Association (PDA) announced yesterday that they have submitted their responses to the supervision consultation.

The consultation launched in December and will close next week on Thursday 29 February.

RPS president Professor Claire Anderson described the consultation as ‘a welcome step towards supporting the clinical role of pharmacists and making the most of the skills within pharmacy teams to support patient care’.

She added: ‘With the forthcoming general election, I would urge the government to reflect on the consultation responses and bring forward legislative change as soon as possible.’

RPS ‘supports legislative change’ but says ‘clarification’ needed

Professor Anderson said that the RPS’ visions across England, Scotland and Wales ‘highlight the upskilling of all members of the pharmacy team as a key way to release the capacity for pharmacists to utilise their clinical and prescribing skills’.

But she said that proposals must ‘balance supporting access to medicines with patient safety’.

While the RPS welcomed moves to enable pharmacy teams to hand out pre-checked and bagged medicines to patients in the absence of a pharmacist when safe and authorised by a pharmacist to do so, it has said that the concept of ‘authorisation’ needs to be clarified. This included: documentation, accountability, the role of superintendent pharmacist and responsible pharmacist, and ensuring pharmacists are uninhibited from exercising their professional judgment.

In its response, the RPS has said that ‘consistent patient access to pharmacist expertise’ must be maintained.

‘Patient groups continue to tell us about the importance of consistent access to pharmacy services and it is vital that changes to legislation do not set us down a road that begins to undermine this principle,’ Professor Anderson commented.

‘Implementation must ensure that patients can continue to engage with pharmacists and receive advice and support when they need it.’

And she added that pharmacists and pharmacy teams ‘will require support’ in addition to legislative change.

In particular, the RPS has called for:

  • Consideration of workforce planning and investment
  • Investment in making the public aware of proposed changes
  • Protected time to support professional development and implementation of supervision changes

PDA: Issues around ‘authorisation’

The PDA has described the supervision consultation as ‘one of the most important government consultations for pharmacists in decades’, urging its members to have their say.

Outlining its response, the PDA said that it ‘wants pharmacists to practice with professional fulfilment and job satisfaction’ and wants ‘the most appropriate respective responsibilities for pharmacists and pharmacy technicians to be defined in law’.

‘This should ultimately result in pharmacists being held responsible and accountable for medicines related issues, such as clinical assessments (the clinical check) and clinical patient interactions, and pharmacy technicians being held responsible and accountable for the technical and assembly elements of pharmacy practice – i.e. the accuracy of dispensing,’ the association added.

The PDA disagreed with several points proposed by the Department of Health and Social Care (DHSC) around the concept of ‘authorisation’.

The consultation proposed that the delivery and supervision of tasks relating to the preparation, assembly, dispensing and sale or supply of medicines could be delegated via ‘authorisation’ to a registered pharmacy technician.

DHSC set out what it says is intended to be an ‘enabling’ and ‘broad framework’ for ‘authorisation’, stating that it could be:

  • Given in either specific or general terms;
  • Given orally or in writing;
  • Subject to conditions or restrictions;
  • And varied or withdrawn by the pharmacist by whom it is given.

But the PDA said:

  • ‘There must be no advanced authorisations – authorisation can only be given during a signed in presence of an RP’;
  • Authorisations should not be given remotely;
  • Authorisations should not be simply given orally; ‘they must be fully documented to enable a clear audit trail.’

It added that authorisations ‘must not be the subject of an overriding Standard Operating Procedure (SOP)’ and ‘cannot be irrevocable’.

And it outlined conditions for authorisation that it considers to be essential, such as the decision to authorise being a ‘two-way conversation’ that is ‘agreed and not imposed’ between the pharmacist and pharmacy technician.

The DHSC proposal suggests that ‘authorisation will enable a pharmacist to delegate the dispensing process (barring any clinical check required by professional standards or guidance) to a pharmacy technician’, adding: ‘Extant professional guidance will continue to require some activities to be carried out by a pharmacist (for example, the clinical check).’

And the PDA said in its response: ‘The clinical assessments of a prescription cannot be undertaken remotely or by anyone other than a pharmacist present in the pharmacy.’

It added: ‘The physical presence of the pharmacist in a community pharmacy is the bedrock of community pharmacy practice. This must be explicitly stated in legislation and not merely be inferred as is currently the case.’

The PDA also expressed disappointment that a recommendation around out of hours preparation and assembly made by the cross-sector Supervision Practice Group was not adopted in the DHSC proposals.

The Supervision Practice Group agreed by consensus to recommend that the accuracy of the items assembled when the pharmacy is closed with no responsible pharmacist signed in would fall under the accountability of the superintendent pharmacist.

And the responsible pharmacist would then ‘undertake and be held accountable for the clinical assessment prior to handing any medicines out to patients’.

Considering the ‘critical’ ongoing impact of workload on pharmacists, the PDA said that it was ‘disappointing’ that this recommendation, which was designed to try and alleviate workload, was not included within the DHSC consultation.

The PDA also said that DHSC proposals ‘will not be enough’ on their own, adding that the rules and standards produced by the appropriate regulators must be ‘relevant and supportive’ of the pharmacist profession.