The changes to supervision in community pharmacy are now a significant step closer - they have been approved by the UK Parliament with a final debate in the House of Lords on 21 October.
The draft order is thin on detail but the comments in the debates give important insight into the possible shape of future guidance.
Supervision of supply of medicines by a pharmacist has been around for a long time. The concept of pharmacist supervision was first mentioned before the NHS was created, in 1933.
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The Pharmacy and Poisons Act 1933 made it unlawful to sell any poison unless on registered premises by or under the supervision of a pharmacist.
The case law ebbed and flowed from that point in relation to the degree of supervision that was required to be exercised. A key case in the 1990s (Summers v Congreve Horner [1992] 7WLUK 105) said “[supervision] cannot mean watching somebody for every moment of the day while he is doing his work… Supervision is a matter of degree”
The High Court said in 2016 (Abdul-Razzak v General Pharmaceutical Council [2016] EWHC1204 (admin) on supervision, that “The responsible pharmacist must be present in the pharmacy to supervise the sale or supply of prescription only medicines…” although this case seems to elide the concept of supervision with the duties of the responsible pharmacist.
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Nowhere in the legislation is a clear definition of what is being supervised; there is no legal definition of the process of dispensing.
In introducing the debate in the House of Commons the Minister for Care, Stephen Kinnock, said “Case law has led to restrictive practice and different interpretations of the law.”
So what are the changes that affect community pharmacy ?
The draft order implementing the changes was published in July with the government’s response to the consultation on supervision in community pharmacy. The draft order makes two core changes to community pharmacy supervision:
i. enabling pharmacists to authorise registered pharmacy technicians to carry out, or supervise others carrying out, the preparation, assembly, dispensing, and sale and supply of medicines;
ii. enabling pharmacists to authorise any member of the pharmacy team to hand out checked and bagged prescriptions in the absence of a pharmacist – avoiding repeat visits from patients when a pharmacist is not there;
There is also a third provision which will allow a hospital pharmacy technician to take primary responsibility for the preparation, assembly and dispensing of medicinal products in hospital aseptic facilities but discussion of this is outside the scope of this article.
Parliament
When the draft order was debated, both Houses of Parliament were concerned about how a pharmacist would give authorisation to a member of staff. The draft legislation says that the authorisation can be oral but a written record should be made. A commentator in the House of Commons asked about regulatory safeguards for “supervision” and “authorisation”?
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The House of Lords also echoed the concern about authorisation especially if oral, and questioned how proper record keeping and accountability would be ensured. The response highlighted three things:
· That regulators and professional leadership bodies will support the implementation of the changes with guidance.
· That the guidance will include professional expectations for record-keeping requirements when an authorisation is given.
· That the guidance will also cover staff training which should make it clear that all staff need to follow standard operating procedures for when the authorisation is given, when they should consult the pharmacist and when a supply should not go ahead.
A key difficulty is that the draft order is not detailed; an example is that there is mention of a clinical check in the government response as part of dispensing but in law, there is no requirement for a clinical check and the proposed regulations also make no provision for this.
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The lack of specificity about a clinical check was raised in the Lords and the government response was that professional guidance will set out what the pharmacist’s role is to be — including when and how there will be a need for a clinical check.
Concerns were raised about the risk of a single pharmacist, for example, one working centrally across a chain of stores, writing an authorisation (or even many authorisations) for large groups of pharmacy technicians, implying indirect supervision en masse.
There was also a query about the level of qualification of pharmacy technicians. Although not directly addressed, the introduction of the legislation to the Lords included an emphasis on patient safety when giving an authorisation and it was said that in practice a pharmacist should authorise only staff who are trained, competent and confident to undertake a task.
Next steps
The motion was approved in both Houses of Parliament and it can now become law. The provisions will not apply in Northern Ireland until there is a registered profession of “pharmacy technician”.
The measures allowing checked and bagged items to be handed out in the absence of the pharmacist will enter into force 28 days after the legislation is made.
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No specific date has been given for the measures enabling pharmacists to authorise registered pharmacy technicians to carry out and/or supervise others carrying out, the preparation, assembly, dispensing, and sale and supply of medicines.
The target date is one year after the legislation is made to allow time for professional regulations, standards and guidance to be implemented.
No doubt regulators will have taken note of the concerns of Parliament about what is needed to implement the changes safely into practice so the debates are a useful guide to some of the areas that will be covered by future guidance.
Susan Hunneyball is a partner at Gordons Partnership.
This is a general overview. Independent legal advice should be sought for any specific concerns.