Legal issues for pharmacists in 2022 - the highlights from Gordons Partnership
''''''' Is the safety of patients adequately supported given the lack of clarity about patient records
We are only halfway through 2022 but here are some of the year's key legal issues that have caught eye of pharmacy specialist Susan Hunneyball at law firm Gordons Partnership:-
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Changes to the superintendent pharmacist and responsible pharmacist role
The government response to the consultation looking at the governance requirements of registered pharmacies was published in May, almost four years after the consultation closed. The powers and responsibilities of the GPhC will dramatically increase as many of the obligations on superintendent pharmacists (SI) and responsible pharmacists (RP) will become professional obligations governed by rules and standards. ''Headline changes that look likely to be implemented are:
Superintendent Pharmacist
''''''' A requirement for an SI to be a senior manager of the business. This will be by amendment to the Medicines Act 1968 where the roles and responsibilities of the SI will be defined in law. '
''''''' The extended role of the SP in clinical and public health services is to be determined by regulators.
''''''' In a significant change, the restriction on a SP holding the role for only one retail pharmacy business will now be determined by the pharmacy regulators. Any change would be a fundamental rethink about the way the role is tied into the corporate structure.
''''''' Correcting a bit of an anomaly, the requirement for companies with 'chemist' in title to have the superintendent on the board of directors will be removed.
Responsible Pharmacist
''''''' There is clarification of the role of an RP. The RP is still in charge of the pharmacy when they are signed on as RP and has to ensure the safe and effective running of the pharmacy. They will no longer have a duty to establish, maintain and review procedures but can still make temporary adjustments or choose not to follow a procedure where following it would be detrimental to the patient.
''''''' It made clear that this is a greater responsibility than that of a pharmacist who is not signed in as RP. 'The RP role is concerned with the organisational governance of the pharmacy, whereas supervision by a pharmacist concerns individual transactions.'
''''''' The RP will need to be signed on when the pharmacy is open or when medicines are being prepared for supply. There does not need to be an RP signed on for activities such as shelf stacking while the pharmacy is closed.
Draft Pharmacy (Responsible Pharmacists, Superintendent Pharmacists etc.) Order 2022 together with the government response on the consultation has been laid before Parliament.
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The consultations
There have been some interesting consultations around this year. The big news is that the long-awaited Hub and Spoke consultation is out. But there is also an intriguing consultation by the CPS on Mercy Killing and one on provider selection regimes.
Hub and Spoke - Much to discuss here. The consultation closes on 6 June and looks at arrangements where a central hub assembles prescriptions and either sends them back to the spoke pharmacy for supply to patients or supplies centrally from the hub. Either of these arrangements would involve significant amendments to legislation including the key amendment to section 10 Medicines Act 1968 and amendments to the Human Medicines Regulations 2012 (HMR). There are also proposed amendments to support original pack dispensing and to the description of how the supply of medicines and services is described (rather than 'on premises
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