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Pharmacist supervision has been the subject of debate for as long as I can remember. Strikingly, no one is sure what supervision requires. The Human Medicines Regulations 2012 say it is a criminal offence to sell or supply Pharmacy medicines or Prescription Only Medicines unless a pharmacist makes the sale or supply or, if the transaction is carried out by a non-pharmacist, that person acts under the supervision of a pharmacist. Over the years, some people have argued that supervision requires a clinical check. Others say it requires an accuracy assessment. Yet others have asserted that it requires a final check before a medicine leaves the pharmacy. Things are made more uncertain by the NHS terms of service which require prescription medicines to be supplied under the direct supervision of a pharmacist. No one knows what the word "direct" adds. The wording of the Human Medicines Regulations is not identical to the wording of earlier legislation. In particular, on the only occasions when the courts have been called upon to interpret the requirement for supervision, the Pharmacy and Poisons Act 1933 was in force. In cases decided in 1943 and 1953, the courts decided that a pharmacist who was upstairs when a supply was made could not have been supervising; and that a sale was supervised by pharmacist standing at the cash desk because the pharmacist could intervene if a sale would not be appropriate.

Pharmacy Supervision Practice Group, an organisations from across the community pharmacy sector, who have come together to look into the future "supervision" in community pharmacy, have published their final report. Over the course of nine collaborative and positive workshop-style discussions the Supervision Practice Group aimed to provide recommendations to reframe legislation, regulation and professional standards and guidance to achieve a new vision for community pharmacy. The group have produced a report which makes several recommendations on the subjects of: * the legislation relating to "supervision"; * the temporary absence of the RP from the pharmacy; * delegation; * the preparation and assembly of medicines when the RP is not signed in. The group have provided recommendations on which the Department of and Social Care and the regulators can draft specifically worded revisions to legislation and regulatory standards. These specific legislative and regulatory changes that are proposed by government and regulators will be subject to a full consultation process.

The Pharmacy Supervision Practice Group consisting of members from AIMp, APTUK, CCA, NPA, PDA, PFNI and RPS held its fourth workshop to continue discussions on the future modelling of pharmacy practice. The ideas around 'supervision' shared by the organisation earlier formed the basis of the discussion during the workshop and helped to expand understanding of where there was consensus and disagreement. Examples of ideas explored during the workshop include: the extent to which a pharmacist should supervise the medicines assembly process, the purpose and extent to which a pharmacist might be absent from the pharmacy and how this might affect patient safety as well as the nature of whether fixed rules versus a broad framework were preferable for future practice. Chair of the group, Dr Michael Twigg, Associate Professor of Primary Care Pharmacy, University of East Anglia, said "Once again the sector bodies have come together in a collaborative and positive manner to explore the concept of 'supervision' in the context of current and future community pharmacy practice. This session provided an opportunity to constructively challenge assumptions and viewpoints within the group with the aim of moving the discussion forward." As part of the session, the DHSC, GPhC and PSNI gave an overview of the difference between legislation, regulation and guidance which was helpful to inform the group's thinking. Each of the organisations have been asked to use the conversation to refine the ideas presented in advance of the next workshop.

The government's formal consultation on pharmacy supervision, which closes today (29 February), leaves important questions unanswered, the National Pharmacy Association (NPA) has warned. The Department of Health and Social Care (DHSC) proposals are 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 In its formal response to the consultation, the NPA acknowledged that modernisation of the regulations is long overdue, including enabling non-pharmacist members of the pharmacy team to hand out checked and bagged prescriptions.

The Department of Health and Social Care (DSHC) has launched a consultation to seek views on changes to pharmacy supervision, which is being considered as part of the Primary Care Recovery Plan. Plans set out in the consultation include making better use of pharmacies, improving access to primary care and maximising the contribution of pharmacy professionals across healthcare. In the consultation, the DSHC has set out proposals to amend the Medicines Act 1968 and The Human Medicines Regulations 2012. The proposals aim to allow pharmacists to authorise registered pharmacy technicians to carry out the preparation, assembly, dispensing, sale and supply of pharmacy and prescription only medicines in their absence. Currently, these services can only be carried out by, or under the supervision of, a pharmacist.

Recently, the English Health Secretary has talked about introducing a 'Pharmacy First' model similar to that which exists in Scotland. This would be a win-win outcome providing people with better access to essential healthcare support, advice and treatment whilst relieving strain on other parts of the NHS, not least GPs and A&E. It is a no-brainer and yet despite a few media headlines there are still no firm proposals on the table to make this a reality. It surely cannot be right that you can receive a broad range of patient care services in Scotland which are not available in England. It works well in Scotland, Wales is keen to develop more pharmacy-based services and Northern Ireland, leaving aside the current funding dispute, has had a minor ailments service for many years. If the English Health Secretary is sincere in his interest in adopting an English version of the Scottish model, then there are critical aspects he needs to consider. Firstly, start with the patient journey through the healthcare ecosystem from illness prevention through to long-term condition management. What is the role of community pharmacy and how do we guide people to seek support from the most appropriate healthcare professional? What is the vision for community pharmacy delivering patient care in the next decade? The lesson from Scotland is that the government needs to sit down with the sector and map that out together. There are no quick fix overnight solutions. This needs to be a long-term commitment backed by adequate funding. Supervision regulations need to change and there needs to be a thought through workforce strategy which avoids community pharmacy shortages as that does nothing to deliver improved patient outcomes.

The Royal Pharmaceutical Society (RPS) and the Pharmacists' Defence Association (PDA) have responded to the Department of Health and Social Care (DHSC) consultation on pharmacy supervision, which was launched in early December last year. The DSHC set out proposals to amend the Medicines Act 1968 and The Human Medicines Regulations 2012 to allow registered pharmacy technicians to work without direct supervision, which in turn will help free up pharmacists to provide more clinical care and reduce GP appointments. While the RPS supported the legislative change, it highlighted a range of topics that should be considered and clarified in regulations and guidance. According to RPS, the new concept of 'authorisation', including around documentation, accountability, and the role of superintendent pharmacist and responsible pharmacist, needs clarification.

The Department of Health and Social Care aims to amend the Human Medicines Regulations 2012, thereby enabling pharmacy technicians to provide and administer specific medicines through a patient group direction. In line with this initiative, the Department introduced a six-week consultation to assess whether registered pharmacy technicians should be authorised to dispense medicines using a PGD. The proposals, backed by all four Home Nations, apply exclusively to registered pharmacy technicians. Meanwhile, this coverage will extend to include pharmacy technicians in Northern Ireland upon their achievement of registered professional status. "The proposed statutory instrument, presently applicable in England, Scotland, and Wales would offer 'clear benefits,' especially in areas such as vaccination and the provision of oral contraception and EHC," the DHSC said. According to the Department, facilitating registered pharmacy technicians to execute PGDs might amplify their workload, yet it could simultaneously enhance overall efficiency and cost-effectiveness for pharmacy teams by optimising the utilisation of skill diversity.

Duncan Rudkin, the CEO of the General Pharmaceutical Council (GPhc) has highlighted the importance of strengthening pharmacy governance to provide clarity around how pharmacies are organised and managed. This will ensure that patients and the public continue to receive safe and effective pharmacy care, he said while speaking at the annual Sigma Conference in London on Sunday (5 November). According to him, there could be rules that outlined the essential roles and responsibilities of responsible pharmacists, and professional standards for responsible pharmacists, superintended pharmacists and chief pharmacists. He also announced that the GPhC will be shortly launching a consultation to integrate a new set of standards for the statutory role of hospital chief pharmacists "which up until recently has never been recognised in law." It is expected to be launched by early January 2024. However, Duncan, emphasised that they cannot start the work on standards for responsible and superintendent pharmacists until they know the government plans in relation to supervision. "Because of course, the responsible pharmacists' regime, and the supervision regime are in many ways intertwined, and can't certainly be looked at separately.

In a surprising move that has divided the pharmacy profession, the General Pharmaceutical Council (GPhC) has sanctioned hundreds of pharmacies to allow patients to self-select certain Pharmacy (P) medicines, a decision met with strong opposition from the Royal Pharmaceutical Society (RPS) as well as from the Pharmacy Defense Association (PDA). In a statement, RPS shared that at a board meeting held on 19th June, they expressed "disappointment" over what they described as a lack of prior consultation and comprehensive communication from the GPhC regarding the implications of this policy shift. They argue that allowing patients to self-select certain P medicines could potentially jeopardize established professional guidelines and compromise the role of pharmacists in ensuring safe medication use. "Enabled by the General Pharmaceutical Council, we understand that hundreds of pharmacies, from large multiples to small independents, have been approved by the regulator to enable patients to self-select certain P medicines," the statement said.

The Medicines and Healthcare products Regulatory Agency (MHRA) has maintained the prescription-only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder, following a public consultation and the review of a reclassification application from the manufacturer Maxwellia Ltd. Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18 and 65, such as the urgent need to urinate and frequent urination without pain. The regulator decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine, concluding that a medical prescription continues to be required to ensure the safe use of Aquiette. Since an OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated, the MHRA said the decision would ensure that the medication is used safely and appropriately under medical supervision. "After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg Tablets for women with symptoms of overactive bladder (OAB)," Dr Laura Squire, MHRA chief healthcare quality and access officer, said.

A couple in Maidenhead, Berkshire has been handed suspended sentence for illegal possession and supply of £1.6m of unlicensed medicines. Following investigations initiated by the MHRA, Karina Filimonova and Andrejs Stolarovs were caught with the unlicensed medicines which included prescription-only medications. Southwark Crown Court sentenced each "to eight months imprisonment suspended for 18 months and 150 hours unpaid work" for possessing and intending to supply medicinal products contrary to the Human Medicines Regulations 2012. "This was a sophisticated operation illegally bringing unlicensed medicines into the UK from Singapore and India, and then distributing them across the country and abroad," said Andy Morling, MHRA Deputy Director of Criminal Enforcement. "Criminals trading in medicines illegally like this are not only breaking the law, but they also have no regard for your safety. These are powerful medicines that can lead to serious adverse health consequences if taken without appropriate medical supervision." In 2020, the Royal Mail Group (RMG) informed the MHRA about parcels containing unlicensed medicines discovered during their investigation into suspicious parcel activity. Following this, the MHRA's Criminal Enforcement Unit, in cooperation with local police, launched an investigation and apprehended the couple at their residence in Kidwells Close, Maidenhead.