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The International Pharmaceutical Federation (FIP) has offered a new resource to help countries self-assess readiness of their regulations to enable pharmacist-delivered vaccination services and, where needed, to implement such regulations. Developed by FIP's Regulators Advisory Group, it covers broad pharmacist-led roles related to vaccination from supply chain management to administration and prescribing. "This new resource from FIP is based on the experiences of professional regulators in countries where pharmacy-led vaccination has been successfully introduced and regulated. With it, we aim to support regulators, policymakers and national organisations in developing strategies or enabling regulatory frameworks in countries where the pharmacy workforce has a limited role in vaccination strategies so that it can contribute further to the global imperative of improving immunisation coverage," said Brett Simmonds, group chair. The "Pharmacy-led vaccination services: Regulatory self-assessment and implementation tool" aims to help identify strengths and areas for improvement in order to inform vaccination policy and planning efforts.

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 regulators have reduced the notice periods for change to supplementary opening hours for community pharmacy contractors from 1 October 2022. Following the Pharmaceutical Services Negotiating Committee (PSNC)'s discussions with the Department of Health and Social Care (DHSC) and NHS England as part of Year 4 negotiations, it has been agreed that the required notice periods for changes to supplementary opening hours will reduce to five weeks. Community pharmacy contractors who want to change their supplementary opening hours are required by their terms of service to notify NHS England. "If a contractor wants to increase supplementary opening hours at the pharmacy, this can be done with no notice - but notification of the change must still be given to NHS England," said PSNC. "To decrease supplementary opening hours at the pharmacy, at least five weeks' notice must be given to NHS England prior to implementing the change."

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.

The Royal Pharmaceutical Society (RPS) and Pharmacist Support hosted a roundtable on the impact of pharmacy workforce wellbeing on patient safety on Wednesday (17 May). It also released its annual Workforce Wellbeing Survey which showed continued pressures on pharmacy teams. The discussion explored the actions needed to support staff so they can continue providing safe and effective patient care and included representatives from the NHS, professional bodies, employers, trade unions, education and regulators. A report of the roundtable will be published in the summer. Amandeep Doll, RPS Head of Professional Belonging, said: "We know that pharmacy teams go above and beyond for their patients, but are also under enormous pressure. "Now more than ever, we need to strive to make the pharmacy profession more inclusive and ensure that everyone's wellbeing is supported. "It is vital that we do all we can to encourage people into pharmacy and to support them so they can enhance their skills, develop their careers, and continue to deliver high-quality patient care. "This discussion was a welcome step and showed that making a difference for staff wellbeing requires a concerted effort from stakeholders across the whole of pharmacy.

The recent announcement that Royal Mail will be partnering with distance selling pharmacy (DSP) giant pharmacy2U highlights how standards of regulatory enforcement are being ignored to accommodate the DSP model. The brunt of these double standards hinges around the levelling down of temperature enforcement standards by the Medicines and Healthcare products Regulatory Agency (MHRA) which demands mapping must be audited from the point of dispensing to the patient. The MHRA has a well recognised duty to ensure medicines reach patients in a safe condition. The current anomaly appears to turn a blind eye to this step in the supply chain at the point the wholesaler releases goods to the pharmacy hub. Equally the training on delivering medicines safely and effectively direct to patients should apply fully to all hubs including DSPs. Why is it that DSPs are being treated differently to bricks and mortar pharmacies? It's essentially the same patients receiving the same medicines from the same wholesalers. A further regulatory disparity exists around how parcels must be "tracked and signed for" to be reasonably certain medicines are delivered into the hand of the intended recipient, as per existing regulations. Clearly an untracked, unsigned package cannot be guaranteed to finish in the hands of the intended recipient. There is a very real possibility that such omission could lead to community pharmacy closures which will, in turn, lead to unemployment and a reduction in the care services. At a time when integrated care systems have just gone live, the removal of vital support services leading to further inequalities is the wrong message for both providers and patients alike.

Gisela Abbam today (March 14) officially succeeded Nigel Clarke as new chair of the General Pharmaceutical Council (GPhC). She was appointed in mid-Feruary. The council paid tribute to its outgoing chair for his major contribution to pharmacy regulation and his focus on patient safety for the past eight years on the role. During his tenure Clarke has overseen significant changes to how the GPhC regulates pharmacists, pharmacy technicians and pharmacies to help drive improvements in professional practice and protect patient safety. Chief executive of the GPhC, Duncan Rudkin, said: "I would like to pay tribute to Nigel for everything he has done to support continuous improvement and assure the quality and safety of pharmacy for the benefit of patients and the public.

New amendments to the Human Medicines Regulations will soon allow registered pharmacy technicians to supply and administer medicines under Patient Group Directions (PGDs). Laid before Parliament at the end of May, the legislative changes will come into effect from June 26, 2024, the Community Pharmacy England (CPE) announced today. The introduction of this new legislation follows an announcement made by the Department of Health and Social Care (DHSC) earlier this year. The regulatory adjustments provide the legal framework for pharmacy technicians to engage in the supply and administration of medicines under PGDs in the course of their professional practice. However, there will be no immediate change in the provision of community pharmacy services, the CPE noted

What skills does a pharmacist need these days? You'd think it would be sufficient to have a good understanding of pharmacy and the ability to offer a great patient service. Whilst this is true of course, the reality of the day to day role demands skills which most pharmacists have not been trained for as part of their formal qualification. At the very least, pharmacists find themselves responsible for running the pharmacy, managing people, managing processes and dealing with issues relating to customers, suppliers, surgeries, regulators and stakeholders. Even the most junior pharmacists quickly find themselves being accountable for the financial performance of their department and having to work within budgets or deliver on targets. Remarkably, despite the apparent lack of any formal training in these areas, pharmacists have been able to adapt and meet the challenges of whatever their job has thrown at them. Many pharmacists go even further, bringing out their inner entrepreneurial spirit to set up their own business. There are now over 6,000 pharmacy businesses owned by independent pharmacists, with this segment growing. Whilst pharmacists have historically adapted to their environments and picked up the necessary business skills, the rapidly changing landscape of pharmacy will require pharmacists to establish new skills to help ensure their businesses survive and thrive.

The General Pharmaceutical Council (GPhC) has called for comments and views on the recently launched consultation on selecting the appropriate mode of consultation when assessing a person's needs by pharmacy professionals including pharmacist prescribers. The guidance note sets out what the pharmacy professional or prescriber, in agreement with the patient, needs to consider when selecting the mode of consultation - such as face-to-face; video-link, video-chat, or other online platforms; telephone and online questionnaires - best suited to gaining the information needed to deliver safe and effective pharmacy care. The principles outlined in the guidance apply to consultations undertaken in all pharmacy settings, including those undertaken by online pharmacy services providers. "Our plan is to include the contents of this guidance note in the document: 'In practice: Guidance for pharmacist prescribers' when we undertake our next review," said the regulator.

The Department of Health and Social Care (DHSC) has published plans to amend current pharmacy legislation on dispensing errors and clarify how registered pharmacies are governed. The Department's response to a public consultation on rebalancing medicines legislation and pharmacy regulation programme first proposed in summer 2018 was delayed due to Brexit and the Covid-19 pandemic. The programme aims to clarify and strengthen the organisational governance arrangements of registered pharmacies, specifically to define and clarify the core purpose of the Responsible Pharmacist and Superintendent Pharmacist roles. It will also give the General Pharmaceutical Council (GPhC) powers to define in professional standards how those roles are fulfilled.

The regulatory amendments proposed will enable pharmacists to dispense medicines in their original packaging for private prescriptions starting this Autumn, according to the Department of Health and Social Care. In the recently published draft OPD regulations, the DHSC has indicated that the alterations, permitting pharmacists to vary the dispensed quantity by up to 10 per cent to avoid splitting medicine packs, will be implemented for private prescriptions 'immediately upon the enforcement of the Human Medicines Amendment Regulations in the autumn,' as highlighted in a briefing by Community Pharmacy England. CPE stated that the regulations related to NHS prescriptions will come into effect when the pharmaceutical terms of service regulations expressly apply the OPD amendments. Moreover, new directive mandating the dispensing of sodium valproate products solely in their original packaging (except when an assessment of risk necessitates an alternative approach) will align with the rollout of the private prescription regulations during the autumn. CPE further noted that these regulations are currently in draft, indicating that they are not currently in effect and may undergo revisions prior to their implementation.

The Pharmaceutical Services Negotiating Committee announced last week that it is in discussions with the Department of Health and Social Care (DHSC) and NHS England about relieving capacity pressures, such as a relaxation of pharmacy opening hours requirements. PSNC is also scheduling webinars to talk with contactors about the steps they might be willing to take in future, to cut costs, should emergency financial relief fail to materialise. The pharmacy regulator reported that many of its members felt that it was no longer tenable for pharmacies to keep offering all of the free and non-core services to patients that they would like to, and that all contractors should consider what steps they could take to try to safeguard their businesses and their core services for patients. PSNC is also keen to talk to contractors about their current situation and the steps they might be willing to take in future, should emergency relief not be forthcoming.

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.

Britain's antitrust regulator, the Competition and Markets Authority (CMA) on Wednesday announced that it is investigating the acquisition of LloydsDirect by Pharmacy2U last year, and has launched its first phase of the merger inquiry. The completed deal between two of the UK's foremost online pharmacies was announced in a joint statement issued on 9 October, confirming that they would operate as Pharmacy2U. Commenting on the purchase, Kevin Heath, CEO of Pharmacy2U, then said: "Combining the best of both of our businesses, we can provide patients with greater access and convenience." The regulator is considering "whether it is or may be the case that this merger has resulted in the creation of a relevant merger situation under the merger provisions of the Enterprise Act 2002 and, if so, whether the creation of that situation has resulted, or may be expected to result, in a substantial lessening of competition within any market or markets in the United Kingdom for goods or services."

The General Pharmaceutical Council (GPhC) has decided to increase the renewal fees of pharmacists, pharmacy technicians, and pharmacy premises by 7.5% from April 2024. The pharmacy technician's renewal fee will see an increase by £9 from £121 to £130, pharmacists fees from £257 to £276, and pharmacy premises from £365 to £392. The following decision came even despite the renewal fees being frozen for individual registrants since 2019 and for pharmacy premises since 2021. This move was facilitated through cost savings measures like using financial reserves and downsizing to a smaller office. However, the council confirmed that the fee hike is due to higher rates of inflation, increase in utility bills and supplier costs. Duncan Rudkin, Chief Executive and Registrar of the GPhC, said: "We know that these are challenging times and that this increase will come as unwelcome news to those we regulate. But to be effective in our role of protecting the public we need to make sure the fees we charge cover the cost of regulation going forward."

NHS England has mandated a business continuity plan for pharmacies dealing with temporary closures from the end of this month. Community Pharmacy England (CPE) has put together a briefing and a template plan to help guide pharmacy owners through the process. It explains what is required in the plan, describes how and when to implement it, and outlines some additional considerations. "This could be added as an annex to your pharmacy's existing business continuity plan. A checklist has also been added, which may be used in the event of a temporary suspension," said CPE. "NHS England will be publishing the approved particulars shortly. NHS England is also still to publish guidance on the amendments to the Pharmaceutical Regulations that came into force on 25th May, which will include guidance on these requirements.

The Pharmacists' Defence Association (PDA) has begun conciliation with 86 pharmacy companies to safeguard the interests of former LloydsPharmacy pharmacists. The Advisory, Conciliation and Arbitration Service (Acas), a government agency, serves as a mediator between companies and employees to resolve disputes. If the ongoing mediation prove unsuccessful, individual employees retain the option to file claims in the employment tribunal, the PDA has said. The ongoing dispute centres around employers potentially failing to conduct the required consultation under the Transfer of Undertakings (Protection of Employment) regulations (TUPE) with employees and their representatives during employee transfers, the PDA said. The TUPE legislation, known for its complexity and technical nature, applies when a section of the company, like a pharmacy sold as an asset using standard disposal, undergoes a transfer. According to NHS England's recent pharmaceutical list, LloydsPharmacy has either sold or shuttered 461 branches since September 2022. According to NHSE data, as of June 30, the pharmacy chain operates approximately 512 pharmacies in England. This positions it as the third-largest chain after Boots UK and Well Pharmacy.

The General Pharmaceutical Council (GPhC) has launched a consultation on changes to the quality assurance processes of pharmacy education and training. In its consultation published on 4 April 2024, the pharmacy regulator has proposed four key changes to the procedures, including annual monitoring of all pharmacy education providers, including pharmacy schools offering MPharm courses. The annual audit will enable the GPhC "to identify and address concerns together with providers in a more timely, proportionate and systematic manner". It is considering collecting yearly data, including feedback from students, trainees, supervisors and patients, from educational organisations. The GPhC has also proposed defining clear lines of responsibility and criteria for determining whether to re-approve a course or qualification.

The professional leadership body for pharmacists has urged the General Pharmaceutical Council's (GPhC) to make it mandatory to have a chief pharmacist within organisations to ensure transparency for patients, the public and pharmacy staff. On 23 January, the GPhC launched a consultation seeking views on the new draft Standards for Chief Pharmacists it has developed to strengthen pharmacy governance. These standards outlined the professional responsibilities and qualifications required by a chief pharmacist to support their organisation and its staff to deliver "safe and effective" pharmacy services. The pharmacy regulator highlighted the importance of having a registered chief pharmacist meeting these standards in hospitals (or relevant settings) to benefit from the new legislation regarding accidental errors. In response to the consultation, the RPS expressed that while meeting these standards could enhance pharmacy governance, they may not provide the framework needed to fully support staff in reporting and learning from errors.