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The Royal Pharmaceutical Society (RPS) has submitted evidence to the All-Party Parliamentary Group (APPG) on Pharmacy inquiry into medicines shortages in England. In its submission, the organisation has called on the government to develop a national strategy to address medicine shortages and change legislation to allow community pharmacists to amend prescriptions when medicines are in short supply. Tase Oputu, RPS England Board chair, welcomed the inquiry, and emphasised that medicines shortages continue to impact patients and the work of pharmacists daily. The RPS's evidence draws on its report, Medicines Shortages: Solutions for Shelves, which examines the issue in detail. The report revealed that pharmacy teams are spending more time chasing medicines supplies, identifying and switching patients to alternative medicines, taking their time away from other clinical activities.

A new report from the Royal Pharmaceutical Society (RPS) has called on the government to create a national strategy to manage medicine shortages and to change legislation to empower community pharmacists to amend prescriptions when medicines are in short supply. Currently, patients are required to return to their GP to get their prescriptions amended, leading to delayed access to medication, increased bureaucracy, and additional strain on an already overburdened system. The RPS report, backed by charities and patient groups, proposes allowing pharmacists to make minor amendments, such as adjusting the quantity, strength, or form of prescribed medicines to ensure timely access for patients. Additionally, the report highlighted key factors causing medicine shortages, including manufacturing and supply chain issues, exacerbated by cost pressures and consolidation of manufacturing outlets. This along with unplanned spikes in demand, such as shifts in prescribing practice or increased diagnosis of some conditions, have created "a perfect storm of unstable supply"

The Royal Pharmaceutical Society (RPS) has urged the government to amend medicines legislation to allow pharmacists to make minor amendments to a prescription without any protocol being needed. RPS wants to see a change in the law that makes the whole process of supply of medicines easier and quicker, enabling pharmacists to use their knowledge and expertise in medicines to better support patients. "At present a prescription can only be changed by a prescriber, which causes unnecessary workload for GPs and delays for patients," said RPS. RPS President Professor Claire Anderson said: "We want to see all pharmacists across the UK able to supply a different quantity, strength or formulation of a medicine (for example changing capsules to tablets) when required, to avoid unnecessary bureaucracy and the need for an SSP to be developed, signed and authorised by a Minister. In effect it would mean that pharmacists can help patients straight away - it would future proof the problem to some degree.

The Royal Pharmaceutical Society (RPS) in England and 19 other organisations have written to health secretary Wes Streeting, calling for a cohesive cross-government strategy to tackle medicine shortages across the UK. The letter stresses the need for actions to build supply chain resilience, support UK manufacturing, improve data connectivity, protect access to life-critical medicines, and reduce duplication across the NHS. As the government works on its 10-Year NHS Plan, the signatories emphasise the importance of ensuring patients' continued access to vital medicines, which are "an investment in their health." They underscore that the strategy would require engagement by the government across the NHS and the whole of the medicines supply chain, including manufacturers, suppliers, health professions, and patients. The letter also highlights that delays in accessing medicines could be reduced by changing legislation to empower community pharmacists to make minor amendments to prescriptions when shortages occur.

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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 British Generic Manufacturers Association has backed the UK government's proposed changes to the Statutory Scheme for branded medicines, which includes a 'Life Cycle Adjustment' (LCA) mechanism to permit a lower rebate rate for medicines sold in competitive markets. The association underscored the necessity for crucial amendments to forestall unintended consequences and ensure a practical alignment with market operations. A precisely tailored approach is crucial in ensuring sustainability and growth in this sector, the BGMA said in a statement on Oct. 11. The Department of Health and Social Care is currently working on the successor to the 2019 voluntary scheme for branded medicines and pricing access (VPAS) agreement, slated to end in 2023. Negotiations for this successor, scheduled to begin on January 1, 2024, are already underway. "We are pleased that the Statutory Scheme consultation recognises that branded generic and biosimilar medicines are subject to different market dynamics and competitive pressures," said Mark Samuels, Chief Executive of BGMA. "As such, a one-size-fits-all approach across all branded products is not suitable for the next five years. It is crucial to adopt a precisely tailored approach to this sector, ensuring both sustainability and growth."

Pharmacies in England will soon be allowed to dispense up to 10 per cent more or less than the quantity prescribed for NHS prescriptions, thanks to the introduction of new original pack dispensing (OPD) rules. These changes are part of regulatory amendments laid on Tuesday, 3 September, and will come into effect over the coming months. The amendments are being made to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2024 (PLPS). Starting 1 January 2025, pharmacies will have the option to adjust the prescribed quantity by up to 10 per cent for NHS prescriptions so medicines can be supplied in their original manufacturer's pack. Earlier in October 2023, changes to the Human Medicines Regulations (HMRs) permitted pharmacies to dispense up to 10 per cent more or less than the prescribed quantity for private prescriptions of Prescription Only Medicines (POMs).

The Department of Health and Social Care (DHSC) has finally published its response to the 2022 consultation on hub and spoke dispensing. Considering the consultation evidence and further discussions, the government has expressed its intention to progress the proposals for enabling hub and spoke models across different legal entities as soon as possible. This will be achieved by using the enabling powers outlined in Part 2 of the Medicines and Medical Devices Act 2021 (MMDA) to amend the Medicines Act 1968 and the HMRs. Furthermore, the DHSC has decided to proceed with the implementation of the two models of hub and spoke dispensing that it consulted on. The government response to the consultation reads: "Having considered the responses, the government intend to proceed to implement the necessary changes to medicines legislation to remove the current restrictions that prevent the hub and spoke dispensing models from operating across different legal entities found in section 10 of the Medicines Act 1968.

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

AstraZeneca UK has revised the expiry dates for certain batches of Fluenz Tetra nasal spray vaccines as a precautionary measure, after finding that their potency (strength) dropped faster than predicted once thawed, during routine testing. The Medicines and Healthcare products Regulatory Agency (MHRA) has been informed by the manufacturer that the printed expiry date for a limited number of batches is "incorrect." However, the MHRA has assured patients that the affected batches are safe to use and fully effective within the amended expiry date. If the vaccine is administered after the amended expiry date, it may be less effective in protecting against flu, it said. The UK regulatory authority also reiterated that it "keeps the safety of medicines, including vaccines, under review, and acts where necessary to protect patients and the public."

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 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.

The growing issue of medicine shortages is posing significant challenges for both patients and pharmacy teams across the UK. According to new data from the Office for National Statistics, 20 per cent of adults who used pharmacy prescription services in the last 28 days experienced delays in receiving their medications. The survey, Experiences of NHS healthcare services in England, revealed that over 13 per cent of patients had to return to the same pharmacy at a later time to obtain their prescriptions. Many patients were forced to visit multiple pharmacies or seek alternative services such as a GP or urgent care due to medicine shortages. Pharmacy teams were added with extra burden to manage and resolve these issues. Despite these challenges, 85 per cent of patients expressed satisfaction with pharmacy services, reflecting the dedication and value of pharmacists and pharmacy teams in the community.

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.

"Only around half of ICSs have a Chief Pharmacist," indicating a significant gap in leadership that hampers the pharmacy sector's ability to influence critical healthcare decision, a report on medicine optimisation by the Public Policy Projects (PPP) highlights. In PPP's latest report, a notable concern highlighted is the inadequate representation of pharmacy leadership within Integrated Care Systems (ICSs) despite the role of pharmacy being "central in the delivery of system priorities, with pivotal roles in improving population health and tackling inequalities". In recent years, the role of pharmacy within the NHS has evolved significantly with recent developments including Pharmacy First Services and legislative amendments that allows pharmacy technicians under PGDs to administer and supply medicines.

Amendments to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 along with introduction of a new type of pharmaceutical service come into effect from Tuesday (December 21) and from January 1, 2022. PSNC will be consulted on the new type of enhanced service - the National Enhanced Service (NES), where NHS England and NHS Improvement (NHSE&I) commissions an enhanced service with a service specification that sets standard conditions nationally. Other amendments to the regulations include: Changes in the contractors' terms of service, allowing NHSE&I to introduce a pandemic response programme, by which contractors are required to have various premises and other arrangements for responding to a pandemic. An alternative route to supply pandemic treatments, via a listed prescription items voucher (LPIV). This is a further option for the community pharmacy for supply of treatments or medicines during or in anticipation of pandemic disease;

The government has extended VAT exemption from Monday (1 May) on healthcare services carried out by pharmacy staff under the supervision of pharmacists. HM Revenue and Customs has issued a note detailing the change to the VAT treatment of medical services. The Government said this will bring the VAT treatment of pharmacists in line with other registered health professionals providing medical services to the public. The Pharmaceutical Services Negotiating Committee (PSNC) said: "This is something that PSNC has been seeking Government agreement on for a long time, including in recent CPCF negotiations." PSNC believes that the extension of this VAT exemption will help as community pharmacy businesses try to make better use of the skill mix in their teams both now and in the future. "Not only does it enable contractors to review the VAT status of any locally commissioned services currently provided by non-registered pharmacy staff but also, in time, it could be used to amend nationally commissioned services to allow support staff to provide certain parts. For example, following a recent amendment to the service Directions, pharmacy technicians are now able to perform blood pressure checks as part of the Hypertension Case-Finding Service and deliver the Smoking Cessation Service.

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.