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Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines. Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential savings for the NHS, the consumer healthcare association highlighted during the event. Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process in 1983 to make them available over the counter - OTC. Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium (esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together (tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.

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.

The large majority of adults in the England knew that flu jabs are available in many pharmacies, just over half were aware of the GP Community Pharmacist Consultation Service or the New Medicine Service, according to a new survey by the National Pharmacy Association (NPA). The new survey revealed the need to raise the public awareness of key NHS services such as the New Medicine Service. According to the survey, 56 per cent of those asked believed that pharmacies in England offer NHS consultations for people newly prescribed a medicine for a long-term condition. While 48 per cent believed that many pharmacies in England offer blood pressure monitoring (NHS or private). 51 per cent believed it to be true that GPs can formally refer patients for same-day clinical advice from their local pharmacist about minor ailments.

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.

Boots UK in association with Macmillan Cancer Support and the NHS has launched a Palliative Care Service in its pharmacies to provide easy access to vital medicines and specialist pharmacist advice and support to patients. As part of the new service, Boots has created a list of recommended medicines most used by terminally ill patients. It has committed to maintain stock of these medicines, or formulary, at over 2,000 of its pharmacies with an NHS contract. To further support the launch of the new service, all 4,200 Boots Macmillan Information Pharmacists (BMIP) have received additional training on palliative care, including a range of cancer-related advice and side effects of medication. Marc Donovan, chief pharmacist at Boots said: "Discussing end-of-life care is never easy, but it is very important. At this extremely difficult time for patients and their families and carers, ease of access to medicines and support can make a big difference.

The Royal Pharmaceutical Society (RPS) is refreshing its Professional Standards for Homecare Services and will be shared for consultation in August to allow comment and input on the updated content. The final version is expected to be completed in the autumn. The standards were originally published in 2013 and are a framework to support teams providing and commissioning homecare services. Homecare medicines services deliver medication, and any necessary associated care, direct to the patient's home with their consent. The standards help patients experience a consistent quality of homecare services, irrespective of provider, will protect them from avoidable incidents and help them get the best outcomes from their medicines. Jennifer Allen, The Chief Pharmaceutical Officer's Clinical Fellow leading the refresh at RPS said: "It has been 10 years since the first set of Homecare Standards were published, so it is important that they are reviewed and brought up to date to reflect current service design, medicine pathways and delivery models to ensure patients receive safe and effective medication supply and associated care."

The Pharmaceutical Services Negotiating Committee (PSNC) has expressed its concerns over sustained pressures on medicines supply that are having a very serious impact on community pharmacy teams and their patients. It has asked contractors and their teams to continue using its regular reporting tools to help them demonstrate the scale of the problems to the Department of Health and Social Care (DHSC) and to support escalations as needed. The committee said: "The sustained increases in price concessions that we have seen so far in 2022 - with more than 100 concessions being granted in some months - show no signs of abating, and we know that many pharmacies now find themselves in a critical situation trying to source medicines in timely manner and facing significant financial risk due to greater uncertainty around expected reimbursement prices for a large number of medicines." "We know that some concessions being imposed by the Department do not match contractors' experience on the ground, and we would ask all contractors to continue reporting pricing issues to us on a regular basis to support our representations: Report product over Drug Tariff price."

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

Increased cooperation between countries is needed to ensure better regulation of online pharmacies, said authors of a new report - 'Online pharmacy operations and distribution of medicines', published by the International Pharmaceutical Federation's (FIP) Community Pharmacy Section. The report presents findings of a global survey of pharmacy organisations covering various aspects, such as type of medicines supplied by these pharmacies in different countries, how the authenticity of online pharmacies can be verified, and the usage of e-prescriptions and shared patient health records. Of the 79 countries responding to the survey, 51 per cent acknowledged that no regulation of online pharmacies exists. A quarter of the respondents reported cases of irresponsible self-medication by consumers who had purchased medicines through online pharmacies. A lack of regulation creates "an avenue for illegal pharmacies and may impact the overall quality of medicines and services offered to consumers," authors of the report said. Lars-Åke Söderlund, immediate past president of FIP's Community Pharmacy Section and co-editor of the report, said that the pandemic has increased preference for online services, including in the pharmacy sector.

NHS England has commissioned the Royal Pharmaceutical Society (RPS) to develop guidance that helps community and hospital pharmacy teams across Britain to reduce the impact of pharmacy services, pharmaceutical care and medicines on the environment. The RPS said the Greener Pharmacy Guidance will enable pharmacies to self-assess their impact against the standards, benchmark and improve through evidence-based activities and actions. "I'm delighted our strong commitment to helping pharmacy reduce its environmental impact can now be taken to the next level through developing guidance and accreditation for pharmacy teams," RPS president Professor Claire Anderson said. "Medicines account for 25 per cent of carbon emissions within the NHS and this initiative underscores our commitment to promoting sustainable healthcare and supporting the NHS's goal of achieving 'net zero' emissions by 2040." Peter Morgan, medicines assistant director at NHS England, commented: "Pharmacy staff are involved in the purchasing and dispensing of almost every medicine used in the NHS and the new Greener Pharmacy Guidance and Self-accreditation scheme will provide support for pharmacy professionals by outlining clear actions to deliver more environmentally sustainable pharmacy practices." The RPS said the guidance and digital self-assessment toolkit will integrate with carbon calculator tools to help pharmacy teams to measure their carbon footprint, action plan to reduce use of carbon and improve sustainability.

The Community Pharmacist Consultation Service (CPCS) will be expanded to enable urgent and emergency care settings to refer patients to a community pharmacist for a consultation for minor illness or urgent medicine supply from Monday (15 May), the DHSC and NHSE said. The service builds on the progress made in GP referrals via the CPCS and hospital referrals under the Discharge Medicine Service. It was originally planned to launch in March, and fee for this service will be the existing CPCS fee of £14, as per the agreement for both year 4 and year 5 of the Community Pharmacy Contractual Framework (CPCF) 2019 to 2024 5-year deal. In an update on the CPCF, published today (12 May), the Department of Health and Social Care (DHSC) and NHS England (NHSE) has also committed to the 4 October 2023 launch date for the Tier 2 of the Pharmacy Contraception Service, subject to a positive evaluation of the pilot. The Tier 1 of the service was launched on 24 April, delayed by over three months. This new service enables community pharmacists to provide ongoing management, via a patient group direction (PGD), of routine oral contraception that was initiated in general practice or by a sexual health clinic. The fees for this service are as follows: a fee for each consultation of £18; and a set-up fee of £900, paid in instalments. The Tier 2 will "enable community pharmacists to also initiate oral contraception, via a PGD, and provide ongoing clinical checks and annual reviews," Alette Addison, deputy director for pharmacy, dental and optical at the DHSC and Ali Sparke, director for dentistry, community pharmacy and optometry at the NHSE, said in a letter.

People who use pharmacies in parts of Pendle have suffered shortages or delays in buying prescription medicines such as insulin, councillors have been told. In the Barnoldswick area, a number of pharmacies have been impacted and some councillors hope a new regional NHS organisation might look into the problems. However, pharmacies in the neighbouring town of Nelson are facing shortages with other medicines. A pharmacists in Nelson Pharmacy told Pharmacy Business that he was struggling to meet local demand for children's paracetamol due to ongoing shortages. Pendle Council's West Craven Area Committee heard about the issues at its latest local meeting, held in Earby. An agenda for the committee stated: "Pharmacy provision in West Craven. It is reported that there is an acute problem with people being unable to get prescriptions filled, with Whitworth chemists suffering a breakdown in service. Previously, Well chemists has suffered similar problems." Speaking at the meeting, Lib-Dem Coun David Whipp said: "It's quite an appalling situation where people are queuing 30 minutes to get a prescription filled but when they get to the counter they are told it's not ready. They have to go home and come back at 5pm. It's an ongoing problem. "It includes insulin, which is critical for people with diabetes. I know several people who have failed to get insulin, It's a very serious problem." He added: "I think the committee should contact the local integrated care service. I think they are responsible for primary care which includes pharmacies. We need to find out what's happening and improve things in future. "

The Pharmaceutical Services Negotiating Committee (PSNC) has raised concerns over the impact that high medicine price rises are having on contractor. Recently, the Department of Health and Social Care (DHSC) has granted the final list of price concessions for December 2022. The latest additions bring the total number of concessionary prices granted for the month of December to 198, surpassing the previous record of 159 granted in September 2022. PSNC has heard from hundreds of community pharmacy contractors who are paying inflated prices for antibiotics used for the treatment of Strep A and who have rightly been concerned about the lack of certainty around the final reimbursement prices for these medicines. It added: "We welcomed the involvement of the Competition and Markets Authority (CMA) to look into the pricing of antibiotics. But the number of reports we are getting from contractors about medicines price rises are just not acceptable and this goes far beyond the antibiotic crisis."

The General Pharmaceutical Council's Investigating Committee took decisive action on March 25, 2024, by issuing a warning to Dilsha Kiran Shah, registration number: 2049787, for her conduct as Superintendent Pharmacist of Jhoots Healthcare Ltd. Miss Shah's failure to uphold the Medicines Act 1968, specifically in ensuring the proper management of medicinal products, triggered this warning. The Act mandates supervision in "keeping, preparing, and dispensing medicinal products other than those on a general sale list." Moreover, pharmacies are inspected on five principles - Governance, Staff, Premises, Services including medicines management, and Equipment and facilities to meet the right standards. The alarm was initially raised in August 2021 when a Jhoots Healthcare Ltd pharmacy branch under Miss Shah's supervision operated without a responsible pharmacist. Despite explicit instructions, pharmacy staff were allegedly instructed to proceed without proper supervision, raising grave concerns regarding patient safety.

A new Information Standard has been published to support improved medication and sharing of allergy information across healthcare services in England. The move will standardise medication message content and help reduce medicines related errors and improve patient safety. It will also allow efficient sharing of medicine information between NHS and social care organisations, including hospitals, GP practices, residential care homes, mental health trusts, and community pharmacies. The Standard that came into effect in October "will save healthcare professionals valuable time accessing key medicines information, provide clinicians with access to a richer source of information, consistent across all care settings", said Shahzad Ali, NHS Digital clinical lead for the Interoperable Medicines Programme.

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 Association of the British Pharmaceutical Industry (ABPI) has supported the Department of Health and Social Care's recommendation to 'aggressively expedite and roll out new medicines' that have gone through trials. The ABPI welcomes government report on cancer services in England and the opportunity it provides to refocus how the pharmaceutical industry, NHS and government can improve the lives of cancer patients. David Watson, executive director, Patient Access at the ABPI, said: "Despite progress, UK patients still have much worse five-year survival rates for many cancers than those in similar nations. Early diagnosis and fast and equal access to the latest treatments for all patients is key to reversing poor trends in NHS cancer care. "We are pleased that the report reflects concerns about variable access to cancer medicines. We support the Committee's recommendations to 'aggressively expedite and roll out new medicines' that have gone through trials and to ensure regulatory innovation results in swift uptake in the UK.

Positive Solutions is set to launch its new, innovative, cloud-based medicines management system - HxCare which will be showcased in October at the Care Show. HxCare will be free of charge to community pharmacies signing up to the HxCare Affiliate Programme (HxCAP) making it an ideal platform to support existing care home business and attract new ones. The cloud-based medicines management system aims to digitise workflows, reduce errors and free up care providers to spend more time delivering care to their residents. Designed to be truly mobile, HxCare will be tablet based and has been developed by working closely with both care homes across the sector and their pharmacy partners who relish the prospect of an eMAR solution that integrates into their Analyst PMR. It is one of five new products being launched by Positive Solutions on the Hx platform this year. HxConsult is already live supporting pharmacies looking to maximise their service revenue. HxIntel will deliver real-time dashboards, reports and insights into the performance of pharmacy businesses of all sizes. My Health Hub will revolutionise patient pharmacy relationships whilst HxDispense is set to be the ultimate next generation PMR system. This modular, cloud-based interoperable ecosystem takes healthcare technology to a new level.

The Department of Health and Social Care (DHSC) will introduce new arrangements for the setting of Drug Tariff Category A reimbursement prices from April 2024. Driven by ministers, DHSC's decision aims to equalise access to margin on Category A medicines and it's part of a series of drug reimbursement reforms proposed by the department following a public consultation in 2019. Currently, prices of medicines in Category A are subject to monthly adjustment. From 1 April 2024, these will be updated quarterly based on sales and volume data obtained by DHSC under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. The transition will conclude in July 2025 when the reimbursement prices will be exclusively determined by the new method. Advance notice for contractors regarding the 'new arrangements' has been outlined on the NHSBSA website. However, Community Pharmacy England (CPE) did not support the introduction of the changes at this time as pharmacies are currently grappling with "wider challenges" and there is uncertainty about the potential impact of these changes on the already "turbulent" medicines supply chain

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.