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The European Commission is prepared to rewrite European Union law on medicines to ensure stable supply of generic and life-saving medicines in Northern Ireland. In a press statement issued on Friday (Dec 17), the commission said it put forward a package of measures to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland. In the context of the Northern Ireland Protocol, this means that the same medicines will continue to be available at the same time across the United Kingdom. Commenting on the news, policy manager at the National Pharmacy Association (NPA) Helga Mangion said: "We are encouraged by the EU's statement on medicines availability in Northern Ireland, though of course we await the final outcome of the negotiations. We have been talking to the government, the MHRA and other stakeholders about these issues for months, highlighting the concerns of our members in Northern Ireland."

A recent report by the British Generic Manufacturers Association (BGMA) has shed light on ongoing supply challenges in England's generic medicines market, revealing significant issues impacting patient care. The report highlights significant challenges faced in supply of medicines as currently, 51.72 per cent of generics in short supply lack licensed alternatives, posing substantial hurdles to ensuring continuous patient care. Additionally, 39.08 per cent of affected generics are branded, indicating widespread disruptions across the market. A notable 26.44 per cent of generics experiencing shortages have been affected for over six months, highlighting persistent difficulties in supply chain management. The report indicates that 0.15 per cent of generic medicine presentations listed in the Drug Tariff are currently facing supply issues, impacting accessibility nationwide.

Community Pharmacy England (CPE) to host a Parliamentary drop-in event in July to brief MPs and Peers about the ongoing medicines supply chain issues that are negatively affecting pharmacies and their patients across the country. CPE's Pressures Survey earlier this year highlighted the extent of both the operational and financial impacts of medicines supply issues on pharmacy businesses, therefore it has continued to hear from both pharmacy owners and others about the problems. The event aims to ensure that MPs understand the problems and their impact on pharmacies. Peter Dowd MP is hosting the event, joined by representatives from Community Pharmacy England, the Nuffield Trust, patient groups and more. The event will also be another opportunity to talk to MPs from across the political spectrum about the very serious situation that community pharmacies still find themselves in and the need for further investment in the sector. Janet Morrison OBE, Chief executive of Community Pharmacy England said: "The results of our Pressures Survey earlier this year showed just how much supply issues are continuing to negatively impact pharmacy businesses and all those who work in them. The survey found that almost all pharmacy owners (97%) are facing significant increases in wholesaler and medicine supply issues, with 71% saying this was leading to delays in prescriptions being issued.

The European Parliament on Thursday adopted a proposal from Brussels to ensure the continued supply of medicines from Britain to Northern Ireland - an issue that had dogged the bloc since London left it. "Great news from the @Europarl_EN today with the overwhelmingly positive vote to ensure the continued supply of medicines to Northern Ireland," tweeted Maros Sefcovic, European Commission vice president who had been leading discussions with London. "The EU is delivering on this lasting solution for Northern Ireland in record time," he added, though the EU Council must give final approval. Britain itself has yet to give formal approval on a move that would avoid potential disruption of supplies as London wants an overall accord for matters pertaining to the Northern Ireland protocol governing post-Brexit trade.

To curb the supply issue of HRT medicine, the government has taken a further action by issuing SSPs for Oestrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets - with appropriate alternatives. The move aims to allow community pharmacists to supply specified alternatives to the prescribed HRT products without needing to seek authorisation from the clinician who has prescribed the medicine. The regulator said that the availability of Premique Low Dose has impoved 'thanks to SSPs issued on 29 April to restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months' supply'. "Since these measures were implemented, further deliveries of all three products have been made, with Premique Low Dose returning to good availability this week. The manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking action to increase UK supply." It added, "SSPs restricting prescriptions to a maximum of three months' supply will also be issued for substitute products, as a precautionary measure to ensure the supply of those substitutes is maintained."

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."

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

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.

While Northern Irish business groups has welcomed the certainty a new EU-UK deal on post-Brexit trade rules for the region provided, the pharmaceutical industry too has expressed cautious optimism. In his speech on the Windsor Framework on Monday (February 28) Prime Minister Rishi Sunak said the agreement "delivers a landmark settlement on medicines". "From now on, drugs approved for use by the UK's medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland," he announced. The National Pharmacy Association's Northern Ireland manager Anne McAlister expressed a sense of cautious optimism. She said: "While the devil may yet be in the detail, the Windsor Framework would appear to be good news for pharmacies in Northern Ireland. It seems to address the main concerns we have expressed about medicines supplies to NI, but we want to examine the small print to ensure the new arrangements meet the needs of our members and the patients they serve.

Health and Social Care Secretary Sajid Javid and Madelaine McTernan, head of the HRT supply taskforce, continue to take urgent action to resolve the shortage of HRT medicines by meeting the drug manufacturers and representatives from community pharmacies on Thursday (May 5). In the meeting, manufacturers outlined the steps they're taking to boost supply, and pharmacists shared their experiences on the frontline, as well as sharing their thoughts on wider solutions including improved communications. Aspen Pharmacare, Besins-Healthcare, Gedeon Richter, Novartis, Novo Nordisk, Orion, Pfizer, Theramex, Viatris, and representatives from community pharmacies were part of the meeting. As the government confirmed its intention to work with industry to do what is necessary to fix the HRT supply issue, Javis said he wanted to understand the issues facing suppliers and what can be done to address them. "We will leave no stone unturned in our national mission to boost supply of HRT. Along with appointing Madelaine McTernan as head of the HRT supply taskforce to implement lessons learned from the pandemic, and ensuring prescriptions are issued in shorter cycles for now, we are working collectively with the sector to urgently resolve this issue," he commented. The Association of Independent Multiple Pharmacies (AIMp) said the meeting discussed 'why we got into this position' and the way forward.

The Department of Health and Social Care (DHSC) has issued a medicine supply notification for antibiotics for the treatment of Group A Strep. "Supplies of antibiotics for the treatment of Group A Strep have seen a surge in demand and may be temporarily in limited supply at certain wholesalers and pharmacies," said DHSC. "Supplies are available with manufacturers, and deliveries into wholesalers and pharmacies are being expedited and are expected in the coming days." If the formulation of antibiotic prescribed is unavailable, DHSC has asked clinicians and local pharmacy teams to consider prescribing an alternative form or strength of the antibiotic where appropriate, ensuring the patient is not intolerant to any of the excipients in the alternative and is counselled on the appropriate dose (and volume) required.

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot be hoarded or exported from the UK market. The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs. In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to patients across the UK. The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.

The Department of Health and Social Care (DHSC) has issued Serious Shortage Protocols (SSPs) on three HRT medicines to limit dispensing supply to three months. To ensure women across the UK will be able to more reliably access HRT products SSPs has been issued on the supply of Oestrogel, Ovestin cream and Premique Low Dose. DHSC stated, "Women who have a prescription for more than three months but are only able to access three months' supply will not have to pay an additional prescription charge." "This means women will not incur any additional costs. Imposing a three month limit will mean more women are able to access the medication they want. Any woman who is worried about access to HRT or is unable to access HRT should speak to her GP." Recently, Vaccine Taskforce Director General Madelaine McTernan has been appointed to spearhead a new HRT Supply Taskforce, applying lessons learned from the successful procurement seen during the Covid vaccination programme to identify ways to support the HRT supply chain ensuring it can meet both short and long term demand. The move will save time for patients as well as pharmacists and prescribers who are working tirelessly to tackle the covid backlog.

Professor Harry McQuillan has said community pharmacists in the UK must change their focus from an 'accuracy of supply' to a 'safety of supply' model when it comes to dealing with patients. "The main take away message from tonight's lecture is for pharmacy professionals to really challenge themselves about whether they are focused on accuracy of supply or safety of supply," he said at this year's UCL School of Pharmacy Lecture in London on Thursday, 15 June. "For our community pharmacists it must be about safety, including prescribing, and ensuring patients and citizens get the maximum benefit from prescribed medicines. "To deliver this, we need to invest in our teams - harness technology and always be willing to take the next step in a more clinical future." The Chief Executive Office of Community Pharmacy Scotland, however, noted that at a time when the UK was grappling with an unprecedented national debt crisis exacerbated by severe cost of living and spiraling inflation, community pharmacy will need to make a "compelling case" of where the priority should be in the sector. Expanding on the financial woes of the country, he compared the current national debt of the UK, which stood at a staggering 270 percent of GDP in September 2022, with the previous record-breaking national debt of 250 per cent at the end of WWII.

Pharmaceutical Services Negotiating Committee (PSNC) has expressed its support for alterations in the Human Medicines Regulations 2012 to enable original pack dispensing (OPD) and supply of medicines containing sodium valproate by pharmacists. PSNC's support for changes was in response to the consultation on OPD, initiated by the Department of Health and Social Care (DHSC). The consultation had proposed regulatory changes to allow pharmacists to dispense (up to 10 per cent) more or less than the prescribed quantity of a given medicine in the manufacturer's original packs. Key aims of the proposal are to "support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer's packaging about the safe and effective use of a product," DHSC said.

The Hormone Replacement Therapy (HRT) Taskforce head Madelaine McTernan has returned to working full time as the director general of the Vaccine Taskforce for autumn booster campaign preparation. She has presented a few key recommendations to help ensure continued HRT supply to meet rising demand. "Improved access to data on prescriptions to more easily see where there are shortfalls between HRT packs prescribed and HRT packs supplied by manufacturers," she suggested. "Taking lessons from the HRT supply chain work to inform broader medicine supply work." Madelaine said: "I am pleased to see the situation with HRT supply is improving across the country. I want to thank suppliers and manufacturers for their engagement and positive action to tackle this serious issue.

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 Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October. The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany. However, there has been no evidence that fake Ozempic has been supplied to UK patients. Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with regulatory partners to ensure patients' safety. He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for use in the UK. "Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.

With higher than usual number of cases of scarlet fever, caused by invasive Group A streptococci (iGAS) infections being reported in children across the country, Chief Pharmaceutical Officer for England David Webb has assured pharmacies of sufficient supply of antibiotics. In a letter, shared by the PDA, Webb also urged the pharmacies to order antibiotic stocks sensibly. "Local pharmacy teams may be experiencing a temporary interruption of supply of some relevant antibiotics due to increased demand. On a national level, sufficient stock exists for the NHS," he said. He said NHS is working closely with the Department of Health and Social Care (DHSC) and has taken actions to help ensure medicines continue to be available. He explained that the supplies of antibiotics for the treatment of Group A Strep, particularly phenoxymethylpenicillin presentations, have seen a surge in demand, leading to potential constraints at certain wholesalers and pharmacies,