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Community Pharmacy England (CPE) has explained MPs on instability that puts operational pressures on pharmacies, financial pressures on businesses at a Parliamentary drop-in event held on Monday (10 July). The association has been in Parliament today alongside patient representatives and others to highlight our ongoing concerns about medicines supply to MPs. It said: "Medicines supply remains a critical issue for community pharmacies with disruption causing problems both accessing medicines and procuring them cost effectively." In CPE's recent sector polling, community pharmacy owners rated medicines supply instability as being the most severe pressure facing their businesses. This echoed the results of CPE's Pressures Survey which found 97% of pharmacy owners survey are facing significant increases in wholesaler and medicine supply issues, with 71% saying this was leading to delays in prescriptions being issued. During the Parliamentary drop-in event, CPE talked MPs through the issues and set out what it believe needs to happen to resolve them, calling for- Reform of Serious Shortage Protocols; Allowing generic substitution; An overhaul of the concessions system; and a strategic Government review of medicine supply and pricing with a shift to focusing on how to improve the functioning of the supply chain rather than solely on the drive to depress prices and margins.

The British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, has made several recommendations to alleviate medicine shortages, which not only have serious consequences for patients but also increase workloads for pharmacists. England is currently experiencing twice as many medicine shortages as it did two years ago, with some products remaining out of stock for many months, the BGMA reveals in a report, noting that "the vast majority are commonly used generic medicines." "We have witnessed the number of products facing supply challenges double in the past two years and remain at a high level since September 2023," says BGMA chief executive Mark Samuels. In its report titled 'Solutions to UK medicines shortages' published on 1 October 2024, the BGMA proposes policy changes to tackle medicine shortages, including incorporating supply chain resilience and past performance in hospital medicines tenders. "Tender scoring should include whether supply issues were reported with adequate notice. Suppliers should be informed of changes in prescribing more quickly," the report says.

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.

The General Pharmaceutical Council (GPhC) has published updated guidance on online pharmacy services in Great Britain, introducing additional safeguards to prevent unsafe supply of high-risk medicines, including weight loss injections. Under the new rules, medicines used for weight-management and medicines requiring physical examination before a prescribing decision is made have been added to the list of high-risk medicines. When prescribing these medicines, prescribers can no longer rely solely on online questionnaires. Instead, they must independently verify patient information, either through timely two-way communication with the person, accessing the person's clinical records, or contacting the person's GP, their regular prescriber, or a third-party provider. These measures aim to prevent individuals from providing false information to obtain medicines that may not be clinically appropriate for them, reducing potential harm. The pharmacy regulator updated its guidance in response to concerns identified relating to unsafe prescribing and supply of medicines online.

Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages, EU Health Commissioner Stella Kyriakides said last week (January 17). Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European Commission's proposal to revise the pharmaceuticals legislation is planned for March. "Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said. Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says. The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides said. Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.

The British Generic Manufacturers Association (BGMA) has raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent. The Department of Health Social Care (DHSC) today announced that the 2019 voluntary scheme payment percentage for 2023 will be 26.5%. The 2019 voluntary scheme for branded medicines pricing and access is an agreement between the Department of Health and Social Care, NHS England and the Association of the British Pharmaceutical Industry. BGMA believes that the high VPAS tax for 2023 risks more medicines shortages, rising prices for the NHS via reduced competition, and new medicine launches to the UK being deferred. Mark Samuels, Chief Executive of BGMA, said: "Raising the VPAS tax to 26.5% will damage the UK's medicines supply because it will make some products lossmaking. It is more than a five-fold tax increase from 2021, and no industry can cope with this unpredictable and exceptional tax volatility.

The British Generic Manufacturers Association (BGMA) has sought a judicial review of the Department of Health and Social Care's (DHSC) decision to negotiate a new Voluntary Scheme for branded medicines with the Association of the British Pharmaceutical Industry (ABPI). Mark Samuels, Chief Executive of BGMA said: "The Government has decided not to involve the trade body representing these medicine suppliers in its negotiations on the voluntary scheme for branded medicine pricing (VPAS). "We are deeply concerned by this decision. It has left us no choice but to take legal action." "While not all generic drugs fall within VPAS, four out of ten products in the current scheme are branded generics or biosimilars. As the representative trade body for both generic and biosimilar UK manufacturers, we must play a full part in the VPAS negotiations for the next period of the scheme from 2024 to 2028." "The VPAS tax has risen five-fold in under two years, an unprecedented tax increase. Yet our sector currently has no input into the negotiations on future schemes or rates; this is untenable as any decisions made on VPAS could significantly define the future of our sector in the UK and its ability to supply the NHS. The association had raised its full participation in the negotiations with the Government last November.

Loughborough-based generic and branded pharmaceutical manufacturer Morningside Pharmaceuticals has donated almost 60,000 packs of essential medicines to communities impacted by the war in Ukraine. The donation, which includes 1.29 million doses, was made after the company's founder and chairman, Dr Nik Kotecha OBE, spoke with the Ukrainian ambassador to the United Kingdom, Vadym Prystaiko, at a business event in London. Dr Kotecha, who was also recently appointed a deputy lieutenant of Leicestershire, said: "The heartbreaking situation in Ukraine has touched us all, and like so many people in the United Kingdom, we've been keen to do everything we can to help the victims of this terrible conflict." The large shipment of medicines has been transported in a secure and temperature controlled environment via Morningside's logistics partner to the embassy's distribution hub in Poland. From there the medicines will be supplied to hospitals, healthcare centres and patients throughout Ukraine including the regions hardest hit by the Russian invasion.

The British Generic Manufacturers Association (BGMA) on Monday alerted the Health and Social Care Committee that medicines shortages have increased and are "around double what they were a year ago." BGMA chief executive Mark Samuels told the committee that they have been highlighting the medicine shortage risk to ministers since July 2021 and the association is "very concerned" about the current situation. "We've been monitoring it for several years now, and as you saw in the written evidence, shortages have increased. They're around double what they were a year ago. We have them at 101 shortages in February this year," said Samuels. Dr Rick Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), highlighted that the problem of drug shortages in the UK is a "long-standing issue" and the scarcity of certain medications "continues to be challenging".

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 National Pharmacy Association (NPA), representing independent community pharmacies, has called for tougher regulation of the online sale of weight loss jabs to protect patients amid a prediction of a new year's boom in demand. The association argues that current regulation "leaves the door open for medicines to be supplied without appropriate patient consultation and access to patient records." It has urged the General Pharmaceutical Council (GPhC) to require greater consultation with patients before dispensing weight loss jabs and other high-risk medication online. The association stressed that online sellers should not just rely on information provided in online questionnaires but also gather important historical medical information before a full two-way consultation between prescriber and patient. Draft guidelines on weight loss medication The GPhC proposed changes to their current guidance for online pharmacies to improve patient safety. It launched a consultation on the revised guidance on 17 September, inviting feedback until 9 October 2024 from the public, carers, pharmacists, pharmacy technicians, other healthcare professionals, and pharmacy owners. In its response to proposed guidelines on prescribing weight loss medication, the NPA highlighted critical gaps, stating that proposed safeguards "still leaves the door open for medicines to be prescribed/supplied without appropriate two-way direct patient consultation and access to patient records for a full clinical picture particularly where high-risk medicines are involved, and the risk to patient safety remains".

Department of Health and Social Care (DHSC) has issued a medicine supply notification for Clomifene (Clomid) 50mg tablets on Monday (5 June). It said: "Sanofi will be out of stock of clomifene (Clomid) 50mg tablets from w/c 12 June 2023 until w/c 18 September 2023." "Generic clomifene 50mg tablets remain available from Wockhardt who are able to partially uplift supplies until the end of July 2023. Unlicensed supplies of clomifene 50mg tablets may be sourced, lead times vary. Alternative medicines for use in infertility remain available," it added. The specialist importers- Orifam and Target Healthcare have confirmed to DHSC they can source unlicensed clomifene 50mg tablets. "If there is currently no listing on dm+d for the imported product for prescribers to select using their prescribing systems an EPS prescription for unlicensed clomifene 50mg tablets cannot be issued," said Community Pharmacy England.

Drug shortages have become a global issue, with many countries struggling to maintain a consistent supply of common medications, including antidepressants, immunosuppressants and drugs to treat type 2 diabetes and ADHD. Earlier last month, the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, warned that 111 products were facing supply problems, the highest on record in the UK, and more than double the number recorded at the start of 2022. More than half of products affected (55) are branded generic drugs, which represent 10 per cent of prescription products used in the UK. The trade body blamed the escalating rebate rate of the government's voluntary scheme for branded medicine pricing and access (VPAS) for these shortages, but Brexit is also cited as another reason for the problem.

A BBC investigation has found 20 UK online pharmacies selling prescription-only medicines without adhering to the regulatory standards, such as checking for GP approval or patient's medical records. The news organisation was able to purchase over 1,600 restricted pills, including anti-anxiety drug, painkiller and sleeping medication, from these regulated online pharmacies easily by providing false information. However, the report didn't mention the names of the drugs as "they can be dangerous when taken without medical guidance." Some pharmacies were also found selling high-risk and potentially addictive medicines, including benzodiazepines and antidepressants, based on online questionnaires and did not require further checks. The General Pharmaceutical Council (GPhC), which regulate online pharmacies in the UK, states that selling and supplying medicines at a distance brings "different risks which need to be appropriately managed to protect patient safety."

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.

With the UK General Election set for 4 July, pharmacy bodies are actively engaging with all political parties to secure support for the community pharmacy sector. They are pressing parties to address urgent issues such as pharmacy closures and medicine shortages. "The upcoming general election is a critical opportunity for us to strengthen supporters of community pharmacy in readiness for the new Parliament," said Janet Morrison, chief executive of Community Pharmacy England (CPE). She stressed the need for unity within the sector in advocating for community pharmacy and raising awareness of the issues with election candidates from all parties. As the general election approaches, CPE has called upon all political parties to support pharmacies by "introducing a long-term sustainable funding model and reviewing the medicines supply chain, including much-needed short-term relief measures."

The General Pharmaceutical Council (GPhC) is inviting feedback on proposed changes to its guidance for online pharmacies, aimed at enhancing patient safety. These changes are designed to tackle concerns associated with receiving medicines from online pharmacies, particularly those that may not be clinically appropriate and could potentially harm patients. GPhC has identified concerns relating to inappropriate supplies of weight loss medications that could pose risk to patients' health. Duncan Rudkin, Chief Executive of the GPhC, underscored the importance of addressing risks in online pharmacy services. "We know that there can be significant benefits for people using online pharmacy services to get medicines and treatment, but there are also additional risks that need to be managed, to make sure medicines and other pharmacy services are provided safely to patients and the public.

The World Health Organization (WHO) issued a warning on Thursday regarding falsified semaglutide medications used for treating type 2 diabetes and obesity in select countries. This WHO Medical Product Alert addresses three falsified batches of the specific brand Ozempic that were detected in Brazil (October 2023), the United Kingdom and Northern Ireland (October 2023), and the United States (December 2023). These falsified semaglutide products were distributed through the regulated supply chain. Novo Nordisk, the genuine manufacturer of Ozempic, confirmed that the three products mentioned in the alert are falsified and were not produced by the company. Healthcare professionals, regulatory authorities and the public are advised to remain vigilant regarding these falsified batches of medicines. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, urged stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.

The British Generic Manufacturers Association (BGMA) has warned of the significant implications for future supply as a result of the crippling VPAS rate. The warning comes after the association's judicial review into the Government's decision to bar it from being a full part of the negotiations for the next five-year VPAS period was dismissed. The voluntary scheme for branded medicines pricing and access (VPAS) is an agreement between the Department of Health and Social Care (DHSC), NHS England and The Association of the British Pharmaceutical Industry (ABPI). The scheme aims to limit increases in spending on branded medicines to no more than 2% per year via a rebate system which is charged on companies' sales revenues. Two years ago, the rate was 5.1%, but in 2023 it has soared to 26.5%. All biosimilars and a proportion of the generics market falls into the scheme.

The General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor agonists (GLP-1 RAs). The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that these are being widely prescribed for weight loss purposes and in some cases prescribed off-label." "We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams. The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.