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Maxwellia has revealed its plans to switch some of its medicines in the self-care category from prescription-only-medicine (POM) to a pharmacy (P) medicine. After authorising the switch of Maxwellia's two brands of desogestrel contraceptive pills, Lovima and Hana, MHRA has opened a public consultation on reclassification of Aquiette (overactive bladder treatment) 2.5mg tablets manufactured by the company to be made available from pharmacies. "Maxwellia is currently looking at a number of medicines which treat a range of conditions in major public health categories that can be 'switched' from needing a prescription to being conveniently bought at a local high street or supermarket pharmacy. With its foot firmly on the accelerator it has other applications under assessment with the MHRA, including women's health products," the company stated in a recent statement. "Push to convert more prescription medicines to pharmacy medicines will firmly position pharmacists at heart of nation's public health, helping futureproof NHS," the medicine said.

The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) has seized a quantity of suspected unlicensed medical products including unlicensed versions of Botox, numbing agents and dermal fillers in Bolton, Greater Manchester. Officers from the MHRA and Greater Manchester Police conducted a raid across nine addresses in Bolton, Westhoughton and Leigh in the early hours of Thursday 13 July 2023, where two women and a man were arrested. Andy Morling, MHRA Deputy Director of Criminal Enforcement said: "Medicines like these are powerful and dangerous in the wrong hands, potentially leading to serious adverse health consequences. The criminals trading in these products are not only breaking the law, they also have no regard for your safety. It is illegal to advertise, sell or supply medicines such as these without the appropriate authorisation. If you see these products, or any other powerful medicines, being sold on social media or elsewhere online, think. It's unlikely to be legitimate. You can help the MHRA take action by reporting concerns to us through our Yellow Card scheme.

The European Association of Hospital Pharmacists (EAHP) published a shortage supply report on 17 October. They have officially stated that the shortage has resulted in care delays affecting 58 countries in their recent survey. It has been found in the report that 59 per cent of pharmacists said medicines shortage had delayed patient care, whereas 43 per cent confirmed it resulted in suboptimal treatment and 35 per cent said that it had led to the cancellation of care. András Süle, president of the EAHP spoke on the findings of the report, saying: "Problems caused by medicine shortages remain serious, threaten patient care in hospitals and require urgent action".

The Department of Health and Social Care (DHSC) launched a new Innovative Medicines Fund on Tuesday (June 7) under which £340 million has been made available to purchase potentially life-saving drugs early. This will allow NHS patients in England to have early access to potentially life-saving and cutting-edge treatments Health secretary Sajid Javid said: "I want NHS patients to be the first in the world to access the most promising and revolutionary treatments that could extend or save their lives. "The launch of the Innovative Medicines Fund delivers another manifesto pledge and will fast-track cutting-edge medicines to adults and children to give people renewed hope for a better future." A total of £680 million has been ringfenced for the Innovative Medicines Fund and Cancer Drugs Fund - £340 million each - to fast-track medicines to NHS patients. DHSC said: "The Innovative Medicines Fund will provide quick access to novel treatments, including potentially lifesaving gene therapies for serious conditions with few treatment options. It often takes longer for pharmaceutical companies to collect data on a medicine's clinical and cost effectiveness for rare diseases due to the smaller patient cohort.

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.

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.

A couple in Maidenhead, Berkshire has been handed suspended sentence for illegal possession and supply of £1.6m of unlicensed medicines. Following investigations initiated by the MHRA, Karina Filimonova and Andrejs Stolarovs were caught with the unlicensed medicines which included prescription-only medications. Southwark Crown Court sentenced each "to eight months imprisonment suspended for 18 months and 150 hours unpaid work" for possessing and intending to supply medicinal products contrary to the Human Medicines Regulations 2012. "This was a sophisticated operation illegally bringing unlicensed medicines into the UK from Singapore and India, and then distributing them across the country and abroad," said Andy Morling, MHRA Deputy Director of Criminal Enforcement. "Criminals trading in medicines illegally like this are not only breaking the law, but they also have no regard for your safety. These are powerful medicines that can lead to serious adverse health consequences if taken without appropriate medical supervision." In 2020, the Royal Mail Group (RMG) informed the MHRA about parcels containing unlicensed medicines discovered during their investigation into suspicious parcel activity. Following this, the MHRA's Criminal Enforcement Unit, in cooperation with local police, launched an investigation and apprehended the couple at their residence in Kidwells Close, Maidenhead.

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.

Approximately 25 million GP appointments and 5 million A&E visits are utilised each year for self-treatable illnesses. If these individuals chose to self-treat using over-the-counter (OTC) medications, the potential savings for NHS could amount to at least £1.7 billion annually, according to a research commissioned by Proprietary Association of Great Britain. The study, conducted by analysts at Frontier Economics, revealed that embracing self-care could bring an additional economic benefit of £350 million annually, as employees would avoid unnecessary time off from work for medical appointments. Apart from the savings resulting from the increased OTC medicine use, the report emphasises the potential benefits of reclassifying more prescription-only medications (POMs). A mere 5 per cent reduction in NHS prescribing levels and spending could lead to an annual cost-saving of £1.4 billion, encompassing both prescription costs and GP appointments, it said. "This substantial amount could greatly alleviate financial pressures on the NHS and offer essential resources for recruiting and training much-needed healthcare professionals."

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 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."

A report released by the Independent Commission has blamed Brexit supply issues for medicine shortages. NHS is forced to pay extortionate prices to fulfil the demand for vital antibiotics, anti-depressants, Attention Deficit Hyperactivity Disorder (ADHD), and Hormone Replacement Therapy (HRT) drugs. The report highlights the impact of affected medicine supply issues on community pharmacies and patients. Janet Morrison, the chief executive of Community Pharmacy England, backed the report and said that the "medicine shortages and market instability appear to be as bad as they have ever been". She also explained how the Ukraine conflict, the COVID-19 pandemic, and broader economic instability also play a major factor in the situation.

The 'Life and Health Sciences Launchpad' has been introduced to focus on the precision medicine sector. It would help businesses and researchers to level up their impact on economic growth within the region. The launchpad has been funded by Innovate UK, part of UK Research and Innovation (UKRI). Kerry Curran, Director of GB & EU Trade in the Department for the Economy hailed the decision to support NI's "trailblazing" sector. She said: "Life and Health Science, including our highly innovative precision medicine cluster, is an area the Department is also prioritising through its 10X Economy Vision, and this Launchpad represents a further endorsement of the world-leading growth potential of precision medicine, and indeed life and health science, in Northern Ireland.

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.

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.

The National Pharmacy Association (NPA) has asked the Secretary of State for Health and Social Care to convene a 'medicines supply taskforce', following weeks of problems with antibiotics supplies. The NPA's chief executive Mark Lyonette wrote a letter to Steve Barclay this week. It cited the precedent of the HRT Taskforce which this summer brought together representatives from across the supply chain after months of supply problems affecting women. "We strongly believe that this situation calls for a similar response from the government. It is imperative that we resolve this supply situation urgently and therefore we request that you convene a Medicines Supply Taskforce, with all the relevant stakeholders in the supply chain, to urgently discuss and agree practical solutions to address the disruptions to the supply of medicines. HRT and antibiotics are the most visible examples of a wider problem with medicines supply which needs to be addressed." NPA board members Olivier Picard and Reena Barai were among the stakeholders joining meetings convened by the HRT Taskforce this summer.

Adding to the growing evidence of global medicine shortages, a new study has revealed that the European generic medicines market is "not in shape" to help Europe meet its public health priorities. In the past decade, the rate of generic medicines withdrawals has risen by 12 per cent, while there has been a three per cent decrease in the launch of generic products, as per Teva Pharmaceuticals' recent analysis of IQVIA data. Within the mental therapeutic area, seven per cent of generic products disappeared between 2013 and 2023, while there was a seven per cent decrease in the availability of generic cancer medicines in just six years (2017-2022). These medicines were listed on the Union List of Critical Medicines to help avoid potential shortages, as the European Commission (EC) said this could cause "significant harm to patients and pose important challenges to health systems." While mature generic products constitute the majority of the List, they remain susceptible to withdrawals, despite containing products crucial for safeguarding Europe's public health, the Teva analysis report noted. Since 2013, the number of generic products for the treatment of schizophrenia and bipolar disorder has declined by 25 per cent, with Hungary and Bulgaria experiencing the biggest loss at 83 per cent and 58 per cent respectively.

The NHS in Suffolk and North East Essex has launched a new campaign to reduce the amount of unused medicines that cost the NHS around £300 million a year. Across the UK, it is estimated that £100 million worth of medicines are returned to pharmacies, with an additional £90 million of unused prescription medicines stored in homes. Through social media, posters, and videos, people are encouraged to return unused prescriptions to pharmacies and avoid stockpiling or throwing them away. Reducing medicines waste not only saves money that can be reinvested into patient care within the NHS, but it's also better for the environment. Tania Farrow, who is leading the campaign on behalf of NHS Suffolk and North East Essex Integrated Care Board (ICB), highlighted that everyone has a part to play in reducing medicines waste.

The Government has been forced to intervene formally 50 times in the past two years to authorise the use of alternative drugs because of serious medicine shortages hitting patients, new analysis by the National Pharmacy Association (NPA) has found today. 78 per cent of all Serious Shortage Protocols, produced by the Department of Health and Social Care (DHSC) due to medicine shortages, were issued in 2022/24 - more than three times the rate in the previous two years. The NPA, which represents independent community pharmacies in the UK, is warning that shortages are leading to pharmacists having to increasingly turn patients needing vital medication away. Analysis by the NPA of the NHS's Serious Shortage Protocols (SSPs) issued to pharmacies and other providers over the last five years has found that: The number of SSPs issued in the last two years is 3.5 times higher than in the previous two years.

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