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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.

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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.

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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 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.

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Presently, In the US, around 12% of women develop breast cancer over the course of their lifetime. In Canada, an estimated 26,900 women were expected to be diagnosed with breast cancer in 2019 and breast cancer accounts for nearly 25% of new cases of cancer among Canadian women. Download complete report summary @ http://bit.ly/2vsEa1D

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 Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery. The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn. MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.

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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."

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 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."

Three leading healthcare bodies in Scotland have called for action to reduce the environmental impact caused by medicine prescribing. The Academy of Medical Royal Colleges and Faculties in Scotland, Royal Pharmaceutical Society and the Royal College of General Practitioners Scotland have all urged policymakers to enable a more sustainable approach to prescribing. This includes prioritising the introduction of electronic prescribing across the NHS, introducing the requirement for an environmental impact in NHS medicines procurement and improving the availability of data about the environmental impact of medicines. "We call on Scottish government, including the chief medical officer, to enable the delivery of a realistic medicine approach to prescribing by developing a supportive infrastructure for green social prescribing across Scotland," said the healthcare professionals in a joint statement. They have called on the pharmaceutical industry to make information about the environmental impact of medicines readily available in a standardised data format.

Community Pharmacy England (CPE) has notified pharmacy teams that starting 1 August 2024, three Hormone Replacement Therapy (HRT) medicines will be discontinued and will no longer be covered under the NHS HRT Prescription Prepayment Certificate (HRT PPC) scheme. These are Bedol® 2mg tablets, Climanor® 5mg tablets and Clinorette® tablets. Since Climanor® 5mg tablets have been discontinued, Medroxyprogesterone 5mg tablets will also be removed from the HRT PPC list, as this generic product is no longer available as a licensed HRT medicine. The CPE also noted that Provera® 5mg tablets, being an unlicensed HRT medicine, are not covered by the HRT PPC. Pharmacy staff are advised to check the NHS Business Services Authority (NHSBSA) website for the most current list of HRT medicines covered by the HRT PPC. The CPE has updated its HRT PPC medicines list to reflect these changes, which will also be updated in Part XVI of the August 2024 Drug Tariff.

The NHS is on track to miss out on savings of over a billion pounds as patents for a new lineup of 85 biologics are set to expire within the next five years, the British Generic Manufacturers Association has revealed in its new study. The government's Voluntary Scheme for Branded Medicines Pricing and Access is expected to lead to a cost of more than £1 billion for the NHS in the coming years. The BGMA research found that more than 85 biological medicines will experience loss of exclusivity during the upcoming VPAS Scheme period from 2024 to 2028. "This includes blockbuster products like the cancer medicine Keytruda and wet macular product Eylea, which together generate approximately $25 billion in global sales," BGMA said. "The molecules coming off-patent also cover other disease areas including oncology, diabetes, arthritis, and asthma." While biological medicines dominate the medicines budget, constituting the largest cost and cost growth sectors, NHS England aims to expedite biosimilar availability, yielding substantial savings and expanding patient access to vital treatments. Yet, the report found that "this is jeopardised by the influence of the VPAS Scheme".

The NHS claims that it's been able to save taxpayers £1.2 billion in just three years by procuring hundreds of hospital medicines at a better price. The adoption of cheaper versions of a single drug - adalimumab - which is used to treat more than 45,000 patients with rheumatoid arthritis, inflammatory bowel disease and psoriasis, has accounted for about one third of the savings. After the exclusive patent on the drug - originally known as its brand name Humira - expired in 2018, the NHS struck cost-saving deals to bulk-buy generic versions, which have the same quality, safety and efficacy of a branded one. Since then, tens of millions of pounds have been saved by buying cheaper generic versions of other medicines for conditions ranging from severe skin infections to aggressive blood cancers. Four in five medicines prescribed in the NHS are now non-branded, helping the NHS to achieve significant savings while ensuring the continuity of high-quality patient care. NHS chief executive Amanda Pritchard said: "Smart deals by the NHS mean patients are getting the best medicines and taxpayers are getting best value.