Group items tagged

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 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".

From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.

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.

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.

Hospitals and healthcare providers across the UK have been notified about the shortage of an anti-inflammatory medicine caused by a manufacturing failure. The Department of Health and Social Care (DHSC) on Friday (3 May) issued a National Patient Safety Alert stating that Erelzi 50mg solution for injection in pre-filled pen will be out of stock from early May until mid-July 2024. "The supply issues have been caused by a manufacturing failure resulting in delays in production and the implementation of global allocations," it said. However, it noted that homecare providers (Alcura, Healthnet and Sciensus) have sufficient stock to supply existing patients until mid/late May 2024. Although Erelzi 50mg pre-filled syringes (PFS) are still available, they cannot support a full increase in demand, the DHSC warned.

Following Community Pharmacy England's Parliamentary drop-in event on medicines supply issues last week, several MPs have since raised questions to the Health Secretary during a Health Questions session on July 18th. According to CPE, MPs from all Parties displayed great engagement with the current pressures facing community pharmacies, particularly regarding medicines supply issues. During last week's event, Mike Amesbury, the MP for Weaver Vale, was present and directed a question to the Health Secretary: "Eighteen community pharmacists in my constituency are reporting challenges with medicine supplies. What further actions will the Minister take to address and resolve this situation effectively?" In response, Health Secretary Steve Barclay MP stated, "We have a dedicated team in the Department that focuses on medical supplies, which are an ongoing concern. Challenges in this area are a routine part of our business."

Department of Health and Social Care (DHSC) has issued a medicine supply notification for GLP-1 receptor agonists used in the management of type 2 diabetes on Tuesday (27 June). "There are very limited, intermittent supplies of all glucagon-like peptide-1 receptor agonists (GLP-1 RAs) licensed in the management of Type 2 Diabetes Mellitus (T2DM)," said DHSC. The supply issues have been caused by an increase in demand for these products for licensed and off-label indications and it is not expected to return to normal until at least mid-2024. Pharmacists are urged to refer to the SPS Tool for Medicines Shortages for an up-to-date supply stock situation and clinical guidance on alternative treatment options.

The Royal Pharmaceutical Society (RPS) on Wednesday announced that it is spearheading a new project, which aims to delve into the root causes of the growing challenge of medicines shortages across the United Kingdom and provide solutions to mitigate its impact on patients and pharmacy practice. A newly formed advisory group, chaired by RPS Fellow Dr. Bruce Warner, is set to convene later this month. The group will have experts from primary and secondary care, patient advocacy groups, the pharmaceutical industry, suppliers, regulatory bodies, governmental representatives, and NHS officials. The group aims to formulate a robust report to provide expert thought leadership and support for the wider debate on UK policy. Their work will be informed by a thorough literature review, stakeholder interviews, online RPS member events, and patient stories.

The Royal Pharmaceutical Society (RPS) has urged the government to amend medicines legislation to allow pharmacists to make minor amendments to a prescription without any protocol being needed. RPS wants to see a change in the law that makes the whole process of supply of medicines easier and quicker, enabling pharmacists to use their knowledge and expertise in medicines to better support patients. "At present a prescription can only be changed by a prescriber, which causes unnecessary workload for GPs and delays for patients," said RPS. RPS President Professor Claire Anderson said: "We want to see all pharmacists across the UK able to supply a different quantity, strength or formulation of a medicine (for example changing capsules to tablets) when required, to avoid unnecessary bureaucracy and the need for an SSP to be developed, signed and authorised by a Minister. In effect it would mean that pharmacists can help patients straight away - it would future proof the problem to some degree.