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The Medicines and Healthcare products Regulatory Agency (MHRA) is doubling down on its efforts to combat online pharmacy frauds, emphasising innovation, eradication of legacy systems, and cybersecurity in its updated technology roadmap. The online sale of medicines and medical devices is a "growing phenomenon offering convenience, anonymity, and lower prices " for the public. However the lack of robust cyber monitoring also "poses significant risks", as many online pharmacies are "unregulated, illegal, or fraudulent." According to the MHRA's recent report highlighting the impact of artificial intelligence on the regulation of medical products, the strategic themes of "fundamental to the successful deployment of AI" are essential for protecting consumers from fraudulent medical products.

Highlighting the growing workforce challenges in the UK, a new report has indicated that nearly one in five (18 per cent) flexible health and care sector workers, engaged in agency work through private providers, might leave the sector in the next two years. With tens of thousands of flexible staff working within the sector every week, providing care for thousands of people, the report cautioned that failure to address their concerns could result in poor system performance and patient experience. The report is based on views drawn from over 10,000 flexible health and social care professionals, including a significant number of those working in pharmacy, gathered by strategic workforce partners Acacium Group. According to the report, 24 per cent of workers surveyed reported feeling overstretched by their workload, contributing to burnout and dissatisfaction. Concerns about working conditions and the level of support from management were cited as key reasons why some healthcare professionals are considering leaving the sector.

In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.

Two Indian pharmaceutical companies, Cipla and Glenmark, are pulling back certain products from the American market due to manufacturing concerns, according to the US Food and Drug Administration (USFDA). A New Jersey-based subsidiary of Cipla is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution due to "short fill", news agency PTI reported, quoting the latest Enforcement Report issued by the US health regulator. Produced at the company's Indore SEZ plant, this medication is used to manage symptoms associated with lung diseases, such as asthma, chronic bronchitis and emphysema. Cipla USA decided to recall the affected lot following complaints of less fill volume in respule and few drops of liquid observed in the intact pouch, the USFDA said, adding that the drug maker initiated the Class II recall in the US market on March 26 this year.

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

The latest formulation of XGEVA (denosumab) is now available to patients in the UK, offering a more convenient treatment option for bone metastasis. It is the first product to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new International Recognition Procedure (IRP). Denosumab (XGEVA) is used to prevent serious bone-related complications resulting from bone metastasis in adults and to treat giant cell tumour of bone in both adults and adolescents. The medicine was authorised on 29 February 2024 as a 120 mg solution for injection in a prefilled syringe. In contrast to the current vial presentation, this simplifies the administration process, reducing the volume of liquid injected and lowering the risk of dosing errors. The product was authorised in 30 days by the MHRA, thanks to the new IRP that facilitated a rapid approval process.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."

The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.

The outbreak of Burkholderia cepacia complex (Bcc) in the UK, which is associated with contaminated eye gels imported from India, has led to the death of one person, and many others falling ill, according to a government report. Bcc is a group of antibiotic-resistant bacteria that are widely found within the environment. Although it rarely causes infection, it can result in severe ones in individuals with compromised immune systems and those living with cystic fibrosis, the UK Health Security Agency (UKHSA) said. Between January 2023 and February 2024, there were 52 confirmed and six probable cases across the UK linked to the bacteria outbreak, as revealed in the Health Protection Report published by UKHSA. Forty-one of these cases were hospital inpatients, 38 of which were in critical-care settings. Twenty-five cases were considered to have "clinically significant infections attributable to Bcc", out of which 11 had eye infections, nine had respiratory infections and four had bacteremia (bacteria entering the bloodstream). Two individuals with cystic fibrosis (CF) were infected, and while one was treated, the other died, with the report indicating Bcc infection to have "contributed to the death."

With scarlet fever currently circulating in England, the UK Health Security Agency (UKSHA) has urged parents to remain vigilant for potential symptoms in children. Also known as scarlatina, it is an infectious disease triggered by group A strep bacteria that can lead to symptoms such as fever, a sandpapery rash, sore throat and swollen tonsils. The latest data published by the UKHSA showed that a total of 19,528 cases of scarlet fever were reported in the 2023/24 season, of which 12,176 cases occurring between 1 January and 24 March 2024. While the number of cases recorded this year is lower than those recorded during the same period in 2023, which totaled 15,933 cases, it exceeds the average for the previous five years. "Scarlet fever is a common childhood illness, although it can affect anyone of any age," said Dr Theresa Lamagni at UKHSA. Parents are advised to contact their GP practice or NHS111 when their GP is unavailable, if they suspect they or their child are experiencing symptoms of scarlet fever.

Global logistics company, JAS has received the Wholesale Distribution Authorisation (WDA(H)) license from the UK's Medicine and Healthcare Products Regulatory Agency (MHRA) for its Pharma and Healthcare Division. In a press release issued on Thursday (22 February), the company said that securing the license empowers its UK healthcare division to "seamlessly connect" with its more than 40 GDP (Good Distribution Practice) certified overseas stations, strengthening its capabilities for handling pharmaceutical shipments. Headquartered in Atlanta, Georgia, USA, the company boasts a team of over 7,000 professionals, with operations spanning over 100 countries. Adrian Frodsham, Regional Director for JAS, said that they were granted the WDA(H) license after a "stringent audit process." "JAS UK's pharma and healthcare division prides itself of offering innovative solutions for the international delivery of pharmaceutical products, further enhancing the growth of our pre-established healthcare division," he added.

The government will on Thursday launch a drive to boost childhood vaccination rates, health authorities said, seeking an "urgent reversal" to a fall in uptake as the country faces a worsening measles outbreak. Routine childhood immunisations in Britain for diseases including measles, mumps and rubella, diphtheria and polio, have been falling gradually over the past decade, but dipped more sharply after the Covid-19 pandemic, mirroring a global decline. Last year UNICEF said people worldwide had lost confidence in the importance of routine childhood vaccines during the pandemic, with misinformation, dwindling trust in governments and political polarisation contributing to rising hesitancy. Britons will begin seeing adverts from next week across various media, including a television campaign featuring children reminding parents of the risk of missing out on vaccinations, the UK Health Security Agency (UKHSA) said. "We need an urgent reversal of the decline in the uptake of childhood vaccinations to protect our communities," UKHSA chief executive Jenny Harries said in a statement.

The drop in vaccination rates is believed to be driving a surge in measles cases in England, mainly in the West Midlands. As of 18 January, 216 confirmed cases and 103 probable cases have been reported in the region since 1 October 2023, the UK Health Security Agency (UKHSA) revealed. The majority of cases (around 80 per cent) were from Birmingham, with children aged under 10 years being infected the most. UKHSA Chief Executive, Professor Dame Jenny Harries has warned that the outbreak could spread further to other towns and cities if urgent action is not taken to increase Measles, Mumps and Rubella (MMR) vaccination uptake in areas at greatest risk.

Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use. It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed "when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient." Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions. Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

Eli Lilly's weight-loss medicine Mounjaro, also known as tirzepatide, will be available in the UK within weeks as a four-dose pre-filled injection pen. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the drug to treat adults with type 2 diabetes and for weight management in obese patients. Branded as Mounjaro KwikPen, the injection is to be used together with a reduced-calorie diet and increased physical activity, the regulator said. "The public health importance of safe and effective treatments to help manage diabetes and obesity, which can have a significant impact on people's health, is clear. "This approval enables access to the approved Mounjaro pen in a more convenient presentation of a month's treatment, of one dose per week," said Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access.

Researchers from the London School of Hygiene & Tropical Medicine (LSHTM) have been tasked to evaluate the impact, safety and effectiveness of the Pharmacy First service, which was launched across England in January 2024. They have been awarded £2.4million by the National Institute for Health and Care Research (NIHR) to generate evidence on the new service that allows pharmacies to provide advice and treatment for seven common conditions without the need for a GP appointment. After consultation, if necessary, a community pharmacist can supply some prescription-only medicines to treat earache, sore throat, sinusitis, impetigo, shingles, infected insect bites or uncomplicated urinary tract infections in women. The LSHTM researcher team will be working together with experts at the UK Health Security Agency (UKHSA) and the Universities of Oxford, Manchester and Nottingham on the project. Dr Rebecca Glover, assistant professor in Antimicrobial Resistance at LSHTM, who will lead the three-year project, said they will evaluate "Pharmacy First's impact on GPs and the wider NHS, pharmacy services and patients."

In a collaborative effort, the National Health Services England (NHSE) is set to deliver the RSV(respiratory syncytial virus) vaccination programme where pharmacists alongside other healthcare professionals will play a crucial role in administering the vaccine. The UK Health Security Agency has announced the launch of the new vaccination programme targeting the respiratory syncytial virus (RSV), set to begin on 1 September 2024. Along with GPs, NHS England (NHSE) will "commission a number of community pharmacies to deliver the programme", ensuring broad accessibility and coverage to protect two high-risk groups: older adults and pregnant women. RSV is an RNA virus related to mumps, measles, and human parainfluenza viruses. It commonly causes coughs and colds in winter, transmitted through droplets and secretions from close contact with infected individuals. While most RSV infections are mild, infants under six months and the elderly are particularly susceptible to severe diseases like bronchiolitis and pneumonia, which can lead to hospitalisation.

On June 3, Synnovis, a pathology laboratory serving several NHS organisations in South East London, was targeted by a ransomware attack. This cyber incident has disrupted vital blood testing services, crucial for a range of medical treatments, and raised significant concerns over data security. NHS England confirmed that a cybercriminal group, Qilin, published data online, claiming it was stolen from Synnovis. The National Crime Agency (NCA) and the National Cyber Security Centre (NCSC) are currently working to authenticate the data and understand its contents. A helpline has been established to address patient concerns, and NHS England urges patients to attend their appointments unless otherwise directed. The attack has rendered some of the NHS's blood testing systems inoperable, causing substantial disruption to medical services in South East London.

Healthcare professionals in the UK are being advised to avoid prescribing the migraine and antiseizure medication topiramate, commonly known by the brand name Topamax, to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme. This guidance follows new safety measures introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) following a major safety review, which highlighted a potential increased risk of neurodevelopmental disabilities in children exposed to topiramate during pregnancy. The Commission on Human Medicines (CHM) evaluated studies that examined the risks associated with using topiramate during pregnancy. These studies indicated that children born to mothers who took topiramate during pregnancy had an approximately 2 to 3 times higher risk of intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder. Based on CHM's recommendations, the MHRA now advises that topiramate should not be prescribed for treating epilepsy during pregnancy unless there is no suitable alternative.