Group items tagged

The Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday (9 January) announced that the novel type 2 oral polio vaccine (nOPV2) has been quality-assured (prequalified) by the World Health Organization (WHO). Developed by a team including scientists from the MHRA, nOPV2 is considered a safer polio vaccine that helps to protect children from the disabling and life-threatening disease and lower the risk of vaccine-derived outbreaks. The vaccine received WHO Emergency Use Listing three years ago, and since then 950 million doses have been delivered worldwide. The UN health agency's decision to add it to the list of prequalified vaccines is based on the analysis of outcomes in vaccinated populations that has confirmed strong safety profile and effectiveness.

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 Medicines and Healthcare products Regulatory Agency (MHRA) has authorised a new drug today (1 November) to treat severe alopecia areata. Litfulo is the new hard capsule medicine with a recommended dosage of just 50 mg per day. It contains an active ingredient, ritlecitinib, an enzyme inhibitor treatment for patients over 12 years. Ritlecitinib works by reducing the activity of enzymes in the body called JAK3 and TEC kinases that cause hair follicle inflammation. This reduction in inflammation leads to hair regrowth in patients with alopecia areata. Alopecia areata is an autoimmune disease, where the body's own immune system attacks hair follicles leading to hair loss on the scalp and other parts of the body.

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.

The Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday authorised a Covid-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. The regulator authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.

AstraZeneca UK has revised the expiry dates for certain batches of Fluenz Tetra nasal spray vaccines as a precautionary measure, after finding that their potency (strength) dropped faster than predicted once thawed, during routine testing. The Medicines and Healthcare products Regulatory Agency (MHRA) has been informed by the manufacturer that the printed expiry date for a limited number of batches is "incorrect." However, the MHRA has assured patients that the affected batches are safe to use and fully effective within the amended expiry date. If the vaccine is administered after the amended expiry date, it may be less effective in protecting against flu, it said. The UK regulatory authority also reiterated that it "keeps the safety of medicines, including vaccines, under review, and acts where necessary to protect patients and the public."

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised an innovative and first-of-its-kind gene-editing treatment for sickle-cell disease and transfusion-dependent β-thalassemia. Known as Casgevy (exagamglogene autotemcel), the treatment is based on the innovative gene-editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. Casgevy is the first medicine to be licensed that uses CRISPR, and it is to be used for treating patients aged 12 and over. To date, a bone marrow transplant has been the only permanent treatment option for these life-long conditions, which in some cases can be fatal. The MHRA's authorisation came after a rigorous assessment of its safety, quality and effectiveness.

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.

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.

Maxwellia has appointed Ian Adamson as strategic advisor to shape the next phase of pharmacy medicine launches - a process which involves identifying and converting suitable prescription only medicines into versions people can choose to buy under the supervision of a pharmacist. Ian brings over 30 years' international consumer health and personal care experience to the Maxwellia team. He is currently an advisor to the board of the UK independent pharmacy chain Day Lewis plc, an advisor to the board of Spanish healthcare company ReVa Europe S.L and board advisor to East Midlands Pharmaceuticals Ltd. Prior to this Ian was Chief Commercial Officer and a main board director at SSL International plc (prior to its sale to Reckitt Benckiser) with responsibility for a $1bn portfolio of brands, which included Durex and Scholl. Ian's appointment follows the landmark reclassification of the progestogen only pill by the MHRA, a change spearheaded by Maxwellia, and the company's subsequent launch of its first product Lovima in July 2021; and the current MHRA public consultation on the reclassification of Maxwellia's new pharmacy brand, Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) for the treatment of overactive bladder symptoms which are not adequately controlled by bladder training alone.

The collapse of the three trading entities in the Converse Pharma Group (Testerworld Limited, Doncaster Pharmaceuticals Group Limited and Eclipse Generics Limited) (the Group) in May 2022 undoubtedly caused ripples throughout the pharmacy industry. The Group, a major supplier of pharmaceuticals, had a combined turnover over £300m, employed 1,000 staff members and supplied over 4,000 pharmacies throughout the country. The Group is licensed and regulated by the MHRA. At the beginning of 2021, a breach of the MHRA licensing regulations caused a temporary (but prolonged) cessation of trading. The Group was able to secure the ongoing support of its secured creditors during this time, however, when the licenses were subsequently reinstated, they came with restrictions. Unfortunately for the Group, the period of the suspension and the subsequent restrictions over the licences caused a significant reduction in revenue, from which the Group was unable to recover. Ultimately, by May this year, the companies in the Group had exhausted their working capital and had no prospect of raising the funding they required to continue to trade.

The recent announcement that Royal Mail will be partnering with distance selling pharmacy (DSP) giant pharmacy2U highlights how standards of regulatory enforcement are being ignored to accommodate the DSP model. The brunt of these double standards hinges around the levelling down of temperature enforcement standards by the Medicines and Healthcare products Regulatory Agency (MHRA) which demands mapping must be audited from the point of dispensing to the patient. The MHRA has a well recognised duty to ensure medicines reach patients in a safe condition. The current anomaly appears to turn a blind eye to this step in the supply chain at the point the wholesaler releases goods to the pharmacy hub. Equally the training on delivering medicines safely and effectively direct to patients should apply fully to all hubs including DSPs. Why is it that DSPs are being treated differently to bricks and mortar pharmacies? It's essentially the same patients receiving the same medicines from the same wholesalers. A further regulatory disparity exists around how parcels must be "tracked and signed for" to be reasonably certain medicines are delivered into the hand of the intended recipient, as per existing regulations. Clearly an untracked, unsigned package cannot be guaranteed to finish in the hands of the intended recipient. There is a very real possibility that such omission could lead to community pharmacy closures which will, in turn, lead to unemployment and a reduction in the care services. At a time when integrated care systems have just gone live, the removal of vital support services leading to further inequalities is the wrong message for both providers and patients alike.

Hundreds of children in England are set to benefit from a treatment for cystic fibrosis - Kaftrio, after the UK's Medicines and Healthcare products Regulatory Agency (MHRA) confirmed an extension to its licence. With the licence extension, more than 1,300 children in England with cystic fibrosis, aged six to 11, are newly eligible for this treatment, which improves lung function and improves overall quality of life of patients. Earlier, Kaftrio was only licensed for those aged 12 and above. British patients were the first in Europe to benefit from Kaftrio, when NHS England secured a landmark deal in June 2020. NHS chief executive Amanda Pritchard said: "Since NHS staff delivered one of the fastest rollouts of Kaftrio in the world just over a year ago, the lives of thousands of patients with cystic fibrosis have been transformed. "Innovative treatments like Kaftrio are life-changing for patients and their families, and that is why the NHS has done all it can since we secured the deal for Kaftrio to ensure patients benefit as soon as possible.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024. Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe. According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week. "We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot be hoarded or exported from the UK market. The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs. In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to patients across the UK. The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.

The Royal Pharmaceutical Society (RPS) has said that multi-buy deals on paracetamol violate the existing voluntary sales guidelines. The professional body is urging the government to pass legislation that prohibits retailers from making such offers on medicines for pain relief. They have also sent letters to MP Maria Caulfield who is the Minister for Mental Health and Women's Health. The Medicines and Healthcare Products Regulatory Agency (MHRA) is requesting to take action on the legislation at the earliest. The concern raised is that multi-buy offers such as 'buy one get one free' can encourage people to buy and store excess packs, which may lead to accidental or impulsive overdose.

The Medicines and Healthcare products Regulatory Agency (MHRA) has cautioned people to stop using certain eye gels, highlighting a potential risk of microbial contamination that can cause an infection. As a precaution, the agency on Friday announced recall of specific batches of carbomer-containing lubricating eye gels branded Aacarb, Aacomer and Puroptics, which are generally used to relieve the symptoms of dry eye. Burkholderia cenocepacia is suspected to have caused the microbial contamination, and the issue was raised after an ongoing investigation conducted by UK Health Security Agency (UKHSA) identified a small number of cases of infection. Investigations are on to determine if there is a link between these products and the infections which have been identified. Meanwhile, retailers have been told to withdraw the affected products, and users are asked to return their product to the place of purchase immediately.

Pfizer has recalled all stocks of Accupro - including 5mg, 10mg, 20mg, 40mg film-coated tablets - as a precautionary measure due to the identification of a nitrosamine above the acceptable limit. "Following testing, N-nitroso-quinapril, has been observed at a level above the acceptable limit. Nitrosamines may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. The recall is at pharmacy and wholesaler level," the Pharmaceutical Services Negotiating Committees (PSNC) reported. The Department of Health and Social Care (DHSC) said: "All strengths of quinapril (Accupro) tablets have been recalled with a resupply date to be confirmed. Pfizer are the sole supplier of quinapril tablets in the UK. Alternative ACE inhibitors remain available and can support an uplift in demand."