Group items tagged

Lapses in strategies to tackle COVID-19 this year continue to create the perfect conditions for a deadly new variant to emerge, as parts of China witness a rise in infections, the head of the World Health Organization said on Friday (December 2). The comments by WHO Director-General Tedros Adhanom Ghebreyesus mark a change in tone just months after he said that the world has never been in a better position to end the pandemic. "We are much closer to being able to say that the emergency phase of the pandemic is over, but we're not there yet," Tedros said on Friday. The global health agency estimates that about 90% of the world's population now has some level of immunity to SARS-COV-2 either due to prior infection or vaccination. "Gaps in testing … and vaccination are continuing to create the perfect conditions for a new variant of concern to emerge that could cause significant mortality," Tedros said. COVID-19 infections are at record highs in China and have started to rise in parts of Britain after months of decline.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has asked the pharmacies and wholesalers to stop supplying and quarantine all remaining stock of Dr Reddy's Laboratories (UK)'s Lacidipine 4 mg Film-Coated tablets. The company has recalled two batches of Lacidipine 4 mg Film-Coated tablets as a precautionary measure due to the presence of an unknown solvent-like odour. MHRA said: "The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing. "The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated tablets marketed by Dr Reddy's Laboratories (UK) are not affected."

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 UK Health Security Agency (UKHSA) said last week (Aug 5) there were "early signs" that the monkeypox outbreak was plateauing across the country and that its expansion had slowed. "While the most recent data suggests the growth of the outbreak has slowed, we cannot be complacent," Dr Meera Chand, director of clinical and emerging infections at UKHSA, said. There were 2,859 confirmed and highly probable cases of monkeypox in the UK as of Aug. 4, with nearly 99 per cent of the cases among men, the country's health authority said in a statement. The recent analysis by the UKHSA showed that "monkeypox continues to be transmitted primarily in interconnected sexual networks of gay, bisexual, or other men who have sex with men", it added. British authorities in June were recommending gay and bisexual men at higher risk of exposure to monkeypox be offered a vaccine, as the outbreak of the viral disease had gathered pace, mostly in Europe.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Committees of Advertising Practice (CAP) have issued a joint enforcement notice about the 'illegal' advertising of Kenalog injections on digital platforms. The notice warns all organisations offering Kenalog as a 'hay fever treatment' to stop advertising it in any of their social media or website advertising. "Kenalog is a prescription-only medicine (POM), which must not be directly or indirectly advertised to the public. Kenalog is not licensed for the treatment of hay fever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely on social media," said MHRA. "Now, advertisers must ensure that all references to Kenalog in the text, images or emojis on social media are removed, as well as commonly-used descriptive phrases for the jab such as 'hay fever injection' or hay fever jab' or any account names, testimonials or memes by 29 August 2022." After this date, the CAP's compliance team will remove non-compliant ads using targeted software and those who continue to promote it may be referred to the MHRA for further enforcement action.

Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines and Healthcare products Regulatory Agency (MHRA). The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period for at least one year. The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public consultation. The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists, the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

British health officials on Wednesday (September 28) warned that increased circulation of flu and a resurgence in Covid-19 could lead to a difficult winter that increases pressure on the already stretched NHS. Warnings over a possible "twindemic" of Covid-19 and flu have been issued each winter since the start of the coronavirus pandemic in early 2020, but Covid restrictions that limited social contact have meant flu levels stayed low. However, the government ended coronavirus restrictions earlier this year, meaning that social contact rates have returned to near pre-pandemic norms while immunity to flu is relatively low. The UK Health Security Agency (UKHSA) said that given the risk it was important those eligible took up vaccines against Covid and flu. "There are strong indications we could be facing the threat of widely circulating flu, lower levels of natural immunity due to less exposure over the last three winters and an increase in Covid-19 circulating," said Susan Hopkins, chief medical advisor at UKHSA.

Water is the lifeblood of any business - employees must stay hydrated and productive, and it's needed for many industrial processes. That's why businesses need to filter their water and remove any harmful contaminants. Here are six major reasons why businesses should filter their water. HEALTH HAZARDS Unfiltered water can contain harmful contaminants like bacteria, viruses, and parasites that can cause serious health problems. If these contaminants get into the water supply, they can make employees sick and lead to absenteeism. In some cases, these contaminants can even be deadly. Therefore, if you notice that your employees are getting sick more often, it could be because of the water they're drinking. Other signs could be discolored water, strange taste or odors, or water that contains sediment. Regular water testing and investing in a quality water filtration system can help to remove these contaminants and keep your employees healthy. On the other hand, there are regulations and guidelines in place to make sure that the water supplied to businesses is safe. The Environmental Protection Agency (EPA) regulates public drinking water, and businesses are required to follow these regulations.

Colonis, a subsidiary company of the Clinigen Group has received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for Melatonin 1mg/ml Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD). Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset insomnia. Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children. The prevalence of sleep onset insomnia in children with ADHD ranges from 25%-50%. Sleep onset insomnia in children with ADHD can affect their mood, attention, behaviour and school performance. Henno Welgemoed, Director of Medical Affairs at Colonis said: "We welcome the MHRA's approval for a condition that negatively affects the quality of life for children and adolescents diagnosed with ADHD and increases the burden for support networks."

The National Pharmacy Association (NPA) and BeWell are working together to help provide efficiencies and productivity that address the growing pressures within community pharmacy. BeWell's Pharmacy Management Platform provides robust solutions that include Patient Relationship Management, Omnichannel Communications and Engagement, Services and Bookings Management, access to patient records, NHS Login supported Patient Application, and repeat prescription capabilities for Pharmacy Website and Patient App that include integrations with Surgery Online Services. This single interoperable platform is also integrated with pharmacy PMRs, connecting back office and administrative functions with front-of-house digital patient experiences. In line with the NPA's vision, BeWell has taken a leading role in formulating a unique ecosystem of pharmacy partners uniting marketing agencies, PGD-based service providers, and delivery method partners - integrating their capabilities within the BeWell platform.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice from the CHM's working group on the safe and effective use of AAIs. Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe. Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could save your life."

Diabetes drugs that also promote weight loss such as Novo Nordisk's Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer's disease. Diabetes regimens, from Ozempic to old mainstays like insulin and metformin, appear to address several different aspects of the metabolic system implicated in Alzheimer's disease, including a protein called amyloid and inflammation, researchers say. The hope is that improving glucose utilisation and tamping down inflammation in the entire body - including the brain - could slow progression of debilitating diseases like Alzheimer's and Parkinson's. Several scientists interviewed by Reuters news agency pointed to mounting research supporting testing diabetes drugs against neurodegenerative diseases. Results are years away and success uncertain. But interest has been buoyed by recent positive data on Alzheimer's drugs developed by Eisai with partner Biogen and by Eli Lilly demonstrating that removing sticky amyloid plaques accumulated in the brain can slow cognition decline caused by the fatal mind-wasting disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs.

The Medicines and Healthcare products Regulatory Agency (MHRA) has maintained the prescription-only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder, following a public consultation and the review of a reclassification application from the manufacturer Maxwellia Ltd. Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18 and 65, such as the urgent need to urinate and frequent urination without pain. The regulator decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine, concluding that a medical prescription continues to be required to ensure the safe use of Aquiette. Since an OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated, the MHRA said the decision would ensure that the medication is used safely and appropriately under medical supervision. "After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg Tablets for women with symptoms of overactive bladder (OAB)," Dr Laura Squire, MHRA chief healthcare quality and access officer, said.

French drugmaker Sanofi will make 30 of its treatments, including insulin, available on a not-for-profit basis in 40 lower-income countries in the first step of its plan to increase access to its medicines worldwide. The treatments will be provided under the new Impact brand, part of Sanofi's global health unit launched last year, which sits outside the commercial business. The plan also includes the $25 million Impact fund, which will go towards supporting local start-up healthcare businesses and providing training on using the medicines, Sanofi said. "There's a lot of noise at the moment from different companies jumping into this space… but investing in entrepreneurship, in the ecosystem, is a new thing," said Jon Fairest, who heads the global health unit. The treatments available are on the World Health Organization's essential medicines list, and insulin in particular has been singled out by the UN agency as a life-saving medicine for diabetics that is difficult to access in many lower-income countries, where the burden of disease is growing.

AstraZeneca said on Monday (June 27) two of its existing therapies were recommended for treating patients with some forms of high-risk breast cancers in the European Union, in a boost to the company's oncology portfolio. Lynparza, a cancer drug developed jointly with U.S.-based Merck, was backed for standalone use or in combination with endocrine therapy in adults with a form of genetically mutated early-stage breast cancer. The drug, which has received a similar recommendation in the United States in March, is a key asset for AstraZeneca. It was recommended in patients with low-to-normal levels of a protein known as HER2 that is the target of several new therapies. Enhertu - developed jointly with Japan's Daiichi Sankyo (4568.T) - was the other drug that was endorsed by the European Medicines Agency for treating an aggressive form of breast cancer characterised by a high rate of HER2.

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.

HRA Pharma is celebrating the 1st anniversary of Hana, the first type of daily oral contraception available in the UK without a prescription. The launch of Hana in 2021 followed the historic decision of the Medicines and Healthcare products Regulatory Agency (MHRA) to grant a marketing authorisation and marked a significant step forward in the women's contraception category. The company reports that pharmacists have embraced the reclassification and have found merit in using emergency contraception consultations as an opportunity to educate women on their over-the-counter contraception options. Alison Slingsby, innovations project manager at HRA Pharma, commented: "We have been delighted with Hana's reception - within weeks of launch, it quickly became the best-selling mini-pill without prescription, with more than 95 per cent market share, and has maintained this market leading position ever since. We previously had the experience of switching emergency contraceptive ellaOne to a P medicine, Hana is on track to match and eventually exceed the ellaOne volumes.