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The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a 'biobank' on Thursday (June 01) to tackle the issue of Adverse Drug Reactions (ADRs). Biobank will help to better understand how a patient's genetic makeup can impact the safety of their medicines. "The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA's Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices," said MHRA. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants' genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.

The Medicines and Health products Regulatory Agency (MHRA) on Thursday issued a class 4 medicines defect information notice for Cozaar 100mg film-coated tablets due to an error in the Patient Information Leaflets (PILs) reported by the company. Cozaar is used to treat high blood pressure (hypertension) as well as to slow the progression of kidney disease in people who have type 2 diabetes mellitus. Quadrant Pharmaceuticals Ltd has informed the UK regulatory authority that the PILs that have been packed in certain batches of the products do not have the most up to date safety information. 'Grapefruit juice should be avoided while taking Cozaar'- This information is missing in Section 2 'What you need to know before you take Cozaar', sub section 'Cozaar with food and drink', the company clarified.

Britain has approved a new coronavirus vaccine by the Austrian-French drugmaker Valneva. "An approval has been granted after the Valneva Covid-19 vaccine was found to meet the required safety, quality and effectiveness standards," the Medicines and Healthcare products Regulatory Agency said in a statement on Thursday (April 14), adding: "It is also the first, whole-virus inactivated Covid-19 vaccine to gain regulatory approval in the UK." In vaccines such as Valneva's VLA2001, the virus is grown in a lab and then made completely inactive so that it cannot infect cells or replicate in the body but can still trigger an immune response. It is seen by some as having the potential to win over people wary of some which use new mRNA technology. Valneva CEO Thomas Lingelbach said that "this authorisation could pave the way for the availability of an alternative vaccine solution for the UK population."

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.

The pharmaceutical industry is one of the most important and valuable industries in the world. It is responsible for developing and producing medicines that improve and save lives. However, there are some things you may not know about this fascinating industry. In this blog post, we will discuss six interesting facts about the pharmaceutical industry! 1. THE MANUFACTURING PROCESS OF PHARMACEUTICALS IS HIGHLY REGULATED All pharmaceutical products must go through a rigorous manufacturing process before they can be made available to patients. This process is heavily regulated by various government agencies to ensure that the medicines are safe and effective. The pharmaceutical manufacturing process usually involves multiple steps, including the preparation of raw materials, the manufacturing of active pharmaceutical ingredients (APIs), and the packaging and labeling of finished products. To ensure patient safety, all pharmaceutical companies must adhere to strict regulations set by government agencies such as the Food and Drug Administration (FDA). These regulations are designed to protect patients by ensuring that medicines are safe and effective.

Two weeks prior to the closing of the hub and spoke consultation, issues around patient safety, costs and competition as well as practicalities such as what to do with uncollected medicines were discussed in a webinar on hub and spoke dispensing on Wednesday (May 26). The webinar was organised by Sigma Pharmaceuticals in association with the National Pharmacy Association (NPA). NPA director of corporate affairs Gareth Jones chaired the event and was joined by Sigma's Hatul Shah and Raj Haria as well as NPA vice chair Nick Kaye and NPA head of advice and support services Jasmine Shah. Kaye said: "There are still many 'unknown unknowns' with hub and spoke and the jury's still out on any potential benefits. I have lots of reservations about cost and it worries me how efficient this is for the business and the long term sustainability for the sector as a whole. Above all we need to think about the patient at the centre of all this and the potential confusion for them." Jasmine Shah felt patient safety was going to be the key in regards to whether the spoke and the hub would hold the ultimate responsibility and "who is going to take the accountability as far as patient care goes". She added: "It is most important that GPhC standards and NHS requirement are both met in identifying all the risks associated with the arrangement with hub and spoke and ensuring that (patient safety) measures are in place. Everything that needs to be looked at is by putting the patient at heart of the arrangement and seeing what is the safest way for them to receive care from both spoke and hub."

Pharmacies are the lifeblood of community healthcare, being a vital pathway to care and support in every borough of the UK. There are 11,600 pharmacies across the country, amongst which yours stands proudly. Pharmacies obviously have a duty of care to their patients and customers, and rigorous safety practices surrounding the safe storage and dispensation of medicine - but that duty of care also extends to fellow staff. This is to say that health and safety is a paramount concern for any pharmacy or pharmacist, and that great care should always be taken to uphold the highest possible standards with regard to health and safety. With this in mind, what follows is a refresher on some of the key hazards that could give way to workplace injury in your pharmacy - and how to mitigate the risk of injury. Biological Hazards Biological hazards are ever-present, and prescient in the aftermath of the coronavirus pandemic. Though the COVID-19 virus was eventually shown not to be particularly resilient on surfaces, good practice was still to regularly disinfect surfaces and handles where possible - something which should still be a part of regular routine in your pharmacy. Likewise, face masks are a solid way to reduce the risk of infection or contamination, particularly where the handing over of biological samples is concerned.

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 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."

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

Proper drug storage is essential to ensure the safety of yourself, your family, and those around you. This is especially important if you are taking multiple medications and need to keep track of them all. Knowing how to store drugs correctly can help prevent misuse or accidental ingestion by children or pets. Here are six important guidelines about proper drug storage that everyone should follow: 1. KEEP ALL MEDICATIONS IN THEIR ORIGINAL, LABELED CONTAINERS: Using alternative storage containers can make it difficult to identify medications or keep track of expiration dates. Keeping medications in their original containers also prevents accidental misuse and helps ensure that the correct dosage is taken. In addition, it's important to store all medications out of reach of children and pets. Also, keep medications in a cool, dry place away from direct sunlight. For example, a medicine cabinet in the bathroom or kitchen is a good option. 2. DISPOSE OF EXPIRED MEDICATIONS: Expired medications can be less effective and even potentially harmful if taken, so it's important to regularly check expiration dates and get rid of any outdated medications. The best way to dispose of old drugs is to take them to a drug collection site. If no such sites are available, mix the medication with something like coffee grounds, put it in an opaque container, and then throw it away in your trash bin. Never flush expired medication down the toilet unless instructed by your pharmacist or healthcare provider! 3. STORE DRUGS IN A COOL, DRY PLACE: Extreme temperatures can cause medications to break down and become ineffective. To avoid this, keep all drugs away from direct sunlight, heat sources, and moisture. A medicine cabinet or drawer in the bathroom is an ideal spot for storing most drugs, but some require special storage conditions (more on that below). Different medications should also be separated from one another to avoid confusion and stored differently. For example, if a

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."

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public to avoid buying pre-filled weight loss pens without a prescription. The warning came after 369 fake Ozempic injections have been seized since January 2023. However, Saxenda pens were obtained by members of the public in the UK through "non-legitimate routes". The health regulator has urged the public to buy the pens after consulting a healthcare professional and with a prescription. Dr Alison Cave, MHRA Chief Safety Officer shared her opinion on the matter, she said: "Buying products such as Ozempic or Saxenda without a prescription, from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.

The Professional Records Standards Body (PRSB), which develops information standards for health and social care records, has appointed Professor Reecha Sofat as the new Chair. She will assume the role at the end of October 2024, succeeding Professor Maureen Baker CBE, who will step down after seven years as Chair of the PRSB. A Clinical Pharmacologist, Professor Sofat has held many leadership roles across the NHS, academia and scientific societies. Professor Sofat is Breckenridge Chair of Clinical Pharmacology at the University of Liverpool. She practices general internal medicine and is also an Associate Director at the British Heart Foundation (BHF) Data Science Centre (DSC) which is led by Health Data Research UK (HDRUK). With a passion for data science and extensive clinical and research insights, Professor Sofat is focused on embedding research into routine health and social care. She said: "I am passionate about using the rich health data that is already collected across NHS and social care to better understand the causes and consequences of disease and improve health outcomes.

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 General Pharmaceutical Council (GPhC) has raised concerns over the rising risks related to online pharmacy services. It revealed over 30 per cent of its open Fitness to Practise (FtP) cases were related to online pharmacy, which is disproportionate to the sector of the market that online services occupy. The regulator has advised pharmacists and pharmacy owners providing online services that they should "not work with online providers who try to circumvent the regulatory oversight put in place within the UK to ensure patient safety". In the past five months, the Council has imposed seven interim orders on the registration of pharmacists who have worked for or with online prescribing services - after identifying serious concerns with their practice. It said: "These pharmacists were working as pharmacist independent prescribers for online services or were dispensing medicines prescribed online. Some of these pharmacists were the Responsible Pharmacist (RP) or the Superintendent Pharmacist (SP)."

The General Pharmaceutical Council (GPhC) has alerted pharmacists, pharmacy technicians, and pharmacy owners via email regarding new emergency legislation governing the prescribing and supply of puberty-suppressing hormones, commonly known as 'puberty blockers', for children and young people under 18 in England, Wales, and Scotland. The regulations apply to gonadotropin-releasing hormone (GnRH) analogues, used to suppress puberty as part of treating gender incongruence or gender dysphoria in individuals under 18. Effective from 3 June 2024, new private prescriptions for GnRH analogues from prescribers in the European Economic Area (EEA) or Switzerland who are not UK registered are banned from being dispensed in Great Britain for patients under 18. The emergency ban on these medicines will remain in effect until September 3, 2024, the Department of Health and Social Care (DHSC) announced on 29 May, stating that the action has been taken to address risks to "patient safety."

Oxford Cannabinoid Technologies Holdings plc, which specialises in developing cannabis-derived medicines with pain-relieving properties, has successfully administered the first-in-human dose of its lead pharmaceutical drug compound, OCT461201, in its phase 1 clinical trial. The company holds a portfolio of four drug candidates intended for use as licensed pain medications. The drug is a selective cannabinoid receptor type 2 agonist with the potential to treat chemotherapy-induced peripheral neuropathy and irritable bowel syndrome. The UK trial, conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd., is progressing with healthy volunteers, OCTP said in a statement. Using a single ascending dose protocol, the primary objective is to demonstrate OCT461201's safety and tolerability, while providing information on its pharmacokinetic profile, to confirm its value as a potential drug. Results from the trial, funded entirely by OCTP's existing resources, are expected in the third quarter of 2023, the statement added.

The General Pharmaceutical Council reiterated its stand on Covid-19 vaccination, saying, "Pharmacists and pharmacy technicians working in all settings across Great Britain should be vaccinated against Covid -19, unless they are medically exempt." In a statement issued today (February 11), it strongly urged all pharmacyprofessionals, students and trainees to get fully vaccinated at the earliest. This reiteration follows the government's announcement on January 31, 2022 that it would not proceed with Covid vaccination as a mandatory condition of deployment for health and care staff providing CQC-regulated services in England. The Council stated that clinical trials have proven the efficacy and safety of Covid vaccines and the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised their use in the UK.

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.