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Thorrun Govind, a former chair of the English Pharmacy Board of the Royal Pharmaceutical Society, has joined Brabners' regulatory & professional conduct team. With nearly a decade of experience as a GPhC-registered pharmacist, Govind will provide guidance on regulatory and professional conduct issues. Govind's expertise extends to healthcare advisory and disputes involving NHS Trusts and social care organisations. She has been recognised as the 'Young Pharmacist of the Year' by Pharmacy Business Magazine and is a frequent commentator on public health and healthcare law for major television networks. Her appointment underscores Brabners' commitment to offering top-tier legal services to the healthcare industry.

In the pharmaceutical industry, maintaining high standards for water quality is crucial for ensuring product safety, efficacy, and compliance with regulatory standards. Water is a fundamental ingredient in drug manufacturing, and its quality directly impacts the production process and the end products. This makes adherence to water service compliance a legal obligation and a critical aspect of operational integrity. THE LEGAL COMPLICATIONS OF POOR WATER QUALITY Compliance with water quality standards in the pharmaceutical industry is mandated by regulatory agencies such as the MHRA, several regulations that set strict criteria for the types of water used, including purified water, water for injection, and sterile water. Failure to meet these standards can result in severe penalties, including product recalls, fines, and loss of manufacturing licenses. regulatory compliance ensures the pharmaceutical companies adhere to legislations and avoid legal repercussions that can damage their reputation and financial standing

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of three international work-sharing partnerships. Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally. The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of Regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.

Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

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 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.

Supply of all Champix products, used for smoking cessation, will remain out of stock until further notice from the Medicines and Healthcare products Regulatory Agency (MHRA). The announcement follows a medicine recall order initiated by the MHRA for "all strengths of Champix® tablets" on October 14, 2021 at pharmacy and wholesaler level. Pfizer, the sole supplier of Champix tablets, stopped the distribution of 0.5mg and 1mg tablets in early June 2021. The company is currently unable to confirm when supplies will resume amid global Regulatory investigations relating to the presence of nitrosamine impurities above the Pfizer's acceptable level of daily intake in several lots.

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."

The General Pharmaceutical Council is appointing a new Chief Pharmacy Officer to strengthen the professional voice within the senior leadership team. This introduction is aimed at fostering a culture of enterprise leadership, inclusion and collaboration within the organisation, GPhC said in a statement. According to GPhC, the Chief Pharmacy Officer will serve as the authoritative representative of the pharmacy regulator in public, within the pharmacy professions, and increasingly in multi-disciplinary teams and collaborative regulatory work. "They will act as the executive lead on pharmacy inspection and regulatory insight, providing professional leadership within the GPhC and collaborating closely with pharmacist and pharmacy technician colleagues across the organisation." The Chief Pharmacy Officer, reporting to the Chief Executive and Registrar, will hold the highest professional position within the GPhC executive, providing pharmacy leadership across the organisation, GPhC said.

Pharmacy Supervision Practice Group, an organisations from across the community pharmacy sector, who have come together to look into the future "supervision" in community pharmacy, have published their final report. Over the course of nine collaborative and positive workshop-style discussions the Supervision Practice Group aimed to provide recommendations to reframe legislation, regulation and professional standards and guidance to achieve a new vision for community pharmacy. The group have produced a report which makes several recommendations on the subjects of: * the legislation relating to "supervision"; * the temporary absence of the RP from the pharmacy; * delegation; * the preparation and assembly of medicines when the RP is not signed in. The group have provided recommendations on which the Department of and Social Care and the regulators can draft specifically worded revisions to legislation and regulatory standards. These specific legislative and regulatory changes that are proposed by government and regulators will be subject to a full consultation process.

The International Pharmaceutical Federation (FIP) has offered a new resource to help countries self-assess readiness of their regulations to enable pharmacist-delivered vaccination services and, where needed, to implement such regulations. Developed by FIP's Regulators Advisory Group, it covers broad pharmacist-led roles related to vaccination from supply chain management to administration and prescribing. "This new resource from FIP is based on the experiences of professional regulators in countries where pharmacy-led vaccination has been successfully introduced and regulated. With it, we aim to support regulators, policymakers and national organisations in developing strategies or enabling regulatory frameworks in countries where the pharmacy workforce has a limited role in vaccination strategies so that it can contribute further to the global imperative of improving immunisation coverage," said Brett Simmonds, group chair. The "Pharmacy-led vaccination services: regulatory self-assessment and implementation tool" aims to help identify strengths and areas for improvement in order to inform vaccination policy and planning efforts.

The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October. The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany. However, there has been no evidence that fake Ozempic has been supplied to UK patients. Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with Regulatory partners to ensure patients' safety. He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for use in the UK. "Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.

The UK government will lay legislation today (13 December 2023) to allow the General Medical Council (GMC) to begin the process of regulating medical associates to expand their roles in the NHS. This will support plans to reduce pressure on doctors and GPs and improve access for patients, the Department of Health and Social Care (DHSC) said. Physician associates (PAs) and anaesthesia associates (AAs) will have the same levels of regulatory oversight and accountability as doctors and other regulated healthcare professionals once the regulations come into force, which is expected at the end of 2024. The GMC will design and deliver detailed regulatory processes for registration, education, standards and fitness to practise for both professions.

The Medicines and Healthcare products Regulatory Agency (MHRA) has advised 'no one should stop taking valproate without advice from their healthcare professional.' The latest data on the use of valproate in England revealed that in the last 6 months the number of pregnant women prescribed valproate in a 6-month period has fallen from 68 women in April to September 2018, to 17 women in October 2021 to March 2022. In light of concerns that the current Regulatory requirements for safe use are not being consistently followed, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM). "The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment," said MHRA. "Where possible, existing patients should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply."

In a recent announcement the Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its strategic approach to artificial intelligence (AI), as it sets out to embrace the transformative potential of AI in healthcare regulation. Building upon the Government's white paper 'A pro-innovation approach to AI regulation', released in 2023, the MHRA outlined five key strategic principles guiding its adoption of AI. These principles encompass safety, security, and robustness; appropriate transparency and explainability; fairness, accountability, and governance; and contestability and redress. A science-led organization, the MHRA was tasked with providing an independent view of its approach to AI in medicine and science, aligning with a government white paper. Recognising its role in UK's goal to be a science and tech leader by 2030, MHRA is tasked to evaluate AI's opportunities and risks across Regulatory, public service, and evidence-based decision-making area.

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."

Holland & Barrett, the UK's leading wellness retailer, has become the latest retailer regulatory member of PAGB, the consumer healthcare association. PAGB represents the manufacturers of branded over-the-counter (OTC) medicines, self care medical devices and food supplements in the UK. Holland & Barrett's decision to PAGB follows its recent introduction of a selected range of OTC and healthcare products in its stores across the UK. These include painkillers, cough and cold medicines, children's health essentials, hay fever relief, as well as skin and gastrointestinal products. With this expansion, the retailer aims to not only help customers to stay well, but also provide relief when needed.

The General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor agonists (GLP-1 RAs). The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that these are being widely prescribed for weight loss purposes and in some cases prescribed off-label." "We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams. The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply chain issues.

The Competition and Market Authority (CMA) has suggested regulatory levers to curb "potential competition risk" from hub and spoke dispensing. In its response to the hub and spoke dispensing consultation, led by the Department for Health and Social Care (DHSC) last week, the competition watchdog said that a pro-active approach to monitoring the effect of hub and spoke dispensing and subsequent early consideration of any competition concerns was likely to be more effective and potentially less costly than any "ex-post enforcement any ex-post enforcement or unpicking of subsequently embedded competition issues". The competition watchdog has made a few suggestions to identify and remove the barriers to competition that might emerge with the new business models entering the market. It has asked the department to enable a "more level playing field". "Smaller independent pharmacies should, have improved access to automation and new dispensing models," it said.