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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 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.

Online pharmacies have to operate from bricks & mortar premises that are registered with the General Pharmaceutical Council, but recent cases show that, in reality, the practices of online pharmacies are often very different to other pharmacies, and the regulation of online pharmacies is also different - and evolving as issues arise. For a start, the General Pharmaceutical Council (GPhC) is only one of the regulators taking an interest in online pharmacy services. Other regulators include the Medicines and Healthcare products Regulatory Agency (MHRA) which enforces the advertising and promotion of medicines, and the Care Quality Commission (CQC) which regulates prescribing services. The different regulation of online pharmacies is attributable to the higher risk to patients and the public from medicines bought online. These risks often arise from a combination of patients who do not tell the truth in order to obtain medicines and the nature of a transaction in which a pharmacist does not see patients face-to-face. "The GPhC has strong enforcement powers that it uses when it considers its premises standards have not complied with." However, there are also things that go wrong because pharmacists have simply failed to act professionally or take sufficient care, as well as cases where things have gone wrong through misfortune.

The General Pharmaceutical Council (GPhC) has launched a new draft 'Equality Guidance' for pharmacies to tackle discrimination and make sure that everyone can access safe and effective person-centred pharmacy care. GPhC's consultation is seeking views on "the structure and language of the guidance, if anything is missing and the impacts on patients and members of the public, pharmacy staff, pharmacy owners, and individuals or groups sharing any of the protected characteristics." The regulator said the draft guidance is designed to support pharmacy owners to: demonstrate that they are meeting our standards for registered pharmacies fulfil their legal and regulatory duties in relation to equality help protect the rights of individuals advance equal opportunities for staff, patients and the wider public help improve the experience and healthcare outcomes of patients and members of the public.

A BBC investigation has found 20 UK online pharmacies selling prescription-only medicines without adhering to the regulatory standards, such as checking for GP approval or patient's medical records. The news organisation was able to purchase over 1,600 restricted pills, including anti-anxiety drug, painkiller and sleeping medication, from these regulated online pharmacies easily by providing false information. However, the report didn't mention the names of the drugs as "they can be dangerous when taken without medical guidance." Some pharmacies were also found selling high-risk and potentially addictive medicines, including benzodiazepines and antidepressants, based on online questionnaires and did not require further checks. The General Pharmaceutical Council (GPhC), which regulate online pharmacies in the UK, states that selling and supplying medicines at a distance brings "different risks which need to be appropriately managed to protect patient safety."

The General Pharmaceutical Council (GPhC) and the Chief Pharmaceutical Officer for England have written a letter to pharmacy professionals thanking them for providing the best possible services to patients and the public, despite experiencing high and sustained demands and pressures. GPhC Chief Executive Duncan Rudkin and CPhO David Webb indicated that there will be further challenges over the coming weeks and months due to the ongoing industrial action, and staff shortages due to sickness or caring responsibilities. They expressed concerned that increased pressure will have a significant and potentially prolonged impact on pharmacy teams both personally and professionally. Acknowledging that pharmacy professionals may have to make some difficult decisions as they deal with the pressures they face, the leaders have urged those working in pharmacy to use "your professional judgement to assess and mitigate risk, and to deliver safe and effective care for your patients within your scope of practice."

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 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.

The Pharmaceutical Services Negotiating Committee (PSNC) has urged the pharmacy contractors to follow appropriate procedures for unplanned temporary closures due to current workforce pressure, to avoid a breach of terms of service. "If the temporary closure is not for reasons beyond the contractor's control, this may be a breach of the terms of service," said PSNC. The committee also informed that in some areas, NHS England regional teams may ask contractors to complete a new notification form for any temporary closures that request more information than the standard form, for example, on the mitigating actions taken by the contractor. It added: "Completion of these forms is voluntary but may help to show NHS England that the closure was for reasons beyond the contractor's control, or that the overall circumstances of the closure, including time closed and steps taken to ensure patient and public needs are met, indicate that there is no public interest in taking any regulatory/performance action (such as a breach notice) against the contractor."

The Pharmaceutical Society NI (PSNI) has announced that Michaela McAleer will be replacing Trevor Patterson as Chief Executive of PSNI. After 15 years at the helm, Patterson announced his intention to retire. Jonathan Patton, Vice President of the Society said, "Joining the Society from the construction sector Trevor brought fresh thinking and vigour to the Society and quickly established his credibility with pharmacists, Council, stakeholders and fellow regulatory bodies." "Trevor has presided over tremendous change and development through his tenure with equal measures of professionalism and passion on creating safer protections for the public and ensuring pharmacists achieved world class standards in their profession. We are saddened to see him depart but on behalf of Council I wish him a long and healthy retirement and wish him well in the next chapter of life. We are indebted to him for his dedication to the Pharmaceutical Society NI." "Losing the constant and continuity of our 15 year serving Chief Executive ushers in a time of change and evolution for us as the Pharmacy Regulator. We are in the midst of a fast moving and changing environment as we implement continuous improvement.

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 Council of the Pharmaceutical Society NI (PSNI) to remove the two-year requirement as a registered pharmacist to have an Independent Prescriber (IP) annotation on the pharmacy register in Northern Ireland. It has further endorsed that the two-year requirement for entry onto stand-alone pharmacist independent prescribing courses be removed and replaced with an assessment before admission, by course providers, based upon guidance provided by the regulator. In conjunction with the Department of Health, the PSNI will now work towards a further public consultation on the necessary legislative changes. Dr Jim Livingstone, president of the PSNI, said: "The Department of Health has set a clear direction which will see pharmacist independent prescribers becoming increasingly important in the delivery of pharmacy services in Northern Ireland. Our role is to protect the public, but we are clear that our regulatory objective should not be an unnecessary barrier to the development of the profession and enhanced services being provided to the public."

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 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.

British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency. The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used to detect monkeypox antibody levels. Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment between countries documenting vaccine performance against monkeypox, CEPI said. Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.

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 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.

Britain has approved Novavax's Covid-19 vaccine for use in those 18 years of age and older, the country's medicines regulator said on Thursday (February 3), bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day. "We are continuing our vital safety work in monitoring the use of all Covid-19 vaccines, to ensure that their benefits in protecting people against Covid-19 disease continue to outweigh any risks," MHRA chief executive June Raine said.

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.