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The General Pharmaceutical Council (GPhC) has promoted Louise Edwards to the position of Chief Strategy Officer and Deputy Registrar. Louise is currently the Director of Regulation and Digital Transformation at the Electoral Commission, responsible for the organisation's regulatory work and digital, data, technology and facilities infrastructure. This includes funding and spending at elections and referendums, registering political parties, enforcement work, and data and information management. Louise will take over Mark Voce, the GPhC's current Chief Strategy Officer and Deputy Registrar, who is retiring early in July 2024. Louise said: "Pharmacy services are at the heart of health care for many people. Having effective regulation and standards in place can transform and give confidence in the quality of care that people receive.

Southwark Crown Court on Thursday sentenced two pharmacists to two years of imprisonment each, suspended for 24 months, after they were found guilty of selling 'industrial' quantities of Class C controlled drugs. Mandip Sidhu (47) of Littleover, Derby and Nabeil Nasr (42) of Cheadle, Greater Manchester, pleaded guilty at an earlier hearing following an investigation by the Criminal Enforcement Unit of the Medicines and Healthcare Products Regulatory Authority (MHRA). Both Sidhu and Nasr were pharmacists registered with the General Pharmaceutical Council at the time of the offenses, which took place between May 2013 and June 2017. Sidhu was the director of Pharmaceutical Health Limited (PHL) in Derby, while Nasr owned several pharmacies across the North West of England. Sidhu was sentenced to two years imprisonment on each of five counts of supplying Class C drugs and four months for forgery, all to run concurrently and suspended for 24 months. Additionally, she must complete 200 hours of community service for her role in the illegal supply of diazepam, zolpidem, and zopiclone.

The General Pharmaceutical Council (GPhC) has produced a new resource to support pharmacists and pharmacy technicians who are providing pharmacy services to children and young people with gender incongruence or dysphoria. It emphasises that pharmacy teams providing such services need to adhere to the standard process of clinical assessment and care provision they have been trained to take as healthcare professionals. The starting point is that pharmacy professionals must provide compassionate, inclusive and person-centred care, within the current relevant legal and regulatory context. "It's essential that all patients have access to appropriate, high-quality and respectful healthcare, free from discrimination or bias," the GPhC noted

"Our main concerns are that the use of what they call an asynchronous supply, where the prescriber neither sees nor talks to the patient at the time they issue the prescription, does lay itself open to perhaps people getting hold of medication that they shouldn't," the Head of Policy, PDA said. The Pharmacists' Defence Association (PDA) engages in a critical conversation on BBC Radio 4's Woman's Hour, shedding light on the online prescribing of weight loss drugs and advocating for safer practices. The PDA's spokesperson, Head of Policy Alima Batchelor, emphasised the importance of adhering to professional guidelines to ensure patient safety and mitigate regulatory concerns. During the feature, the PDA highlighted the complexities and risks associated with online supply chains, stressing the necessity for direct clinical consultations and pharmacist involvement in medication management. ""There are guidelines and advice about verification within the DiCE guidance, but it doesn't go quite far enough for us. We are concerned when patients decline to allow the online prescriber to advise their GP of what they're taking," Batchelor highlighted.

The World Health Organization (WHO) issued a warning on Thursday regarding falsified semaglutide medications used for treating type 2 diabetes and obesity in select countries. This WHO Medical Product Alert addresses three falsified batches of the specific brand Ozempic that were detected in Brazil (October 2023), the United Kingdom and Northern Ireland (October 2023), and the United States (December 2023). These falsified semaglutide products were distributed through the regulated supply chain. Novo Nordisk, the genuine manufacturer of Ozempic, confirmed that the three products mentioned in the alert are falsified and were not produced by the company. Healthcare professionals, regulatory authorities and the public are advised to remain vigilant regarding these falsified batches of medicines. Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, urged stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.

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.

A judicial review claim launched by the British Medical Association (BMA) against the General Medical Council (GMC) has parallelly intensified Pharmacists' Defence Association's (PDA) scrutiny over the use of the term 'pharmacy professionals'. PDA has criticised the evolving definition of 'pharmacy professionals,' and the potential risks to patient safety amidst regulatory ambiguity as part of "a far wider agenda." Concerns stem from what the PDA perceives as a blurring of distinctions between pharmacists and pharmacy technicians as "attempted homogenisation" by bodies like the General Pharmaceutical Council (GPhC), NHS, and Royal Pharmaceutical Society (RPS). Raising similar issue as the BMA against the GMC over its use of 'medical professionals for doctors and Medical Associate Professions (MAPs), Mark Koizol, Chairman of the PDA has said:

New amendments to the Human Medicines Regulations will soon allow registered pharmacy technicians to supply and administer medicines under Patient Group Directions (PGDs). Laid before Parliament at the end of May, the legislative changes will come into effect from June 26, 2024, the Community Pharmacy England (CPE) announced today. The introduction of this new legislation follows an announcement made by the Department of Health and Social Care (DHSC) earlier this year. The regulatory adjustments provide the legal framework for pharmacy technicians to engage in the supply and administration of medicines under PGDs in the course of their professional practice. However, there will be no immediate change in the provision of community pharmacy services, the CPE noted

Laganside Crown Court, on Friday, sentenced Gerard Cullinan, a 48-year-old pharmacist and Director of Castlereagh Pharmacy Ltd in East Belfast, for unlawfully supplying controlled prescription medicines, including co-codamol and fentanyl, and for failing to maintain controlled drugs registers. Cullinan was sentenced to 11 months imprisonment, suspended for three years, and his pharmacy was fined £8,000. The sentencing follows an investigation by the Department of Health's Medicines Regulatory Group (MRG), which uncovered that Cullinan's pharmacy on Castlereagh Road had illegally supplied over 300,000 co-codamol tablets between January 2017 and June 2020. Additionally, the MRG investigation identified significant breaches in record-keeping for Class A controlled drugs such as fentanyl, tapentadol, methylphenidate, morphine, and oxycodone. "It is a serious criminal offence to sell or supply prescription only medicines without a prescription," said Peter Moore, Senior Medicines Enforcement Officer at the MRG, who led the investigation.

A man has been sentenced to three and a half years in prison for illegally importing and distributing unlicensed medicines from India, the Middle East, and the Far East. Antoine Christopher Kolias, 31, received his sentence at Southwark Crown Court on 28 June after being found guilty of criminal activities in May. The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) led the investigation, dubbed Operation Bentley. Kolias was discovered to be acting both as a distributor for an established unlicensed medicines dealer and running his own illicit business. He was involved in the sale of sildenafil citrate, the active ingredient in Viagra, as well as Class C drugs including tramadol, zopiclone, and pregabalin between 2018 and 2019, and again between 2020 and 2021.

The Association of the British Pharmaceutical Industry (ABPI) has laid out a series of urgent actions it wants the newly elected Labour government to implement within its first 100 days in office. Among the top priorities, the ABPI has emphasised the urgent need to appoint a new Chair and Chief Executive for the Medicines and Healthcare products Regulatory Agency (MHRA). Additionally, the ABPI has urged the new government to launch the Life Sciences Manufacturing Capital Grants Facility without delay. Other measures the ABPI wants Labour to prioritise include: Rapidly passing outstanding UK clinical trials legislation to enhance the UK's attractiveness for inward investment, including into research within the NHS. Increasing commercial flexibility in the NHS England Commercial Framework for New Medicines to remove barriers for companies to launch new medicines and indications so that NHS patients can access the latest innovative medicines.

Great news for multiple sclerosis patients! The NHS has introduced a new 10-minute injection that can slow the progression of disability while reducing hospital treatment time by over 90 per cent. Currently, MS patients in England receive ocrelizumab (Ocrevus), manufactured by Roche, through twice-yearly intravenous (IV) infusions that can last up to four hours. Now, around 9,000 NHS patients in England will be able to receive the drug via a quick 'under-the-skin' twice-yearly injection. It takes just ten minutes, enabling patients to spend less time in the hospital receiving treatment. This roll-out follows approval from the Medicines and Healthcare products Regulatory Agency (MHRA), making the NHS one of the first healthcare systems worldwide to offer this new MS injection. Drug stocks are expected to be available in the coming weeks.

Kent Pharma UK has announced a precautionary recall of multiple batches of Itraconazole 10mg/ml oral solution following the identification of out-of-specification appearance in the solution, particularly the presence of suspended particles or clusters of crystals. Itraconazole is an antifungal medication prescribed for treating fungal or yeast infections in different parts of the body. Its oral solution form is specifically intended for treating oropharyngeal or esophageal candidiasis, commonly known as thrush or oral thrush. The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the recall following initial investigations, which indicated a solubilisation issue of the active ingredient, itraconazole. This problem may result in some doses containing lower amounts of the active ingredient. The root cause of the issue is currently under investigation. However, due to the potential for underdosage, the affected batches are being recalled as a precautionary measure.

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has announced relaxation in HIPAA rules for covered entities and business associates who participate in good faith in the COVID-19 testing site operation. It doesn't stop there, but HIPAA penalties won't apply to covered healthcare providers for practicing telehealth medicine using third-party applications such as Skype or Facebook Messenger

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has announced relaxation in HIPAA rules for covered entities and business associates who participate in good faith in the COVID-19 testing site operation.

Britain's health regulator is poised to announce that hormone replacement therapy (HRT) will be made available over the counter for the first time, the Daily Telegraph has revealed. The newspaper first reported on Tuesday (February 1) that watchdogs were set to propose a reclassification of the medication so women are able to access it in a pharmacy without a prescription. Every year, some 1.5 million women experience difficult menopausal symptoms, such as hot flushes, night sweats, sleep disturbance and a variety of emotional problems. But only a tenth of them are prescribed HRT, following a consultation with a GP or specialist. According to the newspaper, the latest proposal aims to improve convenience so that women are able to access HRT more easily, without needing a GP appointment.

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."

NHS England's decision to forgo commissioning puberty suppressing hormones (PSH) for children and young people, citing insufficient evidence of their safety and clinical effectiveness, follows a comprehensive review conducted by the National Institute for Health and Care Excellence (NICE) in 2020. The clinical report underscores that "PSH treatment options will not be part of routine commissioning" for people under the age of 18 in England grappling with gender incongruence or dysphoria. The NHS England review analysed nine observational studies on Gonadotrophin Releasing Hormone Analogues (GnRHa) and found no statistically significant difference in gender dysphoria, mental health, body image, and psychosocial functioning among children and adolescents treated with GnRHa. Duncan Rudkin, chief executive of the General Pharmaceutical Council (GPhC), acknowledged the challenges faced by pharmacy professionals regarding prescriptions for puberty suppressing hormones, stating:

With the upcoming general election on the horizon, Proprietary Association of Greater Britain (PAGB) is leading the charge to integrate self-care into the core of all political party manifestos. The aim is to ease strains on the NHS and forge a sustainable healthcare system for the future. In a significant move, PAGB unveiled a comprehensive general election toolkit on Wednesday, laying out a compelling argument for the prioritisation of self-care among stakeholders. The toolkit underscores the importance of public interest, potential NHS cost savings, and the economic advantages of the over-the-counter (OTC) sector. Aimed at unlocking the full potential of self-care and nurturing an enabling environment for its implementation, PAGB's toolkit advocates for greater integration of pharmacy services into primary care.

In a surprising move that has divided the pharmacy profession, the General Pharmaceutical Council (GPhC) has sanctioned hundreds of pharmacies to allow patients to self-select certain Pharmacy (P) medicines, a decision met with strong opposition from the Royal Pharmaceutical Society (RPS) as well as from the Pharmacy Defense Association (PDA). In a statement, RPS shared that at a board meeting held on 19th June, they expressed "disappointment" over what they described as a lack of prior consultation and comprehensive communication from the GPhC regarding the implications of this policy shift. They argue that allowing patients to self-select certain P medicines could potentially jeopardize established professional guidelines and compromise the role of pharmacists in ensuring safe medication use. "Enabled by the General Pharmaceutical Council, we understand that hundreds of pharmacies, from large multiples to small independents, have been approved by the regulator to enable patients to self-select certain P medicines," the statement said.