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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.

There has been extensive national media coverage today (August 11) on how medicine shortages have forced patients to visit multiple pharmacies to get their prescriptions filled or return to their GP to be prescribed alternative drugs. These media reports have been based on a survey involving more than 1,500 pharmacists in the UK, in which over a half of those polled said that their patients' health had been put at risk in the last six months. In response to a query from Pharmacy Business, the Department of Health and Social Care (DHSC) said it monitors the medicines supply chain closely to prevent any shortages and acts swiftly when any issue arises. A DHSC spokesperson told Pharmacy Business: "We take patient safety extremely seriously and we routinely share information about medicine supply issues directly with the NHS so they can put plans in place to reduce the risk of any shortage impacting patients, including offering alternative medication.

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)."

Businesses have a responsibility for the safety of their employees, as well as visitors that are on their premises. If an injury occurs on their property, a company can be held responsible. There are various issues and rules that may apply, so it is important to know the facts regarding such situations. Here are 4 impacts legalities to consider for your business when dealing with such incidents. STATUS OF ENVIRONMENT AND RESPONSIBILITY OF PREMISES When you are looking into injury cases that occur and involve the premises or property of a business, one of the most important aspects to consider is the status of the property itself. All property that has access to the public owned by an individual or business must be maintained in a manner that is safe for people to reasonably move around. This is often associated with sidewalks and pathways, as well as corridors, hallways, and various rooms in businesses. You must ensure that areas where people may be around are safe such as ensuring no water or substance is present on floors that would cause falls or slips, and otherwise having the signage to indicate the need for caution. This is not limited to people, but can also apply to vehicles and equipment, ensuring oil stains and spills do not endanger the operators and employees in the area. Businesses should recognize any risks that are present and also be mindful to address environmental concerns in the immediate area as they are made aware of them. If a business fails to address such potential dangers, they are indeed potentially liable for any injuries and health concerns that come as a result of willful ignorance of the situation.

The Pharmacists' Defence Association (PDA) has urged pharmacists working in Covid-19 vaccination role to report any concerns about the needles and syringes supplied with the Moderna Spikevax Bivalent vaccine. The association has heard reports of bending when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses, needles falling out during manipulation and appearing to be bent even before removal from the packaging. PDA has advised its members who are working in a Covid-19 vaccination role "to report any concerns via the Yellow Card medical device reporting system, and to keep up to date with NHS clinical updates for ongoing information and guidance." Current advice from the NHS includes sharing of video and poster resources (available on FutureNHS) which have been produced by the supplier to support the introduction of the new administration needles and syringes for Spikevax Bivalent. This is following a switch from BD Flu+ 23G x 25mm 1ml syringe combined needle and syringe (CNS) to the Owen Mumford Unifine Safety Retractable Needle 25G x 25mm & 1ml Syringe.

The Royal Pharmaceutical Society (RPS) and Pharmacist Support hosted a roundtable on the impact of pharmacy workforce wellbeing on patient safety on Wednesday (17 May). It also released its annual Workforce Wellbeing Survey which showed continued pressures on pharmacy teams. The discussion explored the actions needed to support staff so they can continue providing safe and effective patient care and included representatives from the NHS, professional bodies, employers, trade unions, education and regulators. A report of the roundtable will be published in the summer. Amandeep Doll, RPS Head of Professional Belonging, said: "We know that pharmacy teams go above and beyond for their patients, but are also under enormous pressure. "Now more than ever, we need to strive to make the pharmacy profession more inclusive and ensure that everyone's wellbeing is supported. "It is vital that we do all we can to encourage people into pharmacy and to support them so they can enhance their skills, develop their careers, and continue to deliver high-quality patient care. "This discussion was a welcome step and showed that making a difference for staff wellbeing requires a concerted effort from stakeholders across the whole of pharmacy.

The NHS claims that it's been able to save taxpayers £1.2 billion in just three years by procuring hundreds of hospital medicines at a better price. The adoption of cheaper versions of a single drug - adalimumab - which is used to treat more than 45,000 patients with rheumatoid arthritis, inflammatory bowel disease and psoriasis, has accounted for about one third of the savings. After the exclusive patent on the drug - originally known as its brand name Humira - expired in 2018, the NHS struck cost-saving deals to bulk-buy generic versions, which have the same quality, safety and efficacy of a branded one. Since then, tens of millions of pounds have been saved by buying cheaper generic versions of other medicines for conditions ranging from severe skin infections to aggressive blood cancers. Four in five medicines prescribed in the NHS are now non-branded, helping the NHS to achieve significant savings while ensuring the continuity of high-quality patient care. NHS chief executive Amanda Pritchard said: "Smart deals by the NHS mean patients are getting the best medicines and taxpayers are getting best value.

The Royal Pharmaceutical Society (RPS) has appointed Dr Anthony Cox from the University of Birmingham as the new chair of its Education and Standards Committee. Anthony is Head of the School of Pharmacy and a Reader in Clinical Pharmacy and Drug Safety. He has previously been a member of the English Pharmacy Board and is a Fellow of the RPS. The Education and Standards Committee provides expert advice and makes recommendations to the RPS Education and Professional Development directorate, reporting directly to the RPS Assembly. Dr Anthony Cox said: "I'm looking forward to working with the committee during this vitally important time for the education of the profession at all levels, and delighted to support the RPS in continuing to develop and deliver its important role in defining and assuring post-registration standards of pharmacy practice."

The Pharmacists' Defence Association (PDA) has launched a brutal attack on some large pharmacy chains for full or part-day closures of some of their shops throughout the UK. It published an Open Letter on Tuesday (July 19) demanding urgent action "to protect patients by ensuring that essential community pharmacy services are provided safely and consistently". PDA chair Mark Koizol, who wrote the letter, went on to allege that many of those closure were "being orchestrated". He wrote that the "pharmacist shortage" narrative cited as a reason for these closures was "very different" from "the reality experienced by our members", including both employed and locum pharmacists. "We have evidence to show that these closures are being announced up to four weeks in advance," Koizol claimed. He gave examples of how a large company attempted to reduce the pre-agreed rate of locums and where this was not accepted, the shift was cancelled, resulting in the pharmacy being closed for part or full day.

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.

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."

Community Pharmacy England (CPE) Chief Executive, Janet Morrison met with the new Pharmacy Minister, Dame Andrea Leadsom MP this week and discussed a range of critical topics, including funding and pressures. Janet informed the minister that community pharmacies continue to face immense financial pressures, and highlighted the need for an improved core contract. She told the minister that 35-50 per cent real term cuts and rising costs have led to closures, consolidations and cashflow. This has weakened the capacity for the network to respond to displaced patients, increased risk in terms of the safety of medicine supply, and led to loss of service for communities in the most deprived areas, she said.

It has been reported that several Austrians have been taken to the hospital after injecting fake Ozempic, as confirmed by health regulator. Austria's Federal Office for Safety in Health Care (BASG) confirmed that the patients have suffered hypoglycaemia and seizures. It is believed that the injections contained insulin instead of the weight loss drug, semaglutide. The health regulator has urged doctors and patients to verify their medication stocks.

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 Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised an innovative and first-of-its-kind gene-editing treatment for sickle-cell disease and transfusion-dependent β-thalassemia. Known as Casgevy (exagamglogene autotemcel), the treatment is based on the innovative gene-editing tool CRISPR, for which its inventors were awarded the Nobel Prize in 2020. Casgevy is the first medicine to be licensed that uses CRISPR, and it is to be used for treating patients aged 12 and over. To date, a bone marrow transplant has been the only permanent treatment option for these life-long conditions, which in some cases can be fatal. The MHRA's authorisation came after a rigorous assessment of its safety, quality and effectiveness.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals prescribing aripiprazole to alert patients about its possible side effects, following a rise in the number of reports of gambling disorder associated with the drug. Patients taking aripiprazole, which is used for the treatment of schizophrenia and bipolar disorder, are at risk of developing unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive. The regulator has received 69 reports of gambling or gambling disorder suspected to be caused by aripiprazole in the last 14 years via the Yellow Card Scheme, out of which 32 were received between 1 January and 31 August this year. Alison Cave, MHRA Chief Safety Officer, said: "The number of reports for suspected gambling and other impulsive behaviours associated with aripiprazole are small in comparison to the frequency with which it is prescribed, but the consequences for any patient developing these conditions can be significant."

The Pharmacists' Defence Association (PDA) says the pharmacy regulator should maintain a two-year post qualification eligibility criteria, in addition to the qualitative measures being introduced which would be in the best interest of patient safety, before a pharmacist is allowed to commence an IP course. The association was responding to an announcement by the GPhC's move to scrap the two year requirement for Independent Prescribing (IP) course. "The PDA accepts that the qualitative approach could mean greater individual consideration of potential IP course candidates and the two-year measure could have sometimes been a blunt tool. However, the PDA is already seeing cases of patient harm and allegations around fitness to practice arising from IP," the association said. The association also said that it supports individual pharmacists with near misses, as well as actual incidents, giving the organisation possibly the most comprehensive understanding of risk. Frontline pharmacists also recognise these issues and in a survey of over 1,000 pharmacists undertaken by the PDA in late 2021, of those who had 2+ years' experience of practice and who were already independent prescribers, 90 per cent said the qualifying period should be two years or more.

Pharmaceutical Services Negotiating Committee (PSNC) has expressed its support for alterations in the Human Medicines Regulations 2012 to enable original pack dispensing (OPD) and supply of medicines containing sodium valproate by pharmacists. PSNC's support for changes was in response to the consultation on OPD, initiated by the Department of Health and Social Care (DHSC). The consultation had proposed regulatory changes to allow pharmacists to dispense (up to 10 per cent) more or less than the prescribed quantity of a given medicine in the manufacturer's original packs. Key aims of the proposal are to "support increased patient safety by ensuring patients receive the necessary information that is included in the original manufacturer's packaging about the safe and effective use of a product," DHSC said.

GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.

The Pharmacists' Defence Association has reported an increase in the number of pharmacists calling its advice line to inform about the incidences of violence and intimidation from protesters opposing the Covid-19 vaccination programme. The association noted that such incidents have become more common with protesters "gaining entry to premises in groups and trying to disrupt Covid-19 vaccinations from taking place." In many cases, pharmacists, staff, and members of the public have been subjected to verbal threats, causing distress and anxiety among those working to deliver the vaccination programme in a safe environment. The PDA reminded that employers, having a contract with the NHS for the Covid-19 vaccinations, have a duty to keep their staff safe whilst at work. The General Pharmaceutical Council (GPhC) standards for pharmacy premises also carry a duty to ensure the safety of staff and the public receiving services on those premises.