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The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have authorised community pharmacies throughout the UK to dispense original full packs of Valproate-containing medicines upon prescription. The necessary changes in regulations came into effect on 11 October which was strongly supported by 85 per cent of respondents concerned about risks to the unborn baby if valproate-containing medicines are used in pregnancy. The decision was made to ensure patients receive safety warnings and pictograms, including a patient card and the Patient Information Leaflet (PIL), contained in the manufacturer's original full pack. Valproate is a treatment for epilepsy and bipolar disorder but is also associated with birth defects and neurological disabilities.

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.

NHS England has confirmed the initial sites that will test and implement Martha's Rule in the first phase of the programme. This follows the announcement in February regarding NHSE funding for the major patient safety initiative for this financial year. The scheme is named after Martha Mills, who died from sepsis at the age of 13 in 2021. She had been treated at King's College Hospital, London, where a failure to escalate her to intensive care and a lack of response to her family's concerns about her deteriorating condition contributed to her death. Martha's Rule aims to provide a consistent and understandable way for patients and families to seek an urgent review if their or their loved one's condition deteriorates and they are concerned this is not being responded to. NHS England on Monday (27 May) announced that the scheme will be implemented at 143 hospital sites across the country by March 2025.

Following concerns raised about cracked cartridges and insulin leaks, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system. The regulator have asked patients to check the pre-filled glass insulin cartridge for cracks before use. It advised against using the cartridge if it has been dropped even if no cracks are visible and urged to closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. Leakages also occurred in cases where no cracks in the cartridge were visible, the regulator said. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis, a serious complication of diabetes when the body produces high levels of blood acids called ketones. Healthcare professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. "Because of the rare risk of insulin leakage from the Roche Accu-Chek Insight Insulin Pump, patients should check the pre-filled glass insulin cartridge for any cracks prior to usage," Dr June Raine, MHRA chief executive, said.

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.

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.

Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use. It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed "when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient." Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions. Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

General practitioners (GPs) across England have made a resolute stand against proposed alterations in the 2024/25 national GP General Medical Services (GMS) contract put forth by the Department of Health and Social Care (DHSC) and NHS England. This firm opposition coincides with the declaration of an extended six-month strike by 33,869 junior doctors within the NHS, advocating for full pay reinstatement and reforms in the pay recommendation process. The latest survey conducted by the British Medical Association (BMA) has revealed that an overwhelming 99.2% of GPs in England are against any changes to the existing contract. The proposed amendments, slated for implementation from April 1st, 2024, encompass a meagre national practice contract baseline funding uplift of just 1.9%, notably falling short of recent inflation rates. This corroborates with GP Online poll that recently unveiled widespread GP dissatisfaction with proposed changes to the national GMS contract. 83% of GPs in favour of strikes cite pay and funding concerns, while burnout, high workloads, and patient safety also fuel discontent.

The Medicines and Healthcare products Regulatory Agency's (MHRA) Criminal Enforcement Unit (CEU) has seized a quantity of suspected unlicensed medical products including unlicensed versions of Botox, numbing agents and dermal fillers in Bolton, Greater Manchester. Officers from the MHRA and Greater Manchester Police conducted a raid across nine addresses in Bolton, Westhoughton and Leigh in the early hours of Thursday 13 July 2023, where two women and a man were arrested. Andy Morling, MHRA Deputy Director of Criminal Enforcement said: "Medicines like these are powerful and dangerous in the wrong hands, potentially leading to serious adverse health consequences. The criminals trading in these products are not only breaking the law, they also have no regard for your safety. It is illegal to advertise, sell or supply medicines such as these without the appropriate authorisation. If you see these products, or any other powerful medicines, being sold on social media or elsewhere online, think. It's unlikely to be legitimate. You can help the MHRA take action by reporting concerns to us through our Yellow Card scheme.

Pharmaceutical giant GlaxoSmithKline aims to get its respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data showed the vaccine was effective in a keenly-watched late-stage study involving older adults. RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956. Companies including Pfizer, J&J, Sanofi, Moderna and AstraZeneca are also racing to get an RSV therapy or vaccine approved. The latest GSK trial is the first to show statistically significant efficacy for RSV in adults aged 60 years and older, the British drugmaker said of the ongoing study on Friday (June 10). If approved, the RSV vaccine is expected to generate billions for GSK, which is already the world's biggest vaccine maker by sales but has faced pressure from activist investors such as Elliott Management who have urged the London-based company to shore up its drug pipeline.

Errors of any kind in medical settings can have dire consequences for patients and healthcare systems. Unfortunately, negligence, misdiagnosis, and medication errors aren't uncommon in the UK. In this article, we discuss the nature of medication errors in the NHS, outline potential causes, and delve into how and why technology could be turning the tide on the issue. Prevalence and consequences of medication errors Medication errors are incidents involved with the administering, prescribing, dispensing or monitoring of medicine to patients. It can happen at many different steps in the healthcare process and by any medical professional in the system. Many cases are avoidable. According to analysis from BMJ, there are an estimated 237 million medication errors made in England every year. The majority of these are minor errors, but 1 in 4 cases has the potential to cause moderate to serious harm to patients. Not only do these errors cost the NHS significantly, at almost £100 million every year, but there is a shocking cost to public health. Lives are being lost because of medication errors which is unforgivable and tragic for the families involved. Drains on NHS resources have widespread impacts on public health and the operations of healthcare organisations up and down the country. Individual errors and mistakes may seem inconsequential (in minor cases), but they all add up in the big picture to a significant concern for policymakers.

Reckitt has recalled certain catches of Nutramigen LGG stage 1 and stage 2 Hypoallergenic Formula powders over the possible presence of Cronobacter sakazakii. While the products, which are used for special medical purposes for infants, are mainly prescribed, they are also available without a prescription. The precautionary step has been taken after an isolated overseas sample of the product tested positive for Cronobacter sakazakii, said the consumer goods company, adding that a thorough investigation is on. Cronobacter sakazakii is a type of bacteria that can easily survive in dry foods, like powdered infant formula, powdered milk, herbal teas, and starches.