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A new Information Standard has been published to support improved medication and sharing of allergy information across healthcare services in England. The move will standardise medication message content and help reduce medicines related errors and improve patient safety. It will also allow efficient sharing of medicine information between NHS and social care organisations, including hospitals, GP practices, residential care homes, mental health trusts, and community pharmacies. The Standard that came into effect in October "will save healthcare professionals valuable time accessing key medicines information, provide clinicians with access to a richer source of information, consistent across all care settings", said Shahzad Ali, NHS Digital clinical lead for the Interoperable Medicines Programme.

Pharmaceutical recalls are complicated and expensive, just like in any other business. Pharmaceutical recalls, however, pose a further risk because they might change both short- and long-term health effects. To ensure smooth recalls with few negative effects on public health, it is crucial to understand the pharmaceutical product recall procedure and the roles of each key player. Throughout the recall procedure, patient safety is crucially ensured by the FDA, pharmaceutical companies, pharmacy technicians, and other healthcare professionals. Learning about pharma recalls, procedures, and responsibilities is essential for guaranteeing patient safety for key actors like the Food and Drug Administration (FDA), manufacturers, and other medical specialists. RECALL CLASSIFICATIONS Recalls can fall into one of three categories-class I, II, or III-with class I being the most serious and lethal. Products that have the potential to result in serious, permanent complications or death are subject to Class I recalls. Class II recalls are recommended for product flaws that have a low likelihood of harmful events or that can result in reversible side effects. Last but not least, class III recalls typically arise from problems with packaging that do not pose a risk. Since they are frequently issued out of an abundance of prudence rather than due to any negative impacts, many people may even describe this kind of recall as benign.

Pharmacies are the lifeblood of community healthcare, being a vital pathway to care and support in every borough of the UK. There are 11,600 pharmacies across the country, amongst which yours stands proudly. Pharmacies obviously have a duty of care to their patients and customers, and rigorous safety practices surrounding the safe storage and dispensation of medicine - but that duty of care also extends to fellow staff. This is to say that health and safety is a paramount concern for any pharmacy or pharmacist, and that great care should always be taken to uphold the highest possible standards with regard to health and safety. With this in mind, what follows is a refresher on some of the key hazards that could give way to workplace injury in your pharmacy - and how to mitigate the risk of injury. Biological Hazards Biological hazards are ever-present, and prescient in the aftermath of the coronavirus pandemic. Though the COVID-19 virus was eventually shown not to be particularly resilient on surfaces, good practice was still to regularly disinfect surfaces and handles where possible - something which should still be a part of regular routine in your pharmacy. Likewise, face masks are a solid way to reduce the risk of infection or contamination, particularly where the handing over of biological samples is concerned.

The Medicines & Healthcare products Regulatory Agency has initiated a recall of three batches of Quantum Pharmaceutical's Diltiazem HCl 2% Cream, which is an unlicensed medicine. MHRA issued a precautionary recall of the cream due to a change in the product's appearance that affected its thickness. Pharmacists are instructed to halt supply, quarantine remaining stock, and contact Quantum Pharmaceutical to return affected batches M1402497, M1402574, and M1402680. Patients using this product may encounter application issues with the cream due to its consistency. However, MHRA said that this has not impacted the product's effectiveness or posed any risk to patient safety. The MHRA also reported that medac GmbH (t/a medac Pharma LLP) is conducting a recall of two batches of Sodiofolin 50 mg/ml solution for injection/infusion (400mg/8ml vial) with batch numbers G220393B and G220393C. This class 2 medicines recall is a result of particles detected during long-term stability tests.

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."

Hospitals and healthcare providers across the UK have been notified about the shortage of an anti-inflammatory medicine caused by a manufacturing failure. The Department of Health and Social Care (DHSC) on Friday (3 May) issued a National Patient Safety Alert stating that Erelzi 50mg solution for injection in pre-filled pen will be out of stock from early May until mid-July 2024. "The supply issues have been caused by a manufacturing failure resulting in delays in production and the implementation of global allocations," it said. However, it noted that homecare providers (Alcura, Healthnet and Sciensus) have sufficient stock to supply existing patients until mid/late May 2024. Although Erelzi 50mg pre-filled syringes (PFS) are still available, they cannot support a full increase in demand, the DHSC warned.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the reclassification of codeine linctus to a prescription-only medicine after considering multiple Yellow Card reports for its opioid effects, rather than for its intended use as a cough suppressant. This medication is currently licensed as a pharmacy medicine, which means that it is available to purchase over the counter in pharmacies. If reclassified as a prescription-only medicine, all strengths of codeine linctus will only be available upon presentation of a prescription. Dr Alison Cave, MHRA Chief Safety Officer, said: "Codeine linctus is an effective medicine, but as it is an opioid, its misuse and abuse can have major health consequences. Every response received will help us to develop a broader view on whether codeine linctus should be restricted to prescription-only status. We want to hear from members of the public, health professionals and others who would be affected by this potential change so we can make a properly considered decision for the benefit of patients, carers, and healthcare professionals across the UK.

The Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery. The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn. MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.

The Department of Health and Social Care (DHSC) announced on Monday (November 22) that it would integrate NHS Digital, NHSX and Health Education England into NHS England and Improvement (NHSE&I) as part of major workforce planning and technology reforms. The merger is part of the government's long-term strategy for the recruitment, training and retention of healthcare staff coupled with a digital transformation of working practices. The overhaul is based on recommendations made by NHS Digital chair Laura Wade-Gery who led a government-commissioned review to improve patient care, centralise the NHS workforce and accelerate digital delivery. Commenting on her recommendations, Wade-Gery, said: "In the rest of our lives, digital has really changed how we live and we must now make this true in healthcare. The goal of my review is to equip the national centre with the right capability to support Integrated Care Systems to deliver better citizen health. We need to have the culture, operating model, skills, capabilities and processes to put data, digital and technology at the heart of how we transform health services."

The Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.

The Medicines and Healthcare products Regulatory Agency (MHRA) has reclassified codeine linctus, a medicine used for the treatment of dry cough, from a pharmacy-only medicine (P) to a prescription-only medicine (POM) owing to the risk of dependence, addiction, and overdose. This implies that the dry cough syrup, which is also known as codeine oral solution, can only be dispensed upon the submission of a prescription at a pharmacy, rather than being accessible over the counter upon request. Patients are cautioned that as an opioid medicine, codeine can be addictive, and the risk of addiction may increase, particularly with prolonged use over an extended period. According to the medicines regulator, codeine is converted into morphine by the liver enzyme CYP2D6. In individuals identified as ultra-rapid metabolizers, this conversion from codeine to morphine occurs at a faster rate than in others. "If you want to stop taking it and have been taking codeine linctus for a long time, then it is important to reduce the amount you take slowly with the help of your prescriber," the agency said in its drug safety update issued on Tuesday, 20 February.

The Department of Health and Social Care (DHSC) has issued an alert to update healthcare professionals on the shortage of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), which are used to treat type 2 diabetes. It has informed that the supply of the drugs continues to be limited, and is not expected to return to normal until at least the end of 2024. An increase in demand for these products for licensed and off-label indications is cited as the cause of the supply issues. "Rybelsus® (semaglutide) tablets are now available in sufficient quantities to support initiation of GLP1 RA treatment in people with type 2 diabetes (T2DM) in whom new initiation of GLP-1 RA therapy would be clinically appropriate," the DHSC's National Patient Safety Alert reads.

The Medicines and Healthcare products Regulatory (MHRA) and Genomics England to launch a brand-new genetic research resource, known as a 'biobank' on Thursday (June 01) to tackle the issue of Adverse Drug Reactions (ADRs). Biobank will help to better understand how a patient's genetic makeup can impact the safety of their medicines. "The Yellow Card biobank, which will contain genetic data and patient samples, will operate alongside the MHRA's Yellow Card reporting site for suspected side effects and adverse incidents involving medicines and medical devices," said MHRA. The biobank pilot will officially begin on 1 June 2023 with participant recruitment commencing later this year, on 1 September. The sequencing of participants' genetic material will begin in Spring 2024, with initial research findings from the pilot due to be published in 2025. Genomics England will be supporting the MHRA with sequencing and storage of genetic material through use of their well-established and secure infrastructure.

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 Scottish government has announced funding to help community pharmacy contractors purchase air extraction equipment for their premises. The funding will be available to pharmacies that have fitted or committed to fit air extraction equipment on or after 1 April 2020. The funding is aimed at supporting both staff and patient safety, as pharmacists in Scotland provide face to face healthcare services to people every day. The investment is seen as an important protection measure against respiratory infections, including Covid-19 transmission, as Scotland begins to open-up again following the pandemic.

The Professional Records Standards Body (PRSB), which develops information standards for health and social care records, has appointed Professor Reecha Sofat as the new Chair. She will assume the role at the end of October 2024, succeeding Professor Maureen Baker CBE, who will step down after seven years as Chair of the PRSB. A Clinical Pharmacologist, Professor Sofat has held many leadership roles across the NHS, academia and scientific societies. Professor Sofat is Breckenridge Chair of Clinical Pharmacology at the University of Liverpool. She practices general internal medicine and is also an Associate Director at the British Heart Foundation (BHF) Data Science Centre (DSC) which is led by Health Data Research UK (HDRUK). With a passion for data science and extensive clinical and research insights, Professor Sofat is focused on embedding research into routine health and social care. She said: "I am passionate about using the rich health data that is already collected across NHS and social care to better understand the causes and consequences of disease and improve health outcomes.

CMS signals its full efficiency after pandemic and starts from conducting regular state reviews. Given is the detail about the types of expected surveys in the near future.

PBR Staff Writer Published 21 March 2014 Novartis has launched the Lucentis (ranibizumab) pre-filled syringe (PFS) in Germany and plans to introduce the product in other markets throughout 2014. In October 2013, the company has received approval from the European authorities for Lucentis PFS, which is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.