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A couple in Maidenhead, Berkshire has been handed suspended sentence for illegal possession and supply of £1.6m of unlicensed medicines. Following investigations initiated by the MHRA, Karina Filimonova and Andrejs Stolarovs were caught with the unlicensed medicines which included prescription-only medications. Southwark Crown Court sentenced each "to eight months imprisonment suspended for 18 months and 150 hours unpaid work" for possessing and intending to supply medicinal products contrary to the Human Medicines Regulations 2012. "This was a sophisticated operation illegally bringing unlicensed medicines into the UK from Singapore and India, and then distributing them across the country and abroad," said Andy Morling, MHRA Deputy Director of Criminal Enforcement. "Criminals trading in medicines illegally like this are not only breaking the law, but they also have no regard for your safety. These are powerful medicines that can lead to serious adverse health consequences if taken without appropriate medical supervision." In 2020, the Royal Mail Group (RMG) informed the MHRA about parcels containing unlicensed medicines discovered during their investigation into suspicious parcel activity. Following this, the MHRA's Criminal Enforcement Unit, in cooperation with local police, launched an investigation and apprehended the couple at their residence in Kidwells Close, Maidenhead.

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when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn.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 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 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 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 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.

Professor Harry McQuillan has said community pharmacists in the UK must change their focus from an 'accuracy of supply' to a 'safety of supply' model when it comes to dealing with patients. "The main take away message from tonight's lecture is for pharmacy professionals to really challenge themselves about whether they are focused on accuracy of supply or safety of supply," he said at this year's UCL School of Pharmacy Lecture in London on Thursday, 15 June. "For our community pharmacists it must be about safety, including prescribing, and ensuring patients and citizens get the maximum benefit from prescribed medicines. "To deliver this, we need to invest in our teams - harness technology and always be willing to take the next step in a more clinical future." The Chief Executive Office of Community Pharmacy Scotland, however, noted that at a time when the UK was grappling with an unprecedented national debt crisis exacerbated by severe cost of living and spiraling inflation, community pharmacy will need to make a "compelling case" of where the priority should be in the sector. Expanding on the financial woes of the country, he compared the current national debt of the UK, which stood at a staggering 270 percent of GDP in September 2022, with the previous record-breaking national debt of 250 per cent at the end of WWII.

Pharmacy professionals to be included as key stakeholders in the implementation, delivery and evaluation of a wide range of genomic services, said the Royal Pharmaceutical Society (RPS). RPS's statement has been developed in collaboration with pharmacy organisations who have co-badged the report, such as the British Oncology Pharmacy Association, the UK Clinical Pharmacy Association, Association of Pharmacy Technicians and the College of Mental Health Pharmacy. It looks at current and future roles for pharmacy professionals in genomic medicine across many aspects of practice such as person-centred care and collaboration, professional practice, education, leadership, management and research. Pharmacists and pharmacy technicians in the UK have already established roles in the application of genomic medicine in some areas of practice, such as antimicrobial stewardship and infectious diseases, and the management of certain genetic conditions, such as cystic fibrosis. The society believes, the current role of pharmacy professionals in genomics can be expanded upon in the future to both lead and support many relevant aspects of genomic implementation. These are described across all healthcare sectors, within the Genome UK strategy produced by the UK Government, and within the implementation plans published in England, Scotland and Wales. Lead for Pharmacogenomics at RPS Sophie Harding said: "Pharmacy professionals are the gatekeepers of medication safety and efficacy across all areas of healthcare. They are skilled at interpreting complex scientific data and use evidence-based medicine to maximise the benefits of treatments for patients, whilst supporting shared decision-making with patients and the multidisciplinary team.

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."

While responding to the consultation on hub and spoke dispensing, trade unions for pharmacists have emphasised that the patient safety and care must be the priority in hub and spoke dispensing. The Royal Pharmaceutical Society (RPS) has welcomed the opportunity provided by a change in legislation to enable community pharmacies to make use of hub and spoke dispensing but reaffirmed that patient care must be at the heart of future changes. With regards to patient safety, the Pharmaceutical Services Negotiating Committee (PSNC) considers that only Model 1 is appropriate, with manageable risks related to patient safety, and is a model that has the potential to allow the whole sector to benefit fairly. In its response to the consultation on Hub and Spoke dispensing, PSNC highlighted that Model 2 in the consultation, a hub direct to patient supply of dispensed medicines, raises patient safety issues and it cannot be supported. RPS President Professor Claire Anderson said: "In all models, patients need to continue to have access to a pharmacist at the time of supply of medicines so they have the opportunity to discuss, ask questions or raise concerns, and receive appropriate information with counselling and advice.

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.

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."

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.

Teva UK has begun replacing its existing packaging with a new design which is "clearer and easier to read". The new look is "unique, recognisable and distinctive." It "enhances safety and provides a recognisable and distinguishable pack range." One of the UK's leading generics manufacturers, Teva UK supplies more than 500 generic pharmaceutical products to retail and hospital pharmacies. The company says each product within the portfolio is distinguishable by colour, ensuring no two different packs have the same drug and strength colours and with additional product information on the side of the pack and a simplified back, it makes it even easier to identify the correct product when dispensing and supports patients when taking their medication. "Our medicines impact the lives of millions of people every day and our packaging is often the first touchpoint for our patients and our customers", said Kim Innes, general manager of Teva UK and Ireland.

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.

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 Health products Regulatory Agency (MHRA) on Thursday issued a class 4 medicines defect information notice for Cozaar 100mg film-coated tablets due to an error in the Patient Information Leaflets (PILs) reported by the company. Cozaar is used to treat high blood pressure (hypertension) as well as to slow the progression of kidney disease in people who have type 2 diabetes mellitus. Quadrant Pharmaceuticals Ltd has informed the UK regulatory authority that the PILs that have been packed in certain batches of the products do not have the most up to date safety information. 'Grapefruit juice should be avoided while taking Cozaar'- This information is missing in Section 2 'What you need to know before you take Cozaar', sub section 'Cozaar with food and drink', the company clarified.

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 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.

Two weeks prior to the closing of the hub and spoke consultation, issues around patient safety, costs and competition as well as practicalities such as what to do with uncollected medicines were discussed in a webinar on hub and spoke dispensing on Wednesday (May 26). The webinar was organised by Sigma Pharmaceuticals in association with the National Pharmacy Association (NPA). NPA director of corporate affairs Gareth Jones chaired the event and was joined by Sigma's Hatul Shah and Raj Haria as well as NPA vice chair Nick Kaye and NPA head of advice and support services Jasmine Shah. Kaye said: "There are still many 'unknown unknowns' with hub and spoke and the jury's still out on any potential benefits. I have lots of reservations about cost and it worries me how efficient this is for the business and the long term sustainability for the sector as a whole. Above all we need to think about the patient at the centre of all this and the potential confusion for them." Jasmine Shah felt patient safety was going to be the key in regards to whether the spoke and the hub would hold the ultimate responsibility and "who is going to take the accountability as far as patient care goes". She added: "It is most important that GPhC standards and NHS requirement are both met in identifying all the risks associated with the arrangement with hub and spoke and ensuring that (patient safety) measures are in place. Everything that needs to be looked at is by putting the patient at heart of the arrangement and seeing what is the safest way for them to receive care from both spoke and hub."