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The recent announcement that Royal Mail will be partnering with distance selling pharmacy (DSP) giant pharmacy2U highlights how standards of regulatory enforcement are being ignored to accommodate the DSP model. The brunt of these double standards hinges around the levelling down of temperature enforcement standards by the Medicines and Healthcare products Regulatory Agency (MHRA) which demands mapping must be audited from the point of dispensing to the patient. The MHRA has a well recognised duty to ensure medicines reach patients in a safe condition. The current anomaly appears to turn a blind eye to this step in the supply chain at the point the wholesaler releases goods to the pharmacy hub. Equally the training on delivering medicines safely and effectively direct to patients should apply fully to all hubs including DSPs. Why is it that DSPs are being treated differently to bricks and mortar pharmacies? It's essentially the same patients receiving the same medicines from the same wholesalers. A further regulatory disparity exists around how parcels must be "tracked and signed for" to be reasonably certain medicines are delivered into the hand of the intended recipient, as per existing regulations. Clearly an untracked, unsigned package cannot be guaranteed to finish in the hands of the intended recipient. There is a very real possibility that such omission could lead to community pharmacy closures which will, in turn, lead to unemployment and a reduction in the care services. At a time when integrated care systems have just gone live, the removal of vital support services leading to further inequalities is the wrong message for both providers and patients alike.

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.

Proprietary Association of Great Britain, PAGB - which represents manufacturers of branded over-the-counter (OTC) medicines, self-care medical devices and food supplements - on Tuesday (12 December) celebrated 40 years of reclassification of medicines. Expanding self-care for common ailments and minor injuries will not only help ease pressure on primary care services, but also provides significant potential savings for the NHS, the consumer healthcare association highlighted during the event. Nurofen (ibuprofen) and Imodium (loperamide) were the first medicines to go through Medicines and Healthcare products Regulatory Agency (MHRA)'s switch process in 1983 to make them available over the counter - OTC. Other reclassified medicines which were once available on prescription only include Voltarol (diclofenac dimethylammonium), Canesten (clotrimazole), Nexium (esomeprazole), Nicorette, Nicotinell and Niquitin (nicotine replacement therapies), Regaine (minoxidil), Viagra Connect (sildenafil), Cialis Together (tadalafil) for erectile dysfunction and Gina (estradiol hemihydrate) for the treatment of postmenopausal symptoms such as vaginal dryness.

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) is considering the reclassification of Aquiette 2.5mg tablets contains oxybutynin hydrochloride that is used to treat women with milder symptoms of overactive bladder from Prescription-Only-Medicine (POM) to Pharmacy (P) medicine. The agency is encouraging pharmacists, GPs and other health care professionals, the public and women to take part in the reclassification consultation to make a treatment for overactive bladder available for women without the need for a prescription. Public consultation on a set of proposals to make Aquiette 2.5mg Tablets (oxybutynin hydrochloride) available from pharmacies will close on 13 May, 2022. It would be the first time a medicine for the treatment of overactive bladder would be available without prescription, if the reclassification consultation receives positive responses. After the decision is made to reclassify this treatment, pharmacists will have access to training materials and a checklist to enable them to identify women who can be supplied this medicine safely.

The Medicines and Healthcare products Regulatory Agency (MHRA) has been accepted as a full member of three international work-sharing partnerships. Through these partnerships the agency said it will play vital international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, Two of these, the International Medical Device Regulatory Forum (IMDRF) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) are focused on improving the harmonisation and convergence of medicines and medical devices regulation globally. The partnerships will also help the MHRA to share expertise with other leading organisations, support the development of regulatory guidelines and drive greater harmonisation of regulation around the world. This will help deliver timely access to innovative medical products not just in the UK but globally.

The Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) seized a large quantity of suspected illegally traded medicines, including powerful prescription-only medicines, during raids conducted at two residential and two business premises across North Manchester. Officers from the MHRA and Greater Manchester Police carried out searches across two residential addresses in Oldham and Cheetham in the early hours of Wednesday (29 November), and arrested a man in his 20s on "suspicion of conspiracy to supply controlled drugs, breaches of the Human Medicines Regulations 2012 and money laundering." They also seized thousands of illegal medicines from two business addresses in Bury and Miles Platting, including powerful opioid painkillers and antidepressants, as well as unlicensed versions of erectile dysfunction drugs.

The Manchester Crown Court on Friday (9 December) sentenced three men, Cleave Lewis (35) and brothers, Denis Sutherland (58) and David Sutherland (59), to a total of three years in jail after they pleaded guilty to the illegal sale and supply online of prescription-only medicines and controlled Class B and Class C drugs, worth more than £1.5m. They were found in possession of nearly 1.3m tablets of prescription-only drugs, including powerful sleeping pills, painkillers and anti-anxiety meds, when officers from the Medicines and Healthcare products Regulatory Agency (MHRA) and Greater Manchester Police searched their residential homes and business premises in October 2017. Following investigations by the agency, they also pleaded guilty to illegally making these medicines available online on three different websites for the public to purchase without prescriptions. The officials also recovered controlled medicines, over half a million (525,737) erectile dysfunction, slimming and herbal tablets, with an estimated value of approximately £500k, from them.

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.

Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA communicate with healthcare professionals to improve medicines and medical devices' safety'. Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. "We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients," said MHRA. "We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety."

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.

The European Commission launched an initiative to deal with the ongoing supply crisis on Tuesday (24 October). The following announcement comes after the shortage of key antibiotics last winter identified by the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA). The "European Voluntary Solidarity Mechanism" is a proposed short-term measure that involves a Member State's need for a given medicine to other Member States to redistribute medicines from their available stock. Additionally, the Commission intends to cooperate with member states to improve components of pharmaceutical reform with an aim to strengthen supply security. They are setting up a few actions apart from the launch, a list of critical medicines to analyse the supply chain by early 2024; regulatory flexibilities; strengthening security of supply; and availability of antibiotics and treatments for respiratory viruses by next winter.

Medicines and Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals that use of systemic (oral and injectable) Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy). It has advised that patients who are unsure whether pain relief medicine they are taking is an anti-inflammatory (NSAID), to speak to doctor, midwife, or pharmacist. Some non-prescription pain relief medicines may contain more than one active drug, therefore it is important to read the box or the leaflet provided with the medicine to see if it contains an NSAID like ibuprofen. The use of any non-prescription medicine for the management of pain during pregnancy should be for the shortest possible time at the lowest possible dose, suggested MHRA.

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) made its new International Recognition procedure (IRP) fully operational from 1 January 2024, inviting developers of new medicines to submit their applications for marketing authorisation. Beginning this year, the EC Decision Reliance Procedure (ECDRP) has been replaced by IRP, and the Mutual Recognition/Decentralised Reliance Procedure (MRDCRP) has come under its umbrella. The move is expected to further improve access to life-saving medicines for UK patients following the UK's departure from the European Union.

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.

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 and Healthcare products Regulatory Agency (MHRA) has issued a company-led drug recall for Sodium Chloride Eye Drops 5% 1x10ml (unlicensed medicine) Stockport Pharmaceuticals. Stockport Pharmaceuticals said that the above batch of Sodium Chloride Eye Drops 5% w/v as the sterile eye droppers supplied with the medicinal product have expired (Jan 2022). The authority said, "This recall is being issued as a company-led medicines recall, as this product is only supplied to a small number of customers, and the manufacturer has full traceability of the product's distribution." "Remaining stock of the above batch should be quarantined and returned to Stockport Pharmaceuticals directly."

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 Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot be hoarded or exported from the UK market. The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs. In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to patients across the UK. The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.