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Aquiette 2.5mg Tablets to remain as prescription-only - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has maintained the prescription-only status of Aquiette 2.5mg Tablets for symptoms of overactive bladder, following a public consultation and the review of a reclassification application from the manufacturer Maxwellia Ltd. Aquiette, which contains the active ingredient oxybutynin, is used for the treatment of long-term symptoms of overactive bladder (OAB) in women aged between 18 and 65, such as the urgent need to urinate and frequent urination without pain. The regulator decided against the reclassification of Aquiette 2.5mg Tablets from a prescription-only medicine (POM) to a pharmacy (P) medicine, concluding that a medical prescription continues to be required to ensure the safe use of Aquiette. Since an OAB diagnosis requires medical supervision to ensure that the correct treatment is received, and other health conditions are not overlooked or left untreated, the MHRA said the decision would ensure that the medication is used safely and appropriately under medical supervision. "After taking on board the views of the many patients and healthcare professionals who responded, we have decided to refuse the reclassification of Aquiette 2.5mg Tablets for women with symptoms of overactive bladder (OAB)," Dr Laura Squire, MHRA chief healthcare quality and access officer, said.
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Aquiette 2.5mg tablet:Reclassification as pharmacy medicine - 0 views

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    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.
pharmacybiz

Pharmacy First for 7 Ailments | Launching Jan 31 - 0 views

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    This Pharmacy First Common Ailments service will help patients seek treatment for seven common conditions directly from a pharmacy without the need for a GP appointment or prescription. Launching on 31 January next year although it is subject to IT being ready, the service will cover ailments including "sinusitis, sore throat, earache, infected insect bites, impetigo, shingles, and uncomplicated urinary tract infections (UTIs)" in women. People with symptoms of the above seven conditions will be supplied with a prescription-only treatment under a Patient Group Direction (PGD). Patients seeking assistance at the pharmacy, whether walk-in or referred by NHS 111, GPs, or other sources, can receive consultations. The new service includes self-referring patients plus referrals, and the Community Pharmacist Consultation Service (CPCS) will also be a part of it.
pharmacybiz

Codeine Linctus Reclassified - Your Guide to the Shift - 0 views

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    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.
pharmacybiz

Maxwellia plans to switch products from POM to P medicine - 0 views

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    Maxwellia has revealed its plans to switch some of its medicines in the self-care category from prescription-only-medicine (POM) to a pharmacy (P) medicine. After authorising the switch of Maxwellia's two brands of desogestrel contraceptive pills, Lovima and Hana, MHRA has opened a public consultation on reclassification of Aquiette (overactive bladder treatment) 2.5mg tablets manufactured by the company to be made available from pharmacies. "Maxwellia is currently looking at a number of medicines which treat a range of conditions in major public health categories that can be 'switched' from needing a prescription to being conveniently bought at a local high street or supermarket pharmacy. With its foot firmly on the accelerator it has other applications under assessment with the MHRA, including women's health products," the company stated in a recent statement. "Push to convert more prescription medicines to pharmacy medicines will firmly position pharmacists at heart of nation's public health, helping futureproof NHS," the medicine said.
pharmacybiz

Coeliac Crisis: NHS West Yorkshire's Gluten Free Prescription Cut Sparks Concerns - 0 views

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    NHS West Yorkshire Integrated Care Board (ICB)'s decision to withdraw gluten free prescriptions for people with coeliac disease across Leeds and Calderdale has disappointed Coeliac UK. In a statement released on Thursday, the charity, which provides support and advice to those living with the disease, has raised "grave concerns" about the decision, warning that it will have a detrimental impact on the coeliac community. The policy is currently implemented across the ICB's other places including Bradford district and Craven, Kirklees and Wakefield district, preventing coeliac patients from accessing gluten free bread and flour mix on prescription. NHS West Yorkshire ICB wants to align its gluten free prescribing guidelines across its five places. But the charity is worried that the additional cost of gluten free staple products will poses a real challenge to maintaining the gluten-free diet, which is the only treatment for the condition.
pharmacybiz

UK Expands Naloxone Access: New Legislation to Save Lives from Opioid Overdose - 0 views

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    The UK government has announced plans to update legislation to enable more services and individuals to provide take-home supplies of naloxone - a life-saving opioid overdose antidote - over the next few weeks. Naloxone can immediately reverse the effects of an opioid overdose by reversing breathing difficulties. The medicine can be administered by anyone in an emergency. However, current legislation allows only drug and alcohol treatment services to supply it without a prescription to individuals for future use. The Department of Health and Social Care (DHSC) confirmed on Tuesday (14 May) that more professionals, including nurses, paramedics, police officers, probation officers and pharmacy professionals, will be able to supply the medicine without a prescription to save lives. Health and Social Care Secretary Victoria Atkins warned that opioid addiction can ruin lives and it accounts for the largest proportion of drug-related deaths across the UK.
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pharmacybiz

Hay fever jab:Authorities take action against illegal advert - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) and the Committees of Advertising Practice (CAP) have issued a joint enforcement notice about the 'illegal' advertising of Kenalog injections on digital platforms. The notice warns all organisations offering Kenalog as a 'hay fever treatment' to stop advertising it in any of their social media or website advertising. "Kenalog is a prescription-only medicine (POM), which must not be directly or indirectly advertised to the public. Kenalog is not licensed for the treatment of hay fever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely on social media," said MHRA. "Now, advertisers must ensure that all references to Kenalog in the text, images or emojis on social media are removed, as well as commonly-used descriptive phrases for the jab such as 'hay fever injection' or hay fever jab' or any account names, testimonials or memes by 29 August 2022." After this date, the CAP's compliance team will remove non-compliant ads using targeted software and those who continue to promote it may be referred to the MHRA for further enforcement action.
pharmacybiz

Unlock Convenient Care: Pharmacy First Launches in England - 0 views

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    The much-awaited Pharmacy First service has been launched in England, enabling patients to get treatment for seven common conditions from their community pharmacists without needing to see a GP. According to NHS England, a total of 10,265 community pharmacies, which is equivalent to more than nine in ten community pharmacies in the country, will be offering the ground-breaking initiative. The new scheme allows highly trained pharmacists to give advice and prescription-only medicines for minor ailments including sinusitis, sore throat, earache, infected insect bite, impetigo, shingles, and uncomplicated urinary tract infections in women (under the age of 65). With this major expansion of pharmacy services, the NHS is aiming to free up 10 million GP appointments a year while giving the public more choice in where and how they access care.
pharmacybiz

Reclassification of Medicines: PAGB 40-Year Celebration - 0 views

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    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.
pharmacybiz

Ian Adamson : Maxwellia appoints s Strategic Advisor - 0 views

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    Maxwellia has appointed Ian Adamson as strategic advisor to shape the next phase of pharmacy medicine launches - a process which involves identifying and converting suitable prescription only medicines into versions people can choose to buy under the supervision of a pharmacist. Ian brings over 30 years' international consumer health and personal care experience to the Maxwellia team. He is currently an advisor to the board of the UK independent pharmacy chain Day Lewis plc, an advisor to the board of Spanish healthcare company ReVa Europe S.L and board advisor to East Midlands Pharmaceuticals Ltd. Prior to this Ian was Chief Commercial Officer and a main board director at SSL International plc (prior to its sale to Reckitt Benckiser) with responsibility for a $1bn portfolio of brands, which included Durex and Scholl. Ian's appointment follows the landmark reclassification of the progestogen only pill by the MHRA, a change spearheaded by Maxwellia, and the company's subsequent launch of its first product Lovima in July 2021; and the current MHRA public consultation on the reclassification of Maxwellia's new pharmacy brand, Aquiette 2.5mg Tablets (Oxybutynin Hydrochloride) for the treatment of overactive bladder symptoms which are not adequately controlled by bladder training alone.
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pharmacybiz

Acepiro : Kelso Pharma launches its first product - 0 views

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    Kelso Pharma, the growing UK based specialty pharma business, has announced its first product launch with the release to the UK prescription medicines market of Acepiro (Acetylcysteine) 600mg effervescent tablets. Acepiro 600 mg effervescent tablets are indicated in adults only and are being made available to hospital and community prescribers in 20 and 30 day packs, with the 30 day pack consistent with monthly prescribing. The NHS List Price for the 30 day pack is £4.40, with the 20 day pack priced at £3.65. Acepiro is being launched by Stirling Anglian Pharmaceuticals (SAP), which was acquired by Kelso Pharma one year ago, providing a new UK platform and springboard for future sales growth for the business. The new product complements SAP's existing portfolio of three medicines: CosmoCol (macrogol 3350 plus electrolytes) powder for oral solution - an osmotic laxative indicated for the treatment of chronic constipation and faecal impaction. Stirlescent (naproxen) 250mg effervescent tablets - containing naproxen, which is a non-steroidal anti-inflammatory drug (NSAID).
pharmacybiz

LSHTM Evaluates Impact of Pharmacy First - 0 views

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    Researchers from the London School of Hygiene & Tropical Medicine (LSHTM) have been tasked to evaluate the impact, safety and effectiveness of the Pharmacy First service, which was launched across England in January 2024. They have been awarded £2.4million by the National Institute for Health and Care Research (NIHR) to generate evidence on the new service that allows pharmacies to provide advice and treatment for seven common conditions without the need for a GP appointment. After consultation, if necessary, a community pharmacist can supply some prescription-only medicines to treat earache, sore throat, sinusitis, impetigo, shingles, infected insect bites or uncomplicated urinary tract infections in women. The LSHTM researcher team will be working together with experts at the UK Health Security Agency (UKHSA) and the Universities of Oxford, Manchester and Nottingham on the project. Dr Rebecca Glover, assistant professor in Antimicrobial Resistance at LSHTM, who will lead the three-year project, said they will evaluate "Pharmacy First's impact on GPs and the wider NHS, pharmacy services and patients."
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