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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.

Boots has become the first community pharmacy in the UK to transport prescription medicines by a drone. The pharmacy multiple completed a test flight transporting prescription-only medicines by drone from Portsmouth to the Isle of Wight earlier this month. The flight departed from the British Army's Baker Barracks on Thorney Island near Portsmouth and arrived at St. Mary's Hospital on the Isle of Wight. The medicines were collected by Boots personnel and transported to the multiple's pharmacies across the island, where they will be dispensed to patients with prescriptions for them. Boots worked with medical drone start-up Apian to facilitate the test flight and is now assessing the future potential for drones in medicines delivery. Rich Corbridge, chief information officer at Boots, said: "Drones have a huge potential in the delivery of medicines and it is incredibly exciting to be the first community pharmacy in the UK to transport them in this way. An island location like the Isle of Wight seemed like a sensible place to start a trial of drones and their value to the delivery of medicines to more remote locations is very clear.

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.

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 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 Royal Pharmaceutical Society (RPS) has urged the government to amend medicines legislation to allow pharmacists to make minor amendments to a prescription without any protocol being needed. RPS wants to see a change in the law that makes the whole process of supply of medicines easier and quicker, enabling pharmacists to use their knowledge and expertise in medicines to better support patients. "At present a prescription can only be changed by a prescriber, which causes unnecessary workload for GPs and delays for patients," said RPS. RPS President Professor Claire Anderson said: "We want to see all pharmacists across the UK able to supply a different quantity, strength or formulation of a medicine (for example changing capsules to tablets) when required, to avoid unnecessary bureaucracy and the need for an SSP to be developed, signed and authorised by a Minister. In effect it would mean that pharmacists can help patients straight away - it would future proof the problem to some degree.

A report released by Community Pharmacy England (CPE) has warned that pharmacies across England are grappling with daily medicine supply challenges, posing significant risks to patients' health. The Pharmacy Pressures Survey 2024: Medicines Supply Report, which is based on the views of the owners of over 6,100 pharmacy premises in England and 2,000 pharmacy team members, has exposed some alarming trends concerning medicine supply problems in the country. Almost all pharmacy team members surveyed (97 per cent) reported patients being inconvenienced due to medicine supply issues, and 79 per cent of the participants said that the worsening situation is putting patient health at risk. Nearly all respondents reported patient frustration stemming from medicine supply issues, with 84 per cent of them saying they had experienced aggression from patients. Additionally, 98 per cent indicated an increase in 'owings,' where patients receive only part of their prescription and must return to the pharmacy for the remaining medication(s) at a later time."

Pharmacist supervision has been the subject of debate for as long as I can remember. Strikingly, no one is sure what supervision requires. The Human Medicines Regulations 2012 say it is a criminal offence to sell or supply Pharmacy medicines or Prescription Only Medicines unless a pharmacist makes the sale or supply or, if the transaction is carried out by a non-pharmacist, that person acts under the supervision of a pharmacist. Over the years, some people have argued that supervision requires a clinical check. Others say it requires an accuracy assessment. Yet others have asserted that it requires a final check before a medicine leaves the pharmacy. Things are made more uncertain by the NHS terms of service which require prescription medicines to be supplied under the direct supervision of a pharmacist. No one knows what the word "direct" adds. The wording of the Human Medicines Regulations is not identical to the wording of earlier legislation. In particular, on the only occasions when the courts have been called upon to interpret the requirement for supervision, the Pharmacy and Poisons Act 1933 was in force. In cases decided in 1943 and 1953, the courts decided that a pharmacist who was upstairs when a supply was made could not have been supervising; and that a sale was supervised by pharmacist standing at the cash desk because the pharmacist could intervene if a sale would not be appropriate.

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.

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."

From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.

The MHRA's Criminal Enforcement Unit (CEU), working with other law enforcement partners, has seized more than two million "illegally traded medicines" this year, with a total value of £5 million. The products confiscated in the UK were prescription-only medicines including anti-depressants, pain medication and human growth hormones. The MHRA launched an initiative, Operation Pangea, 15 years ago to combat "illegal internet trade in medical" products. Andy Morling, the Deputy Director of Criminal Enforcement of MHRA, spoke about Operation Pangea's 15-year anniversary. "Fifteen years ago, the MHRA started Operation Pangea, combining our knowledge and resources with those of international partners to disrupt and bring to justice the criminal gangs responsible for selling medicines illegally and causing harm around the world.

Indian multinational pharmaceutical company, Dr. Reddy's Laboratories has made its entry into the UK consumer health market with the launch of an over-the-counter allergy medication. Histallay (Fexofenadine Hydrochloride 120 mg tablets) is the company's first general sale list (GSL) product introduced in the UK market. Previously classified as a Prescription Only Medicine (POM), Dr. Reddy's Fexofenadine 120 mg is now available without prescription, under the brand name 'Histallay'. This allows people with allergic seasonal rhinitis (hay fever) to get direct access to the product via retail outlets such as pharmacies and supermarkets in the UK.

Approximately 25 million GP appointments and 5 million A&E visits are utilised each year for self-treatable illnesses. If these individuals chose to self-treat using over-the-counter (OTC) medications, the potential savings for NHS could amount to at least £1.7 billion annually, according to a research commissioned by Proprietary Association of Great Britain. The study, conducted by analysts at Frontier Economics, revealed that embracing self-care could bring an additional economic benefit of £350 million annually, as employees would avoid unnecessary time off from work for medical appointments. Apart from the savings resulting from the increased OTC medicine use, the report emphasises the potential benefits of reclassifying more prescription-only medications (POMs). A mere 5 per cent reduction in NHS prescribing levels and spending could lead to an annual cost-saving of £1.4 billion, encompassing both prescription costs and GP appointments, it said. "This substantial amount could greatly alleviate financial pressures on the NHS and offer essential resources for recruiting and training much-needed healthcare professionals."

The Department of Health and Social Care (DHSC) has issued Serious Shortage Protocols (SSPs) on three HRT medicines to limit dispensing supply to three months. To ensure women across the UK will be able to more reliably access HRT products SSPs has been issued on the supply of Oestrogel, Ovestin cream and Premique Low Dose. DHSC stated, "Women who have a prescription for more than three months but are only able to access three months' supply will not have to pay an additional prescription charge." "This means women will not incur any additional costs. Imposing a three month limit will mean more women are able to access the medication they want. Any woman who is worried about access to HRT or is unable to access HRT should speak to her GP." Recently, Vaccine Taskforce Director General Madelaine McTernan has been appointed to spearhead a new HRT Supply Taskforce, applying lessons learned from the successful procurement seen during the Covid vaccination programme to identify ways to support the HRT supply chain ensuring it can meet both short and long term demand. The move will save time for patients as well as pharmacists and prescribers who are working tirelessly to tackle the covid backlog.

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.

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).

A Company Chemists' Association (CCA) analysis has shown that 'Pharmacy First' service in England could free up 30m+ GP appointments each year. It has urged the Government and NHS to be even 'bolder in their ambition and go further and faster'. The recent 'Delivery plan for recovering access to primary care' announced a 'Pharmacy First' service for England, mirroring similar approaches in Scotland and Wales. The association has estimated that with the added capability to supply non-prescription medicines and prescribe additional prescription-only medicines, an ambitious 'Pharmacy First' service could free up 30m+ GP appointments annually. Harnessing community pharmacies to deliver care for minor health conditions will effectively create 11,000 urgent care centres in England.

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.

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."