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.
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.
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 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) 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.
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 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.
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.
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."
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.
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.
People are advised to be prepared and order their repeat prescriptions in time so that they don't run out of their routine medicines over the Christmas and
New Year break when services are likely to be busier than normal.
As GP practices will be closed over the bank holidays and only some pharmacies will remain open, local NHS leaders have urged patients to plan ahead to avoid making
last-minute requests for collecting repeat prescriptions, which can add avoidable pressure for doctors, pharmacies, and other NHS services.
Sati Ubhi, Chief Pharmacist at NHS Cambridgeshire & Peterborough, have cautioned patients that running out of their usual medication can have serious consequences.
"By ordering medicines as soon as possible, it allows enough time for it to be processed and dispensed and helps avoid a last-minute rush," she told Fenland Citizen.
The Department of Health and Social Care (DSHC) has launched a consultation to seek views on changes to pharmacy supervision, which is being considered as
part of the Primary Care Recovery Plan.
Plans set out in the consultation include making better use of pharmacies, improving access to primary care and maximising the contribution of pharmacy
professionals across healthcare.
In the consultation, the DSHC has set out proposals to amend the Medicines Act 1968 and The Human Medicines Regulations 2012.
The proposals aim to allow pharmacists to authorise registered pharmacy technicians to carry out the preparation, assembly, dispensing, sale and supply of
pharmacy and prescription only medicines in their absence. Currently, these services can only be carried out by, or under the supervision of, a pharmacist.
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."
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.
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.
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 General Pharmaceutical Council's Investigating Committee took decisive action on March 25, 2024, by issuing a warning to Dilsha Kiran Shah,
registration number: 2049787, for her conduct as Superintendent Pharmacist of Jhoots Healthcare Ltd.
Miss Shah's failure to uphold the Medicines Act 1968, specifically in ensuring the proper management of medicinal products, triggered this warning.
The Act mandates supervision in "keeping, preparing, and dispensing medicinal products other than those on a general sale list."
Moreover, pharmacies are inspected on five principles - Governance, Staff, Premises, Services including medicines management, and Equipment and facilities to
meet the right standards.
The alarm was initially raised in August 2021 when a Jhoots Healthcare Ltd pharmacy branch under Miss Shah's supervision operated without a responsible pharmacist.
Despite explicit instructions, pharmacy staff were allegedly instructed to proceed without proper supervision, raising grave concerns regarding patient safety.