First oral antiviral for COVID-19 approved by MHRA

The antiviral Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today.

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the first oral antiviral for the treatment of COVID-19 to be approved.

Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), Lagevrio works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease.

Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset

Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

Health and Social Care Secretary Sajid Javid said:

“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.

“The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments, and my thanks goes to the expert teams at the MHRA and MSD for this triumph, as well as the Antivirals Taskforce who have procured the treatment.

“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible

“This antiviral will be an excellent addition to our armoury against COVID-19, and it remains vital everyone comes forward for their life-saving COVID-19 vaccine – particularly those eligible for a booster – to ensure as many people as possible are protected over the coming months.”

Dr June Raine, MHRA Chief Executive, said:

“Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.

“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

“The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Lagevrio.

“In clinical trials, Lagevrio was found to be effective in reducing the risk of hospitalisation or death for at-risk non-hospitalised adults with mild to moderate COVID-19 by 50%.

“Based on this and other data that has been carefully reviewed by the Commission and its expert group, it is clear Lagevrio is another safe and effective treatment to help us in our fight against COVID-19.”

Online pharmacy breach advertising standards code

The Advertising Standards Agency (ASA) has upheld a complaint that challenged whether the online pharmacy, Pharmica, had advertised erectile dysfunction (ED) prescription-only medicines (POMs) to the public.

Prescription-only medicines or prescription-only medical treatments must not be advertised to the public.

A paid-for Google ad for an online pharmacy, Pharmica, seen on 31st May 2021, featured text that stated:

“Buy Erection Treatment £7.19 – Lowest UK Price Guarantee. Get 10% Off All ED Treatment. Easily Treat Erectile Dysfunction … Spring Sale: 10% off ED Tablets Today Code ED10.”

The ASA has stated that Pharmica Ltd did not believe the advert in question had promoted POMs. They pointed out that neither the advert nor the landing page to which it linked, included any terms or text relating to POMs. They believed the term “ED Tablets” could refer to either POM or non-POM ED treatments. They pointed out that the savings claim in the advert did not refer to POMs specifically, and said the price promotion had not been used in an attempt to upsell specific POMs.

Commenting on the case the ASA stated:

“We noted that the advert featured the claim “10% off ED Tablets Today”, but did not mention specific products. The website landing page to which the advert linked featured a range of POM and non-POM tablets, for the treatment of ED.

“In that context, we considered that the references to “tablets” in the advert would be understood by consumers as referring to both POM and non-POM tablets for the treatment of ED and that the 10% off promotion, therefore, applied to the advertiser’s POM and non-POM tablets.

“We sought advice from the Medicines & Healthcare products Regulatory Agency (MHRA). Their view was that an advert for ED treatment that included references to “tablets”, and which also had a clear implication that would be the outcome of a consultation, were likely to promote POMs unless it made clear that an over the counter (OTC) product was being advertised.

“We noted that the advert did not refer to any other treatment options and considered that it, therefore, had a clear implication that tablets would be the outcome of a consultation.

“While we noted that the advert did not specifically name any of the POMs that could treat ED, we considered that in the absence of any information stating that the 10% off promotion applied exclusively to non-POMs, the advert promoted POMs to the public and therefore breached the Code.”

The advert breached CAP Code (Edition 12) rule 12.12 (Medicines, medical devices, health-related products and beauty products) and the company was instructed that the advert must not appear again. In addition, the ASA told Pharmica Ltd not to advertise POMs to the public in future.

Pandora’s Bo[to]x

After twenty years of trying to keep “Botox” in its box (i.e. ensure guidance1 from MHRA*, ASA*, GPhC*, JCCP* is followed), I wonder who else in Pharmacy worries like I do about the loss of control of a Prescription Only Medicine (POM)?

Does it matter to anyone in Pharmacy that the regulations we have been entrusted to uphold since the tragic days of Thalidomide, have been ‘worked around’ to such an extent that the public perception of the ‘experts’ on the use of this medicine are now social media ‘influencers’?

These questions come to mind as in the same week the Medication Safety Officers (MSO) observatory and GPhC Regulate both referred to the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021, which has come into force. More information can be found in the All-Party Parliamentary Group on Beauty, Aesthetics and Wellbeing (APPG-BAW) Report2 into advanced aesthetic non-surgical cosmetic treatments and the insights from Kingsley Napley on regulation3.

It seems incongruous that in the middle of a pandemic, parliamentary time had to be created for the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021.

The paradox is stark that regulation was required to mitigate the risks to stop injecting something that is an aesthetic ‘want’, at a time when vaccine hesitancy was gaining momentum. All the while the phrase ‘zoom face’ was being coined and procedures being offered to ‘correct’ it.

During the call for evidence, I wrote to the APPG-BAW, particularly around the role of pharmacy as the experts and leaders in medication safety, and also on informed decision making (given ubiquitous off-label use of Botulinum Toxin).

I had experience in this area, having previously given evidence in 2012 to the House of Commons Select Committee on Science and Technology into the regulation of medical devices, and I had also provided evidence in 2013 to the Review of Regulation of Cosmetic Interventions.

I did not hear back from APPG-BAW and had assumed that the expert voice of pharmacy was being picked up elsewhere.

The APPG- BAW report states that evidence was given from stakeholders including organisations representing the aesthetic industry, operators and practitioners, health bodies, regulatory agencies and consumers themselves. Written evidence was provided by GMC, HCPC and numerous nursing and dental practitioners.

However, it is the absence of pharmacy expertise that shouts out in Annexe 1 and 2 of the APPG-BAW report. The report had support from the APPG on Social Media, although it does not reference any liaison with Pharmacy APPG.

The APPG-BAW report recommendations call for more regulation, standards and enforcement, despite the failure of the POM controls on Botox. The APPG-BAW also considers ethics and mental health and looks at the evidence on the normalisation of invasive techniques. The Nuffield Council on Bioethics4 published a detailed report into the ethical issues in 2017 and raised the issues of supply and demand, as well as corporate social responsibility (CSR) as a way of protecting individuals from public health harms or discrimination. The evidence of the Centre for Appearance Research5 at UWE Bristol looked at how forces such as celebrities and influencers and image-editing phone apps have contributed to a dissatisfaction in appearance, psychological vulnerabilities and seeking “quick fixes” to achieve the “right” look.

The APPG-BAW heard that the majority of aesthetic practitioners do not have the necessary knowledge and skills to carry out psychological assessments. The licensed indications for skin use of Botox are the temporary improvement of appearance when the severity of the facial lines has an important psychological impact in adult patients. Moreover, this is restricted to vertical lines between eyebrows, crow’s feet, and forehead lines. The APPG-BAW recommendations include national minimum standards for risk assessing psychological vulnerabilities. 

The GPhC is clear in its guidance that pharmacist prescribers have an important role in making sure prescribing is safe and effective in non-surgical cosmetic medicine. The GPhC signposts to various references for prescribing cosmetic products, although does not specify the need to join the accredited registers. The Scottish Government ran a consultation6 in 2020 with the aim of closing the legislative gap by amending the definition of “independent clinic” so that it covers pharmacy professionals and would be regulated by Health Improvement Scotland7(HIS). Whilst this requirement is only where premises are not already covered by GPhC and NHS contract, it looks as though HIS separate approach to regulating independent healthcare is providing flexible options (different mechanisms apply in England). 

I am not a pharmacist prescriber and therefore I am unlikely to have direct involvement in these areas. However, I have been involved in medication safety since the NPSA focus on medicine Patient Safety Alerts, and subsequently as a Medication Safety Officer (MSO).

I have also been involved in many investigations where things go wrong, including wider governance issues where professionals work across NHS and private practice. A harmed patient, who is also a pharmacist recently said:

“If you are not actively working towards learning – you are actively letting things go wrong”.

This aligns with the words of Lieutenant General David Morrison – “the standard you walk past is the standard you accept”. In healthcare, this could be considered to be “micro-harms” in that if left unchecked these issues have the potential to lead to patient harm and erosion of professional standards.

Non-surgical cosmetic procedures are not a marginal issue but have become a barometer for wider societal behaviours and there is a need for ethical debate in pharmacy about supply and demand. The conversation about the safe and effective use of non-surgical cosmetic medicines should be a matter for all pharmacy professionals and we need to start a conversation about pharmacy leadership in this area.

Opinion by Karen Harrowing, Pharmacist and Independent Advisor in wider healthcare governance.


References

All links below were accessed 28th October 2021.

  1. *Medicines & Healthcare products Regulatory Agency (MHRA – guidance now archived) available here.

*The Advertising Standards Authority Ltd (ASA) available here.

*General Pharmaceutical Council (GPhC) available here.

*Joint Council for Cosmetic Practitioners (JCCP) available here.

  1. APPG – BAW Report available here.
  1. Kingsley Napley review of APPG – BAW Report here.
  1. Nuffield Council on Bioethics availble here.
  1. Centre for Appearance Research available here.
  1. Scottish Government Consultation available here.
  1. Health Improvement Scotland (HIS) – Independent Clinics available here.
  1. Health Improvement Scotland (HIS) – Independent Healthcare available here.

UK Government push to implement longer HRT prescribing cycles

Women will soon benefit from cheaper and easier access to Hormone Replacement Therapy (HRT) to relieve symptoms of the menopause following commitments made in Parliament at the second reading of Carolyn Harris MPs’ Private Members’ Bill.

Working with NHS England, the government will look to implement longer prescribing cycles, in line with NICE guidelines, so women receive fewer prescriptions, reducing the need to pay frequent prescription charges. The government has asked NHS England to review current practice and the barriers to implementing NICE guidelines.

This could mean women would only have to pay one charge for up to a 12 month supply of HRT, saving up to £205 per year as a result.

To further improve access to HRT prescriptions, the government has also committed to look into combining two hormone treatments into one prescription, which affects approximately 10% of women accessing HRT.

Under current rules, HRT is sometimes classed as two medicines if it contains both Oestrogen and Progesterone meaning women may be charged twice for one course of treatment.

Minister for Women’s Health, Maria Caulfield said:

“We have heard loud and clear from women across the country and MPs that menopause support is a key issue we as a government need to do more to address.

“As a woman and a nurse, I am acutely aware of how challenging the symptoms of the menopause can be to live with.

“Cutting the cost of HRT – which can be a lifeline to women severely impacted by menopause – is a great stride forward, but there is more to do.

“I look forward to further addressing the menopause as part of the Women’s Health Strategy and working with Carolyn on improving support for women across the UK.”

Carolyn Harris MP said:

“Today is a result for women across the country. The Bill was never about wins for either side of the political divide – it was about wins the 51% of the population who will directly experience the menopause.

“The cost of HRT NHS prescriptions will be slashed – with the Government committing to working towards getting this down to a single prescription charge per year – and the new task force will look at all the other areas of support which are currently falling short and failing women.

“I look forward to working with the Minister to revolutionise menopause support in this country and being world leaders in changing the narrative on something that has been a taboo subject for far too long.”

This work is part of the ongoing government commitment to drive Women’s Health to the top of the agenda, ensuring the health and care system works for everyone and enabling women to live healthy, happy lives.

Elements of this story have been shared under the Open Government license.

E-cigarettes could be prescribed on the NHS

England could be the first country in the world to prescribe medicinally licensed e-cigarettes to help reduce smoking rates.

The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing updated guidance that paves the way for medicinally licensed e-cigarette products to be prescribed for tobacco smokers who wish to quit smoking.

Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service.

This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product.

If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.

E-cigarettes contain nicotine and are not risk-free, but expert reviews from the UK and US have been clear that regulated e-cigarettes are less harmful than smoking. A medicinally licensed e-cigarette would have to pass even more rigorous safety checks.

Some of the highest success rates of those trying to quit smoking are among people using an e-cigarette to kick their addiction alongside local Stop Smoking services, with up to 68 % successfully quitting in 2020 -2021.

Health and Social Care Secretary, Sajid Javid said:

“This country continues to be a global leader on healthcare, whether it’s our COVID-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness.

“Opening the door to a licensed e-cigarette prescribed on the NHS has the potential to tackle the stark disparities in smoking rates across the country, helping people stop smoking wherever they live and whatever their background.”

The UK Government will soon publish a new Tobacco Control Plan which will set out the roadmap for achieving a smoke-free England by 2030.

Elements of this story have been shared under the Open Government license.

Pharmacy bodies give mixed responses to the budget

The Company Chemists’ Association (CCA) and its members are acutely aware of the challenges facing the NHS and primary care following the pandemic, especially regarding the workforce and the accessibility of GP appointments.  The CCA have, therefore, welcomed the Budget and Spending Review announcements to invest in the healthcare system.

However, the CCA is concerned that the budget announcements make no mention of the community pharmacy sector which remains underfunded and underutilised.

Malcolm Harrison, CEO of the CCA said:

“Community pharmacists have the skills and expertise to support the NHS backlog by alleviating pressures in the primary care system. However, this potential can only be unlocked through long-term and stable investment.

“Community pharmacy has played a key role in the Covid recovery, staying open for patients to access medicines and other essential healthcare services, as well as more recently ensuring people are able to get their Covid and flu vaccinations. With almost 90% of the population living under a 20-minute walk from community pharmacies, the sector is in a prime position to support the Government to fully level up access to healthcare services across the country.”

In recent years, the CCA has become increasingly concerned that the pharmacy profession is experiencing an acute workforce crisis and long-term planning is urgently needed to address this.

Meanwhile, the Royal Pharmaceutical Society (RPS) English Pharmacy Board Chair has also responded to the Budget, which highlighted the vaccination programme and the crucial role of pharmacists, announced a further investment in the NHS and focused on life sciences.

Commenting on the Autumn Budget and Spending Review, Thorrun Govind, Chair of the RPS in England, said:

“Today’s Budget highlighted the vaccination programme as crucial to supporting the country’s recovery from COVID-19. Pharmacists across the health service have shown how they will be central to maximizing uptake of flu and COVID-19 vaccinations and, as we head into a challenging winter, the Government and NHS must ensure they get the support they need.

“Making a success of the Government’s planned investment in the NHS will now depend on supporting the whole of the health and care workforce to better manage growing demand across the health service. This must be backed by investment in pharmacy education and training to build on pharmacists’ clinical expertise to support patient care.

“Today’s announcement recognises the importance of a better-connected NHS to deliver the best care for patients. Investment in digital technology must include enabling read-write access for pharmacists to a health and care record, wherever they may work.

“We also saw a welcome focus on the UK’s position as a world leader in life sciences. There is a huge potential for innovations such as pharmacogenomic and, with the right support, pharmacists and pharmaceutical scientists will be central to leading the advancement and delivery of new therapies and technologies.”