Community Pharmacy England (CPE) has notified pharmacy teams that starting 1 August 2024, three Hormone Replacement Therapy (HRT) medicines will be
discontinued and will no longer be covered under the NHS HRT Prescription Prepayment Certificate (HRT PPC) scheme.
These are Bedol® 2mg tablets, Climanor® 5mg tablets and Clinorette® tablets.
Since Climanor® 5mg tablets have been discontinued, Medroxyprogesterone 5mg tablets will also be removed from the HRT PPC list, as this generic product is no
longer available as a licensed HRT medicine.
The CPE also noted that Provera® 5mg tablets, being an unlicensed HRT medicine, are not covered by the HRT PPC.
Pharmacy staff are advised to check the NHS Business Services Authority (NHSBSA) website for the most current list of HRT medicines covered by the HRT PPC.
The CPE has updated its HRT PPC medicines list to reflect these changes, which will also be updated in Part XVI of the August 2024 Drug Tariff.
The Department of Health and Social Care (DHSC) has included Tibolone 2.5mg tablets (Livial) and Prasterone 6.5mg pessaries (Intrarosa) to the list of Hormone
Replacement Therapy (HRT).
It has updated the June 2023 Drug Tariff (Part XVI) to include these additional HRT medicines for which patients will be able to purchase an HRT PPC.
"HRT is the replacement of female sex hormones oestrogen and progesterone in women to control symptoms of the menopause. Some medicines that are converted or break
down into oestrogen, progestogen or androgen hormones are prescribed for relief of menopausal symptoms. For the purposes of the HRT PPC these are included within
this definition of HRT," said DHSC.
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.
The Hormone Replacement Therapy (HRT) Taskforce head Madelaine McTernan has returned to working full time as the director general of the Vaccine Taskforce for
autumn booster campaign preparation.
She has presented a few key recommendations to help ensure continued HRT supply to meet rising demand. "Improved access to data on prescriptions to more easily see
where there are shortfalls between HRT packs prescribed and HRT packs supplied by manufacturers," she suggested. "Taking lessons from the HRT supply chain work to
inform broader medicine supply work."
Madelaine said: "I am pleased to see the situation with HRT supply is improving across the country. I want to thank suppliers and manufacturers for their engagement
and positive action to tackle this serious issue.
The Department of Health and Social Care (DHSC) has introduced a new prescription pre-payment certificate (PPC) for Hormone Replacement Therapy (HRT) which
is said to benefit around 400,000 women who suffer from negative symptoms of the menopause in England.
PPC will be rolled-out from 1 April and it reduce the HRT costs to less than £20 a year. Women prescribed HRT - the main treatment for menopause symptoms - will
have access to a new scheme enabling access to a year's worth of menopause prescription items for the cost of two single prescription charges (currently £18.70).
As part of commitments to reduce the cost of HRT for menopausal women, the prescription PPC will be valid for 12 months. It can be used against a list of HRT
prescription items, and a patient can use this against an unlimited number of HRT items, such as patches, tablets and topical preparations. There will be no limit
to how many times the certificate can be used while it is valid.
"The introduction of the certificate delivers one of our year one priorities for the Women's Health Strategy for England. Published last summer, the strategy sets
out an ambitious new agenda for improving the health and wellbeing of women and girls and to improve how the health and care system listens to women. Menopause was
announced as a priority area within the strategy," said DHSC.
Health and Social Care Secretary Sajid Javid and Madelaine McTernan, head of the HRT supply taskforce, continue to take urgent action to resolve the shortage of HRT medicines by meeting the drug manufacturers and representatives from community pharmacies on Thursday (May 5).
In the meeting, manufacturers outlined the steps they're taking to boost supply, and pharmacists shared their experiences on the frontline, as well as sharing their
thoughts on wider solutions including improved communications.
Aspen Pharmacare, Besins-Healthcare, Gedeon Richter, Novartis, Novo Nordisk, Orion, Pfizer, Theramex, Viatris, and representatives from community pharmacies were
part of the meeting.
As the government confirmed its intention to work with industry to do what is necessary to fix the HRT supply issue, Javis said he wanted to understand the issues
facing suppliers and what can be done to address them.
"We will leave no stone unturned in our national mission to boost supply of HRT. Along with appointing Madelaine McTernan as head of the HRT supply taskforce to implement lessons learned from the pandemic, and ensuring prescriptions are issued in shorter cycles for now, we are working collectively with the sector to urgently resolve this issue," he commented.
The Association of Independent Multiple Pharmacies (AIMp) said the meeting discussed 'why we got into this position' and the way forward.
The Royal Pharmaceutical Society (RPS) has welcomed the Health Secretary Sajid Javid's plan to appoint Hormone Replacement Therapy (HRT) tsar to tackle the medicine shortages.
On Sunday (April 24) Sajid Javid told the Mail that he planned to tackle the problem (shortage of HRT medicine) by appointing a new HRT tsar with the role modelled on that of Kate Bingham, who successfully led the government's Covid vaccine taskforce.
"The difficulties in accessing HRT medicine have unfairly impacted women's mental health," said RPS President, Professor Claire Anderson.
"I look forward to working with this new champion for HRT and the Government on how we can better support women's health, building on the positive move to reduce
prescription charges for HRT for women."
Anderson also stressed that "the Government should now go further and end unfair prescription charges for patients in England altogether."
More than 500,000 women in England have benefitted from cheaper hormone replacement therapy (HRT) since the launch of the HRT prescription prepayment
certificates (PPC) on 1 April last year, according to the Department of Health and Social Care (DHSC).
HRT is the main treatment for negative menopause symptoms that can impact all areas of a woman's life.
Introduced as part of the government's Women's Health Strategy, which made menopause a priority area, the HRT PPC reduced prescription costs to just £19.30 per
year, helping patients save hundreds of pounds in prescription charges.
The DHSC has confirmed that more than £11 million was saved by women using the PPC in the last nine months.
Using the HRT PPC, patients can get a range of HRT items, including patches, tablets, and topical preparations at reduced prices, and they can use it many times
as needed throughout the year.
Cutting the red tape that blocks pharmacists to alter the HRT prescription could 'quickly fix' the problem of women unable to access their HRT medicines, the Royal Pharmaceutical Society (RPS) told Daily Mail.
RPS has suggested that allowing pharmacists to prescribe alternative HRT treatment amid nationwide shortage of HRT medicine could help the women who are struggling
to access these medicines.
Thorrun Govind, chair of the English Pharmacy Board, told MailOnline 'changes in prescription rules need to be changed urgently.'
She added, 'For the pharmacists on the ground, they need the ability to get rid of this bureaucracy. When you think about it - who's best able to offer an alternative - that tends to be the pharmacist.'
MailOnline quoted Professor Claire Anderson, president of the Royal Pharmaceutical Society, as said, 'We welcome the Health Secretary meeting with key suppliers and manufacturers to find solutions to the current shortages. But cutting the red tape holding pharmacists back could provide a 'quick fix' that would allow 'women to access their HRT medicines more speedily'.
In a recent meeting with the head of the government's HRT Taskforce, Madelaine McTernan, the National Pharmacy Association (NPA) board members gave a gist on the ongoing medicines supply issues in community pharmacy.
The meeting, which explored possible solutions to end the nationwide shortage of some Hormone Replacement Therapies, took place on Friday (May 20).
Independent contractors Reena Barai and Olivier Picard gave the so-called 'HRT tsar' an overview of the medicines supply issues in community pharmacy and discussed the new Serious Shortage Protocols (SSPs) which the government introduced in response to the on-going HRT disruption.
Earlier this month, the NPA attended an HRT summit organised by the Department of Health and Social Care, alongside other pharmacy bodies, wholesalers and manufacturers.
Health secretary Sajid Javid and pharmacy minister Maria Caulfield said they would be working collaboratively with manufacturers to meet demand and boost supply.
To help manage the ongoing supply disruptions, the health regulators have extended to 28 October 2022, serious shortage protocols (SSPs) for 12 of the 13
hormone replacement therapies (HRT).
"The only HRT SSP set to expire on 29 July 2022 is for SSP021 Premique low dose 0.3mg/1.5mg modified-release tablets. After 29 July, there will be no need to
restrict quantities of Premique tablets as its supply situation has now stabilised," said PSNC.
In addition, the dose equivalence advice and endorsement guidance for SSP024 and SSP025 have been updated.
SSP024 and SSP025 have been updated by DHSC to provide greater clarity to pharmacists on the dose equivalences to determine the appropriate quantity to supply.
Pharmacists are asked to refer to the latest SSP versions and endorsement guidance published on NHSBSA's website.
Britain's health regulator is poised to announce that hormone replacement therapy (HRT) will be made available over the counter for the first time, the Daily Telegraph has revealed.
The newspaper first reported on Tuesday (February 1) that watchdogs were set to propose a reclassification of the medication so women are able to access it in a pharmacy without a prescription.
Every year, some 1.5 million women experience difficult menopausal symptoms, such as hot flushes, night sweats, sleep disturbance and a variety of emotional problems.
But only a tenth of them are prescribed HRT, following a consultation with a GP or specialist.
According to the newspaper, the latest proposal aims to improve convenience so that women are able to access HRT more easily, without needing a GP appointment.
The new Hormone Replacement Therapy (HRT) prescription pre-payment certificate (PPC) has witnessed more than 37,000 purchases both via online website and
in-person in pharmacies since its launch on Saturday (1 April).
As of 12pm today (4 April), 37,240 HRT PPCs have been bought online and 501 in-pharmacy, totalling 37,741 certificates.
Department of Health and Social Care (DHSC) estimated women have saved over £1.13 million in prescription charges for the year, with the average person saving £30
for a year's supply.
The new prescription pre-payment certificate is also predicted to enable around 400,000 women to have cheaper access to menopause support.
On the launch of the scheme on Saturday, the huge demand for the much-anticipated certificate meant some patients were unable to access the website on the morning
of 1 April.
"The NHS Business Service Authority has ensured that the site has been working, allowing thousands of women to continue to successfully purchase a prescription for
a year's worth of hormone replacement therapy products which help treat the menopause," said DHSC.
Minister for Women's Health Strategy, Maria Caulfield said: "Over 37,700 women have come forward to claim cheaper HRT this weekend alone, showing what happens when we
listen to what women want.
Carolyn Harris, Labour MP for Swansea East and co-chair of the Menopause Taskforce, has raised concerns over overcharging of HRT medicines by some online pharmacies, The Telegraph reports.
Carolyn, according to the newspaper, has claimed that some HRT products are being sold online for up to "three times as much as they're worth".
She has also accused the companies of "profiteering" from HRT shortage.
Carolyn has vowed to raise this issue in parliament and will also ensure that health secretary Sajid Javid is aware. She also intends to write to Javid to make sure he is up to date with the alleged "profiteering" taking place.
"Get your act together, this is just exploitation. Anybody who thought it was a good idea to hike the price up because there was a shortage… it's awful, it's just complete profiteering, and making a profit off the back of somebody's desperation is never a good look," she told The Telegraph.
The Pharmaceutical Services Negotiating Committee (PSNC) has published a guidance for community pharmacies to help them in the implementation of the new
Prescription Prepayment Certificate (PPC) for hormone replacement therapy (HRT).
The new policy will rollout from 1 April 2023, patients who are not already exempt from NHS prescription charges will be able to purchase an annual HRT PPC for the
cost of two single prescription charges
Major concern raised by PSNC is that the NHS systems have not kept pace with policy, as the certificate is launching without the IT in place to support it.
PSNC has been clear that this is totally unacceptable, including raising this with Ministers directly and warning them that introducing the PPC without this
infrastructure risks causing confusion for some patients and adding to the burden for pharmacy teams.
"Government recognises the challenges but is determined to move forwards with the policy, said the committee. "DHSC has recognised the impact this will have on
pharmacies and we are still pressing for appropriate financial compensation. We have also sought guidance for GPs, and now published our own guidance to try to
make the launch go as smoothly as it can for pharmacy teams."
To help the pharmacists understand the Serious Shortage Protocols (SSPs) for three Hormone Replacement Therapy (HRT) products that was recently announced by
the Department of Health and Social Care (DHSC)'s, the Pharmaceutical Services Negotiating Committee has shared top tips on the correct SSP endorsement and
submission requirements.
Top Tips by PSNC for pharmacists on HRT SSPs:
Always double check that endorsements reflect the requirements outlined in the supporting guidance published for each SSP on the dedicated page of the NHSBSA's
website.
When endorsing using EPS, contractors are reminded to select the SSP endorsement and input the correct three-digit reference number leaving a space in between 'SSP'
and the three-digit reference number for example, SSP 019. Remember to insert the leading zero in the three digit reference number.
Each of the affected HRT medicines has its own SSP reference number. Check that the correct SSP number is endorsed for e.g. for Oestrogel® Pump-Pack 0.06% gel the
SSP endorsement should be 'SSP 019'. Please note the 'NCSO' endorsement is no longer accepted for SSPs.
Endorse the SSP product dispensed including the quantity. Ensure your endorsements are accurate and clear - NHSBSA processing staff must be able to determine what
has been supplied. Contractors should note that SSP claims submitted using EPS tokens are no longer permitted.
To curb the supply issue of HRT medicine, the government has taken a further action by issuing SSPs for Oestrogel, Ovestin cream, Lenzetto transdermal spray and Sandrena gel sachets - with appropriate alternatives.
The move aims to allow community pharmacists to supply specified alternatives to the prescribed HRT products without needing to seek authorisation from the clinician
who has prescribed the medicine.
The regulator said that the availability of Premique Low Dose has impoved 'thanks to SSPs issued on 29 April to restrict dispensing for Oestrogel, Ovestin and Premique Low Dose to three months' supply'.
"Since these measures were implemented, further deliveries of all three products have been made, with Premique Low Dose returning to good availability this week. The manufacturers of Oestrogel and Ovestin, as well as suppliers of alternative HRT products, are taking action to increase UK supply."
It added, "SSPs restricting prescriptions to a maximum of three months' supply will also be issued for substitute products, as a precautionary measure to ensure the supply of those substitutes is maintained."
The Pharmaceutical Services Negotiating Committee (PSNC) has advised the pharmacy contractors to check that their PMR systems supports correct and complete
SSP endorsements.
Several tips has been shared by the PSNC with pharmacy contractors after NHSBSA received several electronic EPS SSP claims which did not meet the requirements for
a valid SSP between 1 April 2022 and 31 May 2022.
PSNC has been working with NHS Business Services Authority (NHSBSA) to understand whether claims for HRT SSPs are being submitted correctly and in accordance with
the specific supporting guidance for each SSP.
"For any invalid SSP claims, contractors will continue to receive the usual dispensing fee but will not receive any SSP fee (£5.35). Reimbursement for invalid SSP
claims will also be in accordance with the prescribed product rather than the alternative product or quantity supplied in accordance with an SSP," said PSNC.
The National Pharmacy Association (NPA) has asked the Secretary of State for Health and Social Care to convene a 'medicines supply taskforce', following weeks
of problems with antibiotics supplies.
The NPA's chief executive Mark Lyonette wrote a letter to Steve Barclay this week. It cited the precedent of the HRT Taskforce which this summer brought together
representatives from across the supply chain after months of supply problems affecting women.
"We strongly believe that this situation calls for a similar response from the government. It is imperative that we resolve this supply situation urgently and
therefore we request that you convene a Medicines Supply Taskforce, with all the relevant stakeholders in the supply chain, to urgently discuss and agree practical
solutions to address the disruptions to the supply of medicines. HRT and antibiotics are the most visible examples of a wider problem with medicines supply
which needs to be addressed."
NPA board members Olivier Picard and Reena Barai were among the stakeholders joining meetings convened by the HRT Taskforce this summer.
Women in the UK will be able to purchase Gina 10 mg vaginal tablets without prescription from September from their local pharmacies, announced the Medicines
and Healthcare products Regulatory Agency (MHRA).
The Hormone Replacement Therapy (HRT) product, Gina 10 microgram vaginal tablets (containing estradiol) are used for the treatment of vaginal symptoms such as
dryness, soreness, itching, burning and uncomfortable sex caused by oestrogen deficiency in postmenopausal women aged 50 years and above who have not had a period
for at least one year.
The decision to reclassify these vaginal tablets follows a safety review by the MHRA, independent advice from the Commission on Human Medicines (CHM), and a public
consultation.
The UK regulator sought views from patients, pharmacists, prescribers and a wide range of stakeholders including the Royal College of Obstetricians & Gynaecologists,
the Faculty of Sexual & Reproductive Healthcare, the British Pharmacopoeia Commission and the British Menopause Society.