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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 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.

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."

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.

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.

Besins Healthcare has acquired a pharmaceutical manufacturing site in Drogenbos, Belgium to boost the production of hormonal products including Oestrogel. Currently, the site which is being used as one of two manufacturing sites for their gel products [the other site being in France], is a strategic purchase to allow Besins Healthcare to increase production of its own products, offering greater efficiencies and greater integration into the company's supply line. "In the past year, demand for hormone replacement therapy (HRT) treatment in the United Kingdom and Ireland has dramatically increased, resulting in regrettable disruption to supply of Oestrogel. We are looking at a range of options for increasing supplies of this product in the short, medium and longer term," said Alexandre Besins, joint CEO for Besins Healthcare. "Besins strongly believes that by re-integrating our manufacturing capabilities we will have better control over our ability to meet demand and live up to the trust that HCPs and patients have put in us."

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.

Veoza, a non-hormonal treatment for menopause, has been made available on the high street for the first time in the UK. British pharmacy chain Superdrug on Thursday (1st February) announced the launch of the newly approved menopause medication, expanding its comprehensive portfolio of products and services to support menopausal women. Veoza is a prescription medication that is used to manage vasomotor symptoms, specifically hot flushes and night sweats, which affect up to 80 per cent of women during menopause, as estimated by experts. It is recommended for women who prefer not to or are unable to take hormone replacement. Perimenopausal, menopausal and postmenopausal women, aged 45-65 who are not on Hormone Replacement Therapy (HRT) or hormonal contraception, and are suffering from moderate to severe vasomotor symptoms, are eligible to take the medication, the retailer said in a release.

The Department of Health and Social Care (DHSC) has issued two new Serious Shortage Protocols (SSPs) for Estraderm MX 25mcg and 100mcg patches. Effective from 8 September 2022, SSP035 and SSP036 provide that for every Estraderm MX 25mcg or 100mcg patch originally prescribed, one Evorel 25mcg patch or 100mcg patch must be supplied, respectively. Both SSPs are currently set to expire on 16 September 2022. Both SSPs, authorised by the secretary of state for health, have been developed by clinicians and provides pharmacists with procedures to follow in providing either of these suitable alternative products to help reduce the number of patients having to return to their prescriber for a replacement prescription. DHSC informed that there are no SSPs in place for Estraderm MX 50mcg patches and 75mcg patches - these strengths are not affected by supply disruptions and should continue to be dispensed in accordance with the prescriptions "The SSP035 and SSP036 only allow substitution of Estraderm MX 25 or 100 patches with Evorel 25 or 100 patches, respectively."