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 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."
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.
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.
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'.
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 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.
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 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.
A report released by the Independent Commission has blamed Brexit supply issues for medicine shortages.
NHS is forced to pay extortionate prices to fulfil the demand for vital antibiotics, anti-depressants, Attention Deficit Hyperactivity Disorder (ADHD), and
Hormone Replacement Therapy (HRT) drugs.
The report highlights the impact of affected medicine supply issues on community pharmacies and patients.
Janet Morrison, the chief executive of Community Pharmacy England, backed the report and said that the "medicine shortages and market instability appear to be
as bad as they have ever been".
She also explained how the Ukraine conflict, the COVID-19 pandemic, and broader economic instability also play a major factor in the situation.
The Serious Shortage Protocol (SSP), for Estradot 50mcg patches will expire at 23.59pm on Friday 24 February 2023.
Department of Health and Social Care (DHSC) has confirmed that sufficient stock of Estradot 50mcg patches are now available to meet normal demand.
"After 24th February, any prescriptions for Estradot 50mcg patches must be dispensed in accordance with the prescription, and SSP048 will no longer be valid for
use," said DHSC.
Top tips for SSP claims by PSNC:
Where available, use the claim amend facility on the PMR system to rectify any incorrect EPS claims already submitted this month.
For any supplies made in accordance with SSPs, check that the correct number of patient charges are collected and declared on the end of month FP34C submission.
NHSBSA advise that contractors must follow the specific endorsement guidance issued with each SSP and endorsements should be clear and unambiguous - NHSBSA
processing staff must be able to determine what has been supplied. NHSBSA have published information on common SSP endorsing errors they see when processing claims.
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."
Pharmacists can dispense Paracetamol 120mg suppositories in accordance with the prescription, as the Department of Health and Social Care (DHSC) has confirmed
that sufficient stocks are available to meet normal demand.
This means the Serious Shortage Protocol - SSP033 - for Paracetamol 120mg suppositories has now expired since 26 August 2022.
Top tips for SSP claims
NHSBSA advise that contractors must follow the specific endorsement guidance issued with each SSP and endorsements should be clear and unambiguous - NHSBSA
processing staff must be able to determine what has been supplied. NHSBSA have published information on common SSP endorsing errors they see when processing claims.
Any paper prescriptions with SSP claims need to be placed in the red separator provided by the NHSBSA.
Although an SSP cannot be used outside its period of validity, claims can be submitted up to three calendar months after expiry or withdrawal of the SSP to help
manage any owings for other items issued on the same prescription form. For example, for SSP033 Paracetamol 120mg suppositories, which expires at 23.59pm on Friday
26 August 2022, the NHSBSA would continue to look for the "SSP" endorsement on prescriptions for Paracetamol 120mg suppositories that are submitted with the August
batch (submitted by 5 September), September batch (submitted by 5 October) and October batch (submitted by 5 November).
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."