A total of 14 Serious Shortage Protocols (SSP) will expire today (12 May) as the Department of Health and Social Care has confirmed availability of the
products to meet normal demand.
The products include Sandrena 0.5mg and 1mg gel sachets, Lipitor 10mg chewable tablets, Phenoxymethylpenicillin 125mg/5ml and 250mg/5ml oral solution, sugar free
variant of both doses and 250mg tablets, and Paracetamol 120mg and 240mg suppositories.
The expiring SSPs include three related to Sandrena gel sachets, one for Lipitor, eight concerning Phenoxymethylpenicillin and two for Paracetamol. These will expire
at 23.59pm on Friday 12 May and any prescriptions for these products must be dispensed in accordance with the prescription after that.
Patient safety should remain a top priority in any healthcare setting. People should always receive the right advice, and pharmacists aren't 'GPs on the cheap.'
Staff should be fully trained, and medical equipment should be correctly maintained at all times. In turn, this helps create a safer environment for patients and
professionals alike. In this article, we'll discuss some of the factors that can enhance patient safety in healthcare settings.
AUTOMATION AND MONITORING
Automating processes within a facility can help streamline operations. This has the potential to reduce or eliminate human error that could result in serious injury
or death. In addition, automated systems often provide instant alerts when something goes wrong - allowing medical staff to react quickly and appropriately. Automated
solutions can help facilities achieve hand hygiene monitoring standards, and it's possible to schedule a demo and see their outcomes. They can reduce staff sick time
and HAIs, as well as Joint Commission citations and associated costs.
Monitoring helps ensure compliance with safety protocols. It's essential for improving patient safety and gaining data on all aspects of a facility's operations. It
also helps organizations track the effectiveness of their protocols and procedures over time. This helps them constantly evaluate and refine their policies, to
maximize patient safety benefits.
ADEQUATE STAFFING
In order to provide quality care, it's essential to have enough staff on hand to meet patient needs and ensure all protocols are being followed. Without this,
healthcare providers may struggle to provide prompt, efficient care - which can put patient safety at risk. Adequate staffing levels should be determined by a
variety of factors. They include patient numbers, the complexity of care required, and the size and layout of the facility.
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 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.
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The European Parliament on Thursday adopted a proposal from Brussels to ensure the continued supply of medicines from Britain to Northern Ireland - an issue that had dogged the bloc since London left it.
"Great news from the @Europarl_EN today with the overwhelmingly positive vote to ensure the continued supply of medicines to Northern Ireland," tweeted Maros Sefcovic, European Commission vice president who had been leading discussions with London.
"The EU is delivering on this lasting solution for Northern Ireland in record time," he added, though the EU Council must give final approval.
Britain itself has yet to give formal approval on a move that would avoid potential disruption of supplies as London wants an overall accord for matters pertaining to the Northern Ireland protocol governing post-Brexit trade.
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 Department of Health and Social Care (DHSC) has announced that sufficient stock of Lipitor 10mg chewable tablets is now available to meet normal demand.
Therefore, the Serious Shortage Protocol, SSP032 Lipitor 10mg chewable tablets expired at 23.59pm on Friday (9 September).
"After this date, any prescriptions for Lipitor 10mg chewable tablets must be dispensed in accordance with the prescription, and the SSP032 will no longer be valid for use," said DHSC.
The Scottish government has issued a circular to inform community pharmacy contractors that the Serious Shortage Protocol (SSP) for Clarithromycin 125mg/5ml
oral suspension, an antibiotic product, due to expire on 15 December 2023, has been extended until Friday 12 January 2024.
The extension is applicable to SSP053 which allows community pharmacists to substitute this product with Clarithromycin 250mg/5ml oral suspension for patients
presenting with an NHS or private prescription.
Scotland's chief pharmaceutical officer, Alison Strath, has advised health boards to spread this information to community pharmacy contractors on their
pharmaceutical lists and area pharmaceutical committees, as well as general practices.
Community pharmacists have been advised to review and familiarise themselves with the new end date for the noted SSP.
While Northern Irish business groups has welcomed the certainty a new EU-UK deal on post-Brexit trade rules for the region provided, the pharmaceutical
industry too has expressed cautious optimism.
In his speech on the Windsor Framework on Monday (February 28) Prime Minister Rishi Sunak said the agreement "delivers a landmark settlement on medicines".
"From now on, drugs approved for use by the UK's medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland," he
announced.
The National Pharmacy Association's Northern Ireland manager Anne McAlister expressed a sense of cautious optimism.
She said: "While the devil may yet be in the detail, the Windsor Framework would appear to be good news for pharmacies in Northern Ireland. It seems to address
the main concerns we have expressed about medicines supplies to NI, but we want to examine the small print to ensure the new arrangements meet the needs of our
members and the patients they serve.
The Department of Health and Social Care has issued a Serious Shortage Protocol (SSP) in response to a significant ongoing disruption to the supply of Paracetamol 120mg and 240mg suppositories.
Effective from Tuesday (Jan 25), SSP015 provides that for every Paracetamol 120mg or 240mg suppository originally prescribed, one Paracetamol 125mg or 250mg
suppository must be supplied.
SSP015, authorised by the Secretary of State, has 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.
The SSP may be amended or revoked at any time but currently expires on 18 February 2022 - PSNC will update contractors on any changes.
Oxford Cannabinoid Technologies Holdings plc, which specialises in developing cannabis-derived medicines with pain-relieving properties, has successfully
administered the first-in-human dose of its lead pharmaceutical drug compound, OCT461201, in its phase 1 clinical trial. The company holds a portfolio of four
drug candidates intended for use as licensed pain medications.
The drug is a selective cannabinoid receptor type 2 agonist with the potential to treat chemotherapy-induced peripheral neuropathy and irritable bowel syndrome.
The UK trial, conducted by Simbec Research Limited, part of Simbec-Orion Group Ltd., is progressing with healthy volunteers, OCTP said in a statement. Using a single
ascending dose protocol, the primary objective is to demonstrate OCT461201's safety and tolerability, while providing information on its pharmacokinetic profile, to
confirm its value as a potential drug.
Results from the trial, funded entirely by OCTP's existing resources, are expected in the third quarter of 2023, the statement added.
Community Pharmacy England (CPE) has explained MPs on instability that puts operational pressures on pharmacies, financial pressures on businesses at a
Parliamentary drop-in event held on Monday (10 July).
The association has been in Parliament today alongside patient representatives and others to highlight our ongoing concerns about medicines supply to MPs.
It said: "Medicines supply remains a critical issue for community pharmacies with disruption causing problems both accessing medicines and procuring them cost
effectively."
In CPE's recent sector polling, community pharmacy owners rated medicines supply instability as being the most severe pressure facing their businesses. This
echoed the results of CPE's Pressures Survey which found 97% of pharmacy owners survey are facing significant increases in wholesaler and medicine supply issues,
with 71% saying this was leading to delays in prescriptions being issued.
During the Parliamentary drop-in event, CPE talked MPs through the issues and set out what it believe needs to happen to resolve them, calling for- Reform of
Serious Shortage Protocols; Allowing generic substitution; An overhaul of the concessions system; and a strategic Government review of medicine supply and pricing
with a shift to focusing on how to improve the functioning of the supply chain rather than solely on the drive to depress prices and margins.
The Department of Health and Social Care (DHSC) has extended the Serious Shortage Protocols (SSPs) for Fluoxetine 10mg tablets (SSP005) and Lipitor 10mg
chewable tablets (SSP032) to Wednesday, 7 December 2022.
SSP005 for Fluoxetine 10mg tablets was due to expire on 12 August 2022.
DHSC has also updated that SSP032 for Lipitor 10mg chewable tablets was due to expire on 12 August 2022 but the end date has been further extended to Friday 26
August 2022.
SSP005 provides that for every Fluoxetine 10mg tablet originally prescribed, one Fluoxetine 10mg capsule must be supplied:
"Expiry dates of an SSP may be brought forward or extended, and the content may be amended at any time during the life of an SSP. Pharmacists should ensure they
are using the latest version of an SSP before considering the supply of an alternative product," said DHSC.
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."
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).
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.