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.
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 Pharmaceutical Services Negotiating Committee (PSNC) has issued a revised guidance for the dispensing of controlled drugs in instalments on 19 September
that has been declared as a bank holiday for Her Majesty The Queen's state funeral.
PSNC said: "Many instalment prescriptions have already been issued in advance of the upcoming Bank Holiday. Where they contain the Home Office approved wording
"Please dispense instalments due on pharmacy closed days on a prior suitable day" then you will need to plan to make these supplies at an appropriate time. This
wording would also permit the supply of the initial dose of a prescription starting on the Bank Holiday Monday where the date of the signature is before this."
However, PSNC is aware that not all prescriptions will contain such a direction to support the supply, in advance, of a dose for Monday 19 September where the
supplying pharmacy is closed.
"We recognise that this client group are often vulnerable with multi-morbidities and that the risk to them may be significant. You should therefore exercise your
professional discretion in determining when to make an instalment supply for the Bank Holiday Monday. Make the care of the patient your first priority and consider
the potential impact of both making the supply in advance and of not making the supply in your decision making process. The exceptional circumstances that led to
the Bank Holiday and its short notice may inform your decision."
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.
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."
A report released by Community Pharmacy England (CPE) has warned that pharmacies across England are grappling with daily medicine supply challenges, posing
significant risks to patients' health.
The Pharmacy Pressures Survey 2024: Medicines supply Report, which is based on the views of the owners of over 6,100 pharmacy premises in England and 2,000 pharmacy
team members, has exposed some alarming trends concerning medicine supply problems in the country.
Almost all pharmacy team members surveyed (97 per cent) reported patients being inconvenienced due to medicine supply issues, and 79 per cent of the participants
said that the worsening situation is putting patient health at risk.
Nearly all respondents reported patient frustration stemming from medicine supply issues, with 84 per cent of them saying they had experienced aggression from
patients.
Additionally, 98 per cent indicated an increase in 'owings,' where patients receive only part of their prescription and must return to the pharmacy for the
remaining medication(s) at a later time."
A recent report by the British Generic Manufacturers Association (BGMA) has shed light on ongoing supply challenges in England's generic medicines market,
revealing significant issues impacting patient care.
The report highlights significant challenges faced in supply of medicines as currently, 51.72 per cent of generics in short supply lack licensed alternatives,
posing substantial hurdles to ensuring continuous patient care.
Additionally, 39.08 per cent of affected generics are branded, indicating widespread disruptions across the market.
A notable 26.44 per cent of generics experiencing shortages have been affected for over six months, highlighting persistent difficulties in supply chain management.
The report indicates that 0.15 per cent of generic medicine presentations listed in the Drug Tariff are currently facing supply issues, impacting accessibility
nationwide.
In the parliamentary drop-in-event hosted by Community Pharmacy England last week, Members of Parliament (MPs) questioned the Health Secretary on the rising
issue of medicines supply.
"Eighteen community pharmacists in my constituency are reporting challenges on medicine supplies. What more is the Minister going to do to get a grip of this
situation?", Mike Amesbury MP for Weaver Vale, who was present at the event last week, asked the Health Secretary.
In his response, the Health Secretary, Steve Barclay MP said: "We have a long-standing team in the Department focused on medical supplies, which are a continual
issue; as a matter of routine business, there are often challenges in that area."
The Shadow Pharmacy Minister, Karin Smyth MP, also asked: "People across the country rely on local, accessible pharmacies, but whether it is high street closures
or supply problems leading to the absurd situation where women are phoning or visiting multiple pharmacies for a prescribed dose of hormone replacement therapy and
other drugs…They have repeatedly announced plans to expand the role of community pharmacies but have failed to update legislation that could possibly help. … Why
will they not do so?
Insuman Comb 50 100units/ml suspension for injection 3ml cartridges has been discontinued with stocks being exhausted imminently, notified Department of Health
and Social Care (DHSC).
The department has issued a medicine supply notification for Insulin isophane biphasic human 50/50 (Insuman Comb 50) 100units/ml suspension for injection 3ml
cartridge.
"Humolog Mix 50 remains available, as do other biphasic insulin preparations, and the manufacturers can support a full uplift in supply," said DHSC.
A copy of this medicine supply notification, including further information, has been sent to all pharmacy NHS email addresses.
DHSC and NHSE/I's newly launched online Medicines supply Tool provides up to date information about medicine supply issues. The contents of these MSNs can now be
viewed on the Tool.
The Department of Health and Social Care (DHSC) has allowed pharmacists to supply alternative penicillin to treat Strep A. It has issued Serious Shortage
Protocols (SSPs) for three penicillin medicines.
"The SSPs will help mitigate local supply issues of oral penicillin and allow pharmacists to supply alternative forms of the medicine if they do not have the
specific formulation stated on the prescription," said DHSC.
SSPs have been issued across the UK for 3 penicillin medicines on Thursday (December 15.
"Issuing an SSP allows pharmacists to legally supply a specified alternative medicine, removing the need for the patient to return to the prescriber - which saves
time in GP practices and inconvenience for patients."
"Demand for penicillin has risen recently as it is used to treat strep A and scarlet fever, and the increased demand means that some pharmacists are experiencing
temporary and localised supply issues and may not have the specific formulation listed on the prescription."
Following Community Pharmacy England's Parliamentary drop-in event on medicines supply issues last week, several MPs have since raised questions to the Health
Secretary during a Health Questions session on July 18th.
According to CPE, MPs from all Parties displayed great engagement with the current pressures facing community pharmacies, particularly regarding medicines supply
issues.
During last week's event, Mike Amesbury, the MP for Weaver Vale, was present and directed a question to the Health Secretary: "Eighteen community pharmacists in my
constituency are reporting challenges with medicine supplies. What further actions will the Minister take to address and resolve this situation effectively?"
In response, Health Secretary Steve Barclay MP stated, "We have a dedicated team in the Department that focuses on medical supplies, which are an ongoing concern.
Challenges in this area are a routine part of our business."
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.
Community Pharmacy England (CPE) to host a Parliamentary drop-in event in July to brief MPs and Peers about the ongoing medicines supply chain issues that
are negatively affecting pharmacies and their patients across the country.
CPE's Pressures Survey earlier this year highlighted the extent of both the operational and financial impacts of medicines supply issues on pharmacy businesses,
therefore it has continued to hear from both pharmacy owners and others about the problems.
The event aims to ensure that MPs understand the problems and their impact on pharmacies.
Peter Dowd MP is hosting the event, joined by representatives from Community Pharmacy England, the Nuffield Trust, patient groups and more.
The event will also be another opportunity to talk to MPs from across the political spectrum about the very serious situation that community pharmacies still find
themselves in and the need for further investment in the sector.
Janet Morrison OBE, Chief executive of Community Pharmacy England said: "The results of our Pressures Survey earlier this year showed just how much supply issues
are continuing to negatively impact pharmacy businesses and all those who work in them. The survey found that almost all pharmacy owners (97%) are facing
significant increases in wholesaler and medicine supply issues, with 71% saying this was leading to delays in prescriptions being issued.
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 Scottish Government and Community Pharmacy Scotland have agreed to roll out next month a new national service to provide emergency access to supplies
of naloxone.
An NHS circular signed by Alison Strath, Chief Pharmaceutical Officer of Scotland, advises that the emergency supply service will be added to the community
pharmacy Public Health Service from 30 October 2023. It states that community pharmacy contractors and pharmacy teams should ensure they are familiar with the
new arrangements.
Community pharmacy contractors have been asked to ensure that pharmacy teams complete the e-learning module for naloxone emergency supply. They are also encouraged
to join webinars to support the implementation of the service which will be held on Wednesday 4 October and Tuesday 14 November at 19:30. Details of how to register
can be found at on NHS Scotland's Turas platform.
Danish drug developer Novo Nordisk on Wednesday (February 1) warned of supply constraints on its best-selling drug.
The company, which develops diabetes and obesity drugs, said it expected "periodic supply constraints" this year, partly driven by higher than expected demand for
its blockbuster diabetes drug, Ozempic, and manufacturing constraints.
"supply of Ozempic cannot keep up with demand in some markets," Novo's Chief Financial Officer Karsten Munk Knudsen told journalists on Wednesday, but said Ozempic
was available in the United States, the firm's biggest single market.
Shortages of human growth hormone would also cause sales in its rare disease franchise to drop by a "mid-single digit" percentage in 2023, as its Norditropin drug
would be out of stock in certain markets, Knudsen said.
The European Commission launched an initiative to deal with the ongoing supply crisis on Tuesday (24 October).
The following announcement comes after the shortage of key antibiotics last winter identified by the European Health Emergency Preparedness and Response
Authority (HERA) and the European Medicines Agency (EMA).
The "European Voluntary Solidarity Mechanism" is a proposed short-term measure that involves a Member State's need for a given medicine to other Member States
to redistribute medicines from their available stock.
Additionally, the Commission intends to cooperate with member states to improve components of pharmaceutical reform with an aim to strengthen supply security.
They are setting up a few actions apart from the launch, a list of critical medicines to analyse the supply chain by early 2024; regulatory flexibilities;
strengthening security of supply; and availability of antibiotics and treatments for respiratory viruses by next winter.
Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU
Commission proposal. An agreement, in principle, has been reached by the UK and EU.
The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure
that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom.
Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for
Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result.
However, the burden on the UK Pharma supply chain will be eased.
Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023
Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on
the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products
within the Northern Ireland market.
Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The
pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee
the supply of medicines within the whole United Kingdom.
The Department of Health and Social Care (DHSC) has issued a medicine supply notification for antibiotics for the treatment of Group A Strep.
"Supplies of antibiotics for the treatment of Group A Strep have seen a surge in demand and may be temporarily in limited supply at certain wholesalers and
pharmacies," said DHSC.
"Supplies are available with manufacturers, and deliveries into wholesalers and pharmacies are being expedited and are expected in the coming days."
If the formulation of antibiotic prescribed is unavailable, DHSC has asked clinicians and local pharmacy teams to consider prescribing an alternative form or
strength of the antibiotic where appropriate, ensuring the patient is not intolerant to any of the excipients in the alternative and is counselled on the
appropriate dose (and volume) required.
he Healthcare Distribution Association (HDA) and the Pharmaceutical Services Negotiation Committee (PSNC) have urged the NHS England and the Department of
Health and Social Care (DHSC) to issue urgent communications requesting that all those involved in medicines supply do not hoard, stockpile or over-prescribe Strep
A antibiotics.
In a statement HDA said that the sudden spike in demand for antibiotics used for the treatment of Strep A has meant that there is not enough of these medicines in
the supply chain currently to meet this increased demand. As a result, wholesalers are working extremely hard with manufacturers to increase the supply of antibiotics.
It added: "As regards pricing, the prices charged to pharmacies by HDA wholesale distributors will directly reflect the increase in prices wholesalers are having
to pay for these medicines from manufacturers at the moment, in order to be able to continue supplying these medicines to pharmacies. This will be the case until
supply and demand are more in sync."