Proposed changes to a European Union pharmaceuticals law will include stronger obligations for the supply of medicines and earlier notifications of shortages,
EU Health Commissioner Stella Kyriakides said last week (January 17).
Kyriakides told a session of the European Parliament that shortages of antibiotics are a growing problem for many European countries. She said the European
Commission's proposal to revise the pharmaceuticals legislation is planned for March.
"Our objective is and remains to secure access to medicines for all patients in need and to avoid any market disruption of medicines in the EU," Kyriakides said.
Shortages of antibiotics have been reported in 26 European countries, the European Medicines Agency says.
The unseasonably early upsurge in respiratory infections in Europe this winter and insufficient production capacity are the root causes of the shortages, Kyriakides
said.
Numerous EU lawmakers speaking at the session said the shortages needed to be tackled urgently. But experts say shortages of essential generic medicines like
antibiotics are likely to be recurrent in Europe due to problems in the sector such as the gradual migration of generic manufacturing to Asia.
The Government has been forced to intervene formally 50 times in the past two years to authorise the use of alternative drugs because of serious medicine
shortages hitting patients, new analysis by the National Pharmacy Association (NPA) has found today.
78 per cent of all Serious Shortage Protocols, produced by the Department of Health and Social Care (DHSC) due to medicine shortages, were issued in
2022/24 - more than three times the rate in the previous two years.
The NPA, which represents independent community pharmacies in the UK, is warning that shortages are leading to pharmacists having to increasingly turn
patients needing vital medication away.
Analysis by the NPA of the NHS's Serious Shortage Protocols (SSPs) issued to pharmacies and other providers over the last five years has found that:
The number of SSPs issued in the last two years is 3.5 times higher than in the previous two years.
From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among
patients, the government, and the wider pharma industry.
Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine,
and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma
companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February.
The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this
winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like
amoxicillin and Adderall, an ADHD medication.
To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic.
The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply
shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping
containers.
Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution
in times of additional need.
There has been extensive national media coverage today (August 11) on how medicine shortages have forced patients to visit multiple pharmacies to get their
prescriptions filled or return to their GP to be prescribed alternative drugs.
These media reports have been based on a survey involving more than 1,500 pharmacists in the UK, in which over a half of those polled said that their patients'
health had been put at risk in the last six months.
In response to a query from Pharmacy Business, the Department of Health and Social Care (DHSC) said it monitors the medicines supply chain closely to prevent any
shortages and acts swiftly when any issue arises.
A DHSC spokesperson told Pharmacy Business: "We take patient safety extremely seriously and we routinely share information about medicine supply issues directly
with the NHS so they can put plans in place to reduce the risk of any shortage impacting patients, including offering alternative medication.
The British Generic Manufacturers Association (BGMA) on Monday alerted the Health and Social Care Committee that medicines shortages have increased and
are "around double what they were a year ago."
BGMA chief executive Mark Samuels told the committee that they have been highlighting the medicine shortage risk to ministers since July 2021 and the association
is "very concerned" about the current situation.
"We've been monitoring it for several years now, and as you saw in the written evidence, shortages have increased. They're around double what they were a year ago.
We have them at 101 shortages in February this year," said Samuels.
Dr Rick Greville, director of distribution and supply at the Association of the British Pharmaceutical Industry (ABPI), highlighted that the problem of drug
shortages in the UK is a "long-standing issue" and the scarcity of certain medications "continues to be challenging".
People who use pharmacies in parts of Pendle have suffered shortages or delays in buying prescription medicines such as insulin, councillors have been told.
In the Barnoldswick area, a number of pharmacies have been impacted and some councillors hope a new regional NHS organisation might look into the problems.
However, pharmacies in the neighbouring town of Nelson are facing shortages with other medicines. A pharmacists in Nelson Pharmacy told Pharmacy Business that he
was struggling to meet local demand for children's paracetamol due to ongoing shortages.
Pendle Council's West Craven Area Committee heard about the issues at its latest local meeting, held in Earby.
An agenda for the committee stated: "Pharmacy provision in West Craven. It is reported that there is an acute problem with people being unable to get prescriptions
filled, with Whitworth chemists suffering a breakdown in service. Previously, Well chemists has suffered similar problems."
Speaking at the meeting, Lib-Dem Coun David Whipp said: "It's quite an appalling situation where people are queuing 30 minutes to get a prescription filled but when
they get to the counter they are told it's not ready. They have to go home and come back at 5pm. It's an ongoing problem.
"It includes insulin, which is critical for people with diabetes. I know several people who have failed to get insulin, It's a very serious problem."
He added: "I think the committee should contact the local integrated care service. I think they are responsible for primary care which includes pharmacies. We need
to find out what's happening and improve things in future. "
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.
Switzerland is experiencing medicine shortages due to supply chain issues linked to COVID lockdowns in China and war in Europe, the country's pharmacists
association said.
"We have the biggest problems with children's medications, especially fever-reducing syrup," Enea Martinelli from pharmaSuisse told Swiss broadcaster SRF.
"There are also shortages of blood pressure medications, psychiatric medications and Parkinson's medications," he said.
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.
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 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.
The Department of Health and Social Care (DHSC) has issued a Serious Shortage Protocol (SSP) for Salazopyrin EN-Tabs 500 mg due to ongoing shortage of the medicine.
With SSP014 in place from today (November 26), for every prescription one Sulfasalazine 500mg gastro-resistant (GR) tablet will be supplied.
This SSP will expire on December 20, 2021, and PSNC will update contractors in case of any change.
PSNC has advised pharmacists to notify the patient's prescriber while supplying in accordance with this SSP.
Besides, the supervising pharmacist should refer back to the prescriber if a non-chewable atorvastatin tablet would not be appropriate for the patient.
The General Pharmaceutical Council (GPhC) has urged health and care professionals to meet relevant regulatory standards amidst the shortage of GLP-1 receptor
agonists (GLP-1 RAs).
The council said: "We are concerned to hear that people with Type 2 diabetes are experiencing problems accessing GLP-1 receptor agonists (GLP-1 RAs). We know that
these are being widely prescribed for weight loss purposes and in some cases prescribed off-label."
"We recognise the adverse impact that shortages and supply chain issues can have on patients, the public and wider health and care teams.
The Council understands that health and care professionals are using their professional judgement and making decisions in challenging situations, balancing a range
of factors such as individual patient needs, wider public health and pressures and limitations on available resources such as medicines shortages or other supply
chain issues.
Drug shortages have become a global issue, with many countries struggling to maintain a consistent supply of common medications, including antidepressants,
immunosuppressants and drugs to treat type 2 diabetes and ADHD.
Earlier last month, the British Generic Manufacturers Association (BGMA), the trade body for off-patent medicines, warned that 111 products were facing supply
problems, the highest on record in the UK, and more than double the number recorded at the start of 2022.
More than half of products affected (55) are branded generic drugs, which represent 10 per cent of prescription products used in the UK.
The trade body blamed the escalating rebate rate of the government's voluntary scheme for branded medicine pricing and access (VPAS) for these shortages, but
Brexit is also cited as another reason for the problem.
The Department of Health and Social Care (DHSC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) have added five more medicines that cannot
be hoarded or exported from the UK market.
The government has taken the following action to address the "critical shortage" of attention deficit hyperactivity disorder (ADHD) drugs.
In a crucial development on October 9, this strategic move aims to enable wholesalers to fulfil their legal obligation to supply these essential medicines to
patients across the UK.
The updated list of drugs incorporated "all" available strengths and pharmaceutical formulations, ensuring comprehensive coverage for patients' medical needs.
The British Generic Manufacturers Association (BGMA) has raised concerns over the rise in the VPAS rate for 2023 to 26.5 per cent.
The Department of Health Social Care (DHSC) today announced that the 2019 voluntary scheme payment percentage for 2023 will be 26.5%. The 2019 voluntary scheme
for branded medicines pricing and access is an agreement between the Department of Health and Social Care, NHS England and the Association of the British
Pharmaceutical Industry.
BGMA believes that the high VPAS tax for 2023 risks more medicines shortages, rising prices for the NHS via reduced competition, and new medicine launches to the
UK being deferred.
Mark Samuels, Chief Executive of BGMA, said: "Raising the VPAS tax to 26.5% will damage the UK's medicines supply because it will make some products lossmaking. It
is more than a five-fold tax increase from 2021, and no industry can cope with this unpredictable and exceptional tax volatility.
harmacists in the town of Barnoldswick in Lancashire are reportedly suffering from various problems including a lack of medicines and the movement or loss
of pharmacy staff.
Problems, including delays with supply of insulin, were reported at a recent Pendle Council West Craven meeting.
And this week the head of one pharmacy chain, Whitworth, highlighted a range of issues faced by his teams including supply chains, costs, loss of staff and NHS
reimbursement for contractors.
In Barnoldswick, queues have formed inside and outside pharmacies as people attempt to get prescriptions. Some said they had to wait for days to get what they
needed, had made repeat-visits to pharmacies and were unsure when medicines might arrive.
They also said the number of pharmacies in the area have fallen over the years.
Two town centre pharmacies, Whitworth and Well, are located opposite each other, close to a doctors' surgery. Standing in one queue outside Whitworth was Marilyn
King.
She said: "I have been waiting seven days to get my prescription for blood pressure and some other medicines. This week, I've come back time after time. But the
staff say sorry, they have not got it in because nobody has delivered it.
"I came here on Saturday, when there was a queue. But the pharmacist was not here. I came again on Tuesday and then Wednesday. Then finally, just when I reached
the front of the queue, they asked me to come back in an hour…
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."
Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies has said pharmacists have been "struggling to obtain the very basic, most
common cold and flu medicine."
She told the PA news agency that the shortage wasn't around "just the branded medicines" but "also simple things like throat lozenges, cough mixtures or pain
killers - particularly the ones that are soluble."
Stating that the sector was finding it very difficult these shortages she said "those people who are in charge of supporting us with it are denying it."
"The demand has been high because this season we've seen higher cases of colds and flu and people are obviously trying very hard to look after themselves and making
sure that they use the relevant products to manage the symptoms.
The Department of Health and Social Care (DHSC) published a notification regarding the shortage of Guanfacine 2mg and 3mg modified-release tablets has
raised concerns within the healthcare community.
This critical medicine supply notification, issued on March 28th, projects the unavailability of these tablets until the week commencing May 6, 2024.
Guanfacine tablets, commonly prescribed to alleviate symptoms of hyperactivity and impulsivity while enhancing attention and concentration, play a vital role in
managing conditions like attention deficit hyperactivity disorder (ADHD).
However, the scarcity of these specific strengths poses challenges for patients reliant on this medication.
Last year, several countries across the globe experienced shortages of medications for the treatment of attention deficit hyperactivity disorder (ADHD)including
the UK, the US and Australia.
Community Pharmacy England (CPE) has cautioned that while alternative strengths of Guanfacine remain accessible, they may not adequately meet the heightened demand,
potentially resulting in treatment interruptions for patients.