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.
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.
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.
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 European Association of Hospital Pharmacists (EAHP) published a shortage supply report on 17 October.
They have officially stated that the shortage has resulted in care delays affecting 58 countries in their recent survey.
It has been found in the report that 59 per cent of pharmacists said medicines shortage had delayed patient care, whereas 43 per cent confirmed it resulted in
suboptimal treatment and 35 per cent said that it had led to the cancellation of care.
András Süle, president of the EAHP spoke on the findings of the report, saying: "Problems caused by medicine shortages remain serious, threaten patient care in
hospitals and require urgent action".
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".
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.
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. "
In response to significant ongoing disruptions in the supply of certain Quetiapine tablet strengths, the Department of Health and Social Care (DHSC) on Tuesday
issued nine new Serious Shortage Protocols (SSPs), with immediate effect.
These measures aim to ensure the continued availability of quetiapine, an essential medication for managing schizophrenia and bipolar disorder.
Under the new SSPs, community pharmacists are allowed to consider different options to manage the shortage of the three strengths of quetiapine tablets affected
by ongoing supply disruptions: quetiapine 300mg tablets, quetiapine 200mg tablets, and quetiapine 150mg tablets.
Depending on the prescribed quantity of the affected quetiapine tablet, pharmacists can either supply a reduced quantity of the same quetiapine tablet or
substitute with an alternative strength or provide a reduced quantity of a specific alternative product.
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.
Professional leadership bodies from around the world discussed workforce shortages in community pharmacy and other challenges affecting the sector at a global
meeting held in Paris last month.
Delegated from Denmark, Australia, Ireland, New Zealand, Portugal, Spain, US and the UK updated the conference on how the profession was progressing in practice,
technology and workforce development in their respective countries.
The UK was represented at World Pharmacy Council meeting by National Pharmacy Association chair Andrew Lane and chief executive at the Pharmaceutical Services
Negotiating Committee Janet Morrison.
Lane said: "It's very useful to be part of a global network of pharmacy bodies who are all going through similar challenges as we are in the UK. Sharing intelligence
on other pharmacy systems around the world helps us to prepare the right strategy for engaging with the NHS at home.
"Hearing some of the strides in services and digital technology in the profession gives us hope for the future of the sector. It's clear however that key challenges
such as workforce shortages are starting to have an effect in other parts of the world too."
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 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.
Shortage of pharmacists remains a big challenge for community pharmacies as the chief executives of the national community pharmacy bodies met with senior NHS England and NHS Improvement officials to discuss the precarious situation in October-end.
In the last few months, several pharmacy contractors have reported increased staff shortages that caused difficulties in maintaining services, leading to temporary closures in some instances.
The sector is also facing chronic shortage of other staff including van drivers and pharmacy technicians.
During the meeting, NHS England's director for primary care, Ed Waller, and chief pharmaceutical officer Keith Ridge held talks with leaders from across the pharmacy sector on a variety of topics.
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.
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.
When Ignasi Biosca-Reig heard there were shortages of amoxicillin in Spain, he quickly added shifts at his drug company's factories to boost production of the
popular antibiotic.
But a few extra shifts was as far as he could go.
Much as he would have liked to significantly increase supplies, Biosca-Reig said he couldn't justify investing millions of euros in new production lines unless he
was paid more for the generic drug to cover sharply rising costs.
But, like many other European countries, Spain set the price manufacturers are paid for paediatric amoxicillin when the generic version of the drug was first
launched in the country two decades ago, and it has barely budged since.
"It's a non-business," said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre.
"We wanted to react, but we had a problem," he said. "The costs go up, the price remains the same."
The Department of Health and Social Care (DHSC) and NHS England last month issued a "safety critical" national patient safety alert, warning about
the UK-wide shortage of a life-saving drug used to treat patients with chronic breathing issues.
NHS trusts, health authorities, ambulance services, GP practices, private healthcare providers, and community pharmacy contractors were informed that
salbutamol 2.5mg and 5mg nebuliser liquid unit dose vials are in short supply, with the latter likely to remain "out of stock" until mid-April 2024.
As per the alert, the shortage of the drug resulted from a combination of manufacturing issues, leading to heightened demand for alternative suppliers.
It was mentioned that while terbutaline, salbutamol with ipratropium, and ipratropium nebuliser liquids remained available, they could't meet the increased demand.
The British Association of Dermatologists (BAD) has raised concerned about rising cases of scabies in the UK, and suggested that the current shortage of
medicines is contributing to the outbreak.
Usually, this skin condition is treated using topical creams or oral medication in more severe cases, but shortage of scabies drugs has been reported since May 2023.
Both permethrin 5% cream and malathion liquid, which are two main topical treatments for scabies, are in limited supply in the U.K.
Paula Geanau, a spokesperson for BAD, told Fox News Digital on Friday (19 January) that the rate of scabies is double the seasonal average, with three cases
per 100,000 of the population recorded at the end of November by the Royal College of GPs.