Medicine shortages have been an everyday issue for community pharmacy professionals for years. Spending time hunting for items by calling manufacturers is part of the daily schedule. But in September last year C+D discovered that pharmacy teams had suffered shortages in all 36 categories of medicines included in a reader survey over the previous six months. These take up time and energy that could otherwise be spent on patient care.
So why are so many medicines unable to get to pharmacies?
Unable to provide medicines
The C+D survey revealed for the first time the strain that dealing with medicine shortages is placing on community pharmacies. A staggering 95% of the 402 respondents said they are finding it harder to source medicines than 12 months ago. More concerningly, 43% said their team spends more than an hour every day dealing with the problem.
Sometimes this effort is futile, as pharmacies simply can’t source the medicine or an alternative. Three quarters (75%) said they are unable to supply a medicine at all because it is out of stock three or more times a day.
Many described frustration from dealing with medicine shortages. One C+D reader said they are “at breaking point, just about hanging on before we crack under the pressure”. Another said their workplace is a “daily struggle”, especially when it came to explaining to patients that some drugs are only stocked by one wholesaler.
While many patients are understanding of the difficulties pharmacies face, not all are. Reactions range from “disbelief” to “outrage” and “aggression”, C+D respondents reported. Some patients were distressed to the point of trying to change their pharmacy, and many blamed the pharmacy for the inconvenience.
Brexit was frequently mentioned by respondents as a source of concern for patients struggling to obtain their medicines. One C+D reader said: “Patients are getting more and more distressed as Brexit looms closer.
“They can't understand how their essential life-saving medicines are going out of stock, and are very anxious that they might need to go without for a few days until an alternative is arranged.”
One respondent said patients are “cross and blaming Brexit”, while another said “they blame me, they blame Brexit [and] they say our service is poor”.
There is no public list of medicine shortages in the UK, so it is difficult to make accurate comparisons month-by-month. However, a C+D freedom-of-information (FOI) request to the Department of Health and Social Care (DH) revealed that by the end of November there had been 178 medicine shortages officially reported in 2019 – up from 159 in 2018.
This figure is compiled from the reports of shortages in primary and secondary care that its medicine supply team shares with the NHS. The DH stressed to C+D that although the number of reports has “increased”, this may be because “more stakeholders are now regularly reporting issues to us”. Among these are pharmaceutical companies, who have been required by legislation to report supply problems to the DH since January 2019.
Martin Sawer (pictured below), executive director of wholesaler body the Healthcare Distribution Association (HDA), estimated in October 2019 that there are on average 100-150 medicines in short supply at any one time, out of the approximately 15,000 his members handle.
Mr Sawer notes that although the current situation is “not as extreme” as in late 2017, when the suspension of Bristol Laboratories’ manufacturing licence prompted severe shortages of some generics, it is triple the 40-50 medicine shortages the HDA was aware of five years ago.
A “febrile” situation
The HDA appreciates that part of the frustration for pharmacists is a lack of communication from wholesalers, Mr Sawer says. “Some 2.5 million manhours can be wasted annually by pharmacists chasing stock,” he estimates.
In a step that aims to improve this, the HDA launched an infographic in September that it hoped would “dispel some of the myths” surrounding medicines availability issues and “highlight some of the initiatives HDA members take every day to mitigate supply problems”.
Wholesaler representatives hand-delivered a copy to every pharmacy in the UK. “Crucially, the leaflet doesn’t shy away from the complications of supply. We hope it provides reassurance; everything is getting a bit febrile,” Mr Sawer says. The graphic lays out reasons why manufacturers may experience a shortage, including an “active pharmaceutical ingredient shortage” and “competitor product out of stock”. Distributor attempts to mitigate these shortages include “investing in stock” and “fast-tracking”.
Posting on the C+D website, locum pharmacist Joan Richardson says she would like a weekly list explaining reasons for the medicines suffering shortages and a date for the next supply. “This way I would be able to give patients some information, instead of telling them I don't have any idea what is going on,” Ms Richardson says.
The HDA is also working on improving communication of reasons for shortages, Mr Sawer says. It hopes to do this via the patient medication record system. “Pharmacy is crying out” for the improvement, Mr Sawer says. His organisation has been working with pharmacy organisations on the change, which he hopes to roll out this year.
Pharmaceutical Services Negotiating Committee (PSNC) director of funding Mike Dent stresses that shortages are a “long-acknowledged problem”. Like the HDA, the negotiator doesn’t have access to an official list of shortages. “Unfortunately, we don’t have sight of the specific reasons behind most drug shortages – we only see the consequences of it,” Mr Dent says.
National Pharmacy Association (NPA) head of corporate affairs Gareth Jones (pictured below) agrees that medicine shortages are not new for pharmacies. “It’s been a real problem for a decade,” he says. He acknowledges how complicated it is to speak for contractors across the UK, as shortages vary by region. But he does say that many NPA members are highlighting them as a “serious problem” that each pharmacy team must spend up to 10 hours a week handling.
“We get complaints from our members,” Mr Jones suggests. “It has an impact on patient service. There are times where patients go without medicines because of a shortage – rare times, but it does happen. In most cases medicines will come through.”
One potential reason for medicine shortages is the UK’s free market system, which encourages pharmacies to find the lowest price, Mr Jones suggests. The system saves the NHS money, but means international manufacturers may prioritise foreign markets who pay more for their products.
Although there is little public data on medicine shortages, contractors update pharmacy organisations on their experiences of them daily. The Pharmacists’ Defence Association (PDA) says “managing medicine shortages has become an increasing part of PDA members’ working lives”.
The PDA points out that although the entire supply chain has a role to play in medicines management, pharmacies alone must handle the occasionally furious reactions of patients. “Longer term, the reputation of pharmacy could be damaged if the general public believe we have let them down.”
“Shortages create shortages”
Director general of the British Generics Manufacturers Association (BGMA) Warwick Smith (pictured below) says medicine shortages have become “normal”. Unlike Mr Sawer, he believes the level of shortages are “about the same” as they were five years ago. “The reality is there are always going to be shortages. I know that sounds uncaring – it’s not. There are always going to be manufacturing difficulties. In complex supply chains, there are always things that are going to go wrong.”
In response to pharmacists’ requests for more information on the causes of shortages, Mr Smith explains that the DH’s opacity aims to prevent manufacturers from taking advantage of them by increasing their prices. “The DH will not want to put into the public domain any information that drives behaviour that would be unhelpful. If you talk about shortages of products, you create shortages.”
The DH will often have the “fairly bland” explanation for why medicine is in shortage, such as “‘manufacturing issues’, and leave it at that”, Mr Smith says. He believes this is “quite right”, as it aims to reduce the risk of triggering panic.
DH shortages management
Mr Smith claims the DH is “probably the most effective” national body in Europe when it comes to medicines supply, with a “slick system” in place – even if contractors enduring shortages every day are unlikely to see it in the same light. Mr Smith says that the requirement for pharmaceutical companies to report anticipated shortages to the DH since January now gives the government “total transparency” of where medicines are in the country.
The DH is beginning to intervene where necessary. For example, during a Naproxen shortage this year, the DH helped to move stock across the country. When Mylan ran out of EpiPen 300mcg auto-injectors in October 2018, the DH extended the expiry dates on some of the products, Mr Smith says.
But the biggest change for pharmacists came with the government granting them the ability to supply an alternative strength or form of fluoxetine without first contacting the patient’s GP. This was the first time pharmacists could dispense an alternative to a medicine suffering a shortage under a “serious shortage protocol” (SSP). Another SSP was subsequently announced to combat a haloperidol shortage.
To help “tackle” shortages of hormone replacement therapy (HRT) products, the DH announced it had restricted wholesalers from exporting 19 HRT drugs out of the country alongside the first SSP. An expanded export-ban list now includes MMR vaccinations, alogliptin and misoprostol, among others.
Mr Sawer said he had not seen a significant impact on shortages following the implementation of these measures. “They’re only affecting a few products and the volumes are relatively small,” he says. “There’s still a lot of shortage issues out there.”
However, he has noticed that the DH's management of medicine shortages in general has improved. “The supply problems that we read about are all being largely managed in a more successful way than they were a few years ago. Although there’s a lot of products on shortages lists, the supply of products is better. The data available is better.”
Mr Smith was more positive about the impact of the SSPs, saying they “have been successful in managing shortages in the past”. However, he said that the parallel exports ban “probably won’t have much impact on generics”, as “only a minority of products on the shortages list are generics”.
Researcher Dr Paul Morris, a medicine shortages expert who opted not to be associated with his university for this article, says that shortages are global and here to stay. “The pernicious problem has been going on for a long time, over 10 years if not more,” he says. The primary causes have remained the same throughout – economic, regulatory and manufacturing.
“Let’s accept that medicines and devices are in short supply. Instead, deal with the realities of what happens in supply chains, because there’s not enough work done on that.”
Dr Morris says there needs to be better management of stock in the UK. He claims to have identified some regions operating better than others. “Supply chain orientation talks about how adaptable, ready and flexible you are. Management theories have not been applied in healthcare in the same way it has in other industries. It really has to be done at health policy level.”
A key driver behind UK medicine shortages has been globalisation. Stretching the supply chain across the world has “exacerbated” manufacturing issues, Dr Morris says. Around 80% of UK medicines are imported across the Channel, Mr Smith says. In March 2019, he said UK medicines prices were being affected by shortages in India.
Dr Liz Breen, a reader in health service operations at the University of Bradford's School of Pharmacy, agrees that pharmacists in Canada, Australia and Spain are also having similar supply problems.
Impending Brexit has thrust medicines issues into the spotlight, but their causes are complex. “Globally there are a myriad of issues causing this, including poor practice from manufacturers, distributors and suppliers across the world. It’s very difficult to get solid information because [some] companies are very secretive.”
The ongoing risk of a no-deal Brexit may be forcing the supply chain to prepare for the worst, but these arrangements could help the UK in the future, Dr Breen says. “Maybe that’s the point we’re at, to be able to create a supply chain that functions well. [One] which is adaptive, flexible, agile, has all the right components, all the right communication channels, and all the right players in it.”
Dr Breen continues: “There are issues and weaknesses that need to be addressed. There are elements of fragility, where the chain can be infiltrated by consumer terrorism, tampering and counterfeits (which should be addressed by the Falsified Medicines Directive). There will be overreliance on key manufacturers and products.
“There is the potential for a lot of things to go wrong. When you put additional pressure on it you see the [problems] coming through as the system cracks, but hopefully the learning from this landmark event [Brexit] can be built into strengthening this supply chain.”
It's not only the big players who have been forced to act ahead of Brexit. Epilepsy Society medical director Professor Ley Sander (pictured below) says that as a result of hearing about potential medicine shortages in the event of a no-deal Brexit, “a lot of people with epilepsy are stocking up” on medicines.
“People are asking: ‘Can I get an extra month of drugs?’” says Professor Sander. “There is a group of patients with epilepsy who are very concerned, because their tablets are made in Hungary or Portugal, so they stock up just in case.”
The charity saw an increase in calls to its helpline last year, as people rung up if they “can’t get their drug for three days”, he says. Previously “it would be rare to have people running out of medication. Recently this has become a big issue”.
Professor Sander stresses that he has not seen shortages resulting in medical problems, “because there are always alternatives”. But he warns that “many problems coming together make a big storm”.
The issue is exacerbated by patients not understanding their medicines. Professor Sander estimates that 20% of epilepsy patients do not know what they are taking, so they become anxious about switching to alternatives. This anxiety is “compounded” by reading posts on social media about medicine shortages.
The view across Europe
Shortages have made the headlines in recent months, but Europe has been handling the problem for years. The European Medicines Agency (EMA) says that shortages have been a “global problem for the past decade, and are increasingly affecting the EU”.
“They have been increasing in severity in recent years, and are affecting many commonly used medicines including antibiotics, anaesthetics and oncology medicines.”
The EMA created a task force to tackle medicines disruptions in 2016. Its annual report from 2018 included managing the impact of Brexit as one of four objectives.
However, the EMA admits it does “not have a full picture to compare the numbers of medicine shortages affecting different EU member states, and we do not have a database with information on shortages in each country in the EU”.
The EMA is not the only body trying to improve shortages management. The European Cooperation in Science and Technology (COST) association launched a network in 2015 to address medicine shortages by sharing information between states. Jane Nicholson (pictured below, right), COST supply working group lead, says these shortages are an “increasing problem” across Europe and in the UK – but the latter is no worse than other countries.
Ms Nicholson says the EMA is helping build a European portal to show medicine shortages across the continent. She hopes the UK will participate after Brexit.
Another initiative attempting to make information about shortages more accessible is Shortages.EU. The project encourages healthcare workers across the European Economic Area to report medicines that are “commercially unavailable or discontinued” in their country, which it then publishes online, so neighbouring countries can prepare for a potential shortage.
Austeja Dapkute (pictured below), Shortages.EU project manager, finds it “very strange” that there is no central European hub for shortages. Her team had “a problem” with the UK because there was no public database. However, they are seeing an increasingly comprehensive picture of the country’s shortages “maybe because of Brexit”.
The project receives 50-100 reports per country every month, Ms Dapkute says. Although they still don’t receive many from the UK, they are getting more as awareness of the scheme increases. Medicines that have suffered in EU-wide shortages include EpiPens, Ozurdex, Alkeran, Fucidin, piperacillin/tazobactam and cytarabine, Ms Dapkute says.
Shortages are unlikely to disappear, but the DH and EU organisations appear to be doing more than in previous years to improve the situation. In the meantime, pharmacies will continue bearing the brunt of this systemic problem.