Government action required to mitigate medicine shortages

 

The National Pharmacy Association (NPA) has written to the minister for the Cabinet Office Michael Gove, to express concerns over the impact of the Brexit Withdrawal Agreement and the Northern Ireland protocol on the medicines supply chain.

 

In a letter sent to Mr Gove on 27th October, NPA chair Andrew Lane said the requirement for Northern Ireland to continue to comply with EU medicines regulations that will no longer apply in the UK (which is the main source of supply) would distort the medicines supply chain.

 

He warns that the additional cost and complexity of getting medicines into Northern Ireland could result in some manufacturers not bringing products to the market. This in turn could lead to medicines shortages and an increase in procurement costs.

 

Without a clear plan on a transition from the UK-wide system into one that serves only Northern Ireland, it is likely that manufacturers of medicines, particularly generic medicines, will simply stop producing packs that meet the requirements for supply in Northern Ireland, Mr Lane predicts in his letter.

 

The NPA is urging the UK government to apply robust mitigation to the medicines supply chain from 31st December 2020 for a period of at least 18 months, to allow the supply chain to adapt to Brexit-related changes.

 

Earlier this month, the UK Community Pharmacy Falsified Medicine Directive Working Group called on the government in Westminster to protect the supply of medicines into Northern Ireland following the end of the Brexit transition period.  The working group consists of the national organisations representing community pharmacy across the UK (NPA, CCA, AIM, PSNC, CPS, CPW, CPNI).

 

 

What is it like to depend on medicine to treat endometriosis?

 

I have endometriosis.

 

I was diagnosed when I was 16. In the ten years since diagnosis, I have taken Loestrin 20 tablets. Over the years the doctors looking after me have tried three different medicines but to no avail. I have tried mild painkillers, lifestyle and dietary changes too. These were largely experimental medication changes. Together we made various attempts to make things better for me but this inconsistency in my medicines resulted in significant negative changes to my health.

 

I kept coming back to Loestrin 20.

 

And that’s fine because it works. It has been the only medicine that I have taken for endometriosis that has helped me to continue daily life.

 

You probably think I’m making a meal of this or overreacting but please believe me that this medicine helps me to stay well both mentally and physically. The thought of not being able to access it anymore would be terrifying.

 

And that’s what brings me to my story that happened in November 2019. The day everything changed and my life took a seismic hit below the waterline.

 

This was the day that I found out after attempting to collect my prescription from my local pharmacy that I can no longer receive my treatment for endometriosis.

 

At that time I had my last pill and that was it. I was devastated, anxious and uncertain about how the future would unfold. This situation was such a travesty because my health prospects were looking really good.

 

So, of course, I asked why?

 

Apparently, the medicine could not be sourced from anywhere because of ‘manufacturing’ issues or ‘undisclosed issues’ I was told by different places.

 

I sought help from my Doctor, from NHS 24 and other pharmacies. It is a birth control pill for the general population so I was told that my Doctor can simply put me on another pill and I can get on with life as normal. It didn’t seem to be considered a drastic change with challenging knock-on effects.

 

Well, this is the problem you see because Health Professionals often see these things in a binary way and don’t consider fully the impact on us patients.

 

It is quite frankly not the case that this was a minor problem with an easy fix for women with endometriosis. I was upset about the undermining of the severity of endometriosis and changes like this to treatment.

 

I was absolutely terrified tonight about what was going to happen to my health. If I was to be placed on a new pill to ‘test the waters’ for the subsequent for next 3-6 months I would once again be playing another game of risk with my physical and mental health.

 

The times in the past this was attempted my life was turned upside down. I was not ready for this again. I felt sick. Gobsmacked. And angry.

 

I wasn’t informed by my doctor who signed off on the prescription. I didn’t hear from anyone until I went to the pharmacy and searched online.

 

What was going on? Why were patients on this medication not informed?

 

No letters, emails or phone call.

 

I was very disappointed about this on behalf of all women with endometriosis, especially those like me who have been given no warning of these supply problems.

 

Even though these events happened some time ago I have some questions for pharmacists reading this blog that I really hope they can answer:

 

Can anyone shed light on this situation?

 

What’s the plan ahead for changes to medication supplies for chronic conditions like endometriosis?

 

How are medication shortages communicated with Doctors?

 

Who or what is to blame for these shortages of essential medication?

 

I hope this blog triggers at the very least a conversation about this issue and that we can begin to work towards a solution. Obviously, my medication is extremely important to me but I cannot imagine how frightening it must be if my example involved a life-saving medicine.

 

The author of this article wishes to remain anonymous. 

 

 

Pharmacists need authority to manage global medicine shortages

Mr Lars-Åke Söderlund, chair of FIP’s Medicines Shortages Policy Committee and president of FIP’s Community Pharmacy Section.

 

Pharmacists should be given greater authority to solve medicines shortages when they occur and governments should, as soon as possible, instruct medicines regulatory authorities to investigate and develop proposals giving such extended powers to pharmacists. This is one of a number of recommendations in a new Statement of Policy on Medicines Shortages published today by the International Pharmaceutical Federation (FIP).

 

Other recommendations in the policy statement include:

 

  • The global use of a single definition of medicines shortages and a set of harmonised criteria to identify and monitor shortages at the national, regional and international level to enhance understanding of the problem globally through more accurate, reliable and comparable data.
  • Development of a global process to determine the list of critical or vulnerable products.
  • That each country establishes a publicly accessible means of providing information on medicine shortages.
  • That all procurers of medicines move towards active procurement processes that assure the continuity of supply of quality medicines.

 

“The causes of shortages are several, multidimensional and sometimes unpredictable. In the context of a complex global supply chain and a globalised market, there is a growing concern among all stakeholders — including patients, healthcare professionals, governmental organisations, pharmaceutical wholesalers and the pharmaceutical industry — about the future of medicines supplies worldwide,” said Mr Lars-Åke Söderlund, chair of FIP’s Medicines Shortages Policy Committee and president of FIP’s Community Pharmacy Section.

 

“There is evidence that shortages are worsening with time, creating ever more difficulties for healthcare professionals, and compromising patient safety. Shortages have been reported in countries of all income levels, occurring across all healthcare settings and involving essential life-saving medicines, very commonly used medicines and both high- and low-price medicines. In this policy statement, FIP and its member organisations make four commitments, including to develop evidence-based guidelines and competency development programmes targeting pharmacists’ roles in mitigating the impact of medicines shortages.”

 

You can read the full policy here.

 

 

Urgent action required on medicine shortages

 

 

Medicines shortages are a growing problem across Europe, not just in the UK, according to a new report by the Pharmaceutical Group of the European Union (PGEU).

 

All responding countries experienced medicine shortages in community pharmacies in the past 12 months, and the vast majority (87%) of respondents indicated that the situation got worse compared to 2018. All classes of medicines are affected by medicine shortages in community pharmacies.

 

In the majority of responding countries (67%), over 200 medicines were listed as in short supply at the time of completing the survey.

 

All responding countries indicated that they believe medicine shortages cause distress and inconvenience to patients. Interruption of treatments (75% of countries), increased copayments as a result of more expensive/non-reimbursed alternatives (58%) and suboptimal treatment/inferior efficacy (42%) are also perceived as negative consequences of medicine shortages on patients.

 

Medicine shortages are believed to affect community pharmacy businesses in most countries by a reduced level of patient trust (92% of countries), financial loss due to time invested in mitigating shortages (82%) and reduced employee satisfaction (79%).

 

Across European countries, strong differences exist in terms of legal solutions community pharmacists can offer in case of a shortage. Generic substitution (79 % of countries), sourcing the same medicine from alternative authorised sources (such as other pharmacies) (63%), and importing the medicine from a country where it is available (46%) are the solutions which can be provided in most of the European countries.

 

The time pharmacy staff have to spent on dealing with medicine shortages has increased from 5,6 hours per week (2018) to 6,6 hours per week on average.

 

25% of responding countries indicated that there is still no reporting system for shortages in place which can be used by community pharmacists in their country, despite that pharmacists often experience or foresee supply difficulties before the industry or wholesalers are aware that there is, or will be, a problem.

 

Community pharmacists receive the needed information on shortages in most countries from wholesalers (71%), medicines agencies (67%) and pharmacy organisations (42%).

 

The 2019 PGEU Medicine Shortages Survey Results cover the responses from 24 European countries and is created from the perspective of community pharmacists across Europe.

 

Pharmacy associations from all the countries in the PGEU survey said they had experienced medicines shortages in 2019.  Of the 24 countries, 21 said the situation had got worse in the last 12 months.  In the majority of counties, over 200 medicines were listed as being in short supply at the time of completing the survey, which was carried out in November and December 2019.  The most widespread shortages were medications affecting the central nervous system, respiratory medicines and cardiovascular medicines.

 

The shortages were reported to have caused distress and sometimes serious harm.

 

National Pharmacy Association Policy Manager Helga Mangion said:

 

“This data is further evidence of a widespread problem in this country and across Europe.

 

“Because of heroic efforts by pharmacists, patients usually get their medicines when and where they need them, but longstanding faults in the medicines supply chain too often leave patients waiting. It’s time for urgent action, to reduce the risk of harm and to allow pharmacists to spend more time with patients instead of hunting for stock.”

 

The NPA is part of the UK’s delegation to PGEU, alongside the Royal Pharmaceutical Society and the Pharmaceutical Society of Northern Ireland.

 

You can view the survey results below.

 

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