The pain of a medicine shortage – views from a patient and pharma consultant

This is a joint article, written by two of Fusion Pharma’s Senior Regulatory Consultants. The first part is written by Dr Lorraine Marsh from a family impact perspective, followed by Leah Heathman’s view as a regulatory professional having been involved in many medicine shortage resolutions.

The words we dread hearing when visiting the pharmacy to collect our prescriptions:

“Sorry, your medication appears to be out of stock…”

“Oh, it looks like your medicine has been discontinued…”

“I’m afraid there’s going to be a delay in ordering this for you…”

“No, we can’t tell you when it’s likely to come in…”

Whilst for some these words may sound like a mere inconvenience, for those of us reliant on taking daily life-changing medication (or with children who need them) the feelings of panic, confusion, frustration, worry and many other emotions will start to surface.

We may find ourselves asking… How can this have happened? Who is responsible for this? What can I do to find out more? What are the options for alternative medication?

Example case study:

For your child who can’t get their ADHD medication your first thoughts may be how am I going to keep my risk-taking, danger-seeking child safe? Will they still be able to attend school when their impulse control is back to it’s non-medicated state (i.e. no impulse control)? Will I start to get those phone calls from the teacher saying they’ve escaped, injured themselves or someone else, or done something dangerous…? Will we be back to sleepless nights because my child can’t calm their mind without the medication? Will I have to stop work to look after my child who can no longer attend school in this non ADHD-medicated heightened state? Will we have to go back to having the house trashed because my child’s medication has run out?

Sounds stressful? Familiar? This is unfortunately the brutal reality for many parents of children with non-medicated ADHD.

Now Lorraine has set the scene with just one example of how a medicine shortage drastically affects lives, Leah will now focus on what the pharma industry can do when this situation occurs.

The production of medicines is complex – it is highly regulated, often involves multiple sites, and relies heavily on the performance of machinery and testing equipment. External influences such as acquiring raw materials can also have a major impact – and if one company is supplying many pharmaceutical companies, this impact will be multiplied. Production schedules have to be planned months in advance and an imbalance between supply and demand can result simply from media focus of a condition.

The British Generic Manufacturers Association warned that over 100 products were consistently facing supply problems, which was the highest on record and more than double the number from 2022. Sadly shortage notifications are still at an all time high with the Department of Health and Social Care (DHSC) receiving over 1000 notifications each year.

In the UK, the DHSC has overall responsibility for ensuring the continuity of the supply of medicines and pharmaceutical companies are expected, by law, to be fully accountable for their supply chain.

When shortages do arise, the DHSC work closely with the MHRA, NHS and pharmaceutical companies to risk-assess impact to patients and, where necessary, minimise this impact a number of different ways by:

• supporting the pharmaceutical industry by expediting the review of regulatory procedures where appropriate (e.g. reducing timelines to review from 6 months to just a few days),
• identifying alternatives or liaising with other manufacturers to increase production,
• commissioning clinical advice from national experts regarding potential management options,
• identifying sources of product from abroad and expediting import for individual patient use, and
• advising and facilitating communication within the NHS and healthcare providers.

Additionally, along with the MHRA, they have limited the export of certain medicines to other countries to ensure UK patients’ needs are met first.

But could the pharmaceutical industry do more?

The ‘Marketing Authorisation Holder’ (MAH) has a responsibility take all reasonable steps to ensure a continued supply of medicines, including monitoring supply / demand and are expected to develop shortage prevention and response plans.

But the question is ‘is this enough’ and ‘could they do more’? Well, it is a trillion dollar industry – so, undoubtedly, yes the pharmaceutical industry could do more!

Some considerations that may be a good place start include…

• Within a pharmaceutical company, is there enough emphasis on the impact to patients and is this felt across all departments?
• If a company markets life-saving or even life-changing medicines, is there a shortages task force looking at 1) minimising the potential risks and 2) ensuring quick and appropriate action takes place when a shortage is identified?
• Are there effective SOPs in place to ensure appropriate escalation if a shortage takes place, both internally and externally?
• Is the Regulatory Affairs Department fully aware of the role they play and how they can work with the MHRA to expedite approvals or submit batch specific variations?
• How effective are the MAHs at carrying out their responsibilities? Should there be targeted inspections specifically for companies supplying important medicines, or those with repeat shortages?

It’s a tricky topic to navigate as there are so many different factors however, I do believe that a lot more can be done to look at both prevention of and the reaction to a shortage.

From years of experience it is safe to say that all shortages need to be handled on a case by case basis as each shortage faces its own unique set of challenges. The MHRA and DHSC however are always open to discussing these events and will work through your options with your Regulatory Affairs Department and provide flexibility where appropriate.

Written by: Dr Lorraine Sammut Marsh FTOPRA and Leah Heathman