Reporting Adverse Incidents

Guidance on Reporting Adverse Incidents and Side Effects

The Yellow Card scheme is the UK’s system for reporting suspected side effects to medicines and adverse incidents with medical devices.

It is run by the Medicines and Healthcare products Regulatory Agency (MHRA). This month, the agency received its one millionth Yellow Card. This major milestone coincided with the launch of the 5th annual #MedSafetyWeek (2-8 November), which highlights the value of the Yellow Card scheme to the nation’s health.

The MHRA has seen an increased rate of Yellow Card reports and would like to continue to encourage more reporting. Anybody can report an adverse incident or suspected side effect – patients and carers, as well as healthcare professionals and their organisations.

By reporting any occasions on which a medical device fails to perform to the required standards or a patient experiences unexpected side-effects from a medication, users can help to ensure that appropriate steps are taken to prevent any recurrence of the problem.
 

Click the links to go straight to more information on:

What sort of products are concerned?
What is an adverse incident?
What causes an adverse incident?
Who can make a report?
How to make an adverse incident report
Why you should make a report
 

What sort of products are concerned?

• hospital beds
• hoists and slings
• stretchers and trolleys
• standing aids
• manual transfer aids
• specialist seating
• walking aids
• wheelchairs
• pressure relief mattresses and cushions
• bathing equipment
• showering equipment
• commodes and incontinence products
• prosthetics and orthotics
• environmental controls
• hearing aids
• communication aids
• Drugs and other medications

This list is not comprehensive, but is indicative of the main product types which are of particular relevance in the care and independent living sector.
 

What is an adverse incident?

According to the MHRA, the definition of an adverse incident is:
“an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons”

Adverse incidents do not include non-availability of a required item, and any subsequent problems caused by the lack. These events should be reported instead to the National Patient Safety Agency (NPSA).
 

What causes an adverse incident?

There are various possible causes for an adverse incident, including:

• poor design or defective manufacturing of the product
• inadequate maintenance and servicing procedures
• lack of training in correct use of the product
• unsafe modifications
• incorrect storage
• selecting the wrong product for the purpose
 

Who can make a report?

Anybody – whether you are a medical or care professional, family carer, user of the device, patient, or member of the public. There are no restrictions on the person who can make a report of an adverse incident.

You should, however, check any incident reporting procedures within your organisation, as well, as you may be required to report via a Medical Device Liaison Officer or patient safety manager.
 

What sort of incidents should be reported?

You do not need to wait for an injury to be caused. If you are aware of a potential problem with the medical device, you should report it. Apart from the obvious adverse consequences of death, illness or injury, other consequences such as delaying recovery or preventing healing should be considered.

If you are aware of an ongoing fault with a piece of equipment, which is not resolved by servicing and maintenance, this should also be considered as an adverse incident.

Even if it appears that human error alone is responsible for the incident, it should be reported, as it might be a result of defective product design or instructions for use.

Minor issues should be reported, as these can also play a part in helping to develop good practice guidance for other users, as well as helping manufacturer with design improvements.
 

How to make an adverse incident report

You should report any incidents as quickly as possible, generally within 24 hours.

The fastest way of doing so is online. The MHRA Yellow Card scheme enables you to submit reports securely at any time, and this is the way in which 80% of incidents are reported. (link will open in a new browser window)

If you use online reporting, you will get immediate confirmation and a unique reference number for your report, as well as a PDF copy emailed to any specified address, if you wish.

Other ways of reporting incidents include telephone: 020 3080 7080 (answering machine outside office hours). Any telephone report must be followed up in writing.

If you decide to make the report by email (aic@mhra.gsi.gov.uk) or post, you can download forms from the MHRA website, and either complete them electronically, or print them out and post them to:
MHRA Adverse Incident Centre
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
 

Why report an adverse incident?

No product can be entirely free of risk, but the job of the MHRA is to protect public health by working with manufacturers and users to make sure that medical devices are as safe as possible. Most of the time, they work with manufacturers to resolve any reported issues, but if for any reason they are not successful in this, they can take action as the regulatory body.

Prompt reporting of adverse incidents to the Adverse Incident Centre has led to a number of health risks being identified and dealt with early, thus preventing more negative consequences.

Reporting can also help to identify new side effects, as well as unexpected and serious safety problems. It also adds to existing information about known effects. By reporting, patients and the public can help the safe use of medicines for everyone. It helps the MHRA to take action, through effective regulation.
 

A positive example of the benefits of reporting

One recent positive change to medicines information for users involves a woman in the UK who has helped identify a newly recognised side effect from a blood pressure medication.

While pregnant, Liz noticed some unusual side effects when taking her medicine and reported it to the MHRA using the Yellow Card scheme.

Liz comments:

“Shortly after taking each dosage, I would feel an extreme burning sensation in my nipples which intensified over a period of about 20 minutes. It was agonising.

“At first, I didn’t make the link between the tablets and the pain – I presumed it was just a pregnancy side effect. My doctor and other healthcare professionals weren’t aware of it as a reported side effect for my medication.

“I decided to report my symptoms to Yellow Card because, however rare, I wanted to make sure anyone else experiencing it wouldn’t feel alone.

“MHRA investigated my report alongside other reporting and clinical data and found that nipple pain was a symptom of Raynaud’s phenomenon, a known side effect of this particular medicine.

“They worked with the manufacturers to improve the patient safety information – and the medicine now includes nipple pain as a possible side effect of Raynaud’s phenomenon.

“It didn’t take much time to do and I’m glad that anyone else experiencing this problem will now understand its probable cause. It’s good to know I’ve been able to make a difference.”

Liz recovered from the side effect she experienced.
 

How does the MHRA disseminate information?

Medical Device Alerts (MDAs) are the means by which the MHRA advises professional device users of any safety issues, or gives updated advice on using equipment safely.

You can find a list of current Alerts and Recalls concerning drugs and devices on their website – if an MDA is not listed, this means that it has been withdrawn or superseded.
 

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