After a patient nearly choked when accidentally inhaling their lung medication capsule through the wrong part of their inhaler – Jazz, a concerned pharmacist, alerted the Medicines and Healthcare products Regulatory Agency (MHRA) of the potential risk.
Jazz, pharmacist and Yellow Card reporter, said:
I reported to Yellow Card because I thought if this happened to one person, it could happen to others, and I wanted to protect patient safety.
The MHRA did a detailed investigation and found there was potential for confusion when using the medicine and the device in combination. They then worked with the manufacturer to improve the safety information.
Now the products come with warnings about choking and clearer instructions on how to insert the capsule correctly into the device, including pictures that make it easy to understand.
The MHRA also alerted doctors, pharmacists and healthcare professionals across the UK about the safety risk.
It really goes to show that every piece of information is important and can make such a big difference to patient safety.
Mick Foy, Manager at the MHRA’s Vigilance and Risk Management of Medicines Division, said:
Patient safety is at the heart of everything we do, and everyone has a role to play in the safe use of medicines.
The MHRA uses Yellow Card reports to strengthen our investigations and advice on how to use products safely to protect patients. Whether you’ve experienced a side effect, seen a faulty medical device, or observed a potential issue, your report to the Yellow Card scheme helps us take action to protect everyone.
Throughout the week of World Patient Safety Day, the MHRA is reminding the public to report safety concerns involving medicines and medical products using the Yellow Card scheme, and supports the focus of this year’s World Patient Safety Day on healthcare worker safety. The MHRA commends the crucial role healthcare professionals play in reporting and flagging patient safety issues, including reporting through Yellow Card.
Anyone can use the Yellow Card scheme to report suspected side effects of medicines, incidents involving medical devices, and defective or fake medical products.
Reports can be made on the Yellow Card website, via the mobile app from the Google Play Store or Apple App Store, via freephone (0800 731 6789, 9am to 5pm Monday to Friday) or by reporting an issue to their healthcare team who can file a report on their behalf.
Every report is important and helps the MHRA investigate potential issues and monitor the safety and quality of healthcare products in the UK.
Find out more or report suspected safety concerns or incidents involving medical products at the Yellow Card website.
Notes to Editor
The Medicines and Healthcare products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgement to ensure that the benefits justify any risks.
MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health and Social Care.
The Yellow Card scheme is the UK system for collecting and monitoring information on suspected concerns or incidents involving medicines and medical devices. The scheme is run by the MHRA and currently relies on voluntary reporting of suspected issues by health professionals and patients. The purpose of the scheme is to provide an early warning that the safety of a product may require further investigation.
For a medicine to be considered safe, its expected benefits should be greater than any associated risks of harmful reactions. All medicines can cause reactions; however, most people take medicines without suffering any serious side effects. Healthcare professionals should be able to discuss such information with patients, parents and carers, be vigilant in the detecting of suspected safety concerns and prompt in reporting them via the Yellow Card scheme.