1 MHRA: The Yellow Card Scheme

The Yellow Card Scheme helps the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them. On the Yellow Card Scheme website you can report a suspected incident or problem. 

2 The question that will save lives: Interview with Katinka Blackford Newman, founder of Antidepressant Risks

Antidepressant medications are taken by millions of people globally. A small percentage of people who take them will experience rare but dangerous adverse reactions. In this interview, Katinka Blackford Newman tells us about her personal experience of antidepressant-induced psychosis and how this led her to campaign for increased awareness about side effects. She highlights a widespread lack of education and awareness about the risks associated with antidepressants and outlines why she is asking suicide prevention charities to ask callers one simple question about their medication.

3 Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests

In this interview, Marie Lyon talks about her campaign for justice for families affected by hormone pregnancy tests, why she is passionate about reforming medicines regulation and the important role patient campaigners play in improving patient safety.

4 USA: FDA Adverse Event Reporting System (FAERS) public dashboard

FAERS is the U.S. Food and Drug Administration (FDA) primary database for collecting and analysing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by healthcare professionals, consumers, and manufacturers.

5 Recognising adverse events and using the yellow card system

Despite the role of the MHRA’s Yellow Card reporting system in pharmacovigilance in the UK, understanding and uptake of the scheme remains limited. East London NHS Foundation Trust share how they designed a survey to explore healthcare professionals’ awareness, usage and perceptions of the Yellow Card Scheme for reporting adverse drug reactions.

6 Post-SSRI Sexual Dysfunction: After 30 years, why is the health system still failing to recognise this life-limiting adverse effect?

Post-SSRI Sexual Dysfunction (PSSD) is a long-term adverse effect of Selective Serotonin Reuptake Inhibitors (SSRIs), a type of antidepressant medication. In this opinion piece, Harriet Vogt, Patient Safety Partner at NHS Sussex Integrated Care Board, outlines the need for recognition and research into PSSD to allow patients to make truly informed choices when considering SSRIs. She looks at the impact PSSD has on the sexual and emotional lives of thousands of people and highlights a new research study analysing the obstacles to quantifying its incidence and prevalence. Harriet argues that while the health system is beginning to recognise the value of placing patients at the heart of efforts to improve safety, this focus on listening is rarely given to individual patients who express concern about the impact of their medication or treatment.

7 MHRA: Reporting a possible side effect to a medicine – a guide for Children and Young People

The MHRA has produced a guide to download and share to help children and young people learn why it's important to report possible side effects of medication.

8 Sodium Valproate: The Fetal Valproate Syndrome Tragedy

In this article, Sharon Hartles, member of the Open University’s Harm and Evidence Research Collaborative, reflects upon the use of Sodium Valporate, marketed as Epilim, to treat patients at risk of epilepsy and the subsequent harms in fetal development and birth defects that arose from its use. ‘

9 Interview with Charlet Crichton, founder of UKCVFamily

UKCVFamily was set up in November 2021 to support patients in the UK who have had an adverse reaction to a Covid-19 vaccination. The group provides help and advocacy as well as raising awareness amongst healthcare professionals, the media and the Government. In this video, founder of UKCVFamily Charlet Crichton talks to us about the side effects she experienced after having the AstraZeneca Covid vaccine. She outlines why she established the group and describes the support it offers to patients. She outlines some of the issues people face when trying to access diagnosis and treatment, and discusses the limitations of the MHRA's Yellow Card scheme in collecting data about adverse reactions. She also describes how healthcare professionals can support people with adverse reactions by taking their concerns seriously and investigating symptoms thoroughly.

Share your stories

Have you had an adverse reaction to medication? What do you think of the Yellow Card reporting system? Share your thoughts and experiences with us on the hub. You can comment below (you will need to be signed in first; sign up is free and easy) or email us at content@pslhub.org.

Organisations should consider allocating dedicated time or resource to pharmacovigilance activities. Potentially, also looking at ADR champions or leads within the department could help sustain engagement. Metrics, such as the number of reports submitted and staff confidence levels, could be used to guide continuous improvement.

Despite awareness of the scheme, actual usage is very low — 76% have never reported and 12% were unsure if they had reported, suggesting underutilisation of the scheme. Reporting is infrequent: no respondents report regularly; 12% report a few times a year and 20% have only reported one or twice in total.

When asked about barriers to reporting, participants selected: 

• Lack of awareness.
• Uncertainty about what qualifies as reportable.
• Lack of time. .
• Belief that someone else is responsible. 

• Valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. For the majority of patients, other effective treatment options are available.
• At their next annual specialist review, women of childbearing potential and girls receiving valproate should be reviewed using the revised valproate Annual Risk Acknowledgement Form. A second specialist signature will be needed if the patient is to continue on valproate, however subsequent annual reviews will only require one specialist.
• General practice and pharmacy teams should continue to prescribe and dispense valproate and if required offer patients a referral to a specialist to discuss their treatment options. Valproate should be dispensed in the manufacturer’s original full pack.
• Report suspected adverse drug reactions associated with valproate on a Yellow Card.

Advice for healthcare professionals to provide to patients:

• Do not stop taking valproate without advice from a specialist. This is because epilepsy or bipolar disorder may worsen without treatment
• if you are on valproate, please attend any offered appointments to discuss your treatment plan and talk to a healthcare professional if you are concerned.
• Consult the Patient Information Leaflet and new Patient Guide for information about the risks of valproate – see also the MHRA information page for resources.
• As a precaution, male patients who are planning a family within the next year should speak to a healthcare professional about their treatment options.

The Yellow Card Scheme is intended to support the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them.[1] Reports can be made for all medicines, including:

• side effects (also known as adverse drug reactions or ADRs)

• medical device adverse incidents
• defective medicines (those that are not of an acceptable quality)
• counterfeit or fake medicines or medical devices
• safety concerns for e-cigarettes or their refill containers (e-liquids).

IMMDS Review and incident reporting

Published on the 8 July 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review, led by Baroness Julia Cumberlege, highlighted the need to improve incident reporting in healthcare, specifically in regards to medicines and medical devices.[2]

The Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades.

One area of particular concern that the Review raised related to the Yellow Scheme, highlighting the need for reform of this system, stating that:

• it needs to be more user-friendly and accessible
• that the system was hampered by a lack of awareness among both the public and healthcare professionals.

More broadly, the Review recommended that the MHRA needed to revise its approach in relation to adverse event reporting and do more to ensure that it engages with patients and their outcomes. The Government accepted this recommendation in its response to the Review.[3]

Questions in the House of Commons

Below are details of three written questions tabled by Emma Hardy MP concerning the Yellow Card Scheme. All three questions were answered by Will Quince MP, Minister of State (Minister for Health and Secondary Care).

Awareness

Question: To ask the Secretary of State for Health and Social Care, what assessment he has made of the level of awareness of (a) health professionals and (b) the general public of the Adverse Events Yellow Card System; and what steps is he taking to increase awareness of that system among those groups.

Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the importance of both public and healthcare professional understanding of, and access to the MHRA Yellow Card scheme, so that they can promptly report any concerns they have about the safety of healthcare products. The MHRA monitors the number of reports it receives from members of the public and healthcare professionals and strives to keep improving understanding and awareness of the reporting system. The MHRA continually works to encourage reporting of any safety concerns to the Yellow Card scheme and help improve the safe use of medicines and medical devices for everyone.

A sharp increase in reporting, mainly from patients, has been seen due to better awareness of the scheme following significant communications activity at the start of the COVID-19 vaccination campaign.[4]

Data collection

Question: To ask the Secretary of State for Health and Social Care, what assessment he has made of the (a) level and (b) adequacy of data collected by (i) mandatory and (ii) voluntary reporting of adverse clinical events by health professionals before the introduction of the Yellow Card reporting system in England compared to that now collected via the Yellow Card system.

Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed other international mandatory and non-mandatory reporting systems for healthcare professionals and found limited evidence that making reporting mandatory increases the ability to detect safety signals. Very few international mandatory reporting systems have a better reporting rate or a more successful system for detecting safety signals than the United Kingdom.

In both medicines and devices legislation there are requirements for manufacturers to report, but there is no legal obligation for healthcare organisations. However, there are professional body standards and guidelines that make reporting a gold standard for healthcare professionals. The MHRA continues to work with partners across the healthcare system to promote and encourage use of the Yellow Card scheme to help detect safety issues.

The MHRA has reviewed global approaches to mandatory reporting in other regulatory systems and continues to consider the approach in the UK as we work to improve reporting capability and functionality through systems.[5]

Data analysis

Question: To ask the Secretary of State for Health and Social Care, which body has responsibility for analysing data collected by the Adverse Events Yellow Card system; and what assessment has he made of the potential merits of collating this data on a publicly accessible database.

Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) collects and analyses the data received through the Yellow Card Scheme, and publishes data on medicines and COVID-19 vaccines in a searchable database on the Yellow Card website for transparency purposes.

As outlined in the Yellow Card Privacy Policy, the MHRA has responsibilities under both the UK General Data Protection Regulation and the Data Protection Act 2018 to protect confidential data and personal data pertaining to individuals. The content and format of the data is currently being enhanced in line with patient and healthcare professional feedback and will be expanded to include medical devices in due course. The data provided will continue to be aligned to the MHRA’s legal responsibilities to data subjects.[6]

References

1. MHRA, Welcome to the Yellow Card reporting site, Last Accessed 6 June 2023.
2. The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020.
3. Department of Health and Social Care (DHSC), Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021.
4. House of Commons, Yellow Card Scheme, UIN 186945, tabled on 25 May 2023.
5. House of Commons, Yellow Card Scheme, UIN 186944, tabled on 25 May 2023.
6. House of Commons, Yellow Card Scheme, UIN 186946, tabled on 25 May 2023.

Related reading

• A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021)
• Response to the Select Committee report on the Independent Medicines and Medical Devices Safety Review (Patient Safety Learning, 20 January 2023)
• Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom, 15 April 2021)

There are two versions of the tool, one for patients with epilepsy and the other for patients with bipolar disorder. Patients can use the tools with their clinician to help them understand the potential risks and benefits of valproate and help them to decide whether to start or keep taking it.

Any patients who wish to no longer take valproate should have their medication carefully managed as a sudden stop in the use of sodium valproate can cause severe harm.

The tools have been developed with a range of expert clinicians, and patient representatives.

To support the introduction of these tools to both patients and clinicians, NHS England has produced the attached comms toolkit containing key messages, template articles and suggested social media posts and graphics.

ADRe is very simple to use:

1. Nurses use the Profile to check and record problems that might be related to prescribed medicine.
2. Nurses solve some problems, e.g. dental pain, dehydration, by referrals or paying closer attention to intake.
3. Nurses share the completed ADRe Profile with prescribers (GPs or specialists), who decide prescriptions and doses.
4. Repeating the Profile one month later ensures no new issues have arisen.

You can request a copy of the full tool, or even try out part of our digital app by registering.

• side effects (also known as adverse drug reactions or ADRs)
• medical device adverse incidents
• defective medicines (those that are not of an acceptable quality)
• counterfeit or fake medicines or medical devices
• safety concerns for e-cigarettes or their refill containers (e-liquids).