Yellow Card Scheme

The scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman. It is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines. It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999.{{cite news |title=NHS70: major moments in pharmacy 1948–2018 |url=https://www.pharmaceutical-journal.com/20205049.article |access-date=4 September 2018 |publisher=Pharmaceutical Journal |date=22 June 2018 }}{{Dead link|date=March 2023 |bot=InternetArchiveBot |fix-attempted=yes }}

The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government.{{cite web|title=Yellow Card Centre Scotland|url=http://www.yccscotland.scot.nhs.uk/Pages/default.aspx|access-date=8 September 2014|publisher=Yellow Card Centre Scotland}}

{{unreferenced|section|date=January 2023}}

Suspected adverse reactions are collected on all licensed medicines and vaccines, whether issued on prescription or bought over the counter from a pharmacist or supermarket. The scheme also includes all herbal preparations and unlicensed medicines. Adverse reactions can be reported by anyone; this is usually done by healthcare professionals – including doctors, pharmacists and nurses – but patients and carers can also make reports.

The types of adverse reactions that should be reported are:

• Those that have caused death or a serious illness
• Any adverse reaction, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary with a ▼ black triangle)
• Any adverse reaction, however minor, if associated with a child (under 18 years of age) or in pregnancy

Reports can be entered through the MHRA's website, or a smartphone app which is available for iOS and Android devices. The app can also provide news and alerts to users.{{cite press release|author=|title=Digital evolution for ground-breaking Yellow Card Scheme|url=https://www.gov.uk/government/news/digital-evolution-for-ground-breaking-yellow-card-scheme|publisher=gov.uk|date=2015-07-14|access-date=2015-10-11}}

Yellow Cards are available from pharmacies and a few are presented near the back of the BNF as tear-off pages; copies may also be obtained by telephoning +44 (0) 808 100 3352.A side effect of your medicine? Report it using Yellow Card leaflet (2008) {{full citation needed|date=August 2015}} The scheme provides forms that allow members of the public to report suspected side effects, as well as health professionals.{{cite web |url=https://yellowcard.mhra.gov.uk/resources/reporting-forms/ |title=Downloadable information: Reporting forms |publisher=Medicines and Healthcare products Regulatory Agency |access-date=29 November 2020}} Children and Young People can also report suspected Adverse Drug Reactions to the Yellow Card scheme, and specific information for them has been developed and tested. {{Cite journal |last=Hawcutt |first=Daniel B |last2=Jadeja |first2=Mitul |last3=Bhoombla |first3=NIkita |last4=Smith |first4=Sophie |last5=McWilliam |first5=Stephen J |date=July 2022 |title=Information for children and young people about reporting suspected adverse drug reactions |url=https://adc.bmj.com/lookup/doi/10.1136/archdischild-2021-323400 |journal=Archives of Disease in Childhood |language=en |volume=107 |issue=7 |pages=681–685 |doi=10.1136/archdischild-2021-323400 |issn=0003-9888|url-access=subscription }}{{Cite journal |last=Bioletti |first=Louis |last2=Ambassadors |first2=Alder Hey Research |last3=Woodward |first3=Charlotte |last4=Jadeja |first4=Mitul |last5=Hawcutt |first5=Daniel B. |date=2024 |title=Assessing and further developing age-appropriate information for young people about reporting suspected adverse drug reactions |url=https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.15971 |journal=British Journal of Clinical Pharmacology |language=en |volume=90 |issue=3 |pages=863–870 |doi=10.1111/bcp.15971 |issn=1365-2125|doi-access=free }}

NHS Digital publishes an information standard DCB1582 for electronic submission of adverse reactions by IT systems{{Cite web|date=26 October 2017|title=DCB1582: Electronic Yellow Card Reporting|url=https://digital.nhs.uk/data-and-information/information-standards/information-standards-and-data-collections-including-extractions/publications-and-notifications/standards-and-collections/dcb1582-electronic-yellow-card-reporting|access-date=2021-02-20|website=NHS Digital|language=en}} (until 2014, this was ISB 1582 from the Information Standards Board).{{Cite web|title=Amd 28/2012 — ISB|url=http://www.isb.nhs.uk/documents/isb-1582/amd-28-2012/index_html|archive-url=https://webarchive.nationalarchives.gov.uk/ukgwa/20130513113540/http://www.isb.nhs.uk/documents/isb-1582/amd-28-2012/index_html|archive-date=2013-05-13|access-date=2021-02-20|website=NHS}} The specification is based on the ICH E2B (R2) international standard format.{{Cite web|date=28 July 2013|title=ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs)|url=https://www.ema.europa.eu/en/ich-e2b-r3-electronic-transmission-individual-case-safety-reports-icsrs-data-elements-message|access-date=20 February 2021|website=European Medicines Agency}}

• EudraVigilance (European Medicines Agency)
• Pharmacovigilance
• Uppsala Monitoring Centre (World Health Organization (WHO))
• Vaccine Adverse Event Reporting System (USA)
• VigiBase (WHO)

{{reflist}}

• {{Official website}}
• [https://www.gov.uk/government/organisations/commission-on-human-medicines Commission on Human Medicines (CHM)]

Category:Pharmaceuticals policy

Category:Pharmacy in the United Kingdom

Category:Medical regulation in the United Kingdom

Category:Drug safety