Yellow Card Scheme: Difference between revisions
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{{Short description|Pharmacovigilance system in the United Kingdom}} |
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''This article is about Human Medicines. For Veterinary Medicines, see the [[Suspected Adverse Reaction Surveillance Scheme]]''. |
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{{about|adverse reactions in human medicine|veterinary medicine|Veterinary pharmacovigilance in the United Kingdom}} |
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{{Use British English|date=February 2021}} |
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{{Use dmy dates|date=February 2021}} |
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The '''Yellow Card Scheme''' is the United Kingdom's system for collecting information on suspected [[adverse drug reaction]]s (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.<ref>{{cite web |url=https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/ |title=The Yellow Card Scheme |publisher=[[Medicines and Healthcare products Regulatory Agency]] |access-date=8 September 2014}}</ref> |
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== History == |
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The '''Yellow Card Scheme''' is the UK system for collecting information on suspected Adverse Drug Reactions (ADRs) to medicines. The Scheme was founded in 1964 after the [[thalidomide]] disaster, and was developed by Dr [[Bill Inman]]. |
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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.<ref>{{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 }}</ref> |
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The Yellow Card Centre Scotland is a joint venture between MHRA and the [[Scottish Government]].<ref>{{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}}</ref> |
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== Scope == |
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{{unreferenced|section|date=January 2023}} |
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| ⚫ | 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 preparation|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. |
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Yellow Cards are available from pharmacies and a few are presented near the back of the [[British National Formulary|BNF]] as tear-off pages. |
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== Usage == |
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Reports can also be submitted online through the MHRA-run [http://yellowcard.mhra.gov.uk/ Yellow Card Scheme website]. |
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Reports can be entered through the MHRA's website, or a [[smartphone]] app which is available for [[iOS]] and [[Android (operating system)|Android]] devices. The app can also provide news and alerts to users.<ref>{{cite press release|author=<!--Staff writer(s); no by-line.-->|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}}</ref> |
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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.<ref>''A side effect of your medicine? Report it using Yellow Card'' leaflet (2008) {{full citation needed|date=August 2015}}</ref> The scheme provides forms that allow members of the public to report suspected side effects, as well as health professionals.<ref>{{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}}</ref> |
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*[[Medicines and Healthcare products Regulatory Agency]] (MHRA) |
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*[[British National Formulary]] |
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[[NHS Digital]] publishes an information standard DCB1582 for electronic submission of adverse reactions by IT systems<ref>{{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}}</ref> (until 2014, this was ISB 1582 from the Information Standards Board).<ref>{{Cite web|title=Amd 28/2012 — ISB|url=https://webarchive.nationalarchives.gov.uk/+/http://www.isb.nhs.uk/documents/isb-1582/amd-28-2012/index_html|access-date=2021-02-20|website=webarchive.nationalarchives.gov.uk}}</ref> The specification is based on the [[International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use|ICH]] E2B (R2) international standard format.<ref>{{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]]}}</ref> |
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*[http://yellowcard.mhra.gov.uk/ Yellow Card Scheme website] |
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[[Category:National Health Service]] |
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*[[Vaccine Adverse Event Reporting System]] (USA) |
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*[[VigiBase]] (WHO) |
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== References == |
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{{reflist}} |
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{{NHS-stub}} |
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*{{Official website}} |
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{{pharma-stub}} |
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[[Category:Medical regulation in the United Kingdom]] |
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[[Category:Drug safety]] |
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Latest revision as of 10:02, 2 August 2024
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.[1]
History
[edit]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.[2]
The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government.[3]
Scope
[edit] |
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
Usage
[edit]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.[4]
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.[5] The scheme provides forms that allow members of the public to report suspected side effects, as well as health professionals.[6]
NHS Digital publishes an information standard DCB1582 for electronic submission of adverse reactions by IT systems[7] (until 2014, this was ISB 1582 from the Information Standards Board).[8] The specification is based on the ICH E2B (R2) international standard format.[9]
See also
[edit]- EudraVigilance (European Medicines Agency)
- Pharmacovigilance
- Uppsala Monitoring Centre (World Health Organization (WHO))
- Vaccine Adverse Event Reporting System (USA)
- VigiBase (WHO)
References
[edit]- ^ "The Yellow Card Scheme". Medicines and Healthcare products Regulatory Agency. Retrieved 8 September 2014.
- ^ "NHS70: major moments in pharmacy 1948–2018". Pharmaceutical Journal. 22 June 2018. Retrieved 4 September 2018.[permanent dead link]
- ^ "Yellow Card Centre Scotland". Yellow Card Centre Scotland. Retrieved 8 September 2014.
- ^ "Digital evolution for ground-breaking Yellow Card Scheme" (Press release). gov.uk. 14 July 2015. Retrieved 11 October 2015.
- ^ A side effect of your medicine? Report it using Yellow Card leaflet (2008) [full citation needed]
- ^ "Downloadable information: Reporting forms". Medicines and Healthcare products Regulatory Agency. Retrieved 29 November 2020.
- ^ "DCB1582: Electronic Yellow Card Reporting". NHS Digital. 26 October 2017. Retrieved 20 February 2021.
- ^ "Amd 28/2012 — ISB". webarchive.nationalarchives.gov.uk. Retrieved 20 February 2021.
- ^ "ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs)". European Medicines Agency. 28 July 2013. Retrieved 20 February 2021.
