Jump to content

Yellow Card Scheme: Difference between revisions

Edit links
From Wikipedia, the free encyclopedia
Browse history interactively
← Previous edit
Content deleted Content added
VisualWikitext
Corrected broken URL
Importing Wikidata short description: "Pharmacovigilance system in the United Kingdom"
 
(38 intermediate revisions by 26 users not shown)
Line 1: Line 1:
{{Short description|Pharmacovigilance system in the United Kingdom}}
{{about|adverse reactions in human medicine|veterinary medicine|Suspected Adverse Reaction Surveillance Scheme}}
{{about|adverse reactions in human medicine|veterinary medicine|Veterinary pharmacovigilance in the United Kingdom}}
{{Use British English|date=February 2021}}
{{Use dmy dates|date=February 2021}}
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>


== History ==
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]].
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>
⚫
It is run by the [[Medicines and Healthcare products Regulatory Agency|Medicines and Healthcare products Regulatory Agency (MHRA)]] and the [[Commission on Human Medicines]] (CHM). Suspected ADRs are collected on all licensed medicines and vaccines, from those issued on prescription to medicines bought over the counter from a pharmacist or supermarket. The Scheme also includes all herbal preparations and unlicensed medicines. ADRs 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 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>
⚫
The sort of ADRs that should be reported are:


== Scope ==
⚫
* ADRs that have caused death or a serious illness
{{unreferenced|section|date=January 2023}}
⚫
* Any ADR, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the [[British National Formulary|British National Formulary (BNF)]] with a ▼ [[Black triangle (pharmacology)|black triangle]])
⚫
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.
⚫
* Any ADR, however minor, if associated with a child (under 18 years of age) or in pregnancy


⚫
The types of adverse reactions that should be reported are:
Yellow Cards are available from pharmacies and a few are presented near the back of the [[British National Formulary|BNF]] as tear-off pages.
⚫
* 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 (pharmacovigilance)|black triangle]])
⚫
* Any adverse reaction, however minor, if associated with a child (under 18 years of age) or in pregnancy


== Usage ==
Reports can also be submitted online through the MHRA-run [http://yellowcard.mhra.gov.uk/ Yellow Card Scheme website]. The NHS Information Standards Board for Health and Social Care is currently developing an [http://www.isb.nhs.uk/library/standard/243/ information standard] for electronic submission of ADRs by IT systems. This is based upon the [http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2B/Step4/E2B_R2__Guideline.pdf ICS E2B (R2)] international standard
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>


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>
⚫
==See also==

*[[Medicines and Healthcare products Regulatory Agency]] (MHRA)
[[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>

⚫
== See also ==
⚫
*[[EudraVigilance]] (European Medicines Agency)
*[[Pharmacovigilance]]
*[[Pharmacovigilance]]
⚫
*[[Uppsala Monitoring Centre]] (World Health Organization (WHO))
⚫
*[[EudraVigilance]]
*[[Vaccine Adverse Event Reporting System]] (USA)
⚫
*[[Uppsala Monitoring Centre]] (WHO)
*[[VigiBase]] (WHO)
*[[British National Formulary]]


==External links==
== References ==
{{reflist}}
⚫
*[http://www.mhra.gov.uk/Committees/Medicinesadvisorybodies/CommissiononHumanMedicines/index.htm Commission on Human Medicines (CHM)]

*[http://yellowcard.mhra.gov.uk/ Yellow Card Scheme website]
== External links ==
*{{Official website}}
⚫
*[https://www.gov.uk/government/organisations/commission-on-human-medicines Commission on Human Medicines (CHM)]


[[Category:Pharmaceuticals policy]]
[[Category:Pharmaceuticals policy]]
[[Category:National Health Service]]
[[Category:Pharmacy in the United Kingdom]]
[[Category:Pharmacy in the United Kingdom]]
[[Category:Medical regulation in the United Kingdom]]

[[Category:Drug safety]]

{{NHS-stub}}
{{pharma-stub}}

Latest revision as of 10:02, 2 August 2024

This article is about adverse reactions in human medicine. For veterinary medicine, see Veterinary pharmacovigilance in the United Kingdom.

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]

References

[edit]
  1. ^ "The Yellow Card Scheme". Medicines and Healthcare products Regulatory Agency. Retrieved 8 September 2014.
  2. ^ "NHS70: major moments in pharmacy 1948–2018". Pharmaceutical Journal. 22 June 2018. Retrieved 4 September 2018.[permanent dead link‍]
  3. ^ "Yellow Card Centre Scotland". Yellow Card Centre Scotland. Retrieved 8 September 2014.
  4. ^ "Digital evolution for ground-breaking Yellow Card Scheme" (Press release). gov.uk. 14 July 2015. Retrieved 11 October 2015.
  5. ^ A side effect of your medicine? Report it using Yellow Card leaflet (2008) [full citation needed]
  6. ^ "Downloadable information: Reporting forms". Medicines and Healthcare products Regulatory Agency. Retrieved 29 November 2020.
  7. ^ "DCB1582: Electronic Yellow Card Reporting". NHS Digital. 26 October 2017. Retrieved 20 February 2021.
  8. ^ "Amd 28/2012 — ISB". webarchive.nationalarchives.gov.uk. Retrieved 20 February 2021.
  9. ^ "ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs)". European Medicines Agency. 28 July 2013. Retrieved 20 February 2021.
[edit]
Retrieved from "https://en.wikipedia.org/enwiki/w/index.php?title=Yellow_Card_Scheme&oldid=1238142373"