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The '''Yellow Card Scheme''' is the UK 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]] |accessdate=8 September 2014}}</ref>
The '''Yellow Card Scheme''' is the UK 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]] |accessdate=8 September 2014}}</ref>


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]] (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 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]] (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 sort of ADRs that should be reported are:
The sort of ADRs that should be reported are:
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* Any ADR, however minor, if associated with a child (under 18 years of age) or in pregnancy
* Any ADR, however minor, if associated with a child (under 18 years of age) or in pregnancy


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}}</ref> The scheme provides form 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/downloadable-information/reporting-forms/ |title=Downloadable information: Reporting forms |publisher=Medicines and Healthcare Products Regulatory Agency |accessdate=8 September 2014}}</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|date=August 2015}}</ref> The scheme provides form 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/downloadable-information/reporting-forms/ |title=Downloadable information: Reporting forms |publisher=Medicines and Healthcare Products Regulatory Agency |accessdate=8 September 2014}}</ref>


The NHS Information Standards Board for Health and Social Care has issued an information standard for electronic submission of ADRs by IT systems.<ref>[http://www.isb.nhs.uk/library/standard/243/ Standard ISB 1582]</ref> This is based upon the ICS E2B (R2) international standard.<ref>[http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2B/Step4/E2B_R2__Guideline.pdf Maintenance of the ICH Guideline On Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports E2b(R2) ]</ref>
The NHS Information Standards Board for Health and Social Care has issued an information standard for electronic submission of ADRs by IT systems.<ref>[http://www.isb.nhs.uk/library/standard/243/ Standard ISB 1582]</ref> This is based upon the ICS E2B (R2) international standard.<ref>[http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2B/Step4/E2B_R2__Guideline.pdf Maintenance of the ICH Guideline On Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports E2b(R2) ]</ref>

Revision as of 16:05, 28 August 2015

This article is about adverse reactions in human medicine. For veterinary medicine, see Suspected Adverse Reaction Surveillance Scheme.

The Yellow Card Scheme is the UK 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]

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 (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 sort of ADRs that should be reported are:

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

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.[2] The scheme provides form that allow members of the public to report suspected side effects, as well as health professionals.[3]

The NHS Information Standards Board for Health and Social Care has issued an information standard for electronic submission of ADRs by IT systems.[4] This is based upon the ICS E2B (R2) international standard.[5]

The Yellow Card Centre Scotland is a joint venture between MHRA and the Scottish Government.[6]

See also

References

  1. ^ "The Yellow Card Scheme". Medicines and Healthcare Products Regulatory Agency. Retrieved 8 September 2014.
  2. ^ A side effect of your medicine? Report it using Yellow Card leaflet (2008) [full citation needed]
  3. ^ "Downloadable information: Reporting forms". Medicines and Healthcare Products Regulatory Agency. Retrieved 8 September 2014.
  4. ^ Standard ISB 1582
  5. ^ Maintenance of the ICH Guideline On Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports E2b(R2)
  6. ^ "Yellow Card Centre Scotland". Yellow Card Centre Scotland. Retrieved 8 September 2014.
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