Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme, YCS) to collect suspected adverse drug reaction (ADR) data. We describe the Yellow card reports received for patients aged ≤1 year across a 10 year period (2001–10).MethodsThe MHRA supplied YCS data for patients aged ≤1 year from the years 2001–2010. This analysis includes all reports involving transplacental, transmammary, or paternal route of exposure. Data were analysed to include number, type and outcome of ADRs.ResultsThere were 279 reports, including 249 different medications (a YCS may contain ≥1 medication). The most commonly reported drugs were fluoxetine (n=25), citalopram (n=22), paroxetine (n=19) and venlafaxine (n=19). The outcome of the ADR was death in 10.4% of reports. Doctors reported 75.4% (n=215) of reports, however only 3.9% (n=11) were from the parent/carer. Gender was documented in 66% cases and gestation was stated in only 15% of reports.ConclusionsDespite many women requiring medications in pregnancy and while lactating, very few YCS reports were received over a 10 year period. Current MHRA advice is for all suspected ADRs in children following transplacental or transmammary exposure to be reported. Strategies to improve reporting in this neglected population are urgently needed.

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SPONTANEOUS ADVERSE DRUG REACTION REPORTS FOR NEONATES AND INFANTS IN THE UK 2001–2010

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-310148.48 ◽

2015 ◽

Vol 101 (1) ◽

pp. e1.43-e1

Author(s):

Dan Hawcutt ◽

Hannah Maqsood ◽

Simon Gomberg ◽

Andrew Riordan ◽

Mark Turner

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Gestational Age ◽

Spontaneous Reporting ◽

Swine Flu ◽

Yellow Card ◽

Neisseria Meningitides ◽

Spontaneous Adverse Drug Reaction ◽

The Uk ◽

Neonates And Infants

AimsThe UK Medicines and Healthcare products Regulatory Agency (MHRA) runs a national spontaneous reporting system (Yellow Card Scheme [YCS]) to collect ‘suspected' adverse drug reaction (ADR) data. We aim to describe the Yellow card reports received for patients aged ≤1 year for a 10 year period and assess their utility.MethodsData on all ADRs reported via the YCS in Infants aged ≤1 years from the years 2001–10 were supplied by the MHRA.ResultsIn total, 3217 suspected ADRs were reported to the YCS between 2001–10 for infants age ≤1 year (Neonates n=97, vaccinations n=2673, infant [neither neonate nor vaccine] n=477). Overall only 0.88 YC per day were received by the MHRA with a male preponderance (Male 50.3%, Female 45.7%); only 25 (0.8%) YC reports stated a gestational age for the affected infant. The medications most frequently reported as suspected of causing an ADR were Swine Flu Vaccine (neonates n=8), Neisseria meningitides (vaccinations n=693) and oseltamivir (infants n=37). Reports associated with vaccinations followed the expected trends. ADRs highlighted by regulators for neonatal and infant populations are not represented in the YCs received by the regulator.Conclusions The frequency of YCS reports for those ≤1 year is low, with less than 1 per day overall. Neonates are poorly represented, and recording of gestational age is very limited. The YCS appears to be more effective for spontaneous reporting of vaccination-related ADRs in infants than for other medications. Action is required to improve reporting of suspected ADRs that affect neonates and infants.

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P015 Yellow cards are still not on everyone’s to do list

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-nppc.25 ◽

2019 ◽

Vol 104 (7) ◽

pp. e2.18-e2

Author(s):

Emily Horan ◽

David Tuthill

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Healthcare Professionals ◽

Drug Event ◽

Yellow Card ◽

Reporting Scheme ◽

Know How ◽

Learning Module ◽

Yellow Card Scheme ◽

E Learning

AimTo look at how the Yellow Card Scheme is used by health care professionals (HCPs) in child health.MethodsAn online SurveyMonkey questionnaire was devised to look at how healthcare professionals (HCPs) have used the Yellow Card Scheme in clinical practice. It comprised of 10 questions (9 multiple choice and 1 freestyle text). What type of healthcare professional are you? Are you aware of the Yellow Card reporting scheme? Have you ever used the Yellow Card Scheme to report an adverse drug reaction? If yes, how did you make the report? (If no, select N/A) If you haven’t ever reported a reaction, would you know how to? Have you ever completed an e learning module about the Yellow Card Scheme? Are you aware that parents can report adverse drug reactions using the Yellow Card Scheme? Have you ever been aware of an adverse drug reaction but decided not to report it? If yes, what was the reason you chose not to report it? (If no, select N/A) Can you think of any ways to make the Yellow Card Scheme more accessible to healthcare professionals? It was piloted on 5 HCPS and minor textural revisions made. The questionnaire was then undertaken via face-to-face interviews during June 2018.Results50 healthcare professionals completed the questionnaire: 16 doctors, 13 nurses, 8 pharmacists, 9 medical students, 2 nursing students and 2 pharmacy technicians. 43/50 were aware of the Yellow Card Scheme (10 undergraduates and 33 postgraduates). 18 participants had used the Yellow Card whilst 32 had not reported an adverse drug event. Out of the 32 respondents who had never reported a reaction, 13 (7 undergraduates and 6 postgraduates) said that they would not know how to report a reaction if required. Only 9 had completed an online e learning module about the Yellow Card scheme. 30 participants were aware that parents could report using the scheme. 10 participants had been aware of an adverse drug reaction but decided not to report it. The most common reason for this was being too busy. The most common suggestion on how to improve accessibility to the Yellow Card Scheme was the implementation of a mobile phone application.ConclusionMost participants were aware of the Yellow Card scheme although undergraduates less so. Many had reported, although some had chosen not to report because they were: too busy; not being concerned enough; not knowing how to; having forgotten. An app already exists, but awareness of this appears low, as it was the commonest suggestion to aid the low reporting.

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Adverse drug reactions in children: reports to the UK yellow card scheme 2000-2009

Archives of Disease in Childhood ◽

10.1136/adc.2011.212563.130 ◽

2011 ◽

Vol 96 (Supplement 1) ◽

pp. A57-A57

Author(s):

D. B. Hawcutt ◽

P. Mainie ◽

R. Appleton ◽

R. Smyth ◽

M. Pirmohamed

Keyword(s):

Adverse Drug Reactions ◽

Drug Reactions ◽

Yellow Card ◽

Yellow Card Scheme ◽

The Uk

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Adverse Drug Reaction Reporting in the UK

Drug Safety ◽

10.2165/11536510-000000000-00000 ◽

2010 ◽

Vol 33 (9) ◽

pp. 775-788 ◽

Cited By ~ 68

Author(s):

David J. McLernon ◽

Christine M. Bond ◽

Philip C. Hannaford ◽

Margaret C. Watson ◽

Amanda J. Lee ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Adverse Drug Reaction Reporting ◽

Reaction Reporting ◽

The Uk

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Resources in the UK for responding to an adverse drug reaction alert

Pharmacoepidemiology and Drug Safety ◽

10.1002/pds.2630010405 ◽

1992 ◽

Vol 1 (4) ◽

pp. 187-190

Author(s):

D. H. Lawson ◽

K. Beard

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

The Uk

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A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme

British Journal of Clinical Pharmacology ◽

10.1111/j.1365-2125.2005.02419.x ◽

2005 ◽

Vol 60 (2) ◽

pp. 221-223 ◽

Cited By ~ 25

Author(s):

Robert C. G. Bracchi ◽

Jane Houghton ◽

Fiona J. Woods ◽

Simon Thomas ◽

Simon A. Smail ◽

...

Keyword(s):

Distance Learning ◽

Adverse Drug Reactions ◽

Drug Reactions ◽

Yellow Card ◽

Yellow Card Scheme ◽

The Uk ◽

Suspected Adverse Drug Reactions

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Adr In Journals: Are They Translated Into Regulatory Frameworks?

Current Drug Safety ◽

10.2174/1574886316666210609115148 ◽

2021 ◽

Vol 16 ◽

Author(s):

Annapurna Kolupoti ◽

Ananya Chakraborty ◽

Shahistha K

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Case Reports ◽

Package Insert ◽

Geographic Location ◽

Scientific Publication ◽

Geographic Region ◽

Package Inserts ◽

Regulatory Authorities ◽

The Uk

Introduction: An adverse drug reaction case report refers to a scientific publication that is written by a health care professional who suspects a causal relationship between a drug and an adverse drug reaction (ADR). ADR case reports help to identify potential risks associated with the use of the drug. Most of the case reports do not mention reporting the ADR to regulatory authorities. With this objective, the aim of this study was to analyze the number of Adverse Drug Reaction (ADR) published as case reports (PubMed indexed journals) from January 2018 to June 2019 and observe if they are translated into a regulatory framework like Vigibase and package inserts. Materials And Methods: 321 ADRs were obtained with the keywords “Adverse Drug Reaction.” Out of those, 158 were independently extracted by two investigators, observed and categorized according to classes of the drugs, geographic location, severity, hospitalization, completeness of ADR, and whether they were reported to the regulatory authority (VigiBase) or listed in the package insert. Literature review articles were excluded. Results: Out of the 158 ADRs, antibiotics accounted for 12.65%, CNS drugs and monoclonal antibodies accounted for 11.39%, anticancer drugs for 9.49%, CVS drugs for 4.43%, anti-virals for 3.79%, and the others for 45.56%. According to geographic region, 26 ADRs published were from USA, 4 from Australia, 3 from Italy, 17 from India, 9 from Turkey, 1 from Singapore and the UK, 20 from China, 2 from Denmark and Canada, 10 from Japan, 9 from France, 1 from Austria, 5 from Korea, 3 from South America, and 2 from Switzerland. Depending upon the severity, causality assessment was performed for 45 ADRs only; it was not performed for 113 ADRs. 41.13% of patients (from 65 case reports) were hospitalized. Among the 158 ADRs, 14 ADRs were not found in VigiBase. 32 ADRs were not mentioned in the drug package inserts. When categorized according to the completeness of case reports, weight accounted for 1.89%, lab values and procedure for diagnosis accounted for 96.8%, risk factors for 95.56%, prior exposure for 88.60%, post ADR status for 60.12%, and the start-stop medication, route of administration, first dose, last dose, and the duration of illness accounted for 100%. Conclusion: Depending upon our observation, we have noticed that there is a deficiency in reporting of suspected ADR to the regulatory authorities. Reporting can be included as mandatory criteria for ADR case reports. Also, there is an increased need for various healthcare workers to be aware about reporting ADR.

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