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

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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SPONTANEOUS ADVERSE DRUG REACTION REPORTS FOR TRANSPLACENTAL AND TRANSMAMMARY ROUTES IN THOSE ≤1 YEAR IN THE UK 2001–2010

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-310148.28 ◽

2015 ◽

Vol 101 (1) ◽

pp. e1.21-e1

Author(s):

Nicki-Jayne Russell ◽

Mark Turner ◽

Dan Hawcutt

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Spontaneous Reporting ◽

Reporting System ◽

Yellow Card ◽

Exposure Data ◽

Yellow Card Scheme ◽

Spontaneous Adverse Drug Reaction ◽

Route Of Exposure ◽

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: content and utility analysis

British Journal of Clinical Pharmacology ◽

10.1111/bcp.13067 ◽

2016 ◽

Vol 82 (6) ◽

pp. 1601-1612 ◽

Cited By ~ 8

Author(s):

Daniel B. Hawcutt ◽

Nicki-Jayne Russell ◽

Hannah Maqsood ◽

Koushan Kouranloo ◽

Simon Gomberg ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Utility Analysis ◽

Spontaneous Adverse Drug Reaction ◽

The Uk ◽

Neonates And Infants

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A Comparison of Publically Available Spontaneous Adverse Drug Reaction Data from National Spontaneous Reporting Schemes

Drug Safety ◽

10.2165/00002018-200629100-00008 ◽

2006 ◽

Vol 29 (10) ◽

pp. 911-1010 ◽

Cited By ~ 1

Author(s):

C. Anton ◽

A. R. Cox ◽

J. J. Coleman ◽

R. E. Ferner

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Spontaneous Reporting ◽

Reaction Data ◽

Spontaneous Adverse Drug Reaction

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

Pharmacoepidemiology and Drug Safety ◽

10.1002/pds.2117 ◽

2011 ◽

Vol 20 (5) ◽

pp. 523-531 ◽

Cited By ~ 25

Author(s):

David J McLernon ◽

Christine M Bond ◽

Amanda J Lee ◽

Margaret C Watson ◽

Philip C Hannaford ◽

...

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Yellow Card ◽

Patient Views ◽

Yellow Card Scheme ◽

The Uk

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ANTIMICROBIAL-RELATED ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2017.v10i8.19380 ◽

2017 ◽

Vol 10 (8) ◽

pp. 229

Author(s):

Jindal M ◽

Sharma Rk

Keyword(s):

Adverse Drug Reaction ◽

Drug Reaction ◽

Spontaneous Reporting ◽

Tertiary Care Hospital ◽

Past History ◽

Tertiary Care ◽

Care Hospital ◽

Beta Lactam ◽

Active Monitoring ◽

Beta Lactam Antibiotics

Objective: The objective of the study was to evaluate the adverse drug reaction (ADR) related to commonly used antimicrobials in a tertiary care hospital.Methods: A prospective spontaneous reporting study involving, active methods (pharmacist actively looking for suspected ADRs) and passive methods (stimulating prescribers to report suspected ADRs) was carried out in all departments of a tertiary care hospital, for 1 year. Patients of all age groups were included in the study. The data for the study were taken from case sheets, investigation reports of patients who had experienced an ADR, personal interviews with reporting persons or clinicians, personal interviews with patient or patient’s attendant, past history of medication use, which were generally obtained from, prescriptions from the past, reports of medical and surgical interventions, referral letters, ADR reporting forms. Collected data were then analyze for causality assessment by Naranjo’s scale and severity assessment by Hartwig and Siegel’s scale.Result: During 1 year of study period, 75 ADRs related to antimicrobial were reported among 1354 patients who were given antibiotic for the treatment. The incidence rate of antibiotic was found to be 5.53%. The department that reported ADR was medicine (10.16%), ENT (4.6%), pediatric (8.12%), orthopedics (06.9%), surgery (06.9%), chest and tuberculosis (04.6%), obstetrics and gynecology (06.9%), dentistry (02.3%), and skin (10.16%). The most common ADRs were related to gastrointestinal tract; dermatological reactions were second in the list of antimicrobial drugs causing ADR. In this study, among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. There was no unknown ADR reported that may need to be further investigated through active monitoring. All patients recovered from ADRs without any complications. The causality was assessed by Naranjo’s scale and it revealed that out of 75 antibiotics related ADR 48 (64%) were possible, 27 (36%) were probable, 3 (4.00%) were definate, and 0% were unlikely. According to the Hartwig and Siegel’s scale, most of ADR were mild 45 (60%) and moderate 30 (40%) in nature.Conclusion: ADRs related to antimicrobials occurs frequently. Among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. The health-care system can promote the spontaneous reporting of antimicrobial ADR to pharmacovigilance center for ensuring safe drug use and patient care.

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