Spontaneous reporting of suspected adverse drug reactions [letter; comment]

BackgroundUK patients of all ages can contribute to the Medicines and Healthcare Regulatory Agency (MHRA) Yellow Card scheme (YCS), reporting suspected adverse drug reactions (ADRs). Children’s and young people’s (CYPs) contribution to, and awareness of, the YCS is not known.MethodsSuspected ADR reports received by the MHRA from 01/01/2008 to 29/11/2018 were examined. Prospective data from CYP and parents in paediatric outpatients were collected as part of the QUestionnaire study about Adverse Drug ReAcTions In Children (QUADRATIC) study (IRAS 242352).ResultsCYP contributed 2.3% of YCS reports for patients < 19 years. Patients from age 10 years old have contributed YCS reports, and CYP reports are increasing annually. Reports from CYP contain different suspected medications and reactions compared to YCS for all patients age < 19 years. Common CYP generated reports prioritiseadolescent vaccinations (Human papilloma virus most reported, n=69), oral contraceptives, acne medication, anti-infectives, and antidepressants.Common CYP generated reports identified depression, anxiety and suicidal ideation, which were not amongst common reports about CYP. Amongst CYP (n=50) attending outpatients, the YCS was not known to any CYP. The YCS was known to 16.3% of parents (8/49) interviewed. From this population of patients with a chronic illness, with high rates of drug therapy, 68 suspected ADRs were identified overall.ConclusionCYP contribute to YCS, with distinct patterns of suspected medications and reactions. Awareness of the YCS appears poor, particularly in populations you would expect to have a greater level of knowledge and understanding about medicines.Disclosure(s)Nothing to disclose

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Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

Journal of Clinical Pharmacy and Therapeutics ◽

10.1111/jcpt.13391 ◽

2021 ◽

Author(s):

Maria Antonietta Barbieri ◽

Paola Maria Cutroneo ◽

Chiara Baratelli ◽

Giuseppe Cicala ◽

Alessandro Battaglia ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Spontaneous Reporting ◽

Reporting System ◽

Spontaneous Reporting System ◽

Oral Anticoagulants ◽

Drug Reactions ◽

System Database

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Relative Risk Analysis of Liver-related Adverse Drug Reactions in Children Based on China’s National Spontaneous Reporting System

The Journal of Pediatrics ◽

10.1016/j.jpeds.2021.03.044 ◽

2021 ◽

Author(s):

Yu-ming Guo ◽

Fei-lin Ge ◽

Peng Xiong ◽

Jing Jing ◽

Ming Niu ◽

...

Keyword(s):

Relative Risk ◽

Risk Analysis ◽

Adverse Drug Reactions ◽

Spontaneous Reporting ◽

Reporting System ◽

Spontaneous Reporting System ◽

Drug Reactions

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A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions

Pharmacoepidemiology and Drug Safety ◽

10.1002/pds.668 ◽

2002 ◽

Vol 11 (1) ◽

pp. 3-10 ◽

Cited By ~ 427

Author(s):

Eug�ne P. van Puijenbroek ◽

Andrew Bate ◽

Hubert G. M. Leufkens ◽

Marie Lindquist ◽

Roland Orre ◽

...

Keyword(s):

Signal Detection ◽

Adverse Drug Reactions ◽

Spontaneous Reporting ◽

Drug Reactions ◽

Reporting Systems

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Consumers' reports of suspected adverse drug reactions volunteered to a consumer magazine

British Journal of Clinical Pharmacology ◽

10.1111/j.1365-2125.2009.03584.x ◽

2010 ◽

Vol 69 (3) ◽

pp. 317-318 ◽

Cited By ~ 15

Author(s):

Lise Aagaard ◽

Ebba Holme Hansen

Keyword(s):

Adverse Drug Reactions ◽

Drug Reactions ◽

Consumer Magazine ◽

Suspected Adverse Drug Reactions

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Spectrum of adverse drug reactions and implicated drugs in a tertiary care centre: a prospective study

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20182680 ◽

2018 ◽

Vol 7 (7) ◽

pp. 1345

Author(s):

Kabilan K. ◽

Sathyanarayanan V. ◽

R. Jammuna Rani

Keyword(s):

Prospective Study ◽

Adverse Drug Reactions ◽

Spontaneous Reporting ◽

Causality Assessment ◽

Tertiary Care ◽

Type A ◽

Drug Reactions ◽

Male Predominance ◽

Organ Systems ◽

A Prospective Study

Background: Adverse Drug Reaction(ADR) is the major limitation in providing health care to patients at a global level. It affects patient’s recovery and is an important cause of mortality and morbidity in both hospitalized and ambulatory patients. ADR can occur with any class of drugs. Early detection and evaluation of ADR is essential to reduce harm to the patients. Thus, the present study was aimed to estimate the number of ADR’s reported, analyze its spectrum and the drugs attributed to it.Methods: This was a prospective study conducted in a tertiary care teaching hospital for a period of 3 months from March 2016 to May 2016 in SRM Medical College and Hospital, Potheri. Adverse drug reactions were collected by spontaneous reporting by active and passive methods. The causality assessment of the reported ADR’s was done using Naranjo causality assessment scale.Results: A total of 38 ADR’s were reported during the study period with male predominance (58%). Most of the ADR’s (42%) were common in patients in the age group 19-39 years. More number of ADR’s were from Medicine (29%) followed by Surgery (16%) and OG (16%) departments. Most commonly affected organ systems were skin (45%) followed by GIT (24%). The drugs mostly accounted were antibiotics (55%) especially Cephalosporins (33%). Most of the reactions were type A (68%) rather than type B (32%) and thus predictable. According to Naranjo’s causality assessment, 63% of reactions were probable, 26% were possible and 11% were definite. No reactions were unlikely. Severity assessment by Modified Hartwig and Seigel scale revealed 45% ADRs to be moderate, 42% were mild and 13% were severe and life threatening.Conclusions: The study concluded that Adverse Drug Reactions are common and some of them resulted in increased healthcare cost due to need of some interventions and increased length of hospital stay. As majority of ADR is predictable (Type A), so preventable. The health system should promote the spontaneous reporting of Adverse Drug Reactions (May be done mandatory). The proper documentation and periodic reporting to regional pharmacovigilance centres to ensure drug safety.

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