Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark

Aagaard, Lise; Stenver, Doris I.; Hansen, Ebba Holme

doi:10.1007/s11096-008-9210-y

Cited by 21 publications

(24 citation statements)

References 11 publications

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“…The reporting of ADRs has been obligatory in Denmark since 1 May 1968 [25]. Initially, only physicians were covered by the obligation; however, in 1972, dentists were also required to report ADRs.…”

Section: Settingmentioning

confidence: 99%

“…Initially, only physicians were covered by the obligation; however, in 1972, dentists were also required to report ADRs. Since 1995, drug manufacturers have been obliged to keep registers of suspected and demonstrated ADRs and to make these available to the authorities [25]. Since July 2003, consumers have been able to report ADRs directly to the authorities.…”

Section: Settingmentioning

confidence: 99%

“…Since July 2003, consumers have been able to report ADRs directly to the authorities. The Danish reporting system has been described in details elsewhere [25]. The Danish ADR system contains all spontaneous reports in Denmark, including those reported directly to the pharmaceutical companies.…”

Section: Settingmentioning

confidence: 99%

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Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions

Aagaard

Hansen

2011

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Off‐label use of medicine in children is common, as few medications are licensed for use in this population.• There is concern about off‐label use of medicines in children due to lack of knowledge about safety beyond the indication area described in the official product information documented in the licensing material.WHAT THIS STUDY ADDS• One‐fifth of all ADRs reported over a decade in Danish children were associated with off‐label prescribing of medicines.• Serious ADRs from off‐label prescribing primarily appeared in therapeutic groups: allergens, dermatologicals and sex hormones.• Until more clinical studies are conducted in children, prescribers and carers must be aware of the risk of potentially serious ADRs from off‐label prescribing, and the safety of off‐label prescribing in the paediatric population should be closely monitored.AIM To identify adverse drug reactions (ADRs) associated with off‐label prescribing of medicines in a paediatric population.METHODS We analysed spontaneous ADR reports for children from ages 0 to 17 years submitted to the Danish national ADR database from 1998 to 2007. We defined off‐label prescribing as prescriptions outside the licensed age group. Off‐label ADRs were categorized by therapeutic group, age of child, type and severity. The unit of analysis was one ADR.RESULTS We analysed 4388 ADRs for children reported in the national database. Approximately 17% of reported ADRs were associated with off‐label use, 60% of them serious. More than one half of off‐label ADRs were reported in adolescents. Serious ADRs due to off‐label prescribing are more likely to be reported for hormonal contraceptives (ATC group G), anti‐acne preparations (ATC group D) and allergens (ATC group V).CONCLUSION One‐fifth of all ADRs reported over a decade in Danish children was associated with off‐label prescribing, and serious ADRs due to off‐label prescribing were primarily present in three therapeutic groups: sex hormones, dermatologicals and allergens. There is a need for more research into the prescribing of these medicines in the teenage population, as well as tighter reporting and monitoring of ADRs for medicines prescribed off‐label in the paediatric population.

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Section: Settingmentioning

confidence: 99%

Section: Settingmentioning

confidence: 99%

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Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions

Aagaard

Hansen

2011

Brit J Clinical Pharma

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“…3,4 Annual reporting rates of between 300-500 reports per 1,000,000 population had been reported in Australia, Denmark, France, Ireland, Sweden and UK. 5,6 Although reporting rates of adverse drug reactions by healthcare professionals had not been studied in Ghana, studies in Nigeria had reporting rates of between 2% to 32%. 7,9 This is less than reporting rates of 47% to 77% identified by Belton, et al 1997 in some European countries with well-established spontaneous reporting systems.…”

Section: Introductionmentioning

confidence: 99%

Adverse drug reaction reporting by doctors in a developing country: A case study from Ghana

Sabblah¹,

Akweongo

Darko³

et al. 2015

Ghana Medical Journal

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“…At the same time, spontaneous systems for the reporting of adverse drug reactions (ADRs) were established in some well developed countries. The major purposes of these systems are to detect unknown or poorly understood adverse effects of medicines [2,3].…”

Section: Introductionmentioning

confidence: 99%

Prevalence and Extent of Adverse Drug Reactions in Sudanese Patients in Highly Active Anti-retroviral Therapy Regimens

Elnagar¹

2017

IJP

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Structures and processes in spontaneous ADR reporting systems: a comparative study of Australia and Denmark

Cited by 21 publications

References 11 publications

Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions

Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions

Adverse drug reaction reporting by doctors in a developing country: A case study from Ghana

Prevalence and Extent of Adverse Drug Reactions in Sudanese Patients in Highly Active Anti-retroviral Therapy Regimens

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