Abstract
Pharmacovigilance, which is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems, generates knowledge to facilitate the rational use of medicines. When a medicine is first marketed, there is limited information on adverse drug reactions (ADRs), especially in paediatrics, where medicines are less likely to have been extensively studied. Knowledge in drug safety is built up over time when more (in number, and more heterogeneous) patients are treated than were studied in the randomised controlled trials preceding the marketing of a medicine. Previously not recognised ADRs are often initially described in case reports and case series. Prospective cohort studies are useful in determining the incidence and risk factors of common ADRs. Case series and pharmacovigilance reporting systems have been useful in identifying previously unknown uncommon ADRs and risk factors for specific ADRs. This brief review provides examples that illustrate how various study designs and data sources contribute to the evolving knowledge of ADRs that is essential to help develop guidelines and improve the rational use of medicines.
Highlights
adverse drug reactions (ADRs) can be induced by drug–drug interactions, misuse, medication errors, or be associated with risk factors such as genetic susceptibility, age, gender or pre-existing medical history
Before a medicine is considered safe and effective, it has been tested on animals and patients in randomized clinical trials (RCTs)
Prospective cohort studies are useful for providing information on the incidence and risk factors of common ADRs [2,9,10]
Summary
Prospective cohort studies are useful for providing information on the incidence and risk factors of common ADRs [2,9,10] This is because a group of patients are followed over time and, thereby, the denominator is known, which allows one to calculate the incidence. The knowledge compiled from these different sources is used to guide healthcare professionals and patients in their efforts to mitigate risks from medication use The aims of this brief review are to illustrate different methods of studying drug safety and to explore how they have been applied to enhance safe prescribing in paediatric patients. This paper is not a comprehensive review of drug safety in children, but rather focuses on examples of ADRs that illustrate the route from suspicion of the ADR to recognition by clinicians, and on how various study designs and data sources contribute with increasing knowledge
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