Abstract
Pharmacovigilance is a tool proposed during the post-marketing process of the pharmaceutical product lifecycle to monitor drug safety in everyday life and to identify adverse drug reactions. The identification of adverse reactions, however, is a significant cause of concern and a challenge to pharmacovigilance structures. Regulators use three basic principles in determining the risk-benefit balance to decide whether to approve a drug or a biological product and to maintain it on the market: safety, quality and effectiveness. In particular, paediatric patients, especially new-borns and infants, are at risk of drug-related adverse reactions. Drugs are also prescribed in an unlicensed and/or off-label manner to new-borns, infants and teenagers, leading paediatric patients to a higher risk of experiencing adverse drug reactions (ADRs). ADRs in children < 2 years of age are often reported and can often be alarming. The practise of paediatric pharmacovigilance needs to be strengthened by stimulating spontaneous paediatric reporting and successful post-marketing surveillance. The current study highlights the importance of paediatric pharmacovigilance and the role of different stakeholders like healthcare providers, regulators, and consumers in increasing the ADR reporting rate. Also, it discusses the pharmacovigilance tools and various initiatives that are taken by various regulatory authorities like the United States, the United Kingdom, Japan, and India.
Highlights
It is of vital importance to track the safe use of medicines in children because, during the clinical development of medicines, only limited data on this aspect is provided through clinical trials
It is of particular interest to provide information on the frequency, severity and types of medications most commonly involved in adverse drug reactions (ADRs) in the paediatric age group, as pre-marketing clinical trials are often performed in adults
Periodic Safety Update Reports (PSURs) for actives/combinations not currently specified in the EURD (European Union Reference Dates) and not subject to the Single Assessment Process should be sent to the Medicines and Healthcare products Regulatory Agency (MHRA) at least six months after marketing during the first two years, once a year for the two years and every three years thereafter
Summary
It is of vital importance to track the safe use of medicines in children because, during the clinical development of medicines, only limited data on this aspect is provided through clinical trials. A wide variety of different physiologies are found in the paediatric population, representing the extremely varied duration from the fatal and embryonic stages, through birth and infancy, through puberty and adolescence This makes children very susceptible to ADRs [ 1]. It is of particular interest to provide information on the frequency, severity and types of medications most commonly involved in ADRs in the paediatric age group, as pre-marketing clinical trials are often performed in adults. They represent a reported 9.5 percent of occurrences, including 2.1 percent of hospital admissions, with. One potential categorization is the following [8]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
