Pharmacovigilance is an identifying and responding process against a problem encountered in the drug administration [1]. The advancement of drugs in the previous decades has brought surprising benefits for the patients, concurrently the incidence of adverse drug reactions (ADRs) has also increased notably [2]. World Health Organization (WHO) describes ADR as “a response to a drug which is harmful, unintended and occurs at normal doses used for the treatment, diagnosis, and prophylaxis of a disease” [3]. ADRs are among the common reasons for morbidity and fatality throughout the globe [4]. Ultimately, these issues have a major impact on public health due to imposing a significant economic load on society and already stretched healthcare systems [5].
The safety of medicines in pediatrics is a global issue and proper knowledge about pharmacovigilance and spontaneous reporting of ADRs is the most essential measure to boost the safe use of therapeutic agents [6, 7]. The very early case of a safety issue that drives to a pharmacovigilance reflection, published in 1877 in the British Medical Journal, was the chloroform issues. In 1898, the commercialization of diacetylmorphine was the second issue that occurred, latterly called heroin, which started to be addictive at the start of the 1910s (Only in the USA, almost 0.5 million dependent patients were reported) [8]. Amid the 1960s, numerous babies were born with agenesis of the limbs and phocomelia as an adverse effect of thalidomide. In 1957, Thalidomide was launched into the market as a safe over-the-counter hypnotic/sedative drug; latterly, it was used to control nausea in pregnant women. This was afterward confirmed in the same year that thalidomide usage was responsible for 20% of the increase in phocomelia and agenesis of the limb’s defects [7].
In reply to the thalidomide tragedy, in 1968, the WHO earlier built up its plan for International Drug Monitoring. Later on, a WHO collaborating center in 1978 named “Uppsala Monitoring Centre (UMC)” was designed to support the specified program [7]. Worldwide, pharmacovigilance studies are the basic demand of the time for an invariable audit of unwanted effects in community and hospitals. Healthcare professionals, i.e., physicians, pharmacists, nurses, and other paramedical staff are all guided about the reporting ADRs, which consequently leads to high medicine safety for the population [6, 9,10,11].
Obtaining, ordering, reproducing, checking, handling, distributing, and managing are the medication stages manner, and mistakes/errors in pediatric medicine may occur at any stage [6, 7]. Medication errors are any preventable action that may injure the patient [9]. Pediatric populations are at greater risk than adults for medication errors as they have immature physiology and developmental disabilities that impair their ability to communicate and self-administer medications. Studies reported that medication errors in pediatrics were 3 times higher than in adult populations. Pediatrics poses a complex and unique set of risks, mainly due to the large differences in body mass, which require doses to be measured individually based on patient age, weight or body surface area, and clinical condition [7, 8]. Such variations raise the probability of errors, particularly dosing mistakes. Additionally, drug formulations are frequently extemporarily formulated to meet the requirement for low doses in such patients, and there is a lake of information on pediatric doses and indications [7]. The possible types of medication errors in pediatric populations are wrong drug, wrong route of administration, an error of use, incorrect or out-of-time, incorrect frequency, incorrect dosage, incorrect case, drug interfaces, intravenous conflict, ignoring mistakes, and incorrect rate of intravenous drug administration [2, 3, 5, 7]. Medication error ultimately leads to an acute to severe ADRs [2, 7, 12].
Previous studies have revealed that almost 5% of all hospital admissions are as a result of ADRs, and that 5% of hospital-admitted children will face an ADR within their stay in hospital and 5% of all acute hospitalizations originated from ADRs [7, 12,13,14]. Children are more prone to ADRs as they rarely express their own drug therapy experiences [15]. Therefore, medications in children have a high risk of developing different types of ADRs [16]. When compared to adults, children can have somewhat more severe side effects. Hence, ADRs can be a major reason for morbidity and mortality in children [17]. Furthermore, very low attentiveness has been given to ADRs in newborns, toddlers, children, and teenagers [18, 19]. Therefore, the basic purpose of the current study was to perform a systematic review of observational studies on ADRs in hospitalized children during the previous decade and to determine the frequency and characteristics of ADRs.
