The evaluation of the post-marketing safety profile of drugs is a continuous monitoring process for approved and marketed medicines and it is crucial for detecting new adverse drug reactions. As such, real-world studies are essential to complement pre-marketing evidence with information concerning drug risk-benefit profile and use in wider patient populations and they have a great potential to support post-marketing drug safety evaluations. A detailed description of the main limitations of real-world data sources (i.e. claims databases, electronic healthcare records, drug/disease registers and spontaneous reporting system databases) and of the main methodological challenges of real-world studies in generating real-world evidence is provided. Real-world evidence biases can be ascribed to both the methodological approach and the specific limitations of the different real-world data sources used to carry out the study. As such, it is crucial to characterize the quality of real-world data, by establishing guidelines and best practices for the assessment of data fitness for purpose. On the other hand, it is important that real-world studies are conducted using a rigorous methodology, aimed at minimizing the risk of bias.

Globally, pharmacovigilance (PV) is crucial for the patient’s safety and proper use of drugs. Spontaneous reporting of adverse drug reaction (ADR) is a professional obligation of every healthcare p...

Drug safety in paediatric patients is a serious public health concern around the world. The paediatric patients are more prone to adverse drug reactions (ADRs) than adults. Moreover, there is a scarcity of information about ADRs in paediatric patients. This study was conducted to determine the frequency, causality, severity, preventability of paediatric patients’ ADRs reported in a tertiary care hospital in Adana, Turkey. A retrospective study was conducted on all spontaneously reported ADRs between January 01, 2020, to July 30, 2021, in paediatric patients. The ADRs reports were evaluated in terms of gender, age, ADR characteristics, suspected drugs and reporting source. All included ADRs reports were characterized according to the Naranjo Algorithm/World Health Organization (WHO) causality scales, Hartwig/Siegel and Common Terminology Criteria for Adverse Events (CTCAE) severity scales, the modified Schoumock and Thornton preventability scale and hospital pharmacovigilance center criteria for seriousness. Therapeutic groups were also coded using the WHO-Anatomical Therapeutic and Chemical (ATC) classification. During the study period, 8,912 paediatric patients who were admitted had 16 ADRs with 1.7 ADRs/1,000 admissions. The majority of ADRs were found in infants (31.2%) and children (56.2%) as compared to adolescents (12.5%). ADRs were observed more in females (81.2%) than males. Skin (62.5%) was the most affected organ due to the ADRs, and maculopapular rash and erythema multiforme were the most commonly reported symptoms. Most ADRs were probable/likely (93.7%), severe (50%), preventable or probably preventable (43.7%) and serious (37.5%). Antibiotics (93.7%) were found to be the most common cause of ADRs in paediatric patients. The majority of ADRs were associated with vancomycin (68.7%). Most of the ADRs were reported by a medical doctor in this study. This small sample size study highlights significant problems of ADRs in paediatric patients, mainly caused by antibiotics and with a majority of ADRs manifest as skin reactions. Furthermore, a high proportion of the identified ADRs were found to be preventable. More focused efforts are needed at the national level to avoid preventable ADRs in hospitals. Monitoring and management of ADRs and future studies would be beneficial for better patient care and safety.

Background: Pharmacovigilance is an identifying and responding process against an adverse drug reaction (ADRs) problem encountered in the drug administration. ADRs are among the common reasons for morbidity and fatality in pediatrics throughout the globe.Main body: A systemic review of the previous 10 years (2010–2019) published studies were taken into consideration to describe observational studies on ADRs and to determine the incidence and characteristics of ADRs in pediatrics. Electronic relevant literature was searched in PMC, PubMed, Google Scholar, and OvidSP databases using MESH heading and text words. The titles, text, and abstracts were checked for patients below 18 years of age, nature of ADRs, observational studies (prospective or retrospective), and maximum information was recorded to count their frequency. The studies which discussed specific or particular drug exposures were not selected in this review. Of the 36,689 titles retrieved, 27 studies were selected for full-text review. Ten observational studies were added in the final review. Observational studies on pediatric were carried out in seven distinct nations. The predominant study design within observational methodological studies was prospective (n= 5, 50%). The overall average occurrence of ADRs incidence was 9.52%. ADRs reporting in male patients (54.6%) were more than females (45.4%). The severe types of ADRs were reported in four studies. Anti-microbials were the most common class of drugs related to ADRs.Conclusion: This systematic review reveals that ADRs in pediatrics are serious public health problems. Periodic drug surveillance studies are mandatory for the safe and appropriate usage of medicines in pediatrics.

OBJECTIVE: This study evaluates the self-practices with conventional and herbal drug use among ear, nose, and throat outpatients.METHODS: A cross-sectional survey-based study was carried out among all ear, nose, and throat outpatients on their first visit to the otorhinolaryngology department at a tertiary care hospital. The survey comprised a total of 14 questions with 4 different sections, including demographic characteristics, self-medication of conventional medicines, herbal medication usage, and perception regarding herbal medicines.RESULTS: Overall, 255 questionnaires were distributed among patients, of which 183 completed the questionnaire (response rate=71.7%). Respondents reported self-medication (44.8%) with conventional drugs before visiting a hospital. The most commonly used medicine was analgesics (31.7%) and antibiotics (21.9%). Nearly half of the patients (49.2%) used at least one herbal drug. The most commonly used herbal medications were Tilia cordata (78.8%), Zingiber officinale (62.2%), and Camellia sinensis (45.5%). According to the International Union for Conservation of Nature Red List, most of the medicinal herbs were considered as data deficient/least concern. About 36.6% of the participants perceived that herbal drugs are effective for ear, nose, and throat problems. Moreover, 22.9% of the patients did not know about herbal-drug interaction with other medications.CONCLUSIONS: This study observed a considerable prevalence of self-based practices with conventional and herbal medications. Strict national regulations on conventional and herbal medication access and long-term actions should be implemented to discourage inappropriate drug use.