BACKGROUND: Adverse drug reaction (ADR) monitoring is crucial in ensuring patient and pharmaceutical safety. However, there is a lack of evidence regarding ADR reporting trend pattern in Ghana. This study, therefore, aimed to analyse and characterise trends in ADRs reported in Ghana over 16 years.
METHODS: We retrospectively analysed individual case safety retorts (ICSRs) received by the Ghana National Pharmacovigilance Centre from 2005 to 2021. Jointpoint regression was used to estimate age-adjusted ADR rates, stratified by sex and patient characteristics, suspected medication groups, clinical indications, and the manifestation of ADRs. To evaluate trends over time, the percentage annualised estimator was used.
RESULTS: We identified a total of 6853 ICSRs from 2005 to 2021. The age-adjusted ICSR rates increased significantly from 2005 to 2019, with an annual increase of 18.6%; however, there was a downward trend from 2019 to 2021, although not statistically significant. Males accounted for the majority (64.3%) of ICSRs compared to females (35.7%). The suspected medication group most frequently associated with ADRs were antiprotozoals accounting for 35.6% of all ICSRs, while vascular disorders (21.0%) were the most commonly observed clinical indication in relation to ADRs. An increase in ICSR rates was noted for gastrointestinal disorders with an annual increase of 32.5% (95% CI, 20.6-45.6%; p < 0.001). Amodiaquine was the most commonly suspected medication (8.9%) associated with ADRs, while pruritus (7.2%) was the most frequently reported preferred term.
CONCLUSIONS: The study provides a detailed overview of ICSRs received by the Ghana National Pharmacovigilance Centre over the past 16 years and demonstrates an increasing trend of ADR-related medication use as well as clinical indications over time. The findings of this study call for multifaceted strategies aimed at reducing the risks associated with inappropriate drug use, and enhancing knowledge of medication safety, thus improving healthcare service delivery and patient safety.

UNASSIGNED: From 2009 to 2015, the IMI PROTECT conducted rigorous studies addressing questions about optimal implementation and significance of disproportionality analyses, leading to the development of Good Signal Detection Practices. The ensuing period witnessed the independent exploration of research paths proposed by IMI PROTECT, accumulating valuable experience and insights that have yet to be seamlessly integrated.
UNASSIGNED: This state-of-the-art review integrates IMI PROTECT recommendations with recent acquisitions and evolving challenges. It deals with defining the object of study, disproportionality methods, subgrouping, masking, drug-drug interaction, duplication, expectedness, the debated use of disproportionality results as risk measures, integration with other types of data.
UNASSIGNED: Despite the ongoing skepticism regarding the usefulness of disproportionality analyses and individual case safety reports, their ability to timely detect safety signals regarding rare and unpredictable adverse reactions remains unparalleled. Moreover, recent exploration into their potential for characterizing safety signals revealed valuable insights concerning potential risk factors and the patient\'s perspective. To fully realize their potential beyond hypothesis generation and achieve a comprehensive evidence synthesis with other kinds of data and studies, each with their unique limitations and contributions, we need to investigate methods for more transparently communicating disproportionality results and mapping and addressing pharmacovigilance biases.

The purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics.
Individual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years. vigiRank, a data-driven predictive model for emerging safety signals, was used to prioritise the list of drug events by age groups. The list was manually assessed, and potential signals were identified to undergo in-depth assessment to determine whether a signal should be communicated.
A total of 472 drug-event pairs by paediatric age groups were the subject of an initial manual assessment. Twenty-seven drug events from the two older age groups were classified as potential signals. An in-depth assessment resulted in eight signals, of which one concerned harm in connection with off-label use of dextromethorphan and another with accidental overdose of olanzapine by young children, and the remaining signals referred to potentially new causal associations for atomoxetine (two signals), temozolamide, deferasirox, levetiracetam, and desloratadine that could be relevant also for adults.
Clinically relevant signals were uncovered in VigiBase by using vigiRank applied to paediatric age groups. Further refinement of the methodology is needed to identify signals in reports with ages under 2 years and to capture signals specific to the paediatric population as a risk group.

The history of drug safety monitoring, or pharmacovigilance, has been an interesting one. Despite many and ongoing changes, it has typically been characterized by a rather slow-moving and reactive progression. Pharmacovigilance has always lagged behind other fields and industries and has been slow to adapt to new approaches. The main aspect holding it back has been a focus on the administrative and adherence side of creating individual case safety reports (ICSRs) and distributing these reports to the various stakeholders per strict regulatory requirements. Now, in 2018, we are more behind the curve than ever, and the field seems to be at a breaking point, calling for urgent and drastic changes. The question at hand is whether in this era of an abundance of electronically available data and technological advancements, which allow the application of automation, this process still makes sense. Is there still a place for creating and redistributing ICSRs from marketed use in a current, state-of-the-art safety system? Artificial intelligence, deep machine learning, and related technologies are already in place in many other industries. Swift and rigorous change is necessary for the discipline of pharmacovigilance to keep up with what is happening in the world at large.

BACKGROUND: India is a developing country and adverse drug reactions (ADRs) influence most of the diseases in our population, and monitoring is required due to the paucity of ADRs. The present study was done to analyze the ADRs at the ADR monitoring center (AMC) of tertiary care hospital in Raipur during 1 year.
METHODS: Study of ADR monitoring of outpatient and inpatient was a prospective and observational study carried out between September 2015 and August 2016. The ADRs in the form of Individual Case Safety Report (ICSR) was sent to the Indian database (Vigiflow®).
RESULTS: Total ICSRs reported to Vigiflow® were 232 during 1 year. Among them, 63.79% were found to be nonserious and 36.21% were serious. Nearly 45% of ADRs were implicated only due to antimicrobials, which is highest among all other groups of drugs. A maximum number of ADRs were observed in 31-60 years of age group (52.15%). In causality assessment, the probable cases had a higher incidence (67.24%), followed by possible (27.58%) and certain (4.74%). The frequency of ADR reporting at our AMC was low (0.043%) compared to national average. Our AMC shared 0.35% of total ICSRs, which is insignificant (P < 0.001) compared to the JSS, Mysore and PGIMER, Chandigarh, AMCs, which have shared most of the ICSRs in Vigiflow®.
CONCLUSIONS: The frequencies of ADRs reporting in our study are less compared to those reported with other similar studies. Underreporting is a very serious concern in Raipur, and Pharmacovigilance Programme of India must intercede to pick up ADRs across the country.

OBJECTIVE: To develop a method for data-driven exploration in pharmacovigilance and illustrate its use by identifying the key features of individual case safety reports related to medication errors.
METHODS: We propose vigiPoint, a method that contrasts the relative frequency of covariate values in a data subset of interest to those within one or more comparators, utilizing odds ratios with adaptive statistical shrinkage. Nested analyses identify higher order patterns, and permutation analysis is employed to protect against chance findings. For illustration, a total of 164 000 adverse event reports related to medication errors were characterized and contrasted to the other 7 833 000 reports in VigiBase, the WHO global database of individual case safety reports, as of May 2013. The initial scope included 2000 features, such as patient age groups, reporter qualifications, and countries of origin.
RESULTS: vigiPoint highlighted 109 key features of medication error reports. The most prominent were that the vast majority of medication error reports were from the United States (89% compared with 49% for other reports in VigiBase); that the majority of reports were sent by consumers (53% vs 17% for other reports); that pharmacists (12% vs 5.3%) and lawyers (2.9% vs 1.5%) were overrepresented; and that there were more medication error reports than expected for patients aged 2-11 years (10% vs 5.7%), particularly in Germany (16%).
CONCLUSIONS: vigiPoint effectively identified key features of medication error reports in VigiBase. More generally, it reduces lead times for analysis and ensures reproducibility and transparency. An important next step is to evaluate its use in other data.

OBJECTIVE: To study the case series for intussusception associated with the vaccination of rotavirus vaccine in children.
METHODS: The study of spontaneous adverse event monitoring such as intussusception due to rotavirus vaccine was carried out from the year 2011 through 2015. The individual case safety reports (ICSRs) of this event were collated, assessed and recorded as per the requirement of Suspected Adverse Drug Reactions Reporting form of Pharmacovigilance Programme of India (PvPI).
RESULTS: In the present study, 10 ICSRs of intussussception due to rotavirus vaccine were reported to PvPI. Of which 3 ICSRs were found to be causal relationship with rotavirus vaccine, as evidenced by the adequate information provided in ICSRs.
CONCLUSIONS: Since intussusception, the emerging safety as one of the important safety concern, healthcare professionals are advised to monitor and report to the concerned authority for appropriate action.

The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.

OBJECTIVE: To explore whether and how longitudinal medical records could be used as a source of reference in the early phases of signal detection and analysis of novel adverse drug reactions (ADRs) in a global pharmacovigilance database.
METHODS: Drug and ADR combinations from the routine signal detection process of VigiBase® in 2011 were matched to combinations in The Health Improvement Network (THIN). The number and type of drugs and ADRs from the data sets were investigated. For unlabelled combinations, graphical display of longitudinal event patterns (chronographs) in THIN was inspected to determine if the pattern supported the VigiBase combination.
RESULTS: Of 458 combinations in the VigiBase data set, 190 matched to corresponding combinations in THIN (after excluding drugs with less than 100 prescriptions in THIN). Eighteen percent of the VigiBase and 9% of the matched THIN combinations referred to new drugs reported with serious reactions. Of the 112 unlabelled combinations matched to THIN, 52 chronographs were inconclusive mainly because of lack of data; 34 lacked any outstanding pattern around the time of prescription; 24 had an elevation of events in the pre-prescription period, hence weakened the suspicion of a drug relationship; two had an elevated pattern of events exclusively in the post-prescription period that, after review of individual patient histories, did not support an association.
CONCLUSIONS: Longitudinal medical records were useful in understanding the clinical context around a drug and suspected ADR combination and the probability of a causal relationship. A drawback was the paucity of data for newly marketed drugs with serious reactions.