Spontaneous reporting of adverse drug reactions in an Italian region: Six years of analysis and observations

Pharmacovigilance started in Italy in 1965, and from 1987 reporting of ADRs has been mandatory. Doctors have to send the filled forms on suspected ADRs to the Local Health Districts which transmit biannually all the reports to the Health Department. In a Northern Italian Region (Veneto) spontaneous reporting of adverse drug reactions (ADRs) has been studied during the period 1988–1993. This Region contributes a substantial percentage of the total Italian reports. The total number of reports was 3700, most of these (54 per cent) coming from GPs. A great variability in the reporting rate among the 36 districts of Veneto Region (range: 0–8.8 per 10,000 inhabitants per year) and an important under-reporting have been evident. Underreporting is also emphasized by the fact that in 1993 the Veneto doctors who sent at least one report were only 2.7 per cent. On the whole about 35 per cent of reports concerned minor reactions caused by drugs which have a well known toxicological profile. Comparison between reports coming from Veneto and the UK in some cases show a similar safety profile (omeprazole and simvastatin), whereas in other cases (e.g. terfenadine, glafenine, fluoxetine) no correspondence can be found. This article reveals the limits of the actual spontaneous reporting in Italy and suggests some possible measures for improving it.     

Data mining for signals in spontaneous reporting databases: proceed with caution

PURPOSE: To provide commentary and points of caution to consider before incorporating data mining as a routine component of any Pharmacovigilance program, and to stimulate further research aimed at better defining the predictive value of these new tools as well as their incremental value as an adjunct to traditional methods of post-marketing surveillance. METHODS/RESULTS: Commentary includes review of current data mining methodologies employed and their limitations, caveats to consider in the use of spontaneous reporting databases and caution against over-confidence in the results of data mining. CONCLUSIONS: Future research should focus on more clearly delineating the limitations of the various quantitative approaches as well as the incremental value that they bring to traditional methods of pharmacovigilance.     

Ranking Adverse Drug Reactions With Crowdsourcing

BackgroundThere is no publicly available resource that provides the relative severity of adverse drug reactions (ADRs). Such a resource would be useful for several applications, including assessment of the risks and benefits of drugs and improvement of patient-centered care. It could also be used to triage predictions of drug adverse events.ObjectiveThe intent of the study was to rank ADRs according to severity.MethodsWe used Internet-based crowdsourcing to rank ADRs according to severity. We assigned 126,512 pairwise comparisons of ADRs to 2589 Amazon Mechanical Turk workers and used these comparisons to rank order 2929 ADRs.ResultsThere is good correlation (rho=.53) between the mortality rates associated with ADRs and their rank. Our ranking highlights severe drug-ADR predictions, such as cardiovascular ADRs for raloxifene and celecoxib. It also triages genes associated with severe ADRs such as epidermal growth-factor receptor (EGFR), associated with glioblastoma multiforme, and SCN1A, associated with epilepsy.ConclusionsADR ranking lays a first stepping stone in personalized drug risk assessment. Ranking of ADRs using crowdsourcing may have useful clinical and financial implications, and should be further investigated in the context of health care decision making.     

Impact of knowledge,attitude and preceptor behaviour in pharmacovigilance education

This study aimed to determine the level of pharmacovigilance (PV) education in pharmacy programmes and to evaluate the predictive factors for the intent to report adverse drug reactions (ADRs) by pharmacy students in South Korea. Self‐administered questionnaires were collected from a regionally stratified nationwide convenience sample of pharmacy students in September 2017. The association between students' intent to report ADRs and their knowledge and attitude was evaluated by using multivariate logistic regression analysis. In total, 303 pharmacy students participated in the survey; the average age of students was 26.7 (standard deviation 2.9) years and 40.6% were males. Eighty‐eight students (29%) marked the degree of their intent as “strongly high.” Increased knowledge of ADR reporting methods and positive attitude towards the need for ADR reporting were significant predictors of the intent to report ADRs. Further, witnessing reporting by the preceptor (adjusted odds ratio, 2.37; 95% confidence interval, 1.26‐4.46; P < 0.01) was significantly correlated with the knowledge on and attitude towards ADR reporting of pharmacy students. The findings of our study indicated the need for improvements in PV curriculum, such as educational content focused on ADR reporting methods and demonstration of a preceptor's reporting in pharmacy practice experiential rotation, within Korean college of pharmacy curriculum.     

Bisphosphonate-related osteonecrosis of the jaw in four Nordic countries and an indication of under-reporting

Abstract

Objective. To assess reported cases of bisphosphonate-related osteonecrosis of the jaw (BONJ) to Medicines Agencies (MAs) in four Nordic countries and to compare the Norwegian MA data with BONJ cases retrieved through an e-mail survey to Oral and Maxillofacial Surgeons (OMS) in Norway. Material and methods. BONJ cases reported to the national MAs in each country from January 1st 2003 to September 30th 2010 were collected. An e-mail survey was sent to all active members of the Norwegian Association of Oral and Maxillofacial Surgeons (n = 54) included questions on total BONJ cases seen in practice and route of drug administration during January 1st 2003 to December 31st 2009. Results. In total, 253 BONJ cases were reported to the MAs; 39 in Denmark, 44 in Finland, 51 in Norway and 119 in Sweden. These figures result in cumulative incidences (multiplied by 100,000) of 0.7, 0.8, 1.1 and 1.3, respectively. Intravenous administration was reported in 169 of the cases. The e-mail survey resulted in 35 responses reporting 214 BONJ cases, 4-times more cases than reported to the MA. Conclusions. Cumulative incidence of cases reported in this study differs to some degree in the four Nordic countries (Denmark < Finland < Norway < Sweden). In Norway, almost the same number of BONJ cases were reported through the questionnaire by OMS as in all four countries together (214 by OMSs vs 254 to MAs) and included a high number after per oral administration. The present results indicate a notable under-reporting in Norway and most likely in other Nordic countries.