Evaluation of Completeness of Suspected Adverse Drug Reaction Reports Submitted to the Mexican National Pharmacovigilance Centre

Abstract

The completeness of the information provided in the suspected ADR reports submitted during the sample study years was incomplete and, in general, did not fulfil the requirements established by the NOM guidelines. Among the pharmaceutical industry, CEFV and CIFV, the suspected ADR reports were mainly provided by the pharmaceutical industry. It is necessary to improve the pharmacovigilance system in Mexico to achieve a high level of completeness of suspected ADR reports that totally fulfil the standing regulations.

Adverse reactions to fluoroquinolones in the Nigerian population: an audit of reports submitted to the National Pharmacovigilance Centre from 2004 to 2016

“…Our findings are in keeping with the previous studies reporting incompleteness of ADR forms submitted to pharmacovigilance centers in Mexico (Sánchez‐Sánchez et al. ) and Saudi Arabia (Alshammari et al. ), and those submitted to a pharmaceutical company in Italy (Impicciatore and Mucci ).…”

Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria

“…Of the 935 reported ADRs from January to June, only 509 had reported outcomes and 66.8% of the reported ADRs resolved. These findings are consistent with the previous studies reporting incompleteness of ADR forms submitted to pharmacovigilance centers in Mexico and Saudi Arabia, and those submitted to a pharmaceutical company in Italy . Incomplete ADR information may limit the effectiveness and full potential of analysis of reports.…”

Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal

“…So, our results did not show any site‐specific issue nor did they show any type of CT issue as we used data from different types of CT. Moreover, this issue of completeness or accuracy in SAE case reports has been identified as an important factor hampering the usefulness of SAE case reports not only in CT but also in post‐marketing pharmacovigilance . Direct comparison between our results and other published data is not easy because criteria used are different, nethertheless; results go in the same way.…”

“…In 2012, in the same database, only one report in eight (13.0%) provided well‐documented reports . In the Mexican Pharmacovigilance database (post‐marketing database), only 44.5% of AE case reports were considered as complete according to Mexican Official Norms criteria . Concerning CT databases, completeness of AE description is 2.4‐fold greater for CRFs with information from clinical records than for the corresponding forms from Institutional Review Boards (IRB) (95.0% vs 40.3%, p < 0.05) .…”

“…Although SAE case reports are the main way of monitoring safety in CTs, there is little information available about their quality . On the contrary, in post‐marketing pharmacovigilance, lack of quality of AE case reports is a known problem …”