Rafaella’s Literature Update
Dear Friends,
Regulatory agencies are responsible for collecting and evaluating spontaneous reports of suspected problems related to medications, including those from substandard medicines (SM). As the first mailing of 2022, I am sharing the attached article (Fedalto et al. Reports of substandard medicines: a lexicographic analysis of the Brazilian Health Surveillance Report System. Rev Ciênc Farm Básica Apl. 2021;42:e753) that reports on an evaluation of the profile of SM reports submitted to the Brazilian Health Surveillance Notification System (Notivisa) from 1 January 2007 to 31 December 2017.
The authors used a new approach for classification, by means of lexicographic analysis- that is “an innovative and broad approach to content analysis” that “allows insightful look at the studied variables”. The detailed methodology (p. 2-4) can be of interest to researchers and regulators in our group, as “this classification could guide the standardization of SM reporting and contribute to improving surveillance reporting systems worldwide”.
The overall results will be of interest to almost all of us. In short, the 61,775 SM reports in the database, have been classified into five classes:
– Class 1, representing 16.0% of all reports, corresponds to ‘Packaging problems’; in the lexicographic analysis it contains terms such as ‘leakage’ and ‘difficulty opening’.
– Class 2 (21.7%) corresponds to inappropriate ‘Identification and content’, being represented by terms such as ‘illegible information’
– Class 3 (10.9%) refers to ‘Contamination and stability issues, containing terms such as ‘presence of particles’
– Class 5 (22.9%) refers to ‘Damaged tablets/blisters’
– (Class 4 corresponded to adverse event reports that were probably misclassified as SM, but correctly identified by the lexicographic analyses).
Problems were most commonly reported with sodium chloride (9.3%), glucose (3.2%) and dipyrone (1.9%). The main reasons for SM reporting included packaging problems, inadequate drug identification and content, stability, contamination, and damaged tablets/blisters. Interestingly, almost half of the reports were submitted by hospitals, clinics, and other medical care centres, most likely thanks to the pharmacovigilance role played in the national healthcare system by sentinel hospitals. This vigilance model may also contribute to explaining why the volume of reports is higher than in other countries.
Have a nice reading….and a nice start to the new year!
Raffaella