ISSN 2321–3647
Sat, 23 Sep 2017

Users’ Profile of the Adverse Drug Reaction Reporting System in Brazil: A Pilot Study

Carolina Baraldi A. Restini1*, Cleber Massato Toda 2, Jessica Natalia Andre2

1. Full professor and Researcher at the Master Program in Health and Education. Full professor, tutor and researcher at the Medical School. University of Ribeirao Preto UNAERP, Brazil.

2. Master Students Master Program in Health and Education. University of Ribeirao Preto UNAERP, Brazil.


ABSTRACT

To investigate the profile of potential users of the Brazilian Adverse Drug Reaction Reporting System that take care of the pharmaceutical product information, concerning to the their knowledge of its regulatory authorities safety and effective use of drugs. This was an observational cross-sectional study with descriptive and analytical characteristics. Four hundred and fourteen people were surveyed in 2013 from May to August, and after gathering the data. A high percentage of lack of knowledge about the Brazilian Drugs Reporting System was observed regarding consumers with 95.37% (n = 309) (95% CI: 93.08- 97.66) and professionals who deal with medications and drugs with 68.89% (n = 62) (95% CI: 59.32- 78.45). Considering the population who knows about the System, only a few number of notifications were observed, consumers with 0.93 % (n = 3) (95% CI: 0.12 - 1.97) and health professionals with 8.89 % (n = 8) (95% CI: 3.01-14.77). Three Adverse Drugs Reactions cases were observed: Steven Johnson disease (due to phenobarbital use), drug-induced diabetes (betamethasone), and partial loss of voice (chloramphenicol). None of them were reported to the System. The results obtained indicate an elevated percentage of lack of knowledge and underutilization of the Brazilian Adverse Drug Reaction Reporting System. Therefore, it is necessary for educational interventions to be adopted in order to increase notifications.

Keywords: Rational Use of Medicines (RUM), Adverse Drug Reaction Reporting System (ADRRS / NOTIVISA), Adverse Drugs Reactions (ADR), Unified Health System (UHS / SUS), National Healthy Surveillance System (NHSS / ANVISA), Pharmacovigilance.


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