Introduction:

Pharmacovigilance and patient safety programs have in common the monitoring of drugs, but despite sharing epidemiological method, language and legislation, there does not seem to be a clear relationship between them.

Objectives:

Characterize and analyze the reports sent to the institutional patient safety program.

Materials and methods:

Observational descriptive cross-sectional study of the reports database from an institutional patient safety program during 2016. Medication errors were classified according to the document WHO 2009. Adverse Drugs Reactions (ADR) were classified according to Uppsala Monitoring Center.

Results:

From the patient safety program it was detected that the omission of drugs or doses was the most frequent error (42.8%) followed by ADRs (20.9%). Harmful incidents were the most frequent (61.2%) followed by no harm incidents (38.8%). From the pharmacovigilance program 41 ADR and 15 therapeutic failures were identified, in which Phlebitis was the most frequently reported (23, 7%) followed by hypersensitivity reactions (18.4%) and excessive neuromuscular blockade (13.1%).

Conclusions:

A very important amount of incidents is not considered by any of the two programs, losing a valuable risk management opportunity. The program did not identify a clear distinction between harmful incident and ADR.