Unspecified adverse effect of drug or medicament
Conditions
Interventions
A pharmacoepidemiological (observational) study is being conducted with retrospective (stage 1) and prospective (stage 2) analysis by consulting electronic medical records in a secondary hospital in t
(ii) screening of triggers in electronic medical records
(iii) collection of data from electronic medical records of eligible older people
(iv) conducting the pharmacotherapy review and determining the degree of causality
(v) identification of health interventions associated with adverse drug events (i.e., causality analysis with a defined, possible or probable outcome) to estimate direct medical costs. The screening o
Sponsors
Faculdade de Ciências Farmacêuticas (FCF). Universidade Estadual Paulista (UNESP)
Faculdade de Ciências Farmacêutica (FCF-RP). Universidade de São Paulo (USP)
Hospital Alemão Oswaldo Cruz
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Older people (= 60 years old); admitted at least once to any hospital wards
Exclusion criteria
Exclusion criteria: Hospitalizations lasting less than 24 hours; admission for elective surgeries (e.g., admission for cataract surgery); admission for elective health procedures (e.g., transfusion of blood components, imaging exams or administration of specific medications)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to identify the presence of adverse drug events in hospitalized elderly people. Adverse drug events will be assessed through adverse drug reaction causality analysis with the instrument published by the World Health Organization; or through medication error analysis as established by the National Coordinating Council for Medication Error Reporting and Prevention. Through this analysis, it will be possible to identify the prevalence and most frequent adverse drug events in a secondary hospital, thus, it will be possible to corroborate protocols for preventing these outcomes in elderly people. | — |
Secondary
| Measure | Time frame |
|---|---|
| The aim is to identify problems related to pharmacotherapy that may be associated with the occurrence of adverse drug events (polypharmacy, i.e., use of five or more medications; complexity of pharmacotherapy; anticholinergic medications and anticholinergic load; potentially inappropriate medications according to the Pharmacotherapy Criteria Beers and STOPP/START; drug interactions; and therapeutic ineffectiveness), this analysis will allow identifying which are the most common problems and which could be avoided and managed during hospitalization; the positive and negative predictive values, sensitivity and specificity of the trackers, thus, those with a greater chance of detecting certain types of adverse drug events can be implemented in the health service; and costs arising from adverse drug events (costs obtained by top-down and bottom-up), this analysis will show the service the costs associated with adverse drug events and which could have been avoided. | — |
Countries
Brazil
Contacts
Public ContactPatrícia de Carvalho Mastroianni
Faculdade de Ciências Farmacêuticas (FCF). Universidade Estadual Paulista (UNESP)
Outcome results
None listed