Evaluation of the prophylactic use of omeprazole in patients admitted to the State Hospital of Américo Brasiliense

• Grant number: 13/12681-2
• Support Opportunities: Regular Research Grants
• Start date: September 01, 2013
• End date: August 31, 2015
• Field of knowledge: Health Sciences - Pharmacy
• Principal Investigator: Patricia de Carvalho Mastroianni
• Grantee: Patricia de Carvalho Mastroianni
• Host Institution: Faculdade de Ciências Farmacêuticas (FCFAR). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil

Abstract

The prevalence of the use of drugs that act on the gastric system has increased in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use, mainly as a prophylactic to prevent reflux esophagitis, gastric pathological hypersecretory conditions, prevention of recurrence of gastric or duodenal ulcers, gastric mucosal protection against damage caused by nonsteroidal anti-inflammatory drugs and during Zollinger-Ellison syndrome. However, omeprazole is associated with several adverse events due to abusive use or irrational prescribing, in disagreement with the indication, which may cause the ineffectiveness of the drug and decreased patient safety. Objectives. To assess the risk (occurrence of adverse events) and the benefit (effectiveness) of the prophylactic use of omeprazole in hospitalized patients and to know the reasons for the prophylactic use (indicated use or not approved). Patients and Methods. An observational and cross pharmacoepidemiological study will be performed from August to December 2013, in the General State tertiary referral Américo Brasiliense Hospital, with 130 active beds. Hospitalized patients will be separated into three groups: those who make indicated and approved prophylactic use of omeprazole (exposed group 1), those who make not indicated and not approved prophylactic use (exposed group 2), and those who do not use the omeprazole (non-exposed group). Patients who do not make prophylactic use of omeprazole will be excluded. Patients will have their pharmacotherapy monitored and data will be collected daily using an investigation guide of the first day of admission and will be included in group 1 or 2, from the first use of omeprazole to discontinuation (washout period of seven half-lives or higher). NCC MERP (National Coordinating Council for Medication Error Reporting and Prevention) algorithm will be used for causality analysis is used. Data will be tabulated according to the presence or absence of effectiveness and the presence or absence adverse events in the three groups. The odds ratio of adverse events and effectiveness of indicated and approve or not indicated and not approved prophylactic use of omeprazole will be calculated. Expected results. It is intended to know the odds ratio of adverse events in the prophylactic use of omeprazole with or without indication or use approval, and the potential indications, dosage and unapproved methods of prophylactic use inomeprazole label. (AU)

Scientific publications

(8)

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

VARALLO, FABIANA ROSSI; DE NADAI, TALES RUBENS; ALVES DE OLIVEIRA, ALICE ROSA; MASTROIANNI, PATRICIA DE CARVALHO. Potential Adverse Drug Events and Nephrotoxicity Related to Prophylaxis With Omeprazole for Digestive Disorders: A Prospective Cohort Study. CLINICAL THERAPEUTICS, v. 40, n. 6, p. 973-982, JUN 2018. (13/12681-2, 14/03468-6)

VARALLO, FABIANA ROSSI; DAGLI-HERNANDEZ, CAROLINA; PAGOTTOL, CAROLINE; DE NADAI, TALES RUBENS; HERDEIRO, MARIA TERESA; MASTROIANNI, PATRICIA DE CARVALHO. Confounding Variables and the Performance of Triggers in Detecting Unreported Adverse Drug Reactions. CLINICAL THERAPEUTICS, v. 39, n. 4, p. 686-696, APR 2017. (13/12681-2)

MARCELA FORGERINI; MARIA TERESA HERDEIRO; JOSÉ CARLOS FERNANDES GALDURÓZ; PATRÍCIA DE CARVALHO MASTROIANNI. Risk factors associated with drug therapy among elderly people with Alzheimer’s disease: a cross-sectional study. São Paulo Medical Journal, v. 138, n. 3, p. 216-218, 2020-06-22. (18/07501-9, 13/12681-2)

FORGERINI, MARCELA; MIELI, STEPHANIA; MASTROIANNI, PATRICIA DE CARVALHO. Safety assessment of omeprazole use: a review. São Paulo Medical Journal, v. 136, n. 6, p. 557-570, NOV-DEC 2018. (14/03468-6, 13/12681-2)

VARALLO, FABIANA ROSSI; FORGERINI, MARCELA; HERDEIRO, MARIA TERESA; MASTROIANNI, PATRICIA DE CARVALHO. Harmonization of Pharmacovigilance Regulation in Brazil: Opportunities to Improve Risk Communication. CLINICAL THERAPEUTICS, v. 41, n. 3, p. 598-603, MAR 2019. (18/07501-9, 13/12681-2)

FORGERINI, MARCELA; VARALLO, FABIANA ROSSI; ALVES DE OLIVEIRA, ALICE ROSA; DE NADA, TALES RUBENS; MASTROIANNI, PATRICIA DE CARVALHO. Assessment of the adherence to and costs of the prophylaxis protocol for venous thromboembolism. Clinics, v. 74, 2019. (18/07501-9, 13/12681-2)

FABIANA ROSSI VARALLO; ROSA CAMILA LUCCHETTA; MARCELA FORGERINI; PATRICIA DE CARVALHO MASTROIANNI. What would be a trigger tool with better performance for detecting drug-induced hyperkalemia?. São Paulo Medical Journal, v. 137, n. 4, p. 386-387, Jul. 2019. (18/07501-9, 13/12681-2)

FORGERINI, MARCELA; HERDEIRO, MARIA TERESA; FERNANDES GALDUROZ, JOSE CARLOS; MASTROIANNI, PATRICIA DE CARVALHO. Risk factors associated with drug therapy among elderly people with Alzheimer's disease: a cross-sectional study. São Paulo Medical Journal, v. 138, n. 3, p. 216-228, MAY-JUN 2020. (18/07501-9, 13/12681-2)