Development of instrument to report and assess causality of adverse events related to herbal medicines

Development of instrument to report and assess causality of adverse events related to herbal medicines

Abstract: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment. Objectives: This study aimed to develop an instrument to allow...

Full description

Bibliographic Details
Main Authors:	Patrícia de Carvalho Mastroianni, Fabiana Rossi Varallo, Marília Amaral Costa, Luis Vitor da Silva Sacramento
Format:	Article
Language:	English
Published:	Universidad de Antioquia
Series:	Vitae
Subjects:	Herbal medicine adverse drug reaction reporting systems pharmacovigilance risk assessment product Surveillance postmarketing
Online Access:	http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0121-40042017000100013&lng=en&tlng=en

Similar Items

Possible adverse drug events leading to hospital admission in a Brazilian teaching hospital
by: Fabiana Rossi Varallo, et al.
Published: (2014-03-01)

Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data
by: Brandon Michael Henry, et al.
Published: (2023-06-01)

The Adverse Drug Reactions Registered During the Postmarketing Period
by: E. V. Shubnikova, et al.
Published: (2019-03-01)

Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine
by: Lina S. Sy, et al.
Published: (2018-02-01)

Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis
by: David A. Blaser, et al.
Published: (2017-11-01)

Design and methods for a Scandinavian pharmacovigilance study of osteonecrosis of the jaw and serious infections among cancer patients treated with antiresorptive agents for the prevention of skeletal-related events
by: Acquavella J, et al.
Published: (2016-07-01)

Pharmacovigilance of herbal medicine in two public health centers of Yogyakarta
by: Dyah Ariani Perwitasari, et al.
Published: (2016-12-01)

Adverse drug reactions induced by cardiovascular drugs in outpatients
by: Gholami K, et al.
Published: (2008-03-01)

Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital
by: Jair Antonio Ruiz-Garzon, et al.
Published: (2019-01-01)

Drug Safety Monitoring Information
by: E. V. Shubnikova, et al.
Published: (2021-07-01)

Analysis of the decisions of foreign regulatory authorities
by: Relevant information
Published: (2019-06-01)

Drug Safety Monitoring—International Information
by: E. V. Shubnikova, et al.
Published: (2020-12-01)

Monitoring of Foreign Drug Safety Information
by: Editorial article
Published: (2019-12-01)

Herbal medicines pharmacovigilance in Iran
by: Mohammad Hadi Zarei
Published: (2022-06-01)

Monitoring Drug Safety Information - Recommendations of Foreign Regulatory Authorities
by: Elena V. Shubnikova, et al.
Published: (2020-03-01)

Analysis of Administrative Decisions of Foreign Regulatory Authorities
by: Information relevant
Published: (2019-09-01)

Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase
by: Florence van Hunsel, et al.
Published: (2019-11-01)

Physicochemical quality control of senna products from Iranian phytopharmaceutics
by: F Mojab, et al.
Published: (2005-05-01)

Statistical methods for exploring spontaneous adverse event reporting databases for drug-host factor interactions
by: Zhiyuan Lu, et al.
Published: (2023-03-01)

From Monitoring Drug Safety to Monitoring Patient Safety: A Strategic Focus for the Activity of Pharmacists
by: Francisco Batel Marques
Published: (2017-10-01)

Nephrotoxicity of Herbal Products in Europe—A Review of an Underestimated Problem
by: Katarzyna Kiliś-Pstrusińska, et al.
Published: (2021-04-01)

Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff
by: Fabiana Rossi Varallo, et al.

Editorial for Special Issue on Herbal Medicines and Natural Products
by: Zhi-Wei Zhou, et al.
Published: (2015-11-01)

Analysis of a pharmacist-led adverse drug event management model for pharmacovigilance in an academic medical center hospital in China
by: He W, et al.
Published: (2018-10-01)

Adverse events with risankizumab in the real world: postmarketing pharmacovigilance assessment of the FDA adverse event reporting system
by: Yamin Shu, et al.
Published: (2023-05-01)

Adverse drug reaction monitoring through active surveillance in the inpatients of general medicine ward of a tertiary care hospital
by: Pooja Roy, et al.
Published: (2022-01-01)

Characteristics of “Hard-to-Use” Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler
by: Kabeya K, et al.
Published: (2020-07-01)

Safety and effectiveness of apixaban in Japanese patients with nonvalvular atrial fibrillation in clinical practice: A regulatory postmarketing surveillance, the STANDARD study
by: Hiroshi Inoue, et al.
Published: (2019-06-01)

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients
by: Zaid AN, et al.
Published: (2016-09-01)

Reporting of adverse events for marketed drugs: Need for strengthening safety database
by: Aditi Anand Apte
Published: (2016-01-01)

Materiovigilance: An Indian perspective
by: Bikash Ranjan Meher
Published: (2018-01-01)

A real-world study of antifibrotic drugs-related adverse events based on the United States food and drug administration adverse event reporting system and VigiAccess databases
by: Menglin He, et al.
Published: (2024-02-01)

Ghana’s herbal medicine industry: prospects, challenges and ways forward from a developing country perspective
by: Alex Asase
Published: (2023-10-01)

Adverse events in patients with leprosy on treatment with thalidomide
by: Paula Lana de Miranda Drummond, et al.
Published: (2019-04-01)

Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study
by: Shigeomi Iimura, et al.
Published: (2023-09-01)

Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): One‐year safety and effectiveness analyses
by: Takeshi Yamashita, et al.
Published: (2020-06-01)

A Semantic Transformation Methodology for the Secondary Use of Observational Healthcare Data in Postmarketing Safety Studies
by: Anil Pacaci, et al.
Published: (2018-04-01)

Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies
by: Valerio Ciccone, et al.
Published: (2023-06-01)

CORRIGENDUM Herbal Medicines in Brazil: Pharmacokinetic Profile and Potential Herb-Drug Interactions
by: Jose Maria Prieto, et al.
Published: (2015-03-01)

Predicting potential adverse events using safety data from marketed drugs
by: Chathuri Daluwatte, et al.
Published: (2020-04-01)