(212) Factors Associated with Under-Reporting of Adverse Drug Reactions: A Systematic Review

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1257

Presenting Author(s)

Carla Torre
– Faculty of Pharmacy University of Lisbon, Lisboa, Lisboa, Portugal

Co-Author(s)

Catarina Rego Costa
– Faculdade de Farmácia da Universidade de Lisboa, Mujães, Viana do Castelo, Portugal
Patricia Abeijón
– Facultad de Medicina y Odontología de la Universidad De Santiago de Compostela, A Coruña, Galicia, Spain, Spain
Adolfo Figueiras
– Department of Preventive Medicine and Public Health, University of Santiago de Compostela, 15702 Santiago de Compostela, Spain;, Spain
Maria Herdeiro
– Prof., University of Aveiro, Aveiro, Portugal

Background: Adverse drug reactions (ADRs) are a major public health concern, since they are a frequent cause of increased morbidity, mortality and healthcare costs. Spontaneous reporting is the most widely used method by pharmacovigilance systems to monitor post-marketing safety information. Nonetheless, ADRs are significantly under-reported worldwide.

Objectives: To identify the sociodemographic characteristics that influence spontaneous reporting and the reasons associated with ADRs under-reporting by healthcare professionals (HCPs) and patients.

Methods: A systematic review was conducted according with the PRISMA guidelines (study registered in PROSPERO network database: CRD42021227944). A literature search of MEDLINE and EMBASE scientific databases was performed to retrieve studies published from January 2007 to February 2021. The search strategy included the following search terms: (attitud* OR knowledge* OR barrier* OR facilitators*) AND (Adverse Drug Reaction Reporting Systems[MesH] OR Drug-Related Side Effects and Adverse Reactions[MeSH]) AND report*. Studies were included if they addressed knowledge and attitudes associated with ADR under-reporting in HCPs and/or patients and were published in Portuguese, English, French or Spanish.

Results: A total of 1679 studies were identified, of which 73 were selected for inclusion. Study findings showed that the sociodemographic characteristics of HCPs had lower association with ADRs reporting unlike patients where this association was higher, with age and qualification being the most mentioned. Under-reporting was shown to be heavily influenced by reasons linked to knowledge, attitudes and excuses. There were differences in the reported factors between HCPs and patients. The most frequent reported reasons by HCPs were ignorance and lethargy, whereas patients mentioned complacency, ignorance, lethargy, among other reasons.

Conclusions: These findings revealed that knowledge, attitudes and excuses have a strong impact in the decision to report ADRs by HCPs and patients. These motives are characteristics that can be changed. Therefore, strategies must be designed to continually educate, train and empower each specific target population in order to positively impact the quantity and quality of notifications and, thus, change the paradigm of underreporting.