Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil

Abstract

BackgroundAdverse drug reactions (ADRs) are recognised as a common cause of hospital admissions, and they constitute a significant economic burden for hospitals. Hospital-based ADR monitoring and reporting programmes aim to identify and quantify the risks associated with the use of drugs provided in a hospital setting. This information may be useful for identifying and minimising preventable ADRs and may enhance the ability of prescribers to manage ADRs more effectively. The main objectives of this study were to evaluate ADRs that occurred during inpatient stays at the Hospital Geral de Palmas (HGP) in Tocantins, Brazil, and to facilitate the development of a pharmacovigilance service.MethodsA prospective study was conducted at HGP over a period of 8 months, from January 2009 to August 2009. This observational, cross-sectional, descriptive study was based on an analysis of medical records. Several parameters were utilised in the data evaluation, including patient demographics, drug and reaction characteristics, and reaction outcomes. The reaction severity and predisposing factors were also assessed.ResultsThe overall incidence of ADRs in the patient population was 3.1%, and gender was not found to be a risk factor. The highest ADR rate (75.8%) was found in the adult age group 15 to 50 years, and the lowest ADR rate was found in children aged 3 to 13 years (7.4%). Because of the high frequency of ADRs in orthopaedic (25%), general medicine (22%), and oncology (16%) patients, improved control of the drugs used in these specialties is required. Additionally, the nurse team (52.7%) registered the most ADRs in medical records, most likely due to the job responsibilities of nurses. As expected, the most noticeable ADRs occurred in skin tissues, with such ADRs are more obvious to medical staff, with rashes being the most common reactions. Metamizole, tramadol, and vancomycin were responsible for 21, 11.6, and 8.4% of ADRs, respectively. The majority of ADRs had moderate severity (58.9%), thus requiring intervention. Type A reactions were the most common (82.1%). At least one predisposing factor was present in 79.9% of the reports examined, and the most common predisposing factor was polypharmacy.ConclusionsThe results obtained will contribute to the development of strategies for the pharmacovigilance service at HGP and other hospitals throughout the country, which will improve the quality of ADR reporting and ensure safer drug use in Brazilian hospitals.

Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital

“…Several other studies have also found similar results. [7][8][9] However, some studies showed female preponderance. 10,11 Thereby concluding that influence of gender is just an incidental finding and it does not affects number of ADR reported.…”

Incidência de internações por eventos adversos a medicamentos em Minas Gerais

“…Muitos estudos sobre os EAM abordam o tema sob a perspectiva de um agravo durante a assistência hospitalar ou ambulatorial, ocorrendo em 3% a 18,3% do total de internações [6][7][8][9], mas não como causa de internações. Alguns estudos que investigaram as internações hospitalares tendo como motivo o uso prévio de medicamentos estimam uma variação de 0,5% a 32,9%, cuja diferença pode ser relacionada ao desenho do estudo, como a população amostral, os métodos de coleta e a seleção de dados [5].…”

“…A diferença, embora estatisticamente significativa, foi pequena, podendo ser considerada clinicamente irrelevante. Estudos publicados na literatura científica [8,11] não identificaram o sexo como fator de risco para EAM.…”

Caracterización de reacciones adversas a medicamentos en adultos mayores de 44 años en Bogotá, D.C., enero - diciembre de 2012

“…En cuanto a la gravedad, la mayoría de las reacciones adversas (69,5 %) se catalogó como moderada.En este punto es importante recordar que todas las notificaciones analizadas provenían de IPS de diferentes niveles de atención y no de la comunidad, por lo que existe la posibilidad de que las reacciones adversas leves, que corresponden a signos y síntomas que se resuelven espontáneamente, no lleguen a las IPS y, por lo tanto, no sean reportadas. Aun con esta salvedad, estos datos son similares a los reportados en otros estudios de farmacovigilancia, como el de Alves de Araujo en Brasil, entre otros (26)(27)(28).…”