Spontaneous reporting of adverse drug reactions at a department of Internal Medicine

Abstract

<jats:title>Abstract</jats:title><jats:p>The aim of the present study was to characterize the pattern of adverse drug reactions (ADRs) reported in a university teaching hospital in south-east Serbia. The study was conducted based on ADRs reported during a six-month period to the ADR reporting unit of the university clinical center. Evaluation of data was done for various parameters, such as patient demographics, drug and reaction characteristics, and outcome of reactions. Assessment was also done for causality, severity and predisposing factors. During the 6-month study period, 44 ADRs were reported, with an overall incidence of 0.33%. No significant difference was seen in the overall incidence of ADRs observed in males and females. Incidence of ADRs among elderly (43.2%) and older (25%) adults was significantly higher than in other age groups. Type A reactions (66.7%) accounted for majority of the reports. The most commonly affected organ system was the renal system, (22.7%) with hyperkalemia as the only reported reaction. ACE inhibitors (48.6%) were the drug class most commonly involved, where fosinopril (25.7%) was the individual drug most frequently reported. Additional treatment was pursued for management of ADRs in majority (52.3%) of the reports. In 52.3 % of the reports, the patient had recovered from the reaction by the time of evaluation. Upon causality assessment, the majority of the reports were rated as probable (43.2%). Mild and moderate reactions accounted for 43.2% and 54.6%, respectively. In 36.3% of the reports, the reaction was considered to be preventable. The most common predisposing factors were polypharmacy and multiple disease state. The pattern of ADRs reported in our hospital is comparable to the results of studies conducted in hospital set up elsewhere. Our evaluations revealed opportunities for intervention to ensure safer drug use.</jats:p>

A demographic study on gender related differences in adverse drug reactions of a tertiary care teaching hospital

“…10 The study had limitations, shows that the number of cases reported is few due to unrecognized ADRs, under reporting of ADRs followed by phobia by the treating doctors not to report as it may cause bad reputation. Most of the ADRs were Probable based followed by Certain in our study which was similar to study done by Jovic et al 11…”

The attitudes of pharmacists and physicians in Bosnia and Herzegovina towards adverse drug reaction reporting

“…They concluded that health care professionals from Bosnia and Herzegovina had the lowest response rate to the questionnaires sent (22). A study from Serbia, a neighboring country to Bosnia and Herzegovina, published in 2010, also showed a low rate of hospital ADR reporting in Serbia in comparison to other countries (23). The results of a survey on hospital pharmacists' services conducted by the European Association of Hospital Pharmacists, showed a low rate of ADR related services in Bosnia and Herzegovina (24).…”

Use of case–time–control design in pharmacovigilance applications: exploration with high‐risk medications and unplanned hospital admissions in the Western Australian elderly

“…4 In the USA, ADEs account for nearly 100 000 emergency hospitalisations each year in this age group. 5 Different approaches exist for estimating medication harm resulting in hospitalisation, such as medical record reviews, [6][7][8][9][10][11][12] analysis of spontaneous reporting data, [13][14][15][16][17][18][19] and identification of ADE-related codes from the International Classification of Diseases (ICD) on inpatient records. [20][21][22][23][24][25][26] Some of these methods are labour-intensive, whereas others are subject to under-reporting and selection bias.…”

“…Different approaches exist for estimating medication harm resulting in hospitalisation, such as medical record reviews, analysis of spontaneous reporting data, and identification of ADE‐related codes from the International Classification of Diseases (ICD) on inpatient records . Some of these methods are labour‐intensive, whereas others are subject to under‐reporting and selection bias …”