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.
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The aim of the study was to test a new model of drug distribution known as unit-dose drug distribution including the effects of implementing this system on total drug consumption, especially in curbing antimicrobial use. The study was carried out in the Department of Surgery at the University Clinical Center in Nis, Serbia. During the first six months of the study (comparative period), drugs were delivered directly from the pharmacy to the urology and orthopedic wards in the traditional way (ward stock system). During the next six months (study period), drugs were delivered directly from the pharmacy to the patients (unit-dose drug distribution system). Drug consumption was measured using the statistical unit defined daily dose (DDD) per 100 bed days according to the anatomical-therapeutic-chemical classification of drugs. Following implementation of the unit-dose drug distribution system, total drug consumption was reduced by 24.34% in the urology ward and by 21.43% in the orthopedic ward. During the comparative period, in the urology and orthopedic wards, systemic antiinfectives (group J) comprised 263.54 and 227.61 DDD/100 bed days or 43.05% and 25.52% of total drug consumption respectively, whereas, during the pilot study period this group of drugs comprised 191.63 and 173.52 DDD/100 bed days or 41.37% and 24.96% of total drug consumption respectively. The unit-dose distribution system of drugs in hospitals leads to a control of drug consumption and substantial savings. Also, the pharmacist-physician interaction began to emerge as an important factor as a direct result of the changes in the drug distribution system.
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Arterial hypertension and proteinuria are important factors associated with the progression of both diabetic and nondiabetic chronic kidney disease. The objective of the present study was to determine the influence of different antihypertensive drug groups on urinary albumin excretion (UAE) as related to blood pressure in non-diabetic population. Subjects (n=39) with chronic renal disease accompanied by mild to moderate hypertension and varying degrees of proteinuria were divided into 3 groups based on UAE values and placed on nonpharmacological and/or treatment with an antihypertensive drug regimen (consisting of one or more antihypertensive drugs [beta blocker, ACE inhibitor or calcium-channel blocker]) to achieve a target blood pressure ≤ 130/85 mmHg. Periodic UAE measurements were performed. A reduction was observed over time in most patients, however, it reached statistical significance only in the microalbuminuric group (P<0.01). Patients were further stratified into 5 groups depending on assigned therapy: 0, nonpharmacological treatment; 1-drug group 1; 12-drug groups 1 and 2; 13-drug groups 1 and 3; 123-all 3 drug groups (1-ACE inhibitors, 2-beta blockers, 3-calcium channel blockers). A statistically significant change in mean UAE values at the start and end of the study period in patients assigned to drug groups 12, 13, and 123 was achieved (P < 0.05). Also, there was a statistically significant difference in the average reduction of proteinuria under varying antihypertensive drug regimens (P < 0.05). In conclusion, in patients with hypertension, changes in UAE depend on initial UAE values and administered antihypertensive treatment. ACE inhibitors combined with calcium channel blockers resulted in a higher UAE reduction than other drug groups.
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