A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital

Abstract

Adverse reactions are the recognized hazards of drug therapy and they can occur with any class of drugs and many studies revealed that the incidence is more in case of antibiotics. The main aim of this study was to detect and analyze Adverse Drug Reactions of antibiotics in inpatients of a tertiary care hospital. A prospective spontaneous reporting study by active and passive methods was carried out for a period of six months. A total of 49 ADRs were reported during the study period with male predominance (53.06%) and geriatric age group. More number of ADRs was from General Medicine and Pediatric departments in which the most affected organ systems were the GIT (38.77%) and the skin (30.61%). The antibiotic classes mostly accounted were cephalosporins (34.69%) followed by fluoroquinolones and others in which type A reactions were more compared to type B and 59.18% of them were predictable. The severity assessment revealed that most of them were moderate (63.26%) followed by mild and severe reactions. Of the reported reactions, 55.10% were definitely preventable and causality assessment was done which showed that 71.42% of the reactions were probable, possible (18.36%), definite (10.20%) and no reactions were unlikely. The study concluded that Adverse Drug Reactions to antibiotics are common and some of them resulted in increased healthcare cost due to the need of some interventions and increased length of hospital stay. The health system should promote the spontaneous reporting of Adverse Drug Reactions to antibiotics, proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.

Pattern of adverse drug reactions due to antibiotics in a tertiary care hospital

“…These data correlate with the study of Starveva et al, Jimmy Jose et al, Priyadharshini et al, where the causality was possible in most of the ADRs. 7,12,16,17 Preventability was assessed by Shumock and Thornton method which showed that majority of the reactions were not preventable 130 (57%) and only 24 (11%) were preventable which also shows that rational antibiotic policy plays an important role in selection of the antibiotics which exists in our hospital. According to a study conducted by Bates, antibiotics were responsible for 9% of preventable and 30% of nonpreventable ADRs.…”

“…8,12,13 Males were slightly more affected than females by the ADRs due to antibiotics in our study. Predominance of any gender being affected by ADR may also be due to the number of males or females admitted to the hospital during that period as seen in the study conducted by Shamna et al 7 Geriatric patients were more prone to antibiotic ADRs due to age related pharmacokinetic and pharmacodynamic changes and the presence of co-morbid illnesses and polypharmacy along with infectious diseases. In our study, age-wise distribution showed the predominance of adult patients followed by geriatric and pediatric patients.…”

“…This finding is in contrast to a study conducted by Shamna et al, where ADRs due to antibiotics were observed more in geriatric age group. 7 Third generation cephalosporins accounted for the majority of the ADRs. The cephalosporins and fluoroquinolones were the most used antibiotic class in the inpatient settings, so that the reported ADRs were also more in these drug classes.…”

“…Four other studies also showed the predominance of cutaneous manifestations. 7,[13][14][15] The causality assessment of ADRs was done using the Naranjo scale in which no reactions were found to be unlikely and majority were possible with a less number of probable and definite reactions. These data correlate with the study of Starveva et al, Jimmy Jose et al, Priyadharshini et al, where the causality was possible in most of the ADRs.…”

“…The total costs associated with antibiotics are not only related to antibiotic use itself, but also to comedication, drug interactions and adverse drug events. 7 This study was done to find out the pattern of ADRs due to antibiotic class of drugs in patients of a tertiary care hospital.…”