Background: A large number of hospital admissions are attributed to adverse drug reactions (ADRs) and they are the fifth leading cause of death worldwide. The present study aimed to assess the causality and preventability of adverse drug events (ADEs) of antibiotics among inpatients having different lengths of hospital stay.
Methods: A prospective, observational study was conducted in four tertiary-care public sector hospitals of Lahore, Pakistan. Study population consisted of hospitalized patients who were prescribed one or more antibiotics. Data were collected between 1st January, 2017 and 30th June, 2017 from 1249 patients. Naranjo score, modified Schumock and Thornton scale were used for causality and preventability assessments, respectively. Medication errors (MEs) were assessed by MEs tracking form. SPSS and Microsoft Excel were used for data analysis.
Results: A total of 2686 antibiotics were prescribed to 1249 patients and 486 ADEs were found. The preventability assessment revealed that most of the ADEs (78.8%) were found among patients having long length of stay (LOS) in hospital and were preventable (59.3% of the ADEs were definitely preventable while 44.7% were probably preventable) and caused by MEs including wrong drug (40.1%) and monitoring errors (25%). The errors were caused due to non-adherence of policies (38.4%) and lack of information about antibiotics (32%). Most of the non-preventable ADEs or ADRs among patients having long and short LOS in hospital were "probable" (35.5%) and "possible" (35.8%), respectively. Logistic regression analysis revealed that ADEs were significantly less among females (OR = 0.047, 95% CI = 0.018─0.121, p-value = < 0.001), patients aged 18─52 years (OR = 0.041, 95% CI = 0.013─0.130, p-value = < 0.001), patients with ARTIs (OR = 0.004, 95% CI = 0.01-0.019, p-value = < 0.001), patients prescribed with 2 antibiotics per prescription (OR = 0.455, 95% CI = 0.319─0.650, p-value = < 0.001) and patients with long LOS (OR = 14.825, 95% CI = 11.198─19.627, p-value = < 0.001).
Conclusion: Antibiotics associated definitely preventable ADEs were more commonly found in patients having long LOS in the inpatient departments because of MEs and lack of proper pharmacovigilance system. The ADRs showed a probable and possible causal association with both β-lactams and non β-lactams antibiotics.
Keywords: Adverse drug events; Adverse drug reactions; Antibiotics; Causality; Length of stay; Preventability.