Off-label antibiotic use in a specialized children care hospital in Punjab, Pakistan: Findings and implications

Abstract

Introduction: Most of the antibiotics currently used in pediatrics are either unlicensed or being prescribed outside the specifications of product label (off-label prescribing). The aim of this study was to assess the extent of off-label antibiotic use in pediatrics.
 Methodology: A six month longitudinal off-label antibiotic utilization survey was carried out from January to June, 2018. A structured questionnaire was designed to collect detailed information for each pediatric patient admitted to participating health center. The data included basic demographic and clinical diagnosis with details of prescribed antibiotics (formulation, dose, dosage, route of administration and indication for use). Data were analyzed using Social packages for Statistical Sciences (SPSS) version 21.0.
 Results: Of 1,810 admissions, 1,795 (99.2%) patients received antibiotics. Out of these, a total of 451 (25.1%) patients (326 patients admitted in the medical ward and 125 patients in ICUs) received at least one unlicensed/off-label antibiotic. Antibiotics were predominantly prescribed for the treatment of infections (n = 311, 69.0%). The majority of the pediatric patients who received off-label antibiotic suffered from respiratory tract infections (n = 223, 49.4%), skin and soft tissue infections (n = 53, 11.8%), gastrointestinal tract infections (n = 56, 12.4%) and other infections (n = 46, 10.2%). Co-amoxiclav (n = 190, 42.1%) was the most frequently off-label prescribed antibiotic to pediatric patients. An inappropriate dose for patients (n = 430, 95.3%) was the most frequent cause of prescribing off-label antibiotics.
 Conclusions: Further evaluation of health and economic outcomes of off-label prescribing and determinants influencing the drug choice is required.

Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications

“…In our study, similar to others [13,35,50,[73][74][75][76], systemic antibiotics were the most frequently prescribed medicines, especially among neonates. This high use of antibiotics reflects the fact that the top indication for off-label or unlicensed use in medicines in our study was for bacterial infections at 26.8%, higher than studies in Spain at 12.0% [42], France at 22% [45], and Uganda at 18.9% [77].…”

“…In addition, an estimated 31.0% of neonatal sepsis deaths are currently due to AMR and are rising [89]. In addition, under-or over-dosing medicines (including antibiotics), which may result from their off-label or unlicensed use, is a concern, as this poses a risk of reduced effectiveness, increased adverse reactions, or both, along with potentially increasing AMR [75,87]. We have seen antimicrobial stewardship (ASP) programmes effectively introduced in hospitals across Africa in recent years to improve antimicrobial prescribing, with hospital pharmacists playing a key role [90][91][92][93].…”

Emerging Trends of Multidrug-Resistant (MDR) and Extensively Drug-Resistant (XDR) Salmonella Typhi in a Tertiary Care Hospital of Lahore, Pakistan

“…In Pakistan, many doctors, as well as patients, unfortunately favor the empirical route of treatment, where patients often seek the help of over-the-counter medicine or untrained medical professionals who do not have the required skill of handling infectious diseases. In this regard, children often belong to the high-risk group for various diseases including typhoid fever [24].…”

Emergence of Resistance to Fluoroquinolones and Third-Generation Cephalosporins in Salmonella Typhi in Lahore, Pakistan

“…Treatment is a challenge because a typical typhoid patient is from a poor socioeconomic background and the treatment of XDR is expensive. In Pakistan many adult patients present to their GP or pharmacist and are treated empirically whereas children are more often brought to the hospital [ 31 ]. The only treatment options that remain in this situation are azithromycin, meropenem, and piperacillin/tazobactam.…”