Abstract
Practitioners should evaluate the prescription pattern of antibiotics in the pediatric population to make health care practitioners more compliant with the guidelines.
A prospective study was conducted over 10 months from March 2021 to May 2022 that included 264 inpatient case records of children admitted to the Father Muller Medical College Hospital in Kankanady, Mangalore, India, with available guidelines.
Out of the 264 cases, the majority of patients were males aged 10 to 14. Third-generation cephalosporins were the antibiotics most commonly prescribed, of which ceftriaxone was more common. The most prescribed formulations were injectables followed by syrups. Highly recommended therapy was empirical followed by definitive therapy following culture report. Branded drugs were more commonly prescribed, of which the majority were from the hospital formulary.
Advanced interventions like matrix assisted laser desorption/ionization-time of flight mass spectrometry (MALDI–TOF) should be used to make prompt diagnosis and reduce the urge for empirical therapy and the burden of antimicrobial resistance. Antimicrobial stewardship programs (MSPs) will help optimize antimicrobials and improve patient outcomes.
Introduction
The pediatric population is more susceptible for various infectious diseases. Antimicrobial agents have been frequently prescribed to children to treat and prevent different infectious diseases in the community as well as in outpatient settings. Their use is rational (appropriate, proper, correct) when patients receive them for the appropriate indication (right medication), in doses that meet their individual requirements, for the right duration, at the right route and at an affordable cost. It is irrational (inappropriate, improper, incorrect) when one or more of these conditions are not met. It is estimated that globally over half of all medicines are prescribed, dispensed or sold inappropriately.1 However, their irrational use can lead to a number of consequences in term of cost, drug interactions, hospital stay and bacterial resistance.1 Hence, periodic evaluation and monitoring is required; without it, antimicrobial resistance can occur, leading to a rise in health care costs and nonadherence to standard guidelines in prescription patterns.2 To avoid the risk of bacterial drug resistance, it is essential to use antibiotics cautiously in pediatric practice.3
The World Health Organization (WHO) prescribing indicators are the bare minimum standards for promoting rational drug use, monitoring and drug utilization evaluation. The Centers for Disease Control and Prevention recommends antibiotic stewardship programs (ASPs) in health institutions to protect and preserve the potential of antibiotics.4
Infants and children are more prone to infection because they don’t have fully developed immune systems and have differences in pharmacodynamics and pharmacokinetics that practitioners are not always familiar with. This makes them vulnerable to the harmful effects of drugs. Therefore, it is necessary to ensure a drug’s rational use and effectiveness.5 The study of prescribing patterns is a part of the medical audit. It monitors, evaluates and if necessary, suggests modifications in prescribing practices to make medical care rational and cost-effective.6
Methodology
Study Design
A prospective study was conducted from March 2021 to May 2022 on pediatric inpatients at the Father Muller Medical College Hospital in Kankanady, Mangalore, India.
Study Population and Sampling Method
The data were collected from 264 inpatient case records from the pediatric intensive care unit, general and private wards and compared with the Father Muller Medical College Hospital Antibiotic Policy-2020, National Treatment Guidelines for Antimicrobial Use in Infectious Diseases, Version 1.0, 2016, and Drug Formulary-2018. This guideline was devised based on WHO prescribing indicators. The antibiotics should have been prescribed, based on the hospital infection treatment policy. A brief summary of the hospital policy includes:
Send for the appropriate investigations in all infections as recommended. These are the minimum required for diagnosis, prognosis and follow-up of the likely infections.
All antibiotic initiations would be done after sending appropriate cultures.
Change in antibiotic would be done only after sending fresh cultures.
Follow hospital policy when choosing antimicrobial therapy whenever possible. If alternatives are chosen, document it in the case records.
Check for factors that will affect drug choice and dose, e.g., renal function, interactions, allergy.
Check that the appropriate dose is prescribed. If uncertain, contact hospital infection control officer or pharmacy or check in the formulary.
The need for antimicrobial therapy should be reviewed on a daily basis. For most infections, five to seven days of antimicrobial therapy is sufficient (simple urinary tract infections can be adequately treated with three days of antibiotics).
All IV antibiotics may only be given for 48 to 72 hours without review and consideration of oral alternatives. New microbiological or other information (e.g., fever defervescence for at least 24 hours, marked clinical improvement; low c-reactive proteins (CRP) at this stage often allows for a switch to oral antibiotics, a switch to an IV narrow spectrum alternative or cessation of antibiotics (no infection present).
Once culture reports are available, the physician shall step down to the narrow spectrum, most efficacious and most cost-effective option. If there is no step down availed, it shall be documented and is subjected to clinical audit.
Empiric therapy: Where delay in initiating therapy to await microbiological results would be life threatening or risk serious morbidity, antimicrobial therapy based on a clinically defined infection is justified. Where empiric therapy is used, the accuracy of diagnosis should be reviewed regularly and treatment altered / stopped when microbiological results become available.
Inclusion criteria
Child aged 1 month to 15 years.
Patient on antibiotics.
Exclusion criteria
Incomplete case records.
Data Analysis
Data were analyzed by Chi-Square/Fishers Exact test.
Ethical Approval
The study was undertaken after the institutional ethics committee approval (Ref No: FMIEC/CCM/317/2021).
Results
A total of 264 case records were reviewed in this study. The majority of the children (58%) were males. Most of the children (43%) were aged 10 to 14. The common infections are depicted in Figure 1. The most commonly prescribed antibiotic among cephalosporins was ceftriaxone as shown in Table 1. Most antibiotics were administered as injectable (77%), followed by oral medications (14%). The majority of the drugs prescribed were branded (52%), of which 90% were prescribed from the hospital formulary. We found 89% of rationality in prescribing patterns, pertaining to empirical therapy and prescribing of a more expensive branded drug when a cheaper, generic option is available.
Discussion
Several studies show that most children who were prescribed antibiotics are younger than 5 years of age.3,5,7 The main reason may be that this group of children has less immunity and are more prone to infections.1 The majority of children in our study were aged 10 to 14. About 68% of the children were prescribed a single antibiotic, while 21%, 9% and 0.75% received two, three and four antibiotics respectively. This is different from a study done by Aghamohammadi7 that showed that 55% of patients were prescribed two antibiotics.
The commonly used antibiotics in our study were ceftriaxone (22%) and amoxicillin-clavulanic acid combination (20%) for upper respiratory tract infections, which is similar to studies done by others.3,8,9 The leading prescribed formulation was injectable; however, the patients were switched to oral formulations when they were stable.
Rational prescribing defines prescribing drugs from the essential drug list (EDL) or hospital formulary provided by the WHO. The standard value is 100% as per the WHO.10 The process of rational treatment includes defining the patient’s diagnosis, specifying the therapeutic objective and choosing a treatment of proven efficacy and safety from different alternatives. Then start the treatment by writing an accurate prescription and providing the patient with clear information and instructions. After some time, monitor the results of the treatment; only then will you know if it has been successful. If the problem has been solved, the treatment can be stopped.15
Few studies reported inappropriate prescription patterns and usage of antibiotics and suggested that effective interventions are required to reduce it.3,7 The drug prescribing indicators were appropriate in some studies when compared with those of the WHO.8,9 Our study showed that most antibiotics were prescribed from the hospital formulary (90%). The rationality in the therapy in our study was 89%, which is different from the study reported by Mathew et al. at 99.41 %. Empirical therapy (92%) is one of the major contributing factors to the emergence of antimicrobial resistance, but it was prescribed in our hospital according to the guidelines. After the culture report was available, the patient was switched to definitive therapy in 8% of the cases, where culture report was positive, a critical principle in infection management. A similar report is seen in a study done by Mgbahurike et al.2 Although hospital antibiotic policy insists on sending blood culture before starting on antibiotics, it may occasionally be missed.
Antibiotic guidelines are standard guidelines for treating infectious diseases based on local culture sensitivity data.6 In our study, definitive therapy following the culture report was found in 8% of cases, which may probably be due to poor yield in culture reports, which in turn may be due to contamination of culture media or culture not being sent. Few studies report similar findings.
In our study, we found that there is a causal relationship between empirical therapy and rationality in the treatment, as shown in Table 2 with a significant P-value: 0.002. Most physicians treat empirically. However, they are required to start with target/definitive therapy following the relevant culture/other laboratory reports when it is available. Antibiotic resistance is hastened by the misuse and overuse of antibiotics, which results in poor infection prevention and control.
Interventions are necessary to promote rational antibiotic use and preserve the effectiveness of available drugs. A strict antibiotic prescribing policy, as defined in the hospital guidelines, significantly reduces the overuse of antibiotics and the development of antibiotic resistance. Moreover, it is essential to have prescription pattern analysis or audits on a large scale in different health sectors so that the study will be more effective and help formulate local policies for antibiotic prescriptions in pediatrics and other specialties.7 Antimicrobial resistance (AMR) has become the most significant burden on the healthcare system, making old medicines ineffective and new ones economically unfit.11
Conclusion
Interventions like compulsorily sending for culture and sensitivity at admission has to be done for prompt diagnosis to reduce the burden of AMR. Prescription audits have to be done periodically to assess rationality and correct, whenever necessary. Antimicrobial stewardship programs (MSPs) are conducted to optimize antimicrobials and improve patient outcomes. Newer technology is available in hospital, such as matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF), that helps to identify bacteria and fungi rapidly and accurately. All consultants in clinical departments and their postgraduates need to be trained regarding MALDI-TOF and its usefulness, on a regular basis and encouraged to use this facility.
References
Conflict of interest statement: All authors have no conflicts.
Author notes
Author Contribution:
DKJ: Performed protocol development, study design, data collection, analysis, and drafted the manuscript.
KZP: Guided in protocol development, data collection, expert advice and editing and revising the manuscript.
BSR: Conceptualized the study design and edited the manuscript.
PK: Data analysis.