Antibiotic use audit among pediatric inpatients
- Conditions
- Certain infectious and parasitic diseases,
- Registration Number
- CTRI/2023/09/057669
- Lead Sponsor
- Dr Padmaja Marathe
- Brief Summary
Infectiousdiseases contribute immensely to the global burden of disease that impactspublic health systems and economies especially affecting children. In 2013,infectious diseases resulted in over 45 million years lost due todisability and over 9 million deaths. According to UNICEF, pneumonia, diarrheaand malaria were responsible for approximately 30 per cent of global deathsamong children under the age of 5 in 2019.In India, infectious diseases account for 58%of all deaths among children aged 5 to 14 years.
Even among neonates, the frequency of infectious diseases,such as typhoid, diarrhea, measles, tuberculosis, and jaundice, remains theprimary cause of infant morbidity andmortality in India. Hasan et alreported that around 3.69 lacs children aged below five years dieevery year from acute respiratory infections in India, accounting for 13-16% ofall child deaths. Pneumonia and diarrhea remain the leading causes of mortalityin India among children, causing about 2 lacs under five mortalities.
Antibiotics areamong the most commonly administered medications in children. In ambulatorysettings in the USA, antibiotics are prescribed during as many as one in five pediatricvisits. Cross-sectional point prevalence studies have shown that more than 35%and 40% of hospitalized children are receiving antimicrobials at any given timein European and non-European countries, respectively. There are Indian studies done onoff-label use of drugs in children which show that antibiotics are the mostcommon off-label prescribed drugs (10 to 70%). Chauthankar et al. showed thatin NICU, of all the drugs prescribed, antibiotics were the most commonoff-label prescription drugs (69.6%). Saiyed et al. states that almost 70% ofthe antibiotics prescribed in hospitalized children are off-label.
An Indian studyshowed that use of antibiotics in PICU is up to 45%. While another study showedthat in a PICU of tertiary care hospital, of all of thepatients admitted 43% received antibiotics prophylactically, 42% empirically,and 15% therapeutically.
There are fewstudies documenting prescription pattern of antibiotics in hospitalizedchildren in India. However, the studies have not looked at drug consumption patternof antibiotics in hospitalized children.
The reason for increased off-label use of drugsbeing more prevalent in children is a smaller number of pediatric clinicaltrials. Both economic and ethical factors can discourage pharmaceuticalcompanies from conducting trials on children which results in potential delayin the authorization of antibiotics for children. Moreover, given the scarcityof information of new drugs including antibiotics in children, data on drug safety andtolerability are often extrapolated from adult studies, with the consequentrisks of underestimating toxicity, inadequate dosages and clinical failures.
Defined daily dose (DDD) as defined by WHO is the assumedaverage maintenance dose per day for a drug used for its mainindication in adults.Prescribed daily dose (PDD) as per WHO is the dose actually prescribed by a physician for an individualperson. The ratio of PDD to DDD is a useful metric to measure drugconsumption in a defined population and it is a valuable WHO indicator in drug utilizationstudies. These indicators can only be used in adult population as per WHO. PediatricDDDs are challenging to assign because of the variability in children’s dosesas per the age and body weight.
Child Defined Daily Dose (cDDD), ChildDrug Utilization index (cDUI), PDD/cDDD ratio indicators have been derivedbased on adult DDD and were used in a study by Hu et al. from pediatricpatients.
There is no Indianstudy reporting evaluation of prescription pattern of antibiotics in pediatricpopulation in terms of WHO indicators, PDD/cDDD ratio and using cDDD and cDUI.
Due tohigher number of infectious diseases in developing countries like Indiaespecially in children, the use of antibiotics is widespread. Because of lackof stringent regulations in India and other developing countries, it is notdifficult to obtain over the counter antibiotics and hence, antibiotics misuseis common. It has been observed that although parents are concerned about theuse of over-the-counter antibiotics, they still demand it for faster relief.In earlier studies assessing parents’ awareness regarding antibiotics, 42.6%declared that antibiotics act against both viruses and bacteria, 55.9% believedantibiotics are required to treat fever, 50% didn’t know the consequences ofantibiotics misuse, 58.4% believed that a doctor’s prescription is not requiredevery time to administer antibiotics and 66.7% trusted the pharmacist in theantibiotic prescription. In an Indian study to find out level of awarenessamong parents, it was found that there were misconceptions about which diseasesrequire antibiotics and the concept of antibiotic overuse leading to resistancewas not known. Majority of them believed antibiotics are required every timethe child falls sick. Misinformation and confusion was more among mothers andthose with lower formal education.
Therefore,the need was felt to understand parents’ knowledge, attitude and practiceregarding the disease condition which the child is suffering from and use ofantibiotics for infectious diseases in their children.
Antimicrobialscontributed around 16.8% of the of the total medicine sales worth USD 12.6billion in India between 2013 and 2014. According to National Sample Survey Organization (NSSO) data onKey Indicators of Social Consumption in India: Health, (2017–18), the monthlyper patient Out of Pocket (OOP) expenditure on infectious diseases byinfection-affected populations is INR 881.56 and INR 1,156.34 in inpatient andoutpatient care in India. One cost analysis study in pediatricpopulation showed that average cost of management of pneumonia in children is 12245 ± 593($187.34 ± 9.07). About 58% of India’s health expenditure is done out of pocketof the patient. In spite of public healthsystem and availability of generic drugs, the financial burden of infectiousdiseases in India is substantial owing to various factors. However, there are no cost analysis Indianstudies for antibiotics used for different types of infections. It is important to know how much financial burden is faced byparents when children are admitted with infections and whether they get therequired antimicrobial agents from the hospital formulary.
The infections in children require prompt use ofantimicrobial agents. It is necessary to find out the clinical outcome ofantibiotic treatment in children as febrile period and number of hospitalizationdays largely depend on response to treatment. Unlike most children gettingcured in developed nations, infectious diseases leading to morbidity andmortality has been reported to be higher in Indian patients. There are very fewglobal studies that has recorded response to treatment with antibiotics inchildren while there are no Indian studies assessing this aspect.
Hence it was ofinterest to evaluate prescription pattern, awareness of parents regarding useof antibiotics, cost analysis and clinical outcome of treatment of infectiousdiseases.
**Primary Objective:**
1. To analyze the prescription pattern ofantibiotics in hospitalized children using WHO drug use indicators and derivedpediatric indicators.
**Secondary Objectives:**
1. To find out awareness of parents of childrenregarding disease and use of antibiotics.
2. To analyze cost of treatment during thehospital stay
3. To assess the clinical outcome of treatment ofinfection.
**Methodology:**
**Study Design**- An Observational,cross- sectional, single-center, Questionnaire based Study
**Study Site**- In-Patient ward of Department of Pediatricsof a Tertiary Care Hospital.
**Study duration**- The total duration of the study will be of 15 months, of which data will becollected over a period of 12 months and analyzed over a period of 3 months.
**Sampling method**-Convenient sampling till the required sample size is achieved.
**Study Population**:The study population will include all admitted children receiving antibioticsin one unit of the Pediatrics department.
**Duration of study participation:** The studyinvolves a single interview with every parent at the end of hospital stay andhence the duration of participation equals the duration of the interview, whichis expected to be 30 minutes for the parents.
**Sample Size Calculation:**
The expected frequency of use of antibiotics in pediatricpopulation is 67%.(28) With confidence level of 95%, keeping margin oferror as 5%, a non-response rate of 10%(29), the sample size can be calculated as follows:
***n = z^2 \* p \* q / e^2***
where:
- z = the z-value for the desired confidence level (1.96 for a 95% confidence level)
- p = the expected frequency of antibiotic use (0.67)
- q = 1 - p (0.33)
- e = the desired level of precision (0.05)
n = (1.96) ^2 \* 0.67 \* 0.33\* / (0.05)^2
n = 340
Therefore, the sample size required for the study is340 patients. However, to account for the non-response rate of 10%, we willhave to recruit additional 38 patients as follows.
(N’=N/(1-d))
d = non-response rate
Therefore, N’=340/ (1-0.1) = 340/0.9 = 378
**Ethical considerations and informed consent:**
This study will be conducted incompliance with the protocol, the IEC, and Indian GCP guidelines and national ICMRguidelines on biomedical health research. During the study, any amendment ormodification to the protocol will be submitted to IEC.
The study will begin after approvalfrom Institutional Ethics Committee. Childrenwho are being admitted to the ward for treatment of infection and fulfillingthe inclusion-exclusion criteria will be enrolled in the study.
Written informed consent will be takenfrom LAR and impartial witness (when applicable) and verbal assent will betaken in children aged 7-12 years in addition to parent/ LAR consent.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 378
- 1.Children hospitalized to the Pediatrics ward.
- 2.Prescribed at least one antibiotic during their hospital stay.
- 3.Age more than 1 month and less than or equal to 12 years.
- 1.Children admitted to the pediatric ICU.
- 2.Legally Authorised Representative or children not willing to give informed consent or assent respectively.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prescription pattern of use of antimicrobial agents in pediatric inpatients To be assessed at Single time point at the time of discharge of hospitalized pediatric patients
- Secondary Outcome Measures
Name Time Method Percentage awareness of parents per item (from the questionnaire) Direct cost occurring that will include
Trial Locations
- Locations (1)
K.E.M. Hospital
🇮🇳Mumbai, MAHARASHTRA, India
K.E.M. Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr Jagriti JhaPrincipal investigator7990081279jagritipjha@gmail.com