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Assessment of use of World Health Organization access, watch, reserve antibiotics and core prescribing indicators in pediatric outpatients in a tertiary care teaching Hospital in Eastern India

1 Department of Pharmacology, Medical College, Kolkata, West Bengal, India
2 Department of Pharmacology, Calcutta National Medical College, Kolkata, West Bengal, India
3 Department of Microbiology, Acharya Prafulla Chandra College, Kolkata, West Bengal, India

Date of Submission20-Jan-2022
Date of Decision05-Apr-2022
Date of Acceptance18-Feb-2022
Date of Web Publication11-Jul-2022

Correspondence Address:
Pragnadyuti Mandal,
Medical College, 88 College Street, Kolkata - 700 073, West Bengal
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.picr_22_22


Objectives: The objective of this study was to analyze antibiotic prescribing patterns in pediatric outpatients in a tertiary care teaching hospital in Eastern India, to identify use of World Health Organization (WHO) access, watch and reserve (AWaRe) antibiotics and to identify rationality of prescribing on the basis of WHO core prescribing indicators.
Materials and Methods: Scanned copies of prescriptions were collected from the pediatrics outpatients and antibiotic utilization pattern was analyzed in reference to WHO AWaRe groupings and core prescribing indicators.
Results: Over the 3 months study period, 310 prescriptions were screened. The prevalence of antibiotic use 36.77%. The majority of the 114 children who received antibiotics were males (52.64%, 60) and belonged to 1–5 year age group (49.12%, 56). The highest number of antibiotic prescriptions was from the penicillin class (58, 46.60%) followed by cephalosporin (23.29%) and macrolide (16.54%). Most number of prescribed antibiotics belonged to Access group (63, 47.37%), followed by Watch group (51, 38.35%). Average number of drugs per prescription was 2.66, percentage of encounters with injections were 0.64%. Most of the prescriptions were prescribed using generic name (74.18%, 612), 58.30% (481) of drugs were from WHO Model List of Essential Medicines for children.
Conclusion: If antibiotics are indicated, more number of antibiotics from the Access group may be used for ambulatory children who attend outpatient department of tertiary care hospitals. A simple combination of metrics based on AWaRe groups and core prescribing indicators may eliminate the problem of unnecessary antibiotic prescribing in children and may broaden the antibiotic stewardship opportunities.

Keywords: Antibiotic utilization, accessx, pediatrics, reserve antibiotics, watch, world health organization drug prescribing indicators

How to cite this URL:
Mandal P, Asad M, Kayal A, Biswas M. Assessment of use of World Health Organization access, watch, reserve antibiotics and core prescribing indicators in pediatric outpatients in a tertiary care teaching Hospital in Eastern India. Perspect Clin Res [Epub ahead of print] [cited 2023 Mar 23]. Available from: http://www.picronline.org/preprintarticle.asp?id=350159

   Introduction Top

Antibiotics are one of the most commonly used as well as misused classes of drugs. In children antibiotics are frequently unnecessarily used, also used without any indication. Misuse, excessive use and inappropriate use of antibiotics give rise to antimicrobial resistance (AMR), which is a global public health problem. Each year 700000 people are dying due to AMR, the toll may rise to 10 million in 2050.[1] Adults are usually affected by antibiotic resistance but studies in United States have revealed increasing rates of resistance to key pathogens in children over the past few years.[2],[3] In India, use of antibiotics has been gradually increasing in recent years. Between the years of 2000 and 2010 antibiotic retail sell in India have been increased to 23%; between 2000 and 2015 consumption of antibiotics have been increased from 3.2 billion to 5.5 billion defined daily doses.[4],[5] On the other hand, in US, antibiotic use in children is gradually declining over the past 10 years, prominent decline was found in 2010.[6] Throughout the globe as well as in India, antibiotics are frequently inappropriately prescribed in children though clinical guidelines exist for rational, judicious use of antibiotics for common childhood diseases like respiratory infections, diarrhea etc.[7],[8],[9],[10] In one study in US, which included patients in outpatient setting, showed that ~34.8 million antibiotic prescriptions were issued to patients <19 years of age, another study in US showed that 50% of antibiotic prescriptions issued by primary care physicians were unnecessary.[11],[12] In United Kingdom, in general practice, antibiotics were prescribed in 34% children for respiratory symptoms who suffered from viral upper respiratory tract infections.[13] Regional differences in antibiotic overuse, misuse and irrational use may only be curtailed by taking adequate efforts on antibiotic stewardship.

Antibiotic stewardship efforts may ensure appropriate and rational use of antibiotics-right antibiotic at the most appropriate dose and duration of therapy. To optimize use of antibiotic in healthcare settings, National Action plan for AMR has been released by India.[14] The 2017 revision of the World Health Organization (WHO) model list of essential medicine for children (EMLc) attempts to strengthen the antibiotic stewardship efforts by creating pressure on health-care systems and clinicians to conserve antibiotics by classifying antibiotics into three groups: Access, watch and reserve (AWaRe).[15] Access group antibiotics should be widely available, affordable and quality assured. Antibiotics such as amoxicillin/ampicillin, benzathine penicillin, trimethoprim-sulfamthoxazole, amoxicillin-clavulanic acid, cloxacillin are included in Access group. Third generation cephalosporins, fluoroquinolones, carbapenemes-which bears high resistance potential, are included in Watch group. The “last resort” antibiotics are classified in the Reserve group in which polymyxins, fourth and fifth generation cephalosporins are included. To facilitate the use of AWaRe antibiotics, WHO has started the global campaign called “Adopt AWaRe, Handle antibiotics with care.” Also WHO aims to improve the antibiotic prescribing practices so that 60% of prescribed antibiotics should be from Access group. Antibiotic sales data in India showed that between 2007 and 2012 consumption of Watch and Reserve group antibiotics are increasing in compare to access group antibiotics.[16] Even some of the Access group antibiotics are not widely available in all health facilities as revealed by a study in Delhi in which benzathine penicillin was unavailable in primary, secondary and tertiary care public sector health facilities in Delhi.[17]

WHO Core Drug Use Indicators provide a simple tool for fast and assuredly figuring out critical aspects of drug use. It recognizes problems in drug use and detects problems in performance of health facilities and prioritizes and focuses subsequent efforts to correct the problems in implementing rational use of drugs and antibiotic stewardship.[18] Need for increased antibiotic stewardship efforts in children have been addressed in studies, newer tools have been developed to tackle the emerging AMR and patterns of use of antibiotics in children in outpatient settings of different regions and different health care settings have also been revealed in studies.[19],[20],[21],[22],[23] However, there is limited data and no recent data available to assess use of AWaRe antibiotics in children particularly in Eastern part of India.

The present study was conducted to generate new evidence on antibiotic utilization in pediatric outpatient department (OPD) of a tertiary care government hospital. The objective of this study was to categorize antibiotic utilization as per WHO AWaRe classification of antibiotics in children, to evaluate the rationality of prescriptions on the basis of WHO core prescribing indicators, to determine the antibiotic prescription prevalence in children and to determine the distribution of prescriptions according to antibiotic classes and individual agents.

   Materials and Methods Top

The observational, cross-sectional study was carried out in the pediatric medicine OPD of a tertiary care teaching hospital in West Bengal. The tertiary care Hospital is situated in the central part of a metropolitan city of the state of which caters at least 10 adjoining districts.

Institutional Ethics Committee approval was obtained beforehand. Written informed consent was obtained from a parent or legal guardian, with the provision of a witness when the guardian was illiterate. Sampling was convenient and purposive; total 310 prescriptions were collected for analysis. Scanned copy of prescriptions of infants and children between 1 month and 12 years of either sex were included over a period of 3 months (June 2018 to August 2018). Prescriptions were randomly collected and scanned at the exit point of the pediatric medicine OPD or from the pharmacy queue adjacent to pediatric OPD, with a provision to collect the prescriptions at least 5 days in a week. Data were captured in a structured case report form.

The hospital is a government one and as per policy of the state government all medicines (including antibiotics) under state essential medicine list (EML) are supplied free to the patients and distributed to the patients through the drug distribution pharmacies of the hospital on production of a valid prescription. Antibiotics were coded according to WHO Anatomical Therapeutic Chemical Classification (ATC) system classification of antibiotics (WHO Collaborating center for Drug Statistics Methodology). All prescriptions containing antibacterials for systemic use (ATC code: J01), dermatological preparations (ATC code: D06) and topical antibiotics used in eye (ATC code: S01AA, S01AX) were identified and included for analysis. Antibiotics were classified as AWaRe on the basis of WHO 2017 EMLc.[15] Antibiotics not included in any of the AWaRe group were defined as unclassified.

This group includes all antibiotics not listed in the EMLc such as second generation cephalosporins (ATC code: J01DC) and fixed combinations of antibiotics excluding beta-lactam plus beta-lactam inhibitor combinations and cotrimoxazole. Information obtained from prescriptions which were considered for analysis were baseline demographic, clinical features of patients'; antibiotic therapeutic category and antibiotic class, molecules with dosing frequency, duration, indications. Rationality of prescriptions was assessed by assessing WHO core prescribing indicators: average number of drugs per encounter, encounters with generic name and from EML, percentage of encounters with injections and antibiotics. Data was summarized by routine descriptive statistics and was presented in numerals and percentages.

   Results and Analysis Top

The present study reveals new evidence on pediatric outpatient antibiotic prescription rates and pattern as well as pattern of use of AWaRe antibiotics in a public sector tertiary care hospital. During the 3 months study period, snapshot of 310 prescriptions were randomly collected of which 114 prescriptions contained one or more antibiotics. A total 133 antibiotics were prescribed to 114 children. Thus the prevalence of antibiotic use was 36.77%. Among these 114 children, 60 (52.64%) were males. Maximum number of children belonged to <5 years of age [Figure 1]. Pattern of antibiotic prescribing have been shown in [Table 1]. The highest number of antibiotic prescriptions was from the penicillin class (58, 46.60%) followed by cephalosporin (31, 23.29%) and macrolide (22, 16.54%). Cotrimoxazole (1.50%), fluoroquinolone (2.25%), linezolid (0.75%) were used sparingly.
Figure 1: Age distribution of study population (n = 114)

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Table 1: Antibiotics prescribed to the study population

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Amoxycillin-clavulanic acid was the single most frequently prescribed drug (58, 46.60%), cefixime (24, 18.04%) was the most frequently prescribed cephalosporin, azithromycin was the only macrolide prescribed in 16.54% (22) of children [Table 1]. The majority of cephalosporins, amoxicillin-clavulanic acid and azithromycin were prescribed for respiratory tract infections and skin infections [Table 2]. Analyzing the antibiotics as per WHO AWaRe classification, it was found that majority of the antibiotics belonged to Access group (63, 47.37%), followed by Watch (51, 38.35%) and unclassified group (18, !3.52%); one prescription of antibiotic contained one reserve group antibiotic [Table 3].
Table 2: Distribution pattern of type of antibiotics used for specific diseases

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Table 3: Frequency of antibiotic prescribing according to World Health Organization AWaRe classification (n=133)

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Analyzing the dosage forms used, it was observed that the most common route of administration for systemic antibiotic was oral, while a small proportion of children received a parenteral antibiotic (0.64%). There were 14 prescriptions of topical D06 preparation of mupirocin and one prescription contained ophthalmological preparation of tobramycin [Table 2]. Rationality of prescriptions was assessed using WHO core prescribing indicators, values of which are presented in [Table 4].
Table 4: World Health Organization core prescribing indicators used to assess study prescriptions

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   Discussion Top

To our knowledge this is the first study in India on patterns of antibiotic use in children attending OPD of a tertiary care hospital that used the WHO AWaRe classification. A systematic review on pediatric antibiotic use in 2019 has revealed availability of robust literature depicting variability in pediatric outpatient antibiotic prescribing.[24]

In the present study, among the reviewed 310 prescriptions, 114 prescriptions contained one or more antibiotics. The antibiotic utilization prevalence in the present study was 36.77%, which is similar to the Antibiotic resistance and Prescribing in European Children (ARPEC) report. According to ARPEC report, the prevalence of antibiotic utilization from 226 hospitals in 41 countries was 36.7%.[25] A systematic review in China in 2021 showed the overall prevalence of antibiotic utilization among pediatric outpatients were 63.8%. A Study in Italy in 2015, antibiotic prescription prevalence in children ranged from 30% to 62% across different local health districts of a region.[26] Studies in different health facilities in different regions of India also reflected variability in prevalence rate in pediatric outpatient antibiotic prescribing, such as Sharma et al.(25.7%), Malpani et al.(45.58%) and Pandey et al.(79%).[19],[22],[27]

In this study, 52.64% subjects were male; broadly similar male preponderance (56.7%, 59.17%, 58.4%) reports have been published from other studies in India.[19],[22],[23] Most of the patients (49.12%, 60/114) in this study were in the 1–5 year age group, percentages of patients in 1–5 year age group reported from other studies were 36.9%, 60.4% and 62.28% respectively.[19],[22],[23]

In this study, penicillins were the most commonly prescribed antibiotics (58, 46.60%) followed by cephalosporins (31, 23.29%) and macrolides (22, 16.54%). In a study in United States by Vaj et al., recent trends in outpatient antibiotic prescribing in children was analyzed, showed that majority of antibiotic prescriptions included penicillins, cephalosporins and second-generation macrolides.[6] In Europe, the most consumed antibiotic in community settings in 2019 were penicillins across all countries, the proportion of consumption varying from 27% (Slovakia) to 66% (Denmark).[28]

A recent systematic review in China revealed that the third-generation cephalosporins, penicillins and macrolides were the most frequently used antibiotics in children.[29]

Studies from different regions of India shows that penicillins and cephalosporins are being interchangeably used as the most commonly prescribed antibiotics.[19],[20],[21],[22],[23],[27] The consistency of our results with previous studies suggests that patterns of use of different classes of antibiotics have changed little over time.

In this study, subgroup analysis of antibiotic classes showed that amoxicillin-clavulanic (58, 46.60%) acid was the only penicillin, azithromycin (22, 16.54%) was the only macrolide but cefixime (24, 18.04%), cephalexin (3, 2.25%), cefuroxime (2, 1.50%), cefpodoxime (1, 0.75%) and ceftriaxone (1, 0.75%) were the cephalosporins which were prescribed for treatment of acute respiratory infections, skin infections, fever not otherwise specified and Urinary tract infections. In all the cases antibiotics were prescribed empirically, as there was no institutional antibiotic prescribing policy or guideline in the institute where the study was carried out. Other studies have also revealed that respiratory tract infections and fever are the common indications for which antibiotics are usually prescribed in children.[20],[22],[23] It was found in a study that for patients of all ages, at least 30% of outpatient antibiotic prescriptions are unnecessary, with the majority of prescriptions written to treat patients with acute respiratory infections.[30]

In the present study, relative use of different antibiotics under the AWaRe grouping was analyzed, prescriptions of the Access group of antibiotics constituted most of the antibiotic prescriptions (47.37%, 74), followed by the Watch group (38.35%, 51) and unclassified group (13.53%, 18), single agent (0.75%) was prescribed from the Reserve group.

In a recent study in India by Bansal A et al., evaluation of AWaRe categorization was assessed for all patients (irrespective of departments) of a tertiary care hospital, who received medicines from hospital drug distribution centers and prescribed with antibiotics. The study showed that, in 2017, 53.31% of antibiotics prescribed belonged to Access, 40.09% to watch and 3.40% to reserve category respectively as compared to 41.21%, 46.94% and 8.15% respectively in 2018.[21] Though the WHO AWaRe classification specified that at least 60% of antibiotics should be prescribed from the Access group, Hsia et al. in their Point Prevalance Survey (PPS survey, included patients from 56 countries) observed high diversity in patterns of AWaRe antibiotic use among countries. They reported very high (74.2%) prescription rate for Access group antibiotics for treatment of neonatal sepsis in Thailand, whereas the use of this group of antibiotics was comparatively lower in India (30.7%), where more number of Watch group antibiotics were prescribed for neonatal sepsis; >50% of antibiotics were used from Watch group against only 38% from Access group for treatment of lower respiratory tract infection in children in India.[31]

In another study by Hsia et al., it was observed that Access to Watch index in India was <1 with lower Access percentage (35%), higher Watch percentage (47.3%), and considerable use of unclassified antibiotics (17.4%).[32]

In a study by McGettigan et al., it was observed that sales of Watch and Reserve group antibiotics in India were increasing more rapidly, driven predominantly by follicular dendritic cells that contain Watch group (57% in 2011–2012) antibiotics.[16] In a study in China, pediatric prescription records of outpatient and emergency department of 16 tertiary care hospitals were analyzed, Watch group antibiotics accounted for 82.2% of all antibiotics.[33]

In another study in China by Wushouer H, patterns of antibiotic use was analyzed according to AWaRe grouping, prescriptions of the Watch group constituted most of the antibiotic prescriptions (89%, n = 2818), followed by Access group (10.5%, n = 333).[34] The present study significantly concords the results of study by Bansal et al. but contrasts the previous other observations from India and abroad and reveals >1 Access to Watch ratio with higher access percentage (47.37%), lower Watch percentage (38.35%) and also lower use of unclassified (13.53%) antibiotics. These variations in observations may be explained by the policy of the state government which was adopted to supply almost all essential medicines to all patients treated in all levels of government hospitals.

Also analysis of Hsia et al. and others included conglomeration of sales data to retail and hospital pharmacies, but they did not specify and differentiate separate consumption pattern between private and public sector pharmacies; furthermore, extrapolation from antibiotic sales to antibiotic consumption might lead to overestimation of antibiotic consumption if not all standard units sold are taken by the child.[32] The PPS survey included only pediatric inpatients, Bansal et al. included data for all patients irrespective of departments and age group.

Universal access to essential medicines and prescribing in generic name are essential prerequisites for rational prescribing. WHO core prescribing indicators have developed to foster rational use of medicine. In the present study, average number of drugs per prescription was 2.66. WHO-INRUD proposed 1.6-1.8 to be the optimal range of average number of drugs per prescription. Ajitha et al., Rahul et al. and Pandey et al. in their study in pediatric outpatient prescription analysis in tertiary care centers in India documented that the average number of drugs per prescription was 1.9, 3.2 and 2.5 respectively.[19],[27],[35]

WHO optimal for prescribing in generic name and EML prescribing is 100%. In the present study, 74.18% (612) medicines were prescribed in generic name, 58.30% (481) of medicines were prescribed from EML. Prescribing in generic name is more than those reported by Rahul et al.(1.94%), Pandey AA et al.(7.4%) and Ajitha et al.(60.2%); prescribing from EML is much higher than those reported by Rahul et al.(48.54%) and Pandey AA et al.(38.9%) but lower than those reported by Ajitha et al.(75.1%). In the present study, percentages of prescriptions with injections were 0.64% which is much lower than other studies (1.6%, 4.1%, 4.83%) reported from India.[19],[27],[35]

   Conclusion Top

At the level of the tertiary care institute, high antibiotic prescribing rate is the major challenge in successful implementation of antibiotic stewardship program; poly-pharmacy and low EML prescribing are the major hindrances in rational prescribing. On the other hand, high Access percentages may be considered as the first step in strengthening the antibiotic stewardship program. Minimum use of injections and high rate of prescribing in generic name are fulfilling the objectives of rational prescribing.

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Conflicts of interest

There are no conflicts of interest.

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  [Table 1], [Table 2], [Table 3], [Table 4]


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