The study was conducted as a prospective study at a community health centre in Kerala, India, after obtaining ethical clearance. The duration of the study was four months with a sample size of 552. The community health centre primarily serves the population in a panchayat. There is no other clinic or hospital there. The daily number of patients attending the outpatient department is between 150 to 200 and of these paediatric patients constitute around 40 to 50 cases per day. In the outpatient department, children of all ages can avail medical consultation at a very nominal cost of Rupees 2/OP ticket and drugs are dispensed free of cost. In the outpatient department, children were seen by doctors in one consultation room. There is token system and the parents can take token on coming to the hospital and they will be called-on when their turn comes. There is no separate queue for paediatric cases. There is a waiting area with lots of chairs. There is a television and water purifier in the waiting area. So, the parents don’t have to stand with the children to see the doctor. The hospital pharmacy counter situated on the nearby room where patients will get the medicines from the pharmacist. The children within the age group of 28 days to 12 years were included in the study. Written informed consent was obtained in the mother tongue from the parents or guardian accompanying the children. Those who came for vaccination and those not willing to give consent were excluded from the study. The “core drug use indicators” formulated by World Health Organization (WHO) and the parameters in the prescription format prescribed by the Medical Council of India forms the basis of the study [Table/Fig-1] [2,8]. This is done outside the institution when the parents and children came out of the hospital so that the doctors inside were not aware of the study and the bias of writing the prescription due to monitoring by the investigator can be avoided. For the same reason, two parameters in the patient care indicators like average consultation time and average dispensing time are not measured in this study. Other patient care indicators like percentage of medicines actually dispensed, whether it is adequately labelled, and the parent’s knowledge of when and in what quantity each drug that the child should receive were analysed. Finally, facility indicators were analysed at the end of the study by looking at the facilities in the institution and enquiring about the availability of essential drug list in the institution, the availability of clinical guidelines and the percentage of key drugs available in the institution. The major parameters analysed in the prescription format prescribed by the Medical Council of India includes the patient details, weight of the patient, whether prescription written in capital letters, signature of the doctor and the pharmacist. The essential drug list prepared by the Kerala Medical Service Corporation Limited (KMSCL) is used in the study [9].

A total of 552 patients with ages ranging from 2 months-12 years were enrolled during the study period of four months [Table/Fig-2]. The mean age of the patients was 6.1 (SD±3.4) years. Male patients were more 306 (55%) compared to female patients 246 (45%). Weight of the patient was recorded in 58.33% of the prescriptions. All prescriptions under the age of five years were recorded the weight of the child. Only 30 prescriptions (5.43%) were written in capital letters. A 100% of the prescriptions contained the details of the child along with provisional diagnosis. Signature of the prescribing doctor was there in 100% of the prescriptions but none of the prescriptions contains the signature of the dispensing person. A total of 1285 individual drugs were prescribed for various diseases of which upper respiratory infection received maximum number of drugs [Table/Fig-3]. The average number of drugs per prescription was 2.29 (SD±35.91). The range of drugs per encounter varied from zero to 4 [Table/Fig-4]. There were 16 prescription where in no drug was prescribed (2.89%). All these were wounds for which local cleaning and dressing were done. Generic prescribing dominated (98.4%). Only the zinc syrup that was not available in the hospital pharmacy was the only branded prescription. Drugs were prescribed in eight different dosage forms. Syrups were most commonly prescribed (62.73%) and injection use was very less (0.006%) [Table/Fig-5]. Antibiotics were widely used for treatment. The number of encounters with antibiotics was 404 out of the total 552 prescriptions (73.18%). Antibiotics constituted 31.43% of the total number of drugs prescribed. A single antibiotic was prescribed in 404 prescriptions. Antibiotics were prescribed to all children diagnosed with acute upper respiratory infections, lower respiratory tract infections, conjunctivitis and chicken pox. Four children with wounds were also given antibiotics. Among the antibiotics-azithromycin, amoxicillin-clavulanic acid, amoxicillin and cephalexin were prescribed for children with acute tonsillitis. Azithromycin and cefixime were prescribed for children with acute otitis media. Azithromycin, amoxicillin-clavulanic acid was the two antibiotics prescribed for children diagnosed with lower respiratory tract infection. All children diagnosed with acute conjunctivitis were given tobramycin eye drops. Acyclovir was prescribed for children with varicella [Table/Fig-6]. Azithromycin was the most commonly prescribed antibiotic. Every child with acute gastroenteritis was prescribed oral rehydration salts. No anti-diarrheal drugs and antibiotics were prescribed in these children. I.V fluids were given to eight children with acute diarrhoea. Zinc syrup was also prescribed in 20 cases with diarrhoea. A 98.44% (1265/1285) of prescribed drugs were actually dispensed by the hospital pharmacy. All the dispensed drugs were in the same strength as prescribed. On cross checking the dispensed medicines given to the patient, it was seen that no patient received a wrong drug or an incorrect dosage. A 100% of the drugs were adequately labelled. A 98.73% (545/552) of parents knew the correct dosage schedule for all the drugs prescribed. Regarding facility indicators the hospital has all the facilities for outpatient care. Three doctors are working at the institution so at a time at least one doctor will be available for patient care even if one or two will be on leave or went for immunization at sub centres/conference/training. There is lab facility at the institution with auto analyser and power back up. There is filtered drinking water and waiting area for the patients at the institution. Soft and hard copy of essential drug list prepared by the KMSCL is available at the institution.

[Table/Fig-2]:

Relationship between age and number of children.

[Table/Fig-4]:

Range of drugs per prescription.

[Table/Fig-5]:

Various dosage forms and their percentage.

The core prescribing indicators measure the performance of prescribers, the patient care indicators measure what patients experience at health facilities and the facility indicators measure whether the health personnel can function smoothly and effectively. Prescribing indicators were analysed by scrutinizing the prescriptions written by the doctors in the institution. The average number of drugs per patient is 2.29 is close to 2.0, the value recommended by the WHO [2] and is less than previous studies [4,7,10]. Maximum number of drugs per prescription is four and range of drugs per prescription is from 0-4 and is less than other similar studies [4,7]. The number of drugs per prescription should be as low as possible because as the number of drugs increases the chances of drug interactions and adverse effects will also increase along with increase in hospital cost. The mean age of patients is 6.1 years and is more than similar studies done previously [4]. So, this shows that breast feeding is adequate in the children offering protection in the toddler age. A 98.4% of the drugs are prescribed in generic name and is more than other studies [4,7,11–13]. The reason for this is due to availability of these key drugs in the hospital itself, which is given free of cost. The number of prescriptions with antibiotic is 73.18% of the total prescriptions and is much higher than one study [6] but slightly less than another study [7]. All diseases diagnosed with upper respiratory infection were given antibiotic and this should be of concern since most of the upper respiratory infections were of viral origin for which antibacterial agents have no role [14,15]. The over prescription of antibiotics is a hindrance in preventing drug resistance which the core objective of antibiotic stewardship program. So why the doctors overprescribed antibiotics needs to be investigated and interventions are needed in this regard. No antibiotics were prescribed for acute diarrheal diseases which is a positive finding in this study compared to other studies [4,16,17]. The usage of injections were also very less in the present study compared to other studies [4]. All the drugs dispensed were in the essential drug list and were available in the hospital and in correct doses. A 100% of the drugs were adequately labelled and is higher than the previous studies [18,19]. Body weight of the patient was recorded only in 58.33% of the patients which needs to be improved. But body weight was recorded for all the patients under the age of five years which is more important. Capital letters were not used in writing majority of the prescriptions and the signature of the dispensing person was not there in none of the prescriptions. So, interventions in the form of awareness training are needed in these issues. There should be adequate facilities for storing the drugs under proper temperatures as in summer season temperature may comes to 40^oC which may result in the loss of efficacy of drugs.

As the study is conducted in patients attending a government hospital the availability of drugs in the institution may influence prescribing patterns. Also, we cannot generalise the same prescribing pattern in all the primary care centres as more study at different institutions needs to be conducted to accurately know the prescribing patterns.

The present study showed that rational prescription can be achieved in primary care level if policy makers take steps to make essential drugs and qualified staff available. Interventions aimed at improving knowledge and training to staff in the issue of over prescription of antibiotics and in following a uniform prescription pattern designed by regulatory authorities is highly advisable. Further studies like this are recommended after imparting such training to healthcare staff.