Drug Utilization Study in the Patients of Childhood Diarrhea Admitted in a Tertiary Care Hospital

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1 Original Research Article Drug Utilization Study in the Patients of Childhood Diarrhea Admitted in a Tertiary Care Hospital Ankita Mishra 1, Syed Ziaur Rahman 1 *, F K Beig 2 1 Department of Pharmacology, 2 Department of Paediatrics, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India Abstract Background: The study was conducted to analyze and audit the prescribing pattern for inpatients suffering from acute diarrhoeal illness, admitted at the paediatric ward of Jawaharlal Nehru Medical College Hospital, Aligarh, from the period of April 2016 to March Methods: Permission to access medical records of past one year of all the children admitted in the paediatric ward from April 2016 to March 2017 was obtained from the competent authority. The inpatient prescriptions were available in the Central Record Section under the International Classification of Diseases (ICD)-10 of the WHO (A08 and A09). The following parameters were taken to analyze and audit prescriptions: (1) Patient details, (2) Mention of diagnosis, legibility and spelling mistakes, (3) Information of the consultant(s), (4) WHO prescribing indicators, (5) Use of antibiotics by various routes, (6) Provision of proper instructions to patients, (7) Additional parameters - Percentage of prescriptions with nutritional supplements, ORS, zinc and antacids. Results:Total number of prescriptions analyzed was 92. Names of the patients were mentioned in all case reports including their age, sex, address and diagnosis. Ten out of 92 patients were above the age of five years. Name and signature of the consulting physicians were present in all of the prescriptions. None of the prescriptions had the doctor s contact number. On an average drugs were written per prescription. The illegible prescriptions were 18.47% and there were 4.35% with spelling mistakes. Instructions for proper intake of medicines were given only in three prescriptions. ORS and Zn were prescribed only in 27 and 34 cases, respectively, out of the total 92 prescriptions, whereas antibiotics were prescribed in 60 of the 92 prescriptions. Oral antibiotics were prescribed in 7 of the 92 prescriptions. In 53 of the prescriptions intravenous antibiotics were prescribed. Conclusions: There is always a scope of improvement in prescribing patterns; hence, promotion of rational drug use among practitioners should be advocated for better treatment of children suffering from diarrhoeal disease. Key words: Prescribing pattern, diarrhea, paediatric *Corresponding author: Dr. S Z Rahman, Professor, Department of Pharmacology, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India. rahmansz@yahoo.com 24 J Rational Pharmacother Res Volume 4 (Issue 1): 2018

2 INTRODUCTION Diarrhoea is defined by WHO as the passage of three or more loose or liquid stools per day (or more frequent passage than is normal for the individual). 1 It occurs at some point in the life of almost every child. It is a major global problem in children and accounts for 18% of child deaths and 13% of all disability-adjusted life years (DALYs). 2 Diarrhoea is a major cause of infant mortality in India also. It is responsible for nearly 650 child deaths below the age of five years each day in India. 3 WHO/UNICEF (2004) recommends low osmolarity oral rehydration salt solution (reduced ORS) and zinc supplement for the treatment of childhood diarrhea. Most of the cases of acute diarrhoea are due to rotavirus. Diarrhoea caused by viruses improves in two to three days without antibiotics. Thus, the role of antimicrobials in acute diarrheal illness is limited. Antimicrobials are indicated only in cases of bloody diarrhea (shigella), suspected cholera and severe malnutrition. 4 In many developing countries, suboptimal prescribing and overuse of marginally effective drugs have led to treatment failure, spread of disease, increased resistance, high health care costs and adverse effects. 5 Deaths due to diarrhoea can be averted in almost all the cases by preventing and treating dehydration with ORS, along with administration of zinc tablets and adequate nutrition. Diarrhoeal illness can be prevented with clean drinking water, proper sanitation, breastfeeding (or appropriate nutrition) and hand-washing. Around 1.1 million children die every year in India, which includes approximately 1.1 lakh deaths due to diarrhea. 6 Prescription auditing is an essential monitoring activity that can help reduce the burden of disease because of medication errors. This study was undertaken to determine the extent of irrational prescribing patterns for diarrhea in admitted children at a tertiary care hospital in North India. MATERIAL AND METHODS This observational retrospective study was conducted in the paediatric inpatient of department of J. N. Medical College, Aligarh (U.P.). All the admitted patients with acute gastroenteritis irrespective of the additional illnesses present were included in this study. The prescriptions were audited from the months of April 2016 to March of Permission to access medical records of all patients with acute gastroenteritis admitted in the Pediatrics ward for this period was obtained through competent authority. The diagnosis was classified according to the International Classification of Diseases (ICD)-10 of the WHO (A08 and A09 according to ICD-10). In this study, 92 prescriptions of the children, suffering from acute diarrhea, were selected. These prescriptions were analyzed after making standard criteria based on those defined by WHO. 7 Following modified parameters 8 were taken to analyze and audit the prescriptions: 1. Patient details like name, age, sex and address. 2. Mention of diagnosis, legibility & spelling mistakes. 3. Details of the consultant such as name, signature and contact number. 4. WHO prescribing indicators - Mean number of drugs per prescription, percentage of drugs prescribed J Rational Pharmacother Res Volume 4 (Issue 1):

3 by generic name, percentage of encounters with an antibiotic prescribed, percentage of encounters with an injection prescribed, percentage of drugs prescribed from national essential drugs list. 5. Use of antibiotics by various routes. 6. Provision of proper instructions to patients. 7. Additional parameters - Percentage of prescriptions with nutritional supplements and antacids. RESULTS Patient details - The names of patients were mentioned in 87 out of 92 (94.57%) of prescriptions; in rest (5.43%) of the prescriptions, mother s name was mentioned (son / daughter of). Age, sex and address were mentioned in 92 out of 92 (100%) of prescriptions. Ten of the 92 children were above the age of 5 years, rest of 82 children were below 5 years of age. Eleven children were equal to / below the age of 2 months. Forty one (44.57%) patients were female and 51 (55.43%) patients were male. All of the (100%) prescriptions had mentioned the diagnosis. Seventeen out of 92 (18.47%) prescriptions were not legible and four out of 92 (4.35%) prescriptions contained spelling mistakes in the names of the drugs (Table 1). Details of the consultant - The name and signature of the consultants were present in all the prescriptions, whereas the contact numbers of the consultants were not present in any of the prescriptions (Table 1). WHO drug use indicators - The 92 prescriptions containing a total of 422 drugs (excluding intravenous fluids and ORS) were analyzed using the following WHO prescribing indicators (Table 2): 1. Mean number of drugs per prescription = 422/92 = 4.587% 2. The least number of drugs per prescription was zero and the highest number of drugs per prescription was Percentage of drugs prescribed by generic name = 17/422 x 100 = 4.028% 4. Percentage of prescriptions with an antibiotic prescribed = 60/92 x 100 = %. 5. Percentage of encounters with an injection prescribed = 88/92 x 100 = % 6. Percentage of drugs prescribed from national list of essential medicines, 2015 = 100% Use of antibiotics by various routes - Oral Antibiotics was prescribed in 7 of the 92 prescriptions. In 53 of the prescriptions intravenous (IV) antibiotics were prescribed (Table1). Provision of proper instructions - Most of the prescriptions did not have complete instructions with respect to oral and IV formulations. Instruction with regards to ORS and other medicines were given only in three out of 92 prescriptions. The interval between food intake and consumption of oral formulations was not specified in most of the prescriptions. The total duration of intake of oral and injectable formulations was also not specified in any of the prescriptions (Table 1). 26 J Rational Pharmacother Res Volume 4 (Issue 1): 2018

4 Table 1 Patient and Consultant Details, Diagnosis, Antibiotics and Instructions Patient s Details Name 87/92 (94.57%) Age (<5 yrs, <2mths) 82/92, 11/92 Sex F=41, M= 51 Address 92/92 Diagnosis, Legibility, Spelling Mistakes 92/92, 75/92, 4/92 Details of the consultant Name, Signature, Contact no. 92/92, 92/92, 0/92 Antibiotics (Oral, IV) 7/92, 85/92 Provision of proper instructions Instruction for ORS 3/92 Interval b/w food intake and oral drug consumption 0/92 Duration of intake of oral and injectable formulations 0/92 Additional parameters (Table 2) : Nutritional supplements (iron, folic acid, vit D, vit A) were prescribed in = 48/92 x 100 = % Prescriptions containing antacids were = 40/92 x 100 = % No. of prescriptions containing ORS with respect to the diagnosis is depicted in Figure 1. ORS was prescribed in = 27/92 x 100 = % IV fluids were prescribed in = 86/92 x 100 = % Number of patients who received zinc along with the ORS is depicted in Figure 2. Tablet Zinc was prescribed in = 34/92 x 100 = %. Most common antibiotic prescribed, in 47 of the prescriptions, was the combination of a Cephalosporin (Ceftriaxone / Cefotaxim) and Amikacin. This was followed by metronidazole which was given in four of the patients. Other antibiotics prescribed were Ofloxacin, Azithromycin, Vancomycin, Sulfamethoxazole and Trimethoprim, Meropenem, Piperacillin and Doxycycline. Figure 3 shows the pattern of antibiotic prescription with respect to disease. Out of 92 patients, 41 had acute gastroenteritis (AGE) with severe dehydration (including patients with shock and patients with severe acute malnutrition), 16 of the patients had AGE with some dehydration and 4 of the patients had AGE with no dehydration. Rest of the 31 patients had presence of systemic or other illness along with AGE (Figure 4). Lab investigation for complete blood count (CBC) and differential leucocyte count (DLC) was carried out in 76 of the patients. Blood culture and sensitivity was done in 32 of the patients. Blood culture and sensitivity result was positive for specific infections in seven of the patients. J Rational Pharmacother Res Volume 4 (Issue 1):

5 Table 2 WHO indicators and additional parameters WHO drug use indicators 422 drugs Mean no. of drugs per prescription 422/92=4.59 % of drugs prescribed by generic name 17/422 (4.028%) % of encounters with an antibiotic prescribed 60/92 (65.22%) % of encounters with an injection prescribed 88/92 (95.65%) % of drugs from national essential drugs list 92/92 (100%) Additional parameters Nutritional supplements (iron, folic acid, vit D, vit A) 48/92 (52.17%) Prescriptions containing antacids 40/92 (43.48%) ORS prescribed 27/92 (29.35%) IV fluids 86/92 (93.48%) T. Zinc 34/92 (36.96%) Blood Culture & Sensitivity send in/ +ve in 32/6 Figure 1: % of patients who received ORS with respect to the disease. AGE- Acute gastroenteritis with no dehydration, AGES- with some dehydration, AGED- with severe dehydration, AGEI- with other illnesses. 28 J Rational Pharmacother Res Volume 4 (Issue 1): 2018

6 Figure 2: Patient % who received Zinc with respect to the disease. AGE-Acute gastroenteritis with no dehydration, AGES - with some dehydration, AGED - with severe dehydration, AGEI- with other illness. Figure 3: Number of patients who received antibiotics with respect to the disease. AGE-Acute gastroenteritis with no dehydration, AGES - with some dehydration, AGED - severe dehydration, AGEI- Acute gastroenteritis with other illness. J Rational Pharmacother Res Volume 4 (Issue 1):

7 Figure 4: Number of patients with respect to the diagnosis. AGE-Acute gastroenteritis with no dehydration, AGES - with some dehydration, AGED - with severe dehydration, AGEI- with other illness, AGE+M - with Meningitis, AGE+B- with Bronchopneumonia, AGE+TB+SAM - with TB and Severe Acute Malnutrition, AGE+CPS-AGE with Complex Partial Seizure, AGE+ HypoNa- AGE with Hyponatremia, AGE+VF- with Ventricular Fibrillation, AGE+AKI- with Acute Kidney Injury DISCUSSION Prescription auditing is important because the indicators of prescribing practices analyze the performance of health care providers in relation to the appropriate use of drugs. In our study, 82 patients of the study population were below the age of five years. Higher incidence of diarrheal episode in this age group was in agreement with that for diarrheal disease. 9 The male and female patient distribution was somewhat even, although the male admitted patients were more (55.43%). An average of 4.59 medicines was given per prescription in our study, which was in compliance with the National List of Essential Medicine Although our findings seems to be in accordance to the WHO guidelines for rational use of drugs, but still where there is a definite lack of communication of the guidelines among the consulting physicians, there is a higher chance of receiving medicines over and above the required doses. The greater the number of medicines given to the patient, greater will be the risk of adverse effects and greater will be the likelihood of drug-drug interaction. Unnecessary medication also increases the cost burden on the parents and the community to treat an ailing infant of diarrhea. 10 Rational use of drugs involves selection of drugs from the essential drug list and prescribing them rationally, following the standard treatment guidelines. ORS is an 30 J Rational Pharmacother Res Volume 4 (Issue 1): 2018

8 essential component in the management of diarrhoea, especially among the children to avoid deaths due to dehydration. ORS and oral zinc have been recommended for the management of acute diarrheal disease in children by the Indian Academy of Paediatrics (IAP) National task force. 11 National Rural Health Mission (NRHM) has included both ORS and zinc (10 mg elemental zinc for infants aged 2 to 6 months and 20 mg/day for children > 6 months for 14 days) and feeding of energy dense feeds along with breastfeeding11 in the list of medicines to be available at the subcenters after recognizing its importance. 12 Our study revealed that overall prescriptions with ORS were 29.35% and total percentage of prescriptions with Zinc was 36.96%. This shows that it is important to create an enabling environment to promote awareness about rational use of drugs in diarrhoea, and to improve accessibility of the standard drugs (ORS and Zinc) to the doctors. The IAP guidelines also lay stress on intake of home available fluids, hand washing and other hygienic practices. Antibiotics are recommended only for Shigella positive culture, cholera, gross blood in stools, associated systemic infection, or severe malnutrition. 11 Use of antimicrobials may not be either necessary or effective even in some cases of infective diarrhoea because of the self-limiting nature of the disease. Not unexpectedly frequent use of antimicrobial was observed (Figure 3). Antimicrobial alone or in combination was prescribed in a total of 60 (65.22%) of the patients.the reason for this may be the anticipation of an impending sepsis or a quicker response, especially in cases of children less than two months of age where fever with diarrhea is suspected to be due to probable sepsis. Also after first exposure of antibiotic the culture reports can be negative. Still the inadvertent use is not justified and suggests lack of awareness on the use of antimicrobials in cases of diarrhea. 13 Indian Academy of Pediatricians (IAP) guidelines for the treatment of acute diarrhoea mentions that antimicrobials should not be given routinely as most of the cases of acute diarrhea are caused by viruses, not bacteria. Furthermore, the episodes of diarrhea caused by enterotoxigenic Escherichia coli cannot be differentiated clinically from those caused by agents such as rotavirus or cryptosporidium. 14 In addition; the inadvertent use of antimicrobials enhances the development of resistance in bacteria. 15 Duration of antibiotic use is also not mentioned in our study. The possible reason could be that the duration was judged by the condition and stay of the inpatient and changes in prescription were made accordingly. As a whole, our findings show a better prescription writing pattern in the department of paediatrics of our medical college as compared to similar studies done elsewhere 10,16 and in some other departments of the same medical college. 17,18,19 CONCLUSION Ensuring mechanisms like continuous prescription audits to monitor and improve the prescribing habits of doctors are the need of the hour to ensure that the doctors adhere to the essential drug list and follow the standard treatment guidelines. Rational J Rational Pharmacother Res Volume 4 (Issue 1):

9 prescribing therefore will be effective in reducing use of unnecessary drugs for diarrhoeal diseases and increasing the use of ORS and Zinc in India. REFERENCES 1. Diarrhoeal disease. Media centre: Fact sheet. [Accessed 2017 October 3] Available from: Fischer Walker CL, Fontaine O, Young MW, Black ER. Zinc and low osmolarity ORS for diarrhoea: A renewed call to action. Bull World Health Organ 2009;87: Gitanjali B, Weerasuriya K. The curious case of zinc for diarrhea: Unavailable, unprescribed and unused. J Pharmacol Pharmacother 2011;2: Tanmaya M, Patil VD, Rajsekhar W, Hiremath MB. The role of antibiotics in childhood diarrhoea. Rec Res Sci Tech 2010;2: Howteerakul N, Hogginbotham N, Dibley MJ. Antimicrobial use in children under five years with diarrhoea in a central region province of Thailand. Southeast Asian J Trop Med Public Health 2004;35: Press Information Bureau, Government of India, Ministry of Health and Family Welfare, Health Ministry launches Intensified Diarrhoea Control Fortnight (IDCF), Intensified efforts to reduce child deaths due to diarrhea, 14-June How to Investigate Drug Use in Health Facilities: Selected Drug Use Indicators. [Accessed 2017 October 3] Available from: / medicinedocs/en/d/js2289e/3.1.html 8. Chaturvedi SK, Sinha P, Chandra PS, Desai G. Improving quality of prescriptions with clinical audit. Indian J Med Sci 2008;62: Bern C, Martines J, de Zoysa I, Glass RI. The magnitude of the global problem of diarrhoeal disease: a ten-year update. Bull World Health Organ 1992;70: Sharma L, Gupta R, Kapadia R, Gupta K, Singhal S, Gupta J.K, et al. Auditing of prescriptions in relation to diarrhea in children below 5 years of age: a multicenter study. Int J Basic Clin Pharmacol 2015;4: Bhatnagar S, Lodha R, Choudhury P, Sachdev HP, Shah N, Narayan S, et al. IAP Guidelines 2006 on management of acute diarrhea. Indian Pediatr 2007;44: Bhatnagar S, Alam S, Gupta P. Management of Acute Diarrhea: From Evidence to Policy. Indian Paediatr 2010;47: World Health Organization- First Steps for Managing an Outbreak of Acute Diarrhea Geneva:WHO;2004. [Accessed 2017 Sep21] Available from: publications/en/first_steps.pdf 14. Kotwani A, Holloway K. Trends in antibiotic use among outpatients in New Delhi, India. BMC Infect Dis 2011;11: Alam MB, Ahmed FU, Rahman ME. Misuse of drugs in acute diarrhoea in under-five children. Bangladesh Med Res Counc Bull 1998;24: Priyadarshini K, Raj V, Balakrishnan S. Audit of use of antibiotics and zinc supplement in childhood diarrhea. Journal of Pharmacology & Pharmacotherapeutics 2013;4: Salman MT, Khan FA, Rahman SZ, Makhdoom M. Drug prescribing pattern in dental practices of a teaching hospital in North India. JK Science. 2009;11: Salman MT, Akram MF, Rahman SZ, Khan SW. Drug prescribing pattern in surgical wards of a teaching hospital in North India. Indian Journal for Prescribing Doctors 2008; 5: Anwar A, Rahman SZ, Singh PB, Osmani MA. Prescription auditing of patients admitted at psychiatry ward of a Tertiary Care Hospital of Western U.P. Int Arch Biomed Clin Res 2015;1: J Rational Pharmacother Res Volume 4 (Issue 1): 2018