|Year : 2010 | Volume
| Issue : 1 | Page : 8-12
Drug utilization pattern of antibacterials used in ear, nose and throat outpatient and inpatient departments of a university hospital at New Delhi, India
MR Ain1, N Shahzad1, M Aqil2, MS Alam1, R Khanam1
1 Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard, New Delhi-110 062, India
2 Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, New Delhi-110 062, India
|Date of Submission||04-Feb-2010|
|Date of Decision||10-Feb-2010|
|Date of Acceptance||25-Feb-2010|
|Date of Web Publication||23-Apr-2010|
Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard, New Delhi-110 062
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objective : We explored the antibacterial prescribing patterns of physicians in ear, nose and throat (ENT) outpatient and inpatient departments (OPD, IPD) of a University Hospital, New Delhi, India. Materials and Methods : A prospective study was conducted, with a sample size of 276 patients, who visited the ENT OPD and IPD over a period of 4 months. Results : It was found that 62.68% were males, 26% patients were in the age group 26-35 years, followed by 22.8% belonging to the age group 26-35 years. Maximum number of patients were diagnosed with ear (37.3%) and throat (36.2%) infections. The most frequently prescribed antibacterials were β-lactams (45.52%) followed by quinolones (26.31%). The most commonly used agent in penicillins was amoxicillin and clavulanic acid (21.74%), in cepahalosporins was cefpodoxime proxetil (5.49%) and in quinolones was gemifloxacin (14.41%). Further, 66.67% of the patients received single antibacterial drug and the average number of antibacterial agents prescribed per patient per course was found to be 1.58. It was also observed that 70.71% of the antibacterials were prescribed by oral route. The most concomitant conditions were found to be diabetes (10.5%), hypertension (6.16%) and coronary heart disease (5.07%). All the drugs were prescribed by their brand names and 48.91% patients showed good adherence with the prescribed therapy. Conclusions : The present work is the maiden drug utilization study conducted in ENT department at our university hospital. It highlighted some rational prescription patterns including less utilization of antibiotics in ENT infections, good adherence by patients and prescription by brand names. The data presented here will be useful in future, long-term and more extensive drug utilization studies in the hospital and in promotion of rational prescribing and drug use in hospitals.
Keywords: Antibacterial agents, drug utilization, ENT infections
|How to cite this article:|
Ain M R, Shahzad N, Aqil M, Alam M S, Khanam R. Drug utilization pattern of antibacterials used in ear, nose and throat outpatient and inpatient departments of a university hospital at New Delhi, India. J Pharm Bioall Sci 2010;2:8-12
|How to cite this URL:|
Ain M R, Shahzad N, Aqil M, Alam M S, Khanam R. Drug utilization pattern of antibacterials used in ear, nose and throat outpatient and inpatient departments of a university hospital at New Delhi, India. J Pharm Bioall Sci [serial online] 2010 [cited 2019 Dec 15];2:8-12. Available from: http://www.jpbsonline.org/text.asp?2010/2/1/8/62695
Diseases of the ear, nose and throat (ENT) affect the functioning of adults as well as children, often with significant impairment of the daily life of affected patients.  It has been envisaged that with increase in global population, infections remain the most important causes of disease, with upper respiratory tract infections (URTIs) causing hearing loss and learning disability, especially in children. In its World Health Report of 2004, the World Health Organization (WHO) estimated that respiratory infections generated 94.6 disability adjusted life years lost worldwide and were the fourth major cause of mortality, responsible for 4 million deaths or 6.9% of global number of deaths in 2002. 
Acute respiratory infections accounts for 20-40% of outpatient and 12-35% of inpatient attendance in a general hospital. URTIs including nasopharyngitis, pharyngitis, tonsillitis and otitis media (OM) constitute 87.5% of the total episodes of respiratory infections.  They are a major source of morbidity and absenteeism at work. The vast majority of acute URTIs are caused by viruses. For instance, common cold is caused by viruses in most circumstances and does not require antimicrobial agent unless it is complicated by acute OM (AOM) with effusion, tonsillitis, sinusitis and lower respiratory tract infection. Most cases of rhino sinusitis are viral and, therefore, resolve spontaneously without antimicrobial therapy. 
The majority of the antibiotics were prescribed for respiratory and ENT infections with a presumed viral etiology, such as rhino-pharyngitis and acute bronchitis. The results of the different surveys were in agreement showing that antibiotic prescriptions are made in approximately 40% of all consultations for rhino-pharyngitis and in 80% of those for acute bronchitis. Antibiotics were prescribed in more than 90% of cases of pharyngitis, irrespective of the age of the patient. The variability in antibiotic prescription is attributable to the infecting organisms and antimicrobial susceptibility that differ from country to country, or even from region to region, but other factors may also be involved including physician preference, local policy, costs and lack of local guidelines. 
Asia is one of the regions where the problem of resistance is most prominent. In particular, the rates of resistant pneumococci in Asian countries have been alarming. In India, almost 100% of the healthy population carries bacteria that are resistant to ampicillin, trimethoprim, nalidixic acid and chloramphenicol. 
Poor patient compliance or noncompliance with medications is particularly important in clinical practice. It has been found to be associated with treatment failure and all its consequences, namely, deterioration of patients' health, the need for additional consultations, the use of extra drugs, additional hospital admissions and increase in direct and indirect costs of disease management. 
Despite several years of clinical use of antibiotics, little is known about how these drugs should be used optimally in the clinic. A central and still largely unanswered question is how antibiotics should be administered clinically to minimize resistance development without compromising safety and efficacy. The International Network for the Rational Use of Drugs (INRUD) was established in 1989 to promote the rational use of drugs in developing countries. Various indicators were developed by INRUD in collaboration with WHO that provided objective indices to allow for assessment of drug use practices.  Still, there is a need for data on both antibiotic use and determinants of use from all the regions of the world.
Therefore, it is imperative to evaluate and monitor the drug utilization patterns from time to time, to enable suitable modifications in prescribing patterns to increase the therapeutic benefit and decrease the adverse effects to optimize the medical services for the patents.  Drug use evaluation is an ongoing, authorized and systemic quality improvement process, which is designed to review the drugs which are prescribed to the patients, provide a right feedback to the clinician/other relevant groups, develop criteria and standards that describe optimal drug use, promote appropriate drug use through education and council the patients.
Hence, the present prospective study was aimed to evaluate drug utilization pattern of antibacterials used in ENT infections in patients of outpatient (OPD) and inpatient (IPD) departments at University Hospital, Hamdard University, New Delhi, India.
| Materials and Methods|| |
The study was carried out in the ENT OPD and IPD of Majeedia Hospital, a 150-bed teaching hospital situated in Hamdard University, New Delhi, India.
It was a prospective study and was based on a Medication Utilization Form, which has been designed on the basis of a WHO format.
Duration of study
The duration of study was 4 months (January 2008 to April 2008). The study was approved by the Jamia Hamdard Institutional Review Board. An oral and written consent was obtained from the patients before their participation in the study.
The present study was conducted on 276 patients who visited the OPD and IPD of ENT department during the 4-month period. The subjects who had willingly participated were enrolled on the basis of inclusion and exclusion criteria. All the patients using antibacterials, irrespective of age and sex, including pregnant and lactating patients were studied. However, patients who were not treated with antibacterials or were unable to comply due to mental retardation, unconsciousness or drug addiction were excluded.
Parameters for evaluation
The present study followed some WHO/INRUD indicators in addition to some other useful indicators. The parameters included gender distribution, average age range of patients, types of infections, types of antibacterial prescribed, most commonly used agents of a particular class, average number of antibacterials per prescription, comparison of antibacterials prescribed in monotherapy versus fixed dose combination therapy, mode of administration, comparison of antibacterials prescribed by generic versus brand name, concomitant diseased conditions, compliance or adherence (using weekly diary cards).
The sources of data were physicians prescribing records, patient's medication profile and weekly diary cards. Patient profile (age, sex, weight, height, patient's address), drugs prescribed (generic/brand name), doses and frequency were recorded. Patients were interviewed after their informed consent was obtained. Interviews were conducted by using structured questionnaire (open question method). Weekly diary cards were used to determine patient compliance. A criterion for noncompliance is <80% of recommended intake of prescribed drugs.
| Results|| |
A total of around 3100 patients visited the ENT OPD and IPD, over a period of 4 months. On the basis of inclusion and exclusion criteria, 276 patients were selected for the present study. Among the 276 ENT patients, 173 were male and 103 were female. The highest number of patients were in the age group 16-25 years and the lowest percentage was geriatric patients [Table 1]. During the study, it was observed that 103 patients visited for treating ear infection, 41 for nose infections, 100 for throat infections and 32 for combination of ENT infections [Table 2].
During the study, it was observed that the most commonly prescribed antibacterials were β-lactam (penicillins and cephalosporins)-199, followed by quinolones-115, macrolides-54, chloramphenicol-43, tetracyclines-17 and aminoglycosides-9 [Table 3]. The most commonly used agent of these classes, i.e, β-lactam was penicillins (amoxicillin with clavulanic acid-95) and cephalosporins (cefpodoxime proxetil-24) followed by quinolones (gemifloxacin-63, chloramphenicol-43), macrolides (azithromycin-38), tetracyclines (doxycycline-16) and aminoglycoside (neomycin with polymyxin B-6) [Table 4].
The prescription of patients showed that a total of 184 patients received antibacterial monotherapy, whereas 92 patients were on multiple drug therapy. Among those who were treated with drug combinations, 62 received two drugs, 18 received three drugs and 12 received four drug regimens [Table 5]. The average number of antibacterial agents prescribed per patient per course was found to be 1.58.
A total of 437 antibacterials were prescribed. Their routes of administration were oral (309), intravenous (72) and ear drop (56). The most frequent comorbid condition of the study population was found to be diabetes (10.50%) followed by hypertension (6.16%) and coronary artery disease (5.07%) [Table 6]. All the antibacterial agents were prescribed by their brand names only. Weekly diary cards were used for daily drug intake to monitor adherence to the prescribed dosage regimen. The standard criteria for noncompliance were <80% of the recommended intake of prescribed drugs. In the present study, 135 of total patients showed a good adherence with the prescribed treatment. Adherence was found to be slightly better in females than in males.
| Discussion|| |
Prescription by a doctor may be taken as a reflection of physician's attitude to the disease and role of the drug in treatment. It also provides an insight into the nature of health care delivery system.  Little information exists about the prescriptive behavior of physicians and the misuse of antibacterials in the management of outpatient and inpatient with ENT infections. In general practice, the therapeutic approach for ENT infections is nearly empirical and the main aim of physicians is to treat as specifically as possible, while covering the most likely pathogens. The present descriptive study indicates general trends of prescribing in the OPD and IPD of ENT department.
Demographic characteristics showed that percentage of males suffering from ENT infections was more than females. Similar findings were also reported by Shankar et al. and Pradhan et al, showing higher percentage of males suffering from ENT infections. , Many other studies showed that females are more sensitive to ENT infections than males; the reason might be their exposure to kitchen smoke.  In our study, the observed percentage of males was predominant which might be due to the occupational reasons.
Further, it was found that a majority of the patients were in the age group of 16-25 years and the lowest percentages were in geriatric group. It indicates that ENT infections are more prevalent in young adults. Few studies have reported that majority of patients fell in different age groups like 45-60 years and greater than 60 years with respiratory infections. 
Patients suffering from various acute and chronic ENT infections were treated with different antibacterial agents. In our study, the number of patients with OM was maximum, however the cases of acute and chronic suppurative OM (ASOM and CSOM) with other ear infections were also observed. The cases of epistaxis, sinusitis and allergic rhinitis predominate in nose-infected patients. However, sore throat, acute pharyngitis and tonsillitis were the maximum cases of throat-infected patients. It was an interesting observation that a significant number of patients with combination of ENT patients suffered from URTIs alone or along with OM and other infections.
Most commonly prescribed categories of antibacterials were found to be β-lactam (45.52%), followed by quinolones (26.31%) and macrolides (12.12%). The chloramphenicol and tetracyclines constituted only 9.84 and 3.89%, respectively. Among the individual antibiotic drugs, maximum patients received a combination of amoxicillin with clavulanic acid (21.74%), followed by gemifloxacin (14.41%), chloramphenicol (9.84%), azithromycin (8.69%), cefpodoxime proxetil (5.49%) and doxycycline (3.66%). In a study, Das et al. reported that ciprofloxacin (23.85%) was preferred, followed by amoxycillin (20.06%), a combination of ampicillin + cloxacillin (9.17%), doxycyclin (5.96%), erythromycin (4.58%) and co-trimoxazole (4.58%).  A similar study reported that amoxicillin, amoxicillin-clavulanate, cefdinir, cefpodoxime proxetil and cefuroxime axetil are all considered appropriate for the initial treatment of acute bacterial rhinosinusitis in children.  It is well known that indiscriminate use of broad spectrum antibiotics increases bacterial resistance.  So, the use of azithromycin and clarithromycin should be indicated only when their broad coverage is required or when other antibiotic use is prohibited due to allergy, etc. However, a change in the prescribing patterns from a small spectrum to penicillin to amoxicillin/clavulanate, as indicative in our study, could be due to an increase in antibiotic resistance which encourages physicians to choose a broader and safer option.
The mean number of antibacterial agents prescribed per patient per course was found to be 1.58. In a similar study, Das et al. reported 1.4 antimicrobial agents per patient in outpatient services of ENT department in a tertiary care hospital of Eastern Nepal.  It is an important indicator for assessing rationality of prescription. Hence, physicians should preferably keep the mean number of drugs per prescription as low as possible as higher figures always lead to increased risk of drug interaction, development of bacterial resistance and increased cost. ,
Further, 66.67% patients received antibacterial monotherapy; whereas 33.33% patients were on multiple drug therapy. Das et al. have reported that single drugs were prescribed the maximum (89.52%), followed by two drugs (9.94%) and three drugs (0.52%) in ENT patients'.  In the present study, the routes of administration of antibacterials were found to be oral 70.71%, parenteral (i.v.) 16.48% and topical (via ear drop) 12.81%. Shankar et al. have carried out a prospective study where 48.9% antibacterial agents were prescribed by the parenteral route.  The trend of prescribing drugs under generic name is declining. 
In our study, it was found that all the antibacterial agents were prescribed by their brand names only, which could be due to the influence of medicinal drug promotional activities. Prescribing the brand name may undermine some of the goals of essential drug concept. On the other hand, prescribing by generic names may reduce overall expenditure on drugs, especially on newer antibiotics, etc.
A significant number (32.2%) of patients were suffering from concomitant diseases. The most frequent comorbid condition of the study population was found to be diabetes (10.5%), followed by hypertension (6.16%), coronary artery disease (5.07%), hypothyroidism and rheumatoid arthritis. In a similar study, Mazzaglia et al. have reported liver disease as the most concomitant condition, followed by diabetes mellitus, heart disease, ischemic heart disease, malignant neoplasm in acute URTIs.  Huchon et al. have reported that the rate of chronic disease was highest in Italy (52%) and lowest in Spain (38%). Therefore, our study indicates that the percentage of concomitant disease (32.2%) was lower than the percentage found in Italy and Spain, whereas diabetes was reported to be common concomitant condition against liver disease in the above mentioned literature. In our study, only 135 (48.91%) patients had taken the drugs properly. Cost of antibiotics could be one of the major contributing factors for noncompliance in a developing country like India.
The study was carried out over a 4-month period, and seasonal variations in disease pattern and drug utilization were not considered. Further, the number of patients was low and the study was restricted to only one hospital, hence the results cannot be considered representative of the whole country. However, in spite of all these limitations, our study highlighted some rational prescribing practices. Continuing education on rational drug use and development of easy to use treatment guidelines for common diseases is suggested. In our future endeavors, we plan to study the effect of regulatory and educational interventions on drug use pattern in the management of ENT infection.
| Conclusions|| |
To conclude, our study in the university teaching hospital highlighted lesser utilization of antibacterials in ENT infections, as some of the ENT infections are not due to bacteria. It appears that majority of the ENT patients visiting the hospital have infections primarily due to bacteria and most of the patients responded well to the use of antibiotics. Majority of the patients used the regimen in accordance with the current guidelines.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]