ABSTRACT

Background Otitis media (AOM) is a very common condition and a leading cause of
health care visits and drug prescription. The aim of this study is to assess the drug
prescribing patterns in ASOM and CSOM at Tertiary care Hospital.

Material and methods A prospective observational drug utilization study was carried
out in the Department of Pharmacology in collaboration with ENT Department. Patients
who attended the ENT outpatient department (OPD) with ASOM and CSOM during 6
months period were included in the study and the data were analysed.

Results: A total of 124 cases of ASOM and 49 cases of CSOM of the patients were
analysed. The study showed higher percentage of males suffering from ENT infections
as compared to females. The present study showed that the age group commonly
affected was 18 to 35 years. In the present study, each prescription contained an
antibiotic, an antihistaminic and analgesics on an average. During this study, it was
found that the most commonly prescribed antimicrobial was Amoxclav followed by
Ciprofloxacin.

Conclusions: The results of this study will be useful in future for making standard
treatment guidelines. It also promotes the rational prescription and rational use of drugs.

Keywords: Drug utilization, Prescribing pattern, ASOM and CSOM

 INTRODUCTION

Drug utilization research is an essential part of pharmacoepidemiology as it provides

insights into the extent, nature and determinants of drug use and drug prescribing.1

Studies on drug utilization focus on factors related to prescribing, dispensing,

administering and taking of medication and its associated events, including the medical

and non-medical determinants of drug utilization, as well as studies of how drug

utilization relates to the effects of drug use, beneficial or adverse.2,3 So, recently,

studies on drug utilization have become a potential tool to be used in the evaluation of

health care system.4

The World Health Organization (WHO) in 1997 defined drug utilization as the marketing,

distribution, prescription and use of drugs in a society, with special emphasis on the

resulting medical, social and economic consequences.5 The ultimate goal of drug

utilization research is to facilitate rational use of drugs, minimize the adverse events and

drug interactions leading to better patient compliance and outcome. It also provides

insight into the efficacy of drug use i.e. whether a certain drug therapy provides value

for money. Drug utilization research can thus help to set priorities for the rational

allocation of health care system budgets.1

Diseases of the ear, nose and throat (ENT) affect the daily functioning of affected

patients, often lead to significant morbidity. It has been envisaged that with increase in

global population, infections remain the most important causes of disease, among

which, Ear infections such as acute & chronic otitis-media have serious consequences

in developing countries.6 Otitis media (AOM) is a very common condition and a leading

cause of health care visits and drug prescription.7 Recently, systematic review
estimates global burden of Acute OM as 709 million cases each year with incidence rate

is 10.85% and that of Chronic suppurative OM 31 million cases with incidence rate is

4.76%. OM-related hearing impairment has a prevalence of 30.82 per ten-thousand.

Each year 21 thousand people die due to complications of OM.8

All prescribing is not necessarily based on patient needs and all patient needs are not

necessarily met with drug therapy. similarly, there is as much concern about

inappropriate and expensive prescribing, as about under-prescribing. The development

of drug utilization as a research area made it possible to study drug prescribing and

drug usage in a scientific and formal manner.9

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.10

The primary aim of this study was to generate up to date information on drug use in the

ENT outpatient service of our hospital and indications for use, aptness of its use. This

would encourage good evidence based practice and facilitate appropriateness of drugs.

Hence the present study was carried out in the ENT OPD at tertiary care hospital.

STUDY OBJECTIVE
The objective of the present study was to evaluate the patterns of drug prescribing

practices in treatment in ASOM & CSOM in ENT OPD.

MATERIALS AND METHODS

Site of Study:

The study was conducted in the Department of Pharmacology in collaboration with OPD
of ENT Department of Government Medical College and Hospital Aurangabad,
Maharashtra, India.

Study design:
Prospective-open label observational drug utilization study.

Study period:
The duration of study was 6 months (Feb 2015 to Aug 2015). The study was approved
by the Institutional ethical committee (IEC), Government medical college, Aurangabad.
Patients were thoroughly informed about the study and written informed consent was
taken before their enrolment into the study.

Study population:
The present study was conducted on 173 patients who visited the OPD of ENT
department during the 6-month period. The subjects who had willingly participated were
enrolled on the basis of inclusion and exclusion criteria.

Inclusion Criteria:
All patients of ASOM & CSOM attending the ENT outpatient Department
Willingness to give written informed consent

Exclusion Criteria:
Associated complications of the diseases under the study
Other Comorbid conditions/diseases
Not Ready to give Informed consent
Parameters for evaluation:
The present study followed some WHO/INRUD indicators in addition to some other
useful indicators. The parameters included types of infections, gender distribution,
average age range of patients, Patterns of prescribed drugs in particular type of
infection, most commonly used agents of a particular class.
Statistical analysis:
After completion of study period computerization of data recorded in CRF was done.
The data collected was analysed statistically using descriptive statistics.
RESULTS
The study monitored the drug utilization pattern to the patients treated ASOM & CSOM

in ENT OPD at Tertiary care Hospital. On the basis of inclusion and exclusion criteria,

173 patients were selected from the ENT OPD over a period of 6 months for

the present study. A total of 124 cases of ASOM and 49 cases of CSOM of the patients

were analysed. All the case records had the complete documentation of information,

including patients demographic characteristics, diagnosis, drug names, dose route and

frequency of intake. Observations of the study are presented in the form of different

tables.

Table 1: Gender-wise distribution of ASOM & CSOM cases

Diagnosis Male % Female %
ASOM 71 57.25 53 42.75
CSOM 26 53.06 23 46.94
 ASOM

43%
57%

Males Females

CSOM

47% 53%

Males Females

Table 2: Age-wise distribution of ASOM cases

ASOM
Age (years) Male Female Total
18-25 27 20 47
25-35 23 16 39
35-45 15 13 28
>45 6 4 10
Total 71 53 124
 No.of patients in ASOM

10

28 47

39

18-25 yrs 25-35 yrs 35-45 yrs >45 yrs

Table 3: Age-wise distribution of CSOM cases

CSOM
Age (years) Male Female Total
18-25 10 8 18
25-35 11 8 19
35-45 5 4 9
>45 2 1 3
Total 28 21 49

No. of patients in CSOM

3
9
18

19

18-25 yrs 25-35 yrs 35-45 yrs >45 yrs

Table 4: Patterns of prescribed drugs in ASOM
ASOM
Medications No. of patients prescribed %
Amox-Clav 101 81.45
Ciprofloxacin 23 18.55
Ear drops 22 17.74
Diclofenac 108 87.09
Pcm + SP + Aceclo 16 12.91
Levocetrizine 107 86.29
Levocet + montelukast 17 13.71
Ranitidine 124 100
MVBC 124 100

% percentage of prescribed drugs in ASOM

100 100
87.09 86.29
81.45

18.55 17.74
12.91 13.71

Table 5: Patterns of prescribed drugs in CSOM

CSOM
Medications No. of patients prescribed %
Amox-Clav 49 100
Ciprofloxacin 36 73.46
Ear drops 35 71.42
Diclofenac 40 81.64
Pcm + SP + Aceclo 9 18.36
Levocetrizine 41 83.67
Levocet + montelukast 8 16.33
Ranitidine 49 100
MVBC 49 100

% of prescribed drugs in CSOM

100 100 100

81.64 83.67
73.46 71.42

18.36 16.33

Discussion

Prescription by a doctor may be taken as a reflection of physicians attitude to the

disease and role of the drug in treatment. It also provides an insight into the nature of

health care system.1. The present descriptive study indicates general trends of

prescribing in the OPD of ENT department. In present study we have observed, 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. 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.2 In the present

study, each prescription contains an antibiotic, an antihistaminic and analgesics on an

average.

In present study, 124 cases were of ASOM and 49 were of CSOM. Among 124 cases of

ASOM, 71 were males and 53 were females. Out of 49 cases of CSOM, 26 were males

and 23 were females. This is in concordance with the study conducted by Yadav et al.

(2010)3, Shankar et al. (2006)4, Pradhan and Jauhari(2007)5 and Ain et al. (2010) 6

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 (Dhingra, 2004). 7

The present study have showed that the age group commonly affected is 18 to 35

years. The similar finding is observed in Yadav et al. (2010)3, kumar R et al (2014). 8

In present study, most common antibiotic prescribed was Amoxicillin + Clavulanic acid.

Although clavulanic acid is not an antibiotic, it protects amoxicillin from enzymatic

destruction by binding to them resulting in potentiating or synergistic effect. This is

similar as observed by Ain et al. (2010) 6, kumar R et al (2014) 8, Khan et al (2011).9

Ciprofloxacin was also used in some cases as alternative in patients who were allergic

to penicillins.

Among the Analgesics Diclofenac was most preferred. In some patients, Paracetamol in

combination with Aceclofenac and Serratiopeptidase was prescribed. Among

antihistaminics Levocetrizine was most commonly prescribed. In some patients it was

used in combination of Montelukast, a leukotriene antagonist. This was followed by use

of Multivitamins and antacids ranitidine in all patients.

Most of the patients were prescribed antibiotics based on presumptive diagnosis and

clinical skills. Generic prescribing is to be encouraged as it works out to be cheaper for

the patient and the possibility of drug errors is reduced. The choice of drugs, the

duration and the route chosen were appropriate in the majority of cases.

Conclusion

To conclude, present study in the tertiary care hospital highlighted pattern of drug
utilization in ASOM and CSOM and most of the patients responded well to prescribed
regimens. Majority of the regimen in accordance with the current guidelines including an
Antibiotic, an Antihistaminc, an Analgesic. The results of this study will be useful in
future for making standard treatment guidelines. It also promotes the rational
prescription and rational use of drugs.

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