INTRODUCTION
Adults and children generally are affected by diseases of the ear, nose,
and throat (ENT), which can cause severe impairment in patients’ daily
lives [1]. With the growing global population, infections are
expected to remain the leading cause of disease, with upper respiratory
tract infections (URTIs) causing hearing loss and learning disabilities.
The World Health Organization (WHO) reported in its World Health Report
that respiratory infections caused 94.6 disability adjusted life years
lost worldwide and were the fourth leading cause of death, accounting
for 4.0 million fatalities or 6.9% of all deaths.
In a general hospital, acute respiratory infections account for 20-40%
of outpatient visits and 12-35 percent of inpatient stays. URTIs, which
include nasopharyngitis, pharyngitis, tonsillitis, and otitis media
(OM), account for 87.5 percent of all respiratory infection episodes.
They are a major cause of morbidity and workplace absenteeism. Viruses
cause the great majority of acute URTIs. In most cases, a common cold is
caused by viruses and does not require the use of antimicrobials unless
it is accompanied by acute OM with effusion, tonsillitis, sinusitis, or
a lower respiratory tract infection. Because most occurrences of rhino
sinusitis are viral, they recover on their own without the need for
antibiotics [2]. Antibiotics were mostly administered for
respiratory and ENT diseases having a viral aetiology, like
rhino-pharyngitis and severe bronchitis. Antibiotic prescriptions are
written in around 40% of all consultations for rhino-pharyngitis and in
about 80% of those for acute bronchitis, according to the findings of
the various surveys. Antibiotics were administered in more than 90% of
pharyngitis cases, regardless of the patient’s age. In contrast, the
frequency of consultations for acute middle ear infections has stayed
essentially stable over the last ten years, while antibiotic
prescriptions have climbed dramatically, reaching 80 percent of
consultations. Antibiotic prescription diversity is due to true
variances in infecting organisms and antimicrobial susceptibility from
country to country or even region to region, but other factors may also
be at play, such as physician choice, local policy, costs, and a lack of
local guidelines [3]. The current global rise in
antibiotic-resistant bacteria, along with a lower trend in new
antibiotic discovery, has major health and economic ramifications.
Antibiotics are widely misused, including use based on false medical
grounds, as well as misuse involving the improper agent, administration
method, dose, and treatment duration. Antibiotic use results in the
development of resistance as a natural biological process. “Poor
patient adherence to dose regimens and the administration of substandard
antibiotics result in suboptimal concentrations that fail to treat
infection and may promote the formation of resistant bacterial
populations; hence, underuse, irrational use, and overuse may both play
a role in promoting resistance.” At this time, there is no such thing
as an ideal antibiotic, and the overuse of broad-spectrum antibiotics in
respiratory infections leads to resistance development in pathogenic
bacteria as well as the patient’s normal bacterial reservoir [4].
Asia is one of the regions with the most serious resistance issues. The
prevalence of resistant pneumococci in Asian countries, in particular,
have been worrying. In India, bacteria resistant to ampicillin,
trimethoprim, nalidixic acid, and chloramphenicol are found in nearly
every healthy person [5]. Despite the fact that antibiotics have
been used in clinical practice for many years, little is understood
about how they should be used best in the clinic. How antibiotics should
be delivered clinically to reduce resistance development while
maintaining safety and efficacy is a crucial and largely unresolved
subject. There is a need for data on both antibiotic use and
determinants of use from all regions in the world. In too many countries
there is no adequate surveillance of prescribing, of drug quality, or of
the resistance problem. Through European surveillance of antimicrobial
consumption (ESAC) project, significant improvements in the surveillance
of antibiotic use in Europe have been achieved. However, a global
approach is needed where comparable data are generated [6].
Therefore, studies reflecting drug utilization are required, as they
assess the appropriateness of drug therapy. Drug use evaluation is an
ongoing, authorized, and systemic quality improvement process that is
designed to review the drugs that are prescribed to patients, provide
appropriate feedback to clinicians/other relevant groups, develop
criteria and standards that describe optimal drug use, and educate and
counsel patients on appropriate drug use. Prospective drug utilization
studies can directly influence patient treatment and outcome.
Pharmacovigilance of antibiotics for its safer use is also essential;
the overall purpose of pharmacovigilance is improvement in the safety of
medicines (WHO, 2004). The estimation of the probability that a drug
caused adverse clinical event is usually based on clinical judgment.
Using the conventional categories and the criteria of definite,
probable, possible and doubtful adverse drug reaction generates wide
variability scales (Naranjo’s and WHO’s probability scale). The
Naranjo’s scale categorizes the reaction as highly probable, probable,
possible and unlikely; this probability scale is based on simple
questionnaire that can be answered rapidly [7], this scale is easier
and time saving as compared to WHO’s probability scale.
Hence, the present prospective study was aimed to evaluate drug
utilization pattern and adverse drug reaction monitoring of antibiotics
use in ear, nose and throat infections.