Assessment of Prescribing Practice of Antibiotics in common cold

(ARI) in children under the age of 5 years in PIMS Islamabad

Submitted To:

Najmuddin Bakrey

Submitted By:

Hadaitullah

Program:

Msc.IR

Semester:

2ND

Registration no:

1443_311007

PRESTON UNIVERSITY, Islamabad campus

1

ACKNOWLEDGEMENTS

All praise and thanks to Allah all mighty, the most merciful and beneficent. He has

always helped us out whenever we are in need.

First of all, our greatest gratitude to Sir.Nujmuddin, our research supervisor, who has

been a source of inspiration for us. He always listened to us and guided us in a very

empathetic way. His constant guidance, criticism and encouragements have enabled us to

accomplish this task. We would like to thanks our parents for their love prayers and

opportunities they provided. We would also like to thanks the chief pharmacist of the

PIMS who allowed me for data collection in PIMS Islamabad.

In the last I would thank specially Sir.Nujmuddin who helped me a lot and spared their

precious time for us.

Hadaitullah

2

Table of contents Table of contents

Sr. No Contents Page No

1. Title Page01

2. Acknowledgments 05

3. Abstract 07

4. Chapter # 1Introduction 08

5. Chapter # 2Objectives 18

6. Chapter # 3Methodology 20

7. Chapter # 4Results 22

3

Abstract:

Background: The spread of antibiotic-resistant bacteria is associated with antibiotic use.

Children receive a significant proportion of the antibiotics prescribed each year and

represent an important target group for efforts aimed at reducing unnecessary antibiotic

use. The judicious prescription of antibiotics has become a central focus of professional

and public health measures to combat the spread of resistant organisms.

Objective: To assess the prescribing practice of Antibiotics in common cold (ARI) in

children under the age of 5 years in PIMS Islamabad and to compare it with standard

treatment guideline.

Significance: Descriptive cross sectional study: A total of 100 prescriptions of children

under the age of 5 years were obtained from the hospital. Prospective method was used to

collect the prescriptions.

Antibiotics were prescribed to 70% of children presenting with symptoms of common

cold in different combination. About 53% of patients were given Antiobiotic +

Antipyretic + Antihistamine combination. About 30% of patients were given Antipyretic

and Antihistamine combination. About 7% of patients were given Antibiotic+ Antipyretic

combination. About 5% of patients were given antibiotic and antihistamines combination

and about 5% of patients were using Antiobiotic +Antipyretic+ Antihistamine

+Multivitamins combination. There was only one class of antibiotic was prescribed by

the physicians and that was penicillin. The number of drugs prescribed per patient varies

considerably for treatment of common cold in childerns. About 55 % of prescription

contains 3 numbers of drugs. 40% of prescription contains 2 numbers of drugs and only 5

% of prescription contains 4 numbers of drugs.

Conclusion: Antibiotics are commonly used in common cold in children under the age of

5 years. The outcome of such irrational practices was loss of these limited resources and

emergence of antibiotic resistance and result poor quality of health.

4

Chapter 1:

Introduction

5

INTRODUCTION:-

The common cold is not a single infectious disease, but rather a group of self-limiting

viral upper respiratory infections (URIs) producing a similar clinical syndrome.[1] The

average preschool child contracts approximately 6 to 10 colds per year, and the average

adult has 2 to 4 colds annually. Roughly 23 million lost work days and 26 million missed

school days are the result of the common cold each year. Many more persons continue

their usual activities with lower productivity and uncomfortable symptoms. Furthermore

expenditures for products used to treat cold symptoms exceed $2.5 billion annually after

adjusting for inflation[2] The common cold is generally regarded as a mild condition that

rarely causes significant morbidity. However, serious exacerbations of underlying disease

may occur in patients with asthma or pre-existing obstructive lung disease. Patients with

the common cold are also more susceptible to acquiring otitis media and sinusitis. [3]

Pediatric populations are important targets for efforts aimed at reducing unnecessary

antibiotic use. Environments unique to children, such as day care and school, enhance the

transmission and spread of drug-resistant S pneumoniae.[4] The frequency and duration of

prior antibiotic exposure are strongly associated with the spread of drug-resistant S

pneumoniae, and children receive a significant proportion of the total antibiotics

prescribed each year. [5]

The common cold is associated with considerable costs in terms of decreased

productivity; time lost from work or school; visits to healthcare providers; and the

volume and cost of drugs prescribed. [6] Despite the lack of effectiveness of antibiotics for

treating common cold symptoms (rhinorrhoea, stuffiness, acute cough, sore throat,

pharyngitis, and laryngitis), general practitioners (GPs) frequently prescribe antibiotics

for patients with such symptoms in response to patients expectation or doctors

perceptions of these expectations.

The over use of antibiotics for primarily viral respiratory tract infections has been

suggested as a contributing factor in the rise of antibiotic pathogens like Streptococcus

6

pneumoniae because of selective pressure, particularly that exerted by broad-spectrum

antibiotics. [7]

INCIDENCE AND PREVALANCE OF COMMON COLD:-

The incidence of infection peaks in the early spring (April and May) and fall, reaching

the highest incidence in the fall. The incidence of infection from coronavirus, the second

most common viral agent, peaks in the early summer and again in the autumn to early

winter. Coronavirus has been detected in up to 30% of upper respiratory infections. [1] The

pattern of RSV infection is similar to that for rhinovirus; however, the peak incidence is

slightly later in the spring (April through June) and fall (October through November). [2]The isolation of influenza A virus from patients with cold-like symptoms is indicative

of a mild influenza illness, and the incidence is expected to follow trends in influenza

illness within a community. Parainfluenza virus type 3 is present in summer months and

is associated with annual outbreaks or epidemics Isolation of adenovirus is fairly constant

throughout the year." [2]

EPIDEMIOLOGY:-

Transmission of the common cold may occur by direct contact with nasopharyngeal

secretions or by inhalation of small and large airborne particles. Viruses can be isolated

from the hands of patients with the common cold. Transmission may occur with a simple

touch or hand¬shake. [3] In addition, viruses can remain viable in nasal secretions for

several hours after being deposited on inanimate objects (e.g., door handles or faucets).

The uninfected individual acquires the virus on his or her hands, and then inoculates the

mucosal surfaces by touching the face, nose, or eyes. IS Prevention of transmission is

possible by washing hands frequently with disinfectants, by using of virucidal tissues,

and perhaps by avoiding facial and eye contact with the hands. However, these methods

are not very practical. One study suggested that aerosol transmission is the chief mode of

transmission in adults. [8]

7

Acute respiratory infections (ARI) are among the most prevalent factors of morbidity in

the world. ARI related mortality is a major issue in children under five years of age in

developing countries.[8] According to WHO, estimated morbidity averages bronchiolitis,

and obstructive laryngitis. [9] One million deaths due to measles, 350,000 to pertussis, and

8,000 to diphtheria are to be added. Infectious agents are first, S. pneumoniae, H.

influenzae and respiratory syncytial virus, second, S. aureus, influenza, and para

influenzae viruses, adenovirus. [8,9] Control programs of ARI are based upon adequate

medical care in primary health care centers, training of health workers, maternal

education, and immunizations. Such programs set up in some developing countries

enabled a 20% decrease of infant mortality and a 25% decrease in children under five

years of age. [10]

Acute respiratory infections (ARI) are a leading cause of childhood morbidity in

Pakistan. The National ARI Control Programme was launched in 1989 in order to reduce

the morbidity attributed to ARI and rationalize the use of drugs in the management of

patients with ARI. [11] WHO standard ARI case management guidelines were adopted to

achieve these objectives. The medical staff at Children’s Hospital, Islamabad were

trained in such management in early 1990; further training sessions were conducted when

new staff arrived. [10,11]

Among under-5-year-olds in Pakistan, acute respiratory infections (ARI) are responsible

for more than one quarter of deaths in the community and one-third of deaths occurring

in hospitals. [12] ARI is also the leading cause of morbidity in childhood. Factors

contributing to complications and mortality due to ARI include delays in talking the child

to a health care provider. Misdiagnosis or delay in diagnosis by the health professional

and inappropriate use of antibiotics for treatment of ARI. [8,9]

Seven countries have established national task forces for ARI control, four have prepared

documents for implementation of the programme and six have specific budget lines for

the ARI Control Programme in the 1988-1989 biennium. [9,10]

CONDITIONS AND ETIOLOGY:-

8

The Common Cold is not a single infectious disease, but rather a group of self-limiting

viral upper respiratory infection (URIs) producing a similar clinical syndrome [1]. URIs

are the most common infectious diseases. They include rhinitis (common cold), sinusitis,

ear infections, acute pharyngitis or tonsillopharyngitis, epiglottitis, and laryngitis—of

which ear infections and pharyngitis cause the more severe complications (deafness and

acute rheumatic fever, respectively) [1,2]

There are many viral pathogens which can cause the symptoms of the common cold; the

most common are the more than 100 serotypes of rhinoviruses.[11] The type of virus

responsible for the greatest number of colds. Other viruses that cause colds include

enteroviruses (echovirus and coxsackie viruses) and coronavirus. In most cases, a specific

virus causes a person to be ill only once, after which they are immune to that virus [11,12].

An estimated 25 million individuals seek medical care for uncomplicated upper

respiratory tract infections (URI) annually in the United States. [13]

TREATMENT OPTIONS AVAILABLE FOR ARI:-

There is no widely accepted specific therapy for the common cold. Use of interferon

nasal spray.[14] zinc gluconate lozenges.i" high-dose vitamin C [15] and investigational

antiviral drugs[14,15] has shown limited or no benefit in shortening the duration of

symptoms and/or reducing viral shedding. High-dose vitamin C (at least 1 gI day) may

provide a small benefit; however, this benefit is controversial. [14] In addition, several of

the treatments (interferon, zinc gluconate, and antiviral drugs) are associated with

significant side effects. Zinc gluconate lozenges are unpalatable. A nasal spray

containing soluble intercellular adhesion molecule 1 (ICAM-l) was shown to reduce cold

symptoms by almost 50% when used before or within 12 hours after experimental

rhinovirus infection. ICAM-l is responsible for binding of rhinovirus to susceptible

nasopharyngeal cells, permitting virus entry. Soluble ICAM-1 is a competitive inhibitor

of this binding. It is likely that this therapy will be expensive if it becomes available.

Moreover, it is not clear if treatment given beyond 12 hours after exposure to rhinovirus

would be effective. [15]

9

CUR R E N T TH E R APY CARRIED OUT FOR COMMON C OL D:-

Current therapy for the common cold focuses on symptomatic relief and includes

analgesics, systemic and topical decongestants, and antihistamines. Aspirin and

acetaminophen suppress the development of antibodies and prolong the duration of viral

shedding. [16] These agents reduce fever that may be a protective response to infection.

However, fever is only present in a small minority of patients. Aspirin and

acetaminophen may be useful to reduce headache, malaise, and muscle aches if they are

present. These agents should not be used routinely for the common cold. The association

of aspirin use and Reye's syndrome in children with influenza warrants further caution in

the routine use of aspirin. [16,17] This association has not been described in association

with the common cold. However, influenza can sometimes mimic the common cold and

Reye's syndrome has been reported, although rarely, with adenoviruses and parainfluenza

viruses. Ibuprofen and naproxen have no detrimental effect on serum antibody response

and virus shedding and appear effective for relieving some cold symptoms. [18]

The use of antihistamines to relieve cold symptoms is controversial. Histamine does not

appear to play a significant role in the pathogenesis of the common cold. Some

antihistamines possess anticholinergic action, which may reduce nasal secretions. [19] The

use of a sustained release formulation of brompheniramine was effective for reducing

sneezing, rhinorrhea, and cough after experimentally induced rhinovirus colds. [20] In

patients with natural colds, clemastine provided some symptomatic relief of rhinorrhea

ana sneezing, but the effects appeared less prominent. [21] A review of studies before

1996 concluded that antihistamines do not have major effects on overall cold symptoms,

although some attenuation of sneezing and rhinorrhea may occur. [22] These minor

benefits must be weighed against the potential for side effects, primarily somnolence and

dry mouth and throat. Intranasal ipratropium bromide, an anticholinergic agent, is

efficacious for reducing rhinorrhea and sneezing. [23]

Systemic and topical decongestants have been widely used to relieve nasal congestion.

Topical solutions of oxymetazoline, xylometazoline, and phenylpropanolamine are

10

rapidly effective in relieving congestion and improving nasal airflow. [24] With

xylometazoline, this effect persists for 6 hours. These agents are only indicated for short-

term use «3 days) because rebound congestion can occur with more prolonged use.

Systemic decongestants including pseudoephedrine and phenylpropanolamine also are

effective for symptomatic relief. A recent study showed that oral pseudoephedrine is

more effective than placebo for relieving nasal congestion. [25]

Intranasal and inhalation formulations of sodium cromoglycate (cromolyn sodium), used

every 2 hours for the first 2 days, then four times daily thereafter, provide symptomatic

relief of cold symptoms compared to placebo. The duration of cold symptoms was

significantly shortened and symptoms decreased in final 3 days. [26]

Cough associated with the common cold is usually related to postnasal drainage and

throat irritation and is under voluntary control. Antitussive agents such as codeine are not

effective for this type of cough. [27],40 Codeine may be useful for chronic cough based on

a reflex mechanism that occurs in some patients after resolution of the cold.

Antihistamines and decongestants may be effective in relieving cough associated with

acute upper respiratory infection. [28]

Considerable interest in the effectiveness of echinacea for prevention and treatment of

the common cold has evolved in recent years. A double-blind placebo-controlled study

showed no benefit of using echinacea for preventing the common cold or respiratory

infection. [29] The relative risk of acquiring an URI was 0.88 (95% confidence interval

[CI] of 0.60 to 1.22) with treatment. Once a cold occurred, the median duration of

symptoms was 4.5 days in the echinacea group and 6.5 days in the placebo group (not

significant). It remains possible that a very small effect would be detected in a larger

trial; however, the clinical significance remains questionable. Variations in the source

and chemical makeup of various echinacea products could explain why other sources

claim efficacy with echinacea for the treatment of the common cold. There is no role for

the use of antibacterial drugs in the treatment of the common cold. [30] Antibiotics may be

11

required only to manage complications such as acute otitis media or acute rhinosinusitis. [31]

IRRATIONAL PRESCRIBING PRACTICES IN COMMON COLD

TREATMENT:-

Although a cold is a viral illness, antibiotics often are inappropriately prescribed to

patients, even when bacterial complications (e.g., pneumonia, bacterial sinusitis) are not

present. Studies of antibiotics for the treatment of the common cold focus on cure rate,

symptom persistence, prevention of secondary bacterial complications, and adverse

effects. [32]

Over prescription and abuse of antibiotics in the treatment of acute respiratory infections

and is a worldwide problem, potentially leading to widespread antibiotic resistance. [33]

The use of antimicrobials is especially prevalent in the very young and the elderly. In one

study, 37 and 70 percent of children, by three and six months of age respectively, had

received at least one antibiotic prescription. [34]

Most antibiotic prescriptions in the ambulatory setting are for respiratory infections.

Studies evaluating physicians' prescribing patterns have found that almost 50 percent of

office visits for colds and upper respiratory tract infections (URIs), and 80 percent of

visits for acute bronchitis are treated with antibacterial agents. [35]

The majority of antibiotics prescribed to adults in ambulatory practice in the United

States are for acute sinusitis, acute pharyngitis, acute bronchitis, and nonspecific upper

respiratory tract infections (including the common cold). For each of these conditions

especially colds, nonspecific upper respiratory tract infections, and acute bronchitis (for

which routine antibiotic treatment is not recommended) [36]

12

IRRATIONAL TREATMENT PRACTICES OF COMMON COLD IN

PAKISTAN:-

A knowledge, attitude and practices (K.A.P.) survey was conducted among doctors

working as general practitioners (GP) in Multan, for diagnosis and management of acute

respiratory infections (ARI) in children under five years of age. GPs in Multan were not

familiar with national ARI control Program and rational drug use guidelines. They rarely

asked about symptoms describing severity of disease while taking patient histories and

did not look for signs of severe pneumonia during physical examinations. Most patients

diagnosed as URTI (upper respiratory tract infection) received oral antibiotics and those

with pneumonia received inject able antibiotics. Other drugs prescribed included cough

syrups, antihistamines and antipyretics. The average number of drugs prescribed per

patient was 3.4. The doctors were deficient in providing home care advice for sick

children to the caretakers. Average time spent by doctors on each patient was two

minutes and twenty-three seconds. A combination of biomedical and social factors help

to perpetuate this irrational prescribing behavior of the GPs. Continuing education

programs for doctors in general practice about ARI management in children and rational

use of drugs and health education of the public may improve the current prescribing

practices. The resolution adopted at the SEARC conference on South East Asian children

in October 1986 provided endorsement to the policy of ARI control at the highest official

level. [9]

SITUATION ANALYSIS IN CHILDREN UNDER 5:-

The highest rates of antibiotic prescribing in primary care are to children with respiratory

illness but surprisingly there have been few prospective controlled studies of the impact

of such prescribing on resistance in a community setting [37]In the 1980s Brook reported

isolation of lactam producing bacteria in 46% of children one week after antibiotic

treatment of otitis media or pharyngitis and 27% after three months compared with a

constant 11% in controls.21 A paper from Malawi in 2000 reported recovery of co-

13

trimoxazole resistant pneumococci in 52% of children one week after malaria treatment

with co-trimoxazole compared with 34% in controls but with no difference after four

weeks[38]. An Australian study in 2002 reported a twofold increase in the odds of recovery

of resistant pneumococci in children who had used lactam antibiotics in the two months

before swab collection.[39] We report a prospective study in children from UK general

practice with new methods for identifying a highly mobile integrative and conjugative

element (ICE) that encodes lactamase and circulates among nasopharyngeal

Haemophilus species.[40]

Studies showed that irrational prescribing practices of common cold is one of the most

critical issue that need to be global considerations. In Pakistan a small efforts is put on

this issue. Lot is to be done in this area therefore this study will have focus on to

document current treatment practices of ARI in selected facilities and try to find the

prevalence of ARI and reason of ARI and reason for prescribing antibiotics in ARI and

identify the problems that need to be sorted out. This work will add to existing literature

in will give you bases will be helpful in research.

14

Chapter 2:

Objectives

15

GENERAL OBJECTIVE:-

Assessment of prescribing practice of antibiotics in common cold under the age of

five years in PIMS Islamabad.

SPECIFIC OBJECTIVES;-

To document the current treatment practices of (ARI) in selected

hospital of Islamabad Pakistan

To identify the most common prescribing combination of drug in ARI .

To determine the %age of patients receiving antibiotics in children under 5

To determine the average number of drugs per patient

To determine the %age of patients receiving different dosage forms

To determine the %age of patients receiving drugs other than antibiotics

16

Chapter 3:

Methodology

17

Methodology:

A descriptive cross sectional study was conducted in Pakistan Institute of Medical

Sciences during the period of September to October. Standard Treatment Guideline was

used as a reference point to describe that antibiotics should not be prescribed in children

under the age of 5 years having common cold. These standard treatment guidelines were

developed from Davidson’s Principles and Practice of Medicine 20th Edition by Nicholas

A. Boon, Nicki R. Colledge, Brian R. Walker, John Hunter.

The data was collected by using data collection tools. In order to collect data from

Pakistan Institute of Medical Sciences an application was written to Director Hamdard

Institute of Pharmaceutical Sciences in order to issue a letter to hospital give

permission to carried out study easily in Pakistan Institute of Medical sciences . Then

this letter was submitted to the Hospital Administration .the letter was processed in

the hospital within three weeks .The permission letter was granted by hospital and also

issue a letter to the Children hospital for permission. After this the field visit for data

collection was planned. The data was collected from Out Patient department of Children

Hospital Pakistan Institute of Medical Sciences .We travel by our own car to reach

Hospital for data collection. We collected data between 10 am to 1pm because at this

time the sufficient patients visit to OPD hospital.

In order to collect quantities data, a data collection form was design by consulting

with teacher and WHO manual How to Investigate Drug use in Health Facility,

after designing the form was pilot tested to check its utility, after the success full

pilot testing the form was used for data collection. Then the permission letter was

shown to the chief pharmacist in Pakistan institute of medical sciences for

issuance of permission for the prescription observation on children OPD. After

collecting the required data, we thank a lot to dispenser for his cooperation. At the

end of the day, we move by car towards home and entered the collected data in

data collection form. . After the completion of data in data collection form, the data

18

was entered in Statistical Package for Social Sciences(SPSS 17) by creating

variables. Then the data was analyzed by applying different statistical test .and

then results were presented in graphical and tabular form.

Chapter 4:

Results

19

Results:

Out of the 100 prescriptions from Pakistan Institute of Medical Sciences to check

among the most commonly prescribe combination of drugs in ARI under 5. the

prescribed drug was antipyretic, antihistamine and antibiotic. From antipyretic

paracitamol, from antihistamine chlorpheneramine and from antibiotic Amoxil. The

percentages of these combinations were shown in Fig-1.

D r u g c o m b in a t io n u s e d

5 3

5 7

3 0

5

0

1 0

2 0

3 0

4 0

5 0

6 0

1

%ag

e

A n t io b io t i c + A n t ip y re t i c + A n t ih i s t a m in e

A n t io b io t i c + A n t ih i s ta m in e

A n t ib io t i c + A n t ip y r e ti c

A n t ih i s t a m in e + A n t ip y r e t i c

A n t io b io t i c + A n t ip y re t i c + A n t ih i s t a m in e +M u l t iv i t a m in

Fig-1

20

The presence of antibiotic in overall prescription was shown in Fig-2.

Fig-2

The no. of drugs per patient was shown in Fig-3.

21

Fig-3The class of antibiotic prescribed was shown in Fig-4.

Fig-4

The age of patient was shown in Fig-5.

22

Fig-5The number of antibiotic per prescribtion was shown in Fig-6.

Fig-6

23

24

25