“ASSESSMENT OF PRESCRIPTION PATTERN OF ANTIBIOTICS IN
PEDIATRIC POPULATION OF A TERRITARY CARE TEACHING
HOSPITAL OF RURAL POPULATION”
SYNOPSIS FOR
M.PHARM DISSERTATION
SUBMITTED TO:
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE.
SUBMITTED BY:
BALABHADRA V B BALAJI B.pharm
Under the guidance of:
N SURESH M.Pharm, MBA ,( Ph.D)
DEPARTMENT OF PHARMACY PRACTICE
S. A. C COLLEGE OF PHARMACY
B.G.NAGARA
RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA.
ANNEXURE-II
PROFORMA OF REGISTRATION OF SUBJECTS FOR DISSERTATION
1.0
NAME OF THE CANDIDATE BALABHADRA V B BALAJI
DEPARTMENT OF PHARMACY PRACTICE,
AND ADDRESS
S.A.C.COLLEGE OF PHARMACY,
B.G. NAGARA, KARNATAKA-571448.
PERMANENT ADDRESS:
S/o B.Srinivasa Rao #6/94
high school colony, Dwarapudi –533341
East Godavari district,
Andhra Pradesh.
2.0
NAME OF THE
INSTITUTION
3.0
COURSE OF THE STUDY
AND SUBJECT
MASTER OF PHARMACY
(PHARMACY PRACTICE)
4.0
DATE OF ADMISSION TO
THE COURSE
TITLE OF THE TOPIC
30/10/2009
5.0
SRI
ADICHUCHANAGIRI
COLLEGE
OF
PHARMACY,
B.G.NAGARA,
MANDYA
DISTRICT-571448
“ASSESSMENT
OF PRESCRIPTION
PATTERN
OF
ANTIBIOTICS
IN
PEDIATRIC
POPULATION
OF
TERRITARY
CARE
TEACHING
HOSPITAL OF RURAL POPULATION”
6.0
BRIEF RESUME OF THE STUDY
6.1 Need for The study:
Among various categories of drugs, antibiotics are the most frequently prescribed
medications in modern medicine. Antibiotics cure disease by killing or injuring bacteria. The
first antibiotic was penicillin, discovered accidentally from a mold culture. Today, over 100
different antibiotics are available to the doctors to cure minor discomforts as well as lifethreatening infections.
Antibiotics are useful in a wide variety of infections, like bacterial infections. Antibiotics are
useless against viral infections (for example, the common cold) and fungal infections (such as
ringworm). The doctor can decide best choice of antibiotic based on the organism1.
Patients who are known to be less than 15 years of age, but whose weight exceeds 36 kg may
still be considered as pediatric patients given their chronological age. For calculating the child
dose from adult dose , the weight of the child must be considered 2.
The following are the classifications of pediatric patients based on the age. This may assist
prehospital personnel in their assessment and management of pediatric patients.
• Neonate: newborn up to first 28 days of life
• Infant: comprises neonatal period up to 12 months
• Toddler: 1-3 years
• Pre-school: 3-5 years
• School-age: 6-10 years
• Adolescent: 11-14 years
The pediatric population comprises of 20-25 percent of the total world population, and
numerous acute and chronic diseases can effect this sub population. Premature neonates have
poorly developed organ functions and are at highest risk of eliciting unexpected toxicity or poor
clinical response from sub optimal dosage regimens of drug usage. This alters the
pharmacokinetics or dosage requirements in this population3.
Among all the populations pediatric population are mainly prone to infectious diseases.
Antibiotics are the drugs used to combat or treat these infectious diseases. The use of antibiotics
has become a routine practice for treatment of pediatric illness. Antibiotics are considered to be
the main stay of treatment for children and hence it is the second leading drugs prescribed
according to the national ambulatory medical care surveys4, 5, 6.
The Pharmacokinetics profile of the paediatrics will be changed based on the age when
compare with adults. So while prescribing of antibiotics the pharmacokinetic profiles must be
considered very seriously. Otherwise they lead to fatal effects7.
Antibiotics are vital in today's medical practice, even though some side effects which overall
are out-weighed by the benefits. The overuse or misuse of antibiotics can result in bacteria
resistance. This is referred as antibiotic resistance. This leads to a development of "super bugs"
and they need combination of antibiotics and experts to fear with the today available antibiotics
for future. An example of such a bug is streptococcus pneumonia is the major cause of ear
infections in children. Because of resistance it is becoming quite difficult to treat.
It is important to have a rational approach to antibiotic use. Most of the infections that seen
in children, including the common cold, diarrhea and vomiting, are caused by viruses and do not
need antibiotics. There are some guidelines that can helps to prevent the development of
antibiotic resistance. Viral infections should not be treated with antibiotics. If the child is
prescribed antibiotics, they should take the whole course even if they feel better. Otherwise it
leads to resistance. Antibiotics should only take when prescribed by the doctor. Without
consultation of physician self medication of antibiotics must be avoided. Without consulting the
physician doesn’t start any antibiotic even though it is a previous infection8.
The choice of antibiotics for infants and children is usually empiric. The antibiotics are
effective and play an important role in management of infectious diseases. But they can lead to
many serious consequences. One of them is the irrational use of antibiotics can lead to
destruction of micro flora including various clinical symptoms like toxic mega colon,
pseudomembraneous colitis, and etc. It can also lead to emergence of multi drug resistant microorganism which is expected to cause more serious infections. Now a day’s many pediatric
physicians include antibiotics in their prescribing pattern without considering it, to be rational or
irrational. Therefore, an effective step should be taken for rational and effective use of antibiotics
especially in pediatric population9, 10.
Prescribing drugs is an important skill which needs to be continuously assed and refined
accordingly. Commonly the prescription behaviour is influenced by by many factors like un
ethical drug promotion, lack of knowledge, direct to consumer advertising, and non availability
of drugs. So there is a chance of irrational drugs in the prescription. The assessment of the
prescription will helps to know the attitude of the physicians towards prescribing and to provide
rationality in the prescription. This rationality of the prescriptions will helps the physician to
upgrade the knowledge and improves attitude towards selecting the most appropriate costeffective treatment11.
Adichunchanagiri institute of Medical Sciences (AIMS) is a 750 beded tertiary care
teaching hospital situated in a rural area of B.G.Nagara of Nagamangala taluk. Which contains
two pediatric units with 60 beds. There were no studies conducted previously in this rural
hospital regarding the prescription pattern of antibiotics in the pediatric population. Hence the
present study is taken to know the the prescription pattern of antibiotics in pediatric population.
This type of study will helps to promote the rationality in the prescribing pattern and minimising
the errors in the prescriptions.
6.2 Review of Literature:

Ansam Sawalha et al carried out a study on “Pattern of Parenteral Antimicrobial
Prescription among Pediatric Patients in Al-Watani Governmental Hospital in
Palestine”. Data on antimicrobial prescribing were collected for 30 consecutive days for
all pediatric patients admitted to Al-Watani government hospital in Palestine. Data on
antimicrobial prescribing were entered and analyzed using Statistical Package for Social
Sciences (SPSS) program. Analysis was done by using various parameters like age, sex,
diagnosis, site of infection, number of antimicrobial agents given, number of times drug
regimen has been changed and the frequency of individual drug use. In this study some
lacking information was found to be “overview about utilization of parenteral
antimicrobial agents among pediatrics was not complete”, this study might be the basis
for more specific research in the future. Antimicrobial agents were used for both
bacterial and viral infection. Improving the availability of rapid diagnostic methods to
differentiate between viral and bacterial infections will helps to reduce irrationality of
antibiotic usage9.

Khan N A et al carried out a study on “Assessment of antimicrobials use in pediatrics in
Moradabad city”. This study concluded that the most common antibiotics prescribed in
pediatric patients belongs to the class of quinolines, among which norfloxacin
predominates. Amoxicillin + clavulanic acid was the next most frequently used
combination. This study also evaluated the prescription rationality and irrationality, it
was found that maximum number of prescriptions were rational based on considering the
number of antibiotics per prescription and drug interaction. The irrational prescriptions
are found less10.

Jennifer L. Costello et al carried out a study on “Effects of pharmacist-led pediatrics
medication safety team on medication-error reporting”. This study was conducted in a
pediatric care center in three phases by appointing a pediatric medication safety team.
Phase 1 consisted of retrospective collection of medication-error reports before any
intervention was made. Phase 2 and 3 include prospective collection of medication error
reports after several interventions by the team. An increase in number of medication
errors reported and a decrease in the severity of errors reports were observed in a
pediatric critical care center after implementation of a pediatrics medication safety team
by educating the health care providers12.

Palikhe N carried out a study on “Prescribing Pattern of Antibiotics in Pediatric
Hospital of Kathmandu Valley”. A retrospective study of one and half month’s duration
was done during the month of November- December 2003. A total number of 121
patients were taken for the study. This study showed that, the children below 1 year or
infants are at special risk for receiving multiple courses of antibiotics. This study
suggested that strategies to control antibiotic usage 13.

Zerusenaydesta et al carried out a study on “Prescribing pattern for out patients in three
hospitals in Ethiopia”. Case notes of out patients attending the Gondar teaching hospital
(n=2023), Bahir Dar regional hospital (n=2597) and Debre Tobar rural hospitals
(n=1808) were reviewed retrospectively for one year period. The study showed that the
average number of drugs prescribed per patient was within the acceptable range. 14.

Das BP et al carried out a study on “Antimicrobial utilization pattern in out patient
services of ENT department of tertiary care hospital of Eastern Nepal”. A total of 191
prescriptions were randomly audited at varying time interval from the department of ENT
in the year 2003. The data was collected in a customized Proforma in the form of
antibacterial audit questionnaire. It also contained Patient particulars, diagnosis,
investigations, drug details and information from the prescriber regarding the indication
for prescribing antimicrobial agent, suspecting organism underlying infection, duration of
therapy and details of any concomitant medications. This study shows that majority of
patients were prescribed irrationally with misleading indications without confirming the
bacteriological culture sensitivity15.

Siby john carried out a study on “Review of aminoglcoside usage in pediatric population
at J S S teaching hospital, Mysore”. A retrospective review of aminoglcoside was
conducted over a period of six months. A total of 197 patients receiving amino glycosides
were evaluated for appropriateness of use. The majority of people were treated with
gentamycin (52.5%) for respiratory tract infection. The appropriateness of use of amino
glycosides was found to be 72.1% - for indication, 86.3%- for dose, 84.8% for duration,
43.1% for safety and 53.1 % for cost effectiveness 16.
6.3.
OBJECTIVES OF THE STUDY
General Objectives:
1. To assess the prescription pattern of antibiotics in pediatric population of a
tertiary care teaching hospital of rural population.
Specific Objectives:
1. To know the common class of antibiotic prescribed and indication for therapy.
2. To evaluate number of single or combination of antibiotics in the prescription.
3. To evaluate the rationality of the antibiotics used.
4. To evaluate the significant interaction caused by the antibiotics
5. To evaluate the appropriateness of antibiotic prescribed.
7.0
MATERIALS & METHODS:
Study design : This is a prospective study
7.1 Sources of Data:
Data obtained from the pediatric prescriptions of inpatients and out patients who visited the
hospitals
7.2 Inclusion Criteria:

All the pediatric patients between 1-14 years of age.

Prescriptions containing antibiotics.
Exclusion criteria:

Prescriptions which does not containing antibiotics

Children below 1 year.
7.3 Methodology:
The study will be conducted by randomly collecting the prescriptions containing antibiotics
of pediatric patients who are visiting the inpatient and outpatient pediatric department.
Prescriptions containing antibiotics were evaluated for the category of antibiotic prescribed and
indication for use. Even the prescription will be evaluated
for commonly used antibiotics and
their combinations. Rationality and irrationality of prescription will be assessed based on drug
interactions and number of antibiotics prescribed in each prescription. The prescriptions will also
be evaluated for any significant interactions which caused by the antibiotics. If interaction is
significant the intervention will be done. Appropriateness of the prescriptions will be evaluated
by considering various parameters like dose, dosage form, and duration of treatment, route and
frequency of administration. The data will be collected, documented and analyzed by using
suitable statistical method.
7.4 Duration of the study:
The study will be conducted over a period of 9 months
7.5 Place of study:
Department of pediatrics ADICHUNCHINAGIRI HOSPITAL AND RESEARCH CENTER
B.G. NAGARA
7.6 Does the study needs ethical committee clearance?
“Yes” it will be obtained from the ethical committee of Adichuchanagiri Hospital and
research center B.G.Nagara.
7.7 Does there any experiments on animals or human beings?
No
8.0
LIST OF REFERENCES:
1. Available from the URL http://www.emedicinehealth.com/antibiotics/article_em.htm
2. Available
from
the
URL
http://www.co.sanmateo.ca.us/vgn/images/portal/cit_609/62/5/233743255Pediatrics_Defi
nitions.pdf
3. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A Text book of Clinical
Pharmacy Practice, orient Longman private Ltd, Ed: 2004; Pg 160-89.
4. Linjie Z, Raquel L, Dilvania N, Etienne S. Juliana M, Kamil S, Carlo L. empiric
antibiotic therapy in children with community acquired pneumonia. Indian pediatric
2008; 45:554-58.
5. SandaraR.Arnold, Upton D. Allen, Mohamed A Z, Darrell H.S. Tan, Elaine E.L.Wang.
Antibiotic prescribing by pediatricians for respiratory tract infection in children. Clinical
infectious diseases 1999; 29:312-317
6. Mccaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based
physicians in the United States. JAMA 1995; 273:214-219.
7. Leonshargel, Alan H. Mutnick, Paul F. Souney, Larry N. Swanson. Comprehensive
pharmacy review seventh edition page no: 754-774.
8. Available from the URL http://www.drpaul.com
9. Ansam S, Ghada AB, Laila A, Waleed S, Rowa AR, Nidal J. Pattern of Parenteral
antimicrobial prescription among pediatric patients in Al-Watani government hospital in
Palestina. An-NajahUniv.J.Res. (N.Sc) 2006; 20:191-206.
10. Jha V, Abid M, Mohanata GP, Patra A, kamalkishore, Khan NA. Assessment of
antimicrobials use in pediatrics in Moradabad city. IJOP, 2010; 3(1), 19-24.
11. Kanakambal S, Murgesh N, shanty M. drug prescribing pattern in a tertiary care teaching
hospital in Madurai (Tamilnadu). Ind J pharmacol 2001 ;( 33)223.
12. Jennifer L. Costello et al Effects of pharmacist-led pediatrics medication safety team on
medication-error reporting. AJHP, 2007; 64, 1422-26.
13. Palikhe N Prescribing Pattern of Antibiotics in Pediatric Hospital of Kathmandu Valley.
Journal of Nepal Health Research Council Vol. 2 No. 2 October 2004.
14. Zerusenay desta et al Prescribing pattern for out patients in three hospitals in Ethiopia.
Ethiop. J. Health Dev. 2002; 16 (2):183-89.
15.Das BP et al Antimicrobial utilization pattern in out patient services of ENT department
of tertiary care hospital of Eastern Nepal. Kathmandu University Medical Journal (2005),
Vol. 3, No. 4, Issue 12, 370-375
16. Siby john. A study on review of aminoglcoside usage in pediatric population at J S S
teaching hospital, Mysore, 2002.
9
Signature of the candidate
BALABHADRA V B BALAJI
10
Remarks of the guide
The proposed research work is original and
designed on rational basis. It would be a
good contribution.
11 11.1 Name
Guide
and
Designation
11.2 Signature
11.3 Co-Guide
of N SURESH
M.Pharm, MBA,( Ph. D)
Assistant professor
Department of Pharmacy Practice
S.A.C. college of pharmacy
B.G. Nagara, Karnataka -571448
K.V.RAMANATH
M.Pharm, MBA , ( Ph. D )
Associate Professor
Department of Pharmacy Practice
S.A.C. college of pharmacy
B.G. Nagara, Karnataka -571448
11.4 Signature
11.5 Head of the Department
K.V.RAMANATH
M.Pharm, MBA , ( Ph. D )
Associate Professor &
H.O.D of Pharmacy Practice
SAC College of pharmacy, B.G. Nagara-48.
11.6 Signature
12 12.1 Remarks of the Principal
12.2 Signature