INTRODUCTION:
Antibiotics are among the most commonly prescribed drugs in paediatrics. Infants and
children are the most vulnerable population groups to contract illnesses. The use of
antibiotics has become a routine practice for the treatment of paediatric illnesses1. Antibiotics
are the most widely prescribed therapeutic agents in children. This is particularly true for
children under-5-year-old population reported to receive the greatest exposure with a
prevalence of up to 50%. It is well established that the majority of antibacterial drugs
prescribed to children are for the treatment of common paediatric conditions (cold, upper
respiratory tract infections, bronchitis) that do not typically benefit from antibiotic therapy. It
has been estimated that nearly 50% of antibiotic prescriptions for children given by general
practitioners (GPs) are unnecessary. Antibiotic resistance has become major global public
health problem by prolonging the suffering of patients, increasing healthcare costs and being
associated with economic implications for society2. Respiratory infections are very common
diseases, especially in childhood which require the treatment with the antibiotics in India3.
The introduction of β-lactam antibiotics into the healthcare system in the latter stages of
World War II represents one of the most important contributions to medical science in recent
history. Today, β-lactams remain the most widely utilized antibiotics owing to their
comparatively high effectiveness, low cost, ease of delivery and minimal side effects 4.
Rational use of antibiotics means that right antibiotics should be prescribed for the right
patient in adequate dose for the sufficient duration as appropriate to the clinical needs of the
patient at the lowest cost. There is need in some cases to carry out a culture sensitivity test
before prescribing antibiotics especially in children as their organs are not fully developed
and they can easily suffer from toxic and adverse effects of drugs5. β-lactam antibiotics
having unique four-membered β-lactam ring. The major two groups are penicillins and
cephalosporins. Monobactams and carbapenems are newer additions6. In 1967 the first
penicillin-resistant Streptococcus pneumonia was observed in Australia, and seven years later
in the U.S. another case of penicillin-resistant S. pneumonia was observed in a patient with
pneumococcal meningitis7. Proper utilization of β-lactam antibiotics is very essential in the
paediatric patients because of its adverse effects which are very commonly observed till
today like hypersensitivity reactions, bone marrow depression, granulocytopenia, hepatitis,
suprainfections, Jarisch-Herxheimer reaction, nephrotoxicity, diarrhoea, low WBC Count,
bleeding, Disulfiram- like reaction8. Prescription pattern is an important transaction between
the physician and the patient. It brings in to focus the diagnostic acumen and therapeutic
proficiency of the physician with instruction for palliation or restoration of the patient’s
health. Prescription of drugs is an important skill which needs to be continuously assessed
and refined accordingly9.
MATERIAL AND METHODS:
STUDY SITE
The study was conducted at Basaveswara Medical College Hospital & Research Centre
(BMCH & RC), Chitradurga. It is a 600 bed tertiary care teaching hospital.
STUDY DESIGN
A prospective study, was carried out to assess the current prescribing pattern of β-lactam
antibiotics in Paediatric department of a Tertiary care teaching hospital.
STUDY DURATION
This study was conducted for a period of six months from December 2012 to May 2013.
STUDY SUBJECTS
This study will include hospital in-patients who were treated with β-lactam antibiotics for
various diseases in Paediatric department. Patient who meets the following criteria will be
enrolled.
Inclusion criteria
1. Patients who were treated with β-lactam antibiotics in paediatric department.
2. Patients admitted to NICU and PICU and on β-lactam antibiotic therapy.
3. Patients of either sex aged below 11 years.
Exclusion criteria
1. Immunosuppressed patients.
2. Patients admitted to other departments.
3. Paediatric patients who are not on the β-lactam antibiotic therapy.
4. Patients treated with β-lactam antibiotics on out- patient basis.
STUDY PROCEDURE
All the patients admitted to paediatric department were reviewed daily to identify the patients
prescribed with β-lactam antibiotics. Those patients who met the study criteria were included
in the study. Patients were divided in to different groups according to their age. Ethical
clearance from the Institutional ethical Committee, BMCH & RC Chitradurga was obtained.
A total of 400 prescriptions containing β-lactam antibiotics were assessed from patient
medical records irrespective of the indications. Patient’s demographic details such as name,
age, sex, clinical data such as diagnosis, therapeutic data such as name of the β-lactam
antibiotic, other concomitant medications, duration of therapy and other necessary details
were collected from patient’s medical records and medication charts. The collected
information was documented in a suitably designed data collection form. All the patient
information was collected from the day of admission to the day of discharge and was
assessed for the clinical outcome. Patient’s prescriptions were screened for any possible drug
interactions and ADRs that had occurred with β-lactam antibiotics.
RESULTS:
A total of 400 inpatients prescribed with β-lactam antibiotics aged < 11 years admitted to the
three different units of Paediatric department, NICU (Neonate intensive care unit), PICU
(Paediatric intensive care unit) and Paediatric ward for the treatment of various diseases were
reviewed over a period of six months from December 2012 to May 2013.
1. Demographic data of study Patients
Of the 400 patients treated with β-lactam antibiotics, male subjects were 63.25% (253) more
than female subjects 36.75% (147). Among them the age group of 1 year-11 years (child)
50% patients were more than the other age groups, Neonates and Infants. The demographic
data of study patients are presented in Table 1.
2. Number of prescriptions with β-lactam antibiotics in various units:
Among three units of the paediatric department the highest number of prescriptions were
found in paediatric ward 251 (62.75%) followed by NICU 88 (22%) and least were found in
PICU 61 (15.25%). The incidence of use of β-lactam antibiotics in different units of
paediatric department are presented in Table 2.
3. Prescribing frequency of different class of β-lactam antibiotics
Among the 495 β-lactam antibiotics, the highest number of Cephalosporins were prescribed
as 352 (71.11%) followed by penicillins and the least prescribed were Carbapenems. There
were no prescriptions with Monobactams. The usage of different class of β-lactam antibiotics
is presented in Table 3.
4. Incidence of use of β-lactam antibiotics in various units
The incidence of use of β-lactam antibiotics was highest in paediatric unit followed by NICU
and PICU. In that Cephalosporins class were widely used in all the three units of the
paediatric department followed by Penicillins and combination of Cephalosporins, Penicillins
with β-lactamase inhibitors. The complete prescription pattern of different class of β-lactam
antibiotics in various units of Paediatric department is presented in Table 4.
5. Age distribution of patients prescribed with different class of β-lactam antibiotics
Patients were categorized into three groups according to their age. Patients aged between
1year–11 years were prescribed β-lactam antibiotics more often than patients of other age
groups. In Neonates, penicillins (n=82) 48.23% were most commonly prescribed followed by
Cephalosporins (n=81) 47.65% whereas infants (n=91) 77.8% and children (n=180) 86.54%
were exposed more to Cephalosporins. The details of the different class of β-lactam
antibiotics prescribed in different age groups were presented in the Table 5.
6. Number of prescriptions Vs Diagnosis
During our study, among 400 prescriptions highest number of prescriptions were found to be
diagnosed as respiratory tract infections (n=138) 34.5%, followed by miscellaneous
conditions (n=105) 26.25%, GI disorders (n=46) 11.55%, CNS disorders (n=41) 10.25%, co-
morbid conditions (n=37) 9.25% and the least number of prescriptions were seen in UTI (12)
3%, hepatic disorders (10) 2.5%, haematological disorders (n=6) 1.5% and endocrine
disorders (n=5) 1.25%. Number of prescriptions in various clinical conditions is presented in
Table 6.
7. Pattern of use of individual β-lactam antibiotics
In our study, out of 400 prescriptions ceftriaxone (n=260) 52.52% was most frequently
prescribed followed by ampicillin (n=84) 16.97% and cefotaxime (n=81) 16.37%. The
pattern of usage of individual β-lactams is presented in table 7.
8. Frequency of Essential β-lactam antibiotics prescribed
Out of 495 β-lactam antibiotics prescribed 453 (91.52%) drugs are from WHO National list
of Essential medicines 2011. The details of the frequency of essential β-lactam antibiotics
prescribed were presented in the Table 8.
9. Drug interactions found between β-lactam antibiotics and other prescribed drugs
Out of 400 prescriptions reviewed, 126 Drug interactions were identified. Most of the
interactions belonged to major n= 81 (64.29%) than minor n=45 (35.71%). Among major
interactions Ampicillin+cefotaxime was found in 70 prescriptions. Of the minor interactions
Piperacillin+Amikacin was found in 23 prescriptions. The details of the drug interactions of
the β-lactam antibiotics with other prescribed drugs were presented in the Table 9.
DISCUSSION:
A prescription by a doctor may be taken as a reflection of physician’s attitude to the diseases
and the role of drug treatment. It also provides an insight into the nature of health care
delivery system10. Inappropriate use of antibiotics is common throughout the country11. Thus,
the reduction of inappropriate use of antibiotics in the community should be considered a
major public health issue12. The paediatricians and other medical personnel who provide
health care for infants and children in developing countries confront a number of challenges
during the day to day practice of medicine due to the shortage of appropriate drugs and other
facilities1. β-lactam antibiotics have long been important in the treatment of paediatric
infections. The management of serious paediatric infections involves several particular
treatment challenges. The purpose of this study is to assess the prescription pattern of βlactam antibiotics.
Of the 400 patients reviewed, the numbers of male patients were prescribed with β-lactam
antibiotics was higher 63.25% (253) than female subjects 36.75% (147). This was due to the
fact that more males were admitted than females for the treatment of various disease
conditions. This result was similar to the study conducted by Omole 2012 in south west
Nigeria which showed higher antibiotic prescriptions for males to be 71.7% whereas females
were 28.3%6. In both males (72.34%) and females (69.03%) the cephalosporins were most
widely prescribed followed by penicillins.
In our study of the 400 prescriptions reviewed, the usage of β-lactam antibiotics according to
the age, it was found that patients between the age group of 1-11yrs (n=208) were highly
prescribed than patients aged below 1yr. In our results we observed that in neonates the
penicillins (16.56%) usage was high followed by cephalosporins (16.37%). Cephalosporins
prescriptions were highly identified in infants (18.38%) and children (36.37%).
In our study, highest numbers of prescriptions were seen in paediatric ward which was
62.75% among various units of the paediatric department. This shows that more number of
patients were admitted to the paediatric ward.
In our study, it was found that 98.98% β-lactam antibiotics were prescribed for parenteral
administration, while only 1.02% was for oral route for the treatment of various diseases in
the units of paediatric department. The study carried out by Vipul Prajapathi and J.D. Bhatt
showed that, 86.81% antimicrobial agents were given by IV route. Route of administration
was selected based on severity of the disease. Parenteral route was preferred for quick onset
of action.
Our study showed that among β-lactam antibiotics prescribed most commonly used
medicines belongs to Essential drug list which was 91.52%. The study conducted by Dimri S
reported that 45% of medicines were prescribed from National list of Essential medicines
which shows much variation with our study.
Out of 400 cases analysed, Culture sensitivity test was not carried out during our study period
with regard for confirmation of diagnosis and to prevent the β-lactam antibiotics resistance.
During our study, a total of 126 interactions were identified in which major drug interactions
were 81 and 45 were minor interactions. Drug interactions are mainly due to exposure of
patient to multiple drug therapy and multiple pharmacological effects of drug. For example
when amoxicillin and ceftriaxone were administered concurrently either increases levels of
the other by decreasing renal clearance. Of the 81 major interactions, the most common drug
interactions were found between Ampicillin+Cefotaxime and this was identified in 70
prescriptions. When ampicillin and cefotaxime were administered concurrently either
increases levels of the other by decreasing renal clearance. So it should be monitored closely.
Among minor interactions the drug interaction between Piperacillin+Amikacin was found in
23 prescriptions. When piperacillin and amikacin were administered concurrently,
piperacillin decreases effects of amikacin by altering mechanism and also increased risk in
renal impairment.
CONCLUSION:
Over a study period, 400 prescriptions were analyzed for prescription pattern of β-lactam
antibiotics from three units of the paediatric department of BMCH & RC.
A majority of the patients in this study were between the age group of 1-11 years and a high
percentage of the patients were males 63.25%. Cephalosporins (71.12%) class of antibiotics
were highly prescribed followed by penicillins (17.37%). Prescribing frequency of newer βlactam antibiotics was low. Overall ceftriaxone was found to be the most frequently
prescribed drug followed by ampicillin and cefotaxime due to its wider spectrum of activity.
Piperacillin+ Tazobactam was the most widely used combination.
Majority of β-lactam antibiotics prescribed were enlisted under Essential drugs list for
paediatrics, India which was 91.52%.
In our study, the incidence of major and minor drug interactions was found to be 31.5%. No
adverse drug reaction was reported in this study. There is a need to carry out culture
sensitivity test and assess prescription for drug-drug interactions which will help to
rationalize the therapy and to prevent the β-lactam antibiotic resistance.
ACKNOWLEDGEMENT:
We are grateful to our principal and head of the department of department of pharmacy
practice and the staff of SJM College of pharmacy for their constant encouragement
throughout our work. We extend our sincere thanks to the staff of BMCH & RC and SJM
Vidyapeetha management for their support.
REFERENCES:
1) Palikhe N. Prescribing pattern of antibiotics in paediatric hospital of Kathmandu valley.
Kathmandu University Medical Journal 2004; 2(1): 6-12.
2) Alessandra R, Antonia C, Maurizio B. Antibiotic prescription and prevalence rate in the
outpatient paediatric population: Analysis of surveys published during 2000-2005.
European Journal of clinical Pharmacology 2007; 63: 1099-1106.
3) Kaur S, Gupta K, Harmesh SB, Kaushal S. Prescribing pattern and cost-identification
analysis of antimicrobial use in respiratory tract infections. JK Science. Jan-Mar 2013;15
(1):19-23.
4) Omole, Kayode M, Michael AA. Rational prescribing of penicillins and cephalosporin
antibiotics. Global journal of medical research 2012; 12(4): 1-7.
5) Tripathi KD. Beta-lactam antibiotics. In: Essentials of medical pharmacology,6th ed.
Jaypee Brothers: New Delhi, 2008: 694-709.
6) Donald E, Azavedo JD, Wises K, Mazzulli T, Kuhn M, Church D, Forward K, Zhane G,
Simor A. Antimicrobial resistance among clinical isolates of Streptococcus pneumonia in
Canada during 2000. Antimicrobial Agents and Chemotherapy May 2002; 46(5): 12951301.
7) Shoemaker NB, Vlamakis H, Hayes K, Salyers A. Evidence for extensive resistance gene
transfer among Bacteriodes spp. and among Bacteriodes of other genera in the human
colon. Applied and Environmental Microbiology February 2001; 67(2): 561-568.
8) Wilke MS, Lovering AL, Strynodka NCJ. Beta-lactam antibiotic résistance. Current
Opinion in Microbiology 2005; 8: 525-533.
9) Prajapathi V, Bhatt JD. Study of prescribing patterns of antimicrobials in the paediatric
wards at tertiary teaching care hospital, Gujarat. International journal of pharmaceutical
sciences and research 2012; 3(7): 2348-2355.
10) Bharathiraja R, Sridharan S, Chelliah LR, Suresh S, Senguttuvan M. Factors affecting
antibiotic prescribing pattern in paediatric practice. Indian journal of Paediatrics 2005;
72: 877-879.
11) Resi D, Milandri M, Moro L and Emilia R. Antibiotic prescriptions in children. Journal
of Antimicrobial Chemotherapy 2003; 52: 282-286.
12) Adam, Dieter MD. Beta-lactam antibiotics: their role in the management of infections in
children. Paediatric Infectious Disease Journal 1998; 17(3): S4-S7.
Table 1: Demographic data of study Patients
Demographic Characteristics
Gender
Age group
Number of Prescriptions (%)
Male
253 (63.25)
Female
147 (36.75)
1day-1 month (Neonate)
90 (22.5)
1 month-1 year (Infant)
110 (27.5)
1year-11 years (Child)
200 (50%)
Table 2: Number of prescriptions with β-lactam antibiotics in various units
Unit
No. of prescriptions
Percentage (%)
NICU
88
22
PICU
61
15.25
Paediatric ward
251
62.75
Total
400
100
Table 3: Prescribing frequency of different class of β-lactam antibiotics
Class of β-lactam antibiotics
No. of prescriptions (%)
Cephalosporins
352 (71.11%)
Penicillins
86 (17.37%)
Penicillins+β-lactamase inhibitors
40 (8.08%)
Cephalosporins+β-lactamase inhibitors
16 (3.23%)
Carbapenems
01(0.20%)
Monobactams
00 (0%)
Table 4: Incidence of use of β-lactam antibiotics in various units
Class of β-lactam antibiotic
NICU
PICU
Paediatric
Penicillins
79
0
7
Cephalosporins
79
54
219
Penicillins+β-lactamase inhibitors
3
11
26
Cephalosporins+β-lactamase inhibitors
3
0
13
Carbapenems
1
0
0
Monobactams
0
0
0
Total
165
65
265
Table 5: Age distribution of patients prescribed with different class of β-lactam
antibiotics
Class of β-lactam antibiotics
Neonates
Infants
Children
(%)
(%)
(%)
Total
Penicillins
82 (16.56)
3(0.60)
1(0.20)
86
Cephalosporins
81 ( 16.37)
91 (18.38)
180(36.37)
352
Penicillins+β-lactamase inhibitors
3(0.60)
17(3.44)
20(4.04)
40
Cephalosporins+β-lactamase
3(0.60)
6 (1.22)
7(1.45)
60
Carbapenems
1(0.20)
0(0)
0(0)
1
Monobactams
0(0)
0(0)
0(0)
0
Total
170
117
208
495(100)
inhibitors
Table 6: Number of prescriptions Vs Diagnosis
DIAGNOSIS
No. of Prescriptions
Percentage (%)
GI Disorders
46
11.5
Respiratory Tract Infections
138
34.5
CNS Disorders
41
10.25
Hepatic Disorders
10
2.5
Haematological Disorders
6
1.5
UTI
12
3
Endocrine Disorders
5
1.25
Co-morbid conditions
37
9.25
MISC
105
26.25
Table 7: Pattern of use of individual β–lactam antibiotics
Route of
administration
Name of β-lactam antibiotics
Number
of prescriptions (%)
Ceftriaxone
260 (52.52%)
Ampicillin
84 (16.97%)
Cefotaxime
81 (16.37%)
Piperacillin+Tazobactam
38 (7.68%)
Ceftazidime+Tazobactam
06 (1.21%)
Ceftazidime
05 (1.02%)
Cefotaxime+Sulbactam
05 (1.02%)
Ceftriaxone+Sulbactam
03 (0.60%)
Cefixime
02 (0.40%)
Amoxicillin+Potassium Clavulanate
01 (0.20%)
Cefpodoxime
01 (0.20%)
Cefotaxime+Tazobactam
01 (0.20%)
Ceftriaxone+Tazobactam
01 (0.20%)
Penicillin-G
01 (0.20%)
Meropenem
01 (0.20%)
Intravenous
490(98.99%)
Total
Oral
Total
Cefixime
02 (0.40%)
Amoxicillin+Potassium Clavulanate
01 (0.20%)
Amoxicillin
01 (0.20%)
Cefadroxil
01 (0.20%)
05(1.01%)
Table 8: Frequency of Essential β-lactam antibiotics prescribed
β-lactam antibiotics
Drugs
Number
of prescriptions (%)
Essential Drugs
Ceftriaxone
260 (52.52%)
Ampicillin
84 (16.97%)
Cefotaxime
81 (16.37%)
Ceftazidime+Tazobactam
06 (1.21%)
Ceftazidime
05 (1.02%)
Cefotaxime+Sulbactam
05 (1.02%)
Cefixime
04 (0.80%)
Ceftriaxone+Sulbactam
03 (0.60%)
Amoxicillin+PotassiumClavulanate
01 (0.20%)
Cefotaxime+Tazobactam
01 (0.20%)
Ceftriaxone+Tazobactam
01 (0.20%)
Amoxicillin+PotassiumClavulanate
01 (0.20%)
Amoxicillin
01 (0.20%)
Total
453(91.52%)
Piperacillin+Tazobactam
38 (7.68%)
Cefpodoxime
01 (0.20%)
Penicillin-G
01 (0.20%)
Meropenem
01 (0.20%)
Cefadroxil
01 (0.20%)
Others
Total
42(8.48%)
Table 9: Drug interactions found between β-lactam antibiotics and other prescribed
drugs
Number of
Prescriptions
400
Major Interactions (%)
Minor Interactions (%)
Total
81 (64.29)
45 (35.71)
126