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Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 51  

 Review Article 

Pharmacovigilance study on the increased use of antibiotics in pediatric 

treatment 

Ghansham Sakhare1, Purva Yelwande1, Sandhya Suryawanshi1, Kiran Ambhore1, Rutuja Pawar1, Kishor 

Jain1  

From, 1 RJSPM’s College of Pharmacy, Dudulgaon, Pune, Maharashtra, India.  

Correspondence to: Ghansham Rajkumar Sakhare, RJSPM’s College of Pharmacy, Pune - 412105, Maharashtra, India. Email: 

sham.sakhare@gmail.com  

ABSTRACT 

Objective: To conduct the pharmacovigilance study on the increased use of antibiotics in pediatric treatment. Materials and Methods: 

A suitable, simple questionnaire associated with the study of pharmacovigilance assessment, for mainly the adverse drug reactions 

associated with the increased antibiotic use in pediatric treatment was designed and distributed among 200 families having children in 

the age groups of <1 to 8 year. This survey was done in Pune region. Amoxicillin, Tetracycline, Cephalexin, Doxycycline were the 

antibiotics selected for the study. Results: About selfmedication more than 50% groups said they did self-medication. And major source 

for it was medicines leftover from previous prescriptions.  Maximum response was obtained from 5–8year age group. ADR were 

detected with the usage of antibiotics in 66 percent of groups. When it comes to the intensity of an adverse drug reaction, 74% of 

respondents said it was light, 22% said it was moderate, and 4% said it was severe. Around 97 % groups said they went to doctor after 

occurrence of adverse drug reaction, 98 % percent groups said they were aware of the risks of self-medication. Majority of groups knew 

about adverse drug reactions reporting system. When it comes to awareness of increased antibiotic use leading to antibiotic resistance, 

98% of groups were found aware of the problem. Discussion: Survey showed that families having small children experienced adverse 

drug reactions as a result of using any of the antibiotics Amoxicillin, Tetracycline, Cephalexin, or Doxycycline. Conclusion: In 

conclusion, our study strongly recommends that there is a great need to create awareness among the middleclass families having children 

to improve the reporting of ADR’s.  

Keywords: Pharmacovigilance, Pediatrics, Anti-microbial resistance (AMR), Amoxicillin, Tetracycline, Cephalexin, Doxycycline

ntibiotics are medicines used to prevent and treat 

bacterial infections. Antibiotic resistance is rising to 

dangerously high levels in all parts of the world. New 

resistance mechanisms are emerging and spreading globally, 

threatening our ability to treat common infectious diseases. A 

growing list of infections such as pneumonia, tuberculosis, 

gonorrhea, and foodborne diseases are becoming harder, and 

sometimes impossible, to treat as antibiotics become less 

effective [1, 2].  

To understand the burden of threat posed by antimicrobial 

resistance, World Health Organisation (WHO) estimated that 

every year in the world, infections caused by multidrug resistant 

(MDR) bacteria result in 700,000 deaths across all ages, of 

which around 200,000 are newborns in Europe, MDR infections 

in pediatric patients may represent up to 30% of the total cases 

in regions of the Middle East, 90% of newborns with sepsis, 

hospitalized in ICU, had resistant bacteria; in some areas of 

South East Asia, 83% of children have E. coli resistant to first  

line antibiotics; in Sub-Saharan Africa, 66% of neonatal sepsis 

and meningitis were found to be caused by bacteria resistant to 

antibiotics [3]. India contribution to the Uppsala Monitoring 

Centre (UMC) database is very little. This is essentially due to 

the absence of a vibrant ADR monitoring system and also due 

to a lack of the reporting culture among the health care workers 

[4, 5].  

Quoting the joint WHO-UNICEF report of 2006: 

“Children are not small adults when taking a drug.” The 

capacity of absorption, distribution, metabolism and 

elimination of a drug are very different between adults and 

children, and they continue to change during the stage of 

development. The risks resulting from the administration of a 

drug that has not been tested and proven in the pediatric 

population may therefore be due to overdose (increase in 

adverse reactions), ineffectiveness of the drug (for dosing) and 

use of a formulation which is not appropriate [6].  

A 



Sakhare G et al.                                                                                                       Pharmacovigilance of antibiotic usage 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 52  

Antibiotics are reported as the most troublesome of drugs 

contributing to approximately 15% - 16% of cases of Adverse 

Drug Reactions (ADR’s), mostly related with the frequency of 

administration that accounts approximately for 23% of all 

adverse events recorded. Children are more at risk of having 

ADR’s because many drugs which are prescribed to this 

population have been marketed with limited or no experience 

of their efficacy and safety [7].  

Rational use of antimicrobials in the long run, therefore, 

demands continuous survey of antimicrobial use and related 

ADR monitoring. [8]. Rational use of antimicrobials in the long 

run, therefore, demands continuous survey of antimicrobial use 

and related ADR monitoring. [9] 

As for antibiotic misuse in pediatrics, although critical, it has 

rarely been tackled in epidemiological studies. It could be 

related to several factors, such as the medication itself (e.g. taste 

acceptability, dilution and conservation), or the treating 

pediatrician (e.g. watchful waiting approach) or even the 

pharmacist (e.g. referral to pediatricians). The occurrence of 

adverse drug reactions (ADR’s) is an-other problem with 

antibiotic use. ADR’s in pediatric population may have 

relatively more severe effect than adults leading to significant 

morbidity among children [10].  

Inappropriate antibiotic-prescribing practices have been well 

described in developed nations [11]. Therefore, using antibiotics 

to treat these viral infections is considered misuse or overuse of 

antibiotics. This misuse/overuse is common in children, and is 

currently considered to be one of the major public health issues 

worldwide [12]. 

MATERIALS AND METHODS  

This was a cross-sectional, questionnaire-based survey which 

was conducted in Pune region. This survey done in 200 

families (Groups); where in number of responses: 111 offline 

responses and 89 online responses were taken. It was 

conducted in middleclass families having children age group 

<1 to 8 years [13, 14]. A standardized questionnaire was made 

in order to identify the antibiotic prescription practices in 

common childhood diseases and attitudes towards 

pharmacovigilance [15].  

The questionnaire was divided into several parts. The first 

part, included self-medication practices questions later part the 

names of antibiotics and adverse drug reactions observed. The 

last part include about awareness about pharmacovigilance 

program in India and antibiotic resistance. The families were 

requested to complete the questionnaire and to return it within 

1 day to RJSPM’S College of Pharmacy Students’ team. This 

survey deals with pharmacovigilance issues like ADR’s due to 

antibiotic administration and the reporting rates of these. The 

method of self-administered questionnaire was implemented 

for data collection purposes [16, 17].  

RESULTS  

Figure 1 represents for question have you ever treated yourself 

(self-medicated) with antibiotics?  56% of group response was 

yes and 44% of groups response was no.   

 

Fig. 1 - Have you ever treated yourself (self-medicated) 

with antibiotics?  

 

Fig. 2 - Where did you usually obtain antibiotics for self-

medication?  

Figure 2 represents for question, where did you usually obtain 

antibiotics from for self-medication? groups response 45% 

positive for leftover from previous prescription  and for 

community pharmacies, it was 24%, while, 16% groups 

responses gone in favor of  online shopping /E-pharmacies and 

responses for any other option were only 10%.  

  

24  %  

45  %  

16  %  

15  %  

Community pharmacies  

Leftover from previous prescription  

Online shopping/E-pharmacies  

Any other 



Sakhare G et al.                                                                                                       Pharmacovigilance of antibiotic usage 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 53  

              

Fig. 3 - What is age group of children?  

Figure 3 represents in case of age group of children, maximum 

groups gave responses for age group 5-8 years i.e., 88 out of 200, 

for 1-3 years 50 responses were recorded and for 3-5 years age 

group 50 were there, and for 0–1-year age group 12 responses 

were recorded.  

Figure 4 represents for question, any type of adverse drug 

reaction is observed with use of antibiotics 66% groups said yes 

and 34% family said no.  

Figure 5 represents n case of severity of adverse drug reaction 

74% responses were for mild ADR, 22% were for moderate 

ADR and 4% were for severe type of ADR. 

Figure 6 represents in case of what action taken by you to 

manage ADR with antibiotics in pediatrics, maximum responses 

i.e., 97% groups said they went to doctor and only 3% were 

waited for subside adverse drug reaction. 

Figure 7 represents for question are you aware of dangers of 

self-medication, 98% groups said yes and 2% said no. 

Figure 8 represents in case of awareness of adverse drug 

reaction reporting system in India, 97% groups are aware of the 

ADR reporting system and 3% are unaware of ADR reporting 

system.  

Figure 9 represents in case of awareness of increase use of 

antibiotics leading to resistance of antibiotics, 98% groups are 

aware of resistance and 2% are unaware.  

DISCUSSION  

0  

10 

20  

30 

40  

50 

60  
70  
80  

90  

Less than 1years I-3 years 3-5  years 5-8   years  

12  

50 50  

88  

Number 

of childern 

      
Fig.   4   -   Any type of adverse drug  

reaction is observed with use of 

antibiotics? 

      Fig. 5 - What is severity of adverse 

drug reaction?  

Fig.   6   -   What action taken by you to  

manage ADR with antibiotics in 

pediatrics? 

      

    

Fig. 7 - Are you aware of dangers of 

self-medication?  

  

      

Fig. 8 - Are you aware of adverse 

drug reaction reporting system in 

India? 
      

Fig. 9 - Are you aware of awareness of 

increase use of antibiotics leading to 

resistance of antibiotics? 



Sakhare G et al.                                                                                                       Pharmacovigilance of antibiotic usage 

Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 54  

For Fig 1 thus, it is seen that almost 50% of the surveyed sample 

have done self-medication at some point of time with antibiotics. 

Verma et al indicates self-medication is very common problem 

in India [18].  

Fig. no.2 which discuss about where did you usually obtain 

antibiotics from for selfmedication? People are understandably 

unwilling to submit to the inconvenience of visiting a doctor for 

what they rightly feel they can manage for themselves. Reasons 

for wide variations may be due to differences in education, 

socio-economic status, nonavailability of medical facilities and 

easy availability of drugs [19].    

Community pharmacy, E pharmacy is responsible factor for 

self-medication according to our study. Fig. 3 tells us current 

study indicates majority population falls between 5 and 8 years 

of age. Fig. no. 4 deals with question, any type of adverse drug 

reaction is observed with use of antibiotics 66% groups said yes 

and 34% family said no. In our study occurrence of ADR is 34 

% indicate higher incidence might be due to poor patient 

compliance. One of the cited research paper results reveal that 

the estimated average ADR incidence in all selected studies was 

9.52%. According to the study which was conducted in 38 

different Italian hospitals and recruited 1332 hospitalized 

patients reported that the onset of at least 1 ADR [6].  

Fig. 5 talk about in case of severity of adverse drug reaction 

74% responses were for mild ADR, 22% were for moderate 

ADR and 4% were for severe type of ADR. Only serious ADRs 

are needed to be reported in pediatric care, seems to be the most 

significant factor of no reporting, according to Mary et al. [20].    

Current study lowest score for severe ADR shows awareness 

about reporting any type of ADR. This might be due to survey 

done in urban part where majority of people are literate. The 

reasons for occurrence of ADR in children may be due to 

immature drug metabolizing organ system in newborn and 

infants that put them at a higher risk of developing an ADR [14].  

Fig. no. 6 tell about almost all groups went to doctor for ADR 

treatment. Fig. no. 7 almost all groups aware about dangers of 

self-medication which is a general indication. Fig. 8 deals about 

in case of awareness of adverse drug reaction reporting system 

in India, 97% groups are aware of the ADR reporting system and 

3% are unaware of ADR reporting system. In northern India, 

study done in year 2013 showed little awareness about the ADR 

reporting system among the doctors in a tertiary care hospital 

[5]. Due to increased use of social media past few years 2022 

may resulted in increase in awareness about ADR reporting in 

current study. Fig. no. 9 indicates all groups aware about 

increase use of antibiotics leading to resistance of antibiotics 

which indicates people are well trained about use of antibiotics.  

Table 1 shows us about many groups experienced adverse 

reaction with antibiotics indicates importance of ADR 

monitoring system. In order to generalize our results, similar 

studies be done in other parts and paramedical colleges of the 

city and other states of the country. Training sessions must 

clarify the roles of the various healthcare professional’s doctors, 

nurses, pharmacists and paramedical workers in 

pharmacovigilance. There should be closer relationship between 

the common public and the pharmacovigilance centers. Results 

showed to be published and discussed in the public domain to 

spread awareness. To the best of our knowledge, this is one of 

the few attempts to explore antibiotics prescribing practices and 

attitudes on pharmacovigilance of hospital pediatricians in Pune 

region.   

Table 1 - Names of the group and the adverse drug reactions 

they experienced as a result of using a certain antibiotic  

Group 

Number   

Antibiotic  Adverse Drug  

Reaction  

Group 1   Azithromycin  Diarrhoea  

Group 2  Azithromycin  Abdominal pain  

Group 3  Amoxicillin  Nausea  

Group 4  Amoxicillin  Fever  

Group 5  Tetracycline  Yellowing of teeth  

Group 6  Amoxicillin  Rashes, fever  

Group 7  Doxycycline  Nausea  

Group 8  Cephalexin  Rashes  

Group 9  Amoxicillin  Rashes, itching  

CONCLUSION  

In conclusion, our study strongly recommends that there is a 

great need to create awareness among the middle-class families 

having children to improve the reporting of ADR’s. The ADR 

reporting should be made an integral part of the clinical activities 

in order to improve the patient care.  

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Vol 1 | Issue 2 | Jul - Sep 2022                                                                                        Indian J Pharm Drug Studies | 55  

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How to cite this article: Sakhare G., Yelwande P, 

Suryawanshi S, Ambhore K, Pawar R, Jain K. 

Pharmacovigilance study on the increased use of 

antibiotics in pediatric treatment. Indian J Pharm Drug 

Studies. 2022;1(2):51-55. 

Funding: None                Conflict of Interest: None Stated 

  


