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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 8  |  Issue : 1  |  Page : 29-32

Cross-sectional study regarding pattern of adverse drug reactions in a tertiary care hospital, Kakinada, India


1 Department of Pharmacology, Rangaraya Medical College, Pithampuram Road, Kakinada, Andhra Pradesh, India
2 Rangaraya Medical College, Pithampuram Road, Kakinada, Andhra Pradesh, India
3 Konaseema Institute of Medical Sciences Research Foundation, NH-216 Chaitanya Health City, Amalapuram, Andhra Pradesh, India

Date of Submission09-Oct-2020
Date of Decision27-Nov-2020
Date of Acceptance27-Nov-2020
Date of Web Publication16-Mar-2021

Correspondence Address:
Mr. Tarun Kumar Suvvari
Rangaraya Medical College, Pithampuram Road, Kakinada 533001, Andhra Pradesh.
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mgmj.mgmj_85_20

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  Abstract 

Introduction: Drugs are considered as double-edged weapons with the potential to cause benefit as well as harm. Recent studies reveal that adverse drug reactions (ADRs) imply a remarkable burden on the length of hospital stay, healthcare facilities, and sometimes they require additional investigations and drug therapies for the treatment of symptoms and diseases caused to the patient. So, further local studies are required to understand the scenario and to improve the safety of prescribing and monitoring drugs and improved patient adherence to medication. Objectives: To evaluate and assess the pattern of adverse drug reactions reported to the ADR Monitoring Centre, Rangaraya Medical College, Kakinada, India. Materials and Methods: The current study was a retrospective and an observational type of study carried out at the ADR Monitoring Centre of a tertiary care hospital. Total ADRs reported during the two years from June 2016 to June 2018 were included in the study. Each ADR was analyzed for demographic data, relationship to drugs as per causality assessment, and frequency of ADRs. Microsoft Excel 2019 and SPPS version 20 were used for data analysis. Results: The most common group of drugs showing ADRs were anti-retroviral therapy (ART) drugs, followed by anti-microbial agents. Most of the ADRs were probable and mild. Rash was the most frequently occurring ADR. Conclusion: The study of ADRs in a particular institute using demographic patterns will contribute to patient safety by sensitizing the clinicians in that particular institute.

Keywords: Adverse drug reaction, anti-microbial drugs, anti-retroviral therapy


How to cite this article:
Bendi SR, Suvvari TK, Kutikuppala LV. Cross-sectional study regarding pattern of adverse drug reactions in a tertiary care hospital, Kakinada, India. MGM J Med Sci 2021;8:29-32

How to cite this URL:
Bendi SR, Suvvari TK, Kutikuppala LV. Cross-sectional study regarding pattern of adverse drug reactions in a tertiary care hospital, Kakinada, India. MGM J Med Sci [serial online] 2021 [cited 2021 Apr 14];8:29-32. Available from: http://www.mgmjms.com/text.asp?2021/8/1/29/311389




  Introduction Top


Drugs are double-edged weapons with the potential to cause benefit as well as harm.[1] A crucial step toward making drugs safer involves preventing the occurrence of an ADR. ADR is defined as a “response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or the modification of physiological function.”[2] The ADRs may be due to a preventable medication error, causes side effects because of medication administration, or maybe an unforeseen error such as an allergic reaction. The ADRs could have severe effects on the patients’ quality of life, and they lead to an increase in the burden on the healthcare system.[3]

The nature and causes of adverse drug events are multifactorial and complex. The ADRs are classified into Acute/ Sub-acute/ latent based on onset, into type A/B/C/D/E/F/G/H based on the type of reaction, and into Minor/ Moderate/ Severe/ Lethal ADRs based on severity. The ADRs are also further classified based on dose/ drug-related, idiosyncrasy, drug allergy, mutagenicity, carcinogenicity, etc. Recently, ADRs were reported as a major problem in patients who are taking multiple medications, mainly in the elderly.[4]

The incidence of ADRs across the world is 6%–20%, whereas in India, it is up to 3%. The ADRs account for one in 16 hospital admissions, and of these, 2% of patients are dying.[5] So, the Government of India started the Pharmacovigilance Programme of India (PVPI) on 14 July 2010, with the vision of monitoring drug safety and of reducing the risk associated with the usage of drugs.[6]

All healthcare professionals must report if they find any ADR reaction, and it is their duty. The most common way to report an ADR is to report electronically to the PVPI through Vigiflow. The ADR monitoring centers are established in various hospitals to encourage the healthcare professionals in reporting ADRs due to the drugs, vaccines, etc. The aims and objectives of the current study are to assess the pattern of ADRs reported to the ADR Monitoring Centre at Rangaraya Medical College, Kakinada.


  Materials and methods Top


An observational, retrospective study was conducted for two years from June 2016 to June 2018 (2 years) at Rangaraya Medical College, Kakinada, Andhra Pradesh, India. The data required for this study were obtained from the ADR Monitoring Centre. A total of 575 ADRs were reported during the study period. As it was a retrospective study, institutional ethical approval was waived off and necessary permission was taken from the institution.

Each ADR was analyzed for demographic data, relationship to drugs as per causality assessment, and frequency of ADRs. Microsoft Excel 2019 and SPPS Version 20 were used for data analysis. The causality was done by using the WHO-UMC system, and the severity assessment was done by using the modified Hartwig and Siegel scale. The ADRs were represented as department and pharmacological classwise frequency. The types of reactions due to ADRs and serious ADRs were also analyzed.


  Results Top


A total of 575 ADRs were reported from both outpatients and inpatients of various departments. Most of the ADRs were found in females (56%) and patients of the age group 18 to 60 years (82%) [Table 1]. Most of the ADRs were reported from the ART center (40%), dermatology (23%), oncology (10%), pediatrics (8%), and medicine (7%). The number of ADRs was distributed according to the department where they were reported [Figure 1]. Overall, 43% of the ADRs are due to the anti-retroviral therapy, 27% due to the antibiotics, and 15% due to the nonsteroidal anti-inflammatory drugs (NSAIDs) [Figure 2].
Table 1: Distribution of ADRs according to age and gender among the study population (n = 575)

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Figure 1: ADRs distribution reported in various departments (n = 575)

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Figure 2: ADRs distribution based on pharmacological class (n = 575)

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Causality assessment was done by using the WHO-UMC scale,[7] in which most of the ADRs were reported as probable (51%) followed by possible (47%) [Table 2]. Severity assessment was done by a modified Hartwig and Siegel scale, in which most of them are mild (72%) [Table 2]. The most commonly occurred ADRs were rash (43%), followed by nausea and vomiting (24%) [Table 3]. Some of the severe ADRs reported were Stevens-Johnson syndrome/ toxic epidermal necrolysis, acute kidney injury, acute psychosis, and febrile neutropenia [Table 3]. Drugs that caused severe ADRs are Zidovudine (ART), Sulfadiazine, sulfamethoxazole (sulfonamide-antibiotics), and Diclofenac sodium (NSAIDs).
Table 2: Distribution of ADRs based on causality and severity assessment (n = 575)

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Table 3: Distribution of ADRs based on types of reactions and severity

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  Discussion Top


The ADRs are one of the most common causes for low adherence to treatment, and evaluation of ADRs may help clinicians to optimize the drug regimens. The demographic details of our study showed female gender predominance over males regarding ADRs, which was similar to the results of other studies conducted by Kumar[8] and Sutradhar et al.[9] Several other studies have found that ADRs are more common in males than in females. So, the influence of gender is purely incidental only and has no influence on the number of ADRs reported.

The most frequently implicated group of medicines in the ADRs were ART drugs, which is similar to a study by Behera et al.[10] The second and third most ADRs are due to the anti-microbial drugs and NSAIDs, which were similar to a study by Sutradhar et al.[9] The organ system most affected by ADRs in this study was the skin (rash, 43%), which was similar to many studies. Causality assessment showed that most of the ADRs were probable (51%); similar results were found in the study by Kumar[8] and Raja et al.[11]

Overall, 47% of the ADRs were reported under “possible” in causality assessment, and multiple drugs that were prescribed at the same time are the reason behind it. The most common and severe forms are SJS/TEN, and they are reported to the WHO-UMC through VIGIFLOW.[12] Most of the ADRs were mild and probably required minimum medical intervention for management. This is similar to another study by Arulmani et al.[13] There are various probable reasons identified for underreporting the ADRs, such as lack of knowledge of physicians, time constraint, nonaccessibility of ADR (CDSCO) reporting forms, lack of incentives, etc. In our interaction with clinicians, similar reasons for underreporting were found.


  Conclusion Top


In our study, most of the ADRs were reported with ART drugs. So, it is advisable to have close monitoring of the ART to prevent ADRs in these patients. Serious ADRs such as SJS and TEN are most familiar with analgesics and sulfa antibiotics. Physicians should advise the patients to abstain from the usage of nonprescription drugs. The study of ADRs in a particular institute using demographic patterns will contribute to patient safety by sensitizing the clinicians in that particular institute.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Halkai K, Kumar S, Deshmukh Y, Rao V An evaluation of adverse drug reactions at ADR monitoring center in tertiary care hospital. Int J Ther Appl 2016;32:86-9. doi: 10.20530/ IJTA_32_86-89  Back to cited text no. 1
    
2.
Safety of Medicines by World Health Organizations [Internet] [Cited 2020 June 28]. Available at: http://archives.who.int/tbs/safety/esd_safety.pdf. (Last accessed on October 26, 2020).  Back to cited text no. 2
    
3.
Khalil H, Huang C Adverse drug reactions in primary care: A scoping review. BMC Health Serv Res 2020;20:5.  Back to cited text no. 3
    
4.
Kaufman G Adverse drug reactions: Classification, susceptibility and reporting. Nurs Stand 2016;30:53-63.  Back to cited text no. 4
    
5.
Singh P, Agrawal M, Hishikar R, Joshi U, Maheshwari B, Halwai A Adverse drug reactions at adverse drug reaction monitoring center in raipur: Analysis of spontaneous reports during 1 year. Indian J Pharmacol 2017;49:432-7.  Back to cited text no. 5
    
6.
Kalaiselvan V, Thota P, Singh GN Pharmacovigilance programme of india: Recent developments and future perspectives. Indian J Pharmacol 2016;48:624-8.  Back to cited text no. 6
    
7.
WHO-UMC Causality assessment system. [Internet] [Cited 2020 June 28]. Available at: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf. (Last accessed on October 26, 2020).  Back to cited text no. 7
    
8.
Kumar PK Patterns of adverse drug reactions: A study in tertiary care. Int J Basic Clin Pharmacol 2019;8:1497-502.  Back to cited text no. 8
    
9.
Sutradhar SD, Ray D A cross-sectional study of patterns of adverse drug reactions reported in the department of pharmacology of a tertiary care teaching hospital in North East India. Int J Compr Adv Pharmacol 2017;2:33-5.  Back to cited text no. 9
    
10.
Behera SK, Rath B, Biswal SB, Mohapatra S Pattern of adverse drug reactions in a tertiary care hospital in Western Odisha. Int J Pharm Sci Res 2018;9:2471-7.  Back to cited text no. 10
    
11.
Raja S, Januna RR, Kala P Pattern of adverse drug reactions in a tertiary care teaching hospital: A cross-sectional study. Asian J Pharm Clin Res 2017;10:170-3.  Back to cited text no. 11
    
12.
Bendi SR, Suvvari TK A case report of stevens: Johnson syndrome and toxic epidermal necrolysis due to diclofenac sodium. Int J Basic Clin Pharmacol 2020;9:1132-4.  Back to cited text no. 12
    
13.
Arulmani R, Rajendran SD, Suresh B Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2008;65:210-6.  Back to cited text no. 13
    


    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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