Dhanush Bellapu*, Padmalatha Kantamneni, Sravanthi Appikonda, Priyanka Jamalapurapu, Lavanya Eli, Lavanya Kancharla
Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada, Andhra Pradesh– 521108 India
*Address of Corresponding Author
Dhanush Bellapu
Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada, Andhra Pradesh– 521108 India
Abstract
Objective: According to World Health Organisation (WHO), “an Adverse Drug Reaction (ADR) is a response to a drug which is noxious and unintended that occurs at doses which are normally used to prophylaxis, diagnosis, therapy of disease or for the modifications of physiological function”. The main aim of the present study was to evaluate and assess the ADRs with prescribing rationale in the patients admitted in General Medicine Department at a tertiary care teaching hospital. Material and Methods: It is a Prospective Observational Study that was carried out for a period of 6 months in new Government General Hospital, Vijayawada. Results and conclusion: A total of 208 subjects were included in this study and assessed using WHO causality assessment scale, Naranjo’s Causlity assessment scale and Hartwig’s Severity assessment scale. Among the 208 subjects 54(25.96) ADRs were observed. Most of the ADRs were seen in males when compared to females between the age groups of 31-40 years and 51-60 years and affected gastrointestinal tract. Depending upon the Causality, most of the ADRs were ‘Probable’ as per WHO-UMC Causality Assessment Scale and ‘Possible’ as per Naranjo’s Causality Assessment Scale.
Keywords: ADRs, drugs, tertiary care hospital, General Medicine department, observational study, causality assessment and severity assessment
Introduction
According to the World Health Organization (WHO), Adverse Drug Reaction (ADR) is defined as “a response to a dangerous and unintended drug, which occurs in doses commonly used for prophylaxis, diagnosis, treatment or physical therapy” (Shukla et al., 2017). Although India accounts for 10% of global drug use, the reported ADR of drugs is 2%. This is mainly due to the poor report of drug abuse in India (Bahri, 2016). The incidence of ADRs as a whole leads to emergency admissions ranging from 0.2% to 41.3% worldwide, while 28.9% are safe (Palanisamy, 2013). Hospital admissions for ADR ranged from 2.9% to 5.6%. About 35% of patients in hospitals receive ADR. In India, the incidence of ADR is between 5.9 to 22.3% while deaths due to ADR accounts as 1.8% (Sivasankaaran et al., 2016). Many factors can put a patient at the forefront of the diagnosis of ADR patients with one or more risk factors for ADR including the pharmacy of Poly, many diseases and current, age, drug characteristics, gender, race and genetic factors (G. Parthasarathi, Sten Olsson). The purpose of this study was to evaluate and evaluate Adverse Drug Reaction with reasonable determination in patients admitted to the General Department of Health of a tertiary education hospital.
Materials and methods
Source of data: Collection of data from the patients admitted into General Medicine
Department of New Government General Hospital, Vijayawada.
Study Procedure: All the patients admitted in the General Medicine department during the
study duration were followed from the day of admission to the day of discharge and during the follow up.
Study Site: New Government General Hospital, Vijayawada.
Study Duration: The study was carried out for a period of 6 months from 1st August 2019 to 31st January 2020.
Study Design: A Prospective Observational Study.
Study Criteria: The study was carried out by considering the following criteria:
Inclusion Criteria:
Exclusion Criteria:
Sample size: 208 subjects
Software Used: MS Excel
Ethical Approval: Approved by Institutional Ethical Committee (IEC) of Siddhartha
Medical College and Government General Hospital, Vijayawada with IEC Ref. No. IEC/2019/096C/SMC on 19th August, 2019.
Results and discussion
The present Prospective Observational study was done at Department of General Medicine, New Government General Hospital, and Vijayawada over a period of 6 months since July 2019 to December 2019. A total number of 208 cases were collected. Among them 54 ADRs were observed.
The age and gender wise distribution of 54 ADRs reported in the study was presented in Table 1 and Figure 1. Among the reported 54 ADRs 11 ADRs were reported in the age group of 21-30 yrs. 15 ADRs were reported in the age group of 31-40 yrs, 13 ADRs were reported in the age group of 41-50 yrs and 15 ADRs were reported in the age group of 51-60 yrs.
Table 1. Demographics of ADRs reported in Study Population
|
Age Groups (yrs) |
No. of ADRs reported |
No. of males |
No. of females |
|
21-30 |
11 |
6 |
5 |
|
31-40 |
15 |
10 |
5 |
|
41-50 |
13 |
9 |
4 |
|
51-60 |
15 |
9 |
6 |
Figure 1. Demographics of ADRs reported in Study Population
The number and percentage of population reported with ADR’s and population without any ADR was presented in Table 2 and Figure 2. In the study population 25.96% of ADRs were reported during the study.
Table 2. Percentage of ADRs in the study population
|
Population |
Percentage (%) |
|
Population with ADRs |
25.96 |
|
Population without ADRs |
74.04 |
Figure 2. Percentage of ADRs in the study population
The distribution of the reported ADRs was presented in Table 3 and Figure 3. One ADR was reported in 44 cases, two ADRs were reported in 2 cases and three ADRs were reported in 2 cases.
Table 3. Distribution of reported ADRs among the Study Population
|
No. of ADRs in a case |
No. of cases |
Percentage (%) |
|
One |
44 |
81.48 |
|
Two |
2 |
3.7 |
|
Three |
2 |
3.7 |
Figure 3. Distribution of reported ADRs among the Study Population
The number and percentages of causality of 54 ADRs reported among the sample size of depending upon the WHO-UMC Causality Assessment scale (Parida S, 2013) (Table 4 and Figure 4). Certain were 8, probable were 13, possible were 41, unlikely were 1, unclassified were 0 and unclassifiable were 0.
Table 4. ADRs based on WHO-UMC Causality Assessment Scale
|
Causality |
No. of ADRs |
Percentage (%) |
|
Certain |
8 |
14.81 |
|
Probable |
31 |
57.42 |
|
Possible |
14 |
25.92 |
|
Unlikely |
1 |
1.85 |
Figure 4. ADRs based on WHO-UMC Causality Assessment Scale
The number and percentages of causality of 54 ADRs reported among the sample depending on Naranjo’s Causality Assessment scale (Naranjo’s et al., 1981) was presented in Table 5 and Figure 5. Unlikely were 0, possible were 29, probable were 22 and definite were 3.
Table 5. ADRs based on Naranjo Causality Assessment Scale
|
Causality |
No. of ADRs |
Percentage (%) |
|
Unlikely |
0 |
0 |
|
Possible |
29 |
53.70 |
|
Probable |
22 |
40.75 |
|
Definite |
3 |
5.55 |
Figure 5. ADRs based on Naranjo Causality Assessment Scale
The number and percentage of organ systems that were mostly affected due to the ADRs was presented in Table 6 and Figure 6. The most commonly affected organ system was gastrointestinal tract followed by CNS, Skin and appendages, ENT, others (fever), CVS, Respiratory system and Musculoskeletal system.
Table 6. Organ systems affected by ADRs
|
System |
No. of ADRs |
Percentage (%) |
|
Gastrointestinal tract |
20 |
37.03 |
|
CNS |
13 |
24.07 |
|
Skin and appendages |
08 |
14.81 |
|
ENT |
4 |
7.04 |
|
others |
3 |
5.56 |
|
CVS |
2 |
3.71 |
|
Respiratory |
2 |
3.71 |
|
Musculoskeletal |
2 |
3.71 |
Figure 6. Organ systems affected by ADRs
The number and percentage of ADRs reported in 54 cases due to different category of drugs was presented in Table 7 and Figure 7. The category of drugs that were mostly causing ADRs were Antibiotics, Anti-hypertensives, Anti-platelets, Corticosteroids, Statins, Analgesics, Anti-emetics, Anti-epileptics, Anti-malarials, Proton pump inhibitors, Supplements, Antispasmodics, Anxiolytics, Benzodiazepines, Bronchodilators, Laxatives and Psycho-stimulants.
Table 7. Drugs that caused ADRs
|
Category of drugs |
No. of ADRs |
Percentage (%) |
|
Antibiotics |
18 |
33.34 |
|
Antihypertensives |
5 |
9.26 |
|
Anti-platelets |
5 |
9.26 |
|
Corticosteroids |
4 |
7.42 |
|
HMG CoA reductase inhibitors |
4 |
7.42 |
|
Analgesic |
2 |
3.7 |
|
Anti-emetics |
2 |
3.7 |
|
Anti-epileptics |
2 |
3.7 |
|
Anti-malarials |
2 |
3.7 |
|
Proton pump inhibitors |
2 |
3.7 |
|
Supplements |
2 |
3.7 |
|
Antispasmodics |
1 |
1.85 |
|
Anxiolytics |
1 |
1.85 |
|
Benzodiazepines |
1 |
1.85 |
|
Bronchodilators |
1 |
1.85 |
|
Laxative |
1 |
1.85 |
|
Psycho stimulants |
1 |
1.85 |
Figure 7. Drugs that caused ADRs
Conclusion
From this study we conclude that 25.96% (54) of ADRs occurred in the population of 208, mostly seen in the age group of 31-40 years and 51-60 years. Male were mostly affected by ADRs when compared to female population. Depending upon the Causality, most of the ADRs were ‘Probable’ as per WHO-UMC Causality Assessment Scale and ‘Possible’ as per Naranjo’s Causality Assessment Scale. The organ system which was vulnerable to ADRs was gastrointestinal tract followed by cardiovascular system. The drugs which caused more ADRs were Antibiotics followed by Anti-hypertensive.
Acknowledgement
The authors are thankful to Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada and Government General Hospital, Vijayawada for their constant support and help.
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