A STUDY OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL OF PUNE

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ABOUT AUTHOR
Steffi Jerry Mammen
Inamdar Multispeciality Hospital,
Pune, Maharashtra

ABSTRACT:
Purpose: To study the adverse drug reactions (ADR’s) reported from wards and critical units in a tertiary care hospital of Pune. The adverse drug reactions were analyzed by Naranjo’s algorithm scale and Hartwig severity assessment scale and the outcomes were studied.
Methods:  This observational and cross-sectional study was conducted for 6months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital of Pune. The data collection was done only in wards and critical units. Patients of all age groups and either sex were included in this study. The adverse drug reactions were assessed for their causality and severity by performing the Naranjo’s algorithm scale and Hartwig’s scale respectively. The outcomes were studied. Data analysis was done by descriptive statistics.

Result: Total 50 adverse drug reactions were reported from wards and critical units. 21-30 years age group was reported to have more adverse drug reactions. The most commonly affected organ is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%). According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite. As per Hartwig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20 (44.44%) and severe 4 (8.88%). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period.
Limitations: Study was conducted only in wards and critical units not in all departments of the hospital. Some of the ADR’s have gone un-reported by Resident Medical Officer (RMO) due to increased work pressure, lack of awareness or busy environment.

Reference Id: PHARMATUTOR-ART-2603

PharmaTutor (Print-ISSN: 2394 - 6679; e-ISSN: 2347 - 7881)

Volume 6, Issue 8

Received On: 28/06/2018; Accepted On: 23/07/2018; Published On: 01/08/2018

How to cite this article: Mammen, S.J. 2018. A Study of Adverse Drug Reactions in a Tertiary care Hospital of Pune. PharmaTutor. 6, 8 (Aug. 2018), 38-43. DOI:https://doi.org/10.29161/PT.v6.i8.2018.38

INTRODUCTION:
Drugs have primarily used for diagnosis, prevention, treatment of various diseases and to alleviate pain. But it is sometimes observed, that these drugs have been proved fatal. This could be due to variable person-to-person response towards a drug. Even at therapeutic doses, people develop adverse effects. 

World health organization (WHO) defines an adverse drug reaction (ADR),” As a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for the modification of physiological function” . According to epidemiological studies, ADR’s account to 5% of hospital admissions and occur in 10-20% of hospitalized patients. It is the 7th leading cause of death. ADR’s are a leading cause of morbidity and mortality in many countries. It is a great concern for public, medical professionals, pharmaceutical industry and regulatory authorities.

India is a country which has supported the WHO program for global monitoring of ADR’s that wholly depends on spontaneous reporting. Spontaneous reporting is a very cost effective and affordable system which can identify rare adverse reactions and generate early signals for new drugs. Because of this reporting system, many drugs are recalled from the market due to safety concerns. The concept of ADR reporting is very new in India and the reporting done is also rare. If proper awareness among health care professionals is provided, it can contribute to drug safety and better patient care. Hence, this study was conducted to identify, analyze the various ADR’s in a clinical setting and study their outcomes.

Review of literature:
Prakash .H. Bhabhor et al (2014) did a study on adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases. They reported that the most commonly implicated organ system was skin and appendages (52.25%). The major causative drug classes were antimicrobials (40.28%), central nervous system (23.61%) and autacoids (15.97%). Cohort study is recommended to confirm the risk factors of serious ADRs in Indian population

Ratan J. Lihite et al (2016) conducted a study on adverse drug reactions in a tertiary care hospital of northeast India in which the topical steroid (betamethasone sodium phosphate) was reported to induce adverse drug reactions in majority of the patients. The commonly reported reaction was acne.

Lateef M. Khan et al (2012) performed a study on adverse drug reactions in hospitalized pediatric patients of Saudi Arabian University hospital and impact of pharmacovigilance in reporting ADR. They reported that ADR was more in patients who received 5–6 drugs. Regarding age, it was the highest in patients of 0–1 year of age (40.7%). Anti-infective agents (40.8%) were the most frequently involved in ADR. This study also demonstrated that, there was high susceptibility of the skin (37%) to the ADR.

R. Arulmani et al (2007) conducted a study on adverse drug reaction monitoring in secondary care hospital in south India. They reported that, about two thirds of the reactions (102, 62.2%) were classified as probable. The majority of the reactions (88, 53.7%) were mild. Most patients (119, 72.6%) recovered from the incidence. The majority of the reactions were of type H (100,61%) which indicates, that they were not predictable and not potentially preventable. An average cost of 481 rupees was spent on each patient to manage ADRs.

Jacoline C. Bouvy et al (2015) did a study on Epidemiology of adverse drug reactions in Europe: A review of Recent Observational studies. They concluded that the median percentage of hospital admissions due to an ADR was 3.5 %, based on 22 studies, and the median percentage of patients who experienced an ADR during hospitalization was 10.1 %, based on 13 studies. These results indicate that the occurrence of ADRs in the European hospital setting—both ADRs that result in hospitalization and ADRs that occur during the hospital stay—are significant.

Raut Aswari et al (2011) conducted a study on incidence, severity and financial burden associated with adverse drug reactions in medicine inpatients and concluded that Gastrointestinal system (25.87%) was most commonly involved. Drug class most commonly associated was Antimicrobials (18.90%). 43.36% ADRs were classified as “Possible” in view of causality, while 62.24% were found to be “mild” in case of severity. Most patients (59.44%) recovered from the ADR. 68.53% ADRs were augmented or type A. Average cost incurred in treating an ADR was found to be Rs.412.79 (US$ 9.30) in India.

Objective:
1. To study the adverse drug reactions reported from wards and critical units in a tertiary care hospital of Pune.
2. To analyze the adverse drug reactions by Naranjo’s algorithm scale and Hartwig severity assessment scale and determine the outcome.

Methodology:
This observational and cross-sectional study was conducted for 6months from November 2016-May 2017 in an inpatient setting of a tertiary care hospital in Pune. The data collection was done only in wards and critical units. Patients of all age groups and either sex were included in this study. The Adverse drug reaction form filled by Resident Medical Officer was considered. The documentation of the adverse drug reaction form was maintained by the clinical pharmacist for evaluation and further study. The adverse drug reactions were assessed for their causality and severity by performing the Naranjo’s algorithm scale and Hartwig’s scale respectively. The outcomes were studied. Data analysis was done by descriptive statistics. 

Exclusion criteria: Known allergies or previous history given by patients regarding drug allergies are excluded from this study. OPD patients are also excluded. The use of alternative system of medicines such as Ayurveda, Homeopathy, Unani etc as well as over dosage, excess consumption, was excluded. Patients who are mentally retarded, drug addicted, suicidal tendencies or consumption of a drug in the influence of alcohol was also excluded.

Statistics:
Description statistics were used for data analysis.

Results and discussion:
In this study, 50patients were reported to experience an ADR during the study. 5 ADR cases were discarded as more than one suspected drug was documented. Out of 45patients, 24 (53.33%) were females and 21 (46.66%) were males. The median age of the patients was 25. The youngest patient was 9months and the oldest was of 84years. Majority of the patients experiencing an ADR were belonging in the age group of 21-30years (Table 1).


Sr.No


Males


Females


Age Range


Total no of patients

(%)


1


 4


1


<1-10


5 (11.11%)


2


5


1


11-20


6 (13.33%)


3


2


11


21-30


13 (28.88%)


4


2


3


31-40


5 (11.11%)


5


0


2


41-50


2 (4.44%)


6


4


2


51-60


6 (13.33%)


7


4


4


<61


8 (17.77%)

Total


21


24


 


45

Table-1

Route of Drug administration

Sr.No

Route

Total (%)

1

Oral

5 (11.11%)

2

Intravenous

30 (66.66%)

3

Subcutaneous

3 (6.66%)

4

Intra-vaginal

2 (4.44%)

5

Topical

4 (8.88%)

6

Intra-muscular

1(2.22%)

Total

 

45

Table-2

It was also found that, the most common route of administration for suspected drugs was Intravenous 30 (66.66%), followed by oral 5(11.11%) and then topical 4 (8.88%)(Table-2). As shown in the (Table-3) the most commonly affected organ is the Skin 32 (71.11%), followed by Respiratory system 3 (6.66%) and nervous system 3 (6.66%).


Organ system affected by ADR


Sr.No


Organ system


No. of ADR (%)


1


Skin


32 (71.11%)


2


Respiratory


3 (6.66%)


3


Musculoskeletal


1(2.22%)


4


Nervous


3(2.22%)


5


Digestive


1(2.22%)


6


Genitourinary


1(2.22%)


7


Other


4 (8.88%)


8


Total


45

Table-3


Drug Class


Sr.No.


Category of drug


No.of ADR’s (%)


1.


Antimicrobials


 

22 (48.88%)


2.


NSAID’s               


5 (11.11%)


3.


Proton pump inhibitors


4 (8.88%)


4.


Vitamins/minerals


4 (8.88%)


5.


Other


4 (8.88%)


6.


Cardiovasculars


3(6.66%)


7.


Anti-emetic


2(4.44%)


8.


Steroid


1(2.22%)

Table-4

The drug class most commonly associated with ADR’s was Antimicrobials 22 (48.88%), followed by NSAID’s 5 (11.11%) (Table-4). Vancomycin 5 (20%) was the drug having majority of the ADR’s. The commonly reported ADR in this study was rash and itching 29 (64.44%).

According to Naranjo’s algorithm scale, 23 (51.11%) suspected ADR’s were probable, 17 (37.77%) ADR’s were possible and 5(11.11%) were definite (Table-5, 6). As per Hartwig’s severity assessment scale, majority of the ADR’s were mild 21 (46.66%), followed by moderate 20(44.44%) and severe 4 (8.88%) (Table7, 8). The outcome of the ADR’s was all recovered 38 (84.44%) during the study period (Table-9).

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