Use of Triggers to Detect Adverse Drug Reaction Induced By Cardiovascular Drugs in Outpatient Department in Nasik City

 

Priyanka Paruthi, Ganesh Pansare and Avinash Khairnar*

University Department of Interpathy Research of Technology, Maharashtra University of Health Science, Nashik (MS) 420 004

Corresponding author: avinashkhairnar@gmail.com

 

ABSTRACT:

The use of “triggers”, clues to identify Adverse Drug Events (ADEs) is an effective method for measuring the overall level of harm from medications in a health care organization.  Cardiovascular drugs have moved to the third place among all drug classes prescribed in the country. The use of multiple medications is a serious problem in current health care system. To detect the ADR in Cardiovascular drugs by using trigger tool methodology was done in the private hospital of Nashik city. Total number of prescriptions was considered and total number of Triggers was calculated in percentage.Total number of positive triggers which had shown ADR was calculated accordingly. Out of 180 sample size total triggers were found to be 21 (11.66%), and ADR reported to be 14 (7.77%), We found 6 (3.33%) such triggers which could not detect any ADR. 71% was the success rate in detecting ADR and 29% was failure in detecting ADR. Improving trigger tools and applying them in analyzing the ADR will surely detect the ADR soon and reduce the risk and harms in patients.

 

KEYWORDS: Cardiovascular system, Adverse drug event, Adverse drug reaction, triggers.

 


INTRODUCTION:

Adverse Drug Reaction (ADR) is defined as noxious unintended and undesired effect of a drug that occurs at doses used for prevention, diagnosis or treatment.1 Any unintended effect on the body as a result of the use of therapeutic drugs, drugs of abuse, or the interaction of two or more pharmacologically active agents.2 ADRs are diverse; any organ can be the principal target or several systems can be involved simultaneously. Knowing this it becomes very difficult to prescribe a medicine safely.3

 

The adverse drug reactions are often not discovered until after the drug has been marketed. Pharmaceutical companies strive to work out the adverse effect profile of a drug before it is marketed, but because the complete range of adverse effects is not known, therefore, most severe drug induced reactions cannot be elucidated before licensing, therefore efficient post marketing surveillance is needed.3

 

Premarketing exposure to the investigational drug is limited usually to 1000 to 3000 subjects. Therefore the probability of identifying adverse reactions with a frequency of less than 1:1000 is remote.4 The full range of adverse reactions may not be known until a drug has been used in hundreds of thousands of people or in some cases after exposure for prolonged periods or only long after exposure to the drug. Proving that a specific drug is responsible for an adverse event in a patient may be extremely difficult because of multiple drug exposures and underlying illnesses.5

 

Before deciding to prescribe a drug to a patient, a doctor must balance the expected benefits of the drug against its potential risks. In other words he must assess the cost/benefit ratio in that particular situation – where benefits will be measured in terms of the efficacy of the drug and the cost in terms of the side effect liability that use of the drug entails.6

 

The use of “triggers”, clues to identify ADEs is an effective method for measuring the overall level of harm from medications in a health care organization7. The use of trigger tool for measuring ADE provides instructions for conducting a retrospective review of patient records using triggers to identify possible ADEs. Each tool includes a limited number of triggers that signal the most common types of adverse events or those that are likely to cause serious harm.8

 

Adverse drug reactions are classified into six types:

dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).9 Triggers for a potential adverse drug event include orders for antidotes, abnormal laboratory values, abrupt medication stop orders, transfer to a higher level of care and development of a rash.10

 

The highest rate of ADRs was recorded to be induced by Diltiazem (23.5%) and the lowest rate was related to Atenolol (3%).11 Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of ADRs induced by this class of medicinal products seems necessary.12 As a result cardiovascular drugs have moved to the third place among all drug classes prescribed in the country.12 therefore present study was carried out to detect ADR’s of cardiovascular

r drugs by trigger tool methodology.

 

METHODOLOGY:

A prospective observational study was done in the tertiary care hospital of Nashik city for 3 months. The Institutional Ethical Committee approval was received before initiation of study. Patients treated for various C.V.S. problems was selected according to the criteria and written informed consent was obtained before enrolling the patient in study. We enrolled 180 patients with various CVS problems and with different drugs in every prescription. Once the informed consent was obtained, patients’ prescription was studied and was followed every 15 days by telephonic conversation and every month in OPD. Prescription was studied and analysed accordingly. Observation of the prescription of the patient using predetermined list of triggers associated with possible ADE was done. ADR assessment was done by WHO Scale, Noronjo’s Scale After finding specific triggerwe kept record of all finding on ADE report form. Finally we summarized all data on monthly data collection sheet and after analyzing the data possible trigger was confirmed. Total number of ADR and Triggers was calculated. List of drugs in which triggers were found was listed. ADR assessment was done.

 

Triggers : -

T1  Diphenhydramine

T2  Vitamin K

T3  Flumazenil

T4  Anti emetics

T5  Naloxone 

T6  Antidiarrhoeals

T7  Sodium polystyrene

T8  Sodium glucose < 50

T9  C. difficile positive

T10  PTT > 100

T11 INR>6

T12  WBC<3000

T13 Platelet Count

T14 Digixin level >2

T15  Rising Sr. Creat

T16  Over sedation

T17  Rash

T18  Abrupt sessation of medication

T19 Transferred to higher level of care

T20  Atropine

T21  Bilirubin >2x normal

T22  Potassium <3.5 mmol

T23  Lip swelling and angio oedema

T24  Seizures/ dizziness *

T25  Decreased level of consciousness

T26  Arrhythmia

T27  New onset of jaundice

T28  Hypotension

T29  Bronchospasm

T30  Parenteral / tropical corticosteroids

T31  Dyspnea

T32  Cough

T33  Chest pain

T34  Weakness

T35  Vertigo

T36  Gastritis

 

RESULT:

Out of 180 sample size total triggers were found to be 21 (11.66%), and ADR reported to be 14 (7.77%)

We found 6 (3.33%) such triggers which could not detect any ADR (Table-1 to 3 and Graph-1 and 2).

1 ADR was reported without finding any triggers.

 

Table No 1:- List of ADRs

Sr. No.

DRUGS

ADR

No. of ADR

1.

Atenolol

Hypotension

4

2.

Amlodepine

Hypotension

2

3.

Nifedepin

Vertigo

2

4.

Ramipril

Cough

4

5.

Losartan

Bipedal oedema

1

6.

Hydrochlorthiazide

Hypokalaemia

1

7.

Digoxin

Palpitaion

1

8.

Digoxin

CCF

1

 

Table No 2: Drugs, Trigger and ADR

Sr. No.

List of Drug

Triggers

No. of

Triggers

ADRs

No. of ADR

1.

Atenolol

Headache

(4)

Hypotension

4

2.

Amlodepine

Headache

1

Hypotension

2

3.

Nifedepin

Generalized Weakness

2

Vertigo

2

4.

Ramipril

Cough

4

Cough

4

5.

Losartan

Swelling over ankle

2

Bipedal oedema

1

6.

Hydrochlorthiazide

Muscle cramp

3

Hypokalemia

1

7.

Digoxin

Restless

2

Palpitation

1

8.

Digoxin

Restless

2

CCF

1

9.

Warfarin

PT INR > 6

1

-

-

 

Table No 3: - List of positive Triggers and ADR

Sr. No

Triggers ( No.)

Positive Triggers

ADR (No.)

1.

Headache (4)

4

Hypotension(6)

2.

Headache (2)

2

 

3.

Generalized weakness(2)

2

Vertigo (2)

4.

Cough ( 4)

4

Cough ( 4)

5.

Swelling over Ankle (2)

1

Bipedal oedema

6

Muscle Cramp(3)

1

Hypokalemia

7.

Restless (4)

2

1-palpitation and 1- CCF

 

GRAPH 1

 

 

GRAPH 2

 

71% we found success in detecting ADR and 29% we could not found any ADR.

 

 

ADR Assessment

ADRs

WHO Scale

Naronjos Scale

Hypotension

Possible

4

Vertigo

Possible

4

Cough

Possible

3

Bipedal oedema

Possible

4

Hypokalamia

Probable

5

Palpitation

Probable

5

CCF

Possible

4

 

Statistical Analysis:-

Total number of prescriptions was considered and total l0020 number of triggers was calculated in percentage. Total number of positive triggers which had shown ADR was calculated accordingly.

 

DISCUSSION:

Our findings shows that the Triggers found were 21 in sample size of 180. Using the trigger tool methodology, ADR findings were 14. The total percentage of Triggers was 11.77% and ADR was %. There was 6 such triggers which has not confirmed with presentation of an ADR. 1 case presented with ADR but without Trigger.

 

Using the trigger tool methodology, several organizations have reduced their ADEs by more than 60% in 6 months. Our efforts were directed towards creating a tool for investigating clinical events associated with harm that could be more widely applied in clinical practice.

 

The current use of the trigger tool is to establish a baseline level of harm in an organization and then, using statistical process control rules, collect data points over time to determine improvement. This is not surprising that pharmacological intervention is so widespread, individual are often receiving several different drugs and the system in place to facilitate therapeutics is varied and often complex. The evolution of the trigger tool into more general method for investigating practice patterns provides a powerful new conceptual framework to understand, quantify and track harmful events.

 

CONCLUSION:

The study result demonstrates that 71.42% we get success in finding ADR after detecting triggers. We found 28.57% failure in reporting ADR. Improving trigger tools and applying them in analyzing the ADR will surely detect the ADR soon and reduce the risk and harms in patients.

 

REFERENCES:

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2.        Shashindran and B.Gitanjali, Adverse Drug Reaction Monitoring Health   Administrator   Vol: XIX Number 1: 20-21, (NCCMERP)

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11.     Rosen AK, Nebeker JR, Shimada S, et al. AHRQ; 2007. Development and Use of Ambulatory Adverse Event Trigger Tools. 2007.

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Received on 10.07.2011          Modified on 24.08.2011

Accepted on 04.09.2011         © RJPT All right reserved

Research J. Pharm. and Tech. 4(12): Dec. 2011; Page 1819-1821