Use of Triggers to Detect Adverse Drug Reactions of Gastrointestinal Tract in Outpatient Department

 

A.S. Khairnar*, P.M. Patil, N.U. Patil and P.R. Gade

University Department of Interpathy Research and Technology, Maharashtra University of Health Science, Nashik

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. The use of multiple medications is a serious problem in current health care system. To detect the Adverse Drug Reactions (ADR) in gastrointestinal drugs by using trigger tool methodology was done in civil hospital and one of the private hospital of Nashik city. It includes enrolment of the patient in Out Patient Department (OPD) according to Inclusion Criteria (IC) and Exclusion Criteria (EC). The patient was selected by using consecutive sampling method.  Written informed consent was taken from recruit patient by using informed consent form. Once the informed consent was obtained, patient’s prescription was studied and was followed every 7 days by telephonic conversation and every month in OPD. Prescription was studied and analysed by observing the prescription of the patient by using predetermined triggers associated with possible adverse drug event for next seven days. After finding specific trigger we kept record of all finding on ADE report form. 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 15 (8.3%), and ADR reported to be 7 (3.8%). We found 8 (4.4%) such triggers which could not detect any ADR. Improving trigger tools and applying them in analyzing the ADR will surely detect the ADR and reduce the risk and harms in patients.

 

KEY-WORDS: Gastrointestinal System, Adverse Drug Reaction, Trigger Tool, Adverse Drug Event

 

 

INTRODUCTION:

There are many terms indicating the harmful and undesirable effects of drug treatment, the term ‘adverse drug reaction’ describes the best1. ADRs are an important cause in hospitalization, morbidity, and mortality in patients. 2 Increase percentage hospital admission due to drug related event in some countries is more than 10 %. High interest in ADR was stimulated by the thalidomide catastrophe in 1960.3 Any unintended effect on the body as a result of the use of therapeutic drugs, drugs abuse, or the interaction of two or more pharmacologically active agents.[4] 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.4

 

A major reason for these drug  products recalls is that remarketing studies treat to few patients (3000– 4000) to detect uncommon drug effects. The adverse drug effect that occurs in only 25,000 people would go unnoticed in only 4000 treated patients in the remarketing phase. It is simply impossible to identify all the unintended consequences of drug before they are marketed.5

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.6 ADR is distinction between type A (pharmacological) and type B (hypersensitivity). Type A is also called as predictable reaction these are based on pharmacological properties of the drug. They are more common dose related, and mostly preventable. It includes side effects, toxic effect, secondary effect, drug interaction. Type B also called as unpredictable reaction. These are less common dose related, generally more serious and require withdrawal of the drug.  It includes immune mediated (allergic reaction).7

 

To avoid or to prevent adverse drug reaction “Triggers” or “Clues” to identify adverse drug events is an effective method for measuring the overall level of harm medication in a Health care organization. The trigger tool for measuring adverse drug events provides instruction for conducting a retrospective review of patient’s records using triggers to identify possible ADE. 8

 

Use of triggers to detect the ADR of the drug relatively low cost, and low technique. The adapted technique appears to increase the rate of ADE detection approximately 50 fold over traditional reporting methodologies.9 In these system specific events including the order for antidotes, surtain abnormal laboratory values and adrift stop orders serve as a triggers to initiate a more detail concurrent chart audit.10 The ability to screen rapidly and comprehensively provides opportunity to rectify the processes that facilitates ADE and reduce their impact on patients while subsets of medication related harm may escapes predictability the rapid identification of these events may revel patterns likely to generate ADEs.[9]This tool accepts the National Co-Coordinating Council For Medication Error Reporting And Prevention index ( NCC MERP) for categorizing error. The tool includes categories E, F, G, H, and I of the NCC MERP index because these categories describes medication harm as this tool is design to find harm. 8

 

Amongst the organ systems affected, gastrointestinal ADRs constituted a major component10 considering increased incidence of ADRs in Gastrointestinal Tract (GIT) in OPD Patient. There is no study which focuses on easy identification of AE in GIT system, therefore present study aims to identify and use triggers tool for detection and prevention of ADR’s of GI in OPD patient.

 

Material and Method:

This study was prospective observational study consider patient from medicine outpatient department in civil hospital and private clinic in Nasik. The Institutional Ethical Committee approval was received before initiation of study. The study was undertaken for 12 weeks. We Triggers tool methodology was used for ADR monitoring. It includes enrolment of the patient in OPD according to IC/EC. Inclusion criteria like subject of irrespective of age included in the study. New Subjects coming to OPD on that particular day. The patient was selected by using consecutive sampling method. Written informed consent was obtained from patient. Once the informed consent was obtained, patients prescription was studied and was followed every 7 days by telephonic conversation and every month in OPD. Prescription was studied and analysed by observing the prescription of the patient by using predetermined triggers associated with possible ADE for next seven days. After finding specific trigger we 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 prescriptions was considered and total number of Triggers was calculated in percentage .Total number of positive triggers which had shown ADR was calculated accordingly.ADR assessment was done by WHO Scale and Naranjo’s causality assessment Scale.

 

RESULT:

Out of 180 patient studied 7 patients (3.8%) developed ADR and 15 (8.3%) triggers were found to detect ADR in GIT out of which 3.8% of triggers were positive (showing response between trigger and adverse event) (table 2). ADRs were found to be of Harm Category E (table no 1) and Mild in Nature. We found 8 (4.4%) such triggers which could not detect any ADR. All ADRs were “possible” according WHO Scale and Naranjo’s causality scale (table 3). Preventability assessment was performed by Schumock and Thornton preventability assessment scale out of ADR received, only one ADR was preventable (table 4).

 

 

TABLE: 1: LIST OF ADR

Sr.  No.

ADR

HARM CATEGORY*

1

Epigastric Pain

E

2

Epigastric Pain

E

3

Epigastric Pain

E

4

Nausea

E

5

Diarrhoea

E

6

Constipation

E

7

Pseudomembranous colitis,

E

*Category E: contributed to or resulted in temporary harm to the patient and required intervention 15.

 

 

TABLE: 2 LIST OF TRIGGERS AND ADR

Sr. No.

List of Triggers

No. of Triggers

ADR

No. of ADR

1

Gastritis

5

Epigastric pain

3

2

Antiemetics

4

Nausea

1

3

Antidiarrhoal

3

Diarrhoea

1

4

Metronidazole (oral)

1

Pseudomembranous colitis,

1

5

Laxatives

2

Constipation

1

 

TABLE: 3 CAUSALITY ASSASSMENT AS PER WHO and NARANJO’S SCALE

ADR

WHO SCALE

Naranjo’s Scale*

Epigastric Pain

Possible

4

Nausea

Possible

4

Diarrhoea

Possible

4

Pseudomembranous colitis,

Possible

3

Constipation

Possible

3

*Naranjo’s Scale: Score • > 9 = definite ADR, • 5-8 = probable ADR, • 1-4 = possible ADR • 0 = doubtful ADR

 

TABLE: 4: PREVENTABILITY ASSESSMENT

ADR

PREVENTABLE*

(YES/NO)

Epigastric Pain

NO

Nausea

NO

Diarrhoea

NO

Pseudomembranous colitis

YES

Constipation

NO

* According to Schumock and Thornton preventability assessment scale14.

 

 

DISCUSSION:

Our efforts were directed towards to use trigger tool for investigating clinical events associated with harm that could be more widely applied in clinical practice. We found 15 triggers in a sample size of 180 and ADR findings were 7. We found ADR like epigastric pain, nausea, constipation, diarrohea, Pseudomembranous colitis, which was of harm category E. Total percentage of ADR was 3.8% and out of 8.3% trigger 3.8% found to detect adverse drug reaction in gastrointestinal tract. Using this tool Mull et al., created 23 triggers that addressed 55 high-harm outpatient drugs and ADEs and concluded that informatics tools can facilitate the design of clinically rich triggers. More investigation is needed to determine whether the performance characteristics of clinically rich triggers are better than those of simple triggers.11

 

Another study done in patient department by Rozich et al., examined data in more than 2800 charts from 86 different hospitals with more than 268 000 separate medication doses using a trigger tool to uncover ADEs. Using teams of two healthcare professionals found that the trigger tool can be efficiently and consistently applied to describe the extent and scope of the ADEs identified in different inpatient organizations.9 One another study done by Michael N Cantor et al., used a trigger phrases methodology detected 38 of 54 cases in the authors’ gold standard set, of which 17 were true positives, for a sensitivity of 31%, a specificity of 98%, and a positive predictive value of 45%. Their proxy measure correlated with 70% of the ADRs in the gold standard and conclude that an automated system can detect ADRs with moderate sensitivity and high specificity, and has the potential to serve as the basis for a larger scale reporting system.[12] The study done a Ascension Health demonstrates that ADEs per 100 patient days have not statistically changed from the baseline mean of 1.39  to a mean of 1.11 At Saint Thomas, ADEs per 100 patient days decreased from a baseline mean of 3.04  to a mean of 1.21 representing a 60% reduction. ADE Trigger Tool results have not shown a consistent reduction in ADEs.13.

 

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. Limitations in our study were found to be loss of follow up of patient in Out Patient Department patient and small sample size. Our study result demonstrates that trigger tool is a relatively simple method which permits consistently accurate identification and measurement of a broad range of adverse events that are directly linked to clinical harm. Present study can be helpful for the GI system practioners to rapid identification and prevention of the ADR. The incidence and severity of ADRs documented in our study are lower than those reported in other study but these results show that trigger tool can detect ADRs and has the potential to serve as the basis for a larger scale reporting system out patient department.

 

REFERENCES:

1)       Vikas dhikav et al., Adverse drug reaction monitoring in India Journal, Indian Academy of Clinical Medicine 2004; 1:27 -33..

2)       Wiffen P, Gill M, Edwards J, Moore A: Adverse drug reactions in hospital patients. A systematic review of the prospective and retrospective studies. Bandolier Extra 2002, 1-16.

3)       Lazarou J,Pomeranz B.H., Corey, P.N. JAMA, 5/2/2001; 279(15); 1200; 1998. Originally posted 6/12/2004; Revised 2006-01-10.

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

5)       Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239- 45.

6)       Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW (2003) the incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 138:161–167 2003.

7)       K.D Tripathi Text Book of Pharmacology. Jaypee Brothers Medical Publishers Ltd New Delhi, 2003.

8)       Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2007.

9)       J D Rozich, C R Haraden, R K Resar- Adverse drug event trigger tool: a practical methodology for measuring medication related harm: Qual Saf Health Care 2003; 12; 194 – 200.

10)    Himanshu Sharma et al., A pharmacovigilance study in the department of medicine of a university teaching hospital: Pharmacy Practice 2007; 5(1): 46-49.

11)    Hillary J. Mull, MPP1, Jonathan R. Nebeker- Informatics Tools for the Development of Action-Oriented Triggers for Outpatient Adverse Drug Events  AMIA . 2008; 505 –509.

12)    Michael N Cantor, Henry J Feldman, Marc M Triola-Using trigger phrases to detect adverse drug reactions in ambulatory care notes: Qual Saf Health Care 2007; 16:132–134.

13)    Kerry Butler et al., Eliminating Adverse Drug Events at Ascension Health The Joint Commission Journal on Quality and Patient Safety2007; 33(9):527- 535.

14)    Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992; 27:538.

15)    IHI Global Trigger Tool for Measuring Adverse Events (UK version). Institute for Healthcare Improvement. September 2008, 3.

 

 

Received on 10.07.2011

Accepted on 10.07.2011     

© A&V Publication all right reserved

Research J. Pharmacology and Pharmacodynamics. 3(5): Sept –Oct. 2011, 260-262