Study ofStudy ofRelationshipRelationship

between trigger toolsbetween trigger toolsbetween trigger tools between trigger tools and adverse drug events and adverse drug events tt S d tS d t PhPh S h jS h jat at SomdetSomdet PhraPhra SangharajaSangharaja

the 19th hospital, the 19th hospital, KanchanaburiKanchanaburi..p ,p ,

Researcher : Duangmee K Phetsai C Khunthongphet U and Sengsoon N

6th year pharmacy student, Faculty of pharmacy, Silpakorn University 

Researcher : Duangmee K.,  Phetsai C., Khunthongphet U., and Sengsoon N. 

Advisor: Assist.Prof.Dr. Tewthanom K.1

O tliOutline

• Introductionh d• Methods

• Results• Conclusion

2

BACKGROUND‐ BACKGROUND‐ TRIGGER TOOLS

IntroductionIntroductionIntroductionIntroduction3

• Adverse drug event (ADE)A N i i t d d t th d d– A Noxious, unintended response to the drug and occur in doses used for people with prophylaxis, diagnosis, therapy, or modification of physiologicdiagnosis, therapy, or modification of physiologic functions.

• Report of Health product vigilance center p p g(March 2013) found 23.5% of severe ADE from all hospitals in Thailand.

• Spontaneous ADR monitoring detect adverse events only 10 to 20 percent of errors are ever

t dreported.

IHI Global Trigger Tool for Measuring Adverse Events (Second Edition) 2009 4

Am J Hosp Pharm, 48. 2611-2616 5

IHI Global Trigger Tool for Measuring Adverse Events (Second Edition) 2009 6

• Trigger tools1

– A retrospective review of a random sample of inpatient hospital records using “triggers” (or clues) to identify possible adverse events.possible adverse events.

– Assess the level of harm from each adverse event– Determine whether adverse events are reduced over time

as a result of improvement efforts.• Rozich JD (2003)2

Th d t d t h i t i th t f– The adapted technique appears to increase the rate of ADE detection approximately 50-fold over traditional reporting methodologies.

2Qual Saf Health Care 2003;12:194–2001IHI Global Trigger Tool for Measuring Adverse Events (Second Edition) 2009 7

• 6 modules of trigger tools that were specify by IHI1. Cares module triggers2. Surgical module triggersMedication Module

Triggers3. Medication module triggers4. Intensive care module triggers

Triggers

gg5. Perinatal module6. Emergency department module6. Emergency department module

8

• Medication module triggersM1: Clostridium difficile positive M7: Diphenhydramine usepcultureM2: PTT greater than 100 sM3: INR greater than 6

p yM8: Flumazenil useM9: Naloxone useM10: Antiemetic useM3: INR greater than 6

M4: Glucose less than 50 mg/dlM5: Rising BUN or Serum C i i h 2 i

M10: Antiemetic use M11: Over-sedation/hypotensionM12 Ab t di ti tCreatinine greater than 2 times

baselineM6: Vitamin K administration

M12: Abrupt medication stopM13: Other

1. Calcium

M3: INR greater than 6 INR greater than 4M5: Rising BUN or Serum Creatinine greater than

polystyrene sulfonate

2 KCl Elixir

IHI Global Trigger Tool for Measuring Adverse Events (Second Edition) 2009 9

g g2 times baseline Rising creatinine of EnalaprilM7: Diphenhydramine use CPM injection use MODIFIED

2. KCl Elixir

S d d i‐ Study design‐ Process

‐ Data analysis‐ Statistical analysis

METHODSMETHODSStatistical analysis

METHODSMETHODS10

• Retrospective cross-sectional descriptiveRetrospective cross sectional descriptive study

• Researchers collected inpatient medical• Researchers collected inpatient medical record during August to September 2013 which existed trigger toolswhich existed trigger tools

11

Reviewed Trigger tools Standard of IHI Global trigger tool (2009) and Thai HA

Specified Trigger tools of each ADEs following IHI Global trigger tool (2009) that could collected data

Brought each Trigger Not

Brought each Trigger tools to search Name, HN, AN of inpatient of Stopped

found

HOSxP program

12

Brought HN to h di l

FoundAnalyzed a relationship

b t th t i

Not related

search medical records

between the trigger tools and adverse

drug events (ADEs)

Stopped

(ADEs)

RelatedCalculated percent

of ADEs which

Categorized Classification of ADEs following NCC MERP Indexcan detect from

using Trigger tools

Rearranged percent of ADEs

Brought data of all trigger tools to calculate Positive predictive value (PPV) and

Brought trigger tool which had the highest of which can detect from using

Trigger tools

Brought trigger tool which had the highest of percent of ADEs which could detect from using

Trigger tools to analyze Sensitivity 13

Example of Record of ADEs that were detected by using trigger tools

14

1 Percent of ADEs and rearranged1. Percent of ADEs and rearranged 2. Percent of each classification of ADEs

following NCC MERP Index (E-I)

Microsoft Microsoft Excel Excel 20132013

following NCC MERP Index (E I)

3 Positive predictive value & SensitivityMedcalcMedcalc

diagnosticdiagnostic3. Positive predictive value & Sensitivity

4 Test for significance level (χ2) [α = 0 05] by

diagnostic diagnostic evaluationevaluation

4. Test for significance level (χ2) [α = 0.05] by

PSPP programPSPP program

15

RESULTSRESULTSRESULTSRESULTS16

Table 5 Summary Data of All trigger tools

Data The number of IPD file that were discovered

The number of IPD file that were found AEs

E 38

F 6

NCC MERP G -

H -

I -

Total IPD Flies 152 44

Average Length of Stay (day) 5

17

Table 15 AE(%) were verified by each trigger tool compared with total trigger tooltotal trigger tool

Trigger tool AE(%) were verified by each trigger tool compared with total trigger tool

1 KCl li i 50 001. KCl elixir 50.00

2. Rising creatinine of Enalapril 15.91

3. Calcium polystyrene sulfonate (Kalimate®) 11.36

4. Chlorpheniramine 11.36

5. Naloxone, Vitamin K 9.09

6.International Normalized Ratio (INR) > 4 2.27( )

18

Table 16 AE(%) were verified by each trigger tool compared with total AEs which arranged in NCC MERP category Etotal AEs which arranged in NCC MERP category E

T i lAE(%) were verified by each trigger

Trigger tool tool compared with total AEs which arranged in NCC MERP category E

1. KCl elixir 43.18

2. Rising creatinine of Enalapril 13.64

3. Calcium polystyrene sulfonate (Kalimate®) 9.09

4. Chlorpheniramine 9.09

5. Naloxone 4.55

6. Vitamin K 4.55

7. INR > 4 2.27

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Table 17 AE(%) were verified by each trigger tool compared with total AEs which arranged in NCC MERP category F

AE(%) were verified by each triggerTrigger tool

AE(%) were verified by each trigger tool compared with total AEs which arranged in NCC MERP category F

1 KCl elixir 6 821. KCl elixir 6.822. Calcium polystyrene sulfonate (Kalimate®) 2.273. Chlorpheniramine 2.274 Rising creatinine of Enalapril 2 274. Rising creatinine of Enalapril 2.275. INR > 4 0.006. Naloxone 0.007 Vitamin K 0 007. Vitamin K 0.00

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Table 18 Positive predictive value and sensitivity of Each trigger tool

Trigger toolNaloxone

administrationINR > 4

Rising creatinine of

E l il

KClelixir CPM

Calcium polystyrene

sulfonate Vitamin Kadministration Enalapril elixir sulfonate

(Kalimate®)

True Positive 2 1 7 22 5 5 2False Positive 0 1 9 32 24 24 20

False Negative Not found

Notfound

Not found 24 5 5 Not

found

PositiveP di ti 1 0 5 0 44 0 41 0 17 0 17 0 09Predictive

value1 0.5 0.44 0.41 0.17 0.17 0.09

Sensitivity Not calculated

Not calculated

Not calculated 0.48 0.50 0.50 Not

calculated

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Table 19 Chi-square of KCL elixir

KCl Hypokalemia

Chi S 1877 01 5634 91Chi-Square 1877.01 5634.91

df 1 3

Asymp. Sig. 0.001 0.001

Chi-square statistics that were calculated by PSPP program found trigger tool, KCl elixir, significance related with hypokalemia from

medicine usage (P = 0 001 Alpha 0 05)medicine usage. (P = 0.001, Alpha 0.05)

22

Table 20 Chi-sqaure of Chlorpheniramine

CPM Hypersensitivity

Chi-Square 1961.62 5959.43q

df 1 3

Asymp. Sig. 0.001 0.001

Chi-square statistics that were calculated by PSPP program found trigger tool ,CPM significance related with Hypersensitivity from

medicine usage. (P =0.001,Alpha 0.05)

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Table 21 Chi-sqaure of Calcium polystyrene sulfonate

Calcium polystyrene sulfonate Hyperkalemia

Chi-Square 1961.62 5959.43

df 1 3

Asymp. Sig. 0.001 0.001

Chi-square statisics that were calculated by PSPP program found trigger tool ,Calcium polystryrene sulfonate, significance related with

Hyperkalemia from medicine usage. (P =0.001,Alpha 0.05)

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CONCLUSIONCONCLUSIONO U IOO U IO25

• Positive predictive value of each trigger tool1) Naloxone (PPV = 1.00) 2) INR > 4 (PPV = 0.5)3) Rising creatinine of Enalapril (PPV = 0.44)4) KCl elixir (PPV = 0.42) Naloxone could

l di) ( )

5) Chlorpheniramine (PPV = 0.17)6) Calcium polystyrene sulfonate (PPV = 0.17)

extremely predict opportunity of i id t i iti

6) Calcium polystyrene sulfonate (PPV 0.17)7) Vitamin K (PPV = 0.09) opioids toxicities

26

From sensitivity analysis• KCl elixir was 0.48.

– Detect hypokalemia from medicine usage about 48 %48 %

• Chlorpheniramine was 0.5. – Detect hypersensitivity from medicine usage about 50 %

C l i l lf 0 5• Calcium polystrene sulfonate was 0.5. – Detect hyperkalemia from medicine usage about 50%50%

27

Chi-square statistics calculation found 3 trigger tools ( KCl elixir Chlorphenira-trigger tools ( KCl elixir, Chlorpheniramine, Calcium polystyrene sulfonate) have p value = 0 001 (alpha < 0 05)have p-value = 0.001 (alpha < 0.05),

So suggest that …

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Trigger tool KCl elixir statistical significantly gg g yrelated with hypokalemia from medicine usage Trigger tool CPM statistical significantlyTrigger tool CPM statistical significantly

related with hypersensitivity from medicine usageusage Trigger tool Calcium polystyrene sulfonate

statistical significantly related withstatistical significantly related with hyperkalemia from medicine usage

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TAKE HOMETAKE HOMETAKE HOME TAKE HOME MESSAGEMESSAGEMESSAGEMESSAGE

30

• Using Trigger tools to design 1.

g gg gprotocol for preventing ADEs

2• Using result of this paper to closely

monitor the occurrences of ADEs2.

Extending collecting time to more3.

• Extending collecting time to more than 2 months

31

Mr. Jetiyanuwat C.Mrs Tananonniwat SMrs. Tananonniwat S.Miss Ngernngam N.

Pharmacists at SomdetPhraSangharajaPharmacists at SomdetPhraSangharaja the 19th hospital, Kanchanaburi.

32

THANK YOUTHANK YOUFORFOR

YOUR ATTENTIONYOUR ATTENTION33

1. Searching ADEs from using trigger toolsg g gg- HOSxP program

2. Confirming the occurrence of ADEs Co g t e occu e ce o s- Medical records - Spontaneous ADR monitoring reportp g p- ADR report in HOSxP program

3. Collecting data that classify by each trigger tool g y y gg- Record of ADEs that were detected by using trigger tools

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Table 5 Summary Data of All trigger tools

Data The number of IPD filethat were discovered

The number of IPD file that were found AEs

SexMale 56 13

Female 96 31

Age

0 - 15 23 3

16 - 30 17 2

31 45 14 6Age (year) 31 – 45 14 6

46 – 60 32 9

≥ 61 66 24 61

35

• Harm– Unintended physical injury resulting from or contributed to– Unintended physical injury resulting from or contributed to

by medical care that requires additional monitoring, treatment or hospitalization, or that results in death.

• This tool utilizes categories E, F, G, H, and I of the NCC MERP Index because these categories describe harm.

Category E: Temporary harm to the patient and required interventionCategory F: Temporary harm to the patient and required initial or prolonged hospitalizationCategor G Permanent patient harmCategory G: Permanent patient harmCategory H: Intervention required to sustain lifeCategory I: Patient death

IHI Global Trigger Tool for Measuring Adverse Events (Second Edition) 2009 36

3. ควรเพิ่มระยะเวลาที่เลือกเก็บขอมูลยอนหลงัใหมากกวา 2่เดือนเนือ่งจากการทบทวนแฟมประวัติผูปวยยอนหลงัใน

ระยะเวลา 2 เดือน รวมกับปจจัยทางดานฤดูกาล อาจทําใหไมพบเหตการณไมพึงประสงคบางเหตการณใหไมพบเหตกุารณไมพงประสงคบางเหตกุารณโดยเฉพาะเหตุการณทีม่โีอกาสพบไดนอย เชน VitaminK กบั Dengue Hemorrhagic fever แตหากทําเพิ่มK กบ Dengue Hemorrhagic fever แตหากทาเพมระยะเวลาที่เลอืกเกบ็ขอมูลอาจจะใชวิธีการสุมตัวอยางทางสถิติเพื่อสุมแฟมประวัติผูปวยที่ใชในการทบทวนแทนุ ู

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