The Importance of Reporting Adverse Drug Reactions and Creating a Culture of Safety

Kristy Malacos

Magruder Hospital

Pharmacy Systems Inc

Objectives

bull Describe Adverse Drug Reactions (ADR)and the importance of reporting for patient safety

bull Illustrate the benefit of successful reporting and how to implement a reporting system and utilize reporting tools

bull Explain the importance of a successful ADR reporting program within the hospital to help create a culture of safety

What is an ADR

bull Harmful unintended reaction to medication that occurs at doses normally used for treatment

ndash World Health Organization

ADR (ASHP)

bull Undesirable experience associated with the use of a medication that may result inndash discontinuing the drugndash changing the drug therapyndash modifying the dosendash necessitates admission to a hospital or prolongs stayndash necessitates supportive treatmentndash significantly complicates diagnosisndash negatively affects prognosisndash results in temporary or permanent harm disability or

death

Side Effects

bull Expected well-documented reactions

bull Results in little or no change in patient management

Objectives

bull Describe Adverse Drug Reactions (ADR)and the importance of reporting for patient safety

bull Illustrate the benefit of successful reporting and how to implement a reporting system and utilize reporting tools

bull Explain the importance of a successful ADR reporting program within the hospital to help create a culture of safety

What is an ADR

bull Harmful unintended reaction to medication that occurs at doses normally used for treatment

ndash World Health Organization

ADR (ASHP)

bull Undesirable experience associated with the use of a medication that may result inndash discontinuing the drugndash changing the drug therapyndash modifying the dosendash necessitates admission to a hospital or prolongs stayndash necessitates supportive treatmentndash significantly complicates diagnosisndash negatively affects prognosisndash results in temporary or permanent harm disability or

death

Side Effects

bull Expected well-documented reactions

bull Results in little or no change in patient management

What is an ADR

bull Harmful unintended reaction to medication that occurs at doses normally used for treatment

ndash World Health Organization

ADR (ASHP)

bull Undesirable experience associated with the use of a medication that may result inndash discontinuing the drugndash changing the drug therapyndash modifying the dosendash necessitates admission to a hospital or prolongs stayndash necessitates supportive treatmentndash significantly complicates diagnosisndash negatively affects prognosisndash results in temporary or permanent harm disability or

death

Side Effects

bull Expected well-documented reactions

bull Results in little or no change in patient management

ADR (ASHP)

bull Undesirable experience associated with the use of a medication that may result inndash discontinuing the drugndash changing the drug therapyndash modifying the dosendash necessitates admission to a hospital or prolongs stayndash necessitates supportive treatmentndash significantly complicates diagnosisndash negatively affects prognosisndash results in temporary or permanent harm disability or

death

Side Effects

bull Expected well-documented reactions

bull Results in little or no change in patient management

Side Effects

bull Expected well-documented reactions

bull Results in little or no change in patient management

Reporting of Medication Events

Adverse Drug Events

bull Medication error

bull Medication administration error

bull Inappropriate dose reductionincrease

Adverse Drug Reactions

bull Harm caused by drug therapy at normal clinical dose and during normal use

ndash Includes allergic reactions

ndash Includes drug product and vaccine issues

Steps to Implementing an ADR Reporting Program

EducateMonitor and Investigate

Communicate

Part 1 - Education

bull Do our nursesstaff understand what an ADR looks like and when to report

bull Do our nursesstaff understand the value in reporting ADRs

bull Do our nursesstaff know wherehow to report an ADR

Why Arenrsquot ADRs Reported

bull Lack of knowledge about the reporting systems or perceived difficulty

bull Uncertainty about whether or not a drug is the cause of an adverse eventndash Concern about medical liability or professional disciplinary

action

bull Lack of time or high workload

bull Lack of understanding about why it is important to report

bull Complacency (believing that serious ADRs are well documented when the drug is released in the market)

Are ADRs Always Preventable

bull Majority of preventable ADRs occur at prescribing and monitoring stages

Who is most at risk for ADRs

bull Elderly

bull Patients taking multiple medications

bull Patients taking medications from specific classes

ndash Antidiabetics and hypoglycemic agents

ndash Cardiovascular drugs

ndash Psychotropics

ndash Anticonvulsants

ndash Antineoplastics

ndash Corticosteroids

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Steps to Implementing an ADR Reporting Program

EducateMonitor and Investigate

Communicate

Part 1 - Education

bull Do our nursesstaff understand what an ADR looks like and when to report

bull Do our nursesstaff understand the value in reporting ADRs

bull Do our nursesstaff know wherehow to report an ADR

Why Arenrsquot ADRs Reported

bull Lack of knowledge about the reporting systems or perceived difficulty

bull Uncertainty about whether or not a drug is the cause of an adverse eventndash Concern about medical liability or professional disciplinary

action

bull Lack of time or high workload

bull Lack of understanding about why it is important to report

bull Complacency (believing that serious ADRs are well documented when the drug is released in the market)

Are ADRs Always Preventable

bull Majority of preventable ADRs occur at prescribing and monitoring stages

Who is most at risk for ADRs

bull Elderly

bull Patients taking multiple medications

bull Patients taking medications from specific classes

ndash Antidiabetics and hypoglycemic agents

ndash Cardiovascular drugs

ndash Psychotropics

ndash Anticonvulsants

ndash Antineoplastics

ndash Corticosteroids

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Part 1 - Education

bull Do our nursesstaff understand what an ADR looks like and when to report

bull Do our nursesstaff understand the value in reporting ADRs

bull Do our nursesstaff know wherehow to report an ADR

Why Arenrsquot ADRs Reported

bull Lack of knowledge about the reporting systems or perceived difficulty

bull Uncertainty about whether or not a drug is the cause of an adverse eventndash Concern about medical liability or professional disciplinary

action

bull Lack of time or high workload

bull Lack of understanding about why it is important to report

bull Complacency (believing that serious ADRs are well documented when the drug is released in the market)

Are ADRs Always Preventable

bull Majority of preventable ADRs occur at prescribing and monitoring stages

Who is most at risk for ADRs

bull Elderly

bull Patients taking multiple medications

bull Patients taking medications from specific classes

ndash Antidiabetics and hypoglycemic agents

ndash Cardiovascular drugs

ndash Psychotropics

ndash Anticonvulsants

ndash Antineoplastics

ndash Corticosteroids

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Why Arenrsquot ADRs Reported

bull Lack of knowledge about the reporting systems or perceived difficulty

bull Uncertainty about whether or not a drug is the cause of an adverse eventndash Concern about medical liability or professional disciplinary

action

bull Lack of time or high workload

bull Lack of understanding about why it is important to report

bull Complacency (believing that serious ADRs are well documented when the drug is released in the market)

Are ADRs Always Preventable

bull Majority of preventable ADRs occur at prescribing and monitoring stages

Who is most at risk for ADRs

bull Elderly

bull Patients taking multiple medications

bull Patients taking medications from specific classes

ndash Antidiabetics and hypoglycemic agents

ndash Cardiovascular drugs

ndash Psychotropics

ndash Anticonvulsants

ndash Antineoplastics

ndash Corticosteroids

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Are ADRs Always Preventable

bull Majority of preventable ADRs occur at prescribing and monitoring stages

Who is most at risk for ADRs

bull Elderly

bull Patients taking multiple medications

bull Patients taking medications from specific classes

ndash Antidiabetics and hypoglycemic agents

ndash Cardiovascular drugs

ndash Psychotropics

ndash Anticonvulsants

ndash Antineoplastics

ndash Corticosteroids

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Who is most at risk for ADRs

bull Elderly

bull Patients taking multiple medications

bull Patients taking medications from specific classes

ndash Antidiabetics and hypoglycemic agents

ndash Cardiovascular drugs

ndash Psychotropics

ndash Anticonvulsants

ndash Antineoplastics

ndash Corticosteroids

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

What Costs are Associated with ADRs

bull Ambulatory-setting cost impact of drug-related problems estimated at $766 billion in 1995

bull Cost estimated at $1774 billion in 2000

ndash New prescriptions

ndash Doctors visits

ndash Admission to hospital

ndash ED visit

ndash LTC admission

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Why are there so Many

bull 75 of patient visits result in a prescription

bull Medicare Patients

ndash 89 take a prescription medicine daily

ndash 46 take greater than 5 prescriptions chronically

ndash 54 take meds prescribed by 2 or more doctors

ndash 5 obtain an Rx from CanadaMexico ƒ

bull ADRs increase exponentially with greater than 4 prescriptions

CDC Fast Stats

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

How Do We Report an ADR

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Part 2 ndash Monitor and Investigate

bull Monitor reporting and evaluate for ADRs

ndash Provide follow up to reporter

bull Investigate potential trends using medication-use evaluation (MUE)

bull Identify unreported ADRs through Trigger Tool

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Reporting Increase

0

5

10

15

20

25

2014 2015

ADR Events Reported

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Investigate Trends

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Investigate through MUE

bull A process focused on evaluating and improving the usage of a medication with the goal of improving patient outcomes

bull Analyze prescribing trends

ndash Examine guidelines treatment protocols and standards of care for specific medication and medication-use processes based on data from recent literature

bull Collect data and evaluate usage

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Indications an MUE is Needed

bull Increase in ADRs or medication errors

bull Multiple occurrences of treatment failure

bull Pharmacy intervention consistently necessary

bull Expensive medication

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Interpreting the Data

bull Develop and implement plans for improvement of the medication- use process based on MUE findings (if indicated)

bull Recommend changes (if any) or suggest alternatives to current prescribing

bull After changes implemented continue to collect data

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Ciprofloxacin MUE

bull By August of 2015 14 ADRs reported

ndash 6 related to infusion of Ciprofloxacin

bullCiprofloxacin is being infused over 60 minutes in the ED but infusion time appears to be increased in MedSurg and ICU to 90-120 minutes

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Ciprofloxacin MUE

Total Ciprofloxacin Doses in 2014 175

Patients Given in ED and Admitted 99

Patients Given in ED and Discharged 43

Patients Given Ciprofloxacin in MedSurg 20

Patients Given in Surgery 2

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Ciprofloxacin MUE

Cost of Levaquin (levofloxacin) Cost of Cipro (ciprofloxacin)

250mg50mL bag $204 200mg100mL $125

500mg100mL bag $298 400mg200mL $215

750mg150mL bag $2676

bullNo Levaquin ADRs have been reported

bullGiving Levaquin for all 175 doses of Cipro dispensed in 2014 would create a cost increase of $1027 for ciprofloxacin 200mg and $13446 for 400mg = total increase of $14473

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Ciprofloxacin MUE

bull Can increase infusion time with no disruption in efficacy

bull Antibiogram shows greater susceptibility to Levaquin then Ciprofloxacin for all areas except pseudomonas

bull Diagnoses most prevalent (UTI and divertulitis) also indicated with Levaquin

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

MUE Recommendations

bull Increase infusion time from 60 minutes to 90 minutes

ndash ED patients being admitted 70 so will not need to worry about infusion time lengthening stay

bull Remove Ciprofloxacin from pre-built order sets for prescribers

ndash Propose utilizing Levaquin instead of Cipro for UTI diverticulitis and when appropriate

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Monitor Results

bull Since implementing recommendations 1 ADR related to ciprofloxacin

ndash Utilized Smart Pump software to determine pre-programmed infusion rate was overridden and infused at 60 minutes

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Increase Reporting

bull Use Smart Pump software for trends of infusion rates being consistently overridden

ndash Evaluate if any overrides created infusion-related ADRs

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Increase Reporting

bull Examine patients who were given antidotes

bull Was this given as an antidote for an ADR

ndash Was it reportedTrigger Process identified

T1 Diphenhydramine Hypersensitivity reaction or drug effect

T2 Vitamin K Over-anticoagulation with warfarin

T3 Flumazenil Oversedation with benzodiazepine

T4 Droperidol Nauseaemesis related to drug use

T5 Naloxone Oversedation with narcotic

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Increase Reporting

bull Create an ADR committee charged with increasing and monitoring ADR reporting

ndash Promotes interdisciplinary problem solving

bull Inservices held with all departments to educate (food always works)

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Part 3 - Communication

bull Disseminate information from PampT Committee

bull Share data with nursing staff

ndash Value of reporting is realized when changes are implemented as a result

bull Communicate through meetingnewsletter

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Internal Reporting Mechanism

Contrast Monitoring (Radiology)

Spontaneous Drug Product Issues

Pharmacist Review of Orders

Retrospective Identification in coding

Medication Use Evaluations

Retrospective Drug Monitoring

ADR Reporting Program

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Creating a Culture of Safety

bull Just Culture addresses behavior and analyzes systems and workflows in place when evaluating errors

bull Encourages reporting of events and coaching at-risk behaviors non-punitive response

bull Open dialogue promotes discussion among departments

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Reporting of Medication Events

0

20

40

60

80

100

120

140

Actual Near Miss ADR Total

2015 Total

2014 Total

2013 Total

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

35

44

39

23

38

48

38

29

36

49

39

22

49

5759

32

60

65

68

48

44

5048

35

51

58

52

43

0

10

20

30

40

50

60

70

80

Composite Score Staff feel like theirmistakes are held against

them

When an event isreported it feels like theperson is being written

up not the problem

Staff worry that mistakesthey make are kept in

their personnel file

NONPUNITIVE RESPONSE TO ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

54

74

35

54

50

71

30

50

47

62

34

45

56

71

36

60

69

84

54

69

62

76

48

6365

79

50

67

0

10

20

30

40

50

60

70

80

90

Composite Score Staff will freely speak up ifthey see something that maynegatively affect patient care

Staff feel free to question thedecisions or actions of those

with more authority

Staff are afraid to askquestions when something

does not seem right

COMMUNICATION OPENNESS

2008 2010 2012 2014 2016 National 6-24 Beds

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

58

45

62

68

52

42

53

60

49

38

51

5856

44

60

65

70

62

67

81

67

59

67

73

69

60

70

77

0

10

20

30

40

50

60

70

80

90

Composite Score We are given feedback aboutchanges put into place based

on event errors

We are informed abouterrors that happen in this unit

In this unit we discuss waysto prevent errors from

happening again

FEEDBACK AND COMMUNICATION REGARDING ERRORS

2008 2010 2012 2014 2016 National 6-24 Beds

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

Conclusion

bull Reporting of ADRs is vital for patient safety

ndash Work to minimize preventable ADRs

bull Successful program can help identify problems and lead to positive change

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf

References

bull Lancet 2000 Oct 7356(9237)1255-9 Adverse drug reactions definitions diagnosis and management Edwards IR1 Aronson JK

bull Adverse Drug Reactions by Joan B Tarloff PhD httpwwwmerckmanualscomprofessionalclinical-pharmacologyadverse-drug-reactionsadverse-drug-reactions

bull ASHP Guidelines on Adverse Drug Reaction Monitoring and Reportingbull httppharmacistslettertherapeuticresearchcomcececourseaspxpc=13-219 The Ins and Outs

of Adverse Event Recognition and ReportingVolume 2013 Course No 219bull Using Clinical Pharmacy Support Technicians to Optimize Pharmaceutical Care in the Intensive

Care Unit Can J Hosp Pharm 2010 Jan-Feb 63(1) 41ndash45bull Transitions of Care Pharmacy Technicians Role in Helping to Reduce Readmissionsbull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training Rachel Lutz

Published Online Thursday November 6 2014 See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training - See more at httpwwwpharmacytimescomnewsPharmacists-Underreport-Adverse-Drug-Reactions-Due-to-Inadequate-TrainingsthashD6A2lZv1dpuf

bull httpswwwaccessdatafdagovscriptsmedwatchindexcfmaction=reportinghomebull httpwwwvagovmsprofessionalsmedicationsadverse_drug_reaction_faqpdf