Welcome to the
NQF Safe Practices for Better Healthcare
2009 Update
Webinar:
Medication Safety – Complex Issues for All
(Safe Practices 17-18)
Hosted by NQF and TMIT
Attendee dial-in instructions:
Toll-free Call-in number (US/Canada): 1-866-764-6260
(direct number, no code needed)
To join the online webinar, go to:
www.safetyleaders.org
Online Access Password: Webinar1 (case-sensitive)
1
Welcome and Overview of the
Medication Management Chapter
of the 2009 NQF Safe Practices
Charles Denham, MD
Chairman, TMIT
Co-chairman, NQF Safe Practices Consensus Committee
Chairman, Leapfrog Safe Practices Program
Safe Practices Webinar
June 18, 2009
2
Panelists
Charles Denham
Peter Angood
Michael Cohen
Mary Andrawis
Jeffrey Schnipper Patti O’Regan
3
Culture SP 1
Culture
Consent & Disclosure
Consent & Disclosure
Work Force
Information Management &
Continuity of Care
Medication Management
Healthcare-Associated
Infections
Condition- &
Site-Specific Practices
© 2008 TMIT All Rights Reserved
4
Culture
Structures
& Systems
Culture Meas,
F.B, & Interv.
Team Training
& Team Interv.
ID Mitigation
Risk & Hazards
CHAPTER 2: Creating and Sustaining a Culture of
Patient Safety (Separated into Practices]
•Leadership Structures & Systems
•Culture Measurement, Feedback and Interventions
•Teamwork Training and Team Interventions
•Identification and Mitigation of Risks and Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life Sustaining
Treatment
Care of
Caregiver
Disclosure
CHAPTER 3: Informed Consent & Disclosure
•Informed Consent
•Life Sustaining Treatment
•Disclosure
•Care of the Caregiver
Work Force
CHAPTER
6: Medication Management
2009
NQF
Report
17.
Medication Reconciliation
Legend:
18. Pharmacist Information
Leadership
Structures and Systems
Management & Continuity of Care
Nursing
Workforce
Direct
Caregivers
No Material
Changes
Material
Changes
New
Labeling
Studies
CHAPTER 4: Workforce
•Nursing Workforce
•Direct Caregivers
•ICU Care
ICU Care
CHAPTER 5: Information Management & Continuity of
Care
•Critical Care Information
•Order Read-back and Abbreviations
•Labeling Studies
•Discharge Systems
•Safe Adoption of Integrated Clinical Systems including
CPOE
Critical
Care Info.
NEW:
• Previous practices including Pharmacist Role, HighMedication Management
Alert Medications, Standardized Medication Labeling
.
& Packaging, and Unit-Dose Medications are bundled
into the Pharmacist Leadership Structures and
Systems practice.
Healthcare Associated Infections
Discharge
System
Read-back
& Abbrev.
CPOE
CHAPTER 6: Medication Management
•Medication Reconciliation
• Pharmacist Leadership Role Including: High-Alert
Med. & Unit Dose Standardized Medication Labeling
& Packaging
Med Recon
Pharmacist Systems Leadership
High Alert, Std Labeling/Pkg, & Unit Dose
UTI
Prevention
VAP
Prevention
MDRO
Prevention
CHAPTER 7: Hospital Associated Infections
• UTI Prevention
• MDRO Prevention
• Care of the Ventilated Patient & VAP,
• Central Venous Catheter Related Blood Stream
Infection Prevention
• Surgical Site Infection Prevention
• Hand Hygiene
• Influenza Prevention
• Medication Reconciliation updated with expanded
Additional Specifications and Example
Condition, Site, and Risk Specific Practices
Implementation Approaches.
Hand Hygiene
Falls
Prevention
Press. Ulcer
Prevention
© 2008 TMIT All Rights Reserved
Influenza
Prevention
Central V. Cath
BSI Prevention
Organ
Donation
Anticoag
Therapy
DVT/VTE
Prevention
Wrong site
Sx Prevention
Glycemic
Control
Contrast
Media Use
5
Sx Site Inf.
Prevention
Pediatric
Imaging
CHAPTER 8:
•Wrong Site, Wrong Procedure, Wrong Person
Surgery Prevention
•Falls Prevention
•Organ Donorship
•Pressure Ulcer Prevention
•DVT/VTE Prevention
•Anticoagulation Therapy
•Gycemic Control
•Contrast Media-Induced Renal Failure Prevention
•Pediatric Imaging
Challenges of Policy Development
for Medication Management
Peter B. Angood, MD, FRCS(C), FACS, FCCM
Senior Advisor, Patient Safety
National Quality Forum
Safe Practices Webinar
June 18, 2009
6
Medication Safety Overview,
Evolution, and Current Issues
Michael Cohen, RPh, MS, ScD
President, Institute for Safe Medication Practices (ISMP)
Safe Practices Webinar
June 18, 2009
7
Epidemiological Review
IOM  Preventing Medication Errors
• Medications harm too many Americans
–At least 1.5 million people per year
–Hospitals
• 400,000 preventable ADEs per year
• About 1 medication error per patient per day
– Outpatient setting
• Also frequent, though data less solid
• 530,000 ADEs/year in Medicare patients
8
Event types reported to Pa-PSRS
9
Hospital Drug Distribution Systems
• Pre-1960s - floor stock system
– Locked narcotic safes/boxes (keys) with manual counts
• 1960s – individual patient prescriptions; 3-to5-day supply, nurses “poured” own meds
• 1970s – unit-dose distribution; IV admixtures
– Errors much more visible
– More pharmacist oversight of drug distribution process
• 1980s-’90s – Clinical pharmacy practice
• 1990s – present - automated dispensing, robotics,
bar-coding, outsourcing for order review
10
Early Studies
Date
Hospital
Error Rate Observed %
1962
University Florida
14.7
1964
University Arkansas
14.4
1967
University Kentucky (UD)
3.5
Kentucky Hosp A
8.3
Kentucky Hosp B
9.9
Kentucky Hosp C
11.5
Kentucky Hosp D
20.6
Johns Hopkins
7.3
Johns Hopkins UD
1.6
1975
11
Historic events in medication safety
Year
Event
1960s-’70s
Studies show hospital ME rates up to 20%; Community Pharmacy 3-5%
1975
ME Feature in Hospital Pharmacy
1990
ISMP and USP form MERP
1992
Dateline NBC premieres with ME story
1995
Events in Florida, Massachusetts, Illinois all make headlines
1995
Leape, Bates, Cullen et al. JAMA
1996-7
IOM chartered study (To Err is Human)
1999
To Err is Human published
1999
TJC SE Alerts – NPSGs – Med Mgt Stds
2006
NQF Safe Practices Medication Management Chapter
2009
NQF Safe Practices Pharmacist Leadership Structures and Systems
12
Clinical
consequences
of a productrelated error
Communication of Drug Information
• “Look-alike”/“sound-alike” drug names combined with
poor order communication, including during digital
transmission
• Dangerous abbreviations and dose designations
• Suffixes misunderstood or omitted
• Confusion related to OTC brand name extensions
• Unsafe practices depicted in journal advertising
• Name confusion with medical terminology or laboratory
nomenclature
• Same established name, different substance internationally
• More than one trademark for brand item
17
Use of mixed-case (tall-man) characters
• Dobutamine 400 mg
• Dopamine 500 mg
• doBUTamine
• doPAmine
• chlorpropamide 100 mg
• chlorpromazine 100 mg
• chlorproPAMIDE
• chlorproMAZINE
• hydralazine 50 mg
• hydroxyzine 50 mg
• hydrALAzine
• hydrOXYzine
19
Example of error due to lack
of Patient Information
20
Sound-alike
• Brand names
– FEMARA (letrozole) & FemHRT
– SEROPHENE (clomiphene) and SARAFEM (fluoxetine)
– INVANZ (morphine extended release) or AVINZA
(ertapenem injection)
• Nonproprietary names
– tamoxifen or tomoxetine (now atomoxetine)
– fomepizole or omeprazole
– torsemide or furosemide
Cohen MR. Medication Errors. Causes, Prevention, and Risk Management; 8.1-8.23.
21
Some changes to brand name as a result
of medication errors
• Losec (confused with Lasix) is now Prilosec
• Levoxine (confused with Lanoxin) is now Levoxyl
• Mazicon (confused with Mivacron) is now
Romazicon
• Pediaprofen (confused with Pediapred) is now
Children’s Motrin
• Altocor (confused with Advocor) is now Altoprev
• Reminyl (confused with Amaryl) is now
Razadyne
• Omacor (confused with Amicar) is now Lovaza 22
Nonproprietary Name Changes
• amrinone or amiodarone (now inamrinone)
• tamoxifen or tomoxetine (now atomoxetine)
• fomepizole or omeprazole (fomepizole was 4methylpyrazole [4-MP] and concern was for
confusion with 6-MP [mercaptopurine]
• torsemide or furosemide (torsemide was
originally torosemide)
23
Oral orders
“Read-back” vs. “Repeat-back”
• The receiver of the order should write down
the complete order or enter it into a computer
• Then the receiver should read it back
• Receive confirmation from the individual who
gave the order
24
Look-alike packaging
26
Lilly insulin color differentiation
29
United States
Before and after – both are same strength
30
High-Alert Medications
• Small number of medications that have a high
risk of causing injury if misused
• Errors may or may not be more common with
these than with other medications, but the
consequences of errors may be devastating
31
Leading Products in Harmful Medication Errors, CY 2005
Generic Name
n
%
Insulin*
386
11.3
Morphine*
164
4.8
Heparin*
120
3.5
Fentanyl*
98
2.9
Hydromorphone*
91
2.7
Warfarin*
88
2.6
Potassium Chloride*
69
2.0
Vancomycin
69
2.0
Enoxaparin*
60
1.8
Metoprolol Tartrate
42
1.2
Furosemide
41
1.2
Methylprednisolone
35
1.0
Meperidine*
33
1.0
MEDMARX annual report 2007
32
Medication Errors Reporting Program (MERP)
Operated by the
United States Pharmacopeia
in Cooperation with the
Institute for Safe Medication Practices
www.ismp.org
Pennsylvania Patient Safety Reporting Program
ISMP is a federally certified
Patient Safety Organization
36
Actionable Items
• Be proactive, not reactive. Learn from experience of other
organizations. Medication safety officer/team.
• Focus on unsafe practices/at risk behaviors (e.g., unlabelled
containers, sharing insulin pens, abbreviating drug names,
patient weight conversions, etc.)
• Implement technologies (smart pumps, bedside bar-code
scanning, follow automated dispensing cabinet guidelines,
e-Rx, etc.)
• Standardize drug concentrations, units of measure, etc.
• Encourage error reporting – internal and external (see “ISMP
Med Safety Alert! Pump up the volume – tips for increasing
reporting. Feb 9, 2006 “)
http://www.ismp.org/Newsletters/acutecare/articles/20060
209.asp
37
Perspectives on the Importance of
the Pharmacist Leadership
Safe Practice in the
Hospital Environment
Mary Andrawis, PharmD, MPH
Director, Clinical Guidelines and Quality Improvement
American Society of Health-System Pharmacists
(ASHP)
Safe Practices Webinar
June 18, 2009
38
The Pharmacist’s Mission
To help patients make the best use of
medicines


Extensively trained to ensure safe and
evidence-based use of medications
Expanded role to meet the need for
comprehensive medication management
39
Literature clearly demonstrates
improved patient outcomes, fewer
adverse events, and reduced costs when
pharmacists are involved in care.
40
Safe Practice 18: Pharmacist
Leadership Structures and Systems
“Pharmacy leaders should have an active
role on the administrative leadership team
that reflects their authority and
accountability for medication
management systems performance across
the organization.”
41
Health-System Administrative Team
Pharmacy Leader
42
Items of Impact on Care
1. Organizational decision-making.
Involve pharmacy leaders with
integral system decisions.
 Direct communication. Engage pharmacy
leaders with the organizations’ leadership team
and the Board.
ASHP Statement on the Roles and Responsibilities of the Pharmacy Executive [PDF] 43
Items of Impact on Care
2. Medication Safety Committee. Create a
committee led by pharmacy leaders to
review errors.
 Walk-rounds. Evaluate
medication processes and
get front-line staff input on
medication safety.
ASHP Guidelines on Preventing Medication Errors in the Hospital [PDF]
44
Items of Impact on Care
3. Technology Readiness Planning. Call on
pharmacy to play central role in planning and
implementation of technologies that affect
medication use.
ASHP Statement on Bar-Code-Enabled Medication Administration Technology [PDF] 45
Items of Impact on Care
4. Pharmacists on Clinical
Teams. Place clinical
pharmacists on rounds to
optimize safe and
evidence-based selection
and monitoring of
medications.
ASHP–SHM Joint Statement on Hospitalist–Pharmacist Collaboration [PDF]
46
 Utilize your pharmacy leaders to get:
 better patient outcomes
 fewer medication errors, and
 lower costs.
 Examples of Pharmacists’ Impact
47
Where the Rubber Meets the Road:
Implementation of Medication
Reconciliation at the Practitioner Level
Jeffrey Schnipper, MD, MPH, FHM
Director of Clinical Research, BWH Hospitalist Service;
Associate Physician, Division of General Medicine,
Brigham and Women's Hospital; Assistant Professor of
Medicine, Harvard Medical School
Safe Practices Webinar
June 18, 2009
48
Goals of This Talk
• To review the experience at Partners
regarding medication reconciliation
– Which patients are at highest risk
– Benefits of Health Information Technology-based
solutions
– Other lessons learned
• To discuss various ways to approach
solutions for medication reconciliation
49
Classifying and Predicting Errors of Inpatient
Medication Reconciliation
Jennifer R. Pippins, MD, Tejal K. Gandhi, MD, MPH, Claus Hamann, MD, MS,
Chima D. Ndumele, MPH, Stephanie A. Labonville, Pharm D, BCPS, Ellen K.
Diedrichsen, Pharm D, Marcy G. Carty, MD, MPH, Andrew S. Karson, MD,
MPH, Ishir Bhan, MD, Christopher M. Coley, MD, Catherine L. Liang, MPH,
Alexander Turchin, MD, MS, Patricia McCarthy, PA, MHA, and Jeffrey L.
Schnipper, MD, MPH
J Gen Intern Med 2008;23(9):1414-22
50
Effect of a Medication Reconciliation
Application and Process Redesign on
Potential Adverse Drug Events:
A Cluster-Randomized Trial
Jeffrey L. Schnipper, MD, MPH, Claus Hamann, MD, MS, Chima D. Ndumele,
MPH, Catherine L. Liang, MPH, Marcy G. Carty, MD, MPH, Andrew S. Karson,
MD, MPH, Ishir Bhan, MD, Christopher M. Coley, MD, Eric Poon, MD, MPH,
Alexander Turchin, MD, MS, Stephanie A. Labonville, Pharm D, BCPS, Ellen K.
Diedrichsen, Pharm D, Stuart Lipsitz, ScD, Carol A. Broverman, PhD, Patricia
McCarthy, PA, MHA, and Tejal K. Gandhi, MD, MPH
Arch Intern Med 2009;169(8):771-80
51
Specific Aims
Determine the effects of a redesigned process
for medication reconciliation, supported by
information technology, on unintentional
medication discrepancies with potential for
patient harm (potential ADEs)
52
Intervention I: PAML Builder
PAML Builder: Action on Admission
Reconciliation at Discharge (Site 1)
Description of Intervention II: Process Re-design
• Admission
– Ordering physician takes medication history, creates PAML
– Nurse confirms accuracy of PAML
– Physician chooses planned action on admission, writes admission
orders
– Pharmacist reconciles PAML and admission orders
• During Hospitalization
– PAML updated during hospitalization as needed
• Discharge
– Physician reviews PAML and current medications, creates discharge
orders, documents reconciliation
– Nurse reconciles PAML, current medications, and discharge
medications, reviews discharge medications with patient/caregiver
56
Medication Reconciliation Errors in the Control Group
Discrepancies
N=180
N = 2066
Intentional
1127 (55%)
Documented
Unintentional
939 (45%)
Undocumented
Potential for Harm
257 (27%)
History Error
186 (72%)
Admission
57 (22%)
Omission
150 (60%)
Dose
53 (21%)
Frequency
24 (10%)
Discharge
129 (50%)
Route
0 (0%)
No Potential for Harm
682 (73%)
Reconciliation Error
78 (30%)
Admission
10 (4%)
Substitution
9 (4%)
Discharge
68 (26%)
Additional
Medication
12 (5%)
Formulation
1 (0.4%)
Other
0 (0%)
PADE Risk Score
Characteristic
Points
Low/medium patient understanding
1
Age under 85
2
≥ 16 preadmission medications
1
≥ 4 high-risk preadmission
medications*
≥ 13 outpatient visits last year
1
Family member/caregiver as source
1
* Gout medications, muscle relaxants, hyperlipidemic medications,
antidepressants, respiratory medications
1
58
Distribution of PADE Risk Scores
Score
Range
% in
Score
Range
17
PADEs per
patient, Mean
(SD)
0.26 (0.64)
Total PADEs
Accounted for by
Group, n (%)
8 (3)
3
31
0.71 (1.26)
40 (16)
4
31
1.72 (1.92)
95 (37)
5-7
21
2.92 (2.50)
113 (44)
0-2
59
Results of RCT
Outcome
Events, N (per
patient) in
Usual Care
Events, N (per
patient) in
Intervention
Adjusted and
Clustered RR (95%
CI)
All PADEs
230 (1.44)
170 (1.05)
0.72 (0.52-0.99)
PADEs due to History
Errors
153 (0.96)
125 (0.77)
0.80 (0.55-1.15)
PADEs due to
Reconciliation Errors
80 (0.50)
52 (0.32)
0.62 (0.29-1.34)
PADEs at Admission
49 (0.31)
44 (0.27)
0.87 (0.51-1.52)
PADEs at Discharge
181 (1.13)
126 (0.78)
0.67 (0.49-0.98)
Subgroup Analyses
Subgroup
Site
Site 1
Site 2
PADE Risk Score
0-3 points
4-7 points
N
Adjusted RR
(95% CI)
P value for
interaction
0.32
170
152
0.60 (0.38-0.97)
0.87 (0.57-1.32)
0.02
155
167
1.09 (0.49-2.44)
0.62 (0.41-0.93)
Discussion
• Intervention successful
– NNT 2.6 to prevent one PADE
– Effective combination of IT and process redesign
• But potentially harmful medication discrepancies
remained
–
–
–
–
Incomplete/inaccurate medication sources
Lack of patient/caregiver knowledge of medications
Lack of clinician adherence with process
Software usability issues
62
Discussion
• Why more successful at Site 1 than Site 2?
–
–
–
–
Differences in timing of roll-out, publicity
Greater involvement of nurses
Software integration at discharge
Chance
63
Reconciliation at Discharge (Site 1)
Reconciliation at Discharge (Site 2)
Implications
• Unintentional medication discrepancies with
potential for patient harm are very common
– Most are due to history errors
– Most occur at discharge
– Most are due to omissions
• Patients at high risk can be identified
– Low understanding of preadmission medications
– Number of total and high-risk preadmission medications
– Frequent outpatient visits
• Efforts need to focus first on taking accurate
medication histories, second on correcting
reconciliation errors at discharge
66
Implications (cont’d)
• Rigorous evidence that medication reconciliation can
benefit patients
• Particular benefits of IT tools
– Ability to use existing electronic sources of ambulatory medication
information
– Better workflow integration in sites with CPOE
– Easier sharing of information across providers
– Automatic production of discharge documentation
– Comparisons of medication lists to facilitate reconciliation and
patient education
– Provision of alerts and reminders to ensure compliance
– Ability to track compliance to inform QI
67
Discussion
• Steps Taken to Improve Intervention
– Incomplete/inaccurate medication sources
• Working on Link to SureScripts/HubRx Data
• Post-discharge medication reconciliation so EMR list is more accurate
next time
– Lack of patient/caregiver knowledge of medications
• Patient education
– Lack of clinician adherence with process
• Cannot write orders if PAML not complete within 24 hours of
admission; continued education; culture change with time
• Better utilization of pharmacists (help with history rather than police of
admission order discrepancies)
– Software usability issues
• Better integration with admission orders
• Improvements to discharge screens still to come
68
Approaches to Medication Reconciliation
1. Pharmacists take medication histories, confirm
reconciliation at admission and discharge in all
patients
– Likely most effective: the most successful interventions in the
literature have had extensive pharmacist involvement
– Also the most resource intensive
2. Pharmacist technicians take medication histories in
the Emergency Department (e.g., Novant Health)
3. Physicians take medication histories in most
patients, pharmacists play supporting role in most
patients; reserve greater pharmacist involvement for
high-risk patients
69
Conclusions
•
•
•
•
•
•
•
•
Medication reconciliation can work
HIT can be part of the solution
Interdisciplinary communication is key
Focus should be on taking good medication histories and
reconciling medications at discharge
With HIT, little usability issues mean a lot
Collectively, we need access to better sources of
preadmission medication information
Patients and caregivers need to be more a part of the
solution
Several approaches to use of personnel are possible; not
clear which is most effective and efficient
70
Patient Perspective on Medication
Management Safe Practices
Patti O’Regan, ARNP, ANP, NP-C, PMHNP-BC
Nurse practitioner, Port Richey, FL;
founding member, TMIT Patient Advocate Panel
Safe Practices Webinar
June 18, 2009
71
Panelists
Charles Denham
Peter Angood
Michael Cohen
Mary Andrawis
Jeffrey Schnipper Patti O’Regan
72
Upcoming Safe Practices Webinars
 July 16 – Leadership and Leadership Principles for Safety
(Safe Practices 1-4)
 September 17 – Important Condition and Common Safety
Issues (Safe Practices 26-34)
 October 22 – Creating Transparency, Openness, and
Improved Safety (Safe Practices 5-8)
 November 19 – Healthier Communication and Safe
Information Management
(Safe Practices 12-16)
 December 17 – Optimizing a Workforce for Optimal Safe
Care (Safe Practices 9-11)
73