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NQF-Endorsed®
Safe Practices for Better Healthcare
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
1
Slide Deck Overview
Slide Set Includes:
 Section 1:
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
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

Section 2:
Section 3:
Section 4:
Section 5:
Section 6:
© 2010 TMIT
© 2006 HCC, Inc. CD000000-0000XX
NQF-Endorsed® Safe Practices for
Better Healthcare Overview
Harmonization Partners
The Problem
Practice Specifications
Example Implementation Approaches
Front-line Resources
2
NQF-Endorsed®
Safe Practices for Better Healthcare
Overview
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
3
2010 NQF Safe Practices for Better
Healthcare: A Consensus Report
34 Safe Practices
• Criteria for Inclusion
• Specificity
• Benefit
• Evidence of Effectiveness
• Generalization
• Readiness
© 2009 TMIT
4
Culture SP 1
2010 NQF Report
© 2010 TMIT
5
Culture
Structures
and Systems
Culture Meas.,
FB., and Interv.
Team Training
and Skill Bldg.
Risk and Hazards
CHAPTER 2: Creating and Sustaining a Culture of
Safety (Separated into Practices]
 Culture of Safety Leadership Structures and Systems
 Culture Measurement, Feedback, and Intervention
 Teamwork Training and Skill Building
 Risks and Hazards
Consent
& Disclosure
Consent
and
Informed
Consent
Life-Sustaining
Treatment
Care of
Caregiver
Disclosure
Workforce
Nursing
Workforce
Direct
Caregivers
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
ICU Care
Information Management and Continuity of Care
Patient
Care Info.
Read-Back
& Abbrev.
Labeling
Diag. Studies
Discharge
Systems
CHAPTER 3: Consent and Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
• Care of the Caregiver
CPOE
Medication Management
CHAPTER 5: Information Management and Continuity
of Care
 Patient Care Information
 Order Read-Back and Abbreviations
 Labeling Diagnostic Studies
 Discharge Systems
 Safe Adoption of Computerized Prescriber Order
Entry
CHAPTER 6: Medication Management
 Medication Reconciliation
 Pharmacist Leadership Structures and Systems
Med. Recon.
Pharmacist Leadership
Structures and Systems
Healthcare-Associated Infections
Influenza
Prevention
Hand Hygiene
Sx-Site Inf.
Prevention
VAP
Prevention
Central Line-Assoc.
BSI Prevention
MDRO
Prevention
UTI
Prevention
Condition- and Site-Specific Practices
Wrong-site
Sx Prevention
Contrast
Media Use
Organ
Donation
Press. Ulcer
Prevention
Glycemic
Control
VTE
Prevention
Falls
Prevention
Anticoag.
Therapy
Pediatric
Imaging
CHAPTER 7: Healthcare-Associated Infections
• Hand Hygiene
• Influenza Prevention
• Central Line-Associated Blood Stream Infection
Prevention
• Surgical-Site Infection Prevention
• Daily Care of the Ventilated Patient
• MDRO Prevention
• Catheter-Associated UTI Prevention
CHAPTER 8: Condition- and Site-Specific Practices
• Wrong-Site, Wrong-Procedure, Wrong-Person
Surgery Prevention
• Pressure Ulcer Prevention
• VTE Prevention
• Anticoagulation Therapy
• Contrast Media-Induced Renal Failure Prevention
• Organ Donation
• Glycemic Control
• Falls Prevention
• Pediatric Imaging
Harmonization Partners
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
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Harmonization – The Quality Choir
© 2010 TMIT
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The Patient – Our Conductor
© 2010 TMIT
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The Objective
Pharmacist Leadership Structures and
Systems
 Pharmacy leadership is the core of a successful
medication safety program. Pharmacy
leadership structures and systems ensure a
multidisciplinary focus and a streamlined
operational approach to achieve organizationwide safe medication use.
© 2010 TMIT
© 2006 HCC, Inc. CD000000-0000XX
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The Problem
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
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The Problem
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[http://cnsnews.com/news/article/58362]
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[http://www.cnn.com/2008/HEALTH/07/10/heparin/]
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[http://content.nejm.org/cgi/content/full/362/5/380]
© 2010 TMIT
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The Problem
Frequency
 Adverse drug events, or ADEs, are the most
frequently cited significant cause of injury
and death among hospital patients
 More than 40% of Americans take at least
one prescription drug
 16% take at least three or more prescription
medicines
 One study showed that 10.4% of patients
experience an ADE (1 ADE per 10 inpaients)
[Bedell, Arch Intern Med 2000 Jul 24;160(14):2129-34; Bates, Saving Money: The Imperative for Computerized Physician
Order Entry in Massachusetts, 2008]
© 2010 TMIT
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The Problem
Severity
 Mortality rate of 1.0% to 2.45% attributed to ADEs
 ADEs contribute to:
 2.5% of emergency department visits for
unintentional injuries
 0.6% of all medical visits
 22% of hospitalizations have been attributed to
patient medication non-adherence
[Bates, JAMA 1995 Jul 5;274(1):29-34; Classen, JAMA 1997 Jan 22-29; 277(4):301-6; Levinson, ADEs in hospitals: overview of key
issues, 2008 ; Budnitz, JAMA 2006 Oct 18;296(15):1858-66; Stagnitti, Statistical Brief #21: Trends in Outpatient Prescription Drug
Utilization and Expenditures: 1997-2000, 2003]
© 2010 TMIT
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The Problem
Preventability
 1.5 million preventable ADEs occur each year in
the United States
 Implementing computerized monitoring systems
can greatly reduce medication errors
 Pharmacists intercepted or intervened in
potential medication errors at a rate of 3 per 100
in the emergency department
 Pharmacist review of medication orders may
decrease preventable ADEs
[Aspden, Preventing Medication Errors: Quality Chasm Series, 2007; Denham, J Patient Saf 2008 Dec;4(4):253-60 ; Agency
for Healthcare Research and Quality, A Critical Analysis of Patient Safety Practices: AHRQ Publication No. 01-E058, 2001;
Nester, Am J Health Syst Pharm 2002 Nov 15;59(22):2221-5; Slee, Pharm J 2002 Mar 30;268(7191):437-8; Gleason, Am J
Health Syst Pharm 2004 Aug 15;61(16):1689-95; Rothschild, Ann Emerg Med]
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The Problem
Cost Impact
 ADEs account for $3.5 billion (2006 dollars) of
additional costs
 Average cost of ADE is $2K-$7K
 National drug expenditures in 2005 were $200.7
billion and continue to rise at double-digit rates
[Senst, Am J Health Syst Pharm 2001 Jun 15;58(12):1126-32; Kaiser, Prescription Drug Trends, 2007; Bates, JAMA 1997 Jan
2229;277(4):307-11]
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Practice Specifications
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
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Safe Practice Statement
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
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Additional Specifications
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Additional Specifications
Leadership and Culture Safety
 Pharmacy leaders should engage in regular,
direct communication with administrative
leaders
 Pharmacists should actively participate in
medication management processes, structures,
and systems
[National Quality Forum, National Voluntary Consensus Standards for the Reporting of Therapeutic Drug Management
Quality, 2006; American Society of Health-System Pharmacists, 2015 ASHP Health-System Pharmacy Initiative, 2003]
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Additional Specifications
Selection and Procurement
 Pharmacists work with physicians to select and
maintain a formulary of medications chosen for
safety, effectiveness, and cost
 Medication selection should be informed by the
best scientific evidence and clinical guidelines
 Pharmacists are actively involved in the
development and implementation of evidencebased drug therapy protocols and/or order sets
[Pederson, Am J Health Syst Pharm 2001 Dec 1;58(23):2251-66; Pederson, Am J Health Syst Pharm 2008 May 1;65(9):827-43;
National Quality Forum, National Voluntary Consensus Standards for the Reporting of Therapeutic Drug Management
Quality, 2006; Am J Health Syst Pharm 2007 May 15;64(10 Suppl 6):S15-20; quiz S21-3; American Society of Health-System
Pharmacists, 2015 ASHP Health-System Pharmacy Initiative, 2003]
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Additional Specifications
Storage
 Identify and, at least annually, review a list of lookalike/sound-alike drugs used in the organization,
and take action to prevent errors involving the
interchange of these drugs
 Ensure that the written medication storage policy
is implemented
 Ensure that all medications are available in unitdose (single unit), age- and/or weight-appropriate,
and ready-to-administer forms
[AHA, Hosp Health Netw 2005 Oct;79(10):57-8; McCoy, Jt Comm J Qual Patient Saf 2005 Jan;31(1):47-53; Rich, Am J Health
Syst Pharm 2004 Jul 1;61(13):1349-58; Joint Commission Resources, 2010 Comprehensive Accreditation Manual: CAMH for
Hospitals: The Official Handbook, 2010]
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Additional Specifications
Ordering and Transcribing
 Ensure with the healthcare team that only
the medications needed to treat the
patient’s condition are ordered, provided,
and administered
[The Joint Commission, Preventing pediatric medication errors, Sentinel Event Alert, 2008; Gardner, Jt Comm J Qual
Patient Saf 2009 May;35(5):278-82]
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Additional Specifications
Preparing and Dispensing
 Pharmacists should review all medication
orders and the patient medication profile for
appropriateness and completeness
 Pharmacists should oversee the preparation of
medications, including sterile products
 Medications should be labeled in a
standardized manner
[Joint Commission Resources, 2010 Comprehensive Accreditation Manual: CAMH for Hospitals: The Official Handbook,
2010 ; Westerlund, J Clin Pharm Ther 2009 Jun;34(3):319-27; Kastango, Am J Health Syst Pharm 2005 Jun 15;62(12):127188; Jennings, AORN J 2007 Oct;86(4):618-25; Shrank, Arch Intern Med 2007 Sep 10;167(16):1760-5; Institute for Safe
Medication Practices, ISMP's List of High-Alert Medications, 2008; Momtaha, Healthc Q 2008;11(3 Spec No.):122-8]
© 2010 TMIT
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Additional Specifications
Preparing and Dispensing Cont’d
 Every unit-dose package label should contain
a machine-readable code identifying the
product name, strength, and manufacturer
 A pharmacist is available by telephone or
accessible at another location that has 24hour pharmacy services
[Department of Veteran Affairs, Quality directive for unit-dose packaging and barcode labeling, 2006; Woodall, Jt Comm J
Qual Saf 2004 Aug;30(8):442-7; Pederson, Am J Health Syst Pharm 2008 May 1;65(9):827-43; ASHP, Am J Health Syst Pharm
2009 Mar 15;66(6):588-90; Joint Commission Resources, 2010 Comprehensive Accreditation Manual: CAMH for Hospitals:
The Official Handbook, 2010]
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Additional Specifications
Medication Administration
 Organizations should consider the use of
medication administration technologies
 The five rights for medication administration do
not address all pertinent organizational systems,
human factors performance, and humantechnology interface issues
 Practitioner’s duty is to follow the procedural
rules designed by the organization to produce
optimal outcomes
[Cohen, Effective approaches to standardization and implementation of smart pump technology: a continuing education
program for pharmacists and nurses, 2007; Fanikos, Am J Cardiol 2007 Apr 1;99(7):1002-5; Paoletti, Am J Health Syst
Pharm 2007 Mar 1;64(5):536-43; Bechtel, J Nurs Care Qual 1993 Apr;7(3):28-34; Institute for Safe Medication Practices, The
Five Rights: A Destination Without a Map, 2007]
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Additional Specifications
Monitoring
 Pharmacists should monitor patient medication
therapy regularly, based on patient needs and
best evidence, for effectiveness, adherence,
persistence, and avoidance of adverse events
 Medication errors and near-miss internal
reports should be shared with organizational
safety, risk, and senior leadership through the
pharmacy leader
[Bond, Pharmacotherapy 2006 Jun;26(6):735-47; Bond, Pharmacotherapy 2007 Apr;27(4):481-93; Lehmann, Jt Comm J
Qual Patient Saf 2007 Jul;33(7):401-7; Montesi, Br J Clin Pharmacol 2009 Jun;67(6):651-5; Cohen, BMJ 2000 Mar
18;320(7237):728-9]
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Additional Specifications
Monitoring Cont’d
 Medication error and near-miss information
is reported through external sources
 Proactive risk mitigation strategies should
be demonstrated to prevent errors in the
organization
[Cohen, BMJ 2000 Mar 18;320(7237):728-9; MCPME, When Things Go Wrong: Responding to Adverse Events, 2006;
Institute for Safe Medication Practices, Quarterly Action Agenda: Free CE for nurses, 2009]
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Additional Specifications
High-Alert Medications
 Identify high-alert medications within the
organization
 Implement institutional processes for:
 procuring
 storing
 ordering
 transcribing
 preparing
 ispensing
 Administering
 monitoring
[Institute for Safe Medication Practices, ISMP's List of High-Alert Medications, 2008; Cohen, Nursing 2007 Sep;37(9):49-55;
quiz 1 p following 55; Federico, Jt Comm J Qual Patient Saf 2007 Sep;33(9):537-42; Joint Commission Resources, 2010
Comprehensive Accreditation Manual: CAMH for Hospitals, 2010]
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Additional Specifications
Evaluation
 Perform medication safety self-assessment to
identify organizational structure, system, and
communication opportunities to target harm
reduction
 Evaluate the ability of the patient to understand
and adhere to medication regimens when in the
community setting
[Institute for Safe Medication Practices, ISMP Medication Errors Reporting Program (MERP), N.D.; Smetzer, Jt Comm J Qual
Saf 2003 Nov;29(11):586-97; Joint Commission Resources, 2010 Comprehensive Accreditation Manual: CAMH for Hospitals:
The Official Handbook, 2010; National Quality Forum, National Voluntary Consensus Standards for the Reporting of
Therapeutic Drug Management Quality, 2006; Davis, Ann Intern Med 2006 Dec 19;145(12):887-94; Davis, J Gen Intern Med
2006 Aug;21(8):847-51]
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Example Implementation
Approaches
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
35
Example Implementation Approaches
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© 2006 HCC, Inc. CD000000-0000XX
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Example Implementation Approaches
 Seek pharmacists with experience, expertise,
and training in management and clinical
services to lead and oversee clinical pharmacy
operations
 Have the pharmacy director or leader regularly
represent the pharmacy at senior leadership
 Enable pharmacy staff collaboration with
medical, nursing, and direct workforce staff in
clinical areas to optimize knowledge transfer
 Prepare patient-specific doses by the
pharmacy to eliminate final preparation of the
dose by nurses
[Garrelts, Am J Health Syst Pharm 2001 Dec 1;58(23):2267-72]
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Example Implementation Approaches
 Provide resources to pharmacists in order to:
 maintain awareness of safe practices
literature
 have the opportunity to attend professional
organization’s continuing education
conferences
 Require pharmacists to complete
credentialing consistent with their scope of
practice
 Encourage professional development, and
implement a reward system for those
pharmacists who seek this further education
© 2010 TMIT
© 2006 HCC, Inc. CD000000-0000XX
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Example Implementation Approaches
 Provide resources to ensure sufficient space
and equipment allocated for pharmacy
activities, facility drug storage areas, and sterile
product information areas
 Provide an organized, well-lit workspace to
decrease errors and reduce distractions
 Organizational training programs should include
extensive education about patient populations
with special needs and treatment considerations
[Flynn, Am J Health Syst Pharm 1999 Jul 1;56(13):1319-25; Simmons, Crit Care Nurs Q 2009 AprJun;32(2):71-4; quiz 75-6; Kaushal, JAMA 2001 Apr 25;285(16):2114-20]
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Example Implementation Approaches
Strategies of Progressive Organizations
 Have daily check-in calls/meetings with the
primary focus of significant safety or quality
issues from the last 24 hours or last shift,
anticipated safety issues in the next 24 hours,
and follow up on critical issues for
accountability of resolution
 High-performing clinics and health systems
have clinical pharmacists providing direct
patient care on interdisciplinary teams
[Resar, Health Serv Res 2006 Aug;41(4 Pt 2):1677-89; Carter, Arch Intern Med 2009 Nov 23;169(21):1996-2002]
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Example Implementation Approaches
Strategies of Progressive Organizations
Cont’d
 Create a Chief Pharmacy Officer post as a
senior administrative position
 Develop 24/7/365 pharmacist coverage
 Establish conflict resolution guidelines for
when questions arise about medication orders
 Implement real-time electronic alert triggers for
potential ADEs
[Ivey, Am J Health Syst Pharm 2005 May 1;62(9):975-8; Clifton, Am J Health Syst Pharm 2003 Dec 15;60(24):2577-82; Paré, J Am
Med Inform Assoc 2007 May-Jun;14(3):269-77; Stratton, Am J Health Syst Pharm 2008 Sep 15;65(18):1727-34; Institute for Safe
Medication Practices, Resolving human conflicts when questions about the safety of medical orders arise, 2008; Young, Am J
Health Syst Pharm 2001 Dec 15;58(24):2362, 2365; Humphries, Ann Pharmacother 2007 Dec;41(12):1979-85]
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Example Implementation Approaches
Strategies of Progressive Organizations
Cont’d
 Senior leadership enables appropriate
pharmacist staffing levels to sustain pharmacy
operations and improvement activities
 Pharmacy interventions are documented and
analyzed for organization-wide improvement
 Pharmacy model where pharmacists are best
able to promote safe use of medications
[Bond, Pharmacotherapy 2002 Feb;22(2):134-47; Malone, Med Care 2007 May;45(5):456-62; Lyons, Am J Health Syst
Pharm 2007 Jul 15;64(14):1467-8; Nesbit, Am J Health Syst Pharm 2001 May 1;58(9):784-90; Kopp, Am J Health Syst
Pharm 2007 Dec 1;64(23):2483-7; Abramowitz, Am J Health Syst Pharm 2010 Aug 15;66(16):1437-46; ASHP PITEComm,
Am J Health Syst Pharm 2009 Sep 1;66(17):1573-7]
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Example Implementation Approaches
Strategies of Progressive Organizations
Cont’d
 Continually reevaluate and redesign medicationuse systems to improve error-prone steps
through technology
 Utilize pharmacy technicians to improve
efficiency
 High-performing organizations understand that:
 Execution is integral to strategy
 Leaders must be engaged
 Leaders have a direct impact on employees
[Bossidy, Execution: The Discipline of Getting Things Done, 2002; Covey, The SPEED of Trust: The One Thing That Changes
Everything, 2006; Desselle, Am J Health Syst Pharm 2005 Oct 1;62(19):1992-7; Desselle, J Am Pharm Assoc (2003) 2005 JulAug;45(4):458-65; Gladwell, Outliers: The Story of Success, 2008; Neuenschwander, Improving medication safety in health
systems through innovations in automation technology. Proceedings of educational symposia and educational sessions,
2010]
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Front-line Resources
Safe Practice 18
Pharmacist Leadership Structures
and Systems
Chapter 6:
Improving Patient Safety Through
Medication Management
© 2010 TMIT
44
The 3 Ts of Leadership Engagement:
Truth, Trust, and Teamwork
Charles Denham
[http://www.ncbi.nlm.nih.gov/pubmed/19241625]
© 2010 TMIT
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[http://www.jointcommission.org/PatientSafety/SpeakUp/]
© 2010 TMIT
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Poster available in Spanish
[http://www.jointcommission.org/PatientSafety/SpeakUp/]
© 2010 TMIT
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Poster available in Spanish
TMIT National Webinar Series
Barcoding End-to-End Solutions:
From Pharmacy to Bedside (SP 16 & 18)
 Charles R. Denham, MD – Topic: Safe Practice Overview
 David W. Bates, MD, MSc – Topic: Bar-Coding and Medication
Safety
 Eric Poon, MD, MPH – Topic: Barcode Medication Verification
Technology: How Strong Is the Evidence?
 Tejal K. Gandhi, MD, MPH –Topic: Clinical and Operational Pearls
 Ulrike Kreysa –Topic: Harmonization of Supply ChainTechnology
Standards
 Dan Ford, MBA – Topic: The Role of the Patient Advocate
 Go to: http://safetyleaders.org/webinars/indexWebinar_June2010.jsp
(June 17, 2010)
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NQF & TMIT National Webinar Series
Leadership Lessons for Pharmacy, Nursing,
and Hospital Leaders
 William W. George, MBA – Topic: 7 Lessons for Leading in
Crisis
 Charles R. Denham, MD – Topic: Review of Safe Practice 1,
Leadership Structures and Systems
 Hayley Burgess, PharmD – Topic: Review Safe Practice 18,
Pharmacist Leadership Structures and Systems
 Peter B. Angood, MD – Topic: National Perspective on
Leadership Issues
 Go to: http://www.safetyleaders.org/pages/idPage.jsp?ID=4945
(August 25, 2009)
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NQF & TMIT National Webinar Series
Medication Safety – Complex Issues for All
(Safe Practices 17-18)
 Peter B. Angood, MD – Topic: Challenges of Policy Development for
Medication Management
 Michael R. Cohen, RPh, MS, ScD – Topic: Medication Safety
Overview, Evolution, and Current Issues
 Mary A. Andrawis, PharmD, MPH – Topic: Perspectives on the
Importance of the Pharmacist Leadership Safe Practice in the
Hospital Environment
 Jeffrey Schnipper, MD, MPH – Topic: Where the Rubber meets the
Road: Implementation of Medication Reconciliation at the Practitioner
Level
 Patti O'Regan, ARNP, ANP, NP-C, PMHNP-BC, LMHC – Discussion:
Patient Perspective on Medication Management Safe Practices
 Go to: http://safetyleaders.org/pages/idPage.jsp?ID=4935
(June 18, 2009)
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TMIT National Webinar Series
Medication Management (Safe Practices 14-18)
 David W. Bates, MD, MSc - Chief of the Division of General
Medicine, Brigham and Women's Hospital
 Hayley Burgess, PharmD - Director, Performance
Improvement, Measures, Standards, and Practices, TMIT
 Mary E. Foley, MS, RN - Associate Director, Center for
Research and Nursing Innovation, University of California,
San Francisco (UCSF)
 Go to: http://www.safetyleaders.org/pages/idPage.jsp?ID=4803
(November 8, 2007)
© 2010 TMIT
© 2006 HCC, Inc. CD000000-0000XX
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