1 © 2010 TMIT NQF-Endorsed ® Safe Practices for Better Healthcare Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management

© 2006 HCC, Inc. CD XX 2 © 2010 TMIT Slide Deck Overview Slide Set Includes:  Section 1: NQF-Endorsed ® Safe Practices for Better Healthcare Overview  Section 2: Harmonization Partners  Section 3:The Problem  Section 4: Practice Specifications  Section 5: Example Implementation Approaches  Section 6: Front-line Resources

3 © 2010 TMIT NQF-Endorsed ® Safe Practices for Better Healthcare Overview Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management

4 © 2009 TMIT 2010 NQF Safe Practices for Better Healthcare: A Consensus Report 34 Safe Practices Criteria for Inclusion Specificity Benefit Evidence of Effectiveness Generalization Readiness

5 © 2010 TMIT Culture SP NQF Report

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 Information Management and Continuity of Care Medication Management Healthcare-Associated Infections Condition- and Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Press. Ulcer Prevention VTE Prevention Anticoag. Therapy VAP Prevention Central Line-Assoc. BSI Prevention Sx-Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Leadership Structures and Systems Med. Recon. Culture CPOE Read-Back & Abbrev. Discharge Systems Patient Care Info. Labeling Diag. Studies Culture Meas., FB., and Interv. Structures and Systems Risk and Hazards Team Training and Skill Bldg. Nursing Workforce ICU Care Direct Caregivers Workforce CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care 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 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 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 Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Consent and Disclosure Informed Consent Life-Sustaining Treatment Disclosure Care of the Caregiver Consent and Disclosure Care of Caregiver MDRO Prevention UTI Prevention Falls Prevention Organ Donation Glycemic Control Pediatric Imaging

7 © 2010 TMIT Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management Harmonization Partners

8 © 2010 TMIT Harmonization – The Quality Choir

9 © 2010 TMIT The Patient – Our Conductor

© 2006 HCC, Inc. CD XX 10 © 2010 TMIT 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 organization- wide safe medication use.

11 © 2010 TMIT Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management The Problem

© 2006 HCC, Inc. CD XX 12 © 2010 TMIT The Problem

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© 2006 HCC, Inc. CD XX 15 © 2010 TMIT

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© 2006 HCC, Inc. CD XX 17 © 2010 TMIT 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): ; Bates, Saving Money: The Imperative for Computerized Physician Order Entry in Massachusetts, 2008]

© 2006 HCC, Inc. CD XX 18 © 2010 TMIT 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): ; Stagnitti, Statistical Brief #21: Trends in Outpatient Prescription Drug Utilization and Expenditures: , 2003]

© 2006 HCC, Inc. CD XX 19 © 2010 TMIT 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): ; 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): ; Rothschild, Ann Emerg Med]

© 2006 HCC, Inc. CD XX 20 © 2010 TMIT 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): ; Kaiser, Prescription Drug Trends, 2007; Bates, JAMA 1997 Jan 2229;277(4):307-11]

21 © 2010 TMIT Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management Practice Specifications

© 2006 HCC, Inc. CD XX 22 © 2010 TMIT 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

© 2006 HCC, Inc. CD XX 23 © 2010 TMIT Additional Specifications

© 2006 HCC, Inc. CD XX 24 © 2010 TMIT 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]

© 2006 HCC, Inc. CD XX 25 © 2010 TMIT 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 evidence- based drug therapy protocols and/or order sets [Pederson, Am J Health Syst Pharm 2001 Dec 1;58(23): ; 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]

© 2006 HCC, Inc. CD XX 26 © 2010 TMIT Additional Specifications Storage  Identify and, at least annually, review a list of look- alike/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 unit- dose (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): ; Joint Commission Resources, 2010 Comprehensive Accreditation Manual: CAMH for Hospitals: The Official Handbook, 2010]

© 2006 HCC, Inc. CD XX 27 © 2010 TMIT 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]

© 2006 HCC, Inc. CD XX 28 © 2010 TMIT 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): ; 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]

© 2006 HCC, Inc. CD XX 29 © 2010 TMIT 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 24- hour 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]

© 2006 HCC, Inc. CD XX 30 © 2010 TMIT 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 human- technology 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]

© 2006 HCC, Inc. CD XX 31 © 2010 TMIT Additional Specifications [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] 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

© 2006 HCC, Inc. CD XX 32 © 2010 TMIT 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]

© 2006 HCC, Inc. CD XX 33 © 2010 TMIT 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]

© 2006 HCC, Inc. CD XX 34 © 2010 TMIT 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]

35 © 2010 TMIT Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management Example Implementation Approaches

© 2006 HCC, Inc. CD XX 36 © 2010 TMIT Example Implementation Approaches

© 2006 HCC, Inc. CD XX 37 © 2010 TMIT 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): ]

© 2006 HCC, Inc. CD XX 38 © 2010 TMIT 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

© 2006 HCC, Inc. CD XX 39 © 2010 TMIT 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): ; Simmons, Crit Care Nurs Q 2009 Apr- Jun;32(2):71-4; quiz 75-6; Kaushal, JAMA 2001 Apr 25;285(16): ]

© 2006 HCC, Inc. CD XX 40 © 2010 TMIT 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): ; Carter, Arch Intern Med 2009 Nov 23;169(21): ]

© 2006 HCC, Inc. CD XX 41 © 2010 TMIT 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): ; Paré, J Am Med Inform Assoc 2007 May-Jun;14(3):269-77; Stratton, Am J Health Syst Pharm 2008 Sep 15;65(18): ; 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): ]

© 2006 HCC, Inc. CD XX 42 © 2010 TMIT 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): ; ASHP PITEComm, Am J Health Syst Pharm 2009 Sep 1;66(17):1573-7]

© 2006 HCC, Inc. CD XX 43 © 2010 TMIT Example Implementation Approaches Strategies of Progressive Organizations Cont’d  Continually reevaluate and redesign medication- use 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 Jul- Aug;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]

44 © 2010 TMIT Safe Practice 18 Pharmacist Leadership Structures and Systems Chapter 6: Improving Patient Safety Through Medication Management Front-line Resources

45 © 2010 TMIT The 3 Ts of Leadership Engagement: Truth, Trust, and Teamwork Charles Denham [

46 © 2010 TMIT [ Poster available in Spanish

47 © 2010 TMIT [ Poster available in Spanish

© 2006 HCC, Inc. CD XX 48 © 2010 TMIT 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: (June 17, 2010)

© 2006 HCC, Inc. CD XX 49 © 2010 TMIT 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: (August 25, 2009)

© 2006 HCC, Inc. CD XX 50 © 2010 TMIT 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: (June 18, 2009) NQF & TMIT National Webinar Series

© 2006 HCC, Inc. CD XX 51 © 2010 TMIT 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: (November 8, 2007)