Safety Pharmacy

MARY E. BURKHARDT, MS, RPh, FASHP, FSMSO

Belleville, MI 586-***-****

*************@*******.***

NATIONAL PHARMACY EXECUTIVE

Director of Medication Safety Program Development Healthcare Administration Professional leader with expertise in all facets of health systems management, pharmacy practice, financial analysis, and medication safety consultation/education within high-profile corporations and academic institutes. Skilled in collaborating with all members of the organization to achieve business and financial objectives. Instrumental in streamlining and improving processes, enhancing productivity and performance, and implementing effective solutions. Award-winning writer and educator with multiple publications, video presentations, and professional development material designed to enhance medication safety and compliance in an ever-changing, dynamic healthcare system.

Pharmacy Operations

Clinical Program Development

Strategic Planning & Analysis

Technology / Automation

Leadership & Education

Budgeting

Policies & Procedures

Human Resources

Regulatory Compliance

Inventory Control

Root Cause Analysis

Safety and Quality Improvement

P ROFESSIONAL E X P E R I ENCE

VA NATIONAL CENTER FOR PATIENT SAFETY, Ann Arbor, MI 2017 – Present National Pharmacy Executive / Program Manager

Returned back to the national program office to manage the medication safety efforts for the national safety office while also responsible for programmatic support of health facilities in VISN 1, VISN 15, VISN 23 and the national Consolidated Mail Outpatient Pharmacy program.

• Member of national the launch team for Veterans Affairs High Reliability Organization (HRO) roll out 2019

• Performing some duties of the agency deputy since July 2018 including supervision of the analysts.

• Managing multiple national medication safety assessment programs for 2018 and 2019 including high alert medication, anti-thrombotic safety, glycemic safety and rapid naloxone access for VA sites nation-wide.

• Provided national training for large patient safety conferences including Root Cause Analysis, Just Culture, Healthcare Failure Mode and Effect Analysis and various hot topics in patient safety.

• Conducting local site visits, Root Cause Analysis training and assessment of patient safety programs including in-briefing, out-briefing and written consultative reports.

• Performed “Go Team” emergency patient safety assessment site visits on short notice for high profile sites struggling with patient safety challenges and under congressional scrutiny. These were conducted at the request of VACO leadership and working collaboratively with other program offices.

• Effectively managing consultative and coaching relationships with VACO leadership, various program offices, Pharmacy Benefits Management, national safety organizations, Joint Commission Resources and numerous chiefs and pharmacy staff members.

• Successfully analyzed a large-scale drug diversion case using CPRS, BCMA and Omnicell records with all the assorted activities, resulting in a guilty plea and subsequent felony conviction. Provided deep dive Pandora reports and innovative problem solving and consulting to facilities on this and other medication safety related issues.

• Mentoring pharmacy chiefs, medication safety officers and other field-based practitioners in solving medication safety related problems

• Redesigned the medication safety resource page to provide contemporary information to the field

• Training Medication Safety Officers in patient safety tools

• Leading the VA effort to partner with other large organizations in the analysis of hundreds of U-500 concentrated insulin adverse events.

• Finalist for “Excellence in Medication Use Safety” award from the American Society of Health-System Pharmacists Foundation. This is for the code cart re-design project which resulted in 2 U.S. Patents and is in use in over 300 healthcare facilities nation-wide and internationally. Poster accepted for the JFPS MARY E. BURKHARDT, MS, RPh, FASHP, FSMSO

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• Project co-lead for the national Joint Patient Safety Reporting System in cooperation with the Department of Defense and working with an outside vendor. Staffing the change review committee

• Leading a team of private sector and VA sites in the pilot testing of a medication safety self-assessment tool for high alert medication and the subsequent tools developed after the assessment was completed

• Working with various pharmacy automation /robotics vendors to establish best practices for automation use based on extensive background in pharmacy information systems, e-prescribing and human factors engineering

• Working on patient safety predictive event analyses using natural language processing for logistics events, specialized searches related to the BCMA IV labels, special requests from FDA and others. VA ANN ARBOR HEALTHCARE SYSTEM, Ann Arbor, MI 2010 – 2016 Chief of Pharmacy Services

Appointed as the Chief of Pharmacy Service for this tertiary care referral hospital in the Department of Veteran Affairs. Simultaneously responsible for the successful renovation and performance improvement of the facility; while restructuring and reorganizing internal processes/practices of the pharmacy, including those of 130 full-time employees in Michigan and Ohio.

Provide leadership and direction for the transition of this healthcare system covering 69,000 patients within 3 states, performing 3000 clinic visits daily. VA Ann Arbor is the second largest facility in VISN 10 but the resources were much lower than average.

Spearhead clinical program development, budgeting for development, and human resource management ensuring all clinical pharmacist and technician practice at the highest level of performance in a federal healthcare environment.

Streamline financial processes and introduced process improvements that enhance productivity.

Manage all aspects of planning, tracking, analysis, reporting, and revenue recognition using sound business acumen.

Procured $38 million in drugs and supplies under the restrictive FAR Regulation with a total drug spend allotment of approximately $78 million.

Expanded the use of Omnicell automation and robotics to promote medication safety and minimize medication dispensing errors.

Successfully installed VistA Chemotherapy Manager, the first hospital in VISN.

Effectively collaborated with the Ross School of Business and the School of Industrial Engineering at the University of Michigan to engage students in problem-solving teams for a code cart redesign project resulting in a US Patent Application for innovative design and a national award for medication safety

Developed and implemented a Pharmacy Cache Program designated “Best Practice”. MEDCO HEALTH SOLUTIONS (now Express Scripts), Franklin Lakes, NJ 2005– 2009 Director of Medication Safety

Established and provided operational management of the Medication Safety Department in the Fortune 50-Company that manages prescription drug benefits for over 60-million Americans. Accountable for all adverse drug event management, including: prevention, medication errors, and adverse drug reaction reporting/documentation.

Established the Medicare Medication Event Reporting System for the company to safeguard adherence to the 2010 Medicare Call Letter specifications.

Developed initiatives to promote a safety-oriented culture and provided training to Medco staff/clients.

Supervised and mentored 7 Pharmacy Practice Residents during medication safety rotations. MARY E. BURKHARDT, MS, RPh, FASHP, FSMSO

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Performed root-cause analyses to identify vulnerabilities and track / trend factors to determine which specifically contributed to adverse drug-related events, reporting findings to senior management to devise strategies to remediate identified vulnerabilities.

Independently composed and submitted annual FDA MedWatch Reports, one of the most active groups in the U.S.

Consistently worked with the Medication Event Analysis Group in Las Vegas to offer guidance and improve safety to a crucial patient and client facing unit.

Served as Safety Consultant for operational staff of Medco Special Pharmacy Division and Accredo Health Group, which includes: Liberty Medical, Accredo Therapeutics, Novofactor, Hemophilia Services, and Critical Care System.

VETERANS AFFAIRS NATIONAL CENTER FOR PATIENT SAFETY, Ann Arbor, MI 2001– 2006 Program Manager

Strategically managed the general programmatic support of the VA Patient Safety Program execution in the field. Provided education and training support with special emphasis on medication usage systems.

Oversaw the improvement efforts of the Bar Code Medication Administration (BCMA) System at VA Hospitals nationwide and obtained funding for the BCMA Collaborative Breakthrough Series, a 30 team national performance and safety improvement initiative (IHI style).

Applied the Healthcare Failure Mode and Effect Analysis (HFMEA) and High Alert Medication Safety processes at 155 hospitals throughout the Veterans Healthcare Administration serving as coach to facilities throughout the nation. Designed the HFMEA worksheet that is still in use nationally

Represented Veteran Affairs at the 2004 JCAHO Summit on medical abbreviations.

Instructor and coordinator for the Patient Safety Improvement Corps, a VA-AHRQ interagency agreement for patient safety training in all 50 states over a 3-year period.

Appointed course coordinator for the Patient Safety Manager Conference in 2005 and charged with planning the medication safety sessions, such as ADE Individual and aggregated RCAs, BCMA updates, Chemotherapy Safety, VA Med-Safe, and “Making your patient safety case through the art of storytelling.” ADDITIONAL E X P E R I ENCE

EXPERT WITNESS - MEDICATION-RELATED LAWSUITS, Michigan / Ohio 1998- Present Referral-based Defense & Plaintiff Cases

INDEPENDENT CONSULTANT, Ann Arbor, MI 1997– Present Medication Safety and Speaker/Trainer

INDISPENSABLE HEALTHCARE, Ann Arbor, MI 2003– 2011 Pharmacy Staffing Agency

BARIX CLINIC-FORREST HEALTH, Ypsilanti, MI 2004-2008 On-Call Pharmacist

ST. JOHN HEALTH SYSTEM-DETROIT MACOMB HOSPITALS 1985-2001 Director of Pharmacy / IV Therapy-Detroit Riverview Hospital Senior Director, DMHC Pharmacies, 1994

Director of Pharmacy, 1988-1994

Assistant Director of Pharmacy, 1985-1988

MARY E. BURKHARDT, MS, RPh, FASHP, FSMSO

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TRAVENOL LABORATORIES, Chicago, IL 1984-1985

Lead Pharmacist Home Health Care and Infusion

ST. JOHN HOSPITAL & MEDICAL CENTER, Detroit, MI 1983-1984 Charge Pharmacist / Staff Pharmacist

MT. CLEMENS GENERAL HOSPITAL, Mt. Clemens, MI 1977-1983 Pharmacy Intern / Staff Pharmacist

EDUCATION & C REDENTIALS

Master of Science in Hospital Pharmacy Administration, Wayne State University, Detroit, MI, 1990 Bachelor of Science in Pharmacy, Wayne State University, Detroit, MI, 1980 Registered Pharmacist (RPh), Michigan

Fellow of the American Society of Health-System Pharmacists (FASHP), 1997 Fellow of the American Society of Medication Safety Officers (FSMSO), 2012 bestowed by board / didn’t apply L E ADERSHIP

Wayne State University College of Pharmacy and Allied Health, Adjunct Faculty, 2015-Present Ferris State University, Big Rapids, MI Faculty Advisor on Pharmacy Curriculum 2006-2012 National Patient Safety Foundation, Board of Governors, 2007-2010 Board of Pharmaceutical Specialties, BCPS Exam Panel, 2006-2012 Institute for Safe Medication Practices (ISMP) USA, Consultant (safety self-assessment tools), 2007-present ISMP Canada, Consultant / Contributor (root-cause framework, investigation team for drug-related injuries), 2004 - present Joint Commission International Center for Patient Safety, Medication Safety Expert Panel 2006-2009 SE Michigan Society of Health-System Pharmacists, President / Past President, Board Member 1992-1995 AWARDS & P UBLICATIONS

References, Awards, Publications, and Video Presentations furnished upon request

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