3/9/2010. Objectives. Pharmacist Role in Medication Safety and Regulatory Compliance

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1 Pharmacist Role in Medication Safety and Regulatory Compliance Janet Greiwe Vice President, Systems Management Cleveland County Health System Objectives By the end of this presentation, you should be able to: Discuss importance of pharmacist leadership in developing and implementing medication safety changes Describe importance of collaborative relationships pharmacists must build to ensure acceptance of medication safety initiatives Summarize Joint Commission challenges Pharmacist Leadership Key to Implementing Medication Safety Changes Pharmacist Leadership Key to Implementing Medication Safety Changes (continued) Pharmacists must: Lead and be involved in all medication safety changes as they are held responsible by regulatory bodies for safe medication use Be recognized in the hospital culture as the experts on safe medication use Pharmacists must: Demonstrate and showcase success of pharmacy-led medication use and medication safety initiatives in various forums - P&T Committee, Medical Executive Committee, Patient Safety Committee, Leadership meetings, etc. Require data and outcome measures Pharmacists Establish Themselves as Leaders in Patient Safety by Pharmacist Leadership is Accomplished by Comprehensive Program Approach Understanding their current state Working in a focused and simplified manner Demonstrating results and meeting patient needs Actively interfacing with internal and external community Operations and systems level review Participation in local, health system, and regional initiatives Pharmacoinformatics and outcomes research in patient safety Develop practice guidelines for safe medication prescribing - Pharmacy Drug Use and Disease State Management Program 1

2 Pharmacists Must Build Collaborative Relationships to Ensure Acceptance Safe Medication Management System Pharmacy leadership should engage: Physician Champion(s) who support medication safety Key nurse leaders who respect and support pharmacists Hospital Administrators, VPs, and president Patient Safety Officer Hospital Director of Accreditation/Regulatory Compliance Risk Management/Patient Safety Department leadership Quality Department leadership A safe medication management system addresses the following medication processes: Planning Selection and procurement Storage Ordering Preparing and dispensing Administration Monitoring Evaluation The Joint Commission has: Standard MM Standards 139 Elements of Performance 48 Direct Impact Elements of Performance The hospital evaluates the effectiveness of its medication management system. Elements of Performance for MM Elements of Performance for MM (continued) 1. The hospital collects data on the performance of its medication 2. The hospital analyzes data on its medication 3. The hospital compares data over time to identify risk points, levels of performance, patterns, trends, and variations of its medication 4. The hospital reviews the literature and other external sources for new technologies and best practices. 5. Based on analysis of its data, as well as review of the literature for new technologies and best practices, the hospital identifies opportunities for improvement in its medication 6. The hospital takes action on improvement opportunities identified as priorities ities for its medication 7. The hospital evaluates its actions to confirm that they resulted in improvements for its medication 8. The hospital takes additional action when planned improvements for its medication management processes are either not achieved or not sustained. 2

3 * National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved 3/9/2010 Four Stages of a Medication Safety Initiative Model Detecting Medication Safety Concerns Stage one: Environment / Culture Stage two: Data Collection Stage three: Data Analysis Stage four: Assessing Impact of Actions Taken What is a Medication Error? High-alert and hazardous medications Look-alike / sound-alike medications Medication protocols Medication security Medication reconciliation Timeliness of medication administration (CMS requirement) NCC MERP* defines a medication error as: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. *National Coordinating Council For Medication Error Reporting and Prevention NCC MERP Index for Categorizing Medication Errors Definitions: NCC MERP Index for Categorizing Medication Errors* Category A: Circumstances or events that have the capacity to cause error Category B: Category C: Category D: An error occurred but the reached the patient and error did not reach the reached the patient but required monitoring to confirm that it resulted in no patient (An error of did not cause patient harm to the patient and/or required intervention to omission does reach the harm preclude harm patient) Category E: Category F: Category G: Category H: may may have have contributed to or contributed to or resulted in may have contributed to required intervention resulted in temporary harm temporary harm to the patient or resulted in permanent necessary to sustain life to the patient and required and required initial or prolonged patient harm intervention hospitalization Category I: No Error may have contributed to Error, No Harm or resulted in the patient s Error, Harm death Error, Death 2001 National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved. Harm - Impairment of the physical, emotional, or psychological function or structure of the body and/or pain resulting there from o Monitoring - To observe or record relevant physiological or psychological signs o Intervention - May include change in therapy or active medical / surgical treatment o Intervention Necessary to Sustain Life - Includes cardiovascular and/or respiratory support (e.g., CPR, defibrillation, intubation) 3

4 Override Medication Use in ADD Develop Override Monitoring Tool to Perform Random Audits Medication override : Practice of nurse obtaining medication from ADD, per MD order,,prior to pharmacist review Certain clinical conditions may initiate this practice (i.e., acute pain requiring immediate dosing) Medication override is not without risk Develop pharmacy-nursing monitoring process and tool Tool identifies 6 criteria that defined appropriate override (all must be met) Review of electronic chart, override activities, and pharmacy computer profile essential to evaluate compliance criteria Monitoring Criteria for Appropriate Override Use Medication Safety Awareness Department Floor Stock 1) Documentation medication was STAT, urgent, or emergent on basis of nurse s clinical judgment 2) MD order for medication found in the chart 3) Documentation on MAR to support medication was given 4) Patient was not allergic to the medication 5) Drug and dose ordered was drug and dose documented as given 6) Medication order was not on pharmacy profile (reviewed by pharmacist) and nurse removed via override Require review and approval of all new floor stock medications by pharmacist Increase staff awareness regarding high alert medications so they may look for issues on patient units and hospital departments Ask pharmacy staff to alert safety pharmacist of all new or unusual floor stock requests (i.e., propofol, concentrated epinephrine ) Medication Safety Awareness Department Floor Stock (continued) Balance Convenience vs. Safety Prior to Pharmacist Review Perform focused review of hospital department floor stock, by drug, to review for safety issues and ensure appropriate stock levels Review medication error reports from hospital departments, which may then initiate a floor stock safety review Develop good rapport with hospital department directors so they inform pharmacy of medication safety concerns or questions Does drug have short expiration? Is it required for urgent use? Will delay by pharmacy delivery cause harm? Is it essential to have drug in floor stock vs. dispensed by pharmacy and why? Yes No Pharmacy must ensure drug in safest form possible (i.e., kit, single dose, dilute form, Do not stock drug RN double check, mixing instructions, outside the pharmacy and warning stickers, ) have pharmacy provide in a timely manner Goal = Medication Safety 4

5 Implementing Medication Safety Changes in Collaboration Barriers to Safety Inform key supporters (MDs, RNs, Risk Managers ) of medication safety concern, along with supporting documentation and evidence Engage their assistance with support of safety change Get proper committee approval and buyin Enact change via multiple communication methods and staff education Perception that pharmacy cannot provide the drug in a timely manner Excessive pressure placed on pharmacy and others by vocal physician(s) Lack of knowledge by pharmacy of unsafe practices by nurses and physicians Summary Pharmacist leadership is key to implementing medication safety changes Accomplished by a comprehensive program approach Pharmacists must build collaborative relationships to ensure acceptance of medication safety initiatives Pharmacists must be ever vigilant in the quest for medication safety Questions? 5