I n t e g r i t y - S e r v i c e - E x c e l l e n c e Air Force Pharmacy New JCAHO/Inspection Standards – P&T Implications & Critical Elements of Design Phil L. Samples, Col(s), USAF, BSC BSPhr, MS, PharmD., BCNSP Associate Director, Biomedical Sciences Corps Associate Corps Chief for Pharmacy, BSC

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Overview Membership Issues Requirements in policy Specific JCAHO issues Implications of DoDI/AFAA Strategies for Success

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Pharmacy & Therapeutics Directives AF – controlled by AFI Medical staff function Must meet minimum 4 times per year Membership is prescribed JCAHO – does not prescribe the make up but will survey to your policy

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Functions Mandatory (AF) Functions Reviews policies, acquisition and use of medications within the facility Reviews medication errors (from ALL sources) Reviews Adverse Drug Reactions (ADRs) Evaluates clinical data on new medications and preparations for use at the MTF

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Membership Members – WHY? 2 physicians 1 dentist 1 pharmacist 1 nurse The Chief of Medical Logistics Remember, JCAHO – does not prescribe the make up but will survey to your policy Possible additions – Resource manager, other interested parties (be careful, the committee can become too cumbersome and difficult to achieve quorum)

I n t e g r i t y - S e r v i c e - E x c e l l e n c e JCAHO Implications and Issues

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Periodic Performance Review Review all standards and identify areas for improvement to include National Patient Safety Goals (NPSG) Develop plan of action for deficiencies Deficiency identified in an Element of Performance (EP) designated with an “M” must identify measure of success Phone conference with JCAHO to approve plan Measure of Success will be reviewed during survey

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Plan of Action Describe planned action for each Element of Performance (EP) marked as partial or insufficient compliance For each EP where a measure of success is required describe: What will bring standard into compliance How action will result in improvement How will you know – measurable objective criteria, performance improvement (PI) data, inspection, interviews

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Definition of Medication DRASTIC CHANGE! Medications Include – standards apply to all of these Prescription DrugsDiagnostic & contrast agents OTC DrugsRespiratory treatments Sample DrugsParenteral Nutrition Herbal remediesBlood derivatives VitaminsIntravenous solutions VaccinesAny drug designated by the FDA as a drug Radioactive meds

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Definition of Medication What is NOT included: Enteral Nutrition Products Oxygen Other medical gases

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Safe Medication Management Patient Specific Information –MM.1.10 Selection & ProcurementStorageOrdering & Transcribing MM.2.10MM.2.20, 2.30, 2.40MM.3.10, 3.20 Preparing & DispensingAdministrationMonitoring MM.4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8MM.5.10, 5.20MM.6.10, 6.20 Special Case High Risk Medications MM.7.10, 7.20, 7.30, 7.40 Evaluation – MM.8.10 Six Critical Processes

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Selection & Procurement MM.2.10 Criteria for addition and deletion to formulary Must include propensity for medication errors, abuse potential and sentinel events MUST be able to monitor med PRIOR to addition (e.g. new lab or radiographic procedure) ANNUAL review of meds based on emerging data Black box warning Process to approve & procure meds not on formulary Orders for non-formulary meds must be approved by an abbreviated process Process for handling medication shortages Communication with staff, developed substitutes, education about protocols, obtaining during disaster

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Selection & Procurement MM.2.10 Compliance tips Document process in P&T Minutes Document evidence of sound alike, look alike potential Excellent sources – USP and ISMP Document ability to monitor Antibiotic sensitivity Anticoagulant monitoring Appropriate equipment in treatment area Develop abbreviated procedure for non-formulary approval

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Proper and Safe Storage MM.2.20 P & T Considerations should document issues concerning consequences of storage Only approved meds are stocked and/or stored Segregation of look-alike, sound alike meds Medication concentrations are standardized NO, repeat NO, concentrated electrolytes in patient care areas (example of exception – perfusionist in cardiac surgery) Meds in most ready-to-use form

I n t e g r i t y - S e r v i c e - E x c e l l e n c e NPSG Specific Requirements of P&T Unapproved abbreviation list must include U (for units) IU (for international units) Q.D. (for once daily) Q.O.D. (for every other day) Trailing zero (e.g. 3.0mg) Lack of leading zero (e.g.,.3mg) MS or MSO 4 (for morphine sulfate or magnesium sulfate) MgSO 4 (for magnesium sulfate)

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Unapproved abbreviations (con’t) Must include 3 new items not on mandatory list by 1 Apr 04 Will include electronic and print media by 2005 NPSG Specific Requirements of P&T

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Monitoring MM.6.10, 6.20 Develop and document strategy to monitor the first few doses of a medication new to the patient Aggregate and analyze data ADR MUE/DUE/AUE

I n t e g r i t y - S e r v i c e - E x c e l l e n c e High Risk Medications MM.7 P&T must identify high-risk medications Document safety steps taken in each area of medication use system Tips Approve and publish list of high-risk medications Develop grid (see next slide)

I n t e g r i t y - S e r v i c e - E x c e l l e n c e High Risk Medications MM.7 Medication/ Drug Class Selection/ Procurement StorageOrdering/ Transcribing Preparing/ Monitoring AdministrationMonitoring Chemo- therapy Neuro- muscular Blockers Cardio- Plegic Solutions ETC, ETC Specific Agents – Warfarin, etc

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Evaluation MM.8.10 Evaluate literature and document actions ISMP Patient Safety Alerts or USP – good sources of data Review internal data for trends or other issues regarding medication safety Good sources - ADR and MUEs

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Successful Hints for the P&T Sub-committees (depending on facility size) New drug requests MUEs Write liberal policies wherever possible Must meet at least 4 times per year Ensure medical staff buy in Select thought leaders to serve Properly vet your minutes through the commander, either directly or through Exec Committee (CC is ultimate authority for obligation of funds)

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Successful Hints for the P&T Detailed Minutes (OPEN: Jul 03, ECD: 12/03, OPR: CMO, OCR: SGA) Enough detail to allow a new person to understand Refer to higher committee when needed Mark compliance issues in minutes Note in margin Group together Documentation of Physician involvement

I n t e g r i t y - S e r v i c e - E x c e l l e n c e Keys to Successful Survey Clean and organized Secure all medications – pharmacy MUST control all medications in all areas Concentrate on Problematic Areas (crash carts, anesthesia, etc.) Emphasize Safe Use of Medications – NPSG! Develop Good P&T Minutes Demonstrate Competence Customize Policies and Procedures Educate and rehearse Take credit for improvements and positive outcomes

I n t e g r i t y - S e r v i c e - E x c e l l e n c e