New JCAHO/Inspection Standards – P&T Implications & Critical Elements of Design

1. 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

2. Overview • Membership Issues • Requirements in policy • Specific JCAHO issues • Implications of DoDI/AFAA • Strategies for Success

3. Pharmacy & Therapeutics Directives • AF – controlled by AFI 44-102 • 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

4. 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

5. 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)

6. JCAHO Implications and Issues

7. 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

8. 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

9. Definition of Medication • DRASTIC CHANGE! • Medications Include – standards apply to all of these

10. Definition of Medication • What is NOT included: • Enteral Nutrition Products • Oxygen • Other medical gases

11. Safe Medication Management Safe Medication Management Patient Specific Information –MM.1.10 Six Critical Processes Selection & Procurement Storage Ordering & Transcribing MM.2.10 MM.2.20, 2.30, 2.40 MM.3.10, 3.20 Preparing & Dispensing Administration Monitoring MM.4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8 MM.5.10, 5.20 MM.6.10, 6.20 Special Case High Risk Medications MM.7.10, 7.20, 7.30, 7.40 Evaluation – MM.8.10

12. 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

13. 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

14. 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

15. 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 MSO4 (for morphine sulfate or magnesium sulfate) • MgSO4 (for magnesium sulfate)

16. NPSG Specific Requirements of P&T • 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

17. 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

18. 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)

19. High Risk Medications MM.7

20. 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

21. 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)

22. 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

23. 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