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Air Force Pharmacy

New JCAHO/Inspection Standards – P&T

Implications & Critical Elements of Design

Phil L. Samples, Col(s), USAF, BSCBSPhr, MS, PharmD., BCNSP

Associate Director, Biomedical Sciences CorpsAssociate Corps Chief for Pharmacy, BSC

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Overview

Membership Issues

Requirements in policy

Specific JCAHO issues

Implications of DoDI/AFAA

Strategies for Success

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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

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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

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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)

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JCAHO Implications and Issues

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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

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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

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Definition of Medication

DRASTIC CHANGE! Medications Include – standards apply to all of these

Prescription Drugs Diagnostic & contrast agents

OTC Drugs Respiratory treatments

Sample Drugs Parenteral Nutrition

Herbal remedies Blood derivatives

Vitamins Intravenous solutions

Vaccines Any drug designated by the FDA as a drug

Radioactive meds

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Definition of Medication

What is NOT included:

Enteral Nutrition Products Oxygen Other medical gases

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Safe Medication Management

Safe Medication Management

Patient Specific Information –MM.1.10

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

Six Critical Processes

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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

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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

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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

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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)

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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

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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

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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)

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High Risk Medications MM.7

Medication/Drug Class

Selection/

Procurement

Storage Ordering/

Transcribing

Preparing/

Monitoring

Administration Monitoring

Chemo-therapy

Neuro-muscular

Blockers

Cardio-

Plegic

Solutions

ETC, ETC

Specific Agents –Warfarin, etc

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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

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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)

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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

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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

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