New JCAHO/Inspection Standards � P&T Implications & Critical

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					    Air Force Pharmacy
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             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

   Membership Issues

   Requirements in policy

   Specific JCAHO issues

   Implications of DoDI/AFAA

   Strategies for Success

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                    Pharmacy & Therapeutics

   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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   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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   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

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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

   For each EP where a measure of success is required
     What will bring standard into compliance
     How action will result in improvement
     How will you know – measurable objective criteria,
      performance improvement (PI) data, inspection,

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                         Definition of Medication

   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

                                              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
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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
           Excellent sources – USP and ISMP
       Document ability to monitor
         Antibiotic sensitivity
         Anticoagulant monitoring
         Appropriate equipment in treatment area

       Develop abbreviated procedure for non-formulary

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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
       MgSO4 (for magnesium sulfate)

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        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

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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

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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/    Selection/   Storage    Ordering/     Preparing/   Administration   Monitoring
Drug Class    Procurement             Transcribing   Monitoring



Agents –

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                            Evaluation MM.8.10

   Evaluate literature and document actions
       ISMP Patient Safety Alerts or USP – good sources of
   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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