Preparing for ExternalInternal Pharmacy Reviews Class

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Preparing for External/Internal Pharmacy
ReviewsClass 118

• John Lowe R.Ph., M.B.A
• Jeanne Tuttle R.Ph.
• Pharmacy Benefits Management Central Office

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Objectives

• At the conclusion of this class students should
  be able to
• List available resources to assist in preparation
  for various oversight inspections.
• Explain the process of OIG, GAO, and SOARS
  reviews
• Identify a process to target for improvement.
• Describe best practice models for meeting
  oversight regulations.
• Integrate information on best practices to their
  facility.

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Preparing for Pharmacy Reviews 118
John Lowe Jeanne Tuttle July 15, 2008
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External and Internal Review Programs

• Office of Inspector General Combined Assessment
  Program (OIG CAP)
• System-wide Ongoing Assessment Review Strategy
  (SOARS)
• Government Accountability Office
• Joint Commission
• Drug Enforcement Agency

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OIG CAP PURPOSE

• Evaluate how well VAs are providing access to
  quality care
• Determine if management controls are in place to
  minimize vulnerability to fraud, waste and abuse
• Provide fraud and integrity awareness training to
  VA staff

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OIG CAP PROCESS
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TRADITIONAL OIG CAP FOCUS AREAS IN PHARMACY

• Purchase cards
• Physical security
• Inventory management (returns, stock levels)
• Controlled substances

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OIG Summary Report April Sept 2007

• VA pharmacist diverted oxycodone and morphine
  from drug dispensing units, and replaced
  injectable solution with saline on 76 occasions.
• VA nurse diverts Schedule II substances from
  AcuDose system for 1 year, altering patient
  records to cover theft.
• VA nurse stole controlled and non-controlled
  substances from VAMC for 9 years, conspiring with
  a incarcerated relative to sell drugs in prison.

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OIG Summary Report 2006-2007

• Several patients medications mailed to incorrect
  patient resulting in privacy violations
• Pharmacy manager pled guilty to conflict of
  interest charges
• VA employee improperly accepted gift from
  prohibited source

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Controlled Substances (CS) Findings

• Random, unannounced inspections not completed in
  all areas monthly
• Returned drugs not secured properly
• CS in research not ordered by pharmacy
• Hard copy verification not completed during
  inspections
• Weekly verification of automated dispensing
  cabinets not done

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CS (continued)

• Drugs for destruction not included in inspection
  or destroyed quarterly
• 72 hr checks not completed, resolved, and records
  maintained for 3 years
• Inspectors not appointed in writing by Director
  for terms up to 3 years
• Refresher training not provided to inspectors,
  and performance not monitored

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CS (continued)

• Losses of CS not reported via 1108.1
• Access to vault not limited by policy
• CS in refrigerators not included in change of
  shift counts
• Unsealed liquids not measured during inspection
• CS prescriptions not secured at window prior to
  pickup

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CS (continued)

• Vault inventory levels excessive
• Lack of accountability in mailroom for CS
• Lack of separation of duties in ordering and
  receiving medications
• AMM or designee not witnessing receipt of CS
• RX pads not secured or inventoried

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Pharmacy Physical Security

• Suspected theft, diversion or suspicious loss not
  reported to VA Police immediately
• Keypad shields not in place
• Alarms not tested monthly
• Electronic access systems not in compliance with
  standards (Card plus PIN for vault)
• Vault construction not meeting standards

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Physical Security (continued)

• Outer vault door not locked when pharmacy closed
• Returned controlled substances not secured and
  stored in vault
• Dispensing windows not bulletproof
• Recommendations from annual physical security
  assessment not completed

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House Veterans Affairs Committee

• Concerned about repeat findings by OIG
• Missed inspections
• Corrective actions planned by VA
• Follow up in near future

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New Focus Areas for OIG CAP

• Polypharmacy in nursing home and mental health
• Controlled substance accountability and
  inspection (renewed emphasis)
• Inventory management system-CMOP
• Pharmacy and vault security
• Environment of care in pharmacy
• USP Chapter 797 compliance

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Poly-Pharmacy

• The Criteria utilized for identifying
  polypharmacy are
• Taking medications that have no apparent
  indication
• Using therapeutic equivalents to treat the same
  illness
• Concurrent use of interacting medications
• Using an inappropriate dosage
• Using other medications to treat adverse drug
  reactions

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Upcoming OIG CAP Visits

• Tennessee Valley
• Fayetteville, NC
• Northampton
• Togus
• Minneapolis

• Little Rock
• Fayetteville, AR
• Butler
• Sacramento
• White City
• Birmingham

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Upcoming OIG Audit

• Accountability of high cost non-controlled
  medications
• National survey of pharmacy chiefs
• Random facility audits
• Try to account for all doses based on 2007 and
  2008 wall to wall inventory, using purchases and
  dispensing records

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Preparation for OIG Audit on Inventory

• Review 2007 and 2008 wall to wall inventory
  results
• Compare actual 2007 and 2008 inventory turns with
  McKesson projected turns report
• Focus attention on high value/high volume
  medications
• Discuss controls in place to prevent diversion

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Targeted Medications

• Atorvastatin
• Carisoprodol  
• Clopidogrel
• Cyclobenzaprine 
• Efavirenz
• Olanzapine
• Risperidone
• Tramadol 
• Valganciclovir
• Vardenafil

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SOARS Program

• Provide assessment and educational consultation
  to VA facilities
• Support a continuous readiness culture
• Help provide quality health services
• Assist medical centers with meeting standards of
  care
• Identify and share strong practices

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2007 SOARS Annual Report

• Site visits to 49 facilities
• 250 trained SOARS consultants
• Assessment guides for 42 areas
• Training films completed for SPD and Pharmacy

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Most Common Identified Areas for Improvement

• Timely termination of employees, volunteers and
  contractors from VA computer system
• Documenting resolution of problems in minutes
• Achieving medication reconciliation in all areas
• Effectively managing medication refrigerator
  temperatures

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Additional Findings

• Storage and labeling of meds (multi-dose vials)
• Unsecured medications in patient care areas
• Controlled substance inspection program not in
  full compliance

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Upcoming SOARS Visits

• VA Sierra Nevada
• Sioux Falls
• Atlanta
• Togus

• Tomah
• Milwaukee
• Long Beach
• VA Western NY

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Office of the Inspector General (OIG)Department
of Defense (DoD)

• 2004 Report on DoD Management of Pharmacy
  Inventory and Returns
• Audit objective to evaluate effectiveness of the
  management of pharmaceutical inventory at medical
  treatment facilities (MTF)
• Reviewed 9 MTFs (6 hospital and 3 clinics)

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Findings

• Inventory levels
• Stock rotation
• Handling expired medications

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Inventory Levels

• Days stock on hand differed among MTFs
• Variation in stock levels not related to workload
• Stock levels not based on data at most sites
• Limited relationship between the days supply of
  stock intended by pharmacy buyer and actual stock
  on hand

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Stock Rotation

• Pharmacy staff stated they followed first-in,
  first-out (FIFO) method of stocking
• Drugs with shortest shelf life not always
  dispensed first
• Shelf reviews found many instances of
  non-compliance with FIFO
• Observed staff placing newly received stock in
  front of existing stock

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Expired Pharmaceuticals

• Expired drugs not identified or removed from
  stock consistently
• Found out of date drugs in dispensing area in 8
  of 9 MTFs
• Out of dates ranged from 1 to 27 of stock

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Returns Program

• MTFs did not conduct inventories of expired
  medications returned for credit
• MTFs did not track credits associated with
  returns
• MTFs did not analyze returns data for trends
  relating to inventory management

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Recommendations

• Establish stock levels based on workload, scope,
  level of care and mission
• Validate stock levels on periodic basis
• Standardize the process for identifying expired
  meds and removing from stock
• Establish written procedures for FIFO
• Establish oversight to ensure policies are
  implemented and followed

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Recommendations

• Ensure an inventory of all returned drugs is
  prepared before the shipment leaves the MTF
• Track credits and costs associated with the
  returns program
• Analyze returns data for trends that indicate a
  need to modify inventory levels or ordering
  practices

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Inventory Management

• Asset management
• Inventory turns (actual and projected)
• Max Loss Savings Report (contract compliance)

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Asset Management

• A, B, C system
• A- 70 of dollars, 10 of items
• B- 20 of dollars, 20 of items
• C- 10 of dollars, 70 of items
• Par levels and reorder points
• Economic order quantities
• Balance inventory and purchasers time

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Impact of Increased Turns
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GAO

• Independent, nonpartisan agency that works for
  Congress.
• Investigates how the federal government spends
  taxpayer dollars.
• Work is done at the request of congressional
  committees or subcommittees or is mandated by
  public laws or committee reports.

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GAO Functions

• Audit agency operations to determine whether
  federal funds are being spent efficiently and
  effectively
• Investigate allegations of illegal and improper
  activities
• Report on how well government programs and
  policies are meeting their objectives
• Perform policy analyses and outlining options for
  congressional consideration
• Issue legal decisions and opinions, such as bid
  protest rulings and reports on agency rules.

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GAO Process
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Follow-up

• GAO
• Selects which recommendations to follow-up on.
• Generally yearly
• No mechanism to close GAO recommendations
• Generally follow for 2-3 years then fall off list

• OIG
• More structured
• Every 90 days ask for an update 30 days to
  respond
• Reports to Congress yearly what has not been
  closed (recommendations not acted upon)

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GAO Report 04-755, July 2004

• VA Medical Centers, Internal Control over
  Selected Operating Functions Needs Improvement
• Visited 6 VA medical centers
• 5 of 6 did not inventory drugs held for return
  and credit
• No analytical review of credits for returns at
  local, network or agency level
• Returned drugs stored in unsecured open bins in 4
  of 6 facilities

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Use of Returns Company

• Standards for internal control in the federal
  government requires reasonable assurance of the
  use of resources
• VA uses an honor system, relying on contractors
• Lack of follow up to ensure all credits received
• 80 of credits via prime vendor, 20 direct from
  company

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Lack of Security

• Physical security over drugs held for return
  lacking in 4 of 6 facilities
• Theft difficult to detect due to lack of
  inventory lists
• 3 employees at one VA center convicted for
  stealing 1.3 million in drugs over 3 years

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Other Findings

• 23 of drugs returned without credit due to
  exceeding manufacturers time frames
• Pharmacy staff claims of not cost effective to
  monitor, without studies or analysis
• VHA received 5.7 million in credit in FY03

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VHA Response to GAO

• Facilities will maintain a list of drugs held for
  credit (VISTA Patch PSA351)
• Non-controlled drugs will be secured
• Facilities will periodically test to see if
  amount of credits received is correct
• Network level PBM or other network staff to
  monitor facility credits for returns
• Data will be analyzed for trends
• National directive published
• Reverse distribution contracts

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VHA Directive 2008-021

• Monitoring of Non-Controlled Substance Medication
  Returns
• Maintain running list of non-controlled
  medications held for return for credit as removed
  from supply
• Compare with contractor-prepared list of returned
  drugs
• Semi-Annually test if amount of credits received
  is correct

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VHA Directive 2008-021

• Analyze information to identify potential
  improvements
• Secure medication as removed from stock
• Locked area
• Separate from normal inventory
• Communicate findings to VISN formulary leader

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Getting Prepared
Don't wait until it happens!
Be Proactive
Do it right, ONCE
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Start today......

• SOARS Website http//soars.vssc.med.va.gov/defaul
  t.aspx
• Assessment guides
• Training films
• List of strong practices
• Upcoming visit schedule
• Information on new consultant training

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SOARS Assessment Guides for Pharmacy

• Controlled substance program
• Pharmacy review
• Physical security
• Vault procedures
• USP 797
• Emergency drug cache
• Medication reconciliation
• Self medication programs

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SOARS Videos

• Seven segments that are between 4 and 10 minutes
  each
• Segment Topics
• Pharmacy and controlled substances
• Pharmacy Leadership
• Exterior Pharmacy Review
• The Vault
• IV Room/Sterile Compounding
• General Pharmacy Review
• Controlled Substance Coordinator

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SOARS - Strong Practices

• Automated Fastfill 64 in CS Vault
• Competencies for Controlled substance inspectors
• Controlled substance Advisory Board
• Controlled Substance Inspector Training
  Program/Inspection Program checklist
• Controlled Substance program
• Inspector recognition program
• Pharmacy security and management of controlled
  substances
• There is a standardized documentation process for
  controlled substance review in the Outpatient
  Vault.
• Pneumonic tube process for dispensing of
  controlled substance to dispensing window.

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Management Review Services (10B5)

• Lead role in coordinating and developing
  responses for the Under Secretary for Health to
  internal and external reviews
• VHAs liaison with OIG, GAO
• OIG-GAO information
• Quarterly reports
• New, ongoing, completed reviews
• Potential agency impacts
• Links to GAO, OIG, SOARS, assessment guides
• http//vaww.ush.va.gov/ManagementReview.asp

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Preparation Tips

• Use SOARS as a practice session for Joint
  Commission and OIG CAP surveys
• Contact SOARS pharmacists with questions in
  advance
• Use SOARS tools for self assessments ongoing
• Review OIG CAP reports on website

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Preparation Tips

• Review data and procedures in vault to ensure
  practice matches policy
• Use internal facility and VISN teams to do
  pre-reviews
• Carefully review and validate all data PRIOR to
  sending it to the OIG
• Make performance improvement part of everyday
  life

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Educate and Empower

• Proactive lead the charge
• Be able to talk it
• If you or your staff are naturally apprehensive
  take an area and discuss it at a staff meeting.
  Ask, how would you answer this question. This is
  also going to tell you what your staff knows and
  what information they need
• Make it positive

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Motivate

• Monthly improvement contest
• Post a finding from another site and ask staff to
  submit a solution
• Offer prizes for solutions put into practice
• Involve staff in performance improvement
  activities
• Communicate how well you are doing newsletters,
  meetings

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Process Improvement

• How should the process work?
• How do you know it is working?
• What do you do when you identify a problem?
• How do you plan to fix problems?
• How do you know when a problem is fixed?
• How do you disseminate learning?

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Example Stock Rotation

• Other facilities have been sited for not rotating
  stock appropriately lets be the model for the
  best practice. Tell me
• What ways can we monitor that we are
  appropriately rotating stock?
• What do you do when you find out of date stock
  on the shelf?

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During Review

• GAO and OIG have very broad authority can have
  anything they ask for
• Answer questions as truthfully and accurately as
  possible
• Educate the reviewer
• Ask for clarification
• be skeptical
• ask for citation

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Preparing for Pharmacy Reviews 118
What have You learned?
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Great Job!!!!
Thank you for playing!
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