Investigational Pharmacy Issues

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Investigational Pharmacy Issues

• Debbie Mundie, RPH
• Aka The Drug Nazi
• She should be in Law Enforcement
• Shes nice, but PICKY
• McGuire VAMC
• Richmond

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Key Issues

• McGuire VAMC Investigational Pharmacy is unique
• Pharmacy meets accreditation standards
• Pharmacy is critical link in the Human Research
  Protection Plan (HRPP)

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McGuire VAMC HRPP Operating Relationships
Top Management
ACOS RD
MRI Board
RD Committee
ACOS Admin Off
McGuire IRB
Investigational Pharmacy
Reporting relationship Membership
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Research at McGuire VAMC

• 275 active studies as of 2/23/04
• 75 involve medications
• 400-600 dispensed prescriptions per month
• 1.2 pharmacist FTE

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The Front Office of the Pharmacy
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Front Office Monitoring Corner
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Half door keeps unauthorized personnel away from
medications
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Workstations
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QA Auditing Tool

• Standards/Elements Reviewed
• Policies/procedures for handling drugs
• Receipt
• Storage
• Security
• Dispensing
• Disposition of Unused Stock
• Drug maintained under custody of Investigational
  Pharmacy

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QA Auditing Tool (cont)

• Investigational drug is kept under double lock
  with limited access
• Storage conditions are documented per protocol
• Temperature logs maintained
• Room temp
• Refrigerator temp
• Freezer temp

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Room Temperature Log
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Refrigerator with automatic temperature log
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QA Auditing Tool (cont)

• Investigational meds separated from other drug
  stocks
• Meds require signed prescription (by those
  authorized on 9012)
• Patients signed informed consent on file prior
  to dispensing drug
• Copy of CWAD on file prior to dispensing drug

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QA Auditing Tool

• ICF Audit at continuing review
• Names of subjects who recd drug
• Date ICF signed
• ICF version signed
• Investigational Drug label and other warning
  labels used as appropriate.
• Unused meds destroyed per policy (when
  authorized)

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QA Auditing Tool (cont)

• Pharmacy File contains
• Approved protocol amendments
• VA Form 9012 for each medication
• Investigator Brochure
• Copies of all subjects signed consents
• Drug dispensing logs
• Drug Study Summaries

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Pharmacy Files are organized by PI, then by
investigational medication
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QA Auditing Tool (cont)

• Policy is followed regarding special handling
  (eg, controlled substances) with appropriate
  documentation
• Order for study drug
• Entered into electronic medical record
• Discontinued order in electronic medical record
  at termination visit
• Confirm that CWAD is removed from CPRS at
  completion of study

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QA Auditing Tool (cont)

• Drug Accountability records complete
• Drug name
• Manufacturer
• Amt, Date, Qty received
• Lot or Control
• Expiration date
• Prescription , Date dispensed
• Patients name
• Amt, date dispensed, balance remaining
• Date protocol approved
• Name of authorized prescriber
• Initials of dispensing RPh
• Disposition of used unused study drug

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Dispensing Log
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Chain of Custody Log
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21CFR 211.137(Lot and Exp date)
(g) New drug products are exempt from the
requirements of this section (lot expiration
date), provided that they meet appropriate
standards or specifications as demonstrated by
stability studies during their use in clinical
investigations. Where new drug products are to
be reconstituted at the time of dispensing, their
labeling shall bear expiration information for
the reconstituted drug product.
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No consent.. No prescription.. NO Drug for YOU!