1. Investigational Pharmacy Issues Debbie Mundie, RPH Aka: The Drug “Nazi” “She should be in Law Enforcement” “She’s nice, but PICKY” McGuire VAMC Richmond

2. Key Issues  McGuire VAMC Investigational Pharmacy is unique  Pharmacy meets accreditation standards  Pharmacy is critical link in the Human Research Protection Plan (HRPP)

3. McGuire VAMC HRPP Operating Relationships ACOS R&D MRI Board* Top Management R&D Committee* McGuire IRB* Investigational Pharmacy ACOS Admin Off Reporting relationship Membership

4. 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

5. The Front Office of the Pharmacy

6. Front Office – Monitoring Corner

7. Half door keeps unauthorized personnel away from medications

8. Workstations

9. 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

10. 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

11. Room Temperature Log

12. Refrigerator with automatic temperature log

13. QA Auditing Tool (cont) Investigational meds separated from other drug stocks Meds require signed prescription (by those authorized on 9012) Patient’s signed informed consent on file prior to dispensing drug Copy of CWAD on file prior to dispensing drug

14. QA Auditing Tool ICF Audit at continuing review:  Names of subjects who rec’d drug  Date ICF signed  ICF version signed “Investigational Drug” label and other warning labels used as appropriate. Unused meds destroyed per policy (when authorized)

15. 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

16. Pharmacy Files are organized by PI, then by investigational medication

17. 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

18. QA Auditing Tool (cont) Drug Accountability records complete:  Drug name  Manufacturer  Amt, Date, Qty received  Lot or Control #  Expiration date  Prescription #, Date dispensed  Patient’s name  Amt, date dispensed, balance remaining  Date protocol approved  Name of authorized prescriber  Initials of dispensing RPh  Disposition of used & unused study drug

19. Dispensing Log

20. Chain of Custody Log

21. 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.

23. “No consent.. No prescription.. NO Drug for YOU!”