PREP Workshop # 20: Investigational Drug Accountability Presented by: Ji-Eun Kim, Research Pharmacist Investigational Pharmacy Core, CRS
CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose. Ji-Eun Kim has nothing to disclose.
OBJECTIVES To review regulatory requirements and discuss best practices for drug accountability record and related documentation Regulatory Requirements Best Practices Investigational Drug Accountability
DRUG ACCOUNTABILITY RECORDS Auditable trail of drug management Receipt Preparation Dispensation Inventory Transfer Distribution Subject Return Return to Sponsor On-site Disposal
REGULATIONS & STANDARDS
FEDERAL REGULATIONS 312.60 General responsibilities of investigators An investigator is responsible for.. the control of drugs under investigation. 312.62 Investigator recordkeeping and record retention An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity and use by subjects. <CFR Title 21 Section 312>
<E6 GCP: 4. Investigator and 5. Sponsor > GCP STANDARDS 4.6.1 Responsibility for IP (Investigational Product) accountability at each site 4.6.2 Delegation of duties for IP accountability to and supervision of an appropriately qualified person 4.6.3 Maintaining documentation of IP management Delivery Inventory Dispensation Return to sponsor or on-site disposal 5.18.4 Monitor's responsibilities
DRUG ACCOUNTABILITY RECORDS Authorized Subjects Authorized Prescribers DARF Compliance with Protocol Compliance with Regulations
FDA AND ORC AUDITS Drug Accountability Record Form: Absent, partial, incomplete and discrepant MISSING RECORDS No retrieval No destruction DISCREPANCY Source documents Actual inventory PRACTICES No scheduled verification No access by back-up staff
LESSONS FROM AUDITS Absent, incomplete, inaccurate and discrepant DARF: Not acceptable data Correct and reconcile Provide sufficient explanations on records Establish and implement procedures (e.g., staff trainings, scheduled inventory verification)
Study-specific Subject-specific NCI ACTG IPC or HRPP
Separate DARF Sheets Each Study Same Study Same PI Each drug Each dosage form Each drug strength Each lot number Each location
Contents Receipt Dispensation Distribution or transfer Periodic inventory verification Subject return Return to sponsor On-site disposal
Study Information North Shore-LIJ Health System Investigational Drug/Biologic Accountability Record Name of Hospital or Center: NSUH Protocol Title: A double-blinded ABC Study Dispensing Area or Pharmacy: NSUH Pharmacy IRB Number: 14-023A PAGE No. Investigator Name: Dr. Jones Investigator and/or Site Number: 06 Investigational Drug/Biologic Name: Dosage Form and Strength: Package Size: Inventory Unit: Storage Temperature: 1 Line No. Date Subject Initials Subject ID No. Dose Quantity Dispensed /Received Balance Forward Lot/Kit Number Expiration Date Recorder Initials Comments 1 2 3 4
Drug Information North Shore-LIJ Health System Investigational Drug/Biologic Accountability Record Name of Hospital or Center: NSUH Protocol Title: A double-blinded ABC Study Line No. 1 2 3 4 Date Subject Initials Subject ID No. Dose Quantity Dispensed /Received Dispensing Area or Pharmacy: NSUH Pharmacy IRB Number: 14-023A Balance Forward Lot/Kit Number Expiration Date PAGE No. 1 Investigator Name: Dr. Jones Investigator and/or Site Number: 06 Investigational Drug/Biologic Name: Healept Package Size: 60 tablets/bottle Inventory Unit: Bottle Dosage Form and Strength: Oral Tablet 100 mg Storage Temperature: 20-25 C (68-77 F) Recorder Initials Comments
Receipt North Shore-LIJ Health System Investigational Drug/Biologic Accountability Record Name of Hospital or Center: NSUH Protocol Title: A double-blinded ABC Study Dispensing Area or Pharmacy: NSUH Pharmacy IRB Number: 14-023A PAGE No. 1 Investigator Name: Dr. Jones Investigator and/or Site Number: 06 Investigational Drug/Biologic Name: Healept Package Size: 60 tablets/bottle Line No. Date Subject Initials Subject ID No. Inventory Unit: Bottle Dose Quantity Dispensed /Received Dosage Form and Strength: Oral Tablet 100 mg Balance Forward Lot/Kit Number Storage Temperature: 20-25 C (68-77 F) Expiration Date Recorder Initials 1 4/30/14 Received 20 20 A1234 6/30/16 JK 2 3 4 Comments
Dispensation North Shore-LIJ Health System Investigational Drug/Biologic Accountability Record Name of Hospital or Center: NSUH Protocol Title: A double-blinded ABC Study Dispensing Area or Pharmacy: NSUH Pharmacy IRB Number: 14-023A PAGE No. 1 Investigator Name: Dr. Jones Investigator and/or Site Number: 06 Investigational Drug/Biologic Name: Healept Package Size: 60 tablets/bottle Line No. Date Subject Initials Subject ID No. Inventory Unit: Bottle Dose Quantity Dispensed /Received Dosage Form and Strength: Oral Tablet 100 mg Balance Forward Lot/Kit Number Storage Temperature: 20-25 C (68-77 F) Expiration Date Recorder Initials 1 4/30/14 Received 20 20 A1234 6/30/16 JK 2 5/15/14 JD A13 2 Tabs BID -2 18 A1234 6/30/16 JK 3 4 Comments
Scheduled Periodic Inventory Verification North Shore-LIJ Health System Investigational Drug/Biologic Accountability Record Name of Hospital or Center: NSUH Protocol Title: A double-blinded ABC Study Dispensing Area or Pharmacy: NSUH Pharmacy IRB Number: 14-023A PAGE No. 1 Investigator Name: Dr. Jones Investigator and/or Site Number: 06 Investigational Drug/Biologic Name: Healept Package Size: 60 tablets/bottle Line No. Date Subject Initials Subject ID No. Inventory Unit: Bottle Dose Quantity Dispensed /Received Dosage Form and Strength: Oral Tablet 100 mg Balance Forward Lot/Kit Number Storage Temperature: 20-25 C (68-77 F) Expiration Date Recorder Initials 1 4/30/14 Received 20 20 A1234 6/30/16 JK 2 5/15/14 JD A13 2 Tabs BID -2 18 A1234 6/30/16 JK 3 6/1/14 Monthly Inventory 18 A1234 6/30/16 JK 4 Comments
Disposal North Shore-LIJ Health System Investigational Drug/Biologic Accountability Record Name of Hospital or Center: NSUH Protocol Title: A double-blinded ABC Study Line No. Date Subject Initials Subject ID No. Dose Quantity Dispensed /Received Dispensing Area or Pharmacy: NSUH Pharmacy IRB Number: 14-023A Balance Forward Lot/Kit Number Expiration Date Recorder Initials 1 4/30/14 Received 20 20 A1234 6/30/16 JK 2 5/15/14 JD A13 2 Tabs BID -2 18 A1234 6/30/16 JK 3 6/1/14 Monthly Inventory 18 A1234 6/30/16 JK 4 6/30/16 Destroyed on site -18 0 A1234 6/30/16 JK PAGE No. 1 Investigator Name: Dr. Jones Investigator and/or Site Number: 06 Investigational Drug/Biologic Name: Healept Package Size: 60 tablets/bottle Inventory Unit: Bottle Dosage Form and Strength: Oral Tablet 100 mg Storage Temperature: 20-25 C (68-77 F) Comments
Incorrect DARF entries should be crossed out with a single line and corrected with the date and the initials of the recorder. No erasure or white-out is allowed. Schedule periodic inventory verification to reconcile any discrepancies, secure sufficient supplies for upcoming subject visits and dispose of any expired drugs. Provide written explanations on any issues, if necessary, and retain them in the binder.
Activities DARF: Look and Find (Individual activity) There are 4 inappropriate records and practices on the form.
Activities Record of Drug Receipt (Group activity) Each bag contains drug supply for your team. First, discuss whether you need separate drug accountability record sheets to enter the receipt of your drug supply. One person in your team documents the receipt of the drugs on the provided form. Another person verifies the record.
Activities Discussion: Investigational Drug Accountability (Group activity) Each team will discuss 2 cases.
DOCUMENTATION Packing slip and invoice Receipt or delivery confirmation Temperature records during transit Signed informed consent forms Treatment arm and dose assignments Kit, bottle or vial assignments Prescriptions and drug orders Study-specific forms Administration records Subject return records Written approval from the sponsor Return to sponsor or on-site disposal records
TOOLS AND GUIDANCE Feinstein Institute for Medical Research Home www.feinsteininstitute.org» For Professionals» Resources for Investigators» Clinical Research Service» Investigational Pharmacy Core» Tools and Guidance http://www.feinsteininstitute.org/professionals/resources-for-investigators/clinical-research-service/pharmacy/tools-and-guidance/#top-anchor Tools for Investigational Drug Management Frequently Asked Questions Templates
CONTACT INFORMATION Ji-Eun Kim, RPh, PhD Research Pharmacist Investigational Pharmacy Core, CRS TEL:516.562.0428 EMAIL: jkim31@nshs.edu