DRUG ACCOUNTABILITY

According to the Cancer Therapy Evaluation Program (CTEP) policy for accountability and storage of investigational drugs, (2013,¶ 1),

FDA regulations require investigators to establish a record of the receipt, use and disposition of all investigational agents. The NCI, as a sponsor of investigational trial, has the responsibility to assure the FDA that systems of agent accountability are being maintained by investigators in their clinical trial program. Investigators may delegate responsibility for drug ordering, storage, accountability, and preparation to his/her designee. However, the investigator is ultimately responsible for all agents shipped in his/her name. The intent of drug accountability is to assure that NCI-supplied agents are administered only to patients enrolled on approved NCI trials and to track complete disposition of the agent.

Drug accountability continues to be the fifth leading deficiency found, (Hamrell, 2012).

It is vital to patient safety that investigational drugs be accounted for, stored properly, and dispensed only to study subjects. The study subjects are the only persons consented to use the investigational agent. Administering study agent to a non-study patient is prohibited and illegal, as is mixing stock and study medication. If there is an untoward effect discovered with a particular lot of study drug, all sites will be notified,and the drugs are pulled from supplies and returned. Patients who have received the applicable lot need to be notified. Therefore, accurate records are needed to track where the drugs are, and who has received them.

Providing commercial agents to study patients in place of the study supplied drug is another accountability problem, as well as a major violation. In this situation, the patient or insurance company cannot be charged for the stock supply that was to be provided by the study. The consent states the medication is provided “Free of Charge”. Further more, if something is wrong with the particular lot number, and it has been given to a non-study subject there could be legal implications.

The following is alisting of some of thedrug accountability regulations based on information from the National Cancer Institute, 2013. Required forms can be accessed:

ORDERING

  • Submit agent requests through the PMB Online Agent Order Processing (OAOP) application.
  • Urgent orders must be received by 2:00 PM EST to receive drug by the next business day & include an express courier account number. Routine orders are processed in 2 working days, and shipped by U.S. Postal Service Priority Mail or other ground service Monday through Thursday.
  • Access to OAOP requires the establishment of a CTEP Identity and Access Management account.
  • Physicians must be registered at the Pharmaceutical Management Branch (PMB) of the NCI, to order investigational drugs (Renew annually).
  • Completed 1572 Form
  • Current CV
  • Financial Disclosure
  • Supplemental Investigator Form

Drug Accountability Record Form (DARF)

Maintain a separate DARF for each protocol, agent, strength, formulation and ordering investigator. Also, maintain a separate DARF for each study participant on patient-specific supply studies as dictated by the protocol. For oral agents, sites must use the NCI Investigational Agent Accountability Record for Oral Agents (Oral DARF) as of March 1, 2014.

Fill in:

  • Page number
/
  • Protocol title, (May abbreviate)

  • Control or Satellite
/
  • Dispensing Area

  • Institution
/
  • Investigator & CTEP ID

  • Protocol number (NCI# & Local #)
/
  • Balance

  • Agent name, dose, form and strength
/
  • Bottle size (if applicable)

RECEIVING

  • Review shipment & compare to shipping receipt for accuracy.
  • SAVE SHIPPING RECIEPT
  • Sign drugs in on the Investigational Drug Accountability Record (NIH 2564)
  • Date & Received from ….
  • Enter strength & Dosage form received
  • Amount received
  • Balance Forward
  • Manufacture & lot #
  • Initial (of person receiving & reviewing shipment)
  • Use a Separate log for each protocol, drug & strength
  • Use a black pen, no correction fluid, no Ditto marks, & no write overs
  • When a number of investigators are participating on a clinical study at the same institution, one investigator should be considered or designated the principal investigator under whom all investigational agents for that protocol should be ordered.

STORAGE

  • All drugs are:
  • Stored separately from commercial drugs
  • Stored in a secure location which is only accessible to authorized personnel
  • Stored under proper environmental conditions with documentation of temperature monitoring.
  • Different lot # , stored separately
  • Stored in a Labeled container or bin with drug name, protocol, strength, formulation and ordering investigator

DISPENSING

  • Record on DAR when drugs are dispensed
  • Date, pt initials, pt ID, Dose, Quantity, Balance, manufacture and lot#
  • For Oral agents: enter expiration date,
  • Initial entry
  • If transferring to satellite write, “Transferred to . . . “ with date, amount, balance, manufacture and lot #, and initial entry.
  • Do not repackage and transfer by mail or overnight delivery

RETURNING

  • For oral agents: when patient returns, enter Date returned, quantity returned and initial the entry.
  • Complete a Return Agent Form
  • Log out on DARF, “Returned to …..
  • Bring balance forward.
  • Mail drugs back with Return Agent Form, (do not need to keep cold, as returned drugs are not used)
  • Drugs may be destroyed on site per institutional policy if allowed by sponsor

TRANSFERS

  • Complete the Transfer I.D. Form
  • Contact the PMB to get permission prior to transfer
  • Drugs from NIH studies cannot be transferred to non NIH studies
  • Drugs may only be transferred to satellites from an institutional central pharmacy via staff or local courier transport. if agents are transported using appropriate temperature controls and hazardous/infectious transportation procedures. The institutions should be tied through an affiliates and share the same professional staff.

References:

Pharmaceutical Management Branch, CTEP, DCTD, National Cancer Institute (2013). Policy and guidelines for Accountability and storage of investigational agents. Retrieved from

Pharmaceutical Management Branch, CTEP, DCTD, National Cancer Institute (2013). Policy and Guidelines for use of the NCI Investigational Agent Accountability Record for Oral Agents (Oral DARF). Retrieved from:

Hammrell, M. (2012). Good Clinical Practice: A question and answer reference guide. Barnett International, Needham, MA.

2/7/2014