Cores & Resources Library site logo (1)

Presenters:

Kevin Zinchuk PharmD, Van Thai CPhT

Breakout Room:

Investigational Drug Service

Contact:

617-732-6410

bwhrxids@partners.org

Investigational Drug Service

The Investigational Drug Service (IDS) service provides 24/7/365 support for storage, preparation and dispensation of medications used as part of clinical trial research at BWH.

Overview

The Brigham and Women’s Hospital Investigational Drug Service (IDS) is division of the Department of Pharmacy Services and is devoted to the coordination of human drug research activities at Brigham and Women’s Hospital.

This includes developing procedures to ensure timely and safe drug dispensing, maintaining inventory of investigational drugs, blinding and randomizing drug studies, serving as an information resource regarding investigational drugs and study protocols, meeting with principle investigators and study groups, participating in protocols as co-investigators and reviewing protocols as members of the Mass General Brigham Human Research Committee.

IDS acts as an informational resource for other Brigham and Women Hospital pharmacists and clinicians to assist in answering questions and solving dispensing issues with foreign drugs, orphan drugs, continued use of non-FDA approved agents from other institutions and emergency use investigational medications.

In an effort to comply with state, federal, accrediting bodies, and study sponsors; the BWH investigational drug services can support the following scenarios:

  • Investigational new drugs being studied under an IND
  • FDA approved drugs being studied under an IND or with IND exemption
  • Drugs being studied under an Emergency IND

 

Services Provided by BWH IDS:

  • Inventory Control
    • Ordering, receipt, expiry tracking, and drug shipment documentation
  • Storage
    • Restricted access storage of investigational product
    • Controlled substance storage
    • Cold drug storage for active protocols at BWH*
    • Electronic temperature monitoring of all IP storage areas in the IDS pharmacy
  • Dispensing and Drug Accountability
    • Investigational Product Accountability documentation
    • Blinding procedures
    • Randomization services for BWH study site protocols
    • EPIC medication package maintenance
  • Compounding
    • Non Sterile Compounding*
    • Sterile Compounding (USP defined Low and Medium Risk ONLY)*

o    Hazardous medication compounding*

*Due to resource limitations, regulatory compliance, and hospital policies and procedures; investigators should contact BWH IDS using the drug intake form during the protocol writing/development to ensure adequate resources are in place to support the protocol at BWH.

 

BWH IDS does NOT provide the following services:

  • Drug supply management for non-clinical research (animal, laboratory)
    • The researcher needs to:
      • Obtain DEA and State registrations
      • Establish Vendor Account
      • Complete MGB Purchase Requisition
      • Send Purchase Order to PHS Purchasing
      • Put procedures in place to ensure adequate oversight of drugs
      • Ensure compliance with State and Federal regulatory requirements governing security and use of Controlled Substances
    • Randomization services for protocols at BWH that do not involve the IDS in investigational product management
    • Randomization services for multicenter studies. Outside vendor services will be required
    • Drug supply management for multicenter studies (coordinating site activities) for activities such as compounding, storage, labeling, repackaging, and shipping. Outside vendor services will be required.
    • Drug potency, stability, sterility, and endotoxin testing. Outside vendor services will be required. Please consult IDS if this needed for the protocol.
    • Management of biohazardous agents that are not supported by BWH pharmacy resources or incur to high of a risk to employees as deemed by the PHS IRB, PHS IBC, BWH Department of Pharmacy, or BWH Department of Occupational Health (examples include select agents designated with a BSL class of 2 or higher, NIH Risk Group 2 or higher).
    • USP defined High Risk Sterile compounding (Non sterile to sterile preparation techniques)
    • Compounding of drugs on the 503a Bulk Drug Substances That May Not Be Used to Compound Drug Products list, unless the protocol is being supervised under an approved IND from the FDA.
    • Electronic data capture (EDC) for study activities not related to dispensing or investigational product storage.

 

Drug Supply Considerations for Investigators

Research protocol drug supply can be accepted from a variety of vendors/sponsors based upon the regulatory pathway of the study protocol. For studies being conducted under and IND, drug may be accepted according to the provisions of drug supply approved by the FDA in the IND application.

For studies NOT being conducted under an IND, or with IND exemption, BWH IDS can accept drug from the following sources:

  • Licensed Drug Manufacturer, Repackager, or Relabeler (510 federal registration)
  • Licensed Drug Wholesaler (requires Massachusetts licensure and federal 583 licensure)
  • Third-Party Logistics Providers (requires 584 federal registration)
  • Federally Registered Human Drug Compounding Outsourcing Facility (requires Massachusetts licensure AND 503b federal licensure)

 

Shipment of Investigational Product

No shipment of investigational product should commence until the primary pharmacist has been assigned and communication of the shipment has been confirmed.

Contact Information, Hours of Operation and Location

Investigational Drug Services – Main Campus – Tower L2 75 Francis Street Boston, MA 02115 Phone: 617-732-6410

Email list serve: BWHRXIDS@partners.org

Hours of Operation:

Monday through Friday: 7:00 AM to 8:00 PM

Saturday and Sunday: 7:00 AM to 5:00 PM.

After hours, a pharmacist is on-call 24 hours a day via pager # 33672 on the MGB paging directory. A message may be left on the general IDS voice mailbox at 617-732-6410.