Investigational Drug Service (IDS)
The IDS is charged with safe and responsible handling of investigational drugs. The purpose of the IDS is to maintain control and accountability of investigational drug use in the Medical Center to promote maximum benefit and safety for patients enrolled in studies.
Investigational drugs are procured, stored, inventoried, dispensed and used through the IDS in compliance with regulations or guidelines of the FDA, JCAHO, ASHP, Code of Federal Regulations, Pennsylvania State Board of Pharmacy, other applicable organizations and in accordance with Hospital, Medical Center and University policies and guidelines.
Services provided for all research protocols:
- Drug procurement.
- Secure, Monitored Storage (there are specific guidelines for storage/security).
- Accountability (for all agents received and disbursed, accurate to the individual dose).
- Preparation (includes sterile preparation if necessary).
- Labeling and Dispensing.
- Meets with study team as needed.
- Meets with sponsor and sponsor's representatives to review protocol and records.
- 24-hour on-call for study-related issues, including off-hour enrollments, guidance for non-study personnel, emergency unmasking of treatment codes, and guidance on admission of study subjects to non-UPHS institutions or vice-versa.
Services provided for research protocols involving the hospital inpatient pharmacy:
- Staff training for pharmacists/technicians.
- Detailed step-by-step procedures.
- Routine internal audits of enrollment, accountability and dispensing activity.
- Assistance to medical and nursing personnel in order entry.
Services provided as necessary based on the needs of the trial:
- Randomization tables (and un-blinding envelopes for off-site clinics).
- Repackaging (e.g. bottles, cartons, boxes).
- Compliance packaging (e.g. blister cards, unit-of-use containers, special labeling).
- Sterile compounding or manufacturing (products for human injection or infusion using purified non-sterile ingredients).
- Non-sterile compounding or manufacturing (over-encapsulation of commercial products, compounding of powders or liquids, placebos, suppositories, etc).
- Dose adjustment (may include sham adjustments of placebo doses, ordering and evaluation of blood tests, etc, to maintain blinding for rest of study team).
Other services available include:
- Consultation on study design and logistics for students, residents, fellows and young investigators.
- Research of protocol-related questions using various drug information references.
- Assistance with IND application development and submission (for manufactured or compounded medications or natural products).