Pharmacy and Investigational Drug Service (IDS)
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Locations
The Johns Hopkins Hospital – Central Investigational Drug Service
Location: Osler 100
Hours: Monday through Friday, 7:30 AM to 5:30 PM
Phone: 410-955-6337 or 410-955-4505
Fax: 410-614-8074
Pager: 410-283-2936
The Johns Hopkins Hospital – Oncology Investigational Drug Service
Location: Weinberg Building, Room 2432
Hours: Monday through Friday, 7:00 AM to 5:00 PM
Phone: 410-502-1036 or 410-955-8998
Fax: 410-955-6371
Pager: 410-283-8261
Email: [email protected] (preferred method of communication)
Johns Hopkins Bayview Medical Center Investigational Drug Service
Contact: Jim Monolakis, PharmD, Investigational Drug Service Manager
Phone: 410-550-2747
Email: [email protected]
Sibley Memorial Hospital Investigational Drug Service
Contact: Amy Laboskie, PharmD, Investigational Drug Service Manager
Phone: 202-537-4242
Email: [email protected]
Suburban Hospital
Contact: Belynda Sanders, PharmD, BCPS, Pharmacy Supervisor
Phone: 301-896-7292
Email: [email protected]
Johns Hopkins Howard County Medical Center
Contact: Susan Shermock, PharmD, Medication Safety Officer
Phone: 410-884-4656
Email: [email protected]
Johns Hopkins All Children’s Hospital Investigational Drug Service
Contact: Dawn Napolitano, PharmD, Investigational Drug Clinical Pharmacist
Phone: 727-767-2599
Email: [email protected]
The Johns Hopkins Health System
Clinical research within The Johns Hopkins Health System is supported by Investigational Drug Service (IDS) staff at The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Sibley Memorial Hospital, Suburban Hospital, Johns Hopkins All Children’s Hospital, and at Johns Hopkins Howard County Medical Center. These locations all provide comprehensive pharmacy services to support clinical trials, such as:
- Pharmacist review of all medication orders and monitoring parameters, if applicable
- Drug preparation and dispensing, pursuant to a valid order or prescription
- Drug information to patients and healthcare team
- Drug management, accountability and regulatory support for clinical trials (Note: Suburban and HCGH do not use Vestigo® software for electronic inventory management at this time)
- Support development of clinical trials, such as:
- Protocol Review
- Development of pharmacy budget and invoice for services
- Facilitate the Epic build of study medications, and, for non-Oncology studies, assist with order set review
- Participate in quality assurance activities for clinical protocols
For inpatient studies a pharmacy shall store, control, prepare, and dispense all drugs used in clinical investigations (DUCI) unless a limited exception is granted by the P&T IRB liaison during the IRB application and approval process. When the IDS pharmacy controls the investigational product for a study, all necessary drug control and recordkeeping functions are conducted for the investigator by the IDS pharmacy.
IDS Pharmacy Support and Inventory Management
Pharmacy Support
A typical study requires approximately 35 hours for pharmacy setup, which includes review of trial documents (protocol, pharmacy manual, investigator brochure), correspondence with sponsor or clinical trials team to initiate the trial, facilitate the build of the electronic order in Epic, preparing concise written instructions for dispensing, and development of an estimated pharmacy budget. Additional pharmacy support of a research project may include any or all of the following services:
- Coordinate, prepare, and dispense investigational product
- Blind investigational product
- Assist with development of matching placebo (Note: HCGH cannot support this service)
- Drug information, patient counseling, adherence monitoring
Pharmacy Inventory Management
The Pharmacy can provide inventory management for the investigational product, which includes:
- Documentation requirements
- Compliance with sponsor, institutional, state and federal regulations
- Monitor inventory
- Receipt of inventory
- Sponsor directed disposition of investigational product
- Track expiration dates and re-test dates
Pharmacy Fees
The IDS pharmacies create estimated budgets to cover pharmacy expenses to support research. Clinical trial teams should contact their designated IDS pharmacy early in the process to create an estimated budget prior to completion of the overall study budget. Standard categories for fees include administrative set-up, inventory management, dispensing cost, and study close out. Additional fees may be added depending on protocol complexity and design. Other fees may consist of drug costs, shipping costs, investigational product compounding and blinding services, additional equipment or supply costs, and monitoring fees.
The estimated budget will be provided to the principal investigator or designee to incorporate in overall budget and is valid for one year from the estimate date. A proposed budget is an estimate, and if substantial changes are made to the protocol the budget may require revisions. Please contact the IDS staff for additional information on current fee schedules.