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Pharmacy and Investigational Drug Service (IDS) at The Johns Hopkins Hospital
The Johns Hopkins Hospital – Osler 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
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
Email: firstname.lastname@example.org (preferred method of communication)
Johns Hopkins Bayview Medical Center Investigational Drug Service
Contact: Jim Monolakis, PharmD, Investigational Drug Service Manager
Sibley Memorial Hospital Investigational Drug Service
Contact: Lucy Chung, PharmD, Investigational Drug Service Manager
Contact: Nicholas Ladikos, PharmD, Investigational Drug Service Pharmacist
Howard County General Hospital
Contact: Susan Shermock, PharmD, Medication Safety Officer
All Children’s Hospital Investigational Drug Service
Contact: Dawn Napolitano, PharmD, Investigational Drug Clinical Pharmacist
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, All Children’s Hospital, and at Howard County General Hospital (HCGH). 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
- Drug information to patients and healthcare team
- Drug management, accountability and regulatory support for clinical trials (Note: Suburban and HCGH do not use electronic inventory management at this time)
- Support development of clinical trials, including:
- Protocol Review
- Development of pharmacy budget and invoice for services
- Review of Investigational Drug Data Sheet (IDDS)
- Review of order sets
- Participate in quality assurance activities for clinical protocols
- Staff education
For inpatient studies a pharmacy shall store, control, prepare, and dispense all drugs used in clinical trials (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.
If an investigator wishes to retain control of an investigational product for outpatient research studies, this must be approved by the P&T IRB liaison during the IRB application and approval process. For studies where the investigator holds the IND, the Investigational Drug Service must audit the storage and recordkeeping system to be used by the investigator for the control of the drug. Audits are performed to ensure that labeling, drug storage, dispensing, and accountability records comply with federal, state, and local regulatory guidelines. The IDS pharmacy performs an audit prior to the start of a study, shortly after patient enrollment begins, upon yearly IRB approval to continue the study, and when the study is terminated. The audit form used by the IDS pharmacy staff may be found here.
IDS Pharmacy Support and Inventory Management
A typical study requires 30 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 pharmacy budget and invoice for services. Additional pharmacy support of a research project may include any or all of the following services:
- Coordinate and dispense investigational product
- Blind investigational product
- Assist with development of matching placebo (Note: HCGH does not participate)
- 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
- Prepare and dispense investigational product
- Destruction of investigational product
- Track expiration dates and re-test dates
The IDS pharmacies create estimated budgets to cover pharmacy expenses to support research. Study 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, study drug compounding and blinding services, additional equipment or supply costs, and monitoring fees.
The estimated budget will be provided to the study 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.