Why do we have to use the Research Pharmacy Service?
The FDA, OHSU, Det Norske Veritas (DNV-GL) and Oregon Board of Pharmacy rules and regulations mandate that all research medications to be overseen by a pharmacy. Research in all areas of OHSU Hospitals and Clinics surveyed by DNV-GL are required to involve Research Pharmacy Services (RPS): Investigational medications are safely controlled and administered, pharmacy controls the storage, dispensing, labeling and distribution of the investigational medication. The Oregon Board of Pharmacy mandates, "all investigational drugs shall be stored in the pharmacy and distributed only from the pharmacy" (OAR 855-041-6260). Institutional requirements also exist. Other medications must also come through RPS if they are FDA approved medications to be billed to the industrial account number or over the counter medications that are to be repackaged or relabeled.
When is an Investigational New Drug (IND) Required?
The product is investigational (has not been cleared for marketing by the FDA), or the investigation of the product (even if cleared for marketing) poses a significantly increased risk or decreased acceptability of risk.
Do investigational devices have to come through the Research Pharmacy?
What are our hours?
Research Pharmacy Services (RPS) is open Monday-Friday from 8:00am to 4:30pm. A research pharmacist is on call 24hrs a day, 7 days a week, including holidays.
What types of services are provided?
- Research medication inventory maintenance
- Research medication supply management, drug return storage, and drug destruction
- Research medication preparation, dispensing, and compounding
- Treatment randomization and research medication billing
- Preparation of cost estimates
- Assistance with protocol development
- Participation in Initial, Follow-Up, and Close-out sponsor visits
How do I contact RPS when a new study is to be started?
RPS is notified of new studies when you send your study for clinical services approval through eCRIS. You may also contact RPS via telephone 503 494-6865, e-mail or campus mail (CR9-4). Whenever contacting RPS, please include the eIRB number. Initial documents necessary to establish services include: protocol, investigational brochure and pharmacy manual (if applicable). Information which will facilitate establishing services include: the estimated start date, special randomization procedures, special handling and any other specific study requirements.
What are the requirements for a medication order or prescription?
The following information is needed for every order:
- IRB number
- Subject number
- Cohort Assignment
All research medication orders are required to be electronic. Include expected pick-up date and time in the order. Medication orders sent by pager, e-mail or fax will not be accepted (all orders electronically placed in EPIC).
How do I schedule an appointment for a monitor visit?
Appointments for monitor appointments are to be scheduled at least 2-3 business days prior to the monitor visit. Please contact RPS via e-mail and an appointment will be made. Monitor visit will be conducted at the Center for Health & Healing (CHH) CHH12 room 12106. Four monitors will be accommodated each day for 1 hour appointments. To ensure an opening is available, contact RPS at least 6 weeks in advance to secure the time slot.
What do you charge for your services?
RPS Fees will be assessed as described in the OHSU healthcare policy, Research Pharmacy Services Fee Structure (HC-PHR-159-POL).
How can I facilitate the process of going though RPS?
Send all information regarding new studies and new patients to firstname.lastname@example.org. Reference the IRB number in all correspondence. Make sure all orders are complete, signed by an MD or authorized prescriber, and received in advance.
How do I get my medication delivered from the Center for Health & Healing (CHH)?
We have several options for medication delivery or pick-up. We have two designated deliveries per a day via courier from RPS to the Central Pharmacy in UHS 4C (0830 and 1200) or Physician's Pavilion Pharmacy. It is requested that the study coordinator, or a designee, come to the RPS location in CHH, 12th floor, Room 12106 to pick up medications. The Tram is a convenient and quick way to come to our location. Arrangements can be made on a case by case basis for RPS staff to make the medication delivery. Inpatient medications will be delivered to the Central Pharmacy in the hospital.