Why do we have to use the Research Pharmacy Service?The Joint Commission (TJC), FDA, OHSU, and Oregon Board of Pharmacy rules and regulations mandate that all research medications to be overseen by the Research Pharmacy Service. All areas of OHSU Hospitals and Clinics surveyed by TJC are required to involve the Research Pharmacy: "Investigational medications are safely controlled and administered, pharmacy controls the storage, dispensing, labeling and distribution of the investigational medication" (TJC MM 7.40). The Oregon Board of Pharmacy mandates, "all investigational drugs shall be stored in the pharmacy and distributed only from the pharmacy" (OAR 855-041-0130). Institutional requirements also exist. Other medications must also come through the service 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. (Clin 05.11)
We currently manage approximately 220 active protocols. Those areas surveyed by TJC at the OHSU Hospital and Clinics are required to use our service.
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?
Only if an IND filing is required by the FDA.
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?
- Investigational drug ordering
- Drug inventory maintenance
- Drug supply, return, and destruction
- Preparation of investigational medications(s)
- Inpatient and Outpatient study drug dispensing delivery of study medications(s)
- Blinding investigational drug
- Clinical checking
- Patient counseling
- Prepare cost estimates
- Dose adjustments
- Assistance with protocol development
- Billing Services
- Institutional Review Board (IRB) Review
- Drug identification
- Drug information
- Treatment randomization
- Drug interaction checking
- Participation in Initial, Follow-Up, and Close-out sponsor visits
How do I contact RPS when a new study is to be started?Please contact via telephone 503 494-6865, e-mail or campus mail (CR9-4). Initial documents necessary to establish services include eIRB number. Please be sure to also include the estimated start date as well as any other information that may be necessary such as special handling. In cases where a protocol study binder has been provided, be sure to provide copies of inventory tracking and other drug accountability forms, and pharmacy manual preparation information.
What are the requirements for a medication order or prescription?
Medication orders and prescriptions must include the following:
- Protocol name and number
- Patient name
- Patient medical record number
- Patient date of birth
- Patient allergies and intolerance's
- Patient's study and/or randomization number
- Date written
- Patient characteristics as needed (height, weight, etc.)
- Investigational drug name, strength, dose and quantity
- Route and frequency of administration
- Acknowledgement of signed consent and initials
- Name and signature of authorized ordering physician
- Address of writing physician in cases of schedule II outpatient prescriptions
- Number of refills
- Industrial account number
- Contact information
- DEA number of writing physician (for outpatient prescriptions of scheduled medications)
- Expected pick-up date and time
- Medication orders sent by pager or e-mail will not be accepted
- Orders with unacceptable abbreviations will not be accepted
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 telephone or e-mail and an appointment will be made. Monitor visit will be conducted at the Center for Health & Healing (CHH) CHH12 room 12106
When I start my study?
We require one week after we receive the IRB approval and study account numbers.
What do you charge for your services?
Contact Research Pharmacy Services
How can I facilitate the process of going though RPS?
- Send all information when possible
- Make reference to the study and eIRB in all correspondence
- E-mail schedules of subjects visits
- Make sure all orders are complete, signed by an MD, 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 HRC 9D20 (0830 and 1300). Stat deliveries will not have an associated charge, but it is requested that if at all possible, the study coordinator, or a designee will come to the RPS location in CHH, 12th floor, Room 12106. 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. Another option exists to send outpatient prescriptions to the Physician's Pavilion Pharmacy on the main campus.