Why do we have to use the Research Pharmacy Service? JCAHO, 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 JCAHO 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” (JCAHO MM 7.40). 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 200 active protocols.  Those areas surveyed by JCAHO at the OHSU Hospital and Clinics are required to use our service.  

What are your hours? Research Pharmacy Services (RPS) is open Monday through 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?

• Drug ordering

• Drug inventory maintenance

• Research drug supply return

• Research drug supply destruction

• Compounding

• Preparation of study medication(s)

• Dispensing of study medication(s)

• Delivery of study medication(s)

• Blinding

• Treatment randomization

• Clinical checking

• Patient Counseling

How do I contact RPS when a new study is to be started? Please contact us via telephone, email or campus mail. Initial documents necessary to establish service include investigator’s brochure, study protocol, a copy of the OHSU IRB approved informed consent form and the IRB approval letter. Please be sure to also specify 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, please be sure to provide copies of inventory tracking and other drug accountability and preparation information and forms.

What are the requirements for a medication order or prescription? Medication orders and prescriptions must include the following:

• ‘Research Protocol’

• Patient name

• Patient Medical Record Number

• Patient date of birth

• Patient allergies and intolerances

• Patient’s study/randomization number

• Date written

• Patient characteristics as needed (height, weight, etc.)

• Protocol number/name

• Drug name, strength, dose and quantity

• Route and frequency of administration

• Acknowledgement of signed informed consent and initials

• Name and signature of authorized ordering physician

• Address of writing physician in cases of schedule II outpatient prescriptions.

• Number of refills

• Alias/Industrial account number

• Contact information

• DEA number of writing physician (for outpatient prescriptions of scheduled medications)

• Expected pickup date/time

• Medication orders sent by pager or email will not be accepted

• Orders with unacceptable abbreviations will not be accepted (see list of unapproved abbreviations). 

How do I get my medication delivered from the CHH Campus? We have several options for medication delivery or pick-up. We have two designated deliveries per day via courier service from RPS located in CHH 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.

Do investigational devices have to come through the Research Pharmacy? Only if an IND filing is required by the FDA.

How do I schedule an appointment for a monitor visit? Appointments for monitor visits are to be scheduled at least 2-3 business days prior to the monitor visit. Please contact RPS via telephone or email and an appointment will be made.  Monitor visits will be conducted at CHH 12 room 12106. 

When can I start my study? We require 1 week after we receive the IRB approved protocol, investigator's brochure, study drug and study account numbers.

What do you charge for your services? See Research Pharmacy Services Fee Structure

How can I help facilitate the process of going through the RPS?

• Send all information when possible
• Make reference to the study in all correspondence
• Send schedules of patient visits
• Make sure all orders are complete and received in advance

 

What is your contact information?

Main Campus: Shipping and Receiving
Oregon Health & Science University
Research Pharmacy Services
3181 SW Sam Jackson Park Road
Mail Code CR 9-4
Portland, OR 97239