1. The pharmacist: at the heart of the research protocols Marie-Pascale Guay, B. Pharm, M. Sc. Julie Roy, B.Pharm, PhD. Jewish General Hospital November 10, 2009 “Poison is in everything, and no thing is without poison. The dosage makes it either a poison or a remedy.”Paracelsus

2. The role of the pharmacist Section 17. The practice of pharmacy consists in determining and ensuring the proper use of medications, particularly to identify and prevent pharmacotherapeutic problems, and in preparing, storing and delivering medications in order to maintain or restore health (…).

3. The five pillars of the profession 1. Dispensing  “Right drug, right patient”  Determining Rx administration methods, modes and schedules  Validating prescriptions  Checking compatibility of medications  Updating patient records  Checking content of prepared medications

4. The five pillars of the profession (cont.) 2.Pharmaceutical care  Evaluating the pharmacotherapy  Developing care plans and determining pharmacotherapeutic objectives  Selecting and initiating medication and adjusting the treatment (Bill 90)  Optimizing a patient’s pharmaceutical care and ensuring the safety of it  Participating in medical rounds and interdisciplinary teams

5. 3.Management  Organizing and supervising the work of technical assistants  Developing and applying mechanisms for optimal drug usage  Controlling the use of non formulary medication  Participating in CMDP committees  Preparing the pharmacoeconomic submission to assist in the formulary decision-making process The five pillars of the profession (cont.)

6. 4.Education and teaching  Educating hospitalized or ambulatory patients about their drug therapy  Teaching pharmacy students  Teaching peers  Organizing professional development activities The five pillars of the profession (cont.)

7. 5.Research Main pharmacy: 72 active studies in 2009 as of now Monitoring visits: 110 in 2008 Patients: 236 in 2008 PI: 19 in 2008 Oncology: More than 200 active studies in 2008 Audits: 5 in 2009 Monitoring visits: 145 in 2009 Drug shipments received: 230 in 2009 Requisition from others hospitals: 307 in 2009 The five pillars of the profession (cont.)

8. Step 1: submission to REC The JGH prescribing guidelines, approved by the MEC and by the P&T Committee, outline the fact that study medications must be dispensed by the Pharmacy Department in order to comply with la loi sur la santé et les services sociaux. To prevent burden: Meet with a research pharmacist to discuss the protocol and its feasibility

9. STEP 2: NOL from pharmacy Research pharmacists and the chief of the department will evaluate the compliance with the protocol’s requirements - - Equipment needed (fridge, freezer, thermometers etc.) - - Standard of care in practice vs protocol - - Ressources needed - - Time of the preparation and particularity of the drug (light, temperature, stability etc) - - Availability of the research staff (night, weekends)

10. Step 3: Site initiation visit (SIV) with sponsor   When a protocol is approved, the study will usually only be activated after a SIV where the local staff will be trained and where issues can be ironed out.   Since many sponsors require to meet with the pharmacy, an appointment is mandatory.   It’s the place where we will share SOPs, review the study requirements, do a pharmacy visit.   The sponsor will verify the qualification of the site and personnel.   Last minute questions and an introduction of the contact personal in case of an emergency.

11. Step 4: Preparation of the protocol To insure patient safety and prevent protocol deviations, pharmacy will prepare the following: Medication entry in medipharm (I.T. system) Activation of IVRS codes Study summary Study worksheet SOP Drug and patient log sheets Temperature log sheets Equipment or medication ordering if needed

12. Step 5: Study begins!   When the screening of the patient starts, please advise the pharmacy   To prepare, we need a valid prescription Sign by PI or sub-PI Unit-number of the patient Kit number when needed Protocol number or name Cohort that the patient will be randomized to if needed When the treatment is needed

13. Step 6: Dispensing of the study drug  Ensuring proper sterile techniques for parental drugs  Adjusting therapy  Ensuring double-blinding of the studies   Patient counselling   Support to nurses in the administration of new drugs   Reordering of study drugs and maintaining sufficent inventory of study drug   Destruction of study medication according to SOP and/or sponsor

14. Step 7: Documentation of the study The pharmacy department has the responsibility: To maintain the drug accountability (expiry, lot number, recall…) To insure the integrity of the study drug To monitor the patient’s returns To monitor and document the drug destruction To document any protocol deviation

15. Step 8: monitoring visit Appointment with the pharmacy mandatoryWhy? To maintain confidentiality between sponsors In order to have all the documents ready and up to date To assure our availability to answer queries

16. Step 9: Audit   A study can be audited by the REC, the sponsor or regulary entities (Health Canada, FDA, NSABP, NCIC, NCI, EMEA etc.   They have the power to close the center if we are not in compliance with regulation and the GCP   We need to be transparent, open-minded and willing to make some changes

17. Step 10: close out visit   All medication left are destroyed on site or returned to the sponsor   Logs are completed and filed in the study binder   Study binders are sent to the PI and filed up to 25 years   Invoices for the pharmacy’s services are sent to the PI

18. Pharmacy fees The pharmacy fees vary: 1. 1. Sponsored study 2. 2. Investigator’s initiated study 3. 3. Extension studies   The pharmacy fees serve to cover the extra work, staff, equipment, space needed   There is no conflict of interest for the research pharmacist

20. Contact information General research in the hospital: Julie Roy, pharmacist ext.: 5295 Michelle Craig, research assistant ext.: 5023 Oncology research: Marie-Pascale Guay, pharmacist ext.: 5940 Carolyn Hubbard, research assitant ext.:2053 Chief of pharmacy: Eva Cohen ext.: 8217