Download The pharmacist

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
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 (…).
The five pillars of the profession
1. Dispensing
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“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
The five pillars of the profession (cont.)
2. Pharmaceutical care
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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
The five pillars of the profession (cont.)
3.
Management
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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.)
4.
Education and teaching
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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.)
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
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
STEP 2: NOL from pharmacy
Research pharmacists and the chief of the
department will evaluate the compliance with
the protocol’s requirements
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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)
Step 3: Site initiation visit (SIV) with
sponsor
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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.
Step 4: Preparation of the protocol
To insure patient safety and prevent protocol
deviations, pharmacy will prepare the
following:
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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
Step 5: Study begins!
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When the screening of the patient starts,
please advise the pharmacy
 To prepare, we need a valid prescription
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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
Step 6: Dispensing of the study drug
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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
Step 7: Documentation of the study
The pharmacy department has the
responsibility:
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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
Step 8: monitoring visit
Appointment with the pharmacy
mandatory Why?
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To maintain confidentiality between sponsors
In order to have all the documents ready and
up to date
To assure our availability to answer queries
Step 9: Audit
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A study can be audited by the REC, the
sponsor or regulary entities (Health Canada,
FDA, NSABP, NCIC, NCI, EMEA etc.
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They have the power to close the center if we
are not in compliance with regulation and the
GCP
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We need to be transparent, open-minded and
willing to make some changes
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
Pharmacy fees
The pharmacy fees vary:
1. Sponsored study
2. Investigator’s initiated study
3. Extension studies
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The pharmacy fees serve to cover the extra
work, staff, equipment, space needed
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There is no conflict of interest for the
research pharmacist
INSCRIPTION FEE
AMOUNT
START UP FEE:
$750.00
Start up fee for extension studies
$250.00
ADMINISTRATIVE FEE
PER PATIENT FEE
Dispensing Only (oral/iv medication)
$30.00 per preparation
Minimal Sterile Preparation
$40.00 per preparation
Complicated Sterile Preparation
$60.00 per preparation
MAXIMUM:
ADDITIONAL FEES
Pharmacist recalled to the hospital
Purchase of special equipment or supplies
eg; IV bag / tubing, refrigerator,
temperature monitors, etc.
$750.00 per patient
AMOUNT
-3 hrs per recall
SERVICE DESCRIPTION
-Review of protocol / Summary preparation
-Evaluation of pharmacy service requirements
-Site initiation visit with sponsor
-Setting up the pharmacy as per sponsor’s
request
-Training of personnel to meet protocol
specifications
SERVICE DESCRIPTION
Drug Handling
-Medication ordering / Storage / Labeling
-Keeping logs of storage temperature
-Randomization
-Drug dispensing / Drug returns
-Drug accountability
-Meet with study sponsors or auditors
Prescription Validation
-Medication history
-Dosage calculations
-Analysis of patient profile
-Medication interactions
-Patient counseling
SERVICE DESCRIPTION
- On Call services, if required (will be charged on
a usage basis)
-As needed to meet the protocol requirements
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