Download What is Pharmacy’s Role in Investigational Studies

What is Pharmacy’s Role in
Investigational Studies?
Ruth LaCasse, RPh
Investigational Pharmacist
Investigational Drug Service
April 14, 2009
University of Connecticut Health Center
Farmington, Connecticut
How Can We Help You?
Objectives
 The purpose of John Dempsey Hospital (JDH)
Investigational Drug Service (IDS)
 Policies for JDH Investigational Drug Service
 The services we can provide to the Investigator and
support team
 Billing overview for JDH Investigational Drug Service
 Information JDH Investigational Drug Service requires
prior to study initiation
 Common Questions JDH Investigational Drug Service is
asked
 Contact Information
Purpose
• JDH has an Investigational Drug Service
(IDS) for the following reasons:
– To provide safe, effective, and responsible
handling of investigational medication
– To provide assistance and support to the
Investigator & Support team
– IDS assures compliance with all federal (FDA,
NIH), state, JCAHO (Standard MM.7.40), and
IRB/HSPO regulations concerning
investigational medication
Policies
• HSPO/IRB Administrative Policies
• JDH Administrative/Nursing/Pharmacy
Policies
– Medication Administration: Investigational
Drug: Inpatient Utilization of
• This hospital policy can be accessed through the
nursing website under Nursing Practice Manual
http://nursing.uchc.edu/
Services
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Clinical study dose verification
– (prior to IRB approval)
Randomization
Drug Accountability
(Ordering, Maintaining appropriate stock, checking for expired drug,
inventory control)
Drug Storage/ Temperature Monitoring
(Storage in area with limited access)
– Refrigerator
– - 20 ºC and - 80 ºC Freezers
Drug Destruction if unable to return to sponsor
Oral Medications
Matched Placebo if needed
Intravenous Medications
Inpatient/Outpatient
Physician Orders
Billing for Pharmacy Services
Maintenance of Discontinued Study Files
Staff Education and Assistance
Billing
Although there is a standard billing structure, financial arrangements are negotiated to
meet the specifications of each individual project.
• Estimated Charge Worksheet
– Completed prior to study initiation
– http://octr.uchc.edu/forms/
– Study Set-Up and Close-Out Fees ($600 initial fee),
Dispensing Costs (Varies), Drug and Supply Costs
(Varies), Off-hour fees, and Study Maintenance ($300
per subsequent year)
• Monthly Charge Worksheet
– Investigational Study charges are billed monthly via
transfer vouchers. Please contact us with appropriate
FRS coding and contact information.
Protocol Requirements
• Prior to initiation of a study, JDH Investigational Drug
Service requires:
– A copy of the current protocol.
• Ruth LaCasse, RPh is responsible for IRB Pharmacy approval
• For any future changes or amendments, please be sure to forward
these to pharmacy as well.
– A copy of the Investigator’s Brochure if the medication is not
commercially available
– Prescription orders or CPOE orders have been done
– Billing charges have been agreed upon
• Ruth LaCasse, RPh is responsible for billing charges
– If needed, a study initiation meeting is highly encouraged to
discuss workflow.
Question One
Why can’t we re-use Medication returned to the pharmacy for cost savings?
Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (CPG 7132.09)
POLICY:
A pharmacist should not return drugs products to his stock once they have been out of his possession.
It could be a dangerous practice for pharmacists to accept and return to stock the unused portions
of prescriptions that are returned by patrons, because he would no longer have any assurance of
the strength, quality, purity or identity of the articles.
Many state boards of pharmacy have issued regulations specifically forbidding the practice. We
endorse the actions of these State boards as being in the interest of public health.
The pharmacist or doctor dispensing a drug is legally responsible for all hazards of contamination or
adulteration that may arise, should he mix returned portions of drugs to his shelf stocks. Some of
our investigations in the past have shown that drugs returned by patrons and subsequently resold
by the pharmacist were responsible for injuries.
Issued: 10/1/80
http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-300.html
Per FDA Guidelines and State Regulations, we cannot re-use medications once they are dispensed
for patient safety.I cannot verify storage conditions were met when the medication has been
stored outside the JDH Investigational Pharmacy.
Question Two
Does JDH Investigational Drug Service store Investigational Medications with
hospital medication supply?
• NO! We store all of our medication
separately from hospital supply medication
All of our room temperature medication (except for 24 hour
studies) are stored in locked cabinets that only the Investigational
Technician and Investigational Pharmacist can access. If an
emergency, a staff pharmacist would be able to get keys for access.
All of our refrigerated and freezer medication are stored in
devices clearly indicated for investigational use only.
Question Three
How does JDH Investigational Drug Service monitor the temperature for all
investigational products in the pharmacy?
• Room Temperature
- Daily Manually Recorded Temperatures
We record once daily a random temperature with the date,
time, and initials of the person taking the recording
• Investigational ONLY Refrigerator, -80 Freezer, and -20 Freezer
- Daily Manually Recorded Temperatures
- Electronic Alarm System
JDH Pharmacy will be notified by the operator via the 24 hour
pharmacy pager (825-3945) that there has been a reading out
of range for more than 30 minutes. JDH Pharmacy could move
investigational stock to hospital storage. JDH Pharmacy will
then contact facilities.
Question Four
What do you make your placebo oral medications with?
• Our most common compounding procedure is to take an
empty gelatin capsule and fill it with an inert substance.
– Empty Gelatin Capsules come in a variety of colors and sizes
(Size 000 to Size 5). We will most often pick an opaque color in
order to maintain the blind. Most of our capsules come from
Gallipot Compounding Supply or Capsugel.
• www.gallipot.com
• www.capsugel.com
– We use either Lactose powder or Starch as an inert substance to
fill the capsule. JDH Investigational Pharmacy recommends to
use starch for placebo capsules in patients with Lactose
Intolerance.
Does the lactose content of medications pose a problem in patients who
are lactose intolerant? Jan 28, 2008 Drug Topics
Question Five
So- How do you blind oral active medication if have a matching
placebo?
• Over-encapsulation is our preferred method. If
necessary, we will also fill with inert substance if
capsule rattles. Disadvantages include the possibility of
the subject opening the capsule.
– See Example Below:
Question Six
How do we dispose of Investigational Medication?
• Any Investigational Medication is destroyed at
JDH Investigational Drug Service in compliance
with state and federal regulations.
– IDS contacts Research Safety when we have
Investigational Medication ready for disposal. They
transport the medication in a red biological waste
bucket. It is then given to Clean Harbors for
incineration.
– IDS is more than willing to take any medication from
any clinics performing studies if they are unable to
send back to the sponsor. DO NOT FLUSH.
– Any medication that is returned to us is counted and
recorded before disposal.
Question Seven
Why do I need a prescription to dispense a product? What
is the definition of dispense?
• A prescription is necessary in order to dispense a product. A
prescription drug should only be given out with written
instructions from a licensed healthcare provider. See
definitions below from the Connecticut Comprehensive Drug
Laws:
– “Prescription” means a lawful order of a prescribing practitioner
transmitted either orally, in writing or by electronic means for a
drug or device for a specific patient
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“Dispense” means those acts of processing a drug or device for delivery or for
administration for a patient pursuant to a prescription consisting of: (A) comparing the
directions on the label with the directions on the prescription to determine accuracy; (B) the
selection of the drug or device from stock to fill the prescription; (C) the counting, measuring,
compounding or preparation of the drug or device; (D) the placing of the drug or device in the
proper container; (E) the affixing of the label to the container and; (F) the addition to a written
prescription of any required notations. “Dispense” does not include the acts of delivering a
drug or device to a patient or of administering the drug or device to the patient.
http://www.ct.gov/dcp/cwp/view.asp?a=1620&Q=275966&PM=1&dcpNav=|&dcpNav_GID=1541&dcpNav=|&dcpNav_GID=1541
Question Eight
Why do we label any medication to be dispensed?
• http://www.ismp.org/Newsletters/acutecare/articles/20071101.asp
– ISMP (The Institute for Safe Medication Practices) reported that current
packaging by sponsors can lead to medication errors.
• Drug Names
• Drug Labels
• Drug Packaging
• Tablet Markings
• Expiration Dates
• Space Limitations
ISMP Recommends that the pharmacy should provide a supplemental label
that meets all standards for prescription dispensing that are applicable in the
state.
http://www.ct.gov/dcp/cwp/view.asp?a=1620&Q=275966&PM=1&dcpNav=|&dcpNav_GID=1541
Question Nine
How do you randomize subjects?
• In order to reduce bias, we have a few
ways to randomize subjects
– URN Randomization
• Method of randomly assigning subjects to groups
– www.randomization.com
– Random Allocation Software
Question Ten
Do we mark up the price of any medication acquired for an
investigational study?
• NO!
– Investigators are charged actual drug cost for
any studies that require pharmacy to
purchase medication
• We obtain supply from Cardinal wholesaler
• For billing purposes – pharmacy must recoup
medication cost
Question Eleven
Help! I have a study that will be used inpatient and will
starting shortly – What do I do?
• Contact Ruth LaCasse, RPh
– I can help provide teaching information for
nursing/pharmacists
– I am unable to program medications into
Computerized Physician Order Entry (CPOE),
but I will contact appropriate help in
Information Technology (IT) Services.
• Currently, the hospital is nearly completely on
CPOE (exceptions include NICU, OB, L+D,
Psych1 and Psych3)
Question Twelve
How long do you store records?
• Currently, we have been storing records
indefinitely
– Most recently closed studies (within the past
year are kept on site)
– Older studies at stored at Iron Mountain
Helpful Websites and References
• Below is a list of websites and references that I have found helpful
www.drugsimple.com
(Access nearly every package insert available)
www.globalrph.com
(Pharmacist driven website with useful calculators and information)
LexiComp Online
(Accessible through UCHC Library Database)
www.ashp.org
(American Society of Health-System Pharmacists.
They offer a email list serve just for investigational pharmacists. I am
able to reach other sites to find out what advice they may offer.)
Contact Information
Monday  Friday
7:30am-4pm
 Investigational Pharmacist
 Ruth LaCasse RPh
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[email protected]
Investigational Technician(s)
 Margaret ( Meg ) Philippi [email protected]
 Francis (Fran) Roman has retired
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Pharmacy is on Second Floor C: 2016
Mail Code: 2205
Technician Phone: (860) 679-8707 or
Pharmacist Phone: (860) 679-2085
Fax: (860) 679-1231
 Pager for Research Technician: (860) 825-7583
 Pager for Pharmacist: (860) 473-2217
 Pager for Hospital Pharmacist (After Hours): (860) 825-3945
Mailing Address
Dr. Principal Investigator
C/O Ruth LaCasse RPh
University of Connecticut Health Center
Department of Pharmacy
263 Farmington Avenue
Farmington, CT 06030-2205
Any Questions?
Thank You.