Investigational Pharmacy Services at MD Anderson Cancer Center
Mark A. Kramer, M.S., R.Ph.
UT MD Anderson Cancer Center
Houston, Texas
The Investigational Pharmacy Service (IPS) at M.D. Anderson
is a collaborative environment that doesn’t necessarily
follow the traditional lines of departmental authorities.
Although the IPS is officially based in the Division of Pharmacy’s
Patient Care Operations, it has strong ties with the Office
of Protocol Research (OPR) which coordinates both the Institutional
Review Board (IRB) and the Clinical Research Committee (CRC).
The OPR also manages the Protocol Data Management System,
coordinates budgeting for funded protocols, distributes protocols
for review and final approved protocols, and handles regulatory
affairs associated with conducting human subject research
for the institution. Due to the wide range of services the
IPS works closely with the OPR and the Division of Pharmacy.
The Department of Investigational Pharmacy Services is responsible
for the administrative management of all investigational drugs
used at the institution. Specific responsibilities include
acquisition, inventory control, and accountability for the
investigational drugs as well as the provision of information
on these drugs and protocols for health professionals.
The protocol approval process at M.D. Anderson provides pharmacists
with a number of opportunities for involvement. The following
are the steps in approval process.
1. Protocol to be submitted to the Department Chair for approval.
Pharmacists may be involved in the protocol development especially
where clinical specialists and physicians have an established
working relationship.
2. Department Chair approves the protocol and it is submitted
to the OPR which disseminates the protocol for review. The
protocol is reviewed by two medical, a nurse, a pharmacist,
a statistician, and radiology reviews
3. The protocol reviews are sent to the principle investigator
(PI) and the OPR and are due one week after protocols are
disseminated for review.
4. The PI has an opportunity to answer the reviews before
presenting the protocol to the CRC.
5. The CRC reviews the protocol and discussed the clinical
and scientific merits of the proposed protocol. Two of the
pharmacists from IPS are voting members of the CRC.
6. After the CRC approves the protocol it is then submitted
to the IRB and reviews it for patient safety and ethical issues.
An IPS pharmacist is a voting member of the IRB.
While the IRB is the only body federally mandated for patient
safety, M.D. Anderson split the review process into a clinical/scientific
review and a patient safety review to better handle the volume
of protocols. Although there are two committees to review
a protocol, some protocols can be approved in as little as
three weeks.
Protocol reviews cover all components of the trial including
objectives, rationale, background, drug information, eligibility,
treatment plan (dose and schedule of medications), statistics,
economic analysis, reimbursement risk analysis, supportive
care recommendations (antiemetics, growth factors), drug availability
and procurement, and economic impact. As part of the review
process, the pharmacist writes up a protocol data sheet for
protocols that include drug therapy. The protocol data sheet
is a summary of the protocol and contains the protocol number,
title, drug name(s), therapeutic class, protocol description
(objectives, study design, treatment course), stability and
storage, availability (supplier, status, how supplied), preparation,
computer entry, administration, notes, and the principle investigator
and the research nurse. These data sheets are used by the
pharmacy department so information is available during preparation
and dispensing. The protocol data sheets are available online
with a printed copy in the IPS office. Clinical pharmacists
with patient care responsibilities sometimes participate in
the review process and are able to provide insight on the
current standard of care and treatment practices and provides
additional credibility with the review.
A drug information form is also written for protocols that
will use a new drug. This information form includes the drug
name, synonyms, therapeutic classification, pharmaceutical
data including dose and dosage forms, stability, storage requirements,
usual dosage range, route of administration, preparation,
known side effects and toxicities, mechanism of action, status
of the study i.e. investigational, phase II, chairman, date,
and references (other protocols that use the particular study
drug.) The form is submitted to the PI and Vice President
for Research Administrations for signature. The forms are
then available on the same network as the protocol data sheets.
Basic information is also programmed into the Protocol Data
Management System so nurses will be able to review drug information
prior to administration of an investigational agent.
The IPS also looks at the financial impact of a protocol
and includes an economic analysis of treatment components
that are not provided both to the institution and the patient.
The analysis looks at the economic impact of the free medication
(how much the pharmaceutical treatment saves the patient),
and a reimbursement risk analysis. The reimbursement risk
analysis is very important for drugs that will be billed and
used beyond package insert guidelines.
Once a protocol is approved, a final version is forwarded
to IPS and study drug is ordered. Meetings are conducted with
the sponsoring company to inspect facilities for proper storage
conditions, record keeping capabilities, staffing and support
requirements. The meeting includes physicians, nurses, pharmacists,
and other healthcare workers. Information is disseminated
to members of the research project and to answer any questions
about the protocol, patient care, or drug preparation. The
IPS pharmacist communicates any necessary information from
the meetings to the pharmacy department.
IPS conducts pharmacy staff in-service meetings once a protocol
is approved and is essential to brief pharmacists on new drugs
or drugs that require special preparation procedures.
IPS is also responsible for handling drug procurement and
distribution. M.D. Anderson uses a computerized inventory
system to track all investigational agents. Once protocols
are activated, information is entered into the computer system
to track inventory. This information includes the PI, protocol
number and name, specific drug information, and patient information.
There is also complete tracking of all drug movement including
drug lot number, protocol number, and patient information.
The system is designed to allow dispensing from multiple pharmacy
satellites. All investigational drugs are received in the
IPS pharmacy and then distributed to the appropriate pharmacy
for dispensing. Proper storage conditions are included in
the computer system to insure proper storage of the agent
and help pharmacy personnel to quickly locate the drug. The
system also keeps a perpetual inventory of every drug by lot
number and protocol and is vital during audits, allowing the
generation of a variety of reports. Federal requirements for
conducting research include the maintenance of accurate records
and complete accountability of all investigational drugs.
The ability to produce reports that demonstrate maintenance
of accurate records and demonstrate accountability of investigational
agents is a prerequisite for conducting research.
The protocols are also reviewed for special requirements
that apply to specific protocols including blinded and randomized
studies. Occasionally this requires special preparation and
handling such as matching placebo or preparing IV fluids with
identical volumes or covering the bag with a protective wrapper
to conceal product differences. Information on the treatment
arm of blinded studies are documented and retained in the
IPS.
The IPS also addresses the compassionate use of investigational
agents and tracks the medications that are used.
The IPS also reviews budget information which includes the
funds required to provide pharmacy services such as salary
and office expenses as well as patient savings. Funded studies
with drug therapy will have a line item for research pharmacy
expenses. The purpose of the charge is to help offset the
personnel expenses associated with managing IPS.
The IPS at M.D. Anderson contributes substantially to positive
patient outcomes. Pharmacists are a member of a collaborative
multidisciplinary team and participate in the entire protocol
process from development to review of the protocol.
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