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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.