Location: The Vanderbilt Clinic
Areas of Service: Review of all chemotherapy orders and preparation of all injectable and selected oral chemotherapy for Vanderbilt University Medical Center (VUMC) (all inpatient and outpatient areas), to include investigational cancer related agents.
Staffing: Oncology Pharmacy Manager - Scott Thompson D.Ph, along with staff and clinical pharmacists.
Receipt of Orders: Orders are received via the Computerized Provider Order Entry (CPOE) systems for inpatients and written orders via the fax machine for outpatients. All written inpatient orders are faxed to the Oncology Pharmacy. Written inpatient chemotherapy orders are accepted for patients in locations not served by the CPOE system or during downtime. Written inpatient orders are entered into the CPOE system (as/if time allows) when downtime is over and are processed by the Oncology Pharmacy.
Transcription of Inpatient Orders on Pharmacy Profiles: Orders are transcribed by a technician or pharmacist but must be checked and initialed by a pharmacist. The oncology pharmacist also checks any orders processed by the central pharmacy. A second pharmacist initials and double-checks all orders. If a second pharmacist is not available, a technician double-checks the labels against the physician's order. The next day, another pharmacist double-checks any new inpatient orders not previously double checked.
Patient files are maintained in the Oncology Pharmacy. Copies of the profiles and associated orders are kept for 6 months after the last treatment.
Professional Review of the Order: The pharmacist reviews each chemotherapy order in relation to all known factors concerning the patient. When the profile and order is initialed and processed in the computer, the pharmacist assumes responsibility for that order. A second tech or pharmacist double-checks the order after computer order entry is complete (preferably a pharmacist). For inpatient orders, a second pharmacist double-checks the orders and computer order entry. If the order was processed the day before when no second pharmacist was available, then the order is double-checked the next day.
If questions arise, the physician originating the order is contacted. It may be appropriate to contact the case manager or the physician's nurse for clarification of some issues. The oncology/hematology fellow on-call is contacted in the evening or at night for their respective patients.
Orders are verified with a protocol, standard regimen or standard dosing guidelines. Doses are compared to the maximum dose chart, if greater (and not being used as part of an investigational protocol) the dose is not dispensed unless okayed by the attending physician. Requesting a reference for the dose is appropriate.
A pharmacist reviews patient laboratory information including, current CBC/diff, metabolic panel, and routine chemistries. Any values out of range are discussed with the fellow or attending. A notation is made on the patient profile indicating this has been done (i.e., Dr. John Doe okayed giving chemotherapy with the sCr 1.8). The physician is responsible for entering an order into the CPOE system indicating he/she has reviewed the lab values and either approves or disapproves the start of the chemotherapy. This is processed as an order by the Oncology Pharmacy staff and the label is placed on the profile.
Most chemotherapy is hand delivered to the appropriate clinic or inpatient unit. Hand delivery of chemotherapy occurs throughout the day as necessary.
Priority is given to the preparation and delivery of outpatient medications. Medications for these orders are provided as quickly as possible, usually within 15-30 minutes, depending on preparation time and other workload. Inpatient orders are provided within 1 hour of receipt or at the specified time due (i.e., begin 6hr after hydration started).
All inpatient chemotherapy is delivered to a nurse on the unit, who signs to indicate all medications were received and when they were received. If a nurse is not available, the technician or pharmacist delivering the medications signs the card and indicates where and when the medications were delivered. Medications are only delivered for inpatient chemotherapy after an order is put in the CPOE system indicating that all labs have been reviewed and the chemotherapy may be given as ordered.
After hours preparation is kept to a minimum.
Each dose prepared is documented in the chemotherapy prep database and on the investigational drug accountability record.
All investigational drug accountability records are maintained by the Oncology Pharmacy and may not be transferred to another department. If the sponsor requires the originals, a copy is maintained in the Oncology Pharmacy. A copy is provided to other appropriate parties if necessary. Documentation is maintained for 15 years after the completion of the study.
Preparation of Chemotherapy Medications:
All chemotherapy medications are logged in the chemotherapy preparation database. The prep date, name of the patient, patient type (adult inpatient AIP, adult outpatient AOP, ped inpatient PIP, ped outpatient POP), due date, drug, dose, manufacturer, manufacturer expiration, number of doses made, pills dispensed (if applicable), investigation drug (if applicable), protocol ID, and any comments are entered.
All chemotherapy is prepared and sent to the clinic or nursing unit in a form that is ready to be administered. Chemotherapy is not prepared by the nursing or physician staff.
All injectable chemotherapy is prepared in the biological safety cabinet (BSC, vertical flow hood).
All personnel are trained and certified prior to working in the BSC. Yearly reassessment is required prior to Performance Evaluations.
Only approved aseptic procedures are used.
When monthly decontamination is performed on the hoods, employees wear the respirator mask they were fitted with by Institutional Safety.
Gloves, gown, hair nets, masks, and shoe covers are required when preparing any medication in the BSC. Double gloving is required, changing gloves at least every hour. Latex free gloves are worn closest to the skin and either latex free chemotherapy or surgical gloves on top. Hands are washed after gloving to remove any powder from the exterior of the gloves. Gloves are changed and hands washed immediately after obvious contamination.
OSHA guidelines are followed for safe handling of antineoplastic cytotoxic, mutagenic agents. The most current ASHP technical assistance bulletin on handling of cytotoxic and hazardous drugs is also required reading on an annual basis by Oncology Pharmacy staff.
Drug Information: The Oncology Pharmacy is a source of drug information for nursing / physician / pharmacy staff. The BMT and ONC Clinical pharmacists facilitate drug information services to their respective teams.
All Cancer Center protocols are reviewed by a pharmacist for accuracy and appropriateness. Errors or concerns with drug related information in the protocol are communicated to the Principal Investigator for the trial.
Drug information in-services are provided to the nursing staff and other appropriate personnel periodically.