Q&A Sylvia Bartel, MPH, RPh,
Vice President of pharmacy and clinical support services,
Dana-Farber Cancer Institute
PP&P: What is the value of a robust chemotherapy validation process?
Sylvia Bartel: As with all medication preparation, final product accuracy and minimization of contamination risk are paramount. In addition, because chemotherapy is a hazardous product, staff safety during the preparation and administration processes also must be emphasized.
Developing and implementing a comprehensive chemotherapy handling process is critical to ensuring medication and employee safety. Therefore, Dana-Farber Cancer Institute utilizes multiple checks to verify accurate chemotherapy preparation. After the pharmacist confirms the order, the label prints prompting the technician to assemble the required components—for example, some medications require filtering or special tubing. At the biological safety cabinet, the technician accesses the patient’s data in the computer and then scans the medication bar code label to ensure the correct medication and quantity has been selected for the right patient. After the technician draws up the drug and prior to injecting it into an IV bag, he or she uses a marker to specify the volume on the syringe for the pharmacist’s double check. The medication is then prepared, labeled, and placed in a sealed plastic bag for the pharmacist to review; the vials and syringe also are included in a separate bag. During the double check, the pharmacist can determine whether the technician performed an override or received a warning during the bar code scanning process. The pharmacist also can visually view the empty vials and syringe to verify the medication was prepared as intended. If the technician did not use all of the medication, he or she must include the remaining drug in the plastic bag so the pharmacist can perform a visual inspection of the leftover medication.
Within the next year we anticipate enhancing our current process by adding digital photography of the various steps in the preparation process. This will allow a visual image of the vial, syringe volume, and final product to be viewed by a pharmacist during final product verification, as well as function as an audit tool.
PP&P: What is the process for developing a comprehensive policy and procedure (P&P) for chemotherapy preparation?
Bartel: Comprehensive P&Ps should not only be developed and implemented to enable safe hazardous medication preparation, but steps also must be taken to ensure these P&Ps are adhered to consistently. Instituting P&Ps for chemotherapy preparation that are all-inclusive requires a multidisciplinary effort by pharmacy, safety, infection control, nursing, and occupational health. Dana-Farber’s chemotherapy preparation P&P details the correct procedure for pharmacy personnel to follow when preparing a hazardous drug. Some of the items it addresses include risk level determination of the sterile product, training and competencies required, preparing the sterile environment, and compounding accuracy checks. P&Ps that are written cogently to invoke a tone that reflects the serious nature of hazardous drug preparation will best ensure technicians preparing these medications adhere to the policy in a fastidious manner. Important elements to integrate in P&Ps include:
P&Ps should be easily accessible for all employees handling hazardous drugs and our P&Ps may be accessed online from any hospital workstation. Since the P&Ps are multidisciplinary for both pharmacy and nursing, we include copies in our patient care and administrative policy manual.
Because our facility is a cancer hospital, chemotherapy is one of the main products used in high volume. Consequently, technicians are well versed in correct chemotherapy preparation P&Ps. If chemotherapy is just one of many service lines at your facility, it is even more crucial to specifically delineate all required steps in P&Ps, as staff may be less familiar with procedures they undertake less frequently.
PP&P: What is the process for determining which concentrations can be standardized and developing reconstitution guidelines for each concentration?
Bartel: Standardizing chemotherapy concentrations wherever possible is prudent to decrease the possibility of calculation mistakes and ensure consistency. Determining which concentrations should be standardized is largely drug-dependent, so it is important to research the medications and dosages on formulary and identify what literature supports the concentration ranges used, in addition to any information provided by the approved manufacturers.
We utilize several resources to develop reconstitution guidelines, including FDA-approved package inserts for each drug, peer-reviewed literature, information from ASHP, and USP <797> stability guidelines. In the guidelines we list the medication, the diluent, whether there is a particular manufactured IV bag we have to use (ie, an empty bag versus one that already has a solution in it), required tubings, filters, infusion rate information, and any special instructions for the pharmacist or technician (see Chemotherapy Reconstitution Chart).
PP&P: What training programs and competency assessments should be required for staff handling hazardous medications?
Bartel: Providing various types of training to staff and requiring both written testing and actual visual demonstration when evaluating staff proficiency will best ensure staff with different learning styles are provided information in a format that suits their needs. Our facility requires orientation training for new staff, as well as yearly training thereafter. In addition, regular direct observation of staff during the handling of these products is performed. Our hands-on training involves a pharmacist or experienced technician demonstrating proper technique for handling and preparing hazardous drugs with the technician repeating the correct procedure. After the initial competency evaluation, staff compliance with P&Ps is assessed yearly using multiple methods, including online education, exams, direct observation, and growth-media testing to ensure continued compliance. In addition, we utilize video training from ASHP that delineates how to safely handle hazardous medications and properly use safety equipment.
PP&P: How do you manage staff absences without compromising chemotherapy preparation quality?
Bartel: As chemotherapy is our facility’s primary service line, much of our staff has been trained and is competent to handle and prepare hazardous drugs. Beyond this, all of our technicians are nationally certified and are sufficiently experienced in sterile technique and compounding. Dana-Farber has one main campus and two satellite locations, which are within a 45- to 60-minute radius of the main facility. Our strategy to manage staff absences in all three locations is to cross-train employees so that in the event of an unexpected staff absence, we have a sufficient number of trained staff to fill in for any location.
For hospitals with multiple service lines, ensuring adequate coverage during unexpected staff absences can be more difficult. Typically, the number of staff that has received appropriate training in chemotherapy handling and preparation is limited. Thus, much of this challenge can be offset by working closely with oncology providers when building staff schedules. Evaluate the number of patients scheduled during any expected staff absences and determine the volume of chemotherapy that will be required to provide appropriate staffing.
Sylvia Bartel, MPH, RPh, is vice president of pharmacy and clinical support services at Dana-Farber Cancer Institute in Boston, Massachusetts. She received her BS in pharmacy at the University of Wisconsin and an MS in public health from Northeastern University. Sylvia’s professional interests include oncology and therapeutic guideline development.
FROM NIOSH: How to Generate Your Own List of Hazardous Drugs1
The OSHA hazard communication standard [29 CFR 1910.1200] requires employers to develop a hazard communication program appropriate for their unique workplace. An essential part of the program is the identification of all hazardous drugs a worker may encounter in the facility. Compliance with the OSHA hazard communication standard entails (1) evaluating whether these drugs meet one or more of the criteria for defining hazardous drugs and (2) posting a list of the hazardous drugs to ensure worker safety. Institutions may wish to compare their lists to the sample listing on the NIOSH Web site (http://www.cdc.gov/niosh/topics/hazdrug/).
It is not likely that every health care provider or facility will use all drugs that have received US FDA approval, and the OSHA hazard communication standard does not mandate evaluation of every marketed drug. Instead, compliance requires practice-specific assessments for drugs used at any one time by a facility. However, hazardous drug evaluation is a continual process. Local hazard communication programs should provide for assessment of new drugs as they enter the marketplace, and when appropriate, reassessment of their presence on hazardous drug lists as toxicological data become available to support recategorization. Toxicological data are often incomplete or unavailable for investigational drugs. However, if the mechanism of action suggests that there may be a concern, it is prudent to handle them as hazardous drugs until adequate information becomes available to exclude them.
With the increased availability of oral antineoplastic and other hazardous drugs, additional precautions are required in order to prevent worker exposure to these formulations. Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (for example, coated tablets or capsules—solid, intact medications that are administered to patients without modifying the formulation). Uncoated tablets may present a risk of exposure from dust by skin contact and/or inhalation when the tablets are counted. However, they may pose a risk if solid drug formulations are altered, such as by crushing tablets or making solutions from them outside a ventilated cabinet.
All hazardous drugs, regardless of the formulation, should be labeled as such to prevent improper handling. Tablet and capsule forms of hazardous drugs should not be placed in automated counting machines, which subject them to stress and may introduce powdered contaminants into the work area. Counting and pouring of hazardous drugs should be done carefully, and clean equipment should be dedicated for use of these drugs. Crushing tablets or opening capsules should be avoided and liquid formulations should be used whenever possible. During the compounding of hazardous drugs (eg, crushing dissolving, or preparing a solution or an ointment), workers should wear non-permeable gowns and double gloves. Compounding should take place in a ventilated cabinet whenever possible.
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