Preparing, handling, and administering chemotherapy in a large health care system can be challenging, as the precise processes and safeguards necessary for safe and efficient care depend on several factors. Not the least of these factors is finding, training, and retaining qualified staff willing to dedicate the time and discipline required for working with chemotherapy and other hazardous medications.
Lee Memorial Health System, located in Fort Myers, Florida, comprises four acute care hospitals and two specialty hospitals. With a total of over 1420 beds, Lee Memorial is the largest public health system in Florida. Due to the scale of our operations, we opened the freestanding Regional Cancer Center (RCC) in the fall of 2008. This move centralized the majority of chemotherapy preparation and administration into one setting and allowed us to exert greater control over the processes of cancer treatment.
Use It or Lose It
As part of our initiative to bring chemotherapy management into a defined focus, we made a decision to only train certain staff in the attendant methods. This includes the pharmacists and technicians that prepare the medications, but also nurses who administer, couriers that transport, and housekeeping and waste management staff that deal with cleaning and maintaining our facilities.
Prior to opening the RCC, we attempted to train all pharmacy staff on chemotherapy preparation activities, but investing in training for staff who only occasionally work with chemotherapy proved inefficient, as this technical activity requires constant working experience. By training dedicated staff, we were able to develop a distinct group of chemotherapy management experts. They not only have the expertise in chemotherapy preparation, but also the expertise in assessing appropriateness of therapy and the need for supportive medications. This also is the reason we created a central location for all of our adult chemotherapy preparation that services all facilities in our health system. We now have four dedicated chemotherapy pharmacists at the cancer center, including myself, as well as 1.5 FTE technicians; these staff members work only with chemotherapy, all day, every day.
Transition from Sterile to Cytotoxic Compounding
Due to the rigorous nature of preparing and handling cytotoxic medications, oncology pharmacy technicians should be selected from the best of your staff. As with many large health systems, we have two levels of technician proficiency—technician 1 and technician 2—both of which have been certified through the PTCB; in order to work with chemotherapy at RCC, a technician must be at least a level 2. Further to eligibility and competency minimums, recruiting staff that have expressed an interest in oncology is paramount. These technicians must have already been trained in sterile compounding techniques, which eases the transition to compounding chemotherapy, as many of the concepts are the same. The main operational differences are direction of airflow—positive pressure for sterile, negative pressure for cytotoxic—and the type of hood used—a CACI for cytotoxic as opposed to a CAI or BSC for sterile compounding. Perhaps the most difficult aspect of transitioning from standard sterile compounding to cytotoxic compounding is becoming accustomed to working in a containment hood as opposed to a regular horizontal flow hood. However, this transition can be best facilitated through didactic, hands-on training. Considering the insidious nature of oncology medications, practitioners must take extra special care when working with them to avoid complacency.
With this in mind, re-evaluating staff at least annually is highly recommended (see Figure 1). While these evaluations are usually conducted to prevent deterioration of technique, they also should be conducted when new products are added or handling guidelines change. To facilitate training, it is best to initiate a step-by-step process for chemotherapy preparation and administration. This not only should define processes for pulling the correct source products (eg, agent, diluent) and ensuring all labeling protocols are correct, but also creating profiles for every patient including the exact products made and administered, the day and time, the rate, and patient-specific information including name, date of birth, diagnosis, attending physician, height, weight, and BSA. In addition to this patient- and product-specific information, the pharmacist who checked the product, the protocol being used, and any special instructions for the order or mixing procedure are also documented. Comparison always should be made among the prepared IV bag label, the original order, and the patient profile to make sure everything matches up; all prepared chemotherapy agents also should be double checked prior to any agent being added to the final IV bag. All oncology pharmacists and technicians must be clear on the entire process from the time raw materials are selected to the time the final product comes out for delivery.
Preparing Hazardous Products On-site
From its onset, the RCC took on as much of the chemotherapy workload as possible from the other Lee Memorial campuses, but there are certain preparations still prepared at those locations. To handle these cases, we keep a few oncology-trained pharmacists and technicians on each campus that have demonstrated competency in sterile preparation and have mastered the proper procedures for mixing chemotherapy. To augment this, we also developed a list of detailed guidelines for preparing specific items that is kept in a shared file on our intranet for oncology-related pharmacy operations. Effectively, these are step-by-step instructions, so if a stat order for bleomycin for pleural effusion is initiated at one of our hospitals, an on-site technician or pharmacist can pull that specific guideline and follow each step in proper order. As most non-RCC pharmacy staff prepare these items infrequently, it is unrealistic to expect them to remember every step. Instructions were created for the six medications that comprise the only hazardous or chemotherapy-related products prepared outside the RCC (with the exception of pediatric chemotherapy):
Common among these products is that they often need to be prepared for immediate use, so the facilities are allowed to prepare them on-site.
Chemotherapy Stability Guidelines
At RCC, we created a list of concentrations and stability information for all chemotherapy-related products for both pediatrics and adults. This includes standardized reconstitution instructions when possible. To develop this document, called Chemotherapy Stability Guidelines, we used the package inserts from individual drugs, as well as known drug references and information from the ASHP’s extended stability reference as our foundation. Following the publication of USP General Chapter <797>, we incorporated its guidelines for stability and risk levels. Given the clarity of the <797> guidelines establishing risk levels and beyond use dates, we have not had to update this document very often.
Now, the guidelines list each medication, the diluent, the type of IV bag to use, and any special instructions. For example, intrathecals or vesicants have special stickers that must be applied to the bag to identify them accordingly. We make a point to update this document as new products or usage information is released, and our oncology-trained staff is cognizant of such updates.
Keep in mind, all chemotherapy preparations are patient-specific with weight being a significant determining factor. The only products that are standardized and can be made ahead of time are items such as antiemetics or pre-medications. Prior to initiating the preparation of any chemotherapy dose, the patient first must be seen by the nurse and cleared for treatment through the assessment of the patient’s status and lab parameters. At that point, an oncology pharmacist reviews the lab results and any other pertinent information, and the technician then begins compounding the preparation.
Managing Concentrations and Diluents
Establishing the exact volume of the final product (IV bag volume) is acutely important for pediatric doses, so all pediatric IV bags are made using the automated compounder. For adult patients, establishing the exact final concentration or volume amount is not as critical. There are products that require a certain concentration for stability reasons, but otherwise we generally use the same amount of dilution for every adult patient. The challenge in making adult doses lies in the amount of medication we can fit in a single bag. With drugs like cisplatin that have a one-to-one concentration—1 mg per 1 mL—they are placed into an IV bag and then have mannitol added as well. Therefore, if the patient’s dose is 150 mg cisplatin plus 50 mL mannitol, there is not a lot of volume remaining in the bag for the diluent. To address this challenge, we prime every bag before adding any active chemotherapy agent, which makes it possible to draw out the same volume that we plan to put back in. Of course, this is conditional on whether the drug being prepared has any other special instructions.
Because chemotherapy preparation cannot be completely standardized, we rely on our specialized staffing approach along with documentation support to ensure proper procedure is always followed. For example, a limited number of tubing types are needed for chemotherapy administration, but special tubing is required for taxanes and infliximab (Remicade), and paclitaxel (Taxol) and docetaxel (Taxotere) both require non-DEHP tubing. So, in addition to listing the strengths and concentrations for each drug, the chemotherapy stability guidelines also specify special instructions such as these.
Given that there will always be products with special preparation requirements, the value of having the same staff consistently preparing chemotherapy is clear. Relying on staff members who are not familiar with the tenets of compounding chemotherapy is far from ideal, but avoiding this situation is not always possible, so the chemotherapy stability guidelines provide necessary guidance. We make every effort to maintain all of our chemotherapy preparation and attendant processes at the RCC (pediatric chemotherapy being a notable exception), but in an emergency situation, a trained staff member who does not normally work in this area should be able to step in as there is a resource to refer to. We also have an oncology pharmacist on call 24/7 in case of emergency.
Ultimately, centralizing these activities is particularly advantageous because it reduces waste and excess labor, and creating a dedicated staff for chemotherapy and other cytotoxic compounding allows a facility or health system to better control these complex and dangerous processes.
Christine (Tina) Gegeckas, RPh, BCOP, is director of the oncology pharmacy at The Regional Cancer Center—Lee Memorial Health System in Fort Meyers, Florida. Tina is a graduate of the University of the Sciences, College of Pharmacy, in Philadelphia and has been practicing oncology pharmacy for 20 years.
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