Q&A with Joseph W. Coyne, RPh
Director of Field Operations
Clinical IQ, LLC
PP&P: How should policies and procedures be designed to support CSTD use?
Joseph W. Coyne, RPh: Closed system drug-transfer device (CSTD) policies and procedures (P&Ps) should be sufficiently specific to allow a new employee to follow the steps to use the CSTD to compound or administer a hazardous drug (HD) without the need for any additional verbal instruction. Some organizations develop P&Ps that include only general statements, such as: Use the appropriate CSTD. This information is insufficient.
A pharmacy’s HD preparation P&P should include comprehensive information about the CSTD and all necessary supplies (including, but not limited to): final bag or container, syringes, and diluent. CSTD P&Ps for nursing should include complete information about the system and all supplies required to administer an HD using the CSTD: primary and secondary HD administration information, setups, priming IV lines, tubing, and CSTD use steps. Vendor-specific information should be included in the P&Ps—for example, if specific vial adaptors or multiple components are required, this must be stated. The P&P must be easily accessed during HD preparation and administration. Housing P&Ps online is one way to ensure all staff members have access to the same information from anywhere within the facility.
PP&P: What are the key elements in an effective CSTD training program?
Coyne: CSTD training should be incorporated into the comprehensive HD handling training. This training should be led by a qualified, designated individual, and must be collaborative. Collaborative training ensures all users of the CSTD understand how their specific components and steps within the process affect other personnel. Review USP <800> recommendations for CSTDs and HD handling to develop training materials. In addition, relying on the CSTD vendor for support can be useful in developing a training process, as they may be able to provide useful resources. However, do not rely solely on the vendor’s input, as effective training must be specific to each organization’s needs and should reflect actual day-to-day practice. Both verbal and written training, as well as direct observation of practice, should be included.
Provide training upon hire, prior to staff handling of any HDs, and annually thereafter; in addition, each employee who handles HDs should pass a competency evaluation to demonstrate that they have mastered safe HD handling. The value of a comprehensive staff training program should be ingrained in the culture of the organization.
PP&P: How should an organization handle HDs administered via alternative delivery methods?
Coyne: USP <800> states that a CSTD should be used when compounding and must be used for administering an HD when the dosage form allows.1 Thus, a CSTD should be used whenever possible—including when preparing those drugs that are to be administered subcutaneously or intramuscularly.
To ensure no additional manipulation is required on the floor, pharmacy should provide nursing with a final, ready-to-administer preparation. In the past, it was not uncommon for nursing to draw up subcutaneous drugs on the floor, but this practice should be avoided. A subcutaneous drug should leave the pharmacy attached to the appropriate needle, in an appropriately labeled transport bag. Although this moves the process into the pharmacy, which may create operational challenges, it is the safest method of preparing hazardous subcutaneous medications. Nurses should wear proper personal protective equipment (PPE) when removing the syringe, preparing the patient’s skin, and administering the medication.2 In general, a CSTD cannot be used when administering a medication subcutaneously.
PP&P: Can you provide some general recommendations for using a CSTD to prepare and administer drugs that are on the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings?3
Coyne: The most recent iteration of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings is anticipated for dissemination in September 2018.4 Its purpose is to provide health care workers and facilities with information on identifying HDs so that proper handing can be performed to reduce worker exposure.
To begin, review the NIOSH HD list to identify which of the medications included therein are used within the organization, and then conduct an assessment of risk for each HD utilized. Clearly, CSTD use is required when compounding and administering antineoplastic drugs (those drugs listed in Table 1 of the NIOSH list). However, drugs on Table 2 (hazardous, non-antineoplastic drugs, including those with manufacturer’s safe-handling guidance) and Table 3 (non-antineoplastic drugs that primarily have adverse reproductive effects) of the NIOSH HD list may also benefit from CSTD use as an alternate containment strategy.5 If the assessment of risk determines that a CSTD is necessary for these drugs, this requirement must be communicated both to the technicians compounding and the nurses administering these medications, and it must be specified in the P&Ps for preparing as well as administering these drugs.
This communication can occur within the EHR, the IV workflow management system, or both (if both are utilized). Organizations without electronic methods can use a simple colored dot system, with one color delineating medications requiring CSTD use during preparation and administration. Whatever method is chosen, it must be assigned immediately upon receipt of the drug in the pharmacy. A medication should not leave the receiving area without proper labeling and handling criteria specified.
Consult the organization’s policies for Resource Conservation and Recovery Act (RCRA) and P- and U-list waste management when undertaking an assessment of risk, as strategies that have been successful for HD waste handling education and implementation may help inform successful strategies proven useful in handling HDs across all facets of the organization.
PP&P: How should an organization document CSTD use, as required in USP <800>?
Coyne: CSTD use should be included in comprehensive HD P&Ps, which should be documented in their entirety in the EHR. Each element required for the HD preparation must be built into the order (including, but not limited to): drug, diluent, bag or final container, syringes, and CSTD (if required). EHR vendors must recognize and provide the capability to document safe HD handling practices per USP <800>’s requirement. Moreover, this capacity should be built into IV workflow management software programs, which can also provide documentation of safe HD practices. In recent years, IV workflow management systems have become increasingly flexible; many software programs are capable of documenting the specific compounding steps taken. Nursing should also document specific HD handling and administration practices: for example, preparation steps, use of a dry connection, use of a specific device, as well as education and training.
To ensure compliance with USP <800>, it is critical to develop a culture within pharmacy that values compliance, as well as the critical nature of documenting compliant practice. Good practice is vital, but without proper documentation, it is incomplete. Documentation should be established as a standard step in the process. Looking to the future, documenting batch compounding records should be standard practice. When pharmacy sends tubing, a needle, a syringe, or an alcohol swab up to nursing with a medication, pharmacy should also document these items as part of preparation to ensure nursing receives all the required elements for administration, each and every time.
PP&P: What can schools of pharmacy do to help ensure safe HD compounding?
Coyne: While training for operational issues, such as HD handling, may not be perceived as an exciting aspect of pharmacy, it is absolutely vital to ensuring safe practice; as such, it should not be ignored. Pharmacists enjoy discussing prescribing, clinical bedside interventions, and practice advancements, but we must not lose sight of education and training, the bedrocks of safe pharmacy practice.
There is significant room for improvement in how HD handling and compounding is taught in pharmacy schools. The amount of time spent on this topic is insufficient to ensure safe HD handling when the student begins working in the hospital environment. Moreover, pharmacy schools may not have a true sterile compounding environment in which to provide training and education. If these environments cannot be constructed on campus, consideration should be given to partnering with appropriate facilities so graduates receive the proper training—not only in HD handling, but also in the broader scope of compounding sterile preparations.
Joseph W. Coyne, RPh, is the director of field operations for Clinical IQ, LLC, where he acts as a trusted source for pharmacy information services and product solutions for clients who range from local start-up operations to established national organizations in the hospital, home care, and specialty compounding industries. He also serves on the faculty of the CriticalPoint Center for Training and Research. Joe has over 25 years’ experience as a pharmacy executive specializing in cancer treatment, hazardous drug handling, sterile compounding, and hospital, hospice, and home care management.