Q&A with Joseph W. Coyne, RPh
Director of Field Operations
Clinical IQ, LLC
Pharmacy Purchasing & Products: What points should be considered when developing a cost-versus-value analysis for CSTD adoption?
Joseph W. Coyne, RPh: Only one question is relevant when deciding whether or not to use a CSTD: Does my organization value staff safety and USP <800> compliance? As an employer, the pharmacy, hospital, or health system is responsible for maintaining a safe working environment for its staff. While CSTDs are varied in design, have different price points, and are not currently reimbursable, cost should not be a consideration when deciding whether or not to implement a CSTD; the cost of CSTD use is simply the cost of doing business, if your business is hazardous drugs (HDs). Moreover, as of December 1, 2019, when USP General Chapter <800>—Hazardous Drugs—Handling in Healthcare Settings will become enforceable, CSTDs will be required for HD administration and recommended for HD compounding.1 Consider, for a moment, the serious repercussions if an employee is harmed as a result of HD exposure. Harm can be prevented when employee safety is deemed a top priority and when CSTDs are used to prevent HD exposure. In addition, taking proper care of staff is simply the right thing to do.
Pharmacy must be the prime advocate for implementing CSTDs for both HD compounding and administration. The pharmacy director should ensure hospital administration or executive leadership has a clear understanding of not only what is required (the CSTD), but why it is required. A CTSD is not simply a disposable piece of equipment that can be operated casually or ignored—it is an essential tool to prevent staff exposure to HDs and must be used. Educate the C-suite on the dangers of HD exposure, the hospital’s potential liability should a staff member experience harm, and how a CSTD can prevent exposure. Members of the C-suite may be unaware of the volume of HDs that pharmacy technicians are preparing and nurses are administering on a daily basis; one technician may prepare dozens, or even hundreds, of HDs each day, with nurses administering a similar volume. CSTD use cannot be optional—it must be required each and every time an HD is compounded and administered.
Secondarily, using a CSTD requires significantly less time than compounding HDs via a negative pressure syringe/needle technique. The time-savings from compounding an HD with a CSTD is certainly an important point to be discussed with administration. Conducting a time study comparing the two techniques may help illustrate the efficiency benefits of CSTD use, which may also translate into cost savings.
PP&P: What are the most important considerations for organizations when choosing which CSTDs to trial in-house?
Coyne: It must be understood that all CSTDs are not created equal; differences exist regarding how they achieve HD containment, ease of use, the number of components, and cost. Points to consider when choosing a CSTD to test in-house include:
- How well does the CSTD prevent HD contamination?
- Should a filter-based or vapor-containment system be chosen?
- How easy is the CSTD to use?
- How many components/manipulations are required to use the CTSD?
- What is the cost of the device? How does the cost correlate with the device’s design, components, and quality?
Consult NIOSH’s proposed CSTD testing protocol to help understand the difference between filter-based units and vapor-containment devices.2
Ease of use is a critical consideration. Each CSTD has its own proprietary method and components of use. Consider the number and types of manipulations required to use the CSTD, which can impact the risk of repetitive stress injury. Be sure to consider ease of use from both a pharmacy and nursing perspective, as nursing’s requirements will differ from pharmacy’s.
Compatibility is equally important. Some CSTDs are incompatible with certain drugs, due to the plastics and materials used in the CSTD manufacturing process. If these drugs are essential to your operations, those CSTDs would be disqualified. In addition, consider the following: Are proprietary pump sets in use that must be compatible with the CSTD? Is IV workflow technology a consideration, and if so, will the CSTD be compatible with this technology? Will robotic technology be utilized in combination with the CSTD? Investigate any technology or automation used upstream in the pharmacy process or downstream in the nursing process that may create challenges for successful CSTD implementation.
PP&P: Who should be involved in reviewing the CSTD options?
Coyne: A diverse, collaborative team should be involved in choosing a CSTD. Because nursing and pharmacy requirements differ, it is critical to include wide representation from both departments. And though there is often a tendency to include only pharmacy and nursing leadership, it is vital to establish representation from frontline staff members who will be using the device. This team need not be large in number, but including staff members responsible for a variety of roles will achieve a better final result.
A system that seems ideal to pharmacy leadership may be viewed differently by a technician who will use the device throughout the workday. Include both new and seasoned staff to ensure ease-of-use and workflow are taken into account in this important decision. In addition, if appropriate, consider inviting a representative from risk management. It is critical to gather individuals with differing opinions—for example, CSTD advocates as well as those who may be reluctant to implement these devices—to ensure the dialogue is rich, fruitful, and diverse. During this process, all members of the group must be made to feel comfortable providing their opinions.
The goal of such collaboration is not only to identify a single device that meets the needs of all stakeholders, but also to ensure that the chosen CSTD is used consistently. The worst-case scenario is having a device chosen that does not collectively meet the needs of pharmacy and nursing, with ensuing workarounds developed that negate the safety benefits of a CSTD. While some organizations have implemented one CSTD for pharmacy compounding and another for nursing administration, I do not recommend this approach. The collaborative group should be able to come to consensus and implement a single device. After the decision is finalized, all stakeholders should walk away from the experience feeling that the best choice has been made for all involved.
PP&P: How can wipe testing be utilized to evaluate CSTD effectiveness?
Coyne: In the radiology department, a dosimeter can be used to pinpoint exactly where contamination exists; in pharmacy, areas containing HD residue are identified via wipe testing. Wipe studies can also help determine how effectively the CSTD is preventing exposure to HDs. It seems reasonable to request that a CSTD manufacturer fund a wipe study to establish the organization’s baseline; future wipe studies will then illustrate the CSTD’s effectiveness. Moreover, consider requesting that the manufacturer fund annual wipe testing, which will illustrate how successfully the CSTD helps maintain safe HD handling on an ongoing basis. Organizations may consider the option of writing this into their contracts with the CSTD manufacturer. A vendor that is willing to fund baseline and/or ongoing wipes studies is clearly a vendor that stands behind its product.
The issue of effectiveness can also be indicative of the vendor’s quality of overall service and support. Has the vendor had any recalls or quality issues with their product? What CSTD training does the vendor provide for staff? A vendor that will work in conjunction with an organization, rather than simply selling the hospital a CSTD like a commodity, inspires trust. If the vendor agrees to fund annual wipe testing, certainly the facility can make the same commitment. NIOSH recommends conducting wipe testing at least every 6 months, as this provides valuable data points into the level of control inside the facility.
When establishing areas to be sampled, choose wisely. For example, sampling within the primary engineering control will not yield meaningful results, as residue is expected in this location. Choose locations where residue should not be found, such as work counters, pass-throughs, nursing work stations, etc. Being selective in sampling locations reduces cost by controlling the number of samples taken and ensures the resulting data is meaningful and actionable when changes in values occur.
PP&P: How often should organizations review new CSTDs that have come onto the market?
Coyne: It can be challenging to find a balance. On one hand, organizations are responsible for keeping abreast of new developments by constantly surveying the CSTD market, but the process for evaluating new devices can be time-consuming, resource-intensive, and costly. Therefore, securing user feedback from other organizations utilizing various devices can help in keeping abreast of the potential benefits and challenges with new CSTDs, while reducing the time and resource commitment of regularly evaluating devices in-house.
After a CSTD has been implemented for compounding and administration, pharmacy should monitor staff reaction to the device: Has the CSTD been consistently used? Have any training challenges been identified? Are team members experiencing any repetitive use injuries? Is there a need to switch from one CSTD to another? If user feedback identifies a need to reconsider CSTDs, that is an opportune time to take another look at the criteria used to select the device, determine whether the chosen device is meeting the organization’s needs, and decide if the time has come to potentially facilitate a switch.
It is anticipated that the NIOSH CSTD protocol, when finalized, will provide additional guidance, including an objective set of data, regarding CSTD choice.
- USP General Chapter <800>—Hazardous Drugs—Handling in Healthcare Settings.www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare. Accessed April 9, 2018.
- A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. NIOSH Docket Number 288-A, CDC-2016-0090. www.cdc.gov/niosh/docket/review/docket288a/default.html. Accessed April 13, 2018.
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.
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