Q&A with Joseph W. Coyne, RPh, president and chief executive officer, Coyne Consulting, LLC

Pharmacy Purchasing & Products: How critical are robust hazardous drug (HD) handling practices and closed system drug-transfer
device use when preparing and administering HDs?

Joseph W. Coyne: Handling HDs without appropriate safety precautions in place can result in dire consequences for health care workers. The CDC/NIOSH Web site contains hundreds of recent publications, guidelines, review articles, and surveys that address occupational exposure to antineoplastic agents and other HDs.1 These published studies have shown that workplace exposures to HDs can cause acute and chronic health effects, including skin rashes, adverse reproductive outcomes (ie, infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers.²

Considering this decades-old knowledge, it may seem surprising that some health care facilities have yet to fully embrace the necessity of protecting staff by employing comprehensive HD handling procedures, including utilizing proper PPE and closed system drug-transfer devices (CSTDs) for preparing and administering these medications. A recent study showed that only 25% of nurses used CSTDs to protect themselves from HD exposure when administering chemotherapy.3 However, with USP <800> finalized and enforceable starting on July 1, 2018, this soon may change. The Chapter specifies that pharmacy should use CSTDs when preparing HDs and requires that nursing use CSTDs during drug administration. (See SIDEBAR 1: Resources for Choosing a CSTD.)

PP&P: How can pharmacy gain buy-in from hospital administration to invest in HD safety efforts?

Coyne: Health care workers are exposed to more known hazardous entities than perhaps any other profession. However, it is not uncommon for hospital administrators—who often are well versed in topics such as financial management, health care marketing, and medical billing and reimbursement—to have limited knowledge of how to protect their employees from HD contact. Without appropriate education, hospital administrators may simply view the cost of implementing safety measures, including CSTDs, as superfluous, especially considering that CSTDs are a non-reimbursable expense.

Education efforts should focus on two realities: the tragic human cost of unsafe HD handling and compounding practices, and the fact that CSTD use in no longer optional. USP <800> recommends CSTDs for drug preparation and requires CSTDs for drug administration, and is federally enforceable. If there is a bright side to the 2012 New England Compounding Center (NECC) disaster, it is that the incident inspired health care organizations to recognize the potential repercussions of failing to follow safe practices. The last thing a health system wants is to become newsworthy due to a safety breach that causes patient harm. Meet with administration and teach them what can happen when organizations fail to follow safe practices. In addition, make it clear that USP <800> is a federally enforceable standard that all health care personnel who handle HD preparations, and all entities that store, prepare, transport, or administer HDs, must adhere to.4

Presenting a unified front is especially critical when educating administration about safe HD handling. Because the issue impacts departments beyond pharmacy, effective management of HDs requires an interdisciplinary effort. It is well documented that vials often enter the facility already contaminated; therefore, protecting every employee who comes into contact with HDs, from shipping and receiving staff to environmental services workers who remove waste, is required. The organization’s safety and quality officers, as well as employee health, can assist in developing a plan to protect all employees and in convincing administration of the importance of investing in safety efforts. For example, one hospital was able to gain administration’s buy-in to purchase safety needles by involving employee health in the request for purchase. Working with employee health and other relevant departments to gain buy-in for HD safety equipment can be similarly achieved.

PP&P: What are key steps to improving regulatory compliance?

Coyne: Accurately assessing the current state of practice must occur prior to effecting change. Perform a gap analysis to identify where improvement is needed. Multiple gap analysis tools are available; alternatively, read the 18 sections of USP <800> and create a simple checklist. Moreover, consultants can provide expert advice about USP <800> compliance.

Honesty is especially important to a successful analysis, so be truthful about what HD practices are occurring in the organization. A positive attitude will facilitate this process. Recognize that while practice may not currently be where one would like it to be, the organization can and will take the necessary steps to improve.

To this end, identifying barriers to compliance requires input from the interdisciplinary team. What are the principal obstacles to improving HD practice in each department? Depending on the organization, issues may include gaining buy-in from staff and administration, improving education and training, improving or implementing a medication surveillance program, fine-tuning cleaning practices, implementing CSTD usage, remodeling the facility, etc.

After gaps have been identified, note that a shared vision is critical to change. Pharmacy cannot make the organization USP <800>-compliant in a vacuum. All stakeholders are required to drive the institution forward, implement change, and reduce practice drift over time. Remember the adage: People respect what you inspect. The safety and quality officers should maintain an active presence in the units and in the pharmacy, as a consistent presence will motivate staff to maintain best practices over time.

Although an interdisciplinary team is required to effect change, pharmacy generally has more knowledge of the Chapter, and, as such, is ideally suited to take a leadership role. Moreover, one individual should be responsible for owning and providing leadership for USP <800> compliance. This person can be a pharmacist, the safety officer, the quality officer, or whoever is best suited in the organization. While the process of becoming compliant requires an interdisciplinary team, a strong leader is critical to ultimately maintain responsibility over the change process.

PP&P: How can pharmacy prepare to demonstrate compliance?

Coyne: Maintaining robust documentation shows auditors that the organization values and is committed to safety. Auditors are on the alert for clear, complete documentation, which shows them that the organization has a comprehensive staff-training program, a strong safety and compliance focus, and a logical plan for addressing compliance deficits.

Documents that should be in place and readily accessible at all times include:

• Standard Operating Procedures (SOPs). SOPs should be comprehensive. Be sure to include procedures for how to clean up spills. Moreover, SOPs must include a hazardous communication program to ensure workers are aware of HD risks, which is required by USP <800> (see SIDEBAR 2)4
• Results of the Gap Analysis. The gap analysis is a positive starting point for documentation purposes. Auditors recognize when an organization has completed a gap analysis and put a plan in place for improvement. In addition, a gap analysis holds the organization accountable to a timeline for implementing improvements
• A Training Log and Policies and Procedures for Staff Training. A training log and training policies and procedures provide a record of evidence that staff has been appropriately trained and has passed competency assessments prior to performing compounding
• Environmental Monitoring Testing Results. Keep records of all environmental monitoring performed, including the relevant standards required for adherence and all surface sampling test results
• Product Testing Results. The list of products that have been tested, which may include any raw materials (ie, active pharmaceutical ingredients [APIs]) that the organization uses to compound medications in-house, any dosage forms that are not in their final form, and/or any other products as defined in USP Chapters <71> (Sterility Tests), <85> (Bacterial Endotoxins Test), and <797> (Pharmaceutical Compounding—Sterile Preparations), must be maintained.

Err on the side of compiling more documentation, rather than less. Remember that documentation serves a dual purpose: it shows that the organization maintains a culture of safety, and also allows the entity to identify trends over time. Does the data show a specific staff member is not following policy? Is there a problem with the training process? While documentation is critical to demonstrating compliance, it also enables continuous improvement. Make full use of the data to identify patterns, create change, and ultimately improve practice.

Joseph W. Coyne, RPh, graduated from the Philadelphia College of Pharmacy and Science and continues to serve there as an adjunct senior clinical professor and a clinical preceptor. He 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. Joseph is currently president and chief executive officer of Coyne Consulting, LLC, which provides clients with the structure and process to create breakthrough projects with an eye toward rapid return on investment, while achieving improvements to patient care, employee safety, and the advancement of pharmacy practice.