Q&A with Robert P. Granko, PharmD, MBA, and Ashley McCallister, PharmD, MBA, Moses H. Cone Memorial Hospital, Greensboro, North Carolina
Pharmacy Purchasing & Products: What are the most significant challenges with ensuring IV safety, and how should they be addressed?
Robert P. Granko and Ashley McCallister: The compounding tragedies in recent years have highlighted the importance of ensuring safety and compliance at each step in the IV preparation process. Primary concerns include poor preparation technique, including failure to use a filter needle when one is required, incorrect drug concentrations, and use of the wrong diluent—particularly in pediatric medications.
Standardization is central to ensuring safety in the IV preparation process. Cone Health’s goal is to develop standard work processes for all compounding sterile products. The term standard work is becoming more prevalent throughout pharmacy, and references a process in which all necessary steps for consistent preparation have been described in a reference document (ie, policy and procedure), can be repeated, and can be monitored through a quality assurance (QA) process. The new quality standards from the United States Pharmacopeia (USP) for preparation of non-sterile, sterile, and hazardous drugs essentially require standardized work practices.
To this end, many institutions have recognized that in-house references for product preparation and documented QA processes are necessary to support pharmacy staff. It is increasingly common for an institution to develop its own Beyond-Use Date (BUD) Compendium, which includes comprehensive, referenceable information for compounding medications used at that facility. The Compendium lists the BUD assigned to a specific preparation based on stability information available in the literature, and also contains instructions for preparing the product, including details such as whether preparation requires a closed system drug-transfer device (CSTD) or a filter. In addition, our BUD Compendium describes the appearance of the final product, as well as a warning about how the final product might appear if there is a problem—for example, cloudy or discolored. If there is a question about how a product was prepared, we are able to refer back to the BUD Compendium for the correct process. Moreover, a standardized BUD Compendium is invaluable in demonstrating that the organization has a reliable, consistent, documented, and referenceable process for preparing CSPs (see online-only TABLE for a sample of Cone Health’s BUD Compendium).
To develop a BUD Compendium, a pharmacist(s) and a technician(s) who are knowledgeable about compounding should work together to review the IV compounding recipes used at the facility and validate each one. Include drug information and references when applicable. Although this process is time-consuming, once complete you will have a comprehensive, validated document to guide sterile product preparation.
PP&P: How can pharmacy identify potential errors in the IV process?
Granko and McCallister: Again, the focus should be on standardization, which is key to identifying potential error points in the process. The concept of standard work is the foundation of a lean approach; lean works to drive out waste in processes so that the work that is performed is valuable. Part of the lean process can include techniques for analyzing various processes in a step-by-step manner to identify error points. Standardizing workflow enables implementation of a baseline process that minimizes the potential for errors. In addition, many institutions, including ours, have prioritized standardizing medication concentrations, with an eye on reducing the possibility of errors.
Developing robust systems for tracking and reporting safety concerns when a process has deviated from the standard practice is critical. Where feasible, facilities should perform after-action reviews to identify the cause(s) of deviations and determine preventative measures, with the goal of minimizing future deviation from standard processes. As part of the lean methodology, this review process incorporates a meeting with those involved to walk through the process, understand the overall outcomes, review the policies and procedures used along with any associated breakdowns, recommend any improvements, and celebrate any accomplishments.
Finally, the Institute for Safe Medication Practices (ISMP) has proposed revisions to the Guidelines for Safe Preparation of Sterile Compounds that emphasize the importance of implementing technological solutions to prevent medication errors.1
PP&P: How do redundancies in the system help prevent IV errors?
Granko and McCallister: One strategy is the deployment of independent double checks for order verification of prepared and administered high-risk medications. Standard practice is for each container to be labeled with the final volume, which reflects the bag volume, the overfill, and the added volume. The pharmacist checks each medication prepared by technicians. Consistent labeling, which is as important for the pharmacy staff as it is for nursing, ensures the pharmacist knows what should be included in the final product.
Utilizing independent double checks prior to infusing, nurses and other staff members who infuse these therapies serve as an additional safety checkpoint. On the front end, they work with prescribers to ensure that medication orders are correct. In addition, nurses should be familiar with the products they administer, such as the correct volume and the appearance of the solution. When nurses have a question about a product, they should know where to direct these queries—pharmacy.
Because nurses are critical to a safe medication-use process, it is important to include nursing staff in training and education regarding medication safety so they have a basic understanding of how sterile products are prepared and the steps the pharmacy takes to ensure medication safety.
PP&P: What compounding training should be provided for pharmacy technicians?
Granko and McCallister: We strive to provide opportunities for pharmacy technicians to receive additional education and training to the greatest extent possible. Staff receive ongoing training in our hospital’s policies and standard work procedures. To supplement, many automation software packages include helpful training modules, and ASHP and ISMP offer sterile compounding educational programs.
Moreover, we also believe it is important for pharmacy technicians to attend educational sessions led by national experts. Technicians should receive continuing education on sterile compounding processes as well as the correct operation of environmental controls. Moving forward, USP <800> requirements will increase opportunities for pharmacy technicians to gain education and advance their practice.
While it is essential to have a competent and well-trained staff for sterile product production, it is equally important to ensure the competency of the trainers. Staff should be knowledgeable in how to use the BUD Compendium or other comprehensive reference document for product preparation, and pharmacy must verify that staff is adhering to these steps and following proper technique.
PP&P: What steps should be taken in the IV room to prevent errors?
Granko and McCallister: Ensuring IV medications are stored correctly is the first step to preventing errors. To that end, identifying the proper storage locations for all drugs is critical. For example, concentrated electrolytes must be segregated— stored separately and compounded apart from other products. Standardizing the ordering process and effective inventory management and restocking also remain critical strategies in proper IV management. The same steps should be taken to improve medication safety in both sterile and non-sterile production areas.
PP&P: What are the benefits of implementing IV workflow management technology?
Granko and McCallister: Implementing IV workflow management software provides visibility into operational processes around sterile product preparation, enables tracking of workflow and QA activities, improves efficiency, and reduces waste. The software allows pharmacy to enter detailed information about the work pharmacy staff is performing, including the roles and responsibilities of the staff on a specific shift, and it provides real-time reporting and analytics that are used for QA activities. For instance, we can retrieve the results of the latest gloved fingertip sample for a particular technician or ascertain when the hood was last cleaned. Additionally, our system allows us to customize each activity—giving us the ability, for example, to include the institution’s instructions on how and when to clean the hood.
Moreover, references and quality control metrics are all in one place for easy access. Should a regulatory body requests a review of certain practices and workflow procedures, it is simple to retrieve the QA and workflow documents that demonstrate the safety of our processes and sterile products. Finally, utilizing an IV workflow management system increases the ability of an organization to control and standardize work practices, which is central to ensuring a safe medication-use process.
It is important to note that although IV workflow technology affords the opportunity to reapply staff time, particularly for education and training, it does not necessarily reduce staffing requirements, because even automated processes require oversight, sometimes to a greater extent than manual processes.
PP&P: How can pharmacy identify and flag incorrect orders?
Granko and McCallister: Again, it is critical to recognize that implementing standard operating procedures and double checks establishes the foundation for identifying and flagging incorrect orders. The process starts with ensuring that the master formulation record in the electronic health record (EHR) is correct. When entering a new product into the system or converting to a new EHR, it is vital that pharmacy be involved to ensure the accuracy of this process. Moreover, as ISMP recommends, Tall-Man lettering should be used in labeling IV medications.
Upon receipt of an order from the provider, the pharmacist first checks that the dose and route of administration are correct. Automated alerts in the EHR help to prevent ordering errors by establishing upper and lower dosage limits. Including hard stops (preventing progress) and soft stops (informing a clinician of a potential problem) can prevent significant deviations from the correct dose or frequency.
Likewise, the verification process also must be standardized to establish that the product accurately reflects the label prior to sending to the floor. The process for checking the product must be included in the compounding and checking policies and procedures. Pharmacists are expected to understand this process and are held accountable through annual competencies and periodic QA checks.
Robert P. Granko, PharmD, MBA, is the director of pharmacy at the Moses H. Cone Memorial Hospital, a 536-bed community teaching hospital and flagship hospital for the Cone Health Network. Previously, he was the associate director of pharmacy at the University of North Carolina Medical Center. Bob received his BS in pharmacy from Long Island University, his PharmD from the University of North Carolina at Chapel Hill, and his MBA from Pfeiffer University.
Ashley McCallister, PharmD, MBA, is a PGY1 acute care pharmacy resident at Moses H. Cone Memorial Hospital in Greensboro, North Carolina. She received her Doctor of Pharmacy from Campbell University College of Pharmacy and Health Sciences and her Master in Business Administration from Campbell University Lundy-Fetterman School of Business.
Working with Outsourcing Facilities
For a variety of reasons, including drug shortages, pharmacy directors may decide to work with an outsourcing facility for some compounded sterile products. With the new Drug Quality and Security Act, the FDA requires that all 503B outsourcing facilities comply with current Good Manufacturing Practices. The intention is to prevent outbreaks similar to those seen in recent compounding tragedies.
Under these more stringent requirements and with an increase in FDA inspections of outsourcing facilities, there has been a corresponding increase in the number of form 483s issued by the FDA. A form 483 indicates that an investigator has observed a condition that may violate the Food Drug and Cosmetic Act; a warning letter indicates a more serious compliance issue. Therefore, pharmacy directors considering working with a 503B outsourcer should review the issues identified in any 483s issued to the facility, as well as the facility’s response and intended resolution. ASHP has developed a contractor assessment tool that can be used to evaluate outsourcing facilities (available at http://outsourcingassessment.org/).