The 2015 ASHP Guidelines on Preventing Medication Errors with Chemotherapy and Biotherapy define best practices for ordering, preparing, and administering high-risk chemotherapy products, and also provide recommendations for improving systems to prevent medication errors and patient harm.1 Additional safety measures are warranted due to the unique challenges associated with chemotherapy use, including narrow therapeutic indexes, complex multidrug regimens, multiple dose calculations and adjustments, as well as a high risk for toxicities. All persons responsible for ordering, verifying, preparing, and administering chemotherapy must maintain continuous diligence to ensure safety throughout the complex medication-use process; additionally, all staff involved must demonstrate competency to perform these functions.

Pharmacists performing order verification are responsible for reviewing the original medication orders and determining appropriateness based on published standards and patient-specific information, such as accurate height and weight and recent laboratory values. The pharmacist also is responsible for reviewing the order to ensure that appropriate supportive medications and ancillary products required for chemotherapy drug delivery have been prescribed, and that orders are complete and accurate. To ensure accurate chemotherapy preparation, drug preparation worksheets are recommended by ASHP as a useful tool to identify specific product containers and administration sets, as well as specific diluents and reconstitution information.1

Revising the Chemotherapy Preparation Process

Sarasota Memorial Health System, an 819-bed regional medical center, is one of the largest public health systems in Florida. Sarasota Memorial Hospital (SMH) is the only hospital in Sarasota County that provides obstetrical services, pediatrics, a Level III neonatal intensive care, and a Level II Trauma Center. At SMH, all chemotherapy orders are entered through computerized prescriber order entry (CPOE) by a physician. Thereafter, a pharmacist reviews patient information, such as height, weight, indication, and labs prior to processing the chemotherapy orders. The IV room pharmacist then prepares the chemotherapy product, utilizing a standard chemotherapy preparation checklist and multiple drug reference sheets to guide drug preparation. A second pharmacist independently reviews the preparation for accuracy prior to dispensing.

Although this process has standardized chemotherapy preparation and verification, we recently identified several areas for improvement related to our order verification and preparation process, as well as in ensuring employee competence. Thus, we embarked on a project to improve the accuracy of the chemotherapy verification and preparation process by incorporating ASHP recommendations regarding chemotherapy verification and preparation, employee competence, and the creation of drug-specific chemotherapy checklists.

Implementing New Methods

SMH received Institutional Review Board (IRB) approval for our process improvement project, which comprised six steps that were critical to success: obtain staff feedback, design and verify checklists, educate staff and ensure competency, implement checklists and collect data, and complete a staff satisfaction survey.

Obtain Staff Feedback

We solicited staff feedback on the current chemotherapy preparation process through direct communication and via email, which elucidated several areas for improvement. Pharmacists reported that the current chemotherapy preparation checklist was too general and required unnecessary information for some drugs, while missing meaningful details for others. As a result, many checklists were not completed and therefore were not being utilized as intended. Additionally, there were several drug reference sheets that required updated drug information and consolidation. We also identified a need for more thorough chemotherapy education for staff. This feedback enabled us to begin revising our chemotherapy preparation process.

Design Checklists

Drug-specific checklists were created for over 50 chemotherapy products on formulary. Each checklist is double-sided; the drug information on side 1 was updated utilizing drug information references. The updated information includes: indications and dosing, dosage adjustments, pre-medications, monitoring parameters, reconstitution, stability and expiration, administration, ancillary products required, and the product formulations available at SMH. This side of the checklist replaced the multiple outdated drug reference sheets that were previously utilized. An individual checklist, specific to each drug, is included on side 2. It is divided into three sections: patient-specific information, order verification, and final product verification.

• The Patient-Specific Information section requires patient height, weight, body-surface area, indication, cycle, and day number.
• The Order Verification section records information such as pre-medications, laboratory monitoring, and dosing.
• The Final Product Verification section is the most detailed, and outlines drug product information, including vial lot number and expiration, specific reconstitution and dilution instructions, administration information, ancillary products required prior to dispensing, and final product expiration.

In contrast to the previous checklist, which included multiple choices that may not apply to a particular drug, the new checklist provides the pharmacist with exact instructions for product preparation and verification for each drug (see Online-Only FIGURE 1 at www.pppmag.com/chemochecklist).

Verify Checklists

The new checklists were independently verified for accuracy by one of the following: a medication safety pharmacist, an IV room team leader pharmacist, or an oncology-trained pharmacist.

Educate Staff and Evaluate Competency

Once the checklists were designed and verified, we developed a staff oncology education module that included a competency assessment. The module was presented to staff via slide presentation, which was recorded for future use in training new hires. The 30-minute presentation included information about commonly used oncology references, clinical pearls related to chemotherapy for pharmacists, and introduced the new chemotherapy checklists and explained appropriate use. Anonymous pre– and post-tests comprising six identical questions were completed by all pharmacists attending the education module.

Implement Checklists and Collect Data

The next step was implementing the checklists and collecting data to ensure they are used as intended. We assessed completeness of the checklists as a surrogate marker of accuracy by performing a random sampling of two groups: the first group comprised checklists from chemotherapy compounded 3 months prior to checklist implementation, and the second group contained checklists from chemotherapy that had been compounded 6 weeks post-implementation. An incomplete checklist was defined as a lack of any of the following required elements: initials on all lines, documentation of date or names of reviewers, or complete content.

Evaluate Staff Satisfaction

The last phase in this process improvement project was a follow-up staff satisfaction survey (see FIGURE 2). An anonymous eight-question survey utilizing a Likert-type scale was delivered to all pharmacists involved in the chemotherapy verification and preparation process after 1 month of use. The questions were intended to compare the old versus the new checklists in regard to usefulness, accuracy, confidence, and satisfaction. The primary outcome for this evaluation was accuracy of the chemotherapy preparation and verification process by comparing completeness of the previous checklists to the new checklists. In addition, we sought to evaluate staff competence through pre- and post-test scores using the education module, and to assess pharmacist satisfaction with the new chemotherapy checklists through survey.

Results

A random sampling of chemotherapy compounded 3 months prior to checklist implementation included a group of 52 checklists. Just 15 out of these 52 checklists (29%) were fully completed. A random sampling of chemotherapy compounded in the first 6 weeks following implementation of the new checklists included a group of 53 checklists; 47 of these 53 checklists (89%) were fully completed. This represents a 60% increase in overall completeness.

A group of 18 pharmacists attended the education module and completed the pre– and post-tests. The average pre-test score was 64% compared with the post-test score of 97%, representing a 33% increase in scores. Ten staff satisfaction surveys were completed; all pharmacists who completed the survey reported that the new checklists were more useful than the previous ones. The majority of pharmacists also reported that the new checklists were more accurate and required less time to verify the final product. Moreover, most pharmacists felt more confident preparing and verifying chemotherapy when using the new checklists compared with the old (see TABLE 1).

Challenges

Improving our chemotherapy preparation and verification process by implementing more accurate checklists was a time– and labor-intensive process. Each checklist was designed by a primary author, verified by a second pharmacist (this step oftentimes required multiple revisions), and ultimately finalized. We estimate that 4 hours were required to develop, approve, and implement each checklist.

In addition, developing the oncology education module and competency assessment and administering it to staff required significant time and dedicated resources.

Conclusions

Converting one standard chemotherapy checklist with multiple drug reference sheets into more than 50 separate drug-specific checklists proved to be extremely useful for SMH pharmacists. Pharmacy staff is satisfied with the revised process, finding the new checklists more accurate and requiring less time to complete than the previous checklist. In addition, pharmacists feel more confident preparing and verifying chemotherapy.

Moving forward, we will use retrospective chart review and continuing education to improve the completeness of the checklists, which will be updated on an as-needed basis. In addition, package inserts and published drug information references will be reviewed on an annual basis to ensure the checklists remain accurate.

Reference

1. Goldspiel B, Hoffman JM, Griffith NL, et al. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J Health Syst Pharm. 2015;72(8):e6-e35.

Kayla McGrath, PharmD, was a PGY1 pharmacy practice resident at Sarasota Memorial Hospital (SMH) in Florida from 2015-2016. She received her pharmacy degree from Husson University and plans to obtain a BCPS next year. Kayla is currently employed as a clinical staff pharmacist at Exeter Hospital in New Hampshire. Her professional interests include internal medicine, infectious diseases, and critical care.

Rebecca Kisgen, PharmD, BCPS, is a clinical pharmacist at SMH, as well as a preceptor for students and residents. She received her pharmacy degree from the University of Florida and completed a PGY1 at SMH. Rebecca’s professional interests include oncology and internal medicine.

Pam Lewis, RPh, is a pharmaceutical care specialist in medication safety at SMH. She received her pharmacy degree from the University of Toledo. Pam’s professional interests include medication and patient safety, human factors engineering, and investigational drugs. She plans to obtain the CPPS (Certified Professional in Patient Safety) credential from the National Patient Safety Foundation, as well as the Medication Safety Certificate from ASHP-ISMP when it becomes available next year.