The Community Oncologist

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1 This material is protected by U.S. Copyright law. Unauthorized reproduction is prohibited. For reprints contact: The Community Oncologist Preventing Chemotherapy Errors Lisa Schulmeister Key Words. Chemotherapy administration Safety Error reporting Learning Objectives After completing this course, the reader will be able to: 1. Define the extent and scope of chemotherapy errors and their impact on patient care. 2. Describe common types of prescribing errors. 3. Recommend procedures to prevent errors in drug orders, preparation, and identification of patients. 4. Identify reporting and monitoring systems both within your institution and at the government levels. CME Access and take the CME test online and receive 1 AMA PRA category 1 credit at CME.TheOncologist.com Abstract A large amount of information on chemotherapy error prevention is available to the practicing oncologist. However, few oncologists have the time and resources to obtain the information and evaluate the evidence. Further, much of the information is generic and does not provide specific direction on how the information Introduction Your morning was unexpectedly busy. Traffic was backed up on the way to the hospital. The emergency consult for anemia has leukemic cells on the peripheral smear. Now you are rushing to the office but first have to take care of Judy Smith. Judy was admitted for treatment of refractory lymphoma and is anxious about receiving her treatment in the hospital. She read hospital errors result in more deaths than a crash of a jumbo jet every day and that 44,000 98,000 patients per year die of medical errors. You tell Judy these studies are nearly 10 years old. You and your staff are smart and care about what you do, so errors cannot happen here. While reassuring Judy, you write her orders and check her labs on the run. You hand the orders to a nurse in the hall. can be applied in clinical practice. This manuscript reviews principles of safe chemotherapy administration, identifies key actions to prevent chemotherapy errors, and provides suggestions on how the information can be incorporated into daily practice. The Oncologist 2006;11: In this scenario, recapitulated with variations thousands of times a day across the country, multiple sources of potential error exist. Cancer chemotherapy has a narrow therapeutic window, and patients with cancer often cannot physically tolerate mistakes. Errors in treating patients also have been associated with losses. Loss of reputation and confidence in the doctor and hospital, financial loss in the law courts, and most importantly loss for the patients. Prevention of error is a matter of remaining vigilant, having systems in place to expose mistakes, and having a culture among coworkers that error prevention is a priority. What are potential sources of vulnerability and how can we build a system that prevents errors? Correspondence: Lisa Schulmeister, R.N., M.N., C.S., O.C.N., 282 Orchard Road, River Ridge, Louisiana , USA. Telephone: (work), (home); Fax: ; LisaSchulmeister@hotmail.com Received March 14, 2005; accepted for publication March 30, AlphaMed Press /2006/$20.00/0 The Oncologist 2006;11:

2 464 Preventing Chemotherapy Errors (1) Recognizing that mistakes occur. (2) Creating a culture that emphasizes error prevention with coworkers. (3) Having accurate, unambiguous orders for chemotherapy. (4) Continuing staff training and instantaneous access to information. (5) Using systems of patient identification. (6) Focusing on pharmacy concerns. If all of the above are not in place, there are chinks in the armor of error prevention, which leaves you vulnerable. (1) Recognizing that Mistakes Occur In fact, the jumbo jet analogy allows only for 7 10 deaths per year per acute care hospital and no deaths in the outpatient or nursing home setting. This mortality statistic is believable. Furthermore, lesser injury must be much more common. (2) Creating a Culture that Emphasizes Error Prevention with Coworkers Assuming that you and your team are all intelligent, well trained, and motivated, still, to err is human. Though medicine is traditionally hierarchical, in reality everyone must Table 1. Chemotherapy error prevention principles Principle Implementation Proactive approach Conduct ongoing review of chemotherapy prescription, transcription, preparation, administration, and patient monitoring processes. Make needed procedural changes before an error occurs. Review near miss events (close calls). Multidisciplinary participation Open communication Systems analysis Redesign vulnerable patient systems Safe practice Information transfer Education, competency, and credentialing Culture of safety Continuous quality improvement Involve everyone who has a role in chemotherapy error prevention (e.g., patients, unit secretaries, patient educators, pharmacy couriers who transport chemotherapy, etc.). Promote team identification. Empower health care providers to speak up and share ideas and safety concerns. Encourage patients to ask questions and express concerns. Examine the overall system of chemotherapy administration and identify how one component can potentially affect another (a flow chart may be helpful to illustrate this process). Conduct a Failure Mode and Effects Analysis (FMEA), which focuses on three aspects of a process (likelihood of failure, chances of failure causing harm, and the likelihood of the failure being undetected). Use human factors engineering to identify and correct system failures (e.g., processes, equipment, etc.). Provide evidence-based care. Adhere to institutional policies and procedures. Review and revise procedures periodically (at least annually). Update and revise procedures as new information becomes available. Review how information is recorded, relayed, and stored. Use information technology (e.g., electronic medical records, personal digital assistants such as handhelds and smartphones, etc.). Evaluate prospective and current employees educational preparation, prior experience, and present knowledge and skill level. Identify and address deficiencies. Provide and support continuing education. Encourage and support board and specialty certification. Delineate credentialing criteria (e.g., specify who has the authority to prescribe and administer chemotherapy). Emphasize safety and error prevention. Create patient safety specialist positions or teams. Demonstrate leadership s support for safety initiatives. (Safety needs to be a priority from the top down.) Create a nonpunitive environment for expressing safety concerns and reporting errors. Consider related areas that impact safety, such as safe handling of chemotherapy. Avoid naming, blaming, and shaming individuals involved in chemotherapy errors and instead ask, How did this happen? Ensure that error prevention is a continuous process that includes ongoing informal evaluation and a more formal evaluation on a periodic basis. Use prospective methods to prevent chemotherapy errors (e.g., observational methods). The Oncologist

3 Schulmeister 465 look out for everyone else. The physician, nurse, and pharmacist should all double-check chemotherapy. Patients are better served if they know about their own treatment. No one should feel intimidated about questioning anyone else. The youngest, least experienced member of the team has to be encouraged to ask questions and look for problems. Safety is a shared challenge (Table 1). (3) Having Accurate, Unambiguous Orders for Chemotherapy Chemotherapy should not proceed if clinical information that could impact patients treatment and outcomes is missing. Chemotherapy order forms can be networked through computers or downloaded on handheld devices; this prevents handwriting problems and ambiguity in verbage. Included in the chemotherapy orders should be all patient data such as height, weight, body surface area, patient s name, and route, time, dose, and date of most recent chemotherapy. Units should be spelled out, not abbreviated. Trailing zeros should not be used, because 2.0 can be mistaken for 20. Leading zeros, on the other hand, should be used to prevent misinterpretation of 0.2 as 2. Cumulative doxorubicin dose, creatinine clearance, bilirubin, albumin, and other drug-specific information can be included in the form. Even with the best technology, your guard cannot be let down. Automated and computerized systems do not eliminate error. In its 2004 annual report, the U.S. Pharmacopeia (USP) noted that 20% of medication errors reported to the USP in 2003 were made with a computerized or automated environment. Dosing errors accounted for 49% of computerized prescriber order entry errors, and automated dispensing devices were implicated in almost 9,000 medications errors [1]. So to err is human, and mechanical as well. Despite the accuracy and facility of computers, errors that are hardwired into a computer can harm many more people than individual orders. The Institute of Safe Medication Practices (ISMP) identified numerous landmines and pitfalls associated with computerized prescriber order entry [2]. Also, many systems can be manually overridden. In a multicenter study of 3,481 computerized order entry alerts, physicians overrode 91.2% of drug allergy and 89.4% of high-severity drug interaction alerts [3]. Table 2 contains recommendations for chemotherapy prescribing and preparation error prevention. These recommendations can support or be used as institutional policies and procedures, especially in smaller community-based oncology practices. (4) Continuing Staff Training and Instantaneous Access to Information Staff members must be trained, and ongoing Continuing Medical Education is essential. Likewise, frequent reemphasis of aseptic technique for procedures such as hand washing and starting i.v. infusions must be done. Moreover, reference texts, computer programs, and/or PDAs should be available at nursing stations. Protocols, particularly experimental protocols, should be readily accessible, preferably on the patient s chart. Table 2. Chemotherapy error prevention recommendations for chemotherapy prescribing and preparation Chemotherapy orders Develop a list of required elements, including patient data, that each set of chemotherapy orders must contain. Use standardized preprinted order forms or computerized prescriber order entry systems with built-in approved protocols and alerts. Never give verbal orders for chemotherapy (fax or orders instead). Use a high-quality fax machine to receive chemotherapy orders and avoid faxing copies of copies. Handwrite chemotherapy orders in printed block letters. Write, imprint, or enter the patient s full name on chemotherapy order forms. Write or enter the date and time the chemotherapy orders are generated, and state the date and time chemotherapy is to be administered if different from the order date and time. Use military time, print AM and PM or use another identifier, such as 12 noon to avoid confusion. Review the patient s allergy and drug-related adverse event history. Calculate or confirm body surface area calculation. Review the patient s data (e.g., diagnosis and stage of disease, laboratory test results, patient s weight) and select the initial treatment protocol. For subsequent treatments, review patient data to determine if dose escalation or reduction is indicated. Review the patient s treatment records. Confirm that there has been an appropriate time interval since the patient s last treatment. Determine the patient s cumulative chemotherapy dose when indicated. Review the patient s response to treatment and identify treatment-related toxicity that may require dose adjustment or a new treatment plan. (continued)

4 466 Preventing Chemotherapy Errors Table 2. (continued) Chemotherapy orders Specify drug name, dose, route, and rate. For continuous chemotherapy infusions, state daily dose and total dose to be administered. Specify sequencing of chemotherapy agents to be administered when applicable. Spell out generic names of chemotherapy agents. Spell out the word units. Use a consistent dose form, such as milligrams (mg), for all doses. Do not use trailing zeros for any dose >1 mg (e.g., 2 mg). Always place a leading zero in doses <1 mg (e.g., 0.8 mg). Double-check dose calculations. Check to see that chemotherapy orders are complete and include antiemetics, hydration, protective agents, and growth factors when indicated. Order test doses of chemotherapy if applicable. Specify patient monitoring parameters and frequency when indicated. Sign the orders and include contact information (e.g., phone or pager number) when required. Chemotherapy preparation Clearly label stock bins of chemotherapy agents. Place look-alike, sound-alike alerts on bins containing chemotherapy agents with similarly appearing or sounding names. Review the patient s allergy and drug-related adverse event history. Review the patient s data (e.g., laboratory test results, patient s weight) and treatment protocol to determine if the chemotherapy orders are consistent with the protocol and appropriate for the patient. Review the patient s treatment records. Confirm that there has been an appropriate time interval since the patient s last treatment. Confirm the patient s cumulative chemotherapy dose if applicable. Review the chemotherapy orders. Recalculate chemotherapy doses. Obtain additional information or clarification when indicated. Calculate and recheck preparation computations (e.g., diluent volumes, final concentrations, additives, overfill, dose) and note special directions, such as using a filter to prepare the drug. Prepare labels and include storage and expiration information. Select vials of chemotherapy that contain appropriate dose strengths and when applicable, note the amount that must be discarded to equal the patient s prescribed dose. Examine expiration dates on the vials and record drug lot numbers. Recheck chemotherapy preparation calculations. Compare prepared labels with chemotherapy orders to ensure that the patient s name, drug, dose, route, and time match. Prepare chemotherapy in accordance with manufacturers recommendations, inspect final solution, and apply labels. Place prepared chemotherapy in a plastic bag and have it transported for administration or store the agents according to the manufacturer s recommendations. Table 3. Chemotherapy error prevention recommendations for chemotherapy administration Review the patient s allergy and drug-related adverse event history. Review the patient s data (e.g., laboratory test results, patient s weight) and treatment protocol to confirm if doses are appropriate and correct. Review the patient s treatment records. Confirm that there has been an appropriate time interval since the patient s last treatment. Confirm the patient s cumulative chemotherapy dose when indicated. Review the patient s response to treatment and identify treatment-related toxicity that may require symptom management. Review the chemotherapy orders. Confirm that all required elements are present, including ancillary medications, such as antiemetics, and patient monitoring instructions. Recalculate chemotherapy doses. Obtain additional information or clarification when indicated. Compare the labels on the prepared chemotherapy agents with the chemotherapy orders and treatment plan or protocol. Note if specific sequencing of agents is prescribed. Provide patient teaching verbally or in writing. Verify patient identity using two identifiers other than the patient s room number or chair assignment. Check armbands, ask patients to state their social security number or complete address, or show their driver s license or other photo identification. Administer chemotherapy agents as prescribed. Monitor the patient for adverse events, such as hypersensitivity reaction, chemotherapy infiltration, vesicant extravasation, etc. Provide or reinforce postchemotherapy patient teaching, including instructions on self-care, monitoring and reporting side effects, symptom management, etc. The Oncologist

5 Schulmeister 467 (5) Using Systems of Patient Identification Having two patients with common names such as Smith in the same hospital unit is a common source of error but not the only one. Five percent of the 3,871 chemotherapy errors reported to the USP involved patients inadvertently receiving the incorrect chemotherapy [4]. Schulmeister [5] found that 14% of 140 reported chemotherapy errors involved patient identification. Outpatients sometimes do not wear armbands, the best patient identification. Here is where the patient can help with telling you their name, date of birth, social security number, and other identifiers present on the chart. At least two identifiers in addition to name should be checked. Table 3 lists chemotherapy administration error prevention strategies that nurses administering chemotherapy can use as a safety checklist. (6) Focusing on Pharmacy Concerns The hospital or office pharmacy can be organized to decrease errors. Because many oncology drugs have names that can look like or sound like other drug names, special care is required when handling these drugs (Table 4). Warning labels and signs to identify them on the shelf draw attention to possible confusion among agents with similar names, such as the vinka alkaloids, the anthracyclines, the taxanes, and actinomycin/daptomycin. Giving the therapeutic dose of vinblastine instead of vincristine could be lethal. Misreading a calendar or miscalculating the number of weeks between treatments can be avoided by scheduling several months in advance on a calendar with a copy for the patient. Error Reporting Chemotherapy error reporting provides information about the types of errors that occur, their severity, and hopefully, factors that led to their occurrence. Error reports are filed internally in most health care institutions and externally to reporting organizations such as the U.S. Food and Drug Administration and USP Medication Reporting (MER) Program. The MER program, operated by the USP in cooperation with the ISMP, is a confidential national voluntary reporting program that analyzes the system causes of medication errors and identifies recommendations for prevention. Regulatory agencies and pharmaceutical manufacturers are notified of needed changes, which may include changes in product naming, packaging, and labeling. The ISMP also created the ISMP Medication Safety-Assessment newsletters. Table 5 lists agencies that are involved in patient safety and medication error prevention. Table 4. Look-alike, sound-alike chemotherapy and supportive care agents Drug Can look and/or sound like Adriamycin Aredia, Idamycin aldesleukin oprelvekin Alkeran Leukeran asparaginase pegaspargase BiCNU CeeNU capecitabine gemcitabine carboplatin cisplatin carmustine lomustine cisplatin carboplatin cyclophosphamide cyclosporine Cytosar Cytoxan, Cytovene Cytoxan Cytosar, cytarabine darbepoetin alfa epoetin alfa daunorubicin doxorubicin docetaxel doxorubicin Doxil, paclitaxel daunorubicin, doxorubicin liposomal, Doxil, Droxia, idarubicin Doxil doxorubicin, Droxia doxorubicin liposomal doxorubicin, doxacillin Epirubicin Daunorubicin, doxorubicin, idarubicin Epogen Neupogen Ethyol ethanol filgrastim pegfilgrastim, sargramostin fluorouracil flucytosine, fluocinonide folinic acid folic acid gemcitabine capecitabine Gemzar Cytosar Idamycin Adriamycin idarubicin doxorubicin interferon Imferon irinotecan Topotecan leucovorin Leukine, Leukeran Leukeran Alkeran, leucovorin, Leukine Leukine Leukeran lomustine carmustine melphalan Myleran methotrexate methohexital mitomycin Mithramycin, mitoxantrone mitoxantrone mitomycin Myerlan melphalan Neumega Neulasta, Neupogen Neupogen Neumega oprelvekin aldesleukin paclitaxel docetaxel, Paxil, paroxetine Paraplatin Platinol -AQ Platinol -AQ Paraplatin Proleukin Leukine tamoxifen Tamiflu, tamsulosin Taxol Paxil, Taxotere Taxotere Taxol vinblastine vincristine, vindesine, vinorelbine vincristine vinblastine, vindesine, vinorelbine

6 468 Preventing Chemotherapy Errors Table 5. Organizations and agencies that promote patient safety and medication error prevention Agency or organization Agency for Healthcare Research and Quality American Society for Healthcare Risk Management American Society of Clinical Oncology American Society of Health-System Pharmacists Institute for Healthcare Improvement Institute for Safe Medication Practices Institute of Medicine Joint Commission on Accreditation of Healthcare Organizations Leapfrog Group National Coordinating Council for Medication Error Reporting and Prevention National Patient Safety Foundation National Quality Forum Oncology Nursing Society U.S. Food and Drug Administration Center for Drug Evaluation and Research U.S. Food and Drug Administration MedWatch Reporting Program U.S. Pharmacopeia Medication Error Reporting Program Summary Chemotherapy agents have a narrow therapeutic index; even minor errors potentially can cause serious harm. Examples of chemotherapy errors include chemotherapy administration to the wrong patient, chemotherapy under- and overdosing, and incorrect route, rate, and time of administration. If treatment plans and chemotherapy orders are not verified during each treatment, errors may be repeated during subsequent chemotherapy treatments and go undetected throughout an References 1 Computer Entry a Leading Cause of Medication Errors in U.S. Health Systems. Rockville, MD: U.S. Pharmacopeia, Available at vocuspr.vocus.com/vocuspr30/dotnet/newsroom/query.aspx?sitena me=uspnews&entity=prasset&sf_prasset_prassetid_eq=95555 &XSL=PressRelease&Cache=True. Accessed February 23, Institute for Safe Medication Practices. Landmines and Pitfalls of Computerized Prescriber Order Entry, Available at Newsletters/acutecare/articles/ asp. Accessed February 2, Web site entire treatment course. To prevent errors, chemotherapy must be viewed as high-alert medication. Policies and procedures need to be in place that address obtaining, storing, ordering, transcribing, dispensing, transporting, administering, and monitoring these agents. Disclosure of Potential Conflicts of Interest The author indicates no potential conflicts of interest. 3 Weingart SN, Toth M, Sands DZ et al. Physicians decisions to override computerized drug alerts in primary care. Arch Intern Med 2003;163: U.S. Pharmacopeia. USP medication error analysis. USP Patient Safety CAPSLink TM, April, 1 5, Schulmeister L. Chemotherapy medication errors: descriptions, severity, and contributing factors. Oncol Nurs Forum 1999;26: The Oncologist

VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Acute Nausea and Vomiting (N&V) Etiologies:

VI.2 Elements for a Public Summary VI.2.1 Overview of Disease Epidemiology Acute Nausea and Vomiting (N&V) Incidence: The incidence of acute and delayed N&V was investigated in highly and moderately emetogenic