Improving the Cancer Chemotherapy Use Process By David S. Fischer, Sandra Alfano, M. Tish Knobf, Constance Donovan, and Nancy Beaulieu Purpose: Reports of the tragic consequences of erroneous cancer chemotherapy overdoses at a prominent cancer center and a university hospital prompted a review of our institution's practices and those of 123 other hospitals to ascertain for each the current in-house process to prevent chemotherapy errors. Methods: A multidisciplinary committee of oncologists, nurses, and pharmacists reviewed the chemotherapy use process and identified opportunities for improvement. A 1 -page facsimile survey was answered by 150 of 215 members of the American Society of Clinical Oncology (ASCO) who received it. Results: We further restricted the writing of cytotoxic chemotherapy orders to physicians who were board-certified or -eligible in hematology or medical, pediatric, and gynecologic oncology and their approved fellows. Dispensation of drugs is limited to oncology-certified pharmacists, and administration to chemotherapy-certified nurses. Standard orders are used either on special oncology forms or designated order sets in the computer.

Procedures to regulate the ordering of antineoplastic drugs for nonmalignant indications by nononcology specialists are outlined. A process to prevent chemotherapy errors is in place in 95% of hospitals. Dedicated medical oncology units are ubiquitous, and most cancer centers and university hospitals have dedicated gynecologic and pediatric oncology units. Chemotherapy orders are generally written by oncology fellows and countersigned by an attending oncologist in cancer centers and university hospitals, whereas private oncology attending physicians write them in most community hospitals. Drugs are administered by oncology-certified nurses in most institutions. Conclusion: These recommendations should improve the safety and effective use of chemotherapy and reduce the error rate to as close to zero as human fallibilitywill allow. J Clin Oncol 14:3148-3155. © 1996 by American Society of Clinical Oncology.

fHYSICIANS, nurses, and pharmacists receive inten-

Under the best of circumstances, cancer chemotherapy is toxic to some degree, and with escalating doses it can be hazardous, with frequent morbidity and occasional mortality. The degree of toxicity is influenced by many factors, which include but are not limited to the drug, drug administration (dose, route, and schedule), combination drug regimens, individual patient status, and multimodality therapy. In recent years, the trend to dose-intensive therapy and marrow-ablative therapy with stem cell or bone marrow transplantation has led to a form of brinksmanship, whereby the patient is given near-lethal or frankly lethal doses of cytotoxic drugs and then provided hematopoietic rescue with stem cells or autologous marrow. This approach has frequently been successful, but leaves little or no margin for error. In March 1995, newspaper headlines revealed the tragic consequences of erroneous cancer chemotherapy overdoses at one of the leading university cancer centers in the United States, with one mortality and one irreversible disablement with severe cardiac damage. 6 This episode emphasized the reality of the risk of drug errors and heightened the awareness of the public, media, patients, and health care professionals. Stimulated by that event and the likelihood that it was representative of other such tragedies that were not reported, a multidisciplinary committee of medical oncologists, nurses, and pharmacists was convened in April 1995 at Yale-New Haven Hospital to review current chemotherapy practice and institutional guidelines and to identify opportunities to improve the overall process. The importance of the committee's goals was further highlighted by the report in June 1995 of yet another fatal chemotherapy drug error at a renowned midwestern university medical center."

1

sive professional education and training for their

critical roles in health care, and have a strong motivation to perform well. Accordingly, the public has placed great trust in them and expects near-flawless performance. One of the earliest self-examinations of the magnitude of iatrogenic injury in health care was from our own institution in 1964, which showed a 20% iatrogenic injury rate on a medical service.' A report in 1981 from another university hospital showed a 36% injury rate, with many of the iatrogenic events being serious or life-threatening and more than 50% medication-related.2 In 1991, a series of reports showed that approximately two thirds of the events were due to errors-and hence preventable. 5 Prominent media coverage of similar reports caused much public apprehension and demands for improvement .6 Analyses of the errors concluded that most involved adverse drug events. Subsequently, many generic suggestions for prevention of drug errors have been made, which include systems improvement and the use of computers. 9 ' 2 This review is related only to cancer chemotherapy drugs and associated guidelines to prevent errors in prescription, dispensation, and administration.

From Yale New Haven Hospital and the Yale Cancer Center, New Haven, CT. Submitted January 24, 1996; accepted.June 17, 1996. Address reprint requests to David S. Fischer, MD, Yale Cancer Center, Yale University School of Medicine, 333 Cedar St, PO Box 208028, New Haven, CT 06520-8028. © 1996 by American Society of Clinical Oncology. 0732-183X/96/1412-0021$3.00/0

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Journal of Clinical Oncology, Vol 14, No 12 (December), 1996: pp 3148-3155

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IMPROVING THE CANCER CHEMOTHERAPY USE PROCESS METHODS In our own institution nearly 20 years ago, there was one fatal and one nonfatal drug error with cancer chemotherapy. That stimulated the development of practice guidelines and institutional policies in an attempt to prevent further treatment-related morbidity. This early change began with a team that consisted of physicians, nurses, and pharmacists, which remains an integral part of oncology practice at Yale-New Haven Hospital. With emphasis on a team approach in which each professional has integral responsibility for patient outcome, it is clearly evident that sharing information is essential. Multidisciplinary communication is the cornerstone in the provision of safe and effective chemotherapy, especially in centers that have large numbers of practitioners, a variety of specialties, and the ability to conduct clinical trials. In 1979, an in-house Cancer Chemotherapy Manual was published and distributed to house staff and oncology nursing units,' 4 and a "Cancer Chemotherapy Certification Course for Registered Nurses" was instituted. The course had both a didactic and a clinical practicum component. In 1986, the responsibility to write chemotherapy orders was restricted to board-certified or board-eligible oncologists and oncology fellows in training, which eliminated the writing of chemotherapy orders by house staff. An oncology pharmacy admixture service was established to provide for pharmacycompounded chemotherapy doses to increase safety and decrease employee exposure. In addition, a standardized chemotherapy prescription form was developed and implemented. Significant improvement in the completeness of chemotherapy orders and a significant decrease in the pharmacy time to clarify orders were observed after implementation of the standard form.'5 In the early 1990s, our institution made a transition to the Alltel (formerly known as TDS) computer system (Atlanta, GA). This clinical-care support system uses physician-order entry. Incorporation of this system has allowed us to standardize orders into an acceptable format and to create order sets, which are hard-coded into the system and available for repeated use. Thus, the standardized prescription form was replaced with computer chemotherapy order sets that included the dosage, day, frequency, and rate of administration for each chemotherapeutic agent in the regimen/protocol, type and amount of administration solution, administration sequence in relation to other agents, and a blank space for the final dose. In addition, an antiemetic and a hydration (if appropriate) regimen were also a part of each order set. At the same time, preprinted order sets for frequently used regimens and protocols were developed using the standard chemotherapy prescription form for the outpatient setting, which is not yet computerized. All order sets were reviewed and approved by the attending physician staff. In addition, greater emphasis was placed on order verification by the pharmacy and nursing staff. Currently, specific pharmacy-based computer systems to track chemotherapy are being evaluated.

eral types of ordering errors had been intercepted. The errors described can be placed into two categories: omissions (eg, not ordering one of the agents in the regimen, no prehydration and posthydration for cisplatin) and wrong dose (eg, full dose ordered in situations that required dose modification, incorrect final dose related to using body surface area in meters squared from the previous cycle in situations in which the patient had significant weight loss, incorrect final dose related to using actual weight in circumstances in which the patient's weight was > 40% above ideal). When nurses detected these ordering errors, they discussed them with the prescribing physician and the errors were then corrected. In recent years, the pharmacy began to record incidents that were prevented. We do not have comparative data that have been collected as our practice guidelines have evolved. However, we have noted an increase in reports from fiscal year 1994, when 32 chemotherapy errors were prevented, to fiscal year 1995, when 59 chemotherapy errors were prevented. This increase may indicate that more errors are prevented by stricter guidelines, or it may simply reflect increased vigilance due to heightened sensitivity on the part of the pharmacists. Of 59 errors prevented in fiscal year 1995, the error was related to the following: the wrong drug was ordered (n = 2), the wrong dose was ordered (n = 24), a potential extra dose was avoided (n = 17), a dose was potentially omitted (n = 10), and the time of administration was incorrect (n = 4). A wide variety of chemotherapy agents were involved, but the most frequent included etoposide (n = 9), cisplatin (n = 10), and cytarabine (n = 6). As an example, a potentially fatal chemotherapy error was averted by a pharmacist's intervention. A surgical resident called the inpatient pharmacy to request methotrexate 50 mg for intravenous use immediately in the operating room. The request was refused because verbal orders for chemotherapy are not acceptable according to our guidelines. Further, it was determined that a medical oncologist had requested that the methotrexate be put into the Ommaya reservoir that was being placed by the neurosurgeon. When the attending oncologist was contacted, he indicated that he had suggested 15 mg, not 50 mg, and canceled the order, deciding to make the correct injection himself. The system worked, and a potential tragedy was averted. Despite the apparent success of the existing standards for chemotherapy use, a number of issues were raised for discussion during the recent process review: acceptability of verbal orders, responsibility for initial transcription of the prescribed chemotherapy, prescribing of chemotherapy drugs by nononcologists, tracking of cumulative doses of specific drugs (eg, doxorubicin, bleomycin, and mitomycin), administration of chemotherapy to patients on nondedicated oncology units, resource availability in a time of organizational restructuring (eg, certified nurses and oncology pharmacists), and educational preparation for new drug therapies. Several of these issues required considerable discussion for consensus on recommendations for institutional practice guidelines.

Reevaluation of the Chemotherapy Process Although significant safeguards and guidelines existed, the committee believed that the process could be further improved. The purpose of the review was to identify collaboratively the opportunities for improvement in the prescribing, compounding, and dispensing of chemotherapy and the administration process. The outcome of the review is a set of recommendations entitled "Multidisciplinary Practice Guidelines." During the process review, we found that the current system of guideline policies had worked well, with no known fatal chemotherapy errors in that period. Anecdotal reports from nurses over the last 3 years indicated that during the order-verification process, sev-

RESULTS Verbal Orders Verbal orders for chemotherapy were generally perceived as unacceptable. However, specific clinical circumstances were identified that challenged the acceptability of verbal orders. To increase patient safety, the committee agreed that verbal orders were not acceptable to initiate chemotherapy, but modification of an existing order to reduce the dose of chemotherapy was reasonable.

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FISCHER ET AL

3150 To increase patient safety further and to decrease professional liability, the committee agreed that two professionals should listen to and document the verbal order to avoid any discrepancy. Chemotherapy Prescription The act of prescribing the chemotherapy (preprinted standard order sets, ad hoc written orders, or computer entry) was perceived by the committee as an essential physician responsibility. Practitioners may argue that another professional, such as a nurse, may commit the order to writing but may not proceed until the physician signs and presumably checks what is written. However, the multidisciplinary committee found this argument unacceptable because the physician's checking step may be rushed or not take place at all. Thus, it was concluded that an essential check (the nurse checks the physician's order) is not confidently being replaced by a comparable check (the physician checks the nurse's written order). Physician responsibility for chemotherapy order-writing is consistent with medicine's and nursing's scope of practice, and ensures the system of checks by each discipline involved before the order is instituted. Drug Cumulative Dosage Some drugs, eg, anthracyclines, bleomycin, and mitomycin, are known to result in patient toxicity if cumulative doses administered to a patient exceed certain maximum levels. Yet it may be difficult to ascertain the current cumulative dose level for an individual patient, since drugs are administered in a variety of settings and patients are often referred from one institution to another. The committee agreed that the attending oncologist maintains the responsibility to track these data and document the current cumulative dose level before each treatment. Education and Resources Communication between the physicians, nurses, and pharmacists involved in new treatment regimens is essential before patient treatment, especially for investigational agents and research protocols. The educational format should be tailored to meet the needs of the service and the disciplines involved. The feasibility to implement a new treatment protocol related to nursing, pharmacy, and institutional resources must be assessed, especially in today's climate of cost control and organizational changes. The committee recommended that all new protocols be reviewed by nursing and pharmacy services to assess the availability and allocation of resources to meet the research requirements and patient needs and ensure safe administration of therapy.

Ordersfor Cytotoxic Chemotherapy Drugs by Nononcologists There are numerous physicians in specialties outside oncology who currently write orders for cytotoxic chemotherapy drugs for a variety of conditions other than cancer, such as dermatologists, gastroenterologists, rheumatologists, infectious disease/AIDS specialists, or neurologists. We believe that every clinical department and section that uses such drugs should have a representative committee compile a list of indications, doses, and protocols for their specific use based on peer-reviewed literature and distribute it to the physicians in their department and to the pharmacy. The lists should be readily available on the clinical units where those drugs will be administered to allow for verification of orders. When a physician uses a drug that is not on the list, he should be required to indicate in the chart in writing why he is ordering a nonstandard drug or regimen and provide a justification. Multidisciplinary Practice Guidelines I. Baseline professional training A. There are three primary disciplines involved in the chemotherapy process. Each professional should have a baseline knowledge of cancer chemotherapy before practicing. Although the committee agreed on most of the following criteria for practice standards, there was not unanimity, and the recommended guidelines are the sole responsibility of the authors. We suggest: 1. Physicians authorized to write chemotherapy orders for neoplastic disease states should be board-certified and/or board-eligible hematologists or medical, pediatric, radiation (for specified drugs on protocol), or gynecologic oncologists and the oncology fellows who have been deemed capable by the section chief. An attending physician thus qualified should routinely check and countersign chemotherapy orders written by an oncology fellow during the first 2 months on the clinical service. 2. In acute-care hospitals, which are not solely cancer centers, many nononcology specialties use antineoplastic drugs for treatment of nonmalignant conditions in dermatology (eg, methotrexate for psoriasis) or rheumatology (cyclophosphamide for patients with lupus nephritis). The recommendations for these nononcology specialties that use cytotoxic

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IMPROVING THE CANCER CHEMOTHERAPY USE PROCESS

chemotherapy include having the department or section register with the pharmacy department the usual agents, dose ranges, and indicated diseases, with provision of published reference sources and/or Institutional Review Board-approved protocols for these treatments. 3. Registered nurses who will handle and administer chemotherapy need to be cancer chemotherapy-certified. Certification includes: * attending a chemotherapy certification course * successful completion of a written examination * demonstrated competency in administering chemotherapy * attendance at a yearly update session to remain certified 4. Pharmacists involved in chemotherapy practice must complete the departmental staff development chemotherapy lecture series. Completion includes: * successful completion of a written examination * demonstrated competency in safe and accurate chemotherapy compounding and handling * attendance at a yearly update session to remain certified II. Standard practice A. Oncologists or oncology fellows should be solely responsible for writing chemotherapy orders and/or entering them into a computer or specially authorized chemotherapy order form. To maintain a system of checks, it is imperative that the physicians complete the first step of order-writing-which includes dose calculations and modifications. This also encompasses a practice of limiting verbal chemotherapy orders to dose reduction in modification of an existing order. B. The chemotherapy order should be composed in a standard format. Computer order sets should be created and/or order sheets preprinted with standard and commonly used regimens. Drugs should always be ordered by the generic or US Assigned Name, which is consistent with usage in our hospital formulary, and the three federally recognized compendia. Although the trade name or an abbreviation or jargon name may be placed in parentheses if it will add to the clarity of the order, it is

not an acceptable substitute for the generic name even though a cooperative group protocol uses it. When free-form chemotherapy orders are written for unusual or nonstandard drug regimens, a reference to the source(s) that provided the basis for the order must be cited and, when possible, a copy of the relevant source placed in the chart and an explanation given in writing as to why this particular therapy was chosen. Initial creation of preprinted orders or order sets should be the responsibility of one discipline and verified independently by the other two. This would include a formal sign-off when the check is complete. C. Journal articles, abstracts, outside institutional protocols, and any other potential treatment references that represent the source of the orders or clarify them should be made known to all involved professionals by placement of a direct copy in the patient's chart before treatment. Copies of outside institutional protocols should also be made available to the pharmacist. This direct copy should contain at least the following information: generic drug name, dose, dosage schedule, side effects or toxicity, rationale for the regimen, necessary dose reductions, and administration guidelines. D. All orders should be written using the following format: generic drug name, dose to be given (in milligrams), dosage used (milligrams per meter squared or per kilogram), frequency, days of administration, and infusion guidelines. Ordinarily, the total dose for the course should not be listed on the order sheet or the computer order screen, lest it be misinterpreted as a single dose to be administered. (For continuous infusion pump delivery, the total dose to be infused over the set period must be included, but there should be a notation of how much is to be delivered each day.) All pertinent information must be supplied to ensure a safe and accurate order capable of verification. Standard chemotherapy reference texts"'6 22 and handbooks 32 26 and standard drug references 27 29 should be readily available to physicians, nurses, and pharmacists on all patient-care areas and the central and decentralized pharmacy. F. An increasing number of patients are being treated on protocols. Any protocol that accrues patients must be approved by the Institutional Review Board. When a new protocol is instituted, multidisciplinary education must take place before patient enrollment. This is especially important when protocols involve investi-

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gational agents, high-dose therapy, and unusual or new combination therapies. This education must ensure adequate communication between the principle investigator, clinic nurses, research nurses, inpatient nurses, and all oncology pharmacists. Copies of all new protocols and amendments must be placed in designated patient-care areas, clinics, and central and decentralized pharmacies. Preprinted or computer order sets should be configured and in place before patient enrollment to avoid order variability and ambiguity. New protocols or unusual therapies should not begin off-hours or on weekends unless it is an acute emergency situation. They should be initiated on weekdays when appropriate specialists and clinicians are available. G. Order verification and/or double-checking enhances safe chemotherapy practice, and there should not be any exceptions to this. The nurse and pharmacist are each independently responsible for the following: * check entire order set against an acceptable reference (protocol, journal article, chemotherapy text or handbook, abstract, computer hard copy of order set, etc.) * verify that current body surface area, height, and weight are correct * verify the final dose of each drug * check the rate of administration, amount, and type of solution * check the antiemetic regimen, prehydration and posthydration, for omissions or additions of ancillary medication therapy * compare current orders with previous therapy-consider any radical changes * check that an x-ray has been read to confirm central venous access for new line placements for continuous vesicant infusions * if dose modification has been made, confirm parameters with reference or research protocol and then consult with prescriber to verify rationale if nonstandard modification was made * determine if appropriate laboratory values are within normal parameters, based on known organ-specific toxicity of each drug, in addition to hematologic parameters; abnormal values should be called to the attention of the prescriber and treatment modifications made after adequate discussion The nursing verification should be completed by two nurses, one of whom is a certified che-

motherapy nurse. Each should sign each chemotherapy order. Nurses must also verify availability of progenitor cells with attending oncologist or oncology fellows in situations that involve bone marrow transplant or stem cell transplant. Research nurses are also responsible for checking laboratory parameters dictated by the research protocol. In addition to the above expectations for pharmacy, pharmacists must ensure that the prescribed solution and administration parameters will enable adequate drug delivery, and ensure compatibility of chemotherapy with intravenous solutions and/or additives. Once orders are double-checked, they should be prepared and labeled following pharmacy compounding policies and safe handling procedures. H. Chemotherapy administration may begin once the final product, which has been checked by a pharmacist, arrives in the designated patientcare area. Two nurses, one of whom must be chemotherapy-certified, must check the final product against the original order before administration. In the clinic setting, one certified nurse and pharmacist should check the final product before administration. The check should take place at the patient's bedside so that the two professionals can ensure that the correct drug is being given to the appropriate patient by checking the identification band in the same fashion that a blood transfusion is checked. The attending oncologist and/or oncology fellow may also administer chemotherapy when necessary after following comparable procedures. I. Chemotherapy administration should occur on dedicated oncology inpatient units and ambulatory oncology sites that are staffed by certified chemotherapy nurses. On occasion, patients are on other units or must be transferred, such as a patient on continuous infusion to an intensive care unit. That nursing staff should then be educated by a certified chemotherapy nurse. All oncology settings should have a standard oncology text, chemotherapy handbook, copies of approved protocols, and a standard drug reference. J. The attending physician who writes the chemotherapy order should be required to include the cumulative dose of anthracycline, bleomycin, and mitomycin previously received by the patient. It should be noted that the system instituted to require notation of previously received cumulative doses should not require current dose and previous dose to be noted on the same

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IMPROVING THE CANCER CHEMOTHERAPY USE PROCESS

screen or together as part of the order, to avoid confusion and potential error. The Multidisciplinary Practice Guidelines offered represent the culmination of two decades of practice evolution at our institution. These guidelines are recommended to establish safe and effective use of chemotherapy in patients treated for cancer. The incidence of chemotherapy-related errors should be zero, but it is human to make mistakes. With guidelines such as those proposed, it is hoped that the error rate will approach zero. Clinical practice guidelines should be reviewed and updated as needed, and at least yearly, by a multidisciplinary team.

1. Does your medical center have a program to monitor cancer chemotherapy orders to prevent or reduce the incidence of error? Yes No Unknown to me 2. Did the publicity in the media last year cause your institution to No Unknown to me Yes reevaluate your program? 3. Does your hospital have a dedicated oncology unit (area) staffed Unknown No with oncology trained nurses? Medical Yes Yes No Unknown Gynecological Unknown Yes No Pediatric 4. Chemotherapy orders are written by: A) Intern; B) Resident C) Any oncology fellow; D) Oncology fellow after 2 mos experience; E) Oncology clinical nurse practitioner; F) Any attending M.D.; G) Only oncology board certified attending M.D.s (check 1 or more) 5. Before dispensing, chemotherapy orders are checked by: A) Floor nurse on duty; B) Oncology certified nurse; C) Pharmacist on duty; D) Oncology certified pharmacist (check 1 or more) Fig 1. Questionaire faxed to 215 ASCO members who were promised that neither they nor their institution would be identified by name in this report. Replies were received from 150 physicians in 123 hospitals.

The Survey To substantiate further the validity of our practice guidelines and to identify the state-of-the-art practice nationwide related to chemotherapy drug safety, a 1-page facsimile was sent to 230 members of the American Society of Clinical Oncology (ASCO) whose names and facsimile numbers were listed in the American Society of Clinical Oncology 1996 Membership Directory. The survey was collected from April 18 to May 16, 1996, with at least one responding ASCO member from every one of the 50 United States, Canada, and Puerto Rico. These respondents included directors of cancer centers, chairpersons of departments, chiefs of sections, senior members of departments, and practicing oncologists in universities and community hospitals. By the nature of ASCO membership, most of these physicians were medical oncologists and/or hematologists, and much smaller numbers were pediatric oncologists, with even fewer gynecologic oncologists. The Official ABMS Directory of Board-CertifiedMedical Specialists 1996 was consulted to connect ASCO members with their major hospital affiliation. Responses were sometimes obtained from two individuals in the same hospital. Survey Results Of 230 surveys sent by facsimile, 15 did not connect, because either the line was out of service or the number was incorrect. Thus, 215 were successfully sent, with 150 physicians responding, a 70% response rate. To compare peer-group institutions, we targeted the inquiries and later the analysis to four groups, two well-defined and two less clearly defined: 1. National Cancer Institute (NCI)-designated Comprehensive Cancer Centers; all 26 responded. 2. NCI-designated Clinical Cancer Centers; all 17 responded. 3. University hospitals, medical school hospitals, and

free-standing children's hospitals with a university affiliation. The university hospitals ranged from large, wellknown institutions to small medical school hospitals in states with relatively small populations and hence small oncology services. 4. Community hospitals. A few were large municipal hospitals; most were medium-sized hospitals with an academic affiliation, but were not significant teaching arms of a medical school. The exact questions asked are shown in Fig 1. The data are listed in Tables 1 and 2, and refer to the 123 hospitals, not individual respondents. When there was a discrepancy about the presence of a dedicated unit in a hospital, we accepted the answer of the individual in the relevant specialty. When there was a discrepancy about who wrote chemotherapy orders, it was usually between individuals on different specialty services, and we credited all responses. The choice of "only oncology board certified attending M.D.s" was confusing and, in retrospect, poorly worded. Many respondents crossed out the word "only," and others crossed out "board certified" and wrote "eligible also" in the margin. The question of who checks chemotherapy orders before dispensation was also confusing to some and definitely misleading to others. A few interpreted the question to refer to the final person checking before dispensing, and indicated either a nurse or a pharmacist, and a few even wrote in "fellow" or "attending." Some knew and pointed out that there is no formal national certification process for pharmacists as there is for nurses. The Oncology Nursing Society certifies nurses on the basis of a standardized national examination as an Oncology Certified Nurse (OCN). This is different from institutional certification for administration of chemotherapy. Most interpreted the question as we meant it: to refer to nurses who had additional specific in-hospital education in che-

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FISCHER ET AL Table 1. Survey of Hospital Programs to Monitor Chemotherapy

Parameter Program in place Recently reevaluated

Comprehensive Cancer Center n = 26)

Clinical Cancer Center In = 17)

No.

No.

%

No.

%

No.

%

University Hospital (n= 49)

Community Hospital In = 31) %

26/26 24/26

100 92

17/17 14/17

100 82

47/49 36/47

96 77

27/31 21/28

87 75

25/25 24/25 22/24

100 96 92

15/15 14/15 12/14

100 93 86

43/43 22/34 28/38

100 65 74

30/31 6/29 3/24

97 21 13

Dedicated Oncology unit Medical Gynecologic Pediatric

NOTE. For the exact questions asked with regard to the existence of programs to monitor chemotherapy to prevent errors and whether these programs were reevaluated after publicity about the tragic errors of 1995, see Fig 1. Also, note that when a category of hospitals has less than the total number of hospitals surveyed as the denominator, it may be because the hospital respondent left that part of the question unanswered, "unknown" was designated, or a specialty hospital had no such unit leg, a veteran's hospital would have no gynecologic or pediatric unit, and a children's hospital would have no adult medical or gynecologic unit). The number of negative responses is the difference between the numerator and the denominator.

motherapy drug administration. Similarly, with regard to pharmaceutical dispensation, most interpreted the question as we intended it: to refer to pharmacists who had attended an in-hospital training program in dispensation of chemotherapy drugs and passed a certifying hospital examination. One respondent even offered to send us a copy of the training and certification program. Survey Conclusions All NCI-designated Cancer Centers have a process in place to prevent chemotherapy errors, and the vast majority of university centers and community hospitals now have such a process in place. Although the tragedies reported in March and June of 1995 have no redeeming features, the publicity associated with them did contribute to a national reawakening to a pervasive problem and Table 2. Survey of Hospital Chemotherapy Order-Writing and -Checking Clinical Comprehensive Cancer University Community Cancer Center Center Hospital Hospital

Parameter Written by Intern

1

0

1

0

Resident

1

0

3

1

18

13

20

3

4

1

10

1

7 7 19

4 4 13

13 10 35

4 7 30

11 22 15 16

7 12 11 10

20 35 25 27

16 26 24 9

Oncology fellow Oncology fellow > 2 months

Oncology nurse Attending physician Attending oncologist Checked by Nurse Oncology nurse Pharmacist Oncology pharmacist

NO E. For the exact questions asked with regard to who wrote the order for chemotherapy and who checked it, see Fig 1. Note that several different categories of individuals may write orders in a given hospital. Before drug administration, a floor nurse or an oncology-trained nurse and a pharmacist or an oncology pharmacist or any combination thereof may check and verify the accuracy and reasonableness of the order.

started most institutions on a program to institute or reevaluate their process to prevent chemotherapy errors. Thirty-eight of 43 Cancer Centers indicated that they had been so motivated, and the few who responded "no" indicated in a marginal note that they had such a process before the publicity and were satisfied with their existing system. Thirty-six of 47 university centers and 21 of 28 community hospitals were stimulated to institute or revise their process, and several are still considering doing so. Dedicated medical oncology units are almost universal regardless of the type of institution. More specialized units (gynecologic and pediatric oncology units) are less common, although several centers indicated that they had no dedicated pediatric oncology unit because there is an affiliated children's hospital nearby that has a dedicated pediatric oncology unit. This explains the slightly lowerthan-expected frequency of dedicated pediatric oncology units. The advantage of a dedicated unit with a trained cadre of pediatric-certified (or at least trained) oncology nurses who handle oncology drugs frequently, versus the traditional age-developmental approach that scatters patients who require chemotherapy, is being debated in some centers. We believe that the added degree of safety related to chemotherapy outweighs any psychologic or other compelling reasons for age-clustering. In Cancer Centers and university hospitals, most chemotherapy orders are written by oncology fellows and usually countersigned by an attending oncologist, boardcertified or -eligible. Interns and residents almost never write the orders. In community hospitals, they are written almost exclusively by oncology attending physicians. In 28 of 123 hospitals overall, oncology clinical nurse practitioners (most often on pediatric services) write chemotherapy orders, which are cosigned by the oncologist attending. Before administration, chemotherapy drugs are checked by the staff nurse approximately one third of the time and by an oncology-certified nurse two thirds of the time.

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About half of the Cancer Centers and university hospitals have specific oncology-trained pharmacists who dispense chemotherapy drugs, whereas community hospitals rarely do. This is an area that is receiving some attention. The American Society of Health-Systems Pharmacists has petitioned the Board of Pharmaceutical Specialties for this recognition and the subsequent development of a certification examination. Subsequent to our initial submission of this article, a series of relevant articles appeared in the American Journal of Health-System Pharmacists(53 [4], 1996). 3 °31 We agree with the recommendation of a tailored education program and a test leading to certification, as well as a call for standardization of the prescribing vocabulary with avoidance of all drug acronyms, abbreviations and brand names. 3 0 DISCUSSION

We were both surprised and gratified by the results of our survey. It is encouraging that most hospitals have a process in place to try to prevent chemotherapy drug errors, and that interns and residents rarely write the orders. We are optimistic that better and more specific training in chemotherapy drug dispensation by pharmacists

and administration by nurses, as well as clustering of patients on dedicated oncology units with resulting greater experience and familiarity with oncology patients and drugs, will lead to greater safety and decreased morbidity. However, much more is required to make this potentially dangerous process as safe as humanly possible. We hope that the implementation of some of our suggestions will contribute to increased safety. Cancer is a major and increasing problem of our civilization. We use many modalities to control it, and we do so most effectively in teams. When using chemotherapy as a modality, the team should include physicians, nurses, and pharmacists who work together on behalf of the patient. Each should have the best training available as attested to by an examination and certification. Each should check the others to prevent errors, for the first rule of medicine remains primum non nocere--first, do no harm. ACKNOWLEDGMENT We would like to thank the 150 members of the ASCO who responded to our survey, and acknowledge the value of the exchange of ideas with the members of the Yale-New Haven Hospital Chemotherapy Process Review Committee.

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