Clinical Study Received: September 17, 2013 Accepted after revision: December 22, 2013 Published online: April 30, 2014

Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

Improving Cancer Patient Care with Combined Medication Error Reviews and Morbidity and Mortality Conferences Florence Ranchon a, f Benoît You b, f Gilles Salles c, e Nicolas Vantard a Vérane Schwiertz a Chloé Gourc a Noémie Gauthier a Marie-Gabrielle Guédat a Pierre-Jean Souquet d Gilles Freyer b, f Véronique Trillet-Lenoir b, f Catherine Rioufol a, f  

 

 

 

 

 

 

 

 

 

 

 

Departments of a Clinical Oncology Pharmacy, b Medical Oncology, c Haematology and d Pneumology, Groupement Hospitalier Sud, Hospices Civils de Lyon, e UMR 5239 and f EMR 3738, University Lyon 1, Lyon, France  

 

 

 

 

 

Key Words Medication error · Medication error review · Mortality-morbidity conference · Oncology · Quality

safety and personnel proficiency. This multidisciplinary work is indispensable to improve future patient management through the critical analysis of past medical errors. © 2014 S. Karger AG, Basel

Abstract Background: To reduce the occurrence of medication errors, a systemic approach was developed combining anti-neoplastic medication error reviews and morbidity and mortality conferences (M&MCs). We report the first experience of implementing this strategy in oncology. Methods: The case reports submitted to combined reviews were prepared by physicians and pharmacists, and medication error(s) were described and chronological and root-cause analyses were performed. Results: Ten combined reviews were conducted, which involved the departments of haematology, medical oncology, pneumology, gastroenterology and clinical oncology pharmacy. A total of 91 errors were analysed, of which 3 had reached the patient. Thirty-four corrective actions were proposed; 53% consisted of changes in practice, 35% in procedural reminders and 12% in on-ward education sessions. Conclusions: The combination of medication error reviews and M&MCs appears to be an efficient means of improving cancer patient

© 2014 S. Karger AG, Basel 0009–3157/14/0595–0330$39.50/0 E-Mail [email protected] www.karger.com/che

Introduction

Morbidity and mortality conferences (M&MCs) were characterised as ‘the delicate nature of learning from error’ by Orlander et al. [1] in 2002, showing how difficult it is to confront participants with errors in meetings. Traditional systematic and collegial analyses of death or complications in hospital patients has resulted in valuable educational benefits in a medical training program for United States physicians [2–4]. M&MCs have further been recognised worldwide as valuable evaluation programs for fulfilling physician’s obligations in assessing their professional practice [5, 6].

Florence Ranchon and Benoît You, and Véronique Trillet-Lenoir and Catherine Rioufol contributed equally to this work.

Catherine Rioufol, PharmD, PhD Department of Clinical Oncology Pharmacy, Groupement Hospitalier Sud Hospices Civils de Lyon, 165 chemin du grand Revoyet FR–69495 Pierre-Bénite Cedex (France) E-Mail Catherine.rioufol @ chu-lyon.fr

The need to reduce avoidable serious events encourages physicians to learn from mistakes, search for root causes and risk factors, and implement corrective and preventive measures. In order to facilitate open discussions about medical errors, defensiveness and blame cultures were gradually abandoned. This approach encourages events be seen as failures of the system rather than an individual’s performance. Beginning with surgery followed by anaesthesiology case reviews [2, 7, 8], M&MCs were more recently extended to other medical subspecialties [9–12]. In oncology, prevention and management of errors are particularly critical because the patients’ health status is poor and the drugs employed are toxic, have a low therapeutic index and are susceptible to be implicated in drug-drug interactions [13–17]. Most studies of medication errors in cancer care report high rates of severe events [18–20]. In a previous study, we found that approximately 5% of anti-neoplastic prescriptions contained at least one medication error [21]. Moreover, errors involving anti-neoplastic agents are recognised as the second most common cause of death related to medication errors [22]. The need to predict individual patient risk in anti-neoplastic treatment led us to investigate risk factors. We identified the following 6 significant risk factors for prescription errors: (1) prescriptions for patients with body surface area ≥2 m2; (2) prescriptions including more than 3 drugs; (3) protocols involving carboplatin dose calculation; (4) protocols requiring at least one modification by the physician; (5) in-patient care prescriptions, and (6) prescriptions by residents [23]. In the present study, we report how we have structured the first systemic approach by combining anti-neoplastic medication error review followed by cancer care M&MCs in order to reduce the occurrence of medication errors in oncology.

Materials and Methods Setting The project was conducted in a French 1,200-bed university hospital (Lyon, France). The centralised cytotoxic preparation unit produces approximately 50,000 doses of anti-neoplastic agents per year for patients treated in the departments of haematology, medical oncology, gastroenterology and pneumology as well as other units involved in the care of cancer patients. The comprehensive prescription process has been defined by consensus. Anti-neoplastic protocols are prescribed by senior physicians and residents. Pharmacists analyse prescriptions by checking patient data (identity, age, weight and height) and the anti-neoplastic regimen to be used. They must check for any dose adjustment

Medication Error Reviews in Oncology

or deviation from the validated anti-neoplastic regimen. Anticancer drugs are prepared by pharmacy technicians, including a double check at each step of the production process and a final real-time analytical control [24]. Case Identification The assessment criterion was medication error, defined as a failure in the prescription/delivery process capable of harming the patient. During routine practice, errors can be detected at every step of the chemotherapy prescription, preparation or administration process by physicians, pharmacists, pharmacy technicians and nurses. Prescription errors are detected by pharmacists by systematic pharmaceutical analysis of all prescribed anti-neoplastic regimens. Preparation errors were detected by double checking the production process, pharmacy technician reporting and final analytical control. Administration errors are reported by nurses and subsequently recorded by physicians. All errors were collected by pharmacists in a dedicated database. Based on our previous results [21, 23], selected events included recent, frequent and severe errors (i.e. errors that contributed to patient damage) or near-miss errors (i.e. errors that did not result in injury, illness or damage, but had the potential to do so). Medication Error Analysis during Combined Medication Error Reviews and M&MCs The methodology was based on published guidelines for M&MCs [25] and medication error reviews [26] using a nonjudgmental and non-punitive approach. The case reports submitted were prepared by physicians and pharmacists, and contained a description of medication error(s) and a chronological analysis. All cases were considered confidential. Events were presented with standardised PowerPoint slides and then analysed during the review process with an open discussion of errors and nearmiss events by all the participants. Whenever it was possible, events were categorised in terms of error types (e.g. dosing error or error in the choice of anti-neoplastic regimens). The rootcause analyses seeking reasons for the failure or the most fundamental factor that may prevent recurrence if eliminated [27] were carried out with a focus on systemic problems, preventability and means of limiting recurrence of the event. Causal analysis included human factors (errors in the judgment or knowledge), equipment malfunction and organisational factors like communication problems, lack of supervision, high-stress situations or understaffing. Descriptive statistics, fishbone diagrams and flow charts were used to analyse cases. The potential severity of the medication error was assessed on the medication error index categorising severity from ‘no patient harm’ to ‘potential patient death’ [28] by physicians and pharmacists. Opportunities for improvement were discussed during the conference and action plans were developed. A report was written for each conference and sent to all participants with detailed corrective or preventive actions decided and the referent for their implementation. Participants Combined medication error reviews and M&MCs were established as an interdisciplinary approach. All health professionals involved in the event or in the care of the patient were asked to participate in these meetings: physicians (residents and senior), pharmacists, nurses and others, as appropriate.

Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

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Table 1. Medication errors intercepted from June 2006 to May 2007 and analysed in the initial combined medication error reviews and M&MCs

Antineoplastic drug prescriptions, n Prescriptions with at least one error, % Type of medication errors Prescription errors, % Data missing on the prescription Dose errors Withdrawal of medical approval Anti-neoplastic regimen error Administration errors, n Pharmaceutical errors, % Data entry Pharmaceutical analysis errors Fabrication errors Storage and dispensation errors

Haematology

Medical oncology

Pneumology

Gastroenterology

Clinical oncology pharmacy department

3,217 4.7

1,632 3.5

2,743 6.1

2,550 4.2

22,138a 0.14b

61.2 (n = 128) 26.8 (n = 56) 2.4 (n = 5) 9.6 (n = 20) 1 – – – –

35.9 (n = 28) 53.8 (n = 42) 3.9 (n = 3) 6.4 (n = 5) 0 – – – –

Potential severity of medication errors assessed by physicians and pharmacists No consequence, % 83.3 76.3 Temporary injury, % 10.7 16.7 Permanent damage, % 4.7 1.8 Vital prognosis compromised and death, % 1.3 5.2

32.5 (n = 25) 57.1 (n = 44) 6.5 (n = 5) 3.9 (n = 3) 0

33.3 (n = 7) 61.9 (n = 13) 0 (n = 0) 4.8 (n = 1) 0

– – – –

– – – –

82.3 15.4 0 2.3

72.2 22.2 5.6 0

– – – – – 11.1 (n = 4) 11.1 (n = 4) 72.2 (n = 26) 5.6 (n = 2) 100 0 0 0

a

 Corresponding to the number of anti-neoplastic preparations. b Corresponding to the number of anti-neoplastic preparations with error.

Results

From November 2009 to January 2012, 10 combined medication error reviews and M&MCs were conducted; they involved the departments of haematology (n  = 3), medical oncology (n = 3), pneumology (n = 1), gastroenterology (n = 1) and the clinical oncology pharmacy (n = 2). On average, 10 health care professionals participated in these meetings (range: 6–14). The first reviews in every subspecialty were aimed at listing all intercepted medication errors from June 2006 to May 2007, and their potential clinical impact if they had reached the patient (table 1). The objective was to inform medical, pharmacy and nursing teams on medication errors. Topics of medication reviews were then defined for subsequent conferences on the basis of the frequency or significance of the detected medication errors. Five combined medication error reviews and M&MCs focused on 3 topics: dosing errors of 3 anti-cancer drugs (carboplatin, trastuzumab and oxaliplatin), anti-neoplastic regimen errors and vincristine administration errors. Tables 2–4 summarise the subjects selected for these 5 conferences, 332

Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

including the types of error presented (e.g. choice of the protocol or dosing error); reasons for selecting topics (e.g. frequency or significance), and analyses of errors, causes, and potential preventive or corrective measures. The relevance of these measures was compared with data published in the literature whenever possible. A total of 91 errors were analysed, of which 3 reached the patient. Others were intercepted before drug administration and were included as near misses. Four meetings involved dosing errors of 3 drugs: carboplatin, which had been identified as a significant risk factor in our previous study [23] (fig.  1); trastuzumab, which was overdosed due to a patient weighing error, and oxaliplatin, which was underdosed in a clinical trial. Regarding carboplatin, the conference identified coapplication of two different calculation formulas (the formula of Chatelut et al. [29] and the formula of Calvert et al. [30]) as the main cause of carboplatin dosing errors. This situation might be a source of confusion, especially for residents used to working in different departments. Moreover, the conference highlighted a population at risk of carboplatin overdose: cachectic or obese patients for which the Thomas formula would be more suitable [31]. Ranchon  et al.  

Table 2. Combined M&MC and medication error reviews (1/3) Topic of the M&MC

Basis for selection

Error analysis

Causes of errors

Preventive and/or corrective measures proposed

Near miss events: Severity anti-neoplastic regimen error

– Non-conformity of anti-neoplastic regimen prescribed compared with the previous cycle or the multidisciplinary medical decision – No prescription in clinical trial sheet – Selection of the wrong protocol in a clinical trial (e.g. arms of treatment)

– Important number of protocols (>800) – Complexity of clinical trial – Limited access to chemotherapy protocol database for resident

– Enhanced level of prescription accuracy of the report of the multidisciplinary medical decision – Classification of protocols in the database – Improved access to computer database protocols

Near miss events: Severity vincristine administration errors

– On 2 occasions, a medical student was stopped just before an intrathecal injection of vincristine instead of methotrexate

– Incomplete reading of the label identifying the contents of the syringe – Lack of knowledge by the medical student of the specific dispensation process for intrathecal preparation

– Replacing the vincristine syringe with an infusion bag – Awareness-raising actions of the change in preparation of vincristine in an infusion bag – Awareness-raising actions of the precaution in the administration of vincristine and vesicant risk if extravasation – Reminder of necessary supervision of medical students for the administration of intrathecal preparations

– Incomplete reading of the protocol – No dose adjustment – Area under the curve not precisely written on the report of the multidisciplinary medical decision – Lack of knowledge or confusion about the formula for calculating the carboplatin dose – Lack of knowledge of the dose limitations of carboplatin at 800 mg used in our hospital

– Enhanced level of accuracy of the report of the multidisciplinary medical decision with the target area under the curve – Creation of a unique calculation tool for all physicians for calculating the carboplatin dose according to the chosen formula – Creation of a decision tree for the choice of formula to be used depending on whether the patient is cachectic or obese – Residents training

Near miss events: Frequency – Error related to the use of an area under the curve [42] different from the carboplatin dose protocol and the one decided on in the errors multidisciplinary medical decision – Error in the application or choice of Chatelut/Calvert formulas – Prescripton of a carboplatin dose >800 mg

A decision tree was drawn up for selecting the best formula among the Chatelut, Thomas and Calvert ones. Anti-neoplastic regimen errors were defined as discrepancies between the prescribed anti-neoplastic regimen and the regimen selected previously by the multidisciplinary medical team. More than 800 distinct anti-neoplastic regimens (prescription forms) are registered in the database, including those of clinical trials open to enrolment. The conference identified this high number of regimens as the main cause of error; however, all are actually used in routine practice. As a result, deleting protocols was not an option. Optimised protocol classification was implemented to facilitate selection with improved computer access in medical wards and pharmaceutical units. A dedicated conference was conducted to analyse 2 near misses involving accidental intrathecal administra-

tion of vincristine, which were both intercepted before administration. Accidental injection of vinca alkaloids into the spinal canal causes ascending paralysis and is known to cause death due to massive encephalopathy and spinal nerve demyelination. As a consequence, the conference considered that 2 deaths had been avoided. However, these 2 near misses demonstrated the insufficiency of previous measures to avoid fatal intrathecal administration of vincristine. A change in presentation (replacing the syringe with an infusion bag) was immediately implemented, in line with published recommendations [32]. During the study period, a total of 34 corrective actions were proposed. Among them, 53% consisted of changes in practice, 35% in procedural reminders and 12% in onward education sessions. The preventive and/or corrective measures proposed were adapted to error typology

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Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

333

Table 3. Combined M&MC and medication error reviews (2/3) Topic of the M&MC

Criterion selection

Errors analysis

Trastuzumab Error – dosing error reaching the patient – –

Oxaliplatin Error – dosing error reaching the patient – – – – – – –

Error transcribing the patient’s weight (+10 kg) on the chemotherapy regimen that resulted in an overdose of 18% in trastuzumab Error not detected by the pharmaceutical analysis of the protocol by the pharmacist Detection of the error during the subsequent course by the pharmacist

Causes of errors

Preventive and/or corrective measures proposed

– Patient’s weight not checked by the prescriber – Weight not checked by the pharmacist

– Comparing the weight of the day with the patient’s weight during the previous course – Having the prescriber write the weight difference on the protocol if it is >5 kg over the previous course – Pharmacist verifies the weight indicated on the protocol

For a clinical trial, supply vials of oxaliplatin – No warning by the promoter (Eloxatin®) as 50 and 100 mg and storage in two of the supply of a new dosage of Eloxatin®(50 mg) different places – Lack of communication No transmission of the receipt of a new dosage (50 mg) and no integration into the between pharmacists and pharmaceutical database pharmacy technicians – Similarity in terms of Prescription of Eloxatin® 189 mg, attribution of packaging and labeling of 2 vials of Eloxatin® 50 mg by the pharmacist for vials of Eloxatin® 50 and the preparation Preparation with 2 vials of Eloxatin® 50 mg instead 100 mg of 2 of 100 mg Detection and interception of this error at the time of double checking of the preparation For the next cycle, prescription of 190 mg of Eloxatin®: attribution of 2 vials of Eloxatin® 50 mg instead of 2 vials of 100 mg by the pharmacist Preparation resulting in an 50% underdosage of Eloxatin®, which was administered to the patient Detection of the error during a monitoring visit

– Awareness-raising actions of the quality of drug storage in clinical trials – Drug attribution in clinical trial double checked by a senior pharmacist – Awareness-raising actions of the quality of double checks during the manufacturing process – Awareness-raising actions of the quality of written and oral transmission of information

Table 4. Combined M&MC and medication error reviews (3/3) Topic of the Criterion M&MC selection

Error analysis

Carboplatin Error – dosing error reaching (fig. 1) the patient – – – – – – – –

334

Prescription of a new line of treatment with carboplatin 800 mg associated with 800 mg of cetuximab based on a misunderstanding of the multidisciplinary medical decision: ‘weekly chemotherapy with cetuximab and carboplatin’ Lack of validated protocol in the database requiring the prescription of two separate regimens for the same patient Preparation and administration to the patient 8 days later, prescription of carboplatin 771 mg and cetuximab 500 mg instead of cetuximab 500 mg alone No detection of the prescription error by the resident pharmacist Pharmaceutical validation of the prescribed protocol without taking into account the existing locks on the pharmaceutical software Preparation of carboplatin 771 mg and cetuximab 500 mg, and administration to the patient 15 days later, prescription of carboplatin 771 mg and cetuximab 500 mg instead of cetuximab 500 mg alone Detection and interception of the error by the senior pharmacist

Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

Causes of errors

Preventive and/or corrective measures proposed



– Double checking by a senior pharmacist of all prescriptions modified by a prescriber – Update protocol database – Update protocols in the pharmaceutical software – Establishing a training program for the pharmacy resident – Information on news related to cancer chemotherapy between pharmacists (student, resident and senior)





Lack of knowledge by medical and pharmacy residents of doses of anti-neoplastic agents Report of the multidisciplinary decision insufficiently detailed Delay too important to create and update new protocols in the database

Ranchon  et al.  

Management

Environment

Quality assurance

Personnel

Overload

Several formulas

Multidisciplinary team Fatigue

Pharmaceutical fabrication software Delay of update

Multidisciplinary decision

Update

Medication

Database of protocol

Procedures

Protocols

Carboplatin dose error

Delay of update

No compliance Number

Inexperienced pharmacist and physician (residents)

Access

Handwritten prescription

Risk factor of error [23] Carboplatin dose calculation

Miscommunication between pharmacist and physician

Knowledge

Pharmaceutical activity

Error prevention

Communication

Lack

Understaffed

Communication

Miscommunication between pharmacists

Lack of details

Materials

Fig. 1. Fish bone diagram on the carboplatin dose error.

and accounted for the specific requirements of every department. Implementation required vigilant monitoring to assess effectiveness.

Discussion

Error management remains a delicate topic, particularly when it concerns patient safety. Pierluissi et al. [33] reported that medical error analysis in M&MCs in 4 North American hospitals covered only 34% of the cases studied, and that only 40% of the errors were explicitly discussed. The high rate of non-recorded errors should encourage the development of structured M&MCs in a blame-free environment [34]. The vast majority of medical errors and preventable deaths actually result from system failures rather than human error [35, 36]. Failure to think critically, provide disciplined treatment strategies and recognise structural failures was recently reported to contribute to a high level of morbidity and mortality [27]. As a consequence, it is critical that M&MC participants feel free to discuss complications without fear of reprisals and focus on improving the quality of care [37]. This report is the first published experience of implementing combined medication error reviews and M&MCs in cancer care. This approach seems necessary to improve cancer patient safety. Indeed, these patients frequently have a poor health status and are treated with Medication Error Reviews in Oncology

drugs that have low therapeutic indexes. These patients are at risk of adverse events at least as much as patients in intensive care units, for whom M&MCs have already been widely developed [5, 11]. Implementation of combined medication error reviews and oncology M&MCs would be facilitated by the pre-existing multidisciplinary team organisation, thereby limiting the need for extra time-consuming meetings. The 10 combined medication error reviews and M&MCs identified 3 topics of investigation. A total of 34 corrective and/or preventive measures were proposed, leading to standardisation of practices, compliance with existing recommendations, and education and training of medical, pharmaceutical and nursing teams. Once put into practice, these measures seem natural, although they frequently emerged after long discussions. All participants in the haematology conferences were already aware of the well-documented fatal risk of accidental intrathecal injection of vincristine [14, 38], but the 2 recent near-miss accidents were reminders that it could still occur. In agreement with other studies, the present report confirms that open discussion of errors and near-miss events may improve error reporting, thereby promoting patient safety [33–35]. Although combining medication error reviews and M&MCs appears to be an efficient means of improving cancer patient safety and personnel education, the approach needs to be defined and standardised in better terms. Case selection appears to be a key but controverChemotherapy 2013;59:330–337 DOI: 10.1159/000358190

335

sial factor of success [27]. Frequent medication errors were the focus of the present study (e.g. dosing error) in order to stimulate participants’ interest and increase the impact of corrective measures. A study of the contents of 279 M&MCs conducted in anaesthesiology departments showed that over half of the cases were presented for their rarity value, which limited the impact of proposed interventions [39]. However, a more recent study demonstrated that formal, evidence-based presentations of minor complications could be of great benefit to an M&MC [40]. Anderson et al. [27] emphasised the importance of confronting medical error directly and in a timely manner by choosing recent cases. Selection of serious errors with potentially fatal outcomes (like accidental intrathecal injection of vincristine) was not controversial. The literature suggests that major adverse events are more likely to be listed than non-major adverse events [37]. M&MC structuration should comprise case preparation and review, analysis, discussion, classification and recommendations as well as case closure and follow-up [11]. Assessing and monitoring preventive and/or corrective measures using indicators and dashboards is essential, and requires the active involvement of all M&MC participants. The optimal frequency and duration of M&MCs should also be addressed. Higginson et al. [34] reported that weekly meetings were helpful because the cases were still fresh, and the small number of cases allowed time for in-depth discussion. On the other hand, participants found weekly meetings less ‘special’ or too frequent, with consequent loss of impact. In other studies, 1-hour conferences held 4–6 times a year were suggested [41], illustrating the high heterogeneity of practices and the lack of any agreed framework. In our study, about 3 combined medication error reviews and M&MCs were conducted per year. Regularity and moderate frequency of these conferences allow ownership by pharmaceutical and medical teams with respect to temporal constraint of each. Some procedures may help standardise the M&MC process. For instance, electronically recording the meeting may facilitate reporting and subsequent identification of issues [34]. The participation of an outside auditor may also provide a more objective perspective than that of the caregivers personally responsible for the patient [11] and ensure that suggested changes are carefully considered and implemented when appropriate [41]. The limitations of this study include the detection method of preparation and administration errors based on self-reporting, the small sample size (limited to a single hospital) and the specific requirements of every de336

Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

partment, like the use of Chatelut, Calvert or Thomas formulas. No specific inclusion or exclusion criteria were defined, leading to the lack of a reliable denominator for the total number of cases during the study period.

Conclusions

Implementation of combined medication error reviews and M&MCs has fostered a cultural change whereby medication errors are openly discussed with less stigma or individualised shame and blame. One of the next steps in this ongoing work will be to structure these conferences now set up in cancer care. This will require a framework based on previous experience drawn from the literature, and specific selection and analysis criteria adapted to cancer care. Combining medication error reviews and M&MCs appears to be an efficient means of improving cancer patient safety and personnel education. This multidisciplinary work is indispensable for us to learn from our mistakes, thereby reducing medication errors, with the prime objective of improving quality of care.

Acknowledgements We would like to acknowledge the medical, pharmaceutical and nursing teams at the Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France. We would also like to acknowledge Dr. Edith Dufay, Centre Hospitalier de Luneville, France.

Disclosure Statement The authors have no conflicts of interest. No direct funding was received for the study. The authors were personally financed by their institutions during the period of writing, although no specific salary was set aside or given for writing the paper.

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Chemotherapy 2013;59:330–337 DOI: 10.1159/000358190

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Improving cancer patient care with combined medication error reviews and morbidity and mortality conferences.

To reduce the occurrence of medication errors, a systemic approach was developed combining anti-neoplastic medication error reviews and morbidity and ...
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