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Download RN COMMUNITY PRACTICE TESTS and more Exams Nursing in PDF only on Docsity! ASSESSMENT OF VINCRISTINE MEDICATION ERRORS AND CONTRIBUTING FACTORS IN KENYATTA NATIONAL HOSPITAL Emmanuel Kipkurui Kurgat (B.Pharm) U51/81931/2015 A thesis submitted in partial fulfilment of requirements for the award of the Degree of Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance of the University of Nairobi. Department of Pharmacology and Pharmacognosy University of Nairobi February, 2018 ii University of Nairobi Declaration of Originality Name of Student: Emmanuel Kipkurui Kurgat Registration Number: U51/81931/2015 College: College of Health Sciences School: Pharmacy Department: Pharmacology and Pharmacognosy Course Name: Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance Title of the work: Assessment of vincristine medication errors and contributing factors in Kenyatta National Hospital. DECLARATION I, Emmanuel Kipkurui Kurgat, declare that: I understand what Plagiarism is and I am aware of the University’s policy in this regard. I declare that this research thesis is my original work and has not been submitted elsewhere for examination, award of a degree or publication. Where other people’s work or my own work has been used, this has properly been acknowledged and referenced in accordance with the University of Nairobi’s requirements. I have not sought or used the services of any professional agencies to produce this work. I have not allowed, and shall not allow anyone to copy my work with the intention of passing it off as his/her own work. I understand that any false claim in respect of this work shall result in disciplinary action, in accordance with the University of Nairobi Plagiarism Policy. Signature Date Emmanuel Kipkurui Kurgat, B.Pharm, USC. v 3.2.2 Study Area Description.......................................................................................................15 3.2.3 Study Population.................................................................................................................15 3.2.4 Sample Size.........................................................................................................................15 3.2.5 Sampling Method................................................................................................................15 3.2.6 Eligibility Criteria...............................................................................................................16 3.2.6.1 Inclusion Criteria.............................................................................................................16 3.2.6.2 Exclusion Criteria............................................................................................................16 3.2.7 Healthcare Failure Mode Effect Analysis Procedure..........................................................16 3.3 Study Variables.......................................................................................................................18 3.4 Data Quality Assurance..........................................................................................................18 3.5 Ethical Considerations............................................................................................................18 3.6 Data Management...................................................................................................................19 3.7 Data Analysis..........................................................................................................................19 CHAPTER FOUR: RESULTS..........................................................................................................21 4.1 Prevalence of Vincristine use among Cancer patients at Kenyatta National Hospital...........21 4.2 Characteristics of cancer patients with Vincristine-based prescriptions................................22 4.3 Prescriber characteristics.............................................................................................................24 4.4 Prevalence of Vincristine Medication Errors..............................................................................25 4.5 Types of Vincristine Medication Errors Identified.....................................................................26 4.6 Assessment of Structural and Process components of patient safety system..............................28 4.7 Proactive risk assessment of vincristine use process using HFMEA method.............................31 4.8 Failure modes and Recommendations.........................................................................................34 CHAPTER FIVE: DISCUSSION......................................................................................................40 5.1 Conceptual Framework...........................................................................................................40 5.2 Vincristine use in Kenyatta National Hospital.......................................................................41 vi 5.2 Prevalence of Vincristine medication errors and contributing factors........................................41 5.3 Proactive risk assessment of vincristine use process..............................................................44 CHAPTER SIX: CONCLUSION AND RECOMMENDATIONS.................................................47 6.1 Conclusion..............................................................................................................................47 6.2 Recommendations..................................................................................................................47 6.2.1 Recommendations for policy and practice......................................................................47 6.2.2 Recommendations for future research.............................................................................47 Study Limitations..............................................................................................................................48 Study findings dissemination plan.....................................................................................................48 REFERENCES....................................................................................................................................49 Appendices:...........................................................................................................................................55 vii Approval by Supervisor This is to certify that this research thesis has been submitted for examination with my approval as the University supervisor. 1. Prof. Anastasia N. Guantai, PhD. Professor of Pharmacology and Therapeutics, Department of Pharmacology and Pharmacognosy, University of Nairobi. Signature............................. Date…………………......... x List of Abbreviations and Acronyms ACSQHC Australian Commission on Safety and Quality in Healthcare ADRs Adverse Drug Reactions AIDS Acquired Immunodeficiency Syndrome BSA Body Surface Area CNS Central Nervous System CPOE Computerised Physician Order Entry ERC Ethics and Research Committee FMEA Failure Mode Effect Analysis HAM High Alert Medicine HFMEA Healthcare Failure Mode Effect Analysis ID Identification IOM Institute of Medicines IP In-patient ISMP Institute of Safe Medication Practices IT Intrathecal IV Intravenous JCAHO Joint Commission on Accreditation of Healthcare Organizations KMTC Kenya Medical Training College KNH Kenyatta National Hospital MEs Medication Errors NCC-MERP National Coordinating Council for Medication Errors Reporting Programme NHS National Health Service NPSA National Patient Safety Agency OP Out-patient SHPA Society of Hospital Pharmacists of Australia UK United Kingdom UoN University of Nairobi USA United States of America xi Definitions of Operational Terms Adults: Patients aged 13 years and above. Adverse Drug reaction: A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Adverse Event: A medical occurrence during the course of treatment associated with the use of a medicinal product, but not necessarily causally related. Documentation errors: Are those that arise due to illegible writing, use of brand names, use of abbreviations, trailing zeroes, and missing contact information of the prescribers. Dosing errors: Are errors occurring due to over dosage, under dosage, wrong strength and dose omission. Failure mode: Different ways that a process or sub-process can fail to provide the anticipated result. Hazard analysis: The process of collecting and evaluating information on hazards associated with the selected process. Medication Error: Unintentional errors in prescribing, dispensing, administration or monitoring of medicines while under the control of a healthcare professional, patient or consumer. Medication order: A written direction provided by a prescriber and refers to the treatment sheet and prescription. Monitoring errors: Include errors due to lack of ordering monitoring parameters and failure to follow up prescribed monitoring. Omission errors: Occurs when an action is not performed and includes failure to prescribe a drug. Opportunities for errors Sum total of the errors that occurred and errors that could possibly have occurred Paediatrics: Patients aged less than 13 years. Patient safety practice: A type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system xii across a range of diseases and procedures. Prescribing Error: The inappropriate selection of a drug (based on indication, contraindications, known allergies, existing drug therapy, and other factors); dose; dosage form; quantity; route of administration; concentration; rate of administration; or inappropriate or inadequate instructions for use of a medication ordered by a physician or other authorized prescriber. Proactive risk assessment: Identification and prevention of product and process problems before they occur. Senior house officer Medical officer on specialist postgraduate training Technical errors: Involve prescribing of vincristine and Intrathecal drugs in one medication order, lack of Tall-Man’s lettering. Timing errors: Involve either use of wrong duration, wrong frequency, missing duration or frequency. Therapeutic Index: Measure used to assess the safety of a drug; it is a ratio of the median lethal dose to the median effective dose. Route errors: Are those that arise when information on the route of administration is either incorrect or omitted. xv List of Appendices Appendix A: Screening and Eligibility form (Vincristine use Prevalence)..........................................55 Appendix B: Screening and Eligibility form (Vincristine Medication errors prevalence)...................56 Appendix C: Data Collection Form (Vincristine Use Prevalence).......................................................57 Appendix D: Data Collection Form (Medication Errors Prevalence)...................................................58 Appendix E: NCC-MERP Medication Error Categories......................................................................60 Appendix F: Informed Consent Form for Healthcare Workers............................................................61 Appendix G: System and Process Factors Audit Tool..........................................................................64 Appendix H: HFMEA Outcome Severity Rating Scale........................................................................67 Appendix I: HFMEA Failure Probability Rating Scale........................................................................67 Appendix J: HFMEA Hazard Scoring Matrix.......................................................................................68 Appendix K: HFMEA Worksheet.........................................................................................................68 Appendix L: Ethical Approval Letter...................................................................................................69 Appendix M: KNH Study Registration Certificate...............................................................................71 xvi Abstract Background: Cancer is the leading cause of death worldwide accounting for 7.6 million deaths annually. Vincristine is a cytotoxic drug used in the management of haematological malignancies and solid tumours in adult and paediatric settings. Vincristine is categorized as a “High Alert” medicine due to its narrow therapeutic index and potential to cause serious morbidity and mortality if not used appropriately. These can be avoided by addressing medication errors. Medication errors are often preventable events with potential adverse outcomes during the course of treatment with medicines. Objective: The main aim of the study was to determine the prevalence of medication errors among cancer patients receiving vincristine as part of their chemotherapy at Kenyatta National Hospital. The secondary objective was to perform a proactive risk assessment of vincristine use process to identify medication errors contributing factors. Methodology: The study was carried out in oncology unit of Kenyatta National Hospital (KNH). The study design was descriptive cross sectional-study with two parts, quantitative and qualitative aspects. The quantitative approach involved two phases. First phase involved retrospective review of oncology in-patient non-schedule forms and out-patient cytotoxics summary form to determine vincristine use prevalence among cancer patients attended to in the oncology out-patient clinic and in- patient oncology units between January and June 2016 whereby 2880 records were reviewed. The second phase entailed concurrent review of 241 oncology patients’ medical records on vincristine- based regimens attended to in November 2016 and March-May 2017 in the out-patient clinic and in- patient wards to identify vincristine medication errors. Descriptive statistics were used to summarize data using median, range, frequency and percentages. The qualitative component involved proactive risk assessment of vincristine use process to determine hazards to patient safety and appropriate preventive measure using Healthcare Failure Mode Effect Analysis (HFMEA). A failure mode with hazard score of 8 and higher was considered for further analysis to determine if there are any mitigation strategies in place or not. Risk mitigation strategies were developed for failure modes that didn’t have any preventive measures in place. Universal and purposive sampling was used for quantitative and qualitative phases of the study respectively. Results: The overall prevalence of vincristine use in the out-patient department was 4% of which majority (93.4%) of the patients were adults. In the in-patient department, vincristine was administered to 36% of the admitted cancer patients on chemotherapy, most (66.9%) of them were xvii paediatrics. Most of the patients (62, 25.73%) had acute lymphoblastic leukaemia as the indication for vincristine-based chemotherapy. Based on the Institute of Safe Medication Practices (ISMP) and other international patient safety organisations criteria for medication errors definition and assessment, the prevalence of vincristine medication errors was found to be 99.6% [95% CI 97.1- 99.9) in 241 patient medical records reviewed. The prevalence was higher in in-patients (100%) than out-patients (87.5%). Majority (81.7%) of the errors identified did not reach the patients. A medication error rate of 18.6% was also determined. Healthcare failure mode effect analysis (HFMEA) multidisciplinary team identified 77 failure modes for the vincristine use processes of prescribing, preparation and dispensing, transportation and storage, administration and monitoring. Twelve failure modes were found to be lacking adequate control measures necessitating development of mitigation strategies for the causes. Conclusion: The prevalence of vincristine medication errors was significantly high based on the criteria set by International Patient Safety Organisations. The hospital system for the management and follow up of oncology patients had weaknesses thus fell short of meeting the criteria hence a high degree of medication errors was observed. Despite the fact that majority of the errors observed were less likely to cause harm, some were potentially fatal thus there is need for strategies to prevent, detect and minimise these errors. 3 high alert medicines (HAMs) by various patient safety organizations like Institute of Safe Medication Practices (ISMP), Australian Commission on Safety and Quality in Healthcare (ACSQHC), National Patient Safety Agency (NPSA) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (10,17–19). In 2003, the Institute for Safe Medication Practices reported that cancer chemotherapy tops the list of high-alert medications, outranking intravenous potassium chloride and insulin as potential threats to patient safety (20) . The risk of medication error is high with vincristine use due to low therapeutic index and increased usage (6). Medication errors associated with vincristine especially inadvertent intrathecal administration have greater potential to cause harm and fatal outcomes (21). There is limited literature on chemotherapy medication errors among cancer patients in Sub-Saharan Africa and more so in Kenya. Therefore there is need for studies to characterize, highlight the extent and types of vincristine medication errors. The results will aid in formulation of appropriate mitigation strategies that will help in detection and prevention of the errors. The results of the study can also be applied to other health institutions especially that county governments are setting up cancers centres across the country. The overall achievement will be improvement of patient outcomes and better quality of care. 1.4 Study Questions 1. What is the prevalence of vincristine medication errors in KNH? 2. What is the prevalence of vincristine use among cancer patients in KNH? 3. What are the factors that predispose patients to vincristine medication errors in KNH? 4. What patient safety systems are in place to prevent vincristine medication errors in KNH? 1.5 Objectives of the Study 1.5.1 Main Objective: To determine the prevalence of vincristine medication errors and assess the contributing factors in KNH. 1.5.2 Specific Objectives: 1. To estimate the prevalence of vincristine medication errors in KNH. 2. To determine vincristine use prevalence among cancer patients in KNH. 3. To identify factors that predisposes patients to vincristine medication errors in KNH. 4. To identify patient safety systems that are in place at KNH to prevent vincristine medication errors. 4 CHAPTER TWO: LITERATURE REVIEW 2.1 Overview of Cancer Cancer is a term used for diseases characterized by uncontrolled abnormal cell division that spread and invade other tissues (7). Cancer initiation and progression is dependent on both external or environmental factors (tobacco, radiations, chemicals and infectious diseases) and internal factors in the cell [genetic mutations, immunity and hormones] (22). Risk factors are acquired from the environment or from lifestyle (23). Cancer is the leading cause of mortality worldwide, in 2008 it accounted for 7.6 million deaths (13%). Close to 70% of these deaths occurred in developing countries. Deaths are projected to hit 13.1 million by 2030. The five most common types of cancer globally are; lung, stomach, liver, colon and breast cancer (23). In Africa, the most common cancers in men are prostate, liver and Kaposi sarcoma while in women are breast and cervical cancer (24). In 2012, 847,000 cancer incidences and 591,000 cancer mortalities were estimated to have occurred in Africa (24). Cancer ranks third in Kenya as the cause of death only after infectious diseases and cardiovascular disease accounting for 7% of the total national mortality annually (23,25). In 2008, the estimated cancer incidence in Kenya was 129.4/1000 (25). The most common cancers in women in Kenya are breast and cervical cancer while in men are prostate, oesophagus, head and neck cancers (23). In children, the commonest cancers are leukaemias and lymphomas (23). Cancer management involves three main approaches which are surgical incision of the tumour, radiotherapy and chemotherapy. They are usually applied depending on the type of cancer and stage of disease development (7,26). Cancer management is divided into three phases. Induction (inducing remission), consolidation or intensification (use of drugs of stronger if not equal strength to the induction phase to consolidate what has been achieved) and maintenance (keeping cancer cells from growing again or achieving total elimination) (23,27). 5 2.2 Indications of Vincristine Vincristine is used in the management of haematological malignancies and solid tumours. Vincristine indications are summarised in Table 1 (9,23,27). Table 1: Indications of Vincristine based drug regimens Indication Drug regimen used 1 Acute lymphoblastic leukaemia. Vincristine, Doxorubicin/Adriamycin, Methotrexate and Prednisolone 2 Hodgkin’s Lymphoma. Vincristine, Cyclophosphamide, Doxorubicin/Adriamycin, Procarbazine and Prednisolone 3 Multiple myeloma. Vincristine, Doxorubicin/Adriamycin and dexamethasone 4 Non-Hodgkin’s lymphoma. Vincristine, Cyclophosphamide, Doxorubicin/Adriamycin, Prednisolone and Methotrexate 5 Rhabdomyosarcoma. Vincristine, Cyclophosphamide, Cis-Platinum, Etoposide, Doxorubicin/Adriamycin and Actinomycin D 6 Neuroblastoma. Vincristine, Cyclophosphamide , Actinomycin D and Doxorubicin/Adriamycin 7 Ewing’s sarcoma. Vincristine, Cyclophosphamide , Actinomycin D and Doxorubicin/Adriamycin 8 Wilms’ tumour. Vincristine , Actinomycin D and Doxorubicin/Adriamycin 9 Brain tumours. Vincristine, Nitroso-ureas, Nitrogen mustard, Procarbazine, Methotrexate 10 Trophoblastic neoplasms. Vincristine, Cisplatin, Cyclophosphamide, Methotrexate and Etoposide 11 Kaposi’s sarcoma Vincristine, Cyclophosphamide and Doxorubicin/Adriamycin 12 Retinoblastoma Vincristine, Etoposide, Carboplatin/Cisplatin 13 Bladder cancer Vincristine, Adriamycin, Cyclophosphamide 14 Brain stem Glioma Vincristine, Actinomycin D, Etoposide, Procarbazine 15 Chronic lymphocytic leukaemia Vincristine, Cyclophosphamide, Doxorubicin, Prednisolone 16 Gastric Adenocarcinoma Vincristine, Cyclophosphamide, Mesna, Doxorubicin, Methotrexate, Cytarabine 17 Hepatoblastoma Vincristine, Adriamycin, Cyclophosphamide 18 High grade sarcoma Vincristine, Adriamycin, Cyclophosphamide, Cisplatin 19 Nasopharyngeal carcinoma Vincristine, Ifosfamide, Carboplatin, Etoposide 20 Orbital sarcoma Vincristine, Adriamycin, cyclophosphamide, Cisplatin 21 Ovarian Dysgerminoma Vincristine, Actinomycin D, Cyclophosphamide, Cisplatin 22 Pleomorphic sarcoma Vincristine, Adriamycin, Cyclophosphamide 23 Osteogenic sarcoma Vincristine, Adriamycin, Cyclophosphamide, Cisplatin, Methotrexate 2.3 Burden of Medication Errors Medication errors (MEs) occur quite frequently in the medical setting, despite being one of the most preventable cause of patient harm (28,29). The precise magnitude of medication errors is unknown 8 appropriate equipments and technologies, lack of process monitoring contribute immensely to increased incidences of medication errors (45). 2.7 Medication Errors Risk Reduction Strategies Patient safety involves measures aimed at preventing and avoiding patient injuries or adverse events from healthcare delivery processes. Medication errors have negative outcomes both to the patient in terms of increased healthcare costs and harm while for the healthcare workers it impacts negatively on the confidence the patients have on the healthcare system. Therefore there is need for mitigation strategies to be put in place to deter the occurrence of the errors (46,47). Chemotherapy errors can be reduced by instituting various strategies. Introduction of computerized prescribing system, pharmacists’ participation in drug rounds, and ensuring availability of key reference materials can aid in error reduction (48,49). Cohen et al have put forward the following set of recommendations to prevent errors in haematology and oncology (50); 1. Educate health care providers to improve their levels of knowledge about chemotherapy drugs and potential drug errors. 2. Design the drug delivery system to have as many independent checks in it as possible, including independent calculation checks by the prescribing physician, pharmacist and nurse. 3. Establish maximum single and total course dosage limits at each institution. These should be communicated in educational programmes for staff. 4. Standardize the prescribing language by using the full names of drugs and routes (for example, INTRAVENOUS versus INTRATHECAL written out in full and in capital letters rather than abbreviated to IV and IT). All doses should be expressed in milligrams or units, prescriptions should be dated, and the prescriber should use a leading zero but not a trailing zero. The patient's current body surface area should also be written on the prescription. 5. Collaborate with drug manufacturers to eliminate ambiguous dosing information on package inserts and in textbooks. 6. Educate patients and their relatives about their drug regime as they are the last line of defence in the system. 7. Set up an interdisciplinary team that continuously reviews the drug delivery process and feeds back findings to hospital staff. 9 2.8 Healthcare Failure Mode Effect Analysis Healthcare is a very complicated system which is predisposed to errors, accidents, near misses, failures, sentinel events and adverse events. Healthcare processes are interdependent and often interlocked. Inconsistencies, various inputs, tight time schedules, culture of hierarchy and dependence on human interventions causes increase in the risk of failures in system processes in the entire organization. Failure Mode Effect Analysis (FMEA) is one of the techniques used for system improvement to enhance human safety. The technique is team-based, proactive, systematic and reasoned-based technique used to prevent process and outcome problems before they happen. It also looks at how severe the effects of the problem will be if it occurs. It helps design preventive measures and if a problem cannot be prevented, FMEA will focus on protective measures that can be designed to deter the failure from reaching the patient or worst still is to mitigate the effects if the failure will cause harm (51). 10 CHAPTER THREE: METHODOLOGY The study consisted of two parts. The quantitative phase involved determining the prevalence of vincristine use and medication errors among cancer patients. The qualitative phase aimed at exploring the threats to patient safety and determining the appropriate medication errors mitigation strategies using Healthcare Failure Mode Effect Analysis (HFMEA) technique. 3.1 Quantitative Phase 3.1.1 Prevalence of Vincristine use 3.1.1.1 Study Design A cross-sectional study seeking to determine prevalence of vincristine use among cancer patients over a 6 months period, 1st January 2016 to 30th June 2016, was undertaken. The study period was chosen to prevent disruption of service provision and capture adequate and representative sample. 3.1.1.2 Study Site The study site was Kenyatta National Hospital (KNH). It is the oldest and one of the busiest public hospitals in Kenya with a bed capacity of 1,800 and offers specialized healthcare to patients from East and Central African region. The hospital hosts University of Nairobi (UoN) College of Health sciences and Kenya Medical Training College (KMTC), Nairobi Branch. The oncology unit serves at least 1100 cancer patients every month. A wide range of practitioners in various fields of specialisation attend to patients in the unit. An array of equipments for cancer detection and management, dedicated cancer patients wards and treatment centre and a robust patient follow-up system exist. Oncology pharmacies managed by 3 oncology pharmacists offer support to the multidisciplinary team in cancer patients’ management and ensure adequate supply of medicines. The study was conducted at the oncology pharmacy of KNH. 3.1.1.3 Study Population The study entailed review of adults and paediatrics in-patient non-schedule forms, out-patient chemotherapy summary forms and oncology electronic dispensing tool entries. 3.1.1.4 Sample Size All records entries made, between 1st January 2016 and 30th June 2106, in the in-patient non-schedule forms, out-patient cytotoxic summary forms and oncology electronic dispensing tool which met the inclusion criteria were reviewed. 13 n0 = 1.962*0.172(1−0.172) 0.052 = 219 patient records The sample size was enhanced by 10% in order to cushion for any missing information to obtain a final sample size of 241 patient records. A total of 241 patient files were reviewed, of which 8 were from oncology out-patient clinic and 233 from in-patient wards. 3.1.2.5 Sampling Method Universal sampling method was used to gather the necessary information due to low turnover of cancer patients on vincristine as part of their chemotherapy in both in-patient and out-patient departments, and also short study duration. Therefore, all records accessed were included in the sample as long as they met the inclusion criteria. The sampling frame used was the out-patient oncology attendance register, the in-patient paediatric and adults’ admission register. Paediatric patients’ records were sampled in the out- patient clinic and the paediatric wards. Adult records were sampled in the oncology out-patient clinic, gynaecology ward and the medical wards until the sample size of 8 for out-patients and 233 for in- patients was achieved. 3.1.2.6 Inclusion and Exclusion Criteria Patients records with cancer diagnosis and had vincristine prescribed as part of the chemotherapy were included in the study. Illegible records were excluded from the study. Patient records screening was done using Screening and Eligibility form (Appendix B). 3.1.2.7 Data Collection Procedures Pre-testing of study of tools was conducted in the first week of data collection where patient records from ward 1E and 8C were randomly selected and data abstraction was done. Requisite adjustments were done to ensure validity and reliability of the research instruments before commencement of the study. 3.1.2.7.1 Data Collection in the Out-patient Clinic Data collection was conducted at the end of each clinic day to prevent disruption of normal running of services. A pharmaceutical technologist was identified as a research assistant to assist in data abstraction due to their daily involvement in dispensing and preparation of drugs at the pharmacy unit level. The 14 oncology clinic attendance register was used to obtain total number of clinic attendants. All records of patients attended to at the clinic were reviewed to identify patients on vincristine-based chemotherapy. ASSESSMENT OF VINCRISTINE MEDICATION ERRORS AND CONTRIBUTING FACTORS IN KENYATTA NATIONAL HOSPITAL Emmanuel Kipkurui Kurgat (B.Pharm) U51/81931/2015 A thesis submitted in partial fulfilment of requirements for the award of the Degree of Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance of the University of Nairobi. Department of Pharmacology and Pharmacognosy University of Nairobi February, 2018 ii University of Nairobi Declaration of Originality Name of Student: Emmanuel Kipkurui Kurgat Registration Number: U51/81931/2015 College: College of Health Sciences School: Pharmacy Department: Pharmacology and Pharmacognosy Course Name: Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance Title of the work: Assessment of vincristine medication errors and contributing factors in Kenyatta National Hospital. DECLARATION I, Emmanuel Kipkurui Kurgat, declare that: I understand what Plagiarism is and I am aware of the University’s policy in this regard. I declare that this research thesis is my original work and has not been submitted elsewhere for examination, award of a degree or publication. Where other people’s work or my own work has been used, this has properly been acknowledged and referenced in accordance with the University of Nairobi’s requirements. I have not sought or used the services of any professional agencies to produce this work. I have not allowed, and shall not allow anyone to copy my work with the intention of passing it off as his/her own work. I understand that any false claim in respect of this work shall result in disciplinary action, in accordance with the University of Nairobi Plagiarism Policy. Signature Date Emmanuel Kipkurui Kurgat, B.Pharm, USC. v 3.2.2 Study Area Description.......................................................................................................15 3.2.3 Study Population.................................................................................................................15 3.2.4 Sample Size.........................................................................................................................15 3.2.5 Sampling Method................................................................................................................15 3.2.6 Eligibility Criteria...............................................................................................................16 3.2.6.1 Inclusion Criteria.............................................................................................................16 3.2.6.2 Exclusion Criteria............................................................................................................16 3.2.7 Healthcare Failure Mode Effect Analysis Procedure..........................................................16 3.3 Study Variables.......................................................................................................................18 3.4 Data Quality Assurance..........................................................................................................18 3.5 Ethical Considerations............................................................................................................18 3.6 Data Management...................................................................................................................19 3.7 Data Analysis..........................................................................................................................19 CHAPTER FOUR: RESULTS..........................................................................................................21 4.1 Prevalence of Vincristine use among Cancer patients at Kenyatta National Hospital...........21 4.2 Characteristics of cancer patients with Vincristine-based prescriptions................................22 4.3 Prescriber characteristics.............................................................................................................24 4.4 Prevalence of Vincristine Medication Errors..............................................................................25 4.5 Types of Vincristine Medication Errors Identified.....................................................................26 4.6 Assessment of Structural and Process components of patient safety system..............................28 4.7 Proactive risk assessment of vincristine use process using HFMEA method.............................31 4.8 Failure modes and Recommendations.........................................................................................34 CHAPTER FIVE: DISCUSSION......................................................................................................40 5.1 Conceptual Framework...........................................................................................................40 5.2 Vincristine use in Kenyatta National Hospital.......................................................................41 vi 5.2 Prevalence of Vincristine medication errors and contributing factors........................................41 5.3 Proactive risk assessment of vincristine use process..............................................................44 CHAPTER SIX: CONCLUSION AND RECOMMENDATIONS.................................................47 6.1 Conclusion..............................................................................................................................47 6.2 Recommendations..................................................................................................................47 6.2.1 Recommendations for policy and practice......................................................................47 6.2.2 Recommendations for future research.............................................................................47 Study Limitations..............................................................................................................................48 Study findings dissemination plan.....................................................................................................48 REFERENCES....................................................................................................................................49 Appendices:...........................................................................................................................................55 vii Approval by Supervisor This is to certify that this research thesis has been submitted for examination with my approval as the University supervisor. 1. Prof. Anastasia N. Guantai, PhD. Professor of Pharmacology and Therapeutics, Department of Pharmacology and Pharmacognosy, University of Nairobi. Signature............................. Date…………………......... x List of Abbreviations and Acronyms ACSQHC Australian Commission on Safety and Quality in Healthcare ADRs Adverse Drug Reactions AIDS Acquired Immunodeficiency Syndrome BSA Body Surface Area CNS Central Nervous System CPOE Computerised Physician Order Entry ERC Ethics and Research Committee FMEA Failure Mode Effect Analysis HAM High Alert Medicine HFMEA Healthcare Failure Mode Effect Analysis ID Identification IOM Institute of Medicines IP In-patient ISMP Institute of Safe Medication Practices IT Intrathecal IV Intravenous JCAHO Joint Commission on Accreditation of Healthcare Organizations KMTC Kenya Medical Training College KNH Kenyatta National Hospital MEs Medication Errors NCC-MERP National Coordinating Council for Medication Errors Reporting Programme NHS National Health Service NPSA National Patient Safety Agency OP Out-patient SHPA Society of Hospital Pharmacists of Australia UK United Kingdom UoN University of Nairobi USA United States of America xi Definitions of Operational Terms Adults: Patients aged 13 years and above. Adverse Drug reaction: A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Adverse Event: A medical occurrence during the course of treatment associated with the use of a medicinal product, but not necessarily causally related. Documentation errors: Are those that arise due to illegible writing, use of brand names, use of abbreviations, trailing zeroes, and missing contact information of the prescribers. Dosing errors: Are errors occurring due to over dosage, under dosage, wrong strength and dose omission. Failure mode: Different ways that a process or sub-process can fail to provide the anticipated result. Hazard analysis: The process of collecting and evaluating information on hazards associated with the selected process. Medication Error: Unintentional errors in prescribing, dispensing, administration or monitoring of medicines while under the control of a healthcare professional, patient or consumer. Medication order: A written direction provided by a prescriber and refers to the treatment sheet and prescription. Monitoring errors: Include errors due to lack of ordering monitoring parameters and failure to follow up prescribed monitoring. Omission errors: Occurs when an action is not performed and includes failure to prescribe a drug. Opportunities for errors Sum total of the errors that occurred and errors that could possibly have occurred Paediatrics: Patients aged less than 13 years. Patient safety practice: A type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system xii across a range of diseases and procedures. Prescribing Error: The inappropriate selection of a drug (based on indication, contraindications, known allergies, existing drug therapy, and other factors); dose; dosage form; quantity; route of administration; concentration; rate of administration; or inappropriate or inadequate instructions for use of a medication ordered by a physician or other authorized prescriber. Proactive risk assessment: Identification and prevention of product and process problems before they occur. Senior house officer Medical officer on specialist postgraduate training Technical errors: Involve prescribing of vincristine and Intrathecal drugs in one medication order, lack of Tall-Man’s lettering. Timing errors: Involve either use of wrong duration, wrong frequency, missing duration or frequency. Therapeutic Index: Measure used to assess the safety of a drug; it is a ratio of the median lethal dose to the median effective dose. Route errors: Are those that arise when information on the route of administration is either incorrect or omitted. xv List of Appendices Appendix A: Screening and Eligibility form (Vincristine use Prevalence)..........................................55 Appendix B: Screening and Eligibility form (Vincristine Medication errors prevalence)...................56 Appendix C: Data Collection Form (Vincristine Use Prevalence).......................................................57 Appendix D: Data Collection Form (Medication Errors Prevalence)...................................................58 Appendix E: NCC-MERP Medication Error Categories......................................................................60 Appendix F: Informed Consent Form for Healthcare Workers............................................................61 Appendix G: System and Process Factors Audit Tool..........................................................................64 Appendix H: HFMEA Outcome Severity Rating Scale........................................................................67 Appendix I: HFMEA Failure Probability Rating Scale........................................................................67 Appendix J: HFMEA Hazard Scoring Matrix.......................................................................................68 Appendix K: HFMEA Worksheet.........................................................................................................68 Appendix L: Ethical Approval Letter...................................................................................................69 Appendix M: KNH Study Registration Certificate...............................................................................71 xvi Abstract Background: Cancer is the leading cause of death worldwide accounting for 7.6 million deaths annually. Vincristine is a cytotoxic drug used in the management of haematological malignancies and solid tumours in adult and paediatric settings. Vincristine is categorized as a “High Alert” medicine due to its narrow therapeutic index and potential to cause serious morbidity and mortality if not used appropriately. These can be avoided by addressing medication errors. Medication errors are often preventable events with potential adverse outcomes during the course of treatment with medicines. Objective: The main aim of the study was to determine the prevalence of medication errors among cancer patients receiving vincristine as part of their chemotherapy at Kenyatta National Hospital. The secondary objective was to perform a proactive risk assessment of vincristine use process to identify medication errors contributing factors. Methodology: The study was carried out in oncology unit of Kenyatta National Hospital (KNH). The study design was descriptive cross sectional-study with two parts, quantitative and qualitative aspects. The quantitative approach involved two phases. First phase involved retrospective review of oncology in-patient non-schedule forms and out-patient cytotoxics summary form to determine vincristine use prevalence among cancer patients attended to in the oncology out-patient clinic and in- patient oncology units between January and June 2016 whereby 2880 records were reviewed. The second phase entailed concurrent review of 241 oncology patients’ medical records on vincristine- based regimens attended to in November 2016 and March-May 2017 in the out-patient clinic and in- patient wards to identify vincristine medication errors. Descriptive statistics were used to summarize data using median, range, frequency and percentages. The qualitative component involved proactive risk assessment of vincristine use process to determine hazards to patient safety and appropriate preventive measure using Healthcare Failure Mode Effect Analysis (HFMEA). A failure mode with hazard score of 8 and higher was considered for further analysis to determine if there are any mitigation strategies in place or not. Risk mitigation strategies were developed for failure modes that didn’t have any preventive measures in place. Universal and purposive sampling was used for quantitative and qualitative phases of the study respectively. Results: The overall prevalence of vincristine use in the out-patient department was 4% of which majority (93.4%) of the patients were adults. In the in-patient department, vincristine was administered to 36% of the admitted cancer patients on chemotherapy, most (66.9%) of them were xvii paediatrics. Most of the patients (62, 25.73%) had acute lymphoblastic leukaemia as the indication for vincristine-based chemotherapy. Based on the Institute of Safe Medication Practices (ISMP) and other international patient safety organisations criteria for medication errors definition and assessment, the prevalence of vincristine medication errors was found to be 99.6% [95% CI 97.1- 99.9) in 241 patient medical records reviewed. The prevalence was higher in in-patients (100%) than out-patients (87.5%). Majority (81.7%) of the errors identified did not reach the patients. A medication error rate of 18.6% was also determined. Healthcare failure mode effect analysis (HFMEA) multidisciplinary team identified 77 failure modes for the vincristine use processes of prescribing, preparation and dispensing, transportation and storage, administration and monitoring. Twelve failure modes were found to be lacking adequate control measures necessitating development of mitigation strategies for the causes. Conclusion: The prevalence of vincristine medication errors was significantly high based on the criteria set by International Patient Safety Organisations. The hospital system for the management and follow up of oncology patients had weaknesses thus fell short of meeting the criteria hence a high degree of medication errors was observed. Despite the fact that majority of the errors observed were less likely to cause harm, some were potentially fatal thus there is need for strategies to prevent, detect and minimise these errors. 3 high alert medicines (HAMs) by various patient safety organizations like Institute of Safe Medication Practices (ISMP), Australian Commission on Safety and Quality in Healthcare (ACSQHC), National Patient Safety Agency (NPSA) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (10,17–19). In 2003, the Institute for Safe Medication Practices reported that cancer chemotherapy tops the list of high-alert medications, outranking intravenous potassium chloride and insulin as potential threats to patient safety (20) . The risk of medication error is high with vincristine use due to low therapeutic index and increased usage (6). Medication errors associated with vincristine especially inadvertent intrathecal administration have greater potential to cause harm and fatal outcomes (21). There is limited literature on chemotherapy medication errors among cancer patients in Sub-Saharan Africa and more so in Kenya. Therefore there is need for studies to characterize, highlight the extent and types of vincristine medication errors. The results will aid in formulation of appropriate mitigation strategies that will help in detection and prevention of the errors. The results of the study can also be applied to other health institutions especially that county governments are setting up cancers centres across the country. The overall achievement will be improvement of patient outcomes and better quality of care. 1.4 Study Questions 1. What is the prevalence of vincristine medication errors in KNH? 2. What is the prevalence of vincristine use among cancer patients in KNH? 3. What are the factors that predispose patients to vincristine medication errors in KNH? 4. What patient safety systems are in place to prevent vincristine medication errors in KNH? 1.5 Objectives of the Study 1.5.1 Main Objective: To determine the prevalence of vincristine medication errors and assess the contributing factors in KNH. 1.5.2 Specific Objectives: 1. To estimate the prevalence of vincristine medication errors in KNH. 2. To determine vincristine use prevalence among cancer patients in KNH. 3. To identify factors that predisposes patients to vincristine medication errors in KNH. 4. To identify patient safety systems that are in place at KNH to prevent vincristine medication errors. 4 CHAPTER TWO: LITERATURE REVIEW 2.1 Overview of Cancer Cancer is a term used for diseases characterized by uncontrolled abnormal cell division that spread and invade other tissues (7). Cancer initiation and progression is dependent on both external or environmental factors (tobacco, radiations, chemicals and infectious diseases) and internal factors in the cell [genetic mutations, immunity and hormones] (22). Risk factors are acquired from the environment or from lifestyle (23). Cancer is the leading cause of mortality worldwide, in 2008 it accounted for 7.6 million deaths (13%). Close to 70% of these deaths occurred in developing countries. Deaths are projected to hit 13.1 million by 2030. The five most common types of cancer globally are; lung, stomach, liver, colon and breast cancer (23). In Africa, the most common cancers in men are prostate, liver and Kaposi sarcoma while in women are breast and cervical cancer (24). In 2012, 847,000 cancer incidences and 591,000 cancer mortalities were estimated to have occurred in Africa (24). Cancer ranks third in Kenya as the cause of death only after infectious diseases and cardiovascular disease accounting for 7% of the total national mortality annually (23,25). In 2008, the estimated cancer incidence in Kenya was 129.4/1000 (25). The most common cancers in women in Kenya are breast and cervical cancer while in men are prostate, oesophagus, head and neck cancers (23). In children, the commonest cancers are leukaemias and lymphomas (23). Cancer management involves three main approaches which are surgical incision of the tumour, radiotherapy and chemotherapy. They are usually applied depending on the type of cancer and stage of disease development (7,26). Cancer management is divided into three phases. Induction (inducing remission), consolidation or intensification (use of drugs of stronger if not equal strength to the induction phase to consolidate what has been achieved) and maintenance (keeping cancer cells from growing again or achieving total elimination) (23,27). 5 2.2 Indications of Vincristine Vincristine is used in the management of haematological malignancies and solid tumours. Vincristine indications are summarised in Table 1 (9,23,27). Table 1: Indications of Vincristine based drug regimens Indication Drug regimen used 1 Acute lymphoblastic leukaemia. Vincristine, Doxorubicin/Adriamycin, Methotrexate and Prednisolone 2 Hodgkin’s Lymphoma. Vincristine, Cyclophosphamide, Doxorubicin/Adriamycin, Procarbazine and Prednisolone 3 Multiple myeloma. Vincristine, Doxorubicin/Adriamycin and dexamethasone 4 Non-Hodgkin’s lymphoma. Vincristine, Cyclophosphamide, Doxorubicin/Adriamycin, Prednisolone and Methotrexate 5 Rhabdomyosarcoma. Vincristine, Cyclophosphamide, Cis-Platinum, Etoposide, Doxorubicin/Adriamycin and Actinomycin D 6 Neuroblastoma. Vincristine, Cyclophosphamide , Actinomycin D and Doxorubicin/Adriamycin 7 Ewing’s sarcoma. Vincristine, Cyclophosphamide , Actinomycin D and Doxorubicin/Adriamycin 8 Wilms’ tumour. Vincristine , Actinomycin D and Doxorubicin/Adriamycin 9 Brain tumours. Vincristine, Nitroso-ureas, Nitrogen mustard, Procarbazine, Methotrexate 10 Trophoblastic neoplasms. Vincristine, Cisplatin, Cyclophosphamide, Methotrexate and Etoposide 11 Kaposi’s sarcoma Vincristine, Cyclophosphamide and Doxorubicin/Adriamycin 12 Retinoblastoma Vincristine, Etoposide, Carboplatin/Cisplatin 13 Bladder cancer Vincristine, Adriamycin, Cyclophosphamide 14 Brain stem Glioma Vincristine, Actinomycin D, Etoposide, Procarbazine 15 Chronic lymphocytic leukaemia Vincristine, Cyclophosphamide, Doxorubicin, Prednisolone 16 Gastric Adenocarcinoma Vincristine, Cyclophosphamide, Mesna, Doxorubicin, Methotrexate, Cytarabine 17 Hepatoblastoma Vincristine, Adriamycin, Cyclophosphamide 18 High grade sarcoma Vincristine, Adriamycin, Cyclophosphamide, Cisplatin 19 Nasopharyngeal carcinoma Vincristine, Ifosfamide, Carboplatin, Etoposide 20 Orbital sarcoma Vincristine, Adriamycin, cyclophosphamide, Cisplatin 21 Ovarian Dysgerminoma Vincristine, Actinomycin D, Cyclophosphamide, Cisplatin 22 Pleomorphic sarcoma Vincristine, Adriamycin, Cyclophosphamide 23 Osteogenic sarcoma Vincristine, Adriamycin, Cyclophosphamide, Cisplatin, Methotrexate 2.3 Burden of Medication Errors Medication errors (MEs) occur quite frequently in the medical setting, despite being one of the most preventable cause of patient harm (28,29). The precise magnitude of medication errors is unknown 8 appropriate equipments and technologies, lack of process monitoring contribute immensely to increased incidences of medication errors (45). 2.7 Medication Errors Risk Reduction Strategies Patient safety involves measures aimed at preventing and avoiding patient injuries or adverse events from healthcare delivery processes. Medication errors have negative outcomes both to the patient in terms of increased healthcare costs and harm while for the healthcare workers it impacts negatively on the confidence the patients have on the healthcare system. Therefore there is need for mitigation strategies to be put in place to deter the occurrence of the errors (46,47). Chemotherapy errors can be reduced by instituting various strategies. Introduction of computerized prescribing system, pharmacists’ participation in drug rounds, and ensuring availability of key reference materials can aid in error reduction (48,49). Cohen et al have put forward the following set of recommendations to prevent errors in haematology and oncology (50); 1. Educate health care providers to improve their levels of knowledge about chemotherapy drugs and potential drug errors. 2. Design the drug delivery system to have as many independent checks in it as possible, including independent calculation checks by the prescribing physician, pharmacist and nurse. 3. Establish maximum single and total course dosage limits at each institution. These should be communicated in educational programmes for staff. 4. Standardize the prescribing language by using the full names of drugs and routes (for example, INTRAVENOUS versus INTRATHECAL written out in full and in capital letters rather than abbreviated to IV and IT). All doses should be expressed in milligrams or units, prescriptions should be dated, and the prescriber should use a leading zero but not a trailing zero. The patient's current body surface area should also be written on the prescription. 5. Collaborate with drug manufacturers to eliminate ambiguous dosing information on package inserts and in textbooks. 6. Educate patients and their relatives about their drug regime as they are the last line of defence in the system. 7. Set up an interdisciplinary team that continuously reviews the drug delivery process and feeds back findings to hospital staff. 9 2.8 Healthcare Failure Mode Effect Analysis Healthcare is a very complicated system which is predisposed to errors, accidents, near misses, failures, sentinel events and adverse events. Healthcare processes are interdependent and often interlocked. Inconsistencies, various inputs, tight time schedules, culture of hierarchy and dependence on human interventions causes increase in the risk of failures in system processes in the entire organization. Failure Mode Effect Analysis (FMEA) is one of the techniques used for system improvement to enhance human safety. The technique is team-based, proactive, systematic and reasoned-based technique used to prevent process and outcome problems before they happen. It also looks at how severe the effects of the problem will be if it occurs. It helps design preventive measures and if a problem cannot be prevented, FMEA will focus on protective measures that can be designed to deter the failure from reaching the patient or worst still is to mitigate the effects if the failure will cause harm (51). 10 CHAPTER THREE: METHODOLOGY The study consisted of two parts. The quantitative phase involved determining the prevalence of vincristine use and medication errors among cancer patients. The qualitative phase aimed at exploring the threats to patient safety and determining the appropriate medication errors mitigation strategies using Healthcare Failure Mode Effect Analysis (HFMEA) technique. 3.1 Quantitative Phase 3.1.1 Prevalence of Vincristine use 3.1.1.1 Study Design A cross-sectional study seeking to determine prevalence of vincristine use among cancer patients over a 6 months period, 1st January 2016 to 30th June 2016, was undertaken. The study period was chosen to prevent disruption of service provision and capture adequate and representative sample. 3.1.1.2 Study Site The study site was Kenyatta National Hospital (KNH). It is the oldest and one of the busiest public hospitals in Kenya with a bed capacity of 1,800 and offers specialized healthcare to patients from East and Central African region. The hospital hosts University of Nairobi (UoN) College of Health sciences and Kenya Medical Training College (KMTC), Nairobi Branch. The oncology unit serves at least 1100 cancer patients every month. A wide range of practitioners in various fields of specialisation attend to patients in the unit. An array of equipments for cancer detection and management, dedicated cancer patients wards and treatment centre and a robust patient follow-up system exist. Oncology pharmacies managed by 3 oncology pharmacists offer support to the multidisciplinary team in cancer patients’ management and ensure adequate supply of medicines. The study was conducted at the oncology pharmacy of KNH. 3.1.1.3 Study Population The study entailed review of adults and paediatrics in-patient non-schedule forms, out-patient chemotherapy summary forms and oncology electronic dispensing tool entries. 3.1.1.4 Sample Size All records entries made, between 1st January 2016 and 30th June 2106, in the in-patient non-schedule forms, out-patient cytotoxic summary forms and oncology electronic dispensing tool which met the inclusion criteria were reviewed. 13 n0 = 1.962*0.172(1−0.172) 0.052 = 219 patient records The sample size was enhanced by 10% in order to cushion for any missing information to obtain a final sample size of 241 patient records. A total of 241 patient files were reviewed, of which 8 were from oncology out-patient clinic and 233 from in-patient wards. 3.1.2.5 Sampling Method Universal sampling method was used to gather the necessary information due to low turnover of cancer patients on vincristine as part of their chemotherapy in both in-patient and out-patient departments, and also short study duration. Therefore, all records accessed were included in the sample as long as they met the inclusion criteria. The sampling frame used was the out-patient oncology attendance register, the in-patient paediatric and adults’ admission register. Paediatric patients’ records were sampled in the out- patient clinic and the paediatric wards. Adult records were sampled in the oncology out-patient clinic, gynaecology ward and the medical wards until the sample size of 8 for out-patients and 233 for in- patients was achieved. 3.1.2.6 Inclusion and Exclusion Criteria Patients records with cancer diagnosis and had vincristine prescribed as part of the chemotherapy were included in the study. Illegible records were excluded from the study. Patient records screening was done using Screening and Eligibility form (Appendix B). 3.1.2.7 Data Collection Procedures Pre-testing of study of tools was conducted in the first week of data collection where patient records from ward 1E and 8C were randomly selected and data abstraction was done. Requisite adjustments were done to ensure validity and reliability of the research instruments before commencement of the study. 3.1.2.7.1 Data Collection in the Out-patient Clinic Data collection was conducted at the end of each clinic day to prevent disruption of normal running of services. A pharmaceutical technologist was identified as a research assistant to assist in data abstraction due to their daily involvement in dispensing and preparation of drugs at the pharmacy unit level. The 14 oncology clinic attendance register was used to obtain total number of clinic attendants. All records of patients attended to at the clinic were reviewed to identify patients on vincristine-based chemotherapy. 15 Data from these patient medical records were abstracted into a predesigned data collection form (Appendix D). A list of patient’s out-patient numbers already reviewed was confidentially maintained by the investigator to ensure that records were not selected more than once. A sample size of 8 out-patient records was obtained during the study period. 3.1.2.7.2 Data collection in the In-patient Wards A list of patients admitted in November 2016 and from March to May 2017 with cancer diagnosis was obtained daily from the in-patient admission register for paediatric, adult medical and gynaecology wards. Patient records were retrieved daily and reviewed to identify those that met the inclusion criteria. Data abstraction was done when ward rounds and treatment administration had been completed. A list of patient’s in-patient numbers already reviewed was confidentially maintained by the investigator to ensure that records were not selected more than once. A sample size of 233 patient records was obtained during the study period. Data abstracted into a predesigned data collection form (Appendix D) included; designation of the prescriber, patient’s demographics, diagnosis, stage of disease, co-morbidities, prescribed medication, number of co-medication, number of treatment cycles received, most recent full haemogram results and actions taken. Each patient record was reviewed to detect presence of any of the 8 prescription errors and 1 monitoring error or both categories. A brief description of each medication error, error type and category were documented. All medication errors were categorized according to NCC-MERP taxonomy of medication errors (Appendix E). Data was transferred into EpiInfo® version 7 for data storage and analysis. A checklist (Appendix G) adapted from JCAHO, ISMP and ACSQHC on recommendations for safe use of vincristine and other vinca alkaloids was administered to unit in-charges and other staff in the 5 paediatric wards, 2 adult oncology wards, gynaecology ward, oncology pharmacy and oncology out- patient clinic. This was done to assess structural and process factors that may contribute to vincristine- related medication errors. The checklist was interviewer-administered to enhance response rate and give clarifications. Data collected from the 11 unit heads were entered into Microsoft Excel for data storage and analysis. 18 working in oncology pharmacy, 2 nurses working in paediatric oncology ward and adult oncology ward participated in the study. The investigator, a pharmacist, led the team. An introductory meeting was held to take the members through the features of the HFMEA process and their roles and responsibilities. A second meeting was held whereby, with the aid of the sample flow diagram (Figure 8) adapted from a study by Cheng et al (14), the investigator consulted the team members in their respective units to refine processes and sub-processes. He worked with a research assistant during the consultative meetings to record the information given by the members. He also requested members to enumerate potential failure modes and causes for each sub-process they are involved in. A third meeting was held where members determined the likelihood of potential failure mode occurring, the severity of its effects on the patient and process and the chances of it being detected and intercepted before it occurs thereby calculating the hazard score. A fourth meeting was held to analyse the failure modes and failure mode causes with a hazard score of 8 or higher and those that are single point weakness for which further action were needed. The failure modes and causes were analysed and categorized as eliminate, control or accept. Then on the fifth meeting, the team made recommendations for each failure mode cause(s) that needed to be controlled or eliminated. Step 3: Processes description The multidisciplinary team enumerated vincristine use processes and sub-processes and numbered them consecutively. Then a graphical representation was done in a flow diagram (Figure 8). An observational study of the entire process was also carried out to verify the processes and sub-process in the flow diagram. Step 4: Hazard analysis The multidisciplinary team members brainstormed on all possible failure modes of each sub-process. All potential failure modes identified were then listed and numbered consecutively. Using consensus (53), the severity and probability of the potential failure modes were determined with the aid of severity rating table (Appendix H) and the probability rating table (Appendix I). Hazard scores were calculated for each failure mode using Hazard scoring matrix (Appendix J). A failure mode with a hazard score of 8 or higher was considered for further analysis using HFMEA decision tree to determine if further action was warranted or not based on absence of effective control measure and lack of detectability. 19 Failure modes with hazard scores less than 8 were further reviewed for criticality to determine if they were single point weaknesses. Criticality, absence of control measures and lack of detectability of a failure mode were used to determine if further actions could be instituted or not. Criticality is the measure of the effect of a single point weakness, which in case it fails, leads to entire system failure while detectability measures the probability of detecting a failure or the effect of the failure before it occurs. Step 5: Identifying mitigation strategies The multidisciplinary team analysed the failure mode causes to determine if there were appropriate mitigation strategies in place to deter the failure from occurring using HFMEA worksheet (Appendix K). These failure mode causes were categorized as: eliminate, control or accept. The HFMEA multi- disciplinary team made recommendations for each failure mode cause(s) that was to be either eliminated or controlled. If the failure or the effect of the failure was unlikely to be detected, the team considered: identifying other events that may occur prior to the failure mode that can serve as “alerts” that the failure mode might happen in developing strategies of preventing such failure modes from occurring. 3.3 Study Variables The main outcome variable was vincristine medication errors. The predictor variables included prescriber cadre, patient age, sex, diagnosis, co-morbidities and number of co-medication. System factors to safeguard patient safety such as availability of process and structural components were also assessed. 3.4 Data Quality Assurance The data collection tools were pre-tested on 5 randomly selected patient records in paediatric oncology ward 1E and adult oncology ward 8C. Induction training of research assistants on the tools to be used in the study and ethical considerations was done prior to commencement of the study. HFMEA tools were adopted from the Veterans Affairs National centre for patient safety (VA-NCPS) (53). The sample HFMEA flow diagram and observation tool was adapted from JCAHO and Cheng et al (14) . Data cleaning was done daily to ensure its completeness and reliability. 3.5 Ethical Considerations Permission to conduct the study was sought and granted by Kenyatta National Hospital/University of Nairobi Ethics and Research Committee (KNH-UoN-ERC) (Appendix L, Reference number KNH- 20 ERC/A/317). The permission to collect data was also granted by the various departments where the study was conducted and registered by KNH Research and Programs Department (Appendix M). Informed consent and voluntary participation was sought from healthcare workers who met the inclusion criteria without coercion or incentives. Participant’s identities were concealed by use of serial numbers and any identifier information was not included in the data tool to ensure confidentiality. Completed data collection forms were kept under lock and key while electronic records were password protected for restricted access. Research assistants were trained on ethical considerations before the commencement of the study. 3.6 Data Management All data collected from the patient medical records and HFMEA process, were entered into EpiInfo® version 7 and Microsoft Excel 2010 respectively. Data cleaning and validation was done thereafter data export to Stata® version 13 was done. Backing up of data was done regularly using a flash disk. 3.7 Data Analysis Stata® version 13 (Stata Corp, USA) was used to analyse the data. Descriptive data analysis was done first. Variables with skewed distribution were expressed using median and interquartile range. Categorical variables were presented using frequency and percentages with 95% confidence interval. The main outcome of interest, prevalence of various medication errors, was presented as a percentage. The level of significance was set at 0.05. The prevalence of medication errors was calculated as follows; Prevalence of MEs = Number of patient records with medication e ror Total number of records reviewed during the study period x 100 Medication error rate is determined by calculating percentage of errors. Medication error rate of 5% and above denotes that a facility has system deficiencies. Roy et al, 2005 (43) formulae was used to calculate medication error rate as follows. Medication error rate = Number of medication errors observed x 100Opportunities for errors 23 In the out-patient oncology clinic, 1,213 (64.4%) female and 671 (35.6%) male cancer patients were attended to. Of these patients, 18 (1 %) were paediatrics and 1866 (99%) were adults. Vincristine was administered to 4% (76) of patients attended to in the out-patient oncology clinic for cancer chemotherapy administration. Majority of the patients on vincristine were adults (71, 93%). In the in-patient wards, 561 (56.3%) of the patients admitted for cancer chemotherapy administration were female while 435 (43.7%) were male. Of these patients, 679 (68.2%) were adults while 371 (31.8%) were paediatrics. Vincristine was administered to 36% (360) of the patients admitted in the in- patient wards for cancer chemotherapy treatment. Many of the patients on vincristine were paediatrics (241, 66.9%). 4.2 Characteristics of cancer patients with Vincristine-based prescriptions A total of 241 patient records were reviewed during the study period of November 2016 and March-May 2017. The desired sample size had been set at 219 thus this gives an overall target achieved at 110%. 233 (96.7%) of the records reviewed were for patients admitted in the in-patient wards while 8 (3.3%) were for patients attended to at the oncology out-patient clinic. The median age for paediatric patients was 6 years, with an interquartile range of 3-9 years. The minimum and maximum age for paediatric patients was 5 months and 12 years respectively. While for the adult patients, the median age was 37.5 years and an interquartile range of 23-55 years. The minimum and maximum age for adult patients was 17 and 76 years respectively. Most of paediatric patients (116, 54%) and adult patients (7, 26.9%) were in the 6-12 and 18-24 years age bracket respectively. More than half of the patients (149, 61.83%) were male. The baseline characteristics of patients on vincristine-based chemotherapy regimen are summarized in Table 4. 24 Table 4: Baseline characteristics of cancer patients on vincristine-based chemotherapy Paediatrics n=215 Adults n=26 Total n=241 Variable Frequency (%) Frequency (%) Frequency (%) Patient Type Out-patient 3 (37.5) 5 (62.5) 8 (3.3) In-patient 212 (91) 21 (9) 233 (96.7) Sex Female 80 (87) 12 (13) 92 (38.2) Male 135 (90.6) 14 (9.4) 149 (61.8) Age Group Paediatrics <13 years 215 (89.21) Adults >13 years 26 (10.79) Age Category < 2 years 11 (5.1) 2 - 5 years 88 (40.9) 6 - 12 years 116 (54) Median (IQR) 6 (3,9) years Min - Max 0.43 - 12 years 13 - 17 years 1 (3.9) 18 - 24 years 7 (26.9) 25 - 34 years 4 (15.4) 35 - 44 years 6 (23.1) 45 - 54 years 1 (3.9) 55 - 65 years 5 (19.2) > 65 years 2 (7.7) Median (IQR) 37.5 (23,55) years Min - Max 17 - 76 years The most common diagnosis was acute lymphoblastic leukaemia (62, 25.7%) of which 59 (95.2%) were paediatric patients. Many of the adult patients were being managed for Non-Hodgkin’s lymphoma (12, 46.2%). Anaemia (30, 12.5%) was the most common comorbidity in the patients attended to occurring in 23(10.7%) of the paediatric patients. Disease staging was not done for more than half (129, 53.5%) of the patients attended to. These characteristics are summarized in Table 5. 25 Table 5: Characteristics of diagnosis and management of cancer patients per age group Paediatrics n=215 Adults n=26 Total n=241 Variable n (%) n (%) n (%) Diagnosis Acute Lymphoblastic Leukaemia Wilm's Tumour(Nephroblastoma) Non-Hodgkin’s Lymphoma Hodgkin’s Lymphoma Neuroblastoma Rhabdomyosarcoma Retinoblastoma Burkitt’s Lymphoma Osteogenic Sarcoma Bladder Cancer Diffuse Large B-Cell Lymphoma Hepatoblastoma Orbital Sarcoma Brainstem Glioma Choriocarcinoma(High Risk GTN) Meduloblastoma Chronic Lymphocytic Leukaemia Gastric Adenocarcinoma High Grade Sarcoma Kaposi Sarcoma Nasopharyngeal Carcinoma Ovarian Dysgerminoma Pleomorphic Sarcoma 59(95.2) 53(100) 10(45.4) 18(90) 18(100) 17(100) 11(91.7) 6(100) 6(100) 3(100) 0(0.0) 3(100) 3(100) 2(100) 0(0.0) 2(100) 0(0.0) 0(0.0) 0(0.0) 1(100) 1(100) 1(100) 1(100) 3(4.8) 0(0.0) 12(54.6) 2(10) 0(0.0) 0(0.0) 1(8.3) 0(0.0) 0(0.0) 0(0.0) 3(100) 0(0.0) 0(0.0) 0(0.0) 2(100) 0(0.0) 1(100) 1(100) 1(100) 0(0.0) 0(0.0) 0(0.0) 0(0.0) 62(25.7) 53(22.1) 22(9.2) 20(8.3) 18(7.5) 17(7.2) 12(5) 6(2.5) 6(2.5) 3(1.2) 3(1.2) 3(1.2) 3(1.2) 2(0.8) 2(0.8) 2(0.8) 1(0.4) 1(0.4) 1(0.4) 1(0.4) 1(0.4) 1(0.4) 1(0.4) Co-Morbidity Anaemia Sepsis Neutropenia Others* None 23(76.7) 9(90) 5(100) 17(81) 161(92) 7(23.3) 1(10) 0(0) 4(19) 14(8) 30(12.5) 10(4.1) 5(2.1) 21(8.7) 175(72.6) Staging Done Not Done 107(95.5) 108(83.7) 5(4.5) 21(16.3) 112(46.5) 129(53.5) *Pancytopenia, HIV/AIDS, malnutrition, sickle cell disease, congenital heart disease, chicken pox, tonsillitis, meningitis and hypertension 4.3 Prescriber characteristics The characteristics of prescribers responsible for cancer chemotherapy prescriptions are show in Table 6. Senior house officers generated most of the prescriptions both in the in-patient wards and oncology out-patient clinic accounting for 215 (89.2%) of the total prescriptions. This could be attributed to the fact that KNH is a teaching and referral hospital. Almost half of the patients (120, 49.8%) were prescribed for 4-6 chemotherapy drugs other than vincristine. 28 0.80% 17.50% An error occurred, but the error did not reach the patient. (196) 81.70% An error occurred that reached the patient but did not cause the harm. (42) An error occurred that required monitoring and/or intervention to preclude harm. (2) The most common type of error was the use of abbreviations (211, 58.9%) in prescribing where “IV” was used instead of “Intravenous” and “VCR” instead of “Vincristine”. Timing error was the second leading type of error depicted by failure to indicate the frequency of administration and indication of schedule of administration rather than frequency of administration. The errors identified were classified according to the NCC-MERP system (Appendix E). The identified errors were assigned to error category B, C and D. Figure 5 illustrates the distribution of vincristine medication errors according to NCC-MERP system of classification. 196 (81.7%) errors were assigned to category B, 42(17.5%) category C and 2 (0.8%) category D. Category D error was encountered in 2 patients, one 6 years old patient was prescribed and administered 4 milligrams of vincristine yet the maximum dose of vincristine is 2 milligrams. This necessitated interventions and monitoring of the patient to preclude harm while another patient with osteosarcoma had haemoglobin level of less than 5mg/dl however blood transfusion was not done for more than a week. In this case there was failure to act on the available results. Figure 4: NCCMERP system error category classification of identified medication errors The medication error rate calculated using Roy et al, 2005 formula was found to be 18.6%. A medication error rate of >5% is an indication of system failures (43). Figure 6 and 7 represents examples of prescriptions with various types of errors encountered during the study. In Figure 6 underdose of vincristine was prescribed due to body surface area (BSA) miscalculations, use of 29 abbreviations and frequency of administration not clear. Patient regimen was also confused for cycle of treatment. Figure 5: An in-patient chemotherapy prescription with dosing, timing errors and use of abbreviations Figure 7 depicts an ambiguous prescription whereby the dose can be confused as 102mg instead of the intended 1.2mg. The route of administration is not indicated while the schedule of treatment has been indicated rather than the frequency of administration. Figure 6: An ambiguous in-patient chemotherapy prescription with route and timing error 4.6 Assessment of Structural and Process components of patient safety system Eleven units where vincristine is utilized were visited to assess the existence of structural and process components of patient safety system. The units were 6 paediatrics wards, adult oncology ward, gynaecology ward, oncology pharmacy and 2 oncology out-patient clinics. 30 Table 8 summarizes structural components in place to minimize or prevent vincristine medication errors. Eight units mainly paediatric wards reported the presence of a guideline related to chemotherapy use namely “Kasili's synopsis of the management of paediatric Cancers in Kenya”. Staff in 9 out of 11 units were encouraged to report medication errors as part of the hospital staff appraisal system however 4 units reported presence of a documented procedure of reporting the errors. Nine units recognized the relevance of the contributions that pharmacists make in their units. None of the units reported presence of formal induction training of new staff but rather on job training is done. Moreover none of the units reported availability and accessibility of all staff to a list of high alert medications and a list of abbreviations to avoid in chemotherapy. Table 8: Structural components in place to minimize or prevent vincristine medication errors Variable n=11 Frequency Percentage 1 Presence of a guideline related to cancer chemotherapy use 8 72.7 2 Presence of a protocol specifically on vincristine use 0 0 3 Guideline includes education and competency requirements for all staff involved 2 18.2 4 Guideline readily accessible to staff 8 72.7 5 Presence of a team that guides and monitor implementation of the guideline 2 18.2 6 Presence of a documented procedure of reporting medication errors 4 36.4 7 Staff encouraged to report medication errors 9 81.8 8 Presence of medication errors reporting tools 9 81.8 9 Medicine information resources available to staff 8 72.7 10 List of High-alert medicines available and accessible to staff 0 0 11 Vincristine recognized as a High-Risk medicine 0 0 12 List of abbreviations to be avoided in chemotherapy available and readily accessible to staff 0 0 13 Presence of a formal process for approving guidelines, prescription order forms and Oncology treatment sheets before use 7 63.3 14 Presence of formal induction training of new staff 0 0 15 Presence of defined responsibilities for pharmacists in the management of patients receiving chemotherapy 9 81.8 ULL), uration of 33 Preparation and dispensingPrescription 1 2 Sub-processes; A. Checking patient’s medical record a. Diagnosis type of malignancy and staging b. Hypersensitivity history c. Co-morbidities and contraindications d. Chemotherapy schedule e. Relevant laboratory results B. Patient routine assessment a. Ordering appropriate tests b. Sample collection C. Dosing a. Measuring height and weight b. Calculating Body surface area c. Dose calculation D. Prescription Detailing a. Patient biodata (Name, age, sex, weight, height, IP/OP No., BSA) b. Diagnosis, staging and regimen c. Date of prescription and cycle number d.Drugs to be given(generic name(F dose, route(FULL), frequency and d duration of administration) e. Days, dates when each drug is to be given f. The prescriber’s name, designation and signature E.Medication order sent to Pharmacy a. Prescription duplicated into Non- Schedule form and S11 b. Medication order and patient file taken to pharmacy Sub-processes; A. Verifying the prescription a. Checking for completeness i. Patient’s basic information (IP/OP number, date, doctor’s information, medicine quantity) ii. Checking administration information( date, medicine name, dosage, days and frequency) B. Prescription Validation a. Checking for protocol adherence b. Confirm test results are optimal c. Dose Re-calculation d. Checking drug interactions, side effects profile and hypersensitivity e. Authorization by Oncology pharmacist C. Medicine Retrieval a. Control on the S11 b. Charge, issue and record in the HMIS c. Checking for medicine availability d. Medicine retrieval e. Labelling of medicine bag f. Labelling of the medication g. Packing the medicine in a medicine bag h. Transportation to the Chemotherapy preparation room D. Medicine Preparation a. Staff don Personal protective equipments b. Checking if the patient identifiers(name, IP/OP No.), prescription, medicine, and label correspond with the original prescription c. Confirming the dosage, volume, and administration date d. Checking that medicine in vial is clear and without any foreign matter e. Syringe selection f. Drawing the medicine into a syringe g. Labelling of the syringe E.Packing the medicine a. Packing the medicine into a medicine bag b. Sealing the medicine bag c. Filling the S11 d.Calling for transport 34 3 4 Storage 5 Administration Transportation Sub-processes A. Calling for transport B. Receiving the medicine  Confirming the medication  Signing for the medicine C. Transport Sub-processes A. Storage in the refrigerator  Sorting the drugs  Arranging the drugs Sub-processes A. Patient Preparation a. Explaining to the patient the administration procedure and seeking informed consent b. Review recent blood tests results and Record baseline vital signs c. Cleaning injection site and fixing IV line B. Assembling Medicine and Materials a. The Nurse ensure the required items are prepared and availed b. Staff don Protective devices(PPEs) C. Medicine Re-confirmation a. Medical officer call the patient by name b. Two MOs checks the medicine against patient ID( 7R’s) c. The Iv line is primed D. Medicine Administration a. Administration by slow Iv Push b. Remove the syringe c. Flush IV line with Sodium chloride d. Hydrate the patient e. Document date of administration and comments on the medication chart and notes E. Monitoring a. Check skin around IV access b. Monitor patient general wellbeing Figure 7: Healthcare Failure Mode Effect Analysis Process Flow Diagram Seventy seven (77) failure modes were identified, from which 19 were classified as high risk using hazard scoring matrix (Appendix J). Table 10 shows number of major steps, sub-steps and failure modes identified for 5 phases of vincristine use process analysed. Six (6) other failure modes were identified to be single point weaknesses in the process. For each failure mode, failure mode causes were identified and hazard scores determined. Twelve (12) of the 25 failure modes identified were not adequately covered by existing control measures. Table 11 illustrates the 12 failure modes and failure mode causes determined by the HFMEA team using the decision tree to be lacking adequate control measures. Recommendations for these failure mode causes were made to militate against the failure 35 modes. Transportation and storage of vincristine were considered as low risk steps by the multidisciplinary team. Table 10: Number of process steps and failure modes identified Stage of medicine use process Major Steps Major and Sub-steps Failure Modes High Risk Failure Modes and Single point Weaknesses No. % No. % No % No. % Prescribing 4 25 16 23.5 15 19.5 10 40 Preparation and Dispensing 5 31.3 28 41.2 31 40.3 10 40 Transport 1 6.3 2 2.9 3 3.9 0 0 Storage 1 6.3 2 2.9 2 2.6 0 0 Administration 5 31.3 20 29.4 26 33.8 5 20 Total 16 68 77 25 4.8 Failure modes and Recommendations Failure Mode 1: Out-dated weight and height measures indicated on the treatment sheet It was observed by the HFMEA multi-disciplinary team that majority of the patients especially in the wards do not have latest weight and height measures in their treatment sheets. This has the potential of patients getting underdose or overdose. The team recommended the amendment of the chart to provide for space for twice monthly charting of the patient weight and height. Failure Mode 2: Past history inconclusive in determining last date of administration The treatment chart doesn’t provide adequate space to indicate the date of administration which makes it difficult for the prescribers to schedule the next course of treatment. Amendments on the treatment sheet to provide space for affixing the date and sensitization of prescribers on the difference between scheduled day of treatment and date of administration were recommended. Failure Mode 3: Dose Miscalculation Dose calculations by prescribers were considered to be a source of errors which can translate to patients receiving underdose or overdose of medications. Double-checks in the wards and in the pharmacy, development of job aids with formulas and dose limits were recommended for adoption 38 Table 11: Vincristine use process failure modes and recommendations FAILURE MODE First Evaluate failure mode before determining potential causes POTENTIAL CAUSE SCORING DECISION TREE ANALYSIS S ev er it y P ro b ab il it y H az ar d s co re S in gl e p oi n t w ea k n es s (Y /N ) A ct io n T yp e (C on tr ol , A cc ep t or E li m in at e) Recommendations 1. Out-dated patient height and weight measures indicated 3 3 9 1. Poor documentation 3 3 9 Control Twice monthly charting of weight and Height be documented on the Treatment sheet/Chemotherapy chart 2. Lack of space to fix latest measures 3 4 12 Control Amend the Chemotherapy chart to provide for the provision of twice monthly charting of weight and height 2. Previous history inconclusive in determining last date of Vincristine administration 3 3 9 1. Misinterpretation between schedule day and date of administration 3 3 9 Control Update prescribers on the difference between the schedule day and Date of administration 2. Inadequate space to affix the date on the Treatment sheet 3 4 12 Eliminate Redesign the Chemotherapy treatment chart to provide adequate space to affix the date 3. Dose miscalculation 4 3 12 Ensure double-checks in wards and pharmacy. 1. Non-adherence to treatment protocol 3 3 9 Control Develop job aids for calculations of BSA, dosages and determine minimum and maximum doses 2. Use of inaccurate BSA 4 3 12 Control Amend the Chemotherapy chart to provide for the provision of twice monthly charting of weight and height 4. Medication order is obscure 4 2 8 Redesign the Treatment chart to give provision for stage of treatment and schedule 1. Use of non-standard abbreviations 3 3 9 Eliminate Sensitize prescribers on non-standard abbreviations to avoid. 2.Handwritten medication orders 3 3 9 Eliminate Adopt the use of CPOE. Computerised Physician Order Entry System in chemotherapy prescribing 5. Incomplete labelling of the primary packaging material (Name/IP No., Route administration, Warnings, Storage conditions) 3 3 9 1.Label on medicine bag misconstrued as appropriate label 3 4 12 Eliminate Design and print (purple) Colour- coded labels with Predesigned Warnings (BOLD) and Route of Administration. Name and IP/OP No. space provided 2. Lack of adequate space to affix the label 3 3 9 Eliminate Print labels or Use Ziplock dispensing envelopes with space for patient name, IP/OP No, 39 FAILURE MODE First Evaluate failure mode before determining potential causes POTENTIAL CAUSE SCORING DECISION TREE ANALYSIS S ev er it y P ro b ab il it y H az ar d s co re Si ng le p oi n t w ea k n es s (Y /N ) A ct io n T yp e (C on tr ol , A cc ep t or E li m in at e) Recommendations 6. Incomplete label affixed on the syringe((Name, IP/OP No, Preparation date, Expiry date, Medication name, dose and route of administration) 3 4 12 Print label and affix on plastic Ziplock bag/ Purchase infusion minibags or use large volume syringes >20cc 1. Lack of clear guidelines on what to affix on the label 3 4 12 Control Develop clear policy guidelines on what to affix on the label and disseminate to staff in the unit 2. Lack of adequate space to affix the label 3 3 9 Control Design colour-coded label, purchase labels printer and print with required items( (Name, IP/OP No, Preparation date, Expiry date, Medication name, dose and route of administration) 7. Failure to affix WARNING label (INTRAVENOUS USE ONLY, FATAL IF ADMINISTERED VIA OTHER ROUTES) 2 4 8 1.Lack of clear guidelines/SOP 2 4 8 Eliminate Design a clear warning label and affix on the syringe(INTRAVENOUS USE ONLY, FATAL IF ADMINISTERED VIA OTHER ROUTES) 2.Lack of awareness on what to affix on the label 2 4 8 Control Sensitize staff on the necessity of affixing warning labels 8. Medication spillage 4 2 8 1. Lack of adequate working space 4 2 8 Accept Ensure all areas where production, storage and administration of cytotoxics have spill kits 2. Production in an inappropriate environment 4 2 8 Control Centralize production of cytotoxics at the pharmacy to be done exclusively by pharmacy staff 3. Poor handling of cytotoxics 4 2 8 Control Sensitize staff on how to handle cytotoxics especially new Senior house officers 9. Failure to adequately confirm vital information before administration (7R’s) 4 1 4 YES Enforce training and education to ensure Independent double checks are done by a Nurse or by two Senior house officers before administration at bedside 1. Heavy workload 4 1 4 Yes Accept Ensure at least 2 staff perform medication administration 10. Vincristine leaks to adjacent tissues(extravasation) 4 3 12 Provision of extravasation kits 1. IV line fixed adjacent to recently used venepuncture 4 3 12 Control Staff training on prevention of extravasation 2. Improper administration rate 4 3 12 Control Ensure administration is by slow IV for at least 2 minutes and flush with 10Ml of Sodium chloride after administration 3. IV line not fixed properly 4 2 8 Control Flushing of IV line before administration. 4.Nonadherance to guidelines 4 2 8 Control Sensitize staff on the guidelines on prevention of extravasation. Dilute vincristine to 10ml volume for <10 years patients and 20ml for >10 years using Sodium chloride 40 FAILURE MODE First Evaluate failure mode before determining potential causes POTENTIAL CAUSE SCORING DECISION TREE ANALYSIS S ev er it y P ro b ab il it y H az ar d s co re S in gl e p oi n t w ea k n es s (Y /N ) A ct io n T yp e (C on tr ol , A cc ep t or E li m in at e) Recommendations 11. Inadvertent intrathecal administration of vincristine 4 1 4 YES 1.Use of small volume syringes that can be confused for intrathecal route use 4 4 16 Eliminate Dilute Vincristine with 0.9% Sodium chloride using large volume syringes; for paediatrics less 10 years use 10Ml syringes, more than 10 years 20Ml or 20ml Minibags for paeds and 50Ml minibags for adults 2.Prescribing vincristine and Intrathecal medication to be administered same day 4 4 16 Eliminate Prescribe vincristine and other intravenous drugs to be administered on a different day and time from Intrathecal medications. Intravenous medications be administered first 3.Transportation and storage of Vincristine and Intrathecal medication in the same place 4 3 12 Control Vincristine and Intrathecal preparations should be packaged separately in colour-coded adequately labelled plastic bags. They should also be stored in separate refrigerators. 4.Lack of Warning label 3 4 12 Eliminate Ensure warning label is affixed black coded label. (INTRAVENOUS USE ONLY, FATAL IF ADMINISTERED VIA OTHER ROUTES) 5.Lack of clear guidelines 3 3 9 Control All staff designated to prescribe, prepare, dispense, transport and administer vincristine should be adequately trained on how to handle cytotoxics 12.The doctors fails to notice exosmosis has occurred 4 2 8 All units should have (Fully Kitted) extravasation kits. Chemotherapy administration be done strictly on weekdays between 8:30 AM and 5:00 PM 1. The doctor was in a hurry due to heavy workload thus patient monitoring wasn’t done after administration 4 2 8 Accept Enforce training on the importance of post-administration monitoring and ensure medication administration is done by at least 2 officers 2. The patient turned around in bed 4 2 8 Accept Ensure that the patient remains in bed still after administration 43 experienced at least one medication error respectively. The prevalence of medication errors in the in- patient population was higher at 100% compared to 87.5% in the out-patient population. The difference in the prevalence could be associated first with the prevalence of use as vincristine is commonly used in the in-patient than the out-patient setting. Secondly, patient workload for cancer patients on vincristine- based regimens is heavier in the in-patient than out-patient setting. Majority (81.7%) of the medication errors identified did not reach the patient thus did not cause harm however, in the event that some of these errors had reached the patients there was a possibility of patient harm. Pharmacists played a big role in intercepting the errors especially dosing errors. Double checks and protocol adherence assessment is done at the pharmacy level. The hospital being a teaching facility cares of the patients in majorly done by senior house officers on training. Lack of formal induction training of these officers could contribute immensely on the high error rate prevalence. Lack of a standard protocol for cancer management in paediatric and adults’ settings with qualifications and competencies of the officers involved in the various processes on patient management could also contribute to the errors observed. Lack of the list of high alert medicines and abbreviations to avoid in chemotherapy was identified as one of the key contributors of the errors as abbreviations contributed to 58.9% of all errors observed which is comparable with Aywak et al, 2015 findings where use of abbreviations accounted for 62% of the errors observed(58). Abbreviations are commonly used to make work easier however some abbreviations can be misread or misinterpreted to mean something totally different which can lead to improper use of a drug and possible patient harm or even death. These said documents were under development during the study period and have since been disseminated to all units. Use of abbreviations can also be explained by lack of monitoring of vincristine use process, lack of standard system of handling medication errors and knowledge gap. These errors can be reduced by the use of computerized physician order entry (60). The 359 medication errors identified in the 241 medical records reviewed during the 15-week study period can be compared to that reported at a hospital in France where 449 medication errors were identified in 6,607 medical records of patients on antineoplastics over a period of 1 year (61). However of the 359 medication errors identified, only 2 errors which reached the patients necessitated intervention and monitoring to preclude harm. One 6 years old patient was prescribed and administered 4 milligrams of vincristine yet the maximum dose of vincristine is 2 milligrams. This necessitated interventions and monitoring of the patient to preclude harm while another patient with osteosarcoma had haemoglobin level of less than 5mg/dl however blood transfusion was not done for more than a 44 week. In the France hospital study, 436 of the errors identified were intercepted before it reached the patient and 2 of the errors that reached the patients required enhanced monitoring (61). Prescription errors represented 98.8% of the errors while monitoring errors accounted for 1.2%. In a study in Spain chemotherapy medication errors were reported in 17.2% of the patients attended to with prescription errors accounting for 75.7%, preparation 21%, dispensing 1.8%, administration 1.1% and monitoring 0.4% (39). While in France hospital study, prescription errors represented 91% of the errors followed by preparation and dispensing (8%) and administration (1%) (61). Prescription errors can be associated with lack of a standard protocol for cancer management, heavy workload, use of handwritten medication orders and lack of formal induction training of new prescribers. These errors can also be explained by the practice in the hospital especially in the wards whereby senior house officers are tasked with prescribing, preparation and administration of chemotherapy. This task shifting act makes them complacent to write complete prescriptions as they are expected to follow their own instructions. This contributes to a greater degree of the use of abbreviations, failure to indicate route and frequency of administration. While overdose on chemotherapy drugs can results in permanent damage or fatality to the patient, underdose can also compromise therapy success (55). Although dosing error rate was low (2.2%), overdose with vincristine can result in permanent neurological damage or death (62). Lack of vincristine use protocol, use of out-dated weight and height measures, lack of clear guideline on maximum dosage and lack of formal induction training of new prescribers contribute to perpetuation of this error. Antineoplastic dosing errors were reported in 59.3% of prescriptions in a study in France. These errors were associated with improper calculation of body surface area and lack of maximum dosage of vincristine (55). The 18.6% medication error rate determined in the study which is comparable with Aywak et al, 2015 of 19.2% (58) indicated to weaknesses in the patient safety systems in the management of patients on vincristine-based chemotherapy. Medication error rate of 5% and above denotes that a facility has system deficiencies. Medication errors are caused by a combination of human system factors (43). Evaluation of structural and process components of patient safety system identified inadequacies in the safeguards against vincristine medication errors. Lack of guideline, lack of team that guides implementation of guidelines, heavy workload and knowledge gap have been reported as key contributors of medication errors (4). 45 Care provided by pharmacists in the hospital for prevention, detection and management of medication errors provide multiple levels of patient protection (28). Pharmacists in KNH are involved in preparation and dispensing of vincristine in the medication use cycle. It was reported that clinical pharmacists are involved in reviewing of patient files regularly in the wards in 3 of the 11 units surveyed and occasionally in the other units. Understaffing is a major hindrance for the clinical pharmacists to participate in ward rounds in all the 11 units. This has been mitigated by ensuring that all patient files are reviewed in the oncology pharmacy before medications are prepared or dispensed. However this has not adequately prevented perpetuation of medication errors due to various institutional cultures and practices. 5.3 Proactive risk assessment of vincristine use process “Anything that can go wrong will go wrong” ~Murphy’s Law (63). The aim of this part of the study was to assess the vincristine use process and determine all possible failure modes and causes then evaluate existing control measures and develop mitigation strategies for high risk failure modes. Twelve high risk failure modes and single point weaknesses without adequate preventive measures were identified by the HFMEA multidisciplinary team. These failure modes are summarised in Table 11. Use of out-dated weight and height measures to calculate patient’s body surface area to be used in dose calculation of vincristine was highlighted by the team as a failure mode that can lead to underdose or overdose. This can be attributed to the restrictive nature of the oncology treatment sheet whereby there is no space to affix latest measures. Use of inaccurate body surface area has been noted as one of risk factors to dosing errors (55). The team recommended that the treatment sheet be redesigned to provide space for at least twice monthly charting of weight and height to ensure that current weight, height and BSA is indicated in the medication order (37). Another documentation-related failure mode was the inability to determine the last date of administration using past history on the oncology treatment sheet. This was ascribed to the fact that there is no adequate space on the oncology treatment sheet to indicate the date of administration. Redesigning of the oncology treatment sheet and sensitisation of prescribers to distinguish between scheduled day of treatment and date of administration were recommended. Dose miscalculations leads to dosing errors (55). This was noted by the team as a salient cause of underdosing and overdosing in KNH. Institution of double-checks in the wards and pharmacy as well as preparation of job aids with formulas and dose limits should be adopted (34,54). Obscure prescriptions or medication orders can lead to misinterpretation of the same. This is usually caused by use of non- 48 CHAPTER SIX: CONCLUSION AND RECOMMENDATIONS 6.1 Conclusion The prevalence of vincristine medication errors was significantly high based on the criteria set by International Patient Safety Organisations. The hospital system for the management and follow up of oncology patients had weaknesses thus fell short of meeting the criteria hence a high degree of medication errors was observed. Despite the fact that majority of the errors observed were less likely to cause harm, some were potentially fatal thus there is need for strategies to prevent, detect and minimise these errors. 6.2 Recommendations 6.2.1 Recommendations for policy and practice The following recommendations are made to KNH management based on the study finding; 1. Hospital MTC to develop and disseminate protocols on safe use of high risk medications and ensure there is a team that guides and monitors implementation. 2. Director of clinical services should ensure formal induction training of new staff especially senior house officers on the use and handling of cytotoxics as well as proper transitioning during staff turnovers is initiated. 3. The pharmacy department coordinator of continuous professional development should ensure regular continuous medical education sessions are held to update staff on drug doses, medication errors and adverse drug events. 4. Job description of pharmacists must include working in clinical areas, including wards and clinics to help intercept and prevent medication errors. 5. Centralise preparation of cytotoxics in adequately equipped pharmacy and adopt the use of mini- bags in the administration of vincristine. 6. The hospital MTC and paediatric oncology protocol development team should update the paediatric oncology treatment sheet and customise it for use in the adult oncology wards. 6.2.2 Recommendations for future research 1. Larger prospective studies are recommended to determine incidence, predictors and outcomes of antineoplastic medication errors. 2. A clinical audit of deceased cancer patients’ records to determine if antineoplastic medication errors could have contributed to the mortality. 49 3. A similar study to determine the prevalence of vincristine medication errors should be done after implementation of the above said recommendations. Study Limitations Due to poor documentation it was not possible to collect some information such as diagnosis from the in-patient non-schedule forms and out-patient cytotoxic summaries. Side effects of vincristine were not assessed in this study. Logistic regression to identify predictors of vincristine medication errors could not be done as almost all medical records reviewed had medication errors. Some respondents may not have given accurate response to the interview-administered questionnaire. HFMEA team members were expected to have biased personal opinions depending on the unit they work, however this was minimised by having a multidisciplinary team. Study findings dissemination plan Efforts will be made to disseminate the findings of this study to the relevant authorities in KNH for this research to have an impact. Presentation at the KNH Medicines and Therapeutics Committee (MTC) meeting and pharmacy department continuous professional development sessions avenues will be explored for study findings dissemination. Opportunities for oral presentations at symposiums and conferences, such as Pharmaceutical Society of Kenya (PSK) annual conference, Hospital Pharmacists Association of Kenya (HOPAK) annual symposium and KNH/UoN conference shall be explored. 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A review of the literature. Eur J Cancer Care. 2010;19(1):285–92. 69. Nurgat ZA, Smythe M., Al-Jedai A. ES. Introduction of vincristine mini-bags and an assessment of the subsequent risk of extravasation. J Oncol Pharm Pract. 2014;21(5):339–47. 70. ISMP. Institute for Safe Medication Practices. 2016-2017 Targeted Medication Safety Best Practices for Hospitals. 2017. Available from: www.ismp.org 58 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. Appendix C: Data Collection Form (Vincristine Use Prevalence) Serial number…………………….. Date of collection……………………… Code Number of participant……………………… I. BIODATA 1. Date of birth: Day….. Month…………….. Year………..Age………… 2. Sex: Male Female (Tick Appropriately) II. CHEMOTHERAPY HISTORY 1. Date of Admission: Day……. Month………….. Year…………….. 2. Was chemotherapy prescribed? YES NO 3. What chemotherapy was prescribed? Table 1. Summary of prescribed chemotherapy Medication name, formulation and strength. Prescribed dose Route of administration Frequency of administration Duration of treatment. 59 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. Appendix D: Data Collection Form (Medication Errors Prevalence) Serial number…………………….. Date of collection……………………… Code Number of participant……………………… I. BIODATA 1. Participant code number……………………………… 2. Date of birth: Day….. Month…………….. Year………..Age………… 3. Sex: Male Female (Tick Appropriately) 4. Weight: …………………. 5. Height: …………………….. 6. Body surface area (BSA m2)………………………….. II. PARTICIPANT MEDICAL RECORD REVIEW 1. In-patient Out-patient 2a.Diagnosis……………………………………………………………………. 2b. Stage of diagnosis………………………………………………………….. 3. Number of cycles prescribed……………………. 4. Co-morbidities if any………………………………………………………… 5a. Is complete blood count monitoring done? YES NO 5b. Are the results acted upon appropriately? YES NO Table 1: Summary of Complete blood Count Results Date of Review Blood Count Done (Y/N) Was Count Low (Y/N) Action Taken Table 2. Summary of prescribed chemotherapy Date medication prescribed Medication name, formulation and strength. Prescribed dose Route of administrati on Frequency of administrat ion Duration of treatment. Designation of prescriber 60 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. II. CATEGORIZATION OF MEDICATION ERROR(S) 1. Medication error(s) identified if any, give brief description of the error 2. Tick appropriately type of error identified above Error code Description of error Tick if present(√) 1. Dosing error ( dose not indicated, overdose or under-dose) 2. Route error ( wrong route, failure to indicate route) 3. Timing error ( wrong frequency, no frequency indicated) 4. Omission error (failure to prescribe or administer the drug) 5. Documentation error (Ambiguous or illegible prescription) 6. Use of abbreviations ( use of “IV” instead of “ Intravenous”, “IT” for intrathecal 7. Failure to request monitoring parameter ( such complete blood count) or place the request 8. Failure to act on available results 2. Indicate the NCCMERP category for the error identified above Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. 62 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. 65 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. 5 Is there a team that guides implementation of the policy, protocol or guideline? 6 How often is the protocol updated? 7 Is there a documented procedure for reporting of medication errors? 8 Are staff encouraged to report medication errors? 9 Are chemotherapy medication errors reporting tools available in KNH? 10 Are there any medicine information resources available to staff? 11 Is a list of high alert medicines available to staff? 12 Does KNH promote Vincristine as a High Risk medicine? 13 Is a list of abbreviations to be avoided in Chemotherapy available and accessible to staff? 14 Is there a formal process for approving guidelines, prescription order forms and Oncology treatment sheets before use in KNH? 15 Is there formal induction training for new staff in the unit? 16 Are there defined responsibilities for pharmacists in the management of patients receiving chemotherapy? 66 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. B. Process component Yes/No Comment 1 Is there a defined Oncology treatment sheet for prescribing chemotherapy? 2 Is there a list of Authorized chemotherapy prescribers with sample signatures? 3 Are chemotherapy orders authorized by an Oncologist especially for new patients? 4 Is there any clear process or procedure for communicating with prescriber when questions arise? 5 Are prescribers contacted to verify medication orders before dispensing or administration? 6 Do patients/Guardians actively participate in management of their Condition? 7 Is patient’ consent sought before chemotherapy administration? 8 Are there cases of chemotherapy orders done by telephone? 9 Is there a procedure for handling verbal orders? 10 Is there any strategy in place to prevent chemotherapy errors? 11 Do pharmacists review the medical records of patients on chemotherapy in the unit? 12 Is Chemotherapy administration done on Weekdays between 8:30AM and 5:30PM? 13 Is Vincristine therapy monitored for success and adverse drug reactions? 14 Is Vincristine use process monitored and reviewed regularly? 67 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. Appendix H: HFMEA Outcome Severity Rating Scale Rating Outcome Category Description 4 Catastrophic Resident experiences death or major permanent loss of function (sensory, motor, physiologic, or intellectual) 3 Major Resident experiences permanent lessening of bodily function (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, or increased level of care for 3 or more days. 2 Moderate Resident experiences an event, occurrence, or situation which could harm the resident but will not cause permanent injury or lessening of bodily function or require the delivery of additional healthcare services 1 Minor Resident may experience a minor injury, but most likely would not be affected by the failure and it would not cause any changes in the delivery of care. Appendix I: HFMEA Failure Probability Rating Scale Rating Description Definition 4 Frequent: failure is most inevitable 1 failure in 5 attempts 3 Occasional: repeated failures 1 failure in 50 attempts 2 Uncommon: infrequent failures 1 failure in 200 attempts 1 Remote: relatively few failures 1 failure in 5000 attempts Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. 70 Assessment of Vincristine Medication errors and Contributing Factors in Kenyatta National Hospital. 2017, Kurgat et al. Appendix M: KNH Study Registration Certificate 71