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Llniversityof 39 Ilertfordshlre Anticoagulation Safety in Clinical Practice 2014 ABSTRACT Background Anticoagulants play an important role in the homeostatic by aiding the management of conditions that may result in spontaneous clot formation in the blood vessels which may in turn lead to the blockage of the vessel at the site of their formation or dislodge to block other vessels at a distant site thromboembolism However a number of incidences involving anticoagulants continue to be reported in clinical practice Purpose The purpose of this study was to describe incidents where anticoagulants were involved using clinical incident data from Cambridge University Hospitals NHS Foundation Trust covering a two year period It sought to determine all clinical incident data involving anticoagulants characterize the reported incidents and make recommendations for improved clinical practice Methods Using retrospective study design the study reviewed the incidents medical reports from the Risk and Patient Safety Department to obtain the necessary data concerning medication errors regarding anticoagulants In order to minimize the inherent limitations and maximize the benefits attributed to retrospective studies the current study adhered to the recommended methodology for conducting a retrospective study For instance research questions were formulated hypotheses developed and clinical scan conducted The researcher then carried out a systematic review of existing relevant literature before developing the research proposal and operationalizing the research variables Thereafter a uniform data abstraction instrument comprising standardized abstractors for capturing the necessary information was developed for purpose of enhancing the validity and reproducibility of the study Abstraction protocols and guidelines which served as a coding manual for the data collection process were also developed Consideration was also given to the ethical and administrative requirements for accessing the incident database of the Trust s Risk and Patient Safety Department The study was also piloted to aid the management of missing data Results Of the 171 reported incidents the surgery department reported the highest number of incidents with 61 reports of wrong prescription dispensing and administration of anticoagulants to patients The medicine department followed closely with 50 reported instances of errors in anticoagulation drug therapy The pharmacy department reported the least incidents of anticoagulation therapy mishap The Trauma and Orthopaedics ward reported the highest number of incidences in the Surgery department n 33 Most of these reported cases ie n13 involved omission of the anticoagulation medicine in the prescription with cases of error in the transfer of drugs and stock shortage being reported the least ie n1 in each case The Respiratory medicine ward in the medicine division yielded the highest number of reported incidents ie n14 Most of the incidence reports in the Respiratory Medicine ward involved the failure of the health personnel to administer the anticoagulation drug to the patient n7 Approximately 50 and 38 of the 71 reported cases involved errors in the administration and prescription of the anticoagulation drug respectively The common errors in the administration of anticoagulation drugs were omission wrong drug wrong dosage wrong time protocol failure unauthorized drug administration repeated dose wrong patient and wrong drug strength all of which are preventable errors The reported risks were majorly 73 low levelgreen risks Conclusion and Recommendations According to the results of this study the surgery department recorded the highest cases 36 of incidences involving anticoagulants with the medicine department following closely at 29 Most of the reported errors were humaninduced and were potentially preventable Administration errors were identified by this study as the most common cause of anticoaguant associated medication errors at the hospital and so were the frequent causes of anticoaguant associated clinical incidences at the facility The study findings also indicated that most of the reported errors approximately 65 involved the anticoagulation drug Dalteparin which is an example of a low molecular weight heparin most of the reported measures that have been adopted by the hospital are mainly aimed at addressing errors that have minor impact on the patients safety In order to minimize the incidences involving anticoagulants and enhance patients safety in health facilities the study recommends inter alia promotion of an integrated approach to implementation of risk reduction strategies the need for regular mandatory staff training on safety solutions as well as updating of anticoagulation therapy guidelines policies and protocols The study also recommends creation of awareness of anticoagulant drug interactions among prescribers and the need for health organizations to undertake regular evaluation of patient safety initiatives DECLARATION This dissertation describes research conducted in the Department of Pharmacy University of Hertfordshire between October 2013 and January 2014 under the supervision of Dr Narinder Bhalla I certify that the research described is original and that any parts of the work that have been conducted by collaboration are clearly indicated I also certify that I have written all the text herein and have clearly indicated by suitable citation any part of this dissertation that has already appeared in publication Turki Mohammed Almoteb This dissertation has been submitted for marking with my approval as University supervisor Signature Dr Narinder Bhalla ACKNOWLEDGEMENT I am grateful to Hertfordshire University for giving me a chance to complete my study successfully In particular a sincerely thank my supervisor Dr Narinder Bhalla for his continued guidance during this study I am indebted to my family members for their material and moral support Above all I thank the Almighty God for enabling me to complete my study successfully TABLE OF CONTENT ABSTRACT 2 DECLARATION 3 ACKNOWLEDGEMENT 4 TABLE OF CONTENT 5 CHAPTER ONE INTRODUCTION 6 11 Background of the Study 6 12 Indications for Anticoagulant Use 6 121 Heart Failure HF 6 122 Stroke 6 123 Surgery 6 13 Clinical Issues associated with Anticoagulant Therapy 6 14 Safety of Anticoagulation Therapy 7 CHAPTER TWO MATERIALS AND METHODS 8 21 Introduction 8 22 Aim of the Study 8 23 Objectives of the Study 8 24 Study Design 8 25 Sampling Procedure 8 26 Data Collection 9 27 Data Analysis 9 CHAPTER THREE RESULTS 9 31 Introduction 9 32 Clinical Incidents Involving Anticoagulants 9 CHAPTER FOUR DISCUSSION OF RESULTS 18 41 Introduction 18 42 Clinical Incident Data Involving Anticoagulants 18 43 Characterization of Incidents 18 44 Conclusion 18 45 Recommendations 18 451 Integrate Implementation of Risk Reduction Strategies 18 452 Mandatory Regular Staff Training 19 453 Updating of Guidelines Protocols and Policies 19 7 454 Awareness of Interactions 19 455 Evaluation of Patient Safety Initiatives 19 456 Implementation and Use of Bar Coding Technology 19 46 Areas for Further Study 19 REFERENCES 20 CHAPTER ONE INTRODUCTION 11 Background of the Study Anticoagulants are drugs that stop blood from forming clots Clot formation will occur spontaneously when blood is exposed to certain triggers Clot formation coagulation is a homeostatic process which solidifies blood in order to prevent excessive blood loss and stop foreign bodies from entering the bloodstream The coagulation process involves a cascade of complex events that are tightly controlled and regulated by the body Smith 2009 This tight control is in place to ensure that no mistakes occur in the coagulation process since errors can prove fatal Disorders of the clotting process can cause excessive bleeding or spontaneous clot formation These abnormalities are life threatening and need to be corrected in order for the affected individual to lead a healthy life Smith 2009 Anticoagulants are specifically used to manage conditions that may result in spontaneous clot formation in the blood vessels Spontaneous clots may block the vessel at the site of their formation or dislodge to block other vessels at a distant site thromboembolism Blockage of blood vessels results in ischemic necrosis of tissues leading to disability or death Smith 2009 Anticoagulants work by preventing formation of new clots and preventing an already formed one from becoming worse if a clot has already been formed an anticoagulant will not break it down Anticoagulants can be used both in and outside hospitals Warfarin Coumadin which can be administered orally and a set of drugs known as low molecular weight heparins LMWH eg enoxaparin Lovenox are the most commonly used anticoagulants outside hospitals Hohnloser Oldgren amp Yang 2012 Unlike does warfarin the LMWHs require minimal monitoring and must be administered through injection Mannucci amp Franchini 2011 The use of anticoagulants may result into excessive bleeding which is considered their main side effect However the risk of excessive bleeding associated with warfarin is normally reduced through a careful adjustment of the dose based on the results obtained from frequent blood tests Caprini 2011 The risk of bleeding associated with anticoagulants must be weighed against the risk of blood clots for each patient FDA 2012 However the determination of the risks can prove fatal especially in cases where anticoagulant therapy is appropriate FDA 2012 Even though anticoagulant therapy is characterized by certain absolute contraindications Mujib 2011 warns that the patient may be predisposed to risks by some conditions These risks can be considered relative contraindications if they outweigh the benefits attributed to anticoagulants Mujib 2011 In order to ensure that the benefits of anticoagulation therapy outweigh the inherit risks Caprini 2011 observes that the relative contraindications associated with therapy ought to be considered on an individual basis The main pharmacological principal behind anticoagulants is to increase the amount of time is takes for blood components to cluster together and therefore increase the time it takes for a clot to be formed The anticoagulants are classified according to the part of the clotting cascade that they target in order to achieve this There are 3 major classes of anticoagulants CoumarinsVitamin K antagonists antiplatelets and Heparin and its derivatives Smith 2009 10 12 Indications for Anticoagulant Use Anticoagulation plays an essential role in the prevention and treatment of thromboembolic disorders Some of the medical agents employed in the treatment of some of the disease states that induce thromboembolism include Vitamin K antagonists VKA factor Xa inhibitors and direct thrombin inhibitors DTI Fuster 2011 The anticoagulants are normally intrinsic in nature a characteristic that predisposes patients to risks of bleeding complications In this regard compliance is considered key during both primary and secondary prophylaxis Katrin 2012 High morbidity and mortality rates are normally associated with thromboembolic events regarding surgical procedures and disease states Mannucci amp Franchini 2011 Cardiac issues such as arrhythmias and myocardial infarction MI hematologic abnormalities as well as cerebrovascular Disorders eg stroke and transient ischemic attacks TA increase the risk of venous and arterial thromboembolism Gutierrez amp Blanchard 2011 In addition thromboembolic events are also caused by surgical procedures such as total hip replacement THR and total knee replacement TKR Lassen 2008 Eriksson 2008 Therefore Fuster 2011 observes that the etiology of the thromboembolic event should inform the choice of the optimal anticoagulant medication Anticoagulation is mainly prescribed to patients as a prophylaxis against conditions that can lead to clot formation within the circulatory system Cousins amp Harris 2006 Although not an absolute guideline the National Patient Safety Agency lists the following as indications for anticoagulation i treatment and prophylaxis for patients who have been diagnosed with thrombus formation in the deep veins of the calf 11 muscles so as to prevent formed clot progression or new clot formation deep venous thrombosis ii abnormal contraction of the heart muscles which may lead to pooling of blood and thrombus formation within the chambers atrial fibrillation iii to treat and prevent recurrence in patients diagnosed with thrombus formation within the lung vasculature pulmonary embolism and iv to prevent clot formation that might lead to a thromboembolism in patients who have artificial heart valves Cousins amp Harris 2006 Common indications for anticoagulant use include the following 121 Heart Failure HF Heat failure HF is a common phenomenon in the contemporary society Approximately 1 to 2 of patients aged 65 years and above are hospitalized because of heart failure Shantsia amp Lip 2010 Whether a patient is diagnosed with either diastolic or systolic HF Haeusler Laufs amp Endres 2011 observe that survival rates attain approximately 35 5 years post diagnosis The mortality rates per year for diastolic and systolic HF patients are estimated to attain up to 9 and 19 respectively Haeusler Laufs amp Endres 2011 HF leads to static blood flow due to dysfunction of the left ventricular and endothelial dysfunction a phenomenon that triggers the activation of the reninaldosteroneangiotensin system thrombogenic cytokines eg tumor necrosis factor or and intereukin 1 as well as increasing the level of fibrin and aggregating thrombocytes thus increasing the incidence of thrombogenic events Freudenberger 2007 This scenario ultimately leads to the hypercoagulable state associated with HF Currently conflicting clinical data relating to the benefits of prophylactic anticoagulation in HF exist For instance a study by Haeusler Laufs amp Endres 2011 indicates a 24 decrease in causes of mortality rates and cases of hospitalization of HF 12 patients who are on warfarin Nevertheless the study shows no reduction in thromboembolism The WATCH trial Warfarin and Antiplatelet Therapy in Chronic Heart Failure found that warfarin reduced occurrences of nonfatal stroke and frequencies of hospitalizations Haeusler Laufs amp Endres 2011 Other trials have reported an increase in stroke rates attributed older HF patients while others have reported an absence of link Haeusler Laufs amp Endres 2011 Given their vulnerability to venous thromboembolism VTE hospitalized HF patients should be subjected to anticoagulation using low molecular weight heparin LMWH fondaparinux or low dose unfractionated heparin LDUH Shantsila amp Lip 2010 122 Stroke The risks attributed to stroke have been on the rise over the last decades Consequently stroke prevention has emerged as an essential clinical practice in the modernized society The type of brain injury and the location of the vascular lesion determine stroke Kleindorfer 2009 Healthcare professionals normally utilize anticoagulation medications to reduce the incidences and recurrence of stroke Furie 2011 FDA has approved a number of coagulants including ASA dipyridamole warfarin clopidogrel or a combination of the coagulants to be used for the secondary prevention of stroke or TIA based on the disease state of the patient Furie 2011 For the primary prevention of strokeT IA the recommended anticoagulants include dabigatran ASA LMWH clopidogrel Rivaroxaban UFH warfarin and dipyridamole Fuster 2011 13 123 Surgery Patients undergoing surgical procedures are characterized by high thromboembolic risk factor It is estimated that about 15 to 30 of patients subjected surgical procedures develop deep vein thrombosis DVT without using anticoagulation prophylaxis Fuster 2011 Total knee replacement TKR and total hip replacement THR surgeries have been identified as the highest risk factors for developing venous thromboembolism evident in about 40 to 60 of patients within one week of the surgical procedure Lieberman amp Hsu 2005 Mechanical eg compression stockings and boots and pharmacological eg pharmacological anticoagulation methods are used to prevent thromboembolic events resulting from surgical procedures Lieberman amp Hsu 2005 The type of anticoagulant to be used in preventing thromboembolic events that result from surgical procedures is determined by the type of surgical procedure Lieberman amp Hsu 2005 13 Clinical Issues associated with Anticoagulant Therapy Although anticoagulants are very important in patient therapy they are not devoid of negative effects Anticoagulants are associated with a number of well known side effects and adverse drug reactions They are also associated with high risk to patients because of their narrow therapeutic window and numerous drug and food interactions especially the oral ones Cousins amp Harris 2006 According to Cousins amp Harris 2006 the narrow therapeutic window is a challenge to clinicians because over coagulation can lead to fatal haemorrhage whereas under coagulation can lead to life threatening thrombus formation Therefore clinicians have to constantly monitor the 14 necessary patient parameters to ensure that the drug levels are within the therapeutic window According to Schulman 2003 the main risk of anticoagulation therapy is haemorrhage In his article he states that the incidence of major bleeding ranges from 05 to 42 episodes per 100 patients annually in clinical studies with selected populations major bleeding episodes are those which require hospitalization or transfusion cause death or intracranial haemorrhage The figure slightly changes in various cohort studies with the range being between 12 to 70 episodes for every 100 patients Minor bleeding episodes of no consequence are estimated to be between 2 to 24 cases per 100 episodes Schulman 2003 observes that the risk of haemorrhage is directly associated with the intensity of the therapy Haemorrhage is just one of the many drug events that can occur when anticoagulation is being administered Gregory et al 2011 carried out a five year retrospective study in the United States of America from May 2004 to May 2009 to identify the type and prevalence of adverse drug events ADEs associated with anticoagulation In their report they established that the total number of adverse drug events were 463 in which 207 96 cases were both adverse drug reactions ADRs and medication errors 305 141 cases were purely ADRs and 488 226 cases were purely medical errors MEs Gregory et al 2011 The study also showed that 76 of the adverse drug events were preventable Medication errors associated with anticoagulation therapy were mainly of the transcription type 488 MEs were also the largest contributors to adverse drug reactions with 40 of the reactions being directly attributed to these errors The researchers also attempted to establish the death 15 rate associated with anticoagulant use Their findings showed that 11 of the patients who were started on anticoagulant therapy died within the first 30 days According to Cousins amp Harris 2006 there were a total of 480 cases of harm to patients reported by the end of 2002 involving anticoagulants in the United Kingdom In the same period 120 deaths were reported to be directly linked to anticoagulant use with 92 cases 77 related to Wafarin and 28 cases 23 related to heparin use In the report figures from the NPSA National Patient Safety Agency incident data gave more detailed information about the types of patient harm reported A total of 1250 cases were reported between 192004 and 31122005 with 699 being Warfarin associated and 416 being heparin associated Cousins amp Harris 2006 The 699 Warfarin cases were categorized according to the type of error prescribing 201 cases29 administration 379 cases54 preparation and dispensing 46 cases7 monitoring 45 cases6 and others 28 cases4 The 416 heparin cases were also categorized according to the type of error prescribing 56 cases14 administration 318 cases76 preparation and dispensing 18 cases4 monitoring 20 cases5 and others 4 cases1 Cousins amp Harris 2006 14 Safety of Anticoagulation Therapy A report by the joint commission published in September 24 2008 lists anticoagulants as one of the top five drugs associated with negative patient incidents in the United Kingdom The report cites the following factors as contributors to the high error rates associated with anticoagulants 16 Prescribing of anticoagulants require strict monitoring procedures and individualized instructions that may fail to be communicated or documented during hospital shift change or transfers Joint Commission 2008 Most anticoagulants have narrow therapeutic ranges and high potential for complications due to the many drug interactions and contraindications Joint Commission 2008 The labeling naming and packaging of most of these drugs is not standardized a phenomenon that leads to confusion during drug administration Joint Commission 2008 Dosing regimes that are constantly updated for different patient populations makes it difficult for most caregivers to keep up with current protocols especially those who do not administer anticoagulants regularly Joint Commission 2008 The joint commission put forward a number of strategies to reduce the risk of anticoagulant therapy in their report One of the recommendations is that organizational wide risk assessment should be implemented for anticoagulation therapy Evidence based protocols for regimes should be used and blanket dose limits should be set with screening of patients for exceptions Clear labeling of all containers and syringes used for anticoagulant administration should be implemented Joint Commission 2008 All patients who have had their therapy stopped due to a procedure should be re evaluated before anticoagulant therapy is resumed All anticoaguant associated lab values should be communicated in a timely manner by those carrying out the tests to the caregiver in charge of managing the patient Patients on therapy should be trained and educated so that they can learn to administer their own medication so as to reduce the risk of errors 17 after discharge Only preservative free heparin should be administered to neonates and all pharmacists informed of this All patients should undergo a thorough history taking and examination to rule out contraindications before initiation of therapy and all those under therapy should be monitored closely Joint Commission 2008 In addition there are various recommendations that have been identified in the British Journal of Clinical Pharmacy published in 2009 concerning the safety of anticoagulant therapy The main recommendation made by working groups towards the safety of these drugs includes ensuring that medical nursing and pharmacy staffs are properly trained about the safety of anticoagulant therapy Regular training for the clinical staff has been described to be essential for ensuring solutions are received concerning the use of these medications It is recommended that such training should be done during the induction of the health care professionals and should be repeated at least every year with special emphases laid on high risk clinical areas or recurrent problems The second recommendation entails the production of new and updated operating procedures and clinical guidelines for anticoagulant services reflecting a safe practice This recommendation state that advice should be given to health care professionals about the initiation and management of anticoagulation in inpatients The recommendation led to the development of inpatient anticoagulation guidelines with special reference to target doses warfarin initiation patient discharge and the management of bleeding as one of the main complications of anticoagulant therapy Most patients are usually unaware of the possible side effects that can be associated with anticoagulant therapy For this reason it was recommended that all patients 18 prescribed anticoagulants should receive appropriate verbal and written information at the beginning of anticoagulant therapy so as to enhance compliance and better prognosis Moreover most health care professionals were not aware of warfarin and other anticoagulant drug interactions and some did not have guideline copies about the use of warfarin therapy For this reason it was recommended that detailed guidance to prescribers and pharmacists about drug interactions involving anticoagulants to be developed 2614 Words 19 CHAPTER TWO MATERIALS AND METHODS 21 Introduction This chapter presents the research methodology adopted by the study In particular it covers the study design sampling procedure data collection process and data analysis 22 Aim of the Study The aim of this study was to describe incidents where anticoagulants were involved using clinical incident data from Cambridge University Hospitals NHS Foundation Trust covering a twoyear period In order to achieve this aim three specific objectives were formulated as follows 23 Objectives of the Study The study aimed at achieving the following specific objectives i To identify all the clinical incident data involving anticoagulants from Cambridge University Hospitals NHS Foundation Trust covering a twoyear period ii To characterise whether the incidents were due to either adverse drug reactions or medical errors iii To make recommendations for improved clinical practice 24 Study Design In order to achieve the above objectives and generate sufficient data for answering the research question an appropriate research design was of the essence While taking the Cambridge University Hospitals NHS Foundation Trust as a case study the study adopted a retrospective research method to obtain the necessary data for analysis A retrospective research also known as a historic cohort study often requires 20 the analysis of data that were originally collected for reasons other than research including medical reports and other clinical incidents reports or administrative data Generally this type of research design enables a researcher to flashback on the events that have already occurred For instance retrospective studies are employed in medicine to describe a ook back at the medical histories and lifestyles of patients Hess 2004 Quality assessment epidemiological investigations and improvement studies often use medical record reviews for scientific investigation Jansen et al 2005 Some of the medical records include physician and nursing notes laboratory and diagnostic testing reports ambulatory and emergency room reports admission and discharge documentation consultations as well as other administrative data Jansen et al 2005 The scientific use of existing clinical records is a common practice in epidemiological inquiries quality assessment studies professional training Pan et al 2005 clinical research Staller Kunwar amp Simionescu 2005 as well as examination of inpatient care Worster amp Haines 2004 According to Worster amp Haines 2004 about 25 of all clinical inquiries contained in emergency medical journals have employed retrospective health record reviews or chart reviews 241 Advantages of a Retrospective Study Since a retrospective study quickly gleans the requisite data for answering a research question from available records most researchers have termed it as quick and dirty Hess 2004 However Worster amp Haines 2004 argues that this may not be the case for a retrospective study that is done effectively Proponents of retrospective study observe that this type of research design is useful particularly where a pilot study 21 needs to be completed in anticipation of a prospective study Gearing et al 2006 Worster amp Haines 2004 points out that it is easy for a researcher to focus the research question using a retrospective study design Similarly a retrospective study design enhances the clarification of a research hypothesis aids the determination of appropriate sample size as well as identifying feasibility issues attributed to a prospective study Unlike prospective studies retrospective studies are carried out on a smaller scale Their completion also requires lesser time compared to their prospective counterparts Worster amp Haines 2004 In addition this type of research design has been proven suitable for analysing a multiple of results and has the capacity to address rare diseases within the medical context which would call for larger cohorts when a prospective study design is employed Gearing et al 2006 Worster amp Haines 2004 argues that since the patients have already been identified a retrospective study becomes suitable for addressing diseases of low incidence The other benefit associated with retrospective studies is their perceived inexpensive nature This is mainly attributed to the fact that in a retrospective study both the outcome and exposure have already taken place and so the available resources are assigned to data collection only Gearing et al 2006 242 Disadvantages of a Retrospective Study Despite the associated benefits a range of limitations also characterizes retrospective studies First these types of studies are normally limited by incomplete documentation including uncoverable data missing charts as well as the difficulty by some researchers to interpret the information eg professional jargons and acronyms 22 contained in certain records Pan et al 2005 Hess 2004 observes that a retrospective researcher may have difficulty in verifying information in medical records as well as establishing the cause and effect variance in the quality of medical information documented by medical professionals Critics argue that retrospective cohort studies promote selection and information bias since it is difficult for a researcher to measure certain statistics when using a retrospective study design Worster amp Haines 2004 Critics further argue that the assessment of the temporal relationship becomes very difficult when using a retrospective study design and that it is not easy to control exposure andor outcome when using this method Gearing et al 2006 Furthermore since a retrospective research mainly depends on others for accurate record keeping Pan et al 2005 observe that it may be difficult for a researcher adopting this method to undertake accurate comparison between the exposed and non exposed 243 Addressing the Challenges In order to minimize the inherent limitations and maximize the benefits attributed to retrospective studies the current study adhered to the recommended methodology for conducting a retrospective study For instance at the conception stage the researcher undertook research formulation by articulating research questions and developing research hypothesis Similarly a clinical scan of the research questions and hypotheses was undertaken at this stage where clinical expertise was sought with a view to identifying methodological barriers Hess 2004 Once conception the researcher carried out a systematic review of the existing literature relevant to the study topic Jansen et al 2005 by searching at relevant databases such as MEDLINE 23 EBSCOhost and EMBASE This was necessary for providing the requisite background and illuminating how previous researchers have operationalized key concepts and variables The research proposal was then developed and operationalization of variables carried out in accordance with the guidelines suggested by Robin Barber and lckowicz 2006 This was followed by the development of a uniform data abstraction instrument comprising standardized abstractors for capturing the necessary information This was deemed necessary for enhancing the validity and reproducibility Jansen et al 2005 of the study Emphasis was also given to the management storage and analysis of the collected data with a view to enhancing its quality and reliability Worster amp Haines 2004 The study also developed abstraction protocols and guidelines which served as a coding manual for the data collection process Hess 2004 The manual played an important role in guiding the abstraction of data from the accessed clinical records by identifying the variables to be captured from such records In order to enhance their effectiveness the data abstraction protocols and guidelines were reviewed accordingly after the study was piloted Consideration was also given to the ethical and administrative requirements for accessing the incident database of the Cambridge University Hospitals NHS Foundation Trust s Risk and Patient Safety Department For instance the research sought to inquire from the Trust about who may access its medical records the available space for reviewing the records the facility s operation and access hours the hospital s photocopying policies as well as the use of its computers Jansen et al 2005 The management of missing data was done through a pilot study which was undertaken 24 before the commencement of the actual data collection process Furthermore the study observed existing ethical considerations such as obtain ethical approval from the relevant institutional review board Grant 2005 as well as withholding the identity of the participants Overally the validity and reliability of the current study was enhanced by identifying and accessing the necessary and accurate data obtaining consistent data enhancing inter rater reliability as well as reducing selection and information bias associated with retrospective study Furthermore reliability and validity of the study was improved through effective management of errors and missing data as well as calculating effective sample size for the study 25 Sampling Procedure The study was conducted at the Cambridge University Hospitals NHS Foundation Trust The Cambridge University Hospitals NHS Foundation Trust runs Addenbrooke s Hospital The sample for the study included all reported incidents involving anticoagulants in patients who had been admitted to the hospital over a period of two years The hospital keeps records of adverse drug events including adverse drug reactions of anticoagulants Therefore inclusion criteria included only records of adverse drug events involving anticoagulants 26 Data Collection The data collection process commenced with research formulation and a clinical scan In research formulation the research questions were articulated followed by the generation of clear hypotheses This enabled the researcher to determine feasibility of retrospective clinical incident report review According to Gearing et al 2005 linking the research methodology to the hypotheses facilitates an informed approach that 25 assists decisions throughout the subsequent research stages p62 They argued that conducting a clinical scan of the research question and hypothesis uncovers unanticipated benefits while identifying potential methodological barriers Developing a simple and clear data abstraction instrument is therefore necessary Such an instrument would organise data mining from the medical records in a logical manner The standardisation of data is important for increasing the internal validity and reliability of retrospective studies In this study an appropriately authorised member of the Trust staff obtained permission from the Trust s Risk and Patient Safety Department to access data from the incident database The researcher retrospectively reviewed complete incident reports chosen purposively for adverse drug events caused by anticoagulants The numbers of incidents representing the sample size of patients were then computed according to the aim of the current study which was to determine incidents where anticoagulants were involved using clinical incident data from Cambridge University Hospital s NHS Foundation Trust covering a twoyear period The incidents were then be scrutinised and characterised as either an adverse drug reaction or a medication error Mortality data are published by the Trust s Risk and Patient Safety Department The cause of death is determined from information on death certificates provided by doctors The underlying cause of death and the causes are coded using disease codes and external cause codes that relate to adverse events The external cause codes can be used to classify death into adverse events The hospital morbidity database contains records of reasons for hospitalizations the procedures the patient underwent and the external causes of injury and poisoning Although this database is not meant to provide 26 information on adverse events the nature and external cause of injury codes can be used to identify the adverse events Coding is based on the information documented in the medical record by trained staff Since the hospitals report this information collection of the data can help in understanding the incidents involving anticoagulants Information about medication errors regarding anticoagulants were obtained by reviewing the incidents medical reports from the Risk and Patient Safety Department Search terms for the Trust s database included administration error medication drug administration prescribing error and dispensing error The collected data was anonymised to protect the identity of the individual patients andor staff members The collected data was thereafter analysed to comparecontrast it with the patterns themes trends and severity of incidents described in the published literature 27 Data Analysis Once the incidents caused by anticoagulants were identified they were sorted to exclude any irrelevant data All incidents reported into the Trust database involving anticoagulants were considered Once this was completed it was necessary to develop a coding system or categories of terms for purposes of sorting the data The researcher categorized the incidents identified according to themes No particular statistical tests were employed because the main data was simple figures or percentages and most of the analyses involved qualitative comparative analyses of patterns and themes that were identified in the incidents under study in this regard the statistical tests were not appropriate for the current study Finally the purpose of this analysis was to draw out clear recommendations for improved clinical practice in use anticoagulants therapy 2022 Words 27 CHAPTER THREE RESULTS 31 Introduction This chapter reports the findings of the study using charts percentages tables and statements 32 Clinical Incidents Involving Anticoagulants A total of 171 incidents were reported during the data collection period from April 2012 to march 2014 Among the department where data was collected from the Surgery department recorded the largest number of incidents with 61 reports of wrong prescription dispensing and administration of anticoagulants to patients The Medicine department became a close second with 50 reported instances of errors in anticoagulation drug therapy The Pharmacy department on the other hand had the least incidence of anticoagulation therapy mishap with one and three cases reported in the first and second year respectively The women and children s department also recorded four cases of errors in administering anticoagulation medicine which was approximately 2 of the total reported incidences as shown in figure 31 IIIlCilIlllEIllt iirepoiirtedll per dllepaiirtmenlt I IVI edicirle I 1 Wrl3I39I11 I1S and Childrerl I Ieu139oscieI1ces I En1e1 geI1cy and P39e139iope139ative Came I Othe139 divisiorls I Su139ge11 Figure 31 Reported incidents of erroneous prescription dispensing and administration of anticoagulants sorted per department 28 The number of cases reported from the surgery department comprises approximately 3567 of the total number of incidents and this data is gathered from six different wards ie Urology Transplant Trauma and Orthopaedics Vascular Surgery General Surgery and the ENT MAXFAX Ophthalmology and Plastic Surgery ward Table 31 shows the number of incidences reported per ward in the Surgery department Table 3 1 Number of recorded incidents of anticoaulation therapy mishap in the Surgery division sorted per ward Ward Number of incidences Urology 4 Transplant Surgery 10 Trauma and Orthopaedics 33 Vascular Surgery 4 General Surgery 7 ENT MAXFAX Ophthalmology and Plastic Surgery 3 Total 61 Trauma and Orthopaedics ward reported the highest number of incidences in the Surgery department n 33 Table 32 shows that among these cases 13 involved omission of the anticoagulation medicine in the prescription 11 cases resulted from the prescription of the wrong dosage of the drug and 5 incidences involved the omission of the drugs in the administration There were 2 cases of duplicated anticoagulation drug prescription a single case of error in the transfer of drugs and an isolated report of stock shortage Table 32 Causes of reported incidence at the Trauma and Orthopaedics ward 29 Cause of incidence Frequency Omission of the anticoagulation medicine in the prescription 13 Prescription of the wrong dosage of the 11 drug Omission of the drugs in the administration 5 Duplicated anticoagulation drug 2 prescription Error in the transfer of drugs 1 Stock shortage 1 Total 33 The ENT MAXFAX Ophthalmology and Plastic Surgery Ward Ward M5 reported the least number of incidences with 3 cases of anticoagulation therapy mishap These cases involved the administration of the wrong concentration of the drug omission of the anticoagulation drug in the prescription and failure of the prescribing protocol The fifty 50 cases reported from the Medicine department comprised approximately 2924 of the total number of incidences reported at the facility This data was pooled from 16 different wards and units Table 33 shows the list of the subdivisions of Medicine from which the data was collected As shown in the table the Respiratory medicine ward and Cardiology both yielded the highest number of incident reports with 14 and 6 cases respectively The Department of Medicine for the Elderly DME also had six incidences of erroneous application of anticoagulation therapy Isolated cases were reported from various wards and units ie Coronary Care Unit CCU Acute Assessment Unit Diabetes and Escalation Unit the discharge lounge the EAU level 4 unit and the Renal ward 30 Table 33 Number of recorded incidents of anticoagulation therapy mishap in the Medicine department sorted per wardunit WardUnit Number of incidences DME 6 Respiratory Medicine 14 Acute Stroke Unit Stroke and Rehabilitation Unit Cardiology Hepatology Medical Short stay Emergency Unit Medihome Coronary Care Unit Acute Assessment Unit Diabetes and Escalation Unit Discharge Lounge Acute Medicine EAU Level 4 Gastroenterology Renal U1 3 l3 gtgtCD Total Most of the incidence reports in the Respiratory Medicine ward involved the failure of the health personnel to administer the anticoagulation drug to the patient n7 Isolated cases of administration of the wrong dose prescribing the wrong dose duplicating the prescription of the drug duplicating the dosage administration failure to follow the drug administering protocol and allergic reaction of the patient to the drug were reported In Cardiology two patients were administered with repeated dosages of Dalteparin and there were isolated reports of duplication of anticoagulation drug in the prescription dose duplication during drug administration and omission as well as administration of the wrong strength of drug A single incident was been reported wherein the patient was prescribed with 12500 units of Dalteparin daily so with no review This prompted an immediate inspection of the patient s discharge letter which revealed that the CTPA was negative and so no PE thus necessitating the 31 discontinued use of Dalteparin The case was of moderate risk and no further doses of Dalteparin were given Approximately 10 of the total number of incidences reported was constituted by reports from various divisions that had few incidents These departments are Finance Pharmacy the Cancer department Investigative Sciences and Trustwide issues Finance and Pharmacy had the lowest record of incidences reported In the Finance department particularly the procurement department new anticoagulation charts almost ran out of supply in the inventory resulting into multiple unfulfilled orders The incidents reported by the Pharmacy involved prescription and dispensation of the wrong dose of drug as well as failure in following prescription protocol The data indicates that there is a prevalence of surgery and other invasive procedure related mishaps in the use of anticoagulation therapy The use of anticoagulants is a matter of concern in preoperative and postoperative patient care Perioperative management of chronically anti coaguated patients andor patients treated with antiplatelet therapy is a complex medical problem Harder et al 2004 Patients with indications for anticoagulation therapy must discontinue the use of the said medications prior to surgery to prevent unnecessary bleeding Heisler 2009 On the other hand discontinued use of anticoagulation drugs might result in thromboembolism Although the effect of the drugs would not immediately disappear after cessation of intake it would require a considerable amount of time post operativey to reestablish therapeutic anticoagulation Kearon and Hirsh 1997 Anticoagulants are also prescribed postoperatively to prevent blood clots from forming and causing harm to the patients Mistakes in anticoagulation therapy may lead to morbid patient outcome The 32 data clearly indicates that there is a wide gap between the current practice of anticoagulation therapy in the city and the ideal application of anticoagulation in the everyday living of people Among the 71 cases reported figure 32 shows that 50 were errors involved in the administration of the anticoagulation drug Mishaps in the prescription of the drug were reported in 38 of the cases as well Erroneous dispensing of anticoagulatives W8S rare Itilrtitlenlt Sttbclass I P39139cs i11 quotlljiI1g I Adntittisttt iott I lliispettsittg I Dtltets Figure 32 Reported incidents of erroneous prescription dispensing and administration of anticoagulants According to the landmark 2006 report entitled Preventing Medication Errors from the Institute of Medicine medication errors injure up 15 million Americans in a year and cost about 35 billion loss in productivity wages and additional medical expenses Anderson 2010 These events compromise the safety and trust of patient in the health service providers The data indicates the common errors in the administration of anticoagulation drugs are omission wrong drug wrong dosage wrong time protocol 33 failure unauthorized drug administration repeated dose wrong patient and wrong drug strength all of which are preventable errors The isolated report of a patient who had an allergic reaction to the anticoagulant is also deemed as a preventable incident through skin testing Since anticoagulants are high alert medications by the Institute for Safe Medication Practices ISMP due to their tendency to cause lifethreatening patients these incidents are a matter of great concern in upholding the safety of patients undergoing anticoagulation therapy Okongwu et al 2007 Due to the narrow therapeutic range of anticoagulants the potential for increased prescribing error is also highly likely Pfoh 2013 According to Fanikos and associates 2004 approximately 62 of anticoagulation medication errors have been due to human error see figure 33 eg memory lapse 19 faulty checking 10 communication failure 9 transcription errors 12 and rule violations 13 Only 23 of mishaps have been attributed to pump or drug delivery malfunction as cited in Okongwu 2007 ll luman Error I Nonrl luman Error Figure 33 Causes of anticoagulation medication errors Source Fanikos et al 2004 34 The prevalence of omission of anticoagulants in prescription and administration could be translated to an increased risk for stroke thromboembolism myocardial infarction and mortality Okongwu et al 2007 Kearon and Hirsh 2007 Considering that most of the patients involved are from the Surgery division Respiratory Medicine ward and Cardiology unit who are at high risk for bleeding pulmonary thromboembolism and myocardial infarction respectively the reported incidences of error indicates increased vulnerability of the patients admitted to the aforementioned facm es Figure 34 shows that approximately 65 of the error reports involved the anticoagulation drug Dalteparin which is an example of a ow moecuar weight heparin Hull et al 2000 observes that the most severe complication that can be caused by administration of wrong dosage of Dalteparin is hemorrhage and severe blood loss I 3 bigatra n I Warfarin I Dalteparin Figure 34 Anticoagulant drugs cited in the medication error reports The 1 error associated with Dabigatran anticoagulant drug could be attributed to the fact that it is still a new medication that is not commonly prescribed in hospitals for patients undergoing anticoagulation therapy In addition Dabigatran is a short onset 35 drugs that requires to be administered in a timely manner Connolly Ezekowitz and Yusuf 2009 Unlike Warfarin Dabigatran does not require frequent blood tests for international normalized ratio INR monitoring while offering similar results in terms of efficacy Connolly Ezekowitz and Yusuf 2009 Apart from GI upset this anticoagulant has no known side effect For instance in a clinical trial to determine the efficacy of Dabigatran and Warfarin Wallentin Yusuf and Ezekowitz 2010 found that patients who were anticoagulated with Dabigatran registered minimal ife threatening bleeds and fewer minor and major bleeds including intracranial bleeds compared to those taking Warfarin Gage 2009 observes that Dabigatran capsules are essential for adequate absorption because they contain tartaric acid which lowers the gastric PH A study by Nutescu Chuatrisorn and Hellenbart 2011 found that patients on Dabigatran developed less intracranial hemorrhage especially hemorrhagic stroke compared to those anticoagulated with Warfarin Wallentin Yusuf and Ezekowitz 2010 have identified this as one of the advantages of dabigatran Connolly Ezekowitz and Yusuf 2009 observe that twice daily dosing of Dabigatran reduces variability in the anticoagulation effect because the drug has an elimination half life of 1217 hours Therefore the lower ie 1 cases of reported errors involving Dabigatran found by the current study could be attributed to the advantages of this drug and the fact that it is still new and not commonly prescribed in most health facilities According to the likelihood and consequence assessment figure 35 indicates that 43 of the medication errors reported were possible and had the capacity to occur Approximately 54 of the cases had little to less tendency to occur while 3 were 36 almost certain to occur The data indicates that there are almost equal chances that an error would occur in the prescription dispensation and administration of anticoagulation drugs The 4 margin between error and safety is relevant and expandable This must be addressed through the identification of the source of errors and subsequent appropriate implementation of preventive measures 17 Y j 1 Qxj L 0 H I LT1t1ikel t I Pbssibwle I Rams I L ikeljr I Alngtost cettaitt Figure 35 Graphical representation of the possibility that the reported medication errors would occur The risk and consequences analysis has shown that majority of the consequences that could result from the reported errors range from moderate to minor consequences Among the errors reported figure 36 shows that 16 could result to major consequences while the remaining 6 had insignificant outcome Table 34 provides the Risk Rating Numbers RRN Figure 36 Consequence assessment of the various medication errors reported From table 34 majority of the reported risks n52 were low risk or what is also commonly referred to as green risks This represented approximately 73 of reported risks in all the 71 cases 37 Table 34 The Risk Rating Number Form Likelihood Consequence Risk Rating No L 0 Number RRN Level of Risk CXL 1 2 4 8 Moderate Risidorange Risk 2 2 2 4 Low RiskGreen Risk 3 3 2 6 Low RiskGreen Risk 4 1 4 4 Low RiskGreen Risk 5 2 3 6 Low RiskGreen Risk 6 4 3 12 Moderate Risidorange Risk 7 3 3 9 Moderate Risidorange Risk 8 1 2 2 Low RiskGreen Risk 9 1 1 1 Low RiskGreen Risk 10 3 2 6 Low RiskGreen Risk 11 3 3 9 Moderate Risidorange Risk 12 3 2 6 Low RiskGreen Risk 13 3 2 6 Low RiskGreen Risk 14 3 2 6 Low RiskGreen Risk 15 3 2 6 Low RiskGreen Risk 16 3 2 6 Low RiskGreen Risk 17 5 1 5 Low RiskGreen Risk 18 3 3 9 Moderate Risidorange Risk 19 3 2 6 Low RiskGreen Risk 20 3 2 6 Low RiskGreen Risk 21 3 2 6 Low RiskGreen Risk 22 3 2 6 Low RiskGreen Risk 23 3 2 6 Low RiskGreen Risk 24 3 2 6 Low RiskGreen Risk 25 3 2 6 Low RiskGreen Risk 26 3 4 12 Moderate Risidorange Risk 27 2 3 6 Low RiskGreen Risk 28 1 1 1 Low RiskGreen Risk 29 2 4 8 Moderate Risidorange Risk 30 3 4 12 Moderate Risidorange Risk 31 1 2 2 Low RiskGreen Risk 32 3 2 6 Low RiskGreen Risk 33 1 3 3 Low RiskGreen Risk 34 3 2 6 Low RiskGreen Risk 35 3 2 6 Low RiskGreen Risk 36 3 2 6 Low RiskGreen Risk 37 3 2 6 Low RiskGreen Risk 38 3 2 6 Low RiskGreen Risk 39 3 2 6 Low RiskGreen Risk 40 3 3 9 Moderate Risidorange Risk 41 3 2 6 Low RiskGreen Risk 42 3 2 6 Low RiskGreen Risk 43 3 2 6 Low RiskGreen Risk 44 1 2 2 Low RiskGreen Risk 45 3 2 6 Low RiskGreen Risk 46 2 2 4 Low RiskGreen Risk 47 3 3 9 Moderate Risidorange Risk 48 1 3 3 Low RiskGreen Risk 38 49 1 2 2 Low RiskGreen Risk 50 3 3 9 Moderate Risidorange Risk 51 1 1 1 Low RiskGreen Risk 52 3 3 9 Moderate Risidorange Risk 53 2 2 4 Low RiskGreen Risk 54 3 4 12 Moderate Risidorange Risk 55 1 2 2 Low RiskGreen Risk 56 1 3 3 Low RiskGreen Risk 57 1 2 2 Low RiskGreen Risk 58 2 4 8 Moderate Risidorange Risk 59 1 2 2 Low RiskGreen Risk 60 2 3 6 Low RiskGreen Risk 61 3 4 12 Moderate Risidorange Risk 62 2 3 6 Low RiskGreen Risk 63 3 3 9 Moderate Risidorange Risk 64 1 2 2 Low RiskGreen Risk 65 2 3 6 Low RiskGreen Risk 66 1 3 3 Low RiskGreen Risk 67 3 3 9 Moderate Risidorange Risk 68 3 3 9 Moderate Risidorange Risk 69 2 4 8 Moderate Risidorange Risk 70 1 2 2 Low RiskGreen Risk 71 1 2 2 Low RiskGreen Risk Legend Likelihood L o Rare 1 o Unlikely 2 o Possible 3 o Likely 4 o Almost certain 5 Consequence C o No harmNegligible 1 LowMinor 2 Moderate 3 SevereMajor 4 DeathCatastrophic 5 Adequate actions were reported to have been taken to mitigate the consequences of the errors Efficient communication among hospital staff members had 39 been utilized in order to implement interventions aimed at preventing harm among the patients Errors which could not be corrected were noted for future reference Anderson 2007 noted that the ISMP identified 10 key elements of proper medication to be used in the clinical setting These elements are necessary in ensuring the continuum of patient safety and satisfaction Among those noted are patient information drug information adequate communication drug packaging labelling and nomenclature medication storage stock standardization and distribution drug devise use acquisition and monitoring environmental factors staff education and competency patient education and quality process and risk management These are the elements that need to be addressed to minimize the occurrence of anticoagulation medication errors Approximately 49 of the actions taken to address the errors had minor impact in patient safety This indicates that more than half of the errors incurred had been addressed to a small degree considering that 234 of the actions taken had moderate impact However approximately 485 of the errors have not been improved This requires further optimization of the patient safety quality checking process and over a improvement of the facility service system 2778 Words 40 CHAPTER FOUR DISCUSSION OF RESULTS 41 Introduction The general aim of this study was to describe incidents where anticoagulants were involved using clinical incident data from the Cambridge University Hospital NHS Foundation Trust covering a twoyear period This chapter therefore presents the results of the study based on the data collected using the retrospective research design as well as the results presented in chapter three 42 Clinical Incident Data Involving Anticoagulants The first objective of this study was to determine the clinical incident data involving anticoagulants from the Cambridge University Hospital NHS Foundation Trust covering a twoyear period Of all the 171 reported incidents the findings of the study shows that the incidents registered at the surgery department were the highest at 36 with the medicine department following closely and 29 Clinical incidents involving anticoagulants were however fewer in the pharmacy and the women and children s departments see figure 31 The findings of the study showed that the Trauma and Orthopaedics ward in the surgery department had the highest number of incidences n33 with the ENT MAXFAX Ophthalmology and Plastic Surgery ward recording the least incidences n3 The above results demonstrate the prevalence of surgery and other procedure related mishaps in the utilization of anticoagulation therapy The higher clinical incidences involving anticoagulants confirms the assertion by Fuster 2011 that most patients being taken through surgical and medical procedures are highly exposed to thromboembolic risks In their study Lieberman amp Hsu 2005 reported that between 15 41 and 30 of the patients undergoing surgical procedure were likely to develop deep vein thrombosis DVT when not using anticoagulation prophylaxis The thromboembolic risk factor is mainly higher among patients undergoing total knee replacement TKR and total hip replacement THR surgeries Lieberman amp Hsu 2005 The higher number of incidences reported in the surgery department thus corroborate the findings of Lieberman amp Hsu 2005 The findings of this study are among the many reports of accidental deaths and overdosing due medical errors committed in the administration of anticoagulants According to Fanikos 2014 anticoagulants are among the top five drugs that influence patient safety incidents in the UK The results of this study therefore confirm the publicly held view that anticoagulants are associated with serious medication errors with most of the errors being human reated Fanikos 2014 In this study most of the medical errors 62 attributed to the administration of anticoagulants were human errors 43 Characterization of Incidents Anticoagulants are among some of the most common medications that lead to adverse drug events ADEs in hospitalized patients Clinical incidences involving anticoagulants have been found to involve both medication errors and adverse drug reactions ADRs According to Zaidenstein Eyal and Efrati 2012 one of the main objectives of the implementation of the electronic heath records including the computerized provider order entry has been to reduce cases of ADRs which is considered as a major source of harm for hospitalized patients A study by Classen Jaser and Budnitz 2010 reported about 65 medication reated adverse events were 42 likely to occur in every 100 hospitalizations According to Classen Jaser and Budnitz 2010 over a quarter of the reported adverse events were due to medical error Piazza et al 2011 argue that medication errors can occur at every stage of the medication process including prescription dispensing administration and transcription The Joint Commission s Sentinel Event Database has ranked performance error eg administration as the most common cause of adverse events involving anticoagulants Similar findings have also been reflected in the current study For instance the findings of this study indicate different types of medication errors committed in the execution of anticoagulation therapy at the Cambridge University Hospitals NHS Foundation Trust s Risk and Patient Safety Department The reported medication errors included administration 50 prescription 38 dispensing 2 and other types of medication errors 10 In this study the surgery department was found to have reported the highest number of incidences ie 36 of the total 71 reported incidences Similarly the Trauma and Orthopaedics ward within the surgery department had the highest cases n33 Most of these cases n13 at the Trauma and Orthopaedics ward were due to omission of the anticoagulation medicine in the prescription with 11 incidences being caused by prescription of the wrong dosage of the drug Omission of drugs in the administration occasioned 5 of the reported incidences at the Trauma and Orthopaedics ward whereas 2 cases were as a result of duplicated anticoagulation drug prescription with error in the transfer of drugs and an isolated report of stock shortage leading to 1 case each From the findings of this study it is evident that most of the reported medication errors in the anticoagulation therapy were humanrelated with most of them being preventable 43 These findings mirror those of Fanikos et al 2004 who reported that approximately 62 of anticoagulation medication errors were human made errors such as memory lapse 19 faulty checking 10 communication failure 9 transcription errors 12 and rule violations 13 According to a citation in Okongwu 2007 only 23 of mishaps have been attributed to pump or drug delivery malfunction According to Piazza et al 2011 about 70 of the clinical incidents involving anticoagulants can be prevented In addition Zaidenstein Eyal and Efrati 2012 argue that the medication errors associated with anticoagulation therapy are mainly caused by transcription errors However this is contrary to the findings of this study which identify administration as the main root cause of anticoaguant associated medication errors According to the findings of the current study approximately 65 of the error reports involved the anticoagulation drug Dalteparin which is an example of a low molecular weight heparin As indicated in figure 34 under the results chapter about 34 of the reported errors involved Warfarin with anticoagulation drug Dagibatran being reported in 1 of the errors According to Hull et al 2000 administration of wrong dosage of Dalteparin can lead to hemorrhage and severe blood loss Fanikos et al 2004 have identified Dalteparin which is classified as low molecular weight heparin LMWH as one of the anticoagulants that frequently features in medication error reports A similar position has also been adopted by MEDMARX Similarly Piazza et al 2011 observes that anticoagulant drugs such as Warfarin and ow moecuar weight Heparin are among the most commonly implicated medications that occasion adverse drug events among most hospitalized patients The findings of this study 44 therefore mirrors most of the findings of the previous studies such as that carried out by Piazza et al 2011 and Fanikos et al 2004 However the findings of the current study regarding the risk of exposure to anticoagulantrelated adverse drug reactions among elderly patients contradict those of most previous studies For instance according to the findings of this study the Department of Medicine for the Elderly DME recorded six incidences of erroneous application of anticoagulation therapy This was relatively lower than the number of cases reported at the Respiratory medicine ward which was ranked highest n14 According to Piazza et al 2011 the elderly and cardiac patients remain at the highest levels of risk of exposure to anticoagulantrelated adverse drug reactions and medication errors In their study aimed at determining the clinical characteristics types root causes and outcomes of anticoaguant associated adverse drug events p1137 at Brigham and Women s Hospital Piazza et al 2011 found that 488 of the clinical events involving anticoagulants were due to medication errors and about 305 of the total reported cases were as a result of adverse drug reactions About 207 of the cases reported by the study were caused by a combination of medication errors and adverse drug reactions Most of the incidences reported in the study were potentially preventable Like the current study Piazza et al 2011 identified medication errors as the main root cause of clinical incidences involving anticoagulants In terms of likelihood of risk occurrence and consequences of the same the current study found that 43 of the reported medication errors were possible and had the capacity to occur Approximately 54 of the reported cases had little to fewer 45 tendencies to occur while 3 were almost certain to occur According to the findings of the study there are almost equal chances that an error would occur in the prescription dispensation and administration of anticoagulation drugs However in terms of risk levels approximately 73 of risks in the reported errors were lowlevel risks or green risks Nevertheless given the fact the relevance and expandability of the 4 gap between error and safety in the reported cases there is need to establish the root cause of the reported errors at the facility and explore suitable mechanisms to prevent their reoccurrences In a bid to address the identified risks the study established that the hospital had identified and was in the process of implemented a range of mechanisms For instance efficient communication among staff was being encouraged at the hospital to minimize potential harm among patients Similarly reported errors that were not easy to correct were noted for future reference Of all the measure undertaken by the hospital to address anticoaguant associated medication errors the study found that about 49 of the measures were aimed at addressing errors whose impact on patients was considered as minor The measures being undertaken by the hospital are among some of the approaches recommended by Anderson 2007 to enhance effective and efficient medication within clinical settings In addition to efficient communication among staff members Anderson 2007 recommends inter alia patient information drug information adequate communication drug packaging labelling and nomenclature medication storage stock standardization and distribution drug devise use acquisition 46 and monitoring environmental factors staff education and competency patient education and quality process and risk management 44 Conclusion The results of this study indicate that the surgery department records the highest cases 36 of incidences involving anticoagulants At 29 the medicine department closely follows this The women and children department recorded the least number of anticoaguant associated medication errors It is also evident from the findings that most of the reported errors were human induced and were potentially preventable Administration errors have been identified by this study as the most common cause of anticoaguant associated medication errors at the hospital and in turn are frequent causes of anticoaguant associated clinical incidences at the facility The study also observed that most of the reported errors approximately 65 involved the anticoagulation drug Dalteparin which is an example of a ow moecuar weight heparin This becomes a major concern given that Dalteparin can lead to hemorrhage and severe blood loss With regard to the likelihood of occurrence the study found that about 43 of the reported medication errors were possible and had the capacity to occur Approximately 54 of the cases had little to less tendency to occur while 3 were almost certain to occur The study shows that majority 73 of the reported risks were low risks or what may be termed as green risks Even though no incident of high risk was reported the 4 margin between error and safety is relevant and expandable Similarly most of the reported measures that have been adopted by the hospital are mainly aimed at addressing errors that have minor impact on the patients safety Therefore in light of 47 the findings herein above this study makes the following recommendations to aid in minimizing the clinical incidences involving anticoagulants and enhance the safety of patients in the anticoagulation therapy 45 Recommendations The following recommendations may go a long way in reducing clinical incidences involving anticoagulants and enhance patient safety during and after anticoagulation therapy 451 Integrate Implementation of Risk Reduction Strategies There is need for health care organizations involved in dispensing prescribing and or administering anticoagulants to implement risk reduction strategies through an integrated manner by involving all key stakeholders eg physicians case managers nurses pharmacists and dieticians The development of such risk reduction strategies should be done in accordance with the United Kingdom s National Patient Safety Agency NPSA 2014 guidelines Staff communication and informational access in health care organizations involved with anticoagulation therapy needs to be enhanced Similarly the organizations should implement efficient pharmacy oversight and involvement Pharmacy oversight is considered as one of anticoagulant safety strategies Implementing an efficient pharmacy oversight framework contributes to the reduction of adverse drug events associated with the complexity of dosing anticoagulant medications enhances the monitoring of the effects of the medications while ensuring that patients comply with outpatient therapy Narinder Howe and Baglin 2009 Standardized practices such as patient involvement can contribute to the reduction of 48 the associated risks of ADEs involving anticoagulants A health organization can implement an efficient pharmacy oversight by constituting a representative working group ie consisting of nurses doctors a medical director pharmacists and other health professionals to audit and compare its existing systems against the goals of the Joint Commission Narinder Howe and Baglin 2009 The working group could then improve the organization s pharmacy system based on the gaps between its current system and the Commission s goals 452 Mandatory Regular Staff Training Health care facilities need to train their staff members on safety solutions Medicine safety training should form part of patient safety action plans of health care organizations Training of all staff members including nurses physicians pharmacists etc should be encouraged during induction and repeated annually with a view to increasing staff capacity to handle recurrent issues or high risk clinical settings In addition pharmacists should be encouraged to pursue electronic training on medicine safety and calculations 453 Updating of Guidelines Protocols and Policies The Trust needs to develop an effective and efficient intranet system to improve access to up to date guidelines policies and protocol concerning anticoagulation The intranet system can also be used for purposes of initiating monitoring and discharging patients who have been subjected to anticoagulation therapy The system should be designed in a manner that allows access to all anticoagulant safety documents through key word searches 49 454 Awareness of Interactions Health care organizations should strive to create awareness of anticoagulant drugs interactions among staff members tasked with their prescription In addition all prescribers should have the British National Formulary and carry it always when performing their duties The prescribers should also make efforts to access updates concerning anticoagulant drugs 455 Evaluation of Patient Safety Initiatives All patient initiatives should be reviewed and audited to enhance the impact of resources on the outcome This will go a long way improving patient safety 456 Implementation and Use of Bar Coding Technology Health care organizations should implement and encourage the use of computerized provider order entry CPOE and bar coding technology to aid the replenishment of anticoagulant medication stock andor automated dispensing cabinets This could be done on a regular basis to improve anticoagulant medication efficiency and effectiveness 46 Areas for Further Study In order to minimize the risks associated with anticoagulants and enhance patient safety through effective and efficient anticoagulation medication further work need to be done in the following areas o There is need to investigate the perception of junior doctors concerning challenges associated with anticoagulation therapy o An audit of the impact of training sessions on the safety of anticoagulation therapy among hospital staffs needs to be undertaken 50 2502 Words 51 REFERENCES Anderson P 2010 Medication errors Do not let them happen to you American Nurse Today 53 Retrieved from httpwwwamericannursetodavcomassetsO434436440 62766334635063568b8dac766061 4521 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stroke Stroke 421 29852990 Harder S Klinkhardt U and J M Alvarez 2004 Avoidance of bleeding during surgery in patients receiving anticoagulant andor antiplatelet therapy pharmacokinetic and pharmacodynamic considerations Clinical pharmacokinetics 4314 963981 Heisler J 2009 August Anticoagulants explained About Surgery Retrieved from httpsurdervaboutcomodc1lossarvofsurqicaltermsc1AnticoaquantsSurqervht m Accessed July 11 2014 Hess D R 2004 Retrospective studies and chart reviews Respiratory Care 4910 11711174 Hohnloser S H Oldgren J amp Yang S 2012 Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RELY Randomized Evaluation of LongTerm Anticoagulation Therapy trial Circulation 1255 669676 Hull RD Pineo G F Francis C Berggvist D Fellenius C Soderberg K Holmquist A Mant M Dear R Baylis B Mah A and R Brant 2000 July 54 Lowmolecularweight heparin prophylaxis using Dalteparin in close proximity to surgery vs warfarin in hip 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Joint Commission 2008 September 24 Sentinel Event Alert Preventing errors relating to commonly used anticoagulants Issue 41 Wallentin L Yusuf S amp Ezekowitz M 2010 Efficacy and safety of dabigatran compared with warfarin at different levels of international normalized ratio control for stroke prevention in atrial fibrillation an analysis of the RELY trial Lancet 3761 97583 Worster A amp Haines T 2004 Advanced statistics Understanding medical record review MRR studies Academic Emergency Medicine 112 187192 Zaidenstein R Eyal S Efrati S 2012 Adverse drug events in hospitalized patients treated with cardiovascular drugs and anticoagulants Pharmacoepidemiol Drug 11 1 235238 57
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