Recommendations on Insulin Safety in Clinical Practice (Dissertation Sample)

Insulin safety in clinical practice
Saleh Alghamdi
Supervisor: Mr Narinder Bhalla
A dissertation submitted to the University of Hertfordshire in partial fulfilment of the requirements for the degree of Master of Science in Advancing Pharmacy Practice,
September 2014.
Abstract
Insulin is classified as a high alert medicine with numerous safety issues. This study was justified to investigate safety issues in insulin use because it is a major health concern. The aim of this study was to examine the patterns, themes, and trends related to insulin drug error incidents from the published literature and to compare and contrast the findings with that from actual clinical incidents recorded from the Cambridge University Hospitals NHS Foundation Trust, with the objective of describing the most common types of error incidents, the severity or clinical impact of the incidents, and recommending strategies to reduce the incidents and clinical impacts of insulin errors. The methodology of the study was a systematic review of literature, to identify safety issues with insulin use. The data was statistically compared to data from Cambridge University Hospitals NHS Foundation Trust which recorded 154 different insulin error incidents between 3/30/2012 and 3/17/2014. The results of the study showed that the most common error categories were administering, prescribing, others, and dispensing errors at 47%, 37%, 9%, and 7% respectively. The specific incidents included mainly errors of omission, protocol failure, wrong drug, miscellaneous, and both wrong rate and dose at 27.27%, 11.70%, 11.00%, 8.40% and 5.8% for each wrong dose and rate respectively while each of the rest of medication errors were less than 4.00%. The severity or clinical impact ranges from insignificant to catastrophic with risk rating number of 1 to 15 respectively depending on the circumstances surrounding each error incident. Out of the 154 error incidents recorded, 1 error incident of dispensing wrong drug was the most severe with catastrophic consequence and risk rating number of 15 while 10 error incidents, 2 protocol failure, 1 miscellaneous, 1 drug repeated, and 1 monitoring error in prescribing, as well as 1 wrong rate, 3 omission and 1 expired drug administering errors, with insignificant clinical impact and risk rating number of 1 were identified. The findings discussed were concomitant with those of the earlier studies despite a few variations. The future work will include incorporating the recommendations into practice to improve the academic, economic, social outcomes, quality of life or patients receiving insulin therapy. The knowledge gaps identified are reasons behind the lack of full cooperation from medical practitioners in reporting incidents, implementing the recommendations of the study, and strategies to reduce error incidents in clinical use. (392 words)

Declaration
This dissertation describes research conducted in the Department of Pharmacy, University of Hertfordshire between May 2014 and September 2014 under the supervision of Mr 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.
Signature: Date:
Acknowledgements
I would like to express my special appreciation and thanks to my supervisor Mr Narinder Bhalla, you have been a tremendous mentor for me. I would like to thank you for encouraging my research and for allowing me to grow as a research scientist. Your advice on both research as well as on my career have been priceless.
Table of Contents
Title page..........................................................................................................1
Abstract.............................................................................................................2
Declaration........................................................................................................4
Table of contents..............................................................................................5
INTRODUCTION..............................................................................................6
Background.......................................................................................................6
Literature Review..............................................................................................6
Aim, Objectives, Justification, and Hypothesis...............................................13
MATERIALS AND METHODS.......................................................................15
Material...........................................................................................................15
Participants.....................................................................................................15
Methodology...................................................................................................16
Ethical Issues..................................................................................................21
RESULTS.......................................................................................................23
DISCUSSION..................................................................................................36
Explaining and Contextualizing the Data........................................................36
Recommendations..........................................................................................42
Academic, Economic, and Social Impact of the Study....................................44
Pathways to Impact.........................................................................................45
Future Work....................................................................................................46
CONCLUSION................................................................................................47
References.....................................................................................................49
Appendix.........................................................................................................53
Introduction
This section introduces the study in such a way that the background and literature review brings out the research problem to be addressed in this study, summarize the available work in the field, and identify the gaps of knowledge in order to give this study a reason to be carried out.
Background
The management of diabetes mellitus which inflicts suffering in approximately 2.3 million people in the United Kingdom (UK) is dependent on insulin. Its therapeutic application, regimens, insulin type, and dosage are controversial in regard to obese or overweight patients, dietary modification, physical exercise, safety, and logical approaches in clinical practice. Pharmacotherapy with insulin is the most appropriate intervention even in cases where the long term effects of the oral drugs are disappointing in single or combined medication (Evans and Krentz, 1999). The Safety profile of insulin allows pharmacists to prescribe it in renal diseases and in circumstances where insulin is of preferential clinical use such as in failure of oral agents to control diabetes mellitus, and late in type 2 diabetes mellitus (Institute of Safe Medication Practice (USA), 2008).
The Safety of insulin must be observed due to complications such as hypoglycaemia, increase in weight, and cardiovascular risks associated with exogenous insulin, but the current evidence is weak. Distiller (2012) demonstrated that glargine insulin safety could be guaranteed in diabetes mellitus when started early without poor glycaemia control, cardiovascular disease, and neoplasm. Numerous safety issues and incidents of error in clinical use of insulin are a health care concern. Safety in prescribing, dispensing, administering, and monitoring insulin in clinical use is important in order to avoid an error incident, considering that insulin is ranked in the top ten high alert medicines (NPSA, 2011).
Literature Review
According to Fowler (2010), the use of insulin in managing diabetes is complicated and evidence shows that the diabetic patient population is increasing in the UK. Inappropriate use of insulin is a significant cause of in-patient hospital admissions following complications such as hypoglycaemia or hyperglycaemia and diabetic ketoacidosis.
Reports by the National Patient Safety Agency link error incidents, lack of vigilance, inefficient systems, and inaccessible information, lack of awareness and education, and failure to monitor treatment contribute largely to complications associated with clinical use of insulin (NPSA, 2010). These complications vary in consequences ranging from insignificant, minor, major, to catastrophic which are likely to cause mortality.
The safety of insulin ensures optimal outcome in the pharmacological management of patients (Pandya, DiGenio, Gao, & Patel, 2013). It is estimated that National Patient Safety Agency (NPSA) has continued to receive incidents of deaths and harm due to inadequate safety in the use of pharmacological products including insulin. The National Health Service (NHS), the National Institute for Health and Clinical Excellence (NICE) in conjunction with NPSA have come up with programmes and elaborate measures aimed at improving patient safety (National Patient Safety Agency, 2007).
A pharmacist ensures a list of vital medicines is identified for timely administration, reviews and making necessary changes concerning the logistics of insulin, and providing guidance on prescribing, dispensing, administering, and monitoring. A pharmacist p...