High-risk medications are associated with an increase in incidents of medical harm. This research aims to conduct e retrospective analysis of incidents regarding patient safety in the UK, based on data from the National Report Learning System (NRLS). The research presented here was secondary research, conducted based on the review of NRLS patient safety reports published during the period January to December 2015. It investigated the increasing safety risk associated with incidents involving medication and also discussed emerging themes concerning such medication incidents.
The results showed that errors in the insulin category had the highest level of occurrence (50.60%), besides that it represented the highest number of incidents that reported ‘low harm’ (18.03%) in comparison to anticoagulants (11.45%) and controlled drugs (9.98%). The degree of ‘moderate harm’ attributed to insulin-related incidents was the highest at 2.52% (12 patients) in comparison to anticoagulants (1.54%) and controlled drugs (1.19%). Recently in the UK, safety issues concerning the use of insulins raised significant concerns, especially in view of the fact that some of the many delivery devices are a cause of confusion to patients; in addition, further confusion arises concerning overdose adjustment of medication [9]. Similarly, in June 2010, a report published by the National Patient Safety Agency (NPSA) in the UK raised grave concerns regarding the issue of safety associated with the administering and prescribing of types of insulin by independent health institutes and the NHS, and called for urgent action in order to reduce any further medication errors involving insulin [10]. This alarming indicator regarding insulin-related medication errors requires further and deeper study using verified data from the NRLS. The findings of this current study are alarming and should be of concern to all healthcare providers such as consultant doctors, GPs, pharmacists, nurses, health policymakers and healthcare management, and should prompt further, and immediate, action targeted at the minimisation of risk and harm associated with medication errors, especially with regard to insulin-related cases.
Medication errors are defined by the as incidents in which a drug has been prescribed, dispensed, prepared, administered, or monitored inadequately, irrespective of the occurrence of harm [11]. The findings of this current study indicated that administration, prescribing and dispensing errors from a total of 11 error types were the major causes of risk and harm in relation to the three categories of medication (insulin, anticoagulants, controlled drugs). In this current study, half of the medication errors are related to drug administration, with the most common medication errors being related to insulin drugs (50.60%), followed by controlled drugs (48.40%) and anticoagulant drugs (46.20%). Similarly, A review of relevant literature revealed that half of the total number of medication error reports (n = 12,552) represented hospital medication administration errors (MAE) with regard to young patients (Ameer, 2015). This indicates a high level of risk when half of the medication errors are related to drug administration involving human and system errors. Moreover, concern was raised by Kelly and others (2011) when it was reported that administration errors in hospitals were at a level of between 3.0 and 8.0%, and that prescribing errors in hospitals had reached 7% [12]. When combined with high-risk drugs, medication errors can be severe and even lead to endangering the lives of patients. This is especially true in the case of medication errors related to the administration of drugs, as outlined by ISMP which are considered to be high risk. Medication errors are becoming an increasingly prevalent problem in the British healthcare system, and such unintentional mistakes related
In this current study, it was found that the reported degree of harm for the three categories of medication showed no incidences of death occurring in the three categories. However, 3 patients were reported to have experienced ‘severe harm’, and there were 180 patients (13.31%) who were reported to have experienced ‘low harm’; the highest number of cases which reported ‘low harm’ was in the insulin category. The degree of ‘moderate harm’ was also the highest for incidents involving insulin 2.52% (12 patients), while anticoagulants accounted for 1.54% (7 patients), and controlled drugs 1.19% (5 patients). During the period from October 2011 to March 2012, a total of 612,414 patient safety incidents were reported to the NRLS in England. Of these, a moderate level of harm occurred in 6% of the incidents, while a severe level of harm, or death, occurred in 1% of the incidents (n = 5,235) [13, 14].
This study found that, in general, the quality of learning for the three main categories of medications was poor, 61.01%, and many of the poor reports belonged to the category of anticoagulants 75.82%, and controlled drugs 67.28%. In contrast, adequate quality of learning was lower for the three main categories, 3.80%, and most of these adequate reports belonged to the category of insulin, 9.41%, while the other categories accounted for 1.57%. Based on the findings of the current research presented above, there remains significantly low quality in the reporting of incidents in the NHS in some medication categories such as anticoagulants and controlled drugs, which prompts a strong recommendation here to health policymakers in the NHS to deal with this concern expeditiously. Similar studies have raised this concern, such as that by Donaldson et al. (2014), which examined NRLS reports on deaths due to care errors and categorised them according to dimensions of systemic failure [15].
Thematic analysis was used as part of this study in order to identify the nature of errors in relation to the main three medication categories: insulin, anticoagulants, and controlled drugs. This was achieved through reviewing and reading all the reports/incidents not excluded by the research criteria, and subsequently coding all the nature of error types (See Appendix 1), refining the codes and then grouping them into categories. Based on these categories, the major themes and sub-themes were generated and defined. The current researcher found contributing a number of factors contributing to patient safety incidents. There were factors found, which contributed to patient safety incidents, which were similar between insulin, anticoagulant and controlled drug cases. With this in mind, only the factors extracted from insulin-related data are presented here. Most insulin-related errors are caused by human mistakes such as lapse of concentration and forgetfulness [16].
The first theme established is ‘Individual Factor’, such as ‘no adequate checking’, as illustrated in the following example:
“Nurse not adequately checking and review TTO: - Insulin Missing – and other medication complete on TTO.”
The second theme is ‘Team Factor’, as illustrated by the following example which relates to ‘protocols not followed’:
“Patient admitted with diabetic ketoacidosis. Sliding scale insulin not recommenced in ED as per plan by ED Dr.”
The third theme is ‘Design of Equipment and Supplies’, and the following example illustrates issues of ‘product’ and ‘packaging storage’:
“Pharmacist dispensing patient’s medication Humalin mix 30 instead Humalin mix 30 kiwipen because same packaging product.”
The fourth theme is the ‘Patient Factor’, and the following example illustrates the issues of ‘task’ and ‘patient refusal’:
“Routine daily visit patient to administer prescribed daily dose of Insulin, patient refused to administered without any realistic reason.”
The four themes, as defined in this study, are part of a set of themes/factors that contribute to patient safety. Lawton et al. (2012) reviewed 34 different studies, of which 13 were carried out in the UK, which identified a number of factors contributing to patient safety incidents: (a) individual variables: these variables refer to attributes such as lack of experience, anxiety, personality, and attitudes that the caregiver may possess and which may be determinants of active failures; (b) communication systems: successful interaction between personnel, patients, groups, departments and services depends on efficient communication systems, written (e.g. documentation) as well as verbal (e.g. handover); and (c) equipment and resources: these must be adequately available and operational [17].
This study identified two major themes that were found across the three main categories of medication: insulin, anticoagulants and controlled drugs. These were extracted from the above themes mentioned: (a) system factor errors, which represent the individual factor, design of equipment and supplies; and (b) human factor errors, which represent the individual factor, team factor and patient factor. High-risk medications can be defined as medications that are highly likely to cause injury or harm when prescribed incorrectly or when administered incorrectly. This type of medication does not have significant error difference compared to other medications, but when applied incorrectly the potential for harm to the patient is considerably higher than in other cases. High-risk medications include opioids, insulin, and anticoagulants [18].
The strength of the current research lies in the analysis of recent NRLS data for 2015 and using a pilot study to ensure reliability and validity; also, the use of thematic analysis to enrich the findings, in particular regarding the nature of errors and exploring their contributory factors to patient safety is beneficial. The major limitation of the current study is its small sample size, which restricts the scale of presenting the phenomena of the research; in addition, not using research questions limits the benefit of this study in terms of its publication in an academic journal.
During the course of the research, various challenges and limitations had to be acknowledged and dealt with. Among them were the following:
- Limitations associated with this study include the randomisation process, which reduced the number of incident reports, as well as the data, which was not representative. In addition, as part of this study, it was not feasible to examine the severity of incidents, or cases resulting in death, due to time restrictions. The sample size used in this study was small and the period of the study was one year, from January 2015 to December 2015; however, if the period of study was extended to 6 months, then the random sample could be more representative.
- Some incidents were repeated; referred to as duplicate incidents, and, therefore, were excluded from the analysis.
- Some incidents lacked, or had little, description; they were classified as “others” and also excluded from the analysis.
- The description of some incidents mentioned NOAC (Noval Oral Anticoagulant); however, a search did not produce any drugs in this group because the term was entered in its acronym form.
- Sometimes, an incident report was written by an individual wishing to make a complaint regarding the procedure. Such incidents are referred to as “call for concern” cases. This type of incident report was typically written by someone not satisfied with the hospital policy, and who wished to change or amend the existing procedure.
- Any errors related to medical devices, such as insulin syringes, should not be treated as medication errors. Therefore, the interpretation and analysis of incidents require researchers to have good experience and knowledge.
- Viewing the incident reports in the NHS database posed a challenge in terms of understanding the abbreviations commonly used in the reporting of incidents. It was therefore necessary to consult the terms used in the NHS Abbreviation List in order to fully understand the content of the incident reports as part of the analysis.
- Dispensing errors can happen when a doctor prescribes warfarin (3mg) and a nurse administers a different drug instead, or when a pharmacist dispenses NovoMix instead of NovoRapid insulin. In addition, some incidents contained more than one error. When both dispensing errors and administration errors were found in the same incident report, such cases were categorised as ‘multi-process errors.’
- In some cases, multiple themes were found in the same incident. One incident included three themes that were relevant to the analysis. Consequently, researchers must approach the analysis of incidents in the NHS database with care.
- Deductive reasoning (thematic analysis) was used to identify the themes from the original incident reports. Although this approach is interesting; making use of it for the first time within the limited timeframe of this study proved to be a challenge.
Based on the findings of the current research, it would be useful to review the incidence of medication errors every year using various methods to evaluate patient safety such as questionnaires, interviews, observation and case studies. Also, involving a number of patients at various levels in terms of reviewing and evaluating patient safety and medication errors. MHRA and the NHS strongly recommended regular evaluation of national medication safety in the UK; they suggest that the staff of health providers should be encouraged to engage in a systemic way with medication incidents. Further research can be specifically targeted at investigating the major medication errors that significantly affect patients’ safety, such as the administering, prescribing and dispensing of medication in the NHS compared with the private health sector in the UK.