Therapeutic errors captured by the New Zealand National Poisons Centre: a retrospective audit.

INTRODUCTION Medication errors are one important cause of harm to patients. Information about medication errors can be obtained from diverse sources, including databases administered by poisons centres as part of their routine operation. AIM The aim of this study was to describe the data regarding therapeutic errors captured by the New Zealand National Poisons Centre (NZNPC). METHODS A retrospective study of calls made to the NZNPC between 1 September 2016 and 31 August 2018 was conducted, which involved human patients and were classified as 'therapeutic error' in the NZNPC database. Variables extracted and analysed included the demographics of the individual, the substance(s) involved, and site of exposure. RESULTS During the study period, a total of 43,578 calls were received by the NZNPC, including 5708 (13%) that were classified as 'therapeutic error'. Just over half of the exposures occurred in females, 3197 (56%) and 4826 (85%) of the calls involved a single substance. All age groups were affected and 2074 (37%) of the calls were related to children aged <12 years. A residential environment (n=5568, 97%) was the site of exposure for almost all reported therapeutic errors, most commonly in the patient's own home (n=5207, 91%). DISCUSSION This study provides insights into therapeutic error-related calls to the NZNPC. Almost all errors occurred in the residential setting. Over one-third of the calls involved children. Enhanced data capture and classification methods are needed to determine the types of errors and their possible causes to better inform prevention efforts.

A new web-based Medication Error Reporting Programme (MERP) to supplement pharmacovigilance in New Zealand--findings from a pilot study in primary care.

AIMS: To determine if primary care clinicians would report medication errors using a new web-based system, and to obtain data illustrating the potential of the information collected to improve medication safety. METHOD: The New Zealand Pharmacovigilance Centre led the development of the Medication Error Reporting Programme (MERP) which was then piloted over an 8- month period involving 38 general practice and 28 community pharmacy staff. The Pharmacy Defence Association also contributed dispensing error claims. An analysis of the characteristics of errors was undertaken. RESULTS: A total of 376 reports were submitted; 55 (15%) reported patient harm, 1 of which required lifesaving intervention. The therapeutic groups most commonly implicated were medicines for managing 'nervous' and 'cardiovascular' systems. Wrong dose (25%) and wrong medicine (22%) were the most common error types, occurring predominantly with the prescribing and dispensing of medications. The most frequent contributing factors to errors in general practice were problems in the process of prescribing whereas in community pharmacy they related to product name and packaging factors. Time pressures, workload and interruptions were commonly cited for both settings. CONCLUSION: Primary care clinicians who volunteered for the pilot were willing and able to use the MERP system to report medication errors. The standardised data obtained through MERP enables rapid analysis and has the potential to inform initiatives for improving patient safety.

Detecting medication errors in the New Zealand pharmacovigilance database: a retrospective analysis.

BACKGROUND: Despite the traditional focus being adverse drug reactions (ADRs), pharmacovigilance centres have recently been identified as a potentially rich and important source of medication error data. OBJECTIVE: To identify medication errors in the New Zealand Pharmacovigilance database (Centre for Adverse Reactions Monitoring [CARM]), and to describe the frequency and characteristics of these events. METHODS: A retrospective analysis of the CARM pharmacovigilance database operated by the New Zealand Pharmacovigilance Centre was undertaken for the year 1 January-31 December 2007. All reports, excluding those relating to vaccines, clinical trials and pharmaceutical company reports, underwent a preventability assessment using predetermined criteria. Those events deemed preventable were subsequently classified to identify the degree of patient harm, type of error, stage of medication use process where the error occurred and origin of the error. RESULTS: A total of 1412 reports met the inclusion criteria and were reviewed, of which 4.3% (61/1412) were deemed preventable. Not all errors resulted in patient harm: 29.5% (18/61) were 'no harm' errors but 65.5% (40/61) of errors were deemed to have been associated with some degree of patient harm (preventable adverse drug events [ADEs]). For 5.0% (3/61) of events, the degree of patient harm was unable to be determined as the patient outcome was unknown. The majority of preventable ADEs (62.5% [25/40]) occurred in adults aged 65 years and older. The medication classes most involved in preventable ADEs were antibacterials for systemic use and anti-inflammatory agents, with gastrointestinal and respiratory system disorders the most common adverse events reported. For both preventable ADEs and 'no harm' events, most errors were incorrect dose and drug therapy monitoring problems consisting of failures in detection of significant drug interactions, past allergies or lack of necessary clinical monitoring. Preventable events were mostly related to the prescribing and administration stages of the medication use process, with the majority of errors 82.0% (50/61) deemed to have originated in the community setting. CONCLUSIONS: The CARM pharmacovigilance database includes medication errors, many of which were found to originate in the community setting and reported as ADRs. Error-prone situations were able to be identified, providing greater opportunity to improve patient safety. However, to enhance detection of medication errors by pharmacovigilance centres, reports should be prospectively reviewed for preventability and the reporting form revised to facilitate capture of important information that will provide meaningful insight into the nature of the underlying systems defects that caused the error.

Incidence, preventability, and impact of Adverse Drug Events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study.

Adverse drug events (ADEs) are an important problem in all hospitalized patients as these events represent medication-related patient harm. Few epidemiologic data exist regarding ADEs in the pediatric inpatient setting and, in particular, the economic impact of such ADEs upon the healthcare sector. To evaluate the incidence, preventability, and seriousness of ADEs and potential ADEs occurring in hospitalized children and to examine the cost implications of these ADEs. This was a prospective observational cohort study conducted in the pediatric, neonatal intensive care unit (NICU), and postnatal wards of a university-affiliated urban general hospital in Dunedin, New Zealand (NZ). The study population was all patients admitted to these wards for >24 hours over a 12-week period from 18 March 2002 to 9 June 2002. Medication-related events were identified by chart review, attendance at multidisciplinary clinical meetings, parent/carer/child interviews, and voluntary and verbally solicited reports from staff. All suspected medication-related events were reviewed by a panel of three health professionals who independently categorized the events and rated them for seriousness, preventability, and causality, using a standardized reviewer form. Costs attributable to ADEs were calculated using both the average cost of a bed day, and specific costs for diagnostic groupings. The main outcome measures of the study were ADEs and potential ADEs. There were 495 eligible study patients, who had a total of 520 admissions and 3037 patient-days of admission, during which 3160 prescription episodes were written. There were 67 ADEs, of which 38 (56.7%) were classified as preventable, and 77 potential ADEs. ADEs occurred at a rate of 2.1 per 100 prescription episodes, 12.9 per 100 admissions, and 22.1 per 1000 patient-days. Potential ADEs occurred at a rate of 2.4 per 100 prescription episodes, 14.6 per 100 admissions, and 25 per 1000 patient-days. Although the greatest number (and rate per 100 admissions) of ADEs occurred in NICU patients, surgical pediatric ward patients had the greatest rate of ADEs per 1000 patient-days. Few events occurred in postnatal patients. Forty-six percent of ADEs were classified as being serious; 15% were deemed to result in persistent disability or were classified as life threatening. Potential ADEs were deemed more likely to be serious with 82% classified as potentially serious events; 33% were deemed as having the potential to result in persistent disability, or the potential to cause a life-threatening event. Fifteen ADEs were judged to have caused the hospital admission or to have prolonged hospital stay. The total number of days attributed to ADEs was 92 (range 1-26 days); of these, 58 were deemed preventable days and 34 non-preventable days. This extrapolates to a total annual cost of $NZ235 214 (2002 values) to the pediatric service, subdivided into $NZ148 287 for preventable ADEs and $NZ86 927 for non-preventable ADEs. ADEs and potential ADEs represent a considerable hazard for the pediatric inpatient population and ADEs represent a large cost imposition upon the healthcare sector. Over half of the ADEs were deemed preventable. This highlights the importance of developing strategies to prevent and ameliorate ADEs both to improve the quality of patient care and to reduce healthcare costs.

Pharmacovigilance in New Zealand: the role of the New Zealand Pharmacovigilance Centre in facilitating safer medicines use.

The New Zealand Pharmacovigilance Centre (NZPhvC) is the national centre responsible for monitoring adverse reactions to therapeutic products in New Zealand(NZ). The NZPhvC operates three pharmacovigilance programmes and this article explains how each of these programmes operate, focuses on their strengths and limitations, and looks to the future for medicines safety monitoring in NZ.

The Intensive Vaccines Monitoring Programme (IVMP): an electronic system to monitor vaccine safety in New Zealand.

New Zealand introduced a tailor-made vaccine (MeNZB) for epidemic control of Group B meningococcal disease. The Intensives Vaccine Monitoring Programme (IVMP), which prospectively collected data electronically on a cohort of children receiving vaccinations in sentinel practices across NZ, was developed as part of a national multi-faceted safety strategy. The main aim of the IVMP was to identify the presence of unexpected adverse events occurring with MeNZB vaccination. We describe the methodology and success factors plus consider the limitations encountered in this system which shows potential as a means for post-marketing vaccine and medicine surveillance in the future.

Preventable medication-related events in hospitalised children in New Zealand.

AIMS: To evaluate the frequency and characteristics of preventable medication-related events in hospitalised children, to determine the yield of several methods for identifying them and to recommend priorities for prevention. METHODS: A prospective observational cohort study was conducted over a 12-week period on the paediatric wards at a university-affiliated urban general hospital in New Zealand. For all admissions of greater than 24 hours, medication-related events were identified using a multifaceted approach and subsequently classified independently by three reviewers (using a standardised reviewer form) by event type, type of error, stage of the medication process, and preventability. RESULTS: There were 495 eligible study patients, who had 520 admissions and 3037 patient days of admission, during which 3160 medication orders were written. Of 761 medication-related events reported during the study period, 630 (83.3%) were identified by chart review; 111 (14.6%) by a voluntary staff quality improvement reporting system; 16 (2.1%) by interview of parents; and 4 (0.53%) events via the concurrent routine hospital-incident reporting system. Excluding duplicate reports and practice-related issues, a total of 696 study patient-specific events were included in the analysis. Excluding the inconsequential events (trivial rule violation and 'other' categories), the majority [368/399 (92.2%)] of events were found to be preventable; comprising 38/67 (56.7%) ADEs, 75/77 (97.4%) potential ADEs, and all 255 (100%) harmless medication errors. Most commonly implicated in preventable ADEs and potential ADEs were, event rate (95%CI): improper dose and the prescribing stage-35 (29 to 42) and 74 (64 to 84) respectively per 1000 patient days; and antibacterial agents and the intravenous route of administration 21 (17 to 25) and 11 (10 to 13) respectively per 100 medication orders. CONCLUSIONS: Preventable medication-related events occur commonly in the paediatric inpatient setting, and importantly over half of the events that caused patient harm were deemed preventable. Voluntary staff reporting in a quality improvement environment was found to be inferior to chart review for identifying events, but a vast improvement on the conventional incident reporting system. Most commonly implicated in the harmful or potentially harmful preventable events, and hence the best targets for prevention are dosing errors, particularly during the prescribing stage of the medication use process, and use of antibacterial agents, particularly when administered by the intravenous route.

Identification of priorities for medication safety in neonatal intensive care.

BACKGROUND: Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritize potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA. METHODS: Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS). RESULTS: The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology. CONCLUSION: Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.