Evaluation of the Prescribing Skills Assessment implementation, performance and medical student experience in Australia and New Zealand.

AIMS: The UK Prescribing Safety Assessment was modified for use in Australia and New Zealand (ANZ) as the Prescribing Skills Assessment (PSA). We investigated the implementation, student performance and acceptability of the ANZ PSA for final-year medical students. METHODS: This study used a mixed-method approach involving student data (n = 6440) for 2017-2019 (PSA overall score and 8 domain subscores). Data were also aggregated by medical school and included student evaluation survey results. Quantitative data were analysed using descriptive and multivariate analyses. The pass rate was established by a modified Angoff method. Thematic analyses of open-ended survey comments were conducted. RESULTS: The average pass rate was slightly higher in 2017 (89%) which used a different examination to 2018 (85%) and 2019 (86%). Little difference was identified between schools for the PSA overall performance or domain subscores. There was low intercorrelation between subscores. Most students provided positive feedback about the PSA regarding the interface and clarity of questions, but an average of 35% reported insufficient time for completion. Further, 70% on average felt unprepared by their school curricula for the PSA, which is in part explained by the low prescribing experience; 69% reported completing ≤10 prescriptions during training. CONCLUSION: The ANZ PSA was associated with high pass rates and acceptability, although student preparedness was highlighted as a concern for further investigation. We demonstrate how a collaboration of medical schools can adapt a medical education assessment resource (UK PSA) as a means for fulfilling an unmet need.

A Survey of Neonatal Nurses on Mydriatic Regimens Used in Neonatal Retinopathy of Prematurity Eye Examinations.

OBJECTIVE: This study was aimed to determine mydriatic regimen(s) used in neonatal units in Aotearoa, New Zealand (NZ), and Australia and to estimate the frequency of adverse drug events following mydriatic administration in preterm neonates. STUDY DESIGN: A cross-sectional survey was sent to neonatal nursing staff listed in the Australian and New Zealand Neonatal Network contact list. Participants were asked to state what mydriatic regimen they use, and to estimate the frequency of adverse drug events when eye drops were administered for retinopathy of prematurity eye examinations (ROPEE). RESULTS: Thirteen different mydriatic regimens were identified; phenylephrine 2.5% and cyclopentolate 0.5% (1 standard drop of each) was the most commonly used regimen. Two of the regimens exceeded adult doses and five regimens included a mydriatic that is equivalent to an adult dose. Following mydriatic instillation, the three most common adverse effects were apnea, tachycardia, and periorbital pallor. CONCLUSION: Low-concentration single-microdrop regimens are currently in use and resulting in successful ROPEE, yet doses exceeding adult doses are in use throughout Aotearoa, NZ, and Australian units. We know from this dataset that neonates are experiencing unwanted and potentially preventable, adverse effects associated with mydriatics, and every effort should be made to minimize this risk. KEY POINTS: · Thirteen different regimens are in use in Aotearoa, NZ, and Australia.. · Three regimens use doses in excess of adult doses.. · Phenylephrine 2.5% and cyclopentolate 0.5% (one standard drop of each) is the most common regimen.

Updated guidelines for the management of paracetamol poisoning in Australia and New Zealand.

INTRODUCTION: Paracetamol is a common agent taken in deliberate self-poisoning and in accidental overdose in adults and children. Paracetamol poisoning is the commonest cause of severe acute liver injury. Since the publication of the previous guidelines in 2015, several studies have changed practice. A working group of experts in the area, with representation from all Poisons Information Centres of Australia and New Zealand, were brought together to produce an updated evidence-based guidance. MAIN RECOMMENDATIONS (UNCHANGED FROM PREVIOUS GUIDELINES): The optimal management of most patients with paracetamol overdose is usually straightforward. Patients who present early should be given activated charcoal. Patients at risk of hepatotoxicity should receive intravenous acetylcysteine. The paracetamol nomogram is used to assess the need for treatment in acute immediate release paracetamol ingestions with a known time of ingestion. Cases that require different management include modified release paracetamol overdoses, large or massive overdoses, accidental liquid ingestion in children, and repeated supratherapeutic ingestions. MAJOR CHANGES IN MANAGEMENT IN THE GUIDELINES: The new guidelines recommend a two-bag acetylcysteine infusion regimen (200 mg/kg over 4 h, then 100 mg/kg over 16 h). This has similar efficacy but significantly reduced adverse reactions compared with the previous three-bag regimen. Massive paracetamol overdoses that result in high paracetamol concentrations more than double the nomogram line should be managed with an increased dose of acetylcysteine. All potentially toxic modified release paracetamol ingestions (≥ 10 g or ≥ 200 mg/kg, whichever is less) should receive a full course of acetylcysteine. Patients ingesting ≥ 30 g or ≥ 500 mg/kg should receive increased doses of acetylcysteine.

Developmental outcomes at age four following maternal antiepileptic drug use.

We investigated whether prenatal antiepileptic drug (AED) exposure was associated with adverse outcomes in the Before School Check (B4SC) assessments, particularly the assessments measuring neurodevelopment. Children exposed to AEDs were identified by linking women dispensed AEDs in the Pharmaceutical Collection to births recorded on the National Minimum Dataset (NMDS). Multinomial logistic regression was used to estimate adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) for outcomes of the parent-completed Parental Evaluation of Developmental Status (PEDS) questionnaire and Strengths and Difficulties Questionnaire (SDQ), after adjusting for gender, ethnicity, and socioeconomic deprivation. Between 2012 and 2016, 606 children with a mother who had been dispensed one or more AEDs during pregnancy had taken part in the B4SC. Prenatal exposure to sodium valproate (n = 161) or lamotrigine (n = 149) monotherapy was associated with an increased risk of having an abnormal SDQ - parent-completed (SDQP) score, ≥17 - indicating emotional or behavioral concerns (9.32% of children exposed to sodium valproate monotherapy had an abnormal score; aRR: 2.11; 1.23-3.63; lamotrigine 8.05%; aRR: 2.21; 1.21-4.02). Prenatal exposure to carbamazepine monotherapy (n = 201) was not associated with an increased risk of having an abnormal total SDQP score but was associated with increased risks in the individual domains of the SDQP. Prenatal exposure to AED polytherapy (n = 57) was associated with the highest risk of abnormal SDQP scores (17.54% of children exposed to polytherapy had abnormal scores; aRR: 2.75; 1.25-6.02). Prenatal exposure to sodium valproate and lamotrigine is associated with an increased risk of concerns about emotional and behavioral development being reported by parents in a neurodevelopmental screening program. Additional investigation is required into why significant differences between AEDs were not seen in this study.

Management of childhood obesity: An audit of clinical practice in secondary care.

AIM: Childhood obesity continues to be a major health issue for children world-wide, with well-recognised major health effects. This study evaluated the prevalence of obesity in children presenting to secondary care in Southern New Zealand, as well as their clinical management. METHODS: Obesity prevalence was determined by a review of data contained in the electronic anthropometry database in the region for the period 19 July 2010-16 July 2015. All clinical records were further examined using a standard data extraction form for 333 obese children regarding their clinical management. RESULTS: A total of 8551 individuals were identified in the database for review. The prevalence of overweight and obesity was higher than the average national rates but stable over the 5-year period. Children of Maori and Pacific Island ethnicity, those most deprived and males were over-represented in terms of obesity. Of the 333 obese children whose clinical management was examined, 45.0% received a diagnosis of obesity. Of those diagnosed, 24.7% had further investigations related to possible obesity complications, and 72.7% were given management plans. Older females were more likely to receive clinical intervention, while Maori and Pacific Island children were less likely. CONCLUSIONS: Of the children seen in this secondary care setting, 40% are overweight or obese, and yet the rate of clinical intervention left room for improvement, suggesting a need for further staff education and clear guidelines. Maori and Pacific Island children have higher obesity burden but were less likely to receive clinical intervention. This may highlight a need for specific education regarding cultural practices.

Introduction and uptake of electronic growth charts in southern New Zealand.

AIM: The introduction of an electronic system for recording and displaying growth measurements replaces multiple paper growth charts and theoretically improves the availability and consistency of information to support clinical decision-making. Introducing this in a single New Zealand District Health Board provided the opportunity to evaluate usage in hospital settings and determine the uptake of growth recording in a defined population. METHODS: All records between 2010 and 2015 in the Southern District Health Board (SDHB) anthropometry database were downloaded and examined in a retrospective cohort analysis. Records were extracted after matching to demographic and clinical setting data from the hospital patient management system. RESULTS: Analysis included 30 670 data entry points, representing 8551 children. Data entry increased over time to a maximum of 8407 observations in 2015. By the fifth year of use, up to 67% of available clinical encounters had anthropometry recorded in the outpatient department. Rates were lower in the inpatient setting, where only up to 18.4% had anthropometry recorded. The errors identified were low (0.2% of all data). Weight was the most commonly recorded measurement (98.2% of anthropometry entries, 35.1% of available clinical presentations). Height was available for 82.6% of entries and 29.5% of presentations. A body mass index z-score was available for 81.5% of entries and 29.1% of presentations. A head circumference was available for 50.2% of children <2 years age who had anthropometry recorded. CONCLUSIONS: The introduction of an electronic anthropometry database has been successful with increasing rates of use over time, especially in outpatient clinics. Further focus to improve inpatient recording of height and weight is needed.

Antiepileptic drug exposure in pregnancy and pregnancy outcome from national drug usage data.

BACKGROUND: Antiepileptic drugs (AEDs) are used by pregnant women to manage conditions such as epilepsy and bipolar disorder even though they pose a risk to the developing foetus. This study aimed to determine the overall use of AEDs by women during their childbearing years and women who are pregnant and the association between AED use and rates of pregnancy termination and spontaneous abortion. METHODS: Retrospective population based cohort study using administrative databases in New Zealand between 2008 and 2014. Women who had been pregnant were identified by the National Minimum Dataset and were linked to the Pharmaceutical Collection to obtain information on use of AEDs. Women aged between 15 and 45 years dispensed AEDs were identified in the Pharmaceutical Collection. RESULTS: There was an increase in the number of women of child-bearing potential prescribed AEDs, from 9 women per 1000 women in 2008 to 11.4 women per 1000 women in 2014. Women who had been dispensed an AED had an increased rate of spontaneous abortion 8.97 spontaneous abortions per 100 pregnancies, compared with, 6.31 per 100 pregnancies (risk ratio 1.42, 95% CI 1.40 to 1.44), and a decreased rate of pregnancy termination, 18.51 terminations per 100 pregnancies compared with 19.58 per 100 pregnancies (risk ratio 1.95, 95% CI 0.94-0.96). CONCLUSION: Use of newer AEDs is increasing in women of child-bearing potential in New Zealand leading to an overall increase in AED use in this group despite a fall in the use of older AEDs. AED use is this study was associated with an increased risk of spontaneous abortion and decreased rate of pregnancy termination, however confounding by indication could not be excluded.

Effect of gestational age and blood glucose on C-peptide excretion rate and clearance in neonates.

AIMS: The aim of this study was to measure urinary C-peptide concentrations, and then calculate C-peptide clearance (Cl), and excretion rate (UER) in neonates. In addition, the effect of gestational age (GA) and blood glucose levels (BGL) on C-peptide UER were investigated. METHODS: Insulin concentrations in plasma and C-peptide concentrations were measured in plasma and urine, in 20 neonates. Chemiluminescent immunoassays were used for insulin and C-peptide measurements, with urine diluted to 40% with bovine serum albumin 1% in phosphate buffered saline. Urine volume and time of collection were recorded and used to calculate UER and Cl. RESULTS: The mean Cl of C-peptide was 0.309 ± 0.329 mL/min/kg, and UER was 0.0329 ± 0.0342 pmol/min/kg. Correlations between Cl or UER and GA were not significant (P > 0.05). No significant correlation was shown between Cl or UER and BGL (P > 0.05). CONCLUSIONS: Both Cl and UER were highly variable in neonates, but were not correlated with GA. Additionally, BGL did not appear to affect C-peptide UER and Cl. As GA and BGL did not appear to affect Cl and UER, urinary C-peptide may provide a non-invasive method of measuring insulin production in neonates.

Population pharmacokinetic-pharmacodynamic modelling to describe the effects of paracetamol and N-acetylcysteine on the international normalized ratio.

Paracetamol is one of the most common pharmaceutical agents taken in self-poisonings, and can increase the prothrombin time (PT) through liver injury, and in overdose without hepatic injury by reducing functional factor VII. PT is a measure of hepatic injury used to predict and monitor hepatotoxicity, reported as the international normalized ratio (INR). The antidote for paracetamol poisoning, N-acetylcysteine (NAC), has been reported to have an effect on the PT. This analysis included patients from a retrospective case series, a prospective inception cohort of paracetamol and psychotropic (control) overdoses, and a cross-over clinical trial. A population pharmacokinetic-pharmacodynamic model describing the pharmacodynamic effects of paracetamol and NAC on the INR was developed in Phoenix NLME. The dataset included 172 patients; the median age was 22 years (range 13-71 years). A one-compartment model with first-order input and linear disposition best described paracetamol pharmacokinetics. The population mean estimate of the concentration that induced a response halfway between the baseline and maximal pharmacological effect of paracetamol was 1302 µmol/L (242), the maximum effect of paracetamol was 0.534 (202; from baseline) and the maximum effect of NAC was 0.325 (9.03; from baseline). Both paracetamol and NAC contributed a pharmacological effect to the elevation of INR. The estimated paracetamol concentration that induced a response halfway between the baseline and maximal pharmacological effect was within the range of plasma paracetamol values studied, fivefold greater than the maximum therapeutic concentration, suggesting that an elevated INR would not be expected within the therapeutic range. Simulated 24 and 48 g paracetamol overdoses with NAC administration produced INR values (50th percentile) that reached the upper limit of, or exceeded, the reference range.

Declining newborn intramuscular vitamin K prophylaxis predicts subsequent immunisation refusal: A retrospective cohort study.

AIM: Low rates of childhood immunisation are linked to outbreaks of infectious disease. Identifying and addressing barriers to immunisation may lead to improved immunisation rates. Immunisation and newborn vitamin K prophylaxis have many similarities. We aimed to investigate whether parents who decline newborn vitamin K are also more likely to decline subsequent childhood immunisations. METHODS: We undertook a retrospective cohort study, examining the relationship between vitamin K administration and immunisation uptake by parents of babies born over a 2-year period (January 2010-December 2011) in Dunedin, New Zealand (NZ). Both written and electronic data from a single birthing unit and the NZ National Immunisation Register (NIR) were analysed to ascertain the relationship between declining newborn vitamin K prophylaxis and subsequent immunisation uptake. RESULTS: Records for 3575 babies were examined. Ninety-two per cent of infants received intramuscular, and 5% received oral vitamin K. An increased risk ratio for non-immunisation of 14.1 (95% confidence interval 7.8-25.9) for babies whose parents declined vitamin K was identified. Receiving oral vitamin K was also associated with subsequent non-immunisation, with a risk ratio of 3.5 (95% confidence interval 1.7-7.3). CONCLUSIONS: Parents who decline newborn vitamin K are more likely to decline immunisation for their child. These parents, as well as those that elect for oral vitamin K, are a small but easily identifiable group to whom additional education about the benefits of immunisation could be offered. This is especially pertinent at a time when there is a resurgence of immunisation preventable diseases.

Population pharmacokinetics of intravenous acetaminophen and its metabolites in major surgical patients.

Intravenous acetaminophen is a commonly used analgesic following surgery. The aims of this study were to determine the population pharmacokinetic profile of intravenous acetaminophen and its metabolites in adult surgical patients and to identify patient characteristics associated with acetaminophen metabolism in the postoperative period. 53 patients were included in the dataset; 28 were men, median age (range) 60 years (33-87), median weight (range) 74 kg (54-129). Patients received 1, 1.5 or 2 g of intravenous acetaminophen every 4-6 h. Plasma and urine samples were collected at various intervals for up to 6 days after surgery. Simultaneous modelling of parent acetaminophen and its metabolites was conducted in Phoenix(®) NLME™ to estimate pharmacokinetic parameters. The population mean estimate (CV%) for central (plasma) volume of distribution of parent acetaminophen (VC) was 13.9 (4.41) L, peripheral (tissue) volume of distribution (VT) was 50.9 (2.96) L, and intercompartmental clearance (Q) was 77.5 (9.29) L/h. The population mean (CV%) metabolic clearances for glucuronidation (CLPG) was 8.92 (3.25) L/h, sulfation (CLPS) was 0.903 (3.47) L/h, and oxidation (CLPO) was 0.533 (7.90) L/h. The population mean (CV%) urinary clearances of parent acetaminophen (CLRP) was 0.137 (5.46) L/h, acetaminophen glucuronide (CLRG) was 3.81 (6.71) L/h, acetaminophen sulfate (CLRS) was 3.13 (4.32) L/h, and acetaminophen cysteine + mercapturate (CLRO) was 3.51 (9.98) L/h. Age was found to be a significant covariate on the formation of acetaminophen glucuronide, and renal function (estimated as creatinine clearance) on the urinary excretion of acetaminophen glucuronide.

Treatment Harms in Paediatric Primary Care.

The aim of this study was to describe the epidemiology in children of harms detectable from general practice records, and to identify risk factors. The SHARP study examined 9076 patient records from 44 general practices in New Zealand, with an enrolled population of 210,559 patients. "Harm" was defined as disease, injury, disability, suffering, and death, arising from the health system. The age group studied was ≤20 years of age. There were 193 harms to 141 children and adolescents during the 3-year study period. Harms were reported in one (3.5%) patient aged <2 years, 80 (6.6%) aged 2 to <12 years, 36 (4.9%) aged 12 to <18 years, and 24 (7.5%) aged 18 to ≤20 years. The annualised rates of harm were 36/1000 child and adolescent population for all harms, 20/1000 for medication-related harm (MRH), 2/1000 for severe MRH, and 0.4/1000 for hospitalisation. For MRH, the drug groups most frequently involved were anti-infectives (51.9%), genitourinary (15.4%), dermatologicals (12.5%), and the nervous system (9.6%). Treatment-related harm in children was less common than in a corresponding adult population. MRH was the most common type of harm and was related to the most common treatments used. The risk of harm increased with the number of consultations.

Low dose or very low dose phenylephrine and cyclopentolate microdrops for retinopathy of prematurity eye examinations (The Little Eye Drop Study): a randomised controlled non-inferiority trial.

OBJECTIVE: To determine if very low dose (VLD, 0.5% phenylephrine, 0.1% cyclopentolate) mydriatic microdrop (approximately 7 µL) administration (up to three doses) is non-inferior to low dose (LD, 1% phenylephrine, 0.2% cyclopentolate) mydriatic microdrop administration for ophthalmologist-determined successful retinopathy of prematurity eye examination (ROPEE). DESIGN: Multicentre, prospective, randomised controlled, non-inferiority clinical trial. SETTING: Four neonatal intensive care units in Aotearoa, New Zealand from October 2019 to September 2021. PATIENTS: Infants with a birth weight less than 1250 g or gestational age less than 30+6 weeks and who required a ROPEE. INTERVENTIONS: The intervention: microdrop (approximately 7 µL) of VLD (0.5% phenylephrine and 0.1% cyclopentolate) to both eyes, or the comparison: microdrop of LD (1% phenylephrine and 0.2% cyclopentolate) to both eyes. Up to three doses could be administered. MAIN OUTCOME MEASURES: The primary outcome measure was an ophthalmologist-determined successful ROPEE. RESULTS: One hundred and fifty preterm infants (LD mean GA=27.4±1.8 weeks, mean birth weight=1011±290 g, VLD mean GA=27.5±1.9 weeks, mean birth weight=1049±281 g,) were randomised. Non-inferiority for successful ROPEE was demonstrated for the VLD group compared with the LD group (VLD successful ROPEE=100%, LD successful ROPEE=100%, 95% CI no continuity correction -0.05 to 0.05) and for Maori (95% CI no continuity correction -0.02 to 0.19). CONCLUSION: VLD microdrops enable safe and effective screening for ROPEE in both Maori and non-Maori preterm infants. TRIAL REGISTRATION NUMBER: ACTRN12619000795190.

The pharmacokinetic profile of intravenous paracetamol in adult patients undergoing major abdominal surgery.

BACKGROUND: Intravenous (IV) paracetamol is commonly used in the postoperative period for the treatment of mild to moderate pain. The main pathways for paracetamol metabolism are glucuronidation, sulfation, and oxidation, accounting for approximately 55%, 30%, and 10% of urinary metabolites, respectively. The aim of this study was to describe the pharmacokinetics of IV paracetamol and its metabolites in adult patients after major abdominal surgery. METHODS: Twenty patients were given 1 g of paracetamol by IV infusion at induction of anesthesia (Interval 1) and every 6 hours thereafter, with the final dose given at 48-72 hours (Interval 2). Plasma and urine samples were collected for up to 8 hours after infusion for both intervals. The samples were analyzed by high-performance liquid chromatography to determine the amount of paracetamol and its metabolites. The data were modeled in Phoenix WinNonlin using a user-defined ASCII parent-metabolite model with linear disposition, to obtain the estimates for volume of distribution, metabolic and urinary clearance. RESULTS: Mean (95% confidence interval) metabolic clearance to paracetamol glucuronide increased from 0.06 (0.05-0.08) to 0.14 (0.11-0.18) L · h⁻¹ · kg⁻¹, P value <0.001 and urinary clearance increased from 0.08 (0.07-0.09) to 0.14 (0.10-0.17) L · h⁻¹ · kg⁻¹, P value 0.002. The mean (95% confidence interval) volume of distribution of paracetamol increased from 0.17 (0.12-0.21) to 0.43 (0.27-0.59) L · kg⁻¹, P value 0.032. CONCLUSIONS: After major abdominal surgery, there were apparent increases in the metabolic conversion to paracetamol glucuronide and its urinary clearance suggesting potential induction of paracetamol glucuronidation.

Premedication for neonatal intubation in Australia and New Zealand: a survey of current practice.

AIM: This study aims to describe the current approach to intubation premedication in neonatal intensive care units (NICUs) in Australia and New Zealand. METHODS: A literature review regarding intubation premedication in the newborn was carried out to inform questionnaire design. A web-based survey of 28 NICUs and two neonatal emergency transport services was conducted and supplemented by telephone contact to ensure completion. RESULTS: All the tertiary NICUs and neonatal emergency transport services in Australia and New Zealand use premedication for elective intubation of neonates. Eighty per cent of units have a written policy. There were 28 of 30 units (93%) that use muscle relaxants, mostly suxamethonium. The choice of sedative medication is varied. CONCLUSIONS: Australian and New Zealand neonatal units have a high use of intubation premedication including muscle relaxants, but vary considerably in their choice of sedative medication.

Key informants' perceptions of how pharmac operates in New Zealand.

OBJECTIVES: The aim of this study is to examine key informants' perceptions of how the New Zealand Pharmaceutical Management Agency (PHARMAC) operates in New Zealand. METHODS: We carried out qualitative analysis of semi-structured interviews with key informants. We obtained ethics approval from the University of Otago School of Pharmacy, and all participants gave informed consent. We digitally recorded the interviews, which were then transcribed, and coded in NVivo. The data were analyzed by theme using constant comparison methods. Twenty informants who had previously published research or commentary on New Zealand's access to medicines, acted as spokespersons for interest groups, or held positions that gave them key insights into New Zealand's medicines system agreed to participate. Informants were purposefully selected to ensure a wide range of views, including five people working in medicine, four in pharmacy, three Members of Parliament from different parties, and two each from PHARMAC and the pharmaceutical industry. RESULTS: Respondents saw PHARMAC as an organization that contained medicine costs effectively, was politically neutral, and resistant to lobbying. It enjoyed broad political support and, with extremely rare exceptions, had been allowed to carry out its functions independently regardless of who was in government. As a result of this political stability, the relationship between PHARMAC and the pharmaceutical industry has been improving. CONCLUSION: PHARMAC's longevity and increasing influence are largely due to political choices made to prioritize containing pharmaceutical expenditure and to respecting PHARMAC's independence. This may be difficult to replicate in other countries.

What's in a name? Brand name confusion and generic medicines.

We need an urgent review of medicines labelling in Australia and New Zealand.

Randomised controlled pilot trial comparing low dose and very low- dose microdrop administration of phenylephrine and cyclopentolate for retinopathy of prematurity eye examinations in neonates.

AIMS: To determine ifVery low dose mydriatic eye microdrop regimen sufficiently dilates the pupil (above 4.1 mm) compared with the currently used low dose mydriatic eye microdrop regimen.Cardiovascular, gastrointestinal and respiratory adverse effects occur following eye drop instillation. METHODS: Seventeen premature infants were recruited into this prospective, randomised controlled pilot trial in January 2017 to November 2018. Data were collected from the single-centre Neonatal Intensive Care Unit, Dunedin Hospital, New Zealand. The inclusion criteria were birth weight less than 1500 g or gestational age less than 31 weeks, or any premature infant requiring red reflex testing. Infants were randomised to receive either phenylephrine 1% or 0.5% and cyclopentolate 0.2% or 0.1%, 1 microdrop in both eyes. Efficacy outcome measures were pupil size at retinopathy of prematurity eye examination (ROPEE) and ophthalmologist rating of ease of screen. RESULTS: All participants had sufficient pupillary dilation for a successful ROPEE. Ophthalmologists rated the ROPEE as easy for 90% of all examinations. Pupil dilation measurements at the time of examination, mean±SD, 4.8±0.2 (95% CI 4.5 to 5.2) mm for treatment A and 5±0.2 (95%CI 4.6 to 5.4) mm for treatment B (p=0.61). There were no statistically significant differences between the groups for safety data. CONCLUSIONS: Very low dose microdrop administration of phenylephrine and cyclopentolate appears to be effective at sufficiently dilating the neonatal pupil for ROPEEs. Low dose and very low dose microdrop mydriatic regimens may also reduce the risk of unwanted adverse effects associated with these medicines. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (reference ACTRN12616001266459p).

Epidemiology of healthcare harm in New Zealand general practice: a retrospective records review study.

OBJECTIVES: To determine the epidemiology of healthcare harm observable in general practice records. DESIGN: Retrospective cohort records review study. SETTING: 72 general practice clinics were randomly selected from all 988 New Zealand clinics stratified by rurality and size; 44 clinics consented to participate. PARTICIPANTS: 9076 patient records were randomly selected from participating clinics. INTERVENTION: Eight general practitioners examined patient records (2011-2013) to identify harms, harm severity and preventability. Analyses were weighted to account for the stratified sampling design and generalise findings to all New Zealand patients. MAIN OUTCOME MEASURES: Healthcare harm, severity and preventability. RESULTS: Reviewers identified 2972 harms affecting 1505 patients aged 0-102 years. Most patients (82.0%, weighted) experienced no harm. The estimated incidence of harm was 123 per 1000 patient-years. Most harms (2160; 72.7%, 72.4% weighted) were minor, 661 (22.2%, 22.8% weighted) were moderate, and 135 (4.5%, 4.4% weighted) severe. Eleven patients died, five following a preventable harm. Of the non-fatal harms, 2411 (81.6%, 79.4% weighted) were considered not preventable. Increasing age and number of consultations were associated with increased odds of harm. Compared with patients aged ≤49 years, patients aged 50-69 had an OR of 1.77 (95% CI 1.61 to 1.94), ≥70 years OR 3.23 (95% CI 2.37 to 4.41). Compared with patients with ≤3 consultations, patients with 4-12 consultations had an OR of 7.14 (95% CI 5.21 to 9.79); ≥13 consultations OR 30.06 (95% CI 21.70 to 41.63). CONCLUSIONS: Strategic balancing of healthcare risks and benefits may improve patient safety but will not necessarily eliminate harms, which often arise from standard care. Reducing harms considered 'not preventable' remains a laudable challenge.