Identification of Prescribing Errors in an Electronic Health Record Using a Retract-and-Reorder Tool: A Pilot Study.

OBJECTIVES: The aims of this study were to develop and to validate an adapted Retract-and-Reorder (RAR) tool to identify and quantify near-miss/intercepted prescribing errors in an electronic health record. METHODS: This is a cross-sectional study between February and March 2021 in an Irish maternity hospital. We used the RAR tool to detect near-miss prescribing errors in audit log data. Potential errors flagged by the tool were validated using prescriber interviews. Chart reviews were performed if the prescriber was unavailable for interview. Errors were judged to be clinical decisions in chart reviews through review of narrative notes, order components, and patient's clinical history. Interviews were analyzed with reference to the London Protocol, a process of incident analysis that categorizes causes of errors into various contributory factors including patient factors, task and technology factors, and work environment. Logistic regression with robust clustered standard errors was used to determine predictors for near-miss prescribing errors. We calculated the positive predictive value of the RAR tool by dividing the number of confirmed near-miss prescribing errors by the total number of RAR events identified. RESULTS: Eighty-four RAR events were identified in 27,407 medication orders. Seventy-one events were confirmed near-miss prescribing errors, resulting in a positive predictive value of 85.0% (95% confidence interval, 75%-91%) and an estimated near-miss prescribing error rate of 259/100,000 medication orders. Duplicate prescribing errors were most common (54/71, 76.1%). No errors were reported by prescribers. Consultants were less likely to make an error than nonconsultant hospital doctors (adjusted odds ratio, 0.10; 95% confidence interval, 0.01-0.84). Factors associated with errors included workload, staffing levels, and task structure. CONCLUSIONS: Our adapted RAR tool identified a variety of near-miss prescribing errors not otherwise reported. The tool has been implemented in the study hospital as a patient safety resource. Further implementations are planned across Irish hospitals.

Medication use in pregnancy and lactation: A gap to be filled in postgraduate medical education.

OBJECTIVE: Medication use is a common therapeutic intervention during pregnancy, in the postpartum period and during lactation. Women routinely consult a variety of medical practitioners to request advice and prescription of medication. However, it is noted internationally that healthcare providers have insufficient knowledge to support women through their therapeutic journeys, and continual education is not provided as routine during postgraduate training and practice. STUDY DESIGN: There are five colleges in Ireland responsible for postgraduate medical training in Ireland for medicine, surgery, general practice, anaesthesiology and psychiatry. These are responsible for the curriculum design and implementation of 45 training programs, with the Royal College of Physicians responsible for 26 training programs and the Royal College of Surgeons of Ireland responsible for 15 training programs. We reviewed the national postgraduate training curricula of all speciality in the Republic of Ireland, excluding care of the elderly and pathology (given these practitioners would not be actively prescribing and treating pregnant or lactating women). RESULTS: We demonstrate that less than 50 % of the 43 post-graduate training programs mention medications in pregnancy and lactation. Pregnancy is not mentioned by 12 programs in any degree, and 18 programs do not mention lactation or breastfeeding in any form. CONCLUSION: It is imperative that consistent knowledge is provided and accessible to healthcare providers in order to support women and their families through healthy pregnancies, and support breastfeeding for as long as possible. Therefore, we call on postgraduate training bodies to include comprehensive education on medications in pregnancy and lactation in their syllabi going forward.

Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period.

BACKGROUND: Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are an important part of postnatal care. Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly-used type of medication in the management of postpartum pain, and their effectiveness and safety should be assessed. This is an update of a review first published in 2016. OBJECTIVES: To determine the effectiveness of a single dose of an oral NSAID for relief of acute perineal pain in the early postpartum period. SEARCH METHODS: For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 December 2019), OpenSIGLE and ProQuest Dissertations and Theses (28 February 2020), and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) assessing a single dose of a NSAID versus a single dose of placebo, paracetamol or another NSAID for women with perineal pain in the early postpartum period. We excluded quasi-RCTs and cross-over trials. We included papers in abstract format only if they had sufficient information to determine that they met the review's prespecified inclusion criteria. DATA COLLECTION AND ANALYSIS: Two review authors (FW and VS) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion. Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked it for accuracy. We assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 35 studies examining 16 different NSAIDs and involving 5136 women (none were breastfeeding). Studies were published between 1967 and 2013. Risk of bias due to random sequence generation, allocation concealment and blinding of outcome assessors was generally unclearly to poorly reported, but participants and caregivers were blinded, and outcome data were generally complete. We downgraded the certainty of evidence due to risk of bias, suspected publication bias, and imprecision for small numbers of participants. NSAID versus placebo Compared to women who receive a placebo, more women who receive a single-dose NSAID may achieve adequate pain relief at four hours (risk ratio (RR) 1.91, 95% confidence interval (CI) 1.64 to 2.23; 10 studies, 1573 women; low-certainty evidence) and at six hours (RR 1.92, 95% CI 1.69 to 2.17; 17 studies, 2079 women; very low-certainty evidence), although we are less certain about the effects at six hours. At four hours after administration, women who receive a NSAID are probably less likely to need additional analgesia compared to women who receive placebo (RR 0.39, 95% CI 0.26 to 0.58; 4 studies, 486 women; moderate-certainty evidence) and may be less likely to need additional analgesia at six hours after initial administration, although the evidence was less certain at six hours (RR 0.32, 95% CI 0.26 to 0.40; 10 studies, 1012 women; very low-certainty evidence). One study reported that no adverse events were observed at four hours post-administration (90 women). There may be little or no difference in maternal adverse effects between NSAIDs and placebo at six hours post-administration (RR 1.38, 95% CI 0.71 to 2.70; 13 studies, 1388 women; low-certainty evidence). Fourteen maternal adverse effects were reported in the NSAID group (drowsiness (5), abdominal discomfort (2), weakness (1), dizziness (2), headache (2), moderate epigastralgia (1), not specified (1)) and eight in the placebo group (drowsiness (2), light-headedness (1), nausea (1), backache (1), dizziness (1), epigastric pain (1), not specified (1)), although not all studies assessed adverse effects. Neonatal adverse effects were not assessed in any of the studies. NSAID versus paracetamol NSAIDs may lead to more women achieving adequate pain relief at four hours, compared with paracetamol (RR 1.54, 95% CI 1.07 to 2.22; 3 studies, 342 women; low-certainty evidence). We are uncertain if there is any difference in adequate pain relief between NSAIDs and paracetamol at six hours post-administration (RR 1.82, 95% CI 0.61 to 5.47; 2 studies, 99 women; very low-certainty evidence) or in the need for additional analgesia at four hours (RR 0.55, 95% CI 0.27 to 1.13; 1 study, 73 women; very low-certainty evidence). NSAIDs may reduce the risk of requiring additional analgesia at six hours compared with paracetamol (RR 0.28, 95% CI 0.12 to 0.67; 1 study, 59 women; low-certainty evidence). One study reported that no maternal adverse effects were observed at four hours post-administration (210 women). Six hours post-administration, we are uncertain if there is any difference between groups in the number of maternal adverse effects (RR 0.74, 95% CI 0.27 to 2.08; 3 studies, 300 women; very low-certainty evidence), with one case of pruritis in the NSAID group and one case of sleepiness in the paracetamol group. Neonatal adverse effects were not assessed in any of the included studies. Comparisons of different NSAIDs or doses did not demonstrate any differences in effectiveness for any primary outcome measures; however, few data were available on some NSAIDs. None of the included studies reported on any of this review's secondary outcomes. AUTHORS' CONCLUSIONS: In women who are not breastfeeding and who sustained perineal trauma, NSAIDs (compared to placebo or paracetamol) may provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia, but uncertainty remains, as the evidence is rated as low- or very low-certainty. The risk of bias was unclear for many studies, adverse effects were often not assessed and breastfeeding women were not included. While this review provides some indication of the likely effect, there is uncertainty in our conclusions. The main reasons for downgrading were the inclusion of studies at high risk of bias and inconsistency in the findings of individual studies. Future studies could examine NSAIDs' adverse effects, including neonatal effects and the compatibility of NSAIDs with breastfeeding, and could assess other secondary outcomes. Future research could consider women with and without perineal trauma, including perineal tears. High-quality studies could be conducted to further assess the efficacy of NSAIDs versus paracetamol and the efficacy of multimodal treatments.

Impact of an electronic health record on task time distribution in a neonatal intensive care unit.

BACKGROUND: An Electronic Health Record (EHR) has been introduced to four Irish maternity units, with further implementations planned. Previous studies indicate that healthcare professionals are concerned that EHRs may increase time spent on documentation and medication-related tasks. OBJECTIVE: To determine the impact of an EHR on task time distribution in a Neonatal Intensive Care Unit (NICU). METHODS: A pre-post, time and motion study. An electronic data collection tool was used to collate time spent on direct care, professional communication, reviewing charts, documentation, and medication-related tasks. Interruptions and contact with the patient zone were quantified. Statistical significance was assessed using two-sample proportion tests, two-sample t-tests, and two-sample Wilcoxon rank-sum tests. A Bonferroni correction set significance at p ≤ 0.0025. RESULTS: 63 doctors and nurses participated, with 169.23 h of data collected. There were no significant changes to nurses' task time distribution. The proportion of time spent by doctors on professional communication increased from 15.4% to 26.0% (p < 0.001). Significant increases to median task times were seen for both doctors and nurses. Interruptions to tasks decreased post-implementation (p < 0.001), as did frequency of contact with the patient zone (p < 0.001). CONCLUSION: The EHR did not redistribute time towards documentation and medication-related tasks. A reduction in interruptions to tasks may streamline workflow. Decreased contact with the patient zone may improve patient safety through reduced potential for pathogen transmission.

The impact of health information technology on prescribing errors in hospitals: a systematic review and behaviour change technique analysis.

BACKGROUND: Health information technology (HIT) is known to reduce prescribing errors but may also cause new types of technology-generated errors (TGE) related to data entry, duplicate prescribing, and prescriber alert fatigue. It is unclear which component behaviour change techniques (BCTs) contribute to the effectiveness of prescribing HIT implementations and optimisation. This study aimed to (i) quantitatively assess the HIT that reduces prescribing errors in hospitals and (ii) identify the BCTs associated with effective interventions. METHODS: Articles were identified using CINAHL, EMBASE, MEDLINE, and Web of Science to May 2020. Eligible studies compared prescribing HIT with paper-order entry and examined prescribing error rates. Studies were excluded if prescribing error rates could not be extracted, if HIT use was non-compulsory or designed for one class of medication. The Newcastle-Ottawa scale was used to assess study quality. The review was reported in accordance with the PRISMA and SWiM guidelines. Odds ratios (OR) with 95% confidence intervals (CI) were calculated across the studies. Descriptive statistics were used to summarise effect estimates. Two researchers examined studies for BCTs using a validated taxonomy. Effectiveness ratios (ER) were used to determine the potential impact of individual BCTs. RESULTS: Thirty-five studies of variable risk of bias and limited intervention reporting were included. TGE were identified in 31 studies. Compared with paper-order entry, prescribing HIT of varying sophistication was associated with decreased rates of prescribing errors (median OR 0.24, IQR 0.03-0.57). Ten BCTs were present in at least two successful interventions and may be effective components of prescribing HIT implementation and optimisation including prescriber involvement in system design, clinical colleagues as trainers, modification of HIT in response to feedback, direct observation of prescriber workflow, monitoring of electronic orders to detect errors, and system alerts that prompt the prescriber. CONCLUSIONS: Prescribing HIT is associated with a reduction in prescribing errors in a variety of hospital settings. Poor reporting of intervention delivery and content limited the BCT analysis. More detailed reporting may have identified additional effective intervention components. Effective BCTs may be considered in the design and development of prescribing HIT and in the reporting and evaluation of future studies in this area.

Direct Observational Study of Interfaced Smart-Pumps in Pediatric Intensive Care.

BACKGROUND: Processes for delivery of high-risk infusions in pediatric intensive care units (PICUs) are complex. Standard concentration infusions (SCIs), smart-pumps, and electronic prescribing are recommended medication error reduction strategies. Implementation rates in Europe lag behind those in the United States. Since 2012, the PICU of an Irish tertiary pediatric hospital has been using a smart-pump SCI library, interfaced with electronic infusion orders (Philips ICCA). The incidence of infusion errors is unknown. OBJECTIVES: To determine the frequency, severity, and distribution of smart-pump infusion errors in PICUs. METHODS: Programmed infusions were directly observed at the bedside. Parameters were compared against medication orders and autodocumented infusion data. Identified deviations were categorized as medication errors or discrepancies. Error rates (%) were calculated as infusions with errors and errors per opportunities for error (OEs). Predefined definitions, multidisciplinary consensus and grading processes were employed. RESULTS: A total of 1,023 infusions for 175 patients were directly observed over 27 days between February and September 2017. The drug library accommodated 96.5% of infusions. Compliance with the drug library was 98.9%. A total of 133 infusions had ≥1 error (13.0%); a further 58 (5.7%) had ≥1 discrepancy. From a total of 4,997 OEs, 153 errors (3.1%) and 107 discrepancies (2.1%) were observed. Undocumented bolus doses were most commonly identified (n = 81); this was the only deviation in 36.1% (n = 69) of infusions. Programming errors were rare (0.32% OE). Errors were minor, with just one requiring minimal intervention to prevent harm. CONCLUSION: The error rates identified are low compared with similar studies, highlighting the benefits of smart-pumps and autodocumented infusion data in PICUs. A range of quality improvement opportunities has been identified.

The Impact of Technology on Prescribing Errors in Pediatric Intensive Care: A Before and After Study.

BACKGROUND: Increased use of health information technology (HIT) has been advocated as a medication error reduction strategy. Evidence of its benefits in the pediatric setting remains limited. In 2012, electronic prescribing (ICCA, Philips, United Kingdom) and standard concentration infusions (SCIs)-facilitated by smart-pump technology-were introduced into the pediatric intensive care unit (PICU) of an Irish tertiary-care pediatric hospital. OBJECTIVE: The aim of this study is to assess the impact of the new technology on the rate and severity of PICU prescribing errors and identify technology-generated errors. METHODS: A retrospective, before and after study design, was employed. Medication orders were reviewed over 24 weeks distributed across four time periods: preimplementation (Epoch 1); postimplementation of SCIs (Epoch 2); immediate postimplementation of electronic prescribing (Epoch 3); and 1 year postimplementation (Epoch 4). Only orders reviewed by a clinical pharmacist were included. Prespecified definitions, multidisciplinary consensus and validated grading methods were utilized. RESULTS: A total of 3,356 medication orders for 288 patients were included. Overall error rates were similar in Epoch 1 and 4 (10.2 vs. 9.8%; p = 0.8), but error types differed (p < 0.001). Incomplete and wrong unit errors were eradicated; duplicate orders increased. Dosing errors remained most common. A total of 27% of postimplementation errors were technology-generated. Implementation of SCIs alone was associated with significant reductions in infusion-related prescribing errors (29.0% [Epoch 1] to 14.6% [Epoch 2]; p < 0.001). Further reductions (8.4% [Epoch 4]) were identified after implementation of electronically generated infusion orders. Non-infusion error severity was unchanged (p = 0.13); fewer infusion errors reached the patient (p < 0.01). No errors causing harm were identified. CONCLUSION: The limitations of electronic prescribing in reducing overall prescribing errors in PICU have been demonstrated. The replacement of weight-based infusions with SCIs was associated with significant reductions in infusion prescribing errors. Technology-generated errors were common, highlighting the need for on-going research on HIT implementation in pediatric settings.

Prevalence of postpartum venous thromboembolism risk factors in an Irish urban obstetric population.

BACKGROUND: Obstetric venous thromboembolism (VTE) is a leading cause of maternal morbidity and mortality. A clear understanding of the burden of VTE risk at a population level is a prerequisite to effective prevention; however, existing data are limited. OBJECTIVES: Describe the prevalence and patterns of VTE risk factors among postpartum women and consider the implications for VTE prevention practices. METHOD: We undertook a cross-sectional study of prospectively collected data from sequential postpartum VTE risk assessments completed between January 2015 and December 2017 in the Rotunda Hospital, Dublin. RESULTS: We analyzed postpartum VTE risk factors in a large unselected Irish urban obstetric cohort of 21 019 consecutively sampled women. This represents more than 90% of all women giving birth in a single institution over a 3-year period. The most common VTE risk factors related to maternal characteristics and delivery characteristics, including overweight and obesity (36%), age ≥35 (35%) and cesarean delivery (32%). More than three-quarters of women had at least 1 VTE risk factor (78%) and more than 40% had multiple (2 or more) VTE risk factors. One-fifth of women had no VTE risk factors before delivery, yet went on to develop VTE risk factors during delivery or in the postpartum period. Reflecting the differences in thromboprophylaxis thresholds internationally, the proportion of women who would have received a recommendation for postpartum thromboprophylaxis ranged from 7% to 37% under various clinical guidelines. CONCLUSION: This study demonstrates the high prevalence of VTE risk factors among postpartum women. Postpartum VTE risk is highly individualized and complex.

Defining electronic-prescribing and infusion-related medication errors in paediatric intensive care - a Delphi study.

BACKGROUND: The use of health information technology (HIT) to improve patient safety is widely advocated by governmental and safety agencies. Electronic-prescribing and smart-pump technology are examples of HIT medication error reduction strategies. The introduction of new errors on HIT implementation is, however, also recognised. To determine the impact of HIT interventions, clear medication error definitions are required. This study aims to achieve consensus on defining as medication errors a range of either technology-generated, or previously unaddressed infusion-related scenarios, common in the paediatric intensive care setting. METHODS: This study was conducted in a 23-bed paediatric intensive care unit (PICU) of an Irish tertiary paediatric hospital. A modified Delphi technique was employed: previously undefined medication-incidents were identified by retrospective review of voluntary incident reports and clinical pharmacist interventions; a multidisciplinary expert panel scored each incident using a 9-point Likert scale over a number of iterative rounds; levels of agreement were assessed to produce a list of medication errors. Differences in scoring between healthcare professionals were assessed. RESULTS: Seventeen potential errors or 'scenarios' requiring consensus were identified, 13 of which related to technology recently implemented into the PICU. These were presented to a panel of 37 participants, comprising of doctors, nurses and pharmacists. Consensus was reached to define as errors all reported smart-pump scenarios (n = 6) and those pertaining to the pre-electronic process of prescribing weight-based paediatric infusions (n = 4). Of 7 electronic-prescribing scenarios, 4 were defined as errors, 2 were deemed not to be and consensus could not be achieved for the last. Some differences in scoring between healthcare professionals were found, but were only significant (p < 0.05) for two and three scenarios in consensus rounds 1 and 2 respectively. CONCLUSION: The list of medication errors produced using the Delphi technique highlights the diversity of previously undefined medication errors in PICU. The increased complexity of electronic-prescribing processes is evident from the difficulty in achieving consensus on those scenarios. Reducing ambiguity in defining medication errors should assist future research on the impact of HIT medication safety initiatives in critical care. The increasing use of HIT and associated new errors will necessitate further similar studies.

Thrombocalc: implementation and uptake of personalized postpartum venous thromboembolism risk assessment in a high-throughput obstetric environment.

INTRODUCTION: Venous thromboembolism risk assessment (VTERA) is recommended in all pregnant and postpartum women. Our objective was to develop, pilot and implement a user-friendly electronic VTERA tool. MATERIAL AND METHODS: We developed "Thrombocalc", an electronic VTERA tool using Microsoft EXCEL™ . Thrombocalc was designed as a score-based tool to facilitate rapid assessment of all women after childbirth. Calculation of a total score estimated risk of venous thromboembolism in line with consensus guidelines. Recommendations for thromboprophylaxis were included in the VTERA output. Implementation was phased. Uptake of the VTERA tool was assessed prospectively by monitoring the proportion of women who gave birth in our institution and had a completed risk assessment. Factors affecting completion and accuracy of risk assessments were also assessed. RESULTS: Thrombocalc was used prospectively to risk-assess 8380 women between September 2014 and December 2015. Compliance with this tool increased dramatically throughout the study period; over 92% of women were risk-assessed in the last quarter of data collection. Compliance was not adversely affected if delivery took place out of working hours [adjusted odds ratio (aOR) 1.03, 95% confidence interval (CI) 0.93-1.14]. Risk assessment was less likely in the case of cesarean deliveries (aOR 0.66, 95% CI 0.60-0.73) and stillborn infants (aOR 0.48, 95% CI 0.29-0.79). Misclassification of risk factors led to approximately 207 (2.5%) inaccurate thromboprophylaxis recommendations. CONCLUSIONS: Our electronic, score-based VTERA tool provides a highly effective mechanism for rapid assessment of individual postpartum venous thromboembolism risk in a high-throughput environment.

Oral non-steroidal anti-inflammatory drugs (single dose) for perineal pain in the early postpartum period.

BACKGROUND: Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are thus an important part of postnatal care. Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly used type of medication in the management of postpartum pain and their effectiveness and safety should be assessed. OBJECTIVES: To determine the effectiveness of a single dose of an oral NSAID for relief of acute perineal pain in the early postpartum period. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2016), OpenSIGLE, ProQuest Dissertations and Theses, the ISRCTN Registry and ClinicalTrials.gov (31 March 2016). We also reviewed reference lists of retrieved papers and contacted experts in the field. SELECTION CRITERIA: Randomised controlled trials (RCTs) assessing a single dose of a NSAID versus a single dose of placebo, paracetamol or another NSAID for women with perineal pain in the early postpartum period. Quasi-RCTs and cross-over trials were excluded. DATA COLLECTION AND ANALYSIS: Two review authors (FW and VS) independently assessed all identified papers for inclusion and risk of bias. Any discrepancies were resolved through discussion and consensus. Data extraction, including calculations of pain relief scores, was also conducted independently by two review authors and checked for accuracy. MAIN RESULTS: We included 28 studies that examined 13 different NSAIDs and involved 4181 women (none of whom were breastfeeding). Studies were published between 1967 and 2013, with the majority published in the 1980s. Of the 4181 women involved in the studies, 2642 received a NSAID and 1539 received placebo or paracetamol. Risk of bias was generally unclear due to poor reporting, but in most studies the participants and personnel were blinded, outcome data were complete and the outcomes that were specified in the methods section were reported.None of the included studies reported on any of this review's secondary outcomes: prolonged hospitalisation or re-hospitalisation due to perineal pain; breastfeeding (fully or mixed) at discharge; breastfeeding (fully or mixed) at six weeks; perineal pain at six weeks; maternal views; postpartum depression; instrumental measures of disability due to perineal pain. NSAID versus placeboCompared to women who received a placebo, more women who received a single dose NSAID achieved adequate pain relief at four hours (risk ratio (RR) 1.91, 95% confidence interval (CI) 1.64 to 2.23, 10 studies, 1573 participants (low-quality evidence)) and adequate pain relief at six hours (RR 1.92, 95% CI 1.69 to 2.17, 17 studies, 2079 participants (very low-quality evidence)). Women who received a NSAID were also less likely to need additional analgesia compared to women who received placebo at four hours (RR 0.39, 95% CI 0.26 to 0.58, four studies, 486 participants (low-quality evidence)) and at six hours after initial administration (RR 0.32, 95% CI 0.26 to 0.40, 10 studies, 1012 participants (low-quality evidence)). Fourteen maternal adverse effects were reported in the NSAID group (drowsiness (5), abdominal discomfort (2), weakness (1), dizziness (2), headache (2), moderate epigastralgia (1), not specified (1)) and eight in the placebo group (drowsiness (2), light headed (1), nausea (1), backache (1), dizziness (1), epigastric pain (1), not specified (1)), although not all studies assessed adverse effects. There was no difference in overall maternal adverse effects between NSAIDs and placebo at six hours post-administration (RR 1.38, 95% CI 0.71 to 2.70, 13 studies, 1388 participants (very low-quality evidence)). One small study (with two treatment arms) assessed maternal adverse effects at four hours post-administration, but there were no maternal adverse effects observed (one study, 90 participants (low-quality evidence)). Neonatal adverse effects were not assessed in any of the included studies. NSAID versus paracetamolNSAIDs versus paracetamol were also more effective for adequate pain relief at four hours (RR 1.54, 95% CI 1.07 to 2.22, three studies, 342 participants) but not at six hours post-administration. There was no difference in the need for additional analgesia between the two groups at four hours (RR 0.55, 95% CI 0.27 to 1.13, one study, 73 participants), but women in the NSAID group were less likely to need any additional analgesia at six hours (RR 0.28, 95% CI 0.12 to 0.67, one study, 59 participants). No maternal adverse effects were reported four hours after drug administration (one study). Six hours post-administration, there was no difference between the groups in the number of maternal adverse effects (RR 0.74, 95% CI 0.27 to 2.08, three studies, 300 participants), with one case of pruritis in the NSAID group and one case of sleepiness in the paracetamol group. Neonatal adverse effects were not assessed in any of the included studies.Comparisons of different NSAIDs and different doses of the same NSAID did not demonstrate any differences in their effectiveness on any of the primary outcome measures; however, few data were available on some NSAIDs. AUTHORS' CONCLUSIONS: In women who are not breastfeeding and who sustained perineal trauma, NSAIDs (compared to placebo) provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia when treated with a NSAID. However, the risk of bias was unclear for many of the included studies, adverse effects were often not assessed and breastfeeding women were not included in the studies. The overall quality of the evidence (GRADE) was low with the evidence for all outcomes rated as low or very low. The main reasons for downgrading were inclusion of studies with high risk of bias and inconsistency of findings of individual studies.NSAIDs also appear to be more effective in providing relief for perineal pain than paracetamol, but few studies were included in this analysis.Future studies should examine NSAIDs' adverse effects profile including neonatal adverse effects and the compatibility of NSAIDs with breastfeeding, and assess other important secondary outcomes of this review. Moreover, studies mostly included women who had episiotomies. Future research should consider women with and without perineal trauma, including perineal tears. High-quality studies should be conducted to further assess the efficacy of NSAIDs versus paracetamol and the efficacy of multimodal treatments.

2009 A/H1N1 influenza vaccination in pregnancy: uptake and pregnancy outcomes - a historical cohort study.

OBJECTIVES: To describe the uptake of 2009 A/H1N1 influenza vaccination among pregnant women and determine if vaccination was associated with adverse pregnancy outcomes. STUDY DESIGN: A historical cohort study was performed using booking, delivery suite and neonatal unit discharge records from the Coombe Women and Infants University Hospital, Dublin, Ireland. Singleton deliveries to women pregnant before (December 2008-September 2009) and during the pandemic (December 2009-September 2010) were included. Information on vaccination status and type of vaccine was collected on admission to the delivery suite. Logistic regression analyses were used to determine maternal characteristics associated with vaccination. Pregnancy outcomes were compared for vaccinated and unvaccinated women, with adjustment for differing maternal characteristics. Outcomes included vaccination status, preterm birth, size for gestational age, neonatal intensive care admission, congenital anomalies and perinatal death. RESULTS: Of 6894 women pregnant during the pandemic, 2996 [43.5%] reported vaccination at delivery. In the early weeks of the vaccination programme rates of over 70% were achieved. Of those vaccinated, 246 [8.2%], 1709 [57.0%] and 1034 [34.5%] were vaccinated in the first, second and third trimesters respectively. Vaccination was less likely in younger age groups, those who were not in the professional/manager/employer socioeconomic group, women from Eastern Europe, Africa and Asia/Middle East, those who reported an unplanned pregnancy, women who booked late for antenatal care and recipients of publicly-funded obstetric care. Irish nationality was associated with reporting vaccination. There was no association between vaccination during pregnancy and adverse pregnancy outcomes. Women who were vaccinated were less likely to have a preterm delivery than unvaccinated women. CONCLUSION: 2009 A/H1N1 influenza vaccination uptake was influenced by maternal sociodemographic factors. High vaccination uptake can be achieved in a pandemic situation. Future public health campaigns should provide clear information on vaccination safety in pregnancy, ensure consistent vaccination recommendations from healthcare professionals and provide easy access to vaccination in order to optimise uptake rates in subgroups of the population who less likely to be vaccinated. There was no association between vaccination and adverse pregnancy outcomes.

Behavioural change in relation to alcohol exposure in early pregnancy and impact on perinatal outcomes--a prospective cohort study.

BACKGROUND: There has been limited research addressing whether behavioural change in relation to alcohol exposure in pregnancy results in better perinatal outcomes. METHODS: A cohort study of 6725 women who booked for antenatal care and delivered in a large urban teaching hospital in 2010-2011. A detailed history of alcohol consumption pre-pregnancy and during early pregnancy was recorded at the first antenatal visit with follow-up of the mother and infant until discharge following birth. Adverse perinatal outcomes were compared for 'non-drinkers', 'ex-drinkers' and 'current drinkers'. RESULTS: Of the 6017 (90%) women who reported alcohol consumption prior to pregnancy 3325 (55%) engaged in binge drinking and 266 (4.4%) consumed more than 14 units on average per week. At the time of booking 5649 (94%) women were ex-drinkers and of the 368 women who continued to drink 338 (92%) had a low intake (0-5 units per week), 30 (8%) an excess intake (6-20+ units per week) and 93 (25%) reported at least one episode of binge drinking. Factors associated with continuing to drink in early pregnancy included older maternal age (30-39 years), (OR 1.6; 95% CI 1.3 to 1.8), Irish nationality (OR 3.1; 95% CI 2.2 to 4.3) and smoking (OR 2.6; 95% CI 1.9 to 3.5). Ex-drinkers had similar perinatal outcomes to non-drinkers. Compared to non-drinkers current drinking was associated with an increased risk of intrauterine growth restriction (IUGR) (13% versus 19%, crude OR 1.6; 95% CI 1.1 to 2.2, adjusted OR 1.2; 95% CI 0.8 to 1.8). The greatest risk of IUGR was among women who continued to both drink and smoke, (9% versus 32%, crude OR 4.8; 95% CI 3.3 to 7.0, adjusted OR 4.5; 95% CI 3.1 to 6.7). CONCLUSIONS: Public Health campaigns need to emphasise the potential health gains of abstaining from both alcohol and smoking in pregnancy.

Methadone dosing and prescribed medication use in a prospective cohort of opioid-dependent pregnant women.

AIMS: This study aimed to (i) describe methadone dosing before, during and after pregnancy, (ii) to compare the incidence of neonatal abstinence syndrome (NAS) between those with dose decreases and those with steady or increasing doses and (iii) to describe prescribed medication use among opioid-dependent pregnant women. DESIGN: Prospective cohort study. SETTING: Two Irish tertiary care maternity hospitals. PARTICIPANTS: A total of 117 pregnant women on methadone maintenance treatment (MMT) recruited between July 2009 and July 2010. MEASUREMENTS: Electronic dispensing records from addiction clinics and the Primary Care Reimbursement Service were used to determine methadone doses and dispensed medications in the year preceding and the month following delivery. The Finnegan score was used to determine need for medical treatment of NAS. FINDINGS: Of the 117 participants, sufficient dosing data were available for 89 women treated with MMT throughout pregnancy; 36 (40.4%) had their dose decreased from a mean pre-pregnancy dose of 73.3 mg [standard deviation (SD) 25.5] to a third-trimester dose of 58.0 mg (SD 26.0). The corresponding figures for those with increased doses (n = 31, 34.8%) were 70.7 mg (SD 25.3) and 89.7 mg (SD 21.0), respectively. The incidence of medically treated NAS did not differ between dosage groups. Antidepressants were dispensed for 29 women (25.7%) during pregnancy, with the rate decreasing from pre-pregnancy to postpartum. Benzodiazepines were prescribed for 43 women (38.0%). CONCLUSION: In the Irish health service, opioid-dependent women frequently have their methadone dose decreased during pregnancy but this does not appear to affect the incidence of the neonatal abstinence syndrome in their babies.

Methadone and perinatal outcomes: a prospective cohort study.

AIMS: Methadone use in pregnancy has been associated with adverse perinatal outcomes and neonatal abstinence syndrome (NAS). This study aimed to examine perinatal outcomes and NAS in relation to (i) concomitant drug use and (ii) methadone dose. DESIGN: Prospective cohort study. SETTING: Two tertiary care maternity hospitals. PARTICIPANTS: A total of 117 pregnant women on methadone maintenance treatment recruited between July 2009 and July 2010. MEASUREMENTS: Information on concomitant drug use was recorded with the Addiction Severity Index. Perinatal outcomes included pre-term birth (<37 weeks' gestation), small-for-gestational-age (<10th centile) and neonatal unit admission. NAS outcomes included: incidence of medically treated NAS, peak Finnegan score, cumulative dose of NAS treatment and duration of hospitalization. FINDINGS: Of the 114 liveborn infants 11 (9.6%) were born pre-term, 49 (42.9%) were small-for-gestational-age, 56 (49.1%) had a neonatal unit admission and 29 (25.4%) were treated medically for NAS. Neonates exposed to methadone-only had a shorter hospitalization than those exposed to methadone and concomitant drugs (median 5.0 days versus 6.0 days, P = 0.03). Neonates exposed to methadone doses ≥80 mg required higher cumulative doses of morphine treatment for NAS (median 13.2 mg versus 19.3 mg, P = 0.03). The incidence and duration of NAS did not differ between the two dosage groups. CONCLUSIONS: The incidence and duration of the neonatal abstinence syndrome is not associated with maternal methadone dose, but maternal opiate, benzodiazepine or cocaine use is associated with longer neonatal hospitalization.

Prevalence, predictors and perinatal outcomes of peri-conceptional alcohol exposure--retrospective cohort study in an urban obstetric population in Ireland.

BACKGROUND: Evidence-based advice on alcohol consumption is required for pregnant women and women planning a pregnancy. Our aim was to investigate the prevalence, predictors and perinatal outcomes associated with peri-conceptional alcohol consumption. METHODS: A cohort study of 61,241 women who booked for antenatal care and delivered in a large urban maternity hospital between 2000 and 2007. Self-reported alcohol consumption at the booking visit was categorised as low (0-5 units per week), moderate (6-20 units per week) and high (>20 units per week). RESULTS: Of the 81% of women who reported alcohol consumption during the peri-conceptional period, 71% reported low intake, 9.9% moderate intake and 0.2% high intake. Factors associated with moderate alcohol consumption included being in employment OR 4.47 (95% CI 4.17 to 4.80), Irish nationality OR 16.5 (95% CI 14.9 to 18.3), private health care OR 5.83 (95% CI 5.38 to 6.31) and smoking OR 1.86 (95% CI 1.73 to 2.01). Factors associated with high consumption included maternal age less than 25 years OR 2.70 (95% CI 1.86 to 3.91) and illicit drug use OR 6.46 (95% CI 3.32 to 12.60). High consumption was associated with very preterm birth (<32 weeks gestation) even after controlling for socio-demographic factors, adjusted OR 3.15 (95% CI 1.26-7.88). Only three cases of Fetal Alcohol Syndrome were recorded (0.05 per 1000 total births), one each in the low, moderate and high consumption groups. CONCLUSIONS: Public Health campaigns need to emphasise the importance of peri-conceptional health and pre-pregnancy planning. Fetal Alcohol Syndrome is likely to be under-reported despite the high prevalence of alcohol consumption in this population.

Methadone and perinatal outcomes: a retrospective cohort study.

OBJECTIVE: The purpose of this study was to examine the relationship among methadone maintenance treatment, perinatal outcomes, and neonatal abstinence syndrome. STUDY DESIGN: This was a retrospective cohort study of 61,030 singleton births at a large maternity hospital from 2000-2007. RESULTS: There were 618 (1%) women on methadone at delivery. Methadone-exposed women were more likely to be younger, to book late for antenatal care, and to be smokers. Methadone exposure was associated with an increased risk of very preterm birth <32 weeks of gestation (adjusted odds ratio [aOR], 2.47; 95% confidence interval [CI], 1.40-4.34), being small for gestational age <10th percentile (aOR, 3.27; 95% CI, 2.49-4.28), admission to the neonatal unit (aOR, 9.14; 95% CI, 7.21-11.57), and diagnosis of a major congenital anomaly (aOR, 1.94; 95% CI, 1.10-3.43). There was a dose-response relationship between methadone and neonatal abstinence syndrome. CONCLUSION: Methadone exposure is associated with an increased risk of adverse perinatal outcomes, even when known adverse sociodemographic factors have been accounted for. Methadone dose at delivery is 1 of the determinants of neonatal abstinence syndrome.

Methadone dose and neonatal abstinence syndrome-systematic review and meta-analysis.

AIM: To determine if there is a relationship between maternal methadone dose in pregnancy and the diagnosis or medical treatment of neonatal abstinence syndrome (NAS). METHODS: PubMed, EMBASE, the Cochrane Library and PsychINFO were searched for studies reporting on methadone use in pregnancy and NAS (1966-2009). The relative risk (RR) of NAS was compared for methadone doses above versus below a range of cut-off points. Summary RRs and 95% confidence intervals (CI) were estimated using random effects meta-analysis. Sensitivity analyses explored the impact of limiting meta-analyses to prospective studies or studies using an objective scoring system to diagnose NAS. RESULTS: A total of 67 studies met inclusion criteria for the systematic review; 29 were included in the meta-analysis. Any differences in the incidence of NAS in infants of women on higher compared with lower doses were statistically non-significant in analyses restricted to prospective studies or to those using an objective scoring system to diagnose NAS. CONCLUSIONS: Severity of the neonatal abstinence syndrome does not appear to differ according to whether mothers are on high- or low-dose methadone maintenance therapy.

Medication use in early pregnancy-prevalence and determinants of use in a prospective cohort of women.

PURPOSE: To examine the extent, nature and determinants of medication use in early pregnancy. METHODS: We reviewed early pregnancy medication use, as reported to a midwife at the booking interview, in women delivering between 2000 and 2007 in a large maternity hospital in Dublin, Ireland (n = 61 252). RESULTS: Excluding folic acid, at least one medication was reported in 23 989 (39.2%) pregnancies. Over the counter (OTC) medications were reported in 11 970 (19.5%) pregnancies, illicit drugs or methadone in 545 (0.9%) and herbal medicines/supplements in 352 (0.58%). FDA category D and X medications were reported by 1532 (2.5%) and 1987 (3.2%) women. Asthma, depression and hypertension were among the most commonly reported chronic medical disorders. Medications with potential for foetal harm were reported by 86 (15.7%) women treated for depression and 68 (20%) women treated for hypertension. Factors associated with reporting the use of medications with potential for foetal harm included unplanned pregnancy (adjusted odds ratio [aOR] 1.31, 95% confidence interval [CI] 1.12-1.52), booking at less than 12 weeks gestation (aOR 1.83, 95%CI 1.58-2.13), being above 25 years of age, unemployed (aOR 2.58, 95%CI 2.03-3.29), nulliparous (aOR 1.41; 95%CI 1.22-1.63), single (aOR 1.28; 95%CI 1.06-1.54) or smoking during pregnancy (aOR 1.96, 95%CI 1.67-2.28). CONCLUSIONS: Women frequently report medication use in early pregnancy. Women and prescribers need to be aware of the lack of pregnancy safety data for many medications, and the need for pre-pregnancy planning. Prescribers should ensure that optimal medications are used when treating women of childbearing potential with chronic medical disorders.

Early pregnancy azathioprine use and pregnancy outcomes.

BACKGROUND: Azathioprine (AZA) is used during pregnancy by women with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. METHODS: The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was studied after adjustment for maternal characteristics that could act as confounders. RESULTS: The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04). Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). CONCLUSIONS: Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness.