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Identification of real-time adverse drug reactions [ADRs] (as opposed to the risk of ADRs) in older poly-medicated people in primary care is a challenging task, often undertaken without an explicit strategy. This systematic review aims to evaluate replicable instruments and methods for identifying and addressing ADRs. A systematic search was conducted in Medline, CINAHL, Scopus, Web of Science and Cochrane library, using controlled vocabulary (MeSH) and free-text terms. Randomised controlled trials (RCTs) implementing strategies to identify or resolve ADRs experienced by patients in primary care were included. Two reviewers independently screened studies, extracted data, and assessed the risk of bias using the Cochrane Risk of Bias tool. Discrepancies were resolved by discussion. From 2,182 unique records, 49 studies were identified for full review. Eight papers reporting results from 6 RCTs were included. All six trials utilised a list of medicine-related unwanted symptoms to identify ADRs. Two of three studies using adverse drug reaction questionnaires reported statistically significant increased rates of ADR reporting. Two of three studies that combined symptom questionnaires with prescriber consultations reported reductions in the number of health problems. Overall, results suggest that the three studies that described multidisciplinary collaborations using lists of ADRs plus prescriber reviews enhanced patient safety. However, the RCTs were unblinded and reported suboptimal retention. When considered as a whole, findings are equivocal and the data are too heterogenous to warrant any firm conclusions, beyond the need for more research to optimise strategies to safeguard patient wellbeing. Adaptable and scalable instruments with decision support are needed in primary care to identify and mitigate medicine-related harm in older poly-medicated people. The effectiveness of adverse drug reaction identification instruments, the value of comprehensive instruments, and the optimum method of delivery should be explored in multicentre trials.

Information on the impact of medicines on breastfeeding and the breastfed infant remains scarce. The aims of this review were to identify databases and cohorts holding this information, and pinpoint current information and research deficits. We searched 12 electronic databases, including PubMed/ Medline and Scopus, using a combination of controlled vocabulary (MeSH terms) and free text terms. We included studies reporting data from databases with information on breastfeeding, medicines exposure, and infant outcomes. We excluded studies not reporting all three parameters. Two reviewers independently selected papers and extracted data using a standardised spreadsheet. Risk of bias was assessed. Recruited cohorts with relevant information were tabulated separately. Discrepancies were resolved by discussion. From 752 unique records, 69 studies were identified for full review. Eleven papers reported analyses from ten established databases with information on maternal prescription or non-prescription drugs, breastfeeding and infant outcomes. Twenty-four cohort studies were also identified. No studies reported educational or long-term developmental outcomes. The data are too sparse to warrant any firm conclusions, beyond the need for more data. The overall picture hints at 1) unquantifiable, but probably rare, serious harms to infants exposed to medicines via breastmilk, 2) unknown long-term harms, and 3) a more insidious but more pervasive harm in terms of reduced breastfeeding rates following medicines exposure in late pregnancy and peri-partum. Analyses of databases reporting on the full population are needed to quantify any adverse effects of medicines and identify dyads at risk of harm from prescribed medicines while breastfeeding. This information is essential to ensure 1) infants are monitored appropriately for any adverse drug reactions 2) inform breastfeeding patients using long-term medicines as to whether the benefits of breastfeeding outweigh exposure to medicines via breastmilk and 3) target additional support to breastfeeding patients whose medicines may affect breastfeeding. The protocol is registered with the Registry of Systematic Reviews, no.994.

Background Administering medicines is one of the most high-risk tasks in health care. However, nurses are frequently interrupted during medicine administration, which jeopardises patient safety. Few studies have examined nurses’ experiences and the strategies they adopt to cope with interruptions during medicine rounds. This paper identifies nurses’ strategies for handling and reducing interruptions and ensuring safety during medicine rounds, within the confines of the hospitals’ organisational systems. Methods This descriptive and exploratory research study was undertaken with experienced nurses in Norwegian hospitals in 2015 using semi-structured interviews. Interviews were designed to elicit experiences and strategies used for handling interruptions to medicine rounds. Data were analysed using qualitative content analysis based on inductive reasoning to identify meaningful subjects and reach an interpretive level of understanding regarding nurses’ experiences. Results All 19 senior nurses who were approached were interviewed. From 644 condensed meaning units, we identified eight interpretative units and three themes: ‘working in environments of interruptions’, ‘personal coping strategies’, and ‘management-related strategies’. Nurses’ working environments were characterised by interruptions and distractions, which often threatened patient safety. To handle this unpredictability and maintain ward organisation, nurses developed their own personal strategies to overcome inherent problems with their working conditions, the absence of effective management, and colleagues’ reluctance to assume responsibility for minimising interruptions. Conclusions Administration of medicines in hospitals can be described as ‘working in a minefield’. Our findings indicate that the hospital management, in cooperation with nurses and other healthcare professionals, should take responsibility for improving the routine process of medicine administration by minimising avoidable interruptions. Patient safety can be improved when the hospital management takes steps to protect nurses’ work environments and assumes responsibility for resolving these challenges.

ObjectivesWe aimed to investigate the feasibility of a cluster randomised controlled trial (RCT) of the ADRe Profile in UK primary care. The ADRe Profile is a patient monitoring system to identify and address adverse drug reactions (ADR) and ADR-related issues to pre-empt clinical deterioration.DesignA preliminary study to test the feasibility of an RCT.SettingGeneral practices (GPs) in South-West Wales, UK.Participants20 patients aged >64 and prescribed >4 long-term medicines.InterventionsParticipants reported their health-related problems using the ADRe-Profile. Participants completed the profile independently initially, then with researcher support, capturing vital signs, clinical observations and patient-reported symptoms.Main outcome measuresFeasibility was assessed based on recruitment, retention, adherence to protocols, potential for clinical impact and staff costs.ResultsWe recruited two GP practices (0.94% of 213 contacted), and 20 patients aged >64 (51.3% of those approached). Retention was 100%. ADRe Profiles had a 98.29% completion rate, identifying 289 clinical problems, including pain (16 of 20 patients), dyspnoea (10/20), dizziness (8/20), bleeding/bruising (7/20) and falls (4/20). Most problems (90%) and vital signs (78%) recorded on ADRe Profiles were absent from existing patient records. Researchers recommended further investigations (164 instances) and interventions (126 suggestions). Despite the potential for clinical benefits, engagement from clinicians was limited. Cost estimates for ADRe administration ranged from £40 to £73, within the funding available from Health and Care Research Wales.ConclusionsAn RCT of the ADRe Profile was feasible, despite gatekeeping by clinicians. Recruitment of GP practices was challenging, with <1% of eligible practices participating. In contrast, patient recruitment and retention were successful. ADRe aligns with WHO patient safety goals and could improve healthcare by addressing ADR-related problems proactively in this vulnerable population.Trial registration numberNCT04663360; Pre-Results.

To explore associations between exposures to medicines prescribed for asthma and their discontinuation in pregnancy and preterm birth [<37 or <32 weeks], SGA [<10th and <3rd centiles], and breastfeeding at 6-8 weeks. Design. A population-based cohort study. Setting. The Secure Anonymised Information Linkage [SAIL] databank in Wales, linking maternal primary care data with infant outcomes. Population. 107,573, 105,331, and 38,725 infants born 2000-2010 with information on premature birth, SGA and breastfeeding respectively, after exclusions. Exposures. maternal prescriptions for asthma medicines or their discontinuation in pregnancy. Methods. Odds ratios for adverse pregnancy outcomes were calculated for the exposed versus the unexposed population, adjusted for smoking, parity, age and socio-economic status. Prescriptions for asthma, whether continued or discontinued during pregnancy, were associated with birth at<32 weeks' gestation, SGA <10th centile, and no breastfeeding (aOR 1.33 [1.10-1.61], 1.10 [1.03-1.18], 0.93 [0.87-1.01]). Discontinuation of asthma medicines in pregnancy was associated with birth at<37 weeks' and <32 weeks' gestation (aOR 1.22 [1.06-1.41], 1.53 [1.11-2.10]). All medicines examined, except ICS and SABA prescribed alone, were associated with SGA <10th centile. Prescription of asthma medicines before or during pregnancy was associated with higher prevalence of adverse perinatal outcomes, particularly if prescriptions were discontinued during pregnancy. Women discontinuing medicines during pregnancy could be identified from prescription records. The impact of targeting close monitoring and breastfeeding support warrants exploration.

Poor and middle-income Thai people rely heavily on primary care health services. These are staffed by a range of professionals. However, it is unknown whether the performance of primary care varies according to the staffing and organization of local service delivery units. Tambon (sub-district) health promotion hospitals (THPHs) were introduced in 2009 to upgrade the services offered by the previous health centres, but were faced with continuing shortages of doctors and nurses. The Ministry of Public Health (MoPH) designated three categories of THPH, defined according to whether they were regularly staffed by a medical practitioner, a qualified nurse or non-clinical public health officers. This study aimed to compare the performance of primary care offered by the three different types of primary care facilities in one public health region of Northern Thailand (Public Health Region 2). A cross-sectional survey was undertaken in 2013. Data were collected on accessibility, continuity, comprehensiveness, co-ordination and community orientation of care from 825 patients attending 23 primary care facilities. These were selected to include the three officially-designated types of Tambon (sub-district) health promotion hospitals (THPHs) led by medical, nursing or public health personnel. Survey scores were compared in unadjusted and adjusted analyses. THPHs staffed only by public health officers achieved the highest performance score (Mean = 85.14, SD. = 7.30), followed by THPHs staffed by qualified nurses (Mean = 82.86, SD. = 7.06). THPHs staffed by a doctor on rotation returned the lowest scores (Mean = 81.63, SD. = 7.22). Differences in overall scores resulted mainly from differences in reported accessibility, continuity, and comprehensiveness of care, rather than staff skill-mix per se. Policy on quality improvement should therefore focus on improving performance in these areas.

The aim of the study was to develop and validate, by consensus, the construct and content of an observations chart for nurses incorporating a modified early warning scoring (MEWS) system for physiological parameters to be used for bedside monitoring on general wards in a public hospital in South Africa. Delphi and modified face-to-face nominal group consensus methods were used to develop and validate a prototype observations chart that incorporated an existing UK MEWS. This informed the development of the Cape Town ward MEWS chart. One specialist anaesthesiologist, one emergency medicine specialist, two critical care nurses and eight senior ward nurses with expertise in bedside monitoring (N = 12) were purposively sampled for consensus development of the MEWS. One general surgeon declined and one neurosurgeon replaced the emergency medicine specialist in the final round. Five consensus rounds achieved ≥70% agreement for cut points in five of seven physiological parameters respiratory and heart rates, systolic BP, temperature and urine output. For conscious level and oxygen saturation a relaxed rule of <70% agreement was applied. A reporting algorithm was established and incorporated in the MEWS chart representing decision rules determining the degree of urgency. Parameters and cut points differed from those in MEWS used in developed countries. A MEWS for developing countries should record at least seven parameters. Experts from developing countries are best placed to stipulate cut points in physiological parameters. Further research is needed to explore the ability of the MEWS chart to identify physiological and clinical deterioration.

To explore associations between exposure to antidepressants, their discontinuation, depression [medicated or unmediated] and preterm birth [<37 and <32 weeks], small for gestational age (SGA) [<10th and <3rd centiles], breastfeeding [any] at 6-8 weeks. Design: A population-based cohort study. Setting: The Secure Anonymised Information Linkage [SAIL] databank in Wales, linking maternal primary care data with infant outcomes. Participants: 107,573, 105,331, and 38,725 infants born 2000-2010 with information on prematurity, SGA and breastfeeding respectively, after exclusions. Exposures: Maternal antidepressant prescriptions in trimesters 2 or 3, discontinuation after trimester 1, recorded diagnosis of depression [medicated or unmediated] in pregnancy. Methods: Odds ratios for adverse pregnancy outcomes were calculated, adjusted for smoking, parity, socio-economic status, and depression. Exclusive formula feeding at 6-8 weeks was associated with prescriptions in trimesters 2 or 3 for any antidepressants (adjusted odds ratio [aOR] 0.81, 95% confidence intervals 0.67-0.98), SSRIs [aOR 0.77, 0.62-0.95], particularly higher doses [aOR 0.45, 0.23-0.86], discontinuation of antidepressants or SSRIs after trimester 1 (aOR 0.70, 0.57-0.83 and 0.66, 0.51-0.87), diagnosis of depression aOR 0.76 [0.70-0.82), particularly if medicated (aOR 0.70, 0.58-0.85), rather than unmedicated (aOR 0.87, 0.82-0.92). Preterm birth at <37 and <32 weeks' gestation was associated with diagnosis of depression (aOR 1.27, 1.17-1.38, and 1.33, 1.09-1.62), particularly if medicated (aOR 1.56, 1.23-1.96, and 1.63, 0.94-2.84); birth at <37 weeks was associated with antidepressants, (aOR 1.24, 1.04-1.49]. SGA <3rd centile was associated with antidepressants (aOR 1.43, 1.07-1.90), and SSRIs (aOR 1.46, 1.06-2.00], particularly higher doses [aOR 2.10, 1.32-3.34]. All adverse outcomes were associated with socio-economic status and smoking. Exposure to antidepressants or depression increased risks of exclusive formula feeding at 6-8 weeks, and prescription of antidepressants was associated with SGA <3rd centile. Prescription of antidepressants offers a useful marker to target additional support and additional care before and during pregnancy and lactation.

Pesticides use in Southeast Asia has increased steadily, driven by the growth of large-scale commercial farming, as well as a desire to maximise food production in rural subsistence economies. Given that use of chemical pesticides, such as organophosphates and carbamates, has known potential health impacts, there are concerns about the safety of agricultural workers, and a need for a better evidence base to underpin regulation and worker education. This study, undertaken in 9 districts in Lao PDR, Thailand and Vietnam, will interview agricultural workers to investigate how they use pesticides, their knowledge of risks and self-protective practices, and their self-reported illness symptoms. In each district researchers will recruit and interview 120 participants engaged in vegetable farming, who have recently used pesticides, making a total of 1080 subjects divided equally between the three study countries. Workers’ degree of pesticides exposure will be determined from acetyl cholinesterase concentrations in capillary blood samples collected using field test kits, and these data will be analysed together with the interview findings. Country findings will be compared and contrasted, and general patterns noted. Knowledge gained about risky behaviours, self-protective practices and degree of association with serious pesticides exposure will assist policy makers and inform health improvement programmes.

Preventable adverse effects of medicines often pass unnoticed, but lead to real harm. Nurse-led monitoring using the structured Adverse Drug Reaction (ADRe) Profile identifies and addresses adverse effects of mental health medicines. This study investigated the implementation and clinical impact of ADRe, and barriers to and facilitators of sustained utilisation in routine practice. Administration of ADRe was observed for 30 residents prescribed mental health medicines in ten care homes. The study pharmacist reviewed completed ADRes against medication records. Policy context was explored in 30 interviews with service users, nurse managers and strategic leads in Wales. Residents were aged 60-95, and prescribed 1-17 (median 9 [interquartile range (IQR) 7-13]) medicines. ADRe identified a median of 18 [IQR 11.5-23] problems per resident and nurses made 2 [1-2] changes to care per resident. For example: falls were reported for 9 residents, and care was modified for 5; pain was identified in 8 residents, and alleviated for 7; all 6 residents recognised as dyspnoeic were referred to prescribers. Nurses referred 17 of 30 residents to prescribers. Pharmacists recommended review for all 30. Doubts about administering ADRe, sometimes expressed by people who had not yet used it, diminished as it became familiar. ADRe was needed to bridge communication between resident, nurses and prescribers. When barriers of time, complacency, and doctors' non-availability were overcome, reporting with ADRe made prescribers more likely to heed nurses' concerns regarding residents' welfare. Clinical gains were facilitated by one-to-one time, staff-resident relationships, and unification of documentation. To our knowledge, ADRe is the only instrument that brings a full account of patients' problems to medication reviews. This juxtaposition of signs and symptoms against prescriptions facilitates dose adjustments and de-prescribing and leads to: reduced pain and sedation; early identification of problems linked to ADRs, such as falls; and timely medication reviews e.g. for dyspnoea.