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Background England operates a National Data Opt-Out (NDOO) for the secondary use of confidential health data for research and planning. We hypothesised that public awareness and support for the secondary use of health data and the NDOO would vary by participant demography and healthcare experience. We explored patient/public awareness and perceptions of secondary data use, grouping potential researchers into National Health Service (NHS), academia or commercial. We assessed awareness of the NDOO system amongst patients, carers, healthcare staff and the public. We co-developed recommendations to consider when sharing unconsented health data for research. Methods A patient and public engagement program, co-created and including patient and public workshops, questionnaires and discussion groups regarding anonymised health data use. Results There were 350 participants in total. Central concerns for health data use included unauthorised data re-use, the potential for discrimination and data sharing without patient benefit. 94% of respondents were happy for their data to be used for NHS research, 85% for academic research and 68% by health companies, but less than 50% for non-healthcare companies and opinions varied with demography and participant group. Questionnaires showed that knowledge of the NDOO was low, with 32% of all respondents, 53% of all NHS staff and 29% of all patients aware of the NDOO. Recommendations to guide unconsented secondary health data use included that health data use should benefit patients; data sharing decisions should involve patients/public. That data should remain in close proximity to health services with the principles of data minimisation applied. Further, that there should be transparency in secondary health data use, including publicly available lists of projects, summaries and benefits. Finally, organisations involved in data access decisions should participate in programmes to increase knowledge of the NDOO, to ensure public members were making informed choices about their own data. Conclusion The majority of participants in this study reported that the use of healthcare data for secondary purposes was acceptable when accessed by NHS. Academic and health-focused companies. However, awareness was limited, including of the NDOO. Further development of publicly-agreed recommendations for secondary health data use may improve both awareness and confidence in secondary health data use. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-021-00281-2., Plain English summary Health data from routine care can be pseudonymised (with a link remaining to the patient but identifying features removed) or anonymised (with identifying features removed and the link to the patient severed) and used for research and health planning; termed “secondary use”. The National Health Service (NHS) is a single publicly-funded health service for the United Kingdom (UK). The NHS supports secondary data use with a National Data opt-out system. The potential benefits of data secondary use are clear but concerns have been raised. Although the Data Opt-Out is publicised, it is unclear how much public awareness there is of this scheme. We report a patient and publicly created and delivered series of activities including > 350 people; with young adults, patients, NHS staff and the public; to assess concerns, knowledge and acceptance of data sharing. Perceptions of and support for secondary health data use varied depending on who was asked (by age, gender) and their experience of health services (Staff member, patient, member of the public). Knowledge of schemes to limit secondary data use (such as the UK National Data Op-Out) was low, even among NHS staff. The main concerns of sharing health data included onward data use, the potential for discrimination and exploitation and commercial gain from data use with no benefit to patients. Despite this, most participants agreed with health data sharing with NHS, academic and commercial health-based entities. Agreed, co-created themes to increase the acceptability of health data secondary use included education about ‘Opt-out’ schemes, health service oversight of data use (as the most trusted partner), public and patient involvement in data sharing decisions and public transparency. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-021-00281-2.

Background: Many studies have investigated drug stability in extended home infusion pumps, but little is known of other factors that may affect the total daily dose the patient receives. It has been noted that up to 40% of these infusions are incomplete after the designated run out time. Aim: This study investigated whether concentration can affect the flow rate of home infusion pumps, and thus the total dose the patient receives in outpatient parenteral antimicrobial therapy (OPAT). Method: The flow rates of 10 different drug and dose formulations (4–18 g in 0.9% sodium chloride) in Baxter LV10 (Old Toongabbie, Australia) infusion pumps were investigated. The pumps were run out at 31°C and weighed at intervals, with flow rate and total volume infused calculated over the 24-h period. Results: Piperacillin/tazobactam 18 g was the only formulation not to meet the minimum standard of 90% of the volume being infused over the 24-h period. This indicates a failure of intended therapy. Across all infusions, the expected dose delivered (DD) can be calculated as %DD = −1.9x + 122.85, where x is the total drug and excipient weight within the infusor. Conclusion: Dose is inversely related to flow rate in the LV10 Baxter infusion pump. Under nominal conditions, any amount greater than 12.02 g in the 240-mL infusion pump will result in an incomplete run out over the 24-h period. Clinicians should be aware that prescribing daily doses higher than 17.28 g may result in

Background: Stability data tested at 25°C may not be suitable for use in the tropics in the home intravenous infusions (Home‐IV) setting. A 24‐h solution temperature profile is needed to investigate medication stability in this setting. Aim: This study investigated and mapped the solution temperature within the Baxter LV10 elastomeric infusor device in a tropical environment over a 24‐h period. Methods: Volunteer patients from Home‐IV clinics in two tropical Australian cities wore elastomeric infusor devices for 24 h over the summer months. Temperature devices were inserted into the solution to directly log solution temperature. Results: Solution temperature was >25°C 79.8% of the time. Mean time to inflection (temperature stops rising and begins fluctuating) was 9.4 h (95% confidence interval (CI) 8.6–10.2), with a maximum inflection point of 14.5 h. The mean (95% CI) temperature at inflection and after inflection was 30.6°C (29.8–31.5) and 29.5°C (29.3–29.6), respectively; the 90th percentile temperature after inflection was 32.5°C. Analysis of variance revealed a significant difference of 3.1°C between air‐conditioned and non‐air‐conditioned data (F1,28 = 13.06, p = 0.001). The 90th percentile temperature after inflection for non‐air‐conditioned data was 33.1°C. Conclusions: Stability studies performed at 25°C are inappropriate for tropical regions. Possible factors contributing to the higher temperatures include body and ambient room temperature. We recommend that medications are tested in 24‐h elastomeric infusor devices in three steps: (1) refrigerated for up to 7 days; (2) steady increase from refrigerated to 34°C over 9 h; and (3) maintained at 34°C for the remaining 15 h. This more accurately reflects the temperature profile experienced in warmer climates. Furthermore, Home‐IV patients should be encouraged to remain in an air‐conditioned environment, or at least indoors, over the summer months to decrease the potential for antibiotic degradation.

Clinical pharmacists provide beneficial services to adult patients, though their benefits for paediatric hospital patients are less defined. Five databases were searched using the MeSH terms 'clinical pharmacist', 'paediatric/paediatric', 'hospital', and 'intervention' for studies with paediatric patients conducted in hospital settings, and described pharmacist-initiated interventions, published between January 2000 and October 2017. The search strategy after full-text review identified 12 articles matching the eligibility criteria. Quality appraisal checklists from the Joanna Briggs Institute were used to appraise the eligible articles. Clinical pharmacist services had a positive impact on paediatric patient care. Medication errors intercepted by pharmacists included over- and under-dosing, missed doses, medication history gaps, allergies, and near-misses. Interventions to address these errors were positively received, and implemented by physicians, with an average acceptance rate of over 95%. Clinical pharmacist-initiated education resulted in improved medication understanding and adherence, improved patient satisfaction, and control of chronic medical conditions.Conclusion: This review found that clinical pharmacists in paediatric wards may reduce drug-related problems and improve patient outcomes. The benefits of pharmacist involvement appear greatest when directly involved in ward rounds, due to being able to more rapidly identify medication errors during the prescribing phase, and provide real-time advice and recommendations to prescribers. What is Known: • Complex paediatric conditions can require multiple pharmaceutical treatments, utilised in a safe manner to ensure good patient outcomes • The benefits of pharmacist interventions when using these treatments are well-documented in adult patients, though less so in paediatric patients What is New: • Pharmacists are adept at identifying and managing medication errors for paediatric patients, including incorrect doses, missed doses, and gaps in medication history • Interventions recommended by pharmacists are generally well-accepted by prescribing physicians, especially when recommendations can be made during the prescribing phase of treatment.

IntroductionHealth Data Research UK designated seven UK-based Hubs to facilitate health data use for research. PIONEER is the Hub in Acute Care. PIONEER delivered workshops where patients/public citizens agreed key principles to guide access to unconsented, anonymised, routinely collected health data. These were used to inform the protocol.MethodsThis paper describes the PIONEER infrastructure and data access processes. PIONEER is a research database and analytical environment that links routinely collected health data across community, ambulance and hospital healthcare providers. PIONEER aims ultimately to improve patient health and care, by making health data discoverable and accessible for research by National Health Service, academic and commercial organisations. The PIONEER protocol incorporates principles identified in the public/patient workshops. This includes all data access requests being reviewed by the Data Trust Committee, a group of public citizens who advise on whether requests should be supported prior to licensed access.Ethics and disseminationEast Midlands–Derby REC (20/EM/0158): Confidentiality Advisory Group (20/CAG/0084). www.PIONEERdatahub.co.uk

Aim To determine if there are sufficient stability data to confirm appropriate prescribing of antibiotics commonly used in outpatient parenteral antimicrobial therapy (OPAT) in warmer climates. Data sources Four databases were systematically searched using the terms ‘beta-lactams’, or ‘antibiotics’, or ‘anti-bacterial agents’ and ‘drug stability’ or drug storage’ for studies specific to drug stability published between 1966 and February 2018. Study selection The search strategy initially identified 2879 potential articles. After title and abstract review, the full-texts of 137 potential articles were assessed, with 46 articles matching the inclusion and exclusion criteria included in this review. Results A large volume of stability data is available for the selected drugs. Stability data at temperatures higher than 25°C were available for several of the medications, however few drugs demonstrated stability in warmer climates of 34°C or higher. Only buffered benzylpenicillin, cefoxitin and buffered flucloxacillin were found to have stability data supporting OPAT in warmer climates. Sequential data, profiling the drug for an extended period in solution under refrigeration prior to the run-out period at the higher temperatures, are also lacking. Limitations This study was limited by including only peer reviewed articles. There may be further grey literature supporting the stability of some of the drugs mentioned. Conclusion There are insufficient stability data of antibiotic use in warmer climates. Studies to verify the stability and appropriate use of many antibiotics used in OPAT at standard room temperature and in warmer climates are urgently required. Several drugs in current use in the OPAT settings are lacking stability data. Implications Further research in this field is needed to develop structured evidence-based guidelines. Results of this review should be further compared with observed patient outcomes in current clinical practice.

There are limited data on the use of elastomeric infusion pumps during hyperbaric oxygen treatment.This study evaluated the flow rate of the Baxter elastomeric LV10 Infusor™ pump under normobaric (101.3 kPa) and three hyperbaric conditions of 203 kPa, 243 kPa and 284 kPa.Elastomeric pumps were secured to participants in the same manner as for a typical patient, except that a container collected the delivered antibiotic solution. Pumps and tubing were weighed before and after the test period to determine volume delivered and to calculate flow rates at sea level and the three commonly used hyperbaric treatment pressures at two different time periods, 0-2 hours (h) and 19-21 h into the infusion.The mean flow rates in ml·h⁻¹ (SD) were: 9.5 (0.4), 10.3 (0.6), 10.4 (0.6), 10.4 (0.5) at 0-2 h and 10.5 (1.0), 12.2 (0.6), 9.4 (0.5), 10.3 (0.9) at 19-21 h for the normobaric, 203 kPa, 243 kPa and 284 kPa conditions respectively. There was no significant association between flow rate and time period (P = 0.166) but the 203 kPa flow rates were significantly faster than the other flow rates (P = 0.008). In retrospect, the 203 kPa experiments had all been conducted with the same antibiotic solution (ceftazidime 6 g). Repeating that experimental arm using flucloxacillin 8 g produced flow rates of 10.4 (0.8) ml·h⁻¹, with no significant associations between flow rate and time period (P = 0.652) or pressure (P = 0.705).In this study, the flow rate of the Baxter LV10 Infusor™ device was not significantly affected by increases in ambient pressure across the pressure range of 101.3 kPa to 284 kPa, and flow rates were generally within a clinically acceptable range of 9-12 ml·h⁻¹. However, there was evidence that the specific antibiotic solution might affect flow rates and this requires further study.

Objectives Clozapine is an atypical antipsychotic used in the treatment of schizophrenia. Due to the patient profile there is a high rate of repackaging of clozapine into dose administration aids (DAAs). Because of reports from hospital pharmacists about discoloration of returned clozapine tablets that have been repackaged into DAAs, the aim of this study was to evaluate the chemical, physical and photostability of these tablets repackaged into a DAA. Method Clozapine tablets were repackaged into DAAs and evaluated for physicochemical stability over a 6-week period at a controlled room temperature (25 ± 1°C; 60 ± 1.5% relative humidity (RH)) and accelerated conditions (40 ± 1°C; 75 ± 1.5% RH). In addition, photostability studies were performed according to the International Committee on Harmonisation (ICH) guidelines. Key findings Chemical stability was confirmed for all storage conditions, including for those photostability (ICH conditions), with the clozapine content occurring within the British Pharmacopoeial (BP) range of 90–110%. Although the physical stability was confirmed for all tests at room temperature (weight uniformity, hardness, friability, disintegration and dissolution), under accelerated conditions the disintegration test did not meet BP requirements. However, the subsequent dissolution test was successful with 85% of clozapine dissolving in 45 min. Conclusions This study illustrates that clozapine, when correctly repackaged, maintains its physical and chemical stability for 6 weeks. As no discoloration of the tablets was observed, it is assumed that the reports received were as a result of improper handling by patients. Based on these findings, it is recommended that patients be advised on the correct handling and storage of their DAAs.