Global burden of preventable medication-related harm in health care: a systematic review

A series of WHO initiatives, such as the Global Patient Safety Challenge: Medication Without Harm and the Global Patient Safety Action Plan 2021-2030, address patient harm associated with use of medications. Medication-related harm is considered preventable if it occurs as a result of an identifiable,modifiable cause and its recurrence can be avoided by appropriate adaptation to a process or adherence to guidelines. Understanding the prevalence, natureand severity of preventable medication-related harm is critical for setting targets for clinically relevant, implementable improvements in patient safety. This report presents an updated systematic review and meta-analysis of studies of the prevalence, nature and severity of preventable medication-related harm in theinternational literature including in low- and middle-income countries (LMICs). A total of 100 studies were included in the review, involving 487 162 patients. Ofthese reports, 70 were from high-income countries (HICs) and 30 from LMICs. The results were as follows. Global prevalence and severity of preventablemedication-related harm: The pooled prevalence of preventable medication-related harm in all 100 studies was 5% (1 in 20 patients). One fourth of the harm was severe or potentially life-threatening. Geographical distribution of preventable medication-related harm: The prevalence of preventable medication-related harm was 7% in 30 studies in LMICs and 4% (3–5%, one in 25 patients) in 70 studies in HICs. The highest prevalence rates of preventable medication-related harm were in the African (9%) and South-East Asian regions (9%). Health care settings in which the most vulnerable patients are managed for preventable medication-related harm: Globally, the highest prevalence ratesfor preventable medication-related harm are for patients managed in geriatric care units (17%) and among patients in highly specialized or surgical care (9%).Stages of medication at which most preventable medication-related harm occurs: Globally about half (53%) of all preventable medication-related harmoccurred at the “ordering/prescribing” stage and 36% at the monitoring/reporting” stage. In LMICs, almost 80% of preventable medication-related harm occurred during the “ordering/prescribing” stage. Medicines that contribute most to medication- related harm: Antibacterials, antipsychotics,cardiovascular medications, drugs for functional gastrointestinal disorders, endocrine therapy, hypnotics, sedatives and non-steroidal anti-inflammatory products contributed most to medication-related harm globally.Way forward: The analysis showed that at least one in 20 patients are affected by preventable medication-related harm globally and that more than one fourthof preventable harm is severe or life-threatening. The prevalence of preventable medication-related harm in LMICs was almost twice as high as in HICs;however, few data were available on the severity and nature of medication-related harm in LMICs. A prerequisite for the success of future strategiesto mitigate preventable medication-related harm in LMICs would be to encourage reporting of any preventable medication-related harm and commission high-quality studies with standard methods for assessing and reporting such harm and also studies of the underlying causes for designing interventions that are most likely to work in LMICs. There is also an urgent need to implement improvement strategies in settings in which patients are managed, especially those who are vulnerable to preventable medication related harm, such as geriatric care and surgical care settings. Finally, most of the evidence summarized in this report was produced in hospitals and should be strengthened with more research in major specialties, including primary care, and mental health

Making the journey with me : a qualitative study of experiences of a bespoke mental health smoking cessation intervention for service users with serious mental illness

BACKGROUND: Smoking is one of the major modifiable risk factors contributing to early mortality for people with serious mental illness. However, only a minority of service users access smoking cessation interventions and there are concerns about the appropriateness of generic stop-smoking services for this group. The SCIMITAR (Smoking Cessation Intervention for Severe Mental Ill-Health Trial) feasibility study explored the effectiveness of a bespoke smoking cessation intervention delivered by mental health workers. This paper reports on the nested qualitative study within the trial. METHODS: Qualitative semi-structured interviews were conducted with 13 service users receiving the intervention and 3 of the MHSCPs (mental health smoking cessation practitioners) delivering the intervention. Topic guides explored the perceived acceptability of the intervention particularly in contrast to generic stop-smoking services, and perceptions of the implementation of the intervention in practice. Transcripts were analysed using the Constant Comparative Method. RESULTS: Generic services were reported to be inappropriate for this group, due to concerns over stigma and a lack of support from health professionals. The bespoke intervention was perceived positively, with both practitioners and service users emphasising the benefits of flexibility and personalisation in delivery. The mental health background of the practitioners was considered valuable not only due to their increased understanding of the service users' illness but also due to the more collaborative relationship style they employed. Challenges involved delays in liaising with general practitioners and patient struggles with organisation and motivation, however the MHSCP was considered to be well placed to address these problems. CONCLUSION: The bespoke smoking cessation intervention was acceptable to service users and the both service users and practitioners reported the value of a protected mental health worker role for delivering smoking cessation to this group. The results have wider implications for understanding how to achieve integrated and personalised care for this high-risk population and further underscore the need for sensitised smoking cessation support for people with serious mental illness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79497236 . Registered 3(rd) July 2009

Primary care consultation rates among people with and without severe mental illness:a UK cohort study using the Clinical Practice Research Datalink

OBJECTIVES: Little is known about service utilisation by patients with severe mental illness (SMI) in UK primary care. We examined their consultation rate patterns and whether they were impacted by the introduction of the Quality and Outcomes Framework (QOF), in 2004. DESIGN: Retrospective cohort study using individual patient data collected from 2000 to 2012. SETTING: 627 general practices contributing to the Clinical Practice Research Datalink, a large UK primary care database. PARTICIPANTS: SMI cases (346 551) matched to 5 individuals without SMI (1 732 755) on age, gender and general practice. OUTCOME MEASURES: Consultation rates were calculated for both groups, across 3 types: face-to-face (primary outcome), telephone and other (not only consultations but including administrative tasks). Poisson regression analyses were used to identify predictors of consultation rates and calculate adjusted consultation rates. Interrupted time-series analysis was used to quantify the effect of the QOF. RESULTS: Over the study period, face-to-face consultations in primary care remained relatively stable in the matched control group (between 4.5 and 4.9 per annum) but increased for people with SMI (8.8-10.9). Women and older patients consulted more frequently in the SMI and the matched control groups, across all 3 consultation types. Following the introduction of the QOF, there was an increase in the annual trend of face-to-face consultation for people with SMI (average increase of 0.19 consultations per patient per year, 95% CI 0.02 to 0.36), which was not observed for the control group (estimates across groups statistically different, p=0.022). CONCLUSIONS: The introduction of the QOF was associated with increases in the frequency of monitoring and in the average number of reported comorbidities for patients with SMI. This suggests that the QOF scheme successfully incentivised practices to improve their monitoring of the mental and physical health of this group of patients

Inequalities in physical comorbidity:a longitudinal comparative cohort study of people with severe mental illness in the UK

OBJECTIVES: Little is known about the prevalence of comorbidity rates in people with severe mental illness (SMI) in UK primary care. We calculated the prevalence of SMI by UK country, English region and deprivation quintile, antipsychotic and antidepressant medication prescription rates for people with SMI, and prevalence rates of common comorbidities in people with SMI compared with people without SMI. DESIGN: Retrospective cohort study from 2000 to 2012. SETTING: 627 general practices contributing to the Clinical Practice Research Datalink, a UK primary care database. PARTICIPANTS: Each identified case (346 551) was matched for age, sex and general practice with 5 randomly selected control cases (1 732 755) with no diagnosis of SMI in each yearly time point. OUTCOME MEASURES: Prevalence rates were calculated for 16 conditions. RESULTS: SMI rates were highest in Scotland and in more deprived areas. Rates increased in England, Wales and Northern Ireland over time, with the largest increase in Northern Ireland (0.48% in 2000/2001 to 0.69% in 2011/2012). Annual prevalence rates of all conditions were higher in people with SMI compared with those without SMI. The discrepancy between the prevalence of those with and without SMI increased over time for most conditions. A greater increase in the mean number of additional conditions was observed in the SMI population over the study period (0.6 in 2000/2001 to 1.0 in 2011/2012) compared with those without SMI (0.5 in 2000/2001 to 0.6 in 2011/2012). For both groups, most conditions were more prevalent in more deprived areas, whereas for the SMI group conditions such as hypothyroidism, chronic kidney disease and cancer were more prevalent in more affluent areas. CONCLUSIONS: Our findings highlight the health inequalities faced by people with SMI. The provision of appropriate timely health prevention, promotion and monitoring activities to reduce these health inequalities are needed, especially in deprived areas

Trials need participants but not their feedback? : A scoping review of published papers on the measurement of participant experience of taking part in clinical trials

CP is funded by the NIHR School for Primary Care Research (Launching Fellowship). Earlier work informing this review was funded by the Medical Research Council (MRC) Hub for Trials Methodology (MR/L004933/2 - R46).Peer reviewedPublisher PD

Priorities for methodological research on patient and public involvement in clinical trials A modified Delphi process

Background Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. Objective To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. Design A modified Delphi process including a two round online survey and a stakeholder consensus meeting. Participants In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. Results Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. Conclusions The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study.

IntroductionPatients being discharged from inpatient mental wards often describe safety risks in terms of inadequate information sharing and involvement in discharge decisions. Through stakeholder engagement, we co-designed, developed and adapted two versions of a care bundle intervention, the SAFER Mental Health care bundle for adult and youth inpatient mental health settings (SAFER-MH and SAFER-YMH, respectively), that look to address these concerns through the introduction of new or improved processes of care.Methods and analysisTwo uncontrolled before-and-after feasibility studies, where all participants will receive the intervention. We will examine the feasibility and acceptability of the SAFER-MH in inpatient mental health settings in patients aged 18 years or older who are being discharged and the feasibility and acceptability of the SAFER-YMH intervention in inpatient mental health settings in patients aged between 14 and 18 years who are being discharged. The baseline period and intervention periods are both 6 weeks. SAFER-MH will be implemented in three wards and SAFER-YMH in one or two wards, ideally across different trusts within England. We will use quantitative (eg, questionnaires, completion forms) and qualitative (eg, interviews, process evaluation) methods to assess the acceptability and feasibility of the two versions of the intervention. The findings will inform whether a main effectiveness trial is feasible and, if so, how it should be designed, and how many patients/wards should be included.Ethics and disseminationEthical approval was obtained from the National Health Service Cornwall and Plymouth Research Ethics Committee and Surrey Research Ethics Committee (reference: 22/SW/0096 and 22/LO/0404). Research findings will be disseminated with participating sites and shared in various ways to engage different audiences. We will present findings at international and national conferences, and publish in open-access, peer-reviewed journals

Modelling Conditions and Health Care Processes in Electronic Health Records : An Application to Severe Mental Illness with the Clinical Practice Research Datalink

BACKGROUND: The use of Electronic Health Records databases for medical research has become mainstream. In the UK, increasing use of Primary Care Databases is largely driven by almost complete computerisation and uniform standards within the National Health Service. Electronic Health Records research often begins with the development of a list of clinical codes with which to identify cases with a specific condition. We present a methodology and accompanying Stata and R commands (pcdsearch/Rpcdsearch) to help researchers in this task. We present severe mental illness as an example. METHODS: We used the Clinical Practice Research Datalink, a UK Primary Care Database in which clinical information is largely organised using Read codes, a hierarchical clinical coding system. Pcdsearch is used to identify potentially relevant clinical codes and/or product codes from word-stubs and code-stubs suggested by clinicians. The returned code-lists are reviewed and codes relevant to the condition of interest are selected. The final code-list is then used to identify patients. RESULTS: We identified 270 Read codes linked to SMI and used them to identify cases in the database. We observed that our approach identified cases that would have been missed with a simpler approach using SMI registers defined within the UK Quality and Outcomes Framework. CONCLUSION: We described a framework for researchers of Electronic Health Records databases, for identifying patients with a particular condition or matching certain clinical criteria. The method is invariant to coding system or database and can be used with SNOMED CT, ICD or other medical classification code-lists

The Role of Primary Care in Service Provision for People with Severe Mental Illness in the United Kingdom

Severe mental illness is a serious and potentially life changing set of conditions. This paper describes and analyses patient characteristics and service usage over one year of a representative cohort of people with a diagnosis of severe mental illness across England, including contacts with primary and secondary care and continuity of care