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REMS in pregnancy: system perfectly designed to the get the results it gets

Quality and Safety in Health Care Journal -

Reproductive drug safety has been a priority for patients and physicians even before the 1960s, when thalidomide—a drug commonly used to alleviate morning sickness—was tied to alarming cases of infants born with phocomelia.1 The Kefauver-Harris Amendment of 1962 prevented thalidomide approval in the USA.1 The legislation also led to immediate reforms in how drugs were approved, but not necessarily how they were prescribed.1 In the decades that followed, processes to regulate safe prescribing lagged.

The first reproductive drug safety initiatives were those for isotretinoin (Accutane) and thalidomide: the Accutane Pregnancy Prevention Program (1988), the System for Thalidomide Education and Prescribing Safety (1998) and the System to Manage Accutane-Related Teratogenicity (2002). In response to persistent gaps in these and other drug safety monitoring programmes, the US Food and Drug Administration (FDA) subsequently implemented the Risk Management and Evaluation Strategy (REMS) programme in 2007.

Nothing soft about 'soft skills: core competencies in quality improvement and patient safety education and practice

Quality and Safety in Health Care Journal -

Quality improvement and patient safety (QIPS) education programmes have proliferated in the past decade given the rising demand for healthcare professionals to develop the knowledge, skills and attitudes required to make improvements in healthcare.1–4 On the one hand, this proliferation is a positive sign of the institutionalisation of QIPS within our educational, practice, professional and regulatory spheres. On the other hand, while numerous QIPS education programmes are up and running, our understanding of key educational processes and how to optimise outcomes is still evolving. For instance, it remains unclear how to simultaneously optimise learning and project outcomes in quality improvement (QI) project-based learning or how to facilitate interprofessional learning in QIPS education.

In this issue of BMJ Quality and Safety, Myers and colleagues5 studied the influence of two postgraduate QIPS fellowship training programme for physicians on graduates’ career outcomes...

Hospital-level evaluation of the effect of a national quality improvement programme: time-series analysis of registry data

Quality and Safety in Health Care Journal -

Background and objectives

A clinical trial in 93 National Health Service hospitals evaluated a quality improvement programme for emergency abdominal surgery, designed to improve mortality by improving the patient care pathway. Large variation was observed in implementation approaches, and the main trial result showed no mortality reduction. Our objective therefore was to evaluate whether trial participation led to care pathway implementation and to study the relationship between care pathway implementation and use of six recommended implementation strategies.

Methods

We performed a hospital-level time-series analysis using data from the Enhanced Peri-Operative Care for High-risk patients trial. Care pathway implementation was defined as achievement of >80% median reliability in 10 measured care processes. Mean monthly process performance was plotted on run charts. Process improvement was defined as an observed run chart signal, using probability-based ‘shift’ and ‘runs’ rules. A new median performance level was calculated after an observed signal.

Results

Of 93 participating hospitals, 80 provided sufficient data for analysis, generating 800 process measure charts from 20 305 patient admissions over 27 months. No hospital reliably implemented all 10 processes. Overall, only 279 of the 800 processes were improved (3 (2–5) per hospital) and 14/80 hospitals improved more than six processes. Mortality risk documented (57/80 (71%)), lactate measurement (42/80 (53%)) and cardiac output guided fluid therapy (32/80 (40%)) were most frequently improved. Consultant-led decision making (14/80 (18%)), consultant review before surgery (17/80 (21%)) and time to surgery (14/80 (18%)) were least frequently improved. In hospitals using ≥5 implementation strategies, 9/30 (30%) hospitals improved ≥6 care processes compared with 0/11 hospitals using ≤2 implementation strategies.

Conclusion

Only a small number of hospitals improved more than half of the measured care processes, more often when at least five of six implementation strategies were used. In a longer term project, this understanding may have allowed us to adapt the intervention to be effective in more hospitals.

Comparative effectiveness of risk mitigation strategies to prevent fetal exposure to mycophenolate

Quality and Safety in Health Care Journal -

Background

In 2012, the US Food and Drug Administration approved a Risk Evaluation and Mitigation Strategy (REMS) programme including mandatory prescriber training and a patient/provider acknowledgement form to prevent fetal exposure to mycophenolate. Prior to the REMS, the teratogenic risk was solely mitigated via written information (black box warning, medication guide (MG period)). To date, there is no evidence on the effectiveness of the REMS.

Methods

We used a national private health insurance claims database to identify women aged 15–44 who filled ≥1 mycophenolate prescription. To compare fetal exposure during REMS with the MG period, we estimated the prevalence of pregnancy at treatment initiation in a pre/post comparison (analysis 1) and the rate of conception during treatment in a retrospective cohort study (analysis 2). Pregnancy episodes were measured based on diagnosis and procedure codes for pregnancy outcomes or prenatal screening. We used generalised estimating equation models with inverse probability of treatment weighting to calculate risk estimates.

Results

The adjusted proportion of existing pregnancy per 1000 treatment initiations was 1.7 (95% CI 1.0 to 2.9) vs 4.1 (95% CI 3.2 to 5.4) during the REMS and MG period. The adjusted prevalence ratio and prevalence difference were 0.42 (95% CI 0.24 to 0.74) and –2.4 (95% CI –3.8 to –1.0), respectively. In analysis 2, the adjusted rate of conception was 12.5 (95% CI 8.9 to 17.6) vs 12.9 (95% CI 9.9 to 16.9) per 1000 years of mycophenolate exposure time in the REMS versus MG periods. The adjusted risk ratio and risk difference were 0.97 (95% CI 0.63 to 1.49) and –0.4 (95% CI –5.9 to 5.0), respectively. Sensitivity analyses on the estimated conception date demonstrated robustness of our findings.

Conclusion

While the REMS programme achieved less pregnancies at treatment initiation, it failed to prevent the onset of pregnancy during treatment. Enhanced approaches to ensure effective contraception during treatment should be considered.

Demonstrating the value of postgraduate fellowships for physicians in quality improvement and patient safety

Quality and Safety in Health Care Journal -

Background

Academic fellowships in quality improvement (QI) and patient safety (PS) have emerged as one strategy to fill a need for physicians who possess this expertise. The authors aimed to characterise the impact of two such programmes on the graduates and their value to the institutions in which they are housed.

Methods

In 2018, a qualitative study of two US QIPS postgraduate fellowship programmes was conducted. Graduates’ demographics and titles were collected from programme files,while perspectives of the graduates and their institutional mentors were collected through individual interviews and analysed using thematic analysis.

Results

Twenty-eight out of 31 graduates (90%) and 16 out of 17 (94%) mentors participated in the study across both institutions. At a median of 3 years (IQR 2–4) postgraduation, QIPS fellowship programme graduates’ effort distribution was: 50% clinical care (IQR 30–61.8), 48% QIPS administration (IQR 20–60), 28% QIPS research (IQR 17.5–50) and 15% education (7.1–30.4). 68% of graduates were hired in the health system where they trained. Graduates described learning the requisite hard and soft skills to succeed in QIPS roles. Mentors described the impact of the programme on patient outcomes and increasing the acceptability of the field within academic medicine culture.

Conclusion

Graduates from two QIPS fellowship programmes and their mentors perceive programmatic benefits related to individual career goal attainment and institutional impact. The results and conceptual framework presented here may be useful to other academic medical centres seeking to develop fellowships for advanced physician training programmes in QIPS.

Deprescribing psychotropic medications in children: results of a national qualitative study

Quality and Safety in Health Care Journal -

Background and Objective

Prescriptions for psychotropic medications to children have risen dramatically in recent years despite few regulatory approvals and growing concerns about side effects. Government policy and numerous programmes are attempting to curb this problem. However, the perspectives of practising clinicians have not been explored. To characterise the perspectives and experiences of paediatric primary care clinicians and mental health specialists regarding overprescribing and deprescribing psychotropic medications in children.

Methods

We conducted 24 semistructured interviews with clinicians representing diverse geographic regions and practice settings in the USA. Interview questions focused on clinician perspectives surrounding overprescribing and experiences with deprescribing. We transcribed audio files verbatim and verified them for accuracy. We analysed transcripts using a grounded theory approach, identifying emergent themes and developing a conceptual model using axial coding.

Results

Analysis yielded themes within four domains: social and clinical contextual factors contributing to overprescribing, opportunities for deprescribing, and facilitators and barriers to deprescribing in paediatric outpatient settings. Most participants recognised the problem of overprescribing, and they described complex clinical and social contextual factors, as well as internal and external pressures, that contribute to overprescribing. Opportunities for deprescribing included identification of high-risk medications, routine reassessment of medication needs and recognition of the broader social needs of vulnerable children. Facilitators and barriers to deprescribing were both internal (eg, providing psychoeducation to families) and external (eg, parent and child preferences) to clinicians.

Conclusion

Our findings highlight a discrepancy between clinicians’ concerns about overprescribing and a lack of resources to support deprescribing in outpatient paediatric settings. To successfully initiate deprescribing, clinicians will need practical tools and organisational supports, as well as social resources for vulnerable families.

Cautionary study on the effects of pay for performance on quality of care: a pilot randomised controlled trial using standardised patients

Quality and Safety in Health Care Journal -

Background

Due to the difficulty of studying incentives in practice, there is limited empirical evidence of the full-impact pay-for-performance (P4P) incentive systems.

Objective

To evaluate the impact of P4P in a controlled, simulated environment.

Design

We employed a simulation-based randomised controlled trial with three standardised patients to assess advanced practice providers’ performance. Each patient reflected one of the following: (A) indicated for P4P screenings, (B) too young for P4P screenings, or (C) indicated for P4P screenings, but screenings are unrelated to the reason for the visit. Indication was determined by the 2016 Centers for Medicare and Medicaid Services quality measures.

Intervention

The P4P group was paid $150 and received a bonus of $10 for meeting each of five outcome measures (breast cancer, colorectal cancer, pneumococcal, tobacco use and depression screenings) for each of the three cases (max $300). The control group received $200.

Setting

Learning resource centre.

Participants

35 advanced practice primary care providers (physician assistants and nurse practitioners) and 105 standardised patient encounters.

Measurements

Adherence to incentivised outcome measures, interpersonal communication skills, standards of care, and misuse.

Results

The Type a patient was more likely to receive indicated P4P screenings in the P4P group (3.82 out of 5 P4P vs 2.94 control, p=0.02), however, received lower overall standards of care under P4P (31.88 P4P vs 37.06 control, p=0.027). The Type b patient was more likely to be prescribed screenings not indicated, but highlighted by P4P: breast cancer screening (47% P4P vs 0% control, p<0.01) and colorectal cancer screening (24% P4P vs 0% control, p=0.03). The P4P group over-reported completion of incentivised measures resulting in overpayment (average of $9.02 per patient).

Limitations

A small sample size and limited variability in patient panel limit the generalisability of findings.

Conclusions

Our findings caution the adoption of P4P by highlighting the unintended consequences of the incentive system.

Does team reflexivity impact teamwork and communication in interprofessional hospital-based healthcare teams? A systematic review and narrative synthesis

Quality and Safety in Health Care Journal -

Background

Teamwork and communication are recognised as key contributors to safe and high-quality patient care. Interventions targeting process and relational aspects of care may therefore provide patient safety solutions that reflect the complex nature of healthcare. Team reflexivity is one such approach with the potential to support improvements in communication and teamwork, where reflexivity is defined as the ability to pay critical attention to individual and team practices with reference to social and contextual information.

Objective

To systematically review articles that describe the use of team reflexivity in interprofessional hospital-based healthcare teams.

Methods

Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, six electronic databases were searched to identify literature investigating the use of team reflexivity in interprofessional hospital-based healthcare teams.

The review includes articles investigating the use of team reflexivity to improve teamwork and communication in any naturally occurring hospital-based healthcare teams. Articles’ eligibility was validated by two second reviewers (5%).

Results

Fifteen empirical articles were included in the review. Simulation training and video-reflexive ethnography (VRE) were the most commonly used forms of team reflexivity. Included articles focused on the use of reflexive interventions to improve teamwork and communication within interprofessional healthcare teams. Communication during interprofessional teamworking was the most prominent focus of improvement methods. The nature of this review only allows assessment of team reflexivity as an activity embedded within specific methods. Poorly defined methodological information relating to reflexivity in the reviewed studies made it difficult to draw conclusive evidence about the impact of reflexivity alone.

Conclusion

The reviewed literature suggests that VRE is well placed to provide more locally appropriate solutions to contributory patient safety factors, ranging from individual and social learning to improvements in practices and systems.

Trial registration number

CRD42017055602.

Learning from complaints in healthcare: a realist review of academic literature, policy evidence and front-line insights

Quality and Safety in Health Care Journal -

Introduction

A global rise in patient complaints has been accompanied by growing research to effectively analyse complaints for safer, more patient-centric care. Most patients and families complain to improve the quality of healthcare, yet progress has been complicated by a system primarily designed for case-by-case complaint handling.

Aim

To understand how to effectively integrate patient-centric complaint handling with quality monitoring and improvement.

Method

Literature screening and patient codesign shaped the review’s aim in the first stage of this three-stage review. Ten sources were searched including academic databases and policy archives. In the second stage, 13 front-line experts were interviewed to develop initial practice-based programme theory. In the third stage, evidence identified in the first stage was appraised based on rigour and relevance, and selected to refine programme theory focusing on what works, why and under what circumstances.

Results

A total of 74 academic and 10 policy sources were included. The review identified 12 mechanisms to achieve: patient-centric complaint handling and system-wide quality improvement. The complaint handling pathway includes (1) access of information; (2) collaboration with support and advocacy services; (3) staff attitude and signposting; (4) bespoke responding; and (5) public accountability. The improvement pathway includes (6) a reliable coding taxonomy; (7) standardised training and guidelines; (8) a centralised informatics system; (9) appropriate data sampling; (10) mixed-methods spotlight analysis; (11) board priorities and leadership; and (12) just culture.

Discussion

If healthcare settings are better supported to report, analyse and use complaints data in a standardised manner, complaints could impact on care quality in important ways. This review has established a range of evidence-based, short-term recommendations to achieve this.

Evaluating improvement interventions using routine data to support a learning health system: research design, data access, analysis and reporting

Quality and Safety in Health Care Journal -

Introduction: learning health systems

Friedman and colleagues1 outline a vision of the learning health system founded on the sharing of data and achieved through alignment of information technology, advanced analytics and clinical expertise. The Institute of Medicine2 recognises the potential of the learning health system to generate new information automatically during the delivery of healthcare, offering continual opportunities to improve healthcare processes for the benefit of public health. The learning health system is promoted as a mechanism to accelerate the adoption of effective treatments into clinical practice, shortening the extended delay3 from publication of research findings to implementation. Furthermore, it harbours the ambition to deliver personalised medicine to each service user, rather than the systematic provision of identical care to groups of patients who share the same characteristics. Worldwide escalating costs in healthcare provision due to demographic changes, compounded by ongoing use...

Verathon, Inc. Recalls GlideScope Core One TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use

FDA MedWatch -

The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The

Verathon, Inc., GlideScope® Core One™ TouchSmart Cable (“OneTouch cable”), Due to partial or complete loss of image during use

FDA MedWatch -

The Core OneTouch Smart Cable is used to connect the GlideScope Spectrum Single-use video laryngoscopes and GlideScope Video Baton 2.0 (Large) to the Core 10 and Core 15 video monitors. If too much force is used to twists the cable to connect the blade in the HDMI port or to the connection port. The

AAA Cosmética, S.A. de C.V. Issues Voluntary Nationwide Recall of all Lots Within Expiry of bio aaa Advance Hand Sanitizer 480 mL Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

FDA MedWatch -

AAA Cosmética, S.A. de C.V. is voluntarily recalling all lots of bio aaa Advance Hand Sanitizer currently in US distribution, packaged in 480 mL bottles, to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

Enhancing Collaborative Learning for Quality Improvement: Evidence from the Improving Clinical Flow Project, a Breakthrough Series Collaborative with Project ECHO

Institute for Healthcare Improvement -

A novel combination of IHI Breakthrough Series Collaborative tools with Project ECHO's telementoring model contributed to building quality improvement (QI) capacity and improving processes and patient experience across FQHCs participating in the Improving Clinical Flow project.

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