FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

Recall affects certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters

Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

BiPAP A30, A40, and V30 devices may shut down due to a Ventilator Interruptions, leading to therapy loss. May cause serious injury or death.

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication

Ethicon Endo-Surgery is correcting the Endopath Echelon due to a potential surgical lockout that stops cutting or stapling and requires extra removal steps.

Edwards recalls arterial cannulae due to risk of wire exposure that may cause serious patient harm.

Baxter is removing mobile lift components due to risk of false attachment, which may result in patient injury due to falls.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.

MicroMyst Applicators are being recalled due to potential non-sterile product., but these devices may not have been properly sterilized.

Maquet is updating Servo Ventilator instructions due to a risk of inaccurate tidal volume delivery when the extended leak test is used.

This May, the World Health Assembly (WHA) will vote on re-establishing a mandate for the WHO to address the health consequences of nuclear weapons and war.1 Health professionals and their associations should urge their governments to support such a mandate and support the new United Nations (UN) comprehensive study on the effects of nuclear war.

The first atomic bomb exploded in the New Mexico desert 80 years ago, in July 1945. Three weeks later, two relatively small (by today’s standards), tactical-size nuclear weapons unleashed a cataclysm of radioactive incineration on Hiroshima and Nagasaki. By the end of 1945, about 213 000 people were dead.2 Tens of thousands more have died from late effects of the bombings.

Last December, Nihon Hidankyo, a movement that brings together atomic bomb survivors, was awarded the Nobel Peace Prize for its ‘efforts to achieve a world free of nuclear weapons...

The article by Cho et al1 in the current issue of BMJ Quality and Safety addresses the persistent and debilitating problem of hospital falls, which remain a challenge worldwide. Despite decades of research on hospital falls,2 considerable effort by health professionals,3 and publication of clinical guidelines on falls prevention,4 5 falls and associated injuries continue to be a major threat to patient safety and quality. The reasons why hospital falls continue to be associated with injuries and increased hospital length of stay are incompletely understood and vary across patients and settings. What is known is that patient falls education early after hospital admission helps to prevent falls.6–8 Staff education on how to prevent hospital falls also helps to reduce the risk.9 Exercise, safe footwear, environmental modifications, use of assistive devices such...

Background

Inpatient falls are adverse events that often result in injury due to complex interactions between the hospital environment and patient risk factors and remain a significant problem in clinical settings.

Objectives

This study aimed to identify (1) practice variations and key issues ranging from hospital fall management protocols to incident detection, and (2) potential approaches to address these challenges.

Design

Retrospective cohort study.

Setting

Four general hospitals in South Korea.

Methods

Qualitative and quantitative data were analysed using the Donabedian quality outcomes model. Data were collected retrospectively during 2015–2023 from four general hospitals on local practice protocols, patient admission and nursing data from electronic records, and incident self-reports. Content analysis of practice protocol and manual chart reviews for hospital falls incidents was conducted at each site. Quantitative analyses of nursing activities and analysis of patient falls prevention interventions were also conducted at each site.

Results

There were variations in fall definitions, risk-assessment tools and inclusion and exclusion criteria among the local fall management protocols. The original and modified versions of the heuristic tools performed poorly to moderately, with areas under the receiver operating characteristic curve of 0.54~0.74 and 0.59~0.80, respectively. Preventive intervention practices varied significantly among the sites, with risk-targeted and tailored interventions delivered to only 1.15%~49.5% of at-risk patients. Fall events were not recorded in self-reporting systems and nursing notes for 29.5%~90.6% and 4.4%~17.1% of patients, respectively.

Conclusion

Challenges in fall prevention included weaknesses in the design and implementation of local fall protocols and low-quality incident self-reporting systems. Systematic and sustainable solutions are needed to help reduce hospital fall rates and injuries.

Background

Limited data exist regarding adverse drug events (ADEs) in the outpatient setting. The objective of this study was to determine the incidence, severity, and preventability of ADEs in the outpatient setting and identify potential prevention strategies.

Methods

We conducted an analysis of ADEs identified in a retrospective electronic health records review of outpatient encounters in 2018 at 13 outpatient sites in Massachusetts that included 13 416 outpatient encounters in 3323 patients. Triggers were identified in the medical record including medications, consultations, laboratory results, and others. If a trigger was detected, a further in-depth review was conducted by nurses and adjudicated by physicians to examine the relevant information in the medical record. Patients were included in the study if they were at least 18 years of age with at least one outpatient encounter with a physician, nurse practitioner or physician’s assistant in that calendar year. Patients were excluded from the study if the outpatient encounter occurred in outpatient surgery, psychiatry, rehabilitation, and paediatrics.

Results

In all, 5% of patients experienced an ADE over the 1-year period. We identified 198 ADEs among 170 patients, who had a mean age of 60. Most patients experienced one ADE (87%), 10% experienced two ADEs and 3% experienced three or more ADEs. The most frequent drug classes resulting in ADEs were cardiovascular (25%), central nervous system (14%), and anti-infective agents (14%). Severity was ranked as significant in 85%, 14% were serious, 1% were life-threatening, and there were no fatal ADEs. Of the ADEs, 22% were classified as preventable and 78% were not preventable. We identified 246 potential prevention strategies, and 23% of ADEs had more than one prevention strategy possibility.

Conclusions

Despite efforts to prioritise patient safety, medication-related harms are still frequent. These results underscore the need for further patient safety improvement in the outpatient setting.

Context

Ambulatory adverse events (AEs) affect up to 25% of the global population and cause over 7 million preventable hospital admissions around the world. Though patients and caregivers are key actors in promoting and monitoring their own ambulatory safety, healthcare teams do not traditionally partner with patients in safety efforts. We sought to identify what patients and caregivers contribute when engaged in ambulatory AE review, focusing on under-resourced care settings.

Methods

We recruited adult patients, caregivers and patient advisors who spoke English, Spanish and/or Cantonese, from primary care clinics affiliated with a public health network in the USA. All had experience taking or managing a high-risk medication (blood thinners, insulin or opioid). We presented two exemplar ambulatory AEs: one involving a warfarin drug-drug interaction, and one involving delayed diagnosis of colon cancer. We conducted semistructured focus groups and interviews to elicit participants’ perceptions of causal factors and potential preventative measures for similar AEs. The study team conducted a mixed inductive-deductive qualitative analysis to derive major themes.

Findings

The sample included 6 English-speaking patients (2 in the focus group, 4 individual interviews), 6 Spanish-speaking patients (individual interviews), 4 Cantonese-speaking patients (2 in the focus group, 2 interviews), and 6 English-speaking patient advisors (focus group). Themes included: (1) Patients and teams have specific safety responsibilities; (2) Proactive communication drives safe ambulatory care; (3) Barriers related to limited resources contribute to ambulatory AEs. Patients and caregivers offered ideas for operational changes that could drive new safety projects.

Conclusions

An ethnically and linguistically diverse group of primary care patients and caregivers defined their agency in ensuring ambulatory safety and offered pragmatic ideas to prevent AEs they did not directly experience. Patients and caregivers in a safety net health system can feasibly participate in AE review to ensure that safety initiatives include their valuable perspectives.

Background

Continuity in the general practitioner (GP)-patient relationship is associated with better healthcare outcomes. However, few studies have examined the impact of permanent discontinuities on all listed patients when a GP retires or relocates.

Aim

To investigate changes in the Norwegian population’s overall healthcare use and mortality after discontinuity due to Regular GPs retiring or relocating.

Methods

Linking national registers, we compared days with healthcare use and mortality for matched individuals affiliated with Regular GPs who retired or relocated versus continued. We included list patients 3 years prior to exposure and followed them up to 5 years after. We assessed changes over time employing a difference-in-differences design with Poisson regression.

Results

From 2011 to 2020, we identified 819 Regular GPs retiring and 228 moving, affiliated with 1 165 295 people. Relative to 3 years before discontinuity, the rate ratio (RR) of daytime GP contacts, increased 3% (95% CI 2 to 4) in year 1 after discontinuity, corresponding to 148 (95% CI 54 to 243) additional contacts per 1000 patients. This increase persisted for 5 years. Out-of-hours GP contacts increased the first year, RR 1.04 (95% CI 0.99 to 1.09), corresponding to 16 (95% CI –5 to 37) contacts per 1000 patients. Planned hospital contacts increased 3% (95% CI 2 to 4) in year 1, persisting into year 5. Acute hospital contacts increased 5% (95% CI 3 to 7), primarily in the first year. These 1-year effects corresponded to 51 (95% CI 18 to 83) planned and 13 (95% CI 7 to 18) acute hospital contacts per 1000 patients. Mortality was unchanged up to 5 years after discontinuity.

Conclusion

Regular GPs retirement and relocation were associated with small to moderate increases in healthcare use among listed patients, while mortality was unaffected.

Background

The Organisation for Economic Co-operation and Development (OECD) Patient-Reported Indicator Surveys (PaRIS) initiative aims to support countries in improving care for people living with chronic conditions by collecting information on how people experience the quality and performance of primary and (generalist) ambulatory care services. This paper presents the development of the conceptual framework that underpins the rationale for and the instrumentation of the PaRIS survey.

Methods

The guidance of an international expert taskforce and the OECD Health Care Quality Indicators framework (2015) provided initial specifications for the framework. Relevant conceptual models and frameworks were then identified from searches in bibliographic databases (Medline, EMBASE and the Health Management Information Consortium). A draft framework was developed through narrative review. The final version was codeveloped following the participation of an international Patient advisory Panel, an international Technical Advisory Community and online international workshops with patient representatives.

Results

85 conceptual models and frameworks were identified through searches. The final framework maps relationships between the following domains (and subdomains): patient-reported outcomes (symptoms, functioning, self-reported health status, health-related quality of life); patient-reported experiences of care (access, comprehensiveness, continuity, coordination, patient safety, person centeredness, self-management support, trust, overall perceived quality of care); health and care capabilities; health behaviours (physical activity, diet, tobacco and alcohol consumption), sociodemographic characteristics and self-reported chronic conditions; delivery system characteristics (clinic, main healthcare professional); health system, policy and context.

Discussion

The PaRIS conceptual framework has been developed through a systematic, accountable and inclusive process. It serves as the basis for the development of the indicators and survey instruments as well as for the generation of specific hypotheses to guide the analysis and interpretation of the findings.