Patient Safety Data Reveal No Improvement in the Rate of Adverse Events

AbstractThere has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of ‘how successful has it been so far’?

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Population-scale patient safety data reveal inequalities in adverse events before and during COVID-19 pandemic

10.1101/2021.01.17.21249988 ◽

2021 ◽

Author(s):

Xiang Zhang ◽

Marissa Sumathipala ◽

Marinka Zitnik

Keyword(s):

Public Health ◽

Patient Safety ◽

Adverse Events ◽

Drug Safety ◽

Gender Gap ◽

Safety Data ◽

Medication Use ◽

Incidence Rates ◽

Drug Interference ◽

Demographic Groups

Adverse patient safety events were associated with 110 thousand deaths in the U.S. alone in 2019. The COVID-19 pandemic has further challenged the ability of healthcare systems to ensure medication safety, and its effects on patient safety remain unknown. Here, we investigate negative outcomes associated with medication use before and during the pandemic. Using a dataset of 10,443,476 reports involving 3,624 drugs and 19,193 adverse events, we develop an algorithmic approach to analyze the pandemic's impact on incidence of drug safety events by evaluating disproportional reporting relative to the pre-pandemic time, quantifying unexpected trends in clinical outcomes, and adjusting for drug interference. Among 64 adverse events identified by our analyses, we find 54 have increased incidence rates during the pandemic, even though reporting of adverse events has decreased by 4.4% overall. We find clinically relevant differences in drug safety outcomes between demographic groups. Comparing to male patients, women report 47.0% more distinct adverse events whose occurrence significantly increased during the pandemic relative to pre-pandemic levels. Out of 53 adverse events with the pre-pandemic gender gap, 33 have increased gap during the pandemic more than would have been expected had the pandemic not occurred. While musculoskeletal and metabolic side effects are disproportionately enriched in women during the pandemic, immune-related adverse events are enriched only in men. We also find the number of adverse events with a higher reporting ratio during the pandemic in adults is higher (16.8%) than in older patients (adjusted for population size). Our findings have implications for safe medication use and public health policy and highlight the role of variation in adverse events for improving patient safety during a public health emergency.

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Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052546 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2546

Author(s):

Noriko Morioka ◽

Masayo Kashiwagi

Keyword(s):

Adverse Event ◽

Patient Safety ◽

Adverse Events ◽

Home Care ◽

Process Of Care ◽

Related Factors ◽

Cross Sectional ◽

Home Care Nursing ◽

Number Of Patients ◽

Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

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Exploring patient safety outcomes for people with learning disabilities in acute hospital settings: a scoping review

BMJ Open ◽

10.1136/bmjopen-2020-047102 ◽

2021 ◽

Vol 11 (5) ◽

pp. e047102

Author(s):

Gemma Louch ◽

Abigail Albutt ◽

Joanna Harlow-Trigg ◽

Sally Moore ◽

Kate Smyth ◽

...

Keyword(s):

Learning Disabilities ◽

Patient Safety ◽

Adverse Events ◽

Grey Literature ◽

Good Practice ◽

Hospital Setting ◽

Eligibility Criteria ◽

Infant Outcomes ◽

Safety Outcomes

ObjectivesTo produce a narrative synthesis of published academic and grey literature focusing on patient safety outcomes for people with learning disabilities in an acute hospital setting.DesignScoping review with narrative synthesis.MethodsThe review followed the six stages of the Arksey and O’Malley framework. We searched four research databases from January 2000 to March 2021, in addition to handsearching and backwards searching using terms relating to our eligibility criteria—patient safety and adverse events, learning disability and hospital setting. Following stakeholder input, we searched grey literature databases and specific websites of known organisations until March 2020. Potentially relevant articles and grey literature materials were screened against the eligibility criteria. Findings were extracted and collated in data charting forms.Results45 academic articles and 33 grey literature materials were included, and we organised the findings around six concepts: (1) adverse events, patient safety and quality of care; (2) maternal and infant outcomes; (3) postoperative outcomes; (4) role of family and carers; (5) understanding needs in hospital and (6) supporting initiatives, recommendations and good practice examples. The findings suggest inequalities and inequities for a range of specific patient safety outcomes including adverse events, quality of care, maternal and infant outcomes and postoperative outcomes, in addition to potential protective factors, such as the roles of family and carers and the extent to which health professionals are able to understand the needs of people with learning disabilities.ConclusionPeople with learning disabilities appear to experience poorer patient safety outcomes in hospital. The involvement of family and carers, and understanding and effectively meeting the needs of people with learning disabilities may play a protective role. Promising interventions and examples of good practice exist, however many of these have not been implemented consistently and warrant further robust evaluation.

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Longitudinal analysis of safety and medication adherence of patients in the Fingolimod patient support program: a real-world observational study

Scientific Reports ◽

10.1038/s41598-021-83220-1 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Aline Bourdin ◽

Marie Paule Schneider ◽

Isabella Locatelli ◽

Myriam Schluep ◽

Olivier Bugnon ◽

...

Keyword(s):

Patient Safety ◽

Medication Adherence ◽

Real World ◽

Safety Data ◽

Support Program ◽

Patient Support ◽

Patient Support Program ◽

Dose Monitoring ◽

Real World Evidence ◽

Patient Reported

AbstractThe Fingolimod Patient Support Program (F-PSP) is an interprofessional specialty pharmacy service designed to ensure responsible use of fingolimod by promoting patient safety and medication adherence. This study aims to evaluate the safety and medication adherence of patients who joined the F-PSP between 2013 and 2016. Sociodemographic and medical characteristics, patient safety data (patient-reported symptoms, discontinuations due to adverse events (AEs), repeated first-dose monitoring), and medication adherence (implementation, persistence, reasons for discontinuation, influence of covariates, barriers and facilitators) were described. Sixty-seven patients joined the F-PSP. Patients reported a high frequency of symptoms. Due to AEs, 7 patients discontinued fingolimod, 3 took therapeutic breaks, and 1 reduced the regimen temporarily. Three patients repeated the first-dose monitoring. Patients had a high medication adherence over the 18-month analysis period: implementation decreased from 98.8 to 93.7%, and fingolimod persistence was 83.2% at 18 months. The patients’ level of education, professional situation, and living with child(ren) influenced implementation. Patients reported more facilitators of medication adherence than barriers. The F-PSP seems valuable for supporting individual patients (ensuring responsible use of fingolimod and inviting patients for shared-decision making) and public health (indirectly gathering real-world evidence).

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1288. Phase 1 First-in-Human Single- and Multiple-Ascending Dose Trial Demonstrates Pharmacokinetics (PK) and Tolerability of SPR720, an Oral DNA GyrB Inhibitor for Mycobacterial Infections

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1471 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S659-S659

Author(s):

Angela Talley ◽

Archie Thurston ◽

Grayson Moore ◽

Myriah M Satterfield ◽

Erika L Manyak ◽

...

Keyword(s):

Adverse Events ◽

Healthy Volunteers ◽

Controlled Trial ◽

Phase 1 ◽

Safety Data ◽

Elderly Subjects ◽

Independent Contractor ◽

Serious Adverse Events ◽

Healthy Elderly ◽

Dose Proportional

Abstract Background SPR720 (phosphate pro-drug of SPR719) is a novel aminobenzimidazole bacterial DNA gyrase (GyrB) inhibitor in development for non-tuberculous mycobacterial lung disease (NTM-LD) and pulmonary tuberculosis. SPR719 has broad-spectrum activity versus clinically relevant mycobacteria in vitro and in murine and hollow fiber (HF) infection models. In this first-in-human single ascending dose (SAD) /multiple ascending dose (MAD) study, the safety, tolerability and pharmacokinetics (PK) of SPR720/SPR719 were evaluated in healthy volunteers. Methods This was a Phase 1 randomized, double-blind, placebo-controlled trial with 7 SAD cohorts (including a food effect cohort) and 5 MAD cohorts. Healthy volunteers (n=8/cohort, 3:1 randomization) received SPR720 or placebo in single oral doses of ranging from 100 mg to 2000 mg or repeat total daily doses ranging from 500 mg to 1500 mg for 7 or 14 days. Safety monitoring and PK sampling occurred throughout the trial. Plasma and urine concentrations of SPR720/SPR719 were measured by validated LC-MS/MS methods. PK parameters were calculated using non-compartmental analysis. Results A total of 96 subjects (including 8 healthy elderly subjects, age ≥ 65 years) were randomized and received study drug. SPR720 was well-tolerated at daily doses up to 1000 mg for up to 14 days. Across SAD/MAD cohorts, the most common adverse events were gastrointestinal (nausea, vomiting and diarrhea) and headache, all of mild or moderate severity and dose dependent. No serious adverse events were reported. Across SAD cohorts, a dose proportional and greater-than-dose proportional increase in SPR719 plasma Cmax and AUC0-24, respectively were observed. SPR720 was rapidly absorbed with a mean SPR719 t1/2 of 2.9-4.5 h. Dosing with food decreased SPR719 plasma AUC by ~20%. No clinically meaningful effect of age on plasma AUC was observed. In the MAD cohorts, SPR719 plasma exposure declined approximately 40% between Day 1 and Day 7, suggesting induction of an elimination pathway. However, plasma AUC0-24 was similar at Days 7 and 14. Conclusion Together with HF pharmacodynamic data, human PK and safety data for SPR720 suggest that predicted therapeutic exposures can be attained with a well-tolerated once-daily dose. Further evaluation in a Phase 2 NTM-LD trial is planned. Disclosures Angela Talley, MD, Spero Therapeutics (Employee, Shareholder) Archie Thurston, Jr., PhD, Spero Therapeutics (Consultant) Grayson Moore, BA, RN, Spero Therapeutics, Inc. (Shareholder, Independent Contractor) Vipul Kumar, PhD, Spero Therapeutics (Employee, Shareholder) Suzanne Stokes, PhD, Spero Therapeutics (Employee, Shareholder) Aaron Dane, MSc, Spero theraputics (Consultant) David Melnick, MD, Spero Therapeutics (Employee)Spero Therapeutics (Employee)

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Development of the “Hamburg Best Practice Guidelines for ICV−Enzyme Replacement therapy (ERT) in CLN2 Disease” Based on 6 Years Treatment Experience in 48 Patients

Journal of Child Neurology ◽

10.1177/0883073821989154 ◽

2021 ◽

pp. 088307382198915

Author(s):

Christoph Schwering ◽

Gertrud Kammler ◽

Eva Wibbeler ◽

Martin Christner ◽

Johannes K.-M. Knobloch ◽

...

Keyword(s):

Patient Safety ◽

Adverse Events ◽

Enzyme Replacement Therapy ◽

Replacement Therapy ◽

Practice Guidelines ◽

Best Practice ◽

Vision Loss ◽

Neuronal Ceroid Lipofuscinosis ◽

Enzyme Replacement ◽

Best Practice Guidelines

Intracerebroventricular enzyme replacement therapy (ICV-ERT) for CLN2 disease represents the first approved treatment for neuronal ceroid lipofuscinosis (NCL) diseases. It is the first treatment where a recombinant lysosomal enzyme, cerliponase alfa, is administered into the lateral cerebral ventricles to reach the central nervous system, the organ affected in CLN2 disease. If untreated, CLN2 children show first symptoms such as epilepsy and language developmental delay at 2-4 years followed by rapid loss of motor and language function, vision loss, and early death. Treatment with cerliponase alfa has shown to slow the rapid neurologic decline. However, the mode of administration by 4 hour-long intracerebroventricular infusions every 14 days represents a potentially greater risk of infection compared to intravenous enzyme replacement therapies. The Hamburg NCL Specialty Clinic was the first site worldwide to perform intracerebroventricular enzyme replacement therapy in children with CLN2 disease. In order to ensure maximum patient safety, we analysed data from our center from more than 3000 intracerebroventricular enzyme replacement therapies in 48 patients over 6 years with regard to the occurrence of device-related adverse events and device infections. Since starting intracerebroventricular enzyme replacement therapy, we have also developed and continuously improved the “Hamburg Best Practice Guidelines for ICV–Enzyme Replacement Therapy (ERT) in CLN2 Disease.” Results from this study showed low rates for device-related adverse events and infections with 0.27% and 0.33%, respectively. Therefore, following our internal procedural guidelines has shown to improve standardization and patient safety of intracerebroventricular enzyme replacement therapy for CLN2 disease.

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Global Trigger Tool methodology to detect adverse events: pilot study at Academic Hospital of Udine

European Journal of Public Health ◽

10.1093/eurpub/ckaa166.522 ◽

2020 ◽

Vol 30 (Supplement_5) ◽

Author(s):

E Scarpis ◽

S Degan ◽

D De Corti ◽

F Mellace ◽

R Cocconi ◽

...

Keyword(s):

Patient Safety ◽

Adverse Events ◽

Academic Hospital ◽

Trigger Tool ◽

Hospital Acquired Infections ◽

Frequent Type ◽

Global Trigger Tool ◽

Clinical Records ◽

Hospital Acquired ◽

Over Time

Abstract Introduction Identification and measurement of adverse events (AEs) is crucial for patient safety in order to monitor them over time and to implement quality improvement programs, testing if they are effective. Global Trigger Tool (GTT) has been proposed as a low-cost method, being also the most effective to detect AEs. This study aims to describe the number of triggers, the rate and level of AEs identified by GTT and the most frequent type of AE. Methods The Italian version of the GTT was used. Ten paper-based clinical records (CRs) randomly selected every 2 weeks were reviewed from January to April 2019 by three independent reviewers (two nurses, one doctor) at the Academic Hospital of Udine. The AEs rates calculated are: AEs per 1,000 patient-days, AEs per 100 admissions, percentage of admissions with an AE. AEs were classified by harm levels according to National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). Results CRs reviewed were 80. Mean age of the patients was 69.3±16.4, women were 37.5%. Mean hospitalisation was 16.8±15.3. Nine were the cases of re-hospitalisation within 30 days (11.3%). The total number of trigger was 156. AEs were 31, with at least one AE on 27.5% of admissions, 38.8 AEs per 100 admissions and 23 AEs per 1,000 patient-days. AEs with harm level E, F and H were respectively 5 (16.1%), 24 (77.4%) and 2 (6.5%). The most frequent type of AE were hospital acquired infections with 15 cases (48.4%). Conclusions The most frequent type of AE was the hospital acquired infections. Rates and levels of AEs were higher than other international studies, probably because of the limited number of CRs reviewed. Key messages Global Trigger Tool is an effective method to detect adverse patient safety events in order to monitor them over time. The most frequent type of adverse events was the hospital acquired infections.

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Pharmacy Leadership Amid the Pandemic: Maintaining Patient Safety During Uncertain Times

Hospital Pharmacy ◽

10.1177/00185787211037545 ◽

2021 ◽

pp. 001857872110375

Author(s):

Irene Derrong Lin ◽

John B. Hertig

Keyword(s):

Patient Safety ◽

Safety Data ◽

Clinical Effectiveness ◽

World Health ◽

Leadership Strategies ◽

Pharmaceutical Supply Chain ◽

The World ◽

Health Organization ◽

Pharmacy Leaders ◽

Effective Treatments

The relentless surges of global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections that caused the Covid-19 disease had pressured researchers and regulators to develop effective treatments quickly. While studying these therapies amid the pandemic, threats to patient care were reported, including (1) maintaining adequate safeguards as clinical effectiveness and safety data evolves, (2) risks from online counterfeit medications, and (3) disruption of the global pharmaceutical supply chain. This article discusses these patient safety threats and suggests strategies that promote patient safety, foster medication intelligence, and mitigate drug shortages. As the world continues to develop safe and effective treatments for Covid-19, patient safety is paramount. In response to the World Health Organization (WHO) Global Safety Challenge: Medication Without Harm, leaders must establish effective approaches to improve medication safety during the pandemic. Successfully integrating these leadership strategies with current practices allows pharmacy leaders to implement robust systems to reduce errors, prevent harm, and advocate for patient safety.

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Attitudes and compliance with the WHO surgical safety checklist: a survey among surgeons and operating room staff in 138 hospitals in China

Patient Safety in Surgery ◽

10.1186/s13037-020-00276-0 ◽

2021 ◽

Vol 15 (1) ◽

Author(s):

Jie Tan ◽

James Reeves Mbori Ngwayi ◽

Zhaohan Ding ◽

Yufa Zhou ◽

Ming Li ◽

...

Keyword(s):

Patient Safety ◽

Adverse Events ◽

Operating Room ◽

World Health ◽

Surgical Patient ◽

Local Data ◽

Cross Sectional ◽

Surgical Safety Checklist ◽

Surgical Safety ◽

Operating Room Staff

Abstract Background Ten years after the introduction of the Chinese Ministry of Health (MoH) version of Surgical Safety Checklist (SSC) we wished to assess the ongoing influence of the World Health Organisation (WHO) SSC by observing all three checklist components during elective surgical procedures in China, as well as survey operating room staff and surgeons more widely about the WHO SSC. Methods A questionnaire was designed to gain authentic views on the WHO SSC. We also conducted a prospective cross-sectional study at five level 3 hospitals. Local data collectors were trained to document specific item performance. Adverse events which delayed the operation were recorded as well as the individuals leading or participating in the three SSC components. Results A total of 846 operating room staff and surgeons from 138 hospitals representing every mainland province responded to the survey. There was widespread acceptance of the checklist and its value in improving patient safety. 860 operations were observed for SSC compliance. Overall compliance was 79.8%. Compliance in surgeon-dependent items of the ‘time-out’ component reduced when it was nurse-led (p < 0.0001). WHO SSC interventions which are omitted from the MoH SSC continued to be discussed over half the time. Overall adverse events rate was 2.7%. One site had near 100% compliance in association with a circulating inspection team which had power of sanction. Conclusion The WHO SSC remains a powerful tool for surgical patient safety in China. Cultural changes in nursing assertiveness and surgeon-led teamwork and checklist ownership are the key elements for improving compliance. Standardised audits are required to monitor and ensure checklist compliance.

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