Affect Health Professionals Research Articles

Impact of the armed conflict in Colombia: consequences in the health system, response and challenges

IntroductionIn Colombia, research on health and conflict has focused on mental health, psychosocial care, displacement, morbidity, and mortality. Few scientific studies have assessed health system functioning during armed conflicts. In a new period characterized by the implementation of the peace agreement with the Revolutionary Armed Forces of Colombia (FARC) armed group, understanding the effects of armed conflict on the health system, the functions, and institutions shaped by the conflict is an opportunity to understand the pathways and scope of post-conflict health policy reforms. Therefore, this study was conducted to assess the effects of armed conflict on the health system, response, and mechanisms developed to protect medical missions during armed conflict in Colombia.MethodsThis research was conducted using a qualitative approach with semi-structured interviews and focus group discussions. The qualitative guide collected information in four sections: (1) conflict and health system, effects and barriers in health service provision, (2) actions and coordination to cope with those barriers, (3) health policies and armed conflict, and (4) post-accord and current situation. Twenty-two people participated in the interviews, including eight policymakers at the national level and seven at the local level, including two NGOs and five members of international organizations. An academic project event in December 2019 and four focus groups were developed (World Cafe technique) to discuss with national and local stakeholders the effects of armed conflict on the health system and an analytical framework to analyze its consequences.ResultsThe conflict affected the health-seeking behavior of the population, limited access to healthcare provision, and affected health professionals, and was associated with inadequate medical supplies in conflict areas. The health system implemented mechanisms to protect the medical mission, regulate healthcare provision in conflict areas, and commit to healthcare provision (mental and physical health services) for the population displaced by conflict.ConclusionThe state’s presence, trust, and legitimacy have significantly reduced in recent years. However, it is crucial to restore them by ensuring that state and health services are physically present in all territories, including remote and rural areas.

Medo de mim: experiências e vivências de residentes em saúde na pandemia de Covid-19

The Covid-19 pandemic has affected health professionals, including residents. This study aims to reflect on the impacts of the pandemic on the mental health of residents in the context of medical and multiprofessional residency and the implications for the training process of these professionals. It is a qualitative research study involving interviews conducted with medical and multiprofessional residents, utilizing thematic content analysis. Health residents were at the forefront of confronting the pandemic and are considered vulnerable professionals due to their exposure to the virus and psychological distress, such as fear of illness. They experienced the effects of social distancing, both as a measure to prevent transmission and due to concerns from family members and cohabitants, resulting in feelings loneliness. The study reveals impacts on mental health, highlighting the importance of planning actions to provide and enhance the training of health residents.

Middle-Range Theory of Occupational Stress in Health Professionals.

Occupational stress affects health professionals; however, no literature was found on the middle-range theory for this outcome in health professionals. Methodological study for the theoretical validation of a nursing diagnosis using the theoretical framework of Walker and Avant and the Betty Neuman systems models. The research was conducted in five stages: comprehension of the system model; selection and review of studies; development of the conceptual-theoretical-empirical structure; elaboration of a diagram and proposition of a nursing diagnosis; and evaluation of the empirical adequacy of the theory and validity of the system model. These steps were conducted using a scoping review and a sample of 138 articles selected in the Scopus, Web of Science, MEDLINE/PubMed, CINAHL, PsycINFO, LILACS, Science Direct, Cochrane Library, and Google Scholar databases. A data extraction instrument was developed, and study variables (attributes, antecedents, and clinical consequences) were analyzed using descriptive statistics (absolute and relative frequencies) and presented in tables. The middle-range theory comprised 16 concepts, 20 propositions, and one diagram. A total of 15 related factors, 29 defining characteristics, six at-risk populations, and one associated condition were indicated to propose the nursing diagnosis for occupational stress. The middle-range theory supported elaborating elements to propose a nursing diagnosis for occupational stress.

The Prevalence of the Burnout Syndrome and Factors Associated in the Students of Dentistry in Integral Clinic: A Cross-Sectional Study.

Burnout syndrome (BS) is composed of three interrelated dimensions (emotional exhaustion, depersonalization, and personal fulfillment), and it has been documented that it affects health professionals from an early age. Determine the prevalence of BS and associated factors in the integral clinic of the Dentistry Pilot School. Material and Methods. Two instruments were applied: (1) Maslach Burnout Inventory, which measures the degree of professional burnout through 22 items that describe the professional's attitudes and feelings toward work, as well as symptoms associated with this phenomenon; (2) the second questionnaire determines the possible symptoms of BS and consists of 14 questions that describe tiredness, sleep problems, digestive problems, respiratory problems and headaches, temporomandibular joint (TMJ), neck pain, back pain, and upper and lower extremity pain. The instruments were answered anonymously by a total of 300 students who participated in the study. The emotional exhaustion of the participants was 48.3% at a higher level, the depersonalization was 46.7% at a higher level, and the low perception of personal fulfillment was 73%. In addition, it was shown that BS is significantly related to marital status (p < 0.001∗), with single people reporting being more exhausted, with the 6-month level (p = 0.011) and with the following symptoms: non-neck pain, head, TMJ, back, waist, upper and lower body pain. It was found that the BS had a prevalence of high levels of exhaustion and depersonalization correlated with the marital status and level of preparation (academic degree) of the person, finding a prevalence of symptoms such as pain in the neck, head, TMJ, and back.

Positive Implications of Experiencing Grief for Health Professionals in Iran: A Qualitative Study

Background: As an unavoidable experience in oncology departments, grief following a patient’s death, coupled with work difficulties, can affect health professionals’ individual and work performance. Objectives: The present research was conducted to explain the positive consequences following the experience of grief for oncology nurses. Methods: In 2021, the present qualitative study utilized content analysis and interviewed 20 nurses working in the oncology wards of hospitals affiliated with universities of medical sciences in Iran. Purposive sampling was performed, and data were collected through unstructured interviews until reaching data saturation. The data collected were analyzed in MAXQDA10 based on conventional content analysis. Results: The main concepts were categorized into three themes and seven subthemes. The themes included “promoting and practicing religious beliefs,” “feeling rewarded after experiencing grief,” and “promoting ethical virtues.” Conclusions: According to the present findings, the nurses identified having profound religious and spiritual beliefs, promoting ethical virtues, and using positive experiences associated with grief over patient deaths as the positive implications of experiencing grief. These results can be employed to design interventions for preventing burnout in nurses and assisting them in providing high-quality care. Strengthening the positive implications of experiencing grief is one way to prevent the negative effects of grief on health professionals. Recommendations include implementing educational programs to improve these outcomes.

Provision of aid (POA) at the intensive care unit setting. How does it affect health professionals?

Provision of aid (POA) at the intensive care unit setting. How does it affect health professionals?

Sleep disturbances in nurse managers during the early and late stages of the COVID-19 pandemic.

Working conditions during the COVID-19 pandemic have affected health professionals' quality of sleep. To date, most of the studies that assess the impact of the COVID-19 pandemic on sleep have been carried out with front-line health personnel, and almost none of them have been carried out with managers. To evaluate the quality of sleep and the level of stress in nurse managers during the early and late stages of the COVID-19 pandemic. Cross-sectional studies were carried out at two time points: after the lockdown period (July 2020) and a year and a half after the start of the pandemic (October 2021). A total of 102 nurse managers of a tertiary hospital were invited to participate. The Perceived Stress Scale (PSS-14) and Pittsburgh Sleep Quality Index (PSQI) were administered to assess stress levels and sleep quality. The response rate was 85.2% in 2020 and 81.3% in 2021. Nursing managers showed alterations in sleep quality throughout the pandemic: 70.1% after confinement and 61.4% at the beginning of the second wave. In addition to stress, the fear of contagion by COVID-19 influenced sleep problems. More than a year after the start of the pandemic, the professionals' fear of contagion decreased. Perceived stress also decreased, but sleep disturbances remained. High stress and poor sleep quality among nurse managers require special attention, and specific interventions need to be implemented. Hospitals should develop programs that help nurse managers develop skills to mitigate stress levels and thus improve sleep quality and professional quality of life.

Subacute thyroiditis associated with COVID-19 affecting health professionals, a case series in high-risk population

Background: Healthcare professionals are more vulnerable to infectious infections, especially ones that are easily transferred, such as COVID-19. Subacute thyroiditis is a self-limiting thyroid gland infection caused by a virus. SARS-CoV-2 infection increases the prevalence of subacute thyroiditis. Objective: This case series addresses the emergence of subacute thyroiditis cases linked to SARS-CoV-2 infection, which is more common in healthcare personnel. Methods: This study analyzed nine COVID-19 cases with neck pain symptoms. The clinical presentation, thyroid markers, ultrasound features of the thyroid gland, and its management were described in this study. Result: There were nine cases included, and seven out of nine were experienced by healthcare professional workers. All of them were patients in the Clinic of Endocrinology Metabolism and Diabetes - Thyroid Center, Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia, from January to June 2021. Most of them presented with mild to moderate neck pain. All patients had clinical improvement within two weeks to two months after receiving treatments. Conclusion: Subacute thyroiditis is a painful thyroid gland disease characterized by acute inflammation of the thyroid gland, which can arise during or after a viral infection such as COVID-19. This case series emphasizes the importance of physicians awareness that subacute thyroiditis could be one of many clinical spectra of SARS-CoV-2 infection that should not be missed.

Sağlık Çalışanları Penceresinden Pandemi Süreci

Amaç: Araştırmada sağlık çalışanlarının pandemi sürecini ve bu süreçte sağlık çalışanı olmayı nasıl algıladıklarının metafor analizi yöntemi ile belirlenmesi amaçlandı.&#x0D; Gereç ve Yöntemler: Fenomonolojik desenin kullanıldığı nitel tipteki araştırma, Nisan- Mayıs 2021 tarihleri arasında bir araştırma hastanesinde çalışan 264 sağlık çalışanı ile yapıldı. Veriler çevrim içi anket tekniği ile Google formlar aracılığıyla toplandı. Nitel verilerin değerlendirilmesinde içerik analizi ve betimsel analiz tekniği kullanıldı.&#x0D; Bulgular: Sağlık çalışanlarının pandemiye yönelik 219 metafor oluşturduğu ve bunlardan 104 metaforun frekanslarının n=1 olduğu belirlendi. Pandemiye yönelik olarak deprem, savaş, karanlık, ateş ve fırtına metaforlarının ilk beş sırada yer aldığı belirlendi. Pandemide sağlık çalışanı olmaya ilişkin oluşturulan 99 metafordan 70 tanesinin frekansının n=1 olduğu belirlendi. Pandemide sağlık çalışanı olmaya yönelik asker, köle, melek, yıldız ve aydınlık/güneş/ışık metaforlarının ilk beş sırada yer aldığı belirlendi. Oluşturulan metaforlar değerlendirildiğinde, pandemiyi algılamaya yönelik altı ve pandemide sağlık çalışanı olmanın algılanmasına yönelik beş kategori belirlendi. Oluşturulan metaforların sayısına bakıldığında sağlık çalışanlarının pandemi sürecini çok farklı olarak algıladıkları söylenebilir.&#x0D; Sonuç: Araştırma bulgularına göre; pandemi sürecinin sağlık çalışanlarını fiziksel, ruhsal, sosyal açılardan çok boyutlu olarak etkilediği ve bu sürecin genel anlamda olumsuz algılandığı söylenebilir. Sağlık çalışanlarının pandemi sürecine ve bu süreçte mesleklerine ilişkin algıları göz önünde bulundurularak sağlık çalışanlarına yönelik psikososyal müdahale programlarının planlanıp uygulanmasının önemli olacağı düşünülmektedir.

The psychological impact of the covid-19 on Tunisian healthcare workers tested positive

IntroductionThe covid19 pandemic has led to a major health crisis and the healthcare workers, who are the first to respond, are generally the ones who pay the highest price. Their safety, both physical and psychological, should be a priority in the management of this pandemic.ObjectivesWe aim to assess anxiety and depression in caregivers with covid19 and to identify the many factors that may be responsible for this psychological distress.MethodsA cross-sectional survey was conducted among healthcare workers at the different health structures located in Kairouan-Tunisia from October to December 2020 within the framework of a crisis unit set up by the Ministry of Health. Through phone interviews, demographic and clinical data were collected at first, then psychological impact was evaluated using hospital anxiety and depression scale (HAD).Results68 healthcare workers (47 females) with covid-19 were included in this study with an average age of 44.12 years: 38 nurses, 21 hospital employees and 9 doctors working at the Ibn Jazzar hospital (47%), the Aghlabite hospital (20%) and the dispensaries of Kairouan (33%). Among them, 8 had a depression score &gt;10 and 20 had an anxiety score &gt;10. Moreover, 90% feared contaminating their loved ones and 43% reported sleep disturbance and irritability during the containment period. The most important causes reported were the non-availability of means of protection (41,2%) and the increase in workload (64,7%).ConclusionsThe prevention of the negative psychological impact of COVID-19 on the affected health professionals is essential to preserve their well-being and to ensure the continuity of care.DisclosureNo significant relationships.

Validation of the German Version of the Moral Injury Symptom and Support Scale for Health Professionals (G-MISS-HP) and Its Correlation to the Second Victim Phenomenon

Introduction: Comparable to second victim phenomenon (SVP), moral injury (MI) affects health professionals (HP) working in stressful environments. Information on how MI and SVP intercorrelate and their part in a psychological trauma complex is limited. We tested and validated a German version of the Moral Injury Symptom and Support Scale for Health Professionals (G-MISS-HP) instrument, screening for MI and correlated it with the recently developed German version of the Second Victim Experience and Support Tool (G-SVESTR) instrument, testing for SVP. Methods: After translating Moral Injury Symptom and Support Scale for Health Professionals (MISS-HP), we conducted a cross-sectional online survey providing G-MISS-HP and G-SVEST-R to HP. Statistics included Pearson’s interitem correlation, reliability analysis, principal axis factoring and principal components analysis with Promax rotation, confirmatory factor and ROC analyses. Results: A total of 244 persons responded, of whom 156 completed the survey (33% nurses, 16% physicians, 9% geriatric nurses, 7.1% speech and language therapists). Interitem and corrected item-scale correlations did not measure for one item sufficiently. It was, therefore, excluded from further analyses. The nine-item score revealed good reliability (Guttman’s lambda 2 = 0.80; Cronbach’s alpha = 0.79). Factor validity was demonstrated, indicating that a three-factor model from the original study might better represent the data compared with our two-factor model. Positive correlations between G-MISS-HP and G-SVESTR subscales demonstrated convergent validity. ROC revealed sensitivity of 89% and specificity of 63% for G-MISS-HP using a nine-item scale with cutoff value of 28.5 points. Positive and negative predictive values were 62% and 69%, respectively. Subgroup analyses did not reveal any differences. Conclusion: G-MISS-HP with nine items is a valid and reliable testing instrument for moral injury. However, strong intercorrelations of MI and SVP indicate the need for further research on the distinction of these phenomena.

Impact of the COVID 19 Pandemic on Health Care Workers in Latin America and the Caribbean

Objective: The objective of this research was to analyze official data on the impact of the COVID-19 pandemic on Latin American and Caribbean health care workers.&#x0D; Materials and Methods: The methodology used was documentary, exploratory and descriptive research. The data were collected from official reports of international organizations such as the World Health Organization, the International Labor Organization and figures provided by the different official spokespersons of the Latin American countries studied, for the period March 2020 - August 2021.&#x0D; Results: The results showed that the top three countries with the highest number of infected and confirmed healthcare workers were Brazil with a total of 503,238 cases, Mexico with 244,711 cases and Argentina with 96,626 cases. The top three countries with the highest number of deaths of health personnel from this cause are Mexico with 4,084 cases, Peru with 1,399 cases and Brazil with 703 cases. Similarly, the countries with the highest fatality rates are Venezuela with 4.6%, Peru with 1.9% and Mexico with 1.7%.&#x0D; Conclusion: It can be concluded that this pandemic has directly affected health professionals in Latin America and the Caribbean, representing one of the greatest challenges ever faced by these professionals in the performance of their duties.

Prevalence of adverse events and their manifestations in health professionals as second victims

ResumenIntroducción. Los eventos adversos pueden causar daño al paciente y también afectar a los profesionales de la salud, lo que los convierte en segundas víctimas. Las intervenciones se han enfocado principalmente en los pacientes, pero poca atención se ha prestado a los profesionales de la salud, probablemente por falta de herramientas.Objetivo. Estimar la prevalencia de eventos adversos y describir sus manifestaciones en el personal asistencial, con el fin de evidenciar el fenómeno de las segundas víctimas en un hospital de alta complejidad.Materiales y métodos. Se hizo un estudio transversal analítico mediante una encuesta a 419 profesionales asistenciales de las áreas de hospitalización, urgencias y cirugía en un hospital de alta complejidad de Medellín en el 2019. Se estimó la frecuencia de eventos adversos, y se determinó su asociación con algunas variables laborales y demográficas. Resultados. El 93,1 % de los entrevistados conocía de casos de incidentes y el 79 %, de eventos adversos graves. El 44,4 % se había visto involucrado en un evento adverso, y el 99 % de estos expresaba sentirse como segunda víctima por experimentar dificultad para concentrarse, sentimientos de culpa, cansancio, ansiedad y dudas sobre sus decisiones. El 95 % quería recibir capacitación para afrontar las consecuencias de los eventos adversos y saber cómo informar al paciente.Conclusiones. Con frecuencia los profesionales de la salud se exponen a eventos adversos que pueden causarles emociones negativas como culpa, cansancio, ansiedad e inseguridad. La mayoría de los profesionales que participan en un evento adverso manifiestan sentimientos como segunda víctima. El informar al paciente sobre un evento adverso requiere preparación y la mayoría de los profesionales entrevistados pidió capacitación en el tema.

A Pilot Observational Exploratory Study of Well-Being in Hospice Interdisciplinary Team Members.

Well-being and turnover intent represent key aspects to the promotion of a healthy workforce. Alarming levels of burnout and low levels of well-being have been documented in health professionals across care settings. Not only do high levels of burnout, low well-being and high turnover affect health professionals, but they are associated with poor patient care. However, limited research has investigated this topic specifically in hospice interdisciplinary team (IDT) members, nurses, chaplains, social workers. Thus, the purpose of this study was to explore hospice IDT members' well-being, and turnover intent. This observational, pilot study used quantitative surveys to examine the well-being, and turnover intention at baseline and at 3 months. Twenty-five hospice IDT members at one site participated. Paired t-tests and percent change demonstrated significant decreases in compassion satisfaction (44.5 vs. 42.1, p = 0.04) and secondary traumatic stress score (18.5 vs. 13.3, p = 0.0001) and a significant increase in burnout score (17.6 vs. 20.5, p = 0.03) from baseline to follow up. Employee turnover slightly decreased from baseline to follow-up. In this pilot study, hospice IDT members had low levels of well-being at baseline that worsened over 3-months indicating a higher potential risk for burnout. Moreover, given the COVID-19 pandemic, this may be an ominous sign of what lies ahead for hospice providers regarding turnover, leading to significant long-term staffing problems in the field. If these results hold true in a larger sample, it could necessitate developing and testing further strategies to ensure a healthy and stable workforce.

Impact of COVID-19 of oncology pharmacy services: Results of 8-months survey

Abstract Introduction: The SARS-CoV-2 pandemic stroke at the beginning of 2020, challenging the health systems worldwide. As hospitals became overwhelmed by the number of cases, and community pharmacies became one of the few non-stop operating services, and the work rhythm and workload of pharmacists changed importantly. Methods: To investigate which and how the changes occurred, especially among oncology pharmacists, the ESOP together with the EAHP developed a survey, translated to 9 languages, and distributed online. The questions were changed over the duration of the survey (August 2020 to March 2021), adapting to the global situation. The answers were analyzed with basic descriptive statistics. Results: Over 1000 health professionals, predominantly pharmacists (over 85%), from 64 countries participated in the monthly survey, providing information relevant to both the hospital and the community pharmacy. More than 50% of hospital pharmacists reported shortage of chemotherapeutics, while the availability of COVID-19 related medications had more fluctuations in the hospital pharmacy. Contrastingly, over 80% of community pharmacists reported medications shortages in April 2020. The survey showed the negative impact of the pandemic on chemotherapeutic preparations, with decreased productions during the first and second waves (February-May 2020, and November 2020 to January 2021). The survey also helped visualize the stress levels and workloads of pharmacists. More than 70% of participants reported in August 2020 to have needed to procure themselves with Personal Protective Equipment. Working hours increased for 43% of the respondents, and more than 60% reported to have felt emotionally stressed. Conclusions: Thus, the presented results give a broad, yet detailed overview of how the pandemic has affected health professionals both in the hospital and the community, how professionals and governments have reacted to the situation, and how the care of oncology patience and the practice of oncology pharmacy has changed and reacted during the first year of the SARS-CoV-2 pandemic.

Technostress and Digital Competence Among Health Professionals in Swiss Psychiatric Hospitals: Cross-sectional Study.

BackgroundPsychiatric hospitals are becoming increasingly digitized because of the disruptive rise in technical possibilities. This digitization leads to new tasks and demands for health professionals, which can have an impact on technostress. It is unclear whether digital competence reduces technostress and how technostress affects health professionals’ mental and physical health.ObjectiveThis study aims to assess the association between digital competence and technostress, considering individual characteristics and the association between technostress and long-term consequences for health professionals.MethodsCross-sectional data from 3 Swiss psychiatric hospitals were analyzed using multiple linear regression. The dependent variables for the models were digital competence, technostress, and long-term consequences (intention to leave the organization or the profession, burnout symptoms, job satisfaction, general health status, quality of sleep, headaches, and work ability). One model was calculated for each long-term consequence. The mean scores for technostress and digital competence could range between 0 (fully disagree) and 4 (fully agree), where a high value for technostress indicated high technostress and a high value for digital competence indicated high digital competence.ResultsThe sample comprised 493 health professionals in psychiatric hospitals. They rated their technostress as moderate (mean 1.30, SD 0.55) and their digital competence as high (mean 2.89, SD 0.73). Digital competence was found to be significantly associated with technostress (β=−.20; P<.001). Among the individual characteristics, age (β=.004; P=.03) and profession were significantly associated with both digital competence and technostress. Technostress is a relevant predictor of burnout symptoms (β=10.32; P<.001), job satisfaction (β=−6.08; P<.001), intention to leave the profession (β=4.53; P=.002), organization (β=7.68; P<.001), general health status (β=−4.47; P<.001), quality of sleep (β=−5.87; P<.001), headaches (β=6.58; P<.001), and work ability (β=−1.40; P<.001).ConclusionsPhysicians and nurses who have more interaction with digital technologies rate their technostress higher and their digital competence lower than those in other professions. Health professionals with low interaction with digital technologies appear to overestimate their digital competence. With increasing digitization in psychiatric hospitals, an increase in the relevance of this topic is expected. Educational organizations and psychiatric hospitals should proactively promote the digital competence of health professionals to manage expected disruptive changes.

Effects of the Simulation Based Training Program on Attitudes of Nurses Towards Older Adults: A Quasi-Experimental Design Study

Purpose: Innovative activities such as the simulation-based training program can affect nurses’ attitudes toward older adults. This study was aimed to determine the effects of the simulation-based training programs on nurses’ attitudes towards older adults in institutional care settings.&#x0D; Methods: A quasi-experimental pretest–posttest design was used. A total of 92 nurses participated in simulation-based training program that comprised presentation about care for older adults, and scenario with aged simulation suit. Data were collected using a Participant Information Form and Kogan’s Attitudes Toward Old People Scale. The value, mean, percentage frequency distribution, and paired sample t-test were used. &#x0D; Results: After the simulation-based training programs were completed, the mean total score (p=0.001) and positive attitudes of score of the nurses was changed statistically significantly (p=0.001). There was no statistically significant change negative attitudes (p=0.274). &#x0D; Conclusions: The simulation-based training program is effective in developing more positive and less negative attitude toward the older adults by nurses in institutional care settings. The aging-simulation experience affected health professionals’ feelings and knowledge. To provide better care for the older adults, it is important that nurses adopt a positive attitude toward the older adults.

Med Check: Updates to Clozapine REMS, Weekly Treatment for OUD, and More

Back to table of contents Previous article Next article Med CheckFull AccessMed Check: Updates to Clozapine REMS, Weekly Treatment for OUD, and MoreTerri D’ArrigoTerri D’ArrigoSearch for more papers by this authorPublished Online:2 Sep 2021https://doi.org/10.1176/appi.pn.2021.9.1FDA Updates Clozapine REMSIn July the Food and Drug Administration (FDA) approved modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS). Several of these changes affect health professionals who prescribe clozapine.Beginning on November 15, the Clozapine REMS requires a New Patient Status Form to document monitoring for all outpatients. This form must be submitted monthly.All health professionals who prescribe clozapine must be recertified by November 15 to continue prescribing the medication and they must re-enroll their patients who will continue taking the medication. Patients who are not re-enrolled by November 15 will no longer be able to receive clozapine.Information on recertifying and re-enrolling in the Clozapine REMS is posted hereWeekly OUD Treatment Gets Fast Track DesignationLyndra Therapeutics’ investigational weekly treatment for opioid use disorder (OUD), LYN-014, has received a fast track designation from the FDA, the company announced in July. LYN-014 is an oral, ultra-long-acting, extended-release levomethadone capsule. The FDA fast track is a process designed to facilitate the development of drugs that treat serious conditions and fill an unmet medical need and expedite their review.Levomethadone, is an enantiomer of racemic methadone (its molecules are a mirror image of those in racemic methadone). Levomethadone is not approved for use in the United States, although it has been approved for use in Europe since the 1960s for pain management and medication treatment for OUD.In April the FDA granted LYN-014 Investigational New Drug status, which enabled Lyndra to initiate a phase 1 clinical trial in patients whose OUD is currently controlled on daily oral immediate-release methadone.FDA Grants Breakthrough Therapy Designation to Investigational Narcolepsy TreatmentIn July Takeda Pharmaceutical Co. Ltd. announced that the FDA granted Breakthrough Therapy designation to TAK-994, the company’s investigational oral orexin agonist for the treatment of excessive daytime sleepiness in patients with narcolepsy type 1. The FDA’s Breakthrough Therapy designation expedites the development and review of drugs for serious conditions. The criteria for Breakthrough Therapy designation require preliminary clinical evidence that indicate that the drug may demonstrate substantial improvement over available therapy on at least one clinically significant endpoint.According to a statement by Takeda, the FDA’s decision to grant the Breakthrough Therapy designation was based in part on early phase and preliminary clinical data suggesting that the drug demonstrates substantially improved objective and subjective measurements of daytime wakefulness in patients with narcolepsy type 1.FDA to Review Diazepam Buccal FilmThe FDA will review Libervant (diazepam) buccal film for the treatment of acute uncontrolled seizures in patients with refractory epilepsy on stable regimens of antiepileptic drugs, Aquestive Therapeutics announced in July.A phase 1/2 open-label trial of 31 patients with seizure disorders who took antiepileptic drugs found that treatment with Libervant resulted in similar systemic exposures to Diastat diazepam rectal gel, the standard treatment.Aquestive originally submitted a New Drug Application (NDA) for Libervant in February 2020, but in September 2020 the FDA issued a Complete Response Letter stating that the study showed a lower drug exposure level than desired in certain weight groups. The letter also noted a number of protocol deviates in blood draws in one of the studies that was included in the NDA. In response, the company provided additional analysis as part of the NDA submission now under FDA review.Kloxxado Now Available to Treat Opioid OverdoseHikma Pharmaceuticals PLC’s nasal spray Kloxxado (naloxone hydrocloride) for the emergency treatment of opioid overdose is now available, the company announced in August. Kloxxado, which was approved by the FDA in April, delivers 8 mg of naloxone directly into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.The FDA approved Kloxxado based on previous findings about the safety and effectiveness of Narcan injection (naloxone hydrochloride) for treating opioid overdose. Hikma Pharmaceuticals also submitted its own safety and effectiveness data. ■ ISSUES NewArchived

Examining the Effectiveness of Strategies Developed to Create an Error Reporting Culture.

This study was conducted to develop strategies for creating an error reporting culture and to assess their effectiveness. This study was planned to explore how to improve patient safety. The study used a quasi-experimental 1-group pre-post design. It examined the culture of reporting through an analysis of employees' attitudes toward medical errors, along with rates of medical error reporting. Four different forms were used as data collection tools. The multiple strategies used in this study constituted the research interventions. These strategies were as follows: "Education on Medical Errors and Medical Error Reporting," "Posting Banners and Posters about the Subject," "Using Social Networks and Creating a Facebook Page Titled 'Leaders of Patient Safety'," "Revising the Institution's Incident/Error Reporting System," and "Patient Safety Symposium." Data were evaluated using descriptive statistics and paired sample t test. It was determined that medical error reporting rates increased in the first 6 months after the initiative, and this increase continued in the second 6 months. Medical error reports in the institution where this study was conducted increased by 10 times at the end of the first year. Multiple strategies applied for creating an error reporting culture and assessing their effectiveness positively affected health professionals' medical error attitudes and increased error reporting rates.

Job Demands, Resources and Strains of Outpatient Caregivers during the COVID-19 Pandemic in Germany: A Qualitative Study.

The COVID-19 pandemic has affected health professionals in a special way, as they are responsible for the care of vulnerable groups. Little is known about how outpatient caregivers perceive their working conditions during the pandemic in Germany and about the difficulties they face. The aims of this study were (1) to examine specific job demands of outpatient caregivers in regard to the COVID-19 pandemic, (2) to illuminate their job resources they can rely on and (3) to identify potential strain reactions they experience. Fifteen semi-structured telephone interviews were conducted with outpatient caregivers working in Northern Germany in the period May–June 2020. Interviews were analyzed by using qualitative content analysis. Outpatient caregivers experienced daily mask obligation, lack of personal protection equipment (PPE) and stricter hygiene regulations as demanding during the pandemic. They also described a higher workload and emotional demands such as fear of infection or infecting others. They perceived team spirit and communication as important work-related resources. Depressive symptoms and feelings of stress were described as strain reactions. Outpatient care services need to be better prepared for sudden pandemic situations and provide their employees with sufficient PPE and education to reduce pandemic-related job demands leading to negative strain reactions.