Building A Strong and Inclusive Workforce for Health: In Conversation with North Carolina Commerce Secretary Machelle Baker Sanders and Health Secretary Kody Kinsley.

North Carolina faces a significant health workforce shortage exacerbated by the COVID-19 pandemic. To meet this challenge, the Department of Commerce and the Department of Health and Human Services are prioritizing equity, creativity, and collaboration.

Building a Workforce for Health in North Carolina.

COVID-19 exposed and exacerbated the historical shortages and maldistribution of the health workforce in North Carolina. This edition of the North Carolina Medical Journal highlights the work being done in our state to address these needs, and calls for an intentional and persistent approach to planning for and developing the workforce needed to produce health.

Long-term safety and effectiveness of canakinumab therapy in patients with cryopyrin-associated periodic syndrome: results from the ß-Confident Registry.

OBJECTIVE: To report the long-term safety and effectiveness of canakinumab, a fully human anti-interleukin 1ß monoclonal antibody, in patients with cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS) and neonatal-onset multisystem inflammatory disease (NOMID), in a real-world setting. METHODS: From December 2009 to December 2015, the ß-Confident Registry prospectively enrolled patients with CAPS and non-CAPS conditions who received canakinumab per routine care and were prospectively followed for up to 6 years. The registry protocol did not mandate specific visits or procedures; however, all observed adverse events (AEs) and serious adverse events (SAEs) had to be recorded. Canakinumab effectiveness was evaluated by Physician's Global Assessment (PGA). RESULTS: Of 288 patients enrolled, 3 were excluded due to missing informed consent. Among the remaining 285 patients, 243 (85.3%) were patients with CAPS and 42 (14.7%) had atypical CAPS (6.3%) or other conditions (8.4%). The median age was 26.6 years. Based on PGA, 58 of 123 (47.2%) patients with CAPS had no disease activity at 48 months, and 65 of 123 (52.8%) experienced mild/moderate disease activity at 48 months. Among CAPS phenotypes, AE incidence rates per 100 patient-years were lowest for FCAS (73.1; 95% CI 60.3 to 87.8) compared with those with MWS (105.0; 95% CI 97.2 to 113.2) or NOMID (104.6; 95% CI 86.6 to 125.2). One hundred twenty-eight SAEs were reported in 68 patients with CAPS (incidence rate/100 patient-years, 14.0; 95% CI 11.6 to 16.6). One death (metastatic rectal adenocarcinoma in a patient with MWS) was reported. CONCLUSIONS: The response to canakinumab was sustained for up to 6 years. Canakinumab demonstrated a favourable safety profile over long-term treatment in patients with CAPS. TRIAL REGISTRATION NUMBER: NCT01213641.

Mortality and comorbidities in patients with multiple sclerosis compared with a population without multiple sclerosis: An observational study using the US Department of Defense administrative claims database.

BACKGROUND: Data are limited for mortality and comorbidities in patients with multiple sclerosis (MS). OBJECTIVES: Compare mortality rates and event rates for comorbidities in MS (n=15,684) and non-MS (n=78,420) cohorts from the US Department of Defense (DoD) database. METHODS: Comorbidities and all-cause mortality were assessed using the database. Causes of death (CoDs) were assessed through linkage with the National Death Index. Cohorts were compared using mortality (MRR) and event (ERR) rate ratios. RESULTS: All-cause mortality was 2.9-fold higher in the MS versus non-MS cohort (MRR, 95% confidence interval [CI]: 2.9, 2.7-3.2). Frequent CoDs in the MS versus non-MS cohort were infectious diseases (6.2, 4.2-9.4), diseases of the nervous (5.8, 3.7-9.0), respiratory (5.0, 3.9-6.4) and circulatory (2.1, 1.7-2.7) systems and suicide (2.6, 1.3-5.2). Comorbidities including sepsis (ERR, 95% CI: 5.7, 5.1-6.3), ischemic stroke (3.8, 3.5-4.2), attempted suicide (2.4, 1.3-4.5) and ulcerative colitis (2.0, 1.7-2.3), were higher in the MS versus non-MS cohort. The rate of cancers was also higher in the MS versus the non-MS cohort, including lymphoproliferative disorders (2.2, 1.9-2.6) and melanoma (1.7, 1.4-2.0). CONCLUSIONS: Rates of mortality and several comorbidities are higher in the MS versus non-MS cohort. Early recognition and management of comorbidities may reduce premature mortality and improve quality of life in patients with MS.

Public health workforce taxonomy.

Thoroughly characterizing and continuously monitoring the public health workforce is necessary for ensuring capacity to deliver public health services. A prerequisite for this is to develop a standardized methodology for classifying public health workers, permitting valid comparisons across agencies and over time, which does not exist for the public health workforce. An expert working group, all of whom are authors on this paper, was convened during 2012-2014 to develop a public health workforce taxonomy. The purpose of the taxonomy is to facilitate the systematic characterization of all public health workers while delineating a set of minimum data elements to be used in workforce surveys. The taxonomy will improve the comparability across surveys, assist with estimating duplicate counting of workers, provide a framework for describing the size and composition of the workforce, and address other challenges to workforce enumeration. The taxonomy consists of 12 axes, with each axis describing a key characteristic of public health workers. Within each axis are multiple categories, and sometimes subcategories, that further define that worker characteristic. The workforce taxonomy axes are occupation, workplace setting, employer, education, licensure, certification, job tasks, program area, public health specialization area, funding source, condition of employment, and demographics. The taxonomy is not intended to serve as a replacement for occupational classifications but rather is a tool for systematically categorizing worker characteristics. The taxonomy will continue to evolve as organizations implement it and recommend ways to improve this tool for more accurate workforce data collection.

Public health accreditation addresses issues facing the public health workforce.

As the Public Health Accreditation Board (PHAB) launched the nation's only accreditation program for state, local, tribal, and territorial health departments in September 2011, attention to the issues facing the public health workforce in these health departments was included. PHAB developed several measures in the accreditation standards and measures related to public health workforce development. The accreditation process calls upon health departments to focus more intentionally on their current workforce, while also supporting the development of future public health workers. Working with a group of public health workforce thought leaders, PHAB developed a long-range plan for the expectation of accredited health departments in workforce development. Beginning with the development of intentional standardization in workforce development and moving into future challenges and issues, PHAB uses its platform of quality improvement to bring emphasis on the current and future public health workforce. This article describes the development of the workforce components of public health department accreditation as well as future plans to ensure that the momentum continues. Using data from the accredited health departments at the time of article submission, PHAB also describes some of the approaches that governmental public health departments that have completed the accreditation process are using to develop their own workforce and support the development of the future public health workforce. Challenges faced by health departments in these areas are also described.

No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database.

OBJECTIVE: To assess the potential association of selected antiretrovirals (ARVs), including efavirenz, with suicidality. DESIGN: Retrospective analysis of the Food and Drug Administration Adverse Event Reporting System (FAERS), by performing a Multi-Item Gamma Poisson Shrinker (MGPS) disproportionality analysis. METHODS: MGPS disproportionality analysis, a technique to identify associations between drugs and adverse events, was performed using cumulative data from the FAERS database collected up to August 2012. This method yields an Empirical Bayesian Geometric Mean score and corresponding 90% confidence interval (EB05, EB95). EB05 scores ≥ 2 were pre-defined as a signal for a potential drug-event association. The FAERS database includes spontaneous adverse-event reports from consumers and healthcare professionals. All FAERS reports of suicidality (including suicidal ideation, suicide attempt and completed suicide or a composite of these) in patients taking efavirenz (as single agent or in fixed-dose combination), atazanavir, darunavir, etravirine, nevirapine and raltegravir were identified. A number of parallel analyses were performed to assess the validity of the methodology: fluoxetine and sertraline, antidepressants with a known association with suicidality, and raltegravir, an ARV with rhabdomyolysis and myopathy listed as "uncommon" events in the US-prescribing information. RESULTS: A total of 29,856 adverse event reports were identified among patients receiving efavirenz, atazanavir, darunavir, etravirine, nevirapine and raltegravir, of which 457 were reports of suicidality events. EB05 scores observed for the composite suicidality term for efavirenz (EB05=0.796), and other ARVs (EB05=0.279-0.368), were below the pre-defined threshold. Fluoxetine and sertraline gave EB05 scores for suicidality >2. Raltegravir gave EB05 scores >2 for myopathy and rhabdomyolysis. CONCLUSIONS: The pre-determined threshold for signals for suicidality, including suicidal ideation, suicide attempt, completed suicide and a composite suicidality endpoint, was not exceeded for efavirenz and other ARVs in this analysis. Efavirenz has been associated with suicidality in clinical trials. Further studies that adjust for confounding factors are needed to better understand any potential association with ARVs and suicidality.

Teaching population health: a competency map approach to education.

A 2012 Institute of Medicine report is the latest in the growing number of calls to incorporate a population health approach in health professionals' training. Over the last decade, Duke University, particularly its Department of Community and Family Medicine, has been heavily involved with community partners in Durham, North Carolina, to improve the local community's health. On the basis of these initiatives, a group of interprofessional faculty began tackling the need to fill the curriculum gap to train future health professionals in public health practice, community engagement, critical thinking, and team skills to improve population health effectively in Durham and elsewhere. The Department of Community and Family Medicine has spent years in care delivery redesign and curriculum experimentation, design, and evaluation to distinguish the skills trainees and faculty need for population health improvement and to integrate them into educational programs. These clinical and educational experiences have led to a set of competencies that form an organizational framework for curricular planning and training. This framework delineates which learning objectives are appropriate and necessary for each learning level, from novice through expert, across multiple disciplines and domains. The resulting competency map has guided Duke's efforts to develop, implement, and assess training in population health for learners and faculty. In this article, the authors describe the competency map development process as well as examples of its application and evaluation at Duke and limitations to its use with the hope that other institutions will apply it in different settings.

Hepatitis B virus and human immunodeficiency virus drugs in pregnancy: findings from the Antiretroviral Pregnancy Registry.

BACKGROUND & AIMS: Fetal safety of antiviral therapies is important given the long-term treatment of women with chronic hepatitis B (CHB) infection who may become pregnant. We analyzed neonatal safety data from the Antiretroviral Pregnancy Registry (APR), the largest safety database in pregnancy for antivirals used for HIV and CHB. METHODS: Data were extracted from APR cases prospectively enrolled between 1989 and 2011. Primary outcomes were major birth defects rates with exposure to all antivirals, individual classes, and drugs compared to population-based controls. Relevant to CHB, only lamivudine (LAM) and tenofovir disoproxil fumarate (TDF) had sufficient individual data for review (≥200 cases). RESULTS: Of 13,711 cases analyzed, the overall birth defect prevalence (2.8%, 95% CI 2.6-3.1%) was comparable to Centers for Disease Control population-based data (2.72%, 2.68-2.76%, p=0.87) and two prospective antiretroviral exposed newborn cohorts (2.8%, 2.5-3.2%, p=0.90 and 1.5%, 1.1-2.0%, p<0.001). The birth defects prevalence between first and second/third trimesters exposure was similar (3.0% vs. 2.7%). No increased risk of major birth defects with LAM or TDF exposure compared to population-based controls was observed. No specific pattern of major birth defects was observed for individual antivirals or overall. CONCLUSIONS: No increased risk of major birth defects including in non-live births was observed for pregnant women exposed to antivirals relevant to CHB treatment overall or to LAM or TDF compared to population-based controls. Continued safety and efficacy reporting on antivirals in pregnancy are essential to inform patients on their risks and benefits during pregnancy.

Pharmacoepidemiology: defining the field and its core content.

PURPOSE: Emerging interests in pharmacoepidemiology make it important to define the profession's core content. The International Society for Pharmacoepidemiology (ISPE)'s Education Committee sought to develop a consensus on its core disciplines. This report recapitulates their efforts and conclusions. METHODS: The survey for skill inventories conducted characterized the field of pharmacoepidemiology by five categories of core competency/knowledge (pharmacovigilance, exposure data, epidemiology, clinical pharmacology, and medical product regulation) plus communication and leadership in these areas. It was sent to pharmacoepidemiology units within the industry, academia, and government representing the membership worldwide. RESULTS: After three waves, 125 members responded (~10% of the membership). Respondents were from North America (61%), European Union (23%), and the remainder from Asian Pacific and South American regions, representing the full spectrum of ISPE membership. Pharmacovigilance, analysis of exposure data, epidemiologic methods, and communication skills were the competencies identified as essential. Fourteen competencies were judged to be "essential" by >80% of the respondents; a further 26 had "essential" as the most frequently rated category but represented <80% of the respondents. Six items had "desirable but not a core competency" as the most commonly selected. None of the proposed competencies scored as "not a core competency" by >25% of the respondents. Only five of the competencies were suggested as "not core" by 10% or more. CONCLUSIONS: This survey identified a wide range of content relevant to the field of pharmacoepidemiology. This list will likely evolve over time. A curriculum around these areas will help prepare the next generation of pharmacoepidemiologists. Copyright © 2012 John Wiley & Sons, Ltd.