No Racial Differences Found in Access to Biologics: A Population-Based Study of Psoriasis Patients in the United States.

BACKGROUND: Conflicting evidence exists regarding the role of race in access to biologics for patients with psoriasis. OBJECTIVE: To compare biologic use among adult and pediatric United States psoriasis patients of different racial backgrounds. METHODS: Population-based study of US psoriasis patients using the 2003 to 2018 Medical Expenditure Panel Survey (MEPS). RESULTS: Among 31,525,500 adults and children with psoriasis (weighted), 3,026,578 (9.6%) were on biologics. Among psoriasis patients, 27,464,864 (87.1%) self-identified as white, 2,033,802 (6.5%) self-identified as Black, 1,173,435 (3.7%) self-identified as Asian or Pacific Islander, and 853,399 (2.7%) self-identified as other races. Among those on biologics, 2,778,239 (91.8%) self-identified as white, 84,971 (2.8%) identified as Black, 89,452 (3.0%) self-identified as Asian or Pacific Islander, and 73,917 (2.4%) self-identified as other races. Multivariate logistic regression revealed no significant differences in biologic access between whites and non-whites after adjusting for sociodemographic factors including insurance status (OR for Blacks: 0.347 [0.118, 1.021], P=0.055; OR for Asians: 0.616 [0.240, 1.579], P=0.311; OR for other races: 0.850 [0.216, 3.336], P=0.814. CONCLUSION: The results of this study suggest that race alone is not independently associated with access to biologics among adult US psoriasis patients. Additional studies are necessary to evaluate factors independently associated with biologics access among adults and children with psoriasis in the US. J Drugs Dermatol. 2023;22(8):835-837. doi:10.36849/JDD.7134 Reddy R, Khan S, Yee D, et al. No racial differences found in access to biologics: a population-based study of psoriasis patients in the United States. .

Assessment of procurement, distribution, availability, and utilization of rabies biologicals for postexposure prophylaxis in seven states of India.

BACKGROUND: To achieve the elimination of dog-mediated human rabies by 2030, all bite victims shall have access to life-saving rabies biologicals across the country. The information on procurement, distribution, availability, and utilization of rabies biologicals for postexposure prophylaxis is insufficient. OBJECTIVES: The objective of the study is to assess the demand, procurement, distribution, availability, storage, and utilization of rabies biologicals and to appraise the monitoring and reporting of rabies biologicals at all the levels. METHODS: A multicentric survey was conducted from July to December 2017 in seven regional representative states across the country. The survey team visited the offices in-charge for logistics of rabies biologicals at the survey states and districts; information was collected using structured pro formas and perusing relevant records. District vaccine stores and health institutions in urban and rural areas were visited to assess the availability and stock-outs of rabies biologicals. RESULTS: Procurement, distribution, and availability of rabies biologicals grossly vary between states, since it is the state subject. In Gujarat, both vaccines and immunoglobulins were available even at the Primary Health Centre level; paradoxically, there was a scarcity of both at the district level in Manipur. Immunoglobulins were used only in nine of the surveyed 27 government health-care facilities (33.3%) and two of the eight private facilities (25%). The cold chain facility for storage of rabies biologicals was satisfactory; however, the monitoring and reporting of rabies biologicals were not complete. CONCLUSION: The procurement, distribution, availability, and utilization of rabies biologicals were not universal across the states. Frequent shortages of supply have to be improved to attain universal coverage.

Market mapping and landscape analysis of human rabies biologicals in India.

BACKGROUND: Rabies vaccines and immunoglobulins are lifesaving in humans following animal exposures. These biologicals should continuously be available throughout the year to prevent and eliminate human rabies by 2030. OBJECTIVES: The present study aimed at assessing availability of different kinds of human rabies biologicals in the country and undertaking market mapping and landscape analysis of human rabies biologicals in India. METHODS: The study comprising both quantitative and qualitative approach was conducted from May to November 2017 as a part of the Indian multicentric rabies survey by Association for Prevention and Control of Rabies in India. All stakeholders (agencies/personnel) associated with rabies biologicals were the study units/participants. Required data were generated through brainstorming sessions with key stakeholders; reviewing of databases/existing literature; conducting in-depth surveys; interviewing; focused group discussions, etc. RESULTS: Two types of cell culture rabies vaccines are available in the country manufactured by different pharmaceutical companies; most of the vaccines are indigenously produced and the market size of the rabies vaccines is about INR 125 crores with highest sales in the northern region followed by South. Likewise, there are 2 types of immunoglobulin available, i.e., equine rabies immunoglobulins (RIGs), which are indigenously produced and human RIGs, which are imported. The market value of RIGs is about INR 83 crores. A novel rabies monoclonal antibody is also been marketed in the country from November 2017. CONCLUSIONS: There are many lacunas in the market availability of rabies biologicals in different parts of the country; therefore, a significant expansion/shift in focus must be considered, through rigorous strategic planning process.

Evaluation of Vietnam's post-exposure prophylaxis delivery system, 2017.

BACKGROUND: Canine-mediated human rabies deaths typically occur in poor and rural populations with limited access to rabies biologics: vaccine and immunoglobulin. A critical aspect of reducing rabies deaths is understanding how these countries procure, deliver, and forecast rabies biologics. Vietnam is one of the few endemic countries where biologics is widely available. However, a formal evaluation of its current rabies biologics distribution system has not been conducted. METHODS: In 2017, we conducted a formal evaluation of Vietnam's rabies biologics distribution system. Our goals were (1) to identify centers providing rabies biologics (2) identify costs to the patient and centers and (3) assess the rabies biologic procurement and delivery system at eligible district and provincial centers (provides and orders biologics for itself and other centers directly from the manufacture). To conduct the formal evaluation, we developed a standardized survey that was distributed to centers. RESULTS: Of the 780 designated rabies biologics centers in Vietnam, 659 (84%) of them provide rabies immunoglobulin (eRIG), vaccine, or both. Of the 177 eligible centers, 90% (160) responded to the survey. The average costs to patients were $8.45 (range: 5.43-12.77) for one dose of IM injection, $13.90 (range: 11.86-16.71) for domestic eRIG, and $23 (21.11-27.11) for imported eRIG. Respondents reported experiencing delays in receiving vaccine in 50 centers and eRIG in 14 centers within the past year. Respondents stated their top three challenges in providing biologics were: delays or shortages from manufactures, lack of funds to pay for biologics, and the high cost of biologics. CONCLUSIONS AND RELEVANCE: Despite the wide availability of biologics in Vietnam, more work is needed to provide affordable and reliable supply of biologics to patients. This includes the expansion of ID injection use throughout the country to lower vaccine demand, and decrease the costs to centers and patients. Furthermore, a more coordinated effort to share biologics among centers, possibly through a more centralized system at the provincial level may alleviate delays and shortages.

Urgent Delivery - Validation and Operational Implementation of Urgent Blood Delivery by Modern High Speed Hospital Pneumatic Tube System to Support Bleeding Emergencies Within a Hospital Massive Transfusion Protocol.

BACKGROUND: Timely blood delivery to patients with critical bleeding poses logistic challenges. A modern, high speed hospital pneumatic tube system (PTS) is one solution, but blood units may be subjected to high-speed torque and acceleration/deceleration forces. OBJECTIVE: To validate a new PTS system for potential use at our 1,400-bed hospital in Singapore. METHOD: Our validation included red blood cells, platelets, thawed plasma, and cryoprecipitate units transported from the blood bank for a distance of 820 meters (PTS track), at a velocity of 3-6 meters per second. Transit time, temperature, bag integrity, and blood quality were assessed visually and through analytical testing on pre- and post-PTS specimens. RESULTS: Blood units arrived physically intact in less than 8 minutes. The temperature for each was within the acceptable range. Comparative testing of pre-PTS and post-PTS specimens showed no significant difference in physical quality and analyzed parameters (P> .05). CONCLUSIONS: High speed PTS transportation of blood components has satisfactory fidelity and speed, without significant impact on quality. As a result, we incorporated PTS blood delivery into the hospital massive-transfusion protocol and successfully operationalized that new system.

CT Epidemiologia 21/03/16: abastecimento de imunobiológicos (soros e vacinas)

Global characteristics of the rabies biologics market in 2017.

In 2017, the World Health Organization, the World Organisation for Animal Health, the Food and Agriculture Organization of the United Nations and the Global Alliance for Rabies control developed a strategic plan to end human rabies deaths by 2030. A survey for manufacturing capacity and product characteristics of rabies biologics was conducted to inform this process. Twenty-three of 42 manufacturers, responded, giving a market capacity for 2017 of 90 million vials for human vaccines, 2.5 million vials for rabies immunoglobulins, 2 million vials for monoclonal antibodies and 181 million vials for dog vaccines. Production capacity could be increased by many manufacturers but was limited by country demand, lack of long-term planning and restricted market expansion. Should countries implement national rabies elimination programmes where biologic needs are forecasted and production lead times respected, manufacturers can meet future supply needs towards global elimination of human dog-mediated rabies deaths.

Why do we have so many molecules and biodiversity but so few antiparasite medicines? / Porqué tenemos tantas moléculas bioactivas y biodiversidad pero tan pocas medicinas antiparasitarias?

Natural products are isolated from biodiversity, that is, from plants, microorganisms, insects, and marine organisms; most of the biodiversity is found in about 10-12 countries located around the Equator. For a long time, people chose this option to alleviate diseases and the industry to discover new medicines; however, from the 70's onwards synthetic products have displaced them. Today there is a rebirth of natural products research and annually hundreds of new natural and synthetic bioactive molecules are reported in specialized journals. On the other hands, new drugs are continually required and especially there is a deficit of them to treat the so-called Neglected Diseases, which affect and threaten the health of billions of people in the world. These diseases paradoxically affect almost all megadiverse countries. Thus, the richest countries in biodiversity do not benefit from the use of natural products because research, development and production of new medicines are carried out in more technologically advanced countries. Why do we have so many molecules in biodiversity and journals but so few medicines? How could new antiparasite drugs be developed quickly and cheaply in the countries affected by Neglected Diseases? A feasible alternative is the Mining in Press, that is, the search of molecules in scientific literature. In this paper we analyze the reasons why these valuable substances have not become drugs and remain curiosities of laboratories and libraries, and the advantages of using this approach as a source of drugs or templates to other bioactive molecules.

Los productos naturales son aislados de la biodiversidad, es decir, de plantas, microorganismos y organismos marinos; gran parte de la biodiversidad se encuentra en cerca de 10-12 paises localizados alrededor del Ecuador. Por mucho tiempo, la gente ha seleccionado esta opción para aliviar sus enfermedades y la industria para descubrir nuevas medicinas; sin embargo, desde los años 70s los productos sintéticos los han desplazado. Hoy hay un renacimiento de la investigación de productos naturales y anualmente cientos de nuevas moléculas naturales y sintéticas bioactivas son reportados en las publicaciones especializadas. De otro lado, continuamente se requieren nuevas drogas y especialmente hay un déficit de ellas para tratar las llamadas Enfermedades Olvidadas, que afectan y amenazan la salud de miles de millones de personas en el mundo. Estas enfermedades paradójicamente afectan casi todos los países megadiversos. De esta manera, los países más ricos en biodiversidad no se benefician del uso de productos naturales, ya que la investigación, el desarrollo y la producción de nuevas medicinas se lleva a cabo en países tecnológicamente avanzados. Por qué tenemos tantas moléculas en la biodiversidad y en las publicaciones, pero tan pocas medicinas? Cómo podrían las drogas antiparasitarias ser desarrolladas de manera mas rápida y barata en los países afectados por las Enfermedades Olvidadas? Una posible alternativa es la Minería de las Publicaciones, es decir, la búsqueda de moléculas en la literatura científica. En este artículo nosotros analizamos las razones por la cuales esas valiosas sustancias no han llegado a ser drogas y permanecen como curiosidades de los laboratorios y bibliotecas, y las ventajas de usar esta aproximación como una fuente de drogas o modelos de otras moléculas bioactivas.

Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade®.

Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality attributes that may contribute to clinically meaningful differences. The process must also meet large commercial demand, while simultaneously being able to accommodate change without sacrificing product consistency. The four key components of successful biologics manufacturing are (1) a stable, well-defined proprietary cell line; (2) a good manufacturing practice (GMP)-compliant supply chain with a process control strategy defining acceptable levels of variability for target product/process attributes and capable of managing complex material flows; (3) a tightly controlled procedure for implementation of proposed process changes that ensures product consistency; and (4) built-in redundancy and flexibility providing the ability to adapt rapidly to unexpected developments. This report describes the requirements for the manufacturing and distribution of biologics, using Remicade® (infliximab, Janssen Biotech, Horsham, PA, USA) as an example of best practices. Since Remicade's first marketing approval in 1998, Janssen has manufactured > 150 million vials used to treat > 2.6 million patients around the world for a variety of inflammatory diseases. Remicade displays a highly consistent quality attribute profile and meets all product/process specifications across multiple manufacturing sites and process scales. Janssen's experience with Remicade demonstrates that deep product knowledge, extensive manufacturing experience, diligent product/process monitoring and a sustained commitment to compliance and research are required to ensure quality, consistency and uninterrupted patient supply for large-volume biologics over the long term.

Propuesta de clasificación de insumos para la gestión de inventarios en la industria biofarmacéutica. Caso de Estudio en el Centro de Inmunología Molecular / A proposal for input classification for inventory management in the biopharmaceutical industry. Study case in the Molecular Immunology Center

El surgimiento del sector biotecnológico inició una revolución en las bases tradicionales de competencia en la industria farmacéutica en términos de desarrollo y fabricación de productos, orientados principalmente a salud humana. La gestión de inventarios en esta industria es muy compleja, con grandes volúmenes y variedad de inventario, dado por la complejidad de mantener dos procesos que tienen efecto en la gestión de inventarios, relacionados con la investigación y desarrollo, y producción. La complejidad de estos procesos exige de un sistema logístico con capacidad y flexibilidad suficiente para adaptarse a las distintas regulaciones existentes y la variación en los planes de ventas, además de un sistema informático que permita integrar las partes del sistema. El presente artículo tiene el propósito de evaluar la situación de la Gestión de Inventarios en el Centro de Inmunología Molecular a partir de la implementación de los conceptos de Insumo Proyecto e Insumo Proceso. Para el desarrollo de la investigación se emplearon diferentes métodos y herramientas como: análisis bibliográfico, entrevistas a expertos, consultas de registros, tormenta de ideas, entre otros. Entre las herramientas utilizadas se encuentran: Modelo de Referencia para la Evaluación de la Gestión de Inventarios, Microsoft Excel y Diagrama Causa-Efecto. Los resultados demuestran el impacto positivo alcanzado por la diferenciación entre los insumos utilizados en procesos productivos e investigación, por el alcance dado en distintos procesos de la Gestión de Inventarios en el orden organizativo y financiero, logrando la mejora de indicadores como rotación de inventarios, ciclo de importación y satisfacción del cliente(AU)

The emergence of the biotechnological sector started a revolution in the traditional competitive basis of the pharmaceutical industries, in terms of development and manufacture of products, especially those aimed at human health. Inventory management in this industry is very complex, with varied, high-volume inventories, given the complexity of executing two processes that have an effect on inventory management: production, and R&D. The complexity of these processes demands a logistical system with the capacity and flexibility to adapt to the many different regulations in existence and changes in sales plans, and an informatics solution that allows integration of the different parts of the system. The current article aims to evaluate the situation of Inventory Management at the Molecular Immunology Center from the implementation of the concepts of Project Input and Process Input. The research was carried out through diverse methods and tools including bibliographic analysis, expert interviews, record querying, and brainstorming. The tools used included: Reference Model for Inventory Management Evaluation, Microsoft Excel, and cause-effect diagrams. The results show a positive impact achieved by differentiating inputs used for production and inputs used for R&D, and its reach into the process of Inventory Management at the organization level, improving indicators like inventory rotation, importing cycle, and client satisfaction(AU)

Sustainable supply, a foundation for natural product development: The case of Indian frankincense (Boswellia serrata Roxb. ex Colebr.).

ETHNOPHARMACOLOGICAL RELEVANCE: Boswellia serrata Roxb. ex Colebr. is a multiple-use tree species used for fodder, timber and is tapped for an oleo-resin known internationally as Indian frankincense or Indian olibanum. The main commercial uses of B. serrata oleo-resin are medicinal, religious, and in cosmetics and perfumery. B. serrata, like other frankincense species, is an important source of boswellic acid used in the pharmaceutical industry. India is the only producer of B. serrata oleo-resin, mainly from the states of Madhya Pradesh, Andhra Pradesh, Gujarat and Jharkhand. Market demands, harvesting and managing practices have pressured Indian frankincense populations into imminent decline and start to affect populations of African frankincense as buyers turn to look for substitutions. AIMS OF THE REVIEW: We have assessed the ecological status of Indian frankincense based on the assumption that current species management practices are not sustainable. This review summarizes the outcomes of this assessment in terms of habitat and population trends, harvesting/collection practices and uses, current threats and management measures. MATERIALS AND METHODS: Firstly, we reviewed published information on B. serrata population biology and studies on impacts of wild harvest from across the geographic range of this species. Secondly, global trade data for B. serrata were analysed. Thirdly, we reviewed published information on B. serrata management measures and cultivation practices. RESULTS: The five largest importers of frankincense from India in 2016-2017 were Trinidad & Tobago, Germany, Guatemala, Mexico and the USA, in order of volume. Total volumes exported were 102.8 metric tonnes in 2015-2016 and 74.56 metric tonnes in 2016-2017. Collection data are less readily available. What could be found, however, points toward market demand for Indian frankincense and its derivatives by far exceeding what can reasonably be harvested/collected without endangering populations of this species, opening the door to adulteration and substitution. CONCLUSIONS: In conclusion, not only sustainable harvesting and management practices, but also establishing sustainable supply chains are needed to protect this species from overexploitation and thus endangerment.

Snakebites in French Guiana: Conclusions of an international symposium.

A workshop on epidemiology and management of snakebites in French Guiana was performed at Cayenne, French Guiana from September 15 to September 16, 2017, under the auspices of the French Regional Health Agency (ARS) and the Pan American Health Organization (PAHO). The activity was attended by experts from France (Angers, Martinique, French Guiana, Guadeloupe, and Paris), Costa Rica, Brazil, Saint Lucia, and Surinam. The epidemiology, clinical manifestations, clinical grading and the management of snakebite in French Guiana were discussed. The conclusions of this symposium illustrated the urgent need to ensure accessibility of effective and safe polyvalent viperid antivenom in French Guiana. Finally, the results of this symposium have forged ties based on mutual goals and objectives.

Management of rheumatoid arthritis in clinical practice using treat-to-target strategy: Where do we stand in the multi-ethnic Malaysia population?

To evaluate the achievement of treat-to-target (T2T) strategy in rheumatoid arthritis (RA) and identify factors associated with failed treatment target in a public rheumatology center. A cross-sectional study was conducted from June 2015 to February 2016. RA patients with disease duration greater than 2 years and under T2T for over a year were invited to the study. Demographic, clinical data, disease activity score of 28 joints (DAS28), and clinical disease activity index (CDAI) were collected in a single routine clinic visit. Treatment target was defined as DAS28 <3.2 or CDAI ≤10. Retrospective chart review was performed to determine reasons of failed treatment target. A total of 371 patients were recruited and 87.1% were female. Mean age and duration of RA were 53.5 years (SD 10.3) and 9.1 years (SD 6.6), respectively. Ethnic distribution was 49% Chinese, 27% Malay, and 24% Indian. T2T was achieved in 81.7% of the cohort. Non-Chinese ethnicity, positive rheumatoid factor, and treatment with three disease modifying anti-rheumatic drugs (DMARDs) were associated with failed treatment target. After controlling for covariates, Malay ethnicity (OR 2.96; 95% CI 1.47-5.96) and treatment with three DMARDs (OR 2.14; 95% CI 1.06-4.35) were associated with failed treatment target. There was no association between age, gender, duration of RA, BMI, smoking status, anti-citrulinated cyclic peptide, and achievement of T2T. The most common reasons of failed treatment target were inability to escalate DMARDs due to side effects (18.8%), lack of biologics fund (15.6%), and persistent disease despite optimum treatment (14.1%). T2T was successfully implemented. Malay patients need aggressive treatment adaptation to achieve optimal outcome.

Anti-Candida albicans natural products, sources of new antifungal drugs: A review.

INTRODUCTION: Candida albicans is the most prevalent fungal pathogen in humans. Due to the development of drug resistance, there is today a need for new antifungal agents for the efficient management of C. albicans infections. Therefore, we reviewed antifungal activity, mechanisms of action, possible synergism with antifungal drugs of all natural substances experimented to be efficient against C. albicans for future. METHODS: An extensive and systematic review of the literature was undertaken and all relevant abstracts and full-text articles analyzed and included in the review. REVIEW: A total of 111 documents were published and highlighted 142 anti-C. albicans natural products. These products are mostly are reported in Asia (44.37%) and America (28.17%). According to in vitro model criteria, from the 142 natural substances, antifungal activity can be considered as important for 40 (28.20%) and moderate for 24 (16.90%). Sixteen products have their antifungal activity confirmed by in vivo gold standard experimentation. Microbial natural products, source of antifungals, have their antifungal mechanism well described in the literature: interaction with ergosterol (polyenes), inhibition 1,3-ß-d-glucan synthase (Echinocandins), inhibition of the synthesis of cell wall components (chitin and mannoproteins), inhibition of sphingolipid synthesis (serine palmitoyltransferase, ceramide synthase, inositol phosphoceramide synthase) and inhibition of protein synthesis (sordarins). Natural products from plants mostly exert their antifungal effects by membrane-active mechanism. Some substances from arthropods are also explored to act on the fungal membrane. Interestingly, synergistic effects were found between different classes of natural products as well as between natural products and azoles. CONCLUSION: Search for anti-C. albicans new drugs is promising since the list of natural substances, which disclose activity against this yeast is today long. Investigations must be pursued not only to found more new anti-Candida compounds from plants and organisms but also to carried out details on molecules from already known anti-Candida compounds and to more elucidate mechanisms of action.

Inequalities in access to biological treatments for psoriasis: results from the Italian Psocare registry.

BACKGROUND: Limited evidence is available on the impact of socioeconomic factors on drug prescriptions for psoriasis. OBJECTIVES: To investigate factors influencing prescription of conventional vs. biological treatment for patients with psoriasis, based on the Italian Psocare registry, with a special focus on socioeconomic factors. METHODS: This was a cross-sectional study evaluating the baseline data of patients included in the Psocare registry. All of the consecutive adult patients with a diagnosis of chronic plaque psoriasis or psoriatic arthritis who were prescribed a systemic treatment for psoriasis at participating centres were included in this study. Univariate and multivariate analyses of the baseline factors associated with a biologics prescription were performed. RESULTS: From September 2005 to September 2009, 12 838 patients were identified. A multivariate analysis revealed that, among other factors, completing a level of education higher than lower secondary school and being employed as a manager or a professional were independent factors associated with a biologics prescription at entry in the registry. Additional analyses on the association between these two variables and a severe psoriasis condition [Psoriasis Area Severity Index (PASI) score > 20] revealed a significantly increasing trend of severe disease towards lower educational attainment, while unemployed patients were more likely to have a more severe condition compared with the other categories of workers. CONCLUSIONS: We documented inequalities of drug prescriptions for psoriasis in Italy, with a trend towards a higher frequency of prescription for more expensive biologics in higher socioeconomic sectors of the population.