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Background: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments., Objective: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries., Method: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage., Results: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2)., Conclusion: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies., (© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)

Objective: Conduct an analysis to determine the existence and updating of national essential medicines lists (EMLs) and clinical practice guidelines (CPGs) for the treatment of diabetes in Latin America and the Caribbean (LAC); and compare the medicines included in each country's list and guidelines both with each other and with those of the World Health Organization (WHO)., Methods: Cross-sectional study. EMLs and CPGs for diabetes were found on the websites of the Pan American Health Organization and national health authorities. Medicines were noted and analyzed according to pharmacological group, based on the fourth level of nomenclature of the Anatomical Therapeutic Chemical (ATC) classification system. F1 scoring was used to assess the proximity of EMLs to the WHO Model List of Essential Medicines (MLEM)., Results: Of the total number of countries, 87.2% have EMLs, and 91% have CPGs (78% and 45% updated in the last five years, respectively). Compared to the six hypoglycemic groups of the MLEM, the EMLs had a median (range) of 6 (4-13) and an F1 score of 0.80; This indicates proper alignment. CPGs had a median (range) of 12 (1-12) hypoglycemic drugs compared to eight in the WHO guidelines. CPGs had a median of 15 more drugs than their respective EMLs., Conclusions: While most LAC countries have EMLs and CPGs for diabetes, the lack of concordance among them limits their effectiveness. It is necessary to align the processes and criteria for the development of these two tools for policymaking on medicines.

Biosimilars are biological medicines highly similar to a previously licensed reference product and their licensing is expected to improve access to biological therapies. This study aims to present an overview of biosimilars approval by thirteen regulatory authorities (RA). The study is a cross-national comparison of regulatory decisions involving biosimilars in Argentina, Australia, Brazil, Chile, Canada, Colombia, Europe, Hungary, Guatemala, Italy, Mexico, Peru and United States. We examined publicly available documents containing information regarding the approval of biosimilars and investigated the publication of public assessment reports for registration applications, guidelines for biosimilars licensing, and products approved. Data extraction was conducted by a network of researchers and regulatory experts. All the RA had issued guidance documents establishing the requirements for the licensing of biosimilars. However, only three RA had published public assessment reports for registration applications. In total, the investigated jurisdictions had from 19 to 78 biosimilars approved, most of them licensed from 2018 to 2020. In spite of the advance in the number of products in recent years, some challenges still persist. Limited access to information regarding the assessment of biosimilars by RA can affect confidence, which may ultimately impact adoption of these products in practice., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Evaluate the feasibility of monitoring the quality of use of medicines in health institutions in countries of the Region of the Americas by means of rational prescription indicators., Methodology: A quantitative study of the use of medicines was conducted during the period 2016-2018. Rational prescription indicators were developed and selected in accordance with international reference values and the best available evidence for: 1) anti-inflammatory drugs: prescription of ibuprofen and/or naproxen as a percentage of all prescribed non-steroidal anti-inflammatory drugs; 2) oral antidiabetics: metformin as a percentage of all prescribed antidiabetics, and metformin and/or sulfonylureas as a percentage of all prescribed antidiabetics; 3) insulins: crystalline insulin and NPH as a percentage of total prescribed insulins; and 4) antihypertensive drugs: angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs-II), and thiazide diuretics as a percentage of all prescribed antihypertensives. The defined daily dose (DDD) per 1 000 inhabitants was used as a measure of consumption per institution., Results: Prescription of metformin as a percentage of all antidiabetics was lower than the value of the reference indicator (27.9%-67.6% vs. 88%), while the prescription of metformin and/or a sulfonylurea was comparable with that value (80.9%-97.5% vs. 88%). The values of NPH, crystalline, and NPH/crystalline insulin in relation to all prescribed insulins were variable with respect to the reference indicator (37.1%-100% vs. 75%). Prescription of ibuprofen and naproxen was below the value of the indicator (20%-50% vs. 80%). The percentage of ACE inhibitors, ARBs, and thiazides with respect to all antihypertensives ranged from 65.2%-77.2% to 65%, consistent with the value of the proposed indicator., Conclusions: The feasibility of applying the selected and constructed indicators of rational prescription was demonstrated. These indicators provide useful information for analyzing the quality of prescription in health institutions in countries in the Region and are a useful tool for periodically monitoring it.

In order to compile an inventory of national data sources for drug utilization research (DUR) in Argentina and to verify publicly available data sources, we performed a cross-sectional study that sought to identify national and provincial databases of drug use. In July 2020, we searched the websites of government institutions, carried out a systematic query of bibliographic databases for "drug utilization research" conducted in Argentina, and conducted a survey with local experts. Data collected included: the institution responsible for the database, population covered, accessibility, source of the data, healthcare setting, geographic information, and whether data were individual or aggregated. Descriptive analyses were then performed. We identified 31 data sources for DUR; only one was publicly and conveniently accessible. Five published aggregated data and provide more detailed access by formal request. Only seven sources (23%) reported national data, and most (n=29) included only data from the public healthcare sector. Although data sources for DUR have been found in Argentina, limited access by researchers and policymakers is still an significant obstacle. Increasing health data transparency by making data sources publicly available for the purpose of analyzing public health information is crucial for building a stronger health system.

Background: In January 2005, Rasulov et al. originally published "First experience in the use of bone marrow mesenchymal stem cells (MSCs) for the treatment of a patient with deep skin burns". Here, we present the first ever treated patient with cadaveric bone marrow mesenchymal stem cells (CMSCs) in the history of Medicine., Methods: A young man, who severely burned 60 % of his total body surface with 30 % of full-thickness burns while working with a grass trimmer that exploded, was involved in the study. MSCs were obtained from the bone marrow of a cadaver donor in a routine procurement procedure of CUCAIBA, the Province of Buenos Aires, Argentina, Ministry of Health, Transplantation Agency, cultured, expanded, and applied on the burned surfaces using a fibrin spray after early escharotomy., Results: So far, our preliminary experience and our early results have been very impressive showing an outstanding safety data as well as some impressive good results in the use of CMSCs., Conclusions: Based on all this, we think that improvements in the use of stem cells for burns might be possible in the near future and a lot of time as well as many lives could be saved by many other research teams all over the world. CMSCs will probably be a real scientific opportunity in Regenerative Medicine as well as in Transplantation.

Current B-cell disorder treatments take advantage of dose-intensive chemotherapy regimens and immunotherapy via use of monoclonal antibodies. Unfortunately, they may lead to insufficient tumor distribution of therapeutic agents, and often cause adverse effects on patients. In this contribution, we propose a novel therapeutic approach in which relatively high doses of Hydroxychloroquine and Chlorambucil were loaded into biodegradable nanoparticles coated with an anti-CD20 antibody. We demonstrate their ability to effectively target and internalize in tumor B-cells. Moreover, these nanoparticles were able to kill not only p53 mutated/deleted lymphoma cell lines expressing a low amount of CD20, but also circulating primary cells purified from chronic lymphocitic leukemia patients. Their safety was demonstrated in healthy mice, and their therapeutic effects in a new model of Burkitt's lymphoma. The latter serves as a prototype of an aggressive lympho-proliferative disease. In vitro and in vivo data showed the ability of anti-CD20 nanoparticles loaded with Hydroxychloroquine and Chlorambucil to increase tumor cell killing in comparison to free cytotoxic agents or Rituximab. These results shed light on the potential of anti-CD20 nanoparticles carrying Hydroxychloroquine and Chlorambucil for controlling a disseminated model of aggressive lymphoma, and lend credence to the idea of adopting this therapeutic approach for the treatment of B-cell disorders.

Objective: Determine how the Mercosur countries access, regulate, and finance costly drugs and propose joint selection and financing strategies at the subregional level., Methods: Qualitative design, using content analyses of primary and secondary sources, document reviews, interviews, focus groups, and case studies. The variables selected included: selection criteria, access, financing, and regulations in the various countries. Costly drugs were divided into those that do not alter the natural course of the disease and those with demonstrated efficacy, using the defined daily dose to compare the costs of classical treatments and those involving costly drugs., Results: The Mercosur countries generally lack formal strategies for dealing with the demand for costly drugs, and governments and insurers wind up financing them by court order. The case studies show that there are costly drugs whose efficacy has not been established but that nonetheless generate demand. The fragmentation of procurement, international commitments with regard to intellectual property, and low negotiating power exponentially increase the price of costly drugs, putting health system finances in jeopardy., Conclusions: Costly drugs must be regulated and rationally selected so that only those that substantively benefit people are accepted. To finance the drugs so selected, common country strategies are needed that include such options as flexible in trade agreements, the creation of national resource funds, or joint procurement by countries to enhance their negotiating power.

The aim of this study was to determine if Rituximab coated Biodegradable Nanoparticles (BNPs) loaded with Chlorambucil and Hydroxychloroquine could induce apoptosis of B-Chronic Lymphocytic Leukemia (B-CLL), MEC-1 and BJAB cells in vitro and evaluate their toxic and therapeutic effects on a Human/Mouse Model of Burkitt Lymphoma at an exploratory, proof of concept scale. We found that Rituximab-Chlorambucil-Hydroxychloroquine BNPs induce a decrease in cell viability of malignant B cells in a dose-dependent manner. The mediated cytotoxicity resulted from apoptosis, and was confirmed by monitoring the B-CLL cells after Annexin V/propidium iodide staining. Additional data revealed that these BNPs were non toxic for healthy animals, and had prolonged survival in this mice model of human lymphoma.

Objective: Describing how medicine was taken by pregnant females living in Buenos Aires, Argentina, during 2008., Methods: A random sample of females who had delivered during 2008 was surveyed and interviewed regarding pertinent general data, the health care they had received during pregnancy and characteristics concerning their deliveries. Information related to antenatal care included maternal reports concerning the use of medicine during pregnancy; medicine was classified as having low, medium or high risk for the foetus. Prescriptions were also analysed. A physical examination of all newborns was performed after delivery to detect any birth defect., Results: 90.6 % of the 1,338 women included had taken at least one medicine/drug during their pregnancy and 81.9 % had taken medicines apart from folate-iron (usually indicted as prophylaxis). Average medicine/drug use was two per pregnant female. Iron (71.8 %), folic acid (40.3 %), antibiotics (40.9 %), analgesics, antiemetics (30.8 %) and vitamins (19.7 %) were the medicines which were most used throughout pregnancy. Logistic regression analysis of medicine use showed increased usage risk for older women, those having a higher education level or those having higher socioeconomic status. Self-medication was observed in 32.3 % of the sample; 21.5 % of the medicines consumed were considered as being high risk medicines by the US FDA. The incidence of malformations detected was 0.6 %., Conclusion: 9 out of 10 females had used at least one drug/medicine during their pregnancy. To avoid unnecessary exposure to potential risk during pregnancy medicine use should be strictly related to patient's health needs, in line with the best benefit/risk ratio.

We describe a novel technology based on nanoengineered multifunctional acellular biologic scaffolds combined with wound dressings and films of the same kind. This method allows selective delivery and release of shielded biomaterials and bioactive substances to a desired wound or damaged tissue while stimulating the selective anchoring and adhesion of endogenous circulating repairing cells, such as mesenchymal stem cells, to obtain a faster and more physiologic healing process. We also present a new controlled enzymatic debridement process for more effective burned tissue scarolysis. In light of our preliminary in vitro and in vivo data, we are convinced that these approaches can include the use of other kinds of adult stem cells, such as endometrial regenerative cells, to improve the vascularization of the constructs, with great potential in the entire tissue and organ regeneration field but especially for the treatment of severely burned patients, changing the way these lesions may be treated in the future.

Objective: This paper evaluates the effectiveness of a Public Health program for the elderly based on health promotion and pathologies prevention, in order to avoid complications associated with illnesses and improves the quality of life (QOL) in elderly adults (EA)., Methods: A 12 month intervention studies used 700 EA randomized in 2 groups: intervention and control. Each group was submitted to pre-post intervention measurements that included weight, height, blood pressure (BP), cholesterol, lipids, glycaemia, cardiovascular (infarct, stroke) and bone fractures events, hospitalization, and a QOL survey. Intervention consisted of periodic physical activity to fortify muscular groups, as well as recreational activities, nutritional and food manipulation training visits. A medical student was assigned to each participant from the intervention group to assure periodical contact and to share activities. The control group continued with their normal activities during observational period., Results: The intervention group showed a significant reduction in the BP, lipids and cholesterol values compared to control group. Reduction on cardiovascular events (-31%), hip fractures (-18.2%) and number of hospital admittance (-21.1%) were obtained for group A in relation to B. The QOL survey showed 28.7% improvement for group A compared with 33.4% improvement compared with control group., Conclusion: The health program with exhaustive follow-up administration, significantly reduced risk factors and complications associated with aging.

Objective: To determine the prevalence and causes of anaemia among adults in Buenos Aires, Argentina., Design: Community-based, cross-sectional, quantitative study, with descriptive and analytic stages., Setting: Study conducted in La Plata, Buenos Aires, Argentina., Participants: Rigorous selection from randomised sampling, with 3-stage stratification: geographical area, health aspects, and social/economic status. Adults >18 years old. RESULTS AND MAIN MEASUREMENTS: Social-economic and nutritional data and blood samples were obtained from each participant. If anaemia was detected, either treatment was given until complete recovery or further studies were conducted until definitive diagnosis was reached. Weight, height, haemoglobin, erythrocytes, haematocrit, transferrin, iron and ferritin levels, daily intake of calories, carbohydrates, lipids, proteins, calcium, iron, and vitamin C were measured. One thousand and thirty-six patients out of 1200 selected were analyzed. The prevalence of anemia in adults was 26.3%. Variables such as low social/economic status, nutritional questions, and frequency of doctor's consultation were associated with risk of anaemia. However, basic unsatisfied needs--a variable consisting of precarious housing and low educational level--, female sex, and living in slums were significant in the multivariate analysis (OR>2.5)., Conclusions: One in 4 adults has anaemia, with iron deficiency as the major cause. Anaemia diagnosis is mainly associated with social and gender questions and the area of residence. This information, if used by the State to plan appropriate and focused preventive measures, could benefit not just adults but the entire community that depends on them.

New ideas and experimental models for tissue and organ regeneration are urgently needed. There are several exciting challenges in the field of organogenesis that need to be defined. The integrated signals and molecular repertoires that shape the particular architecture of specific organs like the kidney or the liver are not completely understood yet. To develop a new scientific platform to be able to build up complex organs we have established a research program using basically Acellular Xenogeneic Isomorphic Matrices (AXIMs) and mesenchymal stem cells (MSCs) generating the necessary concepts for the definition, production, and application of the specific configurations of these matrices for organ regeneration. New and interesting pathways for MSC differentiation were identified. We believe that all extracellular matrices were created fundamentally equal or at least very similar in nature. We also believe that there are true "matrix superhighway configurations" with different three-dimensional geometrical architectures as well as biochemical, electrical, and molecular properties that are tissue and organ specific that influence cell differentiation and organogenesis and will be fundamental for the in vitro regeneration of complex organs for transplantation.

Objectives: Recent work has shown that human bone marrow contains mesenchymal stem cells (MSCs). However, little is known about their presence in peripheral blood. Since these cells are potentially responsible for tissue repair after injury, their number should be increased during these situations. To demonstrate their number during these situations, we measured MSCs in the peripheral blood of healthy donors and burn patients., Materials and Methods: Blood samples were obtained from 15 acute burn patients and 15 healthy donors. We performed flow cytometric analysis, using a large monoclonal antibody panel: CD44, CD45, CD14, DR, CD34, CD19, CD13, CD29, CD105, CD1a, CD90, CD38, CD25. MSC phenotype was considered positive for CD44, CD13, CD29, CD90, and CD105, and negative for the other monoclonals. The testing was performed on day 3 after injury. We correlated the results with the age, sex, and size and type of burns., Results: Cells expressing the MSC phenotype were detected in the peripheral blood of both groups. Noteworthy, compared with samples from healthy donors (0.0078 +/- 0.0044), blood obtained from burn patients showed a higher MSC percentage (0.1643 +/- 0.115; P < .001). The percentage of MSCs correlated with the size and severity of the burn. Increased values were also observed among younger patients., Conclusions: MSCs have an important role in regenerative processes of human tissues. We found cells phenotypically identical to MSCs circulating in physiological number in normal subjects, but in significantly higher amounts during acute large burns. Therefore, they may represent a previously unrecognized circulatory component to the process of skin regeneration.

Objective: To propose an interdisciplinary approach in Community Health through a model based on Home Health Care., Design: A prospective study programmed in two periods: a cross sectional study for data collection followed by home assistance for the health problems detected., Methods: 100 families (570 inhabitants) were randomly submitted to a clinical, nutritional and laboratory examination in order to detect major health problems. Afterwards the same professional team took care of 10 families in health promotion counseling and illness treatment., Results: This study shows that 84% of the patients in whom a health abnormality was detected were not aware of their illness. The population was mainly affected by hypertension, hypercholesterolemia, hypertrigliceridemia, and anemia. None of these problems were listed as the main causes of consultation in a local center belonging to the traditional health services. Almost 70% of the inhabitants consumed a daily diet with less nutrients and calories than recommended. The project included health care for all family members and free drugs provision for all illnesses detected. Ninety-eight percent of patients had a proper and continuous follow up of their illness for a 3 year period, compared with a 31% follow up provided by the traditional health care organization., Conclusions: This work shows an integrated effort by the University, health centers, and all health care disciplines to propose an alternative program that personalizes attention and moves health care from Institutions to people's own homes. This model improved community health conditions, had a high impact on illness follow up and increased health care accessibility.

Objective: To determine the prevalence of anaemia and to evaluate the factors that condition its occurrence.Setting. Out-patient clinics in the La Plata area, Buenos Aires, Argentina., Design: Observational and prospective study., Participants: All the pregnant women consulting for the first time, excluding those with prior pathology or regular use of medical drugs., Measurements: Anaemia was defined at values of Hb < 11 g/dl. Questionnaires were administered for general data and the type of nutrition, and a complete haematological report was compiled., Results: 1218 pregnant women started the study. Anaemia was detected in 196 of them (16%), with average Hb 9.88 g/dl. Between normal and anaemic pregnant women, the following differences were found between the first and second consultations: weight (64.44 vs 59.50, p < 0.00001), family income (US$744.36 vs 568.28, p < 0.0001), kilocalories ingested (2,488.44 vs 2,204.28, p = 0.01), percentage of proteins in diet (15.73 vs 13.69, p = 0.002), and weekly iron consumption (15.24 mg vs 13.04, p < 0.0001)., Conclusions: Pregnant women run a greater risk of suffering anaemia if they have diets of < 1800 kcal, < 13% proteins, less than 7 mg of iron per week, and haemic iron < 10%; and family income below US$400. Ensuring a proper diet and improving the social and economic conditions of this population group will reduce the risk of anaemia during pregnancy and its perinatal consequences.

The diagnosis of megaloblastic anaemias caused by cobalamine or folate deficiency are still difficult. The dosage of these two substances help to differenciate between both carencies, but it is not determinant of any of them and is an expensive method. Homocisteinuria (HC), methylmalonuria (MMA) and formiminoglutamic acid (FIGLU) are cheap tests which could help in the differential diagnosis, if they are used properly. We report 62 patients to whom we made these test simultaneously. All of the patients received 10 micrograms of vit B12 and after 72 hours, 1 mg/day of folic acid (for 3 days). In both cases waiting for the increase of reticulocytyes up to 150 x 10(9)/L as a form of therapeutic test of diagnosis. By this simple way we have detected 97.9% of specificity for cobalamin deficiency of the MMA test, and only 4.2% for HC. This last test had increased its specificity up to 91.6% in association with the negative FIGLU test. We have also found a high specificity (92.3%) for FIGLU due to the detection of folate deficiency, in opposition with other authors who had described it as low as 50%. We have also compared the costs of the 3 tests with the dosage of cobalamine and folate, and we have found that the formers are 11 times less expensive than the last ones.