Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

Cardiovascular events and mortality among type 2 diabetes mellitus patients newly prescribed first-line blood glucose-lowering drugs monotherapies: A population-based cohort study in the Catalan electronic medical record database, SIDIAP, 2010-2015.

AIM: To assess cardiovascular (CV) events and all-cause mortality in type 2 diabetes mellitus (T2DM) patients treated with first-line monotherapies of non-insulin antidiabetic drugs (NIADs). METHODS: Longitudinal retrospective cohort study in the Catalan database SIDIAP (Information System for the Development of Research in Primary Care). T2DM patients ≥18 years newly prescribed first-line monotherapies during 2010-2015 were followed since their first prescription until the composite of major adverse CV events, MACE (myocardium infarction [MI], stroke and all-cause death), its components, heart failure (HF) and peripheral artery disease (PAD) or censoring. Cox proportional hazard models were used to estimate hazard ratios 95% confidence interval (HR [95%CI]). RESULTS: Compared with metformin, the use of sulfonylureas, dipeptidyl peptidase-4 inhibitors (DPP-4 i) and meglitinides were significantly associated with higher risk for MACE (1.55 [1.42-1.68]); 1.49 [1.22-1.84] and 2.01 [1.29-3.12]) and all-cause mortality (1.67 [1.52-1.84], 1.65 [1.30-2.] and 2.08 [1.26-3.42]). Sulfonylureas users had increased risk of MI (1.38 [1.03-1.85]) stroke (1.31 [1.11-1.54]), HF (1.49 [1.28-1.72]) and PAD (1.24 [1.02-1.51]). Meglitinides users were at increased risks of MI, HR 2.03 (1.10-3.74). CONCLUSION: In first-line monotherapies, compared with metformin, sulfonylureas were associated with increased risks in all the outcomes; DPP-4 i and repaglinide showed increased risks of MACE and mortality. Residual confounding cannot be ruled out.

Challenges facing drug utilization research in the Latin American region.

PURPOSE: The International Society of Pharmacoepidemiology (ISPE) in collaboration with the Latin America Drug Utilization Research Group (LatAm DURG), the Medicines Utilization Research in Africa (MURIA) group, and the Uppsala Monitoring Center, is leading an initiative to understand challenges to drug utilization research (DUR) in the Latin American (LatAm) and African regions with the goal of communicating results and proposing solutions to these challenges in four scientific publications. The purpose of this first manuscript is to identify the main challenges associated with DUR in the LatAm region. METHODS: Drug utilization (DU) researchers in the LatAm region voluntarily participated in multiple discussions, contributed with local data and reviewed successive drafts and the final manuscript. Additionally, we carried out a literature review to identify the most relevant publications related to DU studies from the LatAm region. RESULTS: Multiple challenges were identified in the LatAm region for DUR including socioeconomic inequality, access to medical care, complexity of the healthcare system, limited investment in research and development, limited institutional and organization resources, language barriers, limited health education and literacy. Further, there is limited use of local DUR data by decision makers particularly in the identification of emerging health needs coming from social and demographic transitions. CONCLUSIONS: The LatAm region faces challenges to DUR which are inherent in the healthcare and political systems, and potential solutions should target changes to the system.

Cardiovascular outcomes, heart failure and mortality in type 2 diabetic patients treated with glucagon-like peptide 1 receptor agonists (GLP-1 RAs): A systematic review and meta-analysis of observational cohort studies.

BACKGROUND: Cardiovascular outcomes trials (CVOTs) have assessed the effects of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on major adverse cardiovascular events (MACE) and mortality in high cardiovascular (CV) risk populations. Observational research can provide complementary evidence about these effects in unselected populations. AIM: To systematically review retrospective observational cohort studies conducted in electronic healthcare databases (EHDs) assessing GLP-1 RAs´ effects on MACE and/or hospitalisation for heart failure (HHF) and/or all-cause mortality in Type 2 diabetes mellitus (T2DM) patients. METHODS: We systematically searched studies meeting inclusion criteria, compared design, methods and population characteristics, assessed risk for bias and did a meta-analysis (MA) using a random-effects model to calculate overall hazard ratios (HRs) and 95% CI (confidence intervals). RESULTS: Sixteen studies included 285,436 T2DM patients exposed to GLP-1 RAs (exenatide bid, liraglutide, lixisenatide, long-acting exenatide), n ranged from 219 to 160,803 patients. Comparators included: no exposure, other antidiabetic medications (OADs), combined OADs, canagliflozin or multiple comparators. Ten studies estimated all-cause mortality, hazard ratios (HRs) ranged from 0.17 (95% CI 0.02-1.22) to 1.29 (95% CI 0.54-3.13). Thirteen studies assessed cardiovascular events and/or MACE; HRs ranged from 0.27 (95% CI 0.14-0.53) to 1.11 (95% CI 0.99-1.24). Eight studies assessed HHF, HRs ranged from 0.12 (95% CI 0.02-0.66) to 1.64 (95% CI 1.28-2.13). Excluding two studies because of temporal bias, we obtained pooled estimates for all-cause mortality: HR 0.63 (0.44-0.89), CV outcomes HR 0.84 (0.75-0.94) and HHF; HR 0.94 (0.78-1.14), (high between-study variability: I2  = 83.35%; I2  = 70.3%; and I2  = 90.1%, respectively). CONCLUSION: Pooled results of EHDs' studies assessing GLP-1 RAs effects favoured GLP-1 RAs for all-cause mortality and MACE while were neutral for HHF. Results should be interpreted cautiously because of studies' substantial heterogeneity and limitations of observational research.

Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content.

BACKGROUND: Adverse drug reactions (ADRs) are common, often preventable, and a leading cause of morbidity and mortality. Pharmacovigilance (PV) involves detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Education of healthcare professionals (HCPs) involved in drug prescription, dispensing and administration is essential to help prevent and mitigate both ADRs and medication errors and has to be focused on 3 pivotal aspects: •Awareness: All medicines can produce adverse effects. ADRs should always be considered as part of the differential diagnosis if any new adverse condition, symptoms or signs appear after a drug administration or during or after pharmacological treatment. •Knowledge: HCPs must have a sound understanding of the most frequently prescribed drugs and over-the-counter medications, factors that make patients more likely to benefit or more susceptible to harm, as well as of causes of medication errors. •Reporting: HCPs should know how to report ADRs and the role of reporting on regulatory aspects and scientific knowledge. Undergraduate curricula must provide, at a minimum, sufficient skills that warrant the appropriate and safe prescription/dispensing/administration of medications in clinical practice, focusing both on therapeutic effects and prevention of harm. Clinical appraisal skills must include ADRs as differential diagnosis, taking accurate medication history, basic individual causality assessment, identification and proper management of ADRs, and informing patients of possible ADRs. Postgraduate periodic PV training should be mandatory as part of continuing education. Specialised postgraduate education should include advanced contents.

El papel del medico alergista en farmacovigilancia / The role of the alergist in pharmacovigilance

La farmacovigilancia es definida por la OMS como la ciencia y actividades relativas a la deteccion, evaluacion, comprension, y prevencion de los efectos adversos de los medicamentos o de cualquier otro problema relatuvo a ellos. Los medicamentos tiene ubna accion terapeutica, que constituye el beneficio que se espera obtener y tienen tambien riesgos, derivados ya sea de su propia accion farmacologica, o de los excipientes de interacciones con otros farmacos o con alimentos, o riesgos que se producen al interactuar el farmaco con las caracteristicas individuales del paciente(idiosincracia), de la farmacotenia...