Retrospective review of medicine utilization for noncommunicable diseases in three public sector pharmacies in Jamaica / Revisión retrospectiva del uso de medicamentos para enfermedades no transmisibles en tres farmacias del sector público de Jamaica / Revisão retrospectiva do uso de medicamentos para doenças não transmissíveis em três farmácias da rede pública na Jamaica

[ABSTRACT]. Objective. The rational use of medicines offers a cost-saving strategy to maximize therapeutic outcomes for developing and developed countries. The aim of this study was to evaluate the rational use of medicines for selected noncommunicable diseases (NCDs) at three pharmacies at public hospitals in Jamaica using the World Health Organization’s (WHO’s) prescribing indicators. Methods. In this retrospective cross-sectional study, prescriptions for adult outpatients containing at least one medicine for cardiovascular disease, diabetes, cancer, chronic obstructive pulmonary disease or asthma that were filled between January and July 2019 were reviewed using WHO’s prescribing indicators for the rational use of medicines. Data were analyzed and expressed as descriptive and inferential statistics. For all analyses conducted, significance was determined at P < 0.05. Results. A total of 1500 prescriptions covering 5979 medicines were reviewed; prescriptions were mostly written for female patients aged 42–60 years. Polypharmacy was observed in 35.6% (534) of prescriptions, and there was an average of 4 medicines per prescription, with a maximum of 17. Most of the prescriptions at each site were filled, with the main reason for not dispensing a medicine being that it was out of stock. Generic prescribing was high for all sites, accounting for more than 95% (5722) of prescribed medicines. There was full compliance with prescribing according to the WHO Model List of Essential Medicines at two of the sites, but it was just off the target at Site 1, by 1.4%. Conclusions. The WHO guidelines for the rational use of medicines were followed with respect to the proportion of medicines prescribed from the WHO Model List and the proportion of antibiotics prescribed. The number of medicines per prescription and the proportion of medicines prescribed by generic name did not meet the WHO criteria. However, prescribing was aligned with treatment guidelines for the selected NCDs.

[RESUMEN]. Objetivo. El uso racional de los medicamentos proporciona una estrategia de ahorro de costos para maximizar los resultados terapéuticos tanto en los países en desarrollo como en los países desarrollados. El objetivo de este estudio fue evaluar el uso racional de medicamentos para algunas enfermedades no transmisibles (ENT) seleccionadas en tres farmacias de hospitales públicos de Jamaica, usando los indicadores de prescripción de la Organización Mundial de la Salud (OMS). Métodos. En este estudio transversal retrospectivo se examinaron las prescripciones realizadas a pacientes ambulatorios adultos que incluían al menos un medicamento para enfermedades cardiovasculares, diabetes, cáncer, enfermedad pulmonar obstructiva crónica o asma, dispensadas entre enero y julio del 2019, utilizando los indicadores de prescripción para el uso racional de medicamentos de la OMS. Los datos se analizaron y expresaron mediante estadística descriptiva e inferencial. Para todos los análisis realizados se estableció un nivel de significación de p <0,05. Resultados. Se examinó un total de 1 500 prescripciones que incluían 5 979 medicamentos; la mayor parte de ellas correspondían a pacientes de sexo femenino de 42 a 60 años. Se observó que había polimedicación en el 35,6% (534) de las prescripciones, con un promedio de 4 y un máximo de 17 medicamentos por receta. En todos los centros se dispensó la mayor parte de los medicamentos prescritos, y el motivo principal para no hacerlo fue la falta de existencias del medicamento en cuestión. La prescripción de genéricos fue elevada en todos los centros y supuso más del 95% (5 722) de los medicamentos prescritos. En dos centros la prescripción se realizó en su totalidad de acuerdo con la Lista Modelo de Medicamentos Esenciales de la OMS, pero en el centro 1 no se alcanzó el objetivo por un 1,4%. Conclusiones. Se siguieron las directrices de la OMS para el uso racional de medicamentos en cuanto a la proporción de medicamentos prescritos de la Lista Modelo de la OMS y la proporción de antibióticos prescritos. El número de medicamentos por receta y la proporción de medicamentos prescritos mediante su nombre genérico no cumplieron con los criterios de la OMS. Sin embargo, las prescripciones estaban en consonancia con las directrices de tratamiento de las enfermedades no transmisibles seleccionadas.

[RESUMO]. Objetivo. O uso racional de medicamentos é uma estratégia de contenção de custos para maximizar os resultados terapêuticos em países desenvolvidos e em desenvolvimento. O objetivo deste estudo foi avaliar o uso racional de medicamentos para algumas doenças não transmissíveis selecionadas em três farmácias de hospitais públicos na Jamaica a partir dos indicadores de prescrição preconizados pela Organização Mundial da Saúde (OMS). Métodos. Estudo transversal retrospectivo que avaliou receitas médicas de pacientes ambulatoriais adul- tos contendo pelo menos um medicamento prescrito para doença cardiovascular, diabetes, câncer, doença pulmonar obstrutiva crônica ou asma e dispensadas entre janeiro e julho de 2019. A avaliação foi realizada a partir dos indicadores de prescrição preconizados pela OMS para o uso racional de medicamentos. Os dados obtidos foram analisados por meio de estatísticas descritivas e inferenciais. O nível de significância de p <0,05 foi adotado em todas as análises. Resultados. Ao todo, foram analisadas 1 500 receitas médicas compreendendo 5 979 medicamentos. Em sua maioria, as receitas foram prescritas para pacientes do sexo feminino com idades entre 42 e 60 anos. A polifarmácia foi observada em 35,6% (534) das receitas; em média, foram prescritos 4 medicamentos, até um máximo de 17. As farmácias estudadas dispensaram a maior parte dos medicamentos receitados. O principal motivo para não fornecer algum medicamento foi o desabastecimento. O percentual de medicamentos genéricos foi alto em todos os locais, representando mais de 95% (5 722) do volume receitado. Houve plena observância da Lista Modelo de Medicamentos Essenciais da OMS nas receitas analisadas em dois dos locais estudos, e observância quase completa (diferença de 1,4%) no local 1. Conclusões. As diretrizes da OMS de uso racional de medicamentos foram cumpridas no que se refere ao percentual de medicamentos receitados de acordo com a Lista Modelo da OMS e o percentual de antibióticos receitados. Os critérios da OMS não foram cumpridos quanto ao número de medicamentos por receita e ao percentual receitado usando o nome genérico. Porém, os medicamentos foram receitados de acordo com as diretrizes terapêuticas para as doenças não transmissíveis selecionadas.

Relação entre benefício e risco em interações medicamentosas nas prescrições médicas de um hospital universitário no estado de São Paulo / Benefit-risk relationship in drug interactions in prescriptions from a university hospital in the state of São Paulo / Relación beneficio-riesgo en interacciones medicamentosas en prescripciones de un hospital universitario del estado de São Paulo

Objetivo: Avaliar interações medicamentosas (IM), em que os riscos se so- brepõem aos benefícios (nível I) ou os benefícios se sobrepõem aos riscos (nível II); a partir da análise retrospectiva de prescrições médicas em um Hospital Universitário no estado de São Paulo, Brasil. Métodos: Foram analisadas 19762 prescrições médicas des- tinadas à farmácia do hospital, de janeiro a setembro de 2009; com o auxílio de programas sobre IM, para categorizar IM de nível I e II. Resultados: Na análise 26,53% apresentaram IM, em que 23,64% foram classificadas em nível I e 76,35% em nível II. Dentre as IM com maior frequência no nível I, estavam: ácido acetilsalicílico (AAS) e clopidogrel, AAS e heparina, captopril e espironolactona, digoxina e hidroclorotiazida. Houve uma redução em percentual de IM de nível I, comparando janeiro representado por 26,5% e setembro representado por 18,4%. Já nas IM de nível II, tem-se as seguintes associações com maior frequência: AAS e propranolol, AAS e insulina regular humana, AAS e ate- nolol, AAS e enalapril, AAS e carvedilol. Conclusão: A atuação dos farmacêuticos cola- borou à redução de IM de nível I, devido à intervenção por meio de comunicação estabe- lecida com os prescritores; sinalizando a importância da equipe interprofissional em saúde.

Objective: To evaluate drug interactions (MI), in which risks outweigh the benefits (level I) or benefits outweigh the risks (level II); from the retrospective analysis of medical prescriptions in a University Hospital in the state of São Paulo, Brazil. Methods: 19,762 prescriptions destined to the hospital pharmacy were analyzed, from January to September 2009; with the help of programs on MI, to categorize level I and II MI. Results: In the analysis 26.53% presented MI, in which 23.64% were classified in level I and 76.35% in level II. Among the most frequent level I MI were: acetylsalicylic acid (ASA) and clopidogrel, ASA and heparin, captopril and spironolactone, digoxin and hydrochlorothiazide. There was a reduction in the percentage of level I MI, comparing January, which accounted for 26.5%, and September, which accounted for 18.4%. As for level II MI, the following associations were more frequent: ASA and propranolol, ASA and regular human insulin, ASA and atenolol, ASA and enalapril, ASA and carvedilol. Conclusion: The role of pharmacists collaborated to the reduction of level I MI, due to the intervention by means of communication established with the prescribers; signaling the importance of the interprofessional health team.

Objetivo: Evaluar las interacciones medicamentosas (IM), en las que los riesgos superan a los beneficios (nivel I) o los beneficios superan a los riesgos (nivel II); a partir del análisis retrospectivo de las prescripciones médicas en un Hospital Universitario del estado de São Paulo, Brasil. Métodos: Se analizaron 19.762 prescripciones destinadas a la farmacia del hospital, de enero a septiembre de 2009; con la ayuda de programas sobre IM, para categorizar los IM de nivel I y II. Resultados: En el análisis el 26,53% presentaron IM, en el que el 23,64% se clasificaron en nivel I y el 76,35% en nivel II. Entre los IM de nivel I más frecuentes estaban: ácido acetilsalicílico (AAS) y clopidogrel, AAS y heparina, captopril y espironolactona, digoxina e hidroclorotiazida. Hubo una reducción del porcentaje de IM de nivel I, comparando enero, que supuso el 26,5%, y septiembre, que supuso el 18,4%. En cuanto a los IM de nivel II, fueron más frecuentes las siguientes asociaciones: AAS y propranolol, AAS e insulina humana regular, AAS y atenolol, AAS y enalapril, AAS y carvedilol. Conclusiones: El papel de los farmacéuticos colaboró a la reducción de las IM de nivel I, debido a la intervención mediante la comunicación establecida con los prescriptores; señalando la importancia del equipo sanitario interprofesional.

Assessment of efficacy of drug evaluation and classification program in Florida.

OBJECTIVE: The present study aims to assess the effectiveness of the Drug Evaluation and Classification (DEC) program in Florida. METHODS: Data from 236 completed DEC evaluations of central nervous system (CNS) depressants, CNS stimulants, narcotic analgesics, and cannabis were analyzed using a classification process comprising toxicology findings and corresponding Drug Recognition Expert (DRE) opinions. A series of standard measures (sensitivity, specificity, false-alarm rate, miss rate, corroboration, and accuracy) were calculated to assess the effectiveness of the DEC program. RESULTS: DREs provided 172 correct opinions and 23 missed opinions, resulting in an accuracy rate of 88%, sensitivity rate of 97%, specificity rate of 23%, false alarm rate of 77%, miss rate of 3%, and corroboration rate of 91%. The 12-step DRE protocol of the DEC program therefore has the desired effect of DREs formulating correct opinions. The specificity and false alarm rate were influenced by the restricted testing procedures in the state of Florida. In general, law enforcement officers certified in the DEC program with specialized training can identify drugged drivers and the correct drug category of the drug causing impairment at the time of operating a vehicle. The DEC program goals are met through rigorous training and a curriculum establishing the 12-step DRE protocol. CONCLUSIONS: DRE drug classification opinions identify drugged drivers. The limitations of Florida's biological sample testing procedures have an impact on the specificity of DRE opinions. Addressing these limitations could increase the confirmation rates of the presence of drugs in the individual's biological samples, which would directly impact the conviction rates in DUI-related criminal cases. Further Florida's testing procedures need to be further studied and updated to improve the DEC program in Florida.

Children's Oncology Group's 2023 blueprint for research: Pharmacy.

Children's Oncology Group (COG) pharmacists and pharmacy technicians from more than 200 COG-member institutions comprise the COG Pharmacy Discipline. Discipline members serve an essential role in the design and execution of COG clinical trials. Core activities include study drug management, study drug access, clinical trial operations, protocol harmonization, and direct patient care. Discipline members are also actively involved in continuing education, membership engagement, and research across other COG committees/domains. Future areas of committed growth for the discipline include pharmacogenomics, pharmacokinetics, pharmacoeconomics, pharmaceutics, and implementation science.

[Problems and thoughts in clinical safety evaluation of traditional Chinese medicine].

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Factors Affecting Success of New Drug Clinical Trials.

Clinical trials are an essential process in the development of new drugs. In spite of time-consuming processes and high costs, the overall success rate of clinical trials is only 7.9%, which is a high risk for biopharmaceutical companies. However, despite these huge risks, research on finding factors affecting clinical trials to overcome and manage to risks has been insufficient. Considering these characteristics of the pharmaceutical industry, this study investigated the factors affecting the success of sponsor-initiated clinical trials. The success factors investigated were categorized into four factors: quality of clinical trials, speed of clinical trials, relationship type, and communication. Logistic regression was performed to measure each factor by analyzing 24,295 cases of Phase 1 to 4 trials from ClinicalTrials.gov. Because of the analysis, the factors affecting the success of the clinical trials were varied according to each clinical phase and the drug types: New Molecular Entity (NME)/Biologics, and the success ratio in the quality variable affected the overall clinical trial phases. Additionally, the experience, speed, relationship type, and communication variables were also found to be statistically significant for the success of each phase and drug type.

Digital Tools-Regulatory Considerations for Application in Clinical Trials.

During the last few years, the pharmaceutical industry has adopted digital technologies/digital health technology (DHT) to improve the drug development process and the commercialization of new products. Technological advances are strongly supported by both the US-FDA and the EMA, but the regulatory landscape in the US seems to be more suitable to promote innovation in the digital health sector (e.g. Cures Act). In contrast, the new Medical Device Regulation sets high hurdles for Medical Device software to pass regulatory scrutiny.On both sides of the Atlantic, a digital tool must be fit-for-purpose for the intended use in the clinical drug trial. Irrespective of its status as a Medical Device, at least the basic safety and performance requirements according to local regulations should be met, quality system and surveillance requirements should be fulfilled, and the sponsor must ensure conformity with GxP and the local data privacy and cybersecurity legislations.There is an overlap in technical and clinical validation for drug development tool qualification in both regions to ensure that the digital tools deliver reliable data with tangible clinical benefits. Based on an analysis of the regulatory framework of the FDA and the EMA, this study proposes regulatory strategies for a global pharma company: It would be prudent for drug development companies to a) use approved solutions or b) consider qualification of drug development tools early and in parallel to clinical development. Early engagement with the FDA and the EMA/CA is recommended to define evidentiary standards and corresponding regulatory pathways for different contexts-of-use and to clarify regulator's expectations as to what extent data collected by digital tools are acceptable to support marketing authorization applications (MAA).Hence a harmonization of the partly disparate regulatory requirements in the US and the EU accompanied by further development of the regulatory landscape in the EU, could further foster the use of digital tools in drug clinical development. The outlook for the use of digital tools in clinical trials is hopeful.

Diversity, equity, and inclusion in genitourinary clinical trials leading to FDA novel drug approval: An assessment of the FDA center for drug evaluation and research drug trials snapshot.

To determine the distribution of race and ethnicity among genitourinary oncology trial participants leading to FDA approval of novel molecular entities/biologics. Secondarily, we evaluated whether the proportion of Black participants in clinical trials increased over time. We quired the FDA Center for Drug Evaluation and Research Drug Trials Snapshot (DTS) between 2015 and 2020 for urologic oncology clinical trials leading to FDA approval of novel drugs. Enrollment data was stratified by race and ethnicity. Cochran-Armitage Trend tests were used to examine changes in Black patient participation over years. Nine clinical trials were identified that led to FDA approval of 5 novel molecular entities for prostate and 4 molecular entities for urothelial carcinoma treatment. Trials for prostate cancer included 5202 participants of which 69.8% were White, 4.0% Black, 11.0% Asian, 3.6% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 3% other. Trials in urothelial carcinoma had 704 participants of which 75.1% were male, 80.8% White, 2.3% Black, 2.4% Hispanic, <1% American Indian/Alaska Native or Native Hawaiian/Pacific Islander, 5% other. Black participation rates over time did not change for urothelial (P = 0.59) or the combined cancer cohort (P = 0.29). Prostate cancer enrollment trends among Black participant declined over time (P = 0.03). Participants in genitourinary clinical trials leading to FDA approval of novel drugs are overwhelmingly white. Involving stakeholders who represent the needs and interests of underrepresented populations in the design and implementation of clinical trials of novel agents may be a strategy to increase diversity, equity, and inclusion among genitourinary clinical trials.

All-in-one calcium nanoflowers for dual outputs biosensor: A simultaneous strategy for depression drug evaluation and non-invasive stress assessment.

Although enzyme-based signal amplification has been well developed for biosensors, their application in low-abundance biomarker under complicated conditions detection remains challenge. Cortisol is a steroid hormone and a quantitative evaluation of cortisol can objectively assess stress and depression. However, various factors can induce slight cortisol changes in body fluids, and this in turn sets a strict requirement for bedside testing of cortisol for evaluation of stress. Herein, all-in-one calcium nanoflowers (CaHPO4-AM-HRP-SA NFs) integrated with horseradish peroxidase (HRP), α-amylase (α-AM), and streptavidin (SA) have been synthesized to develop a simple but powerful biosensor for cortisol detection. High specific surface area and allosteric modulator provided by the hybrid nanoflowers as inherent advantages significantly boosted the catalytical ability and stability compared with the free enzymes. CaHPO4-AM-HRP-SA NFs also endowed the sensor with two output signals of one sample, leading the as-prepared sensor to realize self-calibration detection. Aside from using a traditional microplate reader to measure the signal, it could also be read out by a handheld blood glucose meter and a mobile phone. The sensor exhibited attractive simplicity and sensitivity with a low LOD of 98.5 pg mL-1. It accomplished the sensitive evaluation of cortisol in rat serum and assessed the antidepressant effects of different medications. The non-invasive and reliable cortisol detection is also achieved in human urine and saliva samples. Overall, we have demonstrated that the sensor can be deployed as a promising platform to evaluate drug efficiency and monitor stress in a simple and non-invasive manner.

Real-world and natural history data for drug evaluation in Duchenne muscular dystrophy: suitability of the North Star Ambulatory Assessment for comparisons with external controls.

Using external controls based on real-world or natural history data (RWD/NHD) for drug evaluations in Duchenne muscular dystrophy (DMD) is appealing given the challenges of enrolling placebo-controlled trials, especially for multi-year trials. Comparisons to external controls, however, face risks of bias due to differences in outcomes between trial and RWD/NHD settings. To assess this bias empirically, we conducted a multi-institution study comparing mean 48-week changes in North Star Ambulatory Assessment (NSAA) total score between trial placebo arms and RWD/NHD sources, with and without adjustment for baseline prognostic factors. Analyses used data from three placebo arms (235 48-week intervals, N = 235 patients) and three RWD/NHD sources (348 intervals, N = 202 patients). Differences in mean ΔNSAA between placebo arms and RWD/NHD sources were small before adjustment (-1.2 units, 95% CI: [-2.0 -0.5]) and were attenuated and no longer statistically significant after adjustment (0.1 units (95% CI: [-0.6, 0.8]). Results were similar whether adjusting using multivariable regression or propensity score matching. This consistency in ΔNSAA between trial placebo arms and RWD/NHD sources accords with prior findings for the six-minute walk distance, provides a well-validated framework for baseline adjustment of prognostic factors, and supports the suitability of RWD/NHD external controls for drug evaluations in ambulatory DMD.

Captopril oral solution for pediatric use: formulation, stability study and palatability assessment in vivo

Abstract he aim of this work was to develop an oral solution of captopril at 5 mg/mL preservative-free. Two formulations were prepared, one containing sweetener (formulation 1) and the other without this excipient (formulation 2). The results found of validation parameters from analytical method performed by HPLC for captopril were, linearity 0.9998, the limit of detection 15.71 µg/mL, the limit of quantification 47.60 µg/mL, repeatability 1.05%, intermediate precision 2.42%, accuracy intraday 101,53%, accuracy inter-day 99.85%. Moreover, the results found for captopril disulfide were, linearity 0.9999, limit of detection 0.65 µg/mL, limit of quantification 1.96 µg/mL, repeatability 2.28%, intermediate precision 1.51%, accuracy intraday 101.36%, accuracy inter-day 100.29%. The appearance of formulations was clear and colorless, pH measures were 3.12 and 3.04, dosage of captopril and captopril disulfide were 99.45% and 99.82%, 0.24% and 0.12% for formulation 1 and formulation 2, respectively. The stability study demonstrated that the concentration of captopril and captopril disulfide in the formulations was > 90% and below 3%, respectively. The in vivo palatability study in animals and humans showed that Formulation 1 containing the sweetener had better acceptance. Thus, the sweetener was able to improve the unpleasant taste of the formulation

Avaliação de medicamentos potencialmente inapropriados e da polifarmácia em pacientes idosos em um hospital universitário / Evaluation of potentially inappropriate medications and polypharmacy in elderly patients at a university hospital

Introdução: O Brasil, assim como outros países, vem alterando seu perfil demográfico elevando o número de pessoas idosas, o que repercute em mudanças não só para sociedade, mas também para saúde pública. Este grupo de pacientes é mais vulnerável devido à fisiologia inerente ao envelhecimento, logo se tornam mais propensos ao uso de medicamentos que podem causar outros problemas de saúde. Essa probabilidade de risco é uma preocupação atual e levou a criação de métodos que norteiam os prescritores para adequarem suas terapêuticas neste grupo de pacientes. Um destes métodos é o critério de Beers, que é atualizado periodicamente trazendo uma lista de medicamentos potencialmente inapropriados (MPIs) para idosos. Objetivo: Avaliar a prescrição de pacientes idosos internados no Hospital Universitário da Universidade Federal de Juiz de Fora (HU-UFJF/Ebserh) quanto à prevalência do uso de MPI e polifarmácia, no período de julho a agosto de 2019. Material e Métodos: Estudo observacional descritivo e retrospectivo, cujos dados foram coletados de prontuários pacientes idosos com idade igual ou superior a 65 anos para obtenção dos resultados que foram avaliados estatisticamente. Resultados: Foram avaliados 187 prontuários, e observada prevalência de 80,2% da prescrição de MPIs, sendo os mais prevalentes omeprazol e benzodiazepínicos. A maioria dos pacientes tiveram polifarmácia (95,7%). Conclusão: Os resultados convergem com base no critério de Beers, para necessidade de adequar a terapia de pacientes idosos. É necessário também avaliar os benefícios e alternativas quanto aos MPIs mais prevalentes, além de realizar estudos observacionais sobre possíveis efeitos adversos que possam ser consequência do uso desses medicamentos, com objetivo de aperfeiçoar a terapia farmacológica e aprimorar a farmacoeconomia, melhorando assim a qualidade de vida dos pacientes idosos.

Introduction: Brazil, like other countries, has been changing its demographic profile, increasing the number of elderly people, which reflects in changes not only for society, but also for public health. This group of patients is more vulnerable due to the inherent physiology of aging, so they become more likely to use medications that can cause other health problems. This risk probability is a current concern and has led to the creation of methods that guide prescribers to adapt their therapies in this group of patients. One of these methods is the Beers criterion, which is periodically updated with a list of potentially inappropriate medications (PIM) for the elderly. Objective: To evaluate the prescription of elderly patients hospitalized at the University Hospital of Juiz de Fora (HU-UFJF/Ebserh) regarding the prevalence of the use of PIM and polypharmacy, from July to August 2019. Material and Methods: Descriptive and retrospective observational study, whose data were collected from medical records of elderly patients aged 65 years or older to obtain the results that were statistically evaluated. Results: A total of 187 medical records were evaluated, and a prevalence of 80.2% of the prescription of PIMs was observed, the most prevalent being omeprazol and benzodiazepines. Most patients had polypharmacy (95.7%). Conclusion: The results converge, based on the Beers criterion, for the need to suit the therapy of elderly patients. It is also necessary to evaluate the benefits and alternatives regarding the most prevalent PIMs, in addition to conducting observational studies on possible adverse effects that may be a consequence of the use of these medications, aiming to refine pharmacological therapy and improve pharmacoeconomics, thus improving quality of life of elderly patients.

Learning from the past: development of safe and effective COVID-19 vaccines.

The rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has elicited an equally rapid response aiming to develop a COVID-19 vaccine. These efforts are encouraging; however, comprehensive efficacy and safety evaluations are essential in the development of a vaccine, and we can learn from previous vaccine development campaigns. In this Perspective, we summarize examples of vaccine-associated disease enhancement in the history of developing vaccines against respiratory syncytial virus, dengue virus, SARS-CoV and Middle East respiratory syndrome coronavirus, which highlight the importance of a robust safety and efficacy profile, and present recommendations for preclinical and clinical evaluation of COVID-19 vaccine candidates as well as for vaccine design and optimization.

Fit-for-Purpose Validation and Establishment of Assay Acceptance and Reporting Criteria of Dendritic Cell Activation Assay Contributing to the Assessment of Immunogenicity Risk.

Validation of key analytical and functional performance characteristics of in vitro immunogenicity risk assessment assays increases our confidence in utilizing them for screening biotherapeutics. Herein, we present a fit-for-purpose (FFP) validation of a dendritic cell (DC) activation assay designed to assess the immunogenicity liability of protein biotherapeutics. Characterization of key assay parameters was achieved using monocyte-derived DCs (MoDCs) treated with cell culture medium only (i.e., background control (BC)), keyhole limpet hemocyanin (KLH) as system positive control (SPC), and 2 therapeutic monoclonal antibodies (mAbs) with known clinical immunogenicity profiles (bococizumab and TAM163) as therapeutic controls (TCs). In the absence of established validation guidelines for primary cell-based assays, the present DC activation assay was validated using a novel FFP approach which allows more flexibility in selection of validation parameters and designing of experiments based on the intended use of the assay. The present FFP validation allowed us to understand the impact of experimental variables on assay precision, develop a clear concise readout for DC activation results, establish a reliable response threshold to define a result as a positive DC activation response, and define in-study donor acceptance criteria and cohort size. FFP validation of this DC activation assay indicated that the assay is sufficient to support its context of use, a preclinical immunogenicity risk management tool.

ASSESSMENT OF THE EFFICACY AND SAFETY OF CHLOROQUINE MONOTHERAPY FOR THE TREATMENT OF ACUTE UNCOMPLICATED GESTATIONAL MALARIA CAUSED BY P. VIVAX, CÓRDOBA, COLOMBIA, 2015-2017.

OBJECTIVE: To determine the efficacy of chloroquine monotherapy in Colombian pregnant women with acute uncomplicated malaria vivax (GMV). METHODS: Prospective cohort study in pregnant women who presented of their own accord between February 1, 2015 and December 31, 2017 to malaria or prenatal care centers in two Colombian towns and in whom the diagnosis of Plasmodium vivax was confirmed by means of blood spot test and and quantitative polymerase chain reaction (qPCR). Measured variables included sociodemographics, therapeutic failure (TF) and serious adverse events at 28 days and frequency of recurrence-relap (RR) over a follow-up period of 120 days. The WHO protocol was applied for the assessment of monotherapy with cloroquine (m-CQ) efficacy. RESULTS: Overall, 47 pregnant women were identified. During the 28-day follow-up period there were no losses, and there were two cases of TP (4.2%=2/47). Of the 45 women followed between 29 and 120 days, 11 were lost (24.4%=11/45) and there were 13 cases of RR, with an RR frequency ranging between 29 and 53 % depending on the type of analysis. CONCLUSIONS: Chloroquine is still highly effective as a cure of acute malaria vivax attack in GM in Colombia, and continues to be a good option for the treatment of acute phase GM. The RR frequency is high. Studies are required that evaluate therapeutic alternatives in MG. There is a pressing need for medications and/or procedures that can help reduce this very high risk.

TITULO: EVALUACIÓN DE LA EFICACIA Y SEGURIDAD DE LA MONOTERAPIA CON CLOROQUINA PARA TRATAR MALARIA GESTACIONAL AGUDA NO COMPLICADA DEBIDA P. VIVAX, CÓRDOBA, COLOMBIA, 2015-2017. OBJETIVO: determinar la eficacia y seguridad de la monoterapia con cloroquina en gestantes colombianas con ataque agudo no complicado de malaria vivax (MGV). METODOS: estudio de cohorte prospectiva en pacientes gestantes que consultaron de manera espontánea entre 1 febrero de 2015 y 31 diciembre de 2017 a los puestos de malaria o de control prenatal en dos poblaciones de Colombia, en quienes se confirmó el diagnóstico de Plasmodium vivax mediante gota gruesa y qPCR (quantitative polymerase chain reaction). Se midieron variables sociodemográficas, falla terapéutica (FT) y eventos adversos serios a los 28 días y la frecuencia de recurrencia-recaída (RR) con seguimiento de 120 días. Se aplicó el protocolo de la OMS para evaluar la eficacia de monoterapia con cloroquina (m-CQ). RESULTADOS: se captaron 47 gestantes; en el seguimiento de 28 días no hubo pérdidas y hubo 4,2 % (2/47) de FT. En el seguimiento de 45 mujeres entre los días 29 y 120 hubo 11 pérdidas (24,4 % = 11/45) y 13 RR con frecuencia que varió entre 29 y 53 % según el tipo de análisis. CONCLUSIONES: la cloroquina conserva muy alta eficacia para curar el ataque agudo de malaria vivax en malaria gestacional (MG) en Colombia, y continúa siendo una buena opción para el tratamiento de la fase aguda. La frecuencia de RR es alta. Se requieren estudios que evalúen alternativas terapéuticas en la MG. Hay urgente necesidad de disponer de medicamentos o procedimientos que reduzcan ese altísimo riesgo.

Empirical Study on the Transparency of Security Risk Information in Chinese Listed Pharmaceutical Enterprises Based on the ANP-DS Method.

Frequent outbreaks of drug safety incidents pose a massive threat to public health and safety, while the transparency of security risk information in medical enterprises is not optimistic. Therefore, this study uses the analytic network process (Dempster-Shafer method) to construct a transparent comprehensive evaluation model for security risk information in listed pharmaceutical enterprises from the perspective of government supervision and listed pharmaceutical enterprises. On the basis of 59,305 data obtained by 303 enterprises listed in the Chinese biomedical sector, this research conducted an empirical study on the transparency of safety risk information in Chinese listed pharmaceutical enterprises. The current study found that the transparency of security risk information in Chinese listed pharmaceutical enterprises is generally between "general" and "relatively good" and tends to be "relatively good." However, administrative punishment information, adverse drug reaction reporting systems, and production processes need continuous improvement.