University Pharmacy: from the foundation to the Pandemic times of Covid-19

Abstract The University Pharmacy Program (FU), from the Federal University of Rio de Janeiro (UFRJ), was created based on the need to offer a curricular internship to students of the Undergraduate Course at the Faculty of Pharmacy. Currently, it is responsible for the care of about 200 patients/day, offering vacancies for curricular internships for students in the Pharmacy course, it has become a reference in the manipulation of many drugs neglected by the pharmaceutical industry and provides access to medicines for low-income users playing an important social function. Research is one of the pillars of FU-UFRJ and several master and doctoral students use the FU research laboratory in the development of dissertations and theses. As of 2002, the Pharmaceutical Care extension projects started to guarantee a rational and safe pharmacotherapy for the medicine users. From its beginning in 1982 until the current quarantine due to the COVID-19 pandemic, FU-UFRJ has been adapting to the new reality and continued to provide patient care services, maintaining its teaching, research, and extension activities. The FU plays a relevant social role in guaranteeing the low-income population access to special and neglected medicines, and to pharmaceutical and education services in health promotion.

Therapeutic alternatives and strategies for drug conservation in the intensive care unit during times of drug shortage: a report of the Ontario COVID-19 ICU Drug Task Force.

During the coronavirus disease (COVID-19) global pandemic, urgent strategies to alleviate shortages are required. Evaluation of the feasibility, practicality, and value of drug conservation strategies and therapeutic alternatives requires a collaborative approach at the provincial level. The Ontario COVID-19 ICU Drug Task Force was directed to create recommendations suggesting drug conservation strategies and therapeutic alternatives for essential drugs at risk of shortage in the intensive care unit during the COVID-19 pandemic. Recommendations were rapidly developed using a modified Delphi method and evaluated on their ease of implementation, feasibility, and supportive evidence. This article describes the recommendations for drug conservation strategies and therapeutic alternatives for drugs at risk of shortage that are commonly used in the care of critically ill patients. Recommendations are identified as preferred and secondary ones that might be less desirable. Although the impetus for generating this document was the COVID-19 pandemic, recommendations should also be applicable for mitigating drug shortages outside of a pandemic. Proposed provincial strategies for drug conservation and therapeutic alternatives may not all be appropriate for every institution. Local implementation will require consultation from end-users and hospital administrators. Competing equipment shortages and available resources should be considered when evaluating the appropriateness of each strategy.

RéSUMé: Pendant la pandémie mondiale du coronavirus (COVID-19), des stratégies urgentes pour réduire les pénuries sont nécessaires. L'évaluation de la faisabilité, de l'aspect pratique et du mérite des stratégies de préservation des médicaments et des alternatives thérapeutiques nécessite une approche collaborative au niveau provincial. Le Groupe de travail ontarien sur les médicaments à l'USI pendant la COVID-19 a reçu comme mandat d'élaborer des recommandations proposant des stratégies de préservation des médicaments et des alternatives thérapeutiques pour les médicaments essentiels utilisés dans les unités de soins intensifs courant un risque de pénurie pendant la pandémie de COVID-19. Des recommandations ont été rapidement élaborées en utilisant une méthode Delphi modifiée, puis évaluées selon leur facilité de mise en œuvre, leur faisabilité et les données probantes les préconisant. Cet article décrit les recommandations quant aux stratégies de préservation des médicaments et aux alternatives thérapeutiques aux médicaments possiblement à risque de pénurie fréquemment utilisés pour les soins des patients en état critique. Les recommandations sont identifiées comme 'à privilégier' ou 'secondaires' si moins souhaitables. Bien que la pandémie de la COVID-19 ait été l'impulsion incitant la création de ce document, ces recommandations devraient également être applicables pour réduire les pénuries de médicaments en contexte normal. Les stratégies provinciales proposées pour la préservation des médicaments et les alternatives thérapeutiques pourraient ne pas être adaptées pour toutes les institutions. La mise en œuvre locale nécessitera la consultation des utilisateurs et des administrateurs hospitaliers. Il faudrait tenir compte des pénuries de matériel concurrentes et des ressources disponibles lors de l'évaluation de la faisabilité de chaque stratégie.

Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts. They also increasingly have recognized that quality needs to be built into systems and processes throughout the lifecycle of the product. Moreover, the recent COVID-19 crisis has emphasized the need to adopt practices that better promote global supply chain resilience. In this paper, the USP Quality Advisory Group explores the various paradigm shifts currently impacting pharmaceutical quality and the approaches that are being taken to adapt to this new environment. Broad adoption of the Analytical Procedure Lifecycle approach, improved data management, and utilization of digital technologies are identified as potential solutions that can help meet the challenges of these quality paradigm shifts. Further discussion and collaboration among stakeholders are needed to pursue these and other solutions that can ensure a continued focus on quality while facilitating pharmaceutical innovation and development.

Medicine shortages: there are solutions! Actions to take to reduce medicine shortages.

The aim of this paper is to propose solutions to reduce the number and frequency of medicine shortages in Australia. Some of the many factors that contribute to medicine shortages, such as manufacturers' production processes and business decisions, are outside the control of Australian stakeholders. But there are many factors that are within the control of stakeholders, including poor communication between stakeholders, incomplete and inaccurate information, unhelpful practices and attitudes of hospital tender authorities, and lack of certainty and incentives for manufacturers in relation to pharmaceutical tenders. The following strategies are designed to address these issues and achieve a significant reduction in the number and frequency of medicine shortages in Australian hospitals. They include improving communication and understanding between stakeholders, providing higher quality information on likely usage, changing practices of hospital tender authorities to better meet stakeholder requirements, and increasing incentives for manufacturers to participate in hospital tenders. The six key actions to implement the medicine shortage-reducing strategies are: (1) initiate a biannual forum for hospitals and industry; (2) establish a medicines substitutes information service operating nationally; (3) share information on likely changes to hospital usage; (4) reform stock allocation strategies; (5) introduce incentives for manufacturers; and (6) change hospital tender authority practices and policies. The first step to reduce medicine shortages is for stakeholders to think differently about the problem, and to act more collaboratively using the proposed strategies and actions, as a framework for change.

A qualitative study on the elderly and accessibility to health services during the COVID-19 lockdown in Buenos Aires, Argentina - Part 2. / Estudio cualitativo sobre los adultos mayores y la accesibilidad a los servicios de salud durante el confinamiento por COVID-19 en Buenos Aires, Argentina - parte 2.

INTRODUCTION: On March 19, 2020, a mandatory lockdown was imposed in Argentina due to the global pandemic caused by SARS-CoV-2. OBJECTIVES: To explore the elderlys healthcare experiences during the lockdown and the problems that may have arisen regarding accessibility to the healthcare system and emerging adaptations to medical care. METHODS: We coded the data using Atlas.ti 8 software and then triangled the analysis among researchers from different backgrounds. Finally, concept maps were developed and themes arising from these were described. RESULTS: Thirty-nine participants were interviewed from the metropolitan area in Buenos Aires from April to July of 2020. The main emerging themes were: 1) access to regularly scheduled consults, 2) access to chronic medication, 3) emergency consultations, and 4) the role of information and communication technologies. Accessibility to the healthcare system was compromised due to reduced outpatient consultations, affecting health checkups, diagnosis, and treatment. However, participants tried to keep their immunizations up to date. Information and communication technologies were used to fill digital prescriptions and online medical consultations. While this was a solution to many, others did not have access to these technologies or had trouble using them. CONCLUSIONS: The global pandemic caused a reduction in outpatient medical consultations. Emerging needs originated new ways of carrying out medical consultations, mainly through information and communication technologies, which was a solution for many but led to the exclusion of others because of the preexisting technology gap.

INTRODUCCIÓN: El 19 marzo de 2020 se decretó el aislamiento social preventivo y obligatorio en Argentina como respuesta a la pandemia por el virus SARS-CoV-2 y la enfermedad que causa, COVID-19. OBJETIVOS: Explorar las experiencias de los adultos mayores con relación al cuidado de su salud durante el confinamiento por COVID-19, los problemas en la accesibilidad al sistema de salud y las adaptaciones emergentes. MÉTODOS: Investigación con abordaje cualitativo. Los participantes fueron adultos mayores de 60 años. Mediante un muestreo en bola de nieve, el equipo investigador contactó telefónicamente a los participantes donde se realizó una entrevista semiestructurada. Se trianguló el análisis de los hallazgos entre los investigadores con distinta formación académica. Se realizaron mapas conceptuales a través de los cuales se eligieron los ejes temáticos a abordar. RESULTADOS: Se entrevistaron a 39 participantes de la Ciudad Autónoma de Buenos Aires y Gran Buenos Aires en el período de abril y julio del año 2020. Los principales temas emergentes fueron: acceso a consultas programadas habituales, acceso a la medicación crónica, consultas agudas y emergentes, y el rol de las tecnologías de información y comunicación. La accesibilidad al sistema de salud se vio comprometida por la disminución de oferta de consultas presenciales, afectando los controles de salud, el diagnóstico y tratamiento de enfermedades. Sin embargo, los participantes intentaron mantener al día sus inmunizaciones. Las tecnologías de la información y comunicación permitieron la emisión de recetas virtuales y las teleconsultas. Si bien esto representó una solución para muchos adultos mayores, también generó un problema para otros que no tenían acceso o no sabían utilizarlas. CONCLUSIÓN: La pandemia afectó la accesibilidad al sistema de salud, principalmente a expensas de un menor acceso a consultas de modalidad presencial. Las necesidades emergentes forzaron la aparición de nuevas estrategias de atención, como las tecnologías de información y comunicación. Esto, si bien significó una solución, también generó nuevos excluidos debido a la brecha tecnológica preexistente.

COVID-19, Diabetes, and Associated Health Outcomes in China: Results from a Nationwide Survey of 10 545 Adults.

This study examined the associations between diabetes and self-reported/familial COVID-19 infection and investigated health-related outcomes among those with diabetes during China's nationwide quarantine. The 2020 China COVID-19 Survey was administered anonymously via social media (WeChat). It was completed by 10 545 adults in all of mainland China's 31 provinces. The survey consisted of 74 items covering sociodemographic characteristics, preventive measures for COVID-19, lifestyle behaviors, and health-related outcomes during the period of quarantine. Regression models examined associations among study variables. Diabetes was associated with a six-fold increased risk of reporting COVID-19 infection among respondents or their family members. Among people with diabetes, individuals who rarely wore masks had double the risk of suspected COVID-19 infection compared with those who always wore masks, with an inverse J-shaped relationship between face mask wearing and suspected COVID-19 infection. People with diabetes tended to have both poor knowledge of COVID-19 and poor compliance with preventive measures, despite perceiving a high risk of personal infection (40.0% among respondents reporting diabetes and 8.0% without diabetes). Only 54-55% of these respondents claimed to consistently practice preventive measures, including wearing face masks. Almost 60% of those with diabetes experienced food or medication shortages during the quarantine period, which was much higher than those without diabetes. Importantly, respondents who experienced medication shortages reported a 63% higher COVID-19 infection rate. Diabetes was associated with an increased risk of self-reported personal and family member COVID-19 infection, which is mitigated by consistent use of face masks.

[The importance of the logistic warehouse in pandemic period: the experience of the USL Umbria 1 (Perugia, Italy) during covid-19.] / L'importanza del magazzino logistico in periodo di pandemia: l'esperienza dell'USL Umbria 1 durante covid-19.

The pandemic period has generated major problems in the pharmacies of hospitals and local health care companies regarding the distribution of drugs to patients undergoing treatment with chronic drugs. This is because the patient, during the lockdown, was forced to leave the house and go several miles away to reach the place where the drug was dispensed. Moreover, very often, the place was placed in covid-19 hospitals, like the one in Perugia, and was also a risk for the patient himself. The logistical organization allows, in addition to the advantages of traceability, efficiency and savings, with the arrival of the drug at home, a very high patient compliance that also translates into greater security in a pandemic period. To the Usl Umbria 1 of Perugia (Italy) has been centralized the activity of warehouse for all the South area that includes three hospitals and four sanitary districts. Such warehouse, through computerized procedure, guarantees the direct distribution with sending of the medicines directly to the district of belonging of the patient. In this way the patient was not forced to make long and risky trips to continue their chronic therapies. Moreover, this logistic warehouse has also allowed to cope with the correct management of many medicinal specialties that have been used against the SARS-CoV-2 virus avoiding their temporary deficiency for patients already on therapy according to the normal therapeutic indications (anti-inflammatory, antiretroviral and immunomodulatory). This paper aims to demonstrate how logistical organization is of vital importance for a National Health System that has to face increasing costs, ensure the traceability of all processes and, last but not least, survive a worldwide pandemic period.

The impact of COVID-19 pandemic on medicine security in Africa: Nigeria as a case study.

COVID-19 is an unprecedented pandemic posing major threat to global public health. In the past decades of years or so, one could have heard of how dangerous it is to be virtually reliant on medicine supply from other countries. Nonetheless, no action was taken because it seemed to many that the global trade system was operational and Nigerians as well as citizens of African countries appear to have sufficient supply of the medications required at quite appealing cost. Currently in 2020, this apprehension has revolved from an imaginary problem to an actual challenge that might have consequences for millions nationwide due to COVID-19 pandemic. Now, African countries can realize that putting all our eggs in one basket was not such a good idea. In Nigeria, over 70% of the prescribed medications are produced from active ingredients (API) primarily sourced from firms in China and India. Access to medicine is an integral part of healthcare systems, uninterrupted access to medicine is much needed and essential for the well-being of the population. We are now approaching the conclusion that it is more reasonable to probably invest a little more to resuscitate a domestic pharmaceutical synthesis and herbal medicine research capacity in Nigeria and across African countries to improve public health.

[Informations on psychotropics and their adaptations for patients suffering from mental disorders in France during the SARS-CoV-2 epidemic]. / Informations relatives aux psychotropes et à leurs adaptations éventuelles pour les patients souffrant de troubles psychiques en France pendant l'épidémie à SARS-CoV-2.

The 2019-20 coronavirus pandemic (SARS-CoV-2; severe acute respiratory syndrome coronavirus 2) has dramatic consequences on populations in terms of morbidity and mortality and in social terms, the general confinement of almost half of the world's population being a situation unprecedented in history, which is difficult today to measure the impact at the individual and collective levels. More specifically, it affects people with various risk factors, which are more frequent in patients suffering from psychiatric disorders. Psychiatrists need to know: (i) how to identify, the risks associated with the prescription of psychotropic drugs and which can prove to be counterproductive in their association with COVID-19 (coronavirus disease 2019), (ii) how to assess in terms of benefit/risk ratio, the implication of any hasty and brutal modification on psychotropic drugs that can induce confusion for a differential diagnosis with the evolution of COVID-19. We carried out a review of the literature aimed at assessing the specific benefit/risk ratio of psychotropic treatments in patients suffering from COVID-19. Clinically, symptoms suggestive of COVID-19 (fever, cough, dyspnea, digestive signs) can be caused by various psychotropic drugs and require vigilance to avoid false negatives and false positives. In infected patients, psychotropic drugs should be used with caution, especially in the elderly, considering the pulmonary risk. Lithium and Clozapine, which are the reference drugs in bipolar disorder and resistant schizophrenia, warrant specific attention. For these two treatments the possibility of a reduction in the dosage - in case of minimal infectious signs and in a situation, which does not allow rapid control - should ideally be considered taking into account the clinical response (even biological; plasma concentrations) observed in the face of previous dose reductions. Tobacco is well identified for its effects as an inducer of CYP1A2 enzyme. In a COVID+ patient, the consequences of an abrupt cessation of smoking, particularly related with the appearance of respiratory symptoms (cough, dyspnea), must therefore be anticipated for patients receiving psychotropics metabolized by CYP1A2. Plasma concentrations of these drugs are expected to decrease and can be related to an increase risk of relapse. The symptomatic treatments used in COVID-19 have frequent interactions with the most used psychotropics. If there is no curative treatment for infection to SARS-CoV-2, the interactions of the various molecules currently tested with several classes of psychotropic drugs (antidepressants, antipsychotics) are important to consider because of the risk of changes in cardiac conduction. Specific knowledge on COVID-19 remains poor today, but we must recommend rigor in this context in the use of psychotropic drugs, to avoid adding, in patients suffering from psychiatric disorders, potentially vulnerable in the epidemic context, an iatrogenic risk or loss of efficiency.