The Impact of the COVID-19 "Infodemic" on Drug-Utilization Behaviors: Implications for Pharmacovigilance.

The coronavirus disease 2019 (COVID-19) pandemic that hit the world in 2020 triggered a massive dissemination of information (an "infodemic") about the disease that was channeled through the print, broadcast, web, and social media. This infodemic also included sensational and distorted information about drugs that likely first influenced opinion leaders and people particularly active on social media and then other people, thus affecting choices by individual patients everywhere. In particular, information has spread about some drugs approved for other indications (chloroquine, hydroxychloroquine, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, favipiravir, and umifenovir) that could have led to inappropriate and therefore hazardous use. In this article, we analyze the rationale behind the claims for use of these drugs in COVID-19, the communication about their effects on the disease, the consequences of this communication on people's behavior, and the responses of some influential regulatory authorities in an attempt to minimize the actual or potential risks arising from this behavior. Finally, we discuss the role of pharmacovigilance stakeholders in emergency management and possible strategies to deal with other similar crises in the future.

COVID-19 pandemic preparedness: A practical guide from clinical pharmacists' perspective.

PURPOSE: To describe our hospital pharmacy department's preparation for an influx of critically ill patients during the coronavirus disease 2019 (COVID-19) pandemic and offer guidance on clinical pharmacy services preparedness for similar crisis situations. SUMMARY: Personnel within the department of pharmacy at a medical center at the US epicenter of the COVID-19 pandemic proactively prepared a staffing and pharmacotherapeutic action plan in anticipation of an expected surge in admissions of critically ill patients with COVID-19 and expansion of acute care and intensive care unit (ICU) capacity. Guidance documents focusing on supportive care and pharmacotherapeutic treatment options were developed. Repurposing of non-ICU-trained clinical pharmacotherapy specialists to work collaboratively with clinician teams in ICUs was quickly implemented; staff were prepared for these duties through use of shared tools to facilitate education and practice standardization. CONCLUSION: As challenges were encountered at the initial peak of the pandemic, interdisciplinary collaboration and teamwork was crucial to ensure that all patients were proactively assessed and that their respective pharmacotherapeutic regimens were optimized.

Systemic corticosteroids in coronavirus disease 2019 (COVID-19)-related smell dysfunction: an international view.

The frequent association between coronavirus disease 2019 (COVID-19) and olfactory dysfunction is creating an unprecedented demand for a treatment of the olfactory loss. Systemic corticosteroids have been considered as a therapeutic option. However, based on current literature, we call for caution using these treatments in early COVID-19-related olfactory dysfunction because: (1) evidence supporting their usefulness is weak; (2) the rate of spontaneous recovery of COVID-19-related olfactory dysfunction is high; and (3) corticosteroids have well-known potential adverse effects. We encourage randomized placebo-controlled trials investigating the efficacy of systemic steroids in this indication and strongly emphasize to initially consider smell training, which is supported by a robust evidence base and has no known side effects.

Relatively mild symptoms after chronic overdose with a double-dose encorafenib: a case report.

Encorafenib (Braftovi) is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, in combination with binimetinib (Mektovi). According to the product label of encorafenib, there are no specific treatment recommendations in case of an overdose. We report on a 63-year-old man who ingested a double dose (900 mg) of encorafenib for 16 days. He developed overall minor chronic overdose symptoms such as nausea and vomiting grade 1 and muscle pain. Based on the most occurring adverse events of encorafenib, liver values, kidney function parameters and QTc interval were measured. Kidney function parameters were normal, whereas liver values were slightly increased (grade 1) and QTc slightly prolonged. The plasma concentration 3 h after the last dose was 2110 ng/mL. We describe the course of a case with a chronic overdose during 16 days of the double dose of encorafenib as well as the followed approach, which could be taken into account when observing an encorafenib overdose. Providing information in times of Covid-19 is challenging, but remains necessary for good clinical care.

Global Quality Statements on Reliever Use in Asthma in Adults and Children Older than 5 Years of Age.

INTRODUCTION: Widespread misuse of short-acting beta-agonists (SABAs) may contribute to asthma-related morbidity and mortality. Recognizing this, the Global Initiative for Asthma neither recommends SABA monotherapy nor regards this formulation as a preferred reliever. Many health systems and healthcare professionals (HCPs) experience practical issues in implementing guidelines. Clear quality standards can drive improvements in asthma care and encourage implementation of global and national medical guidelines. METHODS: A steering group of global asthma experts came together between May and September 2019 to develop quality statements codifying the minimum elements of good quality asthma care. These statements were either evidence based (when robust evidence was available) or reflected a consensus based on clinical expertise and experience of the group. RESULTS: The quality statements (and associated essential criteria) developed emphasize key elements concerning (1) objective diagnosis specific to individual symptoms, (2) treatment appropriate to the long-term management of asthma as an inflammatory disease, consistent with evidence-based recommendations, (3) controlled dispensing of SABA canisters and monitoring to prevent overuse, (4) regular review of patients after treatment initiation or change, and (5) follow-up of patients in primary care after treatment for an exacerbation in a hospital or an emergency department. CONCLUSIONS: The steering group proposes quality statements that national and local clinical groups can implement as quantitative quality standards that are appropriate to their local circumstances, including during the coronavirus disease 2019 (Covid-19) pandemic. By translating these statements into locally relevant quality standards, primary care physicians and HCPs can encourage optimal management and reduce preventable healthcare interactions. The evidence-based evolution of care encapsulated in these statements will further engender high-quality, patient-centered holistic management that addresses asthma as an inflammatory disease. In particular, the statements empower self-management by patients and encourage health-promoting behaviors, which are essential to reduce exacerbations, the primary goal of asthma management.

Treating Epilepsy Patients with Investigational Anti-COVID-19 Drugs: Recommendations by the Israeli Chapter of the ILAE.

BACKGROUND: The coronavirus disease-2019 (COVID-19) and its management in patients with epilepsy can be complex. Prescribers should consider potential effects of investigational anti-COVID-19 drugs on seizures, immunomodulation by anti-seizure medications (ASMs), changes in ASM pharmacokinetics, and the potential for drug-drug interactions (DDIs). The goal of the Board of the Israeli League Against Epilepsy (the Israeli Chapter of the International League Against Epilepsy, ILAE) was to summarize the main principles of the pharmacological treatment of COVID-19 in patients with epilepsy. This guide was based on current literature, drug labels, and drug interaction resources. We summarized the available data related to the potential implications of anti-COVID-19 co-medication in patients treated with ASMs. Our recommendations refer to drug selection, dosing, and patient monitoring. Given the limited availability of data, some recommendations are based on general pharmacokinetic or pharmacodynamic principles and might apply to additional future drug combinations as novel treatments emerge. They do not replace evidence-based guidelines, should those become available. Awareness to drug characteristics that increase the risk of interactions can help adjust anti-COVID-19 and ASM treatment for patients with epilepsy.

Practical considerations for pregnant women with diabetes and severe acute respiratory syndrome coronavirus 2 infection.

Epidemiologic data available so far suggest that individuals with diabetes, especially when not well controlled, are at a greater risk than the general population for severe acute respiratory syndrome coronavirus 2 morbidity such as acute respiratory distress syndrome, multiorgan failure, and mortality. Given the significant correlation between severity of coronavirus disease 2019 and diabetes mellitus and the lack of pregnancy-specific recommendations, we aim to provide some guidance and practical recommendations for the management of diabetes in pregnant women during the pandemic, especially for general obstetricians-gynecologists and nonobstetricians taking care of these patients.

Efficacy and safety of ACEI/ARB drugs in patients with COVID-19 combined with diabetes mellitus: A protocol for systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Novel coronavirus pneumonia (COVID-19) has become a worldwide epidemic, causing huge loss of life and property. Because of its unique pathological mechanism, diabetes affects the prognosis of patients with COVID-19 in many aspects. At present, there are many controversies about whether angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARB) should be used in the treatment of patients with diabetes mellitus and COVID-19 comorbidities. There is an urgent need to provide evidence for the use of ACEI/ARB through high-quality systematic evaluation and meta-analysis. METHODS: We will search electronic databases including PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, and Wanfang database using keywords related to COVID-19, diabetes mellitus, ACEI/ARB drugs, and randomized controlled trials . We will manually search gray literature, such as conference proceedings and academic degree dissertations, and trial registries. Two independent reviewers will screen studies, extract data, and evaluate risk of bias. Data analysis will be conducted using the Review Manager software version 5.3.5 and stata 14.0 software for Mac. Statistical heterogeneity will be assessed using a standard chi-square test with a significance level of P < .10. Biases associated with study will be investigated using funnel plots. RESULTS: This study will provide a high-quality synthesis of efficacy and safety of ACEI/ARB drugs in patients with COVID-19 combined with diabetes mellitus, providing evidence for clinical treatment of diabetes mellitus combined with COVID-19. And the results will be published at a peer-reviewed journal. CONCLUSION: Our study will draw conclusions on the efficacy and safety of ACEI / ARB drugs in patients with diabetes mellitus complicated with covid-19, so as to provide theoretical guidance for clinical practice of diabetes mellitus with covid-19. INPLASY REGISTRATION NUMBER: INPLASY 202060111.

Teleoncology or telemedicine for oncology patients during the COVID-19 pandemic: the new normal for breast cancer survivors?

Background: Telemedicine is seen as a savior during the COVID-19 pandemic. Materials & methods: This study is a descriptive cross-sectional study conducted with cancer patients who were interviewed via telemedicine from a tertiary care comprehensive oncology center. Results: A total of 421 patients were included in the study and 118 of them (28.0%) were >65 years old. Communication was provided most frequently by voice call (n = 213; 50.5%). The majority of the patients contacted by telemedicine had breast cancer (n = 270; 64.1%). For 135 patients (32.1%) no further examination or intervention was required and the previously planned follow-up visit was postponed by the clinician. Conclusion: This study showed that telemedicine could open a new era for medical oncology specialists.

Azithromycin in COVID-19 Patients: Pharmacological Mechanism, Clinical Evidence and Prescribing Guidelines.

The global COVID-19 pandemic has led to a race to find medications that can improve the prognosis of the disease. Azithromycin, in association with hydroxychloroquine or chloroquine, has been proposed as one such medication. The aim of this review is to describe the pharmacological mechanism, clinical evidence and prescribing guidelines concerning azithromycin in COVID-19 patients. There is weak evidence on the antiviral and immunomodulating effects of azithromycin, which in addition is not based on results from COVID-19 patients specifically. Therefore, this antibacterial should be considered only as empirical treatment of community-acquired pneumonia (CAP), although not all current treatment guidelines are in agreement. After the initial expectations raised by a small trial, more recent evidence has raised serious safety concerns on the use of hydroxychloroquine or chloroquine with azithromycin to treat COVID-19 patients, as all these drugs have arrhythmogenic potential. The World Health Organization has not made recommendations suggesting the use of azithromycin with hydroxychloroquine or chloroquine as treatment for COVID-19, but some national organisations have taken a different position, recommending this as first-line treatment. Several scientific societies, including the American College of Cardiology, have cautioned about the risks of this treatment in view of the lack of evidence concerning its benefits.

Corticosteroids in the Management of Pregnant Patients With Coronavirus Disease (COVID-19).

Recent evidence supports the use of an early, short course of glucocorticoids in patients with COVID-19 who require mechanical ventilation or oxygen support. As the number of coronavirus disease 2019 (COVID-19) cases continues to increase, the number of pregnant women with the disease is very likely to increase as well. Because pregnant women are at increased risk for hospitalization, intensive care unit admission, and mechanical ventilation support, obstetricians will be facing the dilemma of initiating maternal corticosteroid therapy while weighing its potential adverse effects on the fetus (or neonate if the patient is postpartum and breastfeeding). Our objective is to summarize the current evidence supporting steroid therapy in the management of patients with acute respiratory distress syndrome and COVID-19 and to elaborate on key modifications for the pregnant patient.

Safe and informed prescribing of psychotropic medication during the COVID-19 pandemic.

Treatment with psychotropic medication may sometimes be jeopardised because of the COVID-19 pandemic. One underlying reason is the lack of COVID-19-specific psychopharmacology guidelines. Here, we discuss five considerations arising from our clinical experience and pharmacological background knowledge to enable safe and well-informed psychopharmacotherapy during the COVID-19 pandemic.