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Pregnant patients deserve access to curated information that informs them on the safe use of medicines to treat or prevent disease. Limited or absent drug information can lead to unsafe use of medicines or even refusal or reluctance to prescribe or receive treatment. Decisions not to treat or inadequately treat comorbid conditions during pregnancy can pose significant health risks to mothers impacted by these decisions and their babies. Experiences gained during the SARS-CoV-2 pandemic that found a higher risk of hospitalization and death in pregnant populations have accentuated the need for targeted efficacy and safety data to optimally treat or prevent disease during pregnancy. In the United States, Congress has previously recognized that the lack of information within drug labels to convey certainty in prescribing medications during pregnancy is an urgent public health issue. Similarly, regulatory agencies such as the Food and Drug Administration acknowledge the role that data evaluating drug disposition, pharmacology, and disease biology play in reducing regulatory uncertainty and informing decisionmaking for the good of public health. Historically, in the absence of labeled drug information, networks such as MotherToBaby, have become the trusted expert source providing evidence-based information on the benefit or risk of medications and other exposures during pregnancy. To facilitate the more timely generation of data to inform the use of medicines in pregnancy, multistakeholder initiatives such as the Task Force on Research in Pregnant Women and Lactating Women (PRGLAC) have been established to identify gaps and provide findings to Congress for action. These initiatives have identified a set of opportunities to address the many challenges contributing to the disproportionate exclusion of pregnant populations in clinical trials. As a complimentary mechanism, broader reforms could be considered to foster a research culture that is purposeful and inclusive of pregnant patients. Together, these approaches can reduce uncertainty in prescribing in pregnancy and better address the needs of mothers and their babies.
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Though not common, drug-induced pericarditis is a serious condition, since pericardial tamponade, should it develop, may be life-threatening. As the number of drugs is constantly expanding, so does the proportion of those capable of causing pericarditis. The authors reviewed the relevant literature in the PubMed database and complemented it with information from the VigiBase database. In their article, the authors present current knowledge about the mechanisms of origin and level of risk of drug-induced pericarditis and discuss relevant information on individual drugs divided into 7 classes. Some medicines are associated with a high risk of developing pericarditis, a fact to be taken into account when treating patients with these agents. © 2022 Czech Society of Cardiology Z.S. All rights reserved.
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BACKGROUND: Drug information centers (DIC) play an important role in providing correct and scientifically supported information on medicinal products. In the pandemic scenario, this action is considered fundamental to the process of health education. OBJECTIVE: To describe and identify the dissemination of educational materials and their acceptance regarding the COVID-19 pandemic by a regional drug information center (RDIC) linked to a Brazilian public university. METHOD: The educational materials were disseminated in the communication channels (social media) of the RDIC and university. Seventeen educational notices were produced and disclosed from May to August 2020. The measure of reach was considered to be the number of "likes", sharing and number of people reached. RESULTS: Overall, 28.9% (n = 4071) of the online visitors "liked" the material about vaccines tested for COVID-19, followed by 12.9% (n = 1824) "likes" of the material about ivermectin for COVID-19 treatment, and 8.9% (n = 1250) "likes" of the material that explained the time necessary to develop and test a vaccine and the duration of the pandemic. CONCLUSION: The interest expressed by the "likes" of educational materials about vaccines indicates that the DIC in question has a strategic role in disseminating scientifically backed information about the COVID-19 pandemic.
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Objectives: One-fifth of the world's population lives in eight countries that constitute the South Asian Association for Regional Cooperation (SAARC). There is very little coordination among SAARC countries regarding the harmonization of pharmaceutical regulations and medicines safety. Pakistan, India and Bangladesh have experienced medicine-related tragedies where many patients have died. This study aims to examine current pharmacovigilance activity in the SAARC region to improve pharmacovigilance practices and to make recommendations for building a platform for collaboration to improve the safety monitoring of medicines in the region. The current review utilized secondary data. We reviewed the official websites of all SAARC countries' national regulatory authorities for pharmacovigilance-related information. A data set with eleven pharmacovigilance indicators were gathered and synthesized. Key Findings: All eight SAARC member countries have pharmacovigilance systems with full membership in the WHO Program for International Drug Monitoring. Out of eleven pharmacovigilance indicators, India met ten;Pakistan, Bangladesh and Bhutan nine;Maldives and Afghanistan seven;Nepal and Sri Lanka five. The SAARC countries do not have a harmonized pharmacovigilance system or centralized database. Due to positioning in different WHO regions, it is proposed to create a consortium on medicine safety among SAARC countries like other regional organizations of the world to strengthen the pharmacovigilance systems and harmonize the pharmacovigilance practices among member countries. Summary: To improve the quality of medicines and to strengthen regional medicine safety, the SAARC secretariat should consider forming a technical group of all member countries' regulatory authorities.Copyright © 2022 The Author(s). Published by Oxford University Press on behalf of the Royal Pharmaceutical Society. All rights reserved.
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Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
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Network pharmacology is a method to study the mechanism of a Traditional Chinese Medicine (TCM) prescription on a disease. However, most articles using network pharmacology to study the mechanism did not combine the weight information of herbs, the weight information of targets of disease, and the interaction information between targets together. We propose a method, network pharmacology combined with two iterations of PageRank algorithm, to make use of these information. It takes prescription-disease system as a whole, calculates PageRank score of targets in the prescription-disease system, which means an importance in the system, and the score is used to rank the analysis results of GO and KEGG pathway which help us to analyze the mechanism of a prescription on a disease. At last, we use two prescription-disease pairs which have been proved effectiveness in clinical trials: Qingfei Paidu Decoction on COVID-19, and FuFang DanShen Diwan on Coronary Heart Disease, and find that the results of our method are consistent with some results of clinical trials.Copyright © 2021
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New HIV drug for experienced patients... New MS drug reduces relapse and brain lesions... Malaria vaccine shows promise... Antibiotic resistance in Western Pacific and South-East Asia... Leukemia pharmacotyping precision medicine blueprint... MIS-C not associated with serious adverse reactions from mRNA vaccines
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Background: To augment traditional sources of health information at a time of reduced accessibility, a free online telepharmacy service was developed during the COVID-19 pandemic. Objectives: This study details the process of developing and operating an online telepharmacy service, analyzes its usage, and assesses users' health information-seeking patterns. Methods: The service utilized various platforms for receiving and processing queries, communication, and promotion. Submissions received from March 20 to May 31, 2020 were processed for analysis. Parameters analyzed were time patterns of query submission, response time, service feedback, user and patient demographics, and subjects of inquiry. Results: A total of 271 queries were analyzed. Query frequency decreased over time, consistent with relaxation of quarantine restrictions and increasing availability of information. Peak hours of query influx were outside typical business hours. The majority of users were from the general public (93.8%) and preferred to receive responses through text (61.2%). The majority of users from the general public belonged to the 15- to 25-year-old age group (41.1%) and sought information for oneself. Most submissions mentioned COVID-related topics. From the general public, there was greatest interest in drug indications and vitamins, supplements, and herbal products, and from healthcare professionals, in drug procurement. Users who provided feedback (n = 12) all expressed satisfaction with the service and the information they received. Conclusion: Transition to the "new normal" entails adopting alternative platforms to augment traditional sources of health information. An online telepharmacy service may be utilized to provide and clarify medication information as part of primary care.
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Objectives: Evaluate the impact of COVID19 on pharmacists' roles and services around the world Methods: A cross-sectional online survey with pharmacists who provided direct patient care during the pandemic. Pharmacists were recruited through social media with assistance from national and international pharmacy organisations. The survey was divided into three sections: 1) demographics, 2) pharmacists' roles and services during the pandemic 3) practice challenges. The data were analysed using SPSS 28, and descriptive statistics were used to report frequencies and percentages. Result(s): A total of 419 pharmacists practicing in 25 countries provided consent to participate. The most common role that pharmacists undertook was responding to drug information requests (90%), followed by allaying patients' fears and anxieties about COVID19 (82.6%), then addressing misinformation about COVID19 treatments and vaccinations (80.4%), and educating the public on strategies to reduce COVID19 transmission (e.g., handwashing) (80.2%). Despite the demands of the pandemic, pharmacists continued to provide clinical services regularly. Managing and/or monitoring patients' chronic diseases was the most frequently provided service (72.6%), followed by treating ambulatory conditions (65.4%), then renewing/extending prescriptions (58%) and prescribing emergency supply refills (52.7%). Interestingly, almost half of the participants reported administering COVID19 vaccines (45.6%). Pharmacists reported being involved in pandemic management through consultations, policy development and participating in taskforces. The most common challenge that pharmacists encountered was increased stress level (84.7%), followed by medication shortages (73.8%), general supply shortages (71.8%), inadequate staffing (69.2%), and concern for the safety of self and others (66.8%). Conclusion(s): Despite the uncertainty, the massive pressure, and the constant need to adapt, pharmacists around the world continued to put the patient first, providing them with highest quality services and making sure that all their needs are met. Pharmacists are definitely the unsung heroes of pandemic and their actions should cement their place as an essential health service.
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Service or Program: Operation Allies Welcome was a unified national humanitarian mission to support Afghanistan evacuees in the United States. The City of Philadelphia, Pennsylvania welcomed approximately 25,000 evacuees from Afghanistan between August and November 2021. This effort included a broad range of medical services including COVID-19 testing, vaccinations, and setting up a medication dispensary. Our pharmacy team was tasked with establishing and operating a dispensary to dispense limited supply of medications to patients for non-life-threatening conditions as they were bridged to definitive care. The objective of this is to describe the pharmacists' role within this coordinated emergency response. Justification/Documentation: This emergency response required that our pharmacy dispensary was adequately staffed and stocked with common medications for the target population. Our roles focused on establishment of standard operating procedures for the dispensary, dispensing medications, creation of a securely shared electronic inventory, creation of standardized staffing process, participation in vaccination efforts, and provision of drug-information. Overall, 1363 prescriptions, for both over the counter (OTC) and prescription medications, were dispensed. The dispensary stocked 82 different medications. Antipyretics, analgesics, antihistamines, prenatal vitamins, proton-pump inhibitors, and topical antibiotics were the most commonly dispensed OTC products. Frequently dispensed prescription medication classes included antibiotics, steroids, antiemetics, anti-diabetic and antihypertensives agents. We successfully leveraged the support of 66 volunteer pharmacists from 9 organizations around Philadelphia, including academic, hospital, non-profit, and pharmaceutical industry institutions. Adaptability: This program has a high level of adaptability for future emergency preparedness efforts. It serves as a playbook to guide pharmacists to respond to future emergencies. Significance: Our service provided much needed pharmacy support for Afghan evacuees. Our practical experiences demonstrated that pharmacists can effectively create and implement a dispensary during emergent crises. Findings from our operation add to the limited literature supporting the importance of pharmacists in these coordinated emergency responses.
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New drug approved for rare enzyme deficiency genetic disorder... New treatment for generalized pustular psoriasis... Nitric oxide may help patients who are pregnant and have COVID-19 pneumonia... Opioid prescriptions decreased between 2012 and 2019... Two-drug strategy confers benefits and risks for patients undergoing coronary artery bypass graft surgery
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Background: Drug shortages represent a longstanding challenge for healthcare providers, including toxicologists, who continue to confront scarcities of antidotes and other agents used to treat poisonings. Prior research examining availability of drugs with toxicologic applications from 2001 to 2013 demonstrated broad shortages including anticholinergic, cholinergic, and cyanide antidotes, anti-hypoglycemics, chelators, antivenom, naloxone, sedative- hypnotics, and decontamination products, many of which were unresolved and involved xenobiotics without therapeutic alternative. Reports of vital agents being scarce or unobtainable have continued since 2013, and new pressures on global and US (United States) supply chains have emerged, most notably the COVID-19 pandemic. Given this, up-to-date analysis of shortages of agents used to treat poisonings is needed. Method(s): US drug shortage data from January 2012 to December 2021 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, shortage reason, shortage duration, number of manufacturing sources, substitute availability, and substitute agent shortage during the study period were investigated. Result(s): 1570 drug shortages were reported during the study period;230 (14.6%) involved agents used to treat poisonings. Of the 230 shortages, 21.3% were unresolved as of December 2021. Mean shortage duration was 13.6 months. The longest shortage involved intravenous calcium gluconate and lasted 78 months. Intravenous dextrose products were the agent most frequently affected by shortage, with 20 shortages in total. 58 agents had multiple shortages. Total shortages peaked in 2017 with 33 shortages reported. 20 shortages were reported in 2020 and 24 in 2021 during the COVID-19 pandemic. 10.9% of shortages involved single-source products;however, this number is limited by incomplete reporting. 80.9% of shortages involved parenteral products. Agent classes with the most shortages reported were: Sedative-hypnotics (12.2% of shortages), anti-hypoglycemics (9.6%), anticoagulant reversal (7.8%), vitamins/electrolytes (7.4%), blood pressure support (7%), antihypertensives (6.5%), antimuscarinic delirium (4.8%), and chelators (4.3%). Three naloxone shortages were reported, one of which is ongoing due to increased demand. Buprenorphine and methadone shortages were reported but are resolved as of December 2021. New shortages of multiple pressors and flumazenil were reported. The most common reason for shortage was a manufacturing issue, occurring in 36.1% of shortages. Shortage reason was not reported 37.8% of the time. For 77% of shortages an alternative therapeutic agent was available, however 97% of alternatives were also affected by shortage at some point during the study period. Conclusion(s): Shortages of agents used to treat poisonings remain problematic. For the time period 2011-2021 previously reported shortages of many products persist and new shortages have emerged. The ongoing naloxone shortage is particularly concerning given the continued rise in drug overdose deaths in the US in 2021, as are shortages of buprenorphine and methadone used to treat opioid use disorder. Despite supply chain stressors, total shortages did not peak during the COVID-19 pandemic.
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Background: Patients with SARS-CoV-2 with a diagnosis of cancer have increased risk of severe COVID-19 outcomes compared to patients without cancer. However, little is known regarding outcomes of patients with COVID-19 and cancer in the setting of human immunodeficiency virus (HIV). Given the unique risks of this population, we sought to understand COVID-19 outcomes using registry data. Methods: This is a descriptive research study utilizing the CCC19 registry, an international multi-institutional registry with healthcare provider-reported cases of patients with cancer and COVID-19. Between March 2020-December 2021, 116 persons with HIV (PWH) and 10,642 persons without HIV (PWOH) with laboratory-confirmed SARS-CoV-2 infection were identified as eligible for the analysis. Results: Median follow-up time for both groups was 90 days, with interquartile range (IQR) 30-180 days. Most PWH were actively receiving antiretroviral therapy (ART) at the time of COVID-19 diagnosis, with 71% (n = 82) having named drug information available;bictegravir/emtricitabine/tenofovir was the most common ART (n = 25). PWH were of younger age (median 57.5 yrs [IQR 46.5-63.25] vs 65 yrs [IQR 55-74]), male (81% vs 47%), and either non-Hispanic Black or Hispanic (71% vs 34%) compared to PWOH. 12% of PWH (n = 14) were current smokers compared to 6% of PWOH (n = 638), and more than half in each group were never smokers (51% of PWH and 53% of PWOH). The following comorbidities were identified in PWH vs PWOH: cardiovascular (16% vs 20%), pulmonary (16% vs 20%), renal (15% vs 14%), and diabetes mellitus (18% vs 27%). A higher proportion of PWH had hematologic malignancy compared to PWOH (33% vs 19%). More PWH had active cancer which was progressing at the time of SARS-CoV-2 infection compared to PWOH (24% vs 14%). 44% of PWH (n = 51) had received active systemic anticancer therapy within the 3 months preceding SARS-CoV-2 infection (including cytotoxic, targeted, endocrine therapies, and immunotherapy) compared to 51% of PWOH (n = 5,420). PWH had an increased rate of hospitalization (58% vs 55%) compared to PWOH. Although a lower proportion of PWH required supplemental oxygen during hospitalization compared to PWOH (34% vs 38%) and ICU admission rates were identical between the two groups (16% vs 16%), PWH had an increased rate of mechanical ventilation (14% vs 10%) and death (24% vs 18%) compared to PWOH. Conclusions: This is the first known study describing outcomes of patients with cancer and COVID-19 in the PWH population from a large multinational dataset. PWH have characteristics associated with adverse outcomes in prior analyses (male sex, non-Hispanic Black or Hispanic, hematologic malignancy, progressing cancer) but are notably younger and have fewer comorbidities. HIV infection may portend increased risk of severe COVID-19 and death;however, additional analyses, including multivariable regression, are warranted.
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The article offers several medical news briefs. Topics include considered that the FDA approved Mounjaro (tirzepatide) injection to improve blood glucose control in adults with type 2 diabetes mellitus as an addition to diet and exercise;and examines that the FDA approved the use of Qelbree for adults 18 years of age and older with attention deficit hyperactivity disorder (ADHD).
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Screening advanced compounds enables discovery of direct repurposing candidates, novel drug-like leads for optimization, and informative pharmacological probes. In this chapter, we describe different types of screening collections used in drug repurposing, discuss issues and considerations in preparing and executing a repurposing screen, and present examples of in vitro and in vivo repurposing assays. We further describe various data sources reporting information on de-risked compounds of different types and illustrate how data mining and chemoinformatic and chemogenomic searches can be used to access large numbers of advanced compounds and assemble collections most suitable for screening in a given disease model. We argue that a view of repurposing screening as a large-scale bet on finding candidates for clinical testing is narrow and incomplete. Rather, when thoughtfully executed, screening of re-risked compounds is informed by target pathobiology and offers a means to efficiently convert advances in the development of sophisticated non-clinical models and new insights in disease mechanisms into novel drug-like leads and candidates for development.