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Objective To explore the influence of chronic disease long prescription management on the treatment effect of the patients with hypertension during the novel coronavirus pneumonia（COVID-19) epidemic period. Methods Eighty patients with hypertension chronic disease and with relatively stable condition, suitable for long medication and documented management in the outpatient department of a hospital from May 2020 to April 2021 were selected and randomly divided into the long term prescription treatment group and conventional treatment group, 40 cases in each group by using a simple randomized sampling method. The two groups conducted the standard management and 1-year follow up.The systolic blood pressure, diastolic blood pressure, body mass index (BMI),satisfaction rate, visit time and cumulative visit times were compared between the two groups, and then the blood pressure control rate was calculated. Results There were no statistically significant differences in the systolic and diastolic blood pressure, blood pressure control and BMI at the first time and final follow up between the two groups（P＞0.05）;the satisfaction rate of the patients in the long prescription treatment group was significantly higher than that in the routine treatment group（P＜0.05）,while the visiting time and cumulative visiting number in the long prescription treatment group were significantly lower than those in the routine treatment group, and the difference was statistically significant（P＜0.05）.Conclusion Compared with the conventional treatment method, the chronic disease long prescription will not have an impact on the treatment effect and safety in the patients with hypertension, but it could effectively shorten the visiting time of the patients, reduce the number of visits, effectively improve the satisfaction rate of the patients, help to improve the treatment compliance of the patients and promote the prognosis of the disease. (English) [ FROM AUTHOR] 目的 探索新型冠状病毒感染疫情防控期间慢病长处方管理对高血压患者疗效的影响. 方法 选取2020年5月至2021年4月在某院门诊就诊的病情相对稳定、适合长期服药, 并且已建档管理的高血压慢性病患者80例, 通过简单随机化抽样方法, 将抽样样本随机分为长处方治疗组和常规治疗组, 每组40例. 2组均规范管理, 随访1年. 比较2组患者收缩压、舒张压、体重指数、满意率、就诊时间和累积就诊次数, 计算血压控制率. 结果 2组患者首次及终末随访收缩压、舒张压、血压控制情况、体重指数比较, 差异均无统计学意义（P＞0.05）;长处方治疗组患者满意率明显高于常规治疗组, 就诊时间和累积就诊次数均明显低于常规治疗组, 差异均有统计学意义（P＜0.05) . 结论 与常规治疗方法比较, 慢病长处方不会对高血压患者疗效、安全性产生影响, 但能有效缩短患者就诊时间, 减少其就诊次数, 有效改善患者的满意度, 有助于提高患者治疗的依从性, 促进疾病转归. (Chinese) [ FROM AUTHOR] Copyright of Journal of Modern Medicine & Health is the property of Journal of Modern Medicine & Health and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Objectives: Opioids play a significant role in the effective management of cancer-related pain. The COVID-19 lock down may have reduced access to opioids and caused a decline in the use of prescription of opioids among cancer survivors. This study compared opioid prescription rates among cancer survivors before and after the onset of COVID-19 pandemic using real-world electronic health records (EHR). Method(s): Cohort analyses of cancer patients using data from EHR database from the TriNetX, a global federated health research network across 76 healthcare organizations. We analyzed changes in prescription opioid use before (March 1, 2018, through March 1, 2019) and after onset of COVID-19 (April 01, 2020, through March 2021) among cancer survivors. The key outcome variable was any opioid prescription within 1 year of cancer diagnosis. One-to-one propensity score matching was used to balance the characteristics (age, sex, race, diagnoses including diabetes, hypertensive diseases, overweight, mood disorders, and visual disturbances) of the two cohorts. Data were analyzed using the TriNetX platform. Result(s): There were 1,502,143 cancer survivors before COVID-19 and 1,412,599 cancer survivors after the onset of COVID-19. The one-to-one propensity-score match yielded 1,382,561 cancer patients, mean age 64 at cancer diagnosis, and 73% were white. Percentage of opioid use among cancer patients declined from 35.6% before the COVID-19 to 35.1% after the onset of the pandemic (OR=0.976, 95% CI 0.971-0.981). Average number of opioid prescriptions within 1 year of cancer diagnosis declined from 5.7 before to 5.3 after the COVID-19 onset (p<0.001). Conclusion(s): Among cancer survivors, a small decline in prescription opioid use was observed after the onset of COVID-19 pandemic. Future studies are needed to distinguish the impact of revised guidelines, opioid prescription policy changes, and COVID-19 lock down on lower rates of prescription opioid use among cancer survivors.Copyright © 2023
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Objectives: Data showed that during the SOVID-19 pandemic the pharmacy is the first place for patient care. The purpose was to study the awareness of pharmacists about the COVID-19 for 2021-2022 in Ukraine to provide complete and quality care. Method(s): Survey was developed to determine the level of knowledge of pharmacists regarding the main symptoms, methods of diagnosis, treatment and prevention of uncomplicated forms of the COVID-19 by using Google form. The heads of pharmacies, pharmacists in eight regions of Ukraine were involved. The research period was December 2021 - December 2022. Result(s): We received, 725 completed questionnaires from 8 regions of Ukraine, of which 69.7% were pharmacy managers, 12.0% were pharmacists, and 18.3% were intern- pharmacists. Of the surveyed pharmacists, 95% called the method of airborne transmission, but 4.7% believe that the coronavirus is transmitted by the contact-household method, and 0.3% - transmissible. We found that 100% of respondents correctly named the main indicators of the condition of a patient with the COVID-19. However, only 95.4% of pharmacists correctly defined the concept of saturation, which requires improvement of information support. For the symptomatic treatment of uncomplicated forms, 91.7% of respondents correctly determined that Paracetamol, Ibuprofen are for the symptomatic treatment of uncomplicated forms, but 8.3% of pharmacists named other drugs. Assessing the need to take antibiotics, 88.5% of pharmacists gave the correct answer, but 5.5% believe that the reason for prescribing antibiotics is an increase in body temperature, and 5.4% named a decrease in saturation, 0.6% - dry a cough, that does not meet the requirements of thee national guideleines Covid-19. Conclusion(s): We found that pharmacists are 100% well-informed with the symptoms and causes of the Covid-19. However, it is necessary to improve the provision of information about the requirements for the treatment of uncomplicated forms of Covid-19 and the dispensing of antibiotics from pharmacies.Copyright © 2023
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Objective: Semaglutide is the first glucagon-like peptide- 1 receptor agonist with oral and subcutaneous formulations. We studied patient adherence and clinical response following their prescription in a primary care setting. Method(s): We searched for patients starting semaglutide between October 2020 to November 2021 in primary care registries in Dudley, West Midlands. We tracked their collection of medications for up to six months, changes in HbA1C and weight if these data were available at 26 weeks (range 22-52 weeks), with significance tested using a t-test. Patients prescribed both formulations were excluded. Result(s): Clinical data were available in 180 of the 443 patients. Baseline HbA1c was 79.0 +/- 18.6mmol/mol (Ozempic) and 81.9 +/- 19.3mmol/mol (Rybelsus) and pre-treatment weight was 108.4 +/- 10.5 kg (Ozempic) and 104.3 +/- 26.7 kg (Rybelsus). 62.8% of patients were of non-white ethnicity and 82.8% were on >= two anti-diabetic drugs. In patients with six-month follow-up data, mean reduction in HbA1c and weight was 17.1 +/- 20.8mmol/ mol and 3.9 +/- 6.2 kg (Ozempic n = 53, p < 0.01) and 18.2 +/- 14.5mmol/mol and 5.9 +/- 4.2 kg (Rybelsus n = 5, p < 0.05). Drug continuation rates were measured in 324 patients. 3.2% and 19.0% of patients for Ozempic and Rybelsus respectively did not obtain further prescriptions after their initial script. At six months, 87.2% continued with Ozempic and 57.2% with Rybelsus. Conclusion(s): This study demonstrates similarly significant reductions in HbA1c and weight with Ozempic and Rybelsus, despite the complexity of follow-up during Covid-19 restrictions. The lower adherence to Rybelsus warrants further study.
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Final Senate approval by a historically narrow 50-46 vote came only after the White House and Califf's supporters lobbied hard to gain sufficient support, a success that is very different from Califf's 89-4 approval back in 2016. Pressure to help control the high cost of prescription drugs will continue to drive FDA support for developing complex generic drugs and biosimilars. There is pressure to clarify rules governing e-cigarettes;a need to address serious health problems arising from contaminated food and seafood, including significant volumes of imported products;and the safety of cosmetic products, dietary supplements, sunscreens, and other non-prescription products raise additional complex issues.
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Medication prescription procedures were reviewed at psychiatric residential treatment centers (RTC), and a quality improvement project was conducted in order to implement integrated electronic medical records (EMR) and computerized provider order entry (CPOE). To assess the impact of preexisting prescribing practices on RTCs, surveys were sent anonymously to current and past providers of regional and local RTCs. The surveys assessed the impact of the prescribing protocol on workflow, the frequency of medication errors, the impact such errors had on patient care, the overall provider satisfaction, and the discrepancies between electronic and paper charts. Current providers were then re-surveyed after implementing the integrated CPOE system in May 2020, during the COVID-19 pandemic. The first round of provider survey results revealed that the majority of staff (n = 10, 70%) observed frequent medication errors and were largely dissatisfied with the current medication ordering and administration process (n = 10;70%). Incident Response Improvement System (IRIS) reports revealed the most common medication errors were omissions, incorrect dosing, and incorrect medications administered. After the initiation and implementation of the CPOE, staff satisfaction increased with the process (n = 14;50%) noting that medication errors were less frequent than before (n = 14;50%). [ FROM AUTHOR] Copyright of Residential Treatment for Children & Youth is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Objectives: Developing a control group of a clinical trial using real world data is desirable and ethically sound despite challenges pertaining to internal validity. To examine the internal validity, we reproduced the control group in a Randomized Controlled Trial (RCT) using Electric Health Record (EHR) data and evaluated the difference between the outcome of the original trial and that of the reproduced analysis. Method(s): We selected an RCT, REMDACTA trial, that was performed to evaluate the efficacy of tocilizumab plus remdesivir against placebo plus remdesivir in patients with severe COVID-19 pneumonia. We reproduced its control group (patients with severe COVID-19 pneumonia taking only remdesivir), using Japanese EHR data, Millennial Medical Record provided by Life Data Initiative. Target patients for the main analysis were those prescribed remdesivir within 2 days after admission and diagnosed with COVID-19 (defined by ICD-10 code, U07.1) and/or with COVID-19 pneumonia (defined by diagnosis name). Patients in the sub analysis included only those with COVID-19 pneumonia diagnosis. Among the target patients, those undergoing image inspection, oxygen administration, and not taking any medicines for pneumonia before the first remdesivir prescription were eligible for the analyses. Median length of stay was compared in the reproduced group and in REMDACTA trial. Result(s): The database included 676 and 110 target patients for the main and sub analyses, respectively. However, only 57 and 14 patients met the eligibility criteria for the main and sub analyses, respectively. The reduction in the number of patients is attributed to the criteria of image inspection and oxygen administration. Median length of stay in the reproduced group were 13 and 11 days in the main and sub analyses, respectively. In REMDACTA trial, 95% CI of median time was 11.0-16.0. Conclusion(s): We successfully reproduced the median time of the control group by EHR data.Copyright © 2023
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Introduction: Aberdeen Royal Infirmary is a low volume centre carrying out approximately 13 oesophagectomies per annum. Due to minimal exposure to post-operative oesophagectomy patients, staff had low perceived confidence in their management within the Intensive Care Unit (ICU). After an initial pause due to the COVID-19 pandemic, oesophagectomy service provision restarted in June 2020. Prior to this project, no standardised care pathway existed for post-operative oesophagectomy patients. A protocol driven management pathway was implemented within the ICU setting in October 2020. Objective(s): 1. Standardise the first 5 days of post-operative care for oesophagectamies 2. Improve 30 day mortality rate 3. Reduce opiate use on step down to High Dependency Unit (HDU) 4. Improve ICU Medical and Nursing staff perceived confidence in the management of oesophagectomy patients. Method(s): A multi-disciplinary approach was taken, with input from ICU, Surgical, Anaesthetic, Physiotherapy, Nursing, Pain and HDU teams. Standards of care for post-operative oesophagectomy patients were identified and a protocol was subsequently produced for use within ICU with reference to current Enhanced Recovery After Surgery (ERAS) guidelines.1 The protocol covered the first 5 days of post-operative care. It identified tasks to be completed each day and highlighted which staff group was responsible for performing each task. Additionally, an information sheet was distributed to Medical and Nursing ICU staff to educate them on oesophagectomy patients and recognition of potential complications that arise when caring for this patient group. Data on 30 day mortality and opiate use at step down to HDU was collected from electronic notes. This was collected retrospectively prior to implementation of the protocol from January 2019 - July 2020 and prospectively following its implementation, from October 2020 - December 2021. ICU staff perceived confidence in managing post-operative oesophagectomy patients was measured using a combined quiz and survey. It was completed by staff prior to introduction of the protocol. Following implementation of the protocol and distribution of the information sheet, the quiz and survey was repeated to evaluate improvement in staff confidence. Result(s): A total of 38 oesophagectomy cases were identified. 21 cases were reviewed prior to implementation of the protocol, with 1 mortality at 30 days. 17 cases were reviewed following implementation of the protocol, with 0 mortalities at 30 days. Qualitative scoring showed a 20% increase in staff confidence to manage this patient group. Review of drug prescription charts revealed a reduction in dose of modified release opiates at step down to HDU. Conclusion(s): Oesophagectomy is major surgery and causes significant staff anxiety in low volume centres. This protocol has successfully standardised care for this patient group and allowed continuation of this essential service provision during the COVID-19 pandemic. This protocol improved 30 day mortality, reduced opiate use at step down to HDU and improved ICU staff perceived confidence in caring for post-operative oseophagectomy patients.
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Introduction: In common with many aspects of critical illness recovery, there is no universally accepted formula for "weaning," the term used to describe the process of liberating patients from mechanical ventilation.1-3 Understanding a patient's progress during a prolonged wean can be difficult and requires integration of various datasets. Therefore, it is good practice to ensure that weaning prescriptions are clear, easy to follow and adhered to and that weaning-associated data and meta data are recorded accurately and are easy to interpret. The prototype Digitally Enhanced Liberation from VEntilation (DELVE) system has been designed to be used in combination with the Puritan Bennett(TM) 980 (PB980) ventilator (Covidien, USA). DELVE is an open-loop system which provides an interactive weaning chart, combining the weaning prescription entered by the clinical staff, with actual settings recorded from the ventilator in order to display compliance with the prescription (Figure 1). DELVE also collects measured data from the ventilator which could be used to display respiratory performance, both real-time and historical. Figure 1. DELVE set up with the PB980 ventilator (in the simulation suite). Objective(s): This feasibility study was designed to inform development of the first DELVE prototype and a future clinical trial to determine clinical effectiveness and usefulness. The study objectives were to determine whether DELVE could: 1. Present a digital weaning chart that staff could use effectively and would be superior to the current paper version. 2. Record and display the patients' ventilatory performance, both real time and historical, during liberation from mechanical ventilation. Method(s): This was a mixed-methods, prospective feasibility study of a complex intervention.4 Ventilated patients with a tracheostomy, commencing the weaning process, were recruited from an adult intensive care unit. DELVE was used alongside the current paper-based system for weaning planning and data collection. Patients remained in the study until they no longer required the support of the PB980 ventilator. Result(s): Twenty patients were enrolled for between 25 and 270 hours each. There were no safety incidents or data breaches. DELVE was successfully operated by staff, who were able to connect DELVE to the ventilator, prescribe weaning plans and analyse adherence. The digital weaning chart user interface was intuitive and easy to navigate. It was clearer, more complete and easier to interpret when compared to the paper weaning charts (Figure 2). DELVE reliably collected data every ten seconds and safely stored over six million items of measured data and 25000 events, such as alarm triggers and setting changes, in a form that could allow analysis and pictorial or graphical presentation. Conclusion(s): This study supported the feasibility of this and future versions of DELVE to present both a digital weaning chart and to facilitate visual and numerical data presentation. Future iterations of the system could include a user-friendly dashboard representing patient progress during the weaning process. Assimilation of large volumes of data could be used to enhance understanding and inform decision making around the prolonged wean.
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The traditional de novo drug discovery is time consuming, costly and in some instances the drugs will fail to treat the disease which result in a huge loss to the organization. Drug repurposing is an alternative drug discovery process to overcome the limitations of the De novo drug discovery process. Ithelps for the identification of drugs to the rare diseases as well as in the pandemic situationwithin short span of time in a cost-effective way. The underlying principle of drug repurposing is that most of the drugs identified on a primary purpose have shown to treat other diseases also. One such example is Tocilizumab is primarily used for rheumatoid arthritis and it is repurposed to treat cancer and COVID-19. At present, nearly30% of the FDA approved drugs to treat various diseases are repurposed drugs. The drug repurposing is either drug-centric or disease centric and can be studied by using both experimental and in silico studies. The in silico repurpose drug discovery process is more efficient as it screens thousands of compounds from the diverse libraries within few days by various computational methods like Virtual screening, Docking, MD simulations,Machine Learning, Artificial Intelligence, Genome Wide Association Studies (GWAS), etc. with certain limitations.These limitationscan be addressed by effective integration of advanced technologies to identify a novel multi-purpose drug.Copyright © 2023, Association of Biotechnology and Pharmacy. All rights reserved.
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Timely, effective, and safe antiviral therapy in COVID-19 patients reduces complications, disability and mortality rates. The greatest concern with remdesivir is the risk of drug-induced liver injury, including in patients whose liver function is compromised by COVID-19. The aim of the study was to investigate the efficacy and safety of remdesivir in patients with confirmed SARSCoV-2 infection who had been admitted to an infectious diseases hospital in the Volgograd region in March 2022. Material(s) and Method(s): the authors carried out an open, non-randomised, single-arm study using medical records of 234 patients who had been diagnosed with "U07.1 COVID-19, virus identified" and prescribed remdesivir upon admission. The effectiveness of therapy was evaluated using two criteria: the need for oxygen supplementation or ventilatory support, or mortality. The authors conducted the evaluation on days 7, 14, and 28 using the six-point ordinal severity scale by Y. Wang et al. The safety of therapy was assessed on the basis of complaints and changes in laboratory findings. Result(s): for the patients prescribed remdesivir at admission, the 7-day mortality rate was 3.0%, the 14-day mortality rate was 5.6%, and the 28-day mortality rate was 7.3%. With the exception of a patient with myocardial infarction, all the patients who had been hospitalised with mild COVID-19 and prescribed remdesivir did not require oxygen therapy and/or transfer to intensive care and were discharged following recovery. The patients with moderate to severe COVID-19 had the 14-day mortality rate of 6.4% and the 28-day mortality rate of 8.6%. 17 patients (7.2%) discontinued remdesivir prematurely for various reasons, including adverse drug reactions. Remdesivir therapy of 5-10 days was associated with an increase in ALT activity by 2.7 +/- 0.8 times in 15.9% of patients with mild COVID-19, by 3.8 +/- 1.8 times in 20.4% of patients with moderately severe COVID-19, and by 4.8 +/- 2.7 times in 24% (12/50) of patients with severe COVID-19. In two patients (0.9%), the increase exceeded 10-fold the upper limit of normal. Conclusion(s): the obtained results support recommending remdesivir to patients with mild, moderate and severe COVID-19, including those with moderately elevated baseline activity of hepatic transaminases.Copyright © NEICON ISP LLC. All rights reserved.
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Background: During the coronavirus disease 2019 (COVID-19) pandemic, established best practices in cancer care were modified to diminish the risk of COVID-19 infection among patients and health-care workers. Objective(s): We aimed to study the modifications in cancer-directed therapy during the first wave of the COVID-19 pandemic. Material(s) and Method(s): A cross-sectional study of patients with cancers of the head and neck, thoracic, urologic, and central nervous systems who visited the medical oncology department of the Tata Memorial Hospital, Mumbai, India, between April 22, 2020 and June 01, 2020, was conducted. Data were prospectively collected in an online pro forma and supplemented from the electronic medical records. Result(s): Of a total of 514 patients, 363 (71%) were men. The most common malignancy was lung cancer in 234 patients (46%). Cancer-directed therapy was modified in 83 patients (16%). Deviations consisted of modification of the chemotherapy regimen (48%), temporary discontinuation of chemotherapy in 37%, and interim chemotherapy to delay surgery in 5%. Changes in the chemotherapy regimen included a shift to a less intensive regimen in 45%, changing from intravenous to oral in 40%, and less frequent dosing of immunotherapy in 7%. Considering missed appointments as a deviation from planned cancer therapy, 68% of patients had a deviation in the standard planned cancer care. Conclusion(s): Almost two-thirds of the patients could not reach the hospital during the COVID-19 pandemic lockdown in India. Of those who could reach the hospital, one of out every six patients with cancer had a change in their cancer-directed treatment, half of which consisted of a modification in the standard chemotherapy regimens. The effects of these therapy deviations are likely to be long-lasting. (Clinical Trials Registry-India, CTRI/2020/07/026533).Copyright © 2023 Neurology India, Neurological Society of India Published by Wolters Kluwer - Medknow.
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It is well known that vitamin D's general immunomodulatory actions are helpful in viral infections and that a shortage is linked to a more serious prognosis for Covid-19. In this sistematic review, we examined the existing literature on evidence as to whether there is also link between vitamin D range levels in pediatric population and the outcome of the Covid-19 infection. We looked for studies that measured vitamin D blood concentrations and examined the effects of vitamin D supplementation in young infected patients. Vitamin D may decrease the risk of respiratory infections in a number of ways through its interactions with numerous cells, including by decreasing viral survival and replication, reducing the cytokine storm, raising angiotensin-converting enzyme 2 concentrations (ACE2) while not damaging the endothelial integrity. The incidence or severity of Covid-19 is linked with blood 25-hydroxyvitamin D concentrations, according to many observational studies. However experimental verification is still needed. Given their safety and broad therapeutic window, vitamin D supplements seem to be an effective way for individuals and doctors to prevent or treat Covid-19. Nonetheless, the outcomes of significant vitamin D randomized controlled trials are further needed.Copyright © 2022 Maria Nicolae et al., published by Sciendo.
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Background: During the first months of the COVID-19 pandemic presentations to emergency psychiatric services sharply declined, despite no significant change in the incidence of psychosis. Aim(s): To investigate the impact of COVID-19 on the duration of untreated psychosis (DUP) in a first-episode service. Method(s): Data was collected by the specialized treatment early in psychosis (STEP) clinic to compare the DUP pre vs. early and late pandemic stages. The onset of the pandemic was defined as the 15th of March 2020, based on an analysis of case numbers and the advent of restrictions. Outcome measures were DUP total (the time elapsed between onset of psychosis and enrolment in the STEP clinic), DUP demand (the time from onset of psychosis to first antipsychotic prescription), and DUP supply (the time from first antipsychotic prescription to enrolment into STEP). Result(s): DUP total decreased significantly (p = .008) during the early pandemic compared with pre-pandemic from a median of 208 (IQR, 24-1020.0) to 55.5 days (IQR, 8.0-560.0). During the late pandemic stage, DUP total increased back to a median of 153.5 days (IQR, 1.0- 885.0). DUP demand decreased significantly (p = .001) during the early pandemic compared to pre-pandemic from a median of 117 (IQR, 17.0-714.0) to 35 days (IQR, 2.0-541.0) and then reduced further to 27.5 (IQR, 0.0-690.0) days during the late pandemic. No significant changes were found in DUP supply (p = .24) across the different stages of the pandemic. This is the first study to show a reduction in DUP associated with the pandemic.
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Objectives: While persistent and relapsing symptoms of COVID-19 are increasingly documented, limited data exist on the post-acute population. The objective of this analysis is to identify the characteristics of patients diagnosed with long COVID using real-world data. Method(s): Children/adolescents (age 0-17) and adults (age 18-39, 40-64 and >=65) with >=2 primary diagnoses for U09.9 "Post COVID-19 condition" from 10/01/2021 (ICD-10 code introduction) until 03/31/2022 were selected from Optum's de-identified Clinformatics Data Mart Database, with the first diagnosis deemed index. Included patients had >=1 diagnosis for COVID-19 and continuous enrollment 12 months prior to index (baseline). To ensure alignment with most institutional definitions, >=4 weeks between initial COVID-19 infection and index was required. Diagnoses recorded +/-2 weeks from index that were not present prior to the initial COVID-19 diagnosis were summarized. Newly prescribed treatments and total medical costs were evaluated during the month following index (continuous enrollment required). Result(s): 3,587 patients met eligibility criteria (mean age 59.02, 57.56% female) with a median time from initial COVID-19 infection to long COVID diagnosis of 83 days (IQR: 46-201 days). The most common concurrent diagnoses included breathing complications such as dyspnea (20.38%) and respiratory failure (15.23%);malaise and fatigue (15.31%);symptoms related to cognitive functioning/anxiety (11.35%);and chest pain (7.67%). Children/adolescents had the highest prevalence of chest pain, while patients >=65 years of age had the highest prevalence of issues with coordination. The average total medical cost during the month following long COVID diagnosis was $4,267 (SD $14,662), with common prescriptions including albuterol (4.42%), prednisone (3.51%), and methylprednisolone (2.01%). Conclusion(s): This retrospective analysis confirms clinically documented symptoms of long COVID in a large, real-world population. Once more data become available, further research on the long term economic and clinical outcomes among patients diagnosed with post-acute COVID-19 syndrome are warranted.Copyright © 2023
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Current FDA programs to accelerate access In order to accelerate the product approval process, four regulatory programs currently exist to reduce development and review times for products that address unmet medical needs for the treatment of serious or life-threatening conditions. In May 2014, FDA issued a Final Guidance for Industry entitled, "Expedited Programs for Serious Conditions-Drugs and Biologics" which addresses fast track designation, breakthrough therapy designation, priority review designation and accelerated approval.3 In addition to this guidance document, under section 564 of the FD&C Act, 21 U.S.C. 360bbb3, in a situation where the Secretary of Health and Human Services (HHS) issues a declaration of emergency or threat justifying authorization of emergency use for a product caused by chemical, biological, radiological or nuclear (CBRN) agents, as well as an infectious disease, the Commissioner of the FDA may authorize an EUA of an unapproved product or an unapproved use of an approved product. In January 2017, the "Emergency Use Authorization of Medical Products and Related Authorities" guidance was finalized.4 Fast Track designation Section 112 of the Food and Drug Administration Modernization Act of 1997 (FDAMA), entitled "Expediting Study and Approval of Fast Track Drugs," mandates the facilitation of the development and processes to expedite review of therapeutics intended to treat serious or life-threatening conditions presenting with unmet medical needs. [...]a two-tiered system of review times, Standard Review and Priority Review was created.
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Objective: To determine the frequency of antibiotic use and to know which clinical and socio-demographic variables were related to the probability of suffering infections associated with COVID-19. Method(s): Adults hospitalized for COVID-19 who received one or more antibiotics during hospitalization were evaluated. We performed a descriptive analysis of variables in the general population' bivariate analysis in two groups (documented vs. suspected infection) and multivariate logistic regression of factors associated with mortality. Result(s): It was determined that 60.4% of adults hospitalized for COVID-19 received antibiotics. Coinfection was documented in 6.2% and superinfection in 23.3%. Gram-negative germs were reported in 75.8% of cultures, fungi in 17.8% and gram-positive in 14.2%. Variables such as age, comorbidities, ICU, anemia, steroids, mechanical ventilation, hemofiltration were statistically significantly related to documented infection. High-flow cannula was associated as a protective factor. Overall mortality was 43.9%, 57.8% in the first group and 38.1% in the second (p=0.002). Conclusion(s): There is a considerable frequency of antibiotic use in subjects hospitalized for COVID-19, particularly related to relevant findings of bacterial superinfection, in those with comorbidities, such as diabetes mellitus, immunosuppression, anemia and fragility, in whom the behavior of the disease is more severe and lethal.Copyright © 2023 Asociacion Colombiana de Infectologia. All rights reserved.
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The antibiotic amoxicillin is usually recommended as a first-line treatment for many common infections affecting children. Repeated lockdowns related to the coronavirus disease 2019 pandemic have contributed to supply difficulties for many drugs, including antibiotics. However, the risks associated with amoxicillin supply shortages appear not to have been sufficiently assessed, and the crisis we are facing today is serious and particularly dangerous for children's health. Without rigorous measures to prevent shortages related to drug production and distribution, populations could face a post-antibiotic era in which common infections and minor injuries can result in serious life-threatening situations. The availability of medicines declared by WHO as essential should be guaranteed not only in production but also in fair distribution. And this principle must be ensured by national and international regulatory agencies.Copyright © 2023 Medico e Bambino. All rights reserved.
ABSTRACT
Introduction: There is a dearth of information on older users (65+ years) of medical cannabis, who may face unique challenges due to altered metabolism with aging, concurrent medication use, and risk of adverse effects. This observational study aimed to describe a large cohort of older medical cannabis users in Canada. Method(s): From Oct 2014 to Oct 2020, a commercial medical cannabis provider based in Canada collected anonymized data for research purposes from patient volunteers. Data included demographic, social, and health details (at intake) and cannabis products, self-perceived changes in symptoms and change in medications (at follow-up, variable duration). Cannabis products were categorized as cannabidiol (CBD) only, tetrahydocannabinol (THC) only or mixed CBD/THC. Of the mixed, formulations could be in 1:1 ratios (CBD+/THC+), predominantly CBD (CBD+/THC-) or predominantly THC (CBD-/THC+). Result(s): In total, 9766 subjects in the older cohort (65+ years old) completed the entire questionnaire (mean age (SD) = 73.6 (6.8) y, 60% female). They represented 23.1% of the total dataset (N = 42,267, mean (SD) =51.5 (16.8) y). The proportion of adults in the older cohort tended to increase over time (pre-2018: 17.6%;2018: 26.7%;2019: 31.2%;2020: 22.7%, when the overall intake decreased from 8869 to 5644). Among the older cohort, 15.5% were previous cannabis users and 67.7% were referred for chronic pain (mainly arthritis, chronic pain, lower back pain). Concomitant analgesic use was common (over-the-counter analgesics: 44.5%;opioids: 28.3%;NSAIDs: 24.5%). 7.9% of the sample (compared to 19.9% in the whole sample) were referred for psychiatric disorders, though 21.4% indicated antidepressant use and 12.3% indicated benzodiazepine use. Another 7% were referred for neurological disorders. Follow-up data were captured in visits (11,992) from 4698 older patients, averaging 2.5 visits per patient. The type of medical cannabis used changed over time, with increasing use of cannabis oil compared to herbal cannabis. In 2020, of 2478 visits, 78.9% use was cannabis oil and 6.7% was herbal forms (pre-2018: 57.6% vs 36.2%). The composition of cannabis oil demonstrated a preference for cannabinoid oil (CBD+) over tetrahydrocannabinol (THC+) in 6043 visits: 45.2% were using CBD+ preparations, only 3.2% were using THC+ preparations, and for CBD/THC combinations, CBD predominated (CBD+/THC-: 30.5%;CBD+/THC+: 16.8%;CBD-/THC+: 4.3%). Adverse-effects (7062 visits) included dry mouth (15.8%), drowsiness (8.6%), dizziness (4%) and hallucinations (0.6%). Patients reported improved pain, sleep and mood over time, though 15-20% reported no improvement or worsening. Medication use was mostly unchanged, though 40% of opioid users reported requiring reduced dosages. Conclusion(s): These data were drawn from a large convenience sample. The data suggest an increasing proportion of older users of medical cannabis, though COVID-19 may have affected recent use. Female users comprised a higher proportion, and cannabis oil containing CBD was preferred. Systematic studies of effectiveness and safety in older users of cannabinoids are needed given its increasing use. Funding(s): No funding was received for this work.Copyright © 2021