scholarly journals Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for COVID-19 Outpatients in Saudi Arabia

2020 ◽  
Author(s):  
Abdulrhman Mohana ◽  
Tarek Suliman ◽  
Nagla Mahmoud ◽  
Mustafa Hassanein ◽  
Amel Alfaifi ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Side Effects ◽  
Adverse Events ◽  
Treatment Protocol ◽  
Healthcare Systems ◽  
National Database ◽  
Surveillance Network ◽  
Safety Outcome ◽  
Study Results ◽  
Gi Symptoms

Background: Healthcare systems globally has been challenged following the COVID-19 pandemic, since late 2019. Multiple approaches and strategies have been performed to relieve the pressure and support existing healthcare systems. The Saudi Arabian Ministry of Health (MOH) launched an initiative to support the National Healthcare System. Since the 5th of June 2020, 238 outpatient fever clinics were established across Saudi Arabia. Methods: A cross-sectional study included 2,733 eligible patients subjected to MOH treatment protocol (hydroxychloroquine and zinc) and revisited the clinics within 3-7 days after treatment initiation. This study aimed to assess the safety outcome and reported adverse events from hydroxychloroquine use among suspected COVID-19 patients. The data was collected through an electronic link and cross-checked with that of the national database (Health Electronic Surveillance Network, HESN) and reports from the MOH Morbidity and Mortality (M&M) Committee. Results: Majority of the cases were males (70.4%). Upon reassessing the studied participants within 3-7 days, 240 patients (8.8%) discontinued the treatment protocol because of the development of side effects (4.1%) and for non-clinical reasons in the remaining (4.7%). Medication side effects overall were reported among (6.7%) of all studied participants, including mainly cardiovascular adverse events (2.5%), followed by gastrointestinal (GI) symptoms (2.4%). No Intensive Care Unit (ICU) admission or death were reported among these patients. Conclusion: In our study, results show that the use of hydroxychloroquine for COVID-19 patients in mild to moderate cases in an outpatient setting, within the protocol recommendation and inclusion/exclusion criteria, is safe, highly tolerable, and with minimum side effects.

Reconsenting patients with cancer on clinical trials: Does added risk influence continued participation?

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15610-e15610
Author(s):  
A. Elegbede ◽  
A. Andrei ◽  
A. Andrei ◽  
K. D. Holen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Event ◽  
Side Effects ◽  
Adverse Events ◽  
Study Participant ◽  
P Value ◽  
Study Participation ◽  
Grade 5 ◽  
Study Results

e15610 Background: The general policy endorsed by multiple professional societies and cooperative groups regarding patients on cancer clinical trials states that subjects should be informed of new adverse events or significant developments during study participation and re-consented to continue on study. However, no information is known as to the effect of re-consenting on a patients’ decision to continue study participation. Our research question addresses how the severity of reported risk to other study participants will impact the subjects’ decision to continue participation in a clinical trial. Methods: We surveyed 34 patients with gastrointestinal (GI) tumors all of whom were currently enrolled in a clinical trial. The survey portrayed hypothetical adverse reactions affecting another study participant ranging from Grade 1 to Grade 5 according to the National Cancer Institutes Common Terminology Criteria for Adverse Effects v. 3.0. The survey asked about subjects’ opinions of the theoretical adverse event categorized as “would not be concerned,” “would be concerned, but would continue the study,” and “would discontinue the study.” Results: Patients willingness to continue the study was highest at Grade 1 with 97% of all participants. However, willingness to continue participation progressively declined as the severity of adverse events increased such that only 44% of participants would continue participation with a reported Grade 5 adverse event. Conclusions: Among surveyed GI cancer patients, willingness to continue participation in a clinical trial declined significantly as the severity of adverse events increased from Grade 1 to Grade 3 - 5 (p-value < 0.001. This could be due to multiple factors, including the terminal nature of the patients’ cancer, the side effects of study therapy and the patients’ response to study treatment. This data could produce a reasonable adverse event grade cut-off for re-consenting patients regarding new side effects. No significant financial relationships to disclose.

scholarly journals Favipiravir Use in Kidney Transplant Recipients with Covid 19: A Single Center Experience

2021 ◽  
Author(s):  
Burcu Kaya ◽  
Dilek Barutcu Atas ◽  
Elif Tigen Tükenmez ◽  
Ebru Asicioglu ◽  
Hakki Arikan ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Kidney Transplant ◽  
Laboratory Data ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Transplant Patients ◽  
Study Results ◽  
Significant Difference ◽  
Kidney Transplant Patients

Aim: Kidney transplant patients are amongst the high-risk groups for severe Covid 19. To date, no specific antiviral agent has been found uniformly effective against severe acute respiratory syndrome coronavirus 2 (SARS-CoV2). Favipiravir, the recommended drug by The Turkish Ministry of Health, was uniformly supplied to all patients diagnosed to have COVID 19 with a positive nasopharyngeal swap PCR test. The aim of our study was to retrospectively compare our kidney transplant recipients who developed COVID-19 infection started on Favipiravir to those who did not use Favipiravir for the clinical course of the disease with a special emphasis on the occurrence of side effects/adverse events. Methods: Thirty-seven consecutive KT recipients with a median age of 46 years and of whom 62.2% were women; 8 deceased /29 living related donor, with a 8.0 (5.5-12.5) years median duration of transplantation were included in the study. Results: Twenty-six (70.3%) patients received Favipiravir, 11(29.7%) did not. There was no statistical significance in baseline demographic, clinical and laboratory findings between the groups except that the Favipiravir group was older and had a higher requirement of oxygen treatment. There was no statistically significant difference in the course and outcome of COVID-19 infection, in the occurrence of side effects/adverse events related to Favipiravir between the two groups. Laboratory data at baseline, day7 and 30 were also comparable between the groups. Conclusion: Although the efficacy of Favipiravir in the treatment of COVID-19 infection is currently controversial, Favipiravir can safely be used in kidney transplant patients.

Ginger and Heart Health: From Mechanisms to Therapeutics

2020 ◽  
Vol 13 ◽  
Author(s):  
Sajad Fakhri ◽  
Jayanta Kumar Patra ◽  
Swagat Kumar Das ◽  
Gitishree Das ◽  
Mohammad Bagher Majnooni ◽  
...  
Keyword(s):  
Side Effects ◽  
Molecular Mechanisms ◽  
Biological Activities ◽  
Health Benefits ◽  
Herbal Medicines ◽  
Cardiovascular Complications ◽  
National Database ◽  
Heart Health ◽  
Natural Entities ◽  
Cardioprotective Effects

Background: As a major cause of morbidity and mortality, cardiovascular diseases (CVDs) are globally increasing. In spite of recent development in the management of cardiovascular complications, CVDs have remained a medical challenge. Numerous conventional drugs are used to play cardioprotective roles; however, they are associated with several side effects. Considering the rich phytochemistry and fewer side effects of herbal medicines, they have gained particular attention to develop novel herbal drugs with cardioprotective potentials. Amongst natural entities, ginger is an extensively used and well-known functional food and condiment, possessing plentiful bioactivities, like antiinflammatory, antioxidant, and antimicrobial properties in several disorders management. Objective: The current review deliberated phytochemical properties as well as the ginger/ginger constituents' biological activities and health benefits in several diseases, with particular attention to cardiovascular complications. Methods: A comprehensive research was conducted using multiple databases, including Scopus, PubMed, Medline, Web of Science, national database (Irandoc and SID), and related articles in terms of the health benefits and cardioprotective effects of ginger/ginger constituents. These data were collected from inception until August 2019. Results: In recent years, several herbal medicines were used to develop new drugs with more potency and also minor side effects. Amongst natural entities, ginger is an extensively used traditional medicine in several diseases. The crude extract, along with related pungent active constituents, is mostly attributed to heart health. The cardioprotective effects of ginger are contributed to its cardiotonic, antihypertensive, anti-hyperlipidemia, and anti-platelet effects. The signaling pathways and molecular mechanisms of ginger regarding its cardioprotective effects are also clarified. Conclusion: This study revealed the biological activities, health benefits, and cardioprotective properties of ginger/ginger constituents along with related mechanisms of action, which gave new insights to show new avenue in the treatment of CVDs.

Proton Pump Inhibitors in 2021: Pros, Cons, and Everything in Between

2021 ◽  
pp. 263451612110217
Author(s):  
Joshua A. Sloan ◽  
Philip O. Katz
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Adverse Events ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Drug Class ◽  
Life Threatening

The medical and lay literature has exploded with reports of adverse events associated with proton pump inhibitors over the last 10 to 15 years. The dissemination of these reports to patients and clinicians have created substantial concerns regarding what has been an exceptionally valuable drug class, dramatically improving patient quality of life, and in many cases preventing life threatening side effects of other medication. Patients are more frequently seeking to avoid these medications, and practitioners are reducing or discontinuing them to the patient’s detriment due to a misunderstanding of the data. This review will discuss the data regarding the most commonly publicized adverse events and attempt to put them in perspective.

scholarly journals The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 24
Author(s):  
Gerald McGwin
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Reporting System ◽  
Large Body ◽  
Science Research ◽  
Gastrointestinal System ◽  
Gastrointestinal Cancers ◽  
H2 Antagonists ◽  
Study Results ◽  
Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

scholarly journals Assessment of Saudi Parents’ Beliefs and Behaviors towards Management of Child Fever in Saudi Arabia—A Cross-Sectional Study

2021 ◽  
Vol 18 (10) ◽  
pp. 5217
Author(s):  
Mohamed N. Al Arifi ◽  
Abdulrahman Alwhaibi
Keyword(s):  
Saudi Arabia ◽  
Side Effects ◽  
Febrile Seizures ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Inclusion Criteria ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Electronic Thermometer ◽  
And Behavior

Objective: Fever alone can lead to rare serious complications in children, such as febrile seizures. The aim of this study is to assess the knowledge, beliefs, and behavior of parents toward fever and its management. Methods: A cross-sectional study using an online questionnaire was applied over a period of 3 months, from January to March 2018, to parents who were living in Saudi Arabia. The inclusion criteria were a parent who is a resident of Saudi Arabia, with at least one child aged 6 years or less, while incomplete questionnaires, having a child aged more than 6 years, or parents who were not living in Saudi Arabia were excluded. Results: A total of 656 parents completed the questionnaire. More than two-thirds of the subjects were female, the majority of whom were aged between 25–33 years old. The best-reported place to measure the temperature of children was the armpit (46%), followed by the ear (28%) and the mouth (10.7%). More than half of the parents considered their children feverish at a temperature of 38 °C. The majority of parents (79.7%) reported that the most serious side effects of fever were seizure, brain damage (39.3%), coma (29.9%), dehydration (29.7%), and death (25%). The most common method used to measure a child’s temperature was an electronic thermometer (62.3%). The most common antipyretic was paracetamol (84.5%). Conclusions: Our study demonstrates the good knowledge of parents in identifying a feverish temperature using the recommended route and tools for measuring body temperature.

scholarly journals Using Design Thinking Principles to Improve Outpatients’ Experiences in Hospital Pharmacies: A Case Study of Two Hospitals in Asir Region, Saudi Arabia

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 854
Author(s):  
Dalia Almaghaslah ◽  
Abdulrhman Alsayari ◽  
Saleh Ali Alyahya ◽  
Rana Alshehri ◽  
Khawlah Alqadi ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Problem Solving ◽  
Management System ◽  
Design Thinking ◽  
Queue Management ◽  
End User ◽  
Study Results ◽  
Hospital Pharmacies ◽  
Asir Region

Introduction: Design thinking, an innovative problem-solving approach, has gained wide popularity in healthcare disciplines. The aim of this work is to improve outpatients’ experiences in hospital pharmacies in two hospitals in Asir region, Saudi Arabia. Methods: The design thinking approach, adopted from Stanford University’s D-School, was used in this study. Results: Several problems were identified: lack of comfortable environment in the pharmacies’ waiting area, lack of a queue management system, and workflow inefficiencies related to ordering and supplies of medicines. A prototype was proposed to overcome these challenges. Discussion and Conclusion: The design thinking approach helped in identifying end-user (patients visiting outpatient pharmacies) values and desires and provided an understanding of their struggles. It also proposed tailored solutions that could improve patients’ experiences while using the services of the outpatient pharmacies.

scholarly journals Increased Emergency Calls during the COVID-19 Pandemic in Saudi Arabia: A National Retrospective Study

Healthcare ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. 14
Author(s):  
Ahmed Al-Wathinani ◽  
Attila J. Hertelendy ◽  
Sultana Alhurishi ◽  
Abdulmajeed Mobrad ◽  
Riyadh Alhazmi ◽  
...  
Keyword(s):  
Saudi Arabia ◽  
Retrospective Study ◽  
Emergency Medical Services ◽  
Indirect Effect ◽  
Mobile Application ◽  
Healthcare Systems ◽  
Emergency Calls ◽  
The World ◽  
Staffing Patterns ◽  
The Impact

The coronavirus 2019 (COVID-19) pandemic has a direct and indirect effect on the different healthcare systems around the world. In this study, we aim to describe the impact on the utilization of emergency medical services (EMS) in Saudi Arabia during the COVID-19 pandemic. We studied cumulative data from emergency calls collected from the SRCA. Data were separated into three periods: before COVID-19 (1 January–29 February 2020), during COVID-19 (1 March–23 April 2020), and during the Holy Month of Ramadan (24 April–23 May 2020). A marked increase of cases was handled during the COVID-19 period compared to the number before pandemic. Increases in all types of cases, except for those related to trauma, occurred during COVID-19, with all regions experiencing increased call volumes during COVID-19 compared with before pandemic. Demand for EMS significantly increased throughout Saudi Arabia during the pandemic period. Use of the mobile application ASAFNY to request an ambulance almost doubled during the pandemic but remained a small fraction of total calls. Altered weekly call patterns and increased call volume during the pandemic indicated not only a need for increased staff but an alteration in staffing patterns.

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