Publications by authors named "Thamir M Alshammari"

55 Publications

Health outcomes and policy in pharmay curricula among Arab countries: An evaluation of 191 academic institutions.

Saudi Pharm J 2021 Aug 12;29(8):799-806. Epub 2021 Jun 12.

Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Introduction: Health outcomes and policies is a growing areas that is needed in the healthcare culture. This study aimed to examine the availability, extent and type of teaching curricula (pharmacoeconomics, pharmacoepidemiology, pharmacovigilance, patient safety) in Arab countries.

Methods: A retrospective observational study was conducted during the period of November 2019 to January 2020. The collection strategy was performed by listing of pharmacy colleges in each country and then reviewing the institutions' websites that met the inclusion criteria. Five criteria were utilized to assess the availability of these courses: full-time mandatory, full-time elective, partial mandatory, partial elective, and not offered.

Results: One hundred ninety-one academic institutions were screened during the study period. Of those, 151 (79.1%) institutions were included in the study and their curricular descriptions were retrieved from their electronic websites. Pharmacoeconomics was the most taught subject among the four subjects. It was offered in 89/151 of the colleges among Arab countries. Among these 89 colleges that offered pharmacoeconomics, 74/89 offered it as a mandatory. While, Pharmacoepidemiology was offered in 51 colleges, with 44/51 offering the subject as a mandatory, and 6 out of those 44 list it as a full-time mandatory, while 38 out of those 44 offer it as a partially mandatory. Only 22 of the colleges offered pharmacovigilance, with 14/22 offering the subject as a mandatory. Finally, there was only one institution that offers the subject of patient safety. Moreover, most of the four courses investigated are only taught in the final two years of study.

Conclusions: The study found a clear shortcoming in the teaching pharmaceutical outcomes. More efforts are needed by academic institutions to adopt and teach these subjects to ensure they meet the work needs and advanced pharmacy practice transformation.
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http://dx.doi.org/10.1016/j.jsps.2021.06.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8360772PMC
August 2021

Characteristics and Outcomes of Over 300,000 Patients with COVID-19 and History of Cancer in the United States and Spain.

Cancer Epidemiol Biomarkers Prev 2021 10 16;30(10):1884-1894. Epub 2021 Jul 16.

Tennessee Valley Healthcare System, Veterans Affairs Medical Center, Nashville, Tennessee.

Background: We described the demographics, cancer subtypes, comorbidities, and outcomes of patients with a history of cancer and coronavirus disease 2019 (COVID-19). Second, we compared patients hospitalized with COVID-19 to patients diagnosed with COVID-19 and patients hospitalized with influenza.

Methods: We conducted a cohort study using eight routinely collected health care databases from Spain and the United States, standardized to the Observational Medical Outcome Partnership common data model. Three cohorts of patients with a history of cancer were included: (i) diagnosed with COVID-19, (ii) hospitalized with COVID-19, and (iii) hospitalized with influenza in 2017 to 2018. Patients were followed from index date to 30 days or death. We reported demographics, cancer subtypes, comorbidities, and 30-day outcomes.

Results: We included 366,050 and 119,597 patients diagnosed and hospitalized with COVID-19, respectively. Prostate and breast cancers were the most frequent cancers (range: 5%-18% and 1%-14% in the diagnosed cohort, respectively). Hematologic malignancies were also frequent, with non-Hodgkin's lymphoma being among the five most common cancer subtypes in the diagnosed cohort. Overall, patients were aged above 65 years and had multiple comorbidities. Occurrence of death ranged from 2% to 14% and from 6% to 26% in the diagnosed and hospitalized COVID-19 cohorts, respectively. Patients hospitalized with influenza ( = 67,743) had a similar distribution of cancer subtypes, sex, age, and comorbidities but lower occurrence of adverse events.

Conclusions: Patients with a history of cancer and COVID-19 had multiple comorbidities and a high occurrence of COVID-19-related events. Hematologic malignancies were frequent.

Impact: This study provides epidemiologic characteristics that can inform clinical care and etiologic studies.
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http://dx.doi.org/10.1158/1055-9965.EPI-21-0266DOI Listing
October 2021

Characteristics and outcomes of 627 044 COVID-19 patients living with and without obesity in the United States, Spain, and the United Kingdom.

Int J Obes (Lond) 2021 11 15;45(11):2347-2357. Epub 2021 Jul 15.

Data Science to Patient Value Program, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.

Background: A detailed characterization of patients with COVID-19 living with obesity has not yet been undertaken. We aimed to describe and compare the demographics, medical conditions, and outcomes of COVID-19 patients living with obesity (PLWO) to those of patients living without obesity.

Methods: We conducted a cohort study based on outpatient/inpatient care and claims data from January to June 2020 from Spain, the UK, and the US. We used six databases standardized to the OMOP common data model. We defined two non-mutually exclusive cohorts of patients diagnosed and/or hospitalized with COVID-19; patients were followed from index date to 30 days or death. We report the frequency of demographics, prior medical conditions, and 30-days outcomes (hospitalization, events, and death) by obesity status.

Results: We included 627 044 (Spain: 122 058, UK: 2336, and US: 502 650) diagnosed and 160 013 (Spain: 18 197, US: 141 816) hospitalized patients with COVID-19. The prevalence of obesity was higher among patients hospitalized (39.9%, 95%CI: 39.8-40.0) than among those diagnosed with COVID-19 (33.1%; 95%CI: 33.0-33.2). In both cohorts, PLWO were more often female. Hospitalized PLWO were younger than patients without obesity. Overall, COVID-19 PLWO were more likely to have prior medical conditions, present with cardiovascular and respiratory events during hospitalization, or require intensive services compared to COVID-19 patients without obesity.

Conclusion: We show that PLWO differ from patients without obesity in a wide range of medical conditions and present with more severe forms of COVID-19, with higher hospitalization rates and intensive services requirements. These findings can help guiding preventive strategies of COVID-19 infection and complications and generating hypotheses for causal inference studies.
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http://dx.doi.org/10.1038/s41366-021-00893-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8281807PMC
November 2021

Medication Error Concept and Reporting Practices in Saudi Arabia: A Multiregional Study Among Healthcare Professionals.

Risk Manag Healthc Policy 2021 4;14:2395-2406. Epub 2021 Jun 4.

Department of Pharmacy Practice, College of Pharmacy, Riyadh Elm University, Riyadh, Saudi Arabia.

Background: Medication errors pose a risk for individual patients and for public health, with the misuse and overuse of medications being linked to severe patient safety problems. Therefore, the objective of this study was to investigate healthcare professionals' (HCPs') knowledge about medication errors, their knowledge about medication error reporting systems, and predictors for HCPs to report medication errors in Saudi Arabia.

Methods: An observational cross-sectional study was conducted among HCPs (physicians, pharmacists, and nurses) between January and March 2020. The study included 6 distinct locations in the Saudi Arabian regions of Hail, Al-Qassim, Al-Jouf, Al-Madinah, the eastern region, and the western region. Descriptive statistical and inferential analyses were computed using Statistical Package for the Social Sciences (SPSS) v.22.

Results: In total, 980 questionnaires for 348 (35.5%) physicians, 144 (14.7%) pharmacists, and 488 (49.8%) nurses were distributed with a response rate of 100%. Interestingly, only 277 (28.3%) of the HCPs had a good understanding of the stages of medication errors. With regard to reporting practices, a high number of the HCPs, 576 (58.8%), had not reported medication errors in their workplaces, and nearly 369 (37.7%) of respondents said they believe that legal implications are a major barrier to the reporting of medication errors. More than half, 524 (53.5%), of HCPs revealed that no clear electronic system is available for the reporting of medication errors in most hospitals. In addition, 537 (54.8%), of the HCPs had not attended any training programs regarding medication error reporting systems within the past year, which is alarming.

Conclusion: Our study identified a huge lack of the reporting of medication errors, knowledge about medication error stages, and training on medication errors. Therefore, an urgent need to address these weaknesses exists.
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http://dx.doi.org/10.2147/RMHP.S281154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8187088PMC
June 2021

Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience.

Pediatrics 2021 09 28;148(3). Epub 2021 May 28.

Data Science to Patient Value Program, Department of Medicine, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.

Objectives: To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children and adolescents diagnosed or hospitalized with coronavirus disease 2019 (COVID-19) and to compare them in secondary analyses with patients diagnosed with previous seasonal influenza in 2017-2018.

Methods: International network cohort using real-world data from European primary care records (France, Germany, and Spain), South Korean claims and US claims, and hospital databases. We included children and adolescents diagnosed and/or hospitalized with COVID-19 at age <18 between January and June 2020. We described baseline demographics, comorbidities, symptoms, 30-day in-hospital treatments, and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome, multisystem inflammatory syndrome in children, and death.

Results: A total of 242 158 children and adolescents diagnosed and 9769 hospitalized with COVID-19 and 2 084 180 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were more common among those hospitalized with versus diagnosed with COVID-19. Dyspnea, bronchiolitis, anosmia, and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital prevalent treatments for COVID-19 included repurposed medications (<10%) and adjunctive therapies: systemic corticosteroids (6.8%-7.6%), famotidine (9.0%-28.1%), and antithrombotics such as aspirin (2.0%-21.4%), heparin (2.2%-18.1%), and enoxaparin (2.8%-14.8%). Hospitalization was observed in 0.3% to 1.3% of the cohort diagnosed with COVID-19, with undetectable ( < 5 per database) 30-day fatality. Thirty-day outcomes including pneumonia and hypoxemia were more frequent in COVID-19 than influenza.

Conclusions: Despite negligible fatality, complications including hospitalization, hypoxemia, and pneumonia were more frequent in children and adolescents with COVID-19 than with influenza. Dyspnea, anosmia, and gastrointestinal symptoms could help differentiate diagnoses. A wide range of medications was used for the inpatient management of pediatric COVID-19.
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http://dx.doi.org/10.1542/peds.2020-042929DOI Listing
September 2021

Use of repurposed and adjuvant drugs in hospital patients with covid-19: multinational network cohort study.

BMJ 2021 05 11;373:n1038. Epub 2021 May 11.

Department of Biomedical Informatics, Ajou University School of Medicine, Suwon, South Korea.

Objective: To investigate the use of repurposed and adjuvant drugs in patients admitted to hospital with covid-19 across three continents.

Design: Multinational network cohort study.

Setting: Hospital electronic health records from the United States, Spain, and China, and nationwide claims data from South Korea.

Participants: 303 264 patients admitted to hospital with covid-19 from January 2020 to December 2020.

Main Outcome Measures: Prescriptions or dispensations of any drug on or 30 days after the date of hospital admission for covid-19.

Results: Of the 303 264 patients included, 290 131 were from the US, 7599 from South Korea, 5230 from Spain, and 304 from China. 3455 drugs were identified. Common repurposed drugs were hydroxychloroquine (used in from <5 (<2%) patients in China to 2165 (85.1%) in Spain), azithromycin (from 15 (4.9%) in China to 1473 (57.9%) in Spain), combined lopinavir and ritonavir (from 156 (<2%) in the VA-OMOP US to 2,652 (34.9%) in South Korea and 1285 (50.5%) in Spain), and umifenovir (0% in the US, South Korea, and Spain and 238 (78.3%) in China). Use of adjunctive drugs varied greatly, with the five most used treatments being enoxaparin, fluoroquinolones, ceftriaxone, vitamin D, and corticosteroids. Hydroxychloroquine use increased rapidly from March to April 2020 but declined steeply in May to June and remained low for the rest of the year. The use of dexamethasone and corticosteroids increased steadily during 2020.

Conclusions: Multiple drugs were used in the first few months of the covid-19 pandemic, with substantial geographical and temporal variation. Hydroxychloroquine, azithromycin, lopinavir-ritonavir, and umifenovir (in China only) were the most prescribed repurposed drugs. Antithrombotics, antibiotics, H2 receptor antagonists, and corticosteroids were often used as adjunctive treatments. Research is needed on the comparative risk and benefit of these treatments in the management of covid-19.
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http://dx.doi.org/10.1136/bmj.n1038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8111167PMC
May 2021

Direct healthcare professional communications: A quantitative assessment study.

Pharmacol Res Perspect 2021 05;9(3):e00763

Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

A retrospective observational study evaluated the direct healthcare professional communication (DHPC) letters disseminated by the Saudi Food and Drug Authority (SFDA) and their compliance with the pharmacovigilance guidelines. The study was utilized all DHPC letters available on the SFDA website, which is intended to communicate drug safety information to healthcare professionals (HCPs). Then, the letters were evaluated based on DHPC letter requirements approved in the European Medicines Agency (EMA) pharmacovigilance guidelines. Statistical analyses were conducted utilizing statistical analysis software (SAS version 9.4). In June 2020, 169 letters were retrieved from the SFDA website. Most of the letters had the marketing authorization holder's logo (97%) and mentioned the date of letter issuance (98.8%). The most frequently discussed safety issues were hyperkalemia risk associated with combining renin-angiotensin-aldosterone system (RAAS) medications (10.6%) and cardiac risks (9%). Antineoplastic and immunosuppressant classes were associated with a majority of DHPC letters (15% for each category). A significant percentage of DHPC letters (10%) did not mention an agreement statement with SFDA, and 42 letters did not include marketing authorization holders (MAHs) contact information. The qualified persons responsible for pharmacovigilance and medical directors had signed most of the DHPC letters (51% and 46%, respectively). Many letters mentioned the details of reporting information to both SFDA and an MAH (82%). Moreover, 66% of the DHPC letters presented safety information within the 2-page limit. In conclusion, the DHPC letters disseminated by MAHs in Saudi Arabia have an acceptable level of compliance with the guidelines.
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http://dx.doi.org/10.1002/prp2.763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8085968PMC
May 2021

Are countries' precautionary actions against COVID-19 effective? An assessment study of 175 countries worldwide.

Saudi Pharm J 2021 May 20;29(5):391-409. Epub 2021 Apr 20.

Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia.

Background: The coronavirus disease 2019 (COVID-19) pandemic has affected many countries negatively, particularly in terms of their health care and financial systems. Numerous countries have attempted to employ precautions to address this pandemic. This study was aimed at exploring and assessing the early precautionary actions taken by 175 countries on six continents to prevent the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Methods: An observational study utilizing available public data was conducted on the basis of data collected from December 31, 2019 until the end of April 2020 and then compared with data in January 2021. Several data were extracted, including information related to the date of the first reported case of SARS-CoV-2, total confirmed cases, total active cases and more. In addition, seven validated indicators were used to assess the countries' preparedness and precautionary actions.

Results: A total of 175 countries were included in the study. The total COVID-19 infection rate increased exponentially and rapidly in North America and Europe from March to April. The application of precautions (indicators) varied between countries. School closures, quarantines and curfews were the most-applied indicators among all countries. As for the relationship between the indicators and their effects on the infection rate, Italy and Spain were the top countries in Europe and adopted all the indicators. Nevertheless, they faced high infection rates: 239,639 and 205,463 COVID-19 cases in Spain and Italy, respectively.

Conclusion: The precautionary actions might have played a role in limiting the spread of COVID-19 in several countries. However, many countries might not benefit from applying these indicators.
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http://dx.doi.org/10.1016/j.jsps.2021.03.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8056940PMC
May 2021

COVID-19 in patients with autoimmune diseases: characteristics and outcomes in a multinational network of cohorts across three countries.

Rheumatology (Oxford) 2021 10;60(SI):SI37-SI50

Real-World Evidence, Trial Form Support, Barcelona, Spain.

Objective: Patients with autoimmune diseases were advised to shield to avoid coronavirus disease 2019 (COVID-19), but information on their prognosis is lacking. We characterized 30-day outcomes and mortality after hospitalization with COVID-19 among patients with prevalent autoimmune diseases, and compared outcomes after hospital admissions among similar patients with seasonal influenza.

Methods: A multinational network cohort study was conducted using electronic health records data from Columbia University Irving Medical Center [USA, Optum (USA), Department of Veterans Affairs (USA), Information System for Research in Primary Care-Hospitalization Linked Data (Spain) and claims data from IQVIA Open Claims (USA) and Health Insurance and Review Assessment (South Korea). All patients with prevalent autoimmune diseases, diagnosed and/or hospitalized between January and June 2020 with COVID-19, and similar patients hospitalized with influenza in 2017-18 were included. Outcomes were death and complications within 30 days of hospitalization.

Results: We studied 133 589 patients diagnosed and 48 418 hospitalized with COVID-19 with prevalent autoimmune diseases. Most patients were female, aged ≥50 years with previous comorbidities. The prevalence of hypertension (45.5-93.2%), chronic kidney disease (14.0-52.7%) and heart disease (29.0-83.8%) was higher in hospitalized vs diagnosed patients with COVID-19. Compared with 70 660 hospitalized with influenza, those admitted with COVID-19 had more respiratory complications including pneumonia and acute respiratory distress syndrome, and higher 30-day mortality (2.2-4.3% vs 6.32-24.6%).

Conclusion: Compared with influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality.
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http://dx.doi.org/10.1093/rheumatology/keab250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989171PMC
October 2021

Unraveling COVID-19: a large-scale characterization of 4.5 million COVID-19 cases using CHARYBDIS.

Res Sq 2021 Mar 1. Epub 2021 Mar 1.

Routinely collected real world data (RWD) have great utility in aiding the novel coronavirus disease (COVID-19) pandemic response [1,2]. Here we present the international Observational Health Data Sciences and Informatics (OHDSI) [3] Characterizing Health Associated Risks, and Your Baseline Disease In SARS-COV-2 (CHARYBDIS) framework for standardisation and analysis of COVID-19 RWD. We conducted a descriptive cohort study using a federated network of data partners in the United States, Europe (the Netherlands, Spain, the UK, Germany, France and Italy) and Asia (South Korea and China). The study protocol and analytical package were released on 11 June 2020 and are iteratively updated via GitHub [4]. We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical 886,193 , and 113,627 . All comorbidities, symptoms, medications, and outcomes are described by cohort in aggregate counts, and are available in an interactive website: https://data.ohdsi.org/Covid19CharacterizationCharybdis/. CHARYBDIS findings provide benchmarks that contribute to our understanding of COVID-19 progression, management and evolution over time. This can enable timely assessment of real-world outcomes of preventative and therapeutic options as they are introduced in clinical practice.
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http://dx.doi.org/10.21203/rs.3.rs-279400/v1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941629PMC
March 2021

Unraveling COVID-19: a large-scale characterization of 4.5 million COVID-19 cases using CHARYBDIS.

Res Sq 2021 Mar 1. Epub 2021 Mar 1.

Routinely collected real world data (RWD) have great utility in aiding the novel coronavirus disease (COVID-19) pandemic response [1,2]. Here we present the international Observational Health Data Sciences and Informatics (OHDSI) [3] Characterizing Health Associated Risks, and Your Baseline Disease In SARS-COV-2 (CHARYBDIS) framework for standardisation and analysis of COVID-19 RWD. We conducted a descriptive cohort study using a federated network of data partners in the United States, Europe (the Netherlands, Spain, the UK, Germany, France and Italy) and Asia (South Korea and China). The study protocol and analytical package were released on 11 June 2020 and are iteratively updated via GitHub [4]. We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical 886,193 , and 113,627 . All comorbidities, symptoms, medications, and outcomes are described by cohort in aggregate counts, and are available in an interactive website: https://data.ohdsi.org/Covid19CharacterizationCharybdis/. CHARYBDIS findings provide benchmarks that contribute to our understanding of COVID-19 progression, management and evolution over time. This can enable timely assessment of real-world outcomes of preventative and therapeutic options as they are introduced in clinical practice.
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http://dx.doi.org/10.21203/rs.3.rs-279400/v1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941629PMC
March 2021

Renin-angiotensin system blockers and susceptibility to COVID-19: an international, open science, cohort analysis.

Lancet Digit Health 2021 02 17;3(2):e98-e114. Epub 2020 Dec 17.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Background: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been postulated to affect susceptibility to COVID-19. Observational studies so far have lacked rigorous ascertainment adjustment and international generalisability. We aimed to determine whether use of ACEIs or ARBs is associated with an increased susceptibility to COVID-19 in patients with hypertension.

Methods: In this international, open science, cohort analysis, we used electronic health records from Spain (Information Systems for Research in Primary Care [SIDIAP]) and the USA (Columbia University Irving Medical Center data warehouse [CUIMC] and Department of Veterans Affairs Observational Medical Outcomes Partnership [VA-OMOP]) to identify patients aged 18 years or older with at least one prescription for ACEIs and ARBs (target cohort) or calcium channel blockers (CCBs) and thiazide or thiazide-like diuretics (THZs; comparator cohort) between Nov 1, 2019, and Jan 31, 2020. Users were defined separately as receiving either monotherapy with these four drug classes, or monotherapy or combination therapy (combination use) with other antihypertensive medications. We assessed four outcomes: COVID-19 diagnosis; hospital admission with COVID-19; hospital admission with pneumonia; and hospital admission with pneumonia, acute respiratory distress syndrome, acute kidney injury, or sepsis. We built large-scale propensity score methods derived through a data-driven approach and negative control experiments across ten pairwise comparisons, with results meta-analysed to generate 1280 study effects. For each study effect, we did negative control outcome experiments using a possible 123 controls identified through a data-rich algorithm. This process used a set of predefined baseline patient characteristics to provide the most accurate prediction of treatment and balance among patient cohorts across characteristics. The study is registered with the EU Post-Authorisation Studies register, EUPAS35296.

Findings: Among 1 355 349 antihypertensive users (363 785 ACEI or ARB monotherapy users, 248 915 CCB or THZ monotherapy users, 711 799 ACEI or ARB combination users, and 473 076 CCB or THZ combination users) included in analyses, no association was observed between COVID-19 diagnosis and exposure to ACEI or ARB monotherapy versus CCB or THZ monotherapy (calibrated hazard ratio [HR] 0·98, 95% CI 0·84-1·14) or combination use exposure (1·01, 0·90-1·15). ACEIs alone similarly showed no relative risk difference when compared with CCB or THZ monotherapy (HR 0·91, 95% CI 0·68-1·21; with heterogeneity of >40%) or combination use (0·95, 0·83-1·07). Directly comparing ACEIs with ARBs demonstrated a moderately lower risk with ACEIs, which was significant with combination use (HR 0·88, 95% CI 0·79-0·99) and non-significant for monotherapy (0·85, 0·69-1·05). We observed no significant difference between drug classes for risk of hospital admission with COVID-19, hospital admission with pneumonia, or hospital admission with pneumonia, acute respiratory distress syndrome, acute kidney injury, or sepsis across all comparisons.

Interpretation: No clinically significant increased risk of COVID-19 diagnosis or hospital admission-related outcomes associated with ACEI or ARB use was observed, suggesting users should not discontinue or change their treatment to decrease their risk of COVID-19.

Funding: Wellcome Trust, UK National Institute for Health Research, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research & Development, IQVIA, South Korean Ministry of Health and Welfare Republic, Australian National Health and Medical Research Council, and European Health Data and Evidence Network.
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http://dx.doi.org/10.1016/S2589-7500(20)30289-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7834915PMC
February 2021

Characteristics, outcomes, and mortality amongst 133,589 patients with prevalent autoimmune diseases diagnosed with, and 48,418 hospitalised for COVID-19: a multinational distributed network cohort analysis.

medRxiv 2020 Nov 27. Epub 2020 Nov 27.

Real-World Evidence, Trial Form Support, Barcelona, Spain.

Objective: Patients with autoimmune diseases were advised to shield to avoid COVID-19, but information on their prognosis is lacking. We characterised 30-day outcomes and mortality after hospitalisation with COVID-19 among patients with prevalent autoimmune diseases, and compared outcomes after hospital admissions among similar patients with seasonal influenza.

Design: Multinational network cohort study.

Setting: Electronic health records data from Columbia University Irving Medical Center (CUIMC) (NYC, United States [US]), Optum [US], Department of Veterans Affairs (VA) (US), Information System for Research in Primary Care-Hospitalisation Linked Data (SIDIAP-H) (Spain), and claims data from IQVIA Open Claims (US) and Health Insurance and Review Assessment (HIRA) (South Korea).

Participants: All patients with prevalent autoimmune diseases, diagnosed and/or hospitalised between January and June 2020 with COVID-19, and similar patients hospitalised with influenza in 2017-2018 were included.

Main Outcome Measures: 30-day complications during hospitalisation and death.

Results: We studied 133,589 patients diagnosed and 48,418 hospitalised with COVID-19 with prevalent autoimmune diseases. The majority of participants were female (60.5% to 65.9%) and aged ≥50 years. The most prevalent autoimmune conditions were psoriasis (3.5 to 32.5%), rheumatoid arthritis (3.9 to 18.9%), and vasculitis (3.3 to 17.6%). Amongst hospitalised patients, Type 1 diabetes was the most common autoimmune condition (4.8% to 7.5%) in US databases, rheumatoid arthritis in HIRA (18.9%), and psoriasis in SIDIAP-H (26.4%).Compared to 70,660 hospitalised with influenza, those admitted with COVID-19 had more respiratory complications including pneumonia and acute respiratory distress syndrome, and higher 30-day mortality (2.2% to 4.3% versus 6.3% to 24.6%).

Conclusions: Patients with autoimmune diseases had high rates of respiratory complications and 30-day mortality following a hospitalization with COVID-19. Compared to influenza, COVID-19 is a more severe disease, leading to more complications and higher mortality. Future studies should investigate predictors of poor outcomes in COVID-19 patients with autoimmune diseases.

What Is Already Known About This Topic: Patients with autoimmune conditions may be at increased risk of COVID-19 infection andcomplications.There is a paucity of evidence characterising the outcomes of hospitalised COVID-19 patients with prevalent autoimmune conditions.

What This Study Adds: Most people with autoimmune diseases who required hospitalisation for COVID-19 were women, aged 50 years or older, and had substantial previous comorbidities.Patients who were hospitalised with COVID-19 and had prevalent autoimmune diseases had higher prevalence of hypertension, chronic kidney disease, heart disease, and Type 2 diabetes as compared to those with prevalent autoimmune diseases who were diagnosed with COVID-19.A variable proportion of 6% to 25% across data sources died within one month of hospitalisation with COVID-19 and prevalent autoimmune diseases.For people with autoimmune diseases, COVID-19 hospitalisation was associated with worse outcomes and 30-day mortality compared to admission with influenza in the 2017-2018 season.
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http://dx.doi.org/10.1101/2020.11.24.20236802DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7709171PMC
November 2020

Pharmacists' roles in emergency and disasters: COVID-19 as an example.

Saudi Pharm J 2020 Dec 21;28(12):1797-1816. Epub 2020 Nov 21.

Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Background: Emergencies and disasters are major threats to health care systems. Coronavirus Disease 2019 (COVID-19) is at the center of a recent emergency situation that requires increased attention from health care professionals, including pharmacists. This study was aimed at providing an overview of pharmacists' roles in disasters and formulating a definition of expected roles and tasks through which they can perform these roles properly.

Methods: A systematic review was conducted utilizing a literature search performed on the Medline, EMBASE and PubMed databases. The last search occurred on 14 July 2020. Data were extracted and recorded on a data extraction sheet by the reviewers, then categorized using the prevention, preparedness, response, and recovery (PPRR) model. Study quality was evaluated using the Critical Appraisal Skills Program (CASP) checklist.

Results: Fifteen articles addressing pharmacists' roles in disasters were included. Of these, three addressed pharmacists' roles during the COVID-19 pandemic. Pharmacists' roles in the prevention of emergencies, including COVID-19, are focused on chronic disease medication supply and education. Regarding pharmacists' preparedness to perform their roles in disasters, they were more focused on health policy and population health planning, especially regarding the COVID-19 pandemic. Direct patient care continues to support patients through medication availability, and pharmacists' clinical roles are examples of their response to disasters. In addition, pharmacists have an important role in disaster recovery that involves several activities, such as restocking emergency kits and reestablishing normal stock. Studies were generally of a reasonable quality. However, some limitations were noted among studies, and higher quality studies that contribute to existing knowledge are needed.

Conclusion: Health care systems' utilization of pharmacists' new roles can result in a well-prepared disaster response, as observed during the COVID-19 pandemic. Pharmacists' engagement in decision-making processes and adequate demonstration of pharmacists' nontraditional roles in the literature can facilitate the health care community's acceptance of such roles.
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http://dx.doi.org/10.1016/j.jsps.2020.11.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679230PMC
December 2020

Nicotinamide Therapy in Dialysis Patients: A Systematic Review of Randomized Controlled Trials.

Saudi J Kidney Dis Transpl 2020 Sep-Oct;31(5):883-897

Department of Pharmacology, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi, India.

Randomized controlled trials (RCTs) have presented variable findings concerning the reduction of phosphorous level by nicotinamide. This systematic review is aimed to explore the safety and efficacy of nicotinamide in hemodialysis patients and was conducted by adhering to the PRISMA guidelines. Studies for inclusion were identified by running the suitable keywords in PubMed, Embase, and Cochrane Central till June 13, 2018. Cochrane risk of bias tool was used to judge the quality of the included RCTs. The primary outcome was change in serum phosphorus, calcium, and calcium-phosphorus product levels. Change in other biochemical parameters including serum calcium, parathormone, platelets, lipid profile parameters, and the safety profile was considered under secondary outcomes. Review Manager (RevMan v5.3) was used for the risk of bias estimate. A total of 12 articles were qualified for inclusion in this study. All the included RCTs showed a statistically significant reduction in mean serum phosphorous and calcium-phosphorus product levels in the treatment arm as compared to the placebo group. Among several biochemical parameters analyzed, only high-density lipoprotein (HDL) was found to be significantly increased from baseline to the endpoint of the study in the nicotinamide group, while the placebo group showed no significant difference. Flushing and diarrhea, followed by thrombocytopenia, were the most commonly reported adverse events in the treatment group. Nicotinamide was found to be effective in reducing the phosphorous level and calcium-phosphorus product level and increasing the HDL cholesterol level in dialysis patients. The safety profile was found to be satisfactory.
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http://dx.doi.org/10.4103/1319-2442.301195DOI Listing
October 2021

Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study.

medRxiv 2020 Oct 30. Epub 2020 Oct 30.

To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children/adolescents diagnosed or hospitalized with COVID-19. Secondly, to describe health outcomes amongst children/adolescents diagnosed with previous seasonal influenza. International network cohort. Real-world data from European primary care records (France/Germany/Spain), South Korean claims and US claims and hospital databases. Diagnosed and/or hospitalized children/adolescents with COVID-19 at age <18 between January and June 2020; diagnosed with influenza in 2017-2018. Baseline demographics and comorbidities, symptoms, 30-day in-hospital treatments and outcomes including hospitalization, pneumonia, acute respiratory distress syndrome (ARDS), multi-system inflammatory syndrome (MIS-C), and death. A total of 55,270 children/adolescents diagnosed and 3,693 hospitalized with COVID-19 and 1,952,693 diagnosed with influenza were studied. Comorbidities including neurodevelopmental disorders, heart disease, and cancer were all more common among those hospitalized vs diagnosed with COVID-19. The most common COVID-19 symptom was fever. Dyspnea, bronchiolitis, anosmia and gastrointestinal symptoms were more common in COVID-19 than influenza. In-hospital treatments for COVID-19 included repurposed medications (<10%), and adjunctive therapies: systemic corticosteroids (6.8% to 37.6%), famotidine (9.0% to 28.1%), and antithrombotics such as aspirin (2.0% to 21.4%), heparin (2.2% to 18.1%), and enoxaparin (2.8% to 14.8%). Hospitalization was observed in 0.3% to 1.3% of the COVID-19 diagnosed cohort, with undetectable (N<5 per database) 30-day fatality. Thirty-day outcomes including pneumonia, ARDS, and MIS-C were more frequent in COVID-19 than influenza. Despite negligible fatality, complications including pneumonia, ARDS and MIS-C were more frequent in children/adolescents with COVID-19 than with influenza. Dyspnea, anosmia and gastrointestinal symptoms could help differential diagnosis. A wide range of medications were used for the inpatient management of pediatric COVID-19.
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http://dx.doi.org/10.1101/2020.10.29.20222083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605587PMC
October 2020

Baseline phenotype and 30-day outcomes of people tested for COVID-19: an international network cohort including >3.32 million people tested with real-time PCR and >219,000 tested positive for SARS-CoV-2 in South Korea, Spain and the United States.

medRxiv 2020 Oct 27. Epub 2020 Oct 27.

Early identification of symptoms and comorbidities most predictive of COVID-19 is critical to identify infection, guide policies to effectively contain the pandemic, and improve health systems' response. Here, we characterised socio-demographics and comorbidity in 3,316,107persons tested and 219,072 persons tested positive for SARS-CoV-2 since January 2020, and their key health outcomes in the month following the first positive test. Routine care data from primary care electronic health records (EHR) from Spain, hospital EHR from the United States (US), and claims data from South Korea and the US were used. The majority of study participants were women aged 18-65 years old. Positive/tested ratio varied greatly geographically (2.2:100 to 31.2:100) and over time (from 50:100 in February-April to 6.8:100 in May-June). Fever, cough and dyspnoea were the most common symptoms at presentation. Between 4%-38% required admission and 1-10.5% died within a month from their first positive test. Observed disparity in testing practices led to variable baseline characteristics and outcomes, both nationally (US) and internationally. Our findings highlight the importance of large scale characterization of COVID-19 international cohorts to inform planning and resource allocation including testing as countries face a second wave.
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http://dx.doi.org/10.1101/2020.10.25.20218875DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605581PMC
October 2020

Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study.

Nat Commun 2020 10 6;11(1):5009. Epub 2020 Oct 6.

Clinical Pharmacology Unit, Zealand University Hospital, Køge, Denmark.

Comorbid conditions appear to be common among individuals hospitalised with coronavirus disease 2019 (COVID-19) but estimates of prevalence vary and little is known about the prior medication use of patients. Here, we describe the characteristics of adults hospitalised with COVID-19 and compare them with influenza patients. We include 34,128 (US: 8362, South Korea: 7341, Spain: 18,425) COVID-19 patients, summarising between 4811 and 11,643 unique aggregate characteristics. COVID-19 patients have been majority male in the US and Spain, but predominantly female in South Korea. Age profiles vary across data sources. Compared to 84,585 individuals hospitalised with influenza in 2014-19, COVID-19 patients have more typically been male, younger, and with fewer comorbidities and lower medication use. While protecting groups vulnerable to influenza is likely a useful starting point in the response to COVID-19, strategies will likely need to be broadened to reflect the particular characteristics of individuals being hospitalised with COVID-19.
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http://dx.doi.org/10.1038/s41467-020-18849-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538555PMC
October 2020

Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study.

Lancet Rheumatol 2020 Nov 21;2(11):e698-e711. Epub 2020 Aug 21.

Janssen Research and Development, Titusville, NJ, USA.

Background: Hydroxychloroquine, a drug commonly used in the treatment of rheumatoid arthritis, has received much negative publicity for adverse events associated with its authorisation for emergency use to treat patients with COVID-19 pneumonia. We studied the safety of hydroxychloroquine, alone and in combination with azithromycin, to determine the risk associated with its use in routine care in patients with rheumatoid arthritis.

Methods: In this multinational, retrospective study, new user cohort studies in patients with rheumatoid arthritis aged 18 years or older and initiating hydroxychloroquine were compared with those initiating sulfasalazine and followed up over 30 days, with 16 severe adverse events studied. Self-controlled case series were done to further establish safety in wider populations, and included all users of hydroxychloroquine regardless of rheumatoid arthritis status or indication. Separately, severe adverse events associated with hydroxychloroquine plus azithromycin (compared with hydroxychloroquine plus amoxicillin) were studied. Data comprised 14 sources of claims data or electronic medical records from Germany, Japan, the Netherlands, Spain, the UK, and the USA. Propensity score stratification and calibration using negative control outcomes were used to address confounding. Cox models were fitted to estimate calibrated hazard ratios (HRs) according to drug use. Estimates were pooled where the value was less than 0·4.

Findings: The study included 956 374 users of hydroxychloroquine, 310 350 users of sulfasalazine, 323 122 users of hydroxychloroquine plus azithromycin, and 351 956 users of hydroxychloroquine plus amoxicillin. No excess risk of severe adverse events was identified when 30-day hydroxychloroquine and sulfasalazine use were compared. Self-controlled case series confirmed these findings. However, long-term use of hydroxychloroquine appeared to be associated with increased cardiovascular mortality (calibrated HR 1·65 [95% CI 1·12-2·44]). Addition of azithromycin appeared to be associated with an increased risk of 30-day cardiovascular mortality (calibrated HR 2·19 [95% CI 1·22-3·95]), chest pain or angina (1·15 [1·05-1·26]), and heart failure (1·22 [1·02-1·45]).

Interpretation: Hydroxychloroquine treatment appears to have no increased risk in the short term among patients with rheumatoid arthritis, but in the long term it appears to be associated with excess cardiovascular mortality. The addition of azithromycin increases the risk of heart failure and cardiovascular mortality even in the short term. We call for careful consideration of the benefit-risk trade-off when counselling those on hydroxychloroquine treatment.

Funding: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, NIHR Senior Research Fellowship programme, US National Institutes of Health, US Department of Veterans Affairs, Janssen Research and Development, IQVIA, Korea Health Industry Development Institute through the Ministry of Health and Welfare Republic of Korea, Versus Arthritis, UK Medical Research Council Doctoral Training Partnership, Foundation Alfonso Martin Escudero, Innovation Fund Denmark, Novo Nordisk Foundation, Singapore Ministry of Health's National Medical Research Council Open Fund Large Collaborative Grant, VINCI, Innovative Medicines Initiative 2 Joint Undertaking, EU's Horizon 2020 research and innovation programme, and European Federation of Pharmaceutical Industries and Associations.
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http://dx.doi.org/10.1016/S2665-9913(20)30276-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7442425PMC
November 2020

Importance of early precautionary actions in avoiding the spread of COVID-19: Saudi Arabia as an Example.

Saudi Pharm J 2020 Jul 22;28(7):898-902. Epub 2020 May 22.

Regional Drug Information and Pharmacovigilance Center, Ministry of Health, Tabuk, Saudi Arabia.

Late in 2019, several cases of infection with a new strain of coronavirus were reported in China. This new strain was later officially named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by the World Health Organization (WHO). This new virus (SARS-CoV2-) mainly affects the respiratory system and causes coronavirus disease 2019 (COVID-19). The first case of COVID-19 was reported to the WHO on December 31st, 2019, and the virus has spread dramatically in many countries worldwide. On March 11th, 2020, the WHO declared that COVID-19 had affected most of the world, and many deaths were linked to COVID-19. Unfortunately, there is no available treatment for COVID-19, and there is no available vaccine against SARS-CoV-2. Thus, preventive methods are the only way to limit the spread of the virus. Preventive actions have been taken by many countries, such as travel bans, closing borders and working from home. Saudi Arabia was one of the countries that took very early precautionary actions in the belief that these actions are the best way to fight the virus. Therefore, we present the actions that were taken by the Kingdom of Saudi Arabia to fight the new viral pandemic.
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http://dx.doi.org/10.1016/j.jsps.2020.05.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242187PMC
July 2020

Renin-angiotensin system blockers and susceptibility to COVID-19: a multinational open science cohort study.

medRxiv 2020 Jun 12. Epub 2020 Jun 12.

Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, UK.

Introduction: Angiotensin converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs) could influence infection risk of coronavirus disease (COVID-19). Observational studies to date lack pre-specification, transparency, rigorous ascertainment adjustment and international generalizability, with contradictory results.

Methods: Using electronic health records from Spain (SIDIAP) and the United States (Columbia University Irving Medical Center and Department of Veterans Affairs), we conducted a systematic cohort study with prevalent ACE, ARB, calcium channel blocker (CCB) and thiazide diuretic (THZ) use to determine relative risk of COVID-19 diagnosis and related hospitalization outcomes. The study addressed confounding through large-scale propensity score adjustment and negative control experiments.

Results: Following over 1.1 million antihypertensive users identified between November 2019 and January 2020, we observed no significant difference in relative COVID-19 diagnosis risk comparing ACE/ARB vs CCB/THZ monotherapy (hazard ratio: 0.98; 95% CI 0.84 - 1.14), nor any difference for mono/combination use (1.01; 0.90 - 1.15). ACE alone and ARB alone similarly showed no relative risk difference when compared to CCB/THZ monotherapy or mono/combination use. Directly comparing ACE vs. ARB demonstrated a moderately lower risk with ACE, non-significant for monotherapy (0.85; 0.69 - 1.05) and marginally significant for mono/combination users (0.88; 0.79 - 0.99). We observed, however, no significant difference between drug- classes for COVID-19 hospitalization or pneumonia risk across all comparisons.

Conclusion: There is no clinically significant increased risk of COVID-19 diagnosis or hospitalization with ACE or ARB use. Users should not discontinue or change their treatment to avoid COVID-19.
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http://dx.doi.org/10.1101/2020.06.11.20125849DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7310640PMC
June 2020

Deep phenotyping of 34,128 patients hospitalised with COVID-19 and a comparison with 81,596 influenza patients in America, Europe and Asia: an international network study.

medRxiv 2020 Jun 28. Epub 2020 Jun 28.

Background In this study we phenotyped individuals hospitalised with coronavirus disease 2019 (COVID-19) in depth, summarising entire medical histories, including medications, as captured in routinely collected data drawn from databases across three continents. We then compared individuals hospitalised with COVID-19 to those previously hospitalised with influenza. Methods We report demographics, previously recorded conditions and medication use of patients hospitalised with COVID-19 in the US (Columbia University Irving Medical Center [CUIMC], Premier Healthcare Database [PHD], UCHealth System Health Data Compass Database [UC HDC], and the Department of Veterans Affairs [VA OMOP]), in South Korea (Health Insurance Review & Assessment [HIRA]), and Spain (The Information System for Research in Primary Care [SIDIAP] and HM Hospitales [HM]). These patients were then compared with patients hospitalised with influenza in 2014-19. Results 34,128 (US: 8,362, South Korea: 7,341, Spain: 18,425) individuals hospitalised with COVID-19 were included. Between 4,811 (HM) and 11,643 (CUIMC) unique aggregate characteristics were extracted per patient, with all summarised in an accompanying interactive website (http://evidence.ohdsi.org/Covid19CharacterizationHospitalization/). Patients were majority male in the US (CUIMC: 52%, PHD: 52%, UC HDC: 54%, VA OMOP: 94%,) and Spain (SIDIAP: 54%, HM: 60%), but were predominantly female in South Korea (HIRA: 60%). Age profiles varied across data sources. Prevalence of asthma ranged from 4% to 15%, diabetes from 13% to 43%, and hypertensive disorder from 24% to 70% across data sources. Between 14% and 33% were taking drugs acting on the renin-angiotensin system in the 30 days prior to hospitalisation. Compared to 81,596 individuals hospitalised with influenza in 2014-19, patients admitted with COVID-19 were more typically male, younger, and healthier, with fewer comorbidities and lower medication use. Conclusions We provide a detailed characterisation of patients hospitalised with COVID-19. Protecting groups known to be vulnerable to influenza is a useful starting point to minimize the number of hospital admissions needed for COVID-19. However, such strategies will also likely need to be broadened so as to reflect the particular characteristics of individuals hospitalised with COVID-19.
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http://dx.doi.org/10.1101/2020.04.22.20074336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239064PMC
June 2020

Real-world data in Saudi Arabia: Current situation and challenges for regulatory decision-making.

Pharmacoepidemiol Drug Saf 2020 10 27;29(10):1303-1306. Epub 2020 May 27.

Research Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Purpose: To present the process of establishing a pharmacoepidemiological database in Saudi Arabia, challenges and models used.

Methods: The database establishment has started in 2017 by piloting the conversion of electronic health records of one hospital to the Observational Health Data Sciences and Informatics (OHDSI), Observational Medical Outcomes Partnership's Common Data Model (OMOP).

Results: During the pilot phase we have faced several challenges such as limited contribution in providing data by local medical institution due to uncertainty about data governance, diversity of systems used by hospitals, inconsistent coding of medical information, and limited awareness about data structure from participating hospital. The pilot phase was completed in 2019 containing information about patient attributes, medical care, therapies, and other additional services for around 130 000 patients in Saudi Arabia. The majority of patients were below the age of 50 years (89%), and acute respiratory infections were the most frequent diagnosis. The data quality was acceptable and no major anomalies were detected during the conversion.

Conclusions: We demonstrated a successful creation of a pilot database using OHDSI Common Data Model. Our experience with the pilot database could be extended to other institutions to create a national dataset that could be used to generate real-world evidence.
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http://dx.doi.org/10.1002/pds.5025DOI Listing
October 2020

Association of medication storage with diabetes control: A cross-sectional study from Saudi Arabia.

Saudi Pharm J 2020 Apr 17;28(4):452-459. Epub 2020 Feb 17.

Medication Safety Research Chair, King Saud University, Riyadh, Saudi Arabia.

Background: In addition to diet restriction and physical activity, diabetes mellitus is managed by the chronic use of medications that require appropriate storage conditions to maintain their stability and effectiveness. However, there is a lack of information regarding patients' knowledge of medication storage and practices in Saudi Arabia. Therefore, the objective of this study was to determine the diabetics' knowledge about medication storage requirements and to evaluate the impact of antidiabetic medications storage on the blood glucose levels.

Methods: This study was a cross-sectional in the form of an interviewer-guided interview using a close-ended questions. The study was conducted among patients diagnosed with diabetes at diabetic clinics of public hospitals and other diabetic specialized clinics in Hail region of Saudi Arabia, over a period of four months between January to April 2019.

Results: A total of 501 completed questionnaires were returned. Of the respondents, 51.5% were males and 48.5% were females. Of the total participants 52.7% never achieved normal blood glucose range, which was associated with health literacy and medication storage knowledge. Almost half of the participants stored the medication correctly and others have poor knowledge and practice of medication storage, of whom 7.8% always store their medicines in their cars.

Conclusion: Almost half of the participants lack the knowledge of appropriate storage conditions of diabetes medications, which was shown to have a significant association with blood glucose levels.
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http://dx.doi.org/10.1016/j.jsps.2020.02.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7132604PMC
April 2020

National Cross-Sectional Study of Community-Based Adverse Drug Reactions in Saudi Arabia.

Drugs Real World Outcomes 2020 Jun;7(2):161-170

Saudi Food and Drug Authority, 6336 Northern Ring Branch Rd, 3372, Riyadh, 13312 6336, Saudi Arabia.

Background: An adverse drug reaction (ADR) is a response to a medicine that is not intended and is harmful, and which occurs at normal dose levels for humans. Currently, there are no estimates of the population-based prevalence of ADRs in the Kingdom of Saudi Arabia (KSA).

Objective: The aims of this study were to (1) estimate the population-based prevalence of ADRs in KSA, (2) describe the ADRs experienced by survey respondents, and (3) investigate the level of awareness of the ADR reporting system.

Patients And Methods: This was a cross-sectional survey using stratified, population-based sampling conducted at a chain of community pharmacies.

Results: Analysis was conducted on 5228 surveys; 50.17% of respondents were males, and the mean age was 39 ± 15 years (min = 18, max = 98). The sample prevalence of ADRs was 23.45% (95% CI 22.30-24.60%, P < 0.001). The estimated population prevalence (after weighting) was 28.00% (26.10-30.00%). Gastrointestinal disorders were the most commonly reported ADRs (58.73%), followed by general disorders and administration site conditions (19.74%). The largest drug class that was reported to lead to ADRs was nonsteroidal anti-inflammatory drugs (NSAIDs) (11%). Over 19% of the respondents who experienced an ADR required medical intervention to control the suffering induced by the ADR. Of the respondents who experienced an ADR, 371 (30.26%) were aware of the ADR reporting system but only 53 (14.29%) said that they had filed a report in the system.

Conclusions: Our study estimated that 28% of the population experienced an ADR over a 1-year period in KSA. Risk factors for ADR included certain chronic disease groups and the use of certain classes of medications. Regulatory authorities in KSA intend to conduct more research and deploy educational interventions to reduce ADR rates in KSA. This will hopefully occur in an international context that promotes the standardized measurement of ADRs in the community. A subset of findings from this report was presented in an oral presentation at the Saudi Food and Drug Authority (SFDA) Annual Conference, September 27, 2018. In addition, a subset of findings from this report were presented on a poster at the International Conference of Pharmacoepidemiology and Therapeutic Risk Management (ICPE), August 27, 2019.
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http://dx.doi.org/10.1007/s40801-020-00186-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7221044PMC
June 2020

National pharmacovigilance programs in Arab countries: A quantitative assessment study.

Pharmacoepidemiol Drug Saf 2020 09 17;29(9):1001-1010. Epub 2020 Mar 17.

Pharmacy Services Department, King Saud University Medical City, Riyadh, Saudi Arabia.

Purposes: The aim of the pharmacovigilance (PV) process is to bring together all the much-needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activities of the national PV centers in Arab countries.

Methods: A cross sectional study was conducted between March and May in 2018. The current survey was adopted and modified from a study that used the questionnaire designed by the World Health Organization Collaborating Centre for International Drug Monitoring. The national PV centers of 22 Arab countries were invited to participate in this study. Descriptive analyses were conducted utilizing the analysis services provided by SurveyMonkey.

Results: In total of, 15 countries responded to our invitation (response rate: 68%). Most Arab countries started their PV program in the last decade, with Palestine implementing its program in 2017. Among the respondents, nine (60%) were members of the WHO International Drug Monitoring Program and were all users of the software provided by the WHO Uppsala Monitoring Center (VigiFlow or VigiBase), except Sudan. In 2017, a total of 27 502 reports were received by the centers in the studied countries, ranging from three reports received in Lebanon to a total of 7362 reports received by the national program of Algeria.

Conclusions: An improvement was noticed among the national PV programs in the Arab countries. However, a considerable difference still exists among the countries in terms of the implementation and practice of PV.
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http://dx.doi.org/10.1002/pds.4991DOI Listing
September 2020

Energy drinks and population health: consumption pattern and adverse effects among Saudi population.

BMC Public Health 2019 Nov 21;19(1):1539. Epub 2019 Nov 21.

Medication Safety Research Chair, King Saud University, Riyadh, Kingdom of Saudi Arabia.

Background: Caffeine containing energy drinks (EDs) are heavily consumed, particularly among young adults. The number of reports of caffeine intoxication from caffeinated EDs and problems related to caffeine dependence and withdrawal is increasing. The objective was to assess the knowledge and perceived beneficial effects of EDs consumers, to assess consumption patterns and determine the adverse effects experienced by different EDs consumer groups residing in Saudi Arabia.

Methods: An observational cross-sectional study with data from a randomly selected Saudi population was conducted during the period of January 15th, 2015, to April 15th, 2015, using a pre-tested 43-item questionnaire. The data were obtained and collected using interview questionnaires. Sociodemographic characteristics and data on EDs consumption patterns, the level of awareness among study subjects, and the purported benefits and reported adverse effects of EDs were collected. Frequency, percentage, and arithmetic means were calculated using Chi-square and ANOVA tests, and data with p < 0.05 were considered significant.

Results: Of the 816 individuals invited to participate in the study, 783 participants responded and completed interviews, response rate was 96%. Consumers attributed the popularity of EDs to massive advertising media (46.7%) and their stimulating and invigorating effects (37.5%). EDs are consumed by subjects for their effects on fatigue reduction (64.6%), increased alertness and focus (75.8%), and assistance during long driving trips (75.7%). Study subjects reported suffering from adverse effects, including mainly diuresis (53.7%), palpitations (50.7%), insomnia (50.7%). Importantly, an inverse association was identified between knowledge of EDs and consumption rate, and a proportional association was identified between experienced adverse effects and consumption frequency. Lower knowledge scores were identified in daily consumers than in 1-3 times monthly consumers; higher adverse events were experienced by daily consumers than by 1-3 times monthly consumers. The majority of consumers (84.6%) recommended that authorities should regulate EDs consumption.

Conclusions: Excessive EDs consumption is associated with an increased risk of experiencing several adverse events, which is commensurate with published studies. Increasing knowledge about EDs and their possible risks could decrease their consumption by the general public.
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http://dx.doi.org/10.1186/s12889-019-7731-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6869250PMC
November 2019

Oral antidiabetic medication adherence and glycaemic control among patients with type 2 diabetes mellitus: a cross-sectional retrospective study in a tertiary hospital in Saudi Arabia.

BMJ Open 2019 07 23;9(7):e029280. Epub 2019 Jul 23.

Division of Pharmaceutical, Administrative and Social Sciences, Duquesne University School of Pharmacy, Pittsburgh, USA.

Objectives: The purpose of this study is to measure the adherence rates of oral antidiabetic drugs (OADs) in patients with type 2 diabetes mellitus (T2DM) and assess the relationship of glycaemic control and adherence to OADs after controlling for other associated factors.

Design: Cross-sectional retrospective study.

Setting: Large tertiary hospital in the central region of Saudi Arabia.

Participants: 5457patients aged 18 years and older diagnosed with T2DM during the period from 1 January 2016 to 31 December 2016.

Primary And Secondary Outcome Measures: The modified medication possession ratio (mMPR) was calculated as a proxy measure for adherence of OADs. The factors associated with OADs non-adherence and medication oversupply were assessed using multinomial logistic regression models. The secondary outcomes were to measure the association between OADs adherence and glycaemic control.

Results: Majority of patients with T2DM were females (n=3400, 62.3%). The average glycated haemoglobin was 8.2±1.67. Among the study population, 48.6% had good adherence (mMPR >0.8) and 8.6% had a medication oversupply (mMPR >1.2). Good adherence was highest among those using repaglinide (71.0%) followed by pioglitazone (65.0%) and sitagliptin (59.0%). In the multivariate analysis, women with T2DM were more likely to have poor adherence (adjusted OR (AOR)=0.76, 95% CI=0.67, 0.86) compared with men. Also, medication oversupply was more likely among patients with hyperpolypharmacy (AOR=1.88, 95% CI=1.36, 2.63), comorbid osteoarthritis (AOR=1.72, 95% CI=1.20, 02.45) and non-Saudi patients (AOR=1.53, 95% CI=1.16, 2.01). However, no association was found between glycaemic control and adherence to OADs.

Conclusion: The study findings support the growing concern of non-adherence to OADs among patients with T2DM in Saudi Arabia. Decision makers have to invest in behavioural interventions that will boost medication adherence rates. This is particularly important in patients with polypharmacy and high burden of comorbid conditions.
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http://dx.doi.org/10.1136/bmjopen-2019-029280DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6661664PMC
July 2019

Factors that facilitate reporting of adverse drug reactions by pharmacists in Saudi Arabia.

Expert Opin Drug Saf 2019 Aug 11;18(8):745-752. Epub 2019 Jul 11.

a Department of Clinical Pharmacy, College of Pharmacy, King Saud University , Riyadh , Saudi Arabia.

: Adverse drug reactions (ADRs) are a pervasive global problem, and its management is integral to patient safety and healthcare quality. Pharmacists play a pivotal role in monitoring and reporting ADRs, which has a direct impact on patient care. The aim of this study was to identify potential factors that facilitate pharmacists in community and hospital settings to report ADRs. : A cross-sectional, online survey using a validated questionnaire was administered to pharmacists working in community and hospital pharmacies in Saudi Arabia. : 1,717 community and 153 hospital pharmacists participated in this study. Only 10.2% and 26.8% of community and hospital pharmacists, respectively, admitted ever reporting an ADR. The most reported factors that may facilitate ADRs reporting have included ongoing improvements in therapeutic knowledge about ADRs, attending educational programs with continuous medical education credits, the seriousness of the experienced ADRs and accessibility to patients' medical profile. The impact of peers by seeing colleagues reporting ADRs and ADRs due to herbal or traditional medicine were the least important factors reported by pharmacists. : The study identified factors that can effectively address the under-reporting of ADRs by pharmacists. A multi-stakeholder, multi-pronged approach of ADR reporting is needed to develop greater awareness of this issue among pharmacists.
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http://dx.doi.org/10.1080/14740338.2019.1632287DOI Listing
August 2019

Knowledge, awareness, attitude, and practice of health-care professionals toward hepatitis B disease and vaccination in Saudi Arabia.

Hum Vaccin Immunother 2019 3;15(12):2816-2823. Epub 2019 Sep 3.

Department of Pharmacology, College of Pharmacy, University of Hail, Hail, Saudi Arabia.

: Health-care professionals (HCPs) are at very high risk for accidental exposure to hepatitis B virus (HBV) from infected patients; as such, this study aimed to investigate the knowledge, awareness, attitude, and practice of HCPs toward hepatitis B vaccination.: We conducted a cross-sectional study with a pre-tested, validated questionnaire in seven major cities in Saudi Arabia from January to April 2015. The questionnaire consisted of four sections: demographics, knowledge, awareness of hepatitis B infection, and attitude of HCPs toward HBV. We analyzed the data collected from study participants using SAS® V9.2.: Approximately 16.5% of participants reported that they had not received the hepatitis B vaccine; however, the majority of participants believed that hepatitis B is common (73.2%) and that vaccination is an effective strategy to reduce disease incidence (75%). Availability of the vaccine was a major barrier to vaccination (48.7%), together with safety concerns surrounding the vaccine (37%).Approximately 31.2% of non-vaccinated participants believed the hepatitis B vaccine is not safe, while only 8% possessed this belief in the vaccinated group. Additionally, 36.4% of non-vaccinated participants were unsure of the effectiveness of the vaccine, compared to 24.3% in the vaccinated group. Inability to afford the vaccine was reported by 18.2% of the non-vaccinated group compared to only 4% of vaccinated participants.: There is notable hepatitis B vaccination coverage among HCPs, but observed levels are below global standards. We believe the hurdles preventing non-vaccinated HCPs from being immunized must be addressed.
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http://dx.doi.org/10.1080/21645515.2019.1629255DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6930104PMC
May 2020
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