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1.
Int J Environ Res Public Health ; 19(5)2022 03 03.
Article in English | MEDLINE | ID: covidwho-1736918

ABSTRACT

(1) Background: Precarious patients are more difficult to care for due to low literacy rates and poor adherence to treatment and hospitalization. These difficulties have detrimental effects on general practitioners (GPs), deteriorating medical communication, advice, diagnoses, and drug prescriptions. To better understand how precariousness affects primary care, we tested whether, among GPs, exposure to high precariousness prevalence more severely impacts drug prescriptions to precarious and non-precarious populations compared to low precariousness prevalence. Materials and methods: This pharmaco-epidemiological study, using linear regression analyses, compared the defined daily dose of 20 drugs prescribed by GPs to precarious and non-precarious patients in four French regions with low and high precariousness prevalence in 2015. (2) Findings: Exposure to high precariousness prevalence significantly impacted the prescriptions of nine medications to precarious patients and two medications to non-precarious patients, and distributed into three interaction patterns. (3) Interpretation: The selective over-prescription of drugs with easy intake modalities to precarious patients probably reflects GPs' attempts to compensate for poor patient compliance. In contrast, the under-prescription of drugs targeting fungal infections in precarious populations and diabetes and cardiovascular diseases in non-precarious populations was seemingly due to a breakdown of empathy and professional exhaustion, causing medical neglect.


Subject(s)
General Practitioners , Drug Prescriptions , Humans , Pharmacoepidemiology , Prevalence , Retrospective Studies
2.
Int J Environ Res Public Health ; 18(24)2021 12 18.
Article in English | MEDLINE | ID: covidwho-1580725

ABSTRACT

Australia spends more than $20 billion annually on medicines, delivering significant health benefits for the population. However, inappropriate prescribing and medicine use also result in harm to individuals and populations, and waste of precious health resources. Medication data linked with other routine collections enable evidence generation in pharmacoepidemiology; the science of quantifying the use, effectiveness and safety of medicines in real-world clinical practice. This review details the history of medicines policy and data access in Australia, the strengths of existing data sources, and the infrastructure and governance enabling and impeding evidence generation in the field. Currently, substantial gaps persist with respect to cohesive, contemporary linked data sources supporting quality use of medicines, effectiveness and safety research; exemplified by Australia's limited capacity to contribute to the global effort in real-world studies of vaccine and disease-modifying treatments for COVID-19. We propose a roadmap to bolster the discipline, and population health more broadly, underpinned by a distinct capability governing and streamlining access to linked data assets for accredited researchers. Robust real-world evidence generation requires current data roadblocks to be remedied as a matter of urgency to deliver efficient and equitable health care and improve the health and well-being of all Australians.


Subject(s)
COVID-19 , Australia , Forecasting , Humans , Pharmacoepidemiology , SARS-CoV-2
3.
Am J Epidemiol ; 190(11): 2405-2419, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1493668

ABSTRACT

Hydroxychloroquine (HCQ) was proposed as an early therapy for coronavirus disease 2019 (COVID-19) after in vitro studies indicated possible benefit. Previous in vivo observational studies have presented conflicting results, though recent randomized clinical trials have reported no benefit from HCQ among patients hospitalized with COVID-19. We examined the effects of HCQ alone and in combination with azithromycin in a hospitalized population of US veterans with COVID-19, using a propensity score-adjusted survival analysis with imputation of missing data. According to electronic health record data from the US Department of Veterans Affairs health care system, 64,055 US Veterans were tested for the virus that causes COVID-19 between March 1, 2020 and April 30, 2020. Of the 7,193 veterans who tested positive, 2,809 were hospitalized, and 657 individuals were prescribed HCQ within the first 48-hours of hospitalization for the treatment of COVID-19. There was no apparent benefit associated with HCQ receipt, alone or in combination with azithromycin, and there was an increased risk of intubation when HCQ was used in combination with azithromycin (hazard ratio = 1.55; 95% confidence interval: 1.07, 2.24). In conclusion, we assessed the effectiveness of HCQ with or without azithromycin in treatment of patients hospitalized with COVID-19, using a national sample of the US veteran population. Using rigorous study design and analytic methods to reduce confounding and bias, we found no evidence of a survival benefit from the administration of HCQ.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , COVID-19/drug therapy , Hospitalization/statistics & numerical data , Hydroxychloroquine/therapeutic use , Veterans/statistics & numerical data , Aged , Aged, 80 and over , Anti-Bacterial Agents/adverse effects , Azithromycin/adverse effects , COVID-19/mortality , Drug Therapy, Combination , Female , Humans , Hydroxychloroquine/adverse effects , Intention to Treat Analysis , Machine Learning , Male , Middle Aged , Pharmacoepidemiology , Retrospective Studies , SARS-CoV-2 , Treatment Outcome , United States/epidemiology
4.
Am J Epidemiol ; 190(11): 2405-2419, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1393147

ABSTRACT

Hydroxychloroquine (HCQ) was proposed as an early therapy for coronavirus disease 2019 (COVID-19) after in vitro studies indicated possible benefit. Previous in vivo observational studies have presented conflicting results, though recent randomized clinical trials have reported no benefit from HCQ among patients hospitalized with COVID-19. We examined the effects of HCQ alone and in combination with azithromycin in a hospitalized population of US veterans with COVID-19, using a propensity score-adjusted survival analysis with imputation of missing data. According to electronic health record data from the US Department of Veterans Affairs health care system, 64,055 US Veterans were tested for the virus that causes COVID-19 between March 1, 2020 and April 30, 2020. Of the 7,193 veterans who tested positive, 2,809 were hospitalized, and 657 individuals were prescribed HCQ within the first 48-hours of hospitalization for the treatment of COVID-19. There was no apparent benefit associated with HCQ receipt, alone or in combination with azithromycin, and there was an increased risk of intubation when HCQ was used in combination with azithromycin (hazard ratio = 1.55; 95% confidence interval: 1.07, 2.24). In conclusion, we assessed the effectiveness of HCQ with or without azithromycin in treatment of patients hospitalized with COVID-19, using a national sample of the US veteran population. Using rigorous study design and analytic methods to reduce confounding and bias, we found no evidence of a survival benefit from the administration of HCQ.


Subject(s)
Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , COVID-19/drug therapy , Hospitalization/statistics & numerical data , Hydroxychloroquine/therapeutic use , Veterans/statistics & numerical data , Aged , Aged, 80 and over , Anti-Bacterial Agents/adverse effects , Azithromycin/adverse effects , COVID-19/mortality , Drug Therapy, Combination , Female , Humans , Hydroxychloroquine/adverse effects , Intention to Treat Analysis , Machine Learning , Male , Middle Aged , Pharmacoepidemiology , Retrospective Studies , SARS-CoV-2 , Treatment Outcome , United States/epidemiology
5.
Therapie ; 76(4): 305-309, 2021.
Article in English | MEDLINE | ID: covidwho-1265885

ABSTRACT

The marketing authorization granted to SARS-Cov-2 vaccines was accompanied by reinforced safety monitoring plans. These plans' implementation was part of the usual logic of post-marketing surveillance of new and innovative health products. It was especially adapted to the context of post-marketing monitoring of drugs developed according to the usual scientific quality standards but in an accelerated schedule. In Europe, the reinforced surveillance system relies on the complementary strengths of pharmacovigilance and pharmacoepidemiology. If the performances of pharmacovigilance monitoring are incomparable for the detection of safety signals relating to rare events of atypical presentation, it needs to be completed with pharmacoepidemiology activities for more common events, either multifactorial or frequently classified as idiopathic. The pharmacoepidemiological monitoring developed in Europe was elaborated before the first SARS-Cov-2 vaccines where marketed, taking into account the lessons learned from the vaccination campaign against 2009 A (H1N1) influenza. It includes numerous academic studies as well as studies performed within vaccines risk management plans. In terms of safety, those defined a priori mostly concerns a list of pre-established health events of specific interest. Aside of these planned activities, ad-hoc studies will be latter developed on purpose to investigate safety signals or potential signals that could be identified as the result of pharmacovigilance activities. Aside of these regulated activities, as for today, very few studies have been published regarding SARS-Cov-2 vaccines; most of the existing consist in preprints that should be considered with caution. Pharmacoepidemiology of vaccines is thought to allow near-real time monitoring that needs sufficient time to provide with valid results. In the constant urge for information that accompanies COVID-related science, it is important not to make haste the enemy of speed and to let pharmacoepidemiology provides with what it is expected to do: rock-solid scientific information contributing to evidence-based decision-making.


Subject(s)
COVID-19 Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , Immunization Programs , Pharmacoepidemiology , COVID-19/immunology , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , Europe/epidemiology , Humans , Influenza A Virus, H1N1 Subtype/immunology , Influenza Vaccines/adverse effects , Influenza Vaccines/immunology , SARS-CoV-2/immunology
6.
Ann Fam Med ; 19(2): 135-140, 2021.
Article in English | MEDLINE | ID: covidwho-1123691

ABSTRACT

The use of big data containing millions of primary care medical records provides an opportunity for rapid research to help inform patient care and policy decisions during the first and subsequent waves of the coronavirus disease 2019 (COVID-19) pandemic. Routinely collected primary care data have previously been used for national pandemic surveillance, quantifying associations between exposures and outcomes, identifying high risk populations, and examining the effects of interventions at scale, but there is no consensus on how to effectively conduct or report these data for COVID-19 research. A COVID-19 primary care database consortium was established in April 2020 and its researchers have ongoing COVID-19 projects in overlapping data sets with over 40 million primary care records in the United Kingdom that are variously linked to public health, secondary care, and vital status records. This consensus agreement is aimed at facilitating transparency and rigor in methodological approaches, and consistency in defining and reporting cases, exposures, confounders, stratification variables, and outcomes in relation to the pharmacoepidemiology of COVID-19. This will facilitate comparison, validation, and meta-analyses of research during and after the pandemic.


Subject(s)
COVID-19/epidemiology , Consensus , Databases, Factual/standards , Medical Records Systems, Computerized/standards , Primary Health Care/organization & administration , Public Health Surveillance , Big Data , COVID-19/diagnosis , Humans , Pharmacoepidemiology , Public Health , United Kingdom/epidemiology
7.
Pharmacoepidemiol Drug Saf ; 30(7): 843-857, 2021 07.
Article in English | MEDLINE | ID: covidwho-1103356

ABSTRACT

INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Health Information Interoperability , Pharmacoepidemiology/methods , Product Surveillance, Postmarketing/methods , Asia/epidemiology , COVID-19/epidemiology , COVID-19/immunology , COVID-19/virology , COVID-19 Vaccines/administration & dosage , Databases, Factual/statistics & numerical data , Electronic Health Records/statistics & numerical data , Geography , Humans , International Cooperation , Pacific Islands/epidemiology , Pharmacoepidemiology/organization & administration , Pharmacovigilance , Product Surveillance, Postmarketing/statistics & numerical data , SARS-CoV-2/immunology
8.
Drug Saf ; 43(12): 1205-1210, 2020 12.
Article in English | MEDLINE | ID: covidwho-1092870

ABSTRACT

Vaccines against COVID-19 are being developed at speeds not previously achieved. With this unprecedented effort comes challenges for post-marketing safety monitoring and challenges for vaccine safety communication. To deploy these new vaccines fast across diverse populations, it is vital that robust pharmacovigilance and active surveillance systems are in place. Not all countries have the capability or resources to undertake adequate surveillance and will rely on data from those who can. The tools exist to assess COVID-19 vaccines as they are deployed such as surveillance systems, administrative data and case definitions for adverse events of special interest. However, stitching these all together and using them effectively requires investment and collaboration. This paper provides a high-level overview of some of the facets of modern vaccine safety assessment and how they are, or can be, applied to COVID-19 vaccines.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Drug Development , Product Surveillance, Postmarketing , COVID-19 Vaccines/therapeutic use , Clinical Trials, Phase IV as Topic , Drug Approval , Humans , Pharmacoepidemiology , Pharmacovigilance , SARS-CoV-2
10.
11.
Pharmacoepidemiol Drug Saf ; 29(8): 825-831, 2020 08.
Article in English | MEDLINE | ID: covidwho-186645

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has triggered several hypotheses regarding use of specific medicines and risk of infection as well as prognosis. Under these unique circumstances, rapid answers require quick engagement in data collection and analyses; however, appropriate design and conduct of pharmacoepidemiologic studies are needed to generate valid and reliable evidence. In this paper, endorsed by the International Society for Pharmacoepidemiology, we provide methodological considerations for the conduct of pharmacoepidemiological studies in relation to the pandemic across eight domains: (1) timeliness of evidence, including the need to prioritise some questions over others in the acute phase of the pandemic; (2) the need to align observational and interventional research on efficacy; (3) the specific challenges related to "real-time epidemiology" during an ongoing pandemic; (4) what design to use to answer a specific question; (5) considerations on the definition of exposures; (6) what covariates to collect; (7) considerations on the definition of outcomes; and (8) the need for transparent reporting.


Subject(s)
Coronavirus Infections/epidemiology , Pharmacoepidemiology/organization & administration , Pneumonia, Viral/epidemiology , Research Design , Betacoronavirus , COVID-19 , Data Collection/methods , Humans , Pandemics , Pharmacoepidemiology/standards , SARS-CoV-2 , Time Factors
12.
Res Social Adm Pharm ; 17(1): 2012-2017, 2021 01.
Article in English | MEDLINE | ID: covidwho-141768

ABSTRACT

Background: Chloroquine or hydroxychloroquine (chloroquine) plus azithromycin is considered as therapy for COVID-19. With benefit evaluations underway, safety concerns due to potential additive effects on QTc prolongation should be addressed. Objective: We compared risk of cardiac adverse events between combinations of chloroquine and azithromycin and chloroquine and amoxicillin. Methods: We conducted a retrospective cohort study using the IBM MarketScan Commercial Claims and Medicare Supplemental Databases, 2005-2018. We included autoimmune disease patients aged ≥18 years initiating azithromycin or amoxicillin for ≥5 days during chloroquine treatment. Patients had continuous insurance coverage ≥6 months before combination use until 5 days thereafter or inpatient death. Two outcomes were sudden cardiac arrest/ventricular arrhythmias (SCA/VA) and cardiac symptoms. We followed patients for up to 5 days to estimate hazard ratios (HR). Covariates were adjusted using stabilized inverse probability treatment weighting. Results: We identified two SVC/VA events among >145,000 combination users. The adjusted incidence of cardiac symptoms among azithromycin and amoxicillin users was 276 vs 254 per 10,000 person-years with an adjusted HR of 1.10 (95%CI, 0.62-1.95). Conclusion: Combination use of chloroquine and azithromycin at routine doses did not show pronounced increases in arrhythmias in this real-world population, though small sample size and outcome rates limit conclusions.


Subject(s)
Azithromycin/administration & dosage , COVID-19/epidemiology , Chloroquine/administration & dosage , Heart Diseases/epidemiology , Hydroxychloroquine/administration & dosage , Pharmacoepidemiology/methods , Adolescent , Adult , Aged , Azithromycin/adverse effects , COVID-19/drug therapy , Chloroquine/adverse effects , Cohort Studies , Drug Therapy, Combination/adverse effects , Female , Heart Diseases/chemically induced , Humans , Hydroxychloroquine/adverse effects , Male , Middle Aged , Retrospective Studies , Risk Factors , Young Adult
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