China
Africa
Explore chapters and articles related to this topic
Drug evaluation in children
Published in Evelyne Jacqz-Aigrain, Imti Choonara, Paediatric Clinical Pharmacology, 2021
Evelyne Jacqz-Aigrain, Imti Choonara
The importance of obtaining evidence for a more rational use of medicines for children, infants and neonates is widely recognised among professionals and lay people (parents, patients, and politicians). However, there is still a dearth of information regarding safety and efficacy in childhood [1,2]. Many aspects can contribute to this underprivileged position of children with respect to optimal drug therapies: different pharmacokinetic and pharmacodynamic profiles during growth and development; ethical and financial reasons; resources and research capabilities; regulatory guidelines and constraints [3]. Thus, more efforts are needed to guarantee a rational drug use: that children receive medications appropriate (safe and effective) to their clinical conditions, in doses and formulations suitable to their personal requirements, for adequate periods of time, and at the lowest cost to their families and their communities [4]. In such a context, pharmacoepidemiology is a health imperative [5] that, with the appropriate methodologies, can improve the effectiveness and efficiency of health care interventions [6]. Patterns of drug use and prescribing in developed and developing countries have been studied extensively [7], but, once again, the profile in children to date appears to be more a rarity than a routine approach [8].
Pharmacology, Pharmacogenetics, and Pharmacoepidemiology: Three P’s of Individualized Therapy
Published in Brian Leyland-Jones, Pharmacogenetics of Breast Cancer, 2020
Pharmacoepidemiology is a sub discipline of epidemiology that focuses on understanding why individuals respond differently to drug therapy. It is defined “as the study of the distribution and determinants of drug-related events in populations and the application of this study to efficacious drug treatments” (8). These drug-related events pertain to both beneficial and adverse events. Pharmacoepidemology, through the use of observational methods, aims to quantify drug exposure and to describe, as well as predict, the effectiveness and safety of the drug within defined populations at specific places and time. Factors important in interpreting the variability in drug outcome include a patient’s health profile, sex, age, diet, associated comorbidities, disease severity and prognosis, drug compliance, drug prescribing and dispensing quality, and genetic profile of the patient and tumor (9,10). Depending on drug effect there are four main groups of patients: (i) responders, (ii) non-responders, (iii) toxic responders, and (iv) toxic non-responders (Fig.2).
The impact of treatment and other clinical and community health interventions: A ‘does it work?’ evaluation
Published in Milos Jenicek, Foundations of Evidence-Based Medicine, 2019
Pharmacoepidemiology has become an additional tool in the study of drug effects. Pharmacoepidemiology is currently defined as ‘the study of the distribution and determinants of drug-related events in populations, and the application of this study to efficacious drug treatment’.3
Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research
Published in Expert Opinion on Drug Safety, 2022
Giulia Scondotto, Salvatore Crisafulli, Ippazio Cosimo Antonazzo, Gianni Virgili, Gianluca Trifirò, Janet Sultana
EMRs are collected during routine medical care for clinical purposes, in either primary or secondary care settings [11] Examples of EMRs include The Healthcare Improvement Agency (THIN) and Clinical Practice Research Datalink (CPRD) in the UK, Cegidim Longitudinal Patient Database Health Search Database and Pedianet in Italy and Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria (BIFAP) in Spain [22]. These databases have been widely used in pharmacoepidemiology research. EMRs contain detailed information on patient demographics, prescriptions and medical diagnoses. The prescription data in EMRs is of particular value to capture medications that are not covered by a healthcare system, including over-the-counter drugs that are prescribed by a doctor. On the other hand, prescriptions may not be filled by patients and therefore drug exposure may be misclassified. Another limitation of EMRs is that drugs which are prescribed by specialists and/or drugs prescribed in secondary/tertiary care settings may not be captured. Concerning medical diagnoses, the main strength of EMRs is that they often contain very detailed data on symptoms which would not be captured using claims databases, as the latter focus on billable conditions.
Kidney, limb and ophthalmic complications, and death in patients with nonvalvular atrial fibrillation and type 2 diabetes prescribed rivaroxaban or warfarin: an electronic health record analysis
Published in Current Medical Research and Opinion, 2021
Olivia S. Costa, Bridget O’Donnell, Burcu Vardar, Khaled Abdelgawwad, Christopher W. Brescia, Nitesh Sood, Craig I. Coleman
This study report was written to comply with the Reporting of Studies Conducted using Observational Routinely Collected Health Data for Pharmacoepidemiology statement. Rivaroxaban was approved for NVAF in the US in November 2011, therefore utilization of data back to November 2010 was required to provide a full 12-month pre-index period for all patients. The Optum EHR dataset includes longitudinal patient-level medical record data for 91+ million patients seen at 700+ hospitals and 7,000+ clinics across the US. Optum EHR contains data on insured and uninsured patients of all ages to provide a representative sample of US patients. This database contains records of prescriptions, over-the-counter medications, laboratory results, vital signs, clinical observations, diagnoses (using ICD-9 and ICD-10) and procedures (using ICD-9, ICD-10, CPT-4, HCPCS, and revenue codes). Use of the Optum EHR data for research purposes has been determined by the New England Institutional Review Board (IRB) to not constitute research involving human subjects. It is therefore exempted from further IRB oversight. All data supplied to the investigators by Optum was done so in a de-identified and Health Insurance Portability and Accountability Act (HIPAA)-compliant format. The study was registered on ClinicalTrials.gov (NCT04509193).
How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting
Published in Expert Opinion on Drug Safety, 2020
Leila Asfour, Zenas Z.N. Yiu, Richard B. Warren
Personalized medicine is one of the most important current global trends and it has been defined by the European Union: ‘ Providing the right treatment to the right patient, at the right dose at the right time.’ [95] The use of Pharmacogenomics, looking at genome-wide association studies reviews whether there is a role of the genome on variability in drug response[96]. Therefore, with the use of genomics, we can develop effective and safe drugs that are tailored to individual patient’s genetic makeup, reducing the probability of developing an AE. Biomarkers may also become useful predicting factors for adverse events or treatment response in the future. For example, there is a strong relationship between the HLA-B*1502 allele and carbamazepine-induced severe drug reaction of Stevens–Johnson Syndrome/Toxic Epidermal Necrolysis seen in Thai and Malaysian populations[97]; current guideline suggests that genetic testing for the HLA-B*1502 allele is carried out prior to administration of carbamazepine in all Asian groups. [98] The expanding use of pharmacoepidemiology/pharmacogenomic research will enable us to make use of descriptive studies such as case reports, case series, cross-sectional studies and patient database/registries in order to create more comprehensive safety profile of medicines being used[99].