Suitability of databases in the Asia-Pacific for collaborative monitoring of vaccine safety.

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.

Tuberculosis drug safety and pharmacovigilance in health system of Kosova: A cross-sectional analysis.

BACKGROUND: Tuberculosis (TB) remains a significant worldwide social and life-threatening epidemiological problem. Because this disease requires multiple drug treatment and prolonged therapy for several months, followed by a high probability of adverse effects (AEs), we assessed AE monitoring for anti-TB drugs in the Health Care System of Kosova. METHODS: This survey was a cross-sectional analysis performed at the primary, secondary and tertiary health care levels in Kosova. We included 930 registered tuberculosis patients within three levels of this health system in our study. Furthermore, we interviewed 62 physicians and 71 nurses at TB health facilities. Data were collected from official TB registers and personal contact with patients for 12 months. RESULTS: The representative age group was 19 to 29 years (30.49%), followed by a group of patients aged >60 years (23.23%). Among 930 patients treated with TB drugs, the total incidence of adverse AEs was 29.03%. Female TB patients had a higher rate of AEs than did male patients (33.56% vs 28.84%, respectively). The highest incidence of registered AEs was recorded in the gastrointestinal system (270, 80.83%), followed by the central nervous system (CNS, 7.50%) and was lower in other organ systems. The reporting of anti-TB drug effects by medical staff (TB medical doctor and TB medical nurse) at different levels of TB medical settings occurred among 62.90% of medical doctors and 81.69% of nurses. Only 53.23% of medical doctors and 46.48% of nurses completed pharmacovigilance training. CONCLUSION: The pharmacovigilance approach in Health System of Kosova is not comprehensible and not systematic. The relatively low incidence of AEs among TB patients is due under reporting of these by medical staff. The knowledge, attitudes, and adherence of medical staff reveal low awareness for pharmacovigilance activities, and this concern should be addressed to reinforce this important issue for the safe treatment of TB patients.

Considerations for pharmacoepidemiological analyses in the SARS-CoV-2 pandemic.

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.

Engaging stakeholders in pharmacoepidemiology research: Current state and recommendations.

PURPOSE: Given current efforts to enhance patient-centered care and shared decision-making, the International Society of Pharmacoepidemiology Workgroup on Patient Engagement assessed patient and other stakeholder engagement in pharmacoepidemiology research and provides recommendations for the field. METHODS: A systematic review used MEDLINE and EMBASE to identify published literature from 2005 to 2016 addressing how stakeholders-patients, caregivers, and others-assisted researchers conducting pharmacoepidemiologic research. Three pairs of Workgroup members screened titles and abstracts to select articles for full-text review and analysis. Two Workgroup members abstracted the following data: research focus, characterization and role of stakeholders, and type(s) of engagement strategy employed. Data were summarized descriptively. RESULTS: We identified 5717 references for abstract screening. Of these, 69 met the criteria for full-text screening, and 11 were selected for data abstraction. Of these 11 studies, seven focused on the development of a research agenda and eight had stakeholders react or advise on an aspect of the study. Although patients were the most commonly identified stakeholders, advocacy groups and health care professionals were also frequently identified. Some studies reported the engagement of other stakeholders, including local government or policy experts. Engagement strategies varied, with five studies using more than one strategy. Studies often did not indicate the involvement of stakeholders in developing the study design or with implementation. CONCLUSIONS: Currently, few pharmacoepidemiology publications mention patient or other stakeholder engagement in the design, analysis, or reporting of research. This suggests that there are opportunities to expand stakeholder engagement and/or increase the transparency of reporting stakeholder engagement.

An overview of pharmacoepidemiology in New Zealand: medical databases, registries and research achievements.

Pharmacoepidemiology is an eclectic blend of epidemiology, clinical pharmacology and biostatistics. In New Zealand there have been recent advances in pharmacoepidemiology to examine drug utilisation, monitor adverse drug events and complement pharmacovigilance. This paper attempts to describe the past, present and future of pharmacoepidemiology, particularly in the area of translational research with a particular focus on medicine use and safety. New Zealand is well-positioned globally to make significant contributions to the knowledge base of drug safety in real-world settings.

[Technical improvement of cohort constitution in administrative health databases: Providing a tool for integration and standardization of data applicable in the French National Health Insurance Database (SNIIRAM)]. / Optimisation de la constitution de cohortes issues de bases de données médico-administratives : mise à disposition d'un algorithme pour l'intégration et la normalisation des données adapté au Système national d'information inter-régimes de l'assurance maladie (SNIIRAM).

AIM: Administrative health databases such as the French National Heath Insurance Database - SNIIRAM - are a major tool to answer numerous public health research questions. However the use of such data requires complex and time-consuming data management. Our objective was to develop and make available a tool to optimize cohort constitution within administrative health databases. METHODS: We developed a process to extract, transform and load (ETL) data from various heterogeneous sources in a standardized data warehouse. This data warehouse is architected as a star schema corresponding to an i2b2 star schema model. We then evaluated the performance of this ETL using data from a pharmacoepidemiology research project conducted in the SNIIRAM database. RESULTS: The ETL we developed comprises a set of functionalities for creating SAS scripts. Data can be integrated into a standardized data warehouse. As part of the performance assessment of this ETL, we achieved integration of a dataset from the SNIIRAM comprising more than 900 million lines in less than three hours using a desktop computer. This enables patient selection from the standardized data warehouse within seconds of the request. CONCLUSION: The ETL described in this paper provides a tool which is effective and compatible with all administrative health databases, without requiring complex database servers. This tool should simplify cohort constitution in health databases; the standardization of warehouse data facilitates collaborative work between research teams.

Identification of inappropriate prescribing in a Brazilian nursing home using STOPP/START screening tools and the Beers' Criteria

The objective of this study was to determine the prevalence of Potentially Inappropriate Medication (PIM) use and associated factors, as well as the prevalence of Prescribing Omissions (PO). A cross-sectional study was conducted in a philanthropic Brazilian nursing home involving 46 individuals aged 60 years or older. The following information was collected from medical records and drug prescriptions: gender, age, health conditions and drugs used in the past thirty days. PIM and PO were identified according to the Beers' Criteria and the STOPP/START screening tools. Over one third (37%) of the population used at least one PIM according to the Beers' Criteria (n=17) and 60.9% according to the STOPP tool. A significant association was found between polypharmacy (use of five or more drugs) and use of PIM according to the Beers' Criteria, but not according to the STOPP. Eight residents (17.4%) were exposed to eight PO. This study allowed the diagnosis of a concerning drug utilization profile with use of a high number of PIMs. Thus, there is an evident need to implement strategies for improving geriatric prescription.

O objetivo deste estudo foi determinar a prevalência de uso de medicamentos potencialmente inadequados (MPI) e fatores associados, bem como a prevalência de omissões farmacoterapêuticas (OF). Trata-se de um estudo transversal realizado em uma instituição filantrópica brasileira de longa permanência com 46 indivíduos com 60 anos ou mais. As seguintes informações foram coletadas a partir de prontuários e prescrições: sexo, idade, condições de saúde e medicamentos utilizados nos últimos trinta dias. MPI e OF foram identificados pelo Critério de Beers e as ferramentas de triagem STOPP/START. Mais de um terço (37%) da população utilizou pelo menos, um MPI de acordo com os critérios de Beers (n=17) e 60.9% de acordo com a ferramenta STOPP. Associação estatisticamente significante foi detectada entre a polifarmácia (consumo de cinco ou mais medicamentos) e uso de MPI de acordo com os critérios de Beers, mas não de acordo com o STOPP. Oito residentes (17,4%) foram expostos a oito OF. Este estudo permitiu o diagnóstico de um perfil de utilização de medicamentos preocupante com número elevado de utilização de MPI. Isso indica a necessidade de implementar estratégias para melhorar a qualidade da prescrição geriátrica.

Epidemiological evidence in forensic pharmacovigilance.

Until recently epidemiological evidence was not regarded as helpful in determining cause and effect. It generated associations that then had to be explained in terms of bio-mechanisms and applied to individual patients. A series of legal cases surrounding possible birth defects triggered by doxylamine (Bendectin) and connective tissue disorders linked to breast implants made it clear that in some instances epidemiological evidence might have a more important role, but the pendulum swung too far so that epidemiological evidence has in recent decades been given an unwarranted primacy, partly perhaps because it suits the interests of certain stakeholders. Older and more recent epidemiological studies on doxylamine and other antihistamines are reviewed to bring out the ambiguities and pitfalls of an undue reliance on epidemiological studies.

Pharmacoepidemiology in the postmarketing assessment of the safety and efficacy of drugs in older adults.

Much of the information on safety and efficacy of drugs in older people is obtained after marketing. Pharmacoepidemiologic studies play an increasing role in obtaining this information. Pharmacoepidemiologic studies contribute significantly to knowledge of risks associated with medicines in older people and less so to that of benefits. Recent improvements in methodology in both pharmacoepidemiology and geriatric medicine have improved the validity and reduced the bias of these studies. Pharmacoepidemiologic studies are a critical component of assessing the risks of medicines in older people. Where possible, findings of pharmacoepidemiologic studies should be tested with well-conducted interventional randomized trials in relevant populations of older people.

Curricular considerations for pharmaceutical comparative effectiveness research.

In the U.S. pharmacoepidemiology and related health professions can potentially flourish with the congressional appropriation of $1.1 billion of federal funding for comparative effectiveness research (CER). A direct result of this legislation will be the need for sufficient numbers of trained scientists and decision-makers to address the research and implementation associated with CER. An interdisciplinary expert panel comprised mostly of professionals with pharmaceutical interests was convened to examine the knowledge, skills, and abilities to be considered in the development of a CER curriculum for the health professions focusing predominantly on pharmaceuticals. A limitation of the panel's composition was that it did not represent the breadth of comparative effectiveness research, which additionally includes devices, services, diagnostics, behavioral treatments, and delivery system changes. This bias affects the generalizability of these findings. Notwithstanding, important components of the curriculum identified by the panel included study design considerations and understanding the strengths and limitations of data sources. Important skills and abilities included methods for adjustment of differences in comparator group characteristics to control confounding and bias, data management skills, and clinical skills and insights into the relevance of comparisons. Most of the knowledge, skills, and abilities identified by the panel were consistent with the training of pharmacoepidemiologists. While comparative effectiveness is broader than the pharmaceutical sciences, pharmacoepidemiologists have much to offer academic and professional CER training programs. As such, pharmacoepidemiologists should have a central role in curricular design and provision of the necessary training for needed comparative effectiveness researchers within the realm of pharmaceutical sciences.

Managing security and privacy concerns over data storage in healthcare research.

PURPOSE: Issues surrounding data security and privacy are of great importance when handling sensitive health-related data for research. The emphasis in the past has been on balancing the risks to individuals with the benefit to society of the use of databases for research. However, a new way of looking at such issues is that by optimising procedures and policies regarding security and privacy of data to the extent that there is no appreciable risk to the privacy of individuals, we can create a 'win-win' situation in which everyone benefits, and pharmacoepidemiological research can flourish with public support. We discuss holistic measures, involving both information technology and people, taken to improve the security and privacy of data storage. METHODS: After an internal review, we commissioned an external audit by an independent consultant with a view to optimising our data storage and handling procedures. RESULTS: Improvements to our policies and procedures were implemented as a result of the audit. CONCLUSIONS: By optimising our storage of data, we hope to inspire public confidence and hence cooperation with the use of health care data in research.

Commentary: Canadian Association for Population Therapeutics: the past, present and future - a personal viewpoint and a call to action.

Canadian leadership in population-based therapeutic research.  

The role of academia and the research community in assisting the Food and Drug Administration to ensure U.S. drug safety.

PURPOSE: Academia can play a prominent role in the drug safety arena, unique from that of industry, and a clearer articulation of how it could positively influence the current system is needed. We sought to examine ways that academia could expand its role in U.S. drug safety. METHODS: An ad hoc meeting of academic experts in drug safety and risk management was convened at the Institute of Medicine (IOM) in Washington, D.C. RESULTS: Academia should develop a stronger partnership with the Food and Drug Administration (FDA) to increase research on regulatory issues and public health questions and facilitate the prioritization of critical issues on drug safety. Such a collaboration could also facilitate the development of a network of academic centers of excellence in pharmacoepidemiology to address drug safety and risk management questions from a public health standpoint in a timely fashion. The development and testing of methodologic innovations on drug safety should also be encouraged. CONCLUSIONS: Greater partnership between academia and the FDA could facilitate the prioritization of important issues on drug safety, allow more research questions on drug safety to be answered in a timely fashion, promote the development of networks for answering these questions, and help generate additional research ideas, ultimately providing enormous benefit to the public health.