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Journal of Clinical Psychopharmacology Aug 2015
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance; Serotonin Syndrome; Syndrome
PubMed: 26066340
DOI: 10.1097/JCP.0000000000000367 -
European Journal of Preventive... Jul 2022
Topics: Humans; Hyperglycemia; PCSK9 Inhibitors; Pharmacovigilance; Proprotein Convertase 9
PubMed: 34940857
DOI: 10.1093/eurjpc/zwab227 -
Therapie Apr 2018The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific...
The characteristics of pharmacology and drug evaluation in the pediatric age group highlight the necessity for the pharmacovigilance community to adjust to the specific features of children. At the time of marketing a medicinal product intended for children, the product's safety profile is sometimes less well known than for adults due to fewer or small sample clinical trials. Furthermore, the frequent off-labeled drug use, the use of unsuitable dosage forms and the need for continuous dose adjustments increase the risk of medication errors and thus lead to avoidable adverse drug reactions (ADRs). The occurrence of child-specific ADRs (such as growth disorders) or ADRs more commonly occurring in children than in adults make it necessary to monitor the safety of child-specific drugs. Pediatric pharmacovigilance includes also the consequences of in utero exposure, whether manifestations are present from birth or occur in early childhood (such as neurodevelopmental disorders). The incidence of ADRs varies with age, setting of medical care (in- or out-patients, pediatric specialties) and by country in which the study was carried out. The drugs most frequently reported with ADRs are those most commonly used in the pediatric age group, i.e. antibiotics and vaccines. The ADRs most often reported are skin, neurological and general disorders. As in adults, spontaneous notification is essential to generate alerts and child-specific pharmacoepidemiological studies are necessary and should be developed.
Topics: Adverse Drug Reaction Reporting Systems; Female; Humans; Medication Errors; Off-Label Use; Pediatrics; Pharmacovigilance; Pregnancy; Prenatal Exposure Delayed Effects
PubMed: 29598957
DOI: 10.1016/j.therap.2017.11.012 -
Drug Safety Aug 2023
Topics: Humans; Pharmacovigilance; Artificial Intelligence
PubMed: 37306853
DOI: 10.1007/s40264-023-01315-2 -
Drug Safety May 2022With the rapid development of artificial intelligence (AI) technologies, and the large amount of pharmacovigilance-related data stored in an electronic manner,... (Review)
Review
With the rapid development of artificial intelligence (AI) technologies, and the large amount of pharmacovigilance-related data stored in an electronic manner, data-driven automatic methods need to be urgently applied to all aspects of pharmacovigilance to assist healthcare professionals. However, the quantity and quality of data directly affect the performance of AI, and there are particular challenges to implementing AI in limited-resource settings. Analyzing challenges and solutions for AI-based pharmacovigilance in resource-limited settings can improve pharmacovigilance frameworks and capabilities in these settings. In this review, we summarize the challenges into four categories: establishing a database for an AI-based pharmacovigilance system, lack of human resources, weak AI technology and insufficient government support. This study also discusses possible solutions and future perspectives on AI-based pharmacovigilance in resource-limited settings.
Topics: Artificial Intelligence; Databases, Factual; Health Personnel; Humans; Pharmacovigilance; Technology
PubMed: 35579814
DOI: 10.1007/s40264-022-01170-7 -
La Revue Du Praticien Sep 2019
Topics: Humans; Hypothyroidism; Pharmacovigilance; Thyroxine
PubMed: 32233310
DOI: No ID Found -
International Journal of Health Policy... Jul 2022Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug...
BACKGROUND
Evaluating a pharmacovigilance system helps identify its deficiencies and could facilitate measures to remedy and improve the quantity and quality of adverse drug reaction (ADR) reports and other opportunities for pharmacovigilance systems strengthening. This study aimed to evaluate the status of pharmacovigilance in Iran using the World Health Organization (WHO) pharmacovigilance indicators with the prospect of identifying the gaps and areas for improvement.
METHODS
This study was conducted in 2 parts. The first part included a secondary analysis of the national data obtained from the Iranian National Pharmacovigilance Center (PVC) using a structured data collection form based on WHO core pharmacovigilance indicators. In the second part, a 3-month prospective study was carried out to investigate 2 outcome indicators, ie, length of stay and costs of medicine-related hospitalization in all patients of 2 main referral hospitals in the southeast and north of Iran.
RESULTS
Iran has a PVC with national policy, trained staff, and a statutory budget. In 2017, the number of ADR reports was 15.0 per 100 000 population, and 262 signals were detected during the preceding 5 years. The average length of stay and costs of medicine-related hospitalization were 5 days and US$817.2 in Afzalipour hospital and 6.6 days and US$306.7 in Razi hospital, respectively. The status of pharmacovigilance in the Iranian public health programs (PHPs) is unknown, and most of the indicators could not be assessed.
CONCLUSION
A robust pharmacovigilance system is a pivotal part of the overall medicines regulatory system. The Iranian pharmacovigilance system has relatively the proper structural condition. Though the underreporting of ADRs, especially medicine-related deaths, is an important issue, and some indicators' status was unclear. The Iranian pharmacovigilance program requires a higher prioritization, particularly in the PHPs, a greater allocation of resources, and cross-sectoral cooperation to bolster and achieve the pharmacovigilance objectives.
Topics: Humans; Iran; Pharmacovigilance; Prospective Studies; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 33590736
DOI: 10.34172/ijhpm.2020.243 -
Drug Safety Jan 2021Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs)... (Review)
Review
Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guidelines. In a number of countries beyond this scope, requirements may deviate from internationally agreed standards, adding a substantial complexity and increasing burden on the stakeholders involved, whilst the benefit for patients' safety may not be evident. Committed to fulfilling safety-regulatory obligations in any country where a product licence is held, global pharmaceutical companies have accumulated a broad and deep experience acquired whilst meeting the expectations of a large array of diverse PV systems across the world. These range from sub-optimal frameworks, according to the World Health Organization (WHO) Global Benchmarking Tool, to highly effective resource-optimised PV systems. In order to support countries creating or further developing their PV systems, especially where infrastructure and resources are limited, the European Federation of Pharmaceutical Industries and Associations (EFPIA) International Pharmacovigilance Group (IPVG) has developed consensus recommendations consistent with harmonised standards for the development and step-wise implementation of key PV system components. These recommendations endorsed by the EFPIA membership constitute the focus of this review article.
Topics: Consensus; Drug Industry; Humans; Patient Safety; Pharmacovigilance; World Health Organization
PubMed: 33289904
DOI: 10.1007/s40264-020-01008-0 -
Current Drug Safety 2023There is a growing awareness of a disease at many levels, its treatment, and treatment outcomes including side effects. Alternative therapy techniques, herbal medicines...
There is a growing awareness of a disease at many levels, its treatment, and treatment outcomes including side effects. Alternative therapy techniques, herbal medicines and formulations are extensively acknowledged and practiced in India and around the world. Herbal medicine is usually considered being safe regardless of the absence of scientific evidence to support its claims. Several issues concerning the methods in which herbal medications are labelled, evaluated, sourced, and used are connected to herbal medicine. Herbal therapeutics in the management and treatment of diabetes, rheumatism, hepatic disorders and other mild to chronic diseases and disorders are widely accepted. However, the adversities are difficult to recognize. The idea that the nature is safe and may be taken without the prescription of a physician has resulted in widespread self-medication across the world, sometimes with disappointing results, side effects, or unpleasant after-effects. The existing pharmacovigilance paradigm and its accompanying tools were created in connection with synthetic medicines. Nevertheless, adopting these approaches to keep records of herbal medications' safety poses a distinct challenge. This might be due to the variations in the usage of non-traditional medicines, which can offer unique toxicological issues whether taken alone or in conjunction with other medications. The goal of pharmacovigilance is to identify, analyse, explain, and minimize the adverse reactions and other drug-related complications associated with herbal, traditional, and complementary medications. Systematic pharmacovigilance is required to collect accurate data on the safety of herbal medications to create adequate guidelines for effective and safe usage.
Topics: Humans; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; India; Physicians; Prescriptions
PubMed: 36883268
DOI: 10.2174/1574886317666220428125943 -
Trends in Pharmacological Sciences Jun 2022Researchers, regulatory agencies, and the pharmaceutical industry are moving towards precision pharmacovigilance as a comprehensive framework for drug safety assessment,... (Review)
Review
Researchers, regulatory agencies, and the pharmaceutical industry are moving towards precision pharmacovigilance as a comprehensive framework for drug safety assessment, at the service of the individual patient, by clustering specific risk groups in different databases. This article explores its implementation by focusing on: (i) designing a new data collection infrastructure, (ii) exploring new computational methods suitable for drug safety data, and (iii) providing a computer-aided framework for distributed clinical decisions with the aim of compiling a personalized information leaflet with specific reference to a drug's risks and adverse drug reactions. These goals can be achieved by using 'smart hospitals' as the principal data sources and by employing methods of precision medicine and medical statistics to supplement current public health decisions.
Topics: Adverse Drug Reaction Reporting Systems; Data Collection; Drug Industry; Drug-Related Side Effects and Adverse Reactions; Hospitals; Humans; Pharmacovigilance
PubMed: 35490032
DOI: 10.1016/j.tips.2022.03.009