No abstract available.
Anaphylaxis ; Pharmacovigilance

Pharmacovigilance ; Drug Therapy

Background: The pharmacovigilance system in the Philippines aims to ensure the safe use of medicines, including herbal products. However, there is a lack of reporting on adverse events related to herbal products, indicating a need for an improved monitoring system. Objectives: This study seeks to develop a community-based adverse event reporting system for herbal products in Calamba and Los Baños Laguna to enhance pharmacovigilance practices in the Philippines. The primary objectives include assessing consumer knowledge, willingness to report adverse events, and evaluating the feasibility of implementing such a system in community pharmacies. Methodology: A mixed-methods approach was employed, involving surveys with herbal product consumers and focus group discussions with community pharmacists. Data analysis utilized Likert scaling for surveys and thematic analysis for discussions, providing a comprehensive understanding of consumer perceptions and pharmacist experiences. Results: The study revealed limited consumer awareness of herbal safety risks but with a positive attitude towards reporting adverse events through community pharmacies. The developed algorithm, tailored to consumer and pharmacist preferences, demonstrated potential benefits in enhancing pharmacovigilance and promoting the rational use of herbal products. Conclusion The proposed community-based adverse event reporting system for herbal products in the Philippines offers a practical and accessible solution to improve pharmacovigilance, empower consumers, and ensure the safe utilization of herbal products. Implementation of this system has the potential to significantly enhance public health outcomes and contribute to the overall well-being of the Filipino population.
Pharmacovigilance ; Pharmacies ; Pharmacists

In 2019, Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system. In 2021, the first Pharmacovigilance Quality Management Standard of China was released. The proposal and implementation of pharmacovigilance were the initial stage in China, and it needed to improve the aspects of pharmacovigilance include institution, monitoring mechanism and database construction. The number of new diagnosed cancer patients in China ranked first in the world. In recent years, the marketing speed of novel antitumor drugs was accelerated, and there were many clinical trials. Therefore, antitumor pharmacovigilance was imperative. In this article, we summarized pharmacovigilance of the origin, clinical practice objectives, procedures, methods. We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China, aiming to provide reference for the development of antitumor pharmacovigilance.
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China ; Humans ; Lung Neoplasms ; Pharmacovigilance

No abstract available.
Drug-Induced Liver Injury ; Electronic Health Records ; Pharmacovigilance

Physicians with their medical background and high caliber play key roles in a wide variety of areas in biopharmaceutical industry. In fact when we look though the array of people in most global pharmaceutical companies, it is easy to find physicians working in various areas, playing various roles, at different levels such as medical affairs, R&D, clinical operations, marketing, regulatory, pharmacovigilance, etc. Conventional doctor-patient relationship is essential to deliver medical care to individual patients. However, for any treatment to be delivered to patients, there are many physicians working in the industry to make that possible by developing new drugs, making sure they are safe and effective, setting values to new treatments, figuring out ways to lower cost and increase accessibilities, assessing adverse effects to minimize risks, making policies, and so on. In Korea, however, although the situation is getting better nowadays, physicians have themselves limited their scope of involvement in biopharmaceutical industry. The lack of necessary medical expertise is widespread throughout all aspects. Regulatory agencies, pharmaceutical and medical policy making bodies, pharmaceutical companies, bio-venture companies, clinical and preclinical contract research organizations, health information technology industry, medical devices companies, all are in need of physician participation. Global biopharmaceutical industry is one of the most competitive areas that only the toughest can survive. Korea is aiming to become one of the world leaders in this field as we have achieved in IT, electronic, and automobile industries. Physicians' commitment can make the difference.
Automobiles ; Contracts ; Electronics ; Electrons ; Humans ; Korea ; Marketing ; Medical Informatics ; Pharmacovigilance ; Physician's Role ; Policy Making

PURPOSE: With the increase in vancomycin use, adverse drug reactions (ADRs) associated with vancomycin have been reported increasingly more often. However, the characteristics of cutaneous ADRs with and without systemic reactions (SRs) have not been described. This study investigated the characteristics of spontaneously reported and assessed ADRs associated with vancomycin by a pharmacovigilance center. METHODS: ADRs (n=121) associated with vancomycin in 96 patients were collected from 2008 to 2009. Records from physician- and nurse-reported suspected cases of vancomycin ADRs, ADR type, latent period, and laboratory results were compared between cutaneous ADRs with and without SRs. RESULTS: The main vancomycin-related ADRs were skin rashes (47.9%), hematologic abnormalities (17.36%), fever (12.4%), and elevated serum creatinine (12.4%). Significant differences were observed in latent period (days) and the mean change in eosinophils (%) between cutaneous (9.21+/-9.71 and 1.4+/-3.4, respectively) and other ADRs (14.03+/-11.71 and -0.5+/-3.5, respectively). Twelve cases of cutaneous ADRs with SRs had been initially reported as cutaneous ADRs only. Mean changes in the eosinophil count were significantly higher for cutaneous ADRs with SRs compared to those without SRs. CONCLUSIONS: Skin rashes accompanied by peripheral eosinophilia, representing suspected immune-mediated delayed hypersensitivity reactions, are a common vancomycin ADR. For the early and exact detection of ADRs associated with vancomycin administration, close monitoring of laboratory tests, including complete blood counts with differential analysis, is recommended.
Blood Cell Count ; Creatinine ; Drug Toxicity ; Eosinophilia ; Eosinophils ; Exanthema ; Fever ; Humans ; Hypersensitivity, Delayed ; Pharmacovigilance ; Vancomycin

Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012. The main missions of the KIDS are to collect, analyze, evaluate, and manage adverse drug reaction (ADR) data, develop drug utilization review (DUR) criteria, distribute medication guidelines for health professionals, perform retrospective DUR, and perform causality assessment on ADRs, or signals derived from spontaneous reporting or other sources. The KIDS aims to provide evidence to enhance national health quality through a better drug safety and risk management system in Korea. The purpose of this paper is to suggest possible approaches and the KIDS's role in strengthening the pharmacovigilance system in Korea.
Drug Toxicity ; Drug Utilization Review ; Health Occupations ; Humans ; Korea ; Missions and Missionaries ; Pharmacovigilance ; Retrospective Studies ; Risk Management

Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine).
Books ; European Union ; organization & administration ; Humans ; Pharmacovigilance ; Product Surveillance, Postmarketing ; standards ; Translating

Post-marketing pharmacovigilance of drugs has become one of the most important activities for regulatory authorities. In China, pharmacovigilance is currently receiving the attention of government, pharmaceutical industries and the public. In order to support high quality pharmacoepidemiological studies and to stimulate innovation that benefits patients and the wider public, the European medicines agency (EMA) organized the European network of centres for pharmacoepidemiology and pharmacovigilance (ENCePP) to formulate and publish the Guide on Methodological Standards in Pharmacoepidemiology as a reference document for the methodological standards of pharmacovigilance activities in the European union (EU). It supplies methodological and scientific guidance, and advises on technical aspects of conducting parmacoepidemiological studies and undertaking parmacovigilance. As advice includes: legal and ethical requirements, general aspects of study protocols, research questions, approaches to data collection, study designs and methods, statistical and epidemiological analysis plans, quality control and quality assurance, reporting of adverse events to regulatory authorities, communication of findings, and so on. The translation and introduction of this guidance can provide a useful technical and methodological reference for us to carry out the pharmacovigilance (especially for parenterally administered Chinese medicine safety monitoring).
Guidelines as Topic ; Humans ; Pharmacoepidemiology ; methods ; standards ; Pharmacovigilance ; Reference Books, Medical ; Translating