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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 -
British Journal of Clinical Pharmacology Feb 2023
Topics: Humans; Pharmacovigilance
PubMed: 36398325
DOI: 10.1111/bcp.15584 -
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 -
Indian Journal of Pharmacology 2019
Topics: Artificial Intelligence; Humans; Pharmacovigilance
PubMed: 32029958
DOI: 10.4103/ijp.IJP_814_19 -
Therapie Apr 2016
Topics: Adverse Drug Reaction Reporting Systems; Humans; Periodicals as Topic; Pharmacovigilance
PubMed: 27080828
DOI: 10.1016/j.therap.2016.02.019 -
Sultan Qaboos University Medical Journal May 2021
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Oman; Pharmacovigilance
PubMed: 34221460
DOI: 10.18295/squmj.2021.21.02.001 -
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 -
Clinical Pharmacology and Therapeutics Oct 2023
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Databases, Factual
PubMed: 37248829
DOI: 10.1002/cpt.2951 -
BMJ Open Apr 2024Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data... (Review)
Review
OBJECTIVES
Pharmacovigilance databases play a critical role in monitoring drug safety. The duplication of reports in pharmacovigilance databases, however, undermines their data integrity. This scoping review sought to provide a comprehensive understanding of duplication in pharmacovigilance databases worldwide.
DESIGN
A scoping review.
DATA SOURCES
Reviewers comprehensively searched the literature in PubMed, Web of Science, Wiley Online Library, EBSCOhost, Google Scholar and other relevant websites.
ELIGIBILITY CRITERIA
Peer-reviewed publications and grey literature, without language restriction, describing duplication and/or methods relevant to duplication in pharmacovigilance databases from inception to 1 September 2023.
DATA EXTRACTION AND SYNTHESIS
We used the Joanna Briggs Institute guidelines for scoping reviews and conformed with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Two reviewers independently screened titles, abstracts and full texts. One reviewer extracted the data and performed descriptive analysis, which the second reviewer assessed. Disagreements were resolved by discussion and consensus or in consultation with a third reviewer.
RESULTS
We screened 22 745 unique titles and 156 were eligible for full-text review. Of the 156 titles, 58 (47 peer-reviewed; 11 grey literature) fulfilled the inclusion criteria for the scoping review. Included titles addressed the extent (5 papers), prevention strategies (15 papers), causes (32 papers), detection methods (25 papers), management strategies (24 papers) and implications (14 papers) of duplication in pharmacovigilance databases. The papers overlapped, discussing more than one field. Advances in artificial intelligence, particularly natural language processing, hold promise in enhancing the efficiency and precision of deduplication of large and complex pharmacovigilance databases.
CONCLUSION
Duplication in pharmacovigilance databases compromises risk assessment and decision-making, potentially threatening patient safety. Therefore, efficient duplicate prevention, detection and management are essential for more reliable pharmacovigilance data. To minimise duplication, consistent use of worldwide unique identifiers as the key case identifiers is recommended alongside recent advances in artificial intelligence.
Topics: Pharmacovigilance; Humans; Databases, Factual; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38684275
DOI: 10.1136/bmjopen-2023-081990 -
Clinical Medicine (London, England) Oct 2016Adverse drug reactions (ADRs) remain a challenge in modern healthcare, particularly given the increasing complexity of therapeutics, an ageing population and rising... (Review)
Review
Adverse drug reactions (ADRs) remain a challenge in modern healthcare, particularly given the increasing complexity of therapeutics, an ageing population and rising multimorbidity. This article summarises some of the key facts about ADRs and explores aspects relating to their prevention, diagnosis, reporting and management in current clinical practice.
Topics: Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 27697815
DOI: 10.7861/clinmedicine.16-5-481