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Annals of Internal Medicine Feb 2019
Topics: Adverse Drug Reaction Reporting Systems; Canagliflozin; Cohort Studies; Pharmacovigilance
PubMed: 30597488
DOI: 10.7326/M18-3550 -
Current Drug Safety 2023The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients.... (Review)
Review
The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients. Pharmacovigilance (PV) enhances the approach to safe medicines and healthcare, but integration into public healthcare remains a challenge in many countries. The Pharmacovigilance Programme of India (PvPI) is a nationwide programme launched by the Ministry of Health and Family Welfare (MoHFW), Government of India, on 14 July 2010. It is currently run by the Indian Pharmacopoeia Commission (IPC). Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of India is the National Regulatory Authority (NRA) of India. This review aims to trace the development of PV in India and its status among the top ADR reporting countries, with a focus on the current status of the studied ADR in different regions in India. Among the top 20 countries enthusiastic about sending ICSR per million population between 2015 and 2020, India shares 2% of the total ICSRs in VigiBase. India is now being recognized as a hub of global clinical trials and clinical research studies. Hence, it is the need of the hour in India to have a dynamic PV network system with an efficient and prudent operation method. Nevertheless, in India, PV programs are at an early stage on par with other countries, and only because of underreporting of ADRs. However, in the future, PvPI may appear as a big dashboard for ADR reporting culture in India as it continuously works hard to improve patients and drug safety.
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; India
PubMed: 36200243
DOI: 10.2174/1574886317666220930145603 -
BMJ (Clinical Research Ed.) May 2023
Topics: Humans; Methotrexate; Pharmacovigilance
PubMed: 37253486
DOI: 10.1136/bmj.p1120 -
Drug Safety Aug 2021This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices... (Review)
Review
This review is intended to present perspectives from the US experience in enhancing pharmacovigilance on current practices and future opportunities. Best practices concepts could be applied worldwide through the presentation of how three pillars of pharmacovigilance: (1) medical and scientific excellence, (2) operational and compliance excellence, and (3) knowledge sharing and experts development in the field could serve as a framework for the establishment of an efficient and successful global pharmacovigilance system.
Topics: Humans; Pharmacovigilance
PubMed: 33993430
DOI: 10.1007/s40264-021-01078-8 -
Pharmacological Research Feb 2015Vaccines have peculiar characteristics as well as their surveillance. Specific requirements, needs and challenges for the vaccine vigilance are discussed in the... (Review)
Review
Vaccines have peculiar characteristics as well as their surveillance. Specific requirements, needs and challenges for the vaccine vigilance are discussed in the perspective to improve the whole system in order to guarantee a safer vaccine use and the keeping of the public confidence in vaccinations. Key elements for the routine safety monitoring, new regulations and some available tools are taken into account. Finally, the Italian experience is shortly described.
Topics: Humans; Italy; Legislation, Drug; Pharmacovigilance; Vaccines
PubMed: 25447592
DOI: 10.1016/j.phrs.2014.10.011 -
British Journal of Clinical Pharmacology Sep 2023Pharmacovigilance studies based on spontaneous reporting systems use disproportionality analysis methods to identify drug-event combinations with higher-than-expected... (Review)
Review
Pharmacovigilance studies based on spontaneous reporting systems use disproportionality analysis methods to identify drug-event combinations with higher-than-expected reporting. Enhanced reporting is deemed as a proxy for a detected signal and is used to generate drug safety hypotheses, which can then be tested in pharmacoepidemiologic studies or randomized controlled trials. Higher-than-expected reporting means that the reporting rate of a drug-event combination of interest is disproportionately higher than the rate in a specific comparator or reference set. Currently, it is unclear which comparator is the most appropriate for use in pharmacovigilance. Moreover, it is also unclear how the selection of a comparator may affect the directionality of the various reporting and other biases. This paper reviews commonly used comparators chosen for signal detection studies (active comparator, class-exclusion comparator, and full data reference set). We give an overview of the advantages and disadvantages of each method based on examples from the literature. We also touch upon the challenges related to the derivation of general recommendations for the selection of comparators when mining spontaneous reports for pharmacovigilance.
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Databases, Factual
PubMed: 37226576
DOI: 10.1111/bcp.15802 -
Vnitrni Lekarstvi 2022Pharmacovigilance is an integral part of medicine. There is always a risk of side effects when using medication; these can be completely trivial, but there are side...
Pharmacovigilance is an integral part of medicine. There is always a risk of side effects when using medication; these can be completely trivial, but there are side effects that can be life-threatening or fatal. Pharmacovigilance practices should prevent such side effects, or at least reduce their incidence, especially by developing preventive measures that are based on adverse drug reaction (ADR) data and the evaluations of these. This article discusses the general concept of pharmacovigilance and compares individual pharmacovigilance systems of several countries and regions.
Topics: Adverse Drug Reaction Reporting Systems; Czech Republic; Drug-Related Side Effects and Adverse Reactions; Humans; Incidence; Pharmacovigilance
PubMed: 36220372
DOI: No ID Found -
British Journal of Clinical Pharmacology Feb 2023
Topics: Humans; Pharmacovigilance
PubMed: 36398325
DOI: 10.1111/bcp.15584 -
Dermatologic Surgery : Official... Dec 2019
Topics: Data Management; Pharmacovigilance; Sclerosing Solutions; World Health Organization
PubMed: 31663875
DOI: 10.1097/DSS.0000000000002169 -
Journal of Ethnopharmacology Jun 2023The use of herbal medicines for prophylaxis, prevention, and treatment of various ailments is rising throughout the world because they are thought to be safer than... (Review)
Review
ETHNOPHARMACOLOGICAL RELEVANCE
The use of herbal medicines for prophylaxis, prevention, and treatment of various ailments is rising throughout the world because they are thought to be safer than allopathic treatments, which they are. However, several investigations have documented the toxicity and adverse drug reactions (ADR) of certain formulations and botanicals if not consumed wisely.
AIM OF THE STUDY
The goal of the current study is to address herbal medication pharmacovigilance (PV) modeling and related considerations for improved patient safety. Also, focus is laid on the comprehensive and critical analysis of the current state of PV for herbal medications at the national and international levels.
MATERIALS AND METHODS
Targeted review also known as focused literature review methodology was utilized for exploring the data from various scientific platforms such as Science Direct, Wiley Online Library, Springer, PubMed, Google Scholar using "pharmacovigilance, herbal medicine, traditional medicine, ADR, under reporting, herb toxicity, herb interactions" as keywords along with standard literature pertaining to herbal medicines that is published by the WHO and other international and national organizations etc. The botanical names mentioned in the present article were authenticated using World Flora Online database.
RESULTS
The historical developments paving the way for PV in regulatory setup were also discussed, along with various criteria's for monitoring herbal medicine, ADR of herbs, phytoconstituents, and traditional medicines, herb-drug interactions, modes of reporting ADR, databases for reporting ADR's, provisions of PV in regulatory framework of different nations, challenges and way forward in PV are discussed in detail advocating a robust drug safety ecosystem for herbal medicines.
CONCLUSION
Despite recent efforts to encourage the reporting of suspected ADRs linked to herbal medicines, such as expanding the programme and adding community pharmacists and other healthcare professionals as recognized reporters, the number of herbal ADR reports received by the regulatory bodies remains comparatively low. Since users often do not seek professional advice or report if they have side effects, under-reporting, is anticipated to be significant for herbal medications. There are inadequate quality control methods, poor regulatory oversight considering herbs used in food and botanicals, and unregulated distribution channels. In addition, botanical identity, traceability of herbs, ecological concerns, over-the-counter (OTC) herbal medicines, patient-physicians barriers requires special focus by the regulatory bodies for improved global safety of herbal medicines.
Topics: Humans; Pharmacovigilance; Ecosystem; Plants, Medicinal; Herbal Medicine; Drug-Related Side Effects and Adverse Reactions; Plant Extracts
PubMed: 36918049
DOI: 10.1016/j.jep.2023.116383