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The British Journal of Dermatology Nov 2020
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 33135791
DOI: 10.1111/bjd.19504 -
Semergen 2018
Topics: Humans; Pharmacovigilance; Practice Patterns, Physicians'; Primary Health Care
PubMed: 29478464
DOI: 10.1016/j.semerg.2018.01.007 -
The International Journal of Risk &... 2012
Topics: Expert Testimony; Forensic Sciences; Humans; Pharmacology; Pharmacovigilance
PubMed: 22436253
DOI: 10.3233/JRS-2012-0555 -
Expert Opinion on Biological Therapy Jul 2013Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007,... (Review)
Review
INTRODUCTION
Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. European experience provides several lessons as the United States (US) healthcare system prepares for biosimilar approvals. These lessons emphasize the need for adequate efficacy and safety studies, post-marketing surveys and a robust pharmacovigilance system that can accurately track and trace biologics, including biosimilars and their reference products, from the patient to the manufacturer.
AREAS COVERED
We review the EU experience with biosimilar pharmacovigilance and discuss the implications for biosimilar pharmacovigilance in the USA. Furthermore, we review several aspects of biosimilar pharmacovigilance, including cohort event monitoring, traceability, biosimilar interchangeability, pharmacovigilance system development, nomenclature and counterfeit tracking.
EXPERT OPINION
The availability of biosimilars as lower-cost biologics must carefully consider issues of safety, efficacy and traceability. Stringent pharmacovigilance procedures are required to detect potential differences in safety signals between biosimilars and their reference products. Pharmacovigilance of biologics should include processes that are easily used by prescribing practitioners to ensure that data are consistent and new safety signals are properly reported and assigned to the correct product.
Topics: Biosimilar Pharmaceuticals; Humans; Pharmacovigilance; Therapeutic Equivalency
PubMed: 23527621
DOI: 10.1517/14712598.2013.783560 -
Drug Safety Feb 2020
Topics: Humans; Pharmacovigilance; Societies, Pharmaceutical
PubMed: 31939078
DOI: 10.1007/s40264-019-00902-6 -
Therapeutic Innovation & Regulatory... Mar 2023Implementation of Pharmacovigilance (PV) systems in resource-limited countries is a real challenge. The objective of this paper is to describe the implementation of an... (Review)
Review
Implementation of Pharmacovigilance (PV) systems in resource-limited countries is a real challenge. The objective of this paper is to describe the implementation of an effective national PV system in Lebanon in the context of COVID-19, within a limited resources setting and with the absence of a guaranteed funding. In 2018, the PV center hosted at the Lebanese University, Faculty of Pharmacy under the supervision of the Quality Assurance of Pharmaceutical Products Program within the Lebanese Ministry of Public Health became an associate member of the World Health Organization (WHO) Program of International Drug Monitoring and recognized as Full member in 2021.This analysis highlights the requirements of the WHO that were met in Lebanon to create an effective PV system. The Lebanese experience shows that it is not only possible, but also crucial to implement a PV system in low to middle-income countries with limited resources and with the absence of a guaranteed funding in order to be able to promote patients' safety. Support from organizations like WHO and World Bank, skilled leadership, hard work and dedicated staff with efficient training, and finally mass awareness initiatives were all considered as key elements to implement a successful PV System. In the midst of a turbulent political, economic and health context, Lebanon has been able to develop one of the most active and rapidly evolving PV systems in the Middle East.
Topics: Humans; Pharmacovigilance; Lebanon; COVID-19; Drug Monitoring; Adverse Drug Reaction Reporting Systems
PubMed: 36109433
DOI: 10.1007/s43441-022-00460-7 -
Therapeutic Innovation & Regulatory... Sep 2022In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing... (Review)
Review
BACKGROUND
In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance.
METHODS
EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance.
RESULTS
Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'.
CONCLUSION
This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.
Topics: Data Collection; Developing Countries; Pharmacovigilance; World Health Organization
PubMed: 35657484
DOI: 10.1007/s43441-022-00415-y -
Gaceta Medica de Mexico 2022
Topics: Humans; Pharmacovigilance; Physicians; Health Knowledge, Attitudes, Practice; Drug-Related Side Effects and Adverse Reactions
PubMed: 36572037
DOI: 10.24875/GMM.M22000692 -
Pharmacoepidemiology and Drug Safety Aug 2021The WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance network of countries sharing Adverse Drug Reaction (ADR) reports....
BACKGROUND
The WHO Programme for International Drug Monitoring (PIDM) is a large Pharmacovigilance network of countries sharing Adverse Drug Reaction (ADR) reports. Pharmacovigilance Experts have suggested that antimicrobial resistance (AMR) is an overlooked adverse event. We undertook this study to investigate the potential role of Pharmacovigilance databases in the surveillance of AMR.
METHODS
Using the AWaRe (Access, Watch and Reserve) list and the WHO Priority Pathogens List, we established a list of antimicrobials and carried out a VigiBase search via VigiAccess, looking for ADR reports with Preferred Terms (PTs) that contained AMR-relevant information. Identified Terms were matched with codes from the Medical Dictionary for Regulatory Activities (MedDRA Version 21.1).
RESULTS
Records on 86 drugs were retrieved with a total of 1 170 751 ADR reports submitted between 1968 and 2018. Seventeen PTs suggesting suspected resistance, ineffectiveness, inappropriate use, or medication error were used to code 15 250 reports. The most frequently used PTs were "Drug Ineffective" (45.6%), "Off label use" (9.5%) and "Pathogen Resistance" (8.9%). A group of six agents (Amoxicillin, Cefalotin, Ciprofloxacin, Clarithromycin, Levofloxacin and Daptomycin) accounted for 38% (n = 5806) of all 15 250 AMR-relevant ADR reports. The PTs most frequently used in 5806 reports were grouped in 4 categories: drug ineffectiveness (62.5%), resistance (19.2%), off-label use (12.1%) and prescription errors (6.2%).
CONCLUSION
Our findings suggest that Pharmacovigilance databases could serve as a tool in tracking antimicrobial use and resistance especially in settings where laboratory capacity is still in its development stages. National Pharmacovigilance centers could play a proactive role in stimulating the reporting of AMR-relevant ADRs which can serve as a basis for resistance suspicion alerts. Further studies focusing on the narrative and other clinical pharmacology details in ADR reports are required.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug Resistance, Bacterial; Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 33864401
DOI: 10.1002/pds.5249 -
Drug Safety Feb 2024
Topics: Humans; Pharmacovigilance; Risk Assessment; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38114758
DOI: 10.1007/s40264-023-01375-4