Challenges and Future Consideration for Pharmacovigilance

Kumar, Vijay

doi:10.4172/2329-6887.1000102

Cited by 14 publications

(6 citation statements)

References 21 publications

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“…Pharmacovigilance is a field in which communication is very crucial, and the exchange of information is expected to be done in a timely manner 20 . Nowadays there is a recognized need for competent and rapid communication between national drug regulatory centers as well as to other countries 21 . By contrast, this “labeling change lag” we found in this study would be a public concern and every effort should be made to shorten the lag in case the final decision is concordant.…”

Section: Discussionmentioning

confidence: 73%

A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States

Hoshino

Narukawa

2021

Pharmacoepidemiology and Drug

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Purpose It is important to make the most up‐to‐date drug safety information available to the public in a timely manner so that health care professionals and patients can consider the information. The aim of the present study was to investigate the consistency and simultaneity of safety related updates in product labeling in Japan and the United States. Methods New safety label changes that were made for new drugs approved concurrently both in Japan and the United States in the recent 5 years were identified and reviewed for concordance and time lag analysis. Factors associated with the time lag were also investigated. Results Despite similar medical practices, population health and regulation in the countries, a low level of concordance (40/115, 34.8%) in the decision of labeling change was found in 31 new active substances. Only 3/40 (7.5%) of the concordant changes were made simultaneously. Labeling change orders issued by regulators and domestic postmarketing adverse event reports were associated with a significant difference in the timing of labeling change between the countries. Conclusions We found a low level of concordance between regulators in the decision of labeling changes and the timeliness of the changes. The low concordance and time lag highlighted the need for further international collaboration between regulators and industry and greater transparency in the decision‐making process for the label change.

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Section: Discussionmentioning

confidence: 73%

A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States

Hoshino

Narukawa

2021

Pharmacoepidemiology and Drug

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“…Due to the voluntary nature of these systems, reporting and detection of adverse events may not be timely and is incomplete. Recent research has exposed the various inadequacies of spontaneous reporting systems, prompting researchers to explore additional sources for ADR monitoring [9, 2, 10]. These systems, for example, suffer from under-reporting, over-reporting of known ADRs, incomplete data, duplicated reporting, and unspecified causal links.…”

Section: Introductionmentioning

confidence: 99%

Utilizing social media data for pharmacovigilance: A review

Sarker

Ginn

Nikfarjam

et al. 2015

Journal of Biomedical Informatics

430

338

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Objective Automatic monitoring of Adverse Drug Reactions (ADRs), defined as adverse patient outcomes caused by medications, is a challenging research problem that is currently receiving significant attention from the medical informatics community. In recent years, user-posted data on social media, primarily due to its sheer volume, has become a useful resource for ADR monitoring. Research using social media data has progressed using various data sources and techniques, making it difficult to compare distinct systems and their performances. In this paper, we perform a methodical review to characterize the different approaches to ADR detection/extraction from social media, and their applicability to pharmacovigilance. In addition, we present a potential systematic pathway to ADR monitoring from social media. Methods We identified studies, describing approaches for ADR detection from social media from the Medline, Embase, Scopus and Web of Science databases, and the Google Scholar search engine. Studies that met our inclusion criteria were those that attempted to utilize ADR information posted by users on any publicly available social media platform. We categorized the studies into various dimensions such as primary ADR detection approach, size of data, source(s), availability, evaluation criteria, and so on. Results Twenty-two studies met our inclusion criteria, with fifteen (68.2%) published within the last two years. The survey revealed a clear trend towards the usage of annotated data with eleven of the fifteen (73.3%) studies published in the last two years relying on expert annotations. However, publicly available annotated data is still scarce, and we found only six (27.3%) studies that made the annotations used publicly available, making system performance comparisons difficult. In terms of algorithms, supervised classification techniques to detect posts containing ADR mentions, and lexicon-based approaches for extraction of ADR mentions from texts have been the most popular. Conclusion Our review suggests that interest in the utilization of the vast amounts of available social media data for ADR monitoring is increasing with time. In terms of sources, both health-related and general social media data have been used for ADR detection— while health-related sources tend to contain higher proportions of relevant data, the volume of data from general social media websites is significantly higher. There is still very limited publicly available annotated data available, and, as indicated by the promising results obtained by recent supervised learning approaches, there is a strong need to make such data available to the research community.

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“…Kullandıkları ilaçlarda adverse etki deneyimi yaamayan çok sayıda insan vardır. Hastalıkların tedavisi için gelitirilen ilaçları kullanırken öngörülü olmak gerekir 23,25 . …”

Section: Yarınıunclassified

“…Elde edilen bu bilgiler yeni ilaç gelitirme aamalarında ve pazarlamada da katkı sağlayabilir. Farmakovijilansın önümüzdeki yıllarda irketlerin lisans alma, ilaç düzenlemeleri ve ilaç gelitirmenin önemli bir parçası olacağına inanılmaktadır 18,25 .…”

Section: Dünüunclassified

Past, present and future of pharmacovigilance

Kaya¹,

Sürmelioğlu²,

Karataş³

2016

Arşiv Kaynak Tarama Dergisi

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Pharmacovigilance, is a scientific study related to followup problems in drug administrations and identify, record, announce and take due precautions for these problems. Pharmacovigilance works on to increase safety and effectiveness of drugs and minimize the risks associated with drug use. It is significantly developed and continues to improve to satisfy the recent needs. While information spreads like wildfire in the world, there is a need for strategic planning which adopts an integrated approach to go through difficulties caused by increased transmission between borders, easy acceptance of medical product diversity and increased safety expectation of public. We will need dynamic improvement and continuation of pharmacovigilance in all its parts to improve public health and safety. Key words: Pharmacovigilance, past, present, future. ÖZET Farmakovijilans, ilaç uygulamasında karılaılan sorunların takibi, sorumlu nedenlerin saptanması, tanınması, kaydedilmesi, duyurulması, gerekli önlemlerin alınması ile ilgili bilimsel çalımadır. Farmakovijilans ilaçların güvenliği ve etkinliği; ilaç kullanımı ile ilikili olası riskleri en aza indirmek üzerine çalıır. Önemli ölçüde gelimitir ve yeni ihtiyaçlara cevap vermek üzere gelimeye de devam edecektir. Dünya genelinde bilginin hızla yayılmasıyla birlikte, sınırlar arasındaki artan iletiim, tıbbi ürünlerin çeitliliğinin kolay kabulü ve kamunun artan güvenlik beklentisi gibi ek zorlukları karılamak için, bütünsel bir yaklaım benimseyen dikkatli bir stratejik planlama için ihtiyaç olumutur. Bizim kamu sağlığını ve güvenliğini artırmak adına farmakovijilansın tüm yönleriyle dinamik geliimine ve devamına ihtiyacımız olacaktır. Anahtar kelimeler: Farmakovijilans, geçmi, bugün, yarın.

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Challenges and Future Consideration for Pharmacovigilance

Cited by 14 publications

References 21 publications

A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States

A comparison of decision and timing of safety related labeling changes for new drugs approved both in Japan and the United States

Utilizing social media data for pharmacovigilance: A review

Past, present and future of pharmacovigilance

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