Literature DB >> 24264884

Ongoing challenges in pharmacovigilance.

Gerald J Dal Pan1.   

Abstract

While pharmacovigilance systems have made substantial progress in the past several decades, all pharmacovigilance systems face a common set of ongoing challenges in drug safety surveillance in five principal interrelated areas: engaging the public, collaboration and partnerships, incorporating informatics, adopting a global approach, and assessing the impact of efforts. In broad terms, these challenges are not new. Rather, advances in science and technology, along with more demanding societal expectations, have changed the nature of these challenges and provided new opportunities to move the field forward. Differences in organization and levels of development, as well as regional differences, necessarily imply that a single approach is not suitable for all regions, though sharing of best practices can help each region.

Mesh:

Year:  2014        PMID: 24264884     DOI: 10.1007/s40264-013-0123-x

Source DB:  PubMed          Journal:  Drug Saf        ISSN: 0114-5916            Impact factor:   5.606


  70 in total

1.  Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.

Authors:  Yolanda Alvarez; Ana Hidalgo; Francois Maignen; Jim Slattery
Journal:  Drug Saf       Date:  2010-06-01       Impact factor: 5.606

2.  Distributed health data networks: a practical and preferred approach to multi-institutional evaluations of comparative effectiveness, safety, and quality of care.

Authors:  Jeffrey S Brown; John H Holmes; Kiran Shah; Ken Hall; Ross Lazarus; Richard Platt
Journal:  Med Care       Date:  2010-06       Impact factor: 2.983

Review 3.  Perspectives on the use of data mining in pharmaco-vigilance.

Authors:  June Almenoff; Joseph M Tonning; A Lawrence Gould; Ana Szarfman; Manfred Hauben; Rita Ouellet-Hellstrom; Robert Ball; Ken Hornbuckle; Louisa Walsh; Chuen Yee; Susan T Sacks; Nancy Yuen; Vaishali Patadia; Michael Blum; Mike Johnston; Charles Gerrits; Harry Seifert; Karol Lacroix
Journal:  Drug Saf       Date:  2005       Impact factor: 5.606

4.  Estimating the extent of reporting to FDA: a case study of statin-associated rhabdomyolysis.

Authors:  Mara McAdams; Judy Staffa; Gerald Dal Pan
Journal:  Pharmacoepidemiol Drug Saf       Date:  2008-03       Impact factor: 2.890

5.  Adverse events: learning the science behind the art.

Authors:  Shantanu Nundy
Journal:  Acad Med       Date:  2008-12       Impact factor: 6.893

6.  The EU-ADR project: preliminary results and perspective.

Authors:  Gianluca Trifiro; Annie Fourrier-Reglat; Miriam C J M Sturkenboom; Carlos Díaz Acedo; Johan Van Der Lei
Journal:  Stud Health Technol Inform       Date:  2009

7.  Evaluation of FDA safety-related drug label changes in 2010.

Authors:  Jean Lester; George A Neyarapally; Earlene Lipowski; Cheryl Fossum Graham; Marni Hall; Gerald Dal Pan
Journal:  Pharmacoepidemiol Drug Saf       Date:  2013-01-02       Impact factor: 2.890

8.  Emergency use authorization for intravenous peramivir: evaluation of safety in the treatment of hospitalized patients infected with 2009 H1N1 influenza A virus.

Authors:  Alfred Sorbello; S Christopher Jones; Wendy Carter; Kimberly Struble; Robert Boucher; Melissa Truffa; Debra Birnkrant; Neha Gada; Sara Camilli; Irene Chan; Scott Dallas; Twanda Scales; Robert Kosko; Elizabeth Thompson; Jesse Goodman; Henry Francis; Gerald Dal Pan
Journal:  Clin Infect Dis       Date:  2012-04-05       Impact factor: 9.079

9.  How do patients contribute to signal detection? : A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK's Yellow Card Scheme.

Authors:  Lorna Hazell; Victoria Cornelius; Philip Hannaford; Saad Shakir; Anthony J Avery
Journal:  Drug Saf       Date:  2013-03       Impact factor: 5.606

10.  Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011.

Authors:  Lise Aagaard; Ebba Holme Hansen
Journal:  BMC Pharmacol Toxicol       Date:  2013-06-13       Impact factor: 2.483

View more
  12 in total

1.  A global view of undergraduate education in pharmacovigilance.

Authors:  Jenny Hartman; Linda Härmark; Eugène van Puijenbroek
Journal:  Eur J Clin Pharmacol       Date:  2017-03-17       Impact factor: 2.953

2.  Undergraduate and postgraduate pharmacovigilance education: A proposal for appropriate curriculum content.

Authors:  Raquel Herrera Comoglio
Journal:  Br J Clin Pharmacol       Date:  2020-02-05       Impact factor: 4.335

3.  Towards Automating Adverse Event Review: A Prediction Model for Case Report Utility.

Authors:  Monica A Muñoz; Gerald J Dal Pan; Yu-Jung Jenny Wei; Chris Delcher; Hong Xiao; Cindy M Kortepeter; Almut G Winterstein
Journal:  Drug Saf       Date:  2020-04       Impact factor: 5.606

4.  Adverse Drug Reaction Case Safety Practices in Large Biopharmaceutical Organizations from 2007 to 2017: An Industry Survey.

Authors:  Stella Stergiopoulos; Mortiz Fehrle; Patrick Caubel; Louise Tan; Louise Jebson
Journal:  Pharmaceut Med       Date:  2019-12

5.  An Empirical Examination of the FDAAA-Mandated "Toll-Free Statement" for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.

Authors:  Kathryn J Aikin; Amie C O'Donoghue; Claudia Squire; Helen W Sullivan; Kevin R Betts
Journal:  J Public Policy Mark       Date:  2016-04-01

6.  Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist.

Authors:  Paulo Henrique Santos Andrade; Amanda Carvalho Barreiros de Almeida; Ana Keilla Santana Dos Santos; Iza Maria Fraga Lobo; Francilene Amaral da Silva; Wellington Barros da Silva
Journal:  Ther Adv Drug Saf       Date:  2020-07-31

7.  A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.

Authors:  Hisham Aljadhey; Mansour A Mahmoud; Thamir M Alshammari; Mohammed Al-Dhaeefi; Herve Le Louet; Susana Perez-Gutthann; Peter J Pitts
Journal:  Saudi Med J       Date:  2015-09       Impact factor: 1.484

8.  Collaboration in pharmacovigilance: lamotrigine and fatal severe cutaneous adverse reactions - a review of spontaneous reports.

Authors:  Neil Brickel; Haris Shaikh; Andrew Kirkham; Greg Davies; Michelle Chalker; Pascal Yoshida
Journal:  Ther Clin Risk Manag       Date:  2017-07-20       Impact factor: 2.423

9.  Educational intervention to improve the knowledge, attitude and practice of healthcare professionals regarding pharmacovigilance in South-South Nigeria.

Authors:  Abimbola O Opadeyi; Annie Fourrier-Réglat; Ambrose O Isah
Journal:  Ther Adv Drug Saf       Date:  2019-01-25

Review 10.  Bioinformatics Accelerates the Major Tetrad: A Real Boost for the Pharmaceutical Industry.

Authors:  Tapan Behl; Ishnoor Kaur; Aayush Sehgal; Sukhbir Singh; Saurabh Bhatia; Ahmed Al-Harrasi; Gokhan Zengin; Elena Emilia Babes; Ciprian Brisc; Manuela Stoicescu; Mirela Marioara Toma; Cristian Sava; Simona Gabriela Bungau
Journal:  Int J Mol Sci       Date:  2021-06-08       Impact factor: 5.923

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.