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Literature DB >> 19763106

New approaches to drug safety: a pharmacovigilance tool kit.

Lesley Wise¹, John Parkinson, June Raine, Alasdair Breckenridge.

Abstract

The importance of pharmacovigilance - the ongoing assessment of the safety of a marketed medicine - has been increasingly appreciated in recent years, owing in part to high-profile safety issues with widely used drugs. In response, strategies to improve the collection, integration and analysis of data related to post-marketing drug safety are being initiated or enhanced. In this article, we summarize the key tools that are available for pharmacovigilance, discuss which might be the most appropriate to use in different situations and consider the future directions of the field.

Mesh：

Year: 2009 PMID： 19763106 DOI： 10.1038/nrd3002

Source DB: PubMed Journal: Nat Rev Drug Discov ISSN： 1474-1776 Impact factor: 84.694

12 in total

1. Malformation risks of antiepileptic drugs in pregnancy: a prospective study from the UK Epilepsy and Pregnancy Register.

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Journal: J Neurol Neurosurg Psychiatry Date: 2005-09-12 Impact factor: 10.154

Review 2. Natalizumab for multiple sclerosis.

Authors: Richard M Ransohoff
Journal: N Engl J Med Date: 2007-06-21 Impact factor: 91.245

Review 3. Risk management strategies in the postmarketing period : safety experience with the US and European bosentan surveillance programmes.

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Journal: Drug Saf Date: 2005 Impact factor: 5.606

4. Combination antiretroviral therapy and the risk of myocardial infarction.

Authors: Nina Friis-Møller; Caroline A Sabin; Rainer Weber; Antonella d'Arminio Monforte; Wafaa M El-Sadr; Peter Reiss; Rodolphe Thiébaut; Linda Morfeldt; Stephane De Wit; Christian Pradier; Gonzalo Calvo; Matthew G Law; Ole Kirk; Andrew N Phillips; Jens D Lundgren
Journal: N Engl J Med Date: 2003-11-20 Impact factor: 91.245

5. What is the harm-benefit ratio of Cox-2 inhibitors?

Authors: T P van Staa; L Smeeth; I Persson; J Parkinson; H G M Leufkens
Journal: Int J Epidemiol Date: 2008-02-08 Impact factor: 7.196

6. Verapamil is associated with an increased risk of cancer in the elderly: the Rotterdam study.

Authors: A B Beiderbeck-Noll; M C J M Sturkenboom; P D van der Linden; R M C Herings; A Hofman; J W W Coebergh; H G M Leufkens; B H Ch Stricker
Journal: Eur J Cancer Date: 2003-01 Impact factor: 9.162

7. HLA-B*5701 screening for hypersensitivity to abacavir.

Authors: Simon Mallal; Elizabeth Phillips; Giampiero Carosi; Jean-Michel Molina; Cassy Workman; Janez Tomazic; Eva Jägel-Guedes; Sorin Rugina; Oleg Kozyrev; Juan Flores Cid; Phillip Hay; David Nolan; Sara Hughes; Arlene Hughes; Susanna Ryan; Nicholas Fitch; Daren Thorborn; Alastair Benbow
Journal: N Engl J Med Date: 2008-02-07 Impact factor: 91.245

8. Safety and usage of atypical antipsychotic medicines in children: a nationwide prospective cohort study.

Authors: Mira Harrison-Woolrych; Juan Garcia-Quiroga; Janelle Ashton; Peter Herbison
Journal: Drug Saf Date: 2007 Impact factor: 5.606

9. [Follow-up of patients with Hunter syndrome: the Hunter Outcome Survey (HOS) registry].

Authors: M del Toro-Riera
Journal: Rev Neurol Date: 2007-02-19 Impact factor: 0.870

10. Individualizing the risks and benefits of postmenopausal hormone therapy.

Authors: Tjeerd P van Staa; Cyrus Cooper; David Barlow; Hubert G M Leufkens
Journal: Menopause Date: 2008 Mar-Apr Impact factor: 2.953

19 in total

1. Development and delivery of clinical pharmacology in regulatory agencies.

Authors: Alasdair Breckenridge
Journal: Br J Clin Pharmacol Date: 2012-06 Impact factor: 4.335

Review 2. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Authors: Lenhangmbong Nkeng; Anne-Marie Cloutier; Camille Craig; Jacques Lelorier; Yola Moride
Journal: Drug Saf Date: 2012-07-01 Impact factor: 5.606

3. Evolution of regulatory frameworks.

Authors: Alasdair Breckenridge; Peter Feldschreiber; Simon Gregor; June Raine; Leigh-Ann Mulcahy
Journal: Nat Rev Drug Discov Date: 2011-01 Impact factor: 84.694

Review 4. Today's challenges in pharmacovigilance: what can we learn from epoetins?

Authors: Hans C Ebbers; Aukje K Mantel-Teeuwisse; Ellen H M Moors; Huub Schellekens; Hubert G Leufkens
Journal: Drug Saf Date: 2011-04-01 Impact factor: 5.606

5. Factors that affect adverse drug reaction reporting among hospital pharmacists in Western China.

Authors: Jun Liu; Zhongliang Zhou; Shimin Yang; Bianling Feng; Jun Zhao; Hua Liu; Haiyan Huang; Yu Fang
Journal: Int J Clin Pharm Date: 2015-04-02

6. Development of a Controlled Vocabulary-Based Adverse Drug Reaction Signal Dictionary for Multicenter Electronic Health Record-Based Pharmacovigilance.

Authors: Suehyun Lee; Jongsoo Han; Rae Woong Park; Grace Juyun Kim; John Hoon Rim; Jooyoung Cho; Kye Hwa Lee; Jisan Lee; Sujeong Kim; Ju Han Kim
Journal: Drug Saf Date: 2019-05 Impact factor: 5.606

Review 7. Risks and benefits of (pharmaco)epidemiology.

Authors: Lesley Wise
Journal: Ther Adv Drug Saf Date: 2011-06

8. The burden of adverse drug events.

Authors: Alasdair Breckenridge
Journal: Br J Clin Pharmacol Date: 2015-06-01 Impact factor: 4.335

9. Characterization of Statin-Associated Myopathy Case Reports in Thailand Using the Health Product Vigilance Center Database.

Authors: Pornwalai Boonmuang; Surakit Nathisuwan; Nathorn Chaiyakunapruk; Wimon Suwankesawong; Pattreya Pokhagul; Nattawat Teerawattanapong; Pairin Supsongserm
Journal: Drug Saf Date: 2013-09 Impact factor: 5.606

10. Implementing ecopharmacovigilance in practice: challenges and potential opportunities.

Authors: Gisela Holm; Jason R Snape; Richard Murray-Smith; John Talbot; David Taylor; Pernilla Sörme
Journal: Drug Saf Date: 2013-07 Impact factor: 5.606