Literature DB >> 15154825

Communication of medical product risk: how effective is effective enough?

Stephen A Goldman1.   

Abstract

Ever-increasing attention is being paid worldwide to the safety of medical products, and the risks associated with their use. The integral role of risk communication in overall risk management is demonstrated by several recent market withdrawals of drugs, in which a perceived incapability of healthcare systems to manage well-characterised, avoidable risks was a significant factor. With advances in clinical pharmacology, pharmacogenomics and pharmacoepidemiology expanding our knowledge of medical products, effective delivery of the latest safety-related information to health professionals and consumers becomes even more imperative. In this regard, it is important to evaluate whether current modes of risk communication lead to desired changes in relevant behaviours such as prescribing or drug monitoring, particularly in context with which achieved level of effectiveness is deemed acceptable. This is crucial, as there have been product-specific risk communication efforts that achieved a fair degree of success, yet were not seen as effective enough to prevent market withdrawal of the medical product in question. In the service of improving public health through enhanced risk communication, it is essential to critically assess current methods, both as to results achieved (or not), and whether each method is applicable to the various types of risks associated with medical product use. Furthermore, just as combining methods may well improve overall risk communication, there are societal and psychological factors that must be considered in attempting to maximise effectiveness. However, in assessing risk communication effectiveness, the particular benefit- risk relationship of any individual medical product must also be part of the evaluative process.

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Year:  2004        PMID: 15154825     DOI: 10.2165/00002018-200427080-00005

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


  41 in total

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Journal:  Soc Sci Med       Date:  1999-03       Impact factor: 4.634

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Journal:  JAMA       Date:  2002-02-06       Impact factor: 56.272

3.  Impact of cisapride label changes on codispensing of contraindicated medications.

Authors:  Jeff Jianfei Guo; Suellen Curkendall; Judith K Jones; Daniel Fife; Earl Goehring; Dewei She
Journal:  Pharmacoepidemiol Drug Saf       Date:  2003-06       Impact factor: 2.890

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Journal:  JAMA       Date:  1990-01-26       Impact factor: 56.272

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Authors:  S A Goldman; R Lieberman; D J Kausal
Journal:  J Clin Pharmacol       Date:  1996-05       Impact factor: 3.126

6.  Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project.

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Journal:  JAMA       Date:  1990-04-04       Impact factor: 56.272

7.  Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of 'Dear Doctor' letters.

Authors:  L B Weatherby; A M Walker; D Fife; P Vervaet; M A Klausner
Journal:  Pharmacoepidemiol Drug Saf       Date:  2001-05       Impact factor: 2.890

8.  Risk factors for development of flucloxacillin associated jaundice.

Authors:  C K Fairley; J J McNeil; P Desmond; R Smallwood; H Young; A Forbes; P Purcell; I Boyd
Journal:  BMJ       Date:  1993-01-23

9.  Mechanism of the cardiotoxic actions of terfenadine.

Authors:  R L Woosley; Y Chen; J P Freiman; R A Gillis
Journal:  JAMA       Date:  1993 Mar 24-31       Impact factor: 56.272

10.  Use of terfenadine and contraindicated drugs.

Authors:  D Thompson; G Oster
Journal:  JAMA       Date:  1996-05-01       Impact factor: 56.272

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  19 in total

Review 1.  Impact of safety-related regulatory action on clinical practice: a systematic review.

Authors:  Sigrid Piening; Flora M Haaijer-Ruskamp; Jonie T N de Vries; Menno E van der Elst; Pieter A de Graeff; Sabine M J M Straus; Peter G M Mol
Journal:  Drug Saf       Date:  2012-05-01       Impact factor: 5.606

2.  A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

Authors:  Peter G M Mol; Sabine M J M Straus; Sigrid Piening; Jonie T N de Vries; Pieter A de Graeff; Flora M Haaijer-Ruskamp
Journal:  Drug Saf       Date:  2010-06-01       Impact factor: 5.606

3.  Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies.

Authors:  Priya Bahri
Journal:  Drug Saf       Date:  2010-12-01       Impact factor: 5.606

Review 4.  Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

Authors:  Craig G Hartford; Kasia S Petchel; Hani Mickail; Susana Perez-Gutthann; Mary McHale; John M Grana; Paula Marquez
Journal:  Drug Saf       Date:  2006       Impact factor: 5.606

5.  Is there still a role for spontaneous reporting of adverse drug reactions?

Authors:  Joel Lexchin
Journal:  CMAJ       Date:  2006-01-17       Impact factor: 8.262

6.  Effectiveness of safety warnings in atypical antipsychotic drugs: an interrupted time-series analysis in Spain.

Authors:  Gabriel Sanfélix-Gimeno; Pedro Cervera-Casino; Salvador Peiró; Beatriz González López-Valcarcel; Amparo Blázquez; Teresa Barbera
Journal:  Drug Saf       Date:  2009       Impact factor: 5.606

7.  Drug vs class-specific black box warnings: does one bad drug spoil the bunch?

Authors:  Stacie B Dusetzina; G Caleb Alexander
Journal:  J Gen Intern Med       Date:  2011-06       Impact factor: 5.128

8.  Pharmacovigilance and the null hypothesis: do we do much for public health?

Authors:  I Ralph Edwards; Ambrose Isah
Journal:  Drug Saf       Date:  2011-02-01       Impact factor: 5.606

9.  Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom.

Authors:  Lucy T Perry; Alice Bhasale; Alice Fabbri; Joel Lexchin; Lorri Puil; Maisah Joarder; Barbara Mintzes
Journal:  JAMA Intern Med       Date:  2019-07-01       Impact factor: 21.873

10.  Risk Communication and the Pharmaceutical Industry: what is the reality?

Authors:  Brian Edwards; Sweta Chakraborty
Journal:  Drug Saf       Date:  2012-11-01       Impact factor: 5.606

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