Literature DB >> 23061778

Protecting the people?: risk communication and the chequered history and performance of bureaucracy.

Bruce Hugman1.   

Abstract

The history and characteristics of bureaucracy1 are examined with a view to understanding the impact of the bureaucratic mindset on medicines' regulation, the pharmaceutical industry and healthcare delivery with a focus on risk communication, pharmacovigilance and patient safety. Controversies and allegations relating to common, negative effects of bureaucratic regulatory and management systems are reviewed and examples of creative and effective practice provided. Strategic directions and specific actions for reform are proposed.2.

Entities:  

Mesh：

Year:  2012        PMID： 23061778     DOI： 10.2165/11635210-000000000-00000

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


  10 in total

1.  Embedding 'speaking up' into systems for safe healthcare product development and marketing surveillance.

Authors:  Brian Edwards; Bruce Hugman; Mary Tobin; Matthew Whalen
Journal:  Drug Saf       Date:  2012-04-01       Impact factor: 5.606

Review 2.  Did regulators fail over selective serotonin reuptake inhibitors?

Authors:  David Healy
Journal:  BMJ       Date:  2006-07-08

3.  Seroxat and the suppression of clinical trial data: regulatory failure and the uses of legal ambiguity.

Authors:  L McGoey; E Jackson
Journal:  J Med Ethics       Date:  2009-02       Impact factor: 2.903

4.  The cancer of bureaucracy: how it will destroy science, medicine, education; and eventually everything else.

Authors:  Bruce G Charlton
Journal:  Med Hypotheses       Date:  2010-01-13       Impact factor: 1.538

5.  Hurdles in modern trial management: as overbureaucracy and commercialization of clinical trials suffocate independent academic research, it's time for a change.

Authors:  Susanne Osanto; Hendrik van Poppel; Jacobus Burggraaf; Reginald R Hall
Journal:  Eur Urol       Date:  2009-06-23       Impact factor: 20.096

6.  The fatal love of forms.

Authors:  Bruce Hugman
Journal:  Drug Saf       Date:  2011-08-01       Impact factor: 5.606

7.  Contraindicated use of cisapride: impact of food and drug administration regulatory action.

Authors:  W Smalley; D Shatin; D K Wysowski; J Gurwitz; S E Andrade; M Goodman; K A Chan; R Platt; S D Schech; W A Ray
Journal:  JAMA       Date:  2000-12-20       Impact factor: 56.272

8.  Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences.

Authors:  Philip F Stahel; Allison L Sabel; Michael S Victoroff; Jeffrey Varnell; Alan Lembitz; Dennis J Boyle; Ted J Clarke; Wade R Smith; Philip S Mehler
Journal:  Arch Surg       Date:  2010-10

9.  Empty ethics: the problem with informed consent.

Authors:  Oonagh Corrigan
Journal:  Sociol Health Illn       Date:  2003-11

10.  Writing ourselves into a web of obedience: a nursing policy analysis.

Authors:  Kasia Bail; Robert Cook; Anne Gardner; Laurie Grealish
Journal:  Int J Nurs Stud       Date:  2009-05-28       Impact factor: 5.837
  10 in total
  2 in total

1.  The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance.

Authors:  Priya Bahri; Alexander N Dodoo; Brian D Edwards; I Ralph Edwards; Irene Fermont; Ulrich Hagemann; Kenneth Hartigan-Go; Bruce Hugman; Peter G Mol
Journal:  Drug Saf       Date:  2015-07       Impact factor: 5.606

2.  Focusing on risk communication about medicines: why now?

Authors:  Priya Bahri; Mira Harrison-Woolrych
Journal:  Drug Saf       Date:  2012-11-01       Impact factor: 5.606
  2 in total

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