Literature DB >> 18725616

Effect of regulatory warnings on antipsychotic prescription rates among elderly patients with dementia: a population-based time-series analysis.

Elmira Valiyeva1, Nathan Herrmann, Paula A Rochon, Sudeep S Gill, Geoffrey M Anderson.   

Abstract

BACKGROUND: Three warnings of serious adverse events associated with the use of atypical antipsychotic drugs among elderly patients with dementia were sent to health care professionals in Canada. We assessed the impact of these warnings on prescription rates of antipsychotic drugs in this patient population.
METHODS: We used prescription drug claims data from Ontario to calculate prescription rates of atypical and conventional antipsychotic drugs among elderly patients with dementia from May 1, 2000, to Feb. 28, 2007. We performed a time-series analysis to estimate the effect of each warning on rates of antipsychotic drug use.
RESULTS: Before the first warning, growth in the use of atypical antipsychotics was responsible for an increasing rate of overall antipsychotic use. Each warning was associated with a small relative decrease in the predicted growth in the use of atypical antipsychotic drugs: a 5.0% decrease after the first warning, 4.9% after the second and 3.2% after the third (each p < 0.05). The overall prescription rate of antipsychotic drugs among patients with dementia increased by 20%, from 1512 per 100 000 elderly patients in September 2002, the month before the first warning, to 1813 per 100 000 in February 2007, 20 months after the last warning.
INTERPRETATION: Although the warnings slowed the growth in the use of atypical antipsychotic drugs among patients with dementia, they did not reduce the overall prescription rate of these potentially dangerous drugs. More effective interventions are necessary to improve postmarket drug safety in vulnerable populations.

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Year:  2008        PMID: 18725616      PMCID: PMC2518182          DOI: 10.1503/cmaj.071540

Source DB:  PubMed          Journal:  CMAJ        ISSN: 0820-3946            Impact factor:   8.262


  21 in total

1.  Coding accuracy of administrative drug claims in the Ontario Drug Benefit database.

Authors:  Adrian R Levy; Bernie J O'Brien; Connie Sellors; Paul Grootendorst; Donald Willison
Journal:  Can J Clin Pharmacol       Date:  2003

2.  Segmented regression analysis of interrupted time series studies in medication use research.

Authors:  A K Wagner; S B Soumerai; F Zhang; D Ross-Degnan
Journal:  J Clin Pharm Ther       Date:  2002-08       Impact factor: 2.512

3.  Impact of mailed warning to prescribers on the co-prescription of tramadol and antidepressants.

Authors:  Deborah Shatin; Jacqueline S Gardner; Andy Stergachis; David Blough; David Graham
Journal:  Pharmacoepidemiol Drug Saf       Date:  2005-03       Impact factor: 2.890

4.  FDA warns antipsychotic drugs may be risky for elderly.

Authors:  Bridget M Kuehn
Journal:  JAMA       Date:  2005-05-25       Impact factor: 56.272

5.  Medicaid's prior authorization program and access to atypical antipsychotic medications.

Authors:  Jennifer M Polinski; Philip S Wang; Michael A Fischer
Journal:  Health Aff (Millwood)       Date:  2007 May-Jun       Impact factor: 6.301

6.  Risk of death in elderly users of conventional vs. atypical antipsychotic medications.

Authors:  Philip S Wang; Sebastian Schneeweiss; Jerry Avorn; Michael A Fischer; Helen Mogun; Daniel H Solomon; M Alan Brookhart
Journal:  N Engl J Med       Date:  2005-12-01       Impact factor: 91.245

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.  Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials.

Authors:  Lon S Schneider; Karen S Dagerman; Philip Insel
Journal:  JAMA       Date:  2005-10-19       Impact factor: 56.272

9.  Olanzapine (Zyprexa): increased incidence of cerebrovascular events in dementia trials.

Authors:  Eric Wooltorton
Journal:  CMAJ       Date:  2004-04-27       Impact factor: 8.262

10.  Antipsychotic drug use and mortality in older adults with dementia.

Authors:  Sudeep S Gill; Susan E Bronskill; Sharon-Lise T Normand; Geoffrey M Anderson; Kathy Sykora; Kelvin Lam; Chaim M Bell; Philip E Lee; Hadas D Fischer; Nathan Herrmann; Jerry H Gurwitz; Paula A Rochon
Journal:  Ann Intern Med       Date:  2007-06-05       Impact factor: 25.391

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  38 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.  Off-label prescribing in older people: the need for increased awareness and caution.

Authors:  Anne Stephenson; Geoffrey M Anderson; Paula Rochon
Journal:  Drugs Aging       Date:  2012-06-01       Impact factor: 3.923

Review 3.  Concerns about health care warnings and their impact on prescribing behaviour.

Authors:  Laurence Y Katz
Journal:  CMAJ       Date:  2008-08-26       Impact factor: 8.262

4.  Trends in use of antipsychotics in elderly patients with dementia: Impact of national safety warnings.

Authors:  Adeline Gallini; Sandrine Andrieu; Julie M Donohue; Naïma Oumouhou; Maryse Lapeyre-Mestre; Virginie Gardette
Journal:  Eur Neuropsychopharmacol       Date:  2013-09-17       Impact factor: 4.600

Review 5.  Are the safety profiles of antipsychotic drugs used in dementia the same? An updated review of observational studies.

Authors:  Gianluca Trifiró; Janet Sultana; Edoardo Spina
Journal:  Drug Saf       Date:  2014-07       Impact factor: 5.606

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

Review 7.  Cerebrovascular accidents in elderly people treated with antipsychotic drugs: a systematic review.

Authors:  Emilio Sacchetti; Cesare Turrina; Paolo Valsecchi
Journal:  Drug Saf       Date:  2010-04-01       Impact factor: 5.606

8.  Curing and caring: the work of primary care physicians with dementia patients.

Authors:  Ester Carolina Apesoa-Varano; Judith C Barker; Ladson Hinton
Journal:  Qual Health Res       Date:  2011-06-17

9.  Can Health Canada protect Canadians from unsafe drugs?

Authors:  Paul C Hébert; Matthew B Stanbrook; Noni MacDonald; Ken Flegel; Jane Coutts; Stuart MacLeod
Journal:  CMAJ       Date:  2011-04-18       Impact factor: 8.262

10.  Detecting and Managing Neuropsychiatric Symptoms in Dementia.

Authors:  Andrea Iaboni; Mark J Rapoport
Journal:  Can J Psychiatry       Date:  2017-03       Impact factor: 4.356

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