Pharmaceutical sales representatives and patient safety: a comparative prospective study of information quality in Canada, France and the United States.
J Gen Intern Med
; 28(10): 1368-75, 2013 Oct.
Article
em En
| MEDLINE
| ID: mdl-23558775
ABSTRACT
INTRODUCTION:
The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards.METHODS:
This is a prospective cohort study in Montreal, Vancouver, Sacramento and Toulouse. We recruited random samples of primary care physicians from May 2009 to June 2010 to report on consecutive sales visits. The primary outcome measure was "minimally adequate safety information" (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).RESULTS:
Two hundred and fifty-five physicians reported on 1,692 drug-specific promotions. "Minimally adequate safety information" did not differ 1.7 % of promotions; range 0.9-3.0 % per site. Sales representatives provided some vs. no information on harm more often in Toulouse than in Montreal and Vancouver 61 % vs. 34 %, OR = 4.0; 95 % CI 2.8-5.6, or Sacramento (39 %), OR = 2.4; 95 % CI 1.7-3.6. Serious adverse events were rarely mentioned (5-6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) "black box" warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time.DISCUSSION:
"Minimally adequate safety information" did not differ in the US and Canadian sites, despite regulatory differences. In Toulouse, consistent with stricter standards, more harm information was provided. However, in all sites, physicians were rarely informed about serious adverse events, raising questions about whether current approaches to regulation of sales representatives adequately protect patient health.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Marketing
/
Indústria Farmacêutica
/
Serviços de Informação sobre Medicamentos
/
Segurança do Paciente
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
País/Região como assunto:
America do norte
/
Europa
Idioma:
En
Revista:
J Gen Intern Med
Assunto da revista:
MEDICINA INTERNA
Ano de publicação:
2013
Tipo de documento:
Article