Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States

Mintzes, Barbara; Lexchin, Joel; Sutherland, Jason M.; Beaulieu, Marie-Claude; Wilkes, Michael S; Durrieu, Geneviève; Reynolds, Ellen

doi:10.1007/s11606-013-2411-7

Cited by 90 publications

(74 citation statements)

References 12 publications

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“…16 The findings of the current study and that by Mintzes and colleagues 15 about sales representatives raise questions about whether this mandate is being fulfilled.…”

Section: Discussionmentioning

confidence: 79%

“…10 The comprehensiveness of the safety information provided by sales representatives when they visit doctors was investigated in a study involving primary care practitioners in Vancouver and Montréal. 15 Minimally adequate safety information, defined a priori as the mention of 1 or more of approved indications, serious adverse events, common nonserious adverse events or contraindications and no unapproved indications or unqualified safety claims (e.g., "this drug is safe"), was provided in 5/412 (1.2%) promotions in Vancouver and 7/423 (1.6%) in Montréal. Representatives did not provide any information about harms (a serious adverse event, a common adverse event or a contraindication) in two-thirds of interactions.…”

Section: Discussionmentioning

confidence: 99%

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The relation between promotional spending on drugs and their therapeutic gain: a cohort analysis

Lexchin

2017

CMAJ Open

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journal advertisements by the Canadian Pharmaceutical Advertising Advisory Board, there is no a priori reason to believe that the situation in Canada is either the same as or different from the one south of the border. This study looks at the most heavily promoted drugs and the therapeutic gain from those products. It also compares the therapeutic gain from the most-promoted drugs and the topselling drugs by dollar value. Examining whether the medicines that are heavily promoted are the ones that provide the most therapeutic gain may help in determining whether doctors should be using promotional material to inform themselves about therapeutically important drugs. Methods Sources of dataI used the annual reports from IMS|Brogan (now QuintilesIMS) as the primary source of data about the amount of money spent on journal advertisements and visits by sales representatives, and the top products by sales revenue, as this company is the only publicly available source that reports this type of information consistently from year to year. IMS|Brogan information is limited to the top 50 drugs in each of the 2 categories. IMS|Brogan sells data and reports to all the top 100 worldwide global pharmaceutical and biotechnology companies, as well as consulting firms, advertising agencies, government bodies and financial firms, 6 and has produced reports for the Canadian federal government. 7 From the reports for 2013, 2014 and 2015, 8-10 I extracted the generic name, brand name and amount spent on promotion for the 50 most heavily promoted drugs in each year. For the 50 top-selling products in each year, I recorded the generic and brand names. The list of the top 50 products includes devices for measuring blood glucose level, and these were excluded from the analysis, as were generic drugs if the brand-name drug was also on the list of top 50 products. Different formulations of the same drug were treated as unique products. Determination of therapeutic gainI determined the therapeutic gain from products from information on the website of the Patented Medicine Prices Review Board (PMPRB) (www.pmprb-cepmb.gc.ca/ pmpMedicines.asp?x=611) and the independent French drug bulletin Prescrire International (http://english.prescrire.org/ en/Search.aspx; subscription required). I chose these sources because they both provide objective assessments of therapeutic value that do not require any subjective interpretation.The PMPRB is a federal agency that is responsible for calculating the maximum introductory price for all new patented medications introduced onto the Canadian market. It is important to note that the PMPRB is not a payer, and, therefore, its decisions about therapeutic value are not influenced by how much it might have to pay for the product. As part of the process of determining the price, the PMPRB's independent Human Drug Advisory Panel determines the therapeutic value of each product it reviews; these evaluations are available on its website. The advisory panel determines the ratings for the drugs before the maximum price...

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“…16 The findings of the current study and that by Mintzes and colleagues 15 about sales representatives raise questions about whether this mandate is being fulfilled.…”

Section: Discussionmentioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

The relation between promotional spending on drugs and their therapeutic gain: a cohort analysis

Lexchin

2017

CMAJ Open

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“…Some misconduct may be evident in how pharmaceutical sales representatives (PSRs) obtain their information and sell their products. Information delivered to physicians by PSRs is often misleading (Lexchin and Kohler 2011) and accompanied by free product samples (Mintzes et al 2013). Social science research suggests that when individuals are given free products, they are more strongly influenced by those products and are more willing to advocate their use (Brennan et al 2006).…”

Section: The Pharmaceutical Industrymentioning

confidence: 99%

“…Social science research suggests that when individuals are given free products, they are more strongly influenced by those products and are more willing to advocate their use (Brennan et al 2006). When physicians were interviewed regarding their experience with PSRs, the results indicated that there was a major lack of information regarding the risks of the products, as the benefits were mentioned twice as often (Mintzes et al 2013). This is a violation of law according to Health Canada, which states that "messages cannot emphasize only product benefits without included safety information" (Health Canada 2011b, p. 1).…”

Section: The Pharmaceutical Industrymentioning

confidence: 99%

A suggestion for evolution of Canada’s health regulatory system

White

Reid

2018

FACETS

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Aspects of Canada's health regulatory system are currently being reviewed. This is timely, as the regulation and definition of drugs, foods, and natural health products (NHPs) is in need of revision to facilitate greater transparency and less ambiguity. A number of studies have illustrated the importance of a nutritious diet to prevent and manage chronic disease. Therefore, legislation surrounding food health claims needs to be adjusted so that it is more informative for disease prevention and, in some cases, treatment. Canada is modernizing the regulation of self-care products, under which NHPs, including probiotic products, are listed. With the growing appreciation for the role that microbes play in human health and the recognition that many foods, including those containing probiotic organisms, can prevent or mitigate disease, this provides an opportunity to reassess regulatory categories.

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“…y Francia difieren en cómo regulan la promoción de medicamentos; los investigadores se preguntaron si esto podría llevar a diferencias en la calidad de la información. En esta "Therapeutics Letter" se revisan los resultados de este estudio (Mintzes et al, 2013) y lo que significan para la atención al paciente.…”

Section: Pontos Resumidosunclassified

Análise da prescrição de fármacos não constantes da Relação Municipal de Medicamentos Essenciais do município de São Paulo, 2008-2013

Bonfim¹

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Versão corrigida São Paulo 2015É expressamente proibido o comércio deste documento, tanto sob forma impressa como eletrônica. Sua reprodução total ou parcial é permitida exclusivamente para fins acadêmicos e científicos, desde que na reprodução figure a identificação do autor, título, instituição e ano da tese. "Ora, se a amizade encerra todas as vantagens, e a valer, ela as ultrapassa todas, porque aureola o futuro de otimismo e não admite nem a desmoralização dos espíritos nem sua capitulação. De fato, observar um verdadeiro amigo equivale a observar uma versão exemplar de si mesmo: os ausentes são então presentes, os indigentes são ricos, os fracos cheios de força e, o que é mais difícil de explicar, os mortos são vivos, na medida em que o respeito, a lembrança, o pesar de seus amigos continuam ligados a eles."Marco Túlio Cícero, 103-43 a. C. Saber envelhecer, seguido de Lélio, ou a Amizade.Tradução de Paulo Neves. Porto Alegre; L & PM; 1997. pág. 88.Dedico este trabalho aos amigos ausentes, que por diversos modos influíram na minha vida pessoal e profissional.• Fernando Vitor de Araújo Alves , ecologista autodidata e político;• Adalgisa Pereira da Silva Aderaldo , um dos fundadores da Editora Hucitec; • Joaquim Alberto Cardoso de Melo (1936Melo ( -1993, cirurgião-dentista sanitarista e educador de Saúde Pública;• Demócrito de Oliveira Moura , jornalista dedicado à saúde, ao meio ambiente e à defesa do consumidor;• Francisco Augusto Vieira Nunes [Bacurau] (1939[Bacurau] ( -1997, fundador do Movimento de Reintegração do Hanseniano (Morhan) e ativista dos direitos humanos; • Guilherme Montenegro Abath , neuropatologista e professor de medicina preventiva e social;• David Capistrano da Costa Filho (1948Filho ( -2000, médico sanitarista e político;• Antonio Sergio da Silva Arouca , médico sanitarista, professor de medicina preventiva e social, e político; • Nailson da Silva Gondim (1950Gondim ( -2005, jornalista, poeta e linguista autodidata;• Maria da Conceição de Souza Cahú (1944, desenhista, caricaturista e pintora;• Eleonora Machado Freire (1946Freire ( -2007, médica sanitarista e dermatologista;• Arnaldo Ferreira dos Santos (1944Santos ( -2007, médico sanitarista e gerontologista;• Gildo Marçal Brandão (1949Brandão ( -2010, jornalista e professor de ciência política;• Denis Antônio de Mendonça Bernardes (1948Bernardes ( -2012, historiógrafo e escritor. E a meus pais Ruben Alcântara Bonfim (1917Bonfim ( -1980 e Lindinalva Ferreira Bonfim , que tudo fizeram para que seus filhos (José Ruben, Osiel, Rômulo, Luiz Ruben, Alessandro e Luciane) se constituíssem cidadãos. AgradecimentosEm primeiro lugar quero registrar meu apreço e gratidão aos profissionais que atuam no campo da biblioteconomia, pois eles têm múltiplas funções e atividades para subsidiar o trabalho do pesquisador, e almejam o progresso de seu mister. Muitas delas foram antevistas por José Ortega y Gasset (1883Gasset ( -1955 É preciso que deixe de ser problema para um autor reunir a bibliografia descritiva e seletiva sobre assunto de seu interesse. Q...

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Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States

Cited by 90 publications

References 12 publications

The relation between promotional spending on drugs and their therapeutic gain: a cohort analysis

The relation between promotional spending on drugs and their therapeutic gain: a cohort analysis

A suggestion for evolution of Canada’s health regulatory system

Análise da prescrição de fármacos não constantes da Relação Municipal de Medicamentos Essenciais do município de São Paulo, 2008-2013

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