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Cochrane Database of Systematic Reviews

Unbranded advertising of prescription medicines to the public by pharmaceutical companies

Información

DOI:
https://doi.org/10.1002/14651858.CD012699Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 10 julio 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Protocol
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Consumidores y comunicación

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Teresa Leonardo Alves

    Correspondencia a: Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands

    [email protected]

  • Aukje K Mantel‐Teeuwisse

    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands

  • Anne Paschke

    Department of Political Sciences, University of Hamburg, Hamburg, Germany

  • Hubert GM Leufkens

    Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands

  • Lorri Puil

    Department of Anesthesiology, Pharmacology & Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, Canada

  • Elita Poplavska

    Faculty of Pharmacy, Riga Stradins University, Riga, Latvia

  • Barbara Mintzes

    Charles Perkins Centre and Faculty of Pharmacy, The University of Sydney, Sydney, Australia

    School of Population and Public Health, University of British Columbia, Vancouver, Canada

Contributions of authors

  • TLA: title registration proposal drafting, protocol drafting.

  • AMT: title registration proposal review, protocol review and input into final draft.

  • AP: protocol review and input into final draft.

  • HGML: title registration proposal review, protocol review.

  • LP: protocol review and input into final draft.

  • EP: protocol review and input into final draft.

  • BM: title registration proposal drafting, protocol drafting and review, input into final draft.

Sources of support

Internal sources

  • WHO Collaborating Center on Pharmaceutical Policy and Regulation, Netherlands.

    The WHO Collaborating Centre on Pharmaceutical Policy and Regulation supports this Cochrane review, as part of its PhD programme for professionals (Teresa Leonardo Alves is a Professional PhD student at the Centre). The Centre ensures supervision by researchers in the field; facilitates attendance of training courses and meetings; provides remote access to the library and other facilities at Utrecht University as well as a fully equipped working environment.

External sources

  • No sources of support supplied

Declarations of interest

Teresa Leonardo Alves: None known.

AK Mantel‐Teeuwisse: Aukje Mantel‐Teeuwisse is the Managing Director of the WHO Collaborating Centre for Pharmaceutical Policy & Regulation, which receives no direct funding or donations from private parties, including the pharmaceutical industry. Research funding from public‐private partnerships, e.g. IMI, TI Pharma (www.lygature.org), is accepted under the condition that no company‐specific product or company‐related study is conducted. The Centre has received unrestricted research funding from public sources, e.g. Netherlands Organisation for Health Research and Development (ZonMW), the Dutch Health Care Insurance Board (CVZ), EU 7th Framework Program (FP7), Dutch Medicines Evaluation Board (MEB), and Dutch Ministry of Health.

Anne Paschke: is engaged in a network of NGOs that advocate for access to medicines and limiting pharmaceutical promotion and works as a consultant with the World Health Organization working on transparency and accountability in the pharmaceutical sector, including pharmaceutical promotion.

HGM Leufkens: Bert Leufkens is Chair of the Dutch Medicines Evaluation Board and the Scientific DIrector of the WHO Collaborating Centre for Pharmaceutical Policy & Regulation. The Centre receives no direct funding or donations from private parties, including the pharmaceutical industry. Research funding from public‐private partnerships, e.g. IMI, TI Pharma (www.lygature.org), is accepted under the condition that no company‐specific product or company‐related study is conducted. The Centre has received unrestricted research funding from public sources, e.g. Netherlands Organisation for Health Research and Development (ZonMW), the Dutch Health Care Insurance Board (CVZ), EU 7th Framework Program (FP7), Dutch Medicines Evaluation Board (MEB), and Dutch Ministry of Health.

Lorri Puil: None known.

Elita Poplavska: None known.

Barbara Mintzes: Barbara Mintzes has acted as an expert witness on behalf of plaintiffs in Canadian class action suits on postmenopausal hormone therapy and breast cancer, and testosterone therapy and cardiovascular risks.

Acknowledgements

We thank the Cochrane Consumers and Communication editors and staff, particularly Ann Jones, Rebecca Ryan and Sophie Hill, for their input to this protocol. 

Version history

Published

Title

Stage

Authors

Version

2017 Jul 10

Unbranded advertising of prescription medicines to the public by pharmaceutical companies

Protocol

Teresa Leonardo Alves, Aukje K Mantel‐Teeuwisse, Anne Paschke, Hubert GM Leufkens, Lorri Puil, Elita Poplavska, Barbara Mintzes

https://doi.org/10.1002/14651858.CD012699

Notes

This protocol is based on standard text and guidance provided by Cochrane Consumers and Communication (CCCG 2014).

Logic model (based on Mosdøl 2015)
Figuras y tablas -
Figure 1

Logic model (based on Mosdøl 2015)

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Table 1. Glossary of key terms

Key term

Definition

Branded direct‐to‐consumer advertising of prescription medicines (DTCA)

Advertising that includes a product's brand name. In the USA, this includes two types of advertising described by the Food and Drug Administration: 1) 'full product advertising', which includes the product name and health claims. Such advertising must also include information on the drug risks; 2) reminder advertising, which states the product's name but makes no health claims. In the USA, this advertising is not allowed for drugs with boxed warnings of serious risks.

Unbranded advertising of prescription medicines

Any paid advertising campaign, in any media, by a pharmaceutical manufacturer, with a focus on a condition treated by one or more of its products, but without any mention of brand or generic names.

Off‐label promotion

The term 'off‐label promotion' refers to promotion of a medicine for an unapproved use. This type of promotion is generally illegal. Physicians may prescribe a medicine for any use, whether it is approved or not, but manufacturers may not promote medicines for off‐label use.

Mixed promotion (both on‐ and off‐label)

'On‐label promotion' refers to promotion for approved uses. 'Off‐label promotion' is for unapproved uses. Mixed promotion is for both types of uses.

Generic drugs or generics

Generic drugs or generics are medicines that have no brand name or registered trademark. Once the patent for a medicine expires, other manufacturers may produce the medicine, and these products are generic drugs.

Direct‐to‐consumer advertising

Direct‐to‐consumer advertising (DTCA) refers to advertising of prescription‐only medicines aimed at the public. Such advertising is fully legal only in two countries, the USA and New Zealand.

Non‐commercial information sources

We define a non‐commercial information source to be any public or private entity, institution, non‐government organisation, foundation or society involved in distributing information about health and treatment which does not derive a commercial gain from inducing the prescription, supply, purchase and/or use of pharmaceutical products, either directly or indirectly.

Third party acting on behalf of pharmaceutical company

Any public relations consultancy, marketing company, professional society, think tank, patient and consumer group, key opinion leader, medical practice or hospital, which has been hired or funded by a pharmaceutical company to promote specific pharmaceutical products.

Figuras y tablas -
Table 1. Glossary of key terms
Ir a la tabla del protocolo