Quality indicators as a tool in improving the introduction of new medicines

Stephen M. Campbell, Brian Godman, Eduardo Diogene, Jurij Fürst, Lars L. Gustafsson, Sean MacBride-Stewart, Rickard E. Malmström, Hanne Pedersen, Gisbert Selke, Vera Vlahović-Palčevski, Menno van Woerkom, Durhane Wong-Rieger, Björn Wettermark

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Quality indicators are increasingly used as a tool to achieve safe and quality clinical care, cost-effective therapy, for professional learning, remuneration, accreditation and financial incentives. A substantial number focus on drug therapy but few address the introduction of new medicines even though this is a burning issue. The objective was to describe the issues and challenges in designing and implementing a transparent indicator framework and evaluation protocol for the introduction of new medicines and to provide guidance on how to apply quality indicators in the managed entry of new medicines. Quality indicators need to be developed early to assess whether new medicines are introduced appropriately. A number of key factors need to be addressed when developing, applying and evaluating indicators including dimensions of quality, suggested testing protocols, potential data sources, key implementation factors such as intended and unintended consequences, budget impact and cost-effectiveness, assuring the involvement of the medical professions, patients and the public, and reliable and easy-to-use computerized tools for data collection and management. Transparent approaches include the need for any quality indicators developed to handle conflict of interests to enhance their validity and acceptance. The suggested framework and indicator testing protocol may be useful in assessing the applicability of indicators for new medicines and may be adapted to healthcare settings worldwide. The suggestions build on existing literature to create a field testing methodology that can be used to produce country-specific quality indicators for new medicines as well as a cross international approach to facilitate access to new medicines.

LanguageEnglish
Pages146-157
Number of pages12
JournalBasic and Clinical Pharmacology and Toxicology
Volume116
Issue number2
Early online date18 Sep 2014
DOIs
Publication statusPublished - 28 Feb 2015

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Remuneration
Conflict of Interest
Accreditation
Quality of Health Care
Information Storage and Retrieval
Budgets
Medicine
Cost-Benefit Analysis
Motivation
Learning
Delivery of Health Care
Costs and Cost Analysis
Drug Therapy
Therapeutics
Testing
Drug therapy
Cost effectiveness

Keywords

  • cost-benefit analysis
  • health services accessibility
  • humans
  • pharmaceutical preparations
  • quality indicators, health care

Cite this

Campbell, S. M., Godman, B., Diogene, E., Fürst, J., Gustafsson, L. L., MacBride-Stewart, S., ... Wettermark, B. (2015). Quality indicators as a tool in improving the introduction of new medicines. Basic and Clinical Pharmacology and Toxicology , 116(2), 146-157. https://doi.org/10.1111/bcpt.12295
Campbell, Stephen M. ; Godman, Brian ; Diogene, Eduardo ; Fürst, Jurij ; Gustafsson, Lars L. ; MacBride-Stewart, Sean ; Malmström, Rickard E. ; Pedersen, Hanne ; Selke, Gisbert ; Vlahović-Palčevski, Vera ; van Woerkom, Menno ; Wong-Rieger, Durhane ; Wettermark, Björn. / Quality indicators as a tool in improving the introduction of new medicines. In: Basic and Clinical Pharmacology and Toxicology . 2015 ; Vol. 116, No. 2. pp. 146-157.
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Campbell, SM, Godman, B, Diogene, E, Fürst, J, Gustafsson, LL, MacBride-Stewart, S, Malmström, RE, Pedersen, H, Selke, G, Vlahović-Palčevski, V, van Woerkom, M, Wong-Rieger, D & Wettermark, B 2015, 'Quality indicators as a tool in improving the introduction of new medicines' Basic and Clinical Pharmacology and Toxicology , vol. 116, no. 2, pp. 146-157. https://doi.org/10.1111/bcpt.12295

Quality indicators as a tool in improving the introduction of new medicines. / Campbell, Stephen M.; Godman, Brian; Diogene, Eduardo; Fürst, Jurij; Gustafsson, Lars L.; MacBride-Stewart, Sean; Malmström, Rickard E.; Pedersen, Hanne; Selke, Gisbert; Vlahović-Palčevski, Vera; van Woerkom, Menno; Wong-Rieger, Durhane; Wettermark, Björn.

In: Basic and Clinical Pharmacology and Toxicology , Vol. 116, No. 2, 28.02.2015, p. 146-157.

Research output: Contribution to journalArticle

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