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

Campbell, Stephen M. and Godman, Brian and Diogene, Eduardo and Fürst, Jurij and Gustafsson, Lars L. and MacBride-Stewart, Sean and Malmström, Rickard E. and Pedersen, Hanne and Selke, Gisbert and Vlahović-Palčevski, Vera and van Woerkom, Menno and Wong-Rieger, Durhane and Wettermark, Björn (2015) Quality indicators as a tool in improving the introduction of new medicines. Basic and Clinical Pharmacology and Toxicology, 116 (2). pp. 146-157. ISSN 1742-7835 (https://doi.org/10.1111/bcpt.12295)

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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.

  • Item type:Article
    ID code:59538
    Dates:
    Date
    Event
    28 February 2015
    Published
    18 September 2014
    Published Online
    7 July 2014
    Accepted
    Notes:This is the peer reviewed version of the following article: 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, which has been published in final form at http://dx.doi.org/10.1111/bcpt.12295. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.
    Subjects:Medicine > Pharmacy and materia medica
    Department:Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
    Depositing user: Pure Administrator
    Date deposited:23 Jan 2017 10:10
    Last modified:11 Nov 2024 11:36
    Related URLs:
    URI:https://strathprints.strath.ac.uk/id/eprint/59538
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