TY - JOUR
T1 - Quality indicators as a tool in improving the introduction of new medicines
AU - Campbell, Stephen M.
AU - Godman, Brian
AU - Diogene, Eduardo
AU - Fürst, Jurij
AU - Gustafsson, Lars L.
AU - Macbride-Stewart, Sean
AU - Malmström, Rickard E.
AU - Pedersen, Hanne
AU - Selke, Gisbert
AU - Vlahović-Palčevski, Vera
AU - van Woerkom, Menno
AU - Wong-Rieger, Durhane
AU - Wettermark, Björn
N1 - Publisher Copyright:
© 2014 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).
PY - 2015/2/1
Y1 - 2015/2/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84921263859&partnerID=8YFLogxK
U2 - 10.1111/bcpt.12295
DO - 10.1111/bcpt.12295
M3 - Article
C2 - 25052464
AN - SCOPUS:84921263859
SN - 1742-7835
VL - 116
SP - 146
EP - 157
JO - Basic and Clinical Pharmacology and Toxicology
JF - Basic and Clinical Pharmacology and Toxicology
IS - 2
ER -