title: Quality indicators as a tool in improving the introduction of new medicines.
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.
authors: Centre for Primary Care, Institute of Population Health, University of Manchester, Manchester, UK; NIHR Greater Manchester Primary Care Patient Safety Translational Research Centre, Institute of Population Health, University of Manchester, Manchester, UK.
authors: Stephen M
authors: SM
authors: Campbell
authors: Brian
authors: B
authors: Godman
authors: Eduardo
authors: E
authors: Diogene
authors: Jurij
authors: J
authors: Fürst
authors: Lars L
authors: LL
authors: Gustafsson
authors: Sean
authors: S
authors: MacBride-Stewart
authors: Rickard E
authors: RE
authors: Malmström
authors: Hanne
authors: H
authors: Pedersen
authors: Gisbert
authors: G
authors: Selke
authors: Vera
authors: V
authors: Vlahović-Palčevski
authors: Menno
authors: M
authors: van Woerkom
authors: Durhane
authors: D
authors: Wong-Rieger
authors: Björn
authors: B
authors: Wettermark
mesh_terms: D003362:Cost-Benefit Analysis; D006297:Health Services Accessibility; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage* / Q000191:economics; D019984:Quality Indicators, Health Care
chemical_list: D004364:Pharmaceutical Preparations