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Part 1: background, methodology, and clinical adoption of pharmacogenetics.

ABSTRACT: Equivalent drug doses may lead to wide interpatient variability with regard to drug response, reflected by differences in drug activity and normal tissue toxicity. A major factor responsible for this variability is variation among patients in their genetic constitution. Genetic polymorphism may affect the activity of proteins encoded, which in turn may lead to changes in the pharmacokinetic and pharmacodynamic behavior of a drug, observed as differences in drug transport, drug metabolism, and pharmacodynamic drug effects. Recent insights into the functional effect of polymorphism in genes that are involved in the pharmacokinetics and pharmacodynamics of anticancer drugs have provided opportunities for patient-tailored therapy in oncology. Individualized pharmacotherapy based on genotype will help to increase treatment efficacy while reducing unnecessary toxicity, especially of drugs characterized by a narrow therapeutic window, such as anticancer drugs. We provide a series of four reviews aimed at implementing pharmacogenetic-based drug and dose prescription in the daily clinical setting for the practicing oncologist. This first part in the series describes the functional impact of genetic polymorphism and provides a general background to and insight into possible clinical consequences of pharmacogenetic variability. It also discusses different methodologies for clinical pharmacogenetic studies and provides a concise overview about the different laboratory technologies for genetic mutation analysis that are currently widely applied. Subsequently, pharmacogenetic association studies in anticancer drug transport, phase I and II drug metabolism, and pharmacodynamic drug effects are discussed in the rest of the series. Opportunities for patient-tailored pharmacotherapy are highlighted.

SUBMITTER: Deenen MJ

PROVIDER: S-EPMC3228225 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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Part 1: background, methodology, and clinical adoption of pharmacogenetics.

Deenen Maarten J MJ Cats Annemieke A Beijnen Jos H JH Schellens Jan H M JH

The oncologist 20110531 6

Equivalent drug doses may lead to wide interpatient variability with regard to drug response, reflected by differences in drug activity and normal tissue toxicity. A major factor responsible for this variability is variation among patients in their genetic constitution. Genetic polymorphism may affect the activity of proteins encoded, which in turn may lead to changes in the pharmacokinetic and pharmacodynamic behavior of a drug, observed as differences in drug transport, drug metabolism, and ph ...[more]

PMID: 21632456

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Project description:BackgroundDespite the benefits offered by biosimilars in terms of cost savings and improved patient access to biological therapies, and an established regulatory pathway in Europe, biosimilar adoption is challenged by a lack of knowledge and understanding among stakeholders such as healthcare professionals and patients about biosimilars, impacting their trust and willingness to use them. In addition, stakeholders are faced with questions about clinical implementation aspects such as switching.ObjectiveThis study aims to provide recommendations on how to improve biosimilar understanding and adoption among stakeholders based on insights of healthcare professionals (physicians, hospital pharmacists, nurses), patient(s) (representatives) and regulators across Europe.MethodThe study consists of a structured literature review gathering original research data on stakeholder knowledge about biosimilars, followed by semi-structured interviews across five stakeholder groups including physicians, hospital pharmacists, nurses, patient(s) (representatives) and regulators across Europe.ResultsAlthough improvement in knowledge was observed over time, generally low to moderate levels of awareness, knowledge and trust towards biosimilars among healthcare professionals and patients are identified in literature (N studies = 106). Based on the provided insights from interviews with European experts (N = 44), a number of challenges regarding biosimilar stakeholder understanding are identified, including a lack of practical information about biosimilars and their use, a lack of understanding about biosimilar concepts and a lack of knowledge about biologicals in general. Misinformation by originator industry is also believed to have impacted stakeholder trust. In terms of possible solutions and actions to improve stakeholder understanding, broad support exists to (1) organize initiatives focussed on explaining the rationale behind biosimilar concepts and the approval pathway, (2) invest in education about biologicals in general, (3) develop clear and one-voice regulatory guidance about biosimilar interchangeability and switching across Europe, (4) disseminate real-world clinical biosimilar (switch) data, (5) share biosimilar experiences by key opinion leaders and among peers, (6) provide practical biosimilar product information, (7) provide guidance about biosimilar use, (8) actively counterbalance misinformation and organize information initiatives by neutral entities, (9) organize multi-stakeholder informational and educational efforts, aligning information between involved stakeholder groups and (10) design initiatives in a way that ensures active information uptake. Furthermore, interviewees argue that governments should be proactive in these regards.ConclusionsThis study argues in favour of a structural, multi-stakeholder framework at both European and national level to improve stakeholder biosimilar understanding and acceptance. It proposes a number of actionable recommendations that can inform policy making and guide stakeholders, which can contribute to realizing healthcare system benefits offered by biosimilar competition.

Dataset Information

Part 1: background, methodology, and clinical adoption of pharmacogenetics.

Publications

Part 1: background, methodology, and clinical adoption of pharmacogenetics.

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