Opening Pandora's box in the UK: A hypothetical pharmacogenetic test for clozapine

Benjamin W J Spencer; Barbara Prainsack; Dan Rujescu; Ina Giegling; David A Collier; Fiona Gaughran; James MacCabe; Cathy L Barr; Engilbert Sigurdsson; Henrik Stovring; Anil K Malhotra; Sarah R Curran; CRESTAR Consortium

doi:10.2217/pgs.13.182

Opening Pandora's box in the UK: A hypothetical pharmacogenetic test for clozapine

Benjamin W J Spencer^*, Barbara Prainsack, Dan Rujescu, Ina Giegling, David A Collier, Fiona Gaughran, James MacCabe, Cathy L Barr, Engilbert Sigurdsson, Henrik Stovring, Anil K Malhotra, Sarah R Curran, CRESTAR Consortium

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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Abstract

Clozapine is a uniquely efficacious antipsychotic drug in treatment-resistant schizophrenia. Its use is restricted due to adverse effects including a rare but dangerous reduction in neutrophils (agranulocytosis) and the mandatory hematological monitoring this entails in many countries. We review the statistical, ethical and legal issues arising from a hypothetical pharmacogenetic test for clozapine, using the UK as an exemplary case for consideration. Our key findings include: a consideration of the probabilistic results that a pharmacogenetic test may return; the impact on drug licensing; and the potential for pharmacogenetic tests for clozapine being used without consent under the UK's legal framework. We make recommendations regarding regulatory changes applicable to the special case of pharmacogenetic testing in clozapine treatment. © 2013 Future Medicine Ltd.

Original language	English
Pages (from-to)	1907-1914
Number of pages	8
Journal	PHARMACOGENOMICS
Volume	14
Issue number	15
DOIs	https://doi.org/10.2217/pgs.13.182
Publication status	Published - Nov 2013

Keywords

Antipsychotic
Capacity
Clozapine
Ethics
Legal
Licensing
Pharmacogenetic
Probabilistic
Psychiatry
Schizophrenia

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10.2217/pgs.13.182

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title = "Opening Pandora's box in the UK: A hypothetical pharmacogenetic test for clozapine",

abstract = "Clozapine is a uniquely efficacious antipsychotic drug in treatment-resistant schizophrenia. Its use is restricted due to adverse effects including a rare but dangerous reduction in neutrophils (agranulocytosis) and the mandatory hematological monitoring this entails in many countries. We review the statistical, ethical and legal issues arising from a hypothetical pharmacogenetic test for clozapine, using the UK as an exemplary case for consideration. Our key findings include: a consideration of the probabilistic results that a pharmacogenetic test may return; the impact on drug licensing; and the potential for pharmacogenetic tests for clozapine being used without consent under the UK's legal framework. We make recommendations regarding regulatory changes applicable to the special case of pharmacogenetic testing in clozapine treatment. {\textcopyright} 2013 Future Medicine Ltd.",

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AU - Collier, David A

AU - Gaughran, Fiona

AU - MacCabe, James

AU - Barr, Cathy L

AU - Sigurdsson, Engilbert

AU - Stovring, Henrik

AU - Malhotra, Anil K

AU - Curran, Sarah R

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KW - Antipsychotic

KW - Capacity

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KW - Ethics

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KW - Licensing

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Opening Pandora's box in the UK: A hypothetical pharmacogenetic test for clozapine

Abstract

Keywords

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