Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure
University Hospital, Basel, Switzerland
400 participants
Oct 15, 2019
OBSERVATIONAL
Conditions
Summary
Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.
Eligibility
Inclusion Criteria5
- New medication with known PGx association (preemptive)
- Current medication with observation of adverse drug reactions probably linked to drugs with known PGx association (reactive)
- Current medication with observation of therapy failure probably linked to drugs with known PGx association (reactive)
- Current and/or new medication and a family history of adverse drug reactions/therapy failure probably linked to drugs with known PGx association
- Signed informed consent; for patients < 14 years, the legal representative needs to sign the informed consent
Exclusion Criteria2
- Insufficient German knowledge
- Not able to personally visit to the study pharmacy
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Interventions
Pharmacogenetic panel testing is conducted by Stratipharm with the DNA of the buccal swab. TaqMan® polymerase chain reaction is proceeded to express the genetic information. Stratipharm is a product offered by Humatrix Aktiengesellschaft (AG). It consists of a laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes, which code for transport proteins, metabolizing enzymes, or drug targets.
Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.
blood sample to determine the actual levels of the compound in patients on medication assumed to be associated to an observed ADR (phenotype).
Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician
One and six months after the communication of test results, the study center will make a phone call to the patient for an unstructured interview in order to gather information about potential outcomes
Locations(1)
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NCT04154553