Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure

University Hospital Basel

Status: Enrolling

Conditions: Adverse Drug Reaction; Therapy Failure

Treatments: Diagnostic Test: EDTA Blood sample (4.9mL); Diagnostic Test: Buccal swab; Other: unstructured interview; Other: communication of test results; Diagnostic Test: Serum sample (7.5mL)

Study type: Observational

Funder types: Other

Identifiers

NCT04154553

2019-01452 ex19Hersberger;

Details and patient eligibility

About

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.

Full description

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. Health-related data of patients experiencing therapy failure (TF) or adverse drug reaction (ADR) is collected and will then be supplemented with pharmacogenetic testing during pharmaceutical care in a study pharmacy. The patient data (diagnoses, medications and results of pharmacogenetic testing) is harmonized in order to generate a compilation of case reports. 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Insufficient German knowledge
• Not able to personally visit to the study pharmacy