bijwerkingen Adverse drug reactions
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be >= 18 years old 2. Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug of interest (Flecainide, Propafenon, Codeine, Tramadol, Capecitabine, Fluorouracil, Irinotecan, Tamoxifen, Tegafur, Acenocoumarol, Clopidrogel , Phenprocoumon, Warfarin, Citalopram , Escitalopram, Paroxetine, Sertraline, Venlafaxine, Amitriptyline, Clomipramine, Doxepine, Imipramine, Nortryptiline, Phenytoin, Metoprolol, Efavirenz, Flucloxacillin, Voriconazole, Aripiprazole, Haloperidol, Pimozide, Zuclopenthixol, Atorvastatin, Simvastatin, Azathioprine, Mercaptopurine, Tacrolimus, Thioguanine or Atomoxetine), which is prescribed to them in routine care. 3. Subject is able and willing to take part and be followed-up for at least 12 weeks 4. Subject is able to donate blood or saliva 5. Subject has signed informed consent
Exclusion criteria
Exclusion criteria: 1. Previous (direct-to-consumer, or clinical) genetic testing for a gene important to the index drug 2. Pregnancy or lactating 3. Life expectancy estimated to be less than three months by treating clinical team 4. Duration of index drug total treatment length is planned to be less than seven consecutive days. A drug whose route of administration changes during the first seven days (e.g. intravenous to oral flucloxacillin) but whose total treatment duration is seven days or longer, is still eligible. 5. For inpatients: hospital admission is expected to be less than 72 hours (to facilitate acting upon the PGX results) 6. Unable to consent to the study 7. Unwilling to take part 8. Subject has no fixed address 9. Subject has no current general practitioner 10. Subject is, in the opinion of the Investigator, not suitable to participate in the study 11. Patient has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care. This would not apply to any drugs specifically given to manage liver/renal impairment/transplantation. 12. Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1,73m2 in a subject with a functioning graft 13. Patients with advanced liver failure (stage Child-Pugh C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of PREPARE is a composite endpoint of clinically relevant drug-genotype associated ADRs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include other clinical outcome measures (e.g. total number of ADEs, dose changes, drug cessations etc.), a cost-effectiveness evaluation, and process metrics for implementation; the latter includes physician and pharmacist adherence to the DPWG guidelines, and the acceptance of PGx-informed prescribing to health care professionals and patients. | — |
Countries
Netherlands
Outcome results
None listed