What is the safety-code card?

The safety-code card is a pocket card that is handed out to all patients assigned to the study group and that contains a quick overview of his or her PGx test results. Furthermore, the card contains a QR code that can be scanned by healthcare providers with, e.g., a smartphone to quickly retrieve PGx-based dosing recommendations relevant to the respective patient. In the context of PREPARE, the safety-code card serves as an auxiliary tool to maximize the accessibility and sharing of PGx results within and between different healthcare settings and healthcare professionals. For more information on the safety-code card, please visit http://www.safety-code.org.

Which guidelines are used to tailor a patient’s therapy to his or her PGx results?

In the PREPARE study, pharmacogenomic dosing guidelines authored by the Dutch Pharmacogenetics Working Group (DPWG) are used for PGx-based prescribing. To assist healthcare providers in using their patients’ PGx results to optimize their therapy, all recommendations relevant to the individual patient are included in the their written PGx report. Furthermore, all relevant recommendations can be accessed by healthcare providers via scanning the QR code of the personal safety-code card that each patient assigned to the study group receives.

How is the test performed?

Patients are asked to provide a blood or saliva sample which is analyzed for over 40 variants across 13 important PGx genes. Genotyping is performed with an array specifically designed for the PREPARE study using the LGC SNPline platform.

Which drugs are relevant to PREPARE?

Therapeutic group Generic name
Antiarrhythmic Flecainide
Propafenon
Analgesic Codeine
Oxycodone
Tramadol
Anticancer Capecitabine
Fluorouracil
Irinotecan
Tamoxifen
Tegafur
Anticoagulation Acenocoumarol
Clopidogrel
Phenprocoumon
Warfarin
Antidepressant (SSRI) Paroxetine
Sertraline
Venlafaxine
Citalopram
Escitalopram
Antidepressant (TCA) Amitriptyline
Clomipramine
Doxepine
Imipramine
Nortriptyline
Antiepileptic Carbamazepine
Phenytoin
Antihypertensive Metoprolol
Anti-infective Efavirenz
Flucloxacillin
Voriconazole
Antipsychotic Aripiprazole
Clozapine
Haloperidol
Pimozide
Zuclopenthixol
Cholesterol – lowering Atorvastatin
Simvastatin
Immuno – suppressive Azathioprine
Mercaptopurine
Tacrolimus
Thioguanine
Other Atomoxetine
Oestrogen containing drugs *

* only if a 2nd prescription, not for primary inclusion

How are patients recruited?

Patients who receive a first prescription for any of the drugs relevant to the study during their treatment at one of the participating institutions and who fulfill all other inclusion criteria are contacted by their local study teams.

What is the study design of PREPARE?

What is the study design of PREPARE?
PREPARE is designed as a multi-center, open, randomized, cross-over study. The sequence of study and control arm is randomized per country to minimize the influence of time dependent variables.

The 7 participating countries were randomized to start with:
1) Implementing pre-emptive PGx testing to guide drug and dose selection (study arm): Greece, Slovenia and Spain
2) Providing standard clinical care (control arm): Netherlands, Austria, Italy and UK