Adverse drug reactions
Conditions
Interventions
Trade Name: Codeine
Pharmaceutical Form: Syrup
INN or Proposed INN: CODEINE
CAS Number: 76-57-3
Current Sponsor code: 668353
Other descriptive name: codeine
Concentration unit: mg milligram(s)
Concent
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject must be = 18 years old • Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 5, which is prescribed to them in routine care. • Subject is able and willing to take part and be followed-up for at least 12 weeks • Subject is able to donate blood or saliva • Subject has signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Previous (direct-to-consumer, or clinical) genetic testing for a gene important to the index drug • Pregnancy or lactating • Life expectancy estimated to be less than three months by treating clinical team • 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. • For inpatients: hospital admission is expected to be less than 72 hours (to facilitate acting upon the PGX results) • Unable to consent to the study • Unwilling to take part • Subject has no fixed address • Subject has no current general practitioner • Subject is, in the opinion of the Investigator, not suitable to participate in the study • 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. • Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per 1,73m2 in a subject with a functioning graft • Patients with advanced liver failure (stage Child-Pugh C)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether implementing pre-emptive PGx testing of an entire panel of clinically relevant PGx markers, to guide the dose and drug selection for over 40 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated adverse drug reactions (ADRs). We hypothesize that the implementation of PGx-guided drug prescribing will reduce both the occurrence and severity of drug-genotype associated ADRs in comparison to patients receiving standard of care treatment. ;Secondary Objective: 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. ;Primary end point(s): The primary endpoint is the frequency of causal (definite, probable or possible), clinically relevant (classified as NCI-CTCAE grade 2, 3, 4, or 5), drug-genotype specific ADRs, for the index drug, for each patient. ;Timepoint(s) of evaluation of this end point: 12 weeks after initiation of the index drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes include: • Total number of ADEs (related to index and subsequent drugs) • Dose adjustments to index drug • Drug cessation (and reason for discontinuation) • Additional drugs that are prescribed during follow-up • Routine drug levels (only those that are collected routinely) as a proxy for exposure • Patient-reported drug adherence • Quality of life • Measurement of effectiveness (QALY) • Total cost estimation (healthcare consumption, cost of drugs, cost of hospitalization, cost of ADEs, cost of genetic testing etc.);Timepoint(s) of evaluation of this end point: 12 weeks after initiation of the index drug | — |
Countries
Austria
Contacts
Public ContactCoordinating Prinicpal Investigator
Leiden University Medical Center
Outcome results
None listed