Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation
- Conditions
- Neoplasm
- Registration Number
- NCT04142567
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.
The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases. The primary endpoint is the prevalence of pharmacist interventions among patients who are going to receive an oral targeted therapy or cancer chemotherapy or immunotherapy
- Detailed Description
The purpose of this observational study is to evaluate the benefits of a pharmacist integration in an oncology ambulatory center, to prevent drug related problems (in particular drug drug interactions) at antitumor treatment initiation.
The hypothesis of this work is that a drug drug interaction will be observed in 30% of cancer patients and will have a major clinical impact in 1% of the cases.
The primary endpoint is the prevalence of pharmacist interventions among cancer patients who are going to receive an oral targeted therapy (140 patients) or cancer chemotherapy or immunotherapy (300 patients).
Pharmacist interventions will be classified according to the SFPC (société française de pharmacie Clinique) classification.
The secondary endpoints are
* The detection of drug drug interactions with theriaque software, Micromedex software and DDI predictor tool.
* The clinical gradation by an independent expert comity of the clinical impact of avoided drug drug interaction. The expert comity will grade avoided clinical consequences in 3 levels (minor, moderate or major),
* The Economic evaluation of pharmacist intervention: Cost of the project to evaluate drug drug interaction and benefits after evaluation of avoided clinical consequences
* The Adherence evaluation of patients treated with oral cancer targeted therapy (Therefore, only patients under oral targeted therapy will be evaluated at Day0, Day15 ,Day 30 and Month 6 to determine adherence.)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- legal age patients
- Affiliated to social security or with another insurance system
- with a solid tumor
- who are going to receive an antitumor treatment (chemotherapy, immunotherapy or oral targeted therapy)
- pregnant women
- minor patient
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of Pharmacist intervention up to 1 week from date of inclusion Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention
- Secondary Outcome Measures
Name Time Method Detection of Drug -drug interactions up to 1 week from date of inclusion Number of drug drug interactions detected
Potential cost of the avoided clinical consequences One year Treatment cost of avoided clinical consequences , balanced with the probability of occurrence
Adherence evaluation with oral cancer targeted therapy by pill count 6 months after oral therapy initiation Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period
Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring day 15, 30 and 6 months after oral therapy initiation Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients
Clinical gradation of drug drug interactions One year Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction
Cost of the pharmacist intervention by avoided clinical consequence One year Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction
Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale day 15, 30 and 6 months after oral therapy initiation Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients
Trial Locations
- Locations (1)
APHP -Cochin Hospital and Georges Pompidou European Hospital
🇫🇷Paris, France