Role of the Pharmacist in Detection of Drug Interactions Before Antitumor Treatment Initiation

Study Overview
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Brief Summary
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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
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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.)

Official Title
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Role of the Clinical Pharmacist in an Oncology Ambulatory Center to Prevent Drug Related Problems Before Antitumor Treatment Initiation

Conditions
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Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: pregnant women minor patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Pharmacist intervention | Percentage of patients whom antitumora treatment or usual treatment has been changed by the pharmacist intervention | up to 1 week from date of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Drug -drug interactions | Number of drug drug interactions detected | up to 1 week from date of inclusion | 
| Clinical gradation of drug drug interactions | Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction | One year | 
| Cost of the pharmacist intervention by avoided clinical consequence | Cost evaluation of pharmacist for analysis and medication review with patient by avoided interaction | One year | 
| Potential cost of the avoided clinical consequences | Treatment cost of avoided clinical consequences , balanced with the probability of occurrence | One year | 
| Adherence evaluation with oral cancer targeted therapy by therapeutic drug monitoring | Patients with plasma drug concentration below the 10th percentile will be classified as nonadherent patients | day 15, 30 and 6 months after oral therapy initiation | 
| Adherence evaluation with oral cancer targeted therapy by the 6 item-Girerd Scale | Patients with a Girerd score greater than or equal to 3 will be classified as nonadherent patients | day 15, 30 and 6 months after oral therapy initiation | 
| Adherence evaluation with oral cancer targeted therapy by pill count | Pill counts will be used to calculate the percent of total prescribed dose taken to prescribed during the 90-day period | 6 months after oral therapy initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug drug interactions, Pharmacist interventions, Cancer patients, Out patient setting