Neoplasm
Conditions
Keywords
Drug drug interactions, Pharmacist interventions, Cancer patients, Out patient setting
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.)
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Detection of Drug -drug interactions | up to 1 week from date of inclusion | Number of drug drug interactions detected |
| 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 |
| 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 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 |
| 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 |
| 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAudrey Thomas-Schoemann, PharmD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed