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

Neoplasm Clinical Trial

— CHOPIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142567
• Other study ID #: 2018-A03512-53
• Status: Completed
• Start date: February 11, 2020
• Est. completion date: October 22, 2021

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: October 22, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm

Locations

Country	Name	City	State
France	APHP -Cochin Hospital and Georges Pompidou European Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (6)

Bonnet C, Boudou-Rouquette P, Azoulay-Rutman E, Huillard O, Golmard JL, Carton E, Noé G, Vidal M, Orvoen G, Chah Wakilian A, Villeminey C, Blanchet B, Alexandre J, Goldwasser F, Thomas-Schoemann A. Potential drug-drug interactions with abiraterone in metastatic castration-resistant prostate cancer patients: a prevalence study in France. Cancer Chemother Pharmacol. 2017 May;79(5):1051-1055. doi: 10.1007/s00280-017-3291-z. Epub 2017 Mar 30. — View Citation

Lees J, Chan A. Polypharmacy in elderly patients with cancer: clinical implications and management. Lancet Oncol. 2011 Dec;12(13):1249-57. doi: 10.1016/S1470-2045(11)70040-7. Epub 2011 Jul 6. Review. — View Citation

P. Boudou Rouquette, A. Thomas-Schoemann, A. Chahwakilian et al., Clinical benefit of a one-day multidisciplinary work-up for risk assessment in unfit cancer patients. ESMO congress, abstract 1558; Amsterdam 2013

Riechelmann RP, Tannock IF, Wang L, Saad ED, Taback NA, Krzyzanowska MK. Potential drug interactions and duplicate prescriptions among cancer patients. J Natl Cancer Inst. 2007 Apr 18;99(8):592-600. — View Citation

Ruddy K, Mayer E, Partridge A. Patient adherence and persistence with oral anticancer treatment. CA Cancer J Clin. 2009 Jan-Feb;59(1):56-66. doi: 10.3322/caac.20004. Review. — View Citation

Thomas-Schoemann A, Blanchet B, Bardin C, Noé G, Boudou-Rouquette P, Vidal M, Goldwasser F. Drug interactions with solid tumour-targeted therapies. Crit Rev Oncol Hematol. 2014 Jan;89(1):179-96. doi: 10.1016/j.critrevonc.2013.08.007. Epub 2013 Aug 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Detection of Drug -drug interactions	Number of drug drug interactions detected	up to 1 week from date of inclusion
Secondary	Clinical gradation of drug drug interactions	Gradation by an independent experts comity of the clinical impact of prevented drug drug interaction	One year
Secondary	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
Secondary	Potential cost of the avoided clinical consequences	Treatment cost of avoided clinical consequences , balanced with the probability of occurrence	One year
Secondary	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
Secondary	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
Secondary	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