The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate management of side effects and interactions with other co-prescribed drugs. Latrogenic risk of these treatments is reinforced in older patients with frequent comorbidities, taking multiple pharmaceutical treatments for long periods and followed by several prescribers. The literature reports an emergence of drug related problems (DRP) in more than 90% of patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced efficacy and potentiation of toxicity) are all the more important that outpatient monitoring of treatments prescribed at the hospital remains underdeveloped due to default of coordination between these two settings. Medical care and prevention of these DRP are difficult because of a lack of information and tools shared between hospital and liberal actors. Experiments are developed according to different organizational models, frequently focused on the pharmaceutical analysis of prescriptions, the detection of DRP and their control, but they stay still undervalued. In this context, the French Society of Oncological Pharmacology (SFPO - Société Française de Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien website and proposes to assess the impact of a program of pharmaceutical interventions named DROP. The hypothesis of the study is that the DROP program will secure the medical care of patients with oral anticancer drugs compared to the usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
248
Multidisciplinary program that includes informative sessions with a hospital pharmacist about the oral anticancer drug: information is given to the patient on adverse events occurrence and there management; and optimizing drug dosage plan, including drug-drug interactions.
In the group with standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessment.
Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud
Pierre-Bénite, France
RECRUITINGNumber of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category
DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).
Time frame: 9 months post-inclusion
Total number of DRP related to all prescribed drugs per patient
DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).
Time frame: 6 months and 9 months post-inclusion
Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient
dose adjustments, cure spacing, interruptions and cessation of treatment.
Time frame: 6 months and 9 months post-inclusion
Relative dose intensity of the oral anticancer drug
Relative dose intensity will be computed by the ratio between the overall dose prescribed during the 6 months of follow-up and the theoretical dosage according to the summary of product characteristics of the market authorization.
Time frame: 6 months post-inclusion
Adherence to the oral anticancer drug
Adherence will be measured with the Girerd questionnaire score 6 items from the Ameli Health Insurance website and the rate of prescription renewal by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).
Time frame: 6 months post-inclusion
Number of imaging acts and nature of acts
To evaluate consumption of unscheduled ambulatory care related to DRP
Time frame: During the 6 months of follow-up
Number of acts of biology and nature of acts
To evaluate consumption of unscheduled ambulatory care related to DRP
Time frame: During the 6 months of follow-up
Number of medical consultations
To evaluate consumption of unscheduled ambulatory care related to DRP
Time frame: During the 6 months of follow-up
Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs
To evaluate consumption of unscheduled ambulatory care related to DRP
Time frame: During the 6 months of follow-up
Number of hospital admissions
To evaluate unplanned hospital admissions related to DRP
Time frame: During the 6 months of follow-up
Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire
Time frame: At inclusion and 6 months from the treatment initiation
Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire
Time frame: At inclusion and 6 months from the treatment initiation
Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
Time frame: At inclusion and 6 months from the treatment initiation
Number of interventions of primary care actors with the patient
To evaluate the involvement of primary care actors in the DROP program
Time frame: During the 9 months of follow-up
Number of time the Oncolien website was used by ambulatory care pharmacists
To evaluate the involvement of primary care actors in the DROP program
Time frame: During the 9 months of follow-up
Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists
To evaluate the involvement of primary care actors in the DROP program
Time frame: During the 9 months of follow-up
Number of patient-advice forms downloaded and delivered to the patient
To evaluate the involvement of primary care actors in the DROP program
Time frame: During the 9 months of follow-up
Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing
To evaluate the involvement of primary care actors in the DROP program
Time frame: During the 9 months of follow-up
Patient's satisfaction for the DROP program
Satisfaction will be measured with a 10-point visual analog scale.
Time frame: At 9 months post-inclusion
Ambulatory care physician's and pharmacist's satisfactions with the DROP program
Satisfaction will be measured with a 10-point visual analog scale.
Time frame: At 9 months post-inclusion
Efficiency of the DROP program
Efficiency will be computed by the incremental cost-efficacy ratio between the DROP program and the usual care.
Time frame: 9 months post-inclusion
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