Informations générales (source: ClinicalTrials.gov)
Impact of the DROP (Drug Related Problems in Oncology Practice) Program of Pharmaceutical Interventions of the French Society of Oncological Pharmacology Versus Usual Care on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors (DROP-SFPO)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2019
septembre 2026
05 avril 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud - 69310 - Pierre-Bénite - France | Catherine RIOUFOL, PharmD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient aged 18 years old or more
- With cancer
- For wich the initiation or change of an oral anticancer drug is prescribed
- With life expectancy estimated to be 6 months or more, in the opinion of the
investigator
- Of which the treatment with oral anticancer medication is estimated to be 6 months
or more in the opinion of the oncologist
- Benefiting from an initiation or a change of oral anticancer agents according to the
MA: cytotoxic agent, targeted therapy, hormonal therapy (excluding adjuvant
treatments);
- of which the oral anticancer drug is delivered in pharmacy of town or in
retrocession hospital;
- With ambulatory status (not hospitalized for the management and treatment )
- Taking 5 or more drugs, including the oral anticancer treatment, and / or treated
with an oral anticancer drug requiring complex regimen (combination of 2 oral
anticancer drugs, or sequential rate of intake, or associated to intravenous
chemotherapy)
- With a sufficient autonomy for the management of medication at home
- Without either cognitive disorders or major psychiatric disorders, in the opinion of
the investigator
- Ability to read, write and understand the French language
- Having given his written consent to participate in the study
- Patient affiliated to the social security scheme or equivalent
- Patient aged 18 years old or more
- With cancer
- For wich the initiation or change of an oral anticancer drug is prescribed
- With life expectancy estimated to be 6 months or more, in the opinion of the
investigator
- Of which the treatment with oral anticancer medication is estimated to be 6 months
or more in the opinion of the oncologist
- Benefiting from an initiation or a change of oral anticancer agents according to the
MA: cytotoxic agent, targeted therapy, hormonal therapy (excluding adjuvant
treatments);
- of which the oral anticancer drug is delivered in pharmacy of town or in
retrocession hospital;
- With ambulatory status (not hospitalized for the management and treatment )
- Taking 5 or more drugs, including the oral anticancer treatment, and / or treated
with an oral anticancer drug requiring complex regimen (combination of 2 oral
anticancer drugs, or sequential rate of intake, or associated to intravenous
chemotherapy)
- With a sufficient autonomy for the management of medication at home
- Without either cognitive disorders or major psychiatric disorders, in the opinion of
the investigator
- Ability to read, write and understand the French language
- Having given his written consent to participate in the study
- Patient affiliated to the social security scheme or equivalent
- Pregnant or lactating woman
- Patient on anti-PD1, anti-PDL-1 or anti-CTLA4-4 immunotherapy concomitant with oral
anticancer treatment
- Patient under radiotherapy concomitant treatment with oral anticancer
- Oral anticancer agent prescribed in a delivery circuit as part of an ATU or clinical
trial;
- Patient with significant cognitive or psychiatric disorders, in the opinion of the
investigator;
- Management of drug treatment at home is performed exclusively by the caregiver;
- Not having declared a doctor;
- Not having a usual city pharmacy, or reporting 2 or more usual city pharmacies;
- Patient who has already benefited from a therapeutic education program
- In institution or guardianship, major protected by the Law.