Program 26 : Pharmaceutics and Cancer

Program 26 : Pharmaceutics and Cancer

PROGRAM LEADERS

Dr Nathalie PONS-KERJEAN, is a Hospital Pharmacist, Head of the Pharmacy Department at Beaujon Hospital and Louis Mourier Hospital. She is also Vice President of the Medical Committee of the GHU Paris Nord and participates in hospital activities and in the development of its structuring projects.

Dr Isabelle MADELAINE, is a Hospital Pharmacist, Head of the Pharmacy department at Saint-Louis Hospital. She is specialized in onco-haematology and the pharmacology of anti-cancer drugs. She is vice-president of the French Society of Oncological Pharmacy (Société Française de Pharmacie Oncologique – SFPO).

HEALTHCARE EXECUTIVE

Valérie KEH 
P26 - Pharmaceutics and Cancer

STRENGTHS IN THE FOLLOWING AREAS

Cancer Care

The pharmacies for internal use are involved throughout the patient care pathway. They are in contact with all the clinical services of medical oncology, hematology or medical specialties in the oncology area, as well as all the transversal and medico-technical services welcoming cancer patients.

Participation in JACIE accreditation: Saint-Louis and Robert-Debré Hospitals.

A very strict control of all activities is ensured by the pharmacists in charge and their teams. Here are some examples below:

  • Injectable cancer treatments:

Double validation for thesaurus information: pharmacist + doctor.

Prescription: computerized and made by senior doctors and then validated by a pharmacist.

Three specific authorized units for the preparation of injectable anti-cancer drugs at Beaujon, Robert Debré and Saint-Louis Hospitals. These units are designed, equipped and organized in order to control the risks for patients, staff and the environment.

Digital tools: the circuit of preparations (from prescription to administration) is fully computerized, using the software CHIMIO® at all sites.

Production (preparation + control): anti-cancer drugs are prepared by a pharmacy technician, with respect to the Good Manufacturing Practices (GMP) guidelines, under the responsibility of the pharmacist managing each pharmacy, or a deputy pharmacist.

Quality control: carried out during the process by cameras (software Drugcam®) or in the end (final preparation) by HPLC and QCRx.

Transport: preparations are transported to the wards by trained staff.

Drug administration: nurses are trained in the administration and monitoring of anti-cancer drugs and record the administration in the CHIMIO® software.

Quality system monitoring: identifying malfunctions to analyze them and decide on corrective actions. Risk analyses, which are mandatory in the GMP, are carried out in priority.

          Preparation activity in 2019: 131,154 preparations

  • Non-injectable anti-cancer drugs: provides pharmaceutical forms suitable for pediatric use.

Activity numbers in 2019: 116,452 capsules, 22,462 units of liquid oral forms.

  • Radiopharmaceuticals (for diagnostic or therapeutic goals):

Five specific authorized units for the preparation of radiopharmaceutical drugs are under the responsibility of many radiopharmacists and work according to the Good Manufacturing Practices (GMP) guidelines.

Digital tools: the circuit of preparations (from prescription to administration) is fully computerized, using the software XPLORE® (deployment ongoing).

Quality control: HPLC or/and TLC.

Preparation activity in 2019: 17,723 preparations.

  • CART cells therapy: several hundreds of patients have been treated since 2016 and 124 reconstitutions have been made in 2019.
  • Clinical pharmacy: an increase in the number of pharmaceutical consultations (383 in 2019, 613 in 2020), coordination of programs (thrombosis and cancer, patients treated with CART cells) and creation of educational tools (videos, etc).

Research

In the pharmacies for internal use, clinical research activity is linked to the activity of clinical services. There are two indicators in terms of activity: the number of clinical oncology clinical trial protocols managed and the number of preparations made.

Clinical Research Protocols:

  • 518 protocols managed
  • 6 961 preparations made

Basic science:

  • INSERM UMR-S 1144 Université de Paris, Therapeutic optimization in neuropsychopharmacology
  • INSERM Unit UMR-S 1223 Pasteur, Dynamics of Immune Responses
  • Inserm Unit UMR1281, CNRS UMR9011 Université Paris-Saclay, CEA, BioMaps – Multimodal Biomedical Imaging Laboratory @Paris-Saclay

Education

  • Initial and continuing training is organized for staff members. Regular service meetings are programmed to inform about eventual changes.
  • Pharmacists participate as speakers in congresses, pharmaceutical and healthcare meetings: European Hematology Association Amsterdam 24th congress, GERPAC, ECOP, Japanese Society of Medical Oncology Annual Meeting.