[Robotic production of injectable anticancer drugs in hospital pharmacies]. / Production robotisée des préparations d'anticancéreux injectables en pharmacie hospitalière.

INTRODUCTION: Following the 2005 decree on securing the medicine supply chain, the production of "chemotherapies", anticancer drugs (cytotoxic, cytostatic, immunotherapy), was centralised within hospital pharmacies. To cope with increasingly growing activities, pharmacies are moving towards robotisation. This work offers feedback from four French sites pioneers in robotic production. MATERIAL AND METHOD: A review of the literature was carried out on the PubMed and Google Scholar scientific databases and GERPAC publications relating to the robotic production of chemotherapy preparations. This review allowed to select 25 articles. RESULTS: The robotisation of the production of "chemotherapies" requires infrastructural prerequisites, a reengineering of the manufacturing process and the patient journey. This impacts all the parties involved in this complex process. The "cobotisation" concept or collaborative robotics must be anticipated by the teams. Robotisation is an institutional decision, which must be owned by the pharmaceutical team and endorsed by the medical team and management. DISCUSSION/CONCLUSION: For reasons of optimisation, safeguarding and management of human resources, a large number of centres get equipped with robotic systems. Robotic preparation should extend to other non-hazardous preparation, as it is already the case in other countries. This strategic view should be carried out today to anticipate problems, ensure safety and improve the healthcare quality.

COVID-19 outbreak: An experience to reappraise the role of hospital at home in the anti-cancer drug injection.

BACKGROUND: The COVID-19 outbreak has posed considerable challenges to the health care system worldwide, especially for cancer treatment. We described the activity and the care organisation of the Hospitalisation At Home (HAH) structure during the pandemic for treating patients with anti-cancer injections. METHODS: We report the established organisation, the eligibility criteria, the patient characteristics, the treatment schemes and the stakeholders' role during two 5-week periods in 2020, before and during the French population's lockdown. RESULTS: The increase of activity during the lockdown (+32% of treated patients, +156% of new patients and +28% of delivered preparations) concerned solid tumour, mainly breast cancer, even if haematological malignancies remained the most frequent. Thirty different drugs were delivered, including three new drugs administered in HAH versus 19 during the routine period (p < 0.01). For those clinical departments accustomed to using HAH, the usual organisation was kept, but with adjustments. Five clinical departments increased the number of patients treated at home and widened the panel of drugs prescribed. Three oncology departments and one radiotherapy department for the first time solicited HAH for anti-cancer injections, mainly for immunotherapy. We adjusted the HAH organisation with additional human resources and allowed to prescribe drugs with an infusion time of <30 min only for the new prescribers. CONCLUSION: HAH allowed for the continuation of anti-cancer injections without postponement during the pandemic, and for a decrease in unnecessary patient travel to hospital with its concomitant COVID-19 transmission risk. Often left out of guidelines, the place of HAH in treating cancer patients should be reappraised, even more so during a pandemic.

Qualification of a chemotherapy-compounding robot.

KIRO® Oncology (Kiro Grifols, Spain) is a robotic system for automated compounding of sterile injectable drugs including intravenous cytotoxic treatments. The present article describes the qualification procedure applied prior to production phases. Peristaltic pumps which ensure the reconstitution of drugs were tested with water and NaCl 0.9%. The performance of the robot (accuracy and precision) to prepare bags, syringes and elastomeric pumps was evaluated with three placebo solutions (aqueous, foaming and viscous) using gravimetric controls. Microbiological controls were also performed. The pumps met the requirements set for volumes ranging from 5 to 100 mL. A total of 274 preparations was compounded. For the bags, the filling accuracy was within the limit of ±10% from 1 to 48 mL with aqueous solution, from 0.6 to 48 mL with foaming solution and from 5 to 48 mL with viscous solution. For all syringes and elastomeric pumps, it was within the limit of ±10%. The precision was validated for all preparations, except for bags and syringes prepared with 0.6 and 0.25 mL, respectively. The samples of surfaces and air complied with ISO 5 class environment. Among the 24 gloves tests performed, two presented microbiological growth. All Media fill tests were validated. The qualification procedure led us to exclude injections of any active principle volume strictly lower than 1 mL. The microbiological contamination of operators' gloves remains a critical point. Our operators will be made aware of the issue during the training period.