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Organizational impacts related to new drugs Role of the hospital pharmacist Volume 26, supplement 6, Décembre 2020

Author
Réseau Oncoral
Hôpital Lyon Sud, Pierre-Bénite, France
* Tirés à part

Access to therapeutic innovation is a major public health issue. Several years can go by between the end of clinical trials and drug implementation in current care. In France, “temporary use authorization” speeds up access to new drugs some months or even years before market authorization. Even so, continuous growth in clinical research and a rising tide of innovative drugs require a new approach to early access to the produce of innovation. In oncology, the stakes are raised by the expectations of patients and families, media pressure and concerns of safety and financial sustainability. Since 2019, French health system funding legislation has broadened the scope of early access to certain health products, with two new provisions: “extension cohort temporary use authorization”, extending indications for drugs that already have market authorization for at least 1 other indication, and “direct access to post-temporary-use status”. Treatment of T-cell lymphoma illustrates the complexity of the system of access to innovations. Clinical trials are an interesting treatment option for patients and, in recent years, have enriched the therapeutic armamentarium with innovative molecules such as romidepsin, which has temporary use authorization for relapse or refractory disease, brentuximab vedotin, which has market authorization for recurrent or refractory anaplastic large cell lymphoma and cutaneous T-cell lymphoma in second-line, and mogamulizumab with “extension cohort temporary use authorization” and vorinostat with temporary use authorization for cutaneous T-cell lymphoma. The role of hospital pharmacists in oncology is primordial, to accompany early access to innovation and secure all the steps of drug development, from clinical trials onward. They centralize the preparation of injectable chemotherapies and immunotherapies with a quality assurance system that ensures patient safety. More recently, the development of oncology clinical pharmacy has contributed to optimizing cancer treatment by integrating pharmaceutic expertise into the care pathway: pharmaceutic analysis of prescriptions, Best Possible Medication History and medication reconciliation, prevention of adverse effects, and detection of drug-drug interactions, including self-medication and phytotherapy. Other programs ensure multidisciplinary community-hospital follow-up of outpatients receiving oral anticancer drugs. The literature shows that such patient-centered programs reduce drug iatrogenesis with a favorable cost/benefit ratio, encouraging deployment to secure access to therapeutic innovation.

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