SCIENTIFIC DATA AND LEGAL ASPECTS IN CLINICAL PRACTICE The oncology point of view

1. SCIENTIFIC DATA AND LEGAL ASPECTS IN CLINICAL PRACTICEThe oncology point of view Paolo Marchetti

2. 2010 ASCO Annual Meeting • Practice Management and Information Technology Track • The Hospital/Physician Relationship: Tensions Arising • Addressing the Cost of Cancer Care with Patients: Practice-based Strategies for Communicating the "New Bad News" • Clinical Practice: The Challenge of Financial Survival • Creating Teams That Work: Hiring Right, Communication Skills, and Disruptive Personalities

3. Recommendations for a Global Core Curriculum in Medical Oncology ESMO/ASCO Task Force, Annals of Oncology, 2004 7. Bioethics, legal, and economic issues • 7.1 Informed consent • The trainee should know the requirements for obtaining informed consent. • 7.2 Ethics • The trainee should understand the ethics involved in the conduct of medical research. • 7.3 Legal issues • They should know the legal issues related to anticancer treatment, institution of life support, and withdrawal of life support systems. • 7.4 Cost efficiency • Trainees should appreciate the cost effectiveness of medical intervention in the management of cancer.

4. SCIENTIFIC DATA AND LEGAL ASPECTS IN CLINICAL PRACTICE • Standard of care: how to transfer published schedule and dosages in clinical practice? • Standard of care: the latest published trial? • Off –label prescription: an opportunity for the Patient or for the Industry? • Are All Medical Errors Equal?

5. What is Standard of Care? • It is the degree of prudence and caution required of an individual who is under a duty of care. • A duty of care is a legal obligation imposed on an individual requiring that they adhere to a standard of reasonable care while performing any acts that could possibly harm others.

6. What is Standard of Care? • TAC is equal to TEC ? • Four adjuvant cycles of TC are equitoxic to six cycles? • How many PEB or M-VAC in clinical practice? • Individual dose reductions? • … and many more …

7. What is Standard of Care? • TAC is equal to TEC ? • Four adjuvant cycles of TC are equitoxic to six cycles? • How many PEB or M-VAC in clinical practice? • Individual dose reductions? • … and many more … A standard ofreasonable care!

8. Off-Label Use of Anticancer Therapies • To determine the most effective treatment, physicians must consider • the type of cancer, • the unique presentation and history and symptoms of each patient, • the stage of cancer, • the available and accessible therapeutic alternatives. • Because cancer can often be life threatening, advances in clinical management outpace the drug approval process. John E. Feldmann, 2005

9. Off labeluseofanticancertherapiesvsinvestigator-sponsored trial

10. Investigator-Sponsored Trials (ISTs) • IST trials may include studies done with an Investigational Agent, which is defined as an agent or formulation that has not been approved for marketing by the appropriate Regulatory Agency. • Must be considered investigational a pharmaceutical form of an active ingredient with a marketing authorization, when used or assembled in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Arrowsmith Oncology LLC, 2005

11. Why are IST Studies Done in Oncology? • Oncologists adopt chemotherapy based on results of published clinical trials. Due to the high level of medical need, off-label use dominates the practice of oncology for most approved agents. • Combination chemotherapy is standard, preferred practice in oncology. Regimens combining a product with other active agents expand usage of both products. • Corporate image (and sales) is enhanced by clinical research activities. Arrowsmith Oncology LLC, 2005

12. Why are IST Studies Done in Oncology? Arrowsmith Oncology LLC, 2005

13. Why are IST Studies Done in Oncology? …but Taxotere received FDA approval for use in prostate cancer only in spring 2004! Arrowsmith Oncology LLC, 2005

14. Why are IST Studies Done in Oncology? • A clinical trial may not be the best solution to a marketing problem, and should not be the first (or only) option which is considered. • Clinical trials are never to be used as rewards for prescribing habits. • Clinical trials are never to be used as inducement to change prescribing habits • All clinical studies are to be funded and administered through the Investigator-Sponsored Trial (IST) process. • Sales budgets will not be used for this purpose. • All Adverse Medical Events are to be investigated and reported through Safety/Pharmacovigilance. Arrowsmith Oncology LLC, 2005

15. Off labeluseofanticancertherapiesvsinvestigator-sponsored trial

16. REQUISITI DEL CONSENSO INFORMATO Il consenso deve essere: • informato (cioè compreso e recepito) • consapevole ( soggetto capace) • personale (dato dall’interessato) • manifesto (non equivoco) • specifico (atto sanitario) • preventivo e attuale • revocabile (in qualsiasi momento, senza conseguenze!!!)

17. TU 165/2001 Disciplina del pubblico impiego Definisce le responsabilità del Personale Sanitario inquadrato come pubblico dipendente in: Responsabilità penale Responsabilità civile Responsabilità amministrativa (contabile) Responsabilità disciplinare (contrattuale)

18. D.L. 3.3.2003 ”Disposizioni per contrastare gli illeciti nel settore sanitario” • “…Sanzione amministrativa non inferiore a 50mila € … per violazione commessa da professionisti sanitari dipendenti dal SSN o convenzionati … i quali, nello svolgimento delle funzioni o del servizio, effettuano prescrizioni farmaceutiche … non pertinenti per tipologia o quantità con la patologia di riferimento … cagionando danno alle aziende sanitarie locali e ospedaliere. … il provvedimento deve essere comunicato all’Ordine per la sospensione o radiazione dall’Albo Professionale …”

19. Off-Label PrescriptionD.Lgs. N.219 del 24.4.2006 “Estensione di alcune disposizioni sulla farmacovigilanza” • Nel prescrivere un medicinale al di fuori delle indicazioni terapeutiche, il medico si assume la piena responsabilità penale, civile, amministrativa e disciplinare anche di qualsiasi effetto indesiderato che derivasse al paziente. • L’impiego off- label in assenza di un adeguato consenso da parte del Paziente e di specifica autorizzazione amministrativa esula dalla copertura assicurativa della R.C. del medico.

20. Scientific Data and Legal Aspects in Clinical Practice • Examples (few!) of Medical Malpractice • Misdiagnosis • Injury During Treatment • Late Diagnosis • Failure to Follow Up • Chances reduction

21. Scientific Data and Legal Aspects in Clinical Practice • Examples (few!) of Medical Malpractice • Misdiagnosis • Injury During Surgery • Late Diagnosis • Failure to Follow Up • Chances reduction • Remedies for Medical Malpractice • The only legal remedy for a medical malpractice case is to file a medical malpractice lawsuit against the doctor, hospital or medical professional responsible.

22. Scientific Data and Legal Aspects in Clinical Practice • Managing Medical Errors in Oncology • Physician and medical team errors • different levels of training and expertise among team members; • unclear assignment of duties; • complex interplay of loyalties, fears, and insecurities of all the team members. • Nurses responsibilities • Pharmacist responsibilities • Hospital responsibilities

23. SCIENTIFIC DATA AND LEGAL ASPECTS IN CLINICAL PRACTICE As it is published! Generally, NO! To be carefully evaluated Generally, NO • Standard of care: how to transfer published schedule and dosages in clinical practice? • Standard of care: the last published trial? • Off –label prescription: an opportunity for the Patient or for the Industry? • Are All Medical Errors Equal?