Learning objectives
The course aims at deepening regulatory issues, management and technical base of centralized preparation of cytotoxic medicinal products ifor the oncohaematological patient, focusing on the design of the laboratory oncology UMaCA and the procedural aspects of the management plan clinical risk from drug and environmental safety.
At the end of the course the student should be able to use the acquired knowledge in order to identify issues related to the therapeutic care of the oncohaematological patient.
The course also aims at providing students with the tools and theoretical concepts for the study of evaluation and choice strategies of drugs, pharmacovigilance and instruments of government spending, the study of the risk deriving from the use of the drug.
Prerequisites
Fundamentals of Pharmacology.
Course unit content
The lesson exposes the rationale for centralization of oncohaematological treatments as a strategy to select and standardize "evidence based" treatment programmes, track all the activity from the prescription of therapy, the preparation and administration. The lesson provides basic knowledge regarding the management of cancer therapies with particular reference to the aspects of clinical risk management, risk employment and economic sustainability. The structural characteristics, instrumental, procedural guarantee of quality, efficacy and safety of the path are examined.
The main devices for handling cytotoxic drugs to protect the prepared infusion and operators are discussed.
The main aspects related to risk management and improvement actions to be taken to reduce errors in the course of drug therapy are shown.
The course also aims at providing students with the tools and theoretical concepts for the study of evaluation and choice strategies of drugs, pharmacovigilance and instruments of government spending, the study of the risk deriving from the use of the drug.
Full programme
1.Description of UMaCA project (objectives, project management)
2. Regulations
3. Technical, plant engineering, instrumental characteristics of the cancer laboratory
4. Clinical Risk Management applied to the use of drugs
5. Ethical and economic aspects of drugs
6. Birth, development and evaluation of drugs
7. Pharmacoepidemiology and Pharmacovigilance
8. Information and documentation on drugs - EBM
9. Choice of drugs in the hospital and Policies acquisition
10. Government expenditure on pharmaceuticals; territorial strategies and hospital
11. Risk management - error in therapy
Bibliography
T.U. 81/08 "Attuazione dell'articolo 1 della legge 3 agosto 2007, n. 123, in materia di tutela della salute e della sicurezza nei luoghi di lavoro“
Provvedimento 5 agosto 1999 “Linee Guida per la sicurezza e la salute dei lavoratori esposti a chemioterapici antiblastici in ambiente sanitario”
Norme di Buona Preparazione dei Medicinali Farmacopea Italiana XII Edizione
GMP Good Manufacturing Practice, Current Edition.
Signorelli C. Elementi di metodologia epidemiologica- Società Editrice Universo Roma
AAVV – Governo Clinico – Il Pensiero Scientifico Editore
Joint Commission Resources ed. italiana – Prevenire gli errori in terapia
OsMed- L’uso dei farmaci in Italia- Ministero della Salute ( www.agenziafarmaco.it)
PFN 2005- AIFA ( www.agenziafarmaco.it)
Casadei-Silva – Farmacosorveglianza- Masson
AAVV- La Medicina delle prove di efficacia- Il Pensiero Scientifico Editore
Teaching materials used during the lessons, provided by the teacher.
Teaching methods
Lectures with the use of visual aids and classroom discussion with students.
Guided visit at a central laboratory for the preparation of anticancer drugs.
Assessment methods and criteria
The learning and the degree of preparation is checked by written examination with multiple choice quizzes and discussions during the lessons.
Other information
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