Clinical governance in drug treatment and medical device use, pharmacovigilance and device vigilance
Learning outcomes of the course unit
The teaching course has the aim to deliver basic knowledge on Clinical Pharmacy and Pharmaceutical Care in Hospital and Territorial Pharmacy and allowing the student to transposing these concepts in practice with the objective to contribute to health care quality assurance with regard to prescription, distribution and
administration of medicines and medical devices.
Course contents summary
-Introduction to Clinical Governance in drug treatment and medical devices (MD) use: definition, objectives, normative sources.
-Quality and safety of medicines and medical devices: role of the Clinical Pharmacy and Pharmaceutical Care.
-Evidence Based Medicines: definition, objectives and tools for selection and use of drugs and medical devices. Scientific documentation and information. Appropriateness of prescription and use of medicines. Governance of the technological innovation in the pharmaceutical and MD field.
-Pharmaceutical care: definition and objectives. The role of community and hospital pharmacist in Pharmaceutical care: patient education and prevention programs, prescription and adherence monitoring, cooperation in health care team focused on improving patient safety and quality of care. National experiences on pharmaceutical care: community and hospital projects
-Special use and off-label procedures: definition, normative sources, application pathways in normal clinical practice.
-Therapeutics and MD Risk Management: definition, normative sources, tools, national projects. Pharmacovigilance and medical device vigilance. registers and monitoring medicines projects
-Clinical galenic production: definition and objectives. Oncological and pediatric galenic formulations
-Pharmacoeconomic analisys to promote sustainable and appropriate medicine and MD use: definition, objectives, tools
-Medical devices: definitions, CE marking, classification based on risk class, national repertoire and CND.
Slides used for lessons are available online, and links to sites of interest (institutional, scientific societies, etc.) are inserted in slides.
Frontal lesson based on PP presentation. In case of prolonged persistence of sanitary emergency the course will be organized as a blended teaching that combines lessons in the classroom, involving a group of students, with lessons on line addressed to the remaining students (via MS Teams platform). Supplementary teaching materials, used to support lessons (slides), are loaded onto the elly platform and made available to students after online registration. The teacher is available by appointment (e-mail) for lesson explanations.
Assessment methods and criteria
The assessment of the achievement of knowledge and understanding of the course content includes a written test. The written test, lasting one hour, is divided into 5 multiple choice questions. For each question a score of 1 point is associated; the test is considered passed with a minimum score of 3/5. Please note that online registration is OBLIGATORY. In case of prolonged persistence of sanitary emergency the assessment of knowledge will be performed as an oral exam via TEAMS platform. Every student will be requested to answer to questions with multiple responses and the evaluation will be done as previously described.