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PHARMACOVIGILANCE AND DRUG UTILIZATION

Francesca SANSONE PHARMACOVIGILANCE AND DRUG UTILIZATION

0760100083
DIPARTIMENTO DI FARMACIA
EQF7
PHARMACY
2023/2024

YEAR OF COURSE 4
YEAR OF DIDACTIC SYSTEM 2020
SPRING SEMESTER
CFUHOURSACTIVITY
648LESSONS
FRANCESCA SANSONE T Curriculum
Objectives
THE AIM OF THIS COURSE IS TO PROVIDE A FOUNDATIONAL UNDERSTANDING OF NATIONAL AND SUPRANATIONAL LEGISLATION AND REGULATORY AUTHORITIES IN THE FIELD OF PHARMACOVIGILANCE. THROUGH THIS COURSE, YOU WILL LEARN ABOUT THE IMPORTANCE OF PRO-ACTIVE AND PASSIVE PHARMACOVIGILANCE ACTIVITIES, AS WELL AS DRUG-UTILIZATION KNOWLEDGE RELATED TO MARKET, DISTRIBUTION, PRESCRIPTION, AND USE OF DRUGS, WITH A FOCUS ON THE RESULTING SOCIAL AND ECONOMIC MEDICAL CONSEQUENCES.BY THE END OF THE COURSE, STUDENT WILL HAVE GAINED:
• THE ABILITY TO UNDERSTAND THE ISSUES THAT ARISE AFTER A DRUG HAS BEEN PLACED ON THE MARKET
•THEORETICAL AND PRACTICAL KNOWLEDGE ABOUT PASSIVE PHARMACOVIGILANCE AND MONITORING SYSTEMS IN DRUG USE
•DEEP APPRECIATION FOR THE ROLE OF THE PHARMACIST IN THESE ISSUES.
•KNOWLEDGE ABOUT ADMINISTRATIVE DATABASES IN WHICH ALL THE PRESCRIPTIONS DISPENSED AT THE EXPENSE OF THE NHS ARE RECORDED, AND THE INDICATORS OF PHARMACEUTICAL EXPENDITURE AND CONSUMPTION.
•KNOWLEDGE OF STATISTICAL STUDIES AND THE APPROPRIATENESS OF USE OF DRUGS
AT THE END OF THE COURSE, THE STUDENT WILL BE ABLE TO:
• USE PHARMACOVIGILANCE REPORTING TOOLS AND CORRELATE PUBLIC HEALTH ISSUES WITH DRUG USE
• APPLY HEALTH LITERACY GUIDELINES FOR PATIENT UNDERSTANDING AND MANAGEMENT IN THE PHARMACY SETTING
• ANALYZE AND ILLUSTRATE THE CHARACTERISTICS OF A DRUG UTILIZATION REVIEW BY APPLYING THE MAIN EXPENDITURE INDICATORS
• DEVELOP RANKINGS OF THE MOST PRESCRIBED AND SOLD DRUGS AND THE PRESCRIPTION VARIABILITY AMONG GEOGRAPHIC OR ADMINISTRATIVE AREAS
READ AND INTERPRET PHARMACOVIGILANCE AND DRUG UTILIZATION REPORTS FOR EVALUATING THE COST-EFFECTIVENESS-SAFETY RELATIONSHIP OF NEW THERAPIES.
Prerequisites
FREQUENCY AT THE COURSES ON PHARMACEUTICAL TECHNOLOGY, SOCIOECONOMICS, LEGISLATION; AND PHARMACOLOGY.
Contents
INTRODUCTION TO PHARMACOVIGILANCE: DEFINITION, OBJECTIVES, METHODS (2 HOURS)
COMMUNICATION AND HEALTH LITERACY; MINISTERIAL GUIDELINES ON COMPLIANCE, ADHERENCE, CONCORDANCE, PERSISTENCE; ROLE OF THE PHARMACIST IN PHARMACOVIGILANCE (4 HOURS)
EUROPEAN REGULATION AND NATIONAL LEGISLATION FOR HUMAN MEDICINAL PRODUCTS AND PHARMACOVIGILANCE, NATIONAL AND SUPRANATIONAL REGULATORY BODIES (WHO, EMA, AIFA, MDS, ISS) (2 HOURS)
REGIONAL PHARMACOVIGILANCE CENTERS, LOCAL AND REGIONAL PHARMACOVIGILANCE OFFICERS, NATIONAL PHARMACOVIGILANCE NETWORK, EUDRAVIGILANCE (2 HOURS)
ADVERSE EVENTS, ADVERSE DRUG REACTIONS (ADR): DEFINITION, CLASSIFICATION, CAUSALITY AND ALGORITHMS, ANALYSIS OF RISK FACTORS, IMPLICATIONS AND COSTS (4 HOURS)
THE REPORTING, REPORTING FORMS, CORRECT COMPILATION, MEDDRA, INCLUSION IN THE NATIONAL PHARMACOVIGILANCE DATABASE, MONITORING, SIGNAL VALIDATION, CORRECTIVE ACTIONS (4 HOURS)
PRAC (PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE), PSUR: ARCHIVE, FREQUENCY OF SUBMISSION, SINGLE ASSESSMENT; POST-AUTHORIZATION SAFETY AND EFFICACY STUDIES, REFERRAL PROCEDURES, GOOD PHARMACOVIGILANCE PRACTICE (4 HOURS)
PHYTOVIGILANCE: DIETARY SUPPLEMENTS, HERBAL MEDICINES, AND FOCUS ON THERAPEUTIC CANNABIS (4 HOURS)
COSMETOVIGILANCE (2 HOURS): EUROPEAN REGULATION, SURVEILLANCE (REPORTING FORM), AND MONITORING (RAPEX SYSTEM)
VETERINARY DRUG SURVEILLANCE (2 HOURS)
VACCINE VIGILANCE, AEFI (ADVERSE EVENTS FOLLOWING IMMUNIZATION), AND CASE STUDIES (2 HOURS)
MEDICAL DEVICES: EUROPEAN REGULATIONS, REGISTRATION AND CE MARKING PROCEDURES, EUDAMED, REPORTING OF INCIDENTS, AND CASE STUDIES (2 HOURS)
DRUG UTILIZATION, MONITORING SYSTEMS FOR PHARMACEUTICAL PRESCRIPTIONS, OSMED, ADMINISTRATIVE DATABASES, DRUG CLASSIFICATION SYSTEM (4 HOURS)
DATA AND MEASURES, DEFINED DAILY DOSE, PRESCRIBING APPROPRIATENESS (2 HOURS)
AIFA NOTES, REGIONAL DIGITAL SYSTEMS (SANIARP AND SINFONIA), KEY INDICATORS OF PHARMACEUTICAL EXPENDITURE AND CONSUMPTION, MONITORING REGISTRIES (4 HOURS)
READING AND INTERPRETATION OF DRUG UTILIZATION REPORTS, CASE STUDIES (4 HOURS)
Teaching Methods
THE COURSE IS ORGANIZED IN LECTURES FOR A TOTAL OF 48 HOURS (6CFU).
ATTENDANCE TO LESSONS IS MANDATORY FOR 80% OF THE HOURS OF LESSON, AS PER THE STUDY COURSE REGULATION, AND IS FUNDAMENTAL IN THE TEACHING LEARNING PROCESS.
Verification of learning
THE ASSESSMENT OF LEARNING IS CONDUCTED THROUGH A WRITTEN EXAM AND AN ORAL EXAM.
THE WRITTEN EXAM CONSISTS OF 15 QUESTIONS WITH 4 POSSIBLE ANSWERS, OF WHICH ONLY ONE IS CORRECT, AND 5 OPEN-ENDED QUESTIONS. THE QUESTIONS COVER THE ENTIRE COURSE CURRICULUM. FOR MULTIPLE-CHOICE QUESTIONS, EACH CORRECT ANSWER IS AWARDED 1 POINT, WHILE EACH WRONG ANSWER RECEIVES A SCORE OF ZERO, WITH A MAXIMUM OF 15 POINTS. THE OPEN-ENDED QUESTIONS ARE EVALUATED FOR A MAXIMUM OF 15 POINTS. THE EVALUATION IS DONE ON A SCALE OF THIRTY. PASSING THE WRITTEN EXAMINATION IS MANDATORY FOR THE ORAL EXAMINATION.

THE ORAL EXAM WILL BE BASED ON INQUIRIES THAT FOCUS ON THE TOPICS COVERED DURING THE COURSE. THE STUDENT'S ABILITY TO CRITICALLY AND COMPREHENSIVELY ADDRESS THE REQUIRED TOPICS WILL BE ASSESSED. THE EVALUATION IS DONE ON A SCALE OF THIRTY. THE STUDENT'S DEMONSTRATION OF MASTERY OF THE SUBJECT MATTER AND THE USE OF SPECIFIC LANGUAGE WILL BE AWARDED EXCELLENT GRADES.

THE FINAL GRADE IS DERIVED FROM THE WEIGHTED AVERAGE OF THE GRADES OBTAINED IN THE TWO EXAMS (WRITTEN + ORAL).
Texts
MANN’S. PHARMACOVIGILANCE, 3RD EDITION. EDITED BY: ELIZABETH B. ANDREWS, NICHOLAS MOORE EDITORS WILEY-BLACKWELL
LEGISLAZIONE FARMACEUTICA NELLA PRATICA PROFESSIONALE. BARBERINI E CASETTARI ED. PICCIN2021
SITO AIFA. WWW.AGENZIAFARMACO.GOV.IT
SITO FARMACOVIGILANZA.WWW.FARMACOVIGILANZA.ORG
HTTPS://WWW.AIFA.GOV.IT/NORMATIVA-DI-RIFERIMENTO-FARMACOVIGILANZA
THE DIDACTIC MATERIAL WILL BE MADE AVAILABLE TO THE STUDENT.
More Information
48 H DI LEZIONE
6 CFU
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