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Course Code: 
PHAR 438
Course Period: 
Spring
Course Type: 
Elective
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
4
Course Language: 
English
Course Coordinator: 
Hande SİPAHİ
Courses given by: 
Hande SİPAHİ
Ahmet AYDIN
Course Objectives: 
The aim of this course is to provide to pharmacy students a general review of pharmacovigilance to protect public health and to evaluate drug safety data by considering the benefit-harm relationship of drugs
Course Content: 

Within the scope of our course, detailed information will be given about the pharmacovigilance activities for the monitoring and prevention of adverse drug reactions, the activities of the Turkish Pharmacovigilance Center and the examination of adverse effect reporting systems, pharmacovigilance practices in generic and originator companies, and information on gaining the necessary qualifications to be responsible for pharmacovigilance will be discussed.

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes

Programme learning outcomes

Teaching Methods

Assessment Methods

1) Being able to understand the general principles of pharmacovigilans.

1,2,3,4,5,6,7,9

1,2,3,4,5,6,7,8

A,B,C,D,E,G,H

2) Being able to understand the national and international regulations and legislations.

1,2,3,4,5,6,7,9

1,2,3,4,5,6,7,8

A,B,C,D,E,G,H

3)  Being able to fill ADR forms.

1,2,3,4,5,6,7,9

1,2,3,4,5,6,7,8

A,B,C,D,E,G,H

4) Being able to use RxMedia program for analysis of drug interactions.

1,2,3,4,5,6,7,9

1,2,3,4,5,6,7,8

A,B,C,D,E,G,H

5) Being able to understand the causality assessment of suspected ADRs.

1,2,3,4,5,6,7,9

1,2,3,4,5,6,7,8

A,B,C,D,E,G,H

6) Being able to understand the MedDRA and ATC classification system.

1,2,3,4,5,6,7,9

1,2,3,4,5,6,7,8

A,B,C,D,E,G,H
 

Course Flow

COURSE CONTENT

Week

Teorical Topics                                     

Study Materials

1

Introduction to Pharmacovigilance

Study the sources.

2

ADRs and Definitions in Pharmacovigilance

Study the sources.

3

Regulations on Pharmacovigilance (Turkey, Europe)

Study the sources.

4

Periodic Safety Update Report

Study the sources.

5

Spontaneous Reports (SRs)

Study the sources.

6

How to fill an CIOMS Form (Case Studies)

Study the sources.

7

RxMedia (Analysis of drug interaction, Practice)

Study the sources.

8

Guest speaker from International Pharmaceutical Company

  

9

Guest speaker from a National Generic Pharmaceutical Company

  

10

 Guest speaker from TÜFAM

  

11

The Medical Dictionary for Regulatory Activities (MedDRA) and Pharmacovigilance

Study the sources.

12

Anatomical Therapeutic Chemical (ATC) Classification system of drugs

Study the sources.

13

Presentations

Preparation of presentation.

14

Presentations

Preparation of presentation.
 

Recommended Sources

RECOMMENDED SOURCES

Textbook

 Lecture notes

Additional Resources
  1. Manual of Drug Safety and Pharmacovigilance, Jones and Barlett Publishers,Inc. , Ed: Barton Cobert, Boston, 2007.
  2. WHO/EDM/2004.8
  3. Pharmacovigilance (Ronald D. Mann, Elızabeth B. Andrews)
  4. Routledge P, Lancet 1998; 351: 1200-01.
  5. Color Atlas of Pharmacology. Thieme Stuttgart, New York, 2000.
  6. WHO Pharmacovigilance an Essential Tool, 2006
  7. Edwards R, Aronson JK, Lancet, 2000
  8. The Importance of Pharmacovigilance, 2002
 

Material Sharing

MATERIAL SHARING

Documents

Shareable.

Assignments

Shareable.

Exams

Not shareable.
 

Assessment

ASSESSMENT

IN-TERM STUDIES

NUMBER

PERCENTAGE

Quiz

1

20

Participation

  

10

Homework

1

70

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

 

40

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

 

60

Total

 

100
 

 

COURSE CATEGORY

Selective
 

Course’s Contribution to Program

COURSE'S CONTRIBUTION TO PROGRAM
No
Program Learning Outcomes
Contribution
1
2
3
4
5

1

Has national and international up-to-date, theoretical and applied knowledge in the field of pharmacy.

        

X

2

Defines problems related to the profession, collects data, evaluates its accuracy and reliability, develops evidence-based solutions, shares them with healthcare professionals, makes necessary explanations to other people.

        

X

3

Communicates accurately and effectively in accordance with cultural and ethical values with all relevant professional groups, especially those working in the field of health, and all segments of society, using information and communication technologies.

        

X

4

Takes into account the law and ethics when dealing with public health issues.

        

X

5

Acts as a pharmacist with high career awareness, self-confidence, leadership spirit, who is prone to teamwork, entrepreneurial, productive and able to manage financial resources.

        

X

6

Based on the principle of pharmaceutical care, Acts as an easily accessible health consultant with a patient-oriented approach and plays an active role in constantly informing the society.

        

X

7

Improves his/her knowledge by participating in in-service training and activities in line with the needs of the century and society, takes part in the professional development of colleagues and adopts the lifelong learning principle.

        

X

8

Suggests and manages multidisciplinary / interdisciplinary research and development projects related to pharmaceuticals, cosmetics, medical devices and shares their results.

          

9

Applies knowledge and skills for the benefits of the society taking part in social responsibility projects.

        

X

10

Fulfills the requirements of quality management systems using the theoretical and applied knowledge acquired in the field.

          
 

ECTS

ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION
Activities
Quantity
Duration
(Hour)
Total
Workload
(Hour)

Course Duration (Including the exam week: 16x Total course hours)

14

2

28

Hours for off-the-classroom study (Pre-study, practice)

15

2

30

Quiz

1

8

8

Homework

1

5

5

Final

1

10

10

Total Work Load

 

 

81

Total Work Load / 25 (h)

 

 

3,24

ECTS Credit of the Course

 

 

3
 
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