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Cyprus International University
TR

PHARMACOVIGILANCE AND DRUG INTERACTIONS

Course
PHAR421 - PHARMACOVIGILANCE AND DRUG INTERACTIONS
Department
Pharmacy - English - Undergraduate
Course Type
Course
Status
Required
Language
English
Credit
2
ECTS
0
T+P+L
2 + 0 + 0
Course Coordinator(s)
-
Prerequisite
-
Keywords
-

Course Description

The main topics are introduction to adverse drug reactions and spontaneous reporting, history and importance of pharmacovigilance, the safety of medicines in public health programmes, necessity of national pharmacovigilance systems, establishment of pharmacovigilance system in Turkey (TUFAM), national reporting, PSUR, international pharmacovigilance data sources.Drug interactions introduction to pharmacokinetics and pharmacodynamics (ADME), drug interactions with antibacterial agents, antiviral and antineoplastic agents, anticoagulants, antihypertansives, antiplatelet and other drugs used in cardiovascular diseases, drugs acting in CNS, With drugs acting in endocrine system, drugs used to treat gastrointestinal disorders, drug interactions with muscle relaxants and antitussive drugs will be covered in the second part of the course.

PHARMACOVIGILANCE AND DRUG INTERACTIONS

Evaluation Tools (Active Term)

No evaluation items have been defined.

Course outcomes

No course outcomes have been defined yet.

Course Syllabus

Week Topic
Week 1 Introduction to Pharmacovigilance History and development of Pharmacovigilance , Importance of safety monitoring of Medicine WHO international drug monitoring programmed
Week 2 Introduction to adverse drug reactions Definitions and classification of ADRs , Detection and reporting , Methods in Causality assessment , Severity and seriousness assessment, Predictability and preventability assessment Management of adverse drug reactions
Week 3 Basic terminologies used in pharmacovigilance Terminologies of adverse medication related events, Regulatory terminologies
Week 4 Drug and disease classification Anatomical, therapeutic and chemical classification of drugs International disease classification daily defined doses Non-proprietary names for international drugs
Week 5 Drug dictionaries and coding in pharmacovigilance WHO adverse reaction terminologies MedDRA and Standardized MedDRA queries WHO drug dictionary,
Week 6 Information resources in pharmacovigilance Basic drug information resources Specialized resources for ADRs
Week 7 Establishing pharmacovigilance programme Establishing in a hospital Establishment & operation of drugsafety department in industry Contract Research Organizations (CROs) Establishing a national programmed
Week 8 Vaccine safety surveillance Vaccine Pharmacovigilance Vaccination failure Adverse events following immunization
Week 9 Pharmacovigilance methods Passive surveillance – Spontaneous reports and case series Stimulated reporting Active surveillance – Sentinel sites, drug event monitoring and registries Comparative observational studies – Cross sectional study, case control study and cohort study Targeted clinical investigations
Week 10 Midterm exam
Week 11 Statistical methods for evaluating medication safety data Safety data generation Pre clinical phase Clinical phase Post approval phase
Week 12 International Conference of Harmonization (ICH) Guidelines for Pharmacovigilance Organization and objectives of ICH Expedited reporting Individual case safety reports Periodic safety update reports Post approval expedited reporting Pharmacovigilance planning Good clinical practice in pharmacovigilance studies
Week 13 Quiz exam
Week 14 Pharmacogenomics of adverse drug reactions Drug safety evaluation in special population Pediatrics, Pregnancy and lactation, Geriatrics
Week 15 Final exam

Reference Books & Course Materials

  1. 01 Pharmacovigilance A Practical Approach, Author : Thao Doan,Publisher : Elsevier Health Sciences Release Date : 2018-07-31 Genre: Medical Pages : 228 ISBN 10 : 978032358117
  2. 02 Pharmacovigilance Author : Ronald D. Mann Publisher : John Wiley & Sons Release Date : 2003-01-24 Genre: Medical Pages : 582
  3. 03 Pharmacovigilance Author : I. Ralph Edwards Publisher : Springer Release Date : 2016-10-27 Genre: Medical Pages : 205 ISBN 10 : 9783319404004
  4. 04 An Introduction to Pharmacovigilance Author : Patrick Waller Publisher : John Wiley & Sons Release Date : 2017-05-01 Genre: Medical Pages : 192 ISBN 10 : 9781119289746

Learning Outcomes

  1. L01 Identifying the hazards associated with pharmaceutical products SOLO 2
  2. L02 Analyzing clinically significant drug-drug interactions SOLO 4
  3. L03 Discussing the need for a company to comply with strict regulations in order to develop, manufacture and commercialize a drug SOLO 5
  4. L04 Arguing continuously monitoring of other side effects on patients, and any new data is collected and reported to health authorities on a regular basis. SOLO 4
  5. L05 Interpreting the importance of Adverse drug events (ADEs) that is an important problem for hospital and primary care. SOLO 3

Program Outcomes

  1. P01 Gain the ability to apply the Pharmacy profession.
  2. P02 Interpret the accuracy and reliability of the current theoretical and practical knowledge in the field of pharmacy, as well as being able to follow and evaluate innovations.
  3. P03 Practically apply the knowledge they gain on pharmaceutical sciences. The acquired knowledge and skills allow the graduates to act as the closest health consultant to the public with the ability to inform the public.
  4. P04 Evaluate and apply current technology related to basic subjects and principles covering pharmacy and health sciences and take part in in-service training seminars.
  5. P05 Know the risks and evaluation of the use of drugs and other chemicals and safe laboratory practices (GMP).
  6. P06 Acquire the ability to interpret the findings obtained by qualitative and quantitative measurements and to reach valid scientific results from the data.
  7. P07 Prepare pharmaceuticals and provide guidance on the use of pharmaceutical products.
  8. P08 Design research and develop projects related to pharmaceutical products; manage and share the results.
  9. P09 Be competent to accurately and intelligibly communicate and transfer knowledge about prescription content and pharmaceutical products to the patient / user. The graduates are trained on taking necessary precautions for safe drug usage and encouraging rational drug use, as well as providing consultancy and supervision.
  10. P10 Work in an interdisciplinary environment. Graduates can cooperate with other professional groups, participate in vocational training and activities, have proper knowledge and communication skills.
  11. P11 Take part in social responsibility projects related to health. Graduates have awareness on sustainable environment and participate in activities and practices related to their profession.
  12. P12 Open a community pharmacy, also work in hospital pharmacies, can work in different fields related with pharmaceuticals, cosmetics, medical and herbal products, as well as production and quality control in the pharmaceutical industry. Takes part in the professional development of herself/himself, her/his colleagues and pharmacy students.
  13. P13 Implements the legal and professional law and ethics as a health professional, in issues concerning public health.
  14. P14 Knows and applies the processes related to drug design from natural or synthetic sources, as well as development, preparation, analysis and metabolism of drugs in the human body.

Po-Lo Matrix

LO P01 P02 P03 P04 P05 P06 P07 P08 P09 P10 P11 P12 P13 P14 Average
L01 - - - - - - - - - - - - - - -
L02 - - - - - - - - - - - - - - -
L03 - - - - - - - - - - - - - - -
L04 - - - - - - - - - - - - - - -
L05 - - - - - - - - - - - - - - -