General provisions

This course substitutes and corresponds to the earlier course 3FX000 Adverse drug reactions and pharmacovigilance. 1.5 credits (hp) correspond to 1 credit point (p) according to previous study regulation.

The course is given in collaboration with Uppsala Monitoring Centre that is a unit within WHO. The course is partly or completely given in English. The course can be included as optional course within the Master of Science in Pharmacy Programme and the Bachelor of Science in Pharmacy Programme.

Entry requirements

For optional course within the Master of Science in Pharmacy Programme 150 credits within the programme of which 60 credits bioscience including the courses in toxicology, drug metabolism and safety assessment, pharmacology, physiology, molecular genetics and biochemistry are required.

For optional course within Bachelor of Science in Pharmacy Programme 180 credits within the programme of which 60 credits bioscience including the courses in toxicology, drug metabolism, safety assessment, pharmacology, physiology and molecular gene technology/molecular biology and biochemistry are required.

Qualified to single subject course are those who have undergraduate degree 150 credits including 60 credits bioscience (biochemistry, physiology, molecular/cell biology, pharmacology, toxicology, drug metabolism) of which at least 10.5 credits pharmacology or the equivalent knowledge within the subject area. Proficiency in Swedish and English equivalent to the general entry requirements for first-cycle (Bachelor's level) studies.

Learning outcomes

After the course the student should be able to:

-Describe how candidate drugs can be tested to demonstrate possible harmful effects

-Analyse preclinical safety studies of candidate drugs given for the first time in humans

-Describe common types of adverse drug reactions

-Explain principal mechanisms for adverse drug reactions in major organ systems

-Explain common causes of individual variation for adverse drug reactions

-Search for and analyse reports of adverse drug reactions in scientific literature and databases

-Describe how the pharmaceutical industry and medical agencies manage reports of adverse drug reactions

-Explain and analyse pharmacovigilance of adverse drug reactions

-Analyse benefits versus risks of pharmaceutical drugs

-Analyse risk management and risk communication in connection with withdrawal of pharmaceutical drugs from the market due to adverse reactions

-Discuss strategies that can be used to reduce the incidence of adverse drug reactions

-Write a short essay on the risks and benefits of a pharmaceutical drug - in proper English language and with a proper scientific vocabulary

-Give an oral presentation and participate in discussions about the risks and benefits of pharmaceutical drugs

Content

The course covers the assessment of benefits and risk of drugs. The course consists of two main parts, preclinical safety assessment of drugs and pharmacovigilance. These two parts are integrated with each other and are examined in one written exam.

Instruction

The teaching consists of lectures, online lectures, seminars and computer training. The instructions are partially or completely in English. A web-based learning platform is used for seminars and assignments. Emphasis is placed on the student's ability to collect and process material as well as the student's ability to write and make oral presentation on the efficacy and safety of pharmaceutical drugs. Seminars (active participation in at least 75% of the scheduled seminars) and a minor essay in English are mandatory.

Assessment

The final examination takes place at the end of the course. Both the final examination (examination code) and the compulsory assignments (examination codes) must be passed in order to pass the course. Failed compulsory assignments can be supplemented at the earliest at next course and only in case of a vacancy.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the disability coordinator of the university.