SFAK18003U Pharmaceutical Policy

Årgang 2021/2022
Engelsk titel

Pharmaceutical Policy

Uddannelse

MSc programme in Pharmacy or Pharmaceutical Sciences - compulsory

MSc programme in Pharmaceutical Sciences (english programme) - elective

MSc programme in Medicinal Chemistry - elective

Kursusindhold

The course focuses on three areas of pharmaceutical policy-making, regulatory science, health-economic evaluation and healthcare ethics.

Students work with real-world cases applying concepts, theories and methods from various scientific disciplines to analyze the cases. 

The main topics of the course are health care systems, key actors in pharmaceutical policy-making, drug regulatory systems, systems to support the rational use of medicines, core ethical concepts used in health care, ethical aspects of pharmaceuticals and medical devices in society, economic tools to manage medicines use and costs, prioritization in health care systems, and health economic evaluation.

  1. Students work with three peer feed-back group exercises (policy, health economics and biotethics) during the course and exam questions are based on the learning outcomes obtained via the group work.
Målbeskrivelser

The aim of the course is to facilitate the students’ understanding of pharmaceutical policy questions on the societal level based on cross-disciplinary, critical and analytical work with real-world cases.

The course should make the student able to argue on real-world issues and to analyze underlying interests, ethical and political standpoints of key actors within the pharmaceutical and medical device arena. In addition, the course should give the student a basic knowledge of how health economics is used in the pharmaceutical policy arena.
 

Upon completion of the course the student should be able to:

Knowledge

  • Classify and describe the general traits of health care systems
  • Describe the overall regulatory aspects in the field of pharmaceuticals and medical devices
  • Outline regulation, funding, pricing and distribution of medicines in society
  • Describe basic concepts in health economics and priority setting in health care
  • Describe basic concepts in health care ethics

 

Skills

  • Identify the different actors' interests and how they argue their positions
  • Apply concepts to identify political, ethical and health economic aspects of pharmaceutical policy
  • Identify ethical issues in the field of pharmaceuticals and medical devices
  • Conduct well-founded ethical argumentation regarding pharmaceutical issues using basic ethics concepts
  • Identify and discuss the relevance of a given health economic evaluation and the outcome measures used
  • Evaluate and discuss the choices made in health economic evaluations

 

Competencies

  • Discuss and synthesize current issues in the field of pharmaceuticals and medical devices overall, based on both political, economic and ethical/ ideological aspects using relevant tools and concepts
  • Be able to critically evaluate and extract well-balanced conclusions from published health economic evaluations.

Rascati K: Essential of Pharmacoeconomics. Lippincott Williams and Wilkins (latest edition).

Atul Gawande: Being Mortal (audiobook publicly available in danish via eReolen)

 

Scientific literature, media debates, articles, links to homepages, etc. posted on Absalon

If you are applying for the course as a credit transfer student, you must have passed SFAB20033U Samfundsfarmaci - metode og formidling or have acquired similar competencies in another course. Documentation for corresponding competencies in the form of a course description and an exam result must be attached to your application.
The course assumes skills commensurate to a Bachelor in Pharmacy.
• Lectures and discussion seminars
• Casework in groups and discussion of cases
• Students should work in groups for exercises 1, 2 and 3 and provide peer-feedback to another group.
• quizzes
• videos and podcasts
The course in English and will provide insight into different healthcare systems, regulatory and health technology assessment bodies. A great focus will be given to the Danish healthcare systems and Danish regulatory bodies.
  • Kategori
  • Timer
  • Forelæsninger
  • 50
  • Forberedelse (anslået)
  • 90
  • Øvelser
  • 12
  • Seminar
  • 16
  • Eksamen
  • 38
  • I alt
  • 206
Skriftlig
Mundtlig
Kollektiv
Peerfeedback (studerende giver hinanden feedback)
Point
7,5 ECTS
Prøveform
Skriftlig prøve, 5 hours med opsyn.
The exam consists of three parts on policy, ethics and economics, respectively. Each part has to be passed independently in order to pass the exam. The exam consists of questions for one or more cases focusing on policy, ethics and economics. Documents relevant for the cases are handed out 24 hours via Absalon, prior to the actual examination. A minor part of each exam part (approx. 20%) is general knowledge questions related to the course content and not directly related to the cases.
Hjælpemidler
Skriftlige hjælpemidler tilladt

There is access to the following, at the exam at KU's exam venue:

  • R – Statistical programme
  • MathType - formular programme
  • Mable
  • Digital Notes (It is allowed to upload notes for the ITX exam via digital exam. You will find a link to this feature from your exam in Digital Exam).

 

Bedømmelsesform
7-trins skala
Censurform
Ekstern censur
Kriterier for bedømmelse

To pass the exam the student must be able to:

Knowledge

  • Classify and describe the general traits of health systems
  • Describe the overall regulatory aspects in the field of pharmaceuticals and medical devices
  • Outline regulation, funding, pricing and distribution of medicines in society
  • Basic concepts in health economics and priority setting in health care
  • Basic concepts in health care ethics

 

Skills

  • Identify the different actors' interests and how they argue their positions
  • Apply concepts to identify political, ethical and health economic aspects of pharmaceutical policy
  • Identify ethical issues in the field of pharmaceuticals and medical devices
  • Conduct well-founded ethical argumentation regarding pharmaceutical issues using basic ethics concepts
  • Identify and discuss the relevance of a given health economic evaluation and the outcome measures used
  • Evaluate and discuss the choices made in health economic evaluations

 

Competencies

  • Be able to discuss and synthesize current issues in the field of pharmaceuticals and medical devices using relevant tools and concepts
  • Be able to critically evaluate and extract well-balanced conclusions from published health economic evaluations.