SFKKIF003U Pharmaceutical policy – an international perspective

Volume 2014/2015
Education
MSc in Pharmaceutical Sciences – elective, MSc in Medical Chemistry – elective, Cand. Scient. Pharm. – elective, Cand.Pharm. - elective
Content

Pharmaceuticals are one of the most regulated products in society. The policies influencing the use of pharmaceuticals are international, intranational, national and local. Decision makers must make policy decisions from the earliest preclinical stages through all phases of drug development, production, distribution and drug use. These decisions affect the supply and use of medicines and impact on public health as well as the health and welfare of groups and individuals.

The course focuses on how pharmaceutical policies are made, how regulations are formulated and administered and, finally, the effects of policy making, particularly with regard to drug utilization and ultimately health. The course introduces the key issues and central aspects of various pharmaceutical policy approaches and policy decision-making, including the central actors and institutions on international, intranational and national levels. Case studies are selected from the areas of drug distribution, financing, drug safety, drug use and health to illustrate the dynamics and consequences of pharmaceutical policy.


The aim of the course is to give participants insight into and understanding of current developments affecting pharmaceutical policy making today. The course also aims to give participants a better understanding of the theories and methods available for analyzing the effects of policy interventions.

Learning Outcome

On completion of the course participants will have a broad knowledge of the various pharmaceutical policy processes. More specifically, participants will be able to:

·         Explain the various approaches to pharmaceutical policymaking; how regulations are formulated and administered; and the effects of policymaking on drug use on international, intranational and national levels

·         Assess the contribution of the major actors associated with pharmaceutical policymaking

·         Evaluate the relationship and dynamics of pharmaceutical policies, regulations and their implications for drug use and health

·         Identify and describe typical and important pharmaceutical policy issues

·         Explain how pharmaceutical policy affects and creates a framework for the supply and the use of medicines.

Abbott FM, Dukes G. Global Pharmaceutical Policy.Edward Elgar, Cheltenham UK. 2009

Mossialos E, Mrazek M, Walley T (eds). Regulating pharmaceuticals in Europe:striving for efficiency, equity and quality. European Observatory on Health Systems and Polices Series. Open University Press 2004.


Articles:

Almarsdóttir AB, Morgall Traulsen J. Rational use of medicines – an important issue in pharmaceutical policy. Pharmacy World & Science 2005; 27: 76-80

Almarsdóttir AB, Morgall Traulsen J. Studying and evaluating pharmaceutical policy – becoming a part of the policy and consultative process. Pharmacy World & Science 2006; 28: 6-12

Almarsdóttir AB, Morgall Traulsen J. Multimethod research into policy changes in the pharmacy sector – The Nordic case. Research in Social and Administrative Pharmacy 2009; 5: 82-90

Almarsdóttir AB, Morgall Traulsen J. Cost-containment as part of pharmaceutical policy. Pharmacy World & Science 2005; 27: 144-148

Eichler H-G, Abadie E, Baker M & Rasi G. Fifty years after thalidomide; what role for drug regulators?. British Journal of Clinical Pharmacology.(2012) 74:5; 731-733.

Larsen JB, Vrangbaek K, Traulsen JM. Advocacy coalitions and pharmacy policy in Denmark – Solid cores with fuzzy edges. Social Science & Medicine 2006; 63: 212-224

Morgall Traulsen J, Almarsdóttir AB. Pharmaceutical policy and the lay public. Pharmacy World & Science 2005; 27: 273-277

Morgall Traulsen J, Almarsdóttir AB. Pharmaceutical policy and the pharmacy profession. Pharmacy World & Science 2005; 27: 359-363

Morgall Traulsen J, Almarsdóttir AB. The argument for pharmaceutical policy. Pharmacy World & Science 2005; 27: 7-12

Noerreslet M, Larsen JB, Traulsen JM. The medicine user – Lost in translation? Analysis of the official political debate prior to the deregulation of the Danish medicine distribution system. Social Science & Medicine 2005; 61: 1733-1740

 

A bachelor degree in health, natural or technical sciences
Seminars, lectures, oral presentations and field trips.
  • Category
  • Hours
  • Field Work
  • 10
  • Guidance
  • 5
  • Lectures
  • 20
  • Preparation
  • 127
  • Seminar
  • 14
  • Study Groups
  • 30
  • Total
  • 206
Credit
7,5 ECTS
Type of assessment
Course participation
Term paper presenting a case study on a topic approved by the course leader.
Students individually write a paper on a case of pharmaceutical policy with international implications. The paper should be based on literature from the curriculum and other sources of data specific for the case. The papers will be presented during seminars, giving students the opportunity to discuss and critique each other’s work. Relevant critique should then be incorporated in the final version of the paper.
Exam registration requirements
Active participation and a minimum of 80% attendance.
Aid
Written aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

The student is able to demonstrate an understanding of the area of pharmaceutical policy in an international perspective.

The student is familiar with basic concepts and current issues within the field.

The student is able to demonstrate the ability to focus on a specific topic, using concepts and literature from the area, and communicate this in a scientific manner through a written report.