Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen ***

Uta Kästner (Abschlußjahr: 2002)

The German Act for the Limitation of Drug Expenses (Gesetz zur Begrenzung der Arzneimittelausgaben der gesetzlichen Krankenversicherung (Arzneimittelausgabenbegrenzungsgesetz - AABG)) came into effect on February 2002. This Act amends the rules governing the supply of medicinal products with the same active substance by pharmacists. Even before the AABG came into effect, pharmacists were obliged to provide an inexpensive medicinal product when the physician prescribed a medicinal product by stating only the active substance or if the physician gave his permission for the medicinal product to be substituted by the pharmacist by an equivalent product with the same active substance, strength, dosage form and indication. After the AABG came into affect pharmacists are now obliged to substitute medicinal products as a rule.

In 2001 the Statutory Health Insurance (GKV) faced a deficit of approximately € 2.8 billion and so is operating under significant pressure. The AABG is one measure in the package of laws to reduce expenditure of the statutory health insurance. Although only approximately 15 % of the expenditure are spent on medicinal products, the government hopes to balance the deficit of the GKV in the field of medicinal products. The legislator envisages savings of € 200-250 million.

This master thesis concentrates on requirements for drug substitution. It examines requirements for substitution like quality of medicinal products described by specifications, bioavailability and bioequivalence. It discusses under which circumstances substitution is possible and evaluates under which circumstances substitution may have a negative influence on therapy outcome, duration or cost of therapy. It tries to provide a critical assessment of different factors influencing the outcome of drug therapy like medical, scientific and psychological aspects.

Pages: 32