Ármey Valdimarsdóttir¹

Anna Bryndís Blöndal^1,2

Hjalti Kristinsson³

¹Faculty of Pharmaceutical Sciences University of Iceland, ²Development Centre for Primary Healthcare in Iceland, Faculty of Pharmaceutical Sciences, University of Iceland, ³Icelandic Medicines Agency.

Correspondence: Ármey Valdimarsdóttir, armey4@gmail.com

Key words: Unlicensed drug, exemption use drug, named-patient basis access, small market supply drugs.

INTRODUCTION: Prescriptions of unlicensed drugs along with public discussion have increased in recent years. The cause of this increase is unclear.

MATERIAL AND METHODS: This is a retrospective descriptive study of applications of unlicensed drugs in Iceland in the years 2020 and 2021, as well as applications in Sweden for the year 2020. Information was collected on unlicensed prescription applications, registered drugs and stock-out time. Information was analyzed and categorized to describe the scope of unlicensed prescriptions in the two countries during the study time.

RESULTS: In Iceland, 49.161 applications were approved in 2020 and 46.581 in 2021. The most common reason for using unlicensed products was that no registered drug was on the market with the same ATC-number (Anatomical Therapeutic Chemical code) and formulation. Shortage of drug was the reason for unlicensed prescription in 8.8% of cases in 2020 and 7.6% in 2021. The list of the 50 most prescribed drugs included the same drugs in 70% of the cases in both years. The five most prescribed drugs were the same in both years. In Sweden, 38.458 applications were approved in 2020. Of the most prescribed unlicensed drug, 46% were as no registered drug with same ATC-number and dosage form was marketed.

CONCLUSION: Many unlicensed drugs, prescribed in Iceland, are the same year after year. Only a small part of the applications approved were due to shortage of drug. The use of drugs without marketing license in Iceland in 2020 was higher than in Sweden when adjusted for the size of the market and population. Getting the five most prescribed unlicensed drugs licensed in Iceland could reduce largely, the total of prescription of unlicensed drugs in Iceland.