An investigation of aspects affecting availability and grading of high-risk antibiotics in Sweden. : Group 3

Abstract: The aim of this report is to investigate aspects affectingavailability and grade high-risk antibiotics in Sweden. 10antibiotics out of 39 antibiotics compiled by the Swedish PublicHealth Authority were studied according to the factors; class(based on chemical structure), industrial production process,number of API manufacturers found, the geographic location of the API manufacturers, number of MAH found in Sweden, number of MAH found in the EEA, number of backorders in Sweden, total length of backorders, currently not provided in Sweden (Number of MAH), assumed profitability per product, uncertainty in annual sales volume (relative standard deviation), uncertainty in annual sales (relative standard deviation), average sales (High/Low) and lastly parallel import to Sweden. The same factors were studied for the remaining 29 antibiotics by group 1 and 2 in order to compile a final grading with the parameters high, medium and low. A grading system was constructed to facilitate the grading system. Itresulted in nine antibiotics graded high, 23 antibiotics graded medium and lastly seven antibiotics were graded low. Also, out of the nine antibiotics formulated as tablets, five were graded ashigh. This drew the conclusion that a correlation between high- risk antibiotics and tablet formulation could be made. Another correlation made was that beta-lactam antibiotics were overrepresented in the antibiotics rated as high. There was also a slight overrepresentation of antibiotics formulated as injection/infusion in the low-risk category. A few limitations occurred during the process of the project such as the research for API manufacturers only included the ones approved in the EEA and the U.S. The grading of the antibiotics assigned to Group 1 and 2 was based only on the tables received from these groups, excluding additional details that may have affected the finalgrading. Nevertheless, the project conceived variation in theresult previously compiled by the Swedish Public Health Authority.