An Investigation of Cefadroxil and Meropenem’s Supply Chain and Estimationof the Health Economic Consequences in Sweden due to Shortage

University essay from Uppsala universitet/Institutionen för kemi - Ångström; Uppsala universitet/Institutionen för kemi - Ångström; Uppsala universitet/Institutionen för kemi - Ångström; Uppsala universitet/Institutionen för kemi - Ångström; Uppsala universitet/Institutionen f

Abstract: Sweden has been increasingly affected by drug shortage and the public healthcare system has identified a large amount of antibiotics risking shortage. Drug shortage of antibiotics is a worldwide problem with complex causes and consequences affecting many countries healthcare systems. The aim of this study is to investigate the shortage of cefadroxil and meropenem. More specifically, to investigate risk factors in the supply chain contributing to their backorders as well as possible consequences for Swedish healthcare due to shortage.  To formulate the supply chain for cefadroxil and meropenem, the active pharmaceutical ingredient (API) manufacturers, final dosage form (FDF) holders and market authorization holders (MAHs)were identified. 4 active API manufactures, 18 active FDF holders and 4 MAHs were identified for cefadroxil and 4 active API manufactures, 32 FDF holders and 8 MAHs were identified for meropenem. In order to analyse the causes behind these antibiotic shortages, problems with the manufactures were researched using various sources. Since API production is the first step in thesupply chain, problems connected to the API manufactures was the sole focus in this study. Research identified several problems with the API manufacturers for both antibiotics, indicating that the shortages can in fact be explained by issues in the supply chain.  In order to calculate and get an estimate of the health economic costs for society, a model based on direct and indirect costs was used. The direct costs were calculated by comparing the most suitable alternative treatment methods. For cefadroxil there were 5 alternatives in the case of shortage for the oral suspension from Mylan AB (the only product covered in this section of the report due to limited data), whereof 3 of the alternatives still were cefadroxil products. These 3 were cefadroxil dispersible tablets, cefadroxil capsules and Grüncef. The other 2 alternatives were Clindamycin and the combination antibiotic Trimethoprim/Sulfamethoxazol (Eusaprim R). Meropenem had only one identified alternative drug called imipenem. In addition to comparing alternative treatments, the cost of extra labor hours spent on dealing with shortages as well as the increased risk of AMR was also also investigated closely. The indirect costs were based on loss of production due to patient care being longer and more demanding as a result of unforeseen side effects caused by the alternative treatments. This was analyzed qualitatively, in other words no definitive cost was calculatedfor loss of production. Results showed that the exchange from Cefadroxil Mylan oral suspension to cefadroxil dispersible tablets would cost Sweden approximately +35 105 SEK/day. The exchange to cefadroxil capsules would cost -30 939 SEK/day and for Grüncef the cost would be +311 814 SEK/day. As for the other 2 antibiotics, the cost would be -23 103 SEK/day for Clindamycin and -53 084 SEK/day for Eusaprim R. When exchanging meropenem for imipenem, the direct cost was estimated to +343 299 SEK/day. Regarding the cost for extra labor hours spent on dealing with shortage, this was estimated to 1.6 MSEK per shortage, regardless of the antibiotic and shortage duration. The costscalculated for the replacement pharmaceuticals were based on worst case scenarios for when all MAHs had their products unavailable. If the calculated values are of any relevance for real life situations depends on the fragility of the supply chain. In other words, how big these health economicconsequences are for Swedish healthcare is dependant on the risk of unavailability for these antibiotics which goes back to the fragility of the supply chain. In regards to AMR, research showed that substituting cefadroxil for clindamycin and meropenem for imipenem increased the risk of AMR and as a consequence, the direct cost increased as well. The use of clindamycin to treat infections caused by Methicillin-Resistant Staphylococcus Aureus (MRSA) could lead to an additional cost of +3665 SEK/outpatient visit in the case of induced resistance against the antibiotic. Substituting meropenem for imipenem would result in an additional cost of +1160 SEK/day assuming that the bacteria behind the infection is ESBLcarba, an Enterobacteriaeac able to break down carbapenems (a class of antibiotics in which meropenem and imipenem reside). Using licensed drugs could minimize this risk but would however come at a cost for the patients health due to the extended lead time as a result of importation. This would in turn increase the indirect cost to society in the form of loss of production. Despite maybe lowering the risk of AMR, the calculated costs for shortage/day show that using licensed drugs would in fact increase the direct cost a great deal. The calculations for Grüncef and imipenem illustrate this as they proved to be much more costly than the other alternative treatments.

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