gms | German Medical Science

Background: Drug shortages have substantially increased, posing a tremendous and unexpected burden to patients, pharmacists and physicians. As shortages seem to rather increase than improve and no counteraction is in sight, healthcare providers need to find mitigation strategies to prevent severe harm from their patients. This is especially true with delicate indications, such as epilepsy or asthma.

The aim of this study is to explore the reasons, the extent, the perception, the impact and potential mitigation strategies of drug shortages.

Materials and Methods: The multi-center mixed-methods study is conducted in the Republic of Kosovo, Austria and Germany. The study comprises of questionnaires and semi-structured interviews with multiple stakeholders. Content and face validation are performed before piloting and amending questionnaires for the final use. Qualitative content analysis according to Mayring will be applied to the semi-structured interview using the software MAXQDA. Quantitative data is analyzed utilizing microsoft excel and SPSS for descriptive statistics.

Results: Interviews with manufacturers revealed global inflation in combination with fixed pricing as a major driver for ongoing drug shortages. Globalization-related logistical issues contributed to temporary shortages only. In Austria, a national task force, which included manufactures provided solutions, such as higher prices or a national reserve. Based on preliminary results of 251 surveys, pharmacists reported that between every second and every third patient interaction is prone to medication shortages (50% in Kosovo, 39% in Germany, 30% in Austria). Pharmacists indicated that their pharmacy experiences significant repercussions from these shortages, with severity ratings of 3.5 out of 4 in Kosovo, 3.7/4 in Germany, and 3.4/4 in Austria. Time to handle the problem in affected patients was an average of 18 minutes in Kosovo, 16 minutes in Germany and 10 minutes in Austria. About half of the pharmacies have produced drugs themselves to mitigate the shortage. German Physicians (n=19) stated that they rather solve the remaining problems themselves (52%) than leaving them to the pharmacy (42%). Both professions estimate the rate of endangered therapies at 14% of all patients. The relationship between pharmacists and physicians did not change significantly, as stated from both sides. Patients perceived the activities of their pharmacists to handle drug shortages mainly positively (exception Kosovo) and in all three countries politicians were held responsible. Patients stated that they needed to interrupt their therapy or that they feel left alone with the problem by politicians.

Conclusion: Preliminary findings suggest global inflation as a major driver of drug shortages, whereas logistics and globalization-related issues are manageable. A national task force including all stakeholders presented solutions in Austria. Pharmacies need one additional workforce to cope with the problem, while patients are sometimes frustrated.