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Background: Recently, the European Union has introduced the Falsified Medicines Directive (FMD). Additionally, in early 2016, a Delegated Act (DA) related to the FMD was published. The main objective of this study was to evaluate the usefulness of external audits in the context of implementing new regulations provided by the FMD in the secondary care environment. Methods: The external, in-person workflow audits were performed by an authentication company in three Polish hospital pharmacies. Each audit consisted of a combination of supervision (non-participant observation), secondary data analysis, and expert interviews with the use of an independently designed authorial Diagnostic Questionnaire. The questionnaire included information about hospital drug distribution procedures, data concerning drug usage, IT systems, medication order systems, the processes of medication dispensing, and the preparation and administration of hazardous drugs. Data analysis included a thorough examination of hospital documentation in regard to drug management. All data were subjected to qualitative analysis, with the aim of generating meaningful information through inductive inference. Results: Only one dispensing location in the Polish hospitals studied has the potential to be a primary authentication area. In the audited hospitals, an Automated Drug Dispensing System and unit dose were not identified during the study. Hospital wards contained an enclosed place within the department dedicated to drug storage under the direct supervision of senior nursing staff. An electronic order system was not available. In the largest center, unused medications are re-dispensed to different hospital departments, or may be sold to various institutions. Additionally, in one hospital pharmacy, pharmacists prepared parenteral nutrition and chemotherapeutic drugs for patients admitted to the hospital. Conclusions: External audits might prove beneficial in the course of introducing new regulations into everyday settings. However, such action should be provided before the final implementation of authentication services. To sum up, FMD can impact several hospital departments.

One of the examples of physical starch modifications is the retention of a starch suspension in water having a temperature slightly lower than the pasting temperature (annealing). The aim of this study was to investigate the effect of the annealing process performed at various temperatures as the first stage of starch modification. The annealed starch preparations were then esterified using acetic acid anhydride. Finally, the annealed and acetylated starch preparations were determined for their properties. The annealing of starch before acetylation triggered changes in the properties of the modified preparations. It contributed to a higher degree of starch substitution with acetic acid residues and to the increased swelling power of starch. Both these properties were also affected by the annealing temperature. The highest resistance to amylolysis was found in the case of the starch preparation annealed at 53.5 °C and acetylated. The double modification involving annealing and acetylation processes increased the onset and end pasting temperatures compared to the acetylation alone. Similar observations were made for the consistency coefficient and yield point.

Background: The introduction of a medicines verification and decommissioning system into the hospital pharmacy may result in an increased workload for pharmacy staff. The pilot implementation allows us to understand all the implications of the process, optimize process workflows, and estimate the time and cost of implementation. Methods: All the packages received at the hospital pharmacy had a 2D data matrix codes and were scanned. We analyzed the time needed to unpack a variety of products, scan them, and receive the notification. Results: In total, 144 packages were scanned at an average time of 3.05 s, with most (86.9%) under 4 s. Manual decommissioning using handheld scanners was less efficient than the automated solution tested and resulted in an additional 0.4 full-time equivalent hours per million packages per year. The pattern and total time of manual scanning depended not only on the quantity but also the size of the package and type of packing. Conclusions: This evaluation of scanning performance allows optimizing the process at operational, technical, and resource levels for medicine verification and decommissioning.

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