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Pharmacy 2017, 5(4), 63;

Hospital Audit as a Useful Tool in the Process of Introducing Falsified Medicines Directive (FMD) into Hospital Pharmacy Settings—A Pilot Study

Department of Public Health, Medical University of Warsaw, Banacha 1a, 02-097 Warsaw, Poland
First Department of Cardiology, Medical University in Gdansk, Dębinki 7, 80-952 Gdańsk, Poland
Institute of Logistics and Warehousing, Ewarysta Estkowskiego 6, 61-755 Poznań, Poland
National Medicines Institute, Chełmska 30/34, 00-725 Warsaw, Poland
Department of Applied Pharmacy, Medical University of Lublin, Chodźki 1, 20-093 Lublin, Poland
Hospital Pharmacy, Mazowiecki Szpitala Specjalistyczny w Ostrołęce, Al. Jana Pawła II 120 A, 07-410 Ostrołęka, Poland
Community Pharmacy, Poland
Quizit Sp. z. o. o., Unit Dose, Sprinterów 2/6, 94-022 Łódź, Poland
Department of Paediatrics, University of Oxford, Level 2, Children’s Hospital, John Radcliffe, Headington, Oxford OX3 9DU, UK
The Oxford—UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), The University of Oxford, Tavistock Square, London WC1H 9JP, UK
Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, BMA House, Tavistock Square, London WC1H 9JP, UK
Harvard Stem Cell Institute, Cambridge, MA 02138, USA
USCF-Stanford Centre of Excellence in Regulatory Science and Innovation (CERSI), San Francisco, CA 94158, USA
Department of Pharmaceutical Technology, Faculty of Pharmacy Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, 85-089 Bydgoszcz, Poland
Author to whom correspondence should be addressed.
Received: 4 October 2017 / Revised: 5 November 2017 / Accepted: 6 November 2017 / Published: 9 November 2017
(This article belongs to the Section Pharmacy Education and Student / Practitioner Training)
Full-Text   |   PDF [221 KB, uploaded 13 November 2017]


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. View Full-Text
Keywords: hospital pharmacy; pharmacist; pharmaceutical law; point of authentication; patient safety; Falsified Medicines Directive hospital pharmacy; pharmacist; pharmaceutical law; point of authentication; patient safety; Falsified Medicines Directive
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Religioni, U.; Swieczkowski, D.; Gawrońska, A.; Kowalczuk, A.; Drozd, M.; Zerhau, M.; Smoliński, D.; Radomiński, S.; Cwalina, N.; Brindley, D.; Jaguszewski, M.J.; Merks, P. Hospital Audit as a Useful Tool in the Process of Introducing Falsified Medicines Directive (FMD) into Hospital Pharmacy Settings—A Pilot Study. Pharmacy 2017, 5, 63.

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