Evaluation of the establishment of a national task force - A systematic measure to manage critical drug shortages in hospitals.

Introduction: Drug shortages (DSs) have become a well-known challenge in health care, and serious patient safety consequences, such as medication errors and adverse patient outcomes are reported. To meet these challenges, a national task force was established to manage and minimize the impact of critical DSs' on hospitals in Denmark. Objective: To evaluate the establishment of the National Task Force for Critical Drug Shortages (NTF) in terms of quality, patient safety, and resources from different actor perspectives related to critical DS management in Danish hospitals. Methods: Five online focus group interviews were held with participants representing different actor perspectives, all of whom were involved in managing DSs. They represent actors from 1) the NTF; 2) hospital pharmacists not involved in the NTF but who manage DSs locally and/or regionally; 3) the procurement departments of hospital pharmacies; 4) pharmacy technicians performing clinical pharmacy services at a patient level, and 5) the procurement and supply unit at Amgros. Results: The thematic analysis revealed four major themes: 1) centralized management of critical DSs is predominantly considered to be positive, 2) collaboration and professional discussion across actors and actor levels, 3) mixed attitudes toward the current communication platforms and format, and 4) short supply of time. Conclusion: The NTF ensures a consistent and qualified management of critical DSs. The NTF ensures the evaluation of different patient safety aspects related to identification of a suitable alternative. Challenges with the communication platform and transparency of the process from the NTF toward hospital pharmacy were mentioned but overall, the NTF contributes to a successful use of resources in health care.

Drug change: 'a hassle like no other'. An in-depth investigation using the Danish patient safety database and focus group interviews with Danish hospital personnel.

BACKGROUND: Drug change (DC) is a common challenge in Danish hospitals. It affects the work of hospital personnel and has potentially serious patient safety consequences. Focus on medication safety is becoming increasingly important in the prevention of adverse events. The aim of this study is to identify and describe patient safety challenges related to DCs, and to explore potential facilitators to improve patient safety in the medication process in Danish hospital setting. METHOD: Two qualitative methods were combined. Data were obtained from the Danish Patient Safety Database (DPSD) containing incidents reports of adverse events related to DCs. Additionally, five semi-structured focus group interviews with hospital personnel (doctors, nurses, pharmacists and pharmacy technicians) from the five regions of Denmark were held. RESULTS: The DPSD search identified 88 incidents related to DCs due to tender or drug shortage. The incidents were linked to prescribing errors, incorrect dose being dispensed/administered, and delayed/omitted treatment. Four themes from the interviews emerged: (1) challenges related to the drug itself; (2) situational challenges; (3) challenges related to the organization/IT systems/personnel; (4) facilitators/measures to ensure patient safety. CONCLUSION: DC is as a complex challenge, especially related to drug shortage. The results allow for a deeper understanding of the challenges and possible facilitators of DCs on the individual and organizational level. Pharmacy personnel were identified to play a key role in ensuring patient safety of DCs in hospitals. Indeed, this emphasizes that pharmacy personnel should be engaged in developing patient safety strategies and support hospital personnel around drug changes.

Evaluation of sources to document extended shelf lives of compounded cytostatics.

BACKGROUND: Due to the increasing demand for compounded cytostatics, future compounding of these drugs has to include automated production and improved logistics, and in both cases batch production for stockholding is needed. This set-up would also meet future staff shortages. Stockholding requires documentation of extended shelf lives in the range of minimum 1-3 months. Documentation is often provided by summary of product characteristics, data provided by the industry which is not included in the summary of product characteristics and data from literature. OBJECTIVE: To evaluate the quality of the three main stability data sources used by hospital pharmacies when assessing extended shelf lives of compounded cytostatics. METHODS: A total of 150 summary of product characteristics for fluorouracil, cyclophosphamid, oxaliplatin, cisplatin, doxorubicin, paclitaxel, vincristin, irinotecan, epirubicin, gemcitabin, docetaxel, carboplatin and cytarabin were examined regarding available information on how to handle the compounded product. A survey of literature for shelf lives for cyclophosphamide, fluorouracil, oxaliplatin and gemcitabine has been made. Dialogues with 14 suppliers of cytostatica have been conducted to clarify the possibility of expanding the fluorouracil information on shelf lives to include information on extended shelf lives of compounded products. RESULTS: The analysis showed that often the information on shelf life stated in the summary of product characteristic is very short and sparse in basic information regarding the compounded product. The dialogues with the companies revealed that longer shelf lives will probably not be stated in the summary of product characteristic, and the literature review revealed very different stability data and uncertainty on the validity of the obtained data. CONCLUSION: None of these data sources can be applied as documentation for extended shelf lives and it is crucial to document the extended stability yourself.