Abstract
Objective: This study aimed to obtain a comprehensive overview on the perception, attitudes, and experience of European pharmacists with prospective risk assessment procedures in everyday practice, as well as to identify challenges and solutions. This is a follow-up study to the surveys on prospective risk assessment previously carried out within the COST Action 15105 among pharmacists across Europe.Methodology: In-depth interviews were performed using an interview guide comprising 25 questions. Interviews were transcribed ad verbatim and imported into NVivo 10 for framework analysis. In NVivo, the interviews were coded through assigning text segments to a responding code from a coding tree, covering the full content of the interviews. Coded text segments were then charted into a matrix, and analyzed by interpreting all text segments per code.Results: In total, 18 interviews were conducted. From the framework analysis, 6 codes and 12 sub-codes emerged. Overall, despite citing specific issues pertaining to its implementation, the interviewees considered multi-stakeholder and multi-disciplinary prospective risk assessment to be essential. While healthcare professionals reported being aware of the importance of risk assessment, they cited insufficient knowledge and skills to be a major obstacle in everyday practice. They also reported inadequate IT support since a paper-based system is still widely in use, thereby complicating data extraction to carry out prospective risk assessment.Conclusion: While prospective risk assessment was found to be valuable, interviewees also found it to be a resource-intensive and time-consuming process. Due to resource constraints, it may not be possible or desirable to conduct prospective risk assessment for every shortage. However, for critical-essential drugs, it is crucial to have a ready-to-use substitute based on risk assessment. Moreover, potential risks of substitutes on patient health should be identified before a shortage occurs and the substitute is dispensed as an alternative.
Highlights
The impact on patient morbidity and mortality as a result of medicine shortages is well-recognized by all key stakeholder groups including national regulatory authorities globally [1,2,3,4,5]
Verbal agreement from all interviewees was obtained. This interviewing process built on a previous survey on prospective risk assessment conducted within the COST Action 15105 among 34 healthcare professionals (HCPs) from 26 European countries [34]
When developing risk assessment strategies, a majority of interviewees do report using primary methodological data sources that consisted of: (i) consulting existing materials on the Internet, which serves as a tool for accessing scientific publications on risk stratification and therapeutic guidelines; (ii) official websites of national medicine-regulatory bodies in Europe and the USA; (iii) healthcare-professional associations; and (iv) quality and safety information in healthcare departments
Summary
The impact on patient morbidity and mortality as a result of medicine shortages is well-recognized by all key stakeholder groups including national regulatory authorities globally [1,2,3,4,5]. Risks must be actively differentiated based on: (i) a shortage’s frequency; (ii) the availability and unavailability of treatment options and (iii) providing alternatives but not accounting for a patient’s clinical status [8]. Changing treatment when a shortage occurs brings about uncertainties as the order, preparation or dispensing procedures that are needed may change, which may lead to medication errors [7]. This can breed unfamiliarity with the dosing schedules, adverse-effect profiles, and treatment efficacy for therapeutic alternatives among healthcare workers [7, 9, 10]. Concerns and unfamiliarity can be enhanced if therapeutic alternatives have not been agreed in advance [11]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
