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Patients perspectives on drug shortages in six European hospital settings – a cross sectional study
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Metrics details. This study aimed to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Furthermore, we wanted to explore information preferences on drug shortages. A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. Recruitment and data collection was conducted over 27 months from November until January Overall, we surveyed patients which completed paper-based questionnaire. Questions related to: general information demographic data , basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing v 3. H-BiH had the highest number of affected patients In addition, Majority of these patients Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. One possible interpretation is that good hospital management practices by healthcare professionals helped to mitigate the perceived impact of shortages. Our study highlights the importance of a good communication especially between patients and healthcare professionals in whom our patients have the greatest trust. Peer Review reports. Medicine shortages represent a significant public health problem that deserves the joint attention of governments and industries \[ 1 , 2 , 3 \]. An increasing number of studies over the past decade report a higher frequency of drug shortages that lead to a high burden of the long-term supplies of key medicines worldwide \[ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 \]. As the World Health Organization WHO has stated, on top of additional costs for health systems, shortages pose risks to the health of patients who fail to receive the medicines they need. This leads to an increased risk of medication errors, adverse drug events or even death \[ 11 \]. Norepinephrine shortage is one of the best example of that, as is it led to higher in-hospital mortality in patients with septic shock despite the available alternative \[ 12 \]. In order to reduce these effects, clinicians routinely operate in crisis mode \[ 2 \]. The most affected therapeutic areas were infectious diseases, oncology, emergency medicine, cardiovascular medicine and anesthesia. Furthermore, the shortage of one medicine has the potential to expand to other generic substitutes or alternatives, and severely limit patient care despite the best mitigation efforts of hospital pharmacists and other healthcare workers \[ 16 , 17 \]. Drug shortages represent a major challenge for all stakeholders involved in the process of providing medication e. They lead to significant healthcare burden. The cost and time related to the labor it takes for hospitals to manage drug shortages and maintain quality patient care is million US dollars per year in additional labor costs for pharmacists, pharmacy technicians, physicians, nurses \[ 2 \]. Consequences of drug shortages also include: increases in drug budget; lost revenue from cancelled infusions and procedures; increased numbers of fulltime pharmacy and technician employees; reallocation of pharmacy resources, which leads to lost productivity and impact in other areas; negative impact on patient care \[ 18 \]. Among all the problems that stem from drug shortages, patient safety stands out as the most crucial and critical \[ 1 , 19 , 20 , 21 \]. Michaud et al. The study found that as a result, some patients altered their medications without professional consultation and others because of a hydroxychloroquine shortage. This is a significant finding, as clinicians have to be aware when patients stop taking their medications without a recommendation from a health professional. Therefore the aim of this study was gathering contemporary data on patients-perceived drug shortages experience and their view on outcomes in different European hospital settings taking into account a humanistic approach. In addition, we wanted to explore information preferences on drug shortages. We conducted retrospective, cross sectional mixed method study in six hospital settings in six European countries. The questionnaire consisted of combined quantitative multiple choice and qualitative open-ended questions. Characteristics of hospitals are shown in Table 1. A cover letter explaining the aim of this study together with a patient friendly leaflet and questionnaire was provided. To improve the response rate a principal investigator with the help from EAHP staff, sent reminders for the study via email, an online information platform EAHP monitor and social networks. We used non-probability convenience sampling method because it is the least expensive, the least time consuming and one of the most convenient method to use. Moreover, we expected similar answers from respondents. The extended data collection period was to allow for a wide range of naturally occurring medication shortages, and to enable a large and geographically distributed selection of hospitals to participate. Patients completed the survey by paper. Inclusion criteria included at least one day of hospitalization overnight, inpatient , and being of age 18 years or older. As we did not find questionnaire in the literature that met our expectations, we designed questions based on our professional experiences in dealing with drug shortages. At first stage two authors of the study developed a questionnaire which was checked by two experts in drug shortages. Questionnaire was then modified and adapted to their suggestions which they checked again and approved. Subsequently, two other experts and non-experts in this field corroborated the questionnaire. After final approval, author of the study validated questionnaire on convenience sample of 50 patients even distribution of both sexes. Final questionnaire consisted of sixteen main questions and eight sub-questions altogether twenty four questions. Fourteen of these were single-selection multiple-choice questions, one was a multi-selection multiple choice question, three were dichotomous questions and six were open-ended. Questions related to general information demographic data , basic knowledge on drug shortages, drug shortages experienced during hospitalization and information preferences on drug shortage. Furthermore, as authors and pilot tested patients agreed on unambiguous and easy to comprehend drug shortage definition and questions, authors concluded that the questionnaire is reliable. The full questionnaire is available in the supplementary material. A generic substitute is a medicine with the same active substance as the drug you a patient are taking but produced by another manufacturer. All methods were carried out in accordance with relevant guidelines and regulations. Survey administration was preceded by informed consent. All participant information obtained during the study was kept confidential. All data are presented in absolute and relative frequencies. Differences are between hospital settings and not between countries. The frequencies of obtained answers were compared with each other between different hospitals. These differences were analyzed using chi-squared test, unless required assumptions were not met i. For age, trends were analyzed using the Cochran-Armitage trend test. We gave patients ' opinion as a textual answer. As this approach is extremely difficult to analyze and objectively present as size or number and compare attitudes between people, Word cloud was used as the best available option. This graphically shows exactly what patients were thinking and talking about when asked about drug shortages. From answered questionnaires, and patients did not answer to questions referring to their own definition on drug shortages and preference on information on drug shortages questions 7 and 16 b. Occupation data is provided in the supplementary material. Detailed tables are available in the supplementary material. Patents reported if they believed they had been affected by a drug shortage while hospitalized. Of the patients that participated in the study, 6. The hospital with highest level of patient-perceived drug shortage was H-BiH with Lack of a substitute drug resulted in treatment cancellation in three cases 7. Patients who believed they had been affected by a drug shortage were asked if they believed the drug shortage had negatively affected their health. Of the An open question allowing patients to express their opinion on how a drug shortage had or might affect their health, was answered by all respondents. The text of these answers was translated into English using Google translate, validated by the co-investigators and aggregated to produce an illustrative word cloud Fig. Overall, most patients Majority of patients Patients differ in their preferences for receiving information on drug shortages. Aim of this study was to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. This provides new insight into the relationship between hospital pharmacists and other healthcare professionals, who appear to be taking measures to successfully mitigate shortage impact on patient care. The indicated finding is important as healthcare and hospital policies are often inadequate e. Consequently, institutions often response in isolation, uncoordinated with each other and management may differ between them. Moreover, hospitals often use different approaches to certain shortages and can be unaware of shortages their neighbors are facing \[ 2 \]. Our study specifically addressed just patients at the day of discharge from hospital and shortages of drugs that did not have generic substitutes. We note that according to the EAHP survey \[ 14 \] Bosnia and Herzegovina has been identified as the country most affected by drug shortages, in terms of both mean duration and frequency. This provides support to our findings of high levels of patient-reported shortages occurring in that country. Despite efforts by healthcare professionals to mitigate drug shortages, they often cannot be mitigated. Furthermore, our results should be taken into account when considering that antimicrobial, oncology, emergency and critical care drugs are increasingly unavailable due to pricing or withdrawal from the market. In addition, when they are withdrawn from the market for reasons other than safety or efficacy, there are limited mechanisms to ensure they remain available to patients that need them \[ 3 , 7 , 12 , 17 , 33 , 34 \]. This is especially true for those hospitalized in hematology and oncology wards where therapy is time dependent and any delay or cancellation can lead to serious long-term consequences \[ 1 , 25 , 33 , 35 , 36 \]. In addition, our findings are in line with a recent systematic review of 40 studies by Phuong et al. Notwithstanding the fact that most supply disruptions and drug shortages occur in areas where a good alternative therapy is available, with minimum health implications for patients \[ 19 \], our results demonstrated drug shortages have clinical significance from the patients point of view as they confirmed that their health worsened due to postponed or cancelled treatment. In addition, this correlates with other respondents who did not experience drug shortages but gave the opinion that shortages could have negative affect on their health. This study shows the importance of patients being made aware that there are alternative treatment options when no generic substitute is available. Although, withholding information on drug shortages is done primarily to avoid causing additional patient anxiety, particularly if only minor effects are anticipated \[ 38 \], informing patients of the alternative treatment process may lead to better outcomes. One example is a research by van Langenberg et al. Patients were actively participating in the study by reporting these adverse events, having been made aware that they were receiving an alternative treatment. All of them had prompt resolution of symptoms upon cessation of alternative therapy \[ 39 \]. By prioritizing these patients for original treatment when available, possibility of therapy discontinuation and therefore health deterioration is reduced to a minimum. We suggest that the reason patients from H-BiH wanted to be informed of drug shortages through all possible information channels is because of the high levels of patient awareness of drug shortages. In contrast to them, patients from H-CR had the least desire to be informed due to less number of affected patients by drug shortages. Lower levels of awareness and not understanding the problem, combined with impatience to be discharged from the hospital as soon as possible, may have resulted in a bias leading to lack of response to the final question of the questionnaire. Moreover, despite the fact that patients from H-SE was the hospital with fewest affected patients, they did not know if they wanted to be informed about drug shortages while hospitalized. This could be due to the immediate impact to awareness caused by participating in this survey, but not being able to decide if this is important or not as had not experienced it. To support this, regulatory authorities should establish carefully planned communication strategies using various tools. These could be the ones preferred by patients in our study such as local or national press releases, television, information leaflets, and websites of national authority. Our primary goal was understanding the perspective of hospitalized patients and this study is not representative of a general population or a general patient population. Due to convenience sampling, after achieving required or almost required minimal number of participants, investigators stopped collecting further data. This explains limitation of our sample size and further studies should survey larger patient populations. While each ethics committee approval was received at each hospital where this survey was administered, a number of hospitals declined approval fearing that interviewed patients would become distressed at the prospect of there having been a drug shortage and may lose trust in the hospital system. Future studies should attempt to address this concern and thus broaden participation. Healthcare professionals, especially hospital pharmacists, are on the frontline of drug shortages where they must alleviate the impact on patient care. They reported that their health worsened. H-BiH was the most affected. This finding highlights the complexity of the problem, the lack of systemic awareness of drug shortages, and lack of adequate attention from national regulatory bodies in European countries. Establishing systematic, timely and transparent reporting is the foundation of a patient-centered approach to drug shortages. Information provided through various communication channels should provide patients with practical and understandable ways that shortages are being mitigated. Drug shortages will continue to impact patient care however, the approaches we have uncovered and advocated in this study could help mitigate the issue by actively involving patients as a part of a systemic solution. The country name for the author affiliation 12 was wrong due to a typesetting error. It has been changed from Greece to Bosnia and Herzegovina. Process of translation and adaptation of instruments. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. Drug shortages: a complex health care crisis. Mayo Clin Proc. Longitudinal Trends in U. Acad Emerg Med. Article Google Scholar. Eur J Hosp Pharm. Systematic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages in 28 European and Western Asian countries. The French reporting system for drug shortages: description and trends from to an observational retrospective study. BMJ Open. Medicine shortages in Australia: a snapshot of shortages in Australian hospitals. Accessed: Canadian Pharmacists Association. Ottawa: Canadian Pharmacists Association. Medicines shortages. Global approaches to addressing shortages of essential medicines in health systems. WHO Drug Inf. Google Scholar. J Crit Care. Heparin Drug Shortage Conservation Strategies. Fed Pract. Drug shortages and labor costs, Measuring a hidden cost of drug shortages on U. Casassus B. Europe urged to take action on drug shortages. Appl Health Econ Health Policy. Drug shortages in the United States: a critical evaluation of root causes and the need for action. ACR Open Rheumatol. Impact of drug shortages on patients receiving parenteral nutrition after laparotomy. Anesth Analg. National survey on the effect of oncology drug shortages on cancer care. Am J Health Syst Phar. A longitudinal cohort study on the impact of the clobazam shortage on patients with epilepsy. Can J Cardiol. Effects on patient care caused by drug shortages: a survey. J Manag Care Pharm. PLoS One. Chemotherapy drug shortages in paediatric oncology: A year single-centre experience in Belgium. J Oncol Pharm Pract. R Core Team. R: A language and environment for statistical computing. Drug shortage management: A qualitative assessment of a collaborative approach. Published Apr Broken drug markets in infectious diseases: Opportunities outside the private sector? Cancer Treat Res. Article PubMed Google Scholar. Goldsack J. Impact of shortages of injectable oncology drugs on patient care. The impact of drug shortages on children with cancer—the example of mechlorethamine. N Engl J Med. Phuong, J. The impacts of medication shortages on patient outcomes: A scoping review. PloS one. Schleipman, A. Narrative Inquiry in Bioethics. Outcomes of a drug shortage requiring switching in patients with ulcerative colitis. World J Gastrointest Pathophysiol. Download references. Additionally, we would like to share our gratitude to all hospital teams and all the patients that actively participated and therefore significantly contributed to the study. You can also search for this author in PubMed Google Scholar. DKP conceptualized the study with contribution from HJ. DKP wrote the study. DK performed the statistical analysis. RF and DGS critically revised the manuscript. All authors contributed to manuscript revision, read, and approved the submitted version. Correspondence to Darija Kuruc Poje. Additionally, co-investigators who agreed to participate in data collection translated survey questions and verified them for accuracy and appropriate understanding of the country-specific arrangements by checking documents, legal acts, and regulations pertinent to each country. Survey administration was preceded by informed consent to participate. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Reprints and permissions. Kuruc Poje, D. Patients perspectives on drug shortages in six European hospital settings — a cross sectional study. Download citation. Received : 28 January Accepted : 30 June Published : 12 July Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. This article has been updated. Methods A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. Conclusions Although drug shortages led to serious medical consequences, our findings show that most of the patients did not perceive shortages as a problem. Background Medicine shortages represent a significant public health problem that deserves the joint attention of governments and industries \[ 1 , 2 , 3 \]. Methods Study design We conducted retrospective, cross sectional mixed method study in six hospital settings in six European countries. Table 1 Characteristics of hospitals Full size table. Table 2 Sex and age - comparisons are made between hospitals Full size table. Patient-perceived drug shortages while hospitalized. Full size image. Patient-perceived drug shortage impact on their health. Opinions of patients on impact of drug shortages on their health. Discussion Patient-perceived drug shortages experience and view on outcomes Aim of this study was to investigate the patients-perceived drug shortages experience and their view on outcomes in different European hospital settings. Willingness to be informed This study shows the importance of patients being made aware that there are alternative treatment options when no generic substitute is available. Limitations and recommendations for the future Our primary goal was understanding the perspective of hospitalized patients and this study is not representative of a general population or a general patient population. Change history 30 July The country name for the author affiliation 12 was wrong due to a typesetting error. References Woodcock J, Wosinska M. Funding Not applicable. View author publications. Consent for publication Not applicable Competing interests The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Supplementary Information. Additional file 1. Additional file 2. About this article. Cite this article Kuruc Poje, D. Copy to clipboard. Contact us General enquiries: journalsubmissions springernature.
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Patients perspectives on drug shortages in six European hospital settings – a cross sectional study
Chania buying MDMA pills
Chania buying MDMA pills
Patients perspectives on drug shortages in six European hospital settings – a cross sectional study
Chania buying MDMA pills
Chania buying MDMA pills
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