Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications

Introduction: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. Methodology: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. Results: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. Conclusion: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe. © Copyright © 2020 Miljković, Godman, Kovačević, Polidori, Tzimis, Hoppe-Tichy, Saar, Antofie, Horvath, De Rijdt, Vida, Kkolou, Preece, Tubić, Peppard, Martinez, Yubero, Haddad, Rajinac, Zelić, Jenzer, Tartar, Gitler, Jeske, Davidescu, Beraud, Kuruc-Poje, Haag, Fischer, Sviestina, Ljubojević, Markestad, Vujić-Aleksić, Nežić, Crkvenčić, Linnolahti, Ašanin, Duborija-Kovačević, Bochenek, Huys and Miljković

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed

Prescriptions parameters, data of pharmacotherapy and educational intervention in patients of Social Care

Objective:The aim of this study was to make a systematic registration, in the population group of Social Care indigent patients, of their pharmaceutical needs, the data of their prescriptions, their knowledge about the use of drugs,their nutrition patterns, the cost of their medication in comparison with data from a population of patients, who are covered by Social Security and to examine the results of a health intervention among Social Care indigent patients. Participants:551 indigent patients insured by Social Care visited the Hospital Pharmacy of Chania. Genaral Hospital compared to 551 patients insured under Social Security Funds visited three Community Pharmacies. The time of the study was from 01/01/95 to 31/12/97. Results: Total population: The socio-demographic profiles of this group reveal an unemployment rate of 95% and an illiteracy rate of 21%. As regards marital status, 20% were bachelors and 12% divorcees. The socio-demographic profiles of the Social Care children reveal an illiteracy rate of 9.7% versus 0% of the Social Security children (ages 6-18). High school attended 13.1% versus 25.9% (ages 12-18). For both groups, the most common drugs categories as D.D.D. were for Cardiovascular system (30% versus 26%), Gastrointestinal system (17% versus 27%) and Nervous system (16% versus 18%). The first diagnosis was Hypertension (10% versus 8%) and the most common drugs were Ranitidine (3% versus 2%), Diclofenac (3% versus 3%), Salbutamol (3% versus 3%) and Paracetamol (2% versus 2%).Σκοπός:της παρούσης εργασίας είναι η μελέτη της συνταγογραφίας, της φαρμακοθεραπείας, των συνηθειών διατροφής, των φαρμακο-οικονομικών συνταγογραφικών παραμέτρων ασθενών υπό την προστασία της Κοινωνικής Πρόνοιας συγκριτικά με ασθενείς ασφαλισμένους στα Ασφαλιστικά Ταμεία. Επίσης η εκτίμηση ενημερωτικής παρέμβασης στην πληθυσμιακή ομάδα των ασθενών της Κοινωνικής Πρόνοιας. Πληθυσμός:Οι συμμετέχοντες ήταν 551 ασθενείς ασφαλισμένοι της Κοινωνικής Πρόνοιας (οι άποροι και τα προστατευόμενα μέλη τους, οι ανασφάλιστοι Ελληνες μετανάστες, οι επαναπατριζόμενοι Ελληνες με τις οικογένειές τους και γενικά όλοι όσοι δεν έχουν ασφαλιστική κάλυψη από ασφαλιστικό φορέα) οι οποίοι επισκέφθηκαν το Φαρμακευτικό τμήμα του Νοσοκομείου Χανίων. Ομάδα σύγκρισης αποτέλεσαν 551 ασθενείς Ασφαλιστικών Ταμείων οι οποίοι επισκέφθηκαν τρία ιδιωτικά Φαρμακεία των Χανίων.Η μελέτη έγινε στο διάστημα 01/01/95-31/ 12/97. Αποτελέσματα: Στο σύνολο των ασθενών:Η δημογραφική κατανομή των ασθενών της Κοινωνικής Πρόνοιας έχει σημαντικές ιδιαιτερότητες. Το 20% ήταν άγαμοι (μεγαλύτεροι των 18 ετών), 12% διαζευγμένοι, 21% αγράμματοι και 95% άνεργοι (Ρ<0.05). Τα παιδιά της Πρόνοιας, παρουσίασαν 9.7% αγραμμάτων (6-18 ετών) έναντι 0% των παιδιών των Ταμείων (Ρ<0.05). Οι μαθητές στη Μέση εκπαίδευση ήταν 13.1% έναντι 25,9% (12-18 ετών)(Ρ<0.05)

Παράμετροι συνταγογραφίας, δεδομένα φαρμακοθεραπείας και ενημερωτική παρέμβαση στους ασθενείς της κοινωνικής πρόνοιας

Objective:The aim of this study was to make a systematic registration, in the population group of Social Care indigent patients, of their pharmaceutical needs, the data of their prescriptions, their knowledge about the use of drugs,their nutrition patterns, the cost of their medication in comparison with data from a population of patients, who are covered by Social Security and to examine the results of a health intervention among Social Care indigent patients. Participants:551 indigent patients insured by Social Care visited the Hospital Pharmacy of Chania. Genaral Hospital compared to 551 patients insured under Social Security Funds visited three Community Pharmacies. The time of the study was from 01/01/95 to 31/12/97. Results: Total population: The socio-demographic profiles of this group reveal an unemployment rate of 95% and an illiteracy rate of 21%. As regards marital status, 20% were bachelors and 12% divorcees. The socio-demographic profiles of the Social Care children reveal an illiteracy rate of 9.7% versus 0% of the Social Security children (ages 6-18). High school attended 13.1% versus 25.9% (ages 12-18). For both groups, the most common drugs categories as D.D.D. were for Cardiovascular system (30% versus 26%), Gastrointestinal system (17% versus 27%) and Nervous system (16% versus 18%). The first diagnosis was Hypertension (10% versus 8%) and the most common drugs were Ranitidine (3% versus 2%), Diclofenac (3% versus 3%), Salbutamol (3% versus 3%) and Paracetamol (2% versus 2%).Σκοπός:της παρούσης εργασίας είναι η μελέτη της συνταγογραφίας, της φαρμακοθεραπείας, των συνηθειών διατροφής, των φαρμακο-οικονομικών συνταγογραφικών παραμέτρων ασθενών υπό την προστασία της Κοινωνικής Πρόνοιας συγκριτικά με ασθενείς ασφαλισμένους στα Ασφαλιστικά Ταμεία. Επίσης η εκτίμηση ενημερωτικής παρέμβασης στην πληθυσμιακή ομάδα των ασθενών της Κοινωνικής Πρόνοιας. Πληθυσμός:Οι συμμετέχοντες ήταν 551 ασθενείς ασφαλισμένοι της Κοινωνικής Πρόνοιας (οι άποροι και τα προστατευόμενα μέλη τους, οι ανασφάλιστοι Ελληνες μετανάστες, οι επαναπατριζόμενοι Ελληνες με τις οικογένειές τους και γενικά όλοι όσοι δεν έχουν ασφαλιστική κάλυψη από ασφαλιστικό φορέα) οι οποίοι επισκέφθηκαν το Φαρμακευτικό τμήμα του Νοσοκομείου Χανίων. Ομάδα σύγκρισης αποτέλεσαν 551 ασθενείς Ασφαλιστικών Ταμείων οι οποίοι επισκέφθηκαν τρία ιδιωτικά Φαρμακεία των Χανίων.Η μελέτη έγινε στο διάστημα 01/01/95-31/ 12/97. Αποτελέσματα: Στο σύνολο των ασθενών:Η δημογραφική κατανομή των ασθενών της Κοινωνικής Πρόνοιας έχει σημαντικές ιδιαιτερότητες. Το 20% ήταν άγαμοι (μεγαλύτεροι των 18 ετών), 12% διαζευγμένοι, 21% αγράμματοι και 95% άνεργοι (Ρ<0.05). Τα παιδιά της Πρόνοιας, παρουσίασαν 9.7% αγραμμάτων (6-18 ετών) έναντι 0% των παιδιών των Ταμείων (Ρ<0.05). Οι μαθητές στη Μέση εκπαίδευση ήταν 13.1% έναντι 25,9% (12-18 ετών)(Ρ<0.05)

Patients perspectives on drug shortages in six European hospital settings : a cross sectional study

BACKGROUND: It is known that drug shortages represent a major challenge for all stakeholders involved in the process, but there is little evidence regarding insights into patients′ awareness and perspectives. 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. METHODS: A retrospective, cross sectional, a mixed method study was conducted in six European hospital settings. One hospital (H) from each of this country agreed to participate: Bosnia and Herzegovina (H-BiH), Croatia (H-CR), Germany (H-GE), Greece (H-GR), Serbia (H-SE) and Poland (H-PO). Recruitment and data collection was conducted over 27 months from November 2017 until January 2020. Overall, we surveyed 607 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. Differences between hospital settings were analyzed using Chi-squared test or Fisher’s exact test. For more complex contingency tables, Monte Carlo simulations (N = 2000) were applied for Fisher’s test. Post-hoc hospital-wise analyses were performed using Fisher’s exact tests. False discovery rate was controlled using the Bonferroni method. Analyses were performed using R: a language and environment for statistical computing (v 3.6.3). RESULTS: 6 % of patients reported experiences with drug shortages while hospitalized which led to a deterioration of their health. The majority of affected patients were hospitalized at hematology and/or oncology wards in H-BiH, H-PO and H-GE. H-BiH had the highest number of affected patients (18.1 %, N = 19/105, p < 0.001) while the fewest patients were in H-SE (1 %, N = 1/100, p = 0.001). In addition, 82.5 %, (N = 501/607) of respondents wanted to be informed of alternative treatment options if there was a drug shortage without a generic substitute available. Majority of these patients (66.4 %, N = 386/501) prefer to be informed by a healthcare professional. CONCLUSIONS: 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12913-021-06721-9