Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process.

Objective: This review aimed to assess the current use and acceptance of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) process. It additionally aimed to discern stakeholders' viewpoints concerning RWD and RWE in HTA and illuminate the obstacles, difficulties, prospects, and consequences associated with the incorporation of RWD and RWE into the realm of HTA. Methods: A comprehensive PRISMA-based systematic review was performed in July 2022 in PubMed/Medline, Scopus, IDEAS-RePEc, International HTA database, and Centre for Reviews and Dissemination with ad hoc supplementary search in Google Scholar and international organization websites. The review included pre-determined inclusion criteria while the selection of eligible studies, the data extraction process and quality assessment were carried out using standardized and transparent methods. Results: Twenty-nine (n = 29) studies were included in the review out of 2,115 studies identified by the search strategy. In various global contexts, disparities in RWD utilization were evident, with randomized controlled trials (RCTs) serving as the primary evidence source. RWD and RWE played pivotal roles, surpassing relative effectiveness assessments (REAs) and significantly influencing decision-making and cost-effectiveness analyses. Identified challenges impeding RWD integration into HTA encompassed limited local data access, complexities in non-randomized trial design, data quality, privacy, and fragmentation. Addressing these is imperative for optimal RWD utilization. Incorporating RWD/RWE in HTA yields multifaceted advantages, enhancing understanding of treatment efficacy, resource utilization, and cost analysis, particularly via patient registries. RWE complements assessments of advanced therapy medicinal products (ATMPs) and rare diseases. Local data utilization strengthens HTA, bridging gaps when RCT data is lacking. RWD aids medical device decision-making, cancer drug reassessment, and indirect treatment comparisons. Challenges include data availability, stakeholder acceptance, expertise, and privacy. However, standardization, training, collaboration, and guidance can surmount these barriers, fostering enhanced RWD utilization in HTA. Conclusion: This study highlights the intricate global landscape of RWD and RWE acceptance in HTA. Recognizing regional nuances, addressing methodological challenges, and promoting collaboration are pivotal, among others, for leveraging RWD and RWE effectively in healthcare decision-making.

CLINICAL AND BEHAVIORAL PRACTICES OF PRIMARY HEALTHCARE PHYSICIANS IN ANTIBIOTICS PRESCRIBING IN GREECE.

OBJECTIVE: Aim: To evaluate primary health physicians' clinical and behavioral practices towards antibiotics administration in a specific region in Greece. PATIENTS AND METHODS: Materials and methods: A cross sectional study was conducted using a questionnaire in all structures of primary health care (PHC) of the Peloponnese Region. The study was conducted in May-October 2020. RESULTS: Results: In total, 306 out of 404 primary healthcare physicians completed the questionnaire (response rate of 75.8%). Our results showed that most of physicians used to prescribing antibiotics empirically in common diseases, except for the prevention of secondary respiratory tract infection. Overall, 66.3% answered that they do not feel diagnostic uncertainty that would lead them to prescribe antibiotics. Approximately 40% of the physicians stated an increase on antibiotics use and patients demand for antibiotic prescribing, however 71.4% "rarely/never" affected by this requirement. 51.9% of the sample used to prescribed brand name antibiotics. Statistically significant differences were found between demographic and professional characteristics, and physicians' clinical and behavioral practices (p≤ 0.05). CONCLUSION: Conclusions: Our findings could provide decision makers with information on how to manage antibiotic prescribing in primary health care in the country, focusing mainly on the use of specific diagnostic tests as well as relevant guidelines and protocols for changing prescription behavior.

Polypharmacy and Adherence Among Diabetic Patients in Greece.

Introduction Elderly patients are particularly susceptible to polypharmacy issues because of age-related changes in pharmacokinetics and pharmacodynamics as well as to chronic diseases resulting in a continuous increasing demand for drugs. Objective This study captures the prevalence of polypharmacy and adherence in Greece and identifies related risk factors in adult patients with diabetes. Design A cross-sectional study was conducted among patients diagnosed with diabetes mellitus attending public and private outpatients' clinics in the regions of Attica and Western Greece. Results A total of 644 outpatients filled out the questionnaire (relative risk = 91.7%). As far as the medications were concerned, 47.8% of patients had been receiving antidiabetic medication monotherapy, 38.2% combination therapy with two antidiabetic drugs, 11.8% with three drugs, and 2.2% with four drugs. The vast majority of diabetic patients adhered to their medication regimen, and fewer adhered to their physician's diet and physical activity recommendations. Statistically significant differences were found between age group and the existence of polypharmacy (P = 0.005). Additionally, 44.4% of patients with comorbidities exhibited polypharmacy, compared with 4.8% of patients who were diagnosed only with diabetes (P = 0.001). Conclusion The development of new strategies and health policies is necessary for polypharmacy and adherence among diabetic patients to be limited.

Health status and access to health services of female prisoners in Greece: a cross-sectional survey.

BACKGROUND: Self-reported health status of prisoners' population and access to health services during incarceration have not been adequately explored in Greece. The purpose of this study was to assess female prisoners' health status and access to healthcare in the Attica detention center "Korydallos". METHODS: A cross-sectional survey was carried out in 2014. A semi-structured questionnaire was developed, including questions on the prisoners' socio-demographic characteristics, self-reported health status before and after incarceration, access to and quality of the provided health services. Inmates who were in solitary confinement, suffered from serious psychiatric problems, or were unable to understand the Greek language were excluded from the study. Data were collected via personal interviews and information received was anonymized. Descriptive statistics and bivariate analyses were used. The difference between self-reported general health status prior to and during detention was analyzed by Wilcoxon test, while the relationship between health status and access to healthcare was explored with coefficient Spearman's rho. Statistical significance was set at p ≤ 0.05 level and statistical analysis was performed using the software SPSS 19. RESULTS: Of the 135 prisoners, 101 participated in the study. 60.4 % mentioned a moderate or poor health status, while the respective percentage before detention was 32.7 %. Health status deterioration and poor mental health were reported by more than half of the respondents. Additionally, the vast majority expressed raised feelings such as sadness, anxiety or discomfort which affected negatively their everyday life while in prison. Regarding risk factors during imprisonment; tobacco consumption has increased by 16.6 % and 7.9 % of the sample admitted having used drugs. Moreover, the access to and the quality of provided health services in prison were described as poor/ very poor by 46.5 % and 49.5 %, respectively. A significant correlation between the access to and the quality of health care services and health status was observed. CONCLUSION: Healthcare provision at the "Korydallos" prison is not satisfying since the access to as well as the quality of healthcare are not adequate. Imprisonment leads to deterioration of self-reported health status. Our findings should constitute a starting point for further research in order to introduce more effective interventions aiming at meeting prisoners' health needs.

Antibiotic resistance and irrational prescribing in paediatric clinics in Greece.

INTRODUCTION: Greece is among the countries with the highest rates of antimicrobial resistance (AMR) and simultaneous antibiotic consumption. AIM: The aim of this study was to assess the perceptions and knowledge of AMR and irrational antibiotic prescribing of nurses working in paediatric hospitals in Greece. METHOD: A self-administered questionnaire was distributed to nurses in paediatric hospitals and paediatric clinics in Greece. Descriptive and multivariate statistical analyses were performed. Levels of significance were two-tailed and statistical significance was p=0.05. RESULTS: A total of 87% of participants reported irrational prescribing to be an important cause of AMR. Diagnostic uncertainty was stated by 55.5% as the main cause of irrational antibiotic prescribing and 94% suggested the use of protocols and guidelines as the main measure to control overprescribing. Parental demand for antibiotics in hospitals has increased according to 51.8% of respondents. Strong correlation was observed between social-demographic characteristics and antibiotic resistance, as well as irrational prescribing. CONCLUSIONS: Assessing nurses' knowledge and perceptions of antimicrobial resistance and irrational prescribing is vital as nurses actively participate in the antibiotics administration process and antimicrobial management in Greece. Their involvement could contribute to educate patients and parents on the public-health implications of overprescribing and antimicrobial resistance.

Knowledge and beliefs of Greek parents towards HPV infection and vaccination - are they willing to vaccinate their sons?

OBJECTIVES: Human papillomavirus (HPV) stands as one of the prevalent sexually transmitted infections (STIs) and serves as the primary factor behind nearly all instances of cervical cancer, along with various other non-cancerous conditions like genital warts. Our objective was to explore the knowledge and beliefs of Greek parents regarding HPV infection and the vaccination of boys against HPV. METHODS: A cross-sectional study took place at a university hospital located in the Peloponnese region of Greece, from January to June 2021. The study employed convenience sampling as its methodology, and data gathering involved the distribution of self-administered questionnaires to parents who had at least one son between the ages of 9 and 18 years. RESULTS: The final sample consisted of 120 individuals. 65.8 % of parents have been informed about HPV vaccination, knew that the HPV vaccine provides immunity against genital warts (50 %), and that minimum of two doses is necessary (46.7 %). 30.8 % intended to vaccinate their boys against HPV if the vaccine were available for males. The most important reasons for vaccination were the perception that both genders share equal responsibility in the prevention of sexually transmitted infections (91.7 %) and the protection against cancer (87.6 %), whereas the fear of adverse reactions and the adequate knowledge about HPV-related diseases were most reported as reasons of the intentions to not vaccinate their sons with 31.7 % and 25.8 % respectively. CONCLUSIONS: Although parents participating in the study know about HPV, however, there are significant lack of knowledge regarding HPV infection and the vaccine effects, which can significantly affect the acceptance of vaccination for boys.

Budget impact analysis on erythropoiesis-stimulating agents use for the management of chemotherapy-induced anaemia in Greece.

BACKGROUND: Chemotherapy-induced anaemia is a common and significant complication of chemotherapy treatment. Blood transfusion and administration of Erythropoiesis-Stimulating Agents (ESAs) either alone or in combination with iron are the most widely used therapeutic options. In Greece, ESAs are among the top ten therapeutic groups with the highest pharmaceutical expenditure, since they are fully reimbursed by social security funds. The objective of the study is to determine potential cost savings related with the use of biosimilar over originator ESAs for the management of the newly diagnosed chemotherapy-induced anemic patients. METHODS: A budget impact analysis has been carried through the elaboration of national epidemiological, clinical and economic data. Epidemiological data derived from WHO (GLOBOCAN) and the European Cancer Anaemia Survey. Clinical data reflect oncology patients' disease management. ESAs consumption was based on data from the biggest social security fund (IKA). The administration of ESAs under different dosing schemes and time periods has been estimated by separating them in originators and biosimilars as well as by classifying anaemic patients in responders and non-responders. Cost analysis is based on newly diagnosed patients' alternative treatment scenarios. Treatment costs and prices are used in 2012 values. The Social Security Funds's perspective was undertaken. RESULTS: Based on the annual incidence rates, 2.551 newly diagnosed chemotherapy-induced anemic patients are expected to be treated with ESAs. Average cost of treatment on originators ESAs for responders is €2.887 for the 15-week ESAs treatment and €5.019 for non-responders, while on biosimilars €2.623 and €4.009 respectively. Treatment cost on biosimilars is 10.1% lower than originators for responders and 25.2% for non-responders. Budget impact estimates show that treating anemic patients with originator ESAs was estimated at €10.084.800 compared to €8.460.119 when biosimilar ESAs were used, leading to an overall 19,20% cost reduction favoring biosimilars. CONCLUSION: In Greece, the treatment on biosimilar ESAs seems to be a cost saving option over originators for the newly diagnosed chemotherapy-induced anemic patients, since it corresponds to 5% of the annual overall consumption and expands patients' access to ESAs treatment. Health care decision making should rely on evidence based treatments in order to achieve social funds' sustainability in an era of economic recession.

Factors Affecting the Implementation of Corporate Social Responsibility in the Health Technology Industry in Greece.

BACKGROUND: Corporate social responsibility (CSR) is an evolving business strategy worldwide, focusing on the sustainability of the enterprise and the provision of multiple benefits to the societies and economies. OBJECTIVE: The aim of this paper was to explore the encouraging and deterrent factors for the implementation of CSR actions in companies specializing in pharmaceutical and biomedical products as well as in medical equipment in Greece. METHODS: A cross-sectional study was conducted (April to June 2021) in member-companies of the Hellenic Association of Pharmaceutical Companies, the Panhellenic Association of Pharmaceutical Industry and the Association of Health-Research and Biotechnology Industry. Data collection was carried out via an anonymous, self-administered questionnaire. Descriptive and inferential statistical analyses were performed, using SPSS version 25 (IBM Corp., Armonk, NY, USA). The significance level was set at p≤0.05. RESULTS: One hundred twelve questionnaires were distributed, out of which 87 were returned (response rate 77.7%). 81.1% of companies included CSR in their annual strategy, while only 32.4% of them follow the Global Reporting Initiative standards. The majority (62.2%) disposes ≤€100.000 from their annual turnover for CSR actions. The contribution to society and the ethical commitment of the enterprise are stated as the main encouraging factors for CSR, while bureaucracy and the lack of incentives as deterrents. Pharmaceutical companies reported social acceptance as the major CSR enabler compared to other companies (p=0.034), while companies specializing only in medical equipment/biotechnology mentioned industry competition (p=0.003). Bureaucracy has been revealed as the major disincentive for all participating companies. Corporate advertising is found as an important encouraging factor for the adoption of CSR for the international companies compared to the national ones (p=0.023). Moreover, 97.3% stated that the government should reward socially responsible companies by increasing financial incentives.  Conclusion: The health technology industry in Greece implements CSR actions. The company's contribution to society and its ethical commitment are important encouraging factors for CSR, while bureaucracy and lack of government incentives are the main deterrents. The reward of socially sensitive companies by the government would provide significant entrepreneurial and societal benefits, supporting the overall Greek economy.

Professional Quality of Life and Occupational Stress in Healthcare Professionals During the COVID-19 Pandemic in Greece.

Background: Health professionals (HPs) coping with the coronavirus pandemic are at risk of working under stressful conditions impacting their professional well-being. The aim of this paper was to explore HP's professional quality of life and occupational stress during the COVID-19 pandemic in Greece. Method: A cross-sectional study was conducted (from October to December 2020) in a COVID-19 reference hospital, one of the biggest in Attica. The method of convenience sampling has been used. Data collection was carried out through an anonymous, self-administered questionnaire including, apart from HPs' demographic and occupational characteristics, Professional Quality of Life Scale (ProQoL) and Job Stress Measure. A total of 250 questionnaires were distributed to physicians and nurses. One hundred eighty-six questionnaires were fully completed (response rate = 78.8%). The analysis was based on descriptive and inductive statistics, using SPSS v25. Results: Participants' mean age was 41.5 ± 10.4 years; 75.3% were women and 62.4% was nursing staff. ProQoL analysis showed that the majority had moderate compassion satisfaction (74.2%) and burnout (78.5%), while 48.8% had moderate level of secondary post-traumatic stress. The mean value of occupational stress was estimated at 2.76, showing a moderate level of stress. HPs' demographic and occupational characteristics seemed to affect both work stress and ProQoL (P ⩽ .05). Occupational stress was positively correlated with both burnout (r = 0.461, P = .001) and secondary post-traumatic stress (r = 0.596, P = .001), indicating that an increase in health professionals' stress at work corresponds to a simultaneous increase in ProQoL. Conclusions: HPs' professional quality of life and occupational stress seemed to be moderate during the COVID-19 pandemic in Greece. In order to achieve an improvement in HPs' overall professional well-being, priority should be given to the strengthening of the capacity of the healthcare system as well as to supporting HPs in both stress management and psychological resilience.

Assessing the Efficiency and Productivity of the Hospital Clinics on the Island of Rhodes during the COVID-19 Pandemic.

(1) Background: The aim was to measure the efficiency and productivity of 15 specialty clinics during the COVID-19 pandemic period 2020-2021 in the General Hospital of Rhodes. (2) Methods: An input-oriented data envelopment analysis and the Malmquist productivity index are used. Labor and capital were used as inputs, and in-patient discharges and days were used as outputs. (3) Results: Five out of the seven clinics in the pathology sector appeared fully efficient with an optimal productivity, and the rest showed progress in 2021. In 2020 the COVID-19 pathology clinic appeared to be inefficient and less productive, while in 2021, it showed a positive performance change. The surgical sector showed very high efficiency rates or even reached an optimal efficiency in both years. The productivity measurement, in most of the surgical clinics, was satisfactory to very high. In 2020 the COVID-19 surgical clinic appeared to be more efficient and productive than in 2021 when its performance declined. (4) Conclusions: The hospital responded to the pressure during the pandemic, by increasing its efficiency and productivity from 2020 to 2021. This was due to the accomplishment of the appropriate organizational changes in the infrastructure, human resources, and technology. The efficiency and productivity assessments should be incorporated in the hospitals' decision making.

Detection and Reporting of Adverse Drug Reactions Related to Antibiotics in Primary Healthcare in Greece.

BACKGROUND: Detection of adverse drug reactions (ADRs) is a challenging matter for healthcare professionals who contribute significantly to the pharmacovigilance system through their participation inspontaneous reporting. OBJECTIVE: The objective of this study was the detection and reporting of ADRs related to antibiotics in primary health care in the region of Peloponnese. METHODS: A cross-sectional study was conducted in all national health system primary health units of the Peloponnese region in Greece. A self-administered questionnaire was distributed to a total of 404 physicians who provided services in these settings. Descriptive and multivariate statistical analysis was performed using the SPSS 25.0. Levels of significance were two-tailed and statistical significance was set at p =0.05. RESULTS: 306 out of 404 physicians responded to the questionnaire, giving a response rate of 75.8%. 81.6% of physicians stated that they rarely observe ADRs related to antibiotic administration during their practice, 49.8% rarely report them, and 33.7% never report them. Non-serious side effects (42.5%), physicians' workload (24.1%), and the lack of knowledge about the reporting obligation (20.6%) have been declared as the main reasons of non - reporting. In addition, physicians with ≤10 years of clinical practice rarely reported that they experienced ADRs after antibiotics' administration compared to those with more work experience and specialized physicians (p= 0.001). CONCLUSION: ADRs reporting rates among physicians in primary healthcare are low. Changes in physicians' attitudes are vital and can be achieved through consistent and continuous training programs as well as the inclusion of ADRs and pharmacovigilance themes into the tertiary education curricula.

[Effects of unemployment on financial hardship and mental health].

The fiscal austerity measures enacted in Greece due to the recent financial crisis resulted in a reduction of household incomes, a rise of unemployment and consequently poverty, eroding social cohesion fabric and health status of the population. The purpose of this study was to investigate the effects of economic hardship and the socio-demographic profile of the unemployed population on their level of mental health. A cross sectional study was conducted in the Employment Promotion Centers (KPA2) of the Manpower Employment Organization (OAED) in Attica. The study population was defined as the unemployed people who were registered in the OAED and visit the KPA2 in the region of Attica. The final sample consisted of 830 unemployed. The data were collected from June 2016 to September 2017. The questionnaires used were the Index of Personal Economic Distress and the Center for Epidemiologic Studies Depression Scale. The statistical analysis was based on the SPSS 25 statistical program. The majority of the unemployed were women (66.1%) and the mean age was 35.8 ±10.3 years. 71.8% of the sample were short-term unemployed. 32.3% had a monthly net income before unemployment from €1001 to €1500, while during unemployment 35.2% had an income from €501 to €1000. Regarding financial status and mental health, 23.1% were in high financial hardship and 55.2% had depressive symptoms respectively. Financial hardship and mental health were positively correlated, proving that as the economic hardship of the unemployed population increases, so depressive symptoms increase (r = 0.328). Living arrangement (b = -0.985,) existence of children (b = 2.649), housing status (b = -2.165), duration of unemployment (b = 0.719), existence of other unemployed members in the household (b = 0.904) and existence of another source of income (b = -0.873), have been shown as predictors of economic hardship. Moreover, predictive factors of mental health were found to be: gender (b = 1.795), age (b = 0.179), existence children (b = -4.511), financial hardship (b = 0.551) and duration of unemployment (b = 2.658). The reduction in household incomes was estimated approximately as a basic wage income monthly, causing financial difficulties in daily needs and affecting the mental health of the unemployed population. The long-term unemployed and people with low socio-economic profiles are at higher risk of economic hardship and depressive symptoms. It is important for policy makers to invest in active employment policies and health policy interventions for the unemployed population.

Assessment of the Mobile Mental Health Units' effectiveness in Cyclades islands.

In Greece, the provision of mental health shows inefficiencies in remote and inaccessible areas due to the lack of appropriate structures and access to healthcare. The purpose of this study was to assess the effectiveness of the Mobile Mental Health Units (MMHUs) in Cyclades with and without MMHUs' operation based on Real-World Evidence (RWE). The study population consisted of 724 people who visited the MMHUs of the western and northeastern Cyclades in 2015. The data derived from the patients' medical records of EPAPSY classified by International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) and the Global Assessment of Functioning (GAF) scale. The analysis revealed that 60.9% of the participants were women and the average age was 50.1. 50.4% of the people who visited MMHUs without referral from primary health care professionals and 18.8% with referral. The calculation of effectiveness was based on DALYs (Disability-Adjusted Life Years) and was performed according to the World Health Organization methodology. In the specific population, there are no recorded deaths caused by mental disorders and thus DALYs are equal to Years Lost due to Disability (YLDs) with MMHUs' operation. 18% of the population was diagnosed with mood disorders (F30-F39) and morbidity burden 9.49 (YLDs), while 17.5% of the patients were diagnosed with neurotic, stress-related and somatoform disorders (F40-F48) and corresponding morbidity burden 4.53 (YLDs). Our results revealed that the effectiveness of MMHUs corresponds to 17.98 Disability-Adjusted Life Years (DALYs) averted in 2015. The mood disorders and the neurotic, stress-related disorders have shown a high morbidity burden. Advanced age, non-permanent employment, existence of psychopathology in the family and referral on patients' own will were found to significantly affect the mental health status of the participants. The implementation and expansion of flexible and alternative community-based interventions, such as MMHUs, constitute a best practice both for obtaining higher clinical outcomes and for facing regional inefficiencies related to population's access to healthcare.

Verbal Abuse in the Operating Room: A Survey of Three General Hospitals in the Peloponnese Region.

Background The operating room is a special place in a hospital structure, which has a very high psychological load and many moments of tension, often leading to difficulties in communication between the health professionals involved, as well as cases of verbal and physical violence. Purpose The purpose of the study was to investigate the existence of verbal violence in the operating rooms of three general hospitals in the Peloponnese region of Greece. Methods A cross-sectional survey was conducted of health professionals (physicians and nurses) employed in the operating rooms of three general hospitals in the Peloponnese region. For the data collection, the Verbal Abuse Scale questionnaire (VAS) was used. A total number of 80 questionnaires were self-completed and collected. The statistical analysis was performed with the SPSS Statistics software v.25 (IBM Corp., Armonk, NY). Results Regarding the frequency of verbal violence faced by health professionals, 36.8% of physicians stated that they experience verbal violence once a year whereas more than 20% of nurses reported that such incidents occur more than once a month (p=0.148). For the physicians, the abuser was usually their supervisor, while for the nurses, a physician. The majority of physicians stated that they felt mainly anger (2.94 ± 1.35), disgust (2.58 ± 1.54), and sadness/hurt (2.35 ± 1.37) after the verbal abuse, whereas most of the nurses felt anger (3.49 ± 1.39), disgust (3.05 ± 1.52) and frustration (2.95 ± 1.47). Conclusion Nurses are more often the victims of verbal abuse than physicians and are more likely to feel frustrated after experiencing verbal abuse. Gradual change to the organizational culture is an important measure to stop the occurrence of such incidents.

Lacosamide as a first-line treatment option in focal epilepsy: a cost-utility analysis for the Greek healthcare system.

BACKGROUND AND AIMS: Epilepsy is the most common serious neurological disorder worldwide. Approximately 40% of patients with focal epileptic seizures remain uncontrolled with antiepileptic drug (AED) monotherapy or polytherapy. Lacosamide has been recently approved by the European Medicines Agency as monotherapy for the treatment of focal seizures. The aim of this study was to estimate the cost-effectiveness of lacosamide compared with zonisamide as first-line treatment of focal epilepsy in patients with epilepsy aged ≥ 16 years to inform clinical decision-making in Greece. METHODS: A discrete event simulation model was adapted to reflect treatment pathways and resource use within the Greek national healthcare system, as specified by clinical experts. The model captures time-varying events and patient characteristics. Clinical inputs were sourced from pivotal trials and a network meta-analysis comparing lacosamide with other AEDs. The model predicts disease progression and seizures, relevant and most common adverse events, withdrawal due to lack of efficacy or adverse events, and epilepsy-specific and all-cause mortality over a 2-year time horizon. Unit costs were retrieved from published Greek sources. Health outcomes were measured as quality-adjusted life years (QALYs); secondary outcome was the cost per seizure avoided. Robustness of the results was tested with univariate and probabilistic sensitivity analyses. RESULTS: The lacosamide treatment pathway was associated with higher costs (i.e. €1,064) and an additional 0.119 QALYs when compared with zonisamide, resulting in an incremental cost-effectiveness ratio of €8,938 per QALY gained. The sensitivity analyses demonstrated that the results are most sensitive to the efficacy and utility estimates. LIMITATIONS: There are a number of limitations which stem from the process of model adaptation and lack of local real-world evidence. CONCLUSIONS: Lacosamide is a cost-effective option at a willingness-to-pay threshold of €30,000 per QALY, representing a valuable monotherapy treatment option for patients with focal epileptic seizures in the Greek setting.

Medication use and patient satisfaction: a population-based survey.

BACKGROUND: In recent years, there is a growing interest to assess patients' satisfaction which further triggers the existing debate on the severe methodological issues regarding the interpretation of comparative surveys results. OBJECTIVE: This cross-sectional national survey aimed to examine satisfaction of Greek households with specific aspects of medication use and their correlates. METHODS: Between November 2004 and February 2005, telephone interviews were used for collecting information about socio-demographic and health-related characteristics in a systematic sample of 1000 Greek households. Respondents were classified into three categories: chronic or short-term prescribed medication use, occasional medication use and no medication use during the 3 months preceding the survey. Satisfaction was assessed through various aspects of medication use like physician's consultation, physician's response to adverse events, consultation and advice by pharmacists, symptoms' resolution, route of drug administration, drug tolerability and drug cost. RESULTS: The prescribed drugs' use in the 3 months preceding the survey interview was 36.9%; 28.6% for subjects under chronic treatment and 8.3% under short-term treatment. During the same time period, 52.8% of the respondents reported the occasional self-use of over the counter drugs for minor symptoms. A high prevalence of hypertension, cardiovascular, musculoskeletal and endocrine disorders has been observed. In general, respondents expressed a high degree of satisfaction with all aspects of medication use examined, the only exception being costs. Age, area of residence, social insurance scheme and self-reported health status were associated with specific aspects of patient satisfaction. CONCLUSIONS: Patient satisfaction with the aspects of medication use examined seems to be influenced by demographic and social factors; this points out to the necessity of taking into account socio-cultural variations and the structure of the health-care system in policymaking.

The Effects of Unemployment and Economic Distress on Depression Symptoms.

INTRODUCTION: The financial crisis in Greece had its strongest impact on unemployment, which led to exacerbation of shrinking incomes and depression symptoms. AIM: To investigate the combined effects of unemployment and economic distress on the Greek population mental health in times of economic crisis. MATERIAL AND METHODS: A cross-sectional study was conducted in the Piraeus Manpower Employment Organization (OAED), during September-December 2017, with 21,600 unemployed people records. A random sample was selected among unemployed who attended this entity. A questionnaire was structured including questions on the unemployed' sociodemographic characteristics, the Index of Personal Economic Distress (IPED), and the CES-D (Center for Epidemiological Studies -Depression) scale. Descriptive and inductive statistics were performed in order to find the statistical significance of differences. Binary logistic regression was realized to investigate the associations of unemployment and economic distress as prognostic factors for the experience of symptoms associated with depression. RESULTS: Totally, 130 unemployed participated in the study. 67.7% was female, the mean age was 37.8 years and 47.7% had a secondary educational level. A significant reduction in household monthly income before and after unemployment was observed (p=0.001). The majority of sample was long-term unemployed and 42.3% was short-term. The mean score of IPED was 12, meaning great economic distress. Moreover, based on CES-D score 63.8% of unemployed presented elevated depression and 36.2% no symptoms of depression. Positive correlation was found between the duration of unemployment with IPED (r=0.565) and with CES-D score (r=0.173). The logistic regression showed that the likelihood of expressing depression was influenced by increasing IPED (OR=1.089) and duration of unemployment (OR=1.322). CONCLUSIONS: The duration of unemployment and economic hardship led to a higher risk of depressive symptoms, thus policy actions must place greater emphasis on providing additional support through the creation of a more adequate and effective integrated social and health care network.

The annual direct costs of stable COPD in Greece.

Introduction: Chronic obstructive pulmonary disease (COPD) places a major burden on health care systems and has substantial economic effects; however, the cost of stable disease in Greece has never been thoroughly explored. The objective of the study was to estimate the annual COPD patient cost during the maintenance phase and explore the relationships between the cost and disease severity. Methods: Data were collected from 245 COPD patients (male: 231, mean age: 69.5±8.8 years) who visited the outpatient unit of University Hospital of Larissa in 2014 and 2015. Patients were classified according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, and the patients' direct cost during the maintenance phase was calculated. Results: Eleven percent of COPD patients were stage I, 48.2% were stage II, 29% were stage III, and 11.8% were stage IV. According to the GOLD groups, 23.3% of patients were grade A, 15.5% were grade B, 22.9% were grade C, and 38.4% were grade D. The mean annual direct cost for stable disease was estimated at €1,034.55 per patient, of which €222.94 corresponded to out-of-pocket payments. The annual cost ranged from €408.23 to €2,041.89 depending on GOLD stages (I-IV) and from €550.01 to €1,480.00 depending on GOLD groups (A-D). The key cost driver was pharmaceutical treatment, which reflected almost 71% of the total expenses for the management of stable disease. The mean annual per-patient cost was two to three times higher for those with advanced disease (stages III-IV) compared to those with stages I-II disease, and it doubled for "high-risk" patients (groups C-D) compared to "low-risk" patients (groups A-B). Conclusion: The cost of COPD during the maintenance phase is remarkable, with the key cost driver found to be pharmaceutical treatment and social insurance funds the key payer for treating COPD patients in Greece. The cost of stable disease is proportional to the severity of COPD, and it is doubled in patients who belong to high-risk groups.

Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries.

Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures. Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined. Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are ~214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014-2016 is presented in Bulgaria and Slovakia. Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant.

The economic burden of treating neonates in Intensive Care Units (ICUs) in Greece.

BACKGROUND: In a period when a public-private mix in Greece is under consideration and hospital budgets become restrained, economic assessment is important for rational decision making. The study aimed to estimate the hospitalization cost of neonates admitted to the ICUs and demonstrate discrepancies with reimbursement. METHODS: Chosen methodology was based on the selection of medical records of all NICUs and intermediate care admissions within February to April 2004. Neonates (n = 99) were classified according to birthweight and gestational age. RESULTS: Mean cost per infant was estimated at euro5.485 while reimbursement from social funds arises to euro3.952. Costs per birthweight or gestational age show an inverse relationship. Personnel costs accounted for 59.9%, followed by enteral/parenteral feeding (16.14%) and pharmaceuticals expenses (11.10%) of all resources consumed. Sensitivity analysis increases the robustness of the results CONCLUSION: Neonatal intensive care in Greece is associated with significant costs that exceed reimbursement from social funds. Reimbursement should be adjusted to make neonatal intensive care economically viable to private hospitals and thus, increase capacity of the services provided.