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.

Maternal education, health profession and cigarette smoking are decisive factors for self-medication in children by parents.

Self-medication of children by their parents (SMCP) is an important public health issue as the effects and potential risks may be unpredictable. The objective of this first national Montenegrin study was to assess the prevalence of and factors influencing SMCP among schoolchildren. Data were obtained from a national representative sample of 4496 schoolchildren aged 7-13 years (50.4 % boys). Parents/caregivers completed a questionnaire concerning their demographic characteristics, socio-economic and cultural status, as well as the self-medication (SM) of their children. The association between SMCP and parents' socio-economic, demographic or cultural status was assessed by logistic regression analyses. The prevalence rate of SMCP was 24.6 %. Univariate logistic regression showed that maternal socio-demographic characteristics (educational level, employment status, health care profession and smoking habits) were relevant for SMCP. In a multiple logistic regression the independent effect /adjusted odds ratio (AOR) (95 % CI)/of maternal factors on SMCP remained for: education /2.23 (1.18-4.24)/, university-level vs. no education; profession /1.50 (1.07-3.00)/, health profession vs. non-health profession; and smoking habit /1.22 (1.04-1.42)/smokers vs. non-smokers. SMCP may be expected for every fourth child in Montenegro. Specific maternal factors that independently raise the probability of SMCP are higher education, health profession and smoking.

Mathematical model in post-mortem estimation of brain edema using morphometric parameters.

Current autopsy principles for evaluating the existence of brain edema are based on a macroscopic subjective assessment performed by pathologists. The gold standard is a time-consuming histological verification of the presence of the edema. By measuring the diameters of the cranial cavity, as individually determined morphometric parameters, a mathematical model for rapid evaluation of brain edema was created, based on the brain weight measured during the autopsy. A cohort study was performed on 110 subjects, divided into two groups according to the histological presence or absence of (the - deleted from the text) brain edema. In all subjects, the following measures were determined: the volume and the diameters of the cranial cavity (longitudinal and transverse distance and height), the brain volume, and the brain weight. The complex mathematical algorithm revealed a formula for the coefficient ε, which is useful to conclude whether a brain edema is present or not. The average density of non-edematous brain is 0.967 g/ml, while the average density of edematous brain is 1.148 g/ml. The resulting formula for the coefficient ε is (5.79 x longitudinal distance x transverse distance)/brain weight. Coefficient ε can be calculated using measurements of the diameters of the cranial cavity and the brain weight, performed during the autopsy. If the resulting ε is less than 0.9484, it could be stated that there is cerebral edema with a reliability of 98.5%. The method discussed in this paper aims to eliminate the burden of relying on subjective assessments when determining the presence of a brain edema.

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.

Prevalence of and contributing factors for overweight and obesity among Montenegrin schoolchildren.

BACKGROUND: Newly emerging Western style economic systems provide new opportunities to study the prevalence and predictors of childhood obesity. We also provide for the first time a national study of childhood obesity using all three international anthropometric criteria. METHODS: The sample included 4097 Montenegrin children, 2076 boys (50.7%) and 2021 girls. Anthropometric measurements were performed in school. The questionnaire for parents included questions on 24 potential contributing factors for childhood obesity. Nutritional status was assessed according to World Health Organization, US Center for Disease Prevention and Control and International Obesity Task Force (IOTF) criteria. RESULTS: Overall percentage of Montenegrin children who are overweight or obese (IOTF) is 22.9% of which 5.3% are obese (7.0% boys vs. 3.5% girls). We found 10 factors to be independently associated with child obesity. Positive relations [odds ratio (95% confidence interval)] were found with maternal obesity [2.05 (1.68-2.51)], paternal obesity [1.67 (1.32-2.10)], paternal employment [1.40 (1.12-1.74)], maternal smoking [1.32 (1.08-1.61)], obesity at birth [1.33 (1.04-1.70)] and computer game playing [per hour--1.11 (1.00-1.24)]. Negative relations were found with female gender [0.64 (0.53-0.78)], the number of siblings [0.88 (0.78-0.98)], birth order [0.73 (0.64-0.83)] and age [0.92 (0.88-0.98)]. CONCLUSION: One out of four Montenegrin children is overweight, with two times more frequent obesity among boys compared with girls. Some previously salient predictors did not appear salient in this sample. To enable worldwide comparability, we propose the use of all three childhood obesity criteria in national studies.

Blood pressure among rural Montenegrin children in relation to poverty and gender.

BACKGROUND: Health inequalities may begin during childhood. The aim of this study was to investigate the main effect of poverty and its interactive effect with gender on children's blood pressure. METHODS: The study was performed in two elementary schools from a rural region near Podgorica, the capital of Montenegro. A questionnaire including questions on family monthly income, children's physical activity and the consumption of junk food was self-administered by parents of 434 children (223 boys and 211 girls) aged 6-13 years. Children's poverty level was assessed using the recommendations from the National Study on Poverty in Montenegro. Children's body weight and height were measured and body mass index-for-gender-and-age percentile was calculated. An oscillometric monitor was used for measurement of children's resting blood pressure in school. RESULTS: A two-factorial analysis of variance with body mass index percentile, physical activity and junk food as covariates showed an interaction of gender and poverty on children's blood pressure, pointing to synergy between poverty and female gender, with statistical significance for raised diastolic pressure (F = 5.462; P = 0.021). Neither physical activity nor the consumption of junk food explained the interactive effect of poverty and gender on blood pressure. CONCLUSION: We show that poverty is linked to elevated blood pressure for girls but not boys, and this effect is statistically significant for diastolic pressure. The results are discussed in the light of gender differences in stress and coping that are endemic to poverty.

[Correlation between disease progression and histopathologic criterions of the lip squamous cell carcinoma].

BACKGROUND/AIM: The most common malignancy of the lip is squamous cell carcinoma (SCC). In our population, according to epidemiological data, almost a half of all (45%) SCC of oral mucous tissue spreads over the lower and upper lip. The aim of this study was to estimate prognostic importance of histopathologic characteristics--histologic grade, nuclear grade and tumor size in relation to the appearance of lymph node metastases and relapse in SCC of the lip. METHODS: In the retrospective-prospective study 70 cases of lower and upper lip SCC were analyzed. They were diagnosed from 2002 to 2006 in the Clinic of Maxillofacial Surgery, Clinical Center of Montenegro. The data about localization of the carcinomas, histopathologic characteristics and lymph node status were taken from medical files of the patients. The patients were followed up in a 3-year period and the disease relapse or/and metastatic disease appearance were registereds. RESULTS: There was statistically significant difference in tumor size among the patients with and without disease relapse (p = 0.027). Logistic regression analysis showed that the tumor size is a statistically significant factor (R = 0.186; p = 0.011) for the appearance of regional lymph node metastases. Relative risk [exp (B)] for the appearance of regional lymph node metastases in relation to tumor size was 2.807. CONCLUSION: Histologic and nuclear grade of lip SCC are not prognostic factors for the appearance of the disease relapse and regional lymph node metastases. Tumor size is a predictive factor of the relapse appearance, as well as for lymph node metastases appearance. In clinical practice, tumor size is a factor that classifies patients with lip SCC into the groups of higher and smaller risk of relapse appearance and for lymph node metastases appearance. Our results suggest that, risk for lymph node metastases appearance increases 2.8 times with increasing of the tumor size over 2 cm in diameter.

Traumatic epidural hematomas in posterior cranial fossa.

Epidural hematoma of the posterior cranial fossa (EHPCF) is a rare complication in head injuries. Furthermore, nonspecific clinical signs and the rare occurrence of this lesion in craniocerebral injuries make the establishment of a diagnosis more difficult. The aim of the paper is to point to the advantages of early diagnosis. During the 1982-2008 period, 18 patients with EHPCF were operated on at University Department of Neurosurgery, Clinical Center of Montenegro in Podgorica. The clinical picture, neuroradiological examination findings and outcome of operated patients were retrospectively analyzed. In our patient series, EHPCF accounted for 0.11% of craniocerebral injuries or 7.9% of epidural hematomas recorded. In 11 cases, the injury was inflicted in traffic accidents and in 7 patients it was caused by fall. Linear fracture of the occipital bone was detected by radiographic investigation in 12, isolated diastasis fracture of lambdoid suture in four, and linear fracture of the occipital bone with diastasis fracture of lambdoid suture in two patients. Glasgow Coma Scale of 8 and less was present in three, 9-12 in seven, and 13-15 in eight patients. The majority of cases (90%) were detected within 24 hours. In all cases, the diagnosis was made by computed tomography. Mortality rate was 11.11%. Early computed tomography of the head in combination with clinical picture and timely surgical intervention could reduce the mortality and morbidity in these lesions.