Pharmacovigilance in Poland

History and current status of monitoring of adverse drug reactions in Poland is presented. The Centre for Monitoring of Adverse Drug Reactions (ADR) was established in 1971. The number of suspected drug reactions reported varied in subsequent years. In the analysed periods of time 1972-1984 and 1985-1994, 956 and 961 reports were received respectively. Due to the small number of reports, in the course of the years many different activities were undertaken with variable rates of success. It is recognized that much effort and time is needed to increase awareness of the necessity of drug safety monitoring in the medical profession. Therefore major reorganization of the ADR monitoring system with regional centres is planned.     

Multivariate analysis of oestrogen receptor alpha, pS2, metallothionein and CD24 expression in invasive breast cancers

Determination of oestrogen receptor alpha (ER) represents at present the most important predictive factor in breast cancers. Data of ours and of other authors suggest that promising predictive/prognostic factors may also include pS2, metallothionein (MT) and CD24. Present study aimed at determining prognostic and predictive value of immunohistochemical determination of ER, pS2, MT, and CD24 expression in sections originating from 104 patients with breast cancer. An univariate and multivariate analysis was performed. Both univariate and multivariate analyses demonstrated that cytoplasmic-membranous expression of CD24 (CD24c-m) represents a strong unfavourable prognostic factor in the entire group and in most of the subgroups of patients. In several subgroups of the patients also a prognostic value was demonstrated of elevated expression of pS2 and of membranous expression of CD24. Our studies demonstrated that all patients with good prognostic factors (higher ER and pS2 expressions, lower MT expression, CD24c-m negativity) survived total period of observation (103 months). The study documented that cytoplasmic-membranous expression of CD24 represented an extremely strong unfavourable prognostic factor in breast cancer. Examination of the entire panel of the studied proteins permitted to select a group of patients of an exceptionally good prognosis.     

Cardiovascular effects of nickel in ambient air

BACKGROUND: Fine particulate matter (FPM) in ambient air causes premature mortality due to cardiac disease in susceptible populations. OBJECTIVE: Our objective in this study was to determine the most influential FPM components. METHODS: A mouse model of atherosclerosis (ApoE-/-) was exposed to either filtered air or concentrated FPM (CAPs) in Tuxedo, New York (85 microg/m3 average, 6 hr/day, 5 days/week, for 6 months), and the FPM elemental composition was determined for each day. We also examined associations between PM components and mortality for two population studies: National Mortality and Morbidity Air Pollution Study (NMMAPS) and Hong Kong. RESULTS: For the CAPs-exposed mice, the average of nickel was 43 ng/m3, but on 14 days, there were Ni peaks at approximately 175 ng/m3 and unusually low FPM and vanadium. For those days, back-trajectory analyses identified a remote Ni point source. Electrocardiographic measurements on CAPs-exposed and sham-exposed mice showed Ni to be significantly associated with acute changes in heart rate and its variability. In NMMAPS, daily mortality rates in the 60 cities with recent speciation data were significantly associated with average Ni and V, but not with other measured species. Also, the Hong Kong sulfur intervention produced sharp drops in sulfur dioxide, Ni, and V, but not other components, corresponding to the intervention-related reduction in cardiovascular and pulmonary mortality. CONCLUSIONS: Known biological mechanisms cannot account for the significant associations between Ni with the acute cardiac function changes in the mice or with cardiovascular mortality in people at low ambient air concentrations; therefore, further research is needed.     

Spinal tumours: recommendations of the Polish Society of Spine Surgery,the Polish Society of Oncology,the Polish Society of Neurosurgeons,the Polish Society of Oncologic Surgery,the Polish Society of Oncologic Radiotherapy,and the Polish Society of Orthopaedics and Traumatology

Purpose

The purpose of these recommendations is to spread the available evidence for evaluating and managing spinal tumours among clinicians who encounter such entities.

Methods

The recommendations were developed by members of the Development Recommendations Group representing seven stakeholder scientific societies and organizations of specialists involved in various forms of care for patients with spinal tumours in Poland. The recommendations are based on data yielded from systematic reviews of the literature identified through electronic database searches. The strength of the recommendations was graded according to the North American Spine Society’s grades of recommendation for summaries or reviews of studies.

Results

The recommendation group developed 89 level A-C recommendations and a supplementary list of institutions able to manage primary malignant spinal tumours, namely, spinal sarcomas, at the expert level. This list, further called an appendix, helps clinicians who encounter spinal tumours refer patients with suspected spinal sarcoma or chordoma for pathological diagnosis, surgery and radiosurgery. The list constitutes a basis of the network of expertise for the management of primary malignant spinal tumours and should be understood as a communication network of specialists involved in the care of primary spinal malignancies.

Conclusion

The developed recommendations together with the national network of expertise should optimize the management of patients with spinal tumours, especially rare malignancies, and optimize their referral and allocation within the Polish national health service system.