Safety of Oral Paracetamol – Analysis of Data from a Spontaneous Reporting System in Poland

Purpose: To determine the safety of oral coated paracetamol tablets 500 mg and oral suspension 120 mg/5 mL produced by Hasco-Lek Poland.Methods: We analyzed sales volume and data obtained from the  monitoring of spontaneous reports on the adverse effects of paracetamol collected in the period between November 2000 and June 2012.Results: A total of 45,694 units of coated paracetamol tablets (500 mg) and 6,048,289 units of paracetamol oral suspension (120 mg/5 mL) were marketed during that period. There were 4 spontaneous reports of adverse effects.Conclusion: Oral paracetamol is a safe medication rarely causing adverse effects but it is possible that the existing spontaneous monitoring system for adverse effects in Poland is not sensitive enough to detect all adverse effects, and needs improvement.Keywords: Adverse reaction, NSAIDs, Pharmacovigillance,  Pharmoepidemiolog

An analysis of hearing among newborns from a chosen neonatal ward in the years 2009–2013

Wstęp. Program powszechnych przesiewowych badań słuchu funkcjonuje w Polsce od jesieni 2002 roku. W przypadku nieprawidłowego wyniku badania słuchu, proces diagnostyczny w kierunku wad słuchu należy zakończyć do szóstego miesiąca życia dziecka. Cele pracy. Analiza wyników badań przesiewowych słuchu u noworodków. Materiał i metody. Dokonano analizy dokumentacji medycznej i wyników przesiewowego badania słuchu u 3970 noworodków . Przesiewowe badanie słuchu przeprowadzono metodą zapisu otoemisji akustycznych wywołanych trzaskiem. Wyniki. Większość przebadanych stanowiły dzieci urodzone powyżej 33. tygodnia ciąży (Hbd). Do poradni audiologicznych skierowano 254 no­worodków (6,4%). Najczęściej występującymi czynnikami ryzyka uszkodzenia słuchu były: leki ototoksyczne, infekcje TORCH oraz wady słuchu występujące w rodzinie. Wnioski. Powszechne wykonywanie badań słuchu u noworodków pozwala wcześnie wykryć nieprawidłowości w funkcjonowaniu narządu. Dzięki badaniom wykrywalność wad słuchu u noworodków wynosi 99%.Introduction. The program of universal hearing screening has been operating since autumn 2002. In the case of abnormal results, the diagnostic process for hearing defects should be completed by the sixth month of life. Aim of the study. The aim of the study was to analyze the results of the screening test for hearing loss in newborns. Material and methods. The analysis of medical documentation of 3970 newborns. Screening test for hearing loss was conducted by the method of recording otoacustic emission inducted by crash. Results. Most of the tested children were born above 33 Hbd. 254 (6,4%) of all newborns, were referred to audiology clinics. The most common risk factors were: ototoxic medicine, TORCH infections and hearing defects in the family. Conclusions. The widespread practice of conducting hearing tests in newborns allows to observe early dysfunction of the organ. Thanks to the practice, the traceability of hearing dysfunctions in newborns amounts to 99%

Comparative epidemiologic characteristics of pertussis in 10 Central and Eastern European countries, 2000-2013

Publisher Copyright: © 2016 Heininger et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.We undertook an epidemiological survey of the annual incidence of pertussis reported from 2000 to 2013 in ten Central and Eastern European countries to ascertain whether increased pertussis reports in some countries share common underlying drivers or whether there are specific features in each country. The annual incidence of pertussis in the participating countries was obtained from relevant government institutions and/or national surveillance systems. We reviewed the changes in the pertussis incidence rates in each country to explore differences and/or similarities between countries in relation to pertussis surveillance; case definitions for detection and confirmation of pertussis; incidence and number of cases of pertussis by year, overall and by age group; population by year, overall and by age group; pertussis immunization schedule and coverage, and switch from whole-cell pertussis vaccines (wP) to acellular pertussis vaccines (aP). There was heterogeneity in the reported annual incidence rates and trends observed across countries. Reported pertussis incidence rates varied considerably, ranging from 0.01 to 96 per 100,000 population, with the highest rates generally reported in Estonia and the lowest in Hungary and Serbia. The greatest burden appears for the most part in infants (<1 year) in Bulgaria, Hungary, Latvia, Romania, and Serbia, but not in the other participating countries where the burden may have shifted to older children, though surveillance of adults may be inappropriate. There was no consistent pattern associated with the switch from wP to aP vaccines on reported pertussis incidence rates. The heterogeneity in reported data may be related to a number of factors including surveillance system characteristics or capabilities, different case definitions, type of pertussis confirmation tests used, public awareness of the disease, as well as real differences in the magnitude of the disease, or a combination of these factors. Our study highlights the need to standardize pertussis detection and confirmation in surveillance programs across Europe, complemented with carefully-designed seroprevalence studies using the same protocols and methodologies.publishersversionPeer reviewe

Neutralization efficiency of alcohol based products used for rapid hand disinfection

Background. Alcohols are the most commonly used active substances in preparations for quick hand disinfection. They should be bactericidal in very short contact time. PN-EN 13727 + A2: 2015-12 standard, for testing hygienic and surgical handrub disinfection preparations, provides mandatory test conditions of disinfectants in contact times with the range of 30 s to 60 s (hygienic handrub disinfection) and 60 s to 5 min (surgical handrub disinfection). A short contact times for hand hygiene products require a short time of neutralization process. For contact times less than or equal to 10 minutes, the estimated neutralization time is 10 s ± 1 s. Neutralization is a process that abolishes the action of disinfectants. Correct application of this process allows for proper use of disinfectants in practice and its biocidal effect. Objectives. Verification of the effectiveness of 10-second neutralization time of alcohol based preparations for hygienic handrub disinfection. Materials and Method. Neutralization of two products with different ethanol content (89% and 70%) for hygienic handrub disinfection according to PN-EN 13727 + A2: 2015-12 was investigated. The effectiveness of the neutralizer was assessed by determining toxicity of neutralizer, activity of residual effects of the tested products and their derivatives produced during neutralization (10 s) for test organisms (Staphylococcus aureus ATCC 6538; Pseudomonas aeruginosa ATCC 15442; Enterococcus hirae ATCC 10541; Escherichia coli K12 NCTC 10538). Results. The 10-second neutralization time was sufficient to eliminate the residual activity of products for hygienic handrub disinfection with differentiated ethanol concentration. The neutralizer used did not show toxicity to bacteria and did not produce toxic products with tested preparations after neutralization. Conclusions. The use of 10-second neutralization time allows in a precise way designate the contact times for hygienic handrub disinfection products.Wprowadzenie. Alkohole są substancjami aktywnymi najczęściej stosowanymi w preparatach do szybkiej dezynfekcji rąk. Powinny one działać dezynfekcyjnie w bardzo krótkich czasach kontaktu. Norma PN-EN 13727+A2: 2015-12 przeznaczona do badania preparatów do higienicznej i chirurgicznej dezynfekcji rąk przewiduje obligatoryjne warunki badania preparatów w czasach kontaktu w zakresie od 30 s do 60 s (higieniczna dezynfekcja rąk) i od 60 s do 5 minut (chirurgiczna dezynfekcja rąk). Krótkie czasy kontaktu produktów przeznaczonych do higieny rąk wymagają zastosowania krótkiego procesu neutralizacji. Dla czasów kontaktu poniżej lub równych 10 minut przewidziany czas neutralizacji wynosi 10 s ± 1s. Neutralizacja jest procesem znoszącym działanie preparatów dezynfekcyjnych. Prawidłowe wykonanie tego procesu warunkuje prawidłowe zastosowanie preparatu w praktyce i jego działanie biobójcze. Cel. Sprawdzenie skuteczności 10-sekundowego czasu neutralizacji wobec preparatów na bazie alkoholu przeznaczonych do higienicznej dezynfekcji rąk. Materiały i metody. Badano etap neutralizacji dwóch produktów o różnej zawartości etanolu (89% i 70%) przeznaczonych do higienicznej dezynfekcji rąk wg normy PN-EN 13727+A2: 2015-12. Skuteczność neutralizatora oceniano poprzez określenie braku wpływu toksyczności neutralizatora oraz działania resztkowego badanych produktów lub ich pochodnych powstałych w czasie neutralizacji (10 s ± 1s) na badane organizmy testowe (Staphylococcus aureus ATCC 6538; Pseudomonas aeruginosa ATCC 15442; Enterococcus hirae ATCC 10541; Escherichia coli K12 NCTC 10538). Wyniki. 10-sekundowy czas neutralizacji był wystarczający do zniesienia aktywności produktów o zróżnicowanej zawartości etanolu przeznaczonych do higienicznej dezynfekcji rąk. Zastosowany neutralizator nie wykazywał działania toksycznego wobec bakterii oraz nie tworzył toksycznych produktów z badanymi preparatami po neutralizacji. Wnioski. Zastosowanie 10-sekundowego czasu neutralizacji pozwala w precyzyjny sposób wyznaczyć czasy działania produktów przeznaczonych do higienicznej dezynfekcji rąk

Asbestosis hospitalizations in Poland (2006–2016): results from the National Hospital Discharge Registry

Introduction and objective. Occupational asbestos exposure is one of the major public health issues. Although asbestos use in Poland has decreased, asbestosis continues to remain an important health concern in the area of occupational medicine. The aim of the study is to perform a descriptive analysis of hospitalization cases in patients suffering from asbestosis in Poland. Materials and method. The authors used hospital discharge records to conduct a retrospective, population-based study. To estimate the asbestosis hospitalization rate, data from the Nationwide General Hospital Morbidity Study conducted by the National Institute of Public Health were used. Events were defined as in-patient hospital discharges during 2006–2016. 1,101 hospitalization records of 764 patients were included in the study. Results. In the study group of first-time hospitalized patients, the mean and median ages were 68.1 and 69 years, respectively; CI: 67.3–68.9; SD: 11.1, min-max:16–99 years. In this group, significant gender differences were observed (560 males vs. 204 female; P<0.001). No statistical differences were observed regarding the place of residence. During the observation period, 61 in-hospital deaths were reported (8% of all patients), 40 of whom (5.2 % of all patients) took place during the first-time hospitalizations. Asbestosis hospitalizations were mainly clustered in the south-western region, whereas the highest hospitalization rates were clustered in several areas of Poland. Conclusions. The authors believe this study to be the first evaluation of asbestosis in Poland made on the basis of the hospital morbidity database. The data presented may be helpful in comparative studies on the epidemiology of asbestosis across European countries

Takayasu’s arteritis: a rare disease in Poland

Introduction. Takayasu’s arteritis (TA) is a rare and potentially life-threatening granulomatous large-vessel vasculitis that involves mostly in the aorta and its proximal branches, and occurs most commonly in young females. This study measures the incidence and prevalence of TA, and assesses the gender distribution and territorial differences in the occurrences of this disease in Poland over a five-year period. To the best of our knowledge, this is the first evaluation of this rare disease in Poland based on a hospital morbidity database. Materials and method. Analyses were performed with population-based administrative data obtained from a national hospital morbidity study carried out between January 2011 – December 2015 by the Polish National Institute of Public Health. Yearly incidence rates and prevalence of TA were calculated using the number of TA patients and corresponding census data for the overall Polish population. Results. Data included 660 hospitalization records. The final study sample comprised 177 patients: 154 female (87%) and 23 male (13%) with first-time hospitalization for TA. The mean age was 45.4years (95% CI: 42.9–47.8; SD 16.8; range 4–81 years), median 47. The incidence rate of TA was estimated at 0.92 per million per year (95% CI: 0.68–1.16). Five-year TA prevalence was estimated to be 4,6 per million. Incidence rates of TA did not vary significantly between more urban and more rural regions. Conclusions. The incidence of TA in Poland was similar or lower to data reported by other European countries. The study provides epidemiological data on TA in Poland that may be useful while comparing it with other geographical regions

The tick-borne encephalitis vaccination coverage among children from a single primary care clinic in Warsaw

Wstęp. Kleszczowe zapalenie opon mózgowo-rdzeniowych i mózgu (KZM) jest wektorową chorobą wirusową, przenoszoną przez kleszcze. Jedynym skutecznym sposobem zabezpieczającym przed zachorowaniem na kleszczowe zapalenie mózgu jest szczepienie ochronne. Cel pracy. Ustalenie stanu zaszczepienia przeciw KZM w populacji dzieci i młodzieży pozostających pod opieką wybranej poradni podstawowej opieki medycznej (POZ) w Warszawie. Materiał i metody. Badanie przeprowadzono wśród dzieci od 1. do 18. roku życia. Dokonano analizy dokumentacji medycznej w postaci kart uodpornienia 5658 dzieci pozostających pod opieką wybranej poradni POZ w Warszawie w latach 2006–2011. Wyniki. W latach 2006–2011 zaszczepiło się przeciw KZM 236 dzieci spośród 5658 dzieci zarejestrowanych w poradni, co stanowi 4%. Najwięcej szczepień wykonano w 2011 r. (24%), a najmniej – w 2006 r. (12%). 65% szczepień wykonano u dzieci w wieku 1–6 lat. Schemat trzydawkowy szczepienia podstawowego zrealizowano u 59% pacjentów. Nie obserwowano niepożądanych odczynów poszczepiennych (NOP). Wnioski. Stan zaszczepienia przeciw KZM dzieci i młodzieży w wybranej poradni POZ w Warszawie był niski (4%), choć zaznacza się tendencja rosnąca w zakresie częstości wykonywania tego szczepienia. Lekarze rodzinni powinni informować pacjentów o szczepieniach zalecanych, w tym o szczepieniu przeciw KZM.Background. Tick-borne encephalitis (TBE) is a vector viral disease. The only effective way to protect oneself is vaccination. Objectives. The purpose of the paper was to determine the tick-borne encephalitis vaccine coverage among children and adolescents from a single primary care setting in Warsaw in 2006–2011 period. Material and methods. The study was conducted among the children aged between one and eighteen. Children’s immunization record cards from one of the health clinics in Warsaw served as the material for the study. Results. In 2006–2011 among 5658 pediatric patients only 236 were vaccinated against TBE (4%). In 2011 the highest number of children was vaccinated against tick-borne encephalitis (24%), whereas in 2006 – the lowest (12%). 65% of vaccinations were conducted among children aged 1–6. The required three doses of primary vaccination were given to 59% of patients. No side effects of vaccination were reported. Conclusions. The tick-borne encephalitis vaccination coverage among patients aged 1–18 years was low (4%). General practitioners should be more involved in an active promotion of recommended vaccines, including TBE vaccine