A Century of Antivenom

Because it primarily affects the poor in undeveloped parts of the world where medical care is often inadequate and insufficient, envenomation is considered a neglected public health issue, despite the existence of antivenom therapy for more than a century. This article provides an overview of the epidemiological situation for important venomous animals, together with achievements in the production, control, technological progress and safety of antivenoms since their discovery

A Century of Antivenom

Because it primarily affects the poor in undeveloped parts of the world where medical care is often inadequate and insufficient, envenomation is considered a neglected public health issue, despite the existence of antivenom therapy for more than a century. This article provides an overview of the epidemiological situation for important venomous animals, together with achievements in the production, control, technological progress and safety of antivenoms since their discovery

DDLM - Quality Standard for Electronic Education Programs in Higher Education of Bosnia and Herzegovina

The Web-based technological revolution has brought new teaching opportunities and concepts. This expands the range of educational opportunities based on new digital technologies, while certain obstacles and dangers appear that this type of education brings with it at the same time. Electronic education systems should be flexible and it would be ideal if able to meet the specific needs of each student individually. On the other hand, it is extremely important to standardize teaching electronic content, define all vertical and horizontal processes in the electronic education system, and set quality standards that must be respected. Higher education institutions must take an active part in the development and implementation of information technologies in teaching processes. DDLM (Demand-Driven Learning Model) clearly defines the structure of Web-based teaching delivery, so that it essentially defines the quality standard of e-learning programs based on Web technologies. The problem of non-standardization of electronic educational content, poorly defined processes in the system, such as the delivery of electronic content, control activities, personalization or irregular updates, is present everywhere in the world, and so with us. The research conducted in this paper examines the population of students of higher years of study, as well as students of the second and third cycle of study at 5 universities in Bosnia and Herzegovina, in order to get a clear picture of the current state of electronic education in our country. The survey was conducted on 565 students between October 2016 and January 2017. Following the methodology of scientific research, the empirical research was primarily conducted through a survey questionnaire, where primary quantitative data were stored in a database and further analysed, after which we reached the relevant scientific knowledge

ETHNIC MINORITIES AND EUROPEAN INTEGRATIONS

Autor piše o dokumentima za zaštitu manjina Vijeća Europe kao najstarije organizacije koja promiče ideje europskog jedinstva, te koracima koje je poduzela Republika Hrvatska s ciljem približavanja euroatlantskim integracijama. Hrvatska državna politika, slijedeći volju hrvatskih građana izraženu na izborima iz siječnja 2000. godine, krenula je u ostvarenje toga cilja, poduzimajući sasvim konkretne korake na zadovoljavanju postavljenih kriterija.The author looks into the documents about the protection of minorities, designed by the Council of Europe as the oldest organization promoting the idea of European unity. He also analyzes the steps that the Republic of Croatia has made in its desire to join the Euro-Atlantic integrations. Croatian politics, in line with the will of the Croatian citizens expressed in the elections of January 2000, has tried to reach that goal by satisfying the required criteria

Onečišćenja u ljekovitom bilju i biljnim proizvodima

Medicinal plants have a long history of use in therapy throughout the world and still make an important part of traditional medicine. Thus, medicinal plants and herbal products must be safe for the patient (consumer). This review addresses biological contaminants (microbes and other organisms) and chemical contaminants (mycotoxins, toxic elements such as heavy metals, and pesticide residues) as major common contaminants of medicinal herbs and herbal products. To prevent and screen for contamination and ensure safety and conformity to quality standards, medicinal herbs and herbal products should be included in appropriate regulatory framework.Ljekovito bilje i biljni proizvodi već tisućljećima nalaze široku primjenu u različitim sustavima tradicionalnog liječenja. Stoga je njihova neškodljivost, ponajprije uvjetovana kakvoćom biljne sirovine, od izuzetne važnosti za javno zdravstvo. Od mogućih čimbenika koji utječu na kakvoću ljekovitog bilja i biljnih proizvoda ovaj pregledni rad osvrće se na najčešće prisutna biološka (mikroorganizmi) i kemijska onečišćenja (mikotoksini, toksični elementi poput teških metala te ostaci pesticida). S ciljem postizanja ujednačenih standarda kakvoće te osiguranja sigurnosti primjene biljnih proizvoda od vitalne su važnosti zakonski propisi koji moraju u odgovarajućim regulatornim okvirima obuhvatiti ovu skupinu proizvoda s naglaskom na sprječavanju i ispitivanju njihovih mogućih onečišćenja

Screening of flavonoid aglycons’ metabolism mediated by the human liver cytochromes P450

Biological effects of flavonoids have been extensively studied in the last 80 years. As flavonoids represent a rather large group of compounds, data on metabolic biotransformations of these compounds is relatively limited to those well studied. The objective of this study was to screen the metabolism of 30 selected flavonoid aglycons mediated by the most relevant metabolic enzymes, human liver cytochromes P450. For this purpose, in vitro experiments with human liver microsomes and recombinant enzymes were conducted. To evaluate flavonoid´s metabolism and structure of the products, high-performance liquid chromatography coupled with high-resolution mass spectrometry was used. Out of 30 flavonoids, 15 were susceptible to oxidative metabolism mediated by cytochromes P450. Dominant reactions were aromatic hydroxylation and O-demethylation, or a combination of these reactions. The dominant enzyme responsible for the observed metabolic reactions is CYP1A2, whereas other human liver cytochromes P450, namely, CYP2C19, CYP2D6, CYP2E1 and CYP3A4, contribute to flavonoid metabolism to a lesser degree. These results, to some extent, contribute to the understanding of the metabolism of constituents found in antioxidant dietary supplements and their possible interactions with other xenobiotics, i.e., medicinal products

Provjera kakvoće cjepiva za sezonsku gripu

The purpose of seasonal influenza vaccination is to prevent its spread. The vaccines contain strains of the influenza virus recommended and approved for a particular season. Just like any other medicinal product, all vaccines require marketing approval. Batches of approved vaccines are extensively tested by the manufacturers and additionally controlled by the approving authorities, which issue the quality control certificates. This article not only to describes the legal background of quality control, but also how control test results obtained by a Croatian official control laboratory are compared to manufacturer’s results. We have found that testing results can slightly differ depending on methods/analytical procedures used in different laboratories. This investigation has also shown how important it is to test finished medicinal products, independently of testing at intermediate stages, and how retesting by control authorities ensures that marketed vaccines meet quality standards.Za prevenciju i suzbijanje širenja gripe kao zarazne bolesti svake se godine provodi sezonsko cijepljenje cjepivima koja u svom sastavu sadržavju sojeve virusa influence preporučene i odobrene za tu sezonu. Da bi se mogla staviti u promet, sva cjepiva moraju od nadležnog tijela dobiti dozvolu za stavljanje u promet kao i drugi lijekovi. Puštanje u promet proizvedenih serija odobrenog cjepiva zahtijeva osim opsežnih ispitivanja od strane proizvođača i dodatnu kontrolu od strane nadležnog tijela koje izdaje Certifi kat o provedenoj provjeri kakvoće temeljem kojeg se cjepivo kao imunološki lijek može staviti u promet. Cilj ovog rada je prikazati ne samo pravnu osnovu provjere kakvoće već i kako su uspoređeni rezultati dobiveni ispitivanjem u hrvatskome kontrolnom laboratoriju u odnosu na rezultate ispitivanja proizvođača. Rezultati pokazuju da postoje manja neslaganja rezultata ispitivanja različitih laboratorija koja su u ovisnosti s korištenim metodama/analitičkim postupcima (sličan ili identičan analitički postupak). Rezultati također pokazuju važnost ispitivanja koja se provode na gotovom proizvodu, neovisno o ispitivanjima provedenim na međuproizvodima, kao i važnost retestiranja koje provodi nadležno tijelo u svrhu osiguranja da se na tržištu nalaze samo imunološki lijekovi koji udovoljavaju zahtjevima kakvoće

Identifikacija krivotvorenih lijekova za erektilnu disfunkciju iz ilegalnog lanca opskrbe

The appearance of counterfeit medicines in supply chains is a global public health problem that may seriously affect patients. Counterfeit drugs do not meet quality standards and do not declare their real composition and/or source for the purposes of fraud. They may be generic or innovative, they may contain genuine constituents in a fake packaging, or wrong ingredients, or inactive ingredients, or an incorrect quantity of the active substance. In Croatia, no cases of counterfeit medicines have been detected so far, but the Agency for Medicinal Products and Medical Devices has received 34 samples of medicines and other products for testing from Zagreb City Police. The samples included medicines for erectile dysfunction: sildenafi l, tadalafi l, and vardenafi l. Twenty-three samples of tablets without marketing authorisation in Croatia were tested with high-performance liquid chromatography (HPLC) for the declared sildenafi l and tadalafi l content. Samples labelled 1 (batch T/33), 3 (batch T/33), 5 (batch 4), 6 (batch M0016J), 10 (batch T-070235), 12 (batch T-070544), 15 (batch 314833201), 16 (batch 832718474), and 17 (batch 504830028) containing sildenafi l and samples labelled 20 (batch 070356), 21 (batch 05668), and 22 (batch T 378 5) containing tadalafi l did not contain the active substance within the acceptable 95 % to 105 % margin of deviation from the declared content. While most samples cannot be described as fake with a reasonable amount of certainty, there is still a suspicion of counterfeit. A correct conclusion can be drawn only with the assistance of the manufacturers and by conducting additional laboratory tests.Pojava krivotvorenih lijekova u lancima opskrbe globalni je javnozdravstveni problem koji može imati ozbiljnih posljedica za pacijenta. Krivotvoreni lijekovi ne zadovoljavaju propisane standarde kakvoće te su u svrhu prijevare drugačije deklarirani u odnosu na njihov stvarni sastav i/ili podrijetlo. Mogu biti generički, ili inovativni, mogu sadržavati ispravne sastojke, ali pogrešno pakiranje, pogrešne sastojke, ne sadržavati djelatnu tvar ili ne sadržavati dovoljnu količinu djelatne tvari. U Hrvatskoj do sada nisu zabilježeni slučajevi krivotvorenih lijekova, ali je Agencija za lijekove i medicinske proizvode od policijske uprave Zagrebačke zaprimila 34 uzorka lijeka i ostalih proizvoda u svrhu ispitivanja. Od lijekova, radilo se o lijekovima za erektilnu disfunkciju sildenafi lu, tadalafi lu i vardenafi lu. 23 uzorka tableta koji nemaju odobrenje za stavljanje lijeka u promet u Hrvatskoj ispitana su metodom tekućinske kromatografi je visokog učinka (HPLC) na deklarirani sadržaj sildenafi la i tadalafi la. Ustanovljeno je da uzorci pod oznakama 1 (serija T/33), 3 (serijaT/33), 5 (serija 4), 6 (serija M0016J), 10 (serija T-070235), 12 (serija T-070544), 15 (serija 314833201), 16 (serija 832718474), 17 (serija 504830028) koji su sadržavali sildenafi l te uzorci 20 (serija 070356), 21 (serija 05668), 22 (serija T 378 5) i 23 (702099) koji su sadržavali tadalafi l, ne sadržavaju djelatnu tvar unutar prihvatljivih granica odstupanja od 95 % do 105 % od deklarirane vrijednosti. Iako se ne može sa sigurnosti za većinu uzoraka reći da se radi o krivotvorini, ipak se može govoriti o sumnji na krivotvorinu, a cjeloviti zaključak može se izvesti jedino uz suradnju i mišljenje proizvođača te provedbom dodatnih laboratorijskih ispitivanja

Analiza prijava sumnji na nuspojave lijekova za liječenje benigne hiperplazije prostate prijavljene HALMED-U

Benign prostatic hyperplasia is one of the most common diseases in men, with a prevalence rate of 50% in their 50s to 80% in their 80s, and is mostly treated with chronic drug therapy. The aim of this study was to analyze adverse drug reactions (ADR) to drugs used in benign prostate hyperplasia (BPH) treatment reported to HALMED from 2008 to 2021. Data on ADR reports in Croatia were obtained from the VigiFlow national database and on the use of drugs for BPH in Croatia from Drug Utilization Reports from HALMED. In the observed period, the number of reports on each BPH drug, total number of reports, seriousness of reported ADR, patient age and sex, type of reporter, and most reported ADRs were analyzed. Results showed that 438 ADR reports were received, of which 45.95% on tamsulosin as the most frequently used drug for BPH. Of all reports, 84% were non-serious, 96% were reported in men and 82% in patients older than 45 years. The most frequently reported ADRs were consistent with the known safety profile of BPH drugs. Pharmacists were the most common (47%) reporters of ADRs for BPH drugs, while 33% were reported by physicians. Analysis of the reported ADRs showed that most frequently reported ones were in line with the known safety profile of BPH drugs. However, given the prevalence of the disease and the extent of the use of BPH drugs, it could be argued that the number of reports could be higher (i.e., 34 reports/year). Reporting on ADRs is necessary to better understand the safety profile of drugs in the post-authorization period, and more information on the safe use of medicines could be collected by raising awareness of healthcare professionals.Benigna hiperplazija prostate (BHP) jedna je od najčešćih bolesti u muškaraca dobi od 50 godina i više, s učestalošću od 50% do 80% u muškaraca starijih od 80 godina. Danas se najčešće liječi kroničnom terapijom lijekovima. Cilj ovoga rada bio je analizirati prijave sumnji na nuspojave lijekova za liječenje BHP prijavljene Agenciji za lijekove i medicinske proizvode (HALMED) od 2008. do 2021. godine. Podaci o prijavama izdvojeni su iz nacionalne baze nuspojava VigiFlow. Analiziran je ukupan broj prijava za lijekove za BHP, broj prijava za svaki lijek za BHP, ozbiljnost prijavljenih nuspojava, dob i spol bolesnika, vrsta prijavitelja i najčešće prijavljene nuspojave. Podaci o potrošnji lijekova izdvojeni su iz HALMED-ovih Izvješća o potrošnji lijekova u Republici Hrvatskoj. U promatranom razdoblju zaprimljeno je 438 prijava sumnji na nuspojave lijekova koji se primjenjuju u liječenju BHP-a, od čega je najviše prijavljeno za tamsulozin (45,95%), koji je i najčešće primjenjivani lijek za BHP. Od ukupnog broja prijava 83,5% prijava je bilo ne-ozbiljne naravi, 95,9% je prijavljeno u muškaraca, a 81,5% prijava prijavljeno je u bolesnika u dobi od 45 godina i više. Najčešći prijavitelji bili su farmaceuti (u 46,7% prijava). Liječnici su prijavili 32,9% prijava. Najčešće prijavljivane nuspojave u skladu su s poznatim sigurnosnim profilom lijekova za BHP. Međutim, uzimajući u obzir učestalost BPH i čestu primjenu farmakoterapije u liječenju BPH moglo bi se zaključiti da bi broj prijava mogao biti veći od sadašnje 34 prijave godišnje. Prijavljivanje sumnji na nuspojave nužno je za bolje razumijevanje sigurnosnog profila lijekova nakon stavljanja u promet. Podizanjem svjesnosti svih zdravstveni djelatnika o važnosti prijavljivanja nuspojava može se doprinijeti prikupljanju veće količine informacija i ukupnom znanju o sigurnoj primjeni lijekova