Abstract | Cilj istraživanja
Cilj ovog istraživanja je dati pregled dosad razvijenih i korištenih analitičkih metoda za detekciju krivotvorenih antibiotika. Zatim, istaknuti negativne zdravstvene učinke koji se pojavljuju kao posljedica krivotvorenih lijekova i opisati radnje koje ljekarnici mogu poduzeti u sprječavanju upotrebe krivotvorenih lijekova. Nadalje, objasniti razloge zašto korištenje antibiotika loše kvalitete dovodi do povećanog rizika od razvoja sojeva otpornih na mikroorganizme, neuspjeha liječenja, gubitka povjerenja u zdravstvene sustave i povezanih socio-ekonomskih učinaka.
Materijali i metode
Istraživanja u ovom specijalističkom radu teorijskog su karaktera. Literatura je pretraživana prema temi i predmetu istraživanja, a pretraga je obuhvaćala stručne i znanstvene članke, relevantne farmakopeje (Internacionalna farmakopeja, Europska farmakopeja, Američka farmakopeja USP/NF i Britanska farmakopeja), smjernice i izvještaje regulatornih tijela, Svjetske zdravstvene organizacije i drugih institucija, kao i razne elektroničke izvore. Na temelju proučavanja navedene literature izvedena su vlastita razmatranja na navedenu temu rada.
Pri pretraživanju literature korištene su baze podataka: PubMed, Science Direct, ResearchGate, Scopus, Web of Science, Medline, Embase.
Rezultati
Niti jedna analitička metoda nije dovoljna sama po sebi za identifikaciju svih vrsta krivotvorenih antibiotika zbog velike varijacije u krivotvorinama. Među korištenim analitičkim tehnikama su tekućinska kromatografija visoke djelotvornosti (HPLC) i plinska kromatografija (GC), uz detekcijske sustave poput ultraljubičaste spektroskopije (UV), spektrometrije mase (MS), fluorescencije i kemiluminiscencije. U zemljama s niskim i srednjim dohotkom, zbog ograničenih resursa, prednost imaju brže i jeftinije metode poput kolorimetrije i tankoslojne kromatografije (TLC), iako su one manje selektivne i osjetljive. U zemljama s visokim dohotkom, napredne tehnike poput HPLC-MS pružaju precizne informacije o vrstama prisutnih sastojaka i njihovim količinama, dok su vibracijske spektroskopske tehnike poput Ramanove i spektrometrije apsorpcije bliskog infracrvenog zračenja (NIR) pogodne za primjenu na terenu.
Zaključak
Antimikrobni lijekovi predstavljaju temeljni stup u liječenju infektivnih bolesti. Međutim, s rastućom prijetnjom antimikrobne rezistencije i problematikom krivotvorenih lijekova, jasno je da je potrebna koordinirana globalna akcija. Iako je vizualna inspekcija korisna prva linija obrane, sofisticirane tehnike krivotvorenja zahtijevaju daljnju analizu. Uvođenje naprednih tehnika označavanja i pakiranja, kao što su hologrami, sigurnosne naljepnice i bar kodovi, pomaže u detekciji krivotvorina. Primjena sofisticiranih analitičkih tehnika, uključujući spektrometriju (Ramanovu i NIR) i kromatografiju (tekućinsku i plinsku), ključna je za točnu identifikaciju krivotvorenih antibiotika. Samo kroz kombiniranje regulatornih mjera, naprednih tehnologija i analitičkih metoda, edukacije i globalne suradnje može se efikasno boriti protiv problema krivotvorenih antibiotika i zaštititi javno zdravlje. |
Abstract (english) | Objectives
The aim of this research is to provide an overview of the analytical methods developed and used so far for the detection of counterfeit antibiotics. Next, highlight the negative health effects that occur as a result of counterfeit drugs and describe actions that pharmacists can take to prevent the use of counterfeit drugs. Furthermore, to explain the reasons why the use of low-quality antibiotics leads to an increased risk of the development of resistant strains of microorganisms, treatment failure, loss of trust in health systems and related socio-economic effects.
Material and Methods
The research in this specialist work is of a theoretical nature. The literature was searched according to the topic and subject of the research, and the search included professional and scientific articles, relevant pharmacopoeias (International Pharmacopoeia, European Pharmacopoeia, American Pharmacopoeia USP/NF and British Pharmacopoeia), guidelines and reports of regulatory bodies, the World Health Organization and other institutions, as well as various electronic sources. Based on the study of the mentioned literature, their own considerations were made on the mentioned topic of the work. The following databases were used for the literature search: PubMed, Science Direct, ResearchGate, Scopus, Web of Science, Medline, Embase.
Results
No single analytical method is sufficient by itself to identify all types of counterfeit antibiotics due to the wide variation in counterfeits. Among the techniques used are high performance liquid chromatography (HPLC) and gas chromatography (GC), along with detection systems such as ultraviolet spectroscopy (UV), mass spectrometry (MS), fluorescence and chemiluminescence. In low- and middle-income countries, due to limited resources, faster and more economical methods such as colorimetry and thin-layer chromatography (TLC) are preferred, even though they are less sensitive. In high-income countries, advanced techniques such as HPLC-MS provide precise information on the types of constituents present and their amounts, while vibrational spectroscopic techniques such as Raman and NIR are suitable for field applications.
Conclusion
Antimicrobial drugs represent a fundamental pillar in the treatment of infectious diseases, with a revolutionary impact on public health since their introduction in the 20th century. However, with the growing threat of antimicrobial resistance and the problem of counterfeit medicines, it is clear that coordinated global action is needed. While visual inspection is a useful first line of defense, sophisticated counterfeiting techniques require further analysis. The introduction of advanced labeling and packaging techniques, such as holograms, security labels and bar codes, helps in the detection of counterfeits. Application of standard analytical techniques, including spectroscopy (Raman, infrared) and chromatography (liquid and gas), is essential for accurate identification of counterfeit antibiotics. Only by combining regulatory measures, advanced technologies and analytical methods, education and global cooperation can we effectively fight the problem of counterfeit antibiotics and protect public health. |