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To date, formaldehyde (FA) is one of the more common chemicals and its use is widespread around the world in different sectors, especially in chemical facilities and health care. FA is widely used in working activities owing to its chemical and physical properties. However, it also represents a concerning hazard for the workers’ health due to its toxicity and recognized carcinogenicity. The FA exposure evaluation in occupational setting has arisen interest in the scientific community that leads to the development of several analytical instruments in order to assess both long term and short-term exposure. The paper presents and discusses an equivalence tests procedure via the 2.4-dinitrophenylhydrazine (DNPH)-active air sampling formaldehyde (FA) reference method and two non-reference instruments based on continuous, direct reading monitoring, namely ProCeas® (AP2E) and NEMo XT (Ethera). The FA standard atmosphere calibration system was used to check the reference method by Pearson’s test. Subsequently, the Passing-Bablok test was carried out between the non-reference methods and the DNPH method for potential systematic or proportional errors, and finally the Bland-Altman plot was applied to determine the mean bias and the variances of the recorded values by the reference and non-reference methods in on-field sampling. The results showed a good correlation between the non-references method and the DNPH ones, suggesting their possible applications in heterogeneous occupational scenarios., Sve do danas formaldehid (FA) često je korištena kemikalija a njegova je uporaba raširena diljem svijeta u različitim sektorima a naročito u kemijskim pogonima i zdravstvu. FA se mnogo koristi u raznim radnim postupcima radi svojih kemijskih i fizikalnih svojstava. Međutim, njegova toksičnost i karcinogeničnost predstavljaju opasnost po zdravlje radnika. Istraživanje izlaganja FA-u u radnom okružju predmet je zanimanja znanstvene zajednice i rezultira razvojem više analitičkih instrumenata kojima se utvrđuje njegov učinak na zdravlje nakon duljeg i kraćeg izlaganja. U radu je predstavljen i opisan postupak za test ekvivalencije pomoću FA referentne metode 2.4 dinitrofenilhidrazin (DNPH) -aktivnim uzimanjem uzoraka i dva nereferentna instrumenta temeljena na kontinuiranom izravnom praćenju očitanja, ProCeas® (AP2E) i NEMo XT (Ethera). Korištena je sustav za FA standardnu kalibraciju kako bi se referentna metoda provjerila pomoću Pearsonovog testa. Zatim je napravljen Passing-Bablok test između nereferentnih metoda i DNPH metode za otkrivanje mogućih sistemskih i proporcionalnih pogrešaka, a na kraju je izrađen Bland-Altman grafikon za određivanje srednjeg odstupanja i varijacija u vrijednostima dobivenima referentnim i nereferentnim metodama uzorkovanja na terenu. Rezultati su pokazali dobru korelaciju između nereferentne metode i DNPH metoda, naznačujući moguće primjene u raznorodnim radnim uvjetima.

Formaldehyde (FA) is a hazardous chemical, highly used in the anatomical pathology laboratories. The adverse health effects related to FA occupational exposure are generally related to long-term exposure, however the short-term exposure to peak concentrations are equally of high concern. The occupational monitoring commonly uses the 8h-Time Weight Average (TWA) metric to assess the exposure, but for those chemicals with acute effects, also the15min short-term exposure is strongly recommended. In this study, the occupational monitoring was carried out in an anatomical pathology laboratory with an in-continuous, instantaneous, and direct reading instrument for 65 work shifts (WS). In none of these, the FA European Union (EU) TWA occupational limit (620 g/m3) was exceeded. Differently, in 40 WS the EU Short Term Exposure Limit (STEL) (740 g/m3) was exceeded, even several times a WS. In sight of this, the 8h-TWA metric only could give poor information of the exposure scenario, involving peak emissions, then a 15min peak exposure assessment, via in continuous monitoring, could help managing the risk. In addition, using the inference equation, an Action Value (AV) of the 8h-TWA above which the 15min measurements are strongly recommended, equal to 23.1 g/m3, is suggested for FA., Formaldehid (FA) je štetna kemikalija koja se vrlo često koristi u anatomskim patološkim laboratorijima. Loši utjecaji FA na zdravlje zaposlenika izloženih toj tvari općenito se povezuju s dugotrajnom izloženošću, iako je i kratkotrajna izloženost vršnim koncentracijama vrlo zabrinjavajuća. Za praćenje utjecaja obično se koristi mjerenje prosjeka 8 h vrijeme-težina (TWA) kako bi se procijenila izloženost, no za kemijske tvari koje imaju akutno djelovanje izrazito se preporučuje izračun utjecaja 15-minutne kratkotrajne izloženosti. Istraživanje praćenja utjecaja FA na radnom mjestu provedeno je u jednom patološkom laboratoriju pomoću kontinuiranog, trenutnog i izravnog očitanja mjernim intstrumentom u 65 radnih smjena (WS). Ni u jednoj EU granica TWA od 620 g/m3 nije bila viša. Nasuprot tome, u 40 radnih smjena prijeđena je EU granica kratkotrajne izloženosti (STEL) od 740 g/m3 i to više puta tijekom radnog vremena. Ako se ovo uzme u obzir, 8-satno TWA mjerenje daje samo šture podatke o scenariju izloženosti vršnim emisijama i o 15-minutnim procjenama najviše izloženosti, dok bi kontinuirano praćenje više pomoglo upravljanju rizikom. Uz to, preporuka za FA jest korištenje inferencijalne jednadžbe Akcijska vrijednost (AV) za 8 h-TWA iznad 23.1 g/m3.

Healthcare workers handling antineoplastic drugs (ADs) in preparation units run the risk of occupational exposure to contaminated surfaces and associated mutagenic, teratogenic, and oncogenic effects of those drugs. To minimise this risk, automated compounding systems, mainly robots, have been replacing manual preparation of intravenous drugs for the last 20 years now, and their number is on the rise. To evaluate contamination risk and the quality of the working environment for healthcare workers preparing ADs, we applied the Failure Mode Effects and Criticality Analysis (FMECA) method to compare the acceptable risk level (ARL), based on the risk priority number (RPN) calculated from five identified failure modes, with the measured risk level (MRL). The model has shown higher risk of exposure with powdered ADs and containers not protected by external plastic shrink film, but we found no clear difference in contamination risk between manual and automated preparation. This approach could be useful to assess and prevent the risk of occupational exposure for healthcare workers coming from residual cytotoxic contamination both for current handling procedures and the newly designed ones. At the same time, contamination monitoring data can be used to keep track of the quality of working conditions by comparing the observed risk profiles with the proposed ARL. Our study has shown that automated preparation may have an upper hand in terms of safety but still leaves room for improvement, at least in our four hospitals., Zdravstveni radnici koji rukuju antineoplastičnim lijekovima u posebnim jedinicama za njihovu pripremu izlažu se zagađenim površinama i riziku od s njima povezanim mutagenim, teratogenim i onkogenim učincima. Da bi se smanjio taj rizik, u posljednjih se 20-ak godina ručna priprema intravenskih lijekova sve više zamjenjuje automatiziranom. Da bismo ocijenili rizik od zagađenja i kakvoću radnog okoliša zdravstvenih radnika koji pripremaju antineoplastične lijekove, oslonili smo se na metodu analize mogućih pogrešaka u postupcima I kritičnosti njihovih posljedica (engl. failure mode effects and criticality analysis, krat. FMECA) radi usporedbe prihvatljive razine rizika (engl. acceptable risk level, krat. ARL), koja je zbroj ocjena prioriteta rizika (eng. risk priority number, krat. RPN) pet utvrđenih načina pogreške s izmjerenom razinom rizika (engl. measured risk level, krat. MRL). Taj nam je model pokazao da antineoplastični lijekovi u prahu i spremnicima koji nisu zaštićeni vanjskim plastičnim omotačem donose povećani rizik, ali nismo utvrdili dosljednu razliku u riziku od zagađenja između ručne i automatizirane pripreme. Ovaj pristup može biti koristan u procjeni i kontroli rizika od profesionalne izloženosti u zdravstvenih radnika rezidualnim citotoksičnim spojevima, bilo da se radi o postojećim ili tek planiranim/novoosmišljenim postupcima pripreme lijekova. Podatci dobiveni redovitim nadzorom (monitoringom) istodobno mogu poslužiti za praćenje kakvoće radnih uvjeta tako što će se usporediti s predviđenim profilom rizika koji je utvrđen ARL-om. Iako je naše istraživanje pokazalo da automatizirana priprema ima prednost nad ručnom u smislu sigurnosti, prostora za njezino poboljšanje ima podosta, naročito u našim četirima bolnicama koje su sudjelovale u istraživanju.

Formaldehyde (FA) is a chemical compound commonly used in anatomical pathology laboratories as a tissue preservative, and it is common and epidemiologically related to cancer. Therefore, the personnel resident in the anatomical pathology laboratories is among the workers most exposed to FA and its related cancer and non-cancerogenic risk. Thus, risk assessment, cancerogenic and non-cancerogenic, and a careful occupational exposure assessment are recommended. In this study, FA was monitored in an Italian anatomical pathology laboratory to perform an occupational exposure assessment, according to the UNI EN 689:219, and to determine the Hazard Quotient (HQ) and the Lifetime Cancer Hazard Risk (LCHR) for carcinogenic and non-carcinogenic risk assessment, respectively. The exposure observed for pathologists and technicians is lower than the EU Occupational exposure limit mandatory (0.62 mg/m3), and both group of workers are in Compliance with it. Nevertheless, concerning the risk assessment, both the HQs and the LCHRs resulted in being higher (1.3 and 1.6 HQ and 3.2x10-5 and 3.9x10-5, for pathologists and technicians, respectively) than the ones observed in similar scenarios. This study shows how the exposure assessment to FA could face striving situations in terms of workers' health safeguard, due to the differences among occupational limits recommended and the high health risks, especially in the healthcare field., Formaldehid je kemijski spoj koji se obično koristi u laboratorijima za anatomsku patologiju kao konzervans za čuvanje tkiva, a često ga se povezuje s rakom. Osoblje u takvim laboratorijima najizloženije je formaldehidu i s njim povezanom raku, a i nekancerogenom riziku. Stoga se preporuča procjena rizika, kancerogenih i nekancerogenih, a također i procjena izloženosti na radu. Ova studija pratila je formaldehid u jednom talijanskom laboratoriju za patologiju kako bi se procijenila izloženost na radu prema UNI EN 689:219 i utvrdio kvocijent opasnosti (HQ) kao i doživotnog rizika od raka (LCHR) te kancerogeni i nekancerogeni rizici. Izloženost patologa i tehničara bila je niža od Europske obvezne granice za izloženost na radu (0.62 mg/m3) i obje skupine bile su ispod te granice. No, ipak, što se tiče procjene rizika, oba parametra HQ i LCHR bila su viša (1.3 i 1.6 HQ, i 3.2x10-5 i 3.9x10-5 za patologe te tehničare, tj. viša od drugih zamijećenih u sličnim situacijama. Studija prikazuje kako procjena izloženosti formaldehidu može pomoći u očuvanju zdravlja radnika utvrđivanjem odstupanja od preporučenih graničnih vrijednosti i posljedično visokih rizika za zdravlje, posebno u zdravstvu.

Antineoplastic drugs (ADs) are essential tools in cancer treatment, but their cytotoxicity poses a risk to workers involved in their handling. In a hospital environment fundamental strategies for minimising exposure involve proper use of safety cabinets and closed-circuit transfer devices, along with personnel training and increased awareness of risks. However, medical gloves remain the first line of defence. In this respect the evaluation of glove materials and best choices can improve hospital safety management and prevent potential hazards and long-term consequences. The aim of this study was to assess contamination of gloves in samples taken from AD administration and preparation units of nine Italian hospitals and to raise awareness of the importance of evaluating chemico-physical properties of gloves. Our findings show that 33 % of the analysed gloves were positive for at least one AD, with contaminations ranging from 0.6 to 20,729 pg/cm2. We proposed the alert glove values (AGVs) for each AD as a limit value for contamination assessment and good practice evaluation. Our findings also point to multiple AD contamination (43 % of positive findings in preparation units), calculated as total AGV (AGV-T), and confirm that gloves should be replaced after 30 min of AD handling, based on cumulative permeation and area under the curve (AUC), to maintain safety and limit dermal exposure., Antineoplastični lijekovi (AD) imaju raširenu i ključnu primjenu u liječenju karcinoma, ali zbog svoje citotoksičnosti predstavljaju rizik za zdravstvene radnike koji njima rukuju. U bolničkom okružju osnovne strategije za smanjenje izloženosti obuhvaćaju pravilnu primjenu zatvorenih sustava za rukovanje i prijenos tih lijekova te obuku osoblja i povećanje svijesti o rizicima. Ipak, prva crta obrane i dalje su medicinske rukavice. U tom smislu, ocjena materijala rukavica i izbor onih najboljih može unaprijediti sigurnost i spriječiti moguće opasnosti i dugoročne posljedice. Cilj je ovog istraživanja bio ocijeniti onečišćenje uzoraka rukavica uzetih nakon pripreme i primjene antineoplastičnih lijekova u devet talijanskih bolnica te ukazati na važnost ocjene fizikalno-kemijskih svojstava takvih rukavica. Pokazalo se da je 33 % analiziranih rukavica bilo pozitivno na barem jedan antineoplastični lijek, a onečišćenje se kretalo u rasponu od 0,6 do 20,729 pg/cm2. Naš novi parametar, koji smo nazvali kritične vrijednosti rukavica (izv. alert glove values, krat. AGV), izračunan za svaki pojedini antineoplastični lijek kao 95. percentil, može dobro poslužiti za usporedbu ocjena onečišćenja. Naši rezultati također upozoravaju na onečišćenje s više antineoplastičnih lijekova odjednom (43 % pozitivnih uzoraka u pripremnim jedinicama), koje je izračunano kroz ukupni AGV, te na potrebu da se rukavice zamijene 30 minuta nakon rukovanja antineoplastičnim lijekom s obzirom na kumulativnu propusnost i površinu ispod krivulje kako bi se sačuvala sigurnost i ograničila izloženost putem kože.

Antineoplastic drugs are a wide and heterogeneous group of substances that, as universally known, can cause highly severe toxic effects to whoever is exposed. From an occupational safety point of view, surface contaminations inside preparation and administration units are a growing issue and therefore require the development and implementation of sensible and fast monitoring methods. The unlikelihood of a unique all-embracing chromatography, able to correctly retain and separate each analyte led to the need to create an orthogonal normal phase analysis, which might be able to fill the gaps in the more common reversed-phase ones. An existing hydrophilic interaction method has thus been expanded to 6 other drugs and applied to real samples after an evaluation of its performances. The experimental data were then used to evaluate the possibility of estimating reliable relationships between the chromatographic retention and the chemical-structural features of the drugs under analysis.

Occupational exposure to antineoplastic drugs (ADs) handling and administration is one of the main risks in the healthcare sector. Dermal absorption represents the primary route of exposure to ADs. Personal preventive equipment, especially medical gloves, is crucial to safeguard the workers health in ADs handling; thus, chemicals permeating through protective materials is an essential aspect to estimate and consider. Several studies on permeation through medical gloves reported that breakthrough time and permeation rate are the values that must be studied, observing that physical-chemical properties of drugs, PPE materials and thickness, and temperature are crucial features to estimate them. In the European Union, standardized permeation testing is not mandatory for gloves used in ADs manipulation, in contrast with the United States, that proposed stringent requirements in the American Society of Testing and Materials International standard D6978-05. This review would help identify the main characteristics of the best protective glove used by employees frequently exposed to ADs: the major aspects implicated in permeation, reported in the literature, are listed and discussed., Radna izloženost rukovanju i primjeni antineoplastičnih lijekova (AD) jedan je od glavnih rizika u zdravstvenom sektoru. Kožna apsorpcija predstavlja primarni put izlaganju AD-ima. Osobna preventivna oprema, posebno medicinske rukavice, presudna je za zaštitu zdravlja radnika u radu s AD-ima; prema tome, kemikalije koje prodiru kroz zaštitne materijale bitan su aspekt za procjenu i razmatranje. Nekoliko studija o prožimanju kroz medicinske rukavice izvijestilo je da su vrijeme proboja i brzina prodiranja vrijednosti koje se moraju proučavati, primjećujući da su fizičko-kemijska svojstva lijekova, OZO materijali i debljina i temperatura ključne značajke za njihovu procjenu. U Europskoj uniji, standardizirano ispitivanje prožimanja nije obvezno za rukavice koje se koriste u manipulaciji ADs, za razliku od Sjedinjenih Država koje su predložile stroge zahtjeve u međunarodnom standardu D6978-05 Američkog društva za ispitivanje i materijale. Ovaj pregled pomogao bi identificirati glavne karakteristike najbolje zaštitne rukavice koju koriste zaposlenici često izloženi AD-ima: glavni aspekti uključeni u prožimanje, priopćeni u literaturi, navedeni su i raspravljeni.