Medicinal products as a causative agent of occupational diseases in pharmaceutical workers (literature review)

Authors

DOI:

https://doi.org/10.26641/2307-0404.2022.4.271172

Keywords:

medicinal products, occupational diseases, pharmaceutical companies

Abstract

The issue of occupational diseases in chemical and pharmaceutical workers is urgent because it stems from the rapid pace of development, the functional features, and the high biological activity of raw materials used by that industry. The study is aimed at summarizing the information on preconditions and nature of occupational diseases among chemical and pharmaceutical workers based on the analysis of literature data. An important prerequisite for the emergence of occupational diseases is the shortcomings in the production process, leading to pollution of surfaces and workspace air with chemicals through the use of semi-automatic equipment in particular. The harmful substances then enter the bodies of workers through the respiratory system, which is the main and most harmful way. The most dangerous processes are the production and processing of substances with high pharmacological activity, and thus the active pharmaceutical ingredients maybe considered to be the leading causative agents of occupational diseases in the industrial production of medicinal products. The range of diseases diagnosed in pharmaceutical workers is diverse and includes acute intoxication, effects on internal organs, reproductive function, changes in hormonal status, and changes in the hemic system and nervous system. The most common are diseases of respiratory organs and diseases of allergic origin. As a result, influential international organizations and many authors emphasize the need to develop criteria and methods for assessing the harmful effects of medicinal products on the health of workers when authorizing their production.

References

Vitiuk AV, Trachenko KR. [Contradictory trends in the development of the pharmaceutical industry of Ukraine]. Visnyk Vinnytskoho politekhnichnoho instytutu. 2018;6:35-43. Ukrainian. doi: https://doi.org/10.31649/1997-9266-2018-141-6-35-43

Horokhova LH, Martynova NA, Kizichenko NV, Lohunova TD. [Hygienic aspects of the state of health of workers in chemical and pharmaceutical production]. Medytsyna v Kuzbasse. 2017;16(3):11-5. Russian.

Horokhova LH, Ulanova EV, Shavtsova HM, Erdeeva SV, Blazhina ON. [The state of health of workers in the chemical and pharmaceutical industry]. Medytsyna truda i promyshlennaia ekolohiia. 2018;6:38-42. Russian. doi: https://doi.org/10.31089/1026-9428-2018-6-38-42

[State Register of Medicines of Ukraine] [Internet]. Kyiv: State Service of Medicines and Drug Control of Ukraine; 2021 [updated 2021 March 31; cited 2021 April 9]. Available from: https://www.dls.gov.ua/

[Economic statistics] [Internet]. Kyiv: State Statistics Service of Ukraine; 2021 [updated 2021 March 12; cited 2021 April 9]. Available from: http://www.ukrstat.gov.ua.

Zahorii HV, Ponomarenko MS, Trokhymchuk VV, Drozdova AO, Hryhoruk YuM. [Comparative structural and statistical analysis of morbidity with temporary disability of personnel of CJSC “Pharma-ceutical firm “Darnytsia” in connection with reengineering processes in the strategy of accelerated development of the enterprise (1996-2000 and 2006-2010)]. Upravlinnia, eko¬nomika ta zabezpechennia yakosti v farmatsii. 2012;1:38-44. Ukrainian.

Zazuliak TS. [Harmful chemical factors in the production of medicines]. Aktualni problemy profilaktychnoi medytsyny. 2021;22:94-109. Ukrainian.

Trakhtenberh IM, editors. [Medical toxicology. Preclinical studies]. Kyiv: Avitsena; 2020. Ukrainian.

Nahorna AM, Sokolova MP, Kononova IH. [Occupational morbidity of medical workers in Ukraine as a medical and social problem]. Ukrainskyi zhurnal z problem medytsyny pratsi. 2016;2(47):3-16. Ukrainian. doi: https://doi.org/10.33573/ujoh2016.02.003

Nahorna AM, Sokolova MP, Kononova IH. [Epi-demiological studies of occupational health in Ukraine]. Ukrai¬nskyi zhurnal z problem medytsyny pratsi. 2018;4(57):3-20. Ukrainian. doi: https://doi.org/10.33573/ujoh2018.04.003

Nahorna OK. [Occupational safety of workers in the pharmaceutical industry]. In: Problemy okhorony pratsi, promyslovoi ta tsyvilnoi bezpeky. Proceedings of the eighteenth all-Ukrainian scientific-methodical Сonfe-rence; 2018 May15-16; Kyiv: KPI im. Ihoria Sikorskoho; 2018. p. 190-3. Ukrainian.

[About medicines. Pub. L. No. 123/96-VR, 1996. Information of the Verkhovna Rada of Ukraine No. 22, Stat. 86. (Apr 04, 1996).

Trakhtenberh IM, Dmytrukha NM. [Industrial toxicology: main directions, results and prospects of scien¬tific activity]. Ukrainskyi zhurnal z problem medytsyny pratsi. 2019;5(2):87-101. Ukrainian. doi: https://doi.org/10.33573/ujoh2019.02.087

Tymoshyna DP, Lubianova IP. [Health problems of medical workers in Ukraine]. Upravlinnia zakladamy okhorony zdorovia. 2015;8:54-58. Ukrainian.

Shafran LM, Tretiakova OV. [The concept of “TOXICITY TESTING-21” in modern toxicology]. Ak-tualni problemy profilaktychnoi medytsyny. 2021;22:8-42. Ukrainian.

Albert F, Bassani R, Coen D, Vismara A. Hypoglycaemia by inhalation. Lancet. 1993;342:47-8. doi: https://doi.org/10.1016/0140-6736(93)91906-3

Allian AD, Shah NP, Ferretti AC, Brown DB, Kolis SP, Sperry JB. Process safety in the pharmaceutical industry – part I: thermal and reaction hazard evaluation processes and techniques. Organic Process Research & Development. 2020;24(11):2529-48. doi: https://doi.org/10.1021/acs.oprd.0c00226

Baxter PJ, Samuel AM, Aw TC, Cocker J. Expo-sure to quinal barbitone sodium in pharmaceutical workers. Br Med J (Clin Res Ed). 1986;292:660-61. doi: https://doi.org/10.1136/bmj.292.6521.660-a

Bhusnure OG, Dongare RB, Gholve SB, Giram PS. Chemical hazards and safety management in pharmaceutical industry. Journal of Pharmacy Research. 2018;12(03):357-69.

Conde-Salazar L, Blancas-Espinosa R, Pérez-Hortet C. Occupational airborne contact dermatitis from omeprazole. Contact Dermatitis. 2007 Jan;56(1):44-6. doi: https://doi.org/10.1111/j.1600-0536.2007.00921.x

European competition authorities working to gether for affordable and innovative medicines: Report from the commission to the council and the European Parliament. Competition enforcement in the pharma-ceutical sector (2009-2017). [Internet]. Brussels; 2019 Jan 28 [cited 2021 April 15]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52019DC0017

Fung VSWC. Risk Assessment and Communication in Pharmaceuticals: Recognizing the Differences in Occupational Health and Medication Safety. J Toxicol Risk Assess. 2019;5:019. doi: https://doi.org/10.23937/2572-4061.1510019

Gathuru IM, Buchanich JM, Marsh GM, Dolan DG. Health Hazards in the Pharmaceutical Industry. Pharmaceut Reg Affairs. 2015;4(3):1-15. doi: https://doi.org/10.4172/2167-7689.1000145

Gomez Torrijos E, Borja J, Galindo PA, et al. Allergic contact dermatitis from mitomycin C. Allergy. 1997;52:687.

doi: https://doi.org/10.1111/j.1398-9995.1997.tb01061.x

Goon ATJ, McFadden JP, McCann M, Royds C, Rycroft RJG. Allergic contact dermatitis from melphalan and chlorambucil: cross-sensitivity or cosensitization? Contact Dermatitis. 2000;47:309. doi: https://doi.org/10.1034/j.1600-0536.2002.4705101.x

Gunnarsson L, Jason R. Snape JR, Verbruggen B, Owen SF, Kristiansson E, et al. Pharmacology beyond the patient – the environmental risks of human drugs. Environment International. 2019 Aug;129:320-32. doi: https://doi.org/10.1016/j.envint.2019.04.075

Heron RJL, Pickering FC. Health effects of expo-sure to active pharmaceutical ingredients (APIs). Occupa-tional Medicine. 2003;53:357-62. doi: https://doi.org/10.1093/occmed/kqg115

Jeebhay M, Mbuli S, Uebel R. Assessment of exposure to chloramphenicol and azathioprine among workers in a South African pharmaceutical plant. Int Arch Occup Environ Health. 1993;65(1 Suppl):119-22. doi: https://doi.org/10.1007/BF00381321

Kiffmeyer ТК, Drrernat, Schmidt KG, Paul JM, Sessink PJM. Vapourpressures, evaporation behaviour and airborne concentrations of hazardous drugs: implications for occupational safety. The pharmaceutical journal. 2002;268:331-7.

Kuzminov BP, Zazulyak TS, Hrushka OI, Kuzminov AB, Shvets IA, Brejdak AA. System Approach to Regulation of the Harmful Influence of Medicines in the Conditions in the Manufacturing Process and Environ-ment. Eksperymentalna ta klinichna fiziolohiia i biokhimiia. 2018;2(82):15-20. doi: https://doi.org/10.25040/ecpb2018.02.015

Milković-Kraus S, Jelena Macan J, Bozica Kanceljak-Macan B. Occupational allergic contact dermatitis from azithromycin in pharmaceutical workers: a case series. Contact Dermatitis. 2007 Feb;56(2):99-102. doi: https://doi.org/10.1111/j.1600-0536.2007.00999.x

Neumark M, Arieh Ingber A, Michael Levin M, Dan Slodownik D. Occupational airborne contact derma-titis caused by pantoprazole. Contact Dermatitis. 2011 Jan;64(1):60-1.

doi: https://doi.org/10.1111/j.1600-0536.2010.01783.x

Park HS, Nahm DH. New occupational allergen in a pharmaceutical industry: serratial peptidase and lysozyme chloride. Ann Allergy Asthma Immunol. 1997 Feb;78(2):225-9.

doi: https://doi.org/10.1016/S1081-1206(10)63392-3

Prasad MH, Pushpavathi K, Devi GS, Reddy PP. Reproductive epidemiology in sulfonamide factory workers. J Toxicol Environ Health. 1996 Feb 9;47(2):109-14. doi: https://doi.org/10.1080/009841096161816

Reichard JF, Maiera MA, Naumann BD, Pec-quet AM, Pfister T, Sandhu R, et al. Toxicokinetic and toxicodynamic considerations when deriving health-based exposure limits for pharmaceuticals. Regulatory Toxicology and Pharmacology. 2016;79(1,15):67-78. doi: https://doi.org/10.1016/j.yrtph.2016.05.027

Romanowska-Słomka I, Szołkowski A. [Dangers of chemical substances in the pharmaceutical industry]. Zeszyty naukowe wyższej szkoły zarządzania ochroną pracy w Katowicach. 2019;1(15):43-57. Polish. doi: https://doi.org/10.32039/WSZOP/1895-3794-2019-01

Ryan PJJ, Rycroft RJG, Aston IR. Allergic contact dermatitis from occupational exposure to ranitidine hydrochloride. Contact Dermatitis. 2003 Feb;48(2):67-8. doi: https://doi.org/10.1034/j.1600-0536.2003.480202.x

Sahu RK, Yadav R, Prasad P, Roy A., Chandrakar S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springer-plus. 2014 Nov;3:695.

doi: https://doi.org/10.1186/2193-1801-3-695

Sarkis M, Bernardi A., Shah N, Papatha¬na-siou MM. Emerging Challenges and Opportunities in Pharmaceutical Manufacturing and Distribution. Processes. 2021;9(3):457. doi: https://doi.org/10.3390/pr9030457

Schenk L, Johanson G. Use of uncertainty factors by the European Commission Scientific Committee on Occupational Exposure Limits: a follow-up. Crit Rev Toxicol. 2018;48(7):513-21. doi: https://doi.org/10.1080/10408444.2018.1483891

Scott AJ. Occupational health in the pharma-ceutical industry: an overview. Occup Med (Lond). 2003 Sep;53(6):354-6. doi: https://doi.org/10.1093/occmed/kqg114

Shuai Deng, Yige Sun, Tianyi Zhao, Yang Hu, Tianyi Zang. A Review of Drug Side Effect Identification Methods. Current Pharmaceutical Design. 2020;26(26):3096-104. doi: https://doi.org/10.2174/1381612826666200612163819

Singal M, Patnode R. Health Hazard Evaluation Report 81-322-1228. [Internet]. Mylan Pharmaceuticals, Morgantown, West Virginia. National Institute for Occupational Safety and Health, Cincinnati, OH: Report No. HETA 81-322-1228; 1982 Nov. [cited 2021 April 15]. Available from: https://www.cdc.gov/niosh/hhe/reports/pdfs/81-322-1228.pdf.

Taskinen H, Lindbohm ML, Hemminki K. Spon-taneous abortions among women working in the pharma-ceutical industry. Br J Ind Med. 1986 Mar;43(3):199-205. doi: https://doi.org/10.1136/oem.43.3.199

Thomson KF, Sheehan-Dare RA, Wilkinson SM. Allergic contact dermatitis from topical carmustine. Contact Dermatitis. 2000;42:112. PMID: 10703643.

Tomei F, Iavicoli S, Iavicoli A, Papaleo B, Baccolo TB. Liver damage in pharmaceutical industry workers. Arch Environ Health. 1995 Jul-Aug;50(4):293-7. doi: https://doi.org/10.1080/00039896.1995.9935957

Whitaker P. Occupational allergy to pharma-ceutical products. Current Opinion in Allergy and Clinical Immunology. 2016 April;16(2):101-6. doi: https://doi.org/10.1097/ACI.0000000000000248

Yan BB, Ma YY, Guo J, Wang YC. Self-micro-emulsifying delivery system for improving bioavailability of water insoluble drugs. Journal of nanoparticle research. 2020 Jan 4;22(1):1-14. doi: https://doi.org/10.1007/s11051-019-4744-6

Zuskin E, Mustajbegovic J, Schachter NE, Kern J, Deckovic-Vukres V, Pucarin-Cvetkovic J, Nola-Premec IA. Respiratory findings in pharmaceutical workers. Am J Ind Med. 2004 Nov;46(5):472-9. doi: https://doi.org/10.1002/ajim.20085

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Published

2022-12-29

How to Cite

1.
Kuzminov B, Zazulyak T. Medicinal products as a causative agent of occupational diseases in pharmaceutical workers (literature review). Med. perspekt. [Internet]. 2022Dec.29 [cited 2024Apr.19];27(4):58-64. Available from: https://journals.uran.ua/index.php/2307-0404/article/view/271172

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THEORETICAL MEDICINE