Introduction: Centralized dissolution of cytostatics in a hospital pharmacy is a modern and economical way of preparing this type of medicinal product. It uses an aseptic method of operation that guarantees the quality of the solutions obtained while ensuring the safety of personnel and protecting the environment.
Aim: The aim of this article is to evaluate the implementation of the change in an ordinance of the Ministry of Health of the Republic of Bulgaria for the introduction of centralized dissolution of cytostatics in hospital pharmacies of oncology and/or onco-hematology wards three years after its adoption.
Methodology: A survey conducted by telephone and/or through online communication among the heads of hospital pharmacies in hospitals in Bulgaria was used. The implementation period was March-April 2019.
The results were analyzed and compared with the registers of the Ministry of Health.
Results: Out of 40 medical establishments with oncology and/or onco-hematology wards, 18 have centralized dissolution of cytostatics in hospital pharmacies compared to 3 before adopting the ordinance. Another few are in the process of reconstructing the pharmacies and their upcoming introduction. Nurses participate in cytostatic dissolution activities in 60 percent of hospital pharmacies in violation of the legal framework..
Conclusion: The process of introducing centralized dissolution of cytostatics in hospital pharmacies in Bulgaria has begun. There are still a number of challenges for healthcare institutions, mainly related to the financial investments that need to be made. A serious problem is the lack of sufficiently qualified staff in hospital pharmacies, which often requires that nurses perform their activities.
Reich SD. Pharmaceutics: antineoplastic agents as potential carcinogens: are nurses and pharmacists at risk? Cancer Nurs. 1981 Dec;4(6):500–2.
Marrs T, Stemplewski H, Gandhi S, Woodward K, Renshaw D, Ritz V, et al. Regulatory Toxicology in the European Union [Internet]. Royal Society of Chemistry; 2018. (ISSN). Available from: https://books.google.bg/books?id=0bWrDwAAQBAJ
IARC. Monographs on the Identification of Carcinogenic Hazards to Humans [Internet]. Agents Classified by the IARC Monographs. 2019. Available from: https://monographs.iarc.fr/agents-classified-by-the-iarc/
Hsu CH, Stedeford T. Cancer Risk Assessment: Chemical Carcinogenesis, Hazard Evaluation, and Risk Quantification [Internet]. Wiley; 2010. Available from: https://books.google.bg/books?id=-bt070a58rAC
Valanis B, Vollmer W, Labuhn K, Glass A. Occupational Exposure to Antineoplastic Agents and Self-Reported Infertility Among Nurses and Pharmacists. J Occup Environ Med. 1997 Jun;39(6):574–80.
Selevan SG, Lindbohm M-L, Hornung RW, Hemminki K. A Study of Occupational Exposure to Antineoplastic Drugs and Fetal Loss in Nurses. N Engl J Med. 1985 Nov 7;313(19):1173–8.
Anderson RW, Puckett WH, Dana WJ, Nguyen T V, Theiss JC, Matney TS. Risk of handling injectable antineoplastic agents. Am J Hosp Pharm. 1982 Nov;39(11):1881–7.
Favier M, Fliche E, Bressolle F. Economic benefit of a centralized reconstitution unit of cytotoxic drugs in isolator. J Oncol Pharm Pract. 1996 Sep 29;2(3):182–5.
Baldo P, Bertola A, Basaglia G, Moneghini M, Sorio R, Zibardi E, et al. A centralized Pharmacy Unit for cytotoxic drugs in accordance with Italian legislation. J Eval Clin Pract. 2007 Apr;13(2):265–71.
Vaz da Conceição A. Oncology pharmacy units: a safety policy for handling hazardous drugs and related waste in low- and middle-income African countries—Angolan experience. Ecancermedicalscience. 2015 Sep 1;9.
Masini C, Nanni O, Antaridi S, Gallegati D, Marri M, Paolucci D, et al. Automated preparation of chemotherapy: Quality improvement and economic sustainability. Am J Heal Pharm. 2014 Apr 1;71(7):579–85.
Easty AC, Coakley N, Cheng R, Cividino M, Savage P, Tozer R, et al. Safe handling of cytotoxics: guideline recommendations. Curr Oncol. 2015 Feb;22(1):e27-37.
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