ISOPP Standards for the Safe Handling of Cytotoxics

doi:10.1177/10781552211070933

Cited by 23 publications

(11 citation statements)

References 155 publications

(198 reference statements)

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“…The International Society of Pharmacy Practitioners (ISOPP) released the Standards for the Safe Handling of Cytotoxic Drugs in 2022. 32 Guidance is provided for specific categories of SACT such as monoclonal antibodies. It does not provide audit recommendations but provides an audit toolkit.…”

Section: Resultsmentioning

confidence: 99%

Quality assurance standards and their use in the preparation of parenteral systemic anticancer therapy products in healthcare establishments: a scoping review

Murphy,

O' Mahony,

McCarthy

et al. 2023

Eur J Hosp Pharm

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ObjectivesThe use of parenteral systemic anticancer therapy (SACT) has led to improved cancer survival. A quality assurance (QA) system of the aseptic compounding process is necessary to ensure safe and consistent production of parenteral SACT. This scoping review identifies international evidence and practice relating to QA standards in the preparation of parenteral SACT in healthcare establishments.MethodsStandards relating to aseptic compounding in hospital pharmacies and literature exploring the aseptic compounding of parenteral SACT were included. Literature relating to the non-aseptic compounding of medicines and records specific to sterile manufacturing in industrial settings were excluded. A search of several electronic databases, trial registries, the grey literature and websites of key European hospital pharmacy groups and accreditation bodies was conducted on 16 March 2022. A narrative discussion was performed by country, and content analysis of articles was conducted.ResultsThirty-seven records were included. Standards reviewed covered the work environment, the preparation process and the safety of the workers who are potentially exposed to hazardous chemicals. It was a common practice to include frequent audits to ensure adherence to standards. Some standards also recommended external inspections to allow for further learnings. Periodic reviews are encouraged to ensure standards maintain relevance. National standards of the countries reviewed were based on international standards, with minor adaptations for local conditions.ConclusionsThe main limitation of this review is that it is limited to countries with a high human development index. The review shows that the use of an internationally recognised standard as a basis for national standards is best practice, and will allow for relevance into the future.

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Section: Resultsmentioning

confidence: 99%

Quality assurance standards and their use in the preparation of parenteral systemic anticancer therapy products in healthcare establishments: a scoping review

Murphy,

O' Mahony,

McCarthy

et al. 2023

Eur J Hosp Pharm

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“…Otherwise, it is well known that headache is a less common side effect of cyclophosphamide treatment, which may be due to the elevation of blood pressure which could happen during the infusion of cyclophosphamide. No data were found about the prevalence of headaches during cyclophosphamide infusion 26 , 27 . The rate of using the treatment for headaches in our study was higher in both groups compared to the previous studies 25 , 26 , 28 .…”

Section: Discussionmentioning

confidence: 99%

“…No data were found about the prevalence of headaches during cyclophosphamide infusion 26 , 27 . The rate of using the treatment for headaches in our study was higher in both groups compared to the previous studies 25 , 26 , 28 . The facility of buying analgesics in Syria may explain these differences.…”

Section: Discussionmentioning

confidence: 99%

Prevalence, types, and characteristics of headache in Behcets disease without involvement of the central nervous system in the Syrian population: a case-cohort study

Rabah,

Deeb

et al. 2024

Annals of Medicine &Amp; Surgery

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Introduction: Oral ulcers, genital ulcers, and uveitis represent the typical trial of Behcet’s disease (BD). It is well common on the Old Silk Road. The mucocutaneous lesions are the hallmark of BD, but neurological involvement is one of the severe symptoms. Headaches may be an early sign of BD neurological involvement. This study aims to investigate the headache prevalence and its types, and characteristics in a Syrian sample of BD patients. Methods: BD patients were clinically interviewed and examined to collect their information, symptoms, and signs. the International Study Group for Behcet’s Disease diagnosis criteria was used to confirm the BD diagnosis. The International Classification of headaches was used when classifying the headaches. Results: 120 participants were included in the study. half of them were BD patients and the control group was also 60 participants. Among Syrian BD patients, 36.7% suffer from primary headaches and 36.7% suffer from secondary headaches. These findings were not significantly different between the BD patients and the healthy population. Our results showed that there was no statistically significant difference between the two groups. Conclusion: Headache should not be considered a predictor for neurological involvement among BD patients. Additional attention to BD patients or the specific treatment for headaches is not required and does not differ from the general population.

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“…The therapeutic benefits of ADs with carcinogenic, mutagenic, and teratogenic properties outweigh the risks for patients but they represent a risk for health care workers. The long-term occupational exposures have been associated with adverse health outcomes including reproduction toxicity or cancer ( 3 , 4 ). Acute adverse health effects in such as skin rashes and hair loss have been also reported ( 5 , 6 ).…”

Section: Introductionmentioning

confidence: 99%

“…Occupational exposures of health care staff to ADs may occur in pharmacies and hospitals through direct dermal contact, inhalation, accidental ingestion, or indirectly via surfaces contaminated by ADs during their preparation, handling or administration to patients ( 3 , 7 ). To minimize the occupational exposure and achieve maximum product safety, the preparation of ADs is regulated.…”

Section: Introductionmentioning

confidence: 99%

Proposals of guidance values for surface contamination by antineoplastic drugs based on long term monitoring in Czech and Slovak hospitals and pharmacies

Bláhová,

Bláha,

Doležalová

et al. 2023

Front. Public Health

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IntroductionThe exposures to hazardous antineoplastic drugs (AD) represent serious risks for health care personnel but the exposure limits are not commonly established because of the no-threshold effects (genotoxic action, carcinogenicity) of many ADs. In this study, we discussed and derived practically applicable technical guidance values (TGV) suitable for management of AD risks.MethodsThe long-term monitoring of surface contamination by eight ADs was performed in pharmacies and hospitals in the Czech Republic and Slovak Republic in 2008–2021; in total 2,223 unique samples were collected repeatedly in 48 facilities. AD contamination was studied by LC-MS/MS for cyclophosphamide, ifosfamide, methotrexate, irinotecan, paclitaxel, 5-fluorouracil and gemcitabine and by ICP-MS for total Pt as a marker of platinum-based ADs.ResultsThe study highlighted importance of exposure biomarkers like 5-fluorouracil and especially carcinogenic and persistent cyclophosphamide, which should be by default included in monitoring along with other ADs. Highly contaminated spots like interiors of laminar biological safety cabinets represent a specific issue, where monitoring of contamination does not bring much added value, and prevention of staff and separated cleaning procedures should be priority. Rooms and surfaces in health care facilities that should be virtually free of ADs (e.g., offices, kitchenettes, daily rooms) were contaminated with lower frequency and concentrations but any contamination in these areas should be carefully examined.Discussion and conclusionsFor all other working places, i.e., majority of areas in pharmacies and hospitals, where ADs are being prepared, packaged, stored, transported, or administered to patients, the study proposes a generic TGV of 100 pg/cm2. The analysis of long-term monitoring data of multiple ADs showed that the exceedance of one TGV can serve as an indicator and trigger for improvement of working practices contributing thus to minimizing of unintended exposures and creating a safe work environment.

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ISOPP Standards for the Safe Handling of Cytotoxics

Cited by 23 publications

References 155 publications

Quality assurance standards and their use in the preparation of parenteral systemic anticancer therapy products in healthcare establishments: a scoping review

Quality assurance standards and their use in the preparation of parenteral systemic anticancer therapy products in healthcare establishments: a scoping review

Prevalence, types, and characteristics of headache in Behcets disease without involvement of the central nervous system in the Syrian population: a case-cohort study

Proposals of guidance values for surface contamination by antineoplastic drugs based on long term monitoring in Czech and Slovak hospitals and pharmacies

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