الفهرس 
Introduction and Aim of the StudyOnly 14 pages are availabe for public view
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Abstract
Antineoplastic drugs (ADs) are commonly used to treat cancer. The increase in cancer incidence and mortality leads to increase in ADs usage. Healthcare providers are exposed on regular basis to ADs mainly during preparation and/or administration. The routes of occupational exposure involve inhalation, dermal, needle stick injuries or even oral.
Unsafe occupational exposure to ADs can lead to short term and/ or long term health consequences in addition to the adverse reproductive outcomes and the risk of cancer. Safe AD handling is a vital step in preventing HCPs from the risks that come with handling ADs.
ISOPP standards of practice had categorized the protective measures for safe handling of ADs into five levels. Level 1 is elimination, substitution, replacement, level 2 is isolation of the hazard/source containment, level 3 is engineering controls, level 3 B is administrative controls and finally level 4 is PPE. Routine medical survillence and training of HCPs who handle ADs in addition to routine environmental monitoring are crucial for comprehensive safe handling of ADs.
Surface wipe sampling is the main procedure used for environmental assessment of work place contamination with ADs. It can be used to define both level and extent of contamination due to improper work practice as well as monitoring the efficieny of cleaning methods.
This study was conducted in two oncology departments in Alexandria University hospitals and the oncology department in an insurance hospital in Alexandria. HCPs exposed to ADs include clinical pharmacists, nurses, cleaners who were involved in the study matched to age and sex the non exposed group. The sample size was 46 exposed and 51 non exposed individuals. A structured pre-designed and pre-coded interviewing questionnaire was used to collect data from the exposed personnel on safe handling of ADs. It consisted of demographic data, employment history, medical history, knowledge on safe handling of ADs, in addition to work practice on safe handling of ADs. An observational check list was used to assess the performance of the exposed population. A blood sample was drawn from the exposed and non exposed participants to measure complete blood count (CBC), liver function tests, and kidney function tests.
Surface wipe samples were collected from frequently used work surfaces to monitor chemical contamination with four surrogate ADs. The choice of the selected ADs was based upon the constant use at the investigated hospitals. The environmental samples were analyzed at The City of Scientific Research and Technological Applications using The SCIEX QTRAP® 5500 LC/MS/MS system.
The following results were obtained:
Females represents the majority (67.4%) of the exposed population. Most of the exposed persons had working experience less than 10 years (0- <5 years = 30%, 5-<10 years = 37%). Of them, 58.7% are single.
The study revealed that only 17.4% of the exposed group had formal training on safe handling of ADs.
Accidental exposure to ADs was disclosed among 56.5% of the study participants. The reported exposures involve accidentally breathed in, needle stick injuries, spill over the worn gloves, spillage on the floor, direct skin contact, and inhalation of volatile ADs. None of the exposures to hazardous drugs were documented in employees’ medical records.
from the exposed population, 40% of the married females have approved they were pregnant and involved in handling ADs. Abortion, malformation, early birth as well as death of the infant after 33 days of labor with nose bleeding at time of death were reported among them.
Fatigue (10.9%) (p= 0.021), hair loss (21.7%) (p= 0.002), eye irritation (13%) (p= 0.049), skin irritation (10.9%) (p= 0.021) and respiratory symptoms (8.7%) (p= 0.047) have statistically significant difference among exposed population in comparison to nonexposed population. Menstrual irregularities represent 43.3% among the exposed females in comparison to 15.6% among the non-exposed females, (p= 0.025).
Considering assessment of knowledge and practice of HCPs; there is generally adequate knowledge (96%) among healthcare professionals regarding safe handling of ADs.
According to the study, only 26.1% of the exposed HCPs comply with the safe handling guidelines and wear double gloves during handling ADs, while 87% of them change gloves
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immediately upon damage or contamination. Handwashing was practiced among 73.9% before wearing gloves, and among 91.3% after removing them in all circumstances. Protective gowns were only worn by pharmacists during preparation of ADs sometimes.
The exposed group got practice scores as follows; the preparation practice score among pharmacists ranged from poor (66.7%), fair (29.2%), and good (4.2%). The administration practice score among nurses was either poor (36.8%), or fair (63.2%). The cleaning of spillage score was either fair (83.3%) or good (16.7%). However, the exposed individuals were following the safe handling guidelines of disposal of ADs.
Challenges prevent HCPs from proper safe handling of ADs include; unavailability of PPE which represents the greatest challenge for HCPs who handle ADs (80.43%), high workload (63.04%), and lack of knowledge (39.1%). Other obstacles include; lack of time, not feeling comfortable in PPE, as well as own attitudes.
All the collected wipe samples show contamination with at least three of the ADs which used as surrogate markers. The wipe samples obtained from the pharmacy preparation area at oncology department A2 were the most contaminated. The highest concentrations with the four analyzed drugs were detected inside the BSC class III at the inside surface of the door that separate the working area from the passthrough, that is a highly touchable surface. Paclitaxel had the highest concentration at that area, (1336ng/cm2), followed by cyclophosphamide (453.44 ng/cm2), FU (28.34 ng/cm2), and finally doxorubicin (5.41 ng/cm2). In general, the wipe samples of the surface facing the operator inside the BSCs showed higher concentrations of the ADs at the pharmacy preparation area at oncology department A2 (BSC III) and the old pharmacy preparation area at oncology department A1 (BSC II).
The results of the wipe samples with the lowest concentrations were seen at the new pharmacy preparation area at location A1, because it was recently operated for preparation of ADs.
The nursing station at department A2 showed surface contamination with the four antineoplastic drugs The highest detected concentrations were at surfaces under patients’ prescription; with cyclophosphamide concentrations (7.94 ng/cm2) and (3.16 ng/cm2), and FU concentration was (0.1883 ng/cm2). The handset of the telephone at the nursing station was surprisingly contaminated with the four ADs, which might be related to the underuse of gloves, and infrequent handwash.
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The basophils count showed statistically significant decrease among healthcare providers who handle ADs in comparison to the non-exposed group, (p=0.001) (OR = 0.116) which indicates myelosuppression. Otherwise, the results of other components of the CBC were not statistically different between the two groups.
Total protein levels showed statistically significant increase among the exposed group in relation to the non-exposed group (p =0.003) (OR = 3.304) which can be related to chronic inflammation related to exposure to ADs.
The decrease in basophils indicating myelosuppression and the increase in total protein indicating chronic inflammation of the liver may be explained by handling ADs. There is a probable association between the surface contamination at places where ADs were handled and the alteration in basophils and total protein.