Preparation Of Anticancer Agents Research Articles

Frequency and component analysis of contaminants generated in preparation of anticancer agents using closed system drug transfer devices (CSTDs)

Occupational exposure of anticancer agents during their preparation has been recognized as a serious hazard. Closed system drug transfer devices (CSTDs) enable “safe” preparation of agents for medical personnel and ensure a safe hospital environment. However, artificial particles of infusion materials have been reported during CSTD use. Here, the incidence of insoluble fine particles during preparation of anticancer agents using CSTDs was examined. Visible insoluble fine particles were found in 465 (9.4%) of 4948 treatment cases at Ehime University Hospital with CSTD use. Contaminants occurred more frequently during preparation of monoclonal antibodies than cytotoxic anticancer agents (19.4% vs. 4.1%, respectively, P < 0.01). A similar survey was conducted at nine hospitals to investigate the incidence of insoluble fine particles with or without CSTDs. Insoluble fine particles were detected in 113 (15.4%) of 732 treatment cases during preparation of monoclonal antibodies with CSTD use. In contrast, the occurrence of insoluble fine particles without CSTDs was found in only 3 (0.073%) of 4113 treatment cases. Contamination with CSTDs might cause harmful effects on patients during cancer therapy. We strongly recommend the use of in-line filters combined with infusion routes after CSTD use to avoid contamination-associated adverse events.

Coenzyme Q0 immobilized on Magnetic Nanoparticle: Synthesis and Antitumoral Effect on Saos, MCF7 and Hela Cell Lines.

Many attempts in medical community focused on the preparation of anticancer agents. Various Coenzyme Q such as CoQ0 analogs have been reported as anti-inflammatory, anticancer, and antioxidant substances. In this study a novel derivatives of Coenzyme Q as an anticancer agent have been introduced. The prepared magnetic nanoparticle, containing CoQ0 were prepared using common chemical methods and also characterized by means of nuclear magnetic resonance (NMR), fourier transform infrared (FT-IR), thermal gravimetric analysis (TGA), and differential scanning calorimetric (DSC). To evaluate the antiproliferative effects of the nanoparticle, the prepared compound was treated with cell lines such as Hela, MCF-7 and Saos. Moreover, the outcomes were compared with normal fibroblast cell line. These assessments were performed by means of MTT assay. Investigation on the capability of this prepared nanoparticle showed some reliable results including cytotoxicities against MCF7, Saos and Hela cancer cell lines which were illustrated by displaying the morphology of the treated cells using AO/EB dual staining fluorescent technique. Employing simple method for preparation as well as the promising cytotoxic results makes it as a promising candidate for further bioexperiments.

Evaluation of a safe handling and cytotoxic drug preparation training program for oncology pharmacy practitioners

Onkofar Health Devices Inc. offers solutions and service for safe and accurate preparation of anticancer agents. Due to the necessity of specific instructions for the drug preparation systems and the widespread use of services including personnel, the company has to train the personnel employed as oncology pharmacy practitioner technicians. This study aimed to investigate the contribution of the training program to the theoretical knowledge and the opinions of the participants about the training by retrospectively analyzing the related data. The training program consisted of a comprehensive theoretical part and an applied practical part. Participants took pre-tests and post-tests and filled out a standard training evaluation form. Between November 2014 and September 2018, 100 people participated in the training. This study included 71 participants' pre-test and post-test results and 72 participants' evaluation forms. The test results showed that the post-test score was higher in all participants. There was a 34% increase between the average of scores. The improvement percentage was at least 9%, whereas the most considerable improvement was 61%. Overall, almost all of the participants conveyed their positive thoughts about the training. The participants' interest seemed to be mostly related to their applied practice. Increased post-test scores showed an increase in theoretical knowledge level. The training was found to meet the expectations and needs to a great extent. Participants' opinions contributed to the shaping of the educational content for future training programs. This study showed that the training program provided improvement and value for participants.

EL32 - Issues Occurring in Preparation of Anticancer Agents

ABSTRACT Risk management is necessary for preparation of anticancer agents in terms of ‘safe handling’ based on recognition of hazards by occupational exposure to the drugs during preparation. However, penetration of the concept of safe handling and discussion on protective measures for the issue by hospital management and pharmacists has been behind for years in Japan compared with other foreign countries Cancer Institute Hospital of JFCR is one of major hospitals with more than 150 patients per day in average in treatment with chemotherapy. Sterile compounding environment in our hospital is controlled with high level of engineering by four biological safety cabinets which are equipped in an isolated negative pressure room to exhaust 100% to outside (Class II type B2). Also it is standard procedure in our department to follow the sterile compounding guideline and pharmacists have donned PPE such as mask, gloves, gown and so on during preparation of chemo drugs. In 2006 wipe and urine tests were carried out in our department which has been considered to comply with the guideline. Cyclophosphamide (CPA) was used as indicator for environmental contamination and human uptake. The test detected 293–22 363 ng/cm2 in the environment and 12.5–45.8 ng/24 h in urine samples of four out of six pharmacists who were engaged in the drug preparation. Consequently improvements were made upon review and revision of cleaning procedure and PPE selection. In addition, pharmacists were educated in regard to occupational exposure during preparation of anticancer agents and also preparation manual and the technique were assessed for improvement. Closed-system drug transfer device (PhaSealⓇ System) was implemented in 2010 for CPA preparation only. Having these interventions enforced, CPA was measured in the same environment again in 2008, 2009 and 2011. Contamination was reduced evidently after implementation of the CSTD (PhaSealⓇ System). Further discussion remains to determine whether the CSTD (PhaSealⓇ System) is necessary for all anticancer drug preparations. Other challenges outside pharmacy include how to protect healthcare workers during transfer, priming in wards and disposing IV bags after administration of anticancer agents.

武庫川女子大学薬学研究科昼夜開講（社会人）大学院におけるＰｈａＳｅａｌ ｓｙｓｔｅｍを用いた模擬抗がん剤調製実習プログラム

There is an increasing need for the participation of pharmacists in cancer chemotherapy in order to ensure the proper use of drugs.Therefore,a postgraduate education program on cancer chemotherapy to enhance the knowledge and skill of pharmacists and give them a professional attitude could contribute much to it.The postgraduate education program in cancer chemotherapy (master course,25 students) at Mukogawa Women’s University has 3 major parts.In the first,students gain a basic knowledge of the toxicity of anticancer agents in anticancer injection preparations,in the second they receive training in the withdrawal technique using a pre-filled vial containing simulated fluorescein sodium (FL) and in the 3rd,the extent that the 25 participants are exposed to the simulated anticancer drug (FL) when the PhaSeal® protective system is used and in its absence is measured to demonstrate the importance of the using PhaSeal® or some other protective system.The extent of exposure was evaluated from the number of splashed-FL spots.When using PhaSeal® ,the number of spots was much less than without it.Also,the score for the level of skill as measured using a checklist was much greater when the PhaSeal® system was used than when it was not used.However,in a questionnaire on items such as the preparation of anticancer agents and the usefulness of the PhaSeal® system,though almost all of the students recognized its importance,some thought that its introduction in a hospital or community pharmacy might not be possible due to its high cost.

Development of Computer-Assisted Biohazard Safety Cabinet for Preparation and Verification of Injectable Anticancer Agents

Background: Medication errors associated with anticancer agents may cause fatal events. Therefore, exact verification of the prescription order and accurate preparation of the mixture of anticancer injections are required for safe management in cancer chemotherapy. Methods: A computer-assisted biohazard safety cabinet was newly developed for verification and preparation of anticancer agents. Using a barcode reader, information on prescription orders was transmitted from an electronic medical record to the computer system installed in the safety cabinet. The computer was controlled using a 3-button foot switch, which avoided interruption of the mixing procedure. A monitor on the cabinet wall displayed the required amounts of anticancer injections and any special information for the dissolution or mixing procedure. The names of anticancer agents were verified using a personal digital assistant and the volume of injection taken, which was automatically converted to weight on the basis of the specific gravity of anticancer solution, was recorded on the computer through a digital scale. Results: Accuracy and efficiency in mixing anticancer injections were compared between procedures with and without the present apparatus. Errors in the amounts were much smaller and the time spent in preparation was significantly shorter using the present apparatus. Conclusions: The present computer-assisted biohazard safety cabinet for preparation of the mixture of anticancer agents is considered to be potentially useful for the safe management in cancer chemotherapy.

フルオレセインナトリウムと標準手技チェックリストを用いた抗がん剤調製実技講習

Since anticancer agents are toxic,their preparation requires the attending pharmacist to have a high level of technical skill to avoid contamination from them.We conducted an educational program which taught the preparation of anticancer agents using fluorescein sodium (FL) as a placebo and a standard procedure-list for 15 persons who had either had no experience of preparation or less than 1 year’s experience.FL was chosen as contamination due to it could be detected under UV and the standard checklist was designed to aid confirmation that the standard procedure was being followed in preparation.In the program,after 1 try at preparation,there was 30 minutes of self study and then participants tried preparing the placebo anticancer agent again by the same procedure.The number of FL spots detected under UV,time for preparation,and score for preparation according to the checklist was compared between the 2 tries at preparation,and additional information was obtained using a questionnaire.As for the results,the number of FL spots detected under UV decreased significantly from 2.3±0.4 to 1.1±0.2 (p= 0.018),the preparation technique score significantly increased from 13.9±1.1 to 17.9±1.0 (p=0.002)and time for preparation decreased from 13.0±1.3 min.to 10.2±0.9 min.(p<0.0001).Additional information obtained through the questionnaire indicated that the participants felt satisfied with the program.In conclusion,we feel that this program is highly beneficial in training on the preparation of anticancer agents.

調製支援情報による抗がん剤調製過誤対策の導入―注射薬調製ラベルを利用したシステムの開発―

調製支援情報による抗がん剤調製過誤対策の導入―注射薬調製ラベルを利用したシステムの開発―