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ACPP Brochure NALAC

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1. ansell.com Testing to dynamic, in-use conditions for safer handling of chemotherapy drugs ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP)

4. 6 | ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP) ACPP RESULTS AT A GLANCE ACPP goes beyond ASTM and EN standards testing. Results should not be directly compared as test conditions and analytical methods are different. ACPP provides a dynamic, in-use perspective of permeation detection to help you select the right Ansell glove for the work you do. With the exception of examination gloves, where permeation was detected at 30 mins, retesting was conducted after 15 mins of exposure except for Carmustine and ThioTEPA, which were tested after 5 and 10 mins, in keeping with the recommended time for handling these drugs. GAMMEX ® PI Hybrid GAMMEX ® Non-Latex GAMMEX ® Latex GAMMEX ® Non-Latex PI SURGICAL DermaShield TM 73-711 GAMMEX ® Non-Latex Sensitive ENCORE ® Latex Acclaim Tested at 37°C Tested at 43°C No permeation detected at 30 mins Permeation detected at 30 mins No permeation detected at 10 mins USE WITH CAUTION Breakage NOT RECOMMENDED No permeation detected at 15 mins USE WITH CAUTION Permeation detected at 5 mins NOT RECOMMENDED HOW TO READ THE ACPP RESULTS No permeation detected at 5 mins USE WITH CAUTION 7 | ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP) These results are ONLY and SOLELY valid for the gloves and molecules tested. Any extrapolation to other materials or brands would be erroneous. TouchNTuff ® DermaShield TM 73-701 MICRO-TOUCH ® Nitrile TouchNTuff ® 73-500 TouchNTuff ® 83-500 MICROFLEX ® 93-853 MICRO-TOUCH ® Blue Nitrile MICROFLEX ® LifeStar EC 93-868 LIFE SCIENCES EXAMINATION MICRO-TOUCH ® Nitrile Accelerator Free MICROFLEX ® 93-850 MICRO-TOUCH ® NITRA-TEX TM MICROFLEX ® MidKnight TM XTRA 93-862 CHEMOTHERAPY DRUG (Concentration) DETECTION OF PERMEATION* Bleomycin/Blenoxane (3.0 mg/ml) Busulfan (6.0 mg/ml) Carboplatin/Paraplatin (10.0 mg/ml) Carmustine (3.3 mg/ml) Cyclophosphamide (20.0 mg/ml) Cytarabine (50.0 mg/ml) Dacarbazine (10.0 mg/ml) Daunorubicin (5.0 mg/ml) Docetaxel (20.0 mg/ml) Epirubicin/Ellence (2.0 mg/ml) Etoposide (20.0 mg/ml) Fludarabine (25.0 mg/ml) Fluorouracil (50.0 mg/ml) Gemcitabine (40.0 mg/ml) Idarubicin (1.0 mg/ml) Ifosfamide (40.0 mg/ml) Irinotecan (20.0 mg/ml) Melphalan (5.0 mg/ml) Methotrexate (100.0 mg/ml) Mitoxantrone (2.0 mg/ml) Paclitaxel (6.0 mg/ml) ThioTEPA (10.0 mg/ml) Vincristine Sulfate (1.0 mg/ml) Cisplatin (1.0 mg/ml) Doxorubicin Hydrochloride (2.0 mg/ml) Mitomycin C (0.4 mg/ml) Oxaliplatin (5.0 mg/ml) DISCLAIMER: Permeation detection results were determined in the laboratory simulating in-use conditions that may not always reflect the actual usage conditions of your specific environment. Variation in the environment or a mix of chemotherapy drugs used may impact the detection of perme ation. Users should test the suitability of the glove selected against their specific chemotherapy drugs and environment. Results have been derived from test s conducted on behalf of Ansell, led by Professor Jérôme Guitton, Head of the Pharma-Toxicology Department, Hospices Civils de Lyon. CAUTION: Safe use of gloves containing natural rubber latex by latex sensitized individuals has not been established. Products containin g natural rubber latex may cause allergic reactions. * Detection limit is based on the permeation rate expressed as the amount (in μg) of chemical per surface area (cm²) of the test specimen per minute (min). ACPP detection limits: Carboplatin, Cisplatin & Oxaliplatin - 0.001x10 -3 μg/cm 2 /min; Cyclophosphamide, Cytarabine, Dacarbazine, Fludarabine, Fluorouracil, Gemcitabine, Ifosfamide, Irinotecan, Melphalan, Paclitaxel & Mitomycin C - 0.002x10 -3 μg/cm 2 /min; Daunorubicin, Epirubicin, Idarubicin, Vincristine Sulphate & Doxorubicin Hydrochloride - 0.004x10 -3 μg/cm 2 /min; Methotrexate - 0.005x10 -3 μg/cm 2 /min; Busulfan, Docetaxel, Etoposide, Mitoxantrone & ThioTEPA - 0.011x10 -3 μg/cm 2 /min; Bleomycin/Blenoxane & Carmustine - 0.112x10 -3 μg/cm 2 /min.

3. There is no safe level of exposure to chemotherapy drugs. 8, 9 Some chemotherapy drugs are more toxic than others. The earlier the permeation of a hazardous drug is detected, the safer your risk assessment becomes. Minimizing the risks of exposure starts with using the available data that best guides you by presenting the earliest possible point of permeation detection. 4 | ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP) MAXIMIZE YOUR CONFIDENCE BY MINIMIZING YOUR EXPOSURE EN and ASTM detection limits, based on the permeation rate of 1.0 and 0.01μg/cm²/min respectively, are the defined thresholds applicable to all drugs tested to these standards. ACPP however, detects for permeation of each drug at its lowest limit of detection which, depending on the chemotherapy drug, varies from 0.00011 to 0.000001μg/cm²/min. This ability for earlier detection is made possible by the highly sensitive analytical devices used. 10 Product Permeation Detection ASTM D6978 Breakthrough time @0.01 μg/cm 2 / min ACPP After 5 & 30 mins exposure @lowest limit of detection for Carmustine* GAMMEX ® Non-Latex PI 10.2 mins Detected at 5 mins MICRO-TOUCH ® Nitrile E.P. 71.3 mins Detected at 30 mins Permeation detection is reported differently for Standards testing and ACPP. ASTM D6978, for example, reports the time when breakthrough of the threshold limit is reached before the maximum 240 min exposure. ACPP, on the other hand, reports if permeation has been detected, or not, based on the test drug’s lowest limit of detection after 30 mins exposure. *For ACPP, both Carmustine and ThioTEPA are also tested after 5 and 10 mins of exposure to reflect clinical practice usage guida nce Example of how permeation for Carmustine is reported CHOOSING THE RIGHT GLOVE: WHAT YOU NEED TO KNOW It may take only one carcinogenic molecule to induce cancer. 11 Unwanted side effects occur not only in cancer patients undergoing treatment but pose risks for healthcare workers who handle chemotherapy drugs. Whether you are reconstituting or administering chemotherapy treatments or involved in clean-up and disposal, the right, chemotherapy-tested gloves must be in place because the primary route of occupational exposure is your skin, directly or indirectly. of nurses and nursing assistants working with chemotherapy drugs reported at least one side effect 12 of gloves used by highly trained lab technicians were contaminated after only one preparation 15 56.9 % The largest group exposed is often pharmacy staff involved in drug preparation due to the frequency of use, and the quantities and concentration used. 16 SAFE HANDLING CONSIDERATIONS Safe handling recommendations across the globe are guided by industry and work safe agencies such as the Oncology Nursing Society (ONS), the National Institute for Occupational Safety & Health (NIOSH), Worksafe Australia, the European Agency for Safety and Health (EU, OSHA), the Japan Society for Clinical Oncology, and others. Fundamentally, best practice guidelines are similar but you should always check the specific guidance from local agencies governing your healthcare setting. In the US, such guidelines are now mandated. The United States Pharmacopeia Convention (USP) released USP <800>, Hazardous Drugs- Handling in Healthcare Settings, to effectively make long-standing recommendations by agencies such as NIOSH, enforceable. 17 Gloves must be chemotherapy-tested and pass the industry standards as required by regulators. Consider dynamic testing permeation data if available. Chemotherapy-tested gloves should be changed every 30 minutes unless otherwise recommended by the manufacturer's documentation. Use two pairs of chemotherapy-tested gloves for double the protection. Double gloving with a colored under glove allows for easy breach detection. Always inspect for physical defects before use. Do NOT use gloves with pinholes or weak spots . When used for sterile compounding, the outer chemotherapy-tested gloves must be sterile . Chemotherapy-tested gloves must be powder-free because powder can contaminate the work area and can absorb and retain Hazardous Drugs. 30 MIN STERILE POWDER- FREE 5 | ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP) Reported effects range from headaches , irritation of eyes/skin , hair loss and dizziness to adverse outcomes including genetic damage leading to infertility , cancer and miscarriages. 12, 13, 14 49 %

5. Ansell, ® and TM are trademarks owned by Ansell Limited or one of its affiliates. © 2021 Ansell Limited. All Rights Reserved. References: 1. Wilson BE, Jacob S, Yap ML, FerlayJ, Bray F, Barton MB. Estimates of global chemotherapy demands and corresponding physician w orkforce requirements for 2018 and 2040: a population-based study. Lancet Oncol. 2019(20): 769–780. 2. ASTM is the American Society of Testing & Materials; and EN is the European Norm. 3. Nalin M, Hug G, Boeckmans E, Machon C, Favier B and Guitton J. Permeation measurement of 27 chemotherapy drugs after simulated dynamic testing on 15 surgical and examination gloves: A knowledge update. Journal of Oncology Pharmacy Practice . 2020;0(0):1-14. 4. Landeck L, Gonzalez E, Koch OM. Handling chemotherapy drugs-Do medical gloves really protect?. Int J Cancer . 2015;137(8):1800-1805. doi:10.1002/ijc.29058. 5. Phalen RN, Le T, Wong WK. Changes in chemical permeation of disposable latex, nitrile, and vinyl gloves exposed to simulated movement. J Occup Environ Hyg . 2014;11(11):716-721. doi:10.1080/15459624.2014.908259. 6. Dillon J and Schroeder L. Permeability and material characteristics of vulcanized latex film during and following cyclic fatigue in a saline environmen t. Journal of Applied Polymer Science . 1997;64(3):553-566. 7. At the time of publishing, Ansell is the only glove manufacturer with its own dynamic testing device called the Ansell Dynamic Testing Device (ADTD). 8. Sessink PJ, Bos RP. Drugs hazardous to healthcare workers. Evaluation of methods for monitoring occupational exposure to chemot herapeutic drugs. Drug Saf . 1999;20:347–59. 9. Oriyama T, Yamamoto T, Yanagihara Y, et al. Evaluation of the permeation of antineoplastic agents through medical gloves of va rying materials and thickness and with varying surface treatments. J Pharm Health Care Sci. 2017;3(13). 10. ACPP uses Inductively coupled plasma-mass spectroscopy (HPLC-DAD) and liquid chromatography-mass spectrometry (LC-MS/MS). 11. Cancer Medicine 4th Edition, Encyclopedia of Cancer, Cancerologie Clinique Thérapeutique du Cancer, Compendium 20th Edition. 12. Ivanova K, Avota M. Antineoplastic Drugs: Occupational Exposure and Side Effects. Proceedings of the Latvian Academy Of Sciences . 2016;70(5):325–329. doi:10.1515/prolas-2016-0049. 13. Hon C, Teschke, K Demers, P. Venners, S. Antineoplastic drug contamination on the hands of employees working throughout the ho spital medication system. Ann Occup Hyg . 2014;58(6): 761-770. 14. Tracy Wyant, DNP, RN-BC, AOCN ® , CHPN ® , CPPS. https://voice.ons.org/newsand-views/what-is-onss-stance-on- handling-chemotherapy-while-pregnant-breastfeeding-or-trying. Accessed 17 Sept 2020. 15. Bertrand Favier Thesis, Hospital Pharmacist, Centre Régional Léon-Bérard, Lyon – France. 16. Hall A, Demers P, Astrakianakis G, Ge C, and Peters C. Estimating National-Level Exposure to Antineoplastic Agents in the Work place: CAREX Canada Findings and Future Research Needs. Annals of Work Exposures and Health . 2017;61(6):656-658. 17. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling- healthcare . Accessed 17 Sept. 2020. ansell.com For more information, visit www.ansell.com or contact your Ansell representative. North America US Tel: 800 952 9916 CA Tel: 844 494 7854 Email: insidesalesus@ansell.com Central & South America Tel: +52(442) 296 20 50 Email: cslac@ansell.com Brazil Tel: +55-11-3356-3100 Email: luvas.medicas@ansell.com Asia Pacific Tel: +603 8310 6688 Email: apac.medical@ansell.com China Tel: +86(21) 3827 5005 Email: infochina@ansell.com Australia & New Zealand Tel: +61 3 9270 7270 Email: protection@ap.ansell.com India Tel: +91 22 38124500 Email: info.india@ansell.com Europe, Middle East & Africa Tel: +32 (0) 2 528 74 00 Email: info@ansell.eu For safer handing of chemotherapy drugs, let ACPP also be your guide.

2. DYNAMIC PERMEATION TESTING FOR GREATER CONFIDENCE AT WORK 2 | ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP) Cancer continues to be on the rise: from 17 million cases in 2018 to 26 million in 2040 1 Ansell gloves are tested to EN 16523-1 and ASTM D6978 standards 2 , or both, to ensure gloves meet the requirements for safe handling of hazardous drugs and their intended use either as medical devices or personal protective equipment (PPE). But we don’t stop there. Ansell’s Cytostatic Permeation Program (ACPP), a unique dynamic permeation test, has been designed to give you an added in-use perspective of permeation detection to help you select the right glove for safer handling of chemotherapy drugs. While ASTM and EN standards determine glove permeation under static test conditions, ACPP mimics the everyday use in your workplace through controlled dynamic conditions. Current standards testing does not consider working conditions that may influence the permeation of your glove’s protective barrier. This includes the concentration and exposure time of the chemotherapy drug being handled, glove properties such as thickness; the stretching and flexing motion of the task, as well as both body and workplace temperatures. 3, 4, 5, 6 It is important you consider how static (standards) vs dynamic (ACPP) testing differs to gain a comprehensive view of how the permeability of a glove to a chemotherapy drug is affected under the different conditions. Working conditions are dynamic, so why not test to in-use conditions? As the global incidences of cancer rise, so will the need to ensure the safe handling of chemotherapy drugs in your workplace. ROOM PARAMETERS GLOVE CHARACTERISTICS EXPOSURE TIME OTHER WORKER ROOM PARAMETERS CYTOSTATIC CHARACTERISTICS Permeation is multi-factorial dependent 1. EN stated in this graphic refers to EN 16523-1. 2. ASTM stated in this graphic refers to ASTM D6978. 3. ACPP uses the ADTD unique to this program. 4. For 400+ mm length gloves, both palm and cuff must be tested. 5. Detection limit is based on the permeation rate expressed as the amount (in μg) of chemical per surface area (cm²) of the test specimen per minute (min). 6. ACPP uses highly sensitive analytical methods, Liquid Chromatography - Mass Spectrometry (LS-MS) and Inductively Coupled Plasma - Mass Spectrometry (ICP-MS), to enable permeation to be detected at a very low level. 7. HIPEC = Hyperthermic intraperitoneal chemotherapy: a highly concentrated, heated chemotherapy treatment. 8. It is not mandatory to test using a chemotherapy drug for EN 16523-1. 9. All 9 drugs tested for ASTM D6978 are chemotherapy drugs. 10. All 27 drugs tested for ACPP are chemotherapy drugs. ACPP mimics in-use conditions, and together with Standards, ensures the right glove for safer handling of hazardous drugs Test Duration Test Type Test Location Permeation Rate 5 Test Temperatures No. of Chemicals/Drugs Tested at 30 mins to correspond with the recommended time for glove change when handling chemotherapy drugs In-motion or dynamic testing simulates the glove stretch when donning or during use Fingers are often the first point of contact when handling chemotherapy drugs Permeation is detected at a lower level 6 Tests at both natural body and HIPEC 7 temperatures Covers a wider range of chemotheraphy drugs 23°C 73.4°F EN 35°C 95°F ASTM 37°C 98.6°F Natural body temp 43°C 109.4°F HIPEC 7 temp Middle finger Palm or Cuff ASTM Pal m 4 EN Glove is tested for permeation under DYNAMIC conditions 3 Glove is tested for permeation under STATIC conditions 1.0 μ g/cm ² /min EN 0.01 μ g/cm ² /min ASTM 27 drugs 10 Min 1 8 E N Min 9 9 AST M 480 mins EN 1 240 mins ASTM 2 30 mins S T A N D A R D S A R E S T A T I C A C P P I S D Y N A M I C Ansell's Cytostatic Permeation Program (ACPP) mimics in-use conditions, and together with Standards, ensures the right glove for safer handling of hazardous drugs The ACPP Advantage Test Criteria 0.00011 – 0.0000011 μ g/cm ² /min At 30 mins Standards are static. Reality is dynamic. Professor Jérôme Guitton “ “ Ansell is the only glove manufacturer 7 with its own dynamic permeation testing method and device, exclusively designed by the Université Catholique de Louvain, Brussels, Belgium. Professor Jérôme Guitton, Head of the Pharma-Toxicology Department, Hospices Civils de Lyon, led the dynamic permeation testing of 15 Ansell surgical and examination gloves covering 27 chemotherapy drugs at high concentration levels based on general practice; and, using ACPP test criteria and the Ansell Dynamic Testing Device. Results are published in the Journal of Oncology Pharmacy Practice, August 2020. 3 Ansell Dynamic Testing Device (ADTD) 3 | ANSELL CYTOSTATIC PERMEATION PROGRAM (ACPP) Figures exclude non-melanomatous skin cancers.

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