Presentation on theme: "Safe Handling of Hazardous Drugs: Preparation & Administration"— Presentation transcript:
1 Safe Handling of Hazardous Drugs: Preparation & Administration
2 Increasing Risk of Hazardous Drug Exposure Consider the RiskIncreasing evidence of exposureIncreasing numbers of cancer patientsMore drug combinationsHigher doses of drugsMore potent drugsIncreasing non-cancer use of antineoplasticsNew treatment settingsSource = Thomas Connor, Ph.D., NIOSHIncreasing Risk of Hazardous Drug ExposureWorld Health Organization predicts a 50% increase of cancer cases over the next 20 yearsIncreased number of cancer cases and more potent chemotherapy drugs only increases risk for exposureHazardous drugs are also being used to treat non-malignant illnessesInvestigational and experimental drugs are considered hazardous until proven otherwise View World Health Organization:
3 Potential Routes of Exposure InhalationBreathing contaminated air (aerosols and vapors)Dermal contactTouching contaminated surfacesDirect contact with drugsIngestionChewing gumHand-to-mouth (eating and drinking)COMMONLY DOCUMENTED CONTAMINATED SURFACESBSC Work Surface, BSC Airfoil, Preparation Room FloorGloves, Gowns, ShoesPharmacy Floor, Pharmacy Office ChairSyringes, Carts, Trash CansPatient Room Floor, Patient Table, Patient ChairChecking Counters in the Pharmacy
4 National Institute for Occupational Safety and Health (NIOSH) Alert Working with or near hazardous drugs in health care settingsmay cause skin rashes, infertility, miscarriage, birth defects,and possibly leukemia or other cancers.Warning!NIOSH Alert Publ. No ;
5 Toxicity of Antineoplastic Drugs Acute EffectsIrritation (skin, eyes)NauseaVomitingHeadacheDizzinessHair lossMucosal soresOrgan damage (liver, kidney, bladder, lung)Long-Term EffectsReproductiveSpontaneous abortionsMalformation of offspringLow birth weightProlonged time to pregnancyDevelopmentalGeneticEnd organ damageCancerEFFECTS ON THE REPRODUCTION/ TERATOGENICITYIncreased risk for miscarraiges by 40-50%Increased risk for low birth weigh by 17-foldIncreased risk for congenial malformations by 5 –fold5
6 Chromosome 5 and 7 abnormalities in oncology personnel handling anticancer drugs Melissa A. McDiarmid, MD, MPH, Marc S. Oliver, MPH, MBA, RN, Tracy S. Roth, RN, BSN et al.ObjectiveTo determine the frequency of “signature” chromosomal abnormalities in oncology workers handling anticancer drugs.Source: Journal of Occupational and Environmental Medicine, Volume 52, no. 10, Pages
7 Results/ConclusionAn excess of structural and total abnormalities of chromosome 5 was observed in the high-exposure group compared with the unexposed. Increased incidence rate ratios (IRRs) for abnormalities of chromosome 5 and for either chromosome 5 or 7 were obtained at 100 handling events. Effect sizes were augmented 2- to 4-fold when alkylating agent handling alone was considered.Biologically important exposure to genotoxic drugs is apparently occurring in oncology work settings despite reported use of safety practices.
8 Closed-System Drug Transfer Devices are Recommended to Prevent Hazardous Drug Exposure NIOSH (2004) “Consider using devices such as closed-system transfer devices... closed systems limit the potential for generating aerosols and exposing workers…”ONS (2005) “The PhaSeal System is the only documented closed system on the market. This system is designed to prevent leakage of drugs into the environment during preparation and administration”ASHP (2006) “Consider using closed-system drug-transfer devices while compounding hazardous drugs…vented, filtered products are not closed”
9 Closed-System Drug Transfer Device (CSTD) “A drug transfer device that mechanically prohibits the transfer of environmental contamination into the system and the escape of hazardous drug or vapor concentrations outside the system.”Published in NIOSH Alert (DHHS [NIOSH] Publication Number 2004–165) on page 44.
10 Closed-System Drug Transfer Device (CSTD) Independent, peer-reviewed, published clinical research shows that – across both preparation and administration – PhaSeal is the only vial transfer device that meets the airtight and leakproof definition of a closed-system drug transfer device (CSTD).
11 Methodologies That Have Been Used to Determine if a Product Meets the NIOSH Definition of a CSTD Surface contamination studiesHuman uptake studiesAirtight studies (to determine containment of aerosols/vapors)Leakproof studies (to determine containment of liquids)pH testMicrobiological contamination studies
12 Using a closed-system protective device to reduce personnel exposure to antineoplastic agents Catherine Wick, Matthew Slawson, James Jorgenson, Linda Tyler, Huntsman Cancer Institute, Salt Lake City, UtahPublished in Am J Health Syst Pharm. 2003; 60:
13 Total Positive Urine Samples Agent # positive samples* %Pre-PhaSeal Cyclophosphamide /48 38Ifosfamide /47 21Post-PhaSeal Cyclophosphamide /49 0Ifosfamide /49 0All 3 groups had positive urine samples Pre-PhaSealAfter using PhaSeal for 6 months, there were no positive urine samples recordedThere is a direct correlation between surface contamination and human uptake.*Fraction represents the number of positive samples collected against the total amount of voids during the 24-hour urine collection time period
14 Contamination Comparison of Transfer Devices Intended for Handling Hazardous Drugs James A. Jorgenson, RPh, MS, FASHP; Susan M. Spivey, RPh, DDS, PharmD; Cam Au, PharmD; David Canann, PharmD; Howard Ritter, PharmD; Bart Smith, Senior Pharmacy InternObjectiveThe purpose of this study was to examine several commercially available systems or devices to ascertain which meet the NIOSH definition of closed-system drug transfer device (CSTD) and the ISOPP definition of containment device (airtight and leakproof).Source: Hospital Pharmacy Vol. 43, No. 9
15 Devices Tested B. Braun OnGuard™ System (Teva Medical LTD) Chemo Mini-Spike Plus™ Dispensing Pin (B. Braun Medical Inc.)Alaris SmartSite® (Cardinal Health)Chemoprotect® Spike (Codan US Corporation)PhaSeal® (Carmel Pharma)
16 Smoke Study: UpdateThe test was reproduced by the University of Utah using these additional devices:Spiros™ and Clave® (ICU Medical)Vial Adapter and Clave® (ICU Medical)CyTwo-Fer (Baxa)CHEMO-AIDE (Baxter)Results still showed that – across both preparation and administration – PhaSeal is the only vial transfer device that meets the airtight and leakproof definition of a closed-system drug transfer device (CSTD).
17 Devices Tested B. Braun OnGuard™ System (Teva Medical LTD) Chemo Mini-Spike Plus™ Dispensing Pin (B. Braun Medical Inc.)Alaris SmartSite® (Cardinal Health)
19 Smoke Study: Update Spiros™ and Clave® (ICU Medical) Vial Adapter and Clave®(ICU Medical)CyTwo-Fer(Baxa)CHEMO-AIDE(Baxter)
20 ResultsFilter products, such as the Tevadaptor (OnGuard) system and the Alaris system, which rely on a 0.22-micron filter, did not retain the titanium particles and, therefore, could not meet the NIOSHdefinition of a CSTD and the ISOPP definition of containment device. They were clearly not airtight or leakproof. These systems also showed visible leakage of fluorescein at the dry connections and, therefore, cannot be considered closed from this perspective either.Only the PhaSeal system met the NIOSH and ISOPP definitions of a CSTD/containment device.
21 Leakproof Connection Integrity Test for Devices Intended for Handling Hazardous Drugs James A. Jorgenson, RPh, MS, FASHP, Director of PharmacyUniversity of Utah Health Care, Salt Lake City, UtahObjectiveTo determine if the ICU Medical System, B. Braun/Tevadaptor™ System, Cardinal/Alaris System or PhaSeal System connections are leakproof or have the potential to allow drugs to escape into the environment during the preparation and administration phases of hazardous drug handling.
22 Clave® Vial Adaptor & Spiros™ Male Connector (ICU Medical, Inc.)B. Braun/Tevadaptor™ Vial Adaptor & Syringe Adaptor(Teva Medical Ltd.)
25 The Only Clinically Proven Closed-System Transfer Device PhaSeal meets the NIOSH definition of a closed-system drug transfer deviceProven efficacious in more than 15 independent, peer-reviewed published studiesNoted by clinical thought leaders as ‘The Gold Standard’ in safe handlingOver 15 years of experience dedicated to the safe handling arena
26 Unique Features Airtight Expansion Chamber Leakproof Double Membrane This sealed chamber contains aerosols and vapors while equalizing pressure in the vial during drug preparation. It allows you to see and know that it’s closed and you’re protected.Leakproof Double MembranePhaSeal’s proven dry connections eliminate exposure when connecting and disconnecting from vials, syringes, IV bags and patient IV lines. And because each membrane is clinically proven to remain dry through multiple manipulations, you can safely conduct multiple-dose administrations using a single, designated port.
27 Unique Features Intuitive, Drug-Saving Design Universal Compatibility The Injector’s smart design enables you to retrieve all the drug from the vial while its ergonomic, passive safety technology allows you to work with ease and confidence. Just push-turn-push and you have a safe, leakproof connection (fig. 5).Universal CompatibilityThe PhaSeal System is universally compatible with your existing protocol to offer full-spectrum protection without hassle or compromise. During preparation, PhaSeal allows you to work with all drugs and standard drug vials – from the largest of multi-dose vials to the smallest 13mm-neck or <10mL vials – while its compatibility with all standard luer lock tubing, connections and ports means you’ll appreciate simple integration in administration, as well.
29 Clinical Training & Support Dedicated certified clinical oncology staff for in-service training and ongoing supportEducation materials to share with your staff such as instructional videos, instructional posters and morePolicies and procedures for various pharmacy and nursing hazardous drug applicationsOnline Continuing Education (CE) credits for pharmacists, nurses and risk managers available via
33 (ICU Medical SpirosTM/Clave® and loss of 1.04ml) Assessing Cost of a DeviceCost of implementing a device is equal to the cost of components plus cost of drug that is lost with its use(ICU Medical SpirosTM/Clave® and loss of 1.04ml)
34 Drug Vial Optimization (DVO) Drug Vial Optimization (DVO) ModelCombining Safety and SavingsFor more than 14 years, the PhaSeal System has been the only clinically proven closed-system drug transfer device on the market. And now, the same System that has been uniquely proven to protect you and your employees from hazardous drug exposure can also help you realize an economic benefit.Here’s how it works.DVOMaintaining microbiological integrity creates cost savingsMaintaining the microbiological integrity of the drug vial enables your facility to extend the use of the drug until the chemical expiration date. Drugs that might otherwise be discarded may instead be conserved. Application of this concept – as well as the purchase of the largest available vials – can result in cost savings for your facility
35 Economic Impact of the Preparation Scenario for Cytotoxic Drugs: An Observational Study Johan Vandenbroucke, PharmD; Hugo Robays, PharmDObjectiveTo evaluate the financial impact of three different preparation and conservation scenarios for cytotoxic drugs.Source: European Journal of Hospital Pharmacy Practice, Volume 14, Pages 37-42
36 Method Three simulation preparation/conservation scenarios: Scenario One: Residual fraction of the drug was discardedafter each preparationScenario Two: Residual fraction of vial was used until the endof the dayScenario Three: Residual fraction of the vial was used until thechemical/physical expiration date
37 Results On average, the overall cost of cytotoxic preparation can be decreased by 7% to 15% depending on the applied scenario.
38 Not All Transfer Devices are Created Equal It is important to differentiate between available products on the marketNot all transfer devices are CSTDsChoosing a CSTD should be based on peer-reviewed and published clinical evidence; not white papers and data on file
39 The Value of PhaSealExperience PhaSeal is supported by Carmel Pharma’s 15+ years of dedicated CSTD research and development.Quality The efficacy of PhaSeal is clinically proven and uniquely validated by more than 15 independent, peer-reviewed, published clinical studies.Ease of Use PhaSeal’s passive safety technology and built-in locking mechanism makes the System easy to use. The Injector’s unique design allows you to retrieve all the drug from the vial for increased cost savings and waste optimization.
40 Summary Consider the Evidence… Hazardous drug exposure is a serious riskStudies show a direct correlation between surface contamination and human uptakeNIOSH, ASHP, ONS, USP <797> and ISOPP all have similar recommendations for the safe handling of hazardous drugs — including use of a (airtight, leakproof) CSTDIndependent, peer-reviewed, published clinical studies confirm that PhaSeal prevents hazardous drug interaction and is the only device available that meets both the NIOSH and ISOPP definition of a CSTD