Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory Landscape PharMEDium Lunch and Learn Series LUNCH AND LEARN

Transcription

1 LUNCH AND LEARN Safe Handling of Hazardous Drugs: An Evolving Legislative and Regulatory Landscape August 14, 2015 Featured Speaker: Firouzan 'Fred' Massoomi, PharmD, FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital 1 CE Activity Information & Accreditation (Pharmacist and Tech CE) 1.0 contact hour Funding: This activity is self funded through PharMEDium. It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Dr. Massoomi has no relevant commercial and/or financial relationships to disclose

2 Online Evaluation, Self-Assessment and CE Credit Submission of an online self assessmentand and evaluation isthe only way to obtain CE credit for this webinar Go to Print your CE Statement online Live CE Deadline: September 11, 2015 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor within 1 to 2 weeks of the completion of the self assessment and evaluation Event Code Code will be provided at the end of today s activity Event Code not needed for On Demand 3 Ask a Question Submit your questions to your site manager. Questions will be answered at the end of the presentation. Your question...? 4 2

3 Resources Visit to access: Handouts Activity information Upcoming live webinar dates Links to receive CE credit 5 Safe Handling of Hazardous Drugs An Evolving Legislative and Regulatory Landscape Firouzan Fred Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital Omaha, Nebraska Fred.Massoomi@nmhs.org 6 3

4 Program Objectives Describe the technical differences between NIOSH, <797> and <> version 1 to 2 for handling hazardous drugs. Describe the cradle to grave process for assessing the hazardous drug process Overview of points to consider when selecting devices for compounding hazardous drugs: closed-system transfer device(s); syringes; powder boxes Discuss the importance of developing and maintaining a joint pharmacy-nursing dialog for implementation of <>related changes. VIDEO: Ordering and Receiving of Hazardous Drugs VIDEO: Spill management 7 March 30, 31, April on PBS 8 4

5 How believable are the risk? Lancet 1979; June 9: 1(8128): Aust NZ J Med 1984;14(6):831 4 Eur J Clin Oncol 1986;22(12): NEJM 1985;313(19): J Pharm Practice 1991;4(1):72 6 J NCI 1993;85: J Occup Environ Med 1997;39(6): AJHP 1993; June 9: 1(8128): Scand J Work Environ Health 1994;20:22 6 BMJ Qual Saf published online August 16, Who is at Risk of Occupational Exposure? 8 million US healthcare workers at risk o Pharmacy, nursing personnel, physicians o Operating room personnel, o Veterinary personnel, o Shipping and receiving personnel, o Laundry workers, waste handlers, maintenance workers Exposure is associated with adverse health outcomes o Acute symptoms o Organ toxicity o Reproductive risks o Cancer Source: NIOSH [2008]. NIOSH Workplace Solution: Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No

6 Public Policy 11 Public Awareness PBS Newshour.org August 5, 2010 NBCNews.com July 10,

7 Guidelines for Hazardous Drugs Source Year ASHP 1982, 1984, 1990, 2006 OSHA 1986, 1995, 1999 AMA Council on Scientific Affairs 1985 Oncology Nursing Society 1988, 2003, 2010 NIOSH Alert 2004, 2010, 2012, 2014 <797> 2004, 2008 <> 2014 (for comment) 33 years of Safe Handling Guidelines 13 A Decade Towards Safety Source: CDC & NIOSH. Preventing occupational exposures to antineoplastic and other hazardous drugs in health care settings. Accessed January 5, 2015 Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. Accessed January 5,

8 Chapter Sections 2014 Proposal Proposal 2 Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. Accessed January 5, Chapter Differences 2014 Proposal 1 Shall = requirement 193 main document 20 in ancillary Should = recommendation 35 main document 2015 Proposal 2 Must = requirement 162 main document 6 in ancillary Should = recommendation 33 main document Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. Accessed January 5,

9 Proposed : Timeline First Release March 2014 Comment Due Date July 31, 2014 Second Release December 2014 Comment Due Date May 31, 2015 Goal Publish Date February 2016 Official Compliance Date August The objective of this chapter is to protect t personnel and dthe environment when handling hazardous drugs (HDs) Sterile and non-sterile products Source: US Pharmacopeial Convention. General Chapter<8OO> Hazardous Drugs-Handling in Healthcare Settings. Accessed January 5,

10 Source: State of Compounding 2015: Pharmacy Purchasing and Products; May Defect Legacy of Current Practices Source: ASHP Study Guide: Safe Handling of Cytotoxic and Hazardous Drugs Source: Bristol Meyers Squibb ONC CE

11 Defect Equipment Compliance NIOSH Survey of Nursing Practices Findings Failure to wear nonabsorbent gown with closed front and tight cuffs (42%); Potentially contaminated clothing taken home (12%); Spill or leak of antineoplastic drug during administration (12%); Failure to wear chemotherapy gloves (12%); Lack of hazard awareness training (4%). Source: Boiano JM, Steege AL, Sweeney MH. Adherence to safe handling guidelines by health care workers who administer antineoplastic drugs. Journal of Occupational and Environmental Hygiene November 2014;11: Defect Compounding Inconsistencies

12 Source: 23 Department of Labor is Concerned Source:

13 Hazard Communication Standard Right to Know Standard Standard (29 CFR part ) A safe and healthful workplace. Know about hazardous chemicals. Complain or request hazard correction from employer. Hazard exposure and medical records. File a complaint with OSHA. Be free from retaliation for exercising safety and health rights. 29 CFR (a)(1) Each employer shall post and keep posted Source: Occupational Safety and Health Administration. (1999). OSHA technical manual: Section VI, chapter 2.,from Accessed January 5, The Hazardous Drug Team Primary Pharmacist Pharmacy technicians/interns Pharmacy purchasing Nursing Surgical Services Risk management Employee health Environmental services Secondary Administration Safety officer Physician office managers Home Health managers Primary Goal: Establish a hazardous drug safety program

14 Visual Hazard Mapping Tool More than 70 published studies Most surfaces that come in direct contact with hazards Some with in-direct contact with hazards Source: Nebraska Methodist Hospital Department of Pharmacy Services 27 Environmental Quality Control Routinely = every 6 months Approximate cost is $250 to $400 per sample

15 NIOSH Hazardous Drug List Proposed 2016 List available 2014 NEW Grouping Risk System Group 1: Antineoplastic drugs 97 drugs listed Group 2: Non-antineoplastic drugs 48 drugs listed Group 3: Reproductive risk men and women 39 drugs listed Guide to handling based on formulation Source: Centers for Disease Control and Prevention, NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, Published September Accessed January 5, Formulary Assessment Application of NEW NIOSH of Hazards Antineoplastic non-antineoplastic Reproductive Class 1 Class 2 Class 3 Continuously stratify with new formulary drugs

16 #1 Safety Concern The Source EVIDENCE: 11 Published studies Drug vial exteriors Not due to damage during shipping & handling 31 Wholesaler Process Limitations Limitations on Hazardous Drugs Cytotoxic only No NIOSH Stratification Site Trick Set up departments within Order based off the department Antineoplastic HD Non-Antineoplastic HD Reproductive HD

17 Segregated Handling of Vials Good Distribution Practices Totes from wholesaler Gloves to handle MUST not Store Unpack Compound Manipulate Drugs left in baggies Removed in Isolator Not a + pressure area Equi-pressure Negative pressure 33 Example As to Why Not Handle Vials Broken Carmustine vial

18 Personal Protective Equipment (PPE) Training Documentation Goal Minimize Contamination *From product to employee and visa versa Proper demonstrative use of PPE Methodist Notes Per Guidelines Hand washing technique No Make up No Jewelry No Fake fingernails No ipods or personal devices No exemptions from garbing requirements 35 Standards Differ Source: 36 Source: JAMA. 2003;290(7):

19 Donning and Doffing PPE Donning Sequence Doffing Sequence Source: Fred Massoomi visit Taipei Veterans Hospital; Taipei, Taiwan; Choosing the Right Glove IMPORTANT: ASTM D6978 and not ASTM F739 due to permeability limits C 25 C temperature delta

20 Primary Engineering Controls Biological Safety Cabinet Class II Type B2 BSC Total Exhaust Isolator Glove Box Compounding Aseptic Containment Isolator (CACI) 39 Secondary Engineering Controls **Low Volume Compounding Exemption ELIMINATED from 797 The ROOM: Separate Room 12 ACPH ISO 7 Negative Pressure

21 C-SCA Containment Segregated Compounding Area Non-HEPA room 12 ACPH Negative pressure NO 797 dating Not for High Risk Max 12 hours dating Line of demarkation PEC: Cabinet Dual HEPA Source: UPS Open Mic Session; February Are Syringes Designed For Drug Storage? Source:

22 Supplemental Environmental Controls Closed System Transfer Devices (CSTDs) Compounding : Recommended Administration : Required Currently 8 US products PhaSeal : BD VialShield with Texium : Carefusion:BD On Guard : B.Braun Chemoclave /Spiros : ICU Medical ChemoLock : ICU Medical PhaSeal Vialshield/Texium Equashield Equashield Halo : Corvida Medical ChemoLock On-Guard All Devices FDA Cleared Four have FDA ONB Code???????????? Halo 43 CSTD Attributes to Consider Source: Massoomi. Pharmacy Purchasing Products 2015; February S1-S

23 Compounding a basic dose: Unpacking, Setup, Transfer of Drug from Vial to a Syringe and into an IV Bag Steps PhaSeal ICU ChemoLock Genie Vialshield with Texium Equashield 1 Unpack PhaSeal Protector (P50) Unpack ChemoLock Genie vial spike (CL77) Unpack Vialshield Vial Adaptor (MV0520) Unpack Equashield Vial Adaptor (VA20/2) 2 Remove Green protective cap Remove the protective cap Attach Vial Adaptor to a 50ml vial Attach Vial Adaptor to a 50ml vial 3 Place P50 on Vial Mounting device Attach Genie to a 50ml vial Remove the protective cap Remove the protective cap 4 Attach Protector to a 50ml vial Unpack a 60ml syringe Unpack the Texium 60mL pre-bonded syringe unit (MY8060) Unpack Equashield 60ml Syringe Unit (SU- EZ60) 5 Unpack a 60ml syringe Unpack a ChemoLock with luer lock (CL2000S) Remove Texium protective cap. Connect the Syringe unit to the vial 6 Draw 50ml of ambient air Remove the protective cap Connect the Syringe Unit to Vialshield Vial Adapter Invert vial and draw 50ml of liquid 7 Unpack Phaseal Injector (N35) Attach ChemoLock to syringe to form syringe Invert vial and draw 50ml of liquid Disconnected Syringe Unit from vial unit 8 Attach Injector to syringe to form the Connect syringe unit to vial Disconnect syringe unit from Vial Adaptor Unpack Spike Adaptor (SA-1)* syringe unit 9 Connect syringe unit to vial Invert vial and draw 50ml of liquid Unpack Bag Spike Adaptor ( T) Attach Spike Adaptor to an IV bag* 10 Inject 50ml of air into the vial Disconnect syringe unit from vial Attach Spike Adaptor to empty IV bag Connect Syringe Unit to empty IV bag 11 Invert vial and draw 50ml of liquid Unpack ChemoLock Bag Spike (CL12)* Connect the syringe unit to Spike Adaptor. Inject 50ml of liquid into the bag 12 Disconnect syringe unit from vial Attach ChemoLock Spike to empty IV bag* Inject 50ml of liquid into the bag Disconnect syringe unit from bag 13 Unpack Infusion Adapter (C100)* Connect syringe unit to the bag Disconnect syringe unit from bag 14 Attach Infusion Adapter to empty bag Inject 50ml of liquid into the bag 15 Connect syringe unit to the bag Disconnect syringe unit from bag 16 Inject 50ml of liquid into the bag 17 Disconnect syringe unit from bag Total Steps Time 87.7 seconds 62.8 seconds 41.1 seconds 36.4 seconds Source: Massoomi. Pharmacy Purchasing Products 2015; July S1-S10 45 Looking for Efficiency Source: Massoomi. Pharmacy Purchasing Products 2015; July S1-S

24 Uptake in CSTD Use in US Source: State of Pharmacy Compounding 2015; Pharmacy Purchasing and Products: May CSTD Drug Incompatibilities N,N-Dimethylacetamide Amsacrine VUMEN (teniposide) BUSULFEX (busulfan) Treanda (Bendamustine) Listed CSTD On-Guard ChemoClave PhaSeal CAUTION, no testing with others! Source: ISMP Medical Safety Alert: February 26, 2015 Source: FDA ALERT: March 10,

25 Users Comments on CSTDs Source: accessdata.fda.gov/scripts/cdrh/cfdocs /cfmaude/search.cfm, Accesed January 5, Bacille Calmette-Guerin (BCG vaccine) Indication: Bladder CA WARNINGS Live Biological Hazard BCG infections in healthcare workers have occurred Case studies of deaths due to cross contamination of TPNs

26 Final Product Preparation Pre-primed bags Line naïve fluid Proper labeling Clear instructions Warning labels Line labels Not, but good practice Safety overbag 51 Delivery of Hazardous Drugs Yes to Hand Delivery NO to Pneumatic Delivery

27 Hazardous Drug Spill Kits/Policy Develop a collaborative policy Define volume limitsit Who is responsible Develop or purchase spill kits Location of kits : Warehouse Training on kits Dating on kits Drill Spills 53 Proper Workspace Preparation 1 Deactivation -2% Sodium Hypochlorite solution 2 Decontamination -Physical wiping of surface -Sodium Thiosulfate 3 Cleaning -Tri or Quadra-valent detergent -Peroxide 4 Disinfection -Sterile Isopropyl Alcohol 70% -UV light

28 Medical Surveillance Program First Step Work with Human Resources; Employee Health & Legal Tier-One Education Tier-Two Employer/Supervisor Surveillance Annual reproductive questionnaire Trending of sick calls Tier-Three Medical Surveillance Hire and annually CBC, urinanalysis, LFT s Urine drug testing by Tier-Four Post-exposure Surveillance Notation in medical record with date and drug Source: Massoomi F, Neff B. Implementing a personnel surveillance program for hazardous drug safety. Pharmacy, Purchasing & Products. April 2008: Gap Pregnancy and Breastfeeding Source: CFR Federal Register / Vol. 80, No. 15 / Friday, January 23, 2015 / Notices page

29 Risks of Hazardous Drugs Exposure 7,094 Nurse & Pharmacy personnel pregnancies Compared to non-risk peers Exposure of mother to handling hazardous drugs during pregnancy was associated with a significant increase risk for spontaneous abortion and stillbirth Increased risk for miscarriages by 40-50% Increased risk for low birth weight by 17-fold Increased risk for congenital malformations by 5-fold Source: Valanis B ; Vollmer WM ; Steele P. Occupational Exposure to Antineoplastic Agents: Self-Reported Miscarriages and Stillbirths Among Nurses and Pharmacists. J of Occupational and Environmental Medicine. 1999; 41(8): Non-Sterile Hazardous Drugs Segregate from non-hazardous NOT required: non-antineoplastic Simple transfers/counting Unit dose formulations Final product Negative pressure room manipulations NO automated packaging devices YES to Automated Dispensing Cabinets

30 Hazardous Waste Management Continuous formulary assessment State and federal regulations DRUG - GENERIC (BRAND) CLASS OF MEDICATION ROUTES/ FORMS COMPANY PREGNANCY CATEGORY MSDS BSC HAZ CLASS (1-4) WASTE STREAM RCRA Y/N Aldesleukin (Proleukin) ONC INJ Chrion C YES YES Class 1 YELLOW N Alitretinoin (Panretin) Retinoid TOPICAL, GEL Ligand D YES Yes, if altered Class 1 YELLOW N Cychlophosphamide ONC INJ, ORAL Multiple D YES YES Class 1 RCRA BLACK Y 59 Hazardous Drug Training Legacy Home Grown Commercially Available programs ASHP videos/print material CriticalPoint Web-based training lessons Covidien's ChemoPlus Training Lab Safety Corporation/Valiteq Pharmacy OneSource Baxter's Blue Book (Training Manual for IV Admixture Personnel) Germfree Video Training Program Kendall's Chemocheck

31 Compounding Competency ChemoChek Fluorescence test Nursing certification program ChemoTEQ Red dye and broth test Videos and training materials on line 61 Hazardous Drug Training Source:

32 Gap Hazardous Drug Consideration Special Delivery Devices 63 What Happens After Treatment? 42 Urine samples were collected from the three patients and their family members; ALL samples were positive for cyclophosphamide and 5-FU Cyclophosphamide was detected at levels of ng/cm2 in 8 of the 12 wipe samples obtained from the homes Study demonstrated contamination of the home setting and exposure of family members Source: J Oncol Pharm Practice 2012;19:

33 Hazardous Drug Rounds Preparation Administration Disposal The Patient 65 Safe Handling of Hazardous Drugs An Evolving Legislative and Regulatory Landscape Firouzan Fred Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital Omaha, Nebraska

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