LUNCH AND LEARN. Proposed USP 800 Safely Handling Hazardous Drugs August 8, 2014

Transcription

1 LUNCH AND LEARN Proposed USP 800 Safely Handling Hazardous Drugs August 8, 2014 Featured Speaker: Firouzan 'Fred' Massoomi, Pharm.D., FASHP Pharmacy Operations Coordinator, Department of Pharmacy Services 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 received Grant and/or Research Support from ICU Medical, BD, Equashield, and Carefusion

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 5, 2014 CPE Monitor CE information automatically uploaded to NABP/CPE Monitor within 3 to 4 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 Proposed USP <800>: Safely Handling Hazardous Drugs Firouzan Fred Massoomi, PharmD, FASHP Pharmacy Operations Coordinator Nebraska Methodist Hospital Omaha, Nebraska Fred.Massoomi@nmhs.org 3

4 What Is the Trend? Source: WHO Globalcan Cancer Death Rates Drop in U.S. Age-adjusted cancer death rates, Males Females Sources: USAToday; CDC

5 Is There a Cost to Improved Care? 9 USP <800>: A Decade of Progress Toward Hazardous Drug Safety

6 Guidelines for Hazardous Drugs Source Year ASHP 1982, 1984, 1990, 2006 Israel Ministry of Health 1984, 2000, 2002, 2004 OSHA 1986, 1995, 1999 AMA Council on Scientific Affairs 1985 Oncology Nursing Society 1988, 2003, 2010 NIOSH Alert 2004, 2010, 2012, HOPA 2009` USP <797> 2004, 2008 USP <800> 2014 (for comment) Globally 42 years of Safe Handling Guidelines 11 Critical Point of Safety: Defect Compounding Inconsistencies DOES NOT: Eliminate i waste Reduce costs Improve quality Delight customers Improve employee satisfaction Increase safety

7 Drivers of USP <797> Compliance Percentages 3 2 Concern About State Board of Pharmacy Sanctions 15% 2 Concern About Other Regulatory Body Sanctions 14% Publicity About Serious Sterile Compounding Errors/Incidents at Other Facilities 21% Another Standard of Practice That Should Be Implemented 45% 21 Sterile Compounding Errors/Incidents in Organization 2% Other 3% Source: Douglass, K, et al. Pharmacy Purchasing & Products. October 2013:S1 S24 13 State Boards of Pharmacy State regulations for compounding Board of Pharmacy or Health Departments Most states have USP 797 specific regulations Specific Hazardous Drug Compounding regulations Washington 2013 California in 2013 North Carolina 2014 Maryland in process Maryland Board of Pharmacy since 2010 Closed system vial transfer devices (CSTD) are employed when handling cytotoxic drugs COMAR (17)

8 The Joint Commission Is Concerned Source: TJC ECNews; March 2014:volume 7; issue3 15 The objective of this chapter is to protect tpersonnel and the environment when handling hazardous drugs (HDs) Sterile and non sterile products Source: Proposed USP <800>;

9 Protection Starts with a Hazardous Drug Team Primary Pharmacist Pharmacy technicians/interns i Pharmacy purchasing Nursing Risk Management Employee health Environmental services Secondary Administration Safety officer Tertiary Customers Primary Goal: Establish a hazardous drug safety program Visual Hazard Mapping Tool

10 Evidence of Exposure in Healthcare Workers Worker Days Urine samples Positive CP samples Positive IF samples Pharmacist Pharmacist Technician Technician Technician Nurse Nurse Control N(pos)= (N=5) 10 (N=2) There is no acceptable level of personnel exposure to HDs Wick et al. Am J Health Syst Pharm. 2003; 60: Occupational Risks Due To Exposure to Hazardous Drugs Kaiser Permanente Center for Health Research 1 7,094 pregnancies of 2,976 pharmacy and nursing staff Increased risk for miscarriages by 40 50% Increased risk for low birth weight by 17 fold Increased risk for congenital malformations by 5 fold NIOSH 2 7,500 nurses Oncology nurses 2 fold risk of miscarriages 2 out of 10 nurses lost pregnancy at week J Occup Environ Med. 1999; 41(8): Lawson et al. Am J Obstet Gynecol. December

11 The Contaminated Environment More than 70 published studies Most surfaces that come in direct contact with hazards Some with indirect contact with hazards Source: B. Braun 21 Hazardous Drug Wipe Study Testing takes approximately 10 minutes

12 USP <800> Formulary Assessment of Hazards NIOSH Appendix A Proposed stratification of Hazards Antineoplastic non Antineoplastic Reproductive Continuously stratify hazards and response 23 #1 Safety Concern: The Source EVIDENCE: 11 Published studies Drug vial exteriors Not due to damage during shipping & handling

13 Vial Contamination Improved Tested: MTX (60); 5FU (110); cisplatin (60) 2 of 230 vials tested were contaminated 1 FU and 1 cisplatin vial Marked improvement NOTE: highly manufacturer specific Source: Hospital Pharmacy 2014:49(4): Look for Safety

14 USP <800> Segregated Handling of Vials Totes from wholesaler Gloves to handle Drugs left in baggies Removed in Isolator Shall not Store Unpack Compound Manipulate Not a positive pressure area Equi pressure Negative pressure 27 USP <800> -- Personal Protective Equipment : Training Documentation Hands & elbows scrubbed CDC hand hygiene document Proper demonstrative use Goal Minimize contamination from product to employee & vice versa No make up or jewels No fake fingernails No ipods No exemptions from garbing requirements 14

15 USP <800> -- Documentation of Garb Competency Garb On Sequence Garb Off Sequence Source: Taipei Veterans Hospital; Taipei, Taiwan 29 USP <800> -- Choosing the Right Glove

16 USP <800> -- Primary Engineering Controls Biological Safety Cabinet Class II Type B2 BSC Isolator Glove Box Compounding Aseptic Containment Isolator Total Exhaust 31 USP <800> -- Secondary Engineering Controls Separate Room 12 ACPH ISO 7 Negative Pressure

17 Closed-System Transfer Devices Supplemental Environmental Controls Current Global Products PhaSeal BD Tevadaptor Teva ChemoLock /Spiros ICU Medical Equashield Chemoshield /Smartsite Carefusion Sure Connect Baxa Q Flo I3 Infusion Inovations Israeli Health Ministry Approved PhaSeal BD Tevadaptor Teva Equashield Smartsite/Texium Equashield PhaSeal ChemoLock On-Guard SureConnect Q-Flow 33 Vapor Control of Hazardous Drugs Antineoplastic Drug Mol. Weight Vapor pressure (Pa) at 20 C Max. concentration (mg/m 3 ) Carmustine Cisplatin Cyclophosphamide Etoposide Fluorouracil Some antineoplastic drugs possess a low vapor pressure. Protective clothes not designed to protect workers from vaporized drugs. Source: Kiffmeyer et al., Pharm J 2002; 268:

18 Uptake in CSTD Use in the U.S. Source: Advisory Board: CSTD Utilization in Drug Vial Optimization and Beyond use Dating; Pharmacy Purchasing and Products : April A Leader In Safety... Source: Mydesk.com document:

19 Time and Motion Study of CSTDs Compared 5 CSTDs to syringe/needle PhaSeal; ChemoClave; On guard; Equashield; Cardinal Texium From Rx to RN 110 Pharmacy personnel and 120 nurses; 3 sites Needle/syringe Average times: Rx 270 sec RN: 216 sec CSTD Average times all 5: Rx 321 sec RN: 156 sec Total time Needle/Syringe: 486 sec vs. CSTD average: 477 sec Source: D. Greisen, 2012 Resident Project 37 Repetitive Strain Injury 19% 81% RSI type pain No pain Source: Abbot L, Johnson T. Minimizing pain resulting from the repetitive nature of aseptic dispensing. Hospital Pharmacist, March

20 CSTD Ergonomic Considerations 39 Final Product Preparation Pre primed bags Line naïve fluid Proper labeling Clear instructions Warning labels Line labels Safety overbag Supplemental Engineering Control

21 Compounding Competency ChemoChek Fluorescence test Nursing certification program ChemoTEQ Red dye and broth test Videos and training materials on line 41 Lack of Competency Can Be Costly Source: cancer drugs doubled to per month/

22 Tool for Protecting Personnel: Hazardous Drug Checklist 43 Hazardous Waste Management How Is drug waste properly managed? Continuous formulary assessment Technion & Al Quds Universities Collaborate For Clean Water. April 29,

23 USP <800> Hazardous Drug Spill Kits/Policy Develop a collaborative policy Dfi Define volume limitsi Who is responsible Develop or purchase spill kits Location of kits Training on kits Dating on kits Drill Spills 45 A Better Approach To Spills!

24 USP <800> Proper Workspace Preparation 1. Deactivation 2% Sodium hypochlorite solution Sodium thiosulfate 2. Decontamination Physical wiping of surface 3. Cleaning Tri or Quadra valent detergent Peroxide 4. Disinfection Sterile isopropyl alcohol 70% UV light 47 USP <800> Medical Surveillance Program Tier One: Education and Self Surveillance Tier Two: Employer/Supervisor Surveillance Annual reproductive questionnaire Trending of sick calls Tier Three: Comprehensive Medical Surveillance Hire and annually CBC, urinalysis, LFT s Urine drug testing by Tier Four: Post exposure Surveillance Notation in medical record with date and drug Massoomi F. Pharm. Purch Prod

25 Baseline Employee Information 49 Oral Hazardous Drugs Segregate from nonhazardous Non sterile characteristics Tablet, capsule, liquid All manipulations in negative pressure room Crushing of product Liquid medication request process Compound into a topical NOT for automated packaging devices

26 Hazardous Drug Consideration Special Delivery Devices 51 Hazardous Drug Consideration: New Chemotherapy Patch Novel, patent pending micropump pfor drug delivery Drug reservoir contains up to 3 chemotherapy drugs Microneedle array for painless drug administration Simple microcontrollerbased electronic circuit for complex programmable delivery scheduling Source: create the future

27 Hazardous Drug Consideration: Bacille Calmette-Guerin Vaccine Indication: Bladder CA WARNINGS Live biological hazard BCG infections in healthcare workers have occurred Case studies of deaths due to cross contamination contamination of TPNs 53 Hazardous Drug Rounds Preparation Administration Disposal

28 Future Considerations Disposable drug delivery devices Genotargeted drugs Micro robot delivery of drugs Nanotechnology drugs Nanopills Nanotopicals Nano injections 55 Sterile Compounding: The Future Is Now Monster Robots on the Market Intellifill IV Baxter RIVA CytoCare McKesson Health Robotics IV Station Apoteca Loccioni Make way for the new micro robots Diana ICU Medical

29 USP <800> -- Comment Period Ended July 31,

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