It s Official, but what is next? USP 800 Safe Handling of Hazardous Drugs. Fred Massoomi, Pharm.D., FASHP. April 19, 2016

Transcription

1 It s Official, but what is next? USP 800 Safe Handling of Hazardous Drugs Fred Massoomi, Pharm.D., FASHP April 19,

2 Learning Objectives Review the historical, current and approved hazardous drug standards Summary of the exis;ng hazardous drug handling standards Discussion of the challenges in mee;ng the new and emerging regulatory requirements for safe handling of hazardous products Review of available resources 2

3 Source: NPA.org 3

4 Compounding Standards Drug Quality & Security Act NAPB Model Rules for Sterile Pharmaceu;cals USP <797> Pharmaceu;cal Compounding Sterile Prepara;ons USP <1074> Dispensing Prac;ces for Sterile Drug Products Intended for Home Use ASHP TAB Quality Assurance for Pharmacy- Prepared Sterile Products USP <1206> Sterile Drug Products for Home Use USP <800> Hazardous Drugs Handling in Healthcare SeWngs NCCLVP Recommenda;ons Best Prac;ce Recommenda;ons Federal Standards Source: Massoomi

5 Timeline of Safe Hazardous Drug Guidelines and Regula;ons Advent of Modern day chemotherapy Loius Goodman and Alfred Gillmon use nitrogen mustard to treat non-hodgkin s Lymphoma First case report of occupational exposure risk with HDs Mutagenicity in the urine of nurses handling cytostatic agents Risk defined for occupational exposure to HDs Risk of handling injectable antineoplastic agents ASHP (TAB) on handling cytotoxic and hazardous drugs OSHA Technical Manual Update: Controlling occupational exposure to HDs First review of carcinogenic potential of anticancer drugs The carcinogenicity of anticancer drugs: A Hazard in Man First US published guidelines for handling HDs Developing guidelines for working with antineoplastic drugs AMA guidelines for HDs Guidelines for handling parenteral antineoplastic OSHA Technical Manual: Controlling occupational exposure to HDs Chapter 21. First US evaluation of a CSTD Evaluation of the PhaSeal hazardous drug containment system USEPA Resource Conservation Act (RCRA) disposal of HDs 5 Source: Massoomi 2016

6 Predictive Safety..recommenda;ons support..maintaining product sterility while providing for the safety of the personnel involved in preparing and administering chemotherapy Bruce Harrison, RPh AJHP

7 Hazardous Drug Compounding United States Pharmacopeia <800>! First Release March 2014! Comment Due Date July 31, 2014! Second Release December 2014! Comment Due Date May 31, 2015! Approval February 01, 2016! Official Compliance Date July 1,

8 Public Policy 8

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10 Compliance With The Basics 241 nurses and 183 pharmacy prac;;oners who compounded hazardous drugs in the seven days prior to the survey Compounding PracSce Assessment Nursing Pharmacy Lack of Hazard Awareness training 9% 13% Lack of safe handling procedures 20% 11% Not wearing 1 pair of gloves 8% 10% Not wearing 2 pairs of gloves 85% 47% Not wearing recommended gown 38% 20% Not always using a CSTD 75% 53% Not always using a BSC/CACI 9% 15% IV line primed with HD 19% 30% Lack of medical surveillance 61% 45% Reported skin contact with HD 11% 4% Source: Boiano JM, Steege AL, Sweeney MH. Journal of Occupational and Environmental Hygiene Volume 12, Issue 9,

11 DEFECT Visualizing The Concerns Source; E.Kastango 11

12 What s Inside the Final Chapter? Source: USP 39-NF 34 Physical Test/<800> Hazardous Drugs-Handling in healthcare sewngs 12

13 Sec;ons To Safety This chapter describes prac;ce and quality standards for handling hazardous drugs (HDs) to promote pa;ent safety, worker safety, & environmental protecson. 1. IntroducSon and scope 2. List of Hazardous Drugs 3. Types of Exposure 4. ResponsibiliSes of Personnel Handling HDs 5. FaciliSes and engineering controls 6. Environmental quality and control 7. Personal ProtecSve Equipment 8. Hazard CommunicaSon Program 9. Personnel training 10. Receiving 11. Labeling, packaging, transport & disposal 12. Dispensing final dosage forms 13. Compounding 14. Administering 15. DeacSvaSng, DecontaminaSng, Cleaning, and DisinfecSng 16. Spill Control 17. DocumentaSon and SOPs 18. Medical Surveillance 13

14 What is Missing? Lancet 1979; June 9: 1(8128): Eur J Clin Oncol 1986;22(12): AJHP 1993; June 9: 1(8128): J Pharm Prac:ce 1991;4(1):72-6 BMJ Qual Saf published online August 16, 2011 J NCI 1993;85: Scand J Work Environ Health 1994;20:22-6 NEJM 1985;313(19): Aust NZ J Med 1984;14(6):831-4 J Occup Environ Med 1997;39(6):

15 1. Introduction & Scope WHO Pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, vets, and vet technicians Not listed Manufacturers; Wholesale Personnel; Researchers; Family 15

16 The Source Source: hlp:// sec;oncode=editorial&templatecode=single&user=31 Source: Massoomi, Firouzan 16

17 2. List of Hazardous Drugs Must have a list (USP; TJC; NIOSH) Type of HD: an;neoplas;c; non-an;neoplas;c; reproduc;ve risk Dosage form Risk of exposure Packaging Manipula;on Source: NIOSH.gov DHHS (NIOSH) Publica;on Number (Supersedes ) 17

18 MSN Ranks Most Dangerous Drugs Source: hlp:// 18

19 3. Types of Exposure Routes of uninten;onal entry: Dermal, -mab do not absorb Mucosal absorp;on, Inhala;on, Carmus;ne; Cispla;n; Cyclophosphamide; Etoposide; Ifosphamide; 5-Fluorouracil Injec;on, Inges;on 19

20 4. Responsibilities of Personnel Handling HDs People! Designated expert! Aptitude of risk! Training! Math skills! Environmental monitor! Clean environment! Trustworthy! Reliability Processes! Address all risk points! Continuous education! Consistency! Documentation of processes! Documented training! Operator testing! Re-training process Products! Safety! Sterility! Labeling! Ingredient standards! Appropriate labeling! Reduce contamination! Consistency! Safe transport Personnel & Patient Safety 20

21 5. Facili;es & Engineering Controls Designated areas must be available for HDs: Receipt & unpacking Storage Non-sterile compounding Sterile compounding 21

22 5.1 Receipt HDs must be unpacked in area: Neutral/Nega;ve pressure 5.2 Storage Must be stored in manner to prevent spillage/breakage HDs requiring manipula;on stored separately Externally vented, Nega;ve pressure, 12 ACPH 22

23 5.2 Compounding Primary Engineering Controls C-PEC Containment C-PEC = The Hood Biological Safety Cabinet Class II BSC types A2, B1, or B2 Containment Asep;c Compounding Isolator (CACI) USP 797 proposed terminology RABS (Restricted Access barrier system) Operate con;nuously Must Externally vented Physically separated located in C-SEC Must follow UPS 795 and USP 797 Should use CSTD for compounding 23

24 5.2 Compounding Secondary Engineering Controls Containment C-SEC = The Room Must be externally vented Must be physically separated Must be nega;ve pressure 0.01 and 0.03 inches water column Power outage plan Sink available Must have eyewash sta;on available Bolles NOT acceptable Within 10 seconds of hazard area 24

25 5.2 Compounding Supplemental Engineering Controls! Compounding : Should! Administra;on : Must! Closed System transfer Devices PhaSeal Vialshield/Texium Equashield! PhaSeal : BD! VialShield with Texium : Carefusion:BD! On-Guard : B.Braun! Chemoclave /Spiros : ICU Medical! ChemoLock : ICU Medical! Equashield ChemoLock On-Guard! Halo : Corvida Medical Halo 25

26 All FDA Cleared FDA ONB Code =??? Simple tests Fluorescence ph test Complex Tests Titanium Tetrachloride NIOSH Alcohol Test 5.2 Compounding Supplemental Engineering Controls 26

27 5.2 Compounding Non-sterile Compounding Must follow USP <795> C-PEC not for final dosage Coun;ng Repackaging C-PEC for manipula;ons CuWng, crushing Externally vented or redundant HEPA Containment Ven;lated Enclosure 27

28 Pill Crusher Options 28

29 6. Environmental Quality & Control Should sample Rou;nely = ini;ally then every 6 months Approximate cost is $400 per sample per drug Source: Nebraska Methodist Hospital Department of Pharmacy Services 29

30 7. Personal Protective Equipment Must define the use of PPE for handling HDs Receipt Storage Transport Compounding (sterile and nonsterile) Administra;on Deac;va;on/decontamina;on, cleaning, and disinfec;ng Spill control Waste disposal 30

31 7. Personal Protective Equipment Head covers Beard covers Eye protec;on for -spill protec;on Disposable Gowns Polyethylene or laminate Close in the back Face mask limited safety Powered airpurifying respirator -for spills 2 pairs 2 pairs Don 2 pairs prior to entry Remove outer when leaving An;-skid 31

32 Source: hlp://gizmodo.com/japan-is-down-to-one-nuclear-power-plant

33 Respiratory Protection 33

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35 8. Hazard Communication Program OSHA requires hazard communica;on program 1. A wrilen plan that describes how the standard will be implemented 2. All containers of hazardous chemicals must be labeled 3. En;;es must have an SDS* for each hazardous chemical they use 4. SDSs* must be readily accessible to personnel 5. Personnel must be provided informa;on and training before job 6. Personnel of reproduc;ve capability must confirm in wri;ng that they understand the risks of handling HDs Right to Know Standard Standard (29 CFR part ) *SDS = Safety Data Sheet 35

36 New OSHA Standards Worker par;cipa;on Hazard iden;fica;on and assessment Hazard preven;on & control Educa;on and training Evalua;on and improvement Coordina;on and communica;on of mul;employer worksites Source: JCRINC.com EC News February

37 9. Personnel Training All personnel who handle HDs must be trained based on their job func;ons Must be assessed every 12 months Must be trained on new HDs and equipment Must document competencies 1. Overview of en;ty's list of HDs and their risks 2. Review of the en;ty's SOPs related to handling of HDs 3. Proper use of PPE 4. Proper use of equipment and devices 5. Response to known or suspected HD exposure 6. Spill management 7. Proper disposal of HDs and trace-contaminated materials 37

38 10. Receiving Totes from wholesaler MUST Not be a + pressure area Gloves to handle Drugs left in baggies Gloves worn for unpacking Spill kit available Visual inspec;on for HDs Damaged stock = spill Removed in Isolator 38

39 11. Labeling, Packaging, Transport and Disposal Labeling Precau;on clearly labeled Packaging Protect against damage, leakage, contamina;on, and degrada;on Transport Transport containers Must Not transport via pneuma;c tubes any liquid HDs 39

40 11. Labeling, Packaging, Transport, and Disposal EPA Oversight Published September 1, 2015 Comment December 31, 2015 Expected compliance 2017 ish No drugs down the drain Requires manual sor;ng Biohazardous Non-hazardous Hazardous RCRA Hazardous RCRA Reac;ve Aerosols Controlled Substances - DEA Source: hlp:// 40

41 12. Dispensing Final Dosage Forms HDs with no manipula;on other than Coun;ng Repackaging of final dosage form Check manufacturer s recommenda;ons Clean equipment azer use An;neoplas;cs must not be placed in automated coun;ng/packaging machines OK for Automated Dispensing Cabinets 41

42 13. Compounding Follow UPS 795 and USP 797 Should use a CSTD for sterile compounding Chemo mat should be used NOTE: Most are not sterile Must dedicate equipment to HDs 42

43 14. Administration Must use CSTDs or protec;ve medical devices and techniques Must pre-priming IV tubing with non-hd solu;on Must wear PPE Minimize risk posed by open systems Must avoid manipula;on SpliWng, crushing, opening capsules Source: Used with permission Seth Eisenberg, RN 43

44 15. Deactivation, Decontaminating, Cleaning, and Disinfecting 1 Deac;va;on -2% Sodium Hypochlorite solu;on 2 Decontamina;on -Physical wiping of surface -Sodium Thiosulfate 3 Cleaning -Tri or Quadra-valent detergent -Peroxide RTU 4 Disinfec;ng -Sterile Isopropyl Alcohol 70% -UV light 44

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46 Is This Right for Our Patients? 46

47 16. Spill Control Must have proper training for spill management PPE NIOSH approved respirators Spill kits Spill signs posted Must have spill kits readily available Must dispose spill materials as hazardous wastes Must address size of spills 47

48 17. Documentation & Standard Operating Procedures SOPs for HDs throughout facility Must review SOP s every 12 months The SOPs for handling of HDs should include: 1. Hazard communica;on program 2. Occupa;onal safety program 3. Designa;on of HD areas 4. Receipt 5. Storage 6. Compounding 7. Use and maintenance of proper engineering controls (e.g., C-PECs, C-SECs, and CSTDs) 8. Hand hygiene and use of PPE based on ac;vity 9. Deac;va;on, decontamina;on, cleaning, and disinfec;on 10. Dispensing 11. Transport 12. Administering 13. Environmental monitoring (e.g., wipe sampling) 14. Disposal 15. Spill control 16. Medical surveillance 48

49 18. Medical Surveillance Plan should be consistent with HR s plan Iden;fy folks at risk of HD exposure Direct Contact with HD or Wastes Direct Contact with Pa;ent on HD Therapy Indirect HD contact or HD pa;ent contact No Contact by posi;on with HD Or Pa;ents on HD No Contact allowed: Pregnancy, Breast Feeding, Alempt at Pregnancy Quan;fy handling risk Medical Assessment on hire and rou;nely Develop exit interview assessment strategy 49

50 18. Medical Surveillance 18.1 Follow-up Plan Post-exposure examine: Type of exposure: needle s;ck; spills Assessment of extent of exposure Organ system involved Treatment Laboratory studies Conduct environmental sampling Verify all engineering controls are working FMEA of processes and policies Develop ac;on plan to prevent future exposures Ensure confiden;al two way communica;on Provide on-going medical surveillance 50

51 Free Gap Tool hlp:// CODE: F800A 51

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53 Contrac;ng for Outsources Pharmacy Oversight Radiopharmaceu;cals Sterile Compounded Drugs Non-Sterile compounded drugs Staff On-site visit(s) Evalua;on of quality documents Recall no;fica;on and process On-going monitoring From a legal and The Joint Commission perspective Hospital is responsible for the services provided to its patients from an outsourced vendor Source:hlp:// 53

54 Source: hlp:// 54

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56 Segregated HD Linen Uline S-12986Y 56

57 Track & Traceability Act Pedigree Act Transac;on History (TH) Owners Transac;on Informa;on (TI) iden;fies the product (NDC, Lot Number, Date of Transac;on, etc.) Transac;on Statement (TS) alests that the TI and TH informa;on is accurate Source: hlp:// 57

58 42 Urine samples were collected from the three pa;ents and their family members; ALL samples were posi;ve 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 contamina;on of the home sewng and exposure of family members Source: J Oncol Pharm Prac;ce 2012;19:

59 Evolu;on Towards Safety The ;me is approaching to make hand filling in cleanrooms a part of our history, something we used to do. Source: 2008 PDA Risk Management in Asep;c Processing Mee;ng; Risk Management, cgmp, and the EvoluSon of AsepSc Processing Technology; PDA J Pharm Sci and Tech 2009,

60 Questions? 60