Safe Hazardous Drug Handling Beyond USP <800> Fred Massoomi, Pharm.D., FASHP Senior Director Visante, Inc.

Transcription

1 Safe Hazardous Drug Handling Beyond USP <800> Fred Massoomi, Pharm.D., FASHP Senior Director Visante, Inc.

2 Safe Hazardous Drug Handling Beyond USP <800>> Important Updates USP is announcing the intent to postpone the official date of General Chapter <800>. The purpose of this postponement is to align the official date of General Chapter <800> with the official date of the next revision of General Chapter <797> Pharmaceu)cal Compounding Sterile Prepara)ons, to provide a unified approach to quality compounding. Important Dates September 29, 2017: NoYficaYon of intent to revise the official date of USP General Chapter <800>. December 1, 2019: USP General Chapter <800> expected official date.

3 Safe Hazardous Drug Handling Beyond USP <800>> Disclosures RecommendaYon to the audience to review nayonally accepted guidelines, FDA approvals, and peer reviewed studies for clarificayon of informayon presented.

4 Safe Hazardous Drug Handling Beyond USP <800>> Learning Objectives u Describe compounding regulayons and perceived compliance in the United States u State the risks associated with handling hazardous drugs to healthcare providers u Explain the key safety standards outlined in USP 800 u IdenYfy strategies for implemenyng key points to a hazardous drug safety program

5 Safe Hazardous Drug Handling Beyond USP <800>> PredicYve Safety Needs...recommendaYons support..maintaining product sterility while providing for the safety of the personnel involved in preparing and administering chemotherapy Am J Hosp Pharm ;38(11):

6 Safe Hazardous Drug Handling Beyond USP <800>> 1. USP <797> PharmaceuAcal Compounding Sterile Compounds 2. USP <800> Hazardous Drug - Handling in Healthcare SeFngs 3. MM AnAbioAc Stewardship Standard A & 503B Compounding B Mega-Guidance Withdrawn Source: hfp://managedhealthcareexecuyve.modernmedicine.com/managed-healthcare-execuyve/news/five-pharmacyregulayons-health-execs-must-keep-their-radars-2017

7 Compounding Standards Drug Quality & Security Act NAPB Model Rules for Sterile PharmaceuAcals USP <797> PharmaceuAcal Compounding Sterile PreparaAons USP <1074> Dispensing PracAces for Sterile Drug Products Intended for Home Use NCCLVP RecommendaAons ASHP TAB Quality Assurance for Pharmacy- Prepared Sterile Products USP <1206> Sterile Drug Products for Home Use Best PracYce RecommendaYons Federal Standards USP <800> Hazardous Drugs Handling in Healthcare SeFngs Copyright 2017 Firouzan Massoomi, Albarello, LLC. All Rights Reserved.

8 Regulatory Hierarchy Professional Best PracAces Industry Best PracAces United States Pharmacopeia <800> United States Pharmacopeia <797> & <795> Regulatory Line State Boards of Health &/or Pharmacy Food and Drug AdministraAon

9 The Total Picture Pharmacy Prepared Sterile Compounded Products Computer Order Entry Pharmacy Prepared Non-Sterile Compounded Products PaAent Manufacturer Prepared Compounded Products Clinical Pharmacy Services Outsourced Products Pharmacy Department

10 EvoluYon of Safety Source: ASHP Institutional Pharmacy Practice; 4 th edition Source: PDA J Pharm Sci and Tech 2009, Source: Kastango,E Clinical IQ, LLC Source: Massoomi, Firouzan Source: Massoomi, Firouzan Source: Massoomi, Firouzan Source: Massoomi, Firouzan

11 Safe Hazardous Drug Handling Beyond USP <800>>

12 Safe Hazardous Drug Handling Beyond USP <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, 2018 hcp://

13 Source: Pharmacy PracAce News: February 7, 2017

14 Safe Hazardous Drug Handling Beyond USP <800>> Road Map to Safety Introduction and scope List of Hazardous Drugs Types of exposure Responsibilities of handling HDs Facilities and engineering controls Environmental quality and control Personal protective equipment Hazard communication program Personnel training Receiving Labeling, packaging, transport & disposal Dispensing final dosage forms Compounding Administering Deactivating, decontaminating, cleaning, & disinfecting Spill Control Documentation and standard operating procedures (SOPs) Medical surveillance Graphic: : Firouzan Massoomi, Pharm.D, FASHP

15 What s 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): Graphic: : Firouzan Massoomi, Pharm.D, FASHP

16 OccupaYonal Risks Due to Hazardous Drugs Kaiser Permanente Center for Health Research 7,094 pregnancies of 2,976 pharmacy and nursing staff studied Increased risk for miscarriages by 40-50% Increased risk for low birth weight by 17-fold

17 Evidence of Exposure Worker Day Number of Urine samples Positive CP samples Positive IF samples Pharmacist Pharmacist Technician Technician Technician Nurse Nurse Control N(pos)= (N=5) 10 (N=2) CP =cyclophosphamide; IF=ifosphamide Source: Wick, C., Slawson, M.H., Jorgenson, J.A., & Tyler, L.S. (2003). Using a closed-system protecave device to reduce personnel exposure to ananeoplasac agents. AJHP, 60(22),

18 Safe Hazardous Drug Handling Beyond USP <800>> 241 nurses and 183 pharmacy pracyyoners who compounded hazardous drugs in the seven days prior to the survey Compounding PracAce Assessment Nursing Pharmacy Not wearing 1 pair of gloves 8% 10% Not wearing 2 pairs of gloves 85% 47% Not wearing recommended gown 38% 20% Reported skin contact with HD 11% 4% Boiano JM, Steege AL, Sweeney MH. Journal of Occupa2onal and Environmental Hygiene Volume 12, Issue 9, 2015

19 Safe Hazardous Drug Handling Beyond USP <800>> The Source Photos: Firouzan Massoomi, Pharm.D, FASHP Photo: Firouzan Massoomi, Pharm.D, FASHP Source: hfp:// secyoncode=editorial&templatecode=single&user=31

20 What s Inside the Final Chapter Copyright 2017 Firouzan Massoomi, Albarello, LLC. All Rights Reserved.

21 Types of Exposure Routes of unintenyonal entry Dermal Mucosal absorpyon InhalaYon InjecYon IngesYon Copyright 2017 Firouzan Massoomi, Albarello, LLC. All Rights Reserved.

22 IntroducYon and Scope This chapter describes pracyce and quality standards for handling hazardous drugs (HDs) to promote payent safety, worker safety, and environmental protecyon. Pharmacists, pharmacy technicians, nurses, physicians, physician assistants, home healthcare workers, vets, and vet technicians Not listed: Manufacturers; Wholesale personnel; Researchers; Family Must incorporate into OccupaYonal Safety Plan

23 Safe Hazardous Drug Handling Beyond USP <800>>

24 Lists of Hazardous Drugs Must have a Hazardous Drug list USP 800 The Joint Commission OccupaYonal Safety & Health Admin. Type of Hazardous Drugs anyneoplasyc non-anyneoplasyc reproducyve risk Risk of exposure considerayons ConYnual and annual update

25 Bacille Calmefe-Guerin (BCG) IndicaYon: Bladder CA WARNINGS Live Biological Hazard BCG infecyons in healthcare workers have occurred Case studies of deaths due to cross contaminayon of TPNs

26 FaciliYes & Engineering Controls Must Have Designated Areas Receipt & unpacking Storage Non-sterile compounding Sterile compounding Example: Signage

27 Safe Hazardous Drug Handling Beyond USP <800>> Receipt Must be unpacked in designated area Neutral/NegaYve pressure Storage Must be stored in manner to prevent spillage/ breakage HDs requiring manipulayon stored separately Externally vented, NegaYve pressure, 12 air changes per hour (ACPH) Cleanability

28 Compounding Containment Primary Engineering Controls Do NOT use Laminar Flow Workbench Do NOT use Compounding AsepAc Isolator (CAI) MUST wear Personal ProtecAve Equipment Must Be unidirecaonal flow Biological Safety Cabinet Class II BSC types A2, B1 Class II B2 (100% vented) Compounding AsepAc Containment Isolator (CACI) RABS Restricted Access barrier system

29 Compounding Containment Secondary Engineering Controls C-SEC = The Room Externally vented Physically separated Temperature: less than 68 F; RH less than 60% NegaYve pressure 0.01 and 0.03 inches water column ISO 7 Air Quality 20 air exchanges per hour Eyewash stayon available

30 SEC Room Afributes Ideal Concerning

31 Non-Sterile Compounding Must follow USP <795> C-PEC not required for final dosage CounYng Repackaging C-PEC required for some manipulayons Cuvng, crushing Containment VenYlated Enclosure

32 Compounding Supplemental Engineering Controls Closed System Transfer Devices CSTDs Pharmacy Compounding: Should Nursing Administration: Must

33 Safe Hazardous Drug Handling Beyond USP <800>> Source: ASHP Study Guide: Safe Handling of Cytotoxic and Hazardous Drugs Source: Bristol Meyers Squibb ONC CE 2001

34 Safe Hazardous Drug Handling Beyond USP <800>>

35 Safe Hazardous Drug Handling Beyond USP <800>>

36 CSTD AdopYon: Are We All In? Chart Ref: State of Pharmacy Compounding 2017; Pharmacy Purchasing and Products; Supplement April 2017, pg. 35

37 FDA Cleared Closed System Transfer Devices Device Manufacturer FDA Cleared BD Phaseal System Becton Dickenson and Company; Carmel Pharma, Inc. (original) Spiros ICU Medical, Inc Texium with SmartSite OnGuard with Tevadaptor Becton Dickinson and Company; CareFusion, Inc. (original) B. Braun Medical Inc. (U.S. distributor) TEVA Medical, Ltd. (manufacturer) ONB Type 1998 Containment 2006 Air Cleaning 2006 Air Cleaning ChemoClave ICU Medical, Inc Containment & Air Cleaning Equashield Equashield, LLC; Plastmed, Ltd. (original) 2008 Containment ChemoLock ICU Medical, Inc Containment & Air Cleaning ChemoSafety Becton, Dickinson and Company; CareFusion, Inc. (original) 2013 Containment & Air Cleaning EquaShield II Equashield, LLC 2014 Containment Halo Corvida Medical 2015 Containment

38 Drug AdministraYon Must use CSTDs Must pre-priming IV tubing with non-hd soluyon Must wear PPE Must avoid manipulayon Splivng, crushing, opening capsules Source: Used with permission Seth Eisenberg, RN

39 Noted Exposures to Nursing Source: hcp://nursing.onclive.com/publicaaons/oncology-nurse/2017/march-2017/aftude-shio-making-safe-handling-of-hazardous-drugs-a-priority-

40 Environmental Quality & Control Recommended RouYnely = iniyally then every 6 months Verify cost for tesyng supplies

41 Safe Hazardous Drug Handling Beyond USP <800>>

42 Personal ProtecYve Equipment Head covers Beard covers Eye protecaon for -spill protecaon 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 AnA-skid

43 Donning and Doffing Garb Safety

44 Personnel & Training Must have a designated specialist All personnel who handle HDs must be trained based on their job funcyons Must be assessed every 12 months Must be trained on new HDs and equipment Must document competencies Photos: Firouzan Massoomi, Pharm.D, FASHP

45 Labeling, Packaging, Transport Labeling PrecauYon clearly labeled Packaging Protect against damage, leakage, contaminayon, and degradayon Transport Transport containers Must Not transport via pneumayc tubes any liquid HDs

46 Safe Disposal

47 DeacYvaYon, DecontaminaYng, Cleaning & DisinfecYng Deactivation Breaking chemical bonds 2% Sodium Hypochlorite solution Cleaning Remove dirt, oils, residue, etc. Tri or Quadra-valent detergent 5 cidal notably: Sporicidal Decontamination Physical wiping of surface Peroxide RTU (ready-to-use) Disinfecting Sterile Isopropyl Alcohol 70% UV-C light

48 Commercially Available Systems Must add Disinfectant Step All 4 steps

49 Insanitary CondiYons at Compounding FaciliYes August 2016 Adulterated- if prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. Vermin (insects or rodents in production area or nearby Visible microbial contamination (bacteria, mold) in production area Non-microbial contamination (rust, glass shaving, hair) Handling beta-lactam, hazardous or highly potent drugs without adequate containment - Lack of cleaning equipment and personnel to prevent cross-contamination Production of drugs while construction is underway Source: hcp://

50 Examples of Insanitary CondiYons PuFng on gowning material improperly-gown touching floor, pufng on sterile gloves and touching outside with bare hands Failing to disinfect or change gloves frequently enough Wearing non-sterile gloves in asepac area Engaging in asepyc acyviyes with exposed hands, wrists, legs, hair, or mouth AsepYc manipulayons outside an ISO 5 area Exposing unprotected sterile product (including stock soluyon) to lower than ISO 5 quality air Engaging in asepac processing aoer leaving cleanroom and re-entering from non-classified area and not replacing apparel (gowns, gloves, masks, foot covers) Touching equipment or other surfaces (telephone) located outside ISO 5 area with gloved hand and not changing gloves Unsealed loose ceiling Ales Visibly dirty or rusty equipment or surfaces such as shelves Presence of sinks or drains in ISO 5 area, Non-sterile disinfecang agents and cleaning pads used in ISO 5 area Sterile Operations Source:hfp:// downloads/drugs/ guidancecomplianceregulatoryi nformayon/guidances/ ucm pdf

51 Safe Hazardous Drug Handling Beyond USP <800>>

52 Safe Hazardous Drug Handling Beyond USP <800>>

53 Safe Hazardous Drug Handling Beyond USP <800>>

54 Spill Control Must have proper training for spill management Must have spill kits readily available Spill materials disposed of as hazardous wastes SOPs Must address size of spills

55 Specific Spill Scenarios Nursing PerspecYve

56 Medical Surveillance Plan should be consistent with Human Resource s Plan Identify folks at risk of HD exposure Quantify handling risk Medical Assessment on hire and routinely Develop exit interview assessment strategy Direct Contact with HD or Wastes Direct Contact with Patient on HD Indirect HD Contact or HD Patient Contact No Contact by Position with HD or Patients on HD No Contact Allowed: Pregnancy, Breast Feeding, Attempt at Pregnancy

57 USP <800> s ImplicaYons to Nursing PracYces Section 1: Identified as at risk healthcare provider Section 2: Knowledge of institution s hazardous drug list Section 3: Competent Personnel Section Non-sterile Compounding Section 7: Personal Protective Equipment (PPE) Section 14: Hazardous Drug Administration Section 16: Spill Control Section 17: Documentation and Standard Operating Procedures Section 18: Medical Surveillance

58 Quick Check to Compliance! Read USP <800>! Assign experts & Set up HD Team! Define Hazard Drug lists! Assess Policies & Procedures! Assess HVAC! Assess PEC (hoods)! Assess SEC (rooms)! Assess PPEs (garb)! Implement Cleaning Protocols! Implement CSTD! Implement conanuous training program! Strive to define best pracaces July 1, 2018

59 Coaching the Moments Source; E.Kastango Source; F. Massoomi Source; S.Eisenberg

60 Safe Hazardous Drug Handling Beyond USP <800>> First and Second GeneraYon AutomaYon

61 Safe Hazardous Drug Handling Beyond USP <800>> Third GeneraYon AutomaYon

62 Safe Hazardous Drug Handling Beyond USP <800>>

63 Safe Hazardous Drug Handling Beyond USP <800> Fred Massoomi, Pharm.D., FASHP Senior Director Visante, Inc.