Preventing Occupational Exposure to Hazardous Drugs

Preventing Occupational Exposure to Hazardous Drugs Preventing Occupational Exposure to Hazardous Drugs - Start

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Consultation Education and Training Division. Michigan Occupational Safety and Health Administration . www.michigan.gov/miosha. 517-284-7720. Module 1. Module 1 Training Overview. Hazardous drug categories. ID: 577272 Download Presentation

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Preventing Occupational Exposure to Hazardous Drugs




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Presentations text content in Preventing Occupational Exposure to Hazardous Drugs

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Preventing Occupational Exposure to Hazardous Drugs

Consultation Education and Training DivisionMichigan Occupational Safety and Health Administration www.michigan.gov/miosha517-284-7720

Module 1

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Module 1 Training Overview

Hazardous drug categoriesSpecific hazards of drugsEmployees at riskApplicable MIOSHA standardsResources

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Hazardous Drugs

Anti-neoplastic medicationsAnti-viral drugsHormonesBioengineered drugs

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List of Hazardous Drugs

Carcinogenicity

Teratogenicity or other developmental toxicityReproductive toxicityOrgan toxicity at low dosesGenotoxicityStructure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteriaProposed 2016 revision

www.cdc.gov/niosh/docs/2014-138

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NIOSH List of Hazardous Drug

Table 1: Antineoplastic drugsTable 2: Non-antineoplastic that meet one or more of the NIOSH criteria for a hazardous drugTable 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding

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What are the Hazards of Exposure?

CancerDevelopmental or reproductive toxicityGenotoxicity: Chromosome 5 or 7 changesHarm to organs:LiverKidney

NauseaRashesHair lossHearing loss

Hazardous drugs may cause the following:

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Hazardous Drugs that are Carcinogens

Known CarcinogensProbable CarcinogensPossible CarcinogensArsenic trioxideTamoxifenAzacitidineAmsacrineAzothiaprineThiotepaCarmustineBleomycinBusulfanTreosulfanCisplatinDacarbazineChlorambucilMOPP*DoxorubicinDaunorubicinCyclophosphamideECB*LomustineMitomycinEtoposideNitrogen MustardMitoxantroneMelphalanProcarbazineStreptozocinSemustineTeniposide*Combination regimens

International Agency for Research on Cancer (IARC) http://www.iarc.fr/

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Who is at Risk?

Pharmacy staffNursing staffPhysiciansMedical assistantsOperating room staffVeterinary care workers Research staff in laboratoriesEnvironmental service workersShipping and receiving personnelOthers

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Potential Routes of Exposure

Dermal absorption:Direct drug contactContact with contaminated surfaces*Contact contaminated body fluidsInjection:SharpsBreakage

Ingestion via contaminated:Food, gumHand-to-mouth transferInhalation:AerosolsVapors

ASHP, 2006; NIOSH, 2014; Polovich, et. al. (ONS), 2014; Polovich, 2011

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Exposure Opportunities: Drug Preparation

Unpacking / stocking hazardous drugsHandling drug vialsBreaking open ampoulesReconstituting / mixing drugsPressure build-up in vialsTransferring drugs from one container to anotherNeedle sticksCrushing oral forms

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Exposure Opportunities: Drug Administration

Injected drugsAerosols from purging airNeedle-sticksIntravenous infusionsSpiking into a drug-filled bagLeaks from prime tubingLoose connectionsNeedle-sticks“Un-spiking”

Intracavitary drugsPoor fitting connectionsSplashingOral drugsBroken tablets / capsulesCrushing tablets / opening capsulesSpilling liquid forms

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Exposure Opportunities: Drug Disposal

Handling contaminated materials Used IV equipmentResidual drugUsed personal protective equipmentCarrying drug waste from administration site to disposal siteReaching into waste containers Using wrong containersOver-full containers

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Exposure Opportunities: Contaminated Excretions

Variable HD excretion: hours to days (48 hours average)Handling body fluids of patients who have received HDsUrinals / urineBedpans / stoolEmesis basins / emesisSweat (?)Flushing toiletsLinen contaminated with bodily fluids

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Applicable MIOSHA Regulations

Hazard Communication - MIOSHA Part 92/430Personal Protective Equipment - MIOSHA Part 33/433Respiratory Protection - MIOSHA Part 451Bloodborne Infectious Diseases - MIOSHA Part 554Housekeeping – MIOSHA Part 1Sanitation – MIOSHA Part 474Recordkeeping – MIOSHA Part 11

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MIOSHA Part 92/430 Hazard Communication (Haz Com)

Requires manufactures and employers to providechemical safety and health information to employees:Written ProgramChemical Inventory (list of chemicals)*Multi-employer worksitesNon-routine TasksLabelingSafety Data Sheets (SDSs)Training** List of Hazardous Drugs reviewed annually and annual documented effective training competency is required by U.S. Pharmacopeial Convention (USP) <800>

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Safety Data Sheets (SDSs)

Maintain SDSs for all hazardous chemicalsExamples:Hazardous drugs (liquid or powdered)DisinfectantsOxygenConsumer products exemptions:Personal use items (i.e. hairspray, aspirin)Other household products used for purpose and quantity intended in the home.Contact manufacturer/distributor/supplier when required SDS not received

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Safety Data Sheets (SDSs) New 16-section standardized SDS format required (ANSI Z400.1)

Section 1 – IdentificationSection 2 – Hazard(s) identification Section 3 – Composition/IngredientsSection 4 – First-aid MeasuresSection 5 – Fire-fighting MeasuresSection 6 – Accidental Release MeasuresSection 7 – Handling and StorageSection 8 – Exposure Controls / PPESection 9 – Physical and Chemical Properties

Section 10 – Stability and ReactivitySection 11 – Toxicological InformationSection 12 – Ecological Information*Section 13 – Disposal Consideration*Section 14 – Transport Information*Section 15 – Regulatory Information*Section 16 – Other information including date of preparation of last revision

*Sections outside of MIOSHA jurisdiction but inclusion of these sections is necessary for a GHS compliant SDS

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MIOSHA Part 33/433Personal Protective Equipment (PPE)

MIOSHA Parts 33 and 433:Perform a Job Hazard Assessment (JHA)Certification of hazard assessmentEmployee trainingClean and sanitize multi-user PPE

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PPE HAZARD ASSESSMENT

An employer shall:Assess the workplace to determine hazards presentSelect PPE needed and required to perform the jobCommunicate selection decision to employees Written certification of PPE assessment includingWorkplace evaluatedPerson who certified assessment Date of hazard assessment completion

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PPE Hazard Assessment Elements

Workstation / Job CategoryHazard SourceBody Part AffectedIs PPE RequiredType of PPE Required

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Example of Assessment Form

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Example of Assessment Form

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PPE TRAINING REQUIREMENTS

Employer shall provide training to each employee who is required use PPE:When PPE is necessaryWhat PPE is necessaryHow toPut it on (don)Take it off (doff)Adjust, and wear PPE

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MIOSHA Part 451 Respiratory Protection

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MIOSHA Part 451 Respiratory Protection

Employer must evaluate exposure and determine:If respiratory protection is requiredExamples:Aerosolization of hazardous drugs – ribavirin, pentamidine, othersPreparing outside a biological safety cabinet- fluorouracil, cyclophosphamide, crushing tablets/dustSpill response

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Selecting the Appropriate Respirator

All must be NIOSH Certified. The type selected depends on the task and form of the drug. Surgical mask: Not appropriate; not a respiratorN-95: for particles but not for vapors or splashSurgical N-95: for particles and splash but not for vaporsHalf-mask with a multi-gas cartridge and P100-filter: unpacking HDs that are not contained in plastic (USP 800 requirement)Full-facepiece chemical cartridge-type respirator: for large spills or while compounding where vapor protection is neededPowered air purifying respirator: for large spills or while compounding

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MIOSHA Part 451 Respiratory ProtectionEmployer responsibilities

For required use of a respirator, the employer must:Supply required respirators at no cost to the employeesMaintain a written program by a program administratorProvide training:UseLimitationsProper care, maintenance and disposalMedical EvaluationFit testing – complete initial then annually

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Types of Respirators

Powered air purifying respirator (PAPR)

Full Face Air purifying w/HEPA filter

Surgical N-95 w/fluid protection

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Evaluation of Respiratory Protection

Is this a respirator?Is this proper use?

1.

2.

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MIOSHA Part 554 Bloodborne Infectious Diseases

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MIOSHA Part 554 Bloodborne Infectious Diseases

Applies where reasonable anticipation of occupational exposure to blood or other potentially infectious materialsNeedle stick with needle contaminated only with hazardous drugs are not covered by Bloodborne StandardBloodborne Standard engineering and work practices controls could be implemented to reduce exposure to hazardous drugs

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Bloodborne Exposure Control Plan Related Provisions

Exposure DeterminationSummary of the training program.Procedures for evaluating exposure incidentsTask-Specific SOP’s to include:Employee recognition of exposurePersonal Protective Equipment (PPE) selection, use, maintenance, and disposal Contingency PlansTask-specific SOPs for management of inadvertent exposures such as needlesticks

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Waste Disposal

Containers or bags that are:ClosableLeakproofColor-coded or labeledFor contaminated sharps all the above plus puncture-resistant

(Image used with permission)

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MIOSHA Part 1 General Provisions and Part 474 Sanitation

General Provisions – Housekeeping:Materials shall be placed in a container in a manner that does not create a hazard to an employeeAll places of employment, aisles, passageways, storerooms, and service rooms shall be kept clean and orderlySanitation - Food and beverages:No employee shall be allowed to consume food or beverages in any area exposed to a toxic materialFood or beverages shall not be stored in an area exposed to a toxic material

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MIOSHA Part 11 Recording and Reporting Occupational Injuries and Illnesses

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Who Must Keep MIOSHA Records?

Employers with more than 10 employees during the previous calendar year.Employers selected to participate in the mandatory Bureau of Labor Statistics (BLS) annual survey. Partially Exempt employers:Employer with <10 employees during the previous calendar year.Employers in designated North American Industry Classification System (NAICS) codes.

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Partially Exempt Healthcare Industrial Codes

6211 Offices of Physicians6212 Offices of Dentists6213 Offices of Other Health Practitioners6214 Outpatient Care Centers6215 Medical and Diagnostic Laboratories

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“Partially Exempt” must report when:

When requested to record/report by the Bureau of Labor Statistics (BLS)Any workplace incident that results in:fatality in-patient hospitalization amputation loss of an eye 

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Expanded Reporting Requirements

Began September 1, 2015, all covered employers must report the following: Within 8 hours: any work-related fatality(No change from previous requirement)Within 24 hours:work-related in-patient hospitalizations of one or more employeeswork-related amputationswork-related losses of an eye

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Occupational Disease Reporting

Employee informationEmployer informationIllness and comments informationReport submitted to the State (see MIOSHA website)

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MIOSHA Resources: Standards and Compliance

Compliance Instruction MIOSHA-COM-16-3Part 92 and 430 Hazard CommunicationPart 431 Hazardous Work in LaboratoriesPart 33 and Part 433 Personal Protective EquipmentPart 451 Respiratory ProtectionPart 474 SanitationPart 554 Bloodborne Infectious DiseasesRecording & Reporting of Occupational Injuries & Illnesses

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MIOSHA Resources: Consultation and Training

Preventing Exposure to Hazardous Drugs Training Module 1 – OverviewPreventing Exposure to Hazardous Drugs Training Module 2 – Staff Fact Sheet: Preventing Exposure to Hazardous Drugs (doc)Hazard Communication Sample Plan (doc)Personal Protective Equipment Guide (doc)Respiratory Protection Program (doc)Bloodborne Sample Exposure Control Plan (doc)

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Federal Resources

Centers for Disease Control and Prevention:NIOSH Hazardous Drugs webpageOSHA:Hazardous Drugs WebsiteHazardous Drugs eToolTechnical Manual Section VI: Chapter 2:Controlling Occupational Exposure To Hazardous Drugs

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