Preventing Occupational Exposure to Hazardous Drugs

Preventing Occupational Exposure to Hazardous Drugs

PREVENTING OCCUPATIONAL EXPOSURE TO HAZARDOUS DRUGS Module 1 Consultation Education and Training Division Michigan Occupational Safety and Health Administration 517-284-7720 MODULE 1 TRAINING OVERVIEW Hazardous drug categories Specific hazards of drugs Employees at risk

Applicable MIOSHA standards Resources 2 HAZARDOUS DRUGS Anti-neoplastic medications Anti-viral drugs Hormones Bioengineered drugs

3 LIST OF HAZARDOUS DRUGS Carcinogenicity Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria

Proposed 2016 revision 4 NIOSH LIST OF HAZARDOUS DRUG Table 1: Antineoplastic drugs Table 2: Non-antineoplastic that meet one or more of the NIOSH criteria for a hazardous drug

Table 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 5 WHAT ARE THE HAZARDS OF EXPOSURE? Hazardous drugs may cause the following: Cancer Nausea Developmental

Rashes or reproductive toxicity Genotoxicity: Chromosome 5 or 7 changes Harm to organs: Hair loss Hearing loss Liver Kidney

6 HAZARDOUS DRUGS THAT ARE CARCINOGENS Known Carcinogens Arsenic trioxide Tamoxifen Azothiaprine Thiotepa Busulfan Treosulfan Chlorambucil MOPP* Cyclophosphamide ECB*

Etoposide Melphalan Semustine *Combination regimens Probable Carcinogens Azacitidine Carmustine Cisplatin Doxorubicin Lomustine Nitrogen Mustard Procarbazine Teniposide

Possible Carcinogens Amsacrine Bleomycin Dacarbazine Daunorubicin Mitomycin Mitoxantrone Streptozocin 7 International Agency for Research on Cancer (IARC) WHO IS AT RISK? Pharmacy

staff Nursing staff Physicians Medical assistants Operating room staff Veterinary care workers Research staff in laboratories Environmental service workers Shipping and receiving personnel Others 8 POTENTIAL ROUTES OF EXPOSURE

Dermal absorption: Ingestion via contaminated: Direct drug contact Food, gum Contact with contaminated surfaces* Hand-to-mouth transfer

Contact contaminated body fluids Injection: Sharps Breakage Inhalation: Aerosols Vapors 9 ASHP, 2006; NIOSH, 2014; Polovich, et. al. (ONS), 2014; Polovich, 2011

EXPOSURE OPPORTUNITIES: DRUG PREPARATION Unpacking / stocking hazardous drugs Handling drug vials Breaking open ampoules Reconstituting / mixing drugs Pressure build-up in vials Transferring drugs from one container to another Needle sticks Crushing oral forms 10 EXPOSURE OPPORTUNITIES: DRUG ADMINISTRATION

Injected drugs Intracavitary drugs Aerosols from purging air Poor fitting connections Needle-sticks Splashing

Intravenous infusions Oral drugs Spiking into a drug-filled bag Broken tablets / capsules Leaks from prime tubing

Crushing tablets / opening capsules Loose connections Spilling liquid forms Needle-sticks Un-spiking 11 EXPOSURE OPPORTUNITIES: DRUG DISPOSAL Handling contaminated materials

Used IV equipment Residual drug Used personal protective equipment Carrying drug waste from administration site to disposal site Reaching into waste containers Using wrong containers Over-full containers 12 EXPOSURE OPPORTUNITIES: CONTAMINATED EXCRETIONS Variable

HD excretion: hours to days (48 hours average) Handling body fluids of patients who have received HDs Urinals / urine Bedpans / stool Emesis basins / emesis Sweat (?) Flushing toilets Linen contaminated with bodily fluids 13 APPLICABLE MIOSHA REGULATIONS Hazard Communication - MIOSHA Part 92/430

Personal Protective Equipment - MIOSHA Part 33/433 Respiratory Protection - MIOSHA Part 451 Bloodborne Infectious Diseases - MIOSHA Part 554 Housekeeping MIOSHA Part 1 Sanitation MIOSHA Part 474 Recordkeeping MIOSHA Part 11 14 MIOSHA PART 92/430 HAZARD COMMUNICATION (HAZ COM) Requires manufactures and employers to provide chemical safety and health information to employees: Written Program Chemical Inventory (list of chemicals)* Multi-employer worksites

Non-routine Tasks Labeling Safety 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> 15 SAFETY DATA SHEETS (SDSS) Maintain SDSs for all hazardous chemicals Examples: Hazardous drugs (liquid or powdered) Disinfectants Oxygen

Consumer 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 16 SAFETY DATA SHEETS (SDSS) NEW 16-SECTION STANDARDIZED SDS FORMAT REQUIRED (ANSI Z400.1) Section 1 Identification

Section 2 Hazard(s) identification Section 3 Composition/Ingredients Section 4 First-aid Measures Section 5 Fire-fighting Measures Section 6 Accidental Release Measures Section 7 Handling and Storage Section 8 Exposure Controls / PPE Section 9 Physical and Chemical Properties Section 10 Stability and Reactivity Section 11 Toxicological Information Section 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 17 MIOSHA PART 33/433 PERSONAL PROTECTIVE EQUIPMENT (PPE) MIOSHA Parts 33 and 433: Perform a Job Hazard Assessment (JHA) Certification of hazard assessment

Employee training Clean and sanitize multi-user PPE 18 PPE HAZARD ASSESSMENT An employer shall: Assess the workplace to determine hazards present Select PPE needed and required to perform the job Communicate selection decision to employees Written certification of PPE assessment including

Workplace evaluated Person who certified assessment Date of hazard assessment completion 19 PPE HAZARD ASSESSMENT ELEMENTS Workstation / Job Category Hazard Source Body Part Affected Is PPE Required Type of PPE Required

20 EXAMPLE OF ASSESSMENT FORM 21 EXAMPLE OF ASSESSMENT FORM 22 PPE TRAINING REQUIREMENTS Employer shall provide training to each employee who is required use PPE: When PPE is necessary What PPE is necessary

How to Put it on (don) Take it off (doff) Adjust, and wear PPE 23 MIOSHA PART 451 RESPIRATORY PROTECTION MIOSHA PART 451 RESPIRATORY PROTECTION Employer must evaluate exposure and determine: If respiratory protection is required Examples: Aerosolization

of hazardous drugs ribavirin, pentamidine, others Preparing outside a biological safety cabinet- fluorouracil, cyclophosphamide, crushing tablets/dust Spill response 25 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 respirator N-95: for particles but not for vapors or splash Surgical N-95: for particles and splash but not for vapors Half-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 needed Powered air purifying respirator: for large spills or while compounding 26 MIOSHA PART 451 RESPIRATORY PROTECTION EMPLOYER RESPONSIBILITIES For required use of a respirator, the employer must: Supply required respirators at no cost to the employees Maintain a written program by a program administrator Provide training: Use Limitations Proper care, maintenance and disposal

Medical Evaluation Fit testing complete initial then annually 27 TYPES OF RESPIRATORS Surgical N-95 w/fluid protection Full Face Air purifying w/HEPA filter Powered air purifying respirator (PAPR)


DISEASES MIOSHA PART 554 BLOODBORNE INFECTIOUS DISEASES Applies where reasonable anticipation of occupational exposure to blood or other potentially infectious materials Needle stick with needle contaminated only with hazardous drugs are not covered by Bloodborne Standard Bloodborne Standard engineering and work practices controls could be implemented to reduce exposure to hazardous drugs 31

BLOODBORNE EXPOSURE CONTROL PLAN RELATED PROVISIONS Exposure Determination Summary of the training program. Procedures for evaluating exposure incidents Task-Specific SOPs to include: Employee recognition of exposure Personal Protective Equipment (PPE) selection, use, maintenance, and disposal Contingency Plans Task-specific

SOPs for management of inadvertent exposures such as needlesticks 32 WASTE DISPOSAL Containers or bags that are: Closable Leakproof Color-coded or labeled For contaminated sharps all the above plus puncture-resistant (Image used with permission)

33 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 employee All places of employment, aisles, passageways, storerooms, and service rooms shall be kept clean and orderly Sanitation - Food and beverages: No employee shall be allowed to consume food or beverages in any area exposed to a toxic material Food or beverages shall not be stored in an area exposed to a toxic material

34 MIOSHA Part 11 Recording and Reporting Occupational Injuries and Illnesses 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. 36 PARTIALLY EXEMPT HEALTHCARE INDUSTRIAL CODES 6211 Offices of Physicians 6212 Offices of Dentists 6213 Offices of Other Health Practitioners 6214 Outpatient Care Centers 6215 Medical and Diagnostic Laboratories

37 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 38 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 employees work-related amputations work-related losses of an eye 39 OCCUPATIONAL DISEASE REPORTING Employee information Employer information

Illness and comments information Report submitted to the State (see MIOSHA website) 40 MIOSHA RESOURCES: STANDARDS AND COMPLIANCE Compliance Instruction MIOSHA-COM-16-3 Part 92 and 430 Hazard Communication Part 431 Hazardous Work in Laboratories Part 33 and Part 433 Personal Protective Equipment Part 451 Respiratory Protection

Part 474 Sanitation Part 554 Bloodborne Infectious Diseases Recording & Reporting of Occupational Injuries & Illnesses 41 MIOSHA RESOURCES: CONSULTATION AND TRAINING Preventing Exposure to Hazardous Drugs Training Module 1 Overview Preventing 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) 42 FEDERAL RESOURCES Centers for Disease Control and Prevention: NIOSH Hazardous Drugs webpage OSHA: Hazardous Drugs Website Hazardous Drugs eTool Technical Manual Section VI: Chapter 2: Controlling Occupational Exposure To Hazardous Drugs 43

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