Preventing Occupational Exposure to Hazardous Drugs Teresa (Terry) Fisk, CIH, CSP, Non-Clinical Loss Control Director, IRMS, Trinity Health fiskt@trinity-health.org 734-343-0907 April 12, 2017
Introduction to Hazardous Drugs in a Healthcare Setting Background- In the United States, an estimated 8 million healthcare workers [BLS 2007] are potentially exposed to hazardous drugs or drug waste. What are hazardous drugs? Many hazardous drugs are used to treat illness such as cancer [chemotherapy/antineoplastic drugs] or HIV infection. Who is occupationally exposed to hazardous drugs?- Pharmacists/pharmacy technicians, Nurses, Physicians/physician assistants, OR personnel, Home healthcare workers, Environmental services workers [housekeeping, laundry, maintenance] and staff who ship, transport or receive hazardous drugs or waste. 2017 Trinity Health 2
Introduction to Hazardous Drugs in a Healthcare Setting What are the Routes of Exposure?- Primary- Skin contact and inhalation Secondary- Ingestion [from hand to mouth] and injection through a needle stick or sharps injury. What are the exposure opportunities?- Drug Preparation [Pharmacy] Drug Administration [Nursing-Oncology] Drug Transport and Disposal [Couriers] Contaminated Excretions [EVS] 2017 Trinity Health 3
Introduction to Hazardous Drugs in a Healthcare Setting What is the potential occupational health risks to healthcare personnel?- Skin disorders Adverse reproductive effects [spontaneous abortions, stillbirths, congenital malformations] Leukemia and other cancers 2017 Trinity Health 4
Introduction to Hazardous Drugs in a Healthcare Setting Control Measures [following the hierarchy of industrial hygiene controls] - #1 Engineering Controls [Class II or three III biological safety cabinets (BSC), compounding aseptic containment isolators, closed system transfer devices and needless systems] #2 Administrative Controls [specific work practices to minimize exposure- such as cleaning biological safety cabinets or using negative pressure techniques and general work practice such as the use of Universal or Standard precautions] #3 Personal Protective Equipment (PPE) [gloves, gowns, respiratory protection, eye and face protection and sleeve, hair and shoe covers] 2017 Trinity Health 5
Introduction to Hazardous Drugs in a Healthcare Setting 2017 Trinity Health 6
Introduction to Hazardous Drugs in a Healthcare Setting Personal Protective Equipment (PPE) Properly garbed for sterile antineoplastic HD preparation 2017 Trinity Health 7
Hazardous Drugs- NIOSH Research and Publications NIOSH Hazardous Drug Exposures in Healthcare Program Mission- Identify and prevent hazardous exposures to pharmaceutical drugs in the healthcare workers that prepare and administer these medications. Identify newly approved drugs that pose an occupational hazard (expert panel and public and stakeholder input) Update the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings every two years (first published in 2004, updated in 2010, 2012, 2014 and 2016) Develop tools and resources that can be utilized to reduce exposures to hazardous drugs
USP-NF General Chapter <800> Hazardous Drugs Handling in Healthcare Settings (2/2016) USP <800> describes requirements including: Activities from receipt to disposal Engineering controls and personal protective equipment Medical surveillance, personnel training, hazard communication Full implementation: July 1, 2018 Available at USP.org (USP Compounding Compendium- $150 online) Applies to pharmacies, hospitals, healthcare institutions, patient treatment clinics, physicians practice facilities and veterinarians' offices Enforceable by The Joint Commission (JC), State Boards of Pharmacy
Achieving Compliance with USP <800> Occupational Safety Plan (OSP) Incorporate requirements of USP <800> At a Minimum, OSP must include: Engineering controls Competent personnel Safe work practices Proper use of appropriate Personal Protective Equipment (PPE) Policies for HD waste segregation and disposal
Achieving Compliance with USP <800> Creating an Occupational Safety Plan for Hazardous Drugs Risk assessment [Identify risk level and types of exposure to hazardous drugs at your practice setting] Several requirements from MIOSHA Training/education of staff- initial, ongoing annual assessment and documentation Policies and procedures Securing appropriate environmental controls Implementing a closed system transfer device (CSTD) at minimum for HD administration Establishing a hazardous drug waste handling/disposal plan
Hazardous Drugs- Environmental Monitoring Considerations Environmental Wipe Sampling for HD Surface Contamination Baseline and every 6 months Costly- approximately $1500-$2000 per kit (6 samples) Test for at least 3-5 marker drugs such as 5- Fluorouracil, ifosfamide, cyclophosphamide, paclitaxel, docetaxel, others... 2 Areas to test Create follow-up plan for positive samples Barriers: COST! Who will test? Who will own follow-up on positives? No current standard for acceptable levels of HD contamination
Hazardous Drugs- Medical Surveillance Considerations Medical surveillance is a second line of defense. It begins with hazard identification that is integrated with surveillance for disease and illness Purpose: Identify the earliest reversible biological effects so that exposure can be reduced or eliminated before the employee sustains irreversible damage [identify early disease patterns] Frequency of medical evaluations- Before job placement, periodically [typically annually] during employment; following acute exposures; and at the time of job termination or transfer Data obtained and evaluated may include- Description of employees duties as they relate to exposure; employee s past and present exposure or anticipated exposure (use of surrogates) and description of PPE Medical [including reproductive] history Physical examination and laboratory assessment [complete blood count with differential, liver function tests, blood urea nitrogen, creatinine, and a urine dipstick] Note: No biological monitoring test [genotoxic markers] is recommended.
Hazardous Drugs- Occupational Safety and Health 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
Questions? 2017 Trinity Health 16