Fundamentals of Fentanyl Safety - in Public Health Laboratory Settings - APHL
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Fundamentals of Fentanyl Safety
®
in Public Health Laboratory Settings
SEPTEMBER 2020
Public health laboratories (PHLs) are important stakeholders
in the fight to end the opioid epidemic in jurisdictions na- CONTENTS
tionwide. Through opioids biosurveillance, the sampling and
Fentanyls Overview....................................1
clinical testing of non–fatal opioid overdose patients for public
health surveillance purposes, PHLs inform and guide a myriad Assessing Exposure Risk..........................1
of stakeholders and public health interventions. Potential Routes of Exposure....................2
As the laboratory role in opioids biosurveillance expands, PHLs
Controlling Fentanyl Exposure Risk:
will be using occupational health and safety and risk mini- Applying the Hierarchy of Controls
mization principles to guide the development of safe clinical Framework..................................................2
sample accessioning, processing and handling procedures,
Personal Protective Equipment ...............4
while preventing exposure to fentanyl and related analogues.
This document provides fundamental occupational health and Safe Management of Chemical and
safety considerations for PHLs active in this area, as well as a Biohazardous Waste .................................4
list of additional resources. Decontamination........................................4
The guidance document may be used in concert with labo-
Opioid Exposure Emergency
ratory risk assessment templates. Due to the scope of and Preparedness and Response Planning....4
inter–laboratory variations in public health laboratory activi-
ties regarding handling of samples, reference standards and Update Documentation and Train Staff ...5
instrumentation, this document is not intended to be compre- Additional Safety Resources for
hensive. It is however, designed to provide a general overview Laboratories and First Responders..........5
of the types of potential hazards and appropriate controls to
References..................................................6
help eliminate or minimize safety risk to public health labora-
tory personnel.
FENTANYLS OVERVIEW
Fentanyl is a highly–addictive, rapid–acting and potent synthetic opiate that is both pharmaceutically and illicitly–pro-
duced. It is 50−100 times more potent than morphine and is prone to misuse and abuse. Synthetic opioids, predominant-
ly fentanyl analogues, have been associated with a significant increase in national opioid poisoning deaths since 2013.
ASSESSING EXPOSURE RISK
Laboratory scientists who work with analytical standards, certified reference materials Traceable Opioid Materials (TOM)
Kits,1 and neat drug standards and containing these potent compounds may be at risk of exposure to fentanyl if proper
precautions are not taken. Thorough exposure assessment, adherence to universal precautions and enforcement of
control solutions significantly reduce exposure risk to fentanyl compounds and bloodborne pathogens. For more infor-
mation regarding bloodborne pathogen control, please see Biosafety in Microbiological and Biomedical Laboratories,
5th Edition.2
APHL Fentanyl Safety for Public Health Laboratories | 1POTENTIAL ROUTES OF EXPOSURE
Without proper safety controls, scientists may come into contact with fentanyls in powder, pill or liquid forms, and may
be subject to accidental exposure via inhalation, ingestion, dermal, ocular and percutaneous routes. Care must be taken
when handling reference materials and analytical standards to avoid incidental inhalation and ingestion exposures, as
could occur if liquid material is splashed onto face or hands.
Fentanyl and fentanyl analogues have low dermal absorptive capacity. Still, care should be taken to avoid dermal con-
tact. Small quantities of fentanyls on the skin for a short time are not sufficient to cause death or other severe adverse
outcomes. Fatal doses are usually associated with exposure to potent drug product over an extended period of time.3
Note that the nature of clinical opioids biosurveillance testing does not involve the handling of large quantities of seized
drug product.
While poisoning associated with dermal absorption is unlikely, estimates of biological availability are as follows:
• Onset of systemic absorption: 1–12 hours3
• Peak concentrations within 16–48 hours3
• >2/3 of the drug is absorbed2
It is not known if fentanyl can be absorbed systemically through the eye.4 Appropriate eye protection required for working
in chemical laboratories (safety goggles or glasses) and working in a chemical fume hood with the sash at the designat-
ed height should provide sufficient protection from ocular exposure.
Handling, sampling and testing the contents of drug paraphernalia such as needles and syringes elevates risk of
percutaneous exposure to both biological and chemical hazards such as bloodborne pathogen (HIV, Hepatitis B and C)
infection and drug intoxication. Given the magnitude of potential adverse health outcomes associated with these risks,
these practices should be discouraged.
Laboratory scientists and occupational health and safety specialists are encouraged to develop and exercise chemical
safety plans to mitigate and manage all potential exposures introduced during clinical opioids biosurveillance testing
procedures. Consider consulting laboratory safety officers and Laboratory Response Network for Biological (LRN–B)
and Chemical Threats (LRN–C) partners and colleagues to learn more about additional safety resources, practices and
equipment that may be available.
CONTROLLING FENTANYL EXPOSURE RISK:
APPLYING THE HIERARCHY OF CONTROLS FRAMEWORK
PHLs engaged in opioids biosurveillance and/or forensic drug testing should thoroughly evaluate their pre–analytical,
analytical and post–analytical procedures, assessing potential risks and implementing controls in accordance with the
National Institutes of Occupational Safety and Health (NIOSH) Hierarchy of Controls (Figure 1). The NIOSH Hierarchy
of Controls is an occupational health and safety framework used to group and prioritize exposure control practices by
effectiveness, reliability and sustainability. Elimination, or total removal of the hazard, is ranked highest on the hierarchy,
while personal protective equipment (PPE) is ranked lowest, given no other potential exposure control solution is feasi-
ble. Additional exposure control strategies include substitution, engineering and administrative control solutions. Effec-
tive implementation of the Hierarchy of Controls substantially reduces risk of illness or injury when used appropriately.5
Elimination and Substitution
Elimination or substitution of exposure risk to fentanyl and other opioids is not possible as these are the target analytes
in clinical opioids biosurveillance testing. Laboratories can consider opportunities to substitute particular solvents used
in the analytical process with less toxic alternatives, however this methodological change will need to be assessed for
efficacy and fully validated to ensure quality test results.
APHL Fentanyl Safety for Public Health Laboratories | 2Figure 1: National Institutes of Occupational Safety and Health (NIOSH) Hierarchy of Controls 5
CONTROL METHOD PARTICIPATION EFFICACY
Elimination Least Most
Physically remove hazard Participation Effective
Substitution
Replace hazard/high risk procedure
Engineering Controls
Change work environment to reduce
exposure or isolate personnel from hazard
Administrative Controls
Develop and implement policies,
procedures and trainings
Personal Protective Equipment Most Least
Protect personnel with PPE Participation Effective
Engineering Controls
The proper use of chemical fume hoods (CFHs), biological safety cabinets (BSCs) or combined CFH/BSCs is crucial to en-
gineering safe testing environments. Although these pieces of equipment may look similar, they each have a wide range
of functionality and purpose. Therefore, PHLs should weigh all factors to select the appropriate control for your applica-
tion and facility.6 Fentanyl compounds should always be handled in a CFH or a combined CFH/BSC cabinet to prevent
exposure to laboratory scientists.
Chemical Fume Hoods: CFHs evacuate chemical vapors, fumes and aerosols from the work area, protecting the labo-
ratory scientist working in the hood. To accomplish this, air flows from outside the CFH and is removed to the outdoor
environment through ducts. A well–designed chemical fume hood, when properly installed and maintained, offers a
substantial degree of protection to the user, provided it is used appropriately and its limitations are understood. Analysts
should keep the hood free of extraneous materials and position the hood sash to the appropriate level to provide a physi-
cal barrier and ensure adequate face velocity and exhaust.5
Biological Safety Cabinets: BSCs utilize high–efficiency particulate air (HEPA) filters to trap infectious agents and release
microbe–free exhaust air back to the laboratory through vents above the cabinet. BSCs afford protection from infectious
agents but not chemical hazards, and therefore are not recommended for the handling of chemical standards or certi-
fied reference materials. Powders should never be handled in a BSC as there is significant potential for BSC airflow to
spread light substances and contaminate the cabinet. BSCs may be used to prepare and process clinical specimens.
Combined CFH/BSC: This dual option affords the greatest level of protection from both chemical hazards and infectious
agents. These hoods, which are hard ducted to the exterior environment, have considerable air intake requirements and
may not be feasible in all laboratory facilities.
Additionally, laboratories should assess other opportunities for engineering controls to minimize potential exposures
APHL Fentanyl Safety for Public Health Laboratories | 3such as: disposable glove boxes, automated dispensing systems, enclosures for auto samplers and balances, and physi-
cal barriers (such as shields) for bench–top procedures.
Laboratories should asses their engineering needs and determine the best solutions for their specific requirements.
Administrative Controls
PHLs are encouraged to review laboratory procedures periodically to assess exposure risk and find opportunities to im-
plement new or strengthen existing administrative controls. Examples of control solutions include but are not limited to:
• Implement a Laboratory ‘Buddy System.’ Laboratory scientists should never work alone in the laboratory.
Supervisors should routinely check on the wellbeing of staff in person and via telephone. Always ensure telephones
are available and operational within the laboratory.
• Promote a culture of safety in the laboratory. Develop written policies that prohibit eating, drinking, vaping
and smoking in the laboratory. Raise awareness of the risks associated with touching your eyes, nose or mouth
after touching standards or reference materials, potentially contaminated surfaces in fume hoods or within the
laboratory, and handling clinical samples. Encourage staff input into the development of policies.
• Train staff on safety policies annually.
• Encourage reporting of accidents and incidents as an opportunity to review and revise policies and procedures to
improve laboratory safety.
• Rotate job assignments to minimize potential exposure, if feasible.
• Post exposure control practices in the laboratory. Immediately wash fentanyl-exposed skin thoroughly with cool
water and soap. Avoid breaking the skin during hand washing and ensure all open wounds are covered. Do not use
hand sanitizers, bleach, or any alcohol–based cleaner as alcohol increases absorption potential.3
PERSONAL PROTECTIVE EQUIPMENT
While implementing the Hierarchy of Controls greatly minimizes exposure risks, it is essential that appropriate PPE be
made available to all laboratory scientists involved in clinical opioids biosurveillance testing. Below is a list of PPE that
should be considered, at a minimum:
• Laboratory coats
• Eye protection (safety glasses, goggles, face shields)
• Disposable nitrile gloves
• Sleeve protectors
It is important to note that the use of NIOSH–Approved N95 Particulate Filtering Facepiece Respirators6 is not required
for laboratory scientists involved in clinical opioids biosurveillance testing. However, laboratory decisions about required
PPE should be informed by risk assessments of the opioids biosurveillance testing program. Forensic laboratory scien-
tists testing seized drugs should assess the inhalation risks and determine appropriate PPE requirements.
Laboratory scientists who wear respirators must be medically evaluated and fit–tested prior to using this personal pro-
tective option. It is important to note that individuals with facial hair will be unable to achieve an adequate seal for the
respirator to function properly.
SAFE MANAGEMENT OF CHEMICAL AND BIOHAZARDOUS WASTE
Proper waste disposal is crucial to reducing potentially harmful exposures in the laboratory. Prior to the initiation of bio-
surveillance testing, laboratory scientists should work with occupational health and safety specialists to develop proce-
dures that are in compliance with local, state and federal regulations.
Fentanyl compounds are neutralized by a 10% hydrogen peroxide solution. It is advisable to have this solution available
to mitigate any fentanyl spills in the laboratory.
APHL Fentanyl Safety for Public Health Laboratories | 4DECONTAMINATION
Instrumentation, equipment and surfaces should be decontaminated both prior to service as well as immediately after
regular use with 10% hydrogen peroxide solution over a 10-minute period.2 Benches and surfaces should then be decon-
taminated with a 5% bleach solution to minimize infectious hazards.
OPIOID EXPOSURE EMERGENCY PREPAREDNESS AND RESPONSE PLANNING
Development and exercise of an opioid exposure response plan is crucial to ensuring laboratory scientists are aware of
the correct steps to take during an exposure incident. Staff should be able to recognize opioid poisonings, implement
first aid action and communication plans, and be adequately trained in the administration of Naloxone.
Signs and Symptoms of Opioid Poisoning/Overdose
Opioids, including fentanyls, depress central nervous system
Figure 2: Opioid Exposure First Aid Measures
and respiratory function and may be associated with adverse
health outcomes, including death. Exposure First Aid Measures
Pathway
Opioid poisoning symptoms include:
• Seek medical attention, Call 911
• Unconsciousness or unresponsiveness
• Wash area with plenty of soap
• Drowsiness Dermal
and water for 15 minutes
• Slow or erratic pulse
• Remove contaminated clothing
• Slow, shallow or absent breathing
• Slow heartbeat • Seek medical attention, Call 911
• Snoring, falling asleep or gurgling sounds • Rinse mouth with water only if
the individual is conscious
• Small, constricted pinpoint pupils Ingestion
• Choking or gurgling Note: Do not induce vomiting
unless directed to do so by medical
• Limp body personnel.
• Pale blue and/or cold skin
• Seek medical attention, Call 911
Opioid Exposure First Aid Measures • Move the individual to fresh air
Inhalation
Individuals experiencing symptoms of opioid poisoning • Keep the individual in a
should receive immediate medical attention. Call 911 to comfortable breathing position
alert emergency medical services (EMS), then attempt to
rouse and stimulate the individual while waiting for EMS • Seek medical attention, Call 911
professionals to arrive. The National Poison Center Hotline Ocular • Immediately flush eyes with
(1.800.222.1222) can provide specialized medical advice to plenty of water for 15 minutes
staff and/or medical professionals.
Percutaneous Seek medical attention, Call 911
Consider Figure 2 when developing first aid plans.
Responding to and Reporting Opioid Exposure Incidents
If a laboratory scientist has been potentially exposed to fentanyl or other opioids, the laboratory should implement their
exposure control plan including appropriate notifications and first aid procedures.
Naloxone Supply, Administration and Safety Training
Naloxone (Narcan, Evzio) should be made easily accessible to laboratory scientists and staff involved in clinical opioids
biosurveillance testing in the public health laboratory. Kits must be properly stored and routinely inspected to ensure
that they meet manufacturer requirements for use. Expired Naloxone kits should be safely and appropriately disposed of
and promptly replaced.
APHL Fentanyl Safety for Public Health Laboratories | 5Naloxone administration and safety training should be made widely available and required for all laboratory scientists
potentially coming into contact with fentanyl and other opioids. It is recommended that laboratories conduct Naloxone
administration and safety trainings at least annually. Laboratories are encouraged to contact local or state health and
emergency response departments to arrange for staff training.
UPDATE DOCUMENTATION AND TRAIN STAFF
After implementing safety measures, routinely re-evaluate and exercise plans to ensure that these measures are suffi-
cient. PHLs are strongly encouraged to incorporate this guidance into existing analytical standard operating procedures
as well as any pre-existing facility exposure management plans.
Prominently display the telephone number for the Poison Control Center (1.800.222.1222) and the steps involved in
responding to an exposed individual.
ADDITIONAL SAFETY RESOURCES FOR LABORATORIES AND FIRST
RESPONDERS
Laboratories
• US Centers for Disease Control and Prevention (CDC):
○ Biosafety in Microbiological and Biomedical Laboratories, 5th Edition
○ Fentanyl Resource Page
○ Fundamentals of Chemical Fume Hood Safety
○ Fundamentals of Working Safely in a Biological Safety Cabinet
○ Respirators
• National Institutes of Health (NIH): Chemical Safety
• US Occupational Safety and Health Administration:
○ Laboratory Safety Guidance
○ Bloodborne Pathogens and Needlestick Prevention
First Responders
• American College of Medical Toxicology/American Academy of Clinical Toxicology:
Position Statement: Preventing Occupational Fentanyl and Fentanyl Analog Exposure to Emergency Responders
• CDC: Illicit Drugs, Including Fentanyl: Preventing Occupational Exposure to Emergency Responders
All Occupations
• American Association of Poison Control Centers: Poison Help Line
• American Medical Association: How to Administer Naloxone
• NIH: Prevention of Occupational Exposure to Fentanyl and Other Opioids
• US Substance Abuse and Mental Health Administration: Naloxone
APHL Fentanyl Safety for Public Health Laboratories | 6REFERENCES
1. Traceable Opioid Material Kits to Improve Laboratory Detection of Synthetic Opioids in the US. CDC; 2020
[webpage]. Available from: https://www.cdc.gov/nceh/dls/erb_opioid_kits.html
2. Biosafety in Microbiological and Biomedical Laboratories, 5th Edition. CDC; 2009.
Available from: https://www.cdc.gov/labs/pdf/CDC–BiosafetyMicrobiologicalBiomedicalLaboratories–2009–P.PDF
3. McKay C, Tinkle B. Safe Handling of Fentanyls in the Laboratory. APHL; 2019 [webinar].
Available from: https://www.aphlnet.org/eweb/DynamicPage.aspx?webcode=EventInfo&Reg_evt_key=5b412cbc–
a659–49f5–9c86–6563939018a2&RegPath=EventRegFees&FreeEvent=&Event=603–19SS%20Safe%20
Handling%20of%20Fentanyls%20in%20the%20Laboratory&FundraisingEvent=0&evt_guest_limit=9999
4. Fentanyl: Incapacitating Agent. CDC; 2011 [webpage].
Available from: https://www.cdc.gov/niosh/ershdb/emergencyresponsecard_29750022.html
5. NIOSH Hierarchy of Control. Hierarchy of Control. CDC; 2015 [webpage].
Available from: https://www.cdc.gov/niosh/topics/hierarchy/default.html
6. Biosafety Cabinets vs. Fume Hoods. US Department of Health and Human Services, Public Health Emergency;
2019 [webpage]. Available from: https://www.phe.gov/s3/BioriskManagement/biocontainment/Pages/BSC–vs–
Fume–Hoods.aspx
7. NIOSH–Approved N95 Particulate Filtering Face piece Respirators. CDC; 2020 [webpage].
Available from: https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.html
ASSOCIATION OF PUBLIC HEALTH LABORATORIES
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the public’s health in the US and globally. APHL’s member laboratories protect the public’s health by
monitoring and detecting infectious and foodborne diseases, environmental contaminants, terrorist
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This publication was supported by Grant or Cooperative Agreement number #5 NU60OE000103, funded by the US Centers for Dis-
ease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views
of the US Centers for Disease Control and Prevention or the Department of Health and Human Services.
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