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10/4/18
USP
THE TOP 10
THINGS YOU
NEED TO
KNOW
Christina Coleman Kim, PharmD
University of New Mexico Hospitals
#1
Go Live Date
Christina Kim 2
110/4/18
GO LIVE INFORMATION
• DECEMBER 1, 2019
• New Mexico Board of Pharmacy is currently re-
writing Title 16, Chapter 19, Part 30 (Compounding
of Non-Sterile Pharmaceuticals) and Part 36
(Compounded Sterile Preparations) to include USP
regulations
• What does this mean for hazardous compounding in
New Mexico facilities?
• We have approximately 14 months to bring our
facilities into compliance with the new regulations
• The New Mexico Board of Pharmacy will require
compliance and will be inspecting for compliance
as of December 1, 2019.
• Get it done early because you’ll have a lot of
people to reach out to!
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#2
Introduction and Scope
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210/4/18
INTRODUCTION AND SCOPE
• WHAT ARE WE DISCUSSING?
• Handling Hazardous Drugs (HDs)
• WHY ARE WE DISCUSSING HANDLING
HAZARDOUS DRUGS?
• To create standards for handling because we care
about patient safety, employee safety and
protecting the environment
• WHO IS AFFECTED?
• Anyone and any institution that handles HD
preparations
• SHARE WHAT WE HAVE AT UNMH
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#3
Designated Person
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310/4/18
DESIGNATED PERSON TO
MANAGE THE PROGRAM
• RESPONSIBILITIES OF DESIGNATED PERSON
• Qualified and trained
• Oversee compliance with USP as well as other applicable
laws and regulations
• Competency of personnel
• Environmental control of storage and compounding areas
• Oversight of facility including testing and monitoring
• Maintaining documentation
• DOES THE “DESIGNATED PERSON” HAVE TO DO
EVERYTHING?
• No, form an interdisciplinary team consisting of nurses,
pharmacists, pharmacy technicians, physicians, veterinarians,
safety personnel, environmental services personnel, etc.
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#4
LIST OF HAZARDOUS
DRUGS
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410/4/18
LIST OF HAZARDOUS DRUGS
• ENTITY MUST CREATE AND MAINTAIN A LIST OF HDs
• A list of HDs is maintained by The National Institute for
Occupational Safety and Health (NIOSH)
• Group 1: Antineoplastic Drugs which may pose a reproductive
risk for susceptible populations
• Group 2: Non-antineoplastic drugs that meet one or more of
the NIOSH criteria for a hazardous drug and may also pose a
reproductive risk for susceptible populations
• Group 3: Drugs that pose a reproductive risk to both men and
women who are actively trying to conceive and women who
are breast feeding
• NIOSH 2016 List plus a proposed addition list for 2018
• Practice-specific assessment of HDs which is evaluated yearly or
whenever a new agent is added to the formulary
• Perform an assessment of risk of the drugs on your list to
determine how to handle HDs
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ASSESSMENT OF RISK
• IT IS ADVISEABLE TO PERFORM AN ASSESSMENT OF RISK
(AOR) OF ALL DRUGS ON YOUR HAZARDOUS DRUG LIST
• Why? Provides for alternative containment strategies and
work practices.
• HDs on the NIOSH List that must follow containment
requirements of USP regardless of AOR include
• Any HD API
• Any antineoplastic requiring manipulation
• Alternative containment strategies and work practices are
allowed for drugs on the NIOSH list if an AOR is completed
• Final dosage forms of compounded HD preparations
• Conventionally manufactured HD products that do
not require any further manipulation
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510/4/18
ASSESSMENT OF RISK
• TOPICS TO INCLUDE IN THE AOR:
1. Type of HD
2. Dosage form (Every form of every drug on the NIOSH list)
3. Risk of exposure
4. Packaging
5. Manipulation
6. Administration (PPE)
• EXAMPLES
1. Final dosage form of compounded antineoplastics (An
AOR may reveal the need for less restrictive storage
requirements)
2. Finasteride (crushing tablets on the floor) (An AOR may
reveal the need for more restrictive requirements.)
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Step 1: Create an Algorithm
• Present it to your group and discuss NIOSH Table 2 or is carcinogenic, genotoxic, or organ toxic
(per criteria in NIOSH guidelines)
• Pick what factors are important and come
up with a consistent set of rules
• You could try to evaluate each drug and Injectable Solution, Topical Tablet, Capsule
each form one-by-one
• After you include all of the forms of each
drug you are looking at a list 300 lines Requires drawing from ampule or vial? Requires manipulation such as mixing?
Requires manipulation sucRequires
manipulation such as crushing or splitting
tablets or opening capsules?
long!
• That’s too much for a group discussion
• Dividing and conquering list-by-list can Yes: Yes:
Yes:
lead to inconsistency Storage: Standard
Storage: Standard
Hood: C-PEC
Storage: Standard
Hood: C-PEC
Hood: C-PEC
Pharmacy garb: Full PPE Pharmacy garb: Full PPE
Pharmacy garb: Full PPE
Hand Delivery non-chemo Hand Delivery non-chemo
Hand delivery non-chemo
Nursing Garb: Chemo gloves Nursing Garb: Chemo gloves
Nursing Garb: Chemo gloves
If not, then it's in its final dosage form If not, then it's in its final dosage form
Storage: Pyxis Storage: Pyxis
No, in final dosage form:
Hood: N/A Hood: N/A
Storage: Pyxis
Pharmacy garb: N/A Pharmacy garb: N/A
Hood: N/A
Pharmacy garb: N/A Delivery: OK to tube Delivery: OK to tube
Nursing garb: Chemo gloves Nursing garb: Chemo gloves
Delivery: OK to tube
Nursing Garb: Chemo gloves
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610/4/18
Step 2: Load Your Algorithm Rules into Excel
• The NIOSH list is not Excel friendly but you can do it!
• Make a bunch of If-Then Statements in Excel based on the
algorithm your group decided on and just drag it through your
NIOSH Excel
• You will end up with a big, overwhelming Excel sheet that
only the safety nerds will appreciate
• It will only take one, hour-long meeting for the algorithm
• From there give one person about two extra hours to set up
the Excel and you’re done!
• If you want to change the algorithm later, just update the
Excel rules!
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UNMH Assessment of Risk
• Do not crush or open any forms of drugs on this list on a nursing unit or anywhere outside of a pharmacy Hazardous hood.
• When administration of a drug requires that pharmacy manipulate any nonsterile HD on this list such as splitting tablets, crushing tablets or opening capsules to create a
slurry, administering personnel must wear two pairs of gloves and a gown.
• The information in this list can be found on the MAR and Pyxis stations.
• Most NIOSH Group 1 drugs are cytotoxic chemotherapy. Cytotoxic drugs will be stickered with a yellow warning sticker that states, "CYTOTOXIC MATERIAL HANDLE PROPERLY."
• NIOSH Group 2 drugs are non-antineoplastic drugs that meet one or more of the NIOSH criteria for an HD, some of these HDs may pose a reproductive risk for susceptible
populations.
• NIOSH Group 3 drugs primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breast feeding.
• Solid form drugs generally pose less risk of exposure than injectable and non-solid form drugs and thus are handled differently.
Drug Information Pharmacy Handling Nursing Unit Handling Additional Information
Pharmacy What type
protection of Hood to AHFS
Generic Name Usual Pharmacy Dispense from Disposa Nursing Storage in Excrement Supplemental Pregnancy NIOSH
Formulation (PPE) for Prepare Delivery Disposal MSHG classificat
(Brand Name) Route Storage Pharmacy l Garb (PPE) Pyxis? /Urine information Category Group
Manipulati (Manipulate ion
on )
Standard Protect Women who are pregnant
Standard Hand Hand from or may be pregnant Antineopla 10:00
Pyxis or Black One pair of Pyxis or Black
abiraterone Oral Tablet Haz garb Haz Hood Delivery, but Delivery, urine/exc should not handle X stic Group antineoplas
Standard bucket gloves Standard bucket
do not tube but do not rement without protection 1 tic agents
tube for 48h (e.g., gloves)
Protect
ado- Haz garb Double Hand from Antineopla 10:00
Hand Deliver Black Hand Deliver Black Conjugated monoclonal
trastuzumab IV Injection Haz Room and use Haz Hood glove and Delivery in urine/exc D stic Group yes antineoplas
in Chemo bag bucket in Chemo bag bucket antibody
emtansine Equashield gown Chemo bag rement 1 tic agents
for 48h
Standard Protect Special warnings on
Standard Hand Hand from contraception for Antineopla 10:00
Pyxis or Black One pair of Pyxis or Black
afatinib* Oral Tablet Haz garb Haz Hood Delivery, but Delivery, urine/exc females while taking D stic Group antineoplas
Standard bucket gloves Standard bucket
do not tube but do not rement and 2 weeks post- 1 tic agents
tube for 48h treatment
Standard Protect
Standard Hand Hand from Antineopla 10:00
Pyxis or Black One pair of Pyxis or Black
altretamine Oral Capsule Haz garb Haz Hood Delivery, but Delivery, urine/exc D stic Group yes antineoplas
Standard bucket gloves Standard bucket
do not tube but do not rement 1 tic agents
tube for 48h
Protect
Haz garb Double Hand from Antineopla NA
Hand Deliver Black Hand Deliver Black
amsacrine IV Injection Haz Room and use Haz Hood glove and Delivery in urine/exc IARC Group 2B† stic Group yes antineoplas
in Chemo bag bucket in Chemo bag bucket
Equashield gown Chemo bag rement 1 tic agents
for 48h
Standard Protect
Standard Hand Hand from Antineopla 10:00
Pyxis or Black One pair of Pyxis or Black
anastrozole Oral Tablet Haz garb Haz Hood Delivery, but Delivery, urine/exc X stic Group antineoplas
Standard bucket gloves Standard bucket
do not tube but do not rement 1 tic agents
tube for 48h
Return to
Protect
pharmacy
Haz garb Areseni Double Hand from Antineopla 10:00
arsenic Hand Deliver Hand Deliver for IARC Group 1
IV Injection Haz Room and use Haz Hood c glove and Delivery in urine/exc D stic Group yes antineoplas
trioxide in Chemo bag in Chemo bag disposal carcinogen; NTP**
Equashield bucket gown Chemo bag rement 1 tic agents
in arsenic
for 48h
bucket
Standard Protect Teratogenic,
Standard Hand Hand from embryotoxic and Antineopla 10:00
Pyxis or Black One pair of Pyxis or Black
axitinib Oral Tablet Haz garb Haz Hood Delivery, but Delivery, urine/exc fetotoxic in mice at D stic Group antineoplas
Standard bucket gloves Standard bucket
do not tube but do not rement exposures lower than 1 tic agents
tube for 48h human exposures
Protect
Haz garb Double Hand from Antineopla 10:00
Hand Deliver Black Hand Deliver Black IARC Group 2A
azacitidine IV Injection Haz Room and use Haz Hood glove and Delivery in urine/exc D stic Group yes antineoplas
in Chemo bag bucket in Chemo bag bucket carcinogen; NTP***
Equashield gown Chemo bag rement 1 tic agents
for 48h
Protect
Bacillus Haz garb Double Hand from See special handling Antineopla
Cathete Hand Deliver Black Hand Deliver Black 80:12
Calmette Injection Haz Room and use Haz Hood glove and Delivery in urine/exc requirements‡; FDA C stic Group yes
r in Chemo bag bucket in Chemo bag bucket vaccines
Guerin (BCG) Equashield gown Chemo bag rement Pregnancy Category C 1
for 48h
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710/4/18
Step 3 Collaborate!
This is a Great Way to Get Pharmacy out there in your Facility!
• Use it as an excuse to get on agendas and network!
• Adult Nurse/Pharmacy
• Peds Nurse/Pharmacy
• Med Safety
• Safety Directors meeting
• Clin Ed
• PPG
• Management Coffee
• Make sure its safe AND practical!
• Participate in Nursing Education on USP 800!
• Build it into your MAR and on to Pyxis
• Work with IT and make it nursing-friendly!
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#5
RECEIVING HDs
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810/4/18
REQUIREMENTS FOR RECEIVING HDs
PROCEDURE REQUIRED FOR RECEIVING HDS
1. Visually examine the shipping container for signs of
damage or breakage and follow entity’s developed
procedure for handling damaged or broken containers
2. The supplier should package HDs in impervious plastic to
segregate them from other drugs. Leave the HDs in the
plastic and deliver to the HD storage area for further
unpacking
3. PPE, including chemotherapy gloves, must be worn when
unpacking (This is where the AOR comes in to play)
4. Remove HDs from their external shipping containers in an
area that is neutral or negative pressure relative to the
surrounding areas.
5. Do not unpack in the sterile compounding area or in any
positive pressure area
6. A spill kit must be accessible in the receiving area
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#6
STORING HDs
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910/4/18
REQUIREMENTS FOR STORING HDs
PROCEDURE REQUIRED FOR STORING HDs
1. Do not store on the floor. Store on secure shelves
with raised front lips to prevent falling and breaking
2. Antineoplastic HDs and HD API requiring physical
manipulation must be stored in an externally
vented, negative pressure room with at least 12 air
changes per hour (ACPH). Example: Hazardous
Ante or Clean room
3. Non-antineoplastic, reproductive risk only, and final
dosage forms of antineoplastic HDs may be stored
with other inventory if permitted by entity policy.
Examples: methotrexate, finasteride and warfarin
tabs
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REQUIREMENTS FOR STORING HDs
PROCEDURE REQUIRED FOR STORING HDs
4. Refrigerated antineoplastic HDs must be stored in a dedicated
refrigerator in a negative pressure area with at least 12
ACPH. Examples: storage room, buffer (clean) room or
containment segregated compounding area (C-SCA). Note: It
is recommended to place the refrigerator in front of an
exhaust vent if the refrigerator is located in a negative
pressure buffer (clean) room
5. The most simple approach to take (if your procedures allows)
is to store sterile HDs that require manipulation in a properly
designed storage room, hazardous ante or clean room or the
C-SCA. Store non-sterile HDs such as tablets or suspensions
with other inventory
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1010/4/18
#7
COMPOUNDING HDs
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COMPOUNDING
PRACTICAL APPROACH TO
COMPOUNDING
• Training
• Personal Protective Equipment
• Facilities and Engineering Controls
• Containment Supplemental Engineering
Controls
• Non-sterile compounding
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1110/4/18
Definitions
Engineering Controls: NIOSH/OSHA term that describes a barrier
between the worker and HD
• Primary Engineering Control:
• Containment Primary Engineering Control (C-PEC):
Haz-hood
• Secondary Engineering Control:
• Containment Secondary Engineering Control (C-SEC):
Haz-room
• Containment segregated compounding area (C-SCA):
Basically a less sterile C-SEC
• Unclassified area: Everywhere else in the world
• Supplemental Engineering Control: Closed-System Drug-
Transfer Device (CSTD)
• Equashield, Phaseal, etc
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TRAINING
STERILE HAZARDOUS COMPOUNDING
1. TRAINING IN NON-HAZARDOUS STERILE COMPOUNDING IS REQUIRED PRIOR TO
BEGINNING HAZARDOUS STERILE COMPOUNDING TRAINING
2. Once non-hazardous compounding training is complete and employee demonstrates
competency then hazardous compounding training can begin
3. The following are required areas of training for any type of hazardous compounding:
• Overview of entity’s list of HDs and risks
• Review of the entity’s policies and procedures for handling HDs
• Proper Use of Personal Protective Equipment
• Proper Use of equipment and devices
• Response to known or suspected HD exposure
• Spill Management
• Proper disposal of HDs and trace-contaminated materials
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1210/4/18
PERSONAL PROTECTIVE EQUIPMENT
1. GLOVES [American Society for Testing and Materials (ASTM) D6978]
• Two pairs of gloves are required. The outside gloves must be sterile
• Change gloves every 30 minutes or when torn, punctured or contaminated
• Wash hands with soap and water after removing gloves
2. GOWNS [Polyethylene-coated polypropylene or other laminate materials]
• Disposable
• Long sleeved
• Close in the back (tie in the back)
• Closed cuffs that are elastic or knit
• Change every 2-3 hours or per the manufacturer’s information. Change immediately
after a spill or splash
• Do not wear the gown outside of the hazardous medication preparation area
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PERSONAL PROTECTIVE EQUIPMENT
3. HEAD, HAIR, SHOE, AND SLEEVE COVERS
• Cover head and hair. Cover beard and moustache with a beard cover
• When entering the hazardous compounding area a second set of shoe covers
must be donned before entering and doffed when exiting the compounding area
• Disposable sleeve covers may be used (polyethylene-coated polypropylene or
other laminate materials offer better protection
4. EYE AND FACE PROTECTION
• Eye protection is typically not used when compounding inside an appropriate biological safety cabinet
• However, goggles must be worn when eye protection is needed
• Face shields in combination with goggles provide full protection against splashes to the eyes and face
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1310/4/18
PERSONAL PROTECTIVE EQUIPMENT
5. RESPIRATORY PROTECTION
• Interestingly enough – USP doesn’t give a recommendation for respiratory protection if
working with a face shield in an appropriate biological safety cabinet
• USP does state that “surgical masks do not provide respiratory protection from drug exposure and must
not be used when respiratory protection from HD exposure is required”
• Remember a mask ensures sterility of the product but even an N-95 doesn’t do much to protect the worker
6. DISPOSAL OF PPE USED DURING COMPOUNDING
• Place in an appropriate waste container inside the containment secondary engineering control area (C-
SEC) also known as the hazardous clean room and dispose of per local, state, and federal regulations
• Remove chemotherapy gloves and sleeve covers used during compounding and discard immediately
into an appropriate waste container inside the contained primary engineering control unit (C-PEC). You
may also place gloves and sleeves into a sealable bag and discard into an appropriate waste
container outside of the C-PEC such as an appropriate container located in the C-SEC. This second
option is a little more practical due to space inside the C-PEC
• Need to don PPE upon entering and doff PPE BEFORE leaving the haz room
• Can’t run things out of the Haz room and re-enter anymore
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FACILITIES AND 1 2
ENGINEERING CONTROLS
In order to compound appropriately and 3 4
safely understand the facility, design and
engineering controls is crucial
5 6
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1410/4/18
USP AND FACILITY DESIGN FOR STERILE
COMPOUNDING
SHARED ANTE ROOM –
ISO 7
ISO
5
Class II B2 BSC
Laminar Air Flow
Hood (LAFH)
POSITIVE PRESSURE BUFFER ROOM
NEGATIVE PRESSURE – ISO 7 – ISO 7 – NON-HAZARDOUS
– HAZARDOUS COMPOUNDING COMPOUNDING – RECIRCULATE AIR
EXTERNALLY VENTED TO THROUGH HEPA FILTERS OR VENT
OUTSIDE AIR TO THE OUTSIDE
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USP AND FACILITY DESIGN FOR HD STERILE
COMPOUNDING – Unclassified Containment-Segregated
Compounding Area (C-SCA) – Requires 12 hour BUD
Class II B2 BSC
NEGATIVE PRESSURE –
Relative to adjacent area
(0.01 – 0.03 in WC)
EXTERNALLY VENTED TO
OUTSIDE AIR
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1510/4/18
PRIMARY ENGINEERING CONTROL
Containment Primary Engineering Controls (C-PECS) NOT ALLOWED for STERILE compounding of HDs
Laminar Air Flow
Hood (LAFH)
Containment
Ventilated Enclosure
(CVE)
Can be used for Non-
Sterile Compounding Class 1 BSC
Fume Hood
(protects worker
but not product)
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PRIMARY ENGINEERING CONTROL
Containment Primary Engineering Controls (C-PECS) ALLOWED for STERILE compounding of HDs
Containment
Ventilated Enclosure
(CVE)
Can be used for Non-
Sterile Compounding
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1610/4/18
PRIMARY ENGINEERING CONTROL – One more!
Compounding aseptic containment isolator (CACI)
• Note that 797 update will require that you put disposable gloves on
your hands, then put your gloved hands into the gloves then put
gloves on top of the gloves
• 3 pair of gloves!
• You still need to put it into a negative pressure room
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CONTAINMENT SUPPLEMENTAL ENGINEERING CONTROLS (CSTDs)
Keyword: Supplemental Not a substitute for a C-PEC
• Offer an additional level of protection during compounding and administration
• A “Should” for preparation, but a “Must” for administration?
• Many Brands in the Marketplace. Examples:
• Equashield
• Icumedical – ChemoLock
• BD Phaseal
• Tevadaptor
COMPOUNDING ADMINISTRATION
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1710/4/18
NON-STERILE COMPOUNDING
• Must also follow standards set in Pharmaceutical Compounding-Nonsterile Preparations
• Handling of final dosage forms in a C-PEC is not required unless you are manipulating in such a way that produces
particles, aerosols or gasses
• If you are manipulating a non-sterile HD then the following table is helpful to determine where to compound:
Engineering Controls for Nonsterile HD Compounding
C-PEC Requirements C-SEC Requirements
• Externally vented • Externally vented
(preferred) or redundant- • 12 ACPH
HEPA filtered in series • Negative Pressure (0.01
• Examples: CVE, Class I or and 0.03 inches of water
II BSC, CACI column) relative to
adjacent areas
• A C-PEC designated for sterile compounding may be used to occasionally compound non-sterile HD. However, the C-
PEC must be decontaminated, cleaned and disinfected before resuming sterile compounding
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Other Recommendations
Engineering Controls: Preferred ISO Class 7 buffer room with
ISO Class 7 ante room
• Not recommended to enter the haz room through the non-haz
room (ante-room preferred)
• But if you do, a method of transportation of HDs is
required. It’s basically required to have a pass-through
• Wipe sampling twice per year
• Talk with your CSTD rep ;)
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1810/4/18
#8
ADMINISTERING HDs
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Help the Nurses!
• No NIOSH medication should be crushed on the units?
• What about paediatric patient education (methotrexate)?
• It’s a SHOULD NOT in USP 800, use a plastic pouch and PPE if
absolutely necessary
• Now you have a Do-Not Crush list and the NIOSH list
• Time to put this info onto the MAR and Pyxis
• Use CSTDs for administration when possible (It’s mandatory)
• Have Chemo-experienced nurses float to administer chemo
• PPE: all of our gloves at UNMH are “Chemo gloves”
• 2 pair for anti-neoplastic HDs
• 2 versus 1 for the rest depends on your assessment of risk
• Eye, face, and respiration protection is optional
• Refer to Oncology Nursing Society guidelines ONS for more
details on PPE
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1910/4/18
#9
SPILL CONTROL of HDs
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Spills!
In addition to PPE requirements described, its up to you to work
with work with EVS and Safety on this one!
• Develop SOPs and train your staff
At UNMH
• Our Spill SOP is built into our USP 800 guideline
• Double-bag contaminated linen blue then yellow on the outside
• Spills less than 5ml
• No spill kit necessary
• Spills greater than 5ml
• Use a spill kit
Christina Kim 40
2010/4/18
#10
MEDICAL SURVEILLANCE
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Accidental Exposure!
• Does every person exposed to chemo need a trip to the ED?
• Consider running this by the ED before putting it in writing!
• Be careful who you mandate goes to the ED
• Our ED does not feel every drop of chemo requires an
emergency visit
• Eye exposure, ingestion, symptomatic skin and symptomatic
inhalation require immediate treatment
• Send patients, visitors and workers to Oc Health or ED
• Injections, rectal, nasal exposure, need immediate help as
well
• Work with your Occupational Health team
Christina Kim 42
2110/4/18
Conclusion
Christina Kim 43
Wow them with Pharmacy!
USP 800 is a big deal and its our time to shine!
• Recruit a multidisciplinary team
• Come up with your own procedure and make it practical and
specific for your institution
• Parade around your work!
• Use it as a networking opportunity for your department and
our profession!
Christina Kim 44
2210/4/18
References
1. NIOSH [2016]. NIOSH list of antineoplastic and other hazardous drugs in
healthcare settings, 2016. By Connor TH, MacKenzie BA, DeBord DG, Trout DB,
O’Callaghan JP. Cincinnati, OH: U.S. Department of Health and Human 1 2
Services, Centers for Disease Control and Prevention, National Institute for
Occupational Safety and Health, DHHS (NIOSH) Publication Number 2016-
161.
2. New Mexico Board of Pharmacy Regulation. Title 16: Occupational and
Professional Licensing. Chapter 19: Pharmacists. Part 30: Compounding of
Non-Sterile Pharmaceuticals
3. New Mexico Board of Pharmacy Regulation. Title 16: Occupational and
Professional Licensing. Chapter 19: Pharmacists. Part 36: Compounded Sterile 3 4
Preparations
4. Hazardous Drugs – Handling in Healthcare Settings. United States
Pharmacopoeia.
5 6
Christina Kim 45
Thank You
CCKIM@SALUD.UNM.EDU
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