#1 Go Live Date Christina Kim 2 1 10/4/18 GO LIVE INFORMATION - - PDF document

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USP <800>

THE TOP 10 THINGS YOU NEED TO KNOW

Christina Coleman Kim, PharmD University of New Mexico Hospitals

Christina Kim

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#1

Go Live Date

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Christina Kim

• DECEMBER 1, 2019
• New Mexico Board of Pharmacy is currently re-

writing Title 16, Chapter 19, Part 30 (Compounding

• f Non-Sterile Pharmaceuticals) and Part 36

(Compounded Sterile Preparations) to include USP <800> 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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GO LIVE INFORMATION

Christina Kim

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#2

Introduction and Scope

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• 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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INTRODUCTION AND SCOPE

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#3

Designated Person

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• RESPONSIBILITIES OF DESIGNATED PERSON
• Qualified and trained
• Oversee compliance with USP <800> 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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DESIGNATED PERSON TO MANAGE THE PROGRAM

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#4

LIST OF HAZARDOUS DRUGS

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• 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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LIST OF HAZARDOUS DRUGS

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• 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 <800> 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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ASSESSMENT OF RISK

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• 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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ASSESSMENT OF RISK

Christina Kim

Step 1: Create an Algorithm

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NIOSH Table 2 or is carcinogenic, genotoxic, or organ toxic (per criteria in NIOSH guidelines)

• Present it to your group and discuss
• Pick what factors are important and come

up with a consistent set of rules

• You could try to evaluate each drug and

each form one-by-one

• After you include all of the forms of each

drug you are looking at a list 300 lines long!

• That’s too much for a group discussion
• Dividing and conquering list-by-list can

lead to inconsistency

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Step 2: Load Your Algorithm Rules into Excel

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• 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
• nly 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!

Christina Kim

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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

• n

• f Hood to

• r may be pregnant

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Step 3 Collaborate!

This is a Great Way to Get Pharmacy out there in your Facility!

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• 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!

Christina Kim

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#5

RECEIVING HDs

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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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REQUIREMENTS FOR RECEIVING HDs

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#6

STORING HDs

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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

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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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REQUIREMENTS FOR STORING HDs

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#7

COMPOUNDING HDs

Christina Kim

PRACTICAL APPROACH TO COMPOUNDING

• Training
• Personal Protective Equipment
• Facilities and Engineering Controls
• Containment Supplemental Engineering

Controls

• Non-sterile compounding

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COMPOUNDING

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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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Definitions

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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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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
• ther 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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PERSONAL PROTECTIVE EQUIPMENT

• 5. RESPIRATORY PROTECTION
• Interestingly enough – USP <800> doesn’t give a recommendation for respiratory protection if

working with a face shield in an appropriate biological safety cabinet

• USP <800> 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

• ption 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 ENGINEERING CONTROLS

In order to compound appropriately and safely understand the facility, design and engineering controls is crucial

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USP <797> AND <800> FACILITY DESIGN FOR STERILE COMPOUNDING

NEGATIVE PRESSURE – ISO 7 – HAZARDOUS COMPOUNDING EXTERNALLY VENTED TO OUTSIDE AIR

SHARED ANTE ROOM – ISO 7 POSITIVE PRESSURE BUFFER ROOM – ISO 7 – NON-HAZARDOUS COMPOUNDING – RECIRCULATE AIR THROUGH HEPA FILTERS OR VENT TO THE OUTSIDE

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Laminar Air Flow Hood (LAFH) Class II B2 BSC ISO 5

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USP <797> AND <800> FACILITY DESIGN FOR HD STERILE COMPOUNDING – Unclassified Containment-Segregated Compounding Area (C-SCA) – Requires 12 hour BUD

NEGATIVE PRESSURE – Relative to adjacent area (0.01 – 0.03 in WC) EXTERNALLY VENTED TO OUTSIDE AIR

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Class II B2 BSC

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PRIMARY ENGINEERING CONTROL

Containment Primary Engineering Controls (C-PECS) NOT ALLOWED for STERILE compounding of HDs

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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)

Christina Kim

PRIMARY ENGINEERING CONTROL

Containment Primary Engineering Controls (C-PECS) ALLOWED for STERILE compounding of HDs

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Containment Ventilated Enclosure (CVE) Can be used for Non- Sterile Compounding

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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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PRIMARY ENGINEERING CONTROL – One more!

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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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NON-STERILE COMPOUNDING

• Must also follow standards set in Pharmaceutical Compounding-Nonsterile Preparations <795>
• 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:
• 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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Engineering Controls for Nonsterile HD Compounding C-PEC Requirements C-SEC Requirements

• Externally vented

(preferred) or redundant- HEPA filtered in series

• Examples: CVE, Class I or

II BSC, CACI

• Externally vented
• 12 ACPH
• Negative Pressure (0.01

and 0.03 inches of water column) relative to adjacent areas

Christina Kim

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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Other Recommendations

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#8

ADMINISTERING HDs

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• 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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Help the Nurses!

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#9

SPILL CONTROL of HDs

Christina Kim

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

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Spills!

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#10

MEDICAL SURVEILLANCE

Christina Kim

• 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

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Accidental Exposure!

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Conclusion

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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
• ur profession!

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Wow them with Pharmacy!

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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 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 Preparations 4. <800> Hazardous Drugs – Handling in Healthcare Settings. United States Pharmacopoeia.

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Thank You

CCKIM@SALUD.UNM.EDU