what is usp-nf? · what is usp-nf? usp’s governing standards-setting and advisory bodies include:...

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HIDDEN HAZARDS Safe Medication Handling Considerations Lauren Eichstadt Forsythe, PharmD, DICVP, FSVHP University of Illinois, Veterinary Teaching Hospital Pharmacy Coordinator [email protected] BACKGROUND INFO WHAT IS USP-NF? Mission of USP: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. WHAT IS USP-NF? USP’s governing standards-setting and advisory bodies include: USP Convention Board of Trustees Counsel of Experts and its Expert Committees Expert Panels Stakeholder Forums Project Teams As specified by U.S. law, USP works with the FDA through the Government Liaison Program which allows FDA representatives and other government agencies to participate in Expert Committee and Expert Panel meetings. THE TRIAD OF CHAPTERS Including vets and vet techs! USP <800> Compounding with Hazardous Chemicals USP <797> Sterile Compounding USP <795> Non-sterile Compounding Topical Ointments Capsules Suspensions Solutions Treats Ophthalmics Injectables Forsythe 2018© Chapters < 1000: enforceable Chapters > 1000: informational WHO PUSHED FOR USP <800>? A practicing veterinarian in AZ Developed cancer at 35 Doctor indicated it could be from handling hazardous drugs at work Had been administering chemotherapy to pets Dedicated his career to improving safety for others Went to USP with his story à USP was already considering hazardous drug concerns Now back into practice but NO chemotherapy http://www.usp.org/true-impact/brett-cordes

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HIDDEN HAZARDSSafe Medication Handling Considerations

Lauren Eichstadt Forsythe, PharmD, DICVP, FSVHPUniversity of Illinois, Veterinary Teaching Hospital

Pharmacy [email protected]

BACKGROUND INFO

WHAT IS USP-NF?

Mission of USP: To improve global health through public standards and

related programs that help ensure the quality, safety, and benefit of medicines

and foods.

WHAT IS USP-NF?USP’s governing standards-setting and advisory bodies include:

• USP Convention

• Board of Trustees

• Counsel of Experts and its Expert Committees

• Expert Panels

• Stakeholder Forums

• Project Teams

As specified by U.S. law, USP works with the FDA through the Government Liaison Program which allows FDA representatives and other government agencies to participate in Expert Committee and Expert Panel meetings.

THE TRIAD OF CHAPTERS

Including vets and vet

techs!

USP <800>Compounding with Hazardous

Chemicals

USP <797>Sterile

Compounding

USP <795>Non-sterile

Compounding Topical Ointments

CapsulesSuspensions

Solutions

Treats

Ophthalmics

Injectables

Forsythe 2018©

Chapters < 1000: enforceable

Chapters > 1000: informational

WHO PUSHED FOR USP <800>?• A practicing veterinarian in AZ• Developed cancer at 35

• Doctor indicated it could be from handling hazardous drugs at work

• Had been administering chemotherapy to pets

• Dedicated his career to improving safety for others• Went to USP with his story à USP was already considering hazardous drug concerns

• Now back into practice but NO chemotherapy

http://www.usp.org/true-impact/brett-cordes

HOW TO GET USP 800

•USP full subscription

•USP Compounding Compendium

•Single chapter download• http://www.usp.org/usp-chapter-800-download

Forsythe 2018©

GETTING STARTED

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1.) ASSEMBLE YOUR WORKING GROUP

•Practice owner(s)

•Practice manager

•Veterinarian(s)

• You

• Technician(s)

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2.) COLLECT THE REGULATIONS

•State Vet Board

•State Pharmacy Board

•OSHA (federal and state specific)

•USP <800>

•EPA

•Other state-specific regulations

10

3.) COMPILE A FACILITY HAZARDOUS DRUG LIST

•Antineoplastic agents

•All other hazardous drugs•Based on NIOSH

• Include similar veterinary medications

11

VETERINARY ONLY DRUGS

• All chemo (injectable and oral)

• Veterinary versions of all drugs on NIOSH list (i.e. Atopica, etc.)

• Drugs similar in structure to NIOSH drugs (i.e. Apoquel)

• SDS warnings

• Package insert warnings

• Pregnancy category D or X

• View ‘supplemental information’ in NIOSH list

• Document reason for inclusion

13

LAUREN’S VETERINARY DRUG LIST

• Tanovea-CA1 - chemotherapy

• Palladia - chemotherapy

• Atopica/Optimmune – veterinary cyclosporine

• Apoquel – similar structure to Palladia and methotrexate

• Regu-Mate – reproductive toxicity

• Butorphanol– SDS warnings*This list is anexample of my

thought process and not all inclusive.

14

LAUREN’S VETERINARY DRUG LIST

• Demecarium bromide – pregnancy category X

• DMSO/Synotic – SDS warnings

• Nitrofurazone – SDS warnings

• Pergolide – package insert warning

• Trilostane - package insert warning*This list is anexample of my

thought process and not all inclusive.

15

(Cont.) 4.) ASSESSMENT OF RISK DETERMINATION

•All antineoplastics requiring manipulation and HD API must comply• Injectable chemotherapy that needs drawn up

•Chemotherapy tablets that are being split or crushed

•All other drugs eligible for assessment of risk

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5.) SUMMARY OF REQUIREMENTS

•Create a summary of all requirements sorted by regulation• Which drugs fall under each requirement?

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6.) COMPARE REGULATIONS

•Which ones are required/enforced?

•Overlap?

18

7.) ORGANIZE REQUIREMENTS

1. Already in place

2. Limited expense/modifications to put in place

3. Expensive/large time commitment/major changes

1. Required – enforced2. Required – questionable enforcement3. Recommended but not required

And/Or

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EXAMPLE

USP <800> Musts:

• Prominent signs designating the hazardous drug areas

• Restricted access to hazardous drug areas

• Hazardous drug areas located away from breakrooms and refreshment areas

• Designated areas for receipt/unpacking, storage, compounding

• Antineoplastics and HD apis unpacked in neutral/negative pressure area and stored separately

• Stored to prevent spillage, not on floor and earthquake proof

USP <800> Shoulds:

• …

21

GAP ANALYSIS

A gap analysis breaks down USP <800> requirements

• Pro: saves you time

• Con: maybe not specific to veterinary medicine or your practice

• Free options:• BD/joint commission tool: hazmedsafety.Com

• Criticalpoint tool: http://www.800gaptool.Com

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BD/JOINT COMMISSION TOOL

GAP ANALYSIS RESULTS

•Use your results to guide your to-do list

•Organize into ‘must do’ and ‘should do’

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8.) DEVELOP A BUDGET DRAFT

• Determine what has associated costs

• Get a rough idea of what that cost is

• Evaluate you income for hazardous medications• Focus on medications that have costly requirements• i.e. How much income does chemotherapy generate?

• Brainstorm ideas of where funds will come from

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9.) DETERMINE IF THERAPY OFFERINGS WILL CHANGE

•Will some drugs/services previously offered be discontinued?

•Will client costs associated with these medications increase?

•Will an more of these medications be administered? (i.e. market being able to it to increase profit and offset costs)

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10.) FINALIZE A TO-DO LIST

• Determine what will be done

• Major/expensive modifications (i.e. facility renovations)• Minor/inexpensive modifications (i.e. writing protocols, increasing signage)

• Designate responsible personnel for each item

• Who is going to write protocols?

• Who is going to get construction estimates?

• Who is going to look into BSCs?

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MAJOR CHANGES (MANDATORY COMPLIANCE DRUGS)

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11.) DECIDE ON CONSTRUCTION OPTIONS

•Renovation or modular cleanroom (i.e. cleanroom in a box)• Look for “USP <800> compliant”

• If renovating, look for builders experienced with USP <800>•Standard can be complicated

• Language differences between vet and contractor

•Consider required maintenance

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12.) FIND A BIOLOGICAL SAFETY CABINET

• Look for ones that state “USP <800> compliant”

• Negative pressure

• Totally enclosed

• Able to be externally vented

• Look for companies that offer regular servicing and inspection

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13.) FINALIZE THE BUDGET

•BSC costs

•Contractor costs

• Identify funding source

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14.) PLAN WORKFLOW DURING RENOVATIONS

If modifications will disrupt workflow, make a plan

•Consider expected renovation time then extend

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MINOR CHANGES

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15.) STANDARD OPERATING PROCEDURES

• Make a check list of the ones that are needed

• Check off what you already have written

• Develop a SOP template

• Determine where SOPs will be stored

• Dropbox, etc.

• Binder in clinic

• Folder on each desktop computer

SOPs need to reflect what is actually done

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Example SOP Template

REQUIRED SOPS

• Hazard communication program

• Occupational safety program

• Designation of HD areas

• Receipt

• Storage

• Compounding

• Dispensing

• Spill control

• Medical surveillance

• Hand hygiene• PPE use based on activity

• Use and maintenance of proper engineering controls• Deactivation, decontamination, cleaning

and disinfection

• Transport

• Environmental monitoring

• Disposal

Gap analysis helps identify

this list

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16.) DOCUMENTATION

Set up a system to document as outlined in SOPs

• Employee acknowledgement of hazard

• Employee training records

• Annual review of SOPs

• Annual review of HD list

• Annual review of assessment of risk documents

• Equipment maintenance

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DOCUMENTATION METHODS

•Signed forms in the employee’s file

•Documentation of reviews/updates on documents•Written and revision dates included as part of document

•Log book of equipment maintenance

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17.) IDENTIFY PATIENT HANDLING PRECAUTIONS

•Consider route of elimination•Urine

• Feces

•Unknown

•Duration of precautions• Limited data

18.) ADD SIGNAGE

• Identify areas where exposure may occur• Prep areas

• Administration areas• Patient areas

•Develop signs identifying these area/patients• Doors• Runs/cages• Patient collars

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EXAMPLE CAGE SIGN 19.) SELECT CSTD

•Closed system transfer device use if dosage form allows•Administration

•Compounding/manipulation • EquaShield• PhaSeal• Onguard

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HOW CSTDS WORK

•Equashield• https://www.equashield.com/how-it-works/

•PhaSeal• https://www.bd.com/en-us/offerings/capabilities/hazardous-drug-safety/phaseal-system

•Onguard• https://www.bbraunusa.com/en/products/b/onguard-closed-

systemtransferdevicecstd.html

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TIPS FOR SELECTING A CSTD

•Research each online

•Determine price

•Contact the company about meeting with a representative

• Test each device

•Ease of use

•No leaks

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20.) OBTAIN APPROPRIATE PPE

• Chemo gloves (ASTM standard D6978)

• Respiratory protection

• Chemo gowns (close in back, long sleeved, closed cuffs)

• Shoe covers

• Hair covers

• Eye/face protection

Used PPE must be disposed of as trace-

contaminated

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20.) WRITE ASSESSMENT OF RISK DOCUMENTS

•Determine all hazardous drugs that are eligible• All chemo that doesn’t require manipulation

• Non-chemo commercial dosage forms

• Identify precautions to minimize risk• Wearing gloves

• Counting on a hazardous drug tray• One way stoppers in liquid bottles

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ASSESSMENT OF RISK REQUIRED INFORMATION

• Type of hazardous drug (antineoplastic, non-antineoplastic, repro risk only)

•Dosage form (blister packs, tablet, liquid, capsule, transdermal)

•Risk of exposure

•Packaging

•Manipulation

Explain what you are going to do to prevent exposure since not conforming to

USP <800>

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21.) ASSEMBLE SPILL KITS

• Must be located in all areas where HDs could be spilled

• Include

• Appropriate PPE

• Sufficient supplies to absorb a 1000 mL spill

• Absorbent, plastic-backed sheets or pads

• Disposable toweling

• At least 2 sealable, thick plastic, pre-labeled hazardous waste disposal bags

• Disposable scoop for collecting glass fragments

• Puncture-resistant container for glass fragments

50

SPILL MANAGEMENT PROCESS

1. Don PPE

2. Place broken vials or other waste into a sealable bag

3. Absorb liquid into absorbent pad or clean dry spills by wetting disposable toweling to limit creation of dust

4. Dispose of used bag and supplies in a hazardous waste container

5. Clean and disinfect the spill zone

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SPILL MANAGEMENT PROCESS

6. Remove PPE and dispose in hazardous waste container

7. Wash hands

8. Document spill (name, approximate volume, how it occurred, management procedures, names of people exposed)

9. Place documentation in affected persons’ files

10.Analyze incident to prevent reoccurrence

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(Cont.)

22.) DECIDE ON WIPE SAMPLING AND ENVIRONMENTAL MONITORING

•Both are should, not shall in USP <800>

•Decide if sufficient information is available to determine what to do if positive tests occur

•Need to make sure plan is specific to types of drugs you are using

53

23.) STAFF EDUCATION

Organize a meeting to go over all changes

• Which drugs are hazardous

• Types/risks of exposure

• SOPs

• Changes to current practices

• Documentation

• CSTD/engineering control usage

• Signage

• Changes to drugs/services offered

• Client education

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STAFF TRAINING MINIMUM REQUIREMENTS

• Overview of entity’s list of HDs and their risks

• Review of SOPs

• Proper use of PPE

• Proper use of equipment and devices (engineering controls)

• Response to known or suspected HD exposure

• Spill management

• Proper disposal of HDs and trace-contaminated materials

55

24.) CLIENT EDUCATION

• Which drugs are extra precautions needed

• Animals that receive chemo• Hazardous drugs owners administer

themselves

• Counseling points

• Do not handle if pregnant• Wear gloves

• Client handouts

• Why are these drugs hazardous now?• What are the risks

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EXAMPLE CLIENT HANDOUT EXAMPLE CLIENT HANDOUT

25.) YEARLY REEVALUATION

•Review all policies, procedures, etc. at a MINIMUM of once a year

•Make sure everything is current

•New drugs

•New administration methods

•All employees up to date on training

59

QUESTIONS?