DEVELOPING STANDARD PROCEDURES FOR SAFE...

DEVELOPING STANDARD PROCEDURES FOR SAFE HANDLING

OF CYTOTOXIC DRUGS

HARBANS DHILLON

Senior Pharmacist

University Malaya Medical Centre

Kuala Lumpur

APOPC JAKARTA 2012 1

OBJECTIVES

Definition of cytotoxic drugs

Who is at risk?

Sources of contamination

Routes of exposure

Goals for safe handling of cytotoxic drugs

Drug administration

Waste disposal

Developing standard procedures


APOPC JAKARTA 2012

DEFINITION OF CT DRUGS

• Genotoxic – damage DNA

• Mutagenic – alter DNA

• Teratogenic – malformation of embryo or fetus

• hazardous to cells

Specific destructive action on cells that may be:

• rheumatoid arthritis

• multiple sclerosis

• auto-immune disorders

Therapeutic agents intended for but not limited to treatment of cancer

Inhibit cell growth by affecting cell cycle resulting in a blockage of cell partition & multiplication.

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DEFINITION OF CT DRUGS

• Cancerous cells

• Cells from the GI tract

• Hair follicles

• Early blood cells in bone marrow

Affect all cells, but more on cells that divide rapidly or uncontrollably


LONG TERM EFFECTS OF CT DRUGS

Small but significant numbers of patients treated successfully with aggressive cancer chemotherapy later present with secondary malignancies, often AML

More commonly used

MTX & cyclophosphamide

to treat RA, MS & other non-malignant diseases


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Contact dermatitis Cytogenetic abnormalities & mutagenic activity related to biological uptake by exposed personnel Alterations to normal blood cell counts

Excretion of drug or metabolites in urine

Abdominal pain, hair loss, nasal sores & vomiting

Liver damage

Foetal loss & malformations

Guidelines for handling cytotoxic drugs and related waste in health care establishments Work Cover NSW

POTENTIAL EFFECTS OF EXPOSURE

Long term effects of occupational exposure to CT are inconclusive

BUT

not appropriate to wait for indisputable evidence of harm

APOPC JAKARTA 2012

SIGNIFICANT REPORTS OF OCCUPATIONAL EXPOSURE TO CT DRUGS: 1979 – 1999

Falck 1979 mutagens in urine of nurses preparing CTX

Neal 1983 CPM & FU aerosols in air of clinics

Hirst 1984 CPM detected in blood of nurses

Selevan 1985 foetal loss in exposed pregnant nurses

Hemminki 1985 defects in offspring of exposed nurses

Saurelle-

Cubizolles

1993 factor in ectopic pregnancies

Sessink 1994 skin contamination a major cause

Valanis 1999 foetal loss, reduced fertility in males, females

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Identify path CT drugs follow from point of entry to exit as

• reconstituted product

• patient waste

• contaminated laundry

• contaminated equipment

Includes:

• receiving

• transportation

• storage

• preparation

• administration

• waste handling

EXPOSURE ASSESSMENT

APOPC JAKARTA 2012

SAFE HANDLING

Who is at risk?

Where?

How?


WHO IS AT RISK?

Everyone involved in the handling

Manufacturers & shipping

Pharmacists & pharmacy assistants

Physicians & nurses

Housekeeping

Family members & friends


SAFE HANDLING

Who is at risk?

Where? Sources of contamination

What?


SOURCES OF CONTAMINATION?

Vials and packaging surface contamination

Leaks/spills

Aerosol generation, spraying, splattering

Excreta of patients

Surface contamination on BSC, carts, tables,

counters, equipment, wards, bedside

•Withdrawing of needles from drug vials

•Use of syringes and needles or filter straws for transfer

•Opening of ampoules

•Expulsion of air from syringe when measuring the

precise volume of drug

Surface contamination


SURFACE CONTAMINATION

Slide courtesy of Thomas Connor ISOPP VIII Vancouver APOPC JAKARTA 2012 13

MANUFACTURER

Some vials have significant cytotoxic drug residue on vial surface – exposure

Plastic coated vials appear safest

Plastic vials also appear safe

Methods of packing for transit to be specified


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Classify & segregate CT drugs

• Areas where drugs are received

• Quarantine packages with visual signs of damage

• Dedicated storage areas

• Use PPE when handling CT drugs

• Wash hands after handling CT drugs

• Spill kit available

• Proper waste disposal of damaged goods & PPEs

Purchase of CT drugs designed to minimise risk of breakage

• unbreakable plastic material

• glass vials provided in specially designed outer plastic containers

• glass vials over-wrapped in plastic

APOPC JAKARTA 2012

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External transport from supplier

• Primary containers designed to minimise breakage

• use of parenteral grade polypropylene vials, resistant to breakage or reinforced plastic coated vials

• Packed in high impact resistant packaging material made from heavy duty corrugated cardboard & lined with moulded foam to prevent accidental damage to contents

Internal transport of commercial product

Internal transport of compounded admixture

• To prevent damage, pack in a labelled, sealed, leak-proof container, protected from light

• ISOPP Standards of Practice Section 5

APOPC JAKARTA 2012

SAFE HANDLING

Who are at risk?

Where?

What? Routes of exposure


ROUTES OF EXPOSURE

Inhalation of droplets or vapour during preparation or administration

Ingestion – surface contamination/substandard practices

Topical contact – spills or improper/inadequate PPE, conjunctival absorption

Direct injection – needle stick injury


Sources of Contamination 1 of 5


ROUTES OF EXPOSURE

Vials & packaging in which cytotoxic drugs are stored

Leaks/spills surface contamination on BSC, carts, tables, counters, equipment…etc

Aerosolisation surface contamination on minibags, syringes, pumps

Handling excreta & linen of patients


INHALATION OF DRUG VAPOUR

Cytotoxic drugs evaporate at 23°C & 37°C

Drug 23°C Drug 37°C

Carmustine ++ Carmustine ++

Nitrogen mustard ++ Cyclophosphamide ++

Cyclophosphamide + Ifosphamide ++

Thiotepa ++

Nitrogen mustard ++

Fluorouracil ? Fluorouracil ?


Protect & secure packages of CT drugs

Educate & train all involved personnel

During manipulation, use of devices & negative pressure techniques

Eliminate potential for exposure with CT drugs


•Disposable gown made of non-linting & non absorbent polyethylene-coated polypropylene material Coverall or gown

Head covering

Closed footwear

•double gloving (nitrile, neoprene latex)

• long enough to cover cuffs of gowns or coveralls

•changed every 30 minutes Gloves

Protective eyewear/goggles

Respirator masks


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CT drugs should be handled & stored within the pharmacy by

trained employees

Preparation of parenteral CT drugs should be undertaken only

by trained pharmacy personnel

Reconstituted product should be protected against microbial,

particulate & chemical contamination

Operators should be protected against exposure to hazardous

drugs.

ISOPP Standards of Practice Section 3

APOPC JAKARTA 2012

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Pharmaceutical analysis & QC implemented

improves quality of preparation

safety of patient is enhanced

Economic benefits

Location:

Commonly – pharmacy

Sometimes - outpatient oncology department or close to inpatient ward

Ease of transport

Enhanced communication between pharmacy, medical & nursing staff

Must be under control of pharmacist


APOPC JAKARTA 2012

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Possess recognized qualification

Received certified training in accordance with local regulations

Assessment of practice undertaken on a regular basis

Staff members should be evaluated on a regular basis to verify compliance with procedures

Strict hygiene must be developed & followed

No eating, drinking, chewing gum & application of cosmetics must be strictly prohibited

No wearing of jewellery


APOPC JAKARTA 2012

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Appropriate staff chosen – good work habits, teachable & fussy

about cleanliness

Personnel must be informed of known & potential hazards of CT

drugs they are handling

Document contents of training & the individual completion of

training

“Worker right to know” regulations

Knowledge of & competence in procedures MUST be tested at the

end of the training

Re-test periodically every 6-12 months

APOPC JAKARTA 2012

Potential risks to exposure to CT agents

Basic pharmacology of CT agents

Theory of aseptic technique

Use of PPE

Theory of containment devices & barriers

Theory of hierarchy of protection measures

Handling of CT waste

CT spills & accidental exposure

Prescribing of CT agents

Validation of CT prescriptions

Hospital policies & procedures on CT management

CT drug use processes drug selection

prescription validation

preparation

dispensing

drug administration & drug use evaluation

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ISOPP Standards of Practice Section 4 APOPC JAKARTA 2012

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Each institution should develop & maintain a procedure

manual, detailing:

policies & procedures for appropriate manufacture &

administration of CT drugs

aseptic techniques

SOPs for reconstitution & administration

cleaning procedures

spill management

transporting CT drugs

health monitoring


APOPC JAKARTA 2012

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A training program in CT reconstitution should be developed

& implemented

Can be offered in-house or by an external training provider

Training should be:

tailored to specific needs of the individual

ongoing with regular updates & information for any new

procedures or products e.g. new hazardous drug introduced at

workplace

Include periodic tests of staff competencies

Structured program which contains important elements


APOPC JAKARTA 2012

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Validation of processes to demonstrate processes used during & staff undertaking aseptic

manipulation are capable of maintaining sterility of product

media fill test is intended to simulate routine aseptic operations

Validation of operator to demonstrate aseptic technique of operator is capable of maintaining

sterility

ensure operators do not contaminate themselves

Validation of training ensure all staff have a satisfactory level of knowledge & competency

Evaluation On-going feedback should be an integral part of the program

Re-training Repeated every 2-3 years


APOPC JAKARTA 2012

Need to ensure protection of product

Aseptic techniques

Microbial contamination

Chemical contamination

Centralised service

Dedicated facilities


STORAGE - ROOM TEMPERATURE


PRODUCT RECONSTITUTED


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Protect handler of vial/ampoule

Vials enclosed in plastic coating

Protect operator during preparation

Closed system in regards to microbiological & chemical

contamination (leakproof, airtight device)

Protect administrator during administration of CT

drug

Techniques to protect patient


APOPC JAKARTA 2012

AIRBORNE PARTICLE CLASSIFICATION

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DRUG PREPARATION WITH CLOSED SYSTEMS


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Administered mainly by nurses

Exposure due to surface contamination of products made by pharmacy, connection/disconnection during administration including oral products using oral liquid dispensing syringes

Use PPEs when administering

Remove IV bag intact or use contained systems

Flushing

Wash hands after administration

Closed systems

Excreta of patient as second dilution of drug

Spill management

Proper disposal of CT waste


APOPC JAKARTA 2012

Double checking for correct

patient, route, dose &

regime

Swabbing rubber bung Administering bolus doses

Setting up the infusion Commencing administration

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Do cut or crush tablets

Use gloves when handling oral CT drugs

Do not open capsules

If necessary, dissolve in warm water

Return excess drugs to pharmacy


UNSAFE PRACTICES


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Leak proof & puncture proof sharps containers

Sharps container no more than ¾ full

Waste tied up & removed after each shift

APOPC JAKARTA 2012

Waste bags made of

polyethylene or

polypropylene, purple in

colour

Segregated, packaged &

disposed properly

Use of dedicated

hardwalled carts

Undertake waste

collection frequently

Incineration at 1100°C

58 APOPC JAKARTA 2012

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Staff

health monitoring

exposure to CTs

education & training

validation

Facilities

microbiological & contamination monitoring

maintenance log

pressure differentials

temperature logs

particle counts

qualification & re-qualification


Training file for each personnel!

APOPC JAKARTA 2012

62

Transport

Outside & within the institution

Cytotoxic spills

Extravasation

Cleaning

BSC/isolator

Sterile room

Workload statistics

Procedure manual

Material safety data sheet (MSDS)


APOPC JAKARTA 2012

CONTROL MEASURES

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Key risk controls include:

• Outsourcing CT drug preparation work

• Purchasing CT drugs in the safest form available

• Reviewing health & safety information about CT drugs

• Using facilities that meet recommended technical & safety standards

• Designing & laying out work area according to recommended standards

• Adopting closed system operations

• Providing employees with information & training

• Automation

Guidelines for handling cytotoxic drugs and related waste in health care establishments WorkCover NSW

APOPC JAKARTA 2012

SAFETY IN HANDLING CT DRUGS

•Policies & procedures

• Minimum standards, ISOPP standards

• Root cause analysis for spills & needle stick injuries

• Maintain records

• Health surveillance

• Training & validation

• Retraining


SAFETY IS IN YOUR HANDS

www.asia4safehandling.org www.isopp.org


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ISOPP Standards of Practice J Oncol Pharm Practice (2007)

Supplement to 13: 1-81

Guidelines for handling cytotoxic drugs and related waste in health

care establishments WorkCover New South Wales

NIOSH Alert: Preventing occupational exposures to antineoplastic &

other hazardous drugs in health care settings 2004

ASHP Guidelines on Handling Hazardous Drugs Am J Health-Sys

Pharm. 2006;1172-93

REFERENCES

APOPC JAKARTA 2012

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