Safe Handling of Hazardous drugs

Tim SizerUniversity of Leeds

2008 .

Best Practice: Practical Aspects of Safe Handling

Scary!!!

Warning!Working with or near hazardous

drugs in health care settings may cause skin rashes, infertility,

miscarriage, birth defects, and possibly leukaemia or other cancers

NIOSH = National Institute for Occupational Safety & Health 2004

Exposure happens

• We have been handling cytotoxic drugs incorrectly for 25 years– NIOSH alert 2004

• Pharmacists and nurses are still forced to handle cytotoxics in less than reasonable conditions*

– Funding issues – Ignorance– Apathy / Incompetence / Laziness

* Yaakov Cass in Pharmacy Europe 2008

Alert:: September 2004

“Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs

in Health Care Settings” NIOSH Publication No.

2004-165:

Contamination is widespreadAND• More treatment• New drugs / combinations• Place and methods of administration

– cancer treatment centres, home care, doctors surgeries / clinics,

• New forms of drug – potential higher toxicity e.g. nanomedicines– Studies show that larger surface area of

inhaled nanoparticles may increase toxicity– Can penetrate deep into lungs & may

move to other areas of the body e.g. liver, brain

Principles of Industrial Hygiene Control

• Limitation of hazard or substitution with a less hazardous chemical (rarely possible in medicine)

• Engineering controls – use of biological safety cabinets, isolators, or closed

systems

• Administrative controls – training & education; – availability of material safety data sheets; – established work practices, policies, SOP’s – surveillance / monitoring

• Personal protective equipment – gloves, gowns, respiratory protection, eye protection

Soule RD. Industrial Hygiene Engineering Controls, in Patty FA (ed). 1978:771–823.

Engineering Controls3 aspects

– product protection– environment protection– controlled access

• Safety Cabinet (Class II Biological Safety

Cabinet) in Class B (Grade 2) clean room

• Isolator in Class C or D clean room– negative pressure vs positive pressure– flexible film vs. rigid– gaseous sterilisation vs. traditional transfer

Controlled Working Environment

Controlled Working EnvironmentEngineering Controls• Reserved for hazardous products

• Minimal storage

• Adequate space for safe working

Ergonomic design

Fully cleanable surfaces and furniture

Waste Disposal arrangements

Administrative Controls4 aspects

– education & training– availability of information e.g. data sheets– SOP’s, policies, agreed work practices– surveillance / monitoring / supervision

• Training:• Only properly trained and assessed staff

should be involved in handling cytos etc.• Retraining & competency testing should

be regular - annually

Controlled Working Environment

Administrative ControlsProcedures• No of staff involved kept to a minimum• Adherence to recommended work practices

(+ the use of engineering controls and PPE) has been shown to substantially reduce worker exposure to antineoplastic drugs

• Standardised Prescribing / Ordering / Documentation systems - reduce errors

• Clear, unambiguous, detailed written SOP’s• Use illustrations / diagrams – in SOP’s & workplace

Controlled Working Environment

Administrative Controls• Monitoring & Supervision• Lack of supervision shown to be a key factor

influence in error rates

• Good supervision ensures – good technique adhered to – procedures undertaken accurately,

correctly, safely – less waste– enhances operator & patient safety

Controlled Working Environment

Personal Protective Equipment - PPE• Variety of equipment available• Garments

– gowns, sleeves classic materials are useless use/wear restricted to work area

– gloves– glasses / goggles masks– Undergarments best strategy - multiple layers

• Mats, swabs• Shields, dispensing aids• Waste handling equipment

Controlled Working Environment

Permeability of Gloves No glove protects

against all hazards, or is suitable for all tasks

• All gloves are permeable to some extent• Permeability increases with stretching & time

• Change regularly or immediately if torn or punctured & after contact with cytotoxic liquid

• Nitrile or Neoprene gloves offer better protection

• Interpret manufacturers claims carefully

• Multi-layers also effective (air gap) wear two pairs of glove

• Hands must be washed before & after gloving

PPE continued Suitable sundries must be made available

• absorbent, plastic backed sheeting• Venting devices as needed to reduce

internal pressure• Luer-lock fittings on all syringes and iv

sets, connectors etc.• Waste collection containers e.g. plastic or metal

tray with sterile gauze to collect excess solution

• Closable, puncture-resistant containers for sharp or breakable materials

• Sealable or plastic bags of sufficient thickness for other waste e.g. gloves, etc

Extract from

Canadian guidance

• Use vented needles or filter needles to normalize vial pressures and minimise aerosols

• Luer-lock syringes – size greater than required volume – never more than 75% (¾) full

Avoid poor practices!

BEST PRACTICE

Vial-access products

• Designed to protect operator during preparation and reduce the risk of product contamination.

• PhaSeal® (Carmel)• Tevadaptor® (Teva)• Codan Cyto® (Codan)• Genie® (ICU Medical)• MixJect® (West Pharmaceuticals)• Ultrasite dispensing-pin® (B Braun)

sealed product system designed to minimise leakage

and spread of aerosols

Carmel Pharma of Mölndal, Sweden

Membrane in hub prevents air leakage through cannula

Expansion chamberPhaSeal®

system combines safety of closed, needle-free system

with ease of use Teva Europe Hospital Products & Specialties

Tevadaptor®

vial adaptor syringe adaptor connecting set

luer-lock adaptor

Codan Cyto®

Reliable aerosol Retention (99.999%)

Needle-free luer-lock

0.2 mm air filter & 0.5mm fluid filter

Vial-access products

• Cost benefit analysis advised!

• System may reduce risk of needlestick injury but other cheaper products also meet this criteria e.g. blunted needles / cannulae

• Other problems

– Manipulation skills

– Waste of drug e.g. if just 1ml trastuzumab inj

(Herceptin®) was lost to transfer device – could add £169.80 per patient per cycle

Ogden S; Eradiri O; Needle R Hospital Pharmacy Europe Issue 38 May/June 2008

• Deal with waste and spills promptly – do NOT leave to dry….

• Consider cleaning issues– Should be removal of cytotoxic residues and

breakdown into less toxic compounds– Some drugs may not be removed by wiping

with water or alcohol 70%– Some cytotoxic materials are affected by the

chemical nature of the cleaning fluide.g. doxorubicin resists alkaline solutions, but

does degrade in these

– Some agents degrade to more toxic by-products e.g. cyclophosphamide >

phosphoramide mustard + acrolein

BEST PRACTICE

Roberts S et al; J Oncol Pharm Practice 2006 12: 95-104

• Dispense in ready-to-administer form• Wipe outside of containers• Leak-proof over-wrap

BEST PRACTICE

• Clear Labelling• Primary & Secondary

• Safe Packaging – Lightweight, Leak-proof, Unbreakable / Protected

• Controlled storage

• Controlled Transport & Distribution– No detours within institution

• Spillage Kit available • Clear Procedures + Contact No’s for emergency

• Trained personnel

BEST PRACTICE

International Society of Oncology Pharmacy

Practitioners

• Guidelines available on site– Actual risks or procedures depend on area and

nature of spill

• PPE Personal Protective Equipment • Containment• Prompt action• Disposal facilities• Spillage kits – may need local additions -

neutralisers etc.

• Incident reporting / documentation

Spillages

Controlled working environment

– protective equipment, facilities, access

Safe work practices • Standardised Prescribing / Ordering / Documentation

systems to reduce errors • Detailed, written procedures and safe work practices for all

aspects of handling cytotoxic drugs (including the management of spills)

• Only by specially trained personnel in conditions which protect workers and environment as well as protecting integrity of product

Education & training of personnel– Periodic evaluation and validation of the training

Focus of safety:

Recent studies - if control measures in place– reduced staff exposure– reduced mutagenic activity in urine– reduced incidences of adverse effects

Risks & hazards can be controlled

Turnover of personnel - Not advised“The employer must reduce to the lowest level the

number of employees exposed or likely to be so” (90/394/CEE) – Because there is not a safe minimum level of exposure, any

exposure could cause harm– Experienced operators make fewer errors

Organise work to reduce / minimise: amount of drugs used duration of exposure number of employees potentially exposed

• Eliminate – physically remove the risk

• Reduce – do less – do less of the hazardous task or – handle less material, – introduce safety systems such as better equipment, improved working practices and procedures

• Inform - tell everyone– show how to avoid or minimise problem

•Control – supervise – stay on top, monitor

Risks & hazards can be controlled

Thank you Thank you very Muchvery Much

That’s all folks!That’s all folks!

Acknowledgements: This presentation owes much to the work of:• Prof. Graham Sewell• Mrs. Maria Connolly • Mr. Mark Oldcorne