Safe Handling of Hazardous drugs

1. Best Practice: Practical Aspects of Safe Handling Safe Handling of Hazardous drugs Tim Sizer University of Leeds 2008 .

2. Scary!!! Warning! Working with or near hazardous drugs in health care settings may cause skin rashes, infertility, miscarriage, birth defects, and possiblyleukaemiaorothercancers NIOSH = National Institute for Occupational Safety & Health 2004

3. 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:

4. Contamination is widespread AND • 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

5. 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.

6. ControlledWorkingEnvironment Engineering Controls 3 aspects • product protection • environment protection • controlled access • SafetyCabinet(ClassIIBiologicalSafety Cabinet)in Class B (Grade 2) clean room • Isolatorin Class C or D clean room • negative pressure vs positive pressure • flexible film vs. rigid • gaseous sterilisation vs. traditional transfer

7. ControlledWorkingEnvironment Engineering Controls • Reserved for hazardous products • Minimal storage • Adequate space for safe working Ergonomic design Fully cleanable surfaces and furniture Waste Disposal arrangements

8. ControlledWorkingEnvironment Administrative Controls 4 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 & competencytesting should be regular - annually

9. ControlledWorkingEnvironment Administrative Controls Procedures • No of staff involved kept to a minimum • Adherence to recommended work practices (+ the use of engineeringcontrols and PPE) has been shown to substantially reduce workerexposure to antineoplastic drugs • Standardised Prescribing / Ordering / Documentation systems - reduce errors • Clear, unambiguous, detailed written SOP’s • Use illustrations / diagrams – in SOP’s & workplace

10. ControlledWorkingEnvironment 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

11. ControlledWorkingEnvironment PersonalProtectiveEquipment-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

12. 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 Nitrileor 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

13. 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

14. BEST PRACTICE Avoid poor practices! • 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

15. 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)

16. 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 chamber PhaSeal®

17. system combines safety of closed, needle-free system with ease of use Teva Europe Hospital Products & Specialties Tevadaptor® luer-lock adaptor vial adaptor syringe adaptor connecting set

18. Codan Cyto® Reliable aerosol Retention (99.999%) Needle-free luer-lock 0.2 mm air filter & 0.5mm fluid filter

19. 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

20. BEST PRACTICE • 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 fluid e.g. doxorubicin resists alkaline solutions, but does degrade in these • Some agents degrade to more toxic by-products e.g. cyclophosphamide > phosphoramidemustard + acrolein • Roberts S et al; J Oncol Pharm Practice 2006 12: 95-104

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

22. International Society of Oncology Pharmacy Practitioners 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+ContactNo’s for emergency • Trained personnel

23. Spillages • Guidelines available on site • Actual risks or procedures depend on area and nature of spill • PPEPersonal Protective Equipment • Containment • Prompt action • Disposal facilities • Spillage kits – may need local additions - neutralisers etc. • Incident reporting/documentation

24. 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) Onlyby 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:

25. 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 f duration of exposure • number of employees potentially exposed

26. Risks & hazards can be controlled • Eliminate– physically remove the risk • Reduce– do less – do lessof the hazardous task or – handle less material, – introduce safety systems such as better equipment, improved working practices and procedures • Inform - tell everyone –showhowto avoidorminimiseproblem • Control – supervise– stay on top, monitor

27. That’s all folks! Thank you very Much • Acknowledgements: • This presentation owes much to the work of: • Prof. Graham Sewell • Mrs. Maria Connolly • Mr. Mark Oldcorne