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PRACTICE STANDARD: HOW DO I START?
HARBANS DHILLONSENIOR PHARMACIST UNIVERSITY MALAYA MEDICAL CENTREKUALA LUMPURMALAYSIA
ONCOLOGY PHARMACY PRACTICE - CURRENT STATUS
In some developing countries CT drug handling practices are very dismal CT drug handling is no different than other
pharmaceuticals CT drugs rarely stored under the custody of
pharmacists Oncology practice sites lack basic infrastructure,
awareness & standard operating procedures
CURRENT STATUS – CONT…
Mixing of CT drugs carried out at patient bedside rather than isolated place
Lack of trained manpower Used & unused CT drugs are stored at patient bedside
making it a potential hazard for patients & practitioners
Healthcare professionals mostly unaware of potential hazards & safe practices
Only few practice sites in the region could be providing safe chemo reconstitution
ISOPP STANDARDS
Mission: To promote & enhance oncology pharmacy practice worldwide in order to improve cancer patient care
Global standard, approved by the total membership of ISOPP & based on existing best practice guidelines & highest norms & regulations from all over the world
For the moment mainly focused on the safety of product & manipulators
In the near future the safety for the patient from a clinical point of view will take a prominent part in the standard
ISOPP GOLD STANDARD
Standard Encompassing Best Practice Global Utility Occupational Health & Safety Use of Technology Education and Training Quality Use of Medicines
ISOPP STANDARDS
Published in Journal of Oncology Pharmacy Practice (2007) Supplement to 13: 1-81
In 2003 approval of a recommendation to establish a new Standards Committee
3 co-chairs were appointed from different regions Thomas Connor (USA) Robert McLauchlan (Australia) Johan Vandenbroucke (Belgium)
Working committee established Existing regulations, guidelines, standards or
recommendations from around the world were examined Structured database was established
ISOPP STANDARDS
Total of 15 documents were entered into the database Workers Compensation Board of British Columbia (CAN) British Columbia Cancer Agency (CAN) German Cytotoxic Workgroup (GER) National Board of Occupational Safety and Health (USA) Occupational Safety and Health Administration (UK) Brazilian Society of Oncology Pharmacy (BRA) Society of Hospital Pharmacists of Australia (AUS) UK Pharmaceutical Isolator Group (UK) Worksafe – Victoria Workcover Authority (AUS) Guidelines of University Hospital Gent (BEL)
ISOPP STANDARDS
10 ISOPP members were actively involved in the writing of the Standard: Asunciόn Albert-Mari, Spain Thomas Connor, USA Sylvie Crauste-Manciet, France Harbans Dhillon, Malaysia Dianne Kapty, Canada Robert McLauchlan, Australia Ioanna Saratsiotou, Greece Graziella Sassi, Italy N Victor Jimenez Torres, Spain Johan Vandenbroucke, Belgium
ISOPP STANDARDS
Evidence based in parts & best practice in parts Reviewing group
Mexico Japan Singapore Canada Belgium Germany South Africa
CONTENTS OF ISOPP STANDARD
1. Introduction and Definitions2. Transport of Cytotoxics3. Personnel4. Education and Training5. Hierarchy of Protection6. Sterile Facilities7. Containment Devices8. Ventilation Tools9. Non Sterile Preparations10.Chemical Contamination11.Checking Procedures
CONTENTS OF ISOPP STANDARD
12.Administration13.Cleaning Procedures14.Spills / Extravasation / Incidents15.Waste Handling16.Laundry17.Alerting Staff18.Homecare19.Risk Management20.Medicines Management21.Documentation
SECTION 1 & 2- IMPLEMENTATION
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
SECTION 2- ISOPP STANDARDS
External transport from supplier Primary containers, packaging, labelling, cytotoxic
spill management, receiving & inventory control Responsibilities of drug manufacturers
Internal transport of commercial product Packaging, labelling, spills
Internal transport of compounded admixture Packaging, drug transport, labelling, cytotoxic spill
management Documentation of cytotoxic drugs transportation
SECTION 3 PERSONNEL
Pharmacy Personnel Only Exclusions
Illness, Family Planning, Abnormal Pathology Results Health Monitoring Facilities Hygiene ISOPP standard dedicates the full responsibility
for the preparation of chemotherapy in the pharmacy under direct supervision of a pharmacist
STORAGE - ROOM TEMPERATURE
SECTION 3- ISOPP STANDARDS
Personnel Education & training Health considerations – informed about the risks of exposure Exclusions from working in cytotoxic preparation – illness, family
planning, abnormal pathology results Medical examinations Facilities Hygiene – no eating, drinking, chewing, no wearing of jewellery Staffing levels - number of staff members Work breaks – recommend a break every 2 hours Documentation – records of personnel working, duration of
shifts, location, number of manipulations, total amount of drug handled
SECTION 4- ISOPP STANDARDS
Education & training Potential risks Basic pharmacology Theory of aseptic
techniques Use of PPE Theory of containment
devices & barriers Theory of hierarchy of
protection measures
Handling of cytotoxic waste
Cytotoxic spills & accidental exposure
Prescribing of CT drugs Validation of CT
prescriptions Hospital policies &
procedures on cytotoxic management
CT drug use processes
SECTION 4- ISOPP STANDARDS
Training in the manipulation & safe handling of CT drugs Potential risks of exposure Working in a cleanroom Aseptic technique Use of PPE Use of containment devices Use of specialised equipment Handling of CT waste Dealing with CT spills
Emergency procedures Documentation Labelling & packaging Transport of CT Environmental monitoring Cleaning procedures Health monitoring Validation processes
SECTION 5 & 6 - ISOPP STANDARDS
Hierarchic order in protection measures for employees at their workplace
Level 1 - change product to another product which is non-toxic or less toxic
Level 2 – isolation of the hazard/source containment Level 3 – apply local & general engineering
controls/ventilation or extraction to dilute CT product Level 3B – administrative controls/organisation
measures to reduce duration of exposure Level 4 – PPE especially of gloves Facilities for sterile cytotoxic drug reconstitution & PPE
SECTION 11 CHECKING PROCEDURES
Computerised prescription Clinical checks Chemotherapy regimen Patient profile Body surface area (BSA) Dose calculations Premedications Laboratory parameters Preparation checks Assembly of raw materials
ISOPP standards state that all prescriptions of chemotherapy should be checked before the preparation of chemotherapy
Checking procedures
SECTION 11- ISOPP STANDARDS
Standard Operating Procedures
Assembly of Raw Materials
Preparation Process
Volume Reconciliation
Finished Product
Pharmacist & Non Pharmacist Staff
Validation of product Validation of the lack of
cross contamination Use of one cabinet to
prepare both CT & BCG vaccine is NOT RECOMMENDED
Validation of computer program
Product Preparation Checks Validation
SECTION 14- ISOPP STANDARDS
Location of Spill BSC/Isolator,
Cleanroom/Anteroom Storeroom, During Transport
Content of Spill Kit Spill Clean Up Procedure Contamination of Staff /
Patient Documentation & Reporting Contamination of staff &/or
patient
Multidisciplinary Institutional Policy
Alert to Presence of Vesicant
List of Vesicant Drugs
Extravasation Kit
Documentation and Reporting
Inclusion of Photograph of Site
CYTOTOXIC SPILLS EXTRAVASATION
WASTE MANAGEMENT
Leak proof & puncture proof sharps bins
Use of dedicated hardwalled carts
WASTE MANAGEMENT
Waste bags made of polyethylene or polypropylene, purple in colour
Segregated, packaged & disposed properly
Closed system disposal
Undertake waste collection frequently
Incineration at 1100°C
AUDIT TOOL
ISOPP members have access to an on-line audit tool allowing them to position themselves against the ISOPP standard but also against other organisations worldwide
ISOPP is closely cooperating in the ISMP to create the International Medication Safety Self Assessment® for Oncology
PRACTICAL SUGGESTIONS FOR IMPLEMENTATION
Establishing some basic guidelines &/or minimum standards for developing countries
Breakdown into phases for its easy implementation Promote the importance of safe handling of CT drugs in
the developing countries through seminars, symposia, media etc
A4SH website for help www.isopp.org
IMPLEMENTING A STANDARD
Local / Regional / National /International Standard Use the Standard to your advantage Work from general to specific Customise for your institution Create a timeline Know your limitations Inform/involve work colleagues Develop/foster useful relationships Assess impact of implementation
SAFETY IS IN YOUR HANDS
www.asia4safehandling.org www.isopp.org
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