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