Safe Administration & Preparation of Cancer Chemotherapy

KESHO Conference 2014

Irene Weru

Oncology Pharmacist

KNH

Irene Weru 2

Introduction

Anticancer Medicines are hazardous They have a narrow therapeutic index Classified as high alert medicines (HAMs) Many are metabolized by the Cytochrome P-450 –

interactions / alterations in concentrations Drug sequencing may increase or decrease the

antitumour effect or impact the severity of toxicities Calculation and manipulation of the actual dose to be

administered is based on many factors including

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Introduction

Safety considerations : Personnel & Care givers Patients Environment

Safety of Personnel & Environment

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Modes of Contact for Drug Exposure

Dermal

Ingestion

Inhalation

Injection

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ISOPP* Standards of Practice

Know Your Risk

Staff Training

Levels of Protection

*ISOPP =International Society of Oncology Pharmacy PractitionersJ Onc Pharm Pract 2007; 13 Suppl.

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Levels of Protection – Top to bottom

Level 1 – Elimination/substitution/replacement Level 2 – Isolation of the hazard/source

containment Level 3 – Engineering controls/Proper ventilation Level 3b – Administrative controls/ Organization

measures Level 4 – Personal protective equipment (PPE)

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Personnel at work in KNH

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Safe handling during reconstitution

Reconstitution has to take place in designated rooms Appropriate protective Gear MUST be worn before start of

procedure Gloves should be changed every 30 minutes. In case of visible contamination, gloves must be changed

immediately Ventilation slots should be left uncovered Work surfaces MUST be cleaned with water and afterwards

with 70% alcohol. All waste MUST be put in the appropriate waste reservoirs After completing procedure, and removing protective

equipment, staff should thoroughly wash hands and face

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Safe handling during administration and nursing of patients receiving cytotoxics Appropriate protective Gear MUST be worn before

start of procedure. Cover skin completely Use swab or cotton pad when injecting into a cytotoxic

drug solution When the application is finished, infusion system

should not be removed or broken off the bottle Contaminated linen should be put immediately into the

laundry bag Protective clothing should be worn when handling

excreta

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Storage of cytotoxic medicines

There should be designated areas for storing cytotoxic medicines.

These designated areas will have clearly visible labels The refrigerators for storing cytotoxic medicines will be

those that are easy to clean

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Handling spillages

After spillage of cytotoxic drugs, the contaminated area should be isolated and cleaned immediately

PPE should be worn during the cleaning Spilled substances should be soaked up with sufficient

quantities of absorbent material Contamination of shoes and clothing should be

avoided The spill kit should be replaced immediately after use

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Safe handling of orally administered cytotoxic drugs

All packages containing cytotoxic drugs should carry clearly visible warning label

Powder free gloves should be worn while counting tablets

A dedicated counting tray and disposable tongue depressor should be used

When tablets have to be broken, a plastic bag should be used

Counted tablets should be placed in a separately labeled dosage box

Tweezers should be used for administration

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Waste Disposal & Management

Cytotoxic waste includes all those materials which have come into contact with cytotoxic drugs during the process of reconstitution and administration

Cytotoxic waste must be segregated, packaged, and disposed of in a way that personnel and the environment are not contaminated.

Cytotoxic waste must be collected in clearly marked dedicated containers made from hard, robust material, which is shock-resistant and can withstand external pressure during transportation.

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Waste Disposal & Management (2)

The containers should be of a dedicated colour and display a recognizable symbol for cytotoxics.

All sharps waste must be placed in puncture resistant containers.

All cytotoxic waste must be placed in secondary packaging and sealed to ensure that leakage cannot occur, and must be clearly labelled to indicate the presence of cytotoxic waste.

Cytotoxic waste should be clearly labelled & stored in easily identifiable and dedicated storage area (awaiting incineration)

Cytotoxic waste must be incinerated in a facility approved for the destruction of cytotoxic waste.

Patient Safety

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Introduction

The overarching principle in medication use should be to ensure:

patients receive medications appropriate to their clinical needs

in doses that meet their own individual requirements for an adequate period of time at the lowest cost to them and their community

—WHO Conference of Experts Nairobi, 1985

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Safety for the Cancer Patients

Chemotherapy – high alert medicines Medicine doses may vary based on diagnosis and

protocol May have comorbid conditions Complex Regimen / Protocols Elderly and Young

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Factors to consider for specific medicines

Cumulative doses Route of administration Regimen Sequence of administration Other treatments (e.g radiation recall with doxorubicin) Renal & hepatic function Other Laboratory and Diagnostic results Compatibilities with infusion fluids and other medicines Pre - medication Side effects / adverse effects

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The Swiss Cheese Model

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Study – March to Dec 2010

13%

77%

7% 3%

Dispensing

Prescribing

Preparation

Administration

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25 5 6

11

19 19

2528

4851

0

10

20

30

40

50

60

1

Type of error

Nu

mb

er

No Dose

BSA calculation

Wrong route

Interaction

Contraindication

Required med notprescribedWrong Medicine /RegimenPremeds missing

Lower doses

Higher doses

Frequency / duration

Medication Safety Self Assessment for Oncology – ISMP

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Areas covered:

Patient information Drug information Communication of drug orders & other drug information Drug labeling, Packaging & Nomenclature Drug Standardization, Storage & distribution Medication device acquisition, Use and monitoring Environmental factors, workflow design & staffing

patterns Staff competency & education Patient education Quality processes & Risk management

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Patient Information

Essential Patient Information is obtained, readily available, in useful form and considered when prescribing, dosing, scheduling, dispensing, administering and monitoring chemotherapy, biotherapy and treatment related medicines

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Patient Information - 2

First & last name, DOB, Medical record number or other unique identifier

Cancer diagnosis (including stage) & Therapeutic goal, Comorbid & Chronic Conditions, Performance status

Allergies, Adverse Reactions history, Immunization status

Medication reconciliation Weight & Height Patency of access devices Informed consent

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Patient Information - 3

Essential patient information is used to monitor & manage the effects of chemotherapy, biotherapy & Treatment related medicines & to adjust the treatment plan when indicated by evidence – based practices

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Patient Information - 4

Easy access of laboratory values by authorized personnel

Electronic Medication order entry interfaced with laboratory

Baseline diagnostic & Laboratory tests – General & Treatment specific

Current laboratory values before each cycle Communication of relevant patient information Standardized toxicity grading scale Dose modification guidelines Documentation of lifetime cumulative doses

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Medicine Information

Essential drug Information is obtained, readily available, in useful form and considered when prescribing, dosing, scheduling, dispensing, administering and monitoring chemotherapy, biotherapy and treatment related medicines

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Medicine Information - 2

Standard references with annual renewal Internally developed tools Standardized protocols, guidelines, dosing formulae,

maximum dose recommendations, checklists Orders screened for contraindications, interactions,

appropriateness of doses Dose range checks Route of administration checks

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Medicine Information - 3

A controlled medicine formulary incorporates specific requirements, restrictions & considerations for chemotherapy, biotherapy & treatment related drugs ; driven by evidence based treatment algorithms, strength of evidence compedia & protocols Formal process for formulary inclusion Ability to monitor & manage adverse events of a

medicine by organization Safety enhancements Use of Non Formulary Investigational medicines

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Communication of Drug orders & Other Drug Information

Methods of communicating chemotherapy, biotherapy and treatment related medication orders and other drug information are standardized & Automated to minimize the risk of error

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Communication of Drug orders & Other Drug Information - 2

Basic information Timing of prescription writing Prescribing module interfaced with pharmacy,

Nursing, Laboratory Standard order sets sequence of critical information (Drug, dose, route,

infusion rate, total volume and duration) Verbal/telephone orders Who orders / prescribes chemotherapy (initial,

subsequent, change) Guidelines for evaluating patient at predetermined

intervals Use of generic prescribing

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Communication of Drug orders & Other Drug Information - 3

Look alike names: vinCRIStine / vinBLAStine; CISplatin / CARBOplatin

Acronyms are defined Specific days are written explicitly e.g Day 1, 2, 3 NOT Day 1- 3 Order sets Documentation of cycle number e.g cycle of 1 of 6 Verification of interval/ rest period Follow up of patient who miss scheduled sessions Clalculations before each cycle e.g BSA, Creatinine clearance, Trailing zeros never used e.g 10mg NOT 10.0mg Leading Zeros always used e.g 0.1mg NOT .1mg Dosing should be written for each day NEVER the entire dosing

for the course Standardized dose rounding procedures Processes for oral chemotherapy

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WHO safety strategies for vinCRIStine & other vinca alkaloids Dispensing in minibags NEVER in syringes

Prominent label “FOR INTRAVENOUS ROUTE ONLY – FATAL IF GIVEN BY OTHER ROUTES”

Presence of vinCRIStine is prohibited in areas where intrathecal medications are administered or stored

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Drug Labeling, Packaging & Nomenclature

Well Designed , readable labels that clearly identify medications as chemotherapy / biotherapy are present on all medication containers up to completion of drug administration

Typed / computer generated Auxiliary labels Standardized labels

Strategies are established to minimize the possibility of errors in the chemotherapy / biotherapy acquisition

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Drug Standardization, Storage & Distribution

Strategies to minimize the possibility of errors in the chemotherapy / biotherapy and treatment related medicines acquisition, storage , production and distribution process

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Drug Standardization, Storage & Distribution - 2

Preparation Authorized distributors Storage Investigational medicines Radio - labelled Medicines Look - Alike / Sound - Alike Non – Standard concentrations

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Drug Standardization, Storage & Distribution - 3

Provision of medicines in a safe secure manner & available for administration within a timeframe that meets the patients needs Delivery from Pharmacy Timeframes established & followed Prevention & Management of extravasations Prevention & Management of Emergencies

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Look - alike Medicines