Standard of antiblastic drug administration

ANTIBLASTIC DRUG ADMINISTRATION

Marina Bragagni and Anita Zeneli

THEORETICAL AND PRACTICAL COURSE IN ONCOLOGY

for Nurses, Medical Doctors and

Pharmaceutical Technicians

Day 2° -June 10th 2014 Oncology Conference Room

Bugando Medical Center - Mwanza

Learning program

� Principles and standard for Chemotherapy management:

� Avoiding drug administration errors; � The 10 Rights to consider before and

during antiblastic drug administration

� learning questionnaire

What happens to the prepared medications ?

The most frequent administration errors

• Wrong prescription

• Wrong patient

• Wrong drug

• Wrong dose

• Wrong time and order

• Wrong route

• Wrong expiration date/hour

Principles and standard for Chemotherapy management

Avoiding drug administration errors:

1. Staff administer chemotherapy

• The Oncology nurses should be specifically trained in the specific aspects of cancer care, including chemotherapy management.

• Providing nursing care to patients undergoing chemotherapy presents many challenges.

Nurses must have knowledge of:

– pharmacology of antineoplastic agents, – proper techniques of ,

, – drug interactions, – possible . – technique of venipuncture and the of various types venous

and drug administration systems. – proper techniques of individual and environmental protection (

) – Nurses and families to manage side effects of chemotherapy

and to report symptoms of potentially serious side effects to avoid serious consequences.

Wich kind of errors ?

Patient identification error

Patient clinical condition error

Patient information error

2. Right Patient Avoiding Wrong patient errors

What can you do to avoid error? Before drug administration call the patient by: Name Surname Date of birth

2. Right Patient – Identification error –

It is the only way to avoid this kind of error!

What can nurses do to avoid it ?

Nursing Assessment before chemotherapy administration!

Nurses need to know

Who, what, why

about the patient undergoing chemotherapy

2. Patient – wrong clinical condition

It is the only way to avoid this kind of error!

Before chemotherapy administration, the infusion nurse should assess:

• Patients’ physical status

• Cancer diagnosis and stage

• Nurses should be aware of all the exam results and general implications *

• Allergies and history of other hyper-sensitivity reactions

• Venous status, if the access device is needed for chemotherapy

administration

• Psychosocial concerns assessment

2. Patient – wrong clinical condition

What can nurses do to avoid it ? Nurses should:

Verify the level of patients’ knowledge

of the disease and its treatment

Check informed consent for chemotherapy

Nurses must know the chemotherapy treatment plan,

cycle, and goals of therapy*.

2. Patient – wrong information

Name Surname : ____Pinco Pallino_ Birthday: /01/01/1960/ Tumor site: oropharynx

Date: /08/06/2014/

Cognitive status: ; Allert �Verbal � Pain �Unresponsive

ADL (ACTIVITIES OF DAILY LIVING): ; Independent � Needs help � Bedridden

Bowel: ; physiological � Incontinent � Constipation Particular conditions:__No__

Feeding: ; Normal diet � Liquid diet

Urine elimination: ; Physiological � Incontinent � Bladder catheter Insertion date:__________

Access devices and vein status: � Peripheral access device Insertion date: _________________ ; PICC Last medication date: ______________

Allergies: ; No � Drug name: _______ � Hyper-sensitivity reactions ___________

Medical devices presence : ; No � Thoracic drainage � Hepatic drainage � Ureterocutaneostomy � Tracheostomy � Nasogastric tube

Comorbidity: ; No � HIV � TBC Skin lesions: ; Yes � No Site: ___________________ � Other: ________________

Other: _____________________________________________________________________________

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Pinco Pallino 08/06/2014 08.00

Remember Always: IF YOU HAVEN’T TICKED IT, YOU HAVEN’T ASKED IT!

Nursing Diary

Surname

Date of birth

Name

Gender

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Remember Always: IF YOU HAVEN’T TICKED IT, YOU HAVEN’T ASKED IT!

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Remember Always: IF YOU HAVEN’T TICKED IT, YOU HAVEN’T ASKED IT!

3. Equipments

Why you have to take the right protective equipments to handle cancer drugs ?

The healthcare professionals may be exposed to a drug throughout

its life cycle: � from manufacture � to transport and distribution, � to use in health care or home care settings, � to waste disposal.

Use the right equipments to protect:

� yourself; � your patients, � your collaegues � the environment from the drug contamination

Because the harmful effects associated to the anticancer agents exposition are well documented.

What can nurses do to avoid it?

Nurses must verify some information about the drug � Drug Name: CHECK the correspondence between the prescribed schema and the prepared drug on the label! (Dose, time, administration order) �Drug adverse events: (YOU MUST BE INFORMED ABOUT AE1: immediate or late? Is premedication required? Beware of possible serious effects2! Inform the patient, recognize AE, tell the doctor, treat with doctor, monitor, record) �Drug stability and conservation mode (photosensitive or not ? Store drug in the fridge or at room temperature ? for how long ?) �Appearance and physical integrity of the drugs

�Administration route and infusion devices needed for administration

4. Right drug - Wrong drug error

To achieve the therapeutic effect, the drug must reach a certain concentration in the

plasma to be maintained for a defined time

Possible errors: Wrong dose

Wrong time and order Wrong route

Wrong expiration date/hour

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PHARMACOKINETIC AND PHARMACODYNAMIC

PHARMACOKINETIC: “What the body does to the drug” Correlation between the plasma concentration of the drug and the time rating: absorption, distribution, metabolism, excretion1 How long the drug remain in the patients body PHARMACODYNAMIC:“What the drug does to the body2” Correlation between the plasma concentration of the drug and its effects on the organism and disease Therapeutic effect and toxic effect

It is important to comply with the right administration route, time and dose, for achieving the desired therapeutic effect of the drug on the disease with fewer side

effects for the patient3

5. Right route and order

� Topical � Oral � Intravenous � Intramuscular � Subcutaneous � Arterial � Intracavitary � Intrathecal routes

it is very important to administer the drug as prescribed by the oncologist because the drug efficacy depend from the administration route also. It is based on the results of previous DRUG’S PHARMACOKINETIC AND PHARMACODYNAMIC STUDIES

BE CAREFUL AT THE SAME CHEMOTHERAPY SCHEMA,

THERE MAY BE DIFFERENT ROUTES OF DRUG ADMINISTRATION!

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6. Right time – Wrong time errors

Possible errors:

Wrong drug infusion rate/duration Wrong drug administration order

ATTENTION: ADMINISTER THE DRUG BY THE RIGHT

ADMINISTRATION TIME! Drug efficacy/unefficacy and drug induced toxicity

depend on it!

Right time

How to calcolate the infusion rate? There are two methods of calculating flow rates: � the number of millilitres per hour and � the number of drops per minute.

Note: Commercial brands of intravenous equipment differ and there are variations in the size of openings of drip chambers and consequently in the number of drops per millilitre. Drops per millilitre are indicated on the container boxes of I.V. infusion

sets. Common drip factors are: � 10, 15 and 20 drops per millilitre for MACRODRIPS � 60 drops per millilitre for MICRODRIPS

Right time

How to calcolate the infusion rate? � Method 1. The number of millilitres per hour (ml/hr) The hourly rate of infusion can be calculated by dividing the total infusion volume by the total infusion time in hours. TOTAL ML FLUID TO BE GIVEN = ML Hour TOTAL HOURS TO BE GIVEN IN Example: 1000 ML = 125 ML/HOUR 8 HOURS

Right time How to calcolate the infusion rate? � Method 2. the number of drops per minute (drops/minute) The drops per minute must be regulated to ensure that the prescribed amounts of solution will infuse. Drops per minute are calculated by the following formula: DROPS/ML X AMOUNT OF FLUID TO BE INFUSED = DROPS/MINUTE TOTAL TIME OF INFUSION (in minutes) Example: If the order for the I.V. is 100 ml/hour the formula is: 10 DROPS/ml X 100ml = 16.7 drops/min. 60 minutes

Drip flow regulation is controlled by tightening or releasing the roller clamp (white plastic clamp) and counting the drops falling into the drip chamber.

For microdrip administration sets note that: drops/minute = mls/hour.

7. Right dose – Wrong dose error Why? Drug efficacy / toxicity

For oncologists : Dosage calculation must be based on: � patient’s total body surface area � previous response to chemotherapy or radiation therapy � major organ function

For Nurses (Assessments): � Before the chemotherapy prescription assess the height, weight and organ function by laboratory to all patients undergoing chemotherapy. � After chemotherapy prescription: prepare medications with dosages prescribed by the oncologist � Before the chemotherapy administration check the correspondence of individual drug dosing parameters on the drug labell with the prescribed schema .

What can you do to avoid it?

8. Right expiration date

Before the drug administration CHECK the expiration date and hour!

When was the drug prepared?

How was the drug conserved?

Is the drug still active ?

What can you do to avoid it ?

Name of the active substance PHOTOSENSIBILITY STABILITY FROM DILUTION TIME

CONSERVATIONE TEMPERATURE OF PREPARED DRUG

SOLUTION

Paclitaxel albumina NO 8 h 2°-8°

Doxorubicina NO NN NN Carmustina SI 24 h 2°-8°

Bleomicina NO 24 h T.ENV Busulfano NO 12h+3h 2°-8°

Leucoverin NO NN 2°-8°

Carboplatino SI 24h 2°-8° Carmustina SI estempora NN Cisplatino SI 48 h 2°-8°

Citarabina SI at most 24h 2°-8°

Daunorubicina SI NN 2°-8°

Citarabina rilas prolungato NO estempora NN

Dacarbazina SI NN Docetaxel anidro SI 3 days (2°-8°) 2°-8°

Doxorubicina Cloridrato SI 28 days (2°-8°) 2°-8°

Doxorubicina NO 24 h 2°-8°

Vindesina NO 24 h 2°-8°

Ciclofosfamide NO (2-3 h) 24 H T.env o 6 gg if

conserved 2°-8° Epirubicina SI 28gg (2°-8°) 2°-8°

Cetuximab NO 20 h SI Cetuximab NO 48 h T. 25° Etoposide NO 120 h ma 0,2 mg/ml 25°

Epirubicina radiologia NN NN Fludarabina NO 28 gg 2°-8°

PREPARED ANTIBLASTIC DRUGS

CONSERVATION CONDITIONS

Name of the active substance FOTOSENSIBILITY STABILITY FROM DILUTION TIME

CONSERVATION TEMPERATURE OF PREPARED DRUG SOLUTION

Fluorouracile SI 48 h NO

Gemcitabina cloridrato NO 5 DAYS (2°-8°) 2°-8° Gemcitabina NO 24h NO Ifosfamide NO 24 h 2°-8°

Topotecan NO 24 h 2°-8° Irinotecan NO 72 h 2°-8°

Bendamustina cloridrato NO 3,5 h T. amb/48 h 2°-8° 2°-8°

Methotrexate SI 24 h T.ENV

Mitomicina SI

USE AS SOON AS POSSIBLE 2° - 8°

Fotemustina SI 0,2 mg- 2 mg/ml 8 H NO Vinorelbina SI 8 days 2°-8° Carmustina SI 1-2h NN

Mitoxantrone NO 24h 2°-8° o T.<25° Oxaliplatino NO 48 h 2°-8° Oxaliplatino NO 24 h 2°-8°

Docetaxel NO 48 h 25°C

Temsirolimus SI 6 h T. < 25° Vinblastina NO 24 h SI

Vinblastina solfato NO 24 h 2°-8° vincristina solfato NO _ 2°-8°

Vincristina SI 48 h 2°-8° 2°-8° Idarubicina NO NN NN

PREPARED ANTIBLASTIC DRUGS

CONSERVATION CONDITIONS

9. Right monitoring and assessment

Why monitor and assess?

To administer the drug safely

To evaluate the disease response to treatment1

To evaluate and document treatment-related toxicities

To modify dose or schema, to discontinuate treatment in

case of toxicities life threatening

To evaluate the adherence with the treatment regimen

When and how to do these evaluation ?

� Disease response

When? (eg,.. every 3 , 5, 6 cycles of therapy) How? (eg., laboratory results, or scans/imaging)

� Treatment-related toxicities evaluation

When? � Before chemotherapy prescription � During chemotherapy administration � During intercicle follow-up How? � PS evaluation � Physical examination, psycosocial concerns,…….. � Laboratory

Classification of Chemotherapy Side Effects

Designed to Facilitate Patient Education

Chemotherapic agents Adverse events

DRUG NAME

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METHOTREXATE X X X X X X X X X

HYDROSSIUREA X X X

FLUDARABINE X X X X X X 5-FU X X X X X X X X CISPLATIN X X X X X X OXALIPLATINO

X X X X X X X X

CHLORAMBUCIL X X X X X X X

IDARUBICIN X X X X X X PROCARBAZINE

X X X X X

EPIRUBICIN X X X X X X ACTINOMYCIN X X X X X

Chemotherapic agents Adverse events Drug name

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DAUNORUBICIN X X X X X X

DOXORUBICINA X X X X X X X X

GEMCITABINA XPLT X X X X

LEUCOVERIN X X

XELODA X X X X

PACLITAXEL XPLT X X X X X X X X X

DOCETAXEL XPLT X X X X X X

ETOPOSIDE X X X X X X

VINCRISTIN X X X X

CICLOFOSFAMIDE X X X X X

BLEOMICINA X X X

BONE MARROW SUPPRESSION*: NEUTROPENIA; ANEMIA; THROMBOCYTOPENIA

Drug Hyper - sensitivity reaction: What Nurses Need to Know ?

What is a hypersensitivity reaction (HSR)? HSR is an exaggerated immune response to an antigen which results in local tissue injury and may include life-threatening systemic effects. HSRs are more likely to occur with intravenous administration.

The HSR is a life-threatening emergency

How to recognise? signs and symptoms fever bronchospasm hemolysis rash, hives, pruritis dyspnea, feelings of impending doom vomiting back pain chills nausea angioedema rigors flushing circulatory collapse diaphoresis (sweating)

Why the HSRs may occur during antiblastic drug administration? 1. Complex, protein-based molecules are more likely to elicit the

immune-mediated response of an acute HSR, which accounts for the increased incidence of acute HSRs with infusions of biological agents such as monoclonal antibodies. These agents are often administered in ambulatory settings to patients with cancers (eg. Rituximab).

2. The smaller molecules, like the penicillins, bind to circulating serum proteins, resulting in increased size and antigenic potential in susceptible individuals. Some diluents used in medication admixture contribute to the risk for HSR. Cremophor, for example, is a diluent for paclitaxel, cyclosporin, and tenoposide.

Drug Hyper - sensitivity reaction: What Nurses Need to Know ?

Drug Hyper - sensitivity reaction: What Nurses Need to Know ?

How to manage? Stop, Call, Assess, Prepare !!!

If you suspect your patient is experiencing early symptoms of an acute HSR, don’t hesitate to implement your emergency interventions: 1. STOP the infusion but maintain IV access. 2. CALL the doctor. 3. ASSESS your patient further: collect vital signs, use a pulse oximeter to obtain

oxygen saturation, listen to breath sounds, and check for symptom progression. 4. PREPARE for emergency treatment, including the potential need to administer IV

fluids, oxygen, and resuscitative medications.

How to prevent ? 1. Assess and document the patient related risk factors1. 2. Premedicate with antihistamines and corticosteroids before the high-risk

drug administration 3. Begin slowly and then gradually increase the dose every 15 to 30 minutes to

induce tolerance. 4. Monitor closely the patient during the drug administration

How to recognise?

�Patient reporting �Visual assessment �Checking the infusion line

Signs and symptoms:

�Discomfort or pain, �Erythema, �Oedema �Discolouration �Slowing of the infusion rate �Lack of blood return from cannula

of the skin near the site near the

injection site.

How to prevent?

� Adequate IV site selection � Know your medications (neutral, irritant, vesicant) � Secure your IV device � Inform the patient to report immediately signs and symptoms � Blood return on before flushing � The IV site must be visible at all times during administration � Check IV site at least hourly or more often if there is any concern during an infusion

Extravasation – the inadvertent infiltration of vesicant/irritant solution or medication into surrounding

tissue.

EXTRAVASATION

MANAGAMENT

• Stop the infusion immediately. DO NOT remove the cannula at this point. Step 1

• Disconnect the infusion (not the cannula/needle). Step 2

• Leave the cannula/needle in place and try to aspirate as much of the drug as possible from the cannula with a 10 mL syringe.

•Avoid applying direct manual pressure to suspected extravasation site. Step 3

• Mark the affected area and take digital images of the site. Step 4

• Remove the cannula/ needle. Step 5

• Collect the extravasation kit (if available), notify the physician on service and seek advice from the chemotherapy team or

Senior Medical Staff. Step 6

• Administer pain relief if required. Complete required documentation. Step 7

How to manage it?

Drug induced Nephrotoxicity How to recognise?

�Hypertension �Fluid imbalance (positive); �Decrease in urine out put �Weight encreasing; �Oedema �Lab test: BUN,Cr

How to manage?

�Diuretic administration �Adequate hydration �Vital signs monitoring (BP, Weight, diuresis, fluid balance..ect)

How to prevent ?

�Adequate hydration associaetad to the nephrotosic drug administration

Monitoring and managing Common Gastrointestinal AEs (nausea, vomiting and diarrhea)

AE Monitoring and Management

Nausea and vomiting

� Ensure baseline and ongoing renal and hepatic function assays � Premedicate for anticipated nausea/vomiting � Monitor the daily number of the AEs � Encourage adequate hydration

Diarrhea � Monitor the daily number of the AEs � Adequate hydration � Antidiarrheal medications � Dietary measures/consult

It is very important to keep under control these Adverse events because they may become the cause of patient dehydration and consequently of increased toxicity.

10. Right documentation

What and when? �Document administration AFTER giving the ordered medication. �Chart the time, route, and any other specific information as necessary. For example, the site of an injection or any laboratory value or vital sign that needed to be checked before giving the drug, adverse events ect.

Why the ducumentation is important? � For cancer care continuity

�Between the professionals of the same team care � Between the professionals of different care setting

�For care quality �For desease response evaluations �For reserach �For legal issues

Now, I invite you to watch together the

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