safe prescription verification of systemic anti-cancer...

Safe prescription verification of Systemic Anti-cancer Therapies (SACT) by pharmacists

May 2015

Version 5.0

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Name of Pharmacist: …………….…….………………………………………………….

GPhC no.: ………………………………………………………………….……………………

Job Title: …………………………………………………………………………………………

Hospital Start Date: …………………………………………………………………………

Department Start Date: .……….…………………………..………………..…………..

Level of Practitioner (e.g.FS2/Band 6) …………………………….………………..

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LCA safe prescription verification by pharmacists: Accreditation Checklist ..................................................... 4

LCA SACT dose calculation examples and competency ..................................................................................... 5

SACT mock prescription verification examples and competency ................................................................... 10

SACT prescription verification Multiple Choice Question (MCQ) Test ............................................................ 44

SACT Supervised Prescription Verification Log................................................................................................ 49

LCA SACT pharmacist competency framework ............................................................................................... 50

Clinical Verification Standards ......................................................................................................................... 56

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The checklist below details the requirements for both local and LCA accreditation/sign-off.

A Pharmacist can be assessed as competent to verify SACT by designated assessors.

Each Trust will have a local list of accredited assessors.

MOCK PRESCRIPTIONS AND WORKED EXAMPLES

Completed examples in the LCA Trainee Workbook: Assessor’s details:

Date:

Correctly completed mock prescriptions in

workbook

Name:

Signature:

Job Title:

Correctly completed calculations in workbook

(Pass mark 100%)

Name:

Signature:

Job Title:

Completed MCQ test (Pass mark 80%) Name:

Signature:

Job Title:

SCREENING LOG

Log of supervised SACT prescriptions completed to

LCA criteria (refer to Passport accreditation

programme guidance):

Solid tumour First cycles

Haemato-oncology Clinical Trials

Oral Paediatrics

Assessor’s details:

Name:

Signature:

Job Title:

LOCAL REGISTER

Pharmacist’s name added to the local register for

clinical verification of SACT

Assessor’s details:

Name:

Signature:

Job Title:

If the above has been successfully completed, please ensure the LCA-assessor for your Trust is given the

paperwork to review and assess for LCA Passport competency.

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Pharmacists are required to achieve 100% accuracy in the calculations section in order to continue with the

accreditation programme.

In clinical practice if in any doubt with calculations please seek advice from a senior colleague.

You should attempt all questions and seek support where needed.

1. A 50 year old woman, diagnosed with metastatic breast cancer (bone and liver) presents for

chemotherapy treatment. She has been assessed as fit for treatment and you are happy her FBC is

acceptable. Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2 have been prescribed.

Calculate the dose of both drugs to be given if the patient’s Body Surface Area (BSA) is 1.6m2

a) Doxorubicin dose: …………………………………………………………

b) Cyclophosphamide dose: ………………………………………………

2. You are in clinic verifying prescriptions and need to check the correct dose has been calculated by the

prescriber:

a) For a drug that is usually prescribed at 75mg per kg; if the patient weighs 60kg,

what should the dose of the drug be in grams?

b) For a drug that is usually prescribed at 0.05g/kg; if the patient weighs 72kg,

what should the dose of the drug be in milligrams?

3. A patient is due to receive Rituximab, for the treatment of lymphoma, as part of R-CHOP 21 regimen at

a dose of 375mg/m2 three-weekly. This drug is a monoclonal antibody and the risk of a hypersensitivity

reaction is high, it is therefore given with paracetamol, chlorphenamine and prednisolone pre-

medications. To reduce the risk of a reaction the drip rate for the infusion is slowly titrated upwards.

The following instruction for the first dose at cycle 1 is given:

Infuse at a rate of 50mg/hour for 30 minutes and if tolerated increase by 50mg/hour every 30

minutes, to a maximum dose of 400mg/hour.

a) What is the dose of Rituximab the patient should be receiving (BSA 1.71m2)? Use the dose

banding table below:

BSA (m2) 1.30-1.39 1.40-1.49 1.50-1.59 1.60-1.69 1.70-1.79 1.80-1.91 1.92-2.06 2.07-2.20

Dose (mg) 500 550 550 600 650 700 750 800

Rituximab dose:

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b) What does your local Intravenous (IV) guide or chemotherapy guide suggest is an adequate

diluent volume for Rituximab for most patients?

c) Based on your answers from above, what rate should be entered on the infusion pump in

mL/hour for a bag of Rituximab? Please complete this without reference to a local standardised

table. Please show your workings and round answers to the nearest whole number.

Vial concentration =10mg/mL

Extra volume added to bag = 65mL

Total bag volume= 565 mL

Final bag concentration = 1.15mg/mL

4. Looking at the dose banding table below what would the dose of Rituximab be for a patient with a BSA

of 1.63m2?

BSA (m2) 1.30-1.39 1.40-1.49 1.50-1.59 1.60-1.69 1.70-1.79 1.80-1.91 1.92-2.06 2.07-2.20

Dose (mg) 500 550 550 600 650 700 750 800

Rituximab dose:

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5. You need to mix a drug which is prescribed at a dose of 675mg and the instruction indicates to dilute to

a concentration of 2mg/mL with either Sodium Chloride 0.9% or Glucose 5%.

a) What volume of diluent should be used?

b) What would be the volume of diluent if the final concentration was to be 4mg/mL?

6. A patient develops haematological toxicities and requires a dose reduction of 25%. If the starting dose

was 175mg what will the new dose be?

7. A patient has been dose reduced by 75% and the dose is now 187.5mg. What was the original dose?

8. You are asked to commence a drug for a patient who is participating in a clinical trial. The drug needs to

be administered at a rate of 2mg per minute for 15 minutes and then increase if tolerated to 4mg per

minute.

Calculate the rate to be administered in mL/hr. The drug dose is 150mg and the bag contains 75mL.

(NB: you will need to sit with the patient and press stop on the pump at the end of 15 minutes)

9. You are asked to commence a drug for a patient who is participating in a clinical trial. The drug needs to

be administered at a rate of 1mg per minute for 15 minutes and then increased if tolerated to 3mg per

minute.

Calculate the rate to be administered in mL/hr. The drug dose is 145mg and the bag contains 58mL.

(NB: you will need to sit with the patient and press stop on the pump at the end of 15 minutes)

10. You need to give atropine as a part of the pre-medication for Irinotecan.

The drug comes in 600 micrograms in 1mL.

The dose prescribed is 0.25mg, how many mLs need to be administered so the patient receives the

correct dose?

11. What volume of diluent [Water For Injections (WFI)] needs to be added to reconstitute a 150mg

powder vial to achieve a concentration of 21mg/mL considering the displacement value of 0.14 per vial:

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12. a) What volume of diluent (WFI) needs to be added to reconstitute a 500mg powder vial to achieve a

concentration of 50mg/mL

b) For the above question how many mL are needed if the displacement value of 0.3mL is taken to

achieve the 50mg/mL concentration

c) The above drug needs further dilution to achieve a maximum concentration of 5mg/ml.

What volume should this dose be made up to if the dose to be given is 750mg?

d) If the 750mg was put into a 250 mL bag what is the rate in mLs/hour that this drug can be

administered over if the minimum infusion rate is 10 mg/minute?

13. Mrs KA is to receive Cisplatin at a dose of 80mg/m2.

She is 72 years old, weighs 52kg Height 165cm and her Serum creatinine is 68 micromol/L

(The recommended dose reductions in renal impairment are (GFR > 60ml/min give 100% dose; GFR

45-59ml/min >give 75% dose; <45ml/min consider carboplatin)

For the purposes of this question please round your answer to the nearest mg.

What is an appropriate dose of Cisplatin for Mrs KA? Please round your answer to the nearest whole

number.

Use the Cockcroft and Gault equation for renal function and Dubois method for BSA

14. Mrs KA returns 3 weeks later for cycle 2 of her cisplatin and her renal function has deteriorated; her

serum creatinine is now 90micromol/L

a) Calculate her new GFR

b) The doctor decides to change her drug to carboplatin AUC6. What dose should she be having (Use

Calvert equation)

(NB: carboplatin doses are usually rounded to the nearest 50mg)

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15. Mr LM is prescribed a Xelox regimen (oxaliplatin 130mg/m2 IV day1 and Capecitabine 1000mg/m2 twice

a day days 1 -14. His BSA is 1.81m2.

a) How many tablets of capecitabine should he be dispensed in total? (Round dose to the nearest whole

tablet combination)

On his next visit, the doctors decide to add 8mmols of magnesium into his fluid bag. The Nurse only

has 50% Magnesium Sulphate Injections

b) How many mLs of this preparation are needed?

16. Drug X is stable for 72 hours in 5% Glucose at a concentration of 0.35mg/mL to 1.5mg/mL. The drug is

available in 100mg vials each of which has to be reconstituted with 4.7mL of WFI; each vial has a

displacement value of 0.3mL. How many mLs of this reconstituted solution would you need and what

volume range of 5% Glucose would be suitable to dilute 245mg of Drug X in?

17. A patient is to receive the IVE regimen; please work out the chemotherapy bags that would need to be

made up with reference to the drugs and diluents for a patient whose BSA is 1.6m2.

IVE Protocol:

Epirubicin 50mg/m2 Day 1 only,

Etoposide 200mg/m2 Day 1 – 3 in 1000ml Sodium Chloride 0.9% over 2 hours

Mesna 1.8g/m2 Day 1 in 100ml Sodium Chloride 0.9% over 30min (pre Ifosfamide)

Ifosfamide 3g/m2/day Day 1 – 3 with Mesna 3g/m2/day D 1-3 prophylaxis

(administered as two bags of 1.5g/m2 Ifosfamide mixed with 1.5g/m2 Mesna each over 11 hours in

1000ml Sodium Chloride 0.9%)

Mesna 5.4g/m2 Day 3 in 1000ml Sodium Chloride 0.9% over 12 hours (post Ifosfamide)

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The following mock prescriptions should be screened in conjunction with the SPC, local protocols, local

guidelines and LCA protocols (available on the LCA website). Consideration should be given to NICE and CDF

funding.

Please refer to the clinical summaries and any other references to screen the chemotherapy prescriptions

and indicate any prescribing errors identified and/or interventions in the boxes below.

Useful links www.medicines.org.uk

www.londoncanceralliance.co.uk

www.nice.org.uk

www.england.nhs.uk

Case Regimen Clinical verification criteria

1 FEC-T

2 R-CHOP

http://www.medicines.org.uk/

http://www.londoncanceralliance.co.uk/

http://www.nice.org.uk/

http://www.england.nhs.uk/

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3 Docetaxel

4 Carboplatin +

Pemetrexed

5 Capecitabine

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6 FOLFIRI + Bevacizumab

7 EC

8 Ipilimumab

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9 Ifosfamide + doxorubicin

10 FOLFOX + Cetuximab

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CASE 1: Oncology & Haematology Directorate Systemic Therapies Referral Form

Patient Details

Patient name Belinda Pocket

Hospital number 0001

NHS number 12345671

DOB 26/4/63

Disease Information

Primary disease Breast cancer

Stage

Disease status

Histology HER 2+

Treatment Information

Aim Adjuvant

Line 1st line

Regimen FEC-T + Trastuzumab SC

No. of cycles 6 cycles chemo + 18 cycles trastuzumab

Response assessment after

Concurrent radiotherapy

Funding

Blood results

Date Hb WBC Plt N

29/9/14 100 4 150 1.5

Biochemistry

Date ALT Bili Cr CrCl (C&G) EDTA

29/9/14 38 16 64

Hickman line/PICC line

LVEF (MUGA/ECHO) 65% Date 18/7/14

ECG

Lung function

Completed by A Doctor Date 14/7/14

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CASE 1 (continued)

The NHS Trust. Administration Breast Unit Ward: MDU

Patient Name: <Belinda Pocket > Patient Number: <0001 > Date of Birth: <26/4/1963 > NHS No: 12345671

FEC-T (FOR ADJUVANT BREAST CANCER)

Cycle 4 (repeat every 3 weeks) for 3 cycles followed by 3 cycles Docetaxel 100mg/m2

Dosing Comments (e.g. 25% dose reduction due to G3 diarrhoea)

Version 1.0

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 164 75 1.8 <version number 1.0>

Allergy Status

Confirmation for Day 1

Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.0 x109/ Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min LVEF FUNDING

Signatures Clinical Confirmation A Doctor Confirmation

comments:

Pharmacy Confirmation

Day/Date Admin Time Drug Dose Route Infusion Duration

Administration Details Date First

check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14 -20min

Dexamethasone 8 mg IV bolus

Ondansetron 8 mg PO stat

T=0

EPIRUBICIN 100 mg/m² 180 mg IV bolus Via fast-running sodium chloride 0.9% infusion

CYCLOPHOSPHAMIDE 500 mg/m² 900 mg IV bolus Via fast-running sodium chloride 0.9% infusion

FLUOROURACIL 500 mg/m² 900 mg IV bolus

Prescribed by: Prescriber signature A Doctor

Date 1/10/14 Screened by:

Pharmacist signature Cordless Date

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CASE 1 (continued)

The NHS Trust. TTO Breast Unit Ward: MDU

Patient Name: <Belinda Pocket >

Patient Number: <0001 >

Date of Birth: <26/4/1963 >

NHS No: 12345671

FEC-T

(FOR ADJUVANT BREAST CANCER) Cycle 4 (repeat every 3 weeks) for 3 cycles followed by

3 cycles Docetaxel 100mg/m2

Dosing Comments

(e.g. 25% dose reduction due to G3 diarrhoea) Version 1.0

___________

Check (Initials) Date

Height

(cm)

Weight

(kg)

BSA

(m2) <version number 1.0>

29/9/14 164 75 1.8

Allergy Status

Day/’Date Drug Dose Route Directions Pharmacy

Disp / Check Pharmacy Release Check / Location

DAY 1

1/10/14

Dexamethasone 4 mg PO TDS for 3 days

Ondansetron 8 mg PO BD for 3 days

Domperidone 10 mg PO TDS for 3 days, then PRN

I have confirmed with the patient that they understand how and when to take the above medication(s) and the main side effects.

Include the following counselling if appropriate:

☐ Cycle 1 chemotherapy ☐ Dose changes

____________________ __________________ ____/____/____ _____:_____

Counselled by (signature) Designation Date Time

TTO given to patient or carer by:

____________________ __________________ ____/____/____ _____:_____

Given by (signature) Designation Date Time



Pharmacist signature

Cordless

Date

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Patient Details

Patient name Jacob Marley


NHS number 12345672

DOB 3/2/45

Disease Information

Primary disease Non-hodgkin’s lymphoma

Stage

Disease status

Histology


Aim Curative

Line 1st line

Regimen R-CHOP

No. of cycles 6

Response assessment after 3

Concurrent radiotherapy No

Funding NICE

Blood results

Date Hb WBC Plt N

29/9/14 107 100 273 5.4

Biochemistry


29/9/14 52 23 64


LVEF (MUGA/ECHO) 72% Date 25/9/14

ECG

Lung function

Completed by A Doctor Date 1/10/14

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CASE 2 (continued)

The NHS Trust. Administration Lymphoma Unit Ward: MDU Version 1.0 Patient Name: < Jacob Marley >

Patient Number: < 0002 > Date of Birth: <03/02/1945 > NHS No: 12345672

R-CHOP FOR NON-HODGKIN’S LYMPHOMA

Cycle 1 (repeat every 3 weeks)


Date Heig

ht (cm)

Weight (kg)

BSA (m2)

29/9/14 184 83 2 <version number 1.0>

Allergy Status NKDA


Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.0 x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min FUNDING

Signatures Clinical Confirmation A Doctor

Confirmation comments:




check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14

-30mins

Paracetamol 1000 mg PO

Chlorphenamine 4mg PO

Prednisolone 100mg PO Days 1-5 use TTO supply (page 2)

T= 0 RITUXIMAB 375 mg/m² (check funding approval)

750 mg IV See

protocol 500ml sodium chloride 0.9% Variable rate. See protocol

+1h 30mins

*1 hours 30 minutes is the minimum time to start the Ondansetron if Rituximab is given by the fast infusion method. This time may be exceeded if the Rituximab infusion above takes longer than 1 hours 30 minutes.

Ondansetron 8mg PO

+1h 50mins

DOXORUBICIN 50mg/m² 100 mg IV bolus Via fast-running drip

VINCRISTINE 1.4mg/m² (max 2mg)

2 mg IV 5-10 min in 50mL sodium chloride 0.9%

CYCLOPHOSPHAMIDE 750mg/m²

1440 mg IV bolus Via fast-running drip




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CASE 2 (continued)

The NHS Trust. TTO Lymphoma Unit Ward: MDU

Patient Name: < Jacob Marley > Patient Number: < 0002 > Date of Birth: <03/02/1945 > NHS No: 12345672

R-CHOP FOR NON-HODGKIN’S LYMPHOMA


Dosing Comments (e.g. 25% dose reduction due to G3 diarrhoea) Version 1.0

__________ Check (Initials

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 184 83 2 <version number 1.0>

Allergy Status NKDA

Day/Date Drug Dose Route Directions Pharmacy


DAY 1 1/10/14

PREDNISOLONE 100 mg PO OD for days 1-5

Allopurinol 300mg PO OD for cycle 1 only (supply 3 weeks)

Metoclopramide 10 mg PO TDS for 3 days then PRN for the relief of sickness (supply 1 op)

Co-Trimoxazole 480 mg PO BD Mon Wed Fri (supply 3 weeks)

Lansoprazole 30mg PO OD (supply 3 weeks)

Filgrastim Weight < 80kg 30MU daily Weight > 80kg 48MU daily

__30___ MU SC OD Days 10-14

I have confirmed with the patient that they understand how and when to take the above medication(s) and the main side effects.

Include the following counselling if appropriate:


____________________ __________________ ____/____/____ _____:_____ Counselled by (signature) Designation Date Time

TTO given to patient or carer by: ____________________ __________________ ____/____/____ _____:_____ Given by (signature) Designation Date Time




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Patient Details

Patient name Horatio Fizkin


NHS number 12345673

DOB 6/11/52

Disease Information

Primary disease Prostate cancer

Stage

Disease status Metastatic

Histology


Aim Palliative

Line 1st line

Regimen Docetaxel + Prednisolone

No. of cycles up to 10



Funding NHS

Blood results

Date Hb WBC Plt N

1/10/14 117 3.4 318 2.6

Biochemistry


1/10/14 58


MUGA/ECHO

ECG

Lung function

Completed by_______ A Doctor Date __1__/_10__/_14__

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CASE 3 (continued)


Patient Name: <Horatio Fizkin > Patient Number: <0003 > Date of Birth: <06/11/1952 > NHS No: 12345673

DOCETAXEL ADJUVANT/ NEOADJUVANT



Version 1.0

Date Heig

ht (cm)

Weight (kg)

BSA (m2)

30/9/2014 193 92 2.2 <version number 1.0>

Allergy Status Penicillin rash


Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.0 x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) ml/min

Signatures

Clinical Confirmation A Doctor Confirmation comments:


Day/Date Admin Time

Drug Dose Route Infusion Duration


check Start time

Sign. nurse

Stop time Sign. nurse

DAY 1 1/10/14

-30 mins Dexamethasone 12 mg IV bolus

T=0 DOCETAXEL 100mg/m2 220 mg IV 1 hour In 250ml or 500ml glucose 5%




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CASE 3 (continued)


Patient Name: <Horatio Fizkin > Patient Number: <0003 > Date of Birth: <06/11/1952 > NHS No: 12345673

DOCETAXEL ADJUVANT/ NEOADJUVANT



___________ Check (Initials)

Date Height (cm)

Weight (kg)

BSA (m2)

30/9/2014 193 92 2.2 <version number 1.0>

Allergy Status Penicillin rash



DAY 1 1/10/14

Domperidone 10 mg PO TDS for 3 days, then PRN

Dexamethasone 8 mg PO BD for 3 days starting the day before chemotherapy

Filgrastim 300 micrograms SC Inject 300micrograms by SUBCUTANOUS injection ONCE a day for 7 days starting on day 5

I have confirmed with the patient that they understand how and when to take the above medication(s) and the main side effects. Include the following counselling if appropriate:







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Patient Details

Patient name Amy Dorrit


NHS number 12345674

DOB 20/8/55

Disease Information

Primary disease Squamous cell Lung cancer

Stage 1

Disease status Loco-regional

Histology


Aim Curative

Line 1st line

Regimen Carboplatin + Pemetrexed

No. of cycles 4


Concurrent radiotherapy no

Funding

Blood results

Date Hb WBC Plt N

1/10/14 102 2.6 234 2.1

Biochemistry


1/10/14 33 12 104 44


MUGA/ECHO

ECG

Lung function


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CASE 4 (continued)

The NHS Trust. Administration Lung Unit Ward: MDU

Patient Name: <Amy Dorrit > Patient Number: <0004 > Date of Birth: <20/8/1955 > NHS No: 12345674

CARBOPLATIN + PEMETREXED Cycle 1 (repeat every 3 weeks)


Version 1.0

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 159 54 1.5 <version number 1.0>

Allergy Status NKDA



Signatures Clinical Confirmation A. Doctor





check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14

-30 min

Hydroxocobalamin 1 mg IM Give week before dose 1, and once every 3 cycles thereafter (cycle 4) Cross off if not required

Dexamethasone * 8 mg IV bolus

*Only give if dexamethasone oral pre-med has not been taken. (Cycle 1 only). Prescribe additional required doses – see TTO section

Ondansetron 8 mg PO

0 min PEMETREXED 500 mg/m² 750 mg IV 10 min

100 mL Sodium Chloride 0.9% via 0.2 micron filter

30 minute break between end of pemetrexed infusion and start of carboplatin infusion.

30 min CARBOPLATIN AUC 5 Dose = (EDTA + 25) x AUC

360 mg IV 1 hour 500 mL Glucose 5%

Prescribed by: Prescriber signature A. Doctor



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CASE 4 (continued)

The NHS Trust. TTO Lung Unit Ward: MDU

Patient Name: <Amy Dorrit > Patient Number: <0004 > Date of Birth: <20/8/1955 > NHS No: 12345674

CARBOPLATIN + PEMETREXED Cycle 1 (repeat every 3 weeks)


__________ Check (Initials)

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 159 54 1.5 <version number>

Allergy Status NKDA



DAY 1 1/10/14

Dexamethasone 4 mg PO BD for 5 days starting the day before chemotherapy

Domperidone 10 mg PO TDS for 5 days

Folic Acid 400 micrograms PO OD (supply 21 days)

Hydroxocobalamin 1 mg IM For dispensing purposes only. Please use administration section for giving dose to patient.

I have confirmed with the patient that they understand how and when to take the above medication(s) and the main side effects. Include the following counselling if appropriate: `




Prescribed by: Prescriber signature A. Doctor



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Patient Details

Patient name Clara Barley


NHS number 12345675

DOB 13/9/41

Disease Information

Primary disease Breast Cancer

Stage

Disease status

Histology


Aim Palliative

Line 3rd line

Regimen Capecitabine

No. of cycles Until progression



Funding n/a

Blood results

Date Hb WBC Plt N

1/10/14 112 2.6 153 0.9

Biochemistry


1/10/14 56 26 135 44


MUGA/ECHO

ECG

Lung function


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CASE 5 (continued)

The Royal Marsden NHS Trust. TTO Breast Unit Ward: OP

Patient Name: <Clara Barley > Patient Number: <0005 > Date of Birth: <13/09/1941 > NHS No: 12345675

CAPECITABINE Cycle 2 (repeat every 3 weeks)


__________ Check (Initials)

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 164 72 1.8 <version number 1.0>

Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.5x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min

Allergy Status NKDA

Confirmation for Day 1 Checked by AD (initials) 1/10/14 (date) 14:30 (time)

Day/’Date Drug Dose Route Directions Pharmacy


DAY 1

1/10/14

CAPECITABINE 1250mg/m² (i.e. 2500 mg/m²/day) Available as 150mg and 500mg tablets

AM 2150 mg PM 2150 mg

PO Take for 14 days continuously, followed by a 7 day rest. Swallow whole within 30 minutes after a meal and approximately 12 hours apart.

Metoclopramide 10 mg PO TDS, when required for the relief of sickness

Loperamide 2 mg PO Take TWO capsules after first loose stool, then ONE capsule after each loose stool when required for the relief of diarrhoea. Maximum 8 capsules per day.








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Patient Details

Patient name Oliver Twist


NHS number 12345676

DOB 06/06/73

Disease Information

Primary disease Colorectal cancer

Stage 4

Disease status Metastatic

Histology RAS wild type


Aim Palliative

Line 2nd line

Regimen FOLFIRI + Bevacizumab

No. of cycles 6



Funding

Blood results

Date Hb WBC Plt N

1/10/14 112 3.2 266 1.5

Biochemistry


1/10/14 40 12 82


LVEF (MUGA/ECHO)

ECG

Lung function


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CASE 6 (continued)

The NHS Trust. Administration GI Unit Ward: MDU

Patient Name: <Oliver Twist > Patient Number: <0006 > Date of Birth: <06/06/1973 > NHS No: 12345676

FOLFIRI + BEVACIZUMAB Cycle 1 (repeat every 2 weeks)


Version 1.0

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 178 64 1.8 <version number>

Allergy Status NKDA


Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.5x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min BP ≤150/100 mmHg Urine Dipstick Proteinuria ≤++ FUNDING


comments:

BP 160/105 trace protein




check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14 0

BEVACIZUMAB 5mg/kg

Funding required Dose round see protocol

325 mg IV 10

minutes

in 100ml sodium chloride 0.9%. If not tolerated administer subsequent infusions over 60-90 minutes

+ 30min

Ondansetron 8 mg PO stat


Atropine 0.25 mg SC bolus

+ 1 hr IRINOTECAN 180mg/m2 240 mg IV 1 hour in 500ml glucose 5%

+ 2 hr FOLINIC ACID 400mg/m2 720 mg IV 1 hour in 250ml glucose 5%

+ 3 hr FLUOROURACIL 400mg/m2 mg IV bolus over 5 minutes

+3 hr 30min FLUOROURACIL 1200mg/m2/day 2100 mg IV 24 hours continuous infusion

DAY 2 +3 hr 30min FLUOROURACIL 1200mg/m2/day 2100 mg IV 24 hours continuous infusion




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CASE 6 (continued)

The NHS Trust. TTO GI Unit Ward: MDU

Patient Name: <Oliver Twist > Patient Number: <0006 > Date of Birth: <06/06/1973 > NHS No: 12345676

FOLFIRI + BEVACIZUMAB Cycle 1 (repeat every 2 weeks)



Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 178 64 1.8 <version number 1.0>

Allergy Status NKDA



DAY 1 1/10/14


Metoclopramide 10 mg PO TDS for 3 days, then if required

Loperamide 2 mg PO Take TWO after first loose stool then ONE after each loose stool. Contact the doctor if diarrhoea is severe or persists for more than 24 hours.

Ciprofloxacin 250 mg PO BD for 7 days. To take after seeking medical advice if diarrhoea persists longer than 24 hours

Lansoprazole 30mg PO OD Supply on odd numbered cycles

CVAD flushing kit (PICCs, tunnelled catheters) Implanted Venous Port flushing kit (implanted ports) Please tick

Only for patients with central venous access devices

I have confirmed with the patient that they understand how and when to take the above medication(s) and the main side effects. Include the following counselling if appropriate: ☐ Cycle 1 chemotherapy ☐ Dose changes






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Patient Details

Patient name Dora Spenlow


NHS number 12345677

DOB 16/5/49

Disease Information

Primary disease Breast cancer (ABVD 20 years ago for HL)

Stage 1

Disease status Loco-regional

Histology HER 2+


Aim Neo-adjuvant

Line 1st line

Regimen EC –T

No. of cycles 4+4



Funding

Blood results

Date Hb WBC Plt N

1/10/14 140 4.0 269 2.6

Biochemistry



LVEF (MUGA/ECHO)

ECG

Lung function


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CASE 7 (continued)


Patient Name: <Dora Spenlow > Patient Number: <0007 > Date of Birth: <16/5/1949 > NHS No: 12345677

EC Cycle 1 (repeat every 3 weeks)


Version 1.0

Date Height (cm)

Weight (kg)

BSA (m2)

1/10/14 176 83 1.96 <version number 1.0>

Allergy Status NKDA


Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.0 x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min

Signatures


Pending biochemistry




check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14 -10mins

Dexamethasone 8mg IV bolus

Ondansetron 8mg PO stat

T = 0 Epirubicin 90mg/m2 170mg IV bolus via a fast running infusion of sodium chloride 0.9%

+ 30mins Cyclophosphamide 600mg/m2 mg IV bolus via a fast running infusion of sodium chloride 0.9%




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CASE 7 (continued)


Patient Name: <Dora Spenlow > Patient Number: <0007 > Date of Birth: <16/5/1949 > NHS No: 12345677

EC Cycle (repeat every 3 weeks)


Version 1.0


Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 176 83 1.96 <version number>

Allergy Status NKDA



DAY 1 1/10/14

Dexamethasone 4mg PO TDS for 3 days

Domperidone 10mg PO TDS for 3 days, then prn

Ondansetron 8mg PO TDS for 3 days

I have confirmed with the patient that they understand how and when to take the above medication(s) and the main side effects. Include the following counselling if appropriate: ☐ Cycle 1 chemotherapy ☐ Dose changes






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Patient Details

Patient name Sydney Carton


NHS number 123455678

DOB 23/11/67

Disease Information

Primary disease Melanoma

Stage

Disease status Unresectable

Histology


Aim Advanced

Line 1st line

Regimen Ipilimumab

No. of cycles



Funding

Blood results

Date Hb WBC Plt N

1/10/14 121 4 260 1.6

Biochemistry


1/10/14 200 43 80


LVEF (MUGA/ECHO)

ECG

Lung function


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CASE 8 (continued)

The NHS Trust. Administration Skin & Melanoma Unit Ward: MDU

Patient Name: <Sydney Carton > Patient Number: <0008 > Date of Birth: <23/11/67 > NHS No: 12345678

IPILIMUMAB Cycle 5 (repeat every 3 weeks)

Dosing Comments (e.g. 25% dose reduction due to G3 diarrhoea) Grade 1 skin rash Version 1.0

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 80 <version number 1.0>

Allergy Status


Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.0 x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min FUNDING NICE

Signatures





check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14

T=0 Ipilimumab 3mg/kg 240 mg IV 90 mins In 100ml sodium chloride 0.9%




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CASE 8 (continued)

The NHS Trust. TTO Skin & Melanoma Unit Ward: MDU

Patient Name: <Sydney Carton > Patient Number: <0008 > Date of Birth: <23/11/67 > NHS No: 12345678

IPILIMUMAB Cycle 5 (repeat every 3 weeks)



Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 80 <version number 1.0>

Allergy Status



DAY 1 Prednisolone 20mg PO OD for 3 weeks








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Patient Details

Patient name Lucy Manette


NHS number 12345679

DOB 3/6/56

Disease Information

Primary disease Soft tissue Sarcoma

Stage

Disease status

Histology


Aim Advanced

Line 1st line

Regimen Ifosfamide + Doxorubicin

No. of cycles



Funding

Blood results

Date Hb WBC Plt N

1/10/14 130 3.6 120 1.5

Biochemistry


1/10/14 35 10 70


LVEF (MUGA/ECHO)

ECG

Lung function


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CASE 9 (continued)

The NHS Trust. Administration

Sarcoma Unit Ward: Dickens

Patient Name: <Lucy Manette > Patient Number: <0009 > Date of Birth: <3/6/56 > NHS No: 12345679

IFOSFAMIDE 9g/m2 + DOXORUBICIN 60mg/m2 over 3 days



Version 1.0

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 177 68 1.8 <version number 1.0>

Allergy Status NKDA


Critical tests FBC: Hb >90 g/L WCC >3 x109/L Plt >100 x109/L Neut >1.0 x109/L Biochem: Cr <60 µmol/L ALT <40 U/L Bil <17µmol/L CrCl (EDTA / C&G) >50ml/min


comments:




check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14

-1 hr Sodium Chloride 0.9% 500ml IV 1 hour

-10 min Dexamethasone 8mg IV bolus

Ondansetron 8mg PO bolus

0 DOXORUBICIN 20mg/m2 36mg IV

Via a fast running drip of sodium chloride 0.9%

+30 min Mesna 600mg/m2 1080mg IV 15 mins In 100ml sodium chloride 0.9%

+45 min Mannitol 10% 200ml IV 30 mins

+1 hr 15mins

IFOSFAMIDE 3000mg/m2 5400mg IV 4 hours In 1000ml sodium chloride 0.9%

MESNA 3000mg/m2 5400mg

+5 hr 15mins

Mesna 1800mg/m2 1080mg IV 12 hours In 100ml sodium chloride 0.9%

Prescribed by: Prescriber signature Date

Screened by: Pharmacist signature Cordless Date

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CASE 9 (continued)

The NHS Trust. Administration Sarcoma Unit Ward: Dickens





Version 1.0

<version number 1.0>



check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 2 -1 hr Sodium Chloride 0.9% 500ml IV 1 hour



0 DOXORUBICIN 20mg/m2 36mg IV bolus Via a fast running drip of sodium chloride 0.9%



+1 hr 15mins IFOSFAMIDE 3000mg/m2 5400mg

IV 4 hours In 1000ml sodium chloride 0.9%


+5 hr 15mins Mesna 1800mg/m2 1080mg IV 12 hours In 100ml sodium chloride 0.9%

DAY 3 -1 hr Sodium Chloride 0.9% 500ml IV 1 hour



0 DOXORUBICIN 20mg/m2 36mg IV Via a fast running drip of sodium chloride 0.9%



+1 hr 15mins IFOSFAMIDE 3000mg/m2 5400mg

IV 4 hours In 1000ml sodium chloride 0.9%


+5 hr 15 mins Mesna 1800mg/m2 1080mg IV 12 hours In 100ml sodium chloride 0.9%



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CASE 9 (continued)

The NHS Trust. TTO Sarcoma Unit Ward: Dickens






Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 177 68 1.8 <version number 1.0>

Allergy Status NKDA



DAY 1 1/10/14

Metoclpramide 10mg PO TDS

Dexamethasone 4mg PO TDS

Corsodyl 5ml MW QDS

Sodium Docusate 100mg PO TDS







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Patient Details

Patient name David Copperfield


NHS number 12345670

DOB 16/9/57

Disease Information

Primary disease Colorectal cancer

Stage 4

Disease status Metastatic liver + lungs

Histology RAS mutant


Aim Advanced

Line 1st line

Regimen FOLFOX + Cetuximab

No. of cycles 12



Funding

Blood results

Date Hb WBC Plt N

1/10/14 111 3.6 150 1.9

Biochemistry


1/10/14 40 17 60


MUGA/ECHO

ECG

Lung function


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CASE 10 (continued)

The NHS Trust. Administration GI

Unit Ward: MDU

Patient Name: <David Copperfield > Patient Number: <0010 > Date of Birth: < 16/9/57 > NHS No: 12345670

FOLFOX + CETUXIMAB Cycle 1 (repeat every 2 weeks)

Dosing Comments (e.g. 25% dose reduction due to G3 diarrhoea) Version 1.0.

Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 174 60 1.7 <version number 1.0>

Allergy Status NKDA



Signatures Clinical Confirmation A Doctor



Day/Date Admin Time Drug Dose Route Infusion Duration Administration Details Date First

check Start time

Sign. nurse

Stop time

Sign. nurse

DAY 1 1/10/14

-10 min Chlorphenamine 10 mg IV bolus


0 min

CETUXIMAB 500mg/m2

Funding required (NICE TA176: Cycle of 8)

850 mg IV 1-2 hours Cycle 1: 2 hours Cycle 2+ : 1 hour Use separate infusion set for cetuximab

Observe patient for 1 hour for hypersensitivity reaction on cycle 1 then on subsequent cycles if previous reaction. * 1hr is the minimum time to start the Ondansetron. This time may be exceeded if there is an observation time.

+1 hr *

Ondansetron 8 mg* IV bolus

OXALIPLATIN 85mg/m2 140 mg IV 2 hours in 250 or 500ml glucose 5% via a y-connector concurrently with folinic acid. (over 6 hours for laryngopharyngeal spasm)

FOLINIC ACID 400mg/m2 680 mg IV 2 hours in 250ml glucose 5%

+3 hr

FLUOROURACIL 400mg/m2 700 mg IV bolus over 5

minutes

FLUOROURACIL 1200mg/m2/day

2100 mg IV 24 hours continuous infusion

DAY 2 +27 hr

FLUOROURACIL 1200mg/m2/day

2100 mg IV 24 hours continuous infusion




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CASE 10 (continued)

The NHS Trust. TTO

GI Unit Ward: MDU

Patient Name: <David Copperfield > Patient Number: <0010 > Date of Birth: < 16/9/57 > NHS No: 12345670

FOLFOX + CETUXIMAB Cycle 1 (repeat every 2 weeks)

Dosing Comments (e.g. 25% dose reduction due to G3 diarrhoea) Version.


Date Height (cm)

Weight (kg)

BSA (m2)

29/9/14 174 60 1.7 <version number 1.0>

Allergy Status NKDA



DAY 1

1/10/14


Metoclopramide 10 mg PO TDS for 3 days, then if required

Diprobase cream topical Apply to the face, hands, feet, neck, back and chest ONCE in the morning. (Supply at cycle 1, then prn)

Hydrocortisone 1% cream topical Apply thinly to face, hands, feet, neck, back and chest ONCE at bedtime. (Supply 4 x 30g at cycle 1)

Lymecycline 408mg PO Take ONCE daily. (Supply 28 capsules on alternate cycles)

CVAD flushing kit (PICCs, tunnelled catheters)

Implanted Venous Port flushing kit (implanted ports) Please tick

Only for patients with central venous access devices

Advise patients to apply sunscreen (para-aminobenzoic acid [PABA] - free, sun protection factor (SPF) 15 or higher, UV-A, and UV-B protection) to exposed skin areas before going outdoors






Date 1/ 10/14 Screened by:


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44

This is an open book test – you can have access to all the necessary resources available in your

department. This may include local trust intranet systems and policies, national and regional guidelines

from bodies such as NHSE, NICE, NPSA, LCA etc. It must be completed independently.

You will have a maximum of 1 hour to complete this test

Please complete section A and Section B

Section A

Select one answer only from the following.

1. The NPSA RRR Risks of incorrect dosing of oral anti-cancer medicines (Jan 2008) makes the following

recommendations for reducing the risk of dosing errors with oral anti-cancer medicines:

a) Oral anti-cancer medicines should be prescribed in the context of written protocols and

treatment plans

b) Treatment should be initiated by a cancer specialist

c) Patient should receive both written and verbal instructions and be fully informed about their oral

anti-cancer therapy

d) All of the above

e) None of the above

2. Which one of the following formulae is commonly used to calculate the BSA for adult patients receiving

chemotherapy?

a) Calvert

b) Cockroft

c) Dubois

d) Jelliffe

e) Wright

3. Which of the following combination of tests should be routinely checked by an oncology pharmacist

when verifying chemotherapy prescriptions?

a) FBC, LFT,

b) FBC, tumour markers, biomarkers

c) FBC, LFT, Renal profile

d) FBC, Bone profile, Coagulation screen

e) LFT, Renal profile

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4. Which of the following combination of results before chemotherapy would indicate that chemotherapy

can be administered to a patient without further tests, dose reductions or delays?

a) ANC 4.0x109/L; platelets 65 x109/L; Bilirubin 18µmol/L; AST 20iu/L;

b) ANC 3.3 x x109/L; platelets 300 x109/L; Hb 6.5g/L; GFR 55mL/min;

c) ANC 0.8 x x109/L; platelets 100 x109/L; Sr Creatinine 160µmol/L; Bilirubin 25µmol/L

d) ANC 1.2 x x109/L; platelets 225 x109/L; GFR 80 mL/min; AST 25 iu/L; BIlirubin 12 µmol/L

e) ANC 1.2 x x109/L; platelets 260 x109/L; GFR 25 mL/min; AST 55 iu/L; Bilirubin 52 µmol/L

5. Which of the following combinations of anti-emetics drugs is commonly prescribed for limiting nausea

vomiting after a highly emetogenic regimen which includes high dose cisplatin?

a) Domperidone prn

b) Domperidone and Dexamethasone

c) Aprepitant, dexamethasone, ondansetron and domperidone

d) Aprepitant, ondansetron and domperidone

e) Dexamethasone and aprepitant

6. Which of the following statements regarding the national Cancer Drug Fund (CDF) is false?

a) The CDF is for additional drugs/indications that would not otherwise be funded by the NHS

b) The CDF applies to patients who live in England only

c) The CDF is used to fund medicines, interventional procedures, medical devices and radiotherapy

used in the treatment of cancer

d) NHS England is accountable for the management of the CDF

e) Individual CDF requests will be considered by NHS England for rarer types of cancers

7. What does a colorectal patient being treated with Cetuximab need to be tested for before

administration?

a) EGFR & BRAF status

b) HER 2 & CD20 status

c) KRAS & NRAS status

d) BRAF & NRAS status

e) CD20 status

8. Which of the following statements about GCSF products is not true?

a) GCSF may be given to patients before chemotherapy in some circumstances

b) Daily GCSF is administered on all the days between cycles

c) Pegfilgrastim is usually given to patients 24 hours after chemotherapy

d) Biosimilar GCSF products are available for use in the UK

e) GCSF can be prescribed for patients as secondary prophylaxis for some regimens

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9. Which one of the following is not essential to check for when you are verifying a prescription for single

agent Bevacizumab?

a) any recent major surgery within the last 28 days

b) the hypertension profile of the patient

c) current renal function status

d) a urine analysis test for proteinuria levels

e) approval from the cancer drug fund

10. Which one of the following drugs does not have a pregnancy prevention program recommended by

the manufacturers?

a) Thalidomide Celgene®

b) Revlimid®

c) Erivedge®

d) Imnovid®

e) Iressa®

Section B – Case study 1

A 58 year old male patient, Mr XC has been prescribed a XELOX regimen (also known as Cape/Ox, consisting

of Oxaliplatin and Capecitabine) and you are going through his medication to go home with. He reveals the

drugs which he is currently taking: Metoprolol 50mg bd; Ramipril 5mg od; Allopurinol 300mg daily; Maalox®

10mls tds; Warfarin 3mgs daily; Simvastatin 20mg nocte.

His height is 180cm and weight is 80kg; WBC= 5.6, ANC= 2.3, SrCr= 75µmol/L; Bilirubin= 12mmol/L.

11. What is the BSA of Mr XC using the Dubois method?

a) 1.66m2

b) 1.75m2

c) 1.86m2

d) 1.97m2

e) 2.00m2

12. What is the correct dose and duration of his Capecitabine tablets?

a) 1000mg twice a day for 14 days every 14 days

b) 1300mg twice a day for 21 days every 21 days

c) 1300mg twice a day for 14 days every 21 days

d) 2000mg twice a day for 14 days every 21 days

e) 2000mg twice a day for 21 days every 21 days

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13. Which of the following combination of preparations that he is on may need reviewing as they may have

a significant interaction with the capecitabine?

a) Ramipril and allopurinol

b) Metoprolol , Simvastatin and Maalox®

c) Allopurinol, Warfarin and Maaolx®

d) Ramipril, allopurinol , simvastatin and warfarin

e) Warfarin only

14. Mr XC comments that the capecitabine tablets are too large to swallow, and asks you how to take

them. Which of the following options would you recommend?

a) Still have to swallow them whole, and take one hour before food

b) May crush them up, transfer to a glass of water and swallow immediately, on an empty stomach

c) Allow to disperse in half a glass of water and take half an hour before food

d) Allow to disperse in half a glass of water and take 30 minutes after food

e) Cut the tablets in half with a tablet cutter and take them 30minutes after food

15. Mr XC comes back on the ward for cycle 2 and his serum creatinine rises to 130µmol/L.

What should his recommended doses be on cycle 2?

a) reduce capecitabine and oxaliplatin by 25%

b) leave capecitabine and oxaliplatin at 100%

c) reduce capecitabine by 25% and leave oxaliplatin at 100%

d) leave capecitabine at 100% and reduce oxaliplatin by 25%

e) leave capecitabine at 100% and omit oxaliplatin

Section B – Case Study 2

Mr AM is a 75 year old male, and comes into the ward for his first cycle of neo adjuvant ECX (epirubicin,

cisplatin, and capecitabine) for his newly diagnosed upper GI cancer. His blood results taken the day before

are as follows:

Ht= 170cm, Wt= 75kg; WBC= 8.2 x 109/L; ANC 4.7x 109/L; Platelets 300x109/L

SrCr= 85 µmol/L; Bilirubin 12 µmol/L; AST -25IU/L; ALT26 IU/L

16. What is the BSA for Mr AM using the Dubois method?

a) 1.75 m2

b) 1.78m2

c) 1.82m2

d) 1.86m2

e) 1.90m2

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17. What should the calculated doses be for his first cycle? (products may be dose banded)

a) Epirubicin 110mg Cisplatin 95mg ; capecitabine 1150mg bd

b) Epirubicin 90mg Cisplatin 110mg ; capecitabine 1250mg bd

c) Epirubicin 95mg Cisplatin 110mg ; capecitabine 1150mg bd

d) Epirubicin 95mg Cisplatin 120mg ; capecitabine 1150mg bd

e) Epirubicin 90mg Cisplatin 100mg ; capecitabine 1150mg bd

18. Mr AM goes home after chemotherapy on Day 1. On Day 9 he phones the pharmacy at 4pm and asks

you what to do because he has missed his morning dose of Capecitabine. As well as asking him to

inform the doctor at the next visit, you advise him to

a) Take the morning dose with the evening dose

b) Take the morning dose immediately and the evening dose as normal

c) Omit the evening dose today and continue as normal tomorrow

d) Omit the morning dose and take the evening dose as normal

e) Talk to the clinician who prescribed him the chemotherapy

19. On day 15, Mr AM phones you again at 9am to say that he has run out of tablets and is not sure about

when to get more supply. What should you do next?

a) Reassure him that he has completed his course and he will be given further supply on his next

visit

b) Confirm the dose he has been taking, look at pharmacy and prescription records, and then call

him back to reassure him that there isn’t a problem and he will get some more the next cycle

c) Confirm the dose he has been taking, look at pharmacy and prescription records, and then call

him back to reassure him that there isn’t a problem and he get some more from his GP who can

prescribe some more

d) Confirm the dose he has been taking, look at pharmacy records, and then tell him to return to the

pharmacy tomorrow as he may need further supply

e) Confirm the dose he has been taking, look at pharmacy records, and then call him to return to

the pharmacy immediately as he will need further supply.

20. On his visit to the hospital for cycle 2, his renal function has deteriorated (SrCr is now 110 µmol/L) and

his doses need to be reduced. What should his new doses be according to the LCA protocols?

a) Epirubicin 95mg Cisplatin 83mg ; capecitabine 1150mg bd

b) Epirubicin 85mg Cisplatin 95mg ; capecitabine 1150mg bd

c) Epirubicin 90mg Cisplatin 90 mg ;capecitabine 1250mg bd

d) Epirubicin 95mg Cisplatin 55mg ; capecitabine 1150mg bd

e) Epirubicin 70mg Cisplatin 110mg ; capecitabine 1150mg bd

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Trainee name: Date started:

Pharmacist accreditation log for SACT prescription screening

Please photocopy as required

Solid tumourS

Haemato-oncologyH

First cyclesF

Oral SACTO

Clinical TrialsCT

PaediatricsP

Page ____ of ____

Date Patient Initials

Chemotherapy Regimen & cycle no.

(Name/Acronym)

Type of prescription

e.g. S = Solid tumour

Comments

To be completed by the trainee pharmacist

Pharmacist’s signature

Accredited checker’s signature

Comments / additional problems

As identified by checker

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Systemic Anti- Cancer Therapy (SACT) Pharmacist Competency Framework

Outcome Theoretical Application: Competent Non-competent

Learning Outcomes achieved

1. Demonstrate a knowledge and understanding of blood results

Check laboratory values, FBC, U&E’s and LFT’s are within accepted limits if appropriate.

Check doses are appropriate with respect to renal and hepatic function and any experienced toxicities

Check other essential tests have been undertaken if appropriate

2. Demonstrates an ability to clinically verify IV SACT prescriptions

See clinical screening assessment below.

Completes necessary Trust SACT clinical screening test

3. Demonstrates an ability to clinically verify PO SACT prescriptions


Completes necessary Trust SACT clinical screening test

4. Demonstrates an ability to clinically verify Intrathecal SACT prescriptions


Completes Intrathecal training requirements

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5. Demonstrates knowledge and understanding of the correct storage, transportation & preparation conditions of SACT.

a) Shows the assessor the designated storage areas, and explains rationale for their use with respect to:

Room temperature SACT drugs

Refrigerated items SACT drugs

b) Shows the assessor the designated transportation bag/box used to transfer cytotoxic material from the aseptics department to the ward/department, and explains it’s rationale for use and the necessary PPE to be worn.

c) Shows the assessor the location of spillage kit and its contents and explains how to deal with spillage – wet and dry spillage

d) Shows the assessor how to find the trust spillage protocol and explains the documentation to be completed afterwards.

e) Explains the rationale for

The use of Protective personal equipment

The purple cytotoxic bins

6. Demonstrates knowledge of the HSE Intrathecal chemotherapy guidance in terms of the cautions necessary & explains how this relates to ones current role.

a) Shows where to find information and advice, with respect to:

Trust Policy and Lead Intrathecal Chemotherapy members of staff

b) Explains the measures in place to reduce the risk of the wrong drug being given intrathecally and names drugs known to have caused harm/death in the past, with respect to:

Competency assessment and the register and relevance in the clinical area

Vinka alkaloids – Minibags verses syringes – Adult and Paediatric Setting.

Presentation of signed prescription to pharmacy regarding release of drug

7. Demonstrates knowledgeable of the routes of the administration of SACT, and the rationale underpinning the choices

a) Explains the rationale for the different routes used predominately within their clinical area in relation to the patient and the regimen

Intravenous / Oral / Subcutaneous or Intramuscular/ Intrathecal

Topical / Isolated Limb Perfusion / Intra-arterial / Intra-cavity: Intra-vesical, Intra-peritoneal, intra-pleural, intra-ventricular (where appropriate)

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8. Demonstrates knowledge and understanding of oral SACT, the risks and associated risk management principles

a) Explains rationale as to why only clinicians listed on the Local SACT prescribing Registers are authorised to prescribe SACT including repeat oral prescriptions.

b) Explains the rationale of the need for a pre-treatment consultation specific to oral SACT.

c) Explains what actions would be taken in terms of prescribed/dispensed oral therapy if a patient’s ability changed in terms of cognition, ability to swallow, or dexterity has altered.

9. Demonstrates knowledge of the differences between research / clinical trial SACT from standard treatment.

a) Explains what a Serious adverse event is and how to report it.

b) Explains who to refer to for support and how to access the relevant clinical trial protocols both in and outside of working hours.

c) Explains how to determine what specific patient monitoring may be required and how to discover what these are and where these are to documented e.g. fluid balance chart, daily weights

d) Demonstrates how to access information about side effects for clinical trial drugs

10. Demonstrates knowledge & understanding of the different groups of SACT drugs, their actions

a) Explains the cell-cycle and the difference between cell-cycle phase specific drugs and cell cycle non-specific drugs and can give one example of each

b) Explains why single or combination therapy is used

c) Lists a minimum of three different groups of SACT drugs and gives a brief description of their modality of action (must include at least one targeted therapy).

d) Demonstrates where to find detailed information about the specific drugs and drug regimens to be administered, including clinical trial protocols.

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11. Demonstrates ability to recognise and respond to common SACT side effects and the interventions patients can use to try and reduce, prevent or cope with these.

a) Names one SACT drug that could cause each of the following common side effects and explains the associated nursing and medical management for each.

Acute nausea and vomiting

Stomatitis and mucositis

Diarrhoea

b) Gives one clinical example of a SACT drug that can cause the following organ toxicities, and explains the associated nursing / medical monitoring required for each, demonstrates where results of investigations can be found and actions to be taken if the results are unavailable.

Cardiac Toxicity

Pulmonary Toxicity

Nephrotoxicity

Hepatic Toxicity

c) Gives one recent practical example of the patient/ carer education in terms of strategies to prevent/reduce and manage their side effects. This must include evidence of

Information resources utilised

Documentation: information prescriptions

d) Explains the difference between immediate, short and long term side effects and how these can impact on Quality of life, function-ability and rehabilitation & survivorship.

e) Explains how side effect grading is determined and why it is needed in clinical practice e.g. Common Toxicity Criteria.

f) Explains which patients receiving SACT is at risk of myelo-suppression and the associated complications, with respect to:

Blood Results – reference ranges

Nadir of individual drug(s)

Monitoring

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12. Demonstrates the rationale underpinning the administration of supportive treatment

a) Check supportive care is prescribed and it is appropriate for the patient and regimen

b) Explains the rationale, the timing, routes of administration and side effects for the pre-medication and supportive treatment prescribed on the proforma e.g. anti-emetic, pre-hydration and antihistamines.

13. Demonstrates knowledge & understanding of the acute oncology and emergency presentations associated with SACT.

a) Ability to prevent, recognise and manage/treat the following SACT related emergency situations:

Neutropenic Sepsis

Tumour Lysis Syndrome

Nausea and Vomiting

Dehydration

Haemorrhage

Thrombus / Pulmonary Embolism

Allergic/hypersensitive reactions – including likelihood reaction with the with the drugs on the proforma

Anaphylaxis

14. Demonstrates the ability to provide information to a patient undergoing SACT treatment

a) Provides the patient (or assessor), with information regarding:

Information on where and how they are to receive these drugs and frequencies of future appointments

How to cope with side effects at home – self-care and self-management strategies

Provision of relevant supportive written material e.g. Macmillan Cancer Care Information, Locally produced booklets and hand held records.

Types of supportive therapy they may receive during the SACT journey

24-hour contact numbers.

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15. Demonstrates ability to clinically assess patients review medications and devise care plans for patients

a) Conduct medication review with patients documenting any issues with medications

b) Be able to devise an appropriate pharmaceutical care plan for patients.

16. Demonstrates ability to clinically assess patients and prescribe medications as a NMP

a) Completion of NMP qualification

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Outcome

The assessor has witnessed that pharmacist does

Competent Non-competent

Outcome

The Assessor has witnessed that pharmacist does

Competent Non-competent

1. Check prescribers details and signature are present and confirm they are authorised to prescribe SACT

10. Ensured that any concerns regarding patient understanding are addressed including carer concerns.

2. Ensure regimen has been through local approval processes e.g. clinical governance and financial approval and/ or is included on a list of locally approved regimens

11.Check body surface area (BSA) is correctly calculated, taking into account recent weight. Note there should be local agreement for frequency of monitoring and checking patient’s weight.

3. On the first cycle check the regimen is the intended treatment as documented in a treatment plan, in the clinical notes or in the electronic record

12. Check all dose calculations and dose units are correct and have been calculated correctly according to the protocol and any other relevant local guidance, e.g. dose rounding / banding

4. Check regimen is appropriate for patient’s diagnosis, medical history, performance status and chemotherapy history (using the treatment plan, clinical notes or electronic record)

13. Check cumulative dose and maximum individual dose as appropriate

5. Check there are no known drug interactions (including with food) or conflicts with patient allergies and other medication(s)

14. Check reason for and consistency of any dose adjustments, e.g. reduction(s) or escalations and ensure reason is documented.

6. Check that the timing of administration is appropriate i.e. interval since last treatment

15. Check method of administration is appropriate

7. Check patient demographics (age, height and weight) have been correctly recorded on prescription.

16. Check laboratory values, FBC, U&E’s and LFT’s are within accepted limits if appropriate

8. Check doses are appropriate with respect to renal and hepatic function and any experienced toxicities

17. Check other essential tests have been undertaken if appropriate

9. Check supportive care is prescribed and it is appropriate for the patient and regimen

18. Sign and date prescription as a record of verification

© London Cancer Alliance 2015

Published by London Cancer Alliance

London Cancer Alliance

5th Floor Alliance House

12 Caxton Street

London SW1H 0QS

www.londoncanceralliance.nhs.uk

http://www.londoncanceralliance.nhs.uk/

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