PHARMACY PRACTICE & DEVELOPMENT DIVISION

MINISTRY OF HEALTH

PROTOCOl
HEPATITIS MEDICATION
THERAPY ADHERENCE CLINIC
(HEPATITIS MTAC)

2nd EDITION
REVISED 6 JUN 2018
Second Edition, 2018
Pharmacy Practice & Development Division
Ministry of Health Malaysia

ALL RIGHTS RESERVED

No part of this publication may be reproduced, stored or transmitted in any form or by any means
whether electronic, mechanical, photocopying, tape recording or others without prior written
permission from the Senior Director of Pharmaceutical Services Programme, Ministry of Health
Malaysia
 PREFACE
Viral hepatitis is one of the major public health problem in Malaysia
which needs serious attention. The number of Hepatitis B and
Hepatitis C cases in Malaysia is alarming and if the diseases left
untreated, more people would end up with cirrhosis, liver failure and
hepatocellular carcinoma. This longterm sequelae of the diseases
will lead to high burden of country’s health system.
In aligning with WHO’s Global Strategy on Viral Hepatitis targets to end HCV by 2030,
Ministry of Health Malaysia is inclined to treat more people living with HCV in the near
future. With the huge evolvement of Hepatitis C treatment from conventional standard
regime of interferon and ribavirin to the advent of oral Direct Acting Antiviral Agents
(DAAs), which promises higher curing rate and shorter treatment duration, more
patients will benefit from this treatment.
Therefore, the first edition of the Protocol Hepatitis Medication Therapy Adherence
Clinic Hepatitis (Hepatitis MTAC) that was published in 2015 has been revised to
provide guidance for pharmacist to play a larger role in this rapidly developing
therapeutic area. Due to the DAAs’ adverse effect profiles, high potential of drug-drug
interactions and potential for nonadherence, pharmacists have great opportunity to
expand their roles in providing pharmaceutical care to the patients.
As part of the healthcare team, pharmacists will participate even more in assisting
providers by providing guidance of identification and detection drug interactions,
educating patients about crucial importance of adherence, and prevention and
management of adverse effects.
Last but not least, I would like to thank the Task Force Hepatitis for their contribution
and commitment to the publication of this protocol.

DR KAMARUZAMAN SALEH, RPH.931

DIRECTOR
Pharmacy Practice and Development Division
Ministry of Health Malaysia

i
 ADVISORS
Dr. Kamaruzaman bin Saleh
Director
Pharmacy Practice & Development Division
MOH, Malaysia

Noraini binti Mohamad

Deputy Director
Pharmaceutical Care Section
Pharmacy Practice & Development Division, MOH, Malaysia

EDITORS
Nor Hasni binti Haron
Senior Principal Assistant Director
Pharmacy Practice & Development Division, MOH, Malaysia

Choe Sze Hwe

Senior Principal Assistant Director
Pharmacy Practice & Development Division, MOH, Malaysia

CONTRIBUTORS
(Alphabetical order)

Khoo Hui Fen

Pharmacist
Hospital Selayang, Selangor

Law Bee Keng

Pharmacist
Hospital Queen Elizabeth, Sabah

REVIEWER
Dr Haniza Binti Omar
Consultant Gastroenterologist & Hepatologist
Hospital Selayang, Selangor

Acknowledgement
Pharmacy Department Pharmacy Department
Hospital Selayang, Selangor Hospital Queen Elizabeth, Sabah

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CONTENTS PAGE
A. Introduction 1
B. Objectives 2
C. Scope of Service 2
D. Manpower Requirement 2
E. Appointment 2
F. Procedures
1. Patient Selection 3
2. Initial Visit 3
3. Subsequent Visits 4
4. Missed Appointment and Discharge Criteria 4
5. Pharmaceutical Review 5
6. Medication Dispensing and Counselling 6
7. Documentation 6
G. References 6
H. Appendices
1. Appendix Ia : Hepatitis MTAC Workflow (Initial Visit) 8
2. Appendix Ib : Hepatitis MTAC Workflow (Subsequent Visit) 9
3. Appendix II : Patient’s Profile & Assessment Form 10
4. Appendix III : ADR & Pharmaceutical Care Issue 12
5. Appendix IVa : Hepatitis C Knowledge Pre/Post Assessment Test 13
6. Appendix IVb : Ujian Pengetahuan Hepatitis C Sebelum/Selepas
Kaunseling 14
7. Appendix V : Pretreatment Counselling Checklist 15
8. Appendix VI : Compliance & Dispensing Record (12 or 24 weeks) 16
9. Appendix VIIa: Patient’s Drug Diary (for patient on DAAs) 17
10. Appendix VIIb: Diari Ubat Pesakit (untuk pesakit DAAs) 21
11. Appendix VIII : Treatment Dosing and Missed Dose Management 25
12. Appendix IX : Treatment Duration Charts 26
13. Appendix Xa : Side Effects of Direct Acting Antivirals 29
14. Appendix Xb : Side Effects of Pegylated Interferon + Ribavirin 30

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CONTENTS PAGE
15. Appendix XIa : Patient’s Medication Diary (for patient on Interferon
Ribavirin) 31

16. Appendix XIb : Diari Ubat-ubatan Pesakit (untuk pesakit Interferon

& Ribavirin) 33
17. Appendix XII : Treatment Dosing & Duration Table 35
18. Appendix XIII : Dosage Adjustment Table 36
19. Appendix XIVa: Self Injection Technique Checklist
S/c Pegylated IFN α-2a 37
20. Appendix XIVb: Self Injection Technique Checklist
S/c Pegylated IFN α-2b 38
21. Appendix XIVc: Self Injection Technique Checklist
S/c Standard Interferon α-2b 39

iv
A. INTRODUCTION

Hepatitis B (HBV) and hepatitis C virus (HCV) infections are global health problems and
remain as the most common infectious diseases worldwide. Latest data from World
Health Organisation (WHO) 2015 reported that 71 million people living with HCV
worldwide, of whom 399,000 die each year.1 Viral hepatitis was reported as the 7th
leading killer disease worldwide, with its attributed death increased by 63% from year
1990 to 2013.2 WHO estimated that there were 400,000 Hepatitis C patients in
Malaysia1 and the estimated incidence rate of hepatitis C infection is 8.35 per 100,000
populations in year 2016.3

Hepatitis C has been associated with many serious clinical sequelae, such as
development of hepatic fibrosis, cirrhosis of the liver and hepatocellular carcinoma.1,2
Management of this disease and its complication are a huge burden to the nation’s
economy. With the constant development of pharmaceuticals, Hepatitis C management
is undergoing a transformation of interferon-based treatment to oral-based direct-acting
antivirals (DAAs) which is very effective with faster and higher curing rates. However,
the prohibitive price have restricted access and use of DAAs in Malaysia. In 2017, the
Government of Malaysia had make a huge success by bringing in the DAAs at the lowest
possible costs. With the accessible of DAAs in Ministry of Health, more patients will be
benefit from this oral regime.

Participation of pharmacists in medication therapy management of patients has

bring many benefits by facilitate the adherence to their therapy, identify drug-drug
interactions, improve outcomes of drug therapy and increase the cost-effectiveness of
the treatment. These positive impacts had been proven in many studies done among
the pharmacist-managed clinic of chronic diseases such as hypertension,4 diabetes
mellitus,5 asthma,5 hyperlipidaemia,6 and hepatitis C.7-12

During Hepatitis Medication Therapy Adherence Clinic (MTAC) sessions,

pharmacists will work together with other healthcare team in order to assist patient to
achieve better therapeutic outcome. Their main contribution is to provide good
pharmaceutical care to hepatitis patients including identifying and responding to
potential opportunities for improvements in medication use especially in terms of drug-
drug interaction and adverse drug reaction.

1
B. OBJECTIVES

1. To maximise the benefits of medication therapy in hepatitis patients.

2. To provide in-depth education for care givers and patients regarding their disease(s)
including appropriate use of their medications and how to engage in wellness and
preventive precautions.
3. To collaborate with healthcare teams and provide consultative services on hepatitis
medication-related issues including adverse effects or complications.
4. To assist patients in achieving treatment goals by improving adherence to
medications and their engagement in the process.
5. To customise counselling for specific medication(s) and follow-up with individualised
medication therapy management.

C. SCOPE OF SERVICE

1. The Hepatitis MTAC service will operate in the clinic area during clinic days or
outpatient pharmacy when necessary.
2. The Hepatitis MTAC pharmacist will perform a multitude of duties throughout the day:
assessing patients and addressing their needs, documenting interventions and plans,
providing appropriate education to patients/caregivers and completing follow-ups.
3. Activities at the clinic should be structured according to the suggested workflow (refer
Procedures).

D. MANPOWER REQUIREMENT

At least one (1) pharmacist should be placed in the clinic during Hepatitis MTAC session.

E. APPOINTMENT

All appointments will be scheduled by the pharmacist or other healthcare provider

participating in the clinic.

2
F. PROCEDURES

1. PATIENT SELECTION
All Hepatitis C patients who are planned for treatment with DAAs or interferon (in
circumstances where the patient is regarded as ineligible or unsuitable for DAAs by
the prescriber)

2. INITIAL VISIT
(Education, Assessment & Dispensing)

2.1 The pharmacist will interview the patient and/or the caregiver and perform initial
assessment on the patient.
The initial evaluation will involve:
a. Patient information
b. Social and family history
c. Past medical & medication history including prescribed medications,
OTC, traditional medication/ drink and health supplement
d. Medication knowledge and adherence towards treatment (if there is
other comorbidity)
e. Allergic status (drug and non-drug)
f. Diet & lifestyle
g. Relevant radiology and laboratory investigations (FBC,
BUSE/creatinine, coagulation profile, LFT, UPT, thyroid function test,
HBsAg & etc)
h. Hepatitis Knowledge Pre Assessment Test (refer Appendix IV)

2.2 For patients on Direct-acting Antiviral Agents (DAAs), examine drug-drug and
drug-supplement interaction with DAAs based on Product Inserts or website of
www.hep-druginteractions.org and explain missed dose management.

2.3 Introduce the program and pharmacist role in hepatitis management

2.4 Provide Hepatitis Education & Pre-Treatment counselling (refer Education

Material & Appendix V)

2.5 Identify pharmaceutical care issues (if any)

2.6 Document on related forms (refer Appendix II & III)

2.7 For patients on DAAs, issue Patient’s Drug Diary (refer Appendix VII), dispense
medications and fill in Compliance & Dispensing Record (refer Appendix VI)

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 2.8 For patients who are treated with interferon and ribavirin, issue medication diary
(refer Appendix XIa/b)

3. SUBSEQUENT VISIT
(Assessment, Monitoring, Counselling & Dispensing)

3.1 Patient’s subsequent appointments should be based on the patient’s next clinic
appointment date. However, the MTAC pharmacist may contact patient to
reschedule appointment date based on the following criteria:
a. Poor adherence
b. Dispensing date
c. Other reasons

3.2 During subsequent visit, pharmacist will review the patient and conduct:
a. Examination of patient’s understanding and emphasize on the
importance of adherence and its relationship of achieving sustained
virological response (SVR) (refer Education Material)
b. Adherence assessment for oral pills by doing pill count and assessing
Patient’s Drug Diary (refer Appendix VI & VII)
c. Reassessment of patient’s drug knowledge (Possible drug-drug
interaction, common side effects and how to overcome/ minimize,
missed dose management)
d. Adverse drug reaction monitoring (refer Appendix III)
e. Virological response and relevant laboratory investigations
f. Post-assessment test at 4th week of treatment (refer Appendix IV) to
reassess patient’s understanding
g. Reassessment on injection technique (for patient on interferon) (refer
Appendix XIV a/b/c)

3.3 Dispense medication and fill in Compliance & Dispensing Record (refer
Appendix VI), decides on next appointment accordingly and documentations
(refer Appendix II & III)

4. MISSED APPOINTMENT AND DISCHARGE CRITERIA

4.1 Patient who missed MTAC appointment will be contacted to reschedule next
follow up date with the pharmacist.

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 4.2 Completion of Hepatitis MTAC programme is considered when treatment course
is completed and patient is followed up till 12 weeks post end of treatment (SVR
12) OR

4.3 Treatment is discontinue by physician due to clinical reasons

5. PHARMACEUTICAL REVIEW
5.1 To be done by Hepatitis MTAC pharmacist at the earliest opportunity based on
patient selection criteria, or after referral by prescribers/ other healthcare
professionals

5.2 Identify medication-related problems:

 E.g. ADRs, renal adjustment dose, interactions, contraindication etc.

5.3 Solve medication-related problems:

 Consider non-pharmacological therapy that may help
 Identify the most suitable pharmacological therapy that may help to prevent
or solve the problem (consider the pros and cons of each therapeutic
alternative)
 Formulate patient-specific action plan with patient and prescriber using
holistic approach (i.e consider the patient’s medical, social and financial need)

5.4 Monitor drug therapy:

 Monitor patient’s adherence to the pharmacotherapy plan
 Follow-up patient’s disease progression (e.g. laboratory investigations etc.).
Discuss with patient and prescribers to ensure the achievement of desired
outcomes; modify the existing plan if necessary
 Assess and counsel on proper use of medications
 Monitor ADRs and determine the action plan whenever needed

5.5 Educate on disease (hepatitis):

 E.g. prevention, transmission, progression etc

5.6 Provide recommendation:

 Offer feedback and evidence-based recommendation to patient and
prescribers

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6. MEDICATION DISPENSING AND COUNSELLING
Pharmacist shall dispense the medication and provide counselling to the patient.
(refer Appendix VI)

7. DOCUMENTATION
All relevant data and recommendations/ interventions shall be recorded in designated
forms and patient’s case note accordingly (refer Appendix II & III)

G.REFERENCES

1. World Health Organization, Global Hepatitis Report, 2017 (work conducted by the
Center for Disease Analysis , CDA).
2. Stanaway JD, Flaxman AD, Naghavi M, et al. The global burden of viral hepatitis
from 1990 to 2013: findings from the Global Burden of Disease Study 2013. Lancet
(London, England). 2016;388(10049):1081-1088.
3. Health Facts, Ministry of Health, Malaysia, 2017. Available at
http://www.moh.gov.my/english.php/pages/view/56
4. Borenstein JE, Graber G, Saltiel E, et al. Physician-pharmacist co-management of
hypertension: a randomized, comparative trial. Pharmacotherapy 2003
5. Yanchick JK. Implementation of a drug therapy monitoring clinic in a primary care
setting. Am J Health Syst Pharm 2000
6. Bozovich M, Rubino CM, Edmunds J. Effect of a clinical pharmacist managed lipid
clinic on achieving national cholesterol education program low-density lipoprotein
goals. Pharmacotherapy 2000
7. Yang S, Britt RB, Hashem MG, Brown JN. Outcomes of pharmacy-led hepatitis C
Direct-Acting Antiviral utilization management at a veteran affairs medical center. J
Manag Care Spec Pharm. 2017 Mar;23(3):364-369.
8. Langness JA, Nguyen M, Wieland A, Everson GT, Kiser JJ. Optimizing hepatitis C
virus treatment through pharmacist interventions: identification and management of
drug-drug interactions. World Journal of Gastroenterology. 2017;23 (9):1618-1626.
doi:10.3748/wjg.v23.i9.1618.
9. Dolder NM, Wilhardt MS, Morreale AP. Justifying a multi-disciplinary high-intensity
hepatitis C clinic by using deci-sion analysis. Am J Health-Syst Pharm 2002
10. Smith JP, Dong MH, Kaunitz JD. Evaluation of a pharmacist managed hepatitis C
care clinic. Am J Health Syst Pharm. 2007;64(6):632-36.
11. Kolor B. Patient education and treatment strategies implemented at a pharmacist-
managed hepatitis C virus clinic. Pharmacotherapy. 2005;25(9):1230-41.

6
12. Rodis JL, Kibbe P. Development of a hepatitis C support group. Am J Health Syst
Pharm. 2006;63(17):1594-96.
13. EASL Recommendations on Treatment of Hepatitis C 2016. European Association
for the Study of the Liver. 2016
14. Hepatitis C screening, testing & treatment Guideline, Ministry of Health Malaysia
Putrajaya, 1st Edition October 2017
15. AASLD.IDSA. HCV Guidance: Recommendations for Testing, Managing, and
Treating Hepatitis C. April 2017
16. Protocol Medication Therapy Adherence Clinic Hepatitis, Pharmaceutical Service
Division, Ministry of Health Malaysia, 1st Edition 2015

7
 Appendix Ia

HEPATITIS MTAC WORKFLOW (INITIAL VISIT)

LOCATION: Clinic/ Outpatient pharmacy

Doctor Candidate for treatment

Patient recruitment to Hepatitis MTAC

Doctor/ Pre-treatment assessment (medication
Pharmacist reconcillation, drug-drug interaction)

Detect any potential drug-drug

Pharmacist
interactions

YES

Provide consultative service to treating

Pharmacist physician drug-drug interactions
management

Drug-drug interaction management:

a. Stop related potential interaction
drugs
NO
Doctor b. Replace with other drug
c. Dosage adjustment
d. Continue the dose but with close
monitoring

Pre-treatment education & counselling

Pharmacist (disease, medication, adherence, missed
dose management, storage & etc.)

Pharmacist Medication dispensing

Pharmacist/ Schedule for next visit/ appointment

Nurse

Pharmacist Documentation

8
 Appendix Ib

HEPATITIS MTAC WORKFLOW (SUBSEQUENT VISITS)

Location: Clinic/ Outpatient pharmacy

Pharmacist Registration

Pharmacist Trace record of follow-up patient

Pharmacist’s assessment and monitoring:

 Adherence (pill count)

Pharmacist
 Drug-drug interactions
 Adverse drug reaction (report if
any found)

Detected potential drug-drug

Pharmacist interactions if any added new
prescribed medications

Refer back to clinic for drug-drug

Pharmacist
interactions

Pharmacist Medication dispensing

Pharmacist Schedule for next visit/ appointment

Medication dispensing

Pharmacist Documentation

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 Appendix II

PATIENT’S PROFILE AND ASSESSMENT FORM

A. DEMOGRAPHIC DATA
Name: I/C: Race: Weight (kg):

M/ C/ I/ Others Height (cm):

Age (year): Gender : Contact No: Allergies:

M/ F

B. DISEASE BACKGROUND
Co-morbidities: HCV genotype: HBsAg:

Baseline Viral Load HCV RNA: Anti-HBs:

Risk factors: Liver Status:

□ IVDU □ Tattoo
□ History of blood products □ Vertical transmission □ Non Cirrhotic
transfusion before 1994 □ Unprotected sex □ Cirrhotic
□ Organ transplantation □ Unsure
□ Hemodialysis □ Others
Treatment If yes, list down ( drug, dose, duration & outcome)
Experience:
Drug & dose:
□ Yes (Year:____)
□ No Duration:

Outcome: □ Null responder □ Intolerance side effects

□ Partial responder □ Breakthrough
□ Relapse
C.TREATMENT
Treatment regimen (drug & Duration:
dose):
Date started: Date ended:

Treatment outcome If no, reason of early discontinuation:

□ Due to side effects
Completion of treatment: □ Non-responder
□ Yes □ No □ Defaulter
SVR 12 achieved:
□ Others
□ Yes □ No
1

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 Appendix II

Concomitant Medications: Potential drug-drug interaction (if any):

Baseline Week

Week Week

Week Week

D.LAB INVESTIGATION
Lab Baseline Week Week Week Week Week Week Week Week
parameter 2 4 8 12 16 20 24 36
(SVR) (SVR)
WBC
Hb
Plt
INR
T. Bil
Alb
T. Prot
ALT
AST
ALP
Urea
Na
K
Creat
Viral load

11
 Appendix III

ADVERSE DRUG REACTION & PHARMACEUTICAL CARE ISSUE

Date Pharmaceutical Care Recommendation/ Outcome
Issue Monitoring

12
 Appendix IVa

HEPATITIS C KNOWLEDGE PRE/ POST-ASSESSMENT TEST

Name:………………………………………………. IC No.:……………………………..
Please circle True (T) or False (F): (Pre Assessment)
No. Question
1 Hepatitis C is a disease that mainly affects the liver. T F
2 Hepatitis C can be spread through saliva, sneezing, hugging and T F
coughing
3 Sharing needles, razors and toothbrush may spread hepatitis C infection. T F
4 Alcohol intake and smoking will affect the treatment of hepatitis C. T F
5 Hepatitis C is preventable by vaccine. T F
6 The standard treatment for hepatitis C consists of oral pill and injection. T F
7 Hepatitis C requires lifelong treatment. T F
8 The oral pills of the treatment must be taken everyday. T F
9 Blood changes (lowering of haemoglobin and white blood cells) are the T F
common side effects of the treatment.
10 HCV-RNA test (check the total virus in the body) is only done ONCE T F
during the therapy.
Total Score: ..…. /10
Pharmacist’s Sign & Stamp:……………………………. Date:………………..

Please circle True (T) or False (F): (Post Assessment)

No. Question
1 Hepatitis C is a disease that mainly affects the liver. T F
2 Hepatitis C can be spread through saliva, sneezing, hugging and T F
coughing
3 Sharing needles, razors and toothbrush may spread hepatitis C infection. T F
4 Alcohol intake and smoking will affect the treatment of hepatitis C. T F
5 Hepatitis C is preventable by vaccine. T F
6 The standard treatment for hepatitis C consists of oral pill and injection. T F
7 Hepatitis C requires lifelong treatment. T F
8 The oral pills of the treatment must be taken everyday. T F
9 Blood changes (lowering of haemoglobin and white blood cells) are the T F
common side effects of the treatment.
10 HCV-RNA test (check the total virus in the body) is only done ONCE T F
during the therapy.
Total Score: ..…. /10

Pharmacist’s Sign & Stamp:……………………………. Date:………………..

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 Appendix IVb

UJIAN PENGETAHUAN HEPATITIS C SEBELUM/ SELEPAS KAUNSELING

Nama:…………………………………………. No.KP:……………………………..
Sila bulatkan Betul (B) atau Salah (S): (Sebelum Kaunseling)
No. Soalan
1 Hepatitis C ialah suatu penyakit yang memberi kesan utama pada hati. B S
2 Hepatitis C boleh disebarkan melalui air liur, bersin, pelukan dan batuk. B S
3 Berkongsi jarum suntikan, pisau cukur dan berus gigi mungkin B S
menyebarkan hepatitis C.
4 Pengambilan alcohol dan merokok akan memberi kesan terhadap B S
rawatan hepatitis C.
5 Hepatitis C boleh dicegah melalui pemberian vaksin. B S
6 Rawatan standard untuk hepatitis C terdiri daripada ubat makan(pil) dan B S
sutikan.
7 Hepatitis C memerlukan rawatan sepanjang hayat. B S
8 Pil untuk rawatan hepatitis C mesti diambil setiap hari. B S
9 Perubatan pada darah (pengurangan haemoglobin dan sel darah putih) B S
adalah kesan sampingan yang biasa apabila menjalani rawatan hepatitis
C.
10 Ujian HCV-RNA (bagi memeriksa jumlah virus dalam badan) hanya B S
dibuat Sekali sepanjang tempoh rawatan.
Jumlah markah: ..…. /10
T/tangan & cop Pegawai Farmasi:………………………… Tarikh:………………..

Sila bulatkan Betul (B) atau Salah (S): (Selepas Kaunseling)

No. Soalan
1 Hepatitis C ialah suatu penyakit yang memberi kesan utama pada hati. B S
2 Hepatitis C boleh disebarkan melalui air liur, bersin, pelukan dan batuk. B S
3 Berkongsi jarum suntikan, pisau cukur dan berus gigi mungkin B S
menyebarkan hepatitis C.
4 Pengambilan alcohol dan merokok akan memberi kesan terhadap B S
rawatan hepatitis C.
5 Hepatitis C boleh dicegah melalui pemberian vaksin. B S
6 Rawatan standard untuk hepatitis C terdiri daripada ubat makan(pil) dan B S
sutikan.
7 Hepatitis C memerlukan rawatan sepanjang hayat. B S
8 Pil untuk rawatan hepatitis C mesti diambil setiap hari. B S
9 Perubatan pada darah (pengurangan haemoglobin dan sel darah putih) B S
adalah kesan sampingan yang biasa apabila menjalani rawatan hepatitis
C.
10 Ujian HCV-RNA (bagi memeriksa jumlah virus dalam badan) hanya B S
dibuat Sekali sepanjang tempoh rawatan.
Jumlah markah: ..…. /10
T/tangan & cop Pegawai Farmasi:……………………………. Tarikh:………………..

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 Appendix V

PRETREATMENT COUNSELLING CHECKLIST

Patient’s Name:…………………………………… IC No.:…………………………

Understanding Hepatitis C (refer Patient Education Materials)

Done Not Done

Functions of liver
Hepatitis C
Disease characteristics
Disease progression
Transmission of hepatitis
Preventive precaution
Pre-treatment laboratory investigation
Factors affecting viral clearance
Patient self management
Hepatitis C treatments
Treatment goals
Best way to take medications
Missed dose management
Common side effects
Treatment monitoring tools including pill
count
*Self-injection technique (if patient on
Pegasys®/Peg-Intron®)

Patient’s concerns regarding hepatitis C and treatment (if any):

____________________________________________________________________
____________________________________________________________________

Recommendations/ notes:
____________________________________________________________________
____________________________________________________________________

Pharmacist’s Sign & Stamp:…………………………….. Date:…………………

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 Appendix VI

COMPLIANCE & DISPENSING RECORD

Drug Accountability (12 weeks/ 24 weeks Treatment)

Visit Date Drug Number of Pills

Remaining Used Expected Missed Dispensed
used dose today
Initiation

Comment:
_____________________________________________________________________

Visit Date Drug Number of Pills

Remaining Used Expected Missed Dispensed
used dose today
Week 4

Comment:
_____________________________________________________________________

Visit Date Drug Number of Pills

Remaining Used Expected Missed Dispensed
used dose today
Week 8

Comment:
_____________________________________________________________________

Visit Date Drug Number of Pills

Remaining Used Expected Missed Dispensed
used dose today
Week 12

Comment:
____________________________________________________________________

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 Appendix VIIa

PATIENT’S DRUG DIARY

HEPATITIS MTAC
(For Direct Acting Antivirals Only)

Name :
IC No. :
Contact Number:

Disease background
Genotype:
Baseline Viral Load HCV RNA:

Treatment
Regimen:
Duration of treatment: _______weeks
Date Started: Date Ended:

Treating Physician:

17
 Appendix VIIa

Drug taking records: Tick (√) if taken

Initiation
Days 1 2 3 4 5 6 7
Date

Week 2
Days 8 9 10 11 12 13 14
Date

Week 3
Days 15 16 17 18 19 20 21
Date

Week 4
Days 22 23 24 25 26 27 28
Date

Week 5
Days 29 30 31 32 33 34 35
Date

Week 6
Days 36 37 38 39 40 41 42
Date

18
 Appendix VIIa

Week 7
Days 43 44 45 46 47 48 49
Date

Week 8
Days 50 51 52 53 54 55 56
Date

Week 9
Days 57 58 59 60 61 62 63
Date

Week 10
Days 64 65 66 67 68 69 70
Date

Week 11
Days 71 72 73 74 75 76 77
Date

Week 12
Days 78 79 80 81 82 83 84
Date

19
 Appendix VIIa

Notes:
 Please keep your medication at room temperature (<300 C).
 Take your medication according to doctor’s instruction everyday.
 Tablets/ pills should be swallowed whole with a drink of water.
 Bring all bottles including the empty bottles of medication and this
diary card when you come for clinic visit and DO NOT keep any
unused medication at home.
 Your medications are not be taken with certain others medications,
please check with your doctors/ pharmacists before taking new
medication during treatment.

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 Appendix VIIb

DIARI UBAT PESAKIT

MTAC HEPATITIS
(Untuk Direct Acting Antivirals Sahaja)

Nama :
No. K/P :
No.Telefon :

Latarbelakang penyakit
Genotype:
Baseline Viral Load HCV RNA:

Rawatan
Regimen:
Durasi rawatan: _______minggu
Tarikh Mula: Tarikh Tamat:

Doktor yang merawat:

21
 Appendix VIIb

Pemantauan Pengambilan Ubat: Sila tanda (√) jika makan ubat

Permulaan
Hari 1 2 3 4 5 6 7
Tarikh

Minggu ke-2
Hari 8 9 10 11 12 13 14
Tarikh

Minggu ke-3
Hari 15 16 17 18 19 20 21
Tarikh

Minggu ke-4
Hari 22 23 24 25 26 27 28
Tarikh

Minggu ke-5
Hari 29 30 31 32 33 34 35
Tarikh

Minggu ke-6
Hari 36 37 38 39 40 41 42
Tarikh

22
 Appendix VIIb

Minggu ke-7
Hari 43 44 45 46 47 48 49
Tarikh

Minggu ke-8
Hari 50 51 52 53 54 55 56
Tarikh

Minggu ke-9
Hari 57 58 59 60 61 62 63
Tarikh

Minggu ke-10
Hari 64 65 66 67 68 69 70
Tarikh

Minggu ke-11
Hari 71 72 73 74 75 76 77
Tarikh

Minggu ke-12
Hari 78 79 80 81 82 83 84
Tarikh

23
 Appendix VIIb

Peringatan:
 Sila pastikan ubat disimpan pada suhu bilik (<300 C).
 Ambil ubat mengikut arahan doktor.
 Makan ubat dengan minum bersama segelas air.
 Sila bawa botol ubat dan kad diari ini setiap kali datang ke klinik/
farmasi. JANGAN simpan ubat berlebihan di rumah.
 Ubat anda tidak boleh diambil bersama dengan sesetengah ubat
tertentu. Sila semak dengan doktor/ pegawai farmasi anda
sebelum mengambil sesuatu ubat.

24
 TREATMENT DOSING & MISSED DOSE MANAGEMENT (Available in Malaysia)

Direct Acting Antivirals

Medication Dosage form & Strength Dosage Missed dose

If within 18 hours of usual time; patients
Sofosbuvir 400 mg/ tab One tablet once daily (morning)
should be instructed to take the tablet as
Sofosbuvir/ledipasvir 400 mg of sofosbuvir and 90 mg of One tablet once daily (morning) soon as possible and the next dose at the
Ledipasvir/ tab usual time.
If after 18 hours of the usual time; the dose
Daclatasvir 30 or 60 mg/ tab One tablet once daily (morning) should be skipped and the next dose taken
at the usual time
Applied the same rule as above
Dasabuvir 250 mg of dasabuvir/ tab One tablet twice daily (morning
Time limited at 6 hours of usual time
and evening)
Applied the same rule as above
Paritaprevir/ 75 mg of paritaprevir, 12.5 mg of Two tablets once daily
Time limited at 12 hours of usual time
ombitasvir and 50 mg of ritonavir/ (morning)
ombitasvir/ ritonavir
tab
Applied the same rule as above
Elbasvir/ 50mg of Elbasvir and 100mg of One tablet once daily (morning)
Time limited at 16 hours of usual time
Grazoprevir Grazoprevir/ tab
*Some treatment dose need to be adjusted, kindly refer Product Insert.
*Treatment duration depends on genotypes, treatment naïve or experience, cirrhosis or without cirrhosis & etc.

Appendix VIII
25
 TREATMENT DURATION CHARTS

Appendix IX
*Reference: EASL Recommendations on Treatment of Hepatitis C 2016. European Association for the Study of the Liver. 2016
Hepatitis C Screening, Testing & Treatment Guideline, Ministry of Health Malaysia Putrajaya, 1st Edition October 2017
26
 Appendix IX
*Reference: EASL Recommendations on Treatment of Hepatitis C 2016. European Association for the Study of the Liver. 2016
Hepatitis C Screening, Testing & Treatment Guideline, Ministry of Health Malaysia Putrajaya, 1st Edition October 2017
27
 Appendix IX

*Reference: Hepatitis C Screening, Testing & Treatment Guideline, Ministry of Health Malaysia Putrajaya,1st Edition
October 2017

28
 Appendix Xa

SIDE EFFECTS OF DIRECT ACTING ANTIVIRALS

*Reference: Hepatitis C screening, testing & treatment Guideline, Ministry of Health Malaysia Putrajaya,1st Edition October 2017

29
 Appendix Xb

SIDE EFFECTS OF PEGYLATED INTERFERON + RIBAVIRIN

*Reference: Hepatitis C screening, testing & treatment Guideline, Ministry of Health Malaysia Putrajaya,1st Edition October 2017

30
 Appendix XIa
PATIENT’S MEDICATION DIARY (for patient on Interferon & Ribavirin)
Patient’s Name:
MRN/IC:
INSTRUCTIONS
RIBAVIRIN: Need to be taken twice daily. If you missed a dose: take as soon as possible on the
same day. If it is already time for a next dose, skip the missed dose. Please state the reason for
skipped or missed dose in the “Comment/Reason for Missed Dose” section, then resume normal
dosing schedule.
PEGYLATED INTERFERON: Record the date each weekly dose was taken and indicate the
dose of pegylated interferon that was taken on a given date. If you missed a dose: Within 4 days,
take the dose. If a dose is missed for 5 or more days, skip the missed dose. Please state the reason
for skipped or missed dose in the “Comment/Reason for Missed Dose ” section, then resume
normal dosing schedule.

PATIENT’S DOSE
Type & dose pegylated interferon:
Administer ___________ subcutaneously once every week.

Ribavirin:
Take with food ______ capsules in the morning and _______ capsules in the evening.

Injection:
Preferably at night
(once a week)
Dispose your pen (injection)
into sharp bin: BRING to clinic
Write down questions and clarify with your at the end of treatment
doctor, pharmacist and nurse. / when sharp bin is full.

Oral Pills:
12 hours apart
(morning and evening
AFTER meals)
Keep oral pills (tablet/
capsules) safely in container:
BRING to clinic at every
appointment.

31
 Appendix XIa
Week Date BW WBC Hb Plt ANC ALT Peg Injected Injection Comment /
IFN (Y/N ) Site Reason for
Dose (L/ R ) Missed Dose
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48

32
 Appendix XIb

DIARI UBAT-UBATAN PESAKIT

Nama Pesakit:
MRN/KP :
ARAHAN
RIBAVIRIN: Perlu dimakan dua kali sehari. Jika anda tertinggal satu dos: Makan secepat yang
mungkin pada hari yang sama. Jika sudah tiba masa untuk dos yang seterusnya, lupakan dos yang
tertinggal. Sila dokumenkan sebab dos ubat tidak diambil pada bahagian “Komen/Sebab Tertinggal
Dos”, kemudian teruskan dengan jadual pengedosan yang biasa.
PEGYLATED INTERFERON: Rekodkan tarikh setiap dos mingguan disuntik. Nyatakan dos
pegylated interferon yang disuntik bagi setiap tarikh. Jika anda tertinggal satu dos: Dalam masa
4 hari, suntik dos itu. Jika 5 hari atau lebih sudah berlalu, lupakan dos yang tertinggal. Sila
dokumenkan sebab dos tersebut tidak disuntik pada bahagian “Komen/Sebab Tertinggal Dos”.
Kemudian teruskan dengan jadual pengedosan yang biasa.
DOS PESAKIT
Jenis & dos pegylated interferon:
Suntik _________ secara subkutaneus seminggu sekali.
Ribavirin:
Makan __________ kapsul pada waktu pagi dan ________ kapsul pada waktu malam bersama
makanan.
Suntikan:
Sebaik-baiknya pada waktu malam
(seminggu sekali)
Buangkan jarum suntikan dalam
bekas kalis tembus: Bawa ke klinik
pada akhir rawatan/setelah bekas
penuh diisi.
Catatkan jika ada sebarang
persoalan dan dapatkan penerangan
daripada doktor, Pegawai Farmasi Pil Oral:
dan jururawat. Setiap 12 jam
(pagi dan petang selepas makan)
Simpan pil oral (tablet/kapsul)
dalam bekas yang selamat:
Bawa ke klinik setiap kali menghadiri
temujanji.

33
 Appendix XIb

M Tarikh Berat WBC Hb Plt ANC ALT Dos Disuntik Tempat Komen / Sebab
i Badan Peg (Y/T ) Suntikan Tertinggal Dos
n IFN (Kiri/
g Kanan)
g
u
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48

34
 Appendix XII

TREATMENT DOSING & DURATION TABLE

Regimen and dose
Indications Duration
Interferon Ribavirin
Chronic Hepatitis C S/C Pegylated IFN α-2a 800mg/day
(CHC) 180 mcg/week OR 24 weeks
(Mono-infected & OR OR
Genotype 2/3) S/C Pegylated IFN α-2b 15 mg/kg BW/day:
if BMI > 25 or there is evidence of 48 weeks:
1.5 mcg/kg/week if have bridging fibrosis or
insulin resistance or metabolic cirrhosis and metabolic
syndrome or severe fibrosis or syndrome
cirrhosis or older age
CHC S/C Pegylated IFN α-2a 48 weeks
(Mono-infected & 180 mcg/week
OR
Genotype 1/4) OR 15 mg/kg BW/day
S/C Pegylated IFN α-2b (in 2 divided doses) 24 weeks:
1.5 mcg/kg/week if G1 with LVL (<400,000 iu/ml)
+ less than bridging fibrosis

CHC S/C Pegylated IFN α-2a 48 weeks

180 mcg/week
(Co-infected with OR
OR 15 mg/kg BW/day
HIV & 24 weeks:
S/C Pegylated IFN α-2b (in 2 divided doses)
all HCV genotypes)
1.5 mcg/kg/week if G2/G3 with RVR+ baseline VL
<400,000iu/ml + less than
bridging fibrosis

S/C Standard IFN α-2b

3 MIU 3x/week after HD
CHC OR Ribavirin not needed
S/C Pegylated IFN α-2a OR 48 weeks
(Hemodialysis
135 mcg/week Lowest possible dose (200mg
& 3x/week or OD)
all HCV genotypes) OR
S/C Pegylated IFN α-2b
1 mcg/kg/week
S/C Pegylated IFN α-2a
48 weeks
Chronic Hepatitis B 180 mcg/week
OR Ribavirin not needed OR
S/C Standard IFNα-2b 16-24 weeks
5 MIU 3x/week

Notes:
1. The recommended dose of ribavirin is 800 to 1400 mg orally based on patient body weight. Ribavirin should be taken
with food. Ribavirin should not be used in patients with creatinine clearance less than 50 mL/min.

2. Ribavirin may cause birth defects and death of the unborn child. Extreme care must be taken to avoid pregnancy in
female patients and in female partners of male patients. Ribavirin causes haemolytic anaemia. The anaemia
associated with ribavirin therapy may result in a worsening of cardiac disease.

3. The Peg-Intron dose of 1.5 mcg/kg/week should be calculated based on the individual subject weight. Use standard
rounding procedures: for 0.1 to 0.4 kg, round down and for 0.5 to 0.9 kg, round up. The volume of Peg-Intron to be
injected depends on the strength of Peg-Intron and patient’s body weight.

35
 Appendix XIII
DOSAGE ADJUSTMENT TABLE
Lab. Result Pegylated IFN α-2a Pegylated IFN α-2b Ribavirin
Haemoglobin level (g/dL)
No cardiac Stable cardiac No cardiac Stable cardiac
disease disease disease disease

Step 1: Step 1:

< 10.0 No change Reduce dose by 50% Decrease > 2 g/dL

(permanent dose Reduce to during 4 weeks
No change reduction) 600 mg/day period:
Reduce to 600
mg/day (permanent
dose reduction)
Step 2: Step 2:

Discontinue Hb < 12 g/dL despite Hb < 12 g/dL

< 8.5 No recommendation Discontinue
permanently 4 weeks in reduced despite 4 weeks in
dose: Discontinue reduced dose:
permanently Discontinue
White blood cell count (x 103/mm3)
Step 1 (first reduction):
Reduce dose to 1 µg/kg/wk
< 1.5 No recommendation -
Step 2 (second reduction):
Reduce dose to 0.5 µg/kg/wk
< 1.0 No recommendation Discontinue permanently -

Neutrophil count (103/mm3)

Step 1 (first reduction):
Reduce dose to 1 µg/kg/wk
< 0.75 Reduce to 135 µg
Step 2 (second reduction):
Reduce dose to 0.5 µg/kg/wk
Suspend treatment until
neutrophil count returns to
< 0.5 Discontinue permanently
> 1 x 103/mm3; restart at
90 µg and monitor
Platelet count (103/mm3)

Step 1 (first reduction):

Reduce dose to 1 µg/kg/wk
< 50 Reduce to 90 µg
Step 2 (second reduction):
Reduce dose to 0.5 µg/kg/wk
< 25 Discontinue permanently Discontinue permanently

Reference: Product inserts.

36
 Appendix XIVa
SELF- INJECTION TECNIQUE CHECKLIST
S/C Pegylated IFN α-2a (Pegasys®)
Injection 1 Recognizing the parts of the Pegasys® -single pre-filled
technique syringe
2 Handwashing and self hygiene before using the prefilled
Pegasys® unit
3. Remove Pegasys® from fridge (2-8C) and allow to bring
to room temperature (5 minutes)
4. Check solution is clear without particles
5. Remove needle protective cover (grey color) from the end
of the needle
6. Remove the rubber cap from the end of the syringe.
Connect the needle firmly on the end of the syringe.
7. Turn clockwise 2-3 times until the syringe firmly attached
to needle
8. Remove the needle cap gently by twisting the cap

9. Lightly tap the syringe to bring any bubbles to the top.

Gently push the plunger up slightly to push air out of the
syringe.
10. Choose site of injection and swab with alcohol swab.
Rotate injection sites each time.
11. Pinch site of injection slightly and inject at 90 degree
angle. Holding not required.
12. Throw pen into sharps bin
13. Storage (2-8 C) and transport of interferon. Bag and ice-
pack provided. These 2 items to be carried on every
appointment for following supply
14. Disposal – prepare own sharps bin --> to be handed over
to clinic for upon completion of treatment for incineration

15. Importance of compliance to interferon

Injection and Ribavirin. Pt to see pharmacist in MTAC
Hepatitis in next appointment.
16. Ensure patient is understood and able to demonstrate back
the correct technique of injecting s/c Pegasys®
17. Witness pt to self-administer the 1st dose by pharmacist

37
 Appendix XIVb
SELF- INJECTION TECNIQUE CHECKLIST
S/C Pegylated IFN α-2b (Peg-Intron®)
Injection 1 Recognizing the parts of the Peg-Intron® redipen
technique:
2. Handwashing and self hygiene before using the Peg-Intron® redipen

3. Remove Peg-Intron® from fridge and allow to bring to room

temperature (5 minutes)
4 Place upright in plastic holder . To mix the powder and the liquid,
press the two halves together firmly by pressing down until you hear
the prefilled pen click”.
5. Wait for mixing and foam to settle. Do not use if solution is not
clear/particles present
6. Gently turn pen upside down twice. To avoid excessive foaming, do
not shake.
7. Swab top of pen with alcohol swab
8 Attach needle and remove cap
9 Choose site of injection and swab with alcohol swab. Rotate
injection sites each time.
10 Dial dose by pulling dialer out and rotating to desired dose

11 Pinch site of injection slightly and inject at 90 degree angle. Hold for
5 seconds to ensure that the dose is delivered completely
12 Throw used pen in sharps bin
13 Storage (2-8 C) and transport of interferon.
Bag and ice-pack provided. These 2 items to be carried on every
appointment for following supply.
14 Disposal – prepare own sharps bin --> to be handed over to clinic for
upon completion of treatment for incineration

15 Importance of compliance to Interferon Injection and Ribavirin. Pt

to see pharmacist in MTAC Hepatitis in next appointment

16 Ensure patient is understood and able to demonstrate back the correct

technique of injecting s/c Peg Intron®.

17 Witness pt to self-administer the 1st dose by pharmacist

38
 Appendix XIVc
SELF- INJECTION TECNIQUE CHECKLIST
S/C Standard Interferon α-2b (Intron-A®)
Injection 1 Recognizing the parts of the Intron A®
technique 2 Handwashing and self hygiene before using the Intron A®
multidose pen
3 Remove multidose pen from fridge and allow to bring to
room temperature (5 minutes)
4 Pull off the cap of the pen and disinfect the rubber
membrane
5 Remove the protective cover from the needle
6 Gently push the needle onto the pen
7 Screw the needle onto the Intron A®pen turning it in a
clockwise direction
8 Pull off the outer needle cap
9 Pull off the inner needle cap. Keep the outer needle cap for
later use
10 Prime the multidose pen by 2 units. If no drops appeared,
repeat the step until a drop appears at the tip.
11 Replace the Intron A® cap with indicator align with the
black triangle
12 To set the dose, hold the pen horizontally by the barrel with
hand. With the other hand, twist the cap as indicated by the
arrow. (Hep C 3MIU= 6 clicks, Hep B 5MIU=10clicks)

13 Choose site of injection and swab with alcohol swab. Rotate

injection sites for each injection.

14 Pinch site of injection slightly and inject at 90 degree angle.

Hold for 5 seconds to ensure the dose delivered completely.
15 Carefully replace the outer cap and discard the capped
needle safely.
16 Storage (2-8 C) and transport of interferon. Bag and ice-
pack provided. These 2 items to be carried on every
appointment for following supply

17 Disposal – prepare own sharp bin --> to be handed over to

clinic for upon completion of treatment for incineration

18 Importance of compliance to interferon injection and

ribavirin. Pt to see pharmacist in MTAC Hepatitis in next
TCA
19 Ensure patient is understood and able to demonstrate back
the correct technique of injecting S/C Intron A®

20 Witness pt to self-administer the 1st dose by pharmacist

39
40