PROTOCOl HEPATITIS MEDICATION THERAPY ADHERENCE … · providing appropriate education to patients/caregivers and completing follow-ups. 3. Activities at the clinic should be structured

PHARMACY PRACTICE & DEVELOPMENT DIVISION

MINISTRY OF HEALTH

2nd EDITION

REVISED 6 JUN 2018

PROTOCOl HEPATITIS MEDICATION

THERAPY ADHERENCE CLINIC (HEPATITIS MTAC)

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

i

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

ii

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


Choe Sze Hwe

Senior Principal Assistant Director


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

iii

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

iv

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

1

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.

2

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.

3

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)

http://www.hep-druginteractions.org/

4

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.

5

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

6

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.

http://www.moh.gov.my/english.php/pages/view/56

7

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

8

Appendix Ia

HEPATITIS MTAC WORKFLOW (INITIAL VISIT)

LOCATION: Clinic/ Outpatient pharmacy

Doctor Candidate for treatment

Provide consultative service to treating

physician drug-drug interactions

management

Pre-treatment education & counselling

(disease, medication, adherence, missed

dose management, storage & etc.)

Doctor/

Pharmacist

Detect any potential drug-drug

interactions

Drug-drug interaction management:

a. Stop related potential interaction

drugs

b. Replace with other drug

c. Dosage adjustment

d. Continue the dose but with close

monitoring

Patient recruitment to Hepatitis MTAC

Pre-treatment assessment (medication

reconcillation, drug-drug interaction)

Schedule for next visit/ appointment

Medication dispensing

Pharmacist

Pharmacist/

Nurse

Pharmacist

Pharmacist

Pharmacist

Doctor

Pharmacist Documentation

YES

NO

9

Appendix Ib

HEPATITIS MTAC WORKFLOW (SUBSEQUENT VISITS)

Location: Clinic/ Outpatient pharmacy

Registration

Trace record of follow-up patient

Pharmacist’s assessment and monitoring:

Adherence (pill count)

Drug-drug interactions

Adverse drug reaction (report if

any found)

Detected potential drug-drug

interactions if any added new

prescribed medications


Refer back to clinic for drug-drug

interactions

Schedule for next visit/ appointment


Pharmacist

Pharmacist

Pharmacist

Pharmacist

Pharmacist

Pharmacist

Pharmacist

Pharmacist Documentation

10

Appendix II

PATIENT’S PROFILE AND ASSESSMENT FORM

A. DEMOGRAPHIC DATA

Name: I/C: Race:

M/ C/ I/ Others

Weight (kg):

Height (cm):

Age (year): Gender : M/ F

Contact No: Allergies:

B. DISEASE BACKGROUND

Co-morbidities:

HCV genotype:

HBsAg: Anti-HBs: Baseline Viral Load HCV RNA:

Risk factors:

□ IVDU □ Tattoo

□ History of blood products □ Vertical transmission

transfusion before 1994 □ Unprotected sex

□ Organ transplantation □ Unsure

□ Hemodialysis □ Others

Liver Status:

□ Non Cirrhotic

□ Cirrhotic

Treatment Experience:

□ Yes (Year:____)

□ No

If yes, list down ( drug, dose, duration & outcome) Drug & dose: Duration:

Outcome: □ Null responder □ Intolerance side effects

□ Partial responder □ Breakthrough

□ Relapse

C.TREATMENT

Treatment regimen (drug & dose):

Duration:

Date started: Date ended:

Treatment outcome

Completion of treatment:

□ Yes □ No

SVR 12 achieved:

□ Yes □ No

If no, reason of early discontinuation:

□ Due to side effects

□ Non-responder □ Defaulter

□ Others

1

11

Appendix II

Concomitant Medications:

Potential drug-drug interaction (if any):

Baseline

Week

Week

Week

Week

Week

D.LAB INVESTIGATION

Lab parameter

Baseline Week 2

Week 4

Week 8

Week 12

Week 16

Week 20

Week 24

(SVR)

Week 36

(SVR)

WBC

Hb

Plt

INR

T. Bil

Alb

T. Prot

ALT

AST

ALP

Urea

Na

K

Creat

Viral load

2

12

Appendix III

ADVERSE DRUG REACTION & PHARMACEUTICAL CARE ISSUE

Date Pharmaceutical Care Issue

Recommendation/ Monitoring

Outcome

13

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 coughing

T F

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 common side effects of the treatment.

T F

10 HCV-RNA test (check the total virus in the body) is only done ONCE during the therapy.

T F

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 coughing

T F

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 common side effects of the treatment.

T F

10 HCV-RNA test (check the total virus in the body) is only done ONCE during the therapy.

T F

Total Score: ..…. /10

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

14

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 menyebarkan hepatitis C.

B S

4 Pengambilan alcohol dan merokok akan memberi kesan terhadap rawatan hepatitis C.

B S

5 Hepatitis C boleh dicegah melalui pemberian vaksin. B S

6 Rawatan standard untuk hepatitis C terdiri daripada ubat makan(pil) dan sutikan.

B S

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) adalah kesan sampingan yang biasa apabila menjalani rawatan hepatitis C.

B S

10 Ujian HCV-RNA (bagi memeriksa jumlah virus dalam badan) hanya dibuat Sekali sepanjang tempoh rawatan.

B S

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 menyebarkan hepatitis C.

B S

4 Pengambilan alcohol dan merokok akan memberi kesan terhadap rawatan hepatitis C.

B S

5 Hepatitis C boleh dicegah melalui pemberian vaksin. B S

6 Rawatan standard untuk hepatitis C terdiri daripada ubat makan(pil) dan sutikan.

B S

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) adalah kesan sampingan yang biasa apabila menjalani rawatan hepatitis C.

B S

10 Ujian HCV-RNA (bagi memeriksa jumlah virus dalam badan) hanya dibuat Sekali sepanjang tempoh rawatan.

B S

Jumlah markah: ..…. /10

T/tangan & cop Pegawai Farmasi:……………………………. Tarikh:………………..

15

Appendix V

PRETREATMENT COUNSELLING CHECKLIST

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

Understanding Hepatitis C (refer Patient Education Materials)

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

____________________________________________________________________

____________________________________________________________________

Recommendations/ notes:

____________________________________________________________________

____________________________________________________________________

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

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®)

16

Appendix VI

COMPLIANCE & DISPENSING RECORD

Drug Accountability (12 weeks/ 24 weeks Treatment)

Visit Date Drug Number of Pills

Remaining Used Expected used

Missed dose

Dispensed today

Initiation

Comment: _____________________________________________________________________



Missed dose

Dispensed today

Week 4

Comment: _____________________________________________________________________



Missed dose

Dispensed today

Week 8

Comment: _____________________________________________________________________



Missed dose

Dispensed today

Week 12

Comment: ____________________________________________________________________

1

17

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:

18

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

1

Appendix VIIa

19

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

2

Appendix VIIa

20

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.

3

21

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:

22

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

1

Appendix VIIb

23

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

2

Appendix VIIb

24

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.

3

25

TREATMENT DOSING & MISSED DOSE MANAGEMENT (Available in Malaysia)

Direct Acting Antivirals

*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.

Medication Dosage form & Strength Dosage Missed dose

Sofosbuvir 400 mg/ tab One tablet once daily (morning) If within 18 hours of usual time; patients

should be instructed to take the tablet as

soon as possible and the next dose at the

usual time.

If after 18 hours of the usual time; the dose

should be skipped and the next dose taken

at the usual time

Sofosbuvir/ledipasvir 400 mg of sofosbuvir and 90 mg of

Ledipasvir/ tab

One tablet once daily (morning)

Daclatasvir 30 or 60 mg/ tab One tablet once daily (morning)

Dasabuvir 250 mg of dasabuvir/ tab One tablet twice daily (morning

and evening)

Applied the same rule as above

Time limited at 6 hours of usual time

Paritaprevir/

ombitasvir/ ritonavir

75 mg of paritaprevir, 12.5 mg of

ombitasvir and 50 mg of ritonavir/

tab

Two tablets once daily

(morning)

Applied the same rule as above


Elbasvir/

Grazoprevir

50mg of Elbasvir and 100mg of

Grazoprevir/ tab

One tablet once daily (morning) Applied the same rule as above


Ap

pen

dix

VIII

26

TREATMENT DURATION CHARTS

*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

Ap

pen

dix

IX

27

*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

Ap

pen

dix

IX

28

Appendix IX

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

October 2017

29

Appendix Xa

SIDE EFFECTS OF DIRECT ACTING ANTIVIRALS

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

30

Appendix Xb

SIDE EFFECTS OF PEGYLATED INTERFERON + RIBAVIRIN

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

31

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 at the end of treatment

/ 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.

Write down questions and clarify with your

doctor, pharmacist and nurse.

32

Appendix XIa

Week Date BW WBC Hb Plt ANC ALT Peg

IFN

Dose

Injected

(Y/N )

Injection

Site

(L/ R )

Comment /

Reason for

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

33

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.

Pil Oral: Setiap 12 jam

(pagi dan petang selepas makan)

Simpan pil oral (tablet/kapsul) dalam bekas yang selamat: Bawa ke klinik setiap kali menghadiri temujanji.

Catatkan jika ada sebarang

persoalan dan dapatkan penerangan

daripada doktor, Pegawai Farmasi

dan jururawat.

34

Appendix XIb

M

i

n

g

g

u

Tarikh Berat

Badan

WBC Hb Plt ANC ALT Dos

Peg

IFN

Disuntik

(Y/T )

Tempat

Suntikan

(Kiri/

Kanan)

Komen / Sebab

Tertinggal Dos

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

35

Appendix XII

TREATMENT DOSING & DURATION TABLE

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.

Indications Regimen and dose

Duration Interferon Ribavirin

Chronic Hepatitis C (CHC)

(Mono-infected & Genotype 2/3)

S/C Pegylated IFN α-2a 180 mcg/week

OR S/C Pegylated IFN α-2b

1.5 mcg/kg/week

800mg/day

OR

15 mg/kg BW/day: if BMI > 25 or there is evidence of

insulin resistance or metabolic syndrome or severe fibrosis or

cirrhosis or older age

24 weeks

OR

48 weeks: if have bridging fibrosis or

cirrhosis and metabolic syndrome

CHC

(Mono-infected &

Genotype 1/4)


OR

S/C Pegylated IFN α-2b 1.5 mcg/kg/week

15 mg/kg BW/day

(in 2 divided doses)

48 weeks

OR

24 weeks:

if G1 with LVL (<400,000 iu/ml) + less than bridging fibrosis

CHC

(Co-infected with HIV &

all HCV genotypes)


OR

S/C Pegylated IFN α-2b 1.5 mcg/kg/week

15 mg/kg BW/day

(in 2 divided doses)

48 weeks

OR

24 weeks:

if G2/G3 with RVR+ baseline VL <400,000iu/ml + less than

bridging fibrosis

CHC

(Hemodialysis &

all HCV genotypes)

S/C Standard IFN α-2b 3 MIU 3x/week after HD

OR


OR

S/C Pegylated IFN α-2b 1 mcg/kg/week

Ribavirin not needed OR

Lowest possible dose (200mg 3x/week or OD)

48 weeks

Chronic Hepatitis B


OR

S/C Standard IFNα-2b 5 MIU 3x/week

Ribavirin not needed

48 weeks

OR

16-24 weeks

36

Appendix XIII DOSAGE ADJUSTMENT TABLE

Lab. Result Pegylated IFN α-2a Pegylated IFN α-2b Ribavirin

Haemoglobin level (g/dL)

< 10.0 No change

No cardiac disease

Stable cardiac

disease

No cardiac disease

Stable cardiac

disease

No change

Step 1:

Reduce dose by 50% (permanent dose

reduction)

Reduce to

600 mg/day

Step 1:

Decrease > 2 g/dL during 4 weeks

period: Reduce to 600

mg/day (permanent dose reduction)

< 8.5 No recommendation Discontinue

permanently

Step 2:

Hb < 12 g/dL despite 4 weeks in reduced dose: Discontinue

permanently

Discontinue

Step 2:

Hb < 12 g/dL despite 4 weeks in

reduced dose: Discontinue

White blood cell count (x 103/mm3)

< 1.5 No recommendation

Step 1 (first reduction): Reduce dose to 1 µg/kg/wk

- Step 2 (second reduction):

Reduce dose to 0.5 µg/kg/wk

< 1.0 No recommendation Discontinue permanently -

Neutrophil count (103/mm3)

< 0.75 Reduce to 135 µg


Step 2 (second reduction):


< 0.5

Suspend treatment until

neutrophil count returns to

> 1 x 103/mm3; restart at

90 µg and monitor

Discontinue permanently

Platelet count (103/mm3)

< 50 Reduce to 90 µg


Step 2 (second reduction):


< 25 Discontinue permanently Discontinue permanently

Reference: Product inserts.

37

Appendix XIVa SELF- INJECTION TECNIQUE CHECKLIST

S/C Pegylated IFN α-2a (Pegasys®)

Injection

technique

1 Recognizing the parts of the Pegasys® -single pre-filled

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

38

Appendix XIVb SELF- INJECTION TECNIQUE CHECKLIST

S/C Pegylated IFN α-2b (Peg-Intron®)

Injection

technique:

1 Recognizing the parts of the Peg-Intron® redipen

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

39

Appendix XIVc SELF- INJECTION TECNIQUE CHECKLIST

S/C Standard Interferon α-2b (Intron-A®)

Injection

technique

1 Recognizing the parts of the Intron A®

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

40

Documents

PROTOCOl HEPATITIS MEDICATION THERAPY ADHERENCE … · providing appropriate education to patients/caregivers and completing follow-ups. 3. Activities at the clinic should be structured