Protocol Medication Therapy Adherence Clinic HEPATITIS · PDF filethe management of hepatitis are expected to play this role. ... Hospital Selayang ... UJIAN PENGETAHUAN HEPATITIS

ProtocolMedicationTherapyAdherenceClinicHEPATITIS

Pharmaceutical Services DivisionMinistry of Health Malaysia

Lot 36, Jalan Universiti,46350 Petaling Jaya, Selangor.

Tel: 03-78413200 Fax: 03-79682222/79682268

Book. Hepatitis MTAC_1.1.indd 1 11/9/15 7:22 PM

First Edition, 2015Pharmaceutical Services DivisionMinistry of Health Malaysia

ALL RIGHTS RESERVEDNo 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 Ministry of Health Malaysia

Perpustakaan Negara MalaysiaCataloguing-in-Publication Data


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PREFACE

Hepatitis is a disease which needs serious attention as long-term complications lead to high health and economic burden. The seriousness of the problem is being addressed through a national strategic plan and pharmacists should be together with other healthcare professionals in managing patients with this disease, thus minimising complications.

Adherence to treatment with interferon and nucleoside analogues is among the critical factors which determine the success of hepatitis treatment. Medication counselling and assessment of adherence are thus indispensable to ensure patients’ adherence to therapy. Pharmacists who are trained in the management of hepatitis are expected to play this role. Apart from that, the ability to identify and solve drug-related problems is the basic skill of a pharmacist through which he or she can contribute effectively as part of the hepatitis care team.

This protocol is meant for pharmacists in the Ministry of Health (MOH) who provide Hepatitis Medication Therapy Adherence Clinic service. The protocol will guide pharmacists who plan to initiate such a service and ensure standardisation of practice throughout all MOH facilities.

I would like to congratulate all contributors for their effort in developing this protocol.

ABIDA HAQ BINTI SYED M. HAQDIRECTORPharmacy Practice and DevelopmentPharmaceutical Services DivisionMinistry of Health Malaysia


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AdvisorsAbida Haq binti Syed M. Haq

Director of Pharmacy Practice and DevelopmentPharmaceutical Services Division, MOH

ContributorsPoh Wei Yoon

Hospital Selayang

Law Bee KengHospital Queen Elizabeth 1, Kota Kinabalu

Loh Sze YanHospital Sultanah Bahiyah, Alor Setar

Nurul Nadiah binti Abd. RahimHospital Melaka

ReviewersRosminah binti Mohd. Din

Deputy DirectorPharmaceutical Services Division, MOH

Noraini binti MohamadSenior Principal Assistant Director

Pharmaceutical Services Division, MOH

Hazimah binti HashimSenior Principal Assistant Director

Pharmaceutical Services Division, MOH

AcknowledgementPharmacy Department

Hospital Selayang


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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 (PATIENT ASSESSMENT AND EDUCATION) ......................... 3 3. SUBSEQUENT VISITS (ASSESSMENT, MONITORING AND COUNSELLING) ..... 4 4. COMPLETION AND MISSED VISIT .............................................................. 4 5. PHARMACEUTICAL REVIEW ....................................................................... 5 6. DOCUMENTATION...................................................................................... 6

G. REFERENCES ....................................................................................... 6 H. APPENDICES

1. Appendix Ia: HEPATITIS MTAC WORKFLOW (INITIAL VISIT)................... 8 2. Appendix Ib: HEPATITIS MTAC WORKFLOW (SUBSEQUENT VISITS) ..... 93. Appendix II: PATIENT’S AGREEMENT FORM ......................................... 10 4. Appendix III: PATIENT’S PROFILE AND ASSESSMENT FORM ............... 11 5. Appendix IVa: PATIENT’S MEDICATION DIARY ..................................... 13 6. Appendix IVb: DIARI UBAT-UBATAN PESAKIT ......................................... 16 7. Appendix Va: HEPATITIS C KNOWLEDGE PRE/POST-ASSESSMENT TEST ..... 19 8. Appendix Vb: UJIAN PENGETAHUAN HEPATITIS C SEBELUM/SELEPAS

KAUNSELING .......................................................................................... 20 9. Appendix VI: PRETREATMENT COUNSELLING CHECKLIST ................. 21 10. Appendix VII: TREATMENT DOSING AND DURATION TABLE ................ 22 11. Appendix VIII: SCHEDULE OF PERIODIC TESTS ................................... 24 12. Appendix IX: DOSAGE ADJUSTMENT TABLE ........................................ 25


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13. Appendix Xa: RESPONSE-GUIDED THERAPY FOR CHRONIC HEPATITIS C: GENOTYPE 1 ..................................................................... 27

14. Appendix Xb: RESPONSE-GUIDED THERAPY FOR CHRONIC HEPATITIS C: GENOTYPE 2 AND 3 .......................................................... 28


15. Appendix XI: TREATMENT RESPONSE: DEFINITION OF TERMS .......... 29 16. Appendix XII: CRITERIA FOR MAJOR DEPRESSIVE EPISODE: DSM-5 ............. 30

19. Appendix XIVc: SELF- INJECTION TECNIQUE CHECKLIST: S/C Standard Interferon α-2b (Intron-A®)

....................................................... 31

18. Appendix XIVb: SELF-INJECTION TECNIQUE CHECKLIST: S/C Pegylated IFN α-2b (Peg-Intron®) ..................................................32

.................................................. 34

17. Appendix XIVa: SELF-INJECTION TECNIQUE CHECKLIST: S/C Pegylated IFN α-2a (Pegasys®)

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A. INTRODUCTION Hepatitis B (HBV) and hepatitis C virus (HCV) infections are global health problems. The latest WHO data suggest that more than 185 million people are infected with HCV worldwide, of whom 350,000 die each year. The estimated prevalence of hepatitis C infection in Malaysia is around 2% of the population.1

Chronic hepatitis C has been associated with serious clinical sequelae, such as development of hepatic fibrosis, cirrhosis of the liver and hepatocellular carcinoma.

Studies have shown that participation of clinical pharmacists in medication therapy management of patients brings a lot of benefits by facilitating patients’ adherence to their therapy, improving outcomes of drug therapy and increasing the cost-effectiveness of treatment. These promising results were shown in the pharmacist-managed clinics of chronic disease states such as diabetes mellitus, hyperlipidaemia and asthma.2,3,4,5,6

Studies have shown that pharmacists were able to identify and respond to potential opportunities for improvements in medication use. In Hepatitis Clinics, pharmacists assist patients with drug adherence, management of drug adverse effects and disease state, provision of medication information and achievement of overall treatment goals which increased the probability of HCV treatment success. 7,8,9,10


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B. OBJECTIVES 1. To maximise the benefits of medication therapy in hepatitis patients. 2. To provide in-depth education for caregivers 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 increasing adherence to medications and their engagement in the process.

5. To customise counselling for specific medication(s) and follow-up with the aim to provide individualised medication therapy management.

C. SCOPE OF SERVICE 1. The Hepatitis MTAC service will operate in the clinic area during clinic

days or in the ward 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 REQUIREMENTOn Hepatitis MTAC days, at least one (1) pharmacist should be placed in the clinic.

E. APPOINTMENTAll appointments will be scheduled by the pharmacist or other healthcare provider participating in the clinic/ward.


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F. PROCEDURES1. PATIENT SELECTION

Hepatitis (B/C) patients who are planned for treatment with interferon.

2. INITIAL VISIT (PATIENT ASSESSMENT AND EDUCATION) 2.1 The pharmacist will perform an interview with the patient and/or

the caregiver and perform initial assessment on the patient. The initial evaluation will involve:A. Patient informationB. Medical and medication historiesC. Medication knowledge and adherence (for other diseases)D. Diet and lifestyleE. Risk factors (social and family histories)F. Relevant radiology and laboratory investigations (FBC, BUSE/

creatinine, LFT, UPT, thyroid function test etc.)

2.2 Hepatitis C education and pretreatment counselling (refer Appendix VI) will be delivered to the patient.

2.3 Hepatitis C knowledge preassessment test (refer Appendix V) will be conducted to assess patient’s understanding.

2.4 Pharmaceutical care issues (if any) should be determined.

2.5 Documentations should be made on related forms (refer Appendix III and IVa/b).

2.6 Patient’s Agreement Form (refer Appendix II) should be filled up during this visit.

2.7 The pharmacist will follow the next clinic appointment date as decided by the prescriber.


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3. SUBSEQUENT VISITS (ASSESSMENT, MONITORING AND COUNSELLING) 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. Poor self–injection technique C. Other reasons as determined by the MTAC pharmacist

3.2 During follow-up visits, the pharmacist will review the patient and conduct: A. Counselling on medication and treatment goals (refer Education

Material) B. Reassessment on injection technique (refer Appendix XIVa/b/c) C. Adherence assessment for oral pills (refer Appendix XIII) D. Adverse drug reaction monitoring (refer Appendix III) E. Monitoring of virological response and other relevant laboratory

investigationsF. Post-assessment test at fifth visit (refer Appendix Va/b) to

reassess patient’s understanding

3.3 The next appointment date should be assigned and documentations should be made accordingly (refer Appendix IVa/b).

4. COMPLETION AND MISSED VISITS 4.1 A patient is considered as having completed Hepatitis MTAC

programme upon completion of his/her treatment course OR upon treatment discontinuation by physician due to clinical reasons.

4.2 Patient will be contacted on the review date if he/she misses a Hepatitis MTAC visit to reschedule the appointment.


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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,renaladjustmentdose,interactions,contraindicationsetc.

5.3 Solve medication-related problems: • Considernon-pharmacologicaltherapythatmayhelp• Identifythemostsuitablepharmacologicaltherapythatmayhelp

to prevent or solve the problem (consider the pros and cons of each therapeutic alternative)

• Formulatepatient-specificactionplanwithpatientandprescriberusing holistic approach (i.e. consider the patient’s medical, social and financial needs)

5.4 Drug therapy monitoring: • Monitorpatient’sadherencetothepharmacotherapyplan• 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

• Assessandcounselonproperuseofmedications• MonitorADRsanddeterminetheactionplanwheneverneeded

5.5 Education on disease (hepatitis): • e.g.prevention,transmission,progressionetc.

5.6 Pharmacist’s recommendation: • Offerfeedbackandevidence–basedrecommendationstopatient

and prescriber


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

G. REFERENCES1. World Health Organization. Guidelines for the screening, care and

treatment of persons with hepatitis infection. [Accessed 19th August 2014].

2. Borenstein JE, Graber G, Saltiel E, Wallace J, Ryu S, Archi J et al. Physician-pharmacist co-management of hypertension: a randomized, comparative trial. Pharmacotherapy. 2003; 23(2):209-16.

3. Yanchick JK. Implementation of a drug therapy monitoring clinic in a primary-care setting. Am J Health Syst Pharm. 2000; 57 Suppl 4: S30-4.

4. 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; 20(11): 1375-83.

5. Dolder NM, Wilhardt MS, Morreale AP. Justifying a multidisciplinary high-intensity hepatitis C clinic by using decision analysis. Am J Health Syst Pharm. 2002; 59(9): 867-71.

6. Snella KA, Sachdev GP. A primer for developing pharmacist-managed clinics in the outpatient setting. Pharmacotherapy. 2003; 23(9):1153-66.

7. Mariño EL, Alvarez-Rubio L, Miró S, Modamio P, Banos F, Lastra CF, et al. Pharmacist intervention in treatment of patients with genotype 1 chronic hepatitis C. J Manag Care Pharm. 2009; 15(2):147-50.

8. 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.


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9. Kolor B. Patient education and treatment strategies implemented at a pharmacist-managed hepatitis C virus clinic. Pharmacotherapy. 2005; 25(9):1230-41.

10. Rodis JL, Kibbe P. Development of a hepatitis C support group. Am J Health Syst Pharm. 2006; 63(17):1594-96.


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Appendix IaHEPATITIS MTAC WORKFLOW (INITIAL VISIT)

Location: Clinic/Ward

Documentation

Candidatefor treatment

Patient recruitment to Hepatitis MTAC by pharmacist based

on selection criteria orby doctor’s referral

Patient to sign agreement form (Appendix II)

Doctor

Doctor/Pharmacist

Pharmacist/ Nurse

Pharmacist

Pharmacist

Pharmacist

Pharmacist

Pharmacist’s assessment, education and counselling

Medication dispensing, provide sharps bin and cooler bag

Schedule for next visit/appointment


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Appendix IbHEPATITIS MTAC WORKFLOW (SUBSEQUENT VISITS)

Location: Clinic

Nurse

Pharmacist/Nurse

Pharmacist/ Nurse

Pharmacist

Doctor

Pharmacist

Pharmacist

Registration offollow-up patient

Documentation

Pharmacist’s assessmentand monitoring

Review andtreatment

Trace record offollow-up patient

Medication dispensing,counselling and education

Schedule for nextvisit/appointment

Contact patients with missed

appointment


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Appendix II

SURAT PERSETUJUAN (PATIENT’S AGREEMENT FORM)

Saya .................................................................. (No. K/P ...................................) bersetuju menyertai Medication Therapy Adherence Clinic (MTAC) Hepatitis yang dianjurkan oleh Jabatan Farmasi. Saya juga berjanji akan menyertai program kaunseling hepatitis dan memberi kerjasama sepenuhnya dengan menghadiri semua temujanji yang ditetapkan oleh Pegawai Farmasi MTAC.

I ................................................................. (I/C No. ..................................) agree to participate in Hepatitis Medication Therapy Adherence Clinic (MTAC) run by Pharmacy Department. I also agree to join the hepatitis counselling programme and give full cooperation by attending all the appointments given by MTAC Pharmacists.

Tandatangan/ Signature

Nama Pesakit/ Patient’s Name

Tarikh/Date

No. Telefon/ Telephone No.

................................

................................

................................

................................

Tandatangan/ Signature

Nama Peg. Farmasi/ Pharmacist’s Name

Tarikh/ Date

................................

................................

................................


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Appendix III

PATIENT’S PROFILE AND ASSESSMENT FORMName: Race: M / C / I / OthersMRN/IC: Weight:Age: Height:Gender: M / F Allergies:Contact no.: Risk factors:HCV genotype: 1 / 2 / 3 / 4 / 5 / 6 Comorbidities:Treatment regimen: Peg IFN + Ribavirin / Std IFN Treatment duration: 24 weeks / 48 weeksDate of treatment initiation: Date of treatment end:Interferon dose: Ribavirin dose:Baseline viral load (HCV RNA):Treatment outcome: Past medication history:

Pre-discharged counselling:

Monitoring Parameter Week(s) of Treatment

0 2 4 8 12 16 20 24 28 32 36 40 44 48 72

No. of interferon unit suppliedNo. of ribavirin suppliedRibavirin doseInterferon doseViral load (HCV RNA)Next appointment date


a Refer to Appendix XIVa/b/c (self-injection technique checklist)

Body weightWhite blood cell count Haemoglobin levelPlatelet countNeutrophil (ANC)ALTMood evaluationMedication adherenceTechnique reassessment

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Appendix III (Cont.)

Adverse Event

Week(s) of Treatment

Date/Visit No.

1 2 4 8 12 16 20 24 28 32 36 40 44 48 72FatigueHeadacheMyalgiaFeverNauseaArthralgiaInsomniaAlopeciaDepression*IrritabilityDiarrhoeaPruritusDermatitis

*Refer Appendix XII (Criteria for Major Depressive Episode: DSM-5)

Date Pharmaceutical Care Issue Recommendation Outcome Pharmacist’s

Stamp and Sign


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Appendix IVa

PATIENT’S MEDICATION DIARY

Patient’s Name : ...............................................................................................................

MRN/IC : ...............................................................................................................

INSTRUCTIONSRIBAVIRIN: Need to be taken twice daily. If you miss a dose: Take as soon as possible on the same day. If it is already time for the next dose, skip the missed dose. Please state the reason for skipped or missed doses in the “Comment/Reason for Missed Dose” section, then resume normal dosing schedule.

PEGYLATED INTERFERON: Record the date each weekly dose is taken and indicate the dose of pegylated interferon that is taken on a given date. If you miss 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 doses in the “Comment/Reason for Missed Dose” section, then resume normal dosing schedule.

PATIENT’S DOSEType of pegylated interferon: ..................................................................Administer ....................................... subcutaneously once every week.

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

ORAL PILL:12 hours apart (morning andevening AFTER meals)Keep oral pills (tablets/capsules)safely in container:BRING to clinic at everyappointment.

2INJECTION:Preferably at night(once a week)Dispose your pen(injection) into sharps bin:BRING to clinic at the endof treatment/when sharpsbin is full.

1

Write down questions and clarify with your doctor, pharmacist and nurse.


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Wee

k

Date

Body

Wei

ght

WBC Hb Pl

t

ANC

ALT

Peg I

FN D

ose

Inje

cted

(Y/N

)

Inje

ctio

n Si

te(L

/R)

Com

men

t /

Reas

on fo

r M

issed

Dos

e

123456789

1011121314151617181920212223242526272829303132

Appendix IVa (Cont.)


15

Wee

k

Date

Body

Wei

ght

WBC Hb Pl

t

ANC

ALT

Peg I

FN D

ose

Inje

cted

(Y/N

)

Inje

ctio

n Si

te(L

/R)

Com

men

t /

Reas

on fo

r M

issed

Dos

e

33343536373839404142434445464748

Appendix IVa (Cont.)


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Appendix IVb

DIARI UBAT-UBATAN PESAKIT

Nama Pesakit : ...............................................................................................................

MRN/KP : ...............................................................................................................

ARAHANRIBAVIRIN: Perlu dimakan dua kali sehari. Jika anda tertinggal satu dos: Makan ubat 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 PESAKITJenis pegylated interferon: ..................................................................Suntik ....................................... secara subkutaneus seminggu sekali.

Ribavirin: Makan ................ kapsul pada waktu pagi dan ................ kapsul pada waktu malam bersama makanan.

2SUNTIKAN:Sebaik-baiknya pada waktumalam (seminggu sekali)Buangkan jarum suntikandalam bekas kalis tembus:BAWA ke klinik pada akhirrawatan/setelah bekas penuh diisi.

1

Catatkan jika ada sebarang persoalan dan dapatkan penerangandaripada Doktor, Pegawai Farmasi dan Jururawat.

PIL ORAL:Setiap 12 jam (pagi danpetang selepas makan)Simpan pil oral (tablet/kapsul)dalam bekas yang selamat:BAWA ke klinik setiap kalimenghadiri temujanji.


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Min

ggu

Tarik

h

Bera

t Bad

an

WBC Hb Pl

t

ANC

ALT

Dos P

eg IF

N

Disu

ntik

(Y/T

)

Tem

pat

Sunt

ikan

(Kiri

/Kan

an)

Kom

en/S

ebab

Te

rting

gal D

os

123456789

1011121314151617181920212223242526272829303132

Appendix IVb (Cont.)


18

Appendix IVb (Cont.)M

ingg

u

Tarik

h

Bera

t Bad

an

WBC Hb Pl

t

ANC

ALT

Dos P

eg IF

N

Disu

ntik

(Y/T

)

Tem

pat

Sunt

ikan

(Kiri

/Kan

an)

Kom

en/S

ebab

Te

rting

gal D

os

33343536373839404142434445464748


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Appendix Va

HEPATITIS C KNOWLEDGE PRE/POST–ASSESSMENT TEST

MRN/IC No. : ................................................. Date : ......................................

Visit No. : .................................................

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

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 twice a day after meals.

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 ........... /10Pharmacist’s Sign & Stamp:

................................................... Date : ......................................


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Appendix Vb

UJIAN PENGETAHUAN HEPATITIS C SEBELUM/SELEPAS KAUNSELING

No.MRN/KP : ................................................. Tarikh : ......................................

No. Lawatan : .................................................

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

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 alkohol 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 suntikan.

B S

7 Hepatitis C memerlukan rawatan sepanjang hayat. B S

8 Pil untuk merawat hepatitis C mesti diambil dua kali sehari selepas makan.

B S

9 Perubahan pada darah (pengurangan hemoglobin 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 skor ........... /10Tandatangan & Cop Pegawai Farmasi:

..................................................................... Tarikh : ......................................


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Appendix VI

MEDICATION THERAPY ADHERENCE CLINIC (HEPATITIS) PRETREATMENT COUNSELLING CHECKLIST

Patient’s Name : ................................................. Date : ......................................

RN/IC : .................................................

Understanding Hepatitis C (refer Patient Education Materials)

What are the liver functions? What is hepatitis C? Why doesn’t a patient feel sick? Transmission of hepatitis Preventive precaution Pretreatment laboratory investigation Factors affecting viral clearance What to know and how to help yourself? Hepatitis C treatments Treatment goals Best way to take medications Common side effects Hints and tips to cope with side effects Treatment monitoring tools Self-injection technique (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 VII

TREATMENT DOSING AND DURATION TABLE

IndicationRegimen and Dose

DurationInterferon 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

800 mg/day OR

15 mg/kg/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)



1.5 mcg/kg/week

15 mg/kg/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)



1.5 mcg/kg/week

15 mg/kg/day (in 2 divided doses)

48 weeks OR

24 weeks: if G2/G3 with

RVR+ baseline VL <400,000 IU/ml

+ less than bridging fibrosis

CHC (Hemodialysis

& all HCV

genotypes)

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

OR S/C Pegylated IFN α-2a

135 mcg/week OR

S/C Pegylated IFN α-2b 1 mcg/kg/week

Ribavirin not needed

OR Lowest possible

dose (200 mg 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


23

Appendix VII (Cont.)

Notes:1. The recommended dose of ribavirin is 800 to 1,400mg per day orally based on

patient’s 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’s 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.


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Appendix VIII

SCHEDULE OF PERIODIC TESTS

TestNo. of Weeks After Start of Treatment

Baseline 2 4 8 12 16 20 24 28 32 36 40 44 48 72

Medical history xVital signs x x x x x x x x x x x x x x xPhysical examinationa x

HCV RNA viral load x x x x x x

HCV genotype xHaemoglobin level x x x x x x x x x x x x x x

Haematocrit x x x x x x x x x x x x x xCBC with differential x x x x x x x x x x x x x x

Platelet count x x x x x x x x x x x x x xPregnancy test (females only) x x x x x x x x x x x x x x

Mood evaluation x x x x x x x x x x x x x x xEvaluation of adverse events x x x x x x x x x x x x x x x

Ophthalmologic examinationb x

HCV = Hepatitis C virus; CBC = complete blood count aPerformed as needed bPerformed as needed for patients at risk Other examinations (e.g. electrocardiogram and pulmonary imaging studies) may be performed as needed


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Appendix IX

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

>2g/dL during

4 weeks period:

Reduce to 600 mg/day (permanent

dose reduction)

<8.5 No recommendation

Discontinue permanently

Step 2:Hb <12g/

dL despite 4 weeks in

reduced dose: Discontinue

permanently

Discontinue

Step 2:Hb <12g/

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 -


26

Appendix IX (Cont.)

Neutrophil count (103/mm3)

<0.75 Reduce to 135 µg




<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




<25 Discontinue permanently Discontinue permanently -

Reference: Product inserts


27

Appendix Xa

RESPONSE-GUIDED THERAPY FOR CHRONIC HEPATITIS C: GENOTYPE 1

Reference: World J Hepatol Sept 27.2013: 5(9):4962504

Weeks 0 4 12 24 48 72

Neg(RVR)

24 weeks treatment if LVL at baseline

400,000 - 800,000 IU/ml and less than bridging fibrosis

Neg(cEVR)

Pos>2 log drop

Pos (No RVR)

Pos <2 log drop(NR)

Pos (PR)

Neg(DVR)

72 weekstreatment

48 weekstreatment

Stop treatment

Stop treatment


28

Appendix Xb

RESPONSE-GUIDED THERAPY FOR CHRONIC HEPATITIS C: GENOTYPE 2 AND 3

Reference: World J Hepatol Sept 27.2013: 5(9):4962504

+ Risk factors(bridging fibrosis,cirrhosis, insulin

resistance)

Weeks 0 4 12 24 48

Neg(RVR)

12 - 16 weeks of treatmentonly if have intolerable side e�ect

Pos (No RVR)

Pos <2 log drop or

positive at Week 24

Pos >2 log drop but

negative therea�er(DVR)

Stop treatment

48 weekstreatment

24 weekstreatment

48 weekstreatment


29

Appendix XI

TREATMENT RESPONSE: DEFINITION OF TERMS

SVR Sustained Virological Response

Undetectable HCV RNA level (<50 IU/ml) 24 weeks after treatment

RVR Rapid Virological Response

Undetectable HCV RNA in a sensitive assay (<50 IU/ml), at Week 4 of therapy, maintained

up to end of treatment

EVR Early Virological Response

Undetectable HCV RNA or more than 2 log reduction of HCV RNA compared with

the baseline level (further subdivided into pEVR & cEVR)

pEVR Partial EVR An EVR with detectable HCV RNA at Week 12

cEVR Complete EVR Undetectable HCV RNA at Week 12

DVR Delayed Virological Response

More than 2 log IU/ml decrease in HCV RNA from baseline at Week 12 of therapy that eventually resulted in undetectable HCV RNA at Week 24

NR Null Responder Less than 2 log IU/ml decrease in HCV RNA from baseline at Week 12 of therapy

PR Partial ResponderMore than 2 log IU/ml decrease in HCV RNA level

from baseline but detectable HCV RNA at Week 12 and 24

BT Breakthrough Reappearance of HCV RNA at any time during treatment after virological response


30

Appendix XII

CRITERIA FOR MAJOR DEPRESSIVE EPISODE: DSM-5

A. Five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.

Note:Do not include symptoms that are clearly due to a general medical condition, or mood-incongruent delusions or hallucinations.• Depressedmoodmostof theday,nearlyeveryday,as indicatedbyeither

subjective report (e.g. feels sad or empty) or observation made by others (e.g. appears tearful). Note: In children and adolescents, can be irritable mood.

• Markedlydiminishedinterestorpleasureinall,oralmostall,activitiesmostof the day, nearly every day (as indicated by either subjective account or observation made by others).

• Significantweight losswhen not dieting orweight gain (e.g. a change ofmore than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day. Note: In children, consider failure to make expected weight gains.

• Insomniaorhypersomnianearlyeveryday.• Psychomotor agitation or retardation nearly every day (observable by

others, not merely subjective feelings of restlessness or being slowed down).• Fatigueorlossofenergynearlyeveryday.• Feelings of worthlessness or excessive or inappropriate guilt (whichmay be

delusional) nearly every day (not merely self-reproach or guilt about being sick).• Diminishedability to thinkor concentrate,or indecisiveness,nearlyevery

day (either by subjective account or as observed by others).• Recurrent thoughts of death (not just fear of dying), recurrent suicidal

ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide.

B. The symptoms cause clinically significant distress or impairment in social, occupational or other important areas of functioning.

C. The symptoms are not due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition (e.g. hypothyroidism).

Source: DSM-V, American Psychiatric Association


Appendix XIVa

SELF-INJECTION TECHNIQUE CHECKLIST S/C Pegylated IFN α-2a (Pegasys®)

1 Recognise the parts of Pegasys® single prefilled syringe.2 Perform handwashing and self hygiene before using the prefilled

Pegasys® unit.3 Remove Pegasys® from fridge (2-8°C) and allow to bring to room

temperature (5 minutes).4 Check solution to ensure it is clear (without particle). 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 is firmly attached to the 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. Hold for 5

seconds, then pull out the needle at the same angle.12 Throw pen into sharps bin.13 Storage: 2-8°C. Transport of interferon: Bag and ice pack provided. These

2 items are to be carried on every appointment for following supply.14 Disposal: Sharps bin to be handed over to the clinic when full or upon

completion of treatment for incineration.15 Emphasize on the importance of adherence to interferon injection and

ribavirin. Remind patient to see pharmacist at Hepatitis MTAC during next appointment.

16 Ensure patient understand and able to demonstrate back the correct technique of injecting S/C Pegasys®.

17 Witness patient self-administer the first dose.


31

Appendix XIVb

SELF-INJECTION TECHNIQUE CHECKLIST S/C Pegylated IFN α-2b (Peg-Intron®)

1 Recognise the parts of Peg-Intron® Clearclick®.

2 Perform handwashing and self hygiene before using the Peg-Intron® Clearclick®.

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

4 Check the name, strength and expiry date of medicine.

5 Turn dial to number 1. There might be a “click” sound.

6 Gently turn the device upside down two times to mix (DO NOT SHAKE). The solution should be clear and colourless. DO NOT USE IF IT IS DISCOLOURED OR IF PARTICLE IS PRESENT.

7 Turn dial to number 2. There might be a “click” sound.

8 Wipe device where needle attaches with an alcohol swab.

9 Remove yellow paper from needle cap before attaching to device.

10 Support device in upright position and push needle straight down firmly.

11 Remove needle cap.

12 Turn dial to the prescribed dose. There might be a “click” sound.

13 As dose is dialled, the needle shield will automatically snap up. It is possible to dial up or down to any dose prior to injection. DO NOT RETRACT THE NEEDLE SHIELD BY HAND. This will cause the dose to spray into air.

14 Choose an injection site on the stomach or thigh.

15 Wipe the injection site with alcohol swab. Let the skin air-dry.

16 Pinch the site of injection and press device against the pinched skin. The shield will glide back to allow needle to inject medication.

17 Hold device against skin for 15 seconds. There might be “clicking” sound, indicating that the medicine is being delivered. Once pen is removed from skin, the needle shield will lock in place.


32

Appendix XIVb (Cont.)

18 Throw used pen in sharps bin.

19 Storage: 2-8°C. Transport of interferon: Bag and ice pack provided. These 2 items are to be carried on every appointment for following supply.

20 Disposal: Sharps bin to be handed over to the clinic when full or upon completion of treatment for incineration.

21 Emphasize on the importance of adherence to interferon injection and ribavirin. Remind patient to see pharmacist at Hepatitis MTAC during next appointment.

22 Ensure patient understand and able to demonstrate back the correct technique of injecting S/C Peg-Intron®.



33

Appendix XIVc

SELF-INJECTION TECHNIQUE CHECKLIST S/C Standard Interferon α-2b (Intron-A®)

1 Recognise the parts of Intron A®.

2 Perform handwashing and self hygiene before using 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 pen, turning it in clockwise direction.

8 Pull off the outer needle cap. Keep the outer needle cap for later use.

9 Pull off the inner needle cap.

10 Prime the multidose pen by 2 units. If no drop appears, repeat the step until a drop appears at the tip of the needle.

11 Replace the Intron A® cap with the black triangle on the cap aligned with the dose indicator on the pen barrel.

12 To set the dose, hold the pen horizontally by the barrel with one hand. Using the other hand, twist the cap as indicated by the arrow (hepatitis C: 3 MIU = 6 clicks; hepatitis B: 5 MIU = 10 clicks).

13 Choose site of injection and swab with alcohol swab. Rotate injection sites each time.

14 Pinch site of injection slightly and inject at 90-degree angle. Hold for 5 seconds to ensure the dose is delivered completely.

15 Carefully, replace the outer cap and discard the capped needle safely.

16 Storage: 2-8°C. Transport of interferon: Bag and ice pack provided. These 2 items are to be carried on every appointment for following supply.

17 Disposal: Sharps bin to be handed over to clinic when full or upon completion of treatment for incineration.


34

Appendix XIVc (Cont.)

18 Emphasize on the importance of adherence to interferon injection and ribavirin. Remind patient to see pharmacist at Hepatitis MTAC during next appointment.

19 Ensure patient understand and able to demonstrate back the correct technique of injecting S/C Intron A®.



35


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