program farmasi - pharmacy.gov.my · letter from the director of pharmacy ... • issuance of...

BAHAGIAN PERKHIDMATAN FARMASIPHARMACEUTICAL SERVICES DIVISION

Kementerian Kesihatan MalaysiaMinistry of Health Malaysia

PROGRAM FARMASILAPORAN TAHUNAN 2016

PHARMACY PROGRAMME ANNUAL REPORT 2016

GAMBARAN KESELURUHAN OVERVIEW .....................................................................01

Mengenai Laporan Ini About This Report ...................................................02Program Farmasi Sekilas Pandang Pharmacy Programme at a Glance .......................03Piagam Pelanggan Client Charter .........................................................05Visi & Misi Vision & Mission .....................................................06Objektif Bahagian Division Objective ...................................................07

PERUTUSAN PENGARAH KANAN SENIOR DIRECTOR’S STATEMENT ................................08

PERUTUSAN PENGARAH DASAR & PERANCANGAN STRATEGIK FARMASI LETTER FROM THE DIRECTOR OF PHARMACY POLICY & STRATEGIC PLANNING .................................10

CARTA ORGANISASI ORGANISATION CHART ................................................12

KEMPIMPINAN KAMI OUR LEADERSHIP .........................................................13

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASI PHARMACY POLICY AND STRATEGIC PLANNING DIVISION .......................................................................17 1.0 Pengenalan Introduction ....................................................19 2.0 Dasar Ubat Nasional (DUNas)

Malaysian National Medicines Policy (MNMP) ................................22

3.0 Cawangan Pembangunan Profesion Farmasi Development of Pharmaceutical Profession Branch ............................................ 25 4.0 Aktiviti dan Sorotan Activities and Highlights ..................................29

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASI PHARMACY PRACTICE AND DEVELOPMENT DIVISION .............................................37 1.0 Pengenalan Introduction ....................................................39 2.0 Statistik

Statistics ..........................................................43 3.0 Aktiviti dan Sorotan

Activities and Highlights ..................................54

BAHAGIAN PENGUATKUASAAN FARMASI PHARMACY ENFORCEMENT DIVISION .........................69 1.0 Pengenalan

Introduction ....................................................71 2.0 Statistik

Statistics ..........................................................74 3.0 Aktiviti dan Sorotan

Activities and Highlights ..................................79

LEMBAGA FARMASI MALAYSIA PHARMACY BOARD MALAYSIA .....................................97 1.0 Pengenalan Introduction ....................................................99 2.0 Statistik

Statistics ........................................................101 3.0 Aktiviti dan Sorotan

Activities and Highlights ................................104

ISI KANDUNGAN INSIDE THIS REPORT

3.0 Cawangan Pembangunan Profesion Farmasi ..... Development of Pharmaceutical Profession Branch

BAHAGIAN REGULATORI FARMASI NEGARA (BRFN) THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA) ...................................107 1.0 Pengenalan

Introduction ..................................................109 2.0 Maklumat Terkini

Latest Information ........................................111 3.0 Statistik

Statistics ........................................................114 4.0 Aktiviti dan Sorotan

Activities and Highlights ................................117

KOLABORASI & PENGLIBATAN ANTARABANGSA INTERNATIONAL PARTICIPATION & COLLABORATION ....................................................125 1.0 Mesyuarat Bilateral

Bilateral Meetings .........................................126 2.0 Penglibatan BRFN di dalam

Kumpulan Kerja Asean NPRA’s Participation in Asean Working Groups .................................127

3.0 BRFN Sebagai Pusat Kolaborasi WHO bagi Kawalan Regulatori untuk Produk Farmaseutikal NPRA as a Who Collaborating Centre for Regulatory Control of Pharmaceuticals .......129

PENERBITAN DAN KAJIAN PUBLICATIONS AND RESEARCH ..................................131 Garis Panduan Perkhidmatan Tambah Nilai

Farmasi (VAS) Pharmacy Value Added Services Guidelines .........132

Polisi dan Garis Panduan Patient’s Own Medicines Patient’s Own Medicines Policy & Guideline ........132

Garis Panduan Pengendalian Bahan Psikotropik Di Dewan Bedah Fasiliti Kesihatan Kementerian Kesihatan Malaysia (KKM) .................................133

Kajian Pemantauan Harga Ubat Medicine Prices Monitoring Survey ........................133

Kajian Kos Ubat Per Preskripsi Survey on Medicines Cost Per Prescription ............134

Kajian Kebangsaan Penggunaan Ubat dalam Kalangan Pengguna di Malaysia A National Survey on The Use of Medicines (NSUM) by Malaysian Consumers .......................................134

Antibiotic Point Prevalence Survey 2016 ........136 Kajian Kepuasan Kerja di Kalangan

Pegawai Farmasi Provisional di Fasiliti Kementerian Kesihatan Malaysia The Satisfaction And Perception of Provisionally Registered Pharmacists in Ministry of Health Facilities ................................136

KajianTechnicalEfficiency Technical Efficiency Study ......................................137

GAMBARAN KESELURUHANOVERVIEW

Sukacitanya kami membentangkan Laporan Tahunan 2016. Laporan tahunan ini menerangkan operasi dan pencapaian Bahagian Perkhidmatan Farmasi dan Bahagian Regulatori Farmasi Negara dalam tahun 2016. Kami berharap laporan tahunan ini dapat memberikan pandangan yang lebih menyeluruh berkaitan usaha-usaha yang telah dijalankan untuk mencapai matlamat jangka pendek dan panjang bagi keseluruhan Program Farmasi.

We are pleased to present our Annual Report 2016. This annual report describes the performance and operation of Pharmaceutical Services Division and National Pharmaceutical Regulatory Agency in 2016. We hope to provide a more holistic view of our collective efforts to achieve our immediate and long-term goals across the entire Pharmacy Programme.

MENGENAI LAPORAN INIABOUT THIS REPORT

Laporan Tahunan Program Farmasi 2016

2

Program Farmasi, Kementerian Kesihatan Malaysia (KKM) ditubuhkan pada tahun 1951, merupakan agensi utama yang bertanggungjawab memastikan orang awam mendapat keluaran farmaseutikal yang berkualiti, selamat dan berkesan, melindungi kepentingan mereka melalui penguatkuasaan undang-undang yang berkaitan, serta memastikan ubat-ubatan digunakan oleh penyedia perkhidmatan kesihatan dan juga pesakit secara wajar.

Kini, Program ini terdiri daripada lima Bahagian utama yang diketuai oleh seorang Pengarah Kanan. Kelima-lima bahagian ini memainkan peranan penting dalam aspek-aspek yang berbeza dengan satu matlamat yang sama iaitu untuk memberikan perkhidmatan farmasi yang terbaik kepada orang ramai.

The Pharmacy Programme of the Ministry of Health (MOH), established in 1951, is the lead agency that ensures the public gets access to safe, efficacious and quality pharmaceutical products, protecting their interest via enforcement of relevant legislations, and ensuring rational use of medicines by both healthcare providers and patients.

Currently, The Programme consists of five main divisions and is headed by a Senior Director. These five main Divisions play important roles in different aspects and approaches with the same objective that is giving the best professional pharmacy service to the public.

PROGRAM FARMASI SEKILAS PANDANGPHARMACY PROGRAMME AT A GLANCE

BAHAGIAN DASARDAN PERANCANGANSTRATEGIK FARMASI,

PHARMACY POLICYAND STRATEGIC

PLANNING DIVISION

BAHAGIAN AMALANDAN PERKEMBANGAN

FARMASIPHARMACY PRACTICEAND DEVELOPMENT

DIVISION

BAHAGIANPENGUATKUASAAN

FARMASIPHARMACY

ENFORCEMENTDIVISION

BAHAGIANREGULATORI

FARMASI NEGARANATIONAL

PHARMACEUTICALREGULATORY AGENCY

LEMBAGAFARMASI

MALAYSIAPHARMACY

BOARDAMALAYSIA

Pharmacy Programme 2016 Annual Report

3

Peratus pengilang berlesen produk farmaseutikal yang memenuhi keperluan Amalan Pengilangan Baik (GMP).Percentage of licensed manufacturer of pharmaceutical products that meet the requirements of Good Manufacturing Practices (GMP).

Peratus kes yang berjaya dalam perbicaraan mahkamah daripada jumlah kes yang didakwa di mahkamah.Percentage of successful case in the trial court out of the number of cases charged in court.

Bilangan Pusat Pungutan Ubat Susulan Setempat Baru yang diwujudkan.

Number of new ‘Pusat Pungutan Ubat Susulan Setempat’ established.

36PUSATCENTRE

Peratus fasiliti KKM mencapai simpanan stok ubat yang optima dalam julat 1-3 bulan.Percentage of MOH facilities achieving optimal drug stockpile in the range of 1-3 month.

Rx

100%PENGILANG

MANUFACTURER

99.2% KES | CASE

79.68%

Peratus produk farmaseutikal yang diuji di bawah Program Pengawasan Mutu Produk Berdaftar mematuhi tahap kualiti yang telah ditetapkan.Percentage of pharmaceutical products tested under the Registered Product Quality Control Program comply with the preset quality standard.

97.47%PRODUK |PRODUCTS

FASILITI |FACILITIES

Bilangan preskripsi susulan yang didispens melalui Perkhidmatan Tambah Nilai.Numbers of follow-up prescription dispensed through Value-Added Services.

2,452,848PRESKRIPSI |PRESCRIPTION


4

PIAGAM PELANGGANBAHAGIAN AMALAN DAN PERKEMBANGAN FARMASI MASA

• Keputusan penyenaraian ubat ke dalam FUKKM dimaklumkan kepada pemohon 100 hari bekerja^

BAHAGIAN PENGUATKUASAAN FARMASI MASA

• Pengeluaran kebenaran Import/Eksport Dadah Berbahaya

• Pengeluaran Lesen Import/Eksport Bahan Psikotropik

• Kelulusan e-Permit (Eksport)

• Kelulusan e-Permit (Import)

• Kelulusan oleh Lembaga Iklan Ubat

7 hari bekerja*

7 hari bekerja*

7 hari bekerja*

3 hari bekerja*

5 hari bekerja#

LEMBAGA FARMASI MALAYSIA MASA

• Pengeluaran Sijil Pendaftaran Ahli Farmasi

• Pengeluaran Sijil Pendaftaran Pertubuhan Perbadanan

• Pengeluaran Sijil Tahunan Ahli Farmasi

• Pengeluaran Sijil Pendaftaran Ahli Farmasi Provisional

• Pengeluaran Sijil Tahunan Pertubuhan Perbadanan

7 hari bekerja*

7 hari bekerja*

7 hari bekerja*

7 hari bekerja*

7 hari bekerja*

* Setelah permohonan lengkap diterima.^ Dari tarikh tutup penghantaran permohonan yang ditetapkan.# Dari tarikh permohonan lengkap diterima / selepas mesyuarat Lembaga Iklan Ubat.

CLIENT CHARTERPHARMACY PRACTICE & DEVELOPMENT TIME

• Notify applicant of the results of MOH Medicines Formulary listing application 100 working days^

PHARMACY ENFORCEMENT TIME

• Issuance of Authorization for the Import & Export of Dangerous Drugs

• Issuance of Authorization for the Import & Export of Psychotropic Substances

• Issuance of e-Permit (Export) Approval

• Issuance of e-Permit (Import) Approval

• Approvals for applications by the Medicine Advertisement Board

7 working days *

7 working days *

7 working days *

3 working days *

5 working days #

PHARMACY BOARD MALAYSIA TIME

• Issuance of Full Registration of Pharmacist Certificate

• Issuance of Registration of Body Corporate Certificate

• Issuance of Annual Retention of Pharmacist Certificate

• Issuance of Registration of Provisional Pharmacist Certificate

• Issuance of Annual Retention of Body Corporate Certificate

7 working days *

7 working days *

7 working days *

7 working days *

7 working days *

* Upon receiving complete application.^ Upon application closing date.# upon receiving complete application/ after the Medicine Advertisement Board Meeting.


5

• Menguatkuasakan undang-undang dan memperbaharui polisi sedia ada yang diperlukan untuk memastikan produk farmaseutikal dan perkhidmatan memenuhi kualiti dan standard.Uphold legislations and improve policies to ensure quality pharmaceutical products and services.

• Memastikan sistem organisasi yang responsif dan efektif demi mencapai perkhidmatan yang kekal berkualiti.Ensure effective and responsive organisational systems towards sustainable quality services.

• Membina warga kerja yang berkeupayaan dan berkebolehan serta profesional menerusi pembangunan tenaga kerja yang berkepakaran dan berdaya saing.Build capabilities and professionalism through talent development and workforce empowerment.

• Memperhebatkan kolaborasi dalam memastikan amalan baik dalam perkhidmatan sentiasa dilaksanakan dan memenuhi standard.Intensify collaboration towards best practices and standards.

MISSIONMISI

VISIONVISIMeningkatkan tahap kesihatan rakyat menerusi kecemerlangan praktis farmasi.

Enhancing our nation’s health through excellence in the practice of pharmacy.


6

OBJEKTIF BAHAGIAN | DIVISION OBJECTIVE

• Memastikan akses berterusan kepada ubat-ubatan yang berkualiti, selamat dan kos efektif.

• Mengukuhkan penggunaan ubat secara selamat dan rasional ke arah kesihatan yang lebih baik.

• Meningkatkan perkhidmatan penjagaan farmaseutikal sejajar dengan standard dan amalan baik.

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASIPHARMACY PRACTICE & DEVELOPMENT DIVISION

• Ensuring continuous access to the quality, safe and cost-effective medicines.

• Strengthening the quality and rational use of medicines towards the better health.

• Enhancing pharmaceutical care services in line with the good standards and practices.

• Memastikan semua penjualan, pembekalan, pemilikan dan pengiklanan bahan-bahan, produk dan kosmetik adalah selaras dengan peruntukan undang-undang.

BAHAGIAN PENGUATKUASAAN FARMASIPHARMACY ENFORCEMENT DIVISION

• Ensuring all sales, supply, possession and advertising of substances, products and cosmetics are in compliance with the legal provisions.

• Membangunkan dasar-dasar bagi sektor farmaseutikal selaras dengan keperluan penjagaan kesihatan negara.

• Memastikan pengurusan sumber yang cekap dan efisien.

BAHAGIAN DASAR DAN PERANCANGAN STRATEGIK FARMASIPHARMACY POLICY AND STRATEGIC PLANNING DIVISION

• Developing policies for the pharmaceutical sector in line with the needs of national healthcare.

• Ensuring excellent and efficient resources management.

• Memastikan produk yang diluluskan untuk dipasarkan adalah selamat, efektif dan berkualiti dan memastikan produk neutral dan kosmetik yang bernotifikasi selamat dan berkualiti.

BAHAGIAN REGULATORI FARMASI NEGARANATIONAL PHARMACEUTICAL REGULATORY AGENCY

• To ensure that products approved for the local market are safe and of quality and also to ensure that natural products and cosmetics are safe and of quality.

• Memastikan pendaftaran ahli farmasi dan pertubuhan perbadanan memenuhi keperluan Akta Pendaftaran Ahli Farmasi 1951 dan peraturannya.

• Menetapkan standard bagi kelakuan, etika, kemahiran, pendidikan dan latihan dan Pembangunan Profesional Berterusan.

LEMBAGA FARMASIPHARMACY BOARD OF MALAYSIA

• Ensuring the registration of pharmacists and body corporate complies with Registration of Pharmacists Act 1951 and its regulations.

• Setting standard for conduct, ethics, proficiency, education and training and Continuous Professional Development (CPD).


7

DATO’ EISAH BINTI A. RAHMAN

Assalamualaikum warahmatullahi wabarakatuh, Salam Sejahtera dan Salam Sihat 1Malaysia.

Pertama sekali marilah kita memanjatkan kesyukuran kepada Allah SWT kerana dengan izinnya Program Farmasi telah mengharungi tahun 2016 dengan penuh komited dari segi pembangunannya yang selaras dengan misi kementerian serta visi dalam mengukuhkan transformasi sistem kesihatan.

Penerbitan laporan tahunan ini merakamkan perjalanan transformasi Program Farmasi serta pencapaian dan pelaksanaan aktiviti-aktiviti daripada pelbagai Bahagian di sepanjang tahun 2016. Tahniah dan syabas saya ucapkan kepada semua warga Program Farmasi yang telah memberikan kerjasama dan komitmen yang padu dalam menjayakan agenda yang telah dirancang. Sekalung tahniah juga diucapkan kepada sidang editorial di atas kejayaan menerbitkan Laporan Tahunan Program Farmasi bagi tahun 2016.

Tahun 2016, membuka lembaran dengan pelbagai sasaran yang harus diberikan tumpuan. Sejajar dengan keperluan semasa, peranan ahli farmasi di Malaysia telah berkembang daripada berpusatkan produk kepada

berasaskan perkhidmatan dan kini profesion ini telah berubah menjadi fokus pesakit.

Program Farmasi akan terus komited untuk meningkatkan tahap kesihatan rakyat menerusi kecemerlangan praktis farmasi. Langkah proaktif sentiasa dilaksanakan bagi memastikan keperolehan ubat-ubatan yang berkualiti, selamat, berkesan dan mampu dimiliki adalah mencukupi, berterusan dan sama rata untuk mencapai hasil kesihatan yang optimum. Selain itu, pelbagai usaha kolaborasi bersama agensi dalam negara mahupun di peringkat antarabangsa telah diadakan bagi membina jaringan kerjasama dalam mengembangkan bidang farmaseutikal negara.

Akhir kalam, sekali lagi saya ingin merakamkan setinggi-tinggi penghargaan kepada seluruh warga farmasi dan pihak-pihak berkepentingan yang sentiasa memberi sokongan padu kepada bidang farmaseutikal negara. Semoga kita sentiasa berganding bahu memberikan perkhidmatan yang terbaik kepada rakyat.

Wabillahi Taufik Walhidayah Wassalamualaikum Warahmatullahi Wabarakatuh.


PERUTUSAN PENGARAH KANANSENIOR DIRECTOR’S STATEMENT


8


Assalamualaikum warahmatullahi wabarakatuh.

First of all, let us be grateful to Allah SWT for his blessing, the Pharmacy Programme for with His blessings, the Pharmacy Programme sailed through the year 2016 and remained steadfast to its commitments on developing and strengthening the health system in line with the Ministry’s mission and vision.

The publication of this annual report records a transformational journey of Pharmacy Programme and its achievement and activities implemented from various division in the year 2016. Congratulations to all Pharmacy staff for their cooperation and commitment in ensuring the success of the planned agenda. Congratulations also goes to the editorial board for successfully publishing the Pharmacy Programme’s Annual Report for the year 2016.

The year 2016 was kick started with many targets to be achieved. In line with current needs, the role of pharmacists in Malaysia has evolved from being product centered to service-based and now finally the profession has transformed by being more patient-focused.

The pharmacy programme continues to be committed to enhancing the nation’s health through excellent pharmacy practice. Proactive steps are always taken to ensure adequate, continuous and equitable access to quality, safe, effective and affordable medicines towards achieving optimal health outcomes. Besides, various collaborative efforts with national and international agencies have been established to build collaborative networks in expanding the country’s pharmaceutical industry.

Lastly, I once again wish to express my deep appreciation to all the Pharmacy staff and stakeholders for their support to the country’s pharmaceuticals industry. May we always be united in providing the best services to the people.

Wabillahi Taufik Walhidayah Wassalamualaikum Warahmatullahi Wabarakatuh.



9

DR RAMLI BIN ZAINAL

Assalamualaikum warahmatullahi wabarakatuh, Salam Sejahtera dan Salam Sihat 1Malaysia.

Terlebih dahulu izinkan saya untuk mengambil kesempatan ini untuk mengucapkan tahniah dan syabas kepada seluruh warga Program Farmasi di atas komitmen padu, khidmat bakti dan sumbangan yang telah diberikan dalam merealisasikan pelbagai program dan aktiviti yang telah dirancang pada tahun 2016.

Pada tahun 2016, Program Farmasi terus mengorak langkah demi langkah dengan empat fokus utama iaitu penekanan pada pengukuhan tadbir urus Program Farmasi, pemantapan penyampaian perkhidmatan melalui inovasi dan teknologi, memperkasakan kemahiran, kepakaran dan kapasiti modal insan dan mempertingkatkan kerjasama dengan pihak berkepentingan serta meningkatkan pengetahuan masyarakat mengenai penggunaan ubat berkualiti.

Warga Program Farmasi yang berpegang teguh kepada prinsip profesionalisme, integriti, kerja berpasukan, efisiensi dan mengutamakan pelanggan dapat membina

PERUTUSAN PENGARAH DASAR & PERANCANGAN STRATEGIK FARMASILETTER FROM THE DIRECTOR OF PHARMACY POLICY & STRATEGIC PLANNING

sistem perkhidmatan kesihatan yang inovatif dan mampan. Semoga kejayaan demi kejayaan yang telah dicapai sepanjang 2016 menjadi pemangkin dan semangat buat semua untuk terus melangkah dan memacu transformasi Program Farmasi ke tahap yang lebih cemerlang.

Akhir kata, saya ingin menyeru semua warga Program Farmasi supaya bersatu hati dan meneruskan kecemerlangan dengan lebih bersemangat agar kualiti perkhidmatan kesihatan yang diberikan pada tahun mendatang lebih baik dari tahun-tahun sebelumnya.

Sekian, terima kasih.

DR RAMLI BIN ZAINAL


10

DR RAMLI BIN ZAINAL

Assalamualaikum warahmatullahi wabarakatuh.

Firstly, allow me to take this opportunity to congratulate the Pharmacy staff for their commitment, dedication and contribution to complete various programs and activities that have been planned in 2016.

In 2016, the Pharmacy Program continues to move forward, step by step with four primary focus emphasising on strengthening the governance of the Pharmacy Program, strengthening service delivery through innovation and technology, strengthening the skills, expertise and human resource capacity, and enhancing cooperation with stakeholders and empowering communities on the quality use of medicines.

The staff of the Pharmacy Program has inculcated the principles of professionalism, integrity, teamwork, efficiency and customer-care are capable of building an innovative and sustainable healthcare system. It is hoped that the success achieved in 2016 would be a catalyst and motivation for all to keep going forward and transform the Pharmacy Program to greater heights.

Finally, I would like to urge all Pharmacy staff to unite and pursue excellence with more endurance to provide exceptional quality of health services in years to come.

Thank you.

DR RAMLI BIN ZAINAL


11

PEN

GA

RAH

BA

HA

GIA

N

REG

ULA

TORI

FA

RMA

SI N

EGA

RA

JUSA

BD

r Sal

mah

Bah

ri

PEN

GA

RAH

BA

HA

GIA

N

PEN

GU

ATK

UA

SAA

N

FARM

ASI

JUSA

CTa

n A

nn L

ing

PEN

GA

RAH

BA

HA

GIA

N

AM

ALA

N D

AN

PE

RKEM

BAN

GA

N

FARM

ASI

- JU

SA C

Abi

da H

aq S

M H

aq

PEN

GA

RAH

BA

HA

GIA

N D

ASA

R &

PER

AN

CA

NG

AN

ST

RATE

GIK

FA

RMA

SI -

JUSA

CD

r Ram

li Za

inal

PEN

GA

RAH

LE

MBA

GA

FA

RMA

SI

MA

LAYS

IAJU

SA C

(KU

P)M

ohd

Yuno

s Sh

aari

TIM

BALA

N

PEN

GA

RAH

K

ESIH

ATA

N N

EGER

I (F

ARM

ASI

)

INST

ITU

SIH

OSP

ITA

L K

UA

LA

LUM

PUR

INST

ITU

T K

AN

SER

NEG

ARA

PEN

GA

RAH

KA

NA

N P

ERK

HID

MAT

AN

FA

RMA

SI J

USA

AD

ato’

Eis

ah A

b. R

ahm

an

TEKN

OLOG

I M

AKLU

MAT

&

INFO

RMAT

IK

FARM

ASI

PEM

BAN

GUN

AN

PROF

ESIO

N PE

NOL

ONG

PEGA

WAI

FAR

MAS

I

PEN

JAGA

AN

FARM

ASEU

TIKA

L

PEN

GURU

SAN

FARM

ASI L

OGIS

TIK

PEN

GIKT

IRAF

AN&

ETIK

APE

MBA

NGU

NAN

PR

OFES

ION

FARM

ASI

PEN

YELI

DIKA

N &

PEM

BAN

GUN

AN

FARM

ASI

PERK

EMBA

NGA

N IN

FRAS

TRUK

TUR

& KU

ALIT

I FAR

MAS

I

PEN

GURU

SAN

FORM

ULAR

I

PEN

GURU

SAN

HAR

GA U

BAT

PEN

GGUN

AAN

UBA

T BE

RKUA

LITI

PEM

BAN

GUN

AN

PHIS

PUSA

T PE

NDA

FTAR

AN

PROD

UK

PUSA

T PE

MBA

NGU

NAN

&

PERA

NCA

NGA

N ST

RATE

GIK

PUSA

T PA

SCA

PEND

AFTA

RAN

PROD

UK &

KAW

ALAN

KO

SMET

IK

PUSA

T KA

WAL

AN

KUAL

ITI

PUSA

T KA

JIAN

PR

ODUK

BAR

U

PUSA

T KO

MPL

IANS

& PE

RLES

ENAN

PUSA

T PE

NTAD

BIRA

N

KAW

ALAN

FA

RMAS

EUTI

KAL &

PE

RLIN

DUNG

AN

PENG

GUNA

PERI

SIKA

N&

OPER

ASI

PERL

ESEN

AN

PERU

NDA

NGA

N

KAW

ALAN

IKLA

N

DASA

R FA

RMAS

IPE

NDA

FTAR

AN

PEN

TADB

IRAN

KEW

ANGA

N

CART

A OR

GANI

SASI

ORGA

NISA

TION

CHA

RT


12

YBhg. Dato’ Eisah binti A. RahmanPengarah KananPerkhidmatan FarmasiSenior Director Pharmacy Services

YBrs. Dr Ramli bin ZainalPengarah Bahagian Dasar & Perancangan Strategik FarmasiDirector Pharmacy Policy & Strategic Planning Division

YBrs. Dr Salmah binti BahriPengarah Bahagian Regulatori Farmasi NegaraNational Pharmaceutical Regulatory Division

YBrs. Encik Tan Ann LingPengarah Bahagian Penguatkuasaan FarmasiDirector Pharmacy Enforcement Division

YBrs. Pn. Abida Haq binti Syed M. HaqPengarah Bahagian Amalan & Perkembangan FarmasiDirector Pharmacy Practice & Development Division

YBrs. Tuan Haji Mohd Yunos bin Shaari Pengarah Lembaga Farmasi MalaysiaDirector Pharmacy Board Malaysia

KEMPIMPINAN KAMI | OUR LEADERSHIPPENGARAH | DIRECTOR


13


Cik Latifah binti Hj. IdrisTimbalan Pengarah Cawangan PelesenanDeputy Director Licensing

Encik Dzafarullah bin DaudTimbalan Pengarah Cawangan Kawalan IklanDeputy Director Advertisement Control

Encik Mazlan bin IsmailTimbalan Pengarah Cawangan Kawalan Farmaseutikal & Perlindungan PenggunaDeputy Director Pharmaceutical Control & Customer Protection

Tuan Haji Ghazali bin MansorTimbalan Pengarah PerundanganDeputy Director Legislation

Tuan Haji Sha’ari bin Abd RahmanTimbalan Pengarah Cawangan Perisikan & OperasiDeputy Director Intelligence & Operation

BAHAGIAN AMALAN & PERKEMBANGAN FARMASIPHARMACY PRACTICE & DEVELOPMENT DIVISION

Pn. Rosminah binti Mohd DinTimbalan Pengarah Cawangan Klinikal & Teknikal FarmasiDeputy Director Clinical & Technical Pharmacy

Pn. Salbiah binti Mohd SallehTimbalan Pengarah Cawangan Harga UbatDeputy Director Medicine Price

Pn. Fatimah binti Abdul RahimTimbalan Pengarah Cawangan Logistik FarmasiDeputy Director Pharmaceutical Logistics

Puan Kamarunnesa binti Mokhtar Ahmad Timbalan Pengarah Cawangan Pembangunan PhISDeputy Director of Pharmacy Information System Development

Pn. Che Pun binti BujangTimbalan Pengarah Cawangan Penggunaan Ubat BerkualitiDeputy Director Quality Use of Medicines

Datin Dr Faridah Aryani binti Md YusofTimbalan Pengarah Cawangan Formulari & FarmakoekonomikDeputy Director Formulary & Pharmacoeconomic

BAHAGIAN DASAR & PENGURUSAN FARMASIPHARMACY POLICY & MANAGEMENT DIVISION

Pn. Siti Aisah binti BahariTimbalan Pengarah Cawangan Pembangunan Profesion FarmasiDeputy Director Pharmacy Professional Development

Pn. Fatkhiah binti Hj KhalilTimbalan Pengarah Cawangan Teknologi Maklumat & Informatik FarmasiDeputy Director Pharmacy Information Technology & Informatics

Pn. Ainul Salhani binti Abdul RahmanTimbalan Pengarah Cawangan Perkembangan Infrastruktur & Kualiti FarmasiDeputy Director Pharmacy Infrastructure Development & Quality

Pn. Nur’ Ain Shuhaila binti ShohaimiTimbalan Pengarah Cawangan Dasar FarmasiDeputy Director Pharmacy Policy

Cik Siti Fauziah binti AbuTimbalan Pengarah Cawangan Penyelidikan & Pembangunan FarmasiDeputy Director Pharmacy Research & Development

Tuan Haji Abu Bakar bin IbrahimKetua Profession Cawangan Pembangunan Profession Penolong Pegawai FarmasiPharmacist Assistant Professional Development


14

LEMBAGA FARMASI MALAYSIAPHARMACY BOARD MALAYSIA

Pn. Fuziah binti Abdul RashidTimbalan Pengarah Cawangan PendaftaranDeputy Director of Registration

Pn. Salwati binti Abd KadirTimbalan Pengarah Cawangan Pengiktirafan & EtikaDeputy Director of Accreditation & Ethics

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAANNATIONAL PHARMACEUTICAL CONTROL BUREAU

Pn. Anis binti TalibTimbalan Pengarah Pusat Pendaftaran ProdukDeputy Director of Centre for Product Registration

Puan Siti Aida binti AbdullahTimbalan Pengarah Pusat Pembangunan OrganisasiDeputy Director of Centre for Organisational Development

Dr. Tajuddin bin AkasahTimbalan Pengarah Pusat Kawalan KualitiDeputy Director of Centre for Quality Control

Cik Sameerah Shaik binti Abdul RahmanTimbalan Pengarah Pusat Pasca Pendaftaran ProdukDeputy Director of Centre for Post Registration of Product

Dr. Kamaruzaman bin SalehTimbalan Pengarah Pusat Kajian Produk BaruDeputy Director Centre for Investigational New Product

Encik Mohammad Lukmani bin IbrahimTimbalan Pengarah Pusat Komplians & PelesenanDeputy Director Centre for Compliance & Licensing

UNIT PENTADBIRAN & KEWANGANADMINISTRATION & FINANCE UNIT

Encik Othman bin AhmadKetua Pusat Pentadbiran BPFKHead of Centre for Administration, NPCB

Pn. Siti Fatimah binti Mohamed KassimPenolong Akauntan Gred W32 Unit Kewangan Bahagian Dasar & Pengurusan FarmasiFinance Unit Pharmacy Policy & Management Division

Pn. Norhasimah binti Abdul AzikPenolong Pegawai Tadbir Gred N29 Unit Pentadbiran Bahagian Dasar& Pengurusan FarmasiAdministration Unit Pharmacy Policy & Management Division

PENGURUSAN SOKONGAN | MANAGEMENT SUPPORT


15

Jumlah Pegawai Farmasi Kementerian Kesihatan Malaysia.

Total Pharmacist in Ministry of Health Malaysia.

Penolong Pegawai Farmasi Kementerian Kesihatan Malaysia.Total Pharmacy Assistant in Ministry of Health Malaysia.

8,376PEGAWAI FARMASI

PHARMACIST

4,279 PENOLONG PEGAWAI FARMASIPHARMACY ASSISTANT

Pegawai Farmasi yang Mencapai Mata Minimum

CPD yang Ditetapkan dalam Masa Setahun.

Percentage of Pharmacist Achieved Minimum CPD

Points Per Year.

Penolong Pegawai Farmasi yang Mencapai Mata Minimum

CPD yang Ditetapkan dalam Masa Setahun.

Percentage of Pharmacy Assistant Achieved Minimum CPD Points

Per Year.

98.97%MATA CPD | CPD POINTS

99.87%MATA CPD | CPD POINTS

Peratus Pegawai Farmasi yang Mendapat Ijazah Sarjana/Doktor Falsafah Selepas Menerima Cuti Belajar Bergaji Penuh (dengan atau Tanpa Biasiswa).

Percentage of Pharmacist Who Obtained Postgraduate Qualifications (Master Degree/Phd) After Being Granted Fully Paid Study Leave (CBBP).

96.5% PEGAWAI FARMASIPHARMACIST


18


Bahagian Dasar dan Perancangan Strategik Farmasi terdiri daripada lima cawangan utama iaitu Cawangan Pembangunan Profesion Farmasi, Cawangan Dasar Farmasi, Cawangan Perkembangan Infrastruktur & Kualiti Farmasi, Cawangan Teknologi Maklumat & Informatik Farmasi, dan Cawangan Penyelidikan dan Pembangunan Farmasi. Bahagian bertanggungjawab untuk:1. Merancang, menggubal, memantau dan menilai

dasar berkaitan penyampaian perkhidmatan dan profesion farmasi.

2. Merancang keperluan sumber manusia untuk Perkhidmatan Farmasi di seluruh negara.

3. Merancang, menyelaras, membangun dan mengembangkan sistem maklumat bagi Perkhidmatan Farmasi.

4. Menyelaras dan memantau sistem kualiti Perkhidmatan Farmasi.

5. Merancang dan membelanjakan peruntukan kewangan secara berhemah.

Pharmacy Policy and Strategic Planning Division consists of five main branches which are the Pharmacy Professional Development Branch, Pharmacy Policy Branch, Pharmacy Infrastructure Development & Quality Branch, Pharmacy Information Technology & Informatics Branch and Pharmacy Research & Development Branch. This Division is responsible for:1. Planning, drafting, monitoring and evaluating policy

related to service delivery and pharmacy profession.2. Planning of human resource needs for the pharmacy

services throughout the country.3. Planning, coordinating, developing and expanding

the information system for pharmacy services.4. Coordinating and monitoring pharmacy service

quality system.5. Planning and prudent spending of the financial

budget.

1.0 PENGENALAN | INTRODUCTION


19

CAWANGAN PEMBANGUNAN PROFESION FARMASIPHARMACY PROFESSIONAL DEVELOPMENT BRANCH • Merancang keperluan sumber manusia untuk

perkhidmatan farmasi di seluruh negara. • Merancang, menyelaras dan memantau latihan

anggota farmasi di peringkat ibu pejabat dan negeri. • Merancang penempatan dan pengisian anggota

farmasi secara optima di seluruh negara. • Merancang dan menyelaras pembangunan dan laluan

kerjaya anggota farmasi. • Menambahbaik pembangunan profesyen farmasi. • Mengenalpasti, merancang dan memantau aktiviti

Continous Professional Development (CPD) bagi meningkatkan kompetensi anggota farmasi.

• Menyelaras dan memantau pegawai yang mengikuti kursus di peringkat sarjana farmasi dan doktor falsafah (PhD).

• Planning for the need of the human resource for pharmacy services nationwide.

• Planning, coordinating and monitoring the training of pharmacy staff at states and headquarter level.

• Planning and optimising the placement and distribution of pharmacy staff across the country.

• Planning and coordinating the development and career pathway for pharmacy staff.

• Improving the development of pharmacy profession. • Identifying, planning and monitoring the activities on

Continous Professional Development (CPD) to improve the competency of pharmacy personnel.

• Coordinating and monitoring pharmacy officers undergoing postgraduate courses.

CAWANGAN PERKEMBANGAN INFRASTRUKTUR & KUALITI FARMASIPHARMACY INFRASTRUCTURE DEVELOPMENT & QUALITY BRANCH • Memantau dan menyelaras aktiviti berkaitan

pembangunan di fasiliti KKM. • Menyelaras dan memantau sistem kualiti perkhidmatan

farmasi seperti KPI, QAP, SSR, KIK, 5S, Inovasi dan Piagam Pelanggan.

• Merancang dan melaksanakan program pembudayaan kualiti anggota.

• Monitor and coordinate activities related to development in MOH facilities.

• Coordinating and monitoring the quality systems for pharmaceutical services such as KPI, QAP, SSR, CIQ, 5S, Innovation and Client’s Charter.

• Coordinating and facilitating intra-agency, inter-agency and international communication.

CAWANGAN DASAR FARMASI PHARMACY POLICY BRANCH • Merancang, menyelaras dan memantau pelaksanaan

semua aktiviti/pelan tindakan Dasar Ubat Nasional. • Menyelaras perhubungan di antara pemegang

berkepentingan (stakeholders) dalam isu-isu berkaitan dengan DUNas dan menyelaraskan aktiviti bersama.

• Menyelaras dan memudahcara perhubungan intraagensi, interagensi dan antarabangsa dalam perkhidmatan farmasi.

• Melaksanakan penilaian dan penggubalan semula Dasar Ubat Nasional dengan mengambil kira penglibatan semua pihak berkepentingan.

• Memantau dan menyelaras aduan. • Menyelaras perhubungan dengan media. • Meningkatkan ketelusan dan akauntabiliti serta

menggalak tadbir urus yang baik bagi semua sektor farmaseutikal tempatan melalui amalan Good Governance for Medicine (GGM).

• Planning, coordinating and monitoring the implementation of all activities/action plan under the National Medicines Policy.

• Coordinating the communication between stakeholders on issues related to NMP and coordinating joint activities.

• Performing evaluation and reviewing of the National Medicines Policy with the involvement of all stakeholders.

• Monitoring and coordinating complaints. • Coordinating strategic communication with the media. • Planning and implementing enculturation of quality

system. • Increase transparency and accountability and promote

good governance for all local pharmaceutical sectors through the practice of Good Governance for Medicine (GGM).


20

CAWANGAN TEKNOLOGI MAKLUMAT & INFORMATIK FARMASIPHARMACY INFORMATION TECHNOLOGY & INFORMATICS BRANCH • Merancang, menyelaras dan melaksanakan keperluan

latihan berkaitan ICT kepada anggota jabatan. • Merancang, menyelaras dan melaksanakan keperluan

prasarana ICT, keselamatan ICT, penyelenggaraan peralatan/rangkaian/bilik server dan perisian ICT jabatan.

• Membuat penilaian teknikal perolehan ICT Jabatan yang tidak melibatkan pembangunan sistem.

• Memberi khidmat sokongan teknikal berkaitan ICT jabatan.

• Penyebaran maklumat farmasi melalui laman web jabatan.

• Merancang, menyediakan, melaksanakan dan memantau polisi berkaitan ICT jabatan.

• Planning, coordinating and implementing appropriate ICT-related training to the members of the PSD.

• Planning, coordinating and implementing the procurement of ICT related items, infrastructure, security and maintenance of ICT equipment/network and systems.

• Technical evaluating of ICT procurement of the Division that does not involve system development.

• Providing support services on technical issues related to ICT.

• Dissemination of pharmacy information through the Division’s web page.

• Planning, drafting, implementing and monitoring ICT related policies.

CAWANGAN PENYELIDIKAN DAN PEMBANGUNAN FARMASIPHARMACY RESEARCH & DEVELOPMENT BRANCH • Merancang dan menyelaras halatuju serta aktiviti-

aktiviti penyelidikan dan pembangunan (R&D) bagi Program Perkhidmatan Farmasi.

• Menyelaras dan memantau pelaksanaan aktiviti-aktiviti R&D farmasi di fasiliti-fasiliti KKM.

• Mengelola dan menjalankan projek penyelidikan farmasi tertentu di peringkat Program Perkhidmatan Farmasi.

• Mengumpul, menganalisa dan menyimpan data-data R&D di peringkat Program Farmasi.

• Merancang, menyelaras dan melaksanakan latihan-latihan berkaitan bagi meningkatkan kemahiran anggota-anggota farmasi di dalam menjalankan penyelidikan.

• Menggalakkan penyebaran hasil penyelidikan farmasi melalui penerbitan dan pembentangan untuk kegunaan rujukan di dalam menambah baik perkhidmatan dan pembentukan dasar-dasar Program Perkhidmatan Farmasi.

• Planning and coordinating research and development (R&D) directions and activities of Pharmaceutical Services Programme.

• Coordinating and monitoring the implementation of R&D activities in MOH facilities.

• Managing and executing planned research projects for the Pharmaceutical Services Programme.

• Collecting, analyzing and archiving research data of planned projects for the Pharmaceutical Services Programme.

• Planning, coordinating and running research related trainings to develop knowledge and expertise in research among pharmacy personnel.

• Promoting and facilitating dissemination of research findings/outcomes through research publications and presentations to be used as references and evidence in pharmacy services improvements and policy developments for the Pharmaceutical Services Programme.


21

PENGENALANDasar Ubat Nasional (DUNas) merupakan satu dokumen rasmi Kerajaan yang menentukan dan mengutamakan matlamat jangka sederhana dan jangka panjang untuk sektor farmaseutikal negara. Dasar ini adalah komitmen kerajaan dan pihak-pihak berkepentingan di sektor awam dan swasta ke arah mencapai matlamat tersebut. DUNas mewujudkan rangka kerja dan perancangan strategi untuk pelaksanaan yang selaras di sektor awam dan swasta. Objektif utama DUNas adalah untuk meningkatkan tahap kesihatan rakyat dengan:a. Keperolehan ubat-ubatan penting secara sama rata. b. Penggunaan rasional ubat-ubatan penting.c. Memastikan ubat-ubatan adalah berkualiti, selamat,

berkesan dan mampu dimiliki.

DUNas telah memasuki penggal kedua selepas semakan penuh terhadap pelaksanaan dasar selama lima tahun. Lima komponen utama DUNas telah dikenalpasti. Antara komponen-komponen DUNas adalah seperti berikut:1. Tadbir Urus dalam Ubat-ubatan.2. Kualiti, Keselamatan dan Keberkesanan Ubat-ubatan.3. Keperolehan Ubat-ubatan.4. Penggunaan Ubat-ubatan secara Berkualiti.5. Perkongsian dan Kerjasama untuk Industri Penjagaan

Kesihatan.

Pelaksanaan DUNas penggal baru adalah berdasarkan Pelan Tindakan Induk yang dihasilkan pada tahun 2013. DUNas berfungsi melalui jawatankuasa-jawatankuasa yang ditubuhkan seperti yang ditunjukkan dalam Rajah 1 di bawah. Oleh kerana ahli jawatankuasa yang dilantik terdiri daripada wakil dari sektor awam dan swasta, DUNas merupakan pangkalan yang mewujudkan kerjasama antara dua sektor tersebut.

INTRODUCTIONThe Malaysian National Medicines Policy (MNMP) is an official document of the Government that defines and prioritises medium and long term goals of the country’s pharmaceutical sector. The policy is a commitment of the Government and stakeholders in the public and private sector towards achieving the goals. The MNMP establishes framework and strategy plans for the coordinated implementation in the public and private sector. The main objective of the MNMP is to improve health outcomes of Malaysians through:a. Promoting equitable access to essential medicines.b. Promoting rational use of medicines.c. Ensuring medicines are with quality, safety,

effectiveness and affordability.

The MNMP has entered into its second term after a full review of its implementation over the past five years. Five main components of the MNMP had been identified. Among the components, they are as followed:1. Governance in Medicines.2. Quality, Safety and Efficacy of Medicines.3. Access to Medicines.4. Quality Use of Medicines.5. Partnership and Collaboration for the Healthcare

Industry.

The implementation of the NMNP is based on the Master Plan of Action which was developed in 2013. The MNMP functions through the establishment of committees as shown in Figure 1. The appointed committee members consist of representatives from the public and private sector. Therefore the MNMP acts as a platform enabling partnership and collaboration between the two sectors.

2.0 DASAR UBAT NASIONAL (DUNas) MALAYSIAN NATIONAL MEDICINES POLICY (MNMP)


22

PENGURUSAN DUNasPemantauan dasar dijalankan melalui pengumpulan status pelaksanaan strategi dan aktiviti. Indikator-indikator bagi setiap aktiviti dan indikator yang dicadangkan oleh Pertubuhan Kesihatan Sedunia (WHO) juga dikumpulkan sebagai langkah untuk memastikan pelaksanaan dasar berjalan seperti yang dirancangkan. Penilaian dan semakan separuh penggal dasar terhadap pelaksanaan pelan tindakan induk DUNas telah diadakan pada tahun 2016.

Bagi mewujudkan kesedaran DUNas, kursus DUNas berdasarkan zon diadakan pada permulaan penggal baru dengan melibatkan pegawai farmasi dari semua negeri. Pengenalan kepada DUNas disebarkan melalui pendidikan berterusan (CME) yang diberikan oleh semua peserta yang telah menghadiri kursus-kursus tersebut. Pihak universiti awam dan swasta tempatan juga digalakkan untuk mengadakan ceramah DUNas bagi mendedahkan pelajar farmasi kepada dasar tersebut.

MNMP MANAGEMENTThe policy is monitored through aggregations of strategy and activity implementation status reports. Indicators for each activity and indicators recommended by the World Health Organization (WHO) are being collected as a way to ensure the policy implementation is carried out as planned. Evaluation and mid-term review of the policy on the implementation of the master plan of action was done in the year 2016.

To create awareness to the policy, MNMP courses based on zones were carried out at the beginning of a new term of the MNMP with the involvement of pharmacists from all states. Introduction to MNMP is extended through continuous education (CME) given by all the participants who attended the courses. The public and private universities are encouraged to conduct MNMP lectures in order to expose the pharmacy students to the policy.

Laporan Prestasi Penggal Pertama DASAR UBAT NASIONAL (DUNas)

First Term Performance ReportNATIONAL MEDICINES POLICY (MNMP)

Laporan Prestasi Penggal KEDUA DASAR UBAT NASIONAL (DUNas)

SECOND Term Performance ReportNATIONAL MEDICINES POLICY (MNMP)


23

Kualiti, Keselamatan dan

Keberkesanan Ubat-ubatan

Quality, Safety and Efficacy of

Medicines

KOMPONEN 2COMPONENT 2

Keperolehan Ubat-ubatan

Access of Medicines


Penggunaan Ubat-ubatan

Secara Berkualiti

Quality Use of Medicines


Tadbir Urus dalam

Ubat-ubatan

Governance in Medicines


Perkongsian dan Kerjasama untuk Industri Penjagan

Kesihatan

Partnership & Collaboration for the Healthcare

Industry


JAWATANKUASA PEMANDU | STEERING COMMITTEEMenasihat Menteri Kesihatan, mengesahkan pelan, menentukan hala tuju.

Advise the Health Minister, authorize plans, decides the direction.

JAWATANKUASA PELAKSANAAN | IMPLEMENTATION COMMITTEEMemantau dan mengkaji perkembangan pelaksanaan.Monitor and review the development of implementation.

JAWATANKUASA TEKNIKAL | TECHNICAL COMMITTEEMerancang, mengenalpasti dan memantau pelaksanaan oleh jawatankuasa kerja.

Plan, identify and monitor the implementations done by the working committee.

JAWATANKUASA KERJA | WORKING COMMITTEEMelaksanakan Pelan Tindakan.

Implement Plan of Action.

Rajah 1: Jawatankuasa-Jawatankuasa yang Ditubuhkan untuk Pengurusan DUNasFigure 1: Committees Established for The Management of MNMP


24

3.0 CAWANGAN PEMBANGUNAN PROFESION FARMASI DEVELOPMENT OF PHARMACEUTICAL PROFESSION BRANCH

Jumlah Kekosongan Jawatan | Total Vacancies Jumlah Pengisian Jawatan | Total Filled Posts

7,703(92%)

673(8%)

Rajah 2: Perjawatan Pegawai Farmasi di KKM 2016. Figure 2: Pharmacist Posts In MOH 2016.

Jadual 1: Statistik Perjawatan Pegawai Farmasi Mengikut Program di KKM 2016.Table 1: Statistic of Pharmacist Posts Based on Programme in MoH 2016.

ProgramProgramme

Aktiviti/FasilitiActivities/Facilities

Jumlah Jawatan

Total Posts

PengisianFilled

KekosonganVacancy

Peratus PengisianPercentage Filled (%)

FarmasiPharmacy

Pengurusan Farmasi Pharmacy Management

51 51 0 100

Dasar dan Perancangan Strategik FarmasiPolicy and Strategic Planning

36 33 3 92

Amalan dan Perkembangan FarmasiPharmacy Practice and Development

218 214 4 98

Penguatkuasaan Farmasi Pharmacy Enforcement

644 620 24 96

Lembaga Farmasi MalaysiaPharmacy Board Malaysia

9 9 0 100

Bahagian Regulatori Farmasi NegaraNational Pharmaceutical Regulatory Division

334 322 12 96

PengurusanManagement

Bahagian Perolehan & Penswastaan Procurement & Privatization Division

2 2 0 100

Kolej Sains Kesihatan BersekutuCollege of Allied Health Sciences

5 2 3 40


25

ProgramProgramme

Aktiviti/FasilitiActivities/Facilities

Jumlah Jawatan

Total Posts

PengisianFilled

KekosonganVacancy

Peratus PengisianPercentage Filled (%)

Kesihatan AwamPublic Health

Bahagian Perkembangan Kesihatan AwamPublic Health Development Division

6 6 0 100

Pejabat Kesihatan Daerah & Klinik KesihatanDistrict Health Offices & Health Clinics

2,182 2,149 33 98

PerubatanMedical

Bahagian Perkembangan PerubatanMedical Development Division

9 9 0 100

Bahagian Perubatan Tradisional & Komplementari Traditional & Complementary Medicine Division

15 14 1 93

Hospital & Institusi Khas Hospital & Special Institutions

4,808 4,218 590 88

Penyelidikan & Sokongan TeknikalResearch & Technical Support

Pusat Penyelidikan Klinikal KebangsaanNational Clinical Research Centres

45 43 2 96

Institut Penyelidikan PerubatanInstitute Medical Research

6 5 1 83

Bahagian PerancanganPlanning Division

2 2 0 100

Institut Penyelidikan Sistem KesihatanInstitute of Health System Research

4 4 0 100

Jumlah KeseluruhanGrand Total 8,376 7,703 673 92


26

0

20

40

60

80

100

120

140

160

180

JumlahUF41UF44UF48UF52UF54JUSA A/B/C

Bilangan Pegawai Farmasi yang Meletak Jawatan | Number of Pharmacist Resigned

Bilangan Pegawai Farmasi yang Bersara | Number of Pharmacist Retired

Bila

ngan

Peg

awai

Far

mas

i N

umbe

r of P

harm

acis

t

0 113 14 14

68

91

0 0 0 0 0 0

173

Rajah 3: Pesaraan & Peletakan Jawatan Pegawai Farmasi di KKM 2016.Figure 3: Retirement and Resignation of Pharmacist in MoH 2016.

Seramai 173 orang Pegawai Farmasi telah meletak jawatan dari 1 Januari sehingga 31 Disember 2016 dan 14 Pegawai Farmasi telah bersara pada tahun yang sama.

PELANTIKAN SECARA KONTRAK PEGAWAI FARMASI BAGI MENJALANI LATIHAN SISWAZAH DAN/ATAU KHIDMAT WAJIB DI KEMENTERIAN KESIHATAN MALAYSIA (KKM)Pelantikan secara kontrak Pegawai Farmasi Gred UF41 untuk menjalani latihan PRP selama satu tahun di fasiliti KKM telah dilaksanakan bermula dari Disember 2016.

Pelantikan secara kontrak adalah untuk memberi peluang kepada graduan farmasi menjalani latihan PRP selama setahun bagi mematuhi keperluan Akta Pendaftaran Ahli Farmasi 1951 dan seterusnya mengamal di sektor awam atau swasta tanpa kekangan jawatan.

Tempoh maksimum kontrak untuk menjalani latihan PRP adalah selama dua tahun manakala tempoh satu tahun adalah bagi menjalani khidmat wajib. Seramai 512 calon telah dilantik sebagai Pegawai Farmasi secara kontrak pada Disember 2016.

PROGRAM PEMBANGUNAN KEPAKARAN FARMASI MELALUI SMEHasil dari beberapa siri perbincangan bersama wakil daripada Jabatan Perkhidmatan Awam (JPA), pada Ogos 2016 Jawatankuasa Pembangunan Kepakaran Farmasi telah bersetuju untuk menggunapakai laluan kerjaya melalui Pakar Bidang Khusus Subject Matter Expert (SME) sebagai satu laluan bagi pengiktirafan kepakaran Program Farmasi. Bidang, kriteria penilaian dan kamus kompetensi bagi SME Program Farmasi akan dikenalpasti dan dibangunkan pada tahun 2017.

A total number of 173 pharmacists resigned since 1st January until 31st December 2016 and 14 pharmacists retired in the same year.

APPOINTMENT OF CONTRACT PHARMACISTS FOR PROVISIONAL TRAINING AND/OR COMPULSORY SERVICE AT MINISTRY OF HEALTH (MOH)The government has started to appoint Pharmacists Grade UF41 on contract basis to undergo one year PRP training in MOH facilities starting from December 2016.

Appointment on contract basis is to enable the pharmacy graduates to undergo one year PRP training and fulfilled the requirements of the Registration of Pharmacists Act 1951 without posts constraints so that they can be registered, thence practice at either the public or private sector.

The maximum contract period for PRP is two years and one year for the compulsory service. A total of 512 candidates have been appointed as contract Pharmacists on December 2016.

PHARMACY SPECIALIZATION PROGRAMME THROUGH THE SME PATHWAYAfter a few series of discussion with representatives from the Department of Public Services Commission, in August 2016 the Pharmacy Specialization Development Committee has agreed to the Subject Matter Expert (SME) pathway for the recognition of specialization in the Pharmacy Programme. The areas of SME, criteria for evaluation and competency dictionary for the SME will be further identified and developed in 2017.


27

AKTIVITI CREDENTIALING PROGRAM FARMASICredentialing merupakan satu aktiviti di bawah komponen sumber manusia DUNas yang dibangunkan oleh Bahagian Perkhidmatan Farmasi, KKM untuk memberi pengiktirafan kemahiran kepada anggota yang terlatih, mahir dan cekap dalam sesuatu bidang yang dikenalpasti.

Pada tahun 2016, Jawatankuasa Credentialing Farmasi meluluskan 46 permohonan Credentialing yang meliputi bidang-bidang berikut:

PHARMACY CREDENTIALING PROGRAMMECredentialing is one of the activities which has been introduced under the Human Resource component, National Medicine Policy and developed by Pharmaceutical Services Division, MOH in order to certify the skills of the pharmacy staff in the specified areas of special interest.

In 2016, the Pharmacy Credentialing Committee has apprroved 46 applications for credentialing in the specified areas of special interest as below:

BidangCredentialing Area Modul Module

Farmasi KlinikalClinical Pharmacy

1. Perkhidmatan Farmasi Wad: i. Penjagaan Rapi (ICU) ii. Pediatrik (Wad) iii. Medikal2. MTAC–Diabetes3. MTAC–Respiratori4. MTAC–Warfarin5. MTAC–RVD6. MTAC–Nefrologi i. CKD ii. Renal Transplant iii. Dialisis7. Farmasi Nuklear8. Farmakokinetik Klinikal9. Farmasi Onkologi10. Farmasi Sokongan Nutrisi

1. Ward Pharmacy Services: i. Intensive Care (ICU) ii. Paediatric (Ward) iii. Medical2. MTAC–Diabetes3. MTAC–Respiratory4. MTAC–Warfarin5. MTAC–RVD6. MTAC–Nephrology i. CKD ii. Renal Transplant iii. Dialysis7. Nuclear Pharmacy8. Clinical Pharmacokinetics9. Oncology Pharmacy10. Nutritional Support Pharmacy


28

4.0 AKTIVITI DAN SOROTAN | ACTIVITIES AND HIGHLIGHTS

Mesyuarat Semakan Dasar Ubat Nasional (DUNas) Penggal Kedua 2016 telah dijalankan dengan jayanya dari 1 hingga 3 November 2016 di The Everly Putrajaya.

Mesyuarat tersebut telah dihadiri oleh wakil-wakil (stakeholders) dari sektor awam dan sektor swasta. Antara sektor awam yang terlibat adalah Bahagian Perkhidmatan Farmasi (pihak penganjur), Lembaga Farmasi Malaysia, Bahagian Regulatori Farmasi Negara, Jabatan Kesihatan Negeri, hospital dan pejabat kesihatan daerah, Bahagian Perubatan Tradisional dan Komplimentari, hospital-hospital universiti, institut pengajian tinggi awam, Angkatan Tentera Malaysia dan Jabatan Kemajuan Islam Malaysia. Wakil-wakil sektor swasta adalah dari Malaysian Pharmaceutical Society, Malaysian Community Pharmacy Guild, Pharmaceutical Association of Malaysia, Malaysian Organisation of Pharmaceutical Industries, Malaysian Association of Pharmaceutical Suppliers, Malaysian Medical Association, Association of Private Hospitals Malaysia, Federation of Malaysian Consumers Association dan Direct Selling Association of Malaysia.

Para peserta telah diberikan taklimat berkenaan mesyuarat tersebut oleh Pengarah Dasar dan Perancangan Strategik Farmasi dari Bahagian Perkhidmatan Farmasi, KKM pada hari pertama. Taklimat tersebut memberikan objektif dan penjelasan kepada cara-cara untuk menyemak dan merangka polisi. Selepas itu, para peserta dibahagikan kepada 4 kumpulan berdasarkan komponen seperti berikut:

Komponen 1 & 5 – Governance in Medicines; Partnership and Collaboration for the Healthcare Industry

Komponen 2 – Quality, Safety and Efficacy of Medicines

Komponen 3 – Access to MedicinesKomponen 4 – Quality Use of Medicines

Perbincangan kumpulan melibatkan pembentangan pencapaian pelan tindakan induk DUNas 2013–2015 berdasarkan komponen oleh pihak urusetia. Selepas pembentangan, pengerusi komponen mempengerusikan perbincangan tersebut dengan semakan dan persediaan draf pelan tindakan berdasarkan format-format yang dijelaskan dalam taklimat pada hari pertama. Persediaan dan perbincangan draf pelan tindakan diteruskan pada hari kedua. Semasa sesi gallery walk pada waktu malam, draf-draf yang disediakan dipamerkan dan dijelaskan oleh pembentang komponen masing-masing. Komen dan cadangan dari ahli kumpulan yang lain diterima dan draf pelan tindakan disemak semula pada malam tersebut dan pagi hari ketiga. Selepas itu, mesyuarat diteruskan dengan sesi pembentangan mengikut komponen dan sesi soal jawab juga diadakan selepas setiap pembentangan. Mesyuarat diakhiri dengan rumusan oleh Pengarah Dasar & Perancangan Strategik Farmasi. Beliau merumuskan bahawa pelan tindakan yang disediakan akan disusuli dan dimurnikan.

MESYUARAT SEMAKAN DASAR UBAT NASIONAL (DUNas) PENGGAL KEDUA 2016


29

The Malaysian National Medicines Policy (MNMP) Mid-Term Review Meeting was carried out successfully and smoothly from 1st to 3rd November 2016 in The Everly Putrajaya.

The meeting was attended by representatives from the public and private sector. Among the public sector involved was the Pharmaceuticals Services Division (the organisers), Pharmacy Board Malaysia, National Pharmaceutical Regulatory Agency, State Health Departments, hospitals and district health offices, Traditional and Complimentary Medicine Division, University hospitals, public universities, Malaysian Armed Forces and Jabatan Kemajuan Islam Malaysia (JAKIM). Representatives of the private sector include the Malaysian Pharmaceutical Society, Malaysian Community Pharmacy Guild, Pharmaceutical Association of Malaysia, Malaysian Organization of Pharmaceutical Industries, Malaysian Association of Pharmaceutical Companies, Malaysian Medical Association, Association of Private Hospitals of Malaysia, Federation of Malaysian Consumers Association, and Direct Selling Association of Malaysia.

During the first day, participants were briefed on the meeting by the Director of Pharmacy Policy and Strategic Planning from the Pharmaceutical Services Division, Ministry of Health. The briefing session gave an explanation of the objectives and the means to review and formulate a policy. Later on, the participants were further divided into 4 groups based on the following components:

MALAYSIAN NATIONAL MEDICINES POLICY (MNMP) MID-TERM REVIEW MEETINGComponent 1 & 5 – Governance in Medicines;

Partnership and Collaboration for the Healthcare Industry

Component 2 – Quality, Safety and Efficacy of Medicines

Component 3 – Access to MedicinesComponent 4 – Quality Use of Medicines

Discussion groups started off with a presentation on the achievement of MNMP’s action plan in 2013 - 2015 according to its component by the Secretariat. After the presentation, the chairman of each component chaired the discussions on the revision and preparation of the draft action plan based on the formats described earlier. On the second day, participants continued to discuss and prepare the draft of the action plan. At night, during the gallery walk, drafts that have been prepared by each group were showcased and explained by the presenters of each component. Comments and suggestions from other group members were received, and the draft action plan was reviewed on the same night and the next morning. The meeting continued with a presentation by each component followed by a question and answer session after each presentation. Meeting ended with a closure from the Director of Pharmacy Policy and Strategic Planning. He concluded that the action plan would be followed up and purified.


30

Sesi Perasmian | Opening Session

Sesi Taklimat | Briefing Session

Sesi Perbincangan Kumpulan | Group Discussion Session


31

Sesi Gallery Walk | Gallery Walk Session

Gambar Kumpulan | Group Photo


32

PERSIDANGAN PENYELIDIKAN DAN PEMBANGUNAN FARMASI KEBANGSAAN KE-9, 20169TH NATIONAL PHARMACY RESEARCH AND DEVELOPMENT (R&D) CONFERENCE 2016Persidangan R&D Farmasi Kebangsaan ke-9 yang bertemakan “Cross-Disciplinary Research: Fostering Hoslistic Healthcare” telah berlangsung di Hotel Everly Putrajaya dari 8 hingga 10 Ogos 2016. Persidangan dilaksanakan dengan kerjasama Persatuan Farmasi Malaysia. Ketua Pengarah Kesihatan Malaysia, YBhg. Datuk Dr Noor Hisham Abdullah telah merasmikan pembukaan persidangan yang dihadiri oleh 421 orang peserta, dari kalangan pegawai farmasi, penolong pegawai farmasi dan profesion kesihatan lain yang berkhidmat di sektor awam dan swasta. Sejumlah 84 tajuk penyelidikan telah dibentangkan secara lisan dan 40 secara poster”.

The 9th National Pharmacy R&D Conference, with the theme “Cross-Disciplinary Research: Fostering Holistic Healthcare” was held at the Everly Hotel Putrajaya from 8th to 10th August 2016. The conference which was organized in collaboration with the Malaysian Pharmaceutical Society was officiated by the Director General of Health, Honorable Datuk Dr. Noor Hisham Abdullah in the presence of 421 participants consisting of pharmacists, assistant pharmacists and other health professionals from both public and private sectors. A total of 84 and 40 research titles were shared via oral and poster presentations respectively during the conference.


33

Bengkel Pemantapan KIK telah diadakan pada 1–3 Ogos 2016 di Concorde Inn KLIA. Sejumlah 47 orang peserta telah menyertai bengkel ini terdiri daripada pegawai farmasi, penolong pegawai farmasi serta kakitangan sokongan daripada seluruh negara. Penceramah jemputan adalah Encik Hasrizal bin Zainul daripada Institut Tadbir Negara (INTAN).

Objektif bengkel ini adalah bagi memastikan projek KIK dibuat mengikut tatacara yang betul, memantapkan dokumentasi dan persembahan kumpulan KIK, serta memahami skema pemarkahan KIK. Bengkel ini juga merupakan salah satu persediaan kumpulan-kumpulan KIK Farmasi ke arah Konvensyen Inovasi dan Kreativiti Farmasi 2017 (KIKF2017).

BENGKEL PEMANTAPAN KUMPULAN INOVATIF DAN KREATIF (KIK)INNOVATIVE AND CREATIVE CIRCLE ADVANCE WORKSHOP

This workshop was conducted on 1–3 August 2016 at Concorde Inn KLIA. A total of 47 participants were involved including pharmacists, pharmacy assistants, and supporting staffs from the whole nation. The invited speaker was Mr Hasrizal bin Zainul from Institut Tadbir Negara (INTAN)

The objectives of this workshop are to ensure ICC projects are being done correctly, to improve on ICC documentations and presentation, as well as to understand the marking scheme of ICC. This event was also one of the preparations for the Pharmacy Innovation and Creativity Convention 2017 (KIKF2017).

Bengkel Pemantapan Quality Assurance (QA) telah diadakan pada 17–19 Oktober 2016 di Seremban Palm Hotel, Negeri Sembilan. Bengkel tersebut dihadiri oleh 38 orang pegawai Farmasi dari seluruh Malaysia. Penceramah dan Fasilitator terlibat adalah Dr Ramli Bin Zainal, Puan Fajaratunur A. Sani, Puan Noor Mariati Binti Othman, Puan Lai Wan Mae dan Puan Adibah Murayadi. Objektif bengkel adalah bagi memastikan projek QA dibuat mengikut tatacara yang betul, pemantapan dokumentasi dan persembahan projek, serta pemahaman skema pemarkahan QA.

Sesi bengkel bermula dengan sesi Ice Breaking sebagai sesi suai kenal dan kemudian para peserta dibahagikan kepada lapan kumpulan untuk aktiviti berkumpulan. Sesi bengkel kali ini mengambil pendekatan yang berbeza dengan penggunaan kajian kes sebagai panduan dalam setiap ceramah yang diberikan. Selain itu, terdapat sesi perkongsian dari pemenang-pemenang projek QA dari Konvesyen Kreativiti Dan Inovasi Farmasi 2015 (KIKF2015).

BENGKEL PEMANTAPAN QUALITY ASSURANCE (QA)QUALITY ASSURANCE ENHANCEMENT WORKSHOP

Quality Assurance Enhancement Workshop Was held on 17–19 October 2016 at Seremban Palm Hotel, Negeri Sembilan. It was attended by 38 pharmacists from all over Malaysia. The speakers and facilitators were Dr Ramli bin Zainal, Puan Fajaratunur A. Sani, Puan Noor Mariati binti Othman, Puan Lai Wan Mae and Puan Adibah Murayadi. The objectives of the workshop are to ensure the QA project conducted in a correct manner, with proper documentation and presentation and the understanding of the marking scheme used.

The workshop started with an Ice Breaking Session as to introduce the participants among themselves. Then, the participants were divided into eight groups for group activities. This workshop took a different approach by using a case study as a guide in each talk given. Besides that, sharing session from previous winners from the Konvesyen Kreativiti Dan Inovasi Farmasi 2015 (KIKF2015) was also included.


34

Kursus berstruktur ini diadakan khusus untuk Pegawai-pegawai Farmasi Kanan Gred UF48 hingga UF54 yang bertujuan untuk mengukuhkan lagi kemahiran dan kualiti kepimpinan Pegawai Farmasi dalam meningkatkan kecemerlangan perkhidmatan dalam organisasi. Kursus tersebut telah berlangsung di Hotel Concorde Inn, KLIA Sepang pada 20 hingga 22 April 2016.

KURSUS KEPIMPINAN DAN PENGURUSAN ORGANISASI PEGAWAI FARMASI (UF48-UF54) TAHUN 2016LEADERSHIP AND MANAGEMENT ORGANIZATION FOR SENIOR PHARMACISTS (UF48–UF54) 2016 COURSE

This is a structured course organized specifically for the senior pharmacists ranging from UF48 to UF54 grades. The objectives of the course are to enhance their talents and leadership skills in managing the organization towards excellence. The workshop was held in Concorde Inn, Hotel, KLIA, Sepang from the 20th April to 22nd April 2016.

Kursus ini telah diadakan pada 26–27 Oktober 2016 bertempat di Cyberview Resort & Spa, Cyberjaya, Selangor. Seramai 30 orang pegawai Farmasi yang terdiri dari daripada pegawai-pegawai kanan Program Farmasi telah menghadiri kursus tersebut. Objektif kursus ini adalah untuk merangsang ciri-ciri kepimpinan dan kemahiran komunikasi serta teknik rundingan berkesan kepada para peserta.

KURSUS EXECUTIVE LEADERSHIP | EXECUTIVE LEADERSHIP COURSEThe course was held on 26–27th October 2016 at Cyberview Resort & Spa, Cyberjaya, Selangor. A total of 30 pharmacists from middle and senior level leaders attended the course. The objectives of this course are to enhance their leadership potentials, communication and negotiation skills for the future leaders.


35

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASIPHARMACY PRACTICE AND DEVELOPMENT DIVISION

RM62.5 JUTAKOS UBAT-UBATAN KELULUSAN KPK.COST OF SPECIAL APPROVAL DRUGS BY KPK.

2,203AKTIVITI KESELAMATAN PENGUBATAN.

MEDICATION SAFETY ACTIVITIES.

RM2,107,609,943PEROLEHAN UBAT-UBATAN KKM.

MOH MEDICINES PROCURED.

RM959,857,340PEROLEHAN BUKAN UBAT.

MOH NON-MEDICINES PROCURED.

JUMLAH PERTANYAAN UBAT.DRUG INFORMATION ENQUIRIES.369,543

AKTIVITI PENGGUNAAN UBAT SECARA BERKUALITIQUALITY USE OF MEDICINES ACTIVITIES4,872

PENYENARAIAN UBAT BARU KE DALAM FORMULARI UBAT KKM.NEW DRUGS LISTED IN THE MOH MEDICINE FORMULARY.15

NEW DRUGS

840FASILITI DENGAN PERKHIDMATAN KLINIKKEPATUHAN TERHADAP UBAT-UBATAN.FACILITIES WITH MEDICATION THERAPYADHEARANCE CLINIC (MTAC) SERVICES.

INTERVENSI PRESKRIPSI PESAKIT DALAM.INTERVENTIONS OF IN-PATIENT PRESCRIPTIONS.879,118

7,689LAWATAN HMR YANG DIJALANKAN.

HOME MEDICATION REVIEW VISITS.

INTERVENSI PRESKRIPSI PESAKIT LUAR.INTERVENTIONS OF OUT-PATIENT PRESCRIPTIONS.369,543


38

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASI PHARMACY PRACTICE AND DEVELOPMENT DIVISION

Bahagian Amalan dan Perkembangan Farmasi (A&P) bertanggungjawab memastikan keperolehan dan kepenggunaan ubat-ubatan yang berkualiti melalui amalan farmasi yang berkesan bagi mempertingkatkan Perkhidmatan Farmasi di Malaysia supaya setanding dengan kemajuan perkembangan perkhidmatan farmasi di negara-negara maju. Enam cawangan telah ditubuhkan di bawah pengawasan A&P, iaitu Penjagaan Farmaseutikal, Harga Ubat, Pengurusan Farmasi Logistik, Penggunaan Ubat Berkualiti, Pengurusan Formulari dan Pembangunan PhIS.

The Pharmacy Practice and Development Division is responsible for ensuring the quality of drug procurement and usage through effective pharmacy practice in order to improve pharmacy services in Malaysia to be on par with other developed countries. Six branches under the management of Pharmacy Practice and Development Division are Pharmaceutical Care, Medicine Price Management, Quality Use of Medicines, Formulary Management and Pharmacy Information System Development.



39

CAWANGAN PENJAGAAN FARMASEUTIKALPHARMACEUTICAL CARE BRANCH • Merancang, menyelaras dan memantau perkhidmatan

farmasi di peringkat hospital dan klinik kesihatan KKM bagi memastikan penyediaan, pembekalan dan pendispensan ubat yang tepat dan selamat kepada pesakit.

• Merancang, memperkembangkan serta menyelaras perkhidmatan penjagaan farmaseutikal (seperti kaunseling ubat-ubatan, MTAC dan perkhidmatan farmasi klinikal) bagi pesakit di fasiliti KKM.

• Menggubal polisi, garis panduan dan dasar berkaitan dengan amalan farmasi serta memantau proses implementasi di fasiliti KKM.

• Plan, coordinate and monitor pharmacy services provided in MOH hospitals and health clinics to ensure the preparation, supply and dispensing of medications are accurate and safe for patients.

• Plan, develop and coordinate pharmaceutical care services (such as medication counseling, MTAC and clinical pharmacy services) in MOH facilities.

• Formulate policies and guidelines related to pharmacy practice and monitor their implementation at the MOH facilities.

CAWANGAN PENGURUSAN FORMULARI FORMULARY MANAGEMENT BRANCH • Menguruskan permohonan penyenaraian ubat ke

dalam Formulari Ubat KKM (FUKKM) yang diterima dari syarikat farmaseutikal dan fasiliti KKM untuk dibentangkan dalam Mesyuarat Panel Kaji Semula Senarai Ubat KKM (Mesyuarat Panel).

• Membangunkan Kod Ubat Malaysia atau Malaysia Drug Code bagi setiap ubat yang disenaraikan dalam FUKKM.

• Menguruskan permohonan ubat-ubat yang memerlukan kelulusan khas Ketua Pengarah Kesihatan (KPK) dan Pengarah Kanan Perkhidmatan Farmasi (PKPF).

• Menilai permohonan ubat untuk penyenaraian ke dalam FUKKM berlandaskan ciri-ciri farmakoekonomik.

CAWANGAN PEMBANGUNAN PHISPHARMACY INFORMATION SYSTEM DEVELOPMENT BRANCH • Menggalak dan menambahbaik kualiti Perkhidmatan

Farmasi KKM menerusi program Quality Assurance (QAP), Petunjuk Prestasi Utama (KPI), Audit Dalaman Amalan Farmasi (ADAF), Piagam Pelanggan dan program-program peningkatan kualiti lain yang dijalankan di peringkat KKM.

• Menyelaras data-data bagi tujuan perancangan dan pengurusan Bahagian Amalan dan Perkembangan Farmasi.

• Menyelaras pembangunan dan pelaksanaan PhIS/CPS di semua fasiliti farmasi KKM.

• Promote and improve the quality of the Pharmacy Services through Quality Assurance Program (QAP), Key Performance Indicators (KPI), Internal Audit Practice of Pharmacy (ADAF), Client’s Charter and other quality improvement programs conducted at MOH level.

• Coordinate data for the purpose of planning and management of Pharmacy Practice and Development Division.

• Coordinate the development and implementation of PhIS/CPS in all MOH pharmacy facilities.

• Manage applications for drug listing into Ministry of Health Medicines Formulary received from pharmaceutical companies and MOH facilties to be presented to MOH Drug List Review Panel.

• Develop Malaysian Drug Code for all drugs listed in MOHMF.

• Manage Special Drug request requiring approval from Director General of Health (DG) and Senior Director of Pharmaceutical Services.

• Conduct drug evaluation for formulary listing applications using pharmacoeconomic principles.


40

CAWANGAN HARGA UBAT MEDICINE PRICE MANAGEMENT BRANCH • Mewujudkan satu pangkalan data harga ubat-ubatan

berdasarkan maklumat harga yang diperolehi daripada peringkat pengedaran ubat, sebagai bahan rujukan dalam proses rundingan dan pemantauan harga ubat-ubatan.

• Memantau dan menjalankan aktiviti-aktiviti pemantauan dan kawalan harga ubat-ubatan.

• Mewujudkan polisi, garis panduan dan ‘Standard Operating Procedure’ (SOP) berkaitan pemantauan dan kawalan harga ubat-ubatan dan pembentukan tariff harga ubat.

• Diseminasi informasi berkenaan harga ubat-ubatan untuk kegunaan orang ramai dan pegawai-pegawai KKM

• Menyediakan harga runcit yang dicadangkan oleh pembekal untuk digunakan sebagai rujukan harga pembelian oleh pengguna.

• Menyediakan senarai pelabelan harga ubat yang dibekalkan kepada pesakit luar di fasiliti KKM.

• Develop medicine price database based on information obtained from every level in the medicine distribution chain, as reference in the negotiation process and monitoring of medicine prices.

• Monitor and control activities related to medicine pricing.

• Develop policies, guidelines and Standard Operating Procedure (SOP) related to monitoring and control of medicine pricing and drug tariff development.

• Dissemination of information related to medicine prices to consumers and staff in Ministry of Health.

• Provide recommended retail price (RRP) reported by wholesaler to be used as a reference price in purchasing by the consumer.

• Provide list of medicine prices for labelling of medicines supplied to outpatients in MOH facilities.

CAWANGAN PENGGUNAAN UBAT BERKUALITIQUALITY USE OF MEDICINES BRANCH • Merancang, memantau dan menganalisis aktiviti

pendidikan berkenaan ubat-ubatan dan penyediaan akses maklumat ubat-ubatan untuk orang awam.

• Memberi pendidikan kepada orang awam berkaitan cara penggunaan ubat berkualiti supaya kefahaman dan pengetahuan tentang ubat-ubatan ditingkatkan untuk menggalakkan kepatuhan dan hasil rawatan yang baik.

• Menyediakan maklumat ubat-ubatan yang tepat, tidak berat sebelah dan relevan untuk disebarkan kepada orang awam melalui sebaran risalah, laman web dan media massa.

• Meningkatkan akses untuk rakyat mendapatkan maklumat ubat melalui National Pharmacy Call Centre (NPCC), portal Know Your Medicine serta secara atas talian.

• Menyediakan modul dan memberi latihan mengenai penggunaan ubat berkualiti kepada pengamal penjagaan kesihatan (Healthcare provider).

• Mengemas kini pangkalan data kesilapan pengubatan berdasarkan laporan-laporan yang diterima dari fasiliti kesihatan awam dan swasta seluruh negara.

• Menganalisis data kesilapan pengubatan dan menyediakan laporan-laporan berkaitan.

• Menggubal polisi/prosedur dan merancang serta menyelaras aktiviti berkaitan keselamatan pengubatan.

• Plan, monitor and analyse educational activities regarding medicines and provide access to drug information to the public.

• Educate the public regarding quality use of medicine in order to improve their knowledge and understanding regarding medicines hence promoting medication adherence and better treatment outcomes.

• Provide and disseminate accurate, relevant and unbiased medicine information to the public via articles, webpage and mass media.

• Improve public access to medicine information via National Pharmacy Call Centre (NPCC), Know Your Medicine portal and via online.

• Prepare modules and provide training on the quality use of medicine to healthcare providers.

• Update the medication error database according to reports received from the public and private health facilities nationwide.

• Analyse medication error data and prepare related reports.

• Develop policy/procedure as well as plan and coordinate activities regarding medication safety.


41

CAWANGAN PENGURUSAN FARMASI LOGISTIKPHARMACEUTICAL LOGISTICS MANAGEMENT BRANCH • Merancang keperluan ubat-ubatan bagi proses tender

baru atau pembaharuan tender. • Memberi sokongan teknikal farmaseutikal bagi aktiviti

pengurusan tender ubat-ubatan (konsesi dan kontrak pusat) yang diselaraskan oleh Bahagian Perolehan dan Penswastaan, KKM.

• Memantau prestasi perkhidmatan bekalan ubat yang diperolehi secara konsesi dan kontrak pusat KKM untuk penambahbaikan.

• Memantau prestasi simpanan stok ubat-ubatan dan bukan ubat di semua stor utama fasiliti KKM bagi memastikan perbelanjaan diuruskan dengan cekap dan simpanan stok sentiasa berada pada tahap yang optima.

• Memantau, menyelaras dan menyeragamkan dalam aktiviti pengurusan stor ubat dan bukan ubat di fasiliti KKM melalui pengauditan, penyediaan garis panduan dan koordinasi dengan agensi berkaitan.

• Membantu Bahagian Perkhidmatan Farmasi KKM dalam menyelaras sebarang aktiviti bersama Bahagian Kawalan Penyakit KKM berkaitan kesiapsiagaan dari semasa ke semasa.

• Forecasting requirements for new tenders or tenders requiring renewal.

• Provide pharmaceutical technical support for tenders (concession and MOH central contract) which is coordinated by MOH Procurement and Privatisation Division.

• Monitor the performance of services provided by concessionaire and MOH central contract in the supply of drugs for services improvement.

• Monitor the performance of the stockpile of drugs and non-drugs in all major stores in MOH facilities to ensure expenses are managed efficiently and stockpile at optimal levels

• To monitor, coordinate and standardize the activities of the store management for drugs and non-drugs in MOH facilities through audits, preparation of guidelines and coordination with relevant agencies.

• Assist the MOH Pharmaceutical Services Division in coordinating activities related to preparedness plans with MOH Disease Control Division which is conducted from time to time.


42

PERBELANJAAN UBAT-UBATAN KEMENTERIAN KESIHATAN MALAYSIA (KKM)MINISTRY OF HEALTH MALAYSIA (MOH) MEDICINES EXPENDITUREPada tahun 2016, nilai perolehan ubat-ubatan di semua hospital, institusi dan klinik kesihatan KKM ialah sebanyak RM2,107,609,943. 25. Nilai perbelanjaan bagi ubat-ubatan tersebut menurun sebanyak 9.28% berbanding tahun 2015 (Jadual 1 dan Rajah 1). Nilai stok penutup bagi ubat pada bulan Disember 2016 adalah RM260,891,217.16, iaitu kira-kira 1.48 (median) bulan simpanan stok.

The total cost of medicines procured in 2016 for all MOH hospitals, institutions and health clinics was RM2,107,609,943.25. The cost of medications purchased shows a decrease of 9.28% in medicines expenditure compared to 2015 (Table 1 and Figure 1). The value of the closing stock of medicines in December 2016 was RM260,891,217.16, which is approximately 1.48 (median) months of stock holding.

2.0 STATISTIK | STATISTICS

Jadual 1: Perbelanjaan Ubat-ubatan KKM, 2012-2016. Table 1: MOH Medicines Expenditure, 2012-2016.

TahunYear

Jumlah Perbelanjaan (RM Juta)Total Expenditure (RM Million)

Peratus Peningkatan Berbanding Tahun Lepas (%)

Percentage Increment Over the Previous Year (%)

2012 1,983.51 12.21

2013 2,200.43 10.94

2014 2,384.64 8.37

2015 2,323.12 -2.58

2016 2,107.61 -9.28

20162015201420132012-15

-10

-5

0

5

10

15

0

500

1,000

1,500

2,000

2,500

3,000

Juta

(RM

) | M

illio

n (R

M)

Pera

tus

Peni

ngka

tan

Bela

nja

(%)

Expe

nditu

re P

erce

ntag

e In

crea

men

t (%

)

Peningkatan Berbanding Tahun Sebelumnya (%) | Percentage Increment Over the Previous Year (%)

Jumlah Perbelanjaan (RM Juta) | Total Expenditure (RM Million)

12.2110.94

8.37

-2.58

-9.28

Rajah 1: Perbelanjaan Ubat-ubatan KKM, 2012-2016. Figure 1: MOH Medicines Expenditure, 2012-2016.


43

Ubat-ubatan ini diperolehi melalui syarikat konsesi, kontrak pusat dan pembelian terus & sebut harga seperti pecahan berikut (Jadual 2 & Rajah 2):

Medicines were purchased through the concessionaire company, MOH central contract and direct purchase & quotations as follows (Table 2 & Figure 2):

Jadual 2: Jenis Perolehan Ubat-ubatan pada Tahun 2016. Table 2: Types of Medicines Procurement in 2016.

TahunYear

APPL (RM Juta)

APPL (RM Million)

Kontrak KKM (RM Juta)

MOH Contract (RM Million)

Pembelian Terus & Sebutharga (RM Juta)

Local Purchase & Quotation (RM Million)

2016 36.7%(773.93)

43.5%(916.20)

19.8%(417.47)

Syarikat Konsesi (APPL) Kontrak KKM Pembelian Terus & Sebutharga

RM916.20juta/million

(43.5%)


(19.8%)


(36.7%)

Rajah 2: Perolehan Ubat-ubatan KKM Berdasarkan Kaedah Perolehan, Tahun 2016. Figure 2: Types of Medicines Procurement in 2016.


44

FORMULARI UBAT KKM (FUKKM)MOH MEDICINES FORMULARY (MOH MF)FUKKM adalah senarai ubat-ubatan yang dibenarkan untuk digunakan oleh semua fasiliti kesihatan KKM. Formulari ini berperanan sebagai panduan kepada anggota kesihatan KKM dalam pemilihan ubat-ubatan dalam rawatan pesakit. Permohonan penyenaraian/pindaan kepada FUKKM dibincangkan melalui mesyuarat Panel Kaji Semula Senarai Ubat KKM. Cawangan Pengurusan Formulari yang bertindak sebagai Sekretariat kepada mesyuarat Panel ini bertanggungjawab untuk memproses dan menilai permohonan penyenaraian/pindaan kepada senarai tersebut.

Pada tahun 2016, sebanyak 71 proforma/dossier telah dibentangkan dalam tiga mesyuarat Panel sepanjang tahun. Sebanyak 30 ubat-ubatan telah disenaraikan dalam formulari manakala 11 ubat dimansuhkan. Sehingga akhir tahun 2016, terdapat sebanyak 1,694 persediaan yang merangkumi 848 entiti kimia telah tersenarai dalam FUKKM (Rajah 3).

MOH MF is the list of all medicines approved to be used in MOH health facilities. It serves as a guide to healthcare professionals in the selection of medicines for the treatment of patients in MOH health facilities. Applications to list or amend the MOH MF will be presented in the MOH MF Review Panel meeting. The Formulary Management Branch acts as the Secretariat for the Panel meeting and is responsible for processing and evaluating the listing applications.

In 2016, 71 proformas/dossiers were presented in three Panel Meetings. Thirty drugs were approved to be listed while 11 were removed from the MOH MF. By the end of 2016, there are 1,694 preparations comprising of 848 chemical entities in the MOH MF (Figure 3).

Bila

ngan

Uba

t | N

umbe

r of M

edic

ine

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

201620152014201320122011

Sediaan Disenaraikan (Drug Listed) Entiti Kimia (Chemical Entity)

Tahun| Year

1,5301,578

802

1,621

821

1,653 1,677 1,694

834 843 848779

Rajah 3: Jumlah Ubat Tersenarai dalam FUKKM (2011-2016). Figure 3: Number of Drugs Listed in the MOH MF (2011-2016).


45

PROSES BARU PERMOHONAN PENYENARAIAN UBAT KE DALAM FUKKMMOH MF NEW SUBMISSION FOR LISTING PROCESSBermula tahun 2016, permohonan penyenaraian bagi kategori ubat baru, indikasi baru serta tambahan formulasi/kekuatan/bentuk dosej baru harus dimohon oleh syarikat farmaseutikal. Yuran pemprosesan dikenakan bagi permohonan penyenaraian dari syarikat tersebut. Satu garis panduan permohonan penyenaraian telah dikeluarkan dan diedarkan kepada fasiliti KKM serta persatuan syarikat farmaseutikal yang berkaitan.

Sepanjang tahun 2016, sebanyak 24 dossier telah diterima bagi kategori penyenaraian ubat baru, 7 dossier bagi kategori penyenaraian indikasi baru dan 5 dossier bagi kategori penyenaraian tambahan formulasi/kekuatan/bentuk dosej baru. Ini menjadikan keseluruhan yuran pemprosesan yang diterima berjumlah RM151,000. 00.

The new submission guidelines for MOH MF has been prepared and distributed to every MOH facilities and relevant pharmaceutical stakeholders. Starting 2016, the submission proformas/dossiers for the new medicines, changes in indication, formulation, strength and dosage form is applied by the pharmaceutical companies. The processing fee is charged for every category.

Throughout 2016, there were 24 dossiers of newly medicines submitted for the purpose of listing, 7 dossiers to list new indication and 5 dossiers to list new formulation/strength/dosage form were received based on the new submission process. Total processing fees received were RM151,000. 00.

PENILAIAN FARMAKOEKONOMIKPHARMACOECONOMICS EVALUATIONSepanjang tahun 2016, sebanyak 234 perbandingan ubat telah dilakukan manakala 61 penilaian ubat yang lengkap dari segi keselamatan, efikasi dan cost-effectiveness bagi permohonan penyenaraian ubat baru. Berbanding dengan tahun sebelumnya, terdapat 30% peningkatan dari segi perbandingan ubat dan 13% peningkatan dari segi penilaian yang dilakukan (Rajah 4).

Throughout 2016, there were 234 drug comparisons conducted while drug reviews conducted were 61. In relation to the previous year, there was 30% increase for drug comparison and 13% increase for drug review (Figure 4).

Pebandingan Ubat (Drug Comparison) Penilaian Ubat (Drug Review)

Tahun| Year

Bila

ngan

Uba

t | N

umbe

r of M

edic

ine

0

50

100

150

200

250

300

201620152014201320122011

271

41

221

191 187

38 35 27

54 61

234

180

Rajah 4: Aktiviti Penilaian Farmakoekonomik (2011-2016). Figure 4: Pharmacoeconomics Evaluation Activities (2011-2016).


46

PENGEMASKINIAN FUKKM | MOH MF UPDATESSelain daripada pengemaskinian FUKKM melalui mesyuarat Panel Kaji Semula Senarai Ubat KKM, pemurnian FUKKM berdasarkan kumpulan anti-diabetik telah dilaksanakan pada tahun 2016. Laporan penilaian ubat kumpulan anti-diabetik dan maklumbalas daripada setiap fasiliti KKM dan pihak yang berkaitan telah dibincangkan di dalam satu mesyuarat pada 19 Mei 2016 dan hasil dari mesyuarat tersebut, cadangan telah dibuat untuk memansuhkan tiga ubat anti-diabetik. Berikutan mesyuarat tersebut, mesyuarat Panel Kaji Semula Senarai Ubat KKM Bil. 2/2016 telah bersetuju untuk mengeluarkan tiga ubat daripada FUKKM, iaitu: • Rosiglitazone 4mg Tablet • Metformin 500mg/Glibenclamide 5mg Fixed-dose

Combination Tablet • Repaglinide 2mg Tablet

FUKKM terkini boleh diakses melalui laman sesawang rasmi Bahagian Perkhidmatan Farmasi, Pharmacy intranet dan aplikasi telefon pintar My Blue Book.

Apart from the annual updates based on the MOH MF Review Panel, one discussion on anti-diabetics in the MOH MF was conducted in 2016. Evaluation report on anti-diabetics was circulated, and feedback from the stakeholders was gathered before presented in a meeting on 19th of May. From that meeting, three anti-diabetics were proposed to be deleted, and the Panel agreed during Panel meeting No. 2/2016. The anti-diabetics removed from MOHMF were: • Rosiglitazone 4mg Tablet • Metformin 500mg/Glibenclamide 5mg Fixed-dose

Combination Tablet • Repaglinide 2mg Tablet

Updated MOH MF can be accessed through the Pharmaceutical Services Division official website, MOH Pharmacy Intranet and My Blue Book smartphone application.


47

0

1,000

2,000

3,000

4,000

5,000

6,000

20162015201420132012 0

10

20

30

40

50

60

70

80

90

100

59.20 52.96

78.5694.96

62.50

Kos

Kelu

lusa

n Ju

ta (R

M) |

Cos

t Mill

ion

(RM

)

Bila

ngan

Kel

ulus

an |

Num

ber o

f App

rova

lsKelulusan | Approvals Kos Kelulusan (RM Juta) | Cost (RM Million)

Rajah 5: Pemohonan Ubat Kelulusan Khas KPK/PKPF (2011-2016). Figure 5: Applications of Special Approval Drugs by KPK/PKPF (2011-2016).

Fasiliti bukan KKM/Institusi SwastaCawangan Pengurusan Formulari mula mengambilalih pemprosesan permohonan ubat dari fasiliti bukan KKM/institusi swasta dari Bahagian Penguatkuasaan Farmasi sejak Mac 2016. Sepanjang tempoh tersebut sehingga akhir tahun 2016, sebanyak 1,804 permohonan ubat melalui kelulusan khas KPK telah diluluskan iaitu 94.4% daripada keseluruhan permohonan yang telah diterima (1,912 permohonan) dengan anggaran kos RM63.8 juta.

1,502 kelulusan diberikan kepada institusi swasta (kos RM56.07 juta) manakala 294 kelulusan diberikan kepada fasiliti kesihatan Kementerian Pengajian Tinggi Malaysia (RM7.74 juta) dan 8 kelulusan diberikan kepada Kementerian Pertahanan Malaysia (RM 10,769.13).

Non-MOH/private institutionsFormulary Management Branch has taken over the responsibility to process the special drug approval application from the Enforcement Pharmacy Division since March 2016. In 2016 (March-December), 1,084 (94.4%) special approvals were issued from a total of 1,912 applications received incurring a total cost of RM 61.9 million. Out of these approvals, 1,502 approvals were granted to private institutions (total cost RM56.07 mil) and 294 approvals to the Ministry of Higher Education (RM7.74 mil) and 8 approvals given to the Ministry of Defence (RM10,769.13).

UBAT KELULUSAN KHAS KETUA PENGARAH KESIHATAN (KPK)/PENGARAH KANAN PERKHIDMATAN FARMASI (PKPF)DIRECTOR GENERAL OF HEALTH/SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES SPECIAL APPROVAL DRUGSKelulusan khas daripada KPK/PKPF diperlukan untuk memperolehi dan menggunakan ubat di luar FUKKM yang berdaftar atau tidak berdaftar sebagai alternatif terakhir selepas menggunakan semua ubat-ubatan FUKKM. Sepanjang tahun 2016, sebanyak 3,734 permohonan ubat melalui kelulusan khas KPK telah diluluskan iaitu 90.7% daripada keseluruhan permohonan yang telah diterima (4,119 permohonan) dengan anggaran kos RM62.5 juta. Terdapat 21.2% penurunan kepada bilangan kelulusan yang diberikan pada tahun 2016 berbanding tahun sebelumnya dan 34% penurunan dari segi kos kelulusan.

Special approval is required to obtain and use any drugs outside the MOH MF. It can be used as a last resort of treatment after all options available in the MOH MF has been exhausted. In 2016, 3,734 (90.7%) special approvals were issued from a total of 4,119 applications received incurring a total cost of RM62.5 million. In comparison to the year 2015, there was a 21.2% reduction in the number of approvals with a corresponding 34% reduction in total costs.


48

Kementerian PertahananMinistry of Defence

Kementerian Pengajian TinggiMinistry of Higher Education

Institusi SwastaPrivate Institutions

0

10

20

30

40

50

60

0

200

400

600

800

1,000

1,200

1,400

1,600 56.07

7.74

0.01

Kos

Kelu

lusa

n Ju

ta (R

M) |

Cos

t Mill

ion

(RM

)

Bila

ngan

Kel

ulus

an |

Num

ber o

f App

rova

ls

Kelulusan | Approvals Kos Kelulusan (RM Juta) | Cost (RM Million)

Rajah 6: Kelulusan & Kos Kelulusan (RM juta) Ubat Khas (Mac-Disember 2016) dari fasiliti bukan KKM/institusi swasta.

Figure 6: Approvals & Cost (RM million) of Special Drugs (March-December 2016) from non-MOH/private institutions.

PENGIKTIRAFAN PEGAWAI FARMASICREDENTIALING OF PHARMACISTPengiktirafan Pegawai Farmasi merupakan satu projek yang dibangunkan oleh Bahagian Perkhidmatan Farmasi (BPF) untuk mengiktiraf dan mengenalpasti Pegawai Farmasi yang mempunyai kemahiran dalam sesuatu bidang farmasi.

Sepanjang tahun 2016, seramai 46 orang Pegawai Farmasi telah diiktiraf di bawah aktiviti ini. Pengiktirafan telah diberikan dalam pelbagai pengkhususan berbeza di bawah bidang Amalan dan Perkembangan Farmasi seperti dalam Jadual 3.

Credentialing is a project by The Pharmaceutical Services Division (PSD) to identify, acknowledge and recognise pharmacists that have extensive expertise in specific fields related to pharmacy.

In 2016, 46 pharmacists were credentialed on various specialities under Pharmacy Practice and Development activities as listed in Table 3.

Jadual 3: Pengiktirafan Pegawai Farmasi Mengikut Pengkhususan.Table 3: Credentialing of Pharmacist According to Specialties.

Bil. No. Pengkhususan | Specialty Bilangan Pegawai

Number Of Pharmacists

1 Farmasi Wad (Perubatan Am) | Ward Pharmacy (General Medical) 2

2 Farmasi Wad (Pediatrik) | Ward Pharmacy (Pediatric) 4

3 Farmasi Wad (Rawatan Rapi) | Ward Pharmacy (Critical Care) 3

4 MTAC Diabetes | MTAC Diabetes 16

5 MTAC Nefrologi | MTAC Nefrology 2

6 MTAC Respiratori | MTAC Respiratory 5

7 MTAC RVD | MTAC RVD 4

8 MTAC Warfarin | MTAC Warfarin 10

Jumlah | Total 46

Aktiviti ini akan diteruskan pada tahun yang mendatang bagi mengiktiraf lebih ramai Pegawai Farmasi dari pelbagai bidang yang mempunyai kemahiran khusus untuk membawa perkhidmatan farmasi ke peringkat yang lebih tinggi.

This activity will continue in the future to recognize more pharmacists from various fields who have the expertise to bring the pharmacy services to a higher level.


49

MEDICATION ERROR REPORTING SYSTEMS (MERS)“To ensure medication safety” merupakan objektif ke-7 daripada 13 objektif yang ditetapkan di bawah Majlis Keselamatan Pesakit Malaysia. Medication Error Reporting System (MERS) merupakan kaedah yang digunakan untuk memantau indikator jumlah kesilapan pengubatan yang berlaku di fasiliti kesihatan sama ada kesilapan “actual” ataupun “near misses”. MERS telah dinaik taraf kepada versi baru dan mula digunapakai pada bulan Mac 2016. Beberapa penambahbaikan telah dibuat untuk membolehkan pelapor membuat pelaporan dengan lebih mudah dan efektif.

Pada tahun 2015, sebanyak 20,999 laporan kesilapan pengubatan telah diterima melalui Medication Error Reporting System (MERS). Rajah 7 menunjukkan menunjukkan jumlah pelaporan kesilapan pengubatan meningkat sebanyak 24.3% (4,102 laporan) pada tahun 2015 berbanding 16,897 laporan pada tahun 2014. Peningkatan bilangan laporan yang diterima pada setiap tahun adalah disebabkan oleh aktiviti-aktiviti promosi yang dijalankan telah berjaya meningkatkan kesedaran di kalangan anggota penjagaan kesihatan, termasuk sektor awam dan swasta untuk melaporkan kejadian kesilapan pengubatan yang dikenal pasti melalui MERS. Kebanyakan kes kesilapan pengubatan yang dilaporkan adalah near misses (94.2%) (Rujuk Jadual 4). Kebanyakan kesilapan pengubatan berlaku semasa proses pengurusan ubat-ubatan. Rajah 8 menunjukkan beberapa proses yang terlibat dalam kesilapan pengubatan yang dilaporkan iaitu mempreskripsi (80.8%), pendispensan (16.3%), administrasi (1.3%), kombinasi pelbagai proses (1.3%) dan lain-lain (0.3%). Pegawai Farmasi merupakan pelapor MERS yang tertinggi dan ini menyumbang kepada penemuan kesilapan mempreskripsi yang tinggi.

“To ensure medication safety” is the 7th goal out of 13 goals determines by the Malaysian Patient Safety Council. Medication Error Reporting System (MERS) is a method used to monitor indicators of medication errors occurring in health facilities either “actual” or “near misses”. MERS was upgraded to a new version and started to be used in March 2016. Some of the system features were improved to make the reporting system more user-friendly.

A total of 20,999 medication error reports were received through Medication Error Reporting System (MERS) in the year 2015. Figure 7 showed an increment of 24.3% (4,102 reports) of medication error reports in 2015 compared to 16,897 reports in the year 2014. The number of medication error reports received increase yearly due to the promotional activities carried out to raise awareness among healthcare providers to report identified medication error through MERS. Most of the reported cases are near misses (94.2%) (Refer Table 4). Medication error may occur during the medicine management process. Figure 7 demonstrated the number of processes involved in the medication error reported which include prescribing (80.8%), dispensing (16.3%), administration (1.3%), the combination of processes (1.3%) and others (0.3%). Pharmacists are the highest reporters through MERS and thus contribute to the highest number of prescribing error detected.

2015201420130

5,000

10,000

15,000

20,000

25,000

8,422

16,897

20,999

Bila

ngan

Kes

ilapa

n Pe

ngub

atan

(ME)

Num

ber o

f Med

icat

ion

Erro

r (M

E)

Rajah 7: Jumlah Laporan Kesilapan Pengubatan (ME) Diterima Mengikut Tahun.

Figure 7: Number of Medication Error (ME) Reports Received by Year.

Jadual 4: Jumlah Kesilapan Pengubatan Berdasarkan Kategori (2013-2015).

Table 4: Number of Medication Error Based on ME Category (2013-2015).

2013 2014 2015

Near Misses 7,276 15,713 19,783

Actual Error 1,146 1,184 1,216

Jumlah | Total 8,422 16,897 20,999


50

AUDIT DALAM AMALAN FARMASI (ADAF) Aktiviti ADAF Pusat dan ADAF Negeri 2016Pasukan ADAF Pusat telah melaksanakan audit di sepuluh fasiliti seperti berikut:

ADAF Pusat and ADAF Negeri activities 2016ADAF Pusat has conducted audits in ten facilities as follows:

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

OthersCombination of ProcessAdministrationDispensingPrescribing

2013 2014 2015

Bila

ngan

Kes

ilapa

n |

Num

ber o

f Err

or

5,229

13,056

16,967

2,6453,301 3,426

396 326 269 119 182 278 31 32 59

Rajah 8: Jumlah Kesilapan Pengubatan Mengikut Proses Kesilapan Yang Terlibat (2013-2015). Figure 8: Number of Medication Error Based on the Process in which the Error Occurs (2013-2015).

Jadual 5: Aktiviti ADAF Pusat dan ADAF Negeri 2016. Table 5: ADAF Pusat and ADAF Negeri activities 2016.

Bil. No. Fasiliti | Facility Tarikh Audit

Date of Audit

1 Hospital Tuanku Najihah 21-23 Mac 2016

2 Klinik Kesihatan Kuala Pilah 23-24 Mac 2016

3 Hospital Bintulu 18-21 April 2016

4 Klinik Kesihatan Bintulu 21-22 April 2016

5 Hospital Taiping 25-27 April 2016

6 Klinik Kesihatan Taiping 27-28 April 2016

7 Hospital Seberang Jaya 9-11 Mei 2016

8 Klinik Kesihatan Seberang Jaya 11-12 Mei 2016

9 Hospital Duchess Of Kent 23-25 Mei 2016

10 Klinik Kesihatan Sandakan 25-26 Mei 2016


51

Sasaran aktiviti ADAF adalah untuk mencapai 100% jumlah fasiliti negeri (dengan anggota farmasi) diaudit dalam tempoh 2 tahun. Bagi tahun 2016, ADAF negeri dan ADAF Pusat telah mencapai 99.8% daripada sasaran iaitu jumlah fasiliti yang diaudit adalah 509 berbanding 510 fasiliti yang dirancang. Secara keseluruhan, pencapaian ini merupakan 56% daripada jumlah keseluruhan fasiliti dengan anggota farmasi iaitu 509 fasiliti diaudit berbanding 908 fasiliti. (Jadual 6 dan Rajah 9)

Hasil audit ke atas 509 fasiliti sepanjang tahun 2016 mendapati, 203 fasiliti mendapat status Baik manakala 290 fasiliti mendapat status Sederhana. Walaubagaimanapun, masih terdapat 16 fasiliti yang mendapat status Lemah dan memerlukan lebih banyak langkah penambahbaikan ke atas amalan farmasi di fasiliti tersebut. (Jadual 6 dan Graf 9).

The ADAF target is to ensure that 100% of state facilities (with pharmacy staff) are audited within 2 years. In 2016, ADAF Pusat and ADAF Negeri and have achieved the target of 99.8% with the entire audited facility of 509 compared to 510 planned facilities. Overall, this is an achievement of 56% of the total facility (with pharmacies staff) with the audited facility of 509 out of 908 total facilities. (Table 6 and Graph 9)

The audit reports of 509 facilities inspected in 2016 found out that 203 facilities gained Good status while 290 statuses gained “Moderate” status. However, 16 facilities received the status of “Poor” and needed more improvement on the practice of pharmacy in the facility. (Table 6 and Figure 9)

Jadual 6: Jumlah Fasiliti di Setiap Negeri, Jumlah Fasiliti Dirancang untuk Diaudit dan Jumlah Fasiliti Diaudit 2016. Table 6: The Number of Facilities in Each State, Number of Facilities Planned to be Audited and the Number of Facilities

Audited in 2016.

NegeriState

Jumlah FasilitiTotal Facilities

Jumlah Fasiliti Dirancang untuk

DiauditNumber of Facilities

Planned To Be Audited

Jumlah Fasiliti DiauditNumber of Facilities

Audited

Melaka 33 19 20

Kelantan 78 44 44

Kedah 64 33 33

JKWPKL & Putrajaya 20 10 10

Johor 106 61 61

WP Labuan 2 1 2

Negeri Sembilan 52 27 29

Pahang 83 44 43

Perak 88 44 46

Perlis 10 10 10

Sabah 118 75 67

Sarawak 92 49 59

Selangor 78 39 39

Terengganu 49 25 25

Pulau Pinang 32 16 18

HKL 2 2 2

IKN 1 1 1

Jumlah | Total 908 500 510


52

0

20

40

60

80

100

120

Jumlah Fasiliti Jumlah Fasiliti Dirancang untuk Diaudit Jumlah Fasiliti Diaudit

IKN

HKLW

PLa

buan

WP

KL &

Putr

ajay

a

Sara

wak

Saba

h

Kela

ntan

Tere

ngga

nu

Paha

ng

Joho

r

Mel

aka

Neg

eri

Sem

bila

n

Sela

ngor

Pera

k

Pula

uPi

nang

Keda

h

Perl

is

10 10 10 10 10

2 1 1 1 12 2 2 2

64

33 33 32

16 18

88

106

118

75

67

92

49

61 61 59

20

8378

44 44 4443

49

25 25

78

39 39

52

27 2933

19 20

44 46

Bila

ngan

Fas

iliti

| N

umbe

r of F

acili

ty

Rajah 9: Jumlah Fasiliti yang Diaudit Berbanding Jumlah Fasiliti dan Jumlah yang Dirancang di Setiap Negeri pada Tahun 2016.

Figure 9: Number of Facilities Audited Against Total Facility and Total Planned Facility In Every State in the Year 2016.


53


Pada 28 Februari 2016, sejarah telah terukir apabila Yang Berhomat Menteri Kesihatan Malaysia, Dato’ Seri Dr S. Subramaniam menyempurnakan Majlis Perasmian Pelaksanaan PhIS dan CPS di Hospital Pakar Sultanah Fatimah, Muar Johor.

PhIS dan CPS adalah antara projek yang menyumbang kepada kejayaan mencapai sasaran yang ditetapkan untuk pelaksanaan aplikasi e-Health Kementerian Kesihatan Malaysia ke 500 buah fasiliti.

Pelaksanaan PhIS dan CPS disetiap fasiliti meliputi aktiviti penyediaan infrastruktur rangkaian untuk Local Area Network (LAN) dan pemasangan perkakasan seperti server, komputer serta pencetak. Bagi memastikan pengguna bersedia sepenuhnya, aktiviti seperti Pengurusan Perubahan dan latihan penggunaan sistem dilaksanakan diperingkat zon. Sebanyak empat puluh (40) zon yang terdiri dari hospital dan klinik kesihatan dari beberapa daerah telah dikenalpasti untuk melancarkan aktiviti pelaksanaan.

PELAKSANAAN ‘PHARMACY INFORMATION SYSTEM’ (PHIS DAN CPS)IMPLEMENTATION OF PHARMACY INFORMATION SYSTEM (PHIS AND CPS)

History was made on 28 February 2016, when the honourable Health Minister of Malaysia, Dato‘ Seri Dr S. Subramaniam officiated the ceremony of PhIS and CPS Implementation at Hospital Pakar Sultanah Fatimah, Muar Johor.

PhIS and CPS are among those projects who contributed to the achievement of implementation of e-Health application to 500 facilities.

Implementation of PhIS and CPS activities includes preparation of network infrastructure particularly on Local Area Network and installation of hardware such as servers, computers and printers. To ensure user readiness, Change Management and application training was conducted at the zone level. Forty (40) zones comprise of hospitals and health clinics from few districts have been identified to facilitate the implementation activities.


54

Jadual 7: Status Pelaksanaan PhIS dan CPS setakat Disember 2016. Table 7: PhIS and CPS Implementation Status as at December 2016.

Jenis FasilitiFacility Type

Bilangan Fasiliti Dikenalpasti

Identified Facility

Status Pelaksanaan (Fasa Perintis dan Peluasan)Implementation Status (Pilot and Expansion)

Laksana (a)Implemented (a)

Gugur (b)Dropped (b)

Tangguh (c)Deferred (c)

Hospital/Institut 143 142 0 1

Klinik Kesihatan 989 863 9 103

PKK/PKD/PK 145 105 0 41

MUS/PBFN 8 8 0 0

Jumlah | Total 1,285 1,118 9 145

Jadual 8: Pecahan Kaedah Pelaksanaan PhIS dan CPS. Table 8: PhIS and CPS Implementation Type.

Jenis FasilitiFacility Type

Bilangan LaksanaImplemented

Kaedah/Jenis PelaksanaanImplementation Type

Full Based Pharmacy Based

Inventory Based Indent Based

Hospital/Institut 142 4 113 25 0

Klinik Kesihatan 863 11 555 119 178

PKK/PKD/PK 105 0 0 105 0

MUS/PBFN 8 0 0 8 0

Jumlah | Total 1,118 15 668 257 178


55

Kursus pengurusan stor merupakan salah satu inisiatif berterusan untuk memantapkan dan meningkatkan kecekapan pengurusan stok ubat-ubatan di fasiliti KKM. Kursus ini diadakan khusus untuk pegawai yang terlibat secara langsung di dalam aktiviti perolehan dan pembekalan ubat di fasiliti KKM.

LATIHAN PENGURUSAN STOR | TRAINING ON STORE MANAGEMENTA basic course on store management is one of the ongoing initiatives to strengthen and improve the efficiency of drugs management in MOH facilities. The course is held for personnels who are involved in procurement and supply activities of drugs in MOH facilities.

Kursus ini telah diadakan pada 14-16 Mac 2016 khusus untuk Pegawai Farmasi yang baru bertugas di farmasi logistik. Kursus ini juga telah diadakan pada 10-12 Mei 2016 khusus untuk Penolong Pegawai Farmasi, Penolong Pegawai Tadbir dan Pembantu Tadbir. Seramai 102 orang peserta telah menghadiri kursus ini. Objektif utama kursus: i. Memberi penekanan terhadap prinsip-prinsip asas

pengurusan stor. ii. Memberi pendedahan kepada peserta terhadap

amalan tadbir urus baik ubat-ubatan serta penemuan lazim audit di Unit Farmasi logistik.

iii. Meningkatkan kefahaman integriti melalui penerapan nilai murni serta komitmen diri terhadap kemantapan organisasi.

iv. Memberi pendedahan kepada peserta terhadap pengurusan perubahan dan transformasi minda yang diperlukan sebelum atau semasa pelaksanaan Pharmacy Information System (PhIS)/Clinic Pharmacy System (CPS) di fasiliti.

KURSUS ASAS PENGURUSAN STOR | BASIC COURSE ON STORE MANAGEMENTThe course was held from 14th to 16th March 2016 for Pharmacists who are newly asigned in pharmacy logistics. It was also held from 10th to 12th May 2017 for Pharmacy Assistants, Assistants Administrative Officer and Administrative Assistants. The total number of participants who attended these courses were 102. The main objectives of these courses are:i. To give emphasis on the basic principles of store

management. ii. To give exposure to the participants on good

governance practices for medicines and common audit findings at the Pharmacy Logistics Unit.

iii. To improve the understanding of integrity through moral values and self commitment towards the stability of the organization.

iv. To give exposure to the participants regarding change management and mind transformation that is required before or during the implementation of the Pharmacy Information System (HIS)/Clinic Pharmacy System (CPS) in the facility.

Kursus Asas Pengurusan Stor untuk Pegawai Farmasi. Basic Course on Store Management for Pharmacist.


56

Kursus Asas Pengurusan Stor Untuk Penolong Pegawai Farmasi, Penolong Pegawai Tadbir dan Pembantu Tadbir. Basic Course on Store Management for Pharmacist Assistants, Assistants Administrative Officer and Administrative

Assistants.

Kursus Pemantapan Pengurusan Stor untuk Pegawai Farmasi. Basic Course on Store Management for Pharmacist.

Bengkel ini telah diadakan pada 4 hingga 6 Oktober 2016. Seramai 50 orang peserta yang terdiri daripada Pegawai Farmasi telah menghadiri bengkel ini. Bengkel ini bertujuan untuk memperkukuhkan pengetahuan dan amalan peserta meliputi topik-topik berikut: i. Meningkatkan kefahaman peserta terhadap konsep

asas pengurusan perolehan dan stok di stor farmasi.

ii. Memberi pendedahan kepada peserta terhadap kepentingan kesahihan data semasa pelaporan.

iii. Memantapkan budaya integriti dalam penyediaan laporan serta implikasinya terhadap perkhidmatan.

iv. Memantapkan pemantauan dalam pengurusan perolehan di stor farmasi.

BENGKEL PEMANTAPAN PENGURUSAN STOR UNTUK PEGAWAI FARMASIWORKSHOP ON STORE MANAGEMENT ENHANCEMENT FOR PHARMACISTS

The workshop was held from 4th to 6th October 2016. There were 50 participants among Pharmacists attended this workshop. The aim of this workshop is to enhance participants’ knowledge and practices including:i. To improve participants’ understanding of the basic

concepts of procurement and stock management in the pharmacy store.

ii. To give exposure to participants the importance of data integrity when reporting.

iii. To enhance the culture of integrity in preparing reports and its implications in services.

iv. To enhance the monitoring of procurement management at pharmacy store.


57

MEA merupakan salah satu mekanisme yang digunakan untuk meningkatkan akses ubat-ubatan yang mahal dan berinovatif dengan cara yang mampu diperolehi. Tumpuan MEA adalah untuk menguruskan bajet ubat-ubatan baru dan ketidaktentuan keberkesanan klinikal ubat melalui perkongsian kos/risiko antara pengeluar dan pembayar. Gambaran keseluruhan MEA berkaitan dengan PASc dan bagaimana perjanjian itu boleh digunakan untuk menyokong pelaksanaan dasar kesihatan berasaskan bukti di negara-negara berpendapatan sederhana telah dibincangkan melalui bengkel yang telah diadakan pada 14 April 2016. Terdapat 40 orang peserta di kalangan ahli farmasi dan pihak yang berkaitan telah menghadiri bengkel ini. Bengkel ini juga membincangkan contoh-contoh yang berkaitan dalam aspek operasi MEAs melalui kajian kes.

PATIENT ASSISTANCE SCHEME (PASC) – BENGKEL MANAGED ENTRY AGREEMENT (MEA) PATIENT ASSISTANCE SCHEME (PASC) – MANAGED ENTRY AGREEMENT (MEA) WORKSHOP

MEA is one of the mechanisms used to increase the access of high-cost and innovative medicines in affordable ways. MEA focus on managing the budget of new drugs and the uncertainty of clinical effectiveness of a drug in a real-world setting through cost/risk sharing between manufacturers and payers. An overview of MEAs related to PASc and how the agreement can be applied to support the implementation of evidence based health policy in upper middle income countries was discussed through a workshop that was held on 14th April 2016. There were 40 participants among pharmacists and relevant stockholders attended this workshop. This workshop also discussed relevant examples of operational aspects of MEAs through a case study.

Bengkel PASc. | PASc Workshop.


58

Aktiviti Bengkel Sesi Ceramah dan Pembentangan. Workshop Activity Presentation and Lecture Session.

Satu bengkel Motivational Interviewing Skills in MTAC 2016 & Updates in Clinical Guideline telah diadakan pada 16 hingga 18hb Ogos 2016 di Hotel Saujana, Subang. Objektif bengkel ini adalah untuk:a. Memperkenalkan teknik motivational interviewing

kepada Pegawai Farmasi MTACb. Berkongsi perkembangan terkini garis panduan

klinikal seperti diabetes mellitus, asthma dan COPDc. Mewujudkan satu platform bagi membolehkan

Pegawai Farmasi membincangkan isu-isu yang berkait dengan implementasi MTAC di fasiliti masing-masing

Seramai 45 orang pegawai farmasi yang terlibat dalam MTAC Diabetes, MTAC Respiratori dan MTAC Warfarin telah menyertai bengkel tersebut. Ceramah-ceramah disampaikan oleh pakar-pakar dalam bidang masing-masing. Dr Hariyati Shahrima binti Abdul Majid, yang mempunyai pengalaman luas dalam bidang psikologi kesihatan dan aktif dalam misi-misi kemanusian turut dijemput untuk memberi pendedahan berkaitan teknik motivational interviewing kepada pegawai farmasi.

BENGKEL “MOTIVATIONAL INTERVIEWING SKILLS IN MTAC 2016 & UPDATES IN CLINICAL GUIDELINE”MOTIVATIONAL INTERVIEWING SKILLS IN MTAC 2016 & UPDATES IN CLINICAL GUIDELINE WORKSHOP

The Motivational Interviewing Skills in MTAC 2016 & Updates in Clinical Guideline Workshop had been conducted on the 16-18th August 2016, at Saujana Hotel, Subang. The objectives of this workshop are as follows:a. To introduce motivational interviewing skills to MTAC

pharmacistsb. To share latest clinical guidelines for diabetes mellitus,

asthma and COPDc. To create a platform where pharmacists could discuss

issues on implementation of MTAC

This workshop was attended by 45 pharmacists who are actively involved in MTAC Diabetes, MTAC Respiratory and MTAC Warfarin. Experts from various fields were invited to update the crowd on latest clinical practice guidelines, and Dr Hariyati Shahrima binti Abdul Majid, prestige speakers that are experienced in health psychology and actively involved in humanitarian work were invited to introduce motivational skills technique to the pharmacists.


59

Pada 27 hingga 28 Julai 2016, “10th National Conference for Clinical Research 2016” telah diadakan bertempat di Hotel Istana, Kuala Lumpur. Seramai 789 orang peserta telah menyertai konferens ini yang bertemakan Big Data Driving Clinical Research for Health. Sebanyak 80 buah poster daripada lebih 300 penyertaan yang diterima telah terpilih untuk pusingan akhir.

Poster daripada Cawangan Penjagaan Farmaseutikal yang bertajuk “A National Point Prevalence Study of Antibiotic Utilisation Among Hospitals in Malaysia (APPS)” berjaya memasuki peringkat akhir dan juga dipilih untuk dibentangkan kepada Yang Berhormat Menteri Kesihatan, Datuk Seri Dr S. Subramaniam semasa upacara perasmian. Hasil kajian ini mendapati 43.8% pesakit di dalam wad menerima antibiotik untuk rawatan mereka dengan 74.2% daripadanya menerima hanya satu jenis antibiotik. Cephalosporin merupakan kumpulan antibiotic yang paling kerap digunakan. Sebanyak 79% daripada antibiotik yang dipreskrib adalah untuk kegunaan empirik dengan 72% daripadanya menghantar sampel untuk ujian kultur dan sensitivity.

PENYERTAAN DALAM “10TH NATIONAL CONFERENCE FOR CLINICAL RESEARCH 2016 (NCCR 2016)”PARTICIPATION IN 10TH NATIONAL CONFERENCE FOR CLINICAL RESEARCH 2016 (NCCR 2016)

The 10th National Conference for Clinical Research 2016 was held at Hotel Istana, Kuala Lumpur from 27 to 28 July 2016. The theme of this conference is Big Data Driving Clinical Research for Health, and it was attended by 789 participants. There were 300 posters submissions, and only 80 shortlisted to the final round.

Poster from Pharmaceutical Care Branch, entitled A National Point Prevalence Study of Antibiotic Utilisation Among Hospitals in Malaysia (APPS) was shortlisted and chosen to be presented to the Minister of Health, Datuk Seri Dr S. Subramaniam during the opening ceremony. This study showed that 43.8% of hospitalised patients received antibiotic, with 74.2% of them receiving a single antibiotic. Cephalosporin was the most common prescribed class of antibiotic. About 79% of antibiotics prescribed were indicated for empirical therapy, with 72% of it had culture sent for culture and sensitivity test.

Sesi Penerangan Berkaitan Kajian APPS kepada Yang Berhormat Menteri Kesihatan semasa Perasmian NCCR 2016 di Hotel Istana.

Presentation of APPS Study to the Minister of Health during NCCR 2016 Opening Ceremony at Hotel Istana.


60

Bahagian Amalan dan Perkembangan Farmasi telah terlibat sebagai urusetia bersama bagi sambutan Minggu Kesedaran Antibiotik Sedunia Peringkat Kebangsaan pada 14 hingga 20 November 2016. Tema sambutan pada tahun ini ialah “Antibiotik: Perlu Ke?”. Di antara aktiviti yang telah dijalankan sempena kempen tersebut ialah pendidikan kepada orang awam melalui pameran poster, media cetak, media elektronik dan media sosial. Majlis pelancaran telah disempurnakan oleh Yang Berhormat Menteri Kesihatan, Datuk Seri Dr S. Subramaniam pada 16 November 2016 di Hospital Putrajaya. Sambutan serentak turut diadakan di peringkat negeri dan hospital. Selaras dengan konsep One Health dan penubuhan National Antimicrobial Resistance Committee, Jabatan Perkhidmatan Veterinar dan pelbagai agensi kerajaan lain serta badan bukan kerajaan turut bekerjasama dalam menjayakan sambutan kali ini.

MINGGU KESEDARAN ANTIBIOTIK SEDUNIA PERINGKAT KEBANGSAAN 2016WORLD ANTIBIOTIC AWARENESS WEEK 2016: NATIONAL LEVEL

Pharmacy Practice and Development Division was the co-secretariat for World Antibiotic Awareness Week campaign, which was carried out at the national level from 14 to 20 November 2016. The theme for this campaign was “Antibiotik: Perlu Ke?”. The activities conducted in conjunction with the campaign were public education through poster exhibition as well as printed, electronic and social media. The campaign was officially launched by the Honorary Minister of Health, Datuk Seri Dr S. Subramaniam on 16 November 2016 at Hospital Putrajaya. This campaign was also conducted at state and hospital levels. In line with One Health concept and the establishment of National Antimicrobial Resistance Committee, Department of Veterinary Services and various other government agencies, as well as non-government organisations had collaborated with the Ministry of Health for this year’s campaign.

Sesi Penerangan Berkaitan Kerintangan Antibiotik oleh Pegawai Farmasi kepada Orang Awam yang Melawat Gerai Pameran.

Explaination Session by Pharmacist Regarding Antibiotic Resistance to Member of Public at the Exhibition Booth.


61

Bahagian Perkhidmatan Farmasi dan MYSPOR telah menganjurkan satu seminar bertajuk “Budget Impact Analysis and Current Developments on Drug Selection“ di Hotel Hilton, Petaling Jaya pada 22 Mac 2016. Seminar tersebut telah dihadiri oleh 55 peserta dari kalangan kakitangan BPF serta wakil daripada syarikat farmaseutikal. Para peserta seminar telah didedahkan kepada pengenalan mengenai “Budget Impact Analysis dan Multi-Criteria Decision Analysis (MDCA)” serta aplikasinya kepada pemilihan ubat-ubatan. Taklimat mengenai garis panduan penyenaraian baru Formulari Ubat KKM juga telah diberikan pada akhir seminar tersebut.

SEMINAR BUDGET IMPACT ANALYSIS & CURRENT DEVELOPMENTS ON DRUG SELECTION BUDGET IMPACT ANALYSIS & CURRENT DEVELOPMENTS ON DRUG SELECTION (1-DAY SEMINAR)

Pharmaceutical Services Division co-organized a seminar with MYSPOR on Budget Impact Analysis (BIA) and Current Developments on Drug Selection on 22nd of March 2016. 55 participants from PSD and pharmaceutical companies attended this seminar. The attendees were exposed to BIA and Multi-Criteria Decision Analysis and also the applications on drug selection. Towards the end of the session, there was also a briefing on the new submission guideline for listing into MOH Medicines Formulary.

Sebuah bengkel mengenai EBM telah dianjurkan oleh Bahagian Perkhidmatan Farmasi pada 13-14 Julai 2016 di Hotel Concorde Inn, Sepang. Seramai 70 orang pegawai farmasi pelbagai gred telah menghadiri bengkel tersebut. Para peserta seminar telah didedahkan kepada EBM serta aplikasinya kepada pemilihan ubat-ubatan. Taklimat mengenai garis panduan permohonan kelulusan khas Ketua Pengarah Kesihatan/Pengarah Kanan Perkhidmatan Farmasi juga telah diberikan pada 15 Julai 2016.

BENGKEL EVIDENCE-BASED MEDICINE (EBM) EVIDENCE-BASED MEDICINE (EBM) WORKSHOP

A workshop on EBM was held on 13-14th of July 2016 by Pharmaceutical Services Divisions at Concorde Inn Hotel, Sepang. 70 pharmacists had attended this workshop. The participants were exposed to EBM and its application in drugs selection. A briefing on the special approval guidelines was conducted on 15th July 2016.


62

Kempen Kesedaran Keselamatan Pengubatan: Alahan Ubat-ubatan telah dijalankan di semua negeri dalam tempoh Oktober hingga Disember 2016. Objektif penganjuran kempen adalah untuk meningkatkan kesedaran anggota penjagaan kesihatan dan orang awam tentang alahan ubat-ubatan supaya mereka dapat bertindak bersama bagi mengelakkan kejadian dimana pesakit yang dikenal pasti mempunyai alahan ubat tertentu diberikan ubat yang sama dalam rawatan selanjutnya. Aktiviti yang telah dijalankan termasuk ceramah, pameran, bengkel/kursus dan pertandingan kuiz. Beberapa sesi wawancara radio juga telah diadakan seperti di Mutiara FM (Pulau Pinang), Johor FM dan Labuan FM.

KEMPEN KESEDARAN KESELAMATAN PENGUBATAN: ALAHAN UBAT MEDICATION SAFETY AWARENESS CAMPAIGN ON DRUG ALLERGY

Medication Safety Awareness Campaign: Drug Allergy had been carried out throughout Malaysia from October to December 2016. The main objective of this campaign is to increase the awareness among healthcare providers and public about drug allergy so that they can work together to prevent error(s) especially to avoid recurrent drug allergy in patients with known drug allergy. Activities that have been carried out include talks, exhibition booths, workshops/courses, quiz competitions and radio interviews (eg: Mutiara FM (Penang), Johor FM and Labuan FM).

Program Duta Kenali Ubat Anda merupakan salah satu program community empowerment. Program ini bertujuan menggalakkan wakil masyarakat yang berpengaruh menceburkan diri secara aktif dalam menyampaikan maklumat asas berkaitan ubat-ubatan. Program ini juga menggunakan kaedah pengaruh rakan sebaya dalam menyalurkan informasi secara lebih berkesan kepada masyarakat setempat.

Inisiatif ini merupakan satu program berstruktur yang komprehensif dan seragam meliputi latihan kepada duta bagi memastikan mereka berpengetahuan dalam menyampaikan maklumat asas berkaitan ubat-ubatan. Duta Kenali Ubat Anda diyakini dapat memainkan peranan sebagai pemangkin kepada perubahan tingkah laku dalam komuniti setempat. Program ini merupakan satu usaha Kementerian Kesihatan dalam menjaga kepentingan dan kesejahteraan masyarakat.

PROGRAM DUTA KENALI UBAT ANDAKNOW YOUR MEDICINES AMBASSADORS’ PROGRAMME

The Know Your Medicines Ambassadors Programme is part of the community empowerment programme. It aims to encourage active community participation in the dissemination of necessary information on medicines. Through this approach, the representatives of the community may have a significant contribution towards the public. The Know Your Medicines Ambassadors Programme utilises peer education and behavioural changes approach in ensuring effective dissemination of information to the community.

This comprehensive and structured programme also includes training programmes to the Know Your Medicines Ambassadors to ensure these community leaders are capable to deliver information to the public. The ambassadors will also act as a catalyst to increase the awareness of the public towards the quality use of medicines. The programme is an effort made by the Ministry of Health to protect the wellbeing of the community.

(Kiri) Majlis Pelancaran Majlis Perasmian Minggu Kesedaran Keselamatan Pengubatan: Alahan Ubat-ubatan di Dewan Pesona, Hospital Umum Sarawak. (Kanan) Promosi Wawancara radio di Johor FM.

(Left) Opening Ceremony of Medication Safety Awareness Week: Drug Allergy, Dewan Pesona, Hospital Umum Sarawak. (Right) Radio Interviews (Johor FM).


63

Aktiviti Duta Kenali Ubat Anda.Know Your Medicines Ambassadors’ Activities.

Jadual 9: Statistik Bilangan Aktiviti Duta Kenali Ubat Anda. Table 9: Number of Know Your Medicines Ambassadors’ Activities.

TahunYear

Bilangan Aktiviti Duta Kenali Ubat AndaNumber of Know Your Medicines Ambassadors’ activities

2012 36

2013 119

2014 251

2015 419

2016 631


64

Pelbagai usaha dilakukan untuk menyebarkan informasi berkaitan ubat-ubatan. Antara usaha yang dilakukan adalah penulisan artikel akhbar, wawancara radio dan televisyen, penerbitan video pendidikan dan aktiviti kolaborasi bersama-sama agensi luar serta persatuan mahasiswa farmasi di Universiti awam dan swasta.

Tahun 2016, sebanyak 50 buat artikel berkaitan ubat-ubatan telah berjaya diterbitkan untuk ruangan SIHAT METRO AHAD. Jumlah terkumpul artikel yang telah diterbitkan di ruang SIHAT METRO AHAD adalah sebanyak 134 buah artikel sejak Mei 2014.

Pada tahun 2016 juga menunjukkan peluang wakil-wakil jabatan untuk muncul dalam wawancara berkaitan ubat-ubatan semakin meningkat. Sebanyak 48 slot wawancara di televisyen (TV) telah berjaya diperolehi melibatkan penyiar/stesen TV seperti RTM, Media Prima (TV3 & TV9), TV Al-Hijrah dan Astro. Manakala sebanyak 33 slot wawancara radio berjaya diperolehi melibatkan penyiar/stesen radio seperti, Nasional FM, Asyik FM, Traxx FM, IKIM FM dan Bernama Radio.

MENINGKATKAN PENYEBARAN MAKLUMAT DAN PROMOSI PENGGUNAAN UBAT SECARA BERKUALITI KEPADA MASYARAKATIMPROVEMENT ON MEDICATION INFORMATION DISSEMINATION AND PROMOTION TO COMMUNITY

Various initiatives were made to increase the dissemination of information regarding medicine. The initiatives include publishing articles in newspapers, interviews on television and radio, publication of short educational video clips as well as collaboration with pharmacy societies in both public and private universities.

In 2016, 50 articles relating to the rational use of medicines were published by the local newspaper “Metro Ahad” in its weekly health section. To date, the total articles posted on “Metro Ahad” since Mei 2014 amounts to 134 articles.

Also in 2016, more television and radio interview slots were obtained as compared to previous years. 48 slots have been achieved for a range of channels from various networks including RTM, Media Prima (TV3 & TV9), TV Al-Hijrah and Astro. Whereas, 33 slots for radio were obtained for stations such as Nasional FM, Asyik FM, Traxx FM, IKIM FM and Bernama Radio.

The television and radio interviews from 2015 were compiled into a Video Compact Disc (VCD), and it was then distributed to all State Pharmacy Departments so that each state department could then hand out the VCDs to Hospital and Health Clinics under their jurisdiction. The VCDs were played in patient waiting areas of the health facilities.

As for the short educational video clips, two videos were produced. The first video was focusing on the importance of the Medication Allergy card, and it was made with the cooperation of the Pharmacy Department, Shah Alam Hospital.

The second video emphasised on the importance of medication adherence in preserving long life, entitled

Sebuah VCD koleksi wawancara TV dan Radio tahun 2015 juga berjaya disiapkan dan diedarkan kepada semua Jabatan Kesihatan Negri (Farmasi) agar mereka dapat mengedarkan salinan VCD tersebut kepada semua fasilti kesihatan seperti Hospital dan Klinik Kesihatan untuk mereka mainkan video tersebut di ruang menunggu pesakit.

Dalam penerbitan video pendidikan pengguna pula, sebanyak 2 video berjaya di siapkan. Video pertama berkaitan promosi kepentingan Kad Alahan Ubat-ubatan yang telah berjaya disiapkan dengan kerjasama Jabatan Farmasi Hospital Shah Alam.

Video kedua adalah sebuah video viral “Contohi Wan Rakiah” yang telah berjaya disiapkan dengan kerjasama Pejabat Kesihatan Daerah Temerloh. Video ini telah mendapat 185 ribu tontonan oleh netizen di media sosial Facebook. Video contohi Wan Rakiah ini menceritakan Wan Rakiah yang merupakan seorang pesakit kronik yang telah berumur 93 tahun dan masih kekal sihat serta patuh dalam pengambilan ubat-ubatannya.


65

Selain daripada itu, usaha untuk menyebarkan maklumat dan promosi berkaitan penggunaan ubat secara berkualiti bukan sahaja dilakukan kepada masyarakat umum, namun dilakukan juga dalam kalangan mahasiswa dan mahasiwi di Universiti Awam dan Swasta.

Menerusi kolaborasi dengan Persatuan Pelajar Farmasi Malaysia (MyPSA) sebanyak 9 aktiviti Bengkel Kenali Ubat Anda telah berjaya dilakukan kepada pelajar farmasi di sembilan buah universiti awam dan swasta.

Hasil daripada bengkel ini sebanyak 15 aktiviti pendidikan kesihatan dan ubat-ubatan telah berjaya dianjurkan oleh pelajar-pelajar farmasi. Jabatan Kesihatan Negeri (Farmasi) yang terlibat juga turut membantu dalam menyediakan Pameran Kenali Ubat Anda semasa aktiviti yang dianjurkan oleh pelajar farmasi.

“Contohi Wan Rakiah”. The short clip went viral on the social media network “Facebook”, hitting more than 185 thousand views within weeks of its release. This video was made with the cooperation of the Temerloh District Health Office.

Our promotion and dissemination of information are not limited alone to the public as a whole. It is also conducted for undergraduates from both public and private universities.

Through collaboration with the Malaysian Pharmacy Student Association (MyPSA), a total of 9 Know Your Medicine workshops were held in both public and private schools for pharmacy undergraduates.

As a result, 15 public health campaigns were held by the students that were trained during the Know Your Medicine workshops. During the campaign, students were assisted by officers from the State Pharmacy Department, who helped to set up and run the Know Your Medicine exhibitions.

Aktiviti Duta Kenali Ubat Anda.Know Your Medicines Ambassadors’ Activities.


66

Kursus Pemantapan Auditor Audit Dalam Amalan Farmasi (ADAF) 2016 telah diadakan pada 10-14 Oktober 2016 dengan kehadiran 28 orang pegawai farmasi yang terdiri daripada penyelaras ADAF Negeri dan juga juruaudit ADAF Pusat. Perlaksanaan kursus dengan tema “Pemantapan Auditor Audit Dalam Amalan Farmasi (ADAF) Ke Arah Peningkatan Kualiti ADAF” diadakan selama lima hari di Hotel Premiere Klang Selangor. Objektif kursus ini adalah untuk memperkukuhkan pelaksanaan audit dalam amalan farmasi dengan meningkatkan kemahiran auditor melalui ceramah dan aktiviti audit di fasiliti terpilih. Selain daripada itu, kursus ini juga diharap dapat membantu pihak ADAF negeri untuk meningkatkan kualiti pelaksanaan audit dan menganalisa penemuan audit di peringkat negeri dengan lebih berkesan agar langkah penambahbaikan menggunakan kaedah Corrective Action Preventive Action (CAPA) yang betul dapat dibuat. Kursus ini dapat dijalankan dengan jayanya hasil kekuatan tujuh orang penceramah dan fasilitator yang telah menyampaikan tajuk-tajuk yang berkaitan dengan pelaksanaan audit seperti pengenalan kepada proses audit, persediaan sebelum audit, aktiviti semasa audit berlangsung dan selepas audit tamat. Selain daripada itu, dengan bimbingan fasilitator juga aktiviti hands-on mock audit juga telah dibuat di empat buah fasiliti berhampiran iaitu Hospital Tengku Ampuan Rahimah, Hospital Shah Alam, Klinik Kesihatan Bandar Botanik Bukit Tinggi dan Klinik Kesihatan Bukit Kuda.

KURSUS PEMANTAPAN AUDITOR AUDIT DALAM AMALAN FARMASI (ADAF) 2016AUDIT DALAM AMALAN FARMASI (ADAF) AUDITOR ENHANCEMENT COURSE 2016

Audit Dalam Amalan Farmasi (ADAF) Auditor Enhancement Course 2016 was held on 10th–14th October 2016 with the attendance of 28 pharmacists consisting of ADAF state liaison officer and Central ADAF auditor. This five days course was successfully done with the theme of “Strengthening Auditor Audit Dalam Amalan Farmasi (ADAF) Towards Improved Quality of ADAF” at the Premiere Hotel in Klang. The objective of this course is to strengthen the implementation of audit in the practice of pharmacy by improving auditors’ skills through lectures and audit activities in selected facilities. In addition, this course also aims to help ADAF states to improve the quality of the audit and analyse audit findings more effectively for improvements using the Corrective Action Preventive Action (CAPA) method. Seven speakers and facilitators were invited to present topics related to the audit such as introduction to the audit process, preparation before the session and activities during and after the conclusion of the audit. In this workshop, with the guidance of the facilitators, hands-on mock audit session has also been made in four nearby facility which is Hospital Tengku Ampuan Rahimah Hospital Shah Alam, Bandar Botanic Health Clinic Health Clinic Bukit Tinggi and Bukit Kuda.

Aktiviti latihan semasa pembukaan audit. | Training activities during audit opening.

Aktiviti hands on mock audit di Klinik Kesihatan Bandar Botanik Klang.Hands on mock audit activity at Bandar Botanik Klang Health Clinic.


67

SERBUAN |RAIDS99.92%

Pengeluaran Lesen/ Permit Baru yang Dikeluarkan di Bawah Akta Racun 1952 dalam Tempoh 7 Hari Bekerja.New License/Permit Issued under the Poison Act 1952 During 7 Days of Work.

Serbuan yang Berjaya untuk Diambil Tindakan Penguatkuasaan daripada Jumlah Serbuan yang Dijalankan.Successful Raids Which Enforcement Action Can Be Taken Out of Numbers of Raids Done.

LESEN/PERMIT |LICENSE/PERMIT98.33%

Kertas Siasatan Dikemukakan kepada Timbalan Pendakwa Raya (TPR) Selepas Menerima Laporan Analisa dalam Tempoh 1 Bulan.Inspection Reports Delivered To the Deputy Public Prosecutor Within a Month After Receiving the Analysis Report.

KERTAS SIASATANINSPECTION REPORTS96.28%

Aduan ke Atas Kesalahan yang Berkaitan dengan Akta Farmasi Diverifikasi dan Diberikan Respon dalam Masa 2 Minggu.Complaint on Offences Related To Pharmacy Legislation Verified and Responded Within 2 Weeks.

ADUANCOMPLAINTS99.56%

18,986Pemeriksaan Premis Dilakukan.Premise Inspection Done.

SERBUANRAIDS1,396

Serbuan Dilakukan dengan RM47,870,273 Nilai Rampasan.Raids Done with RM47,870,273 Value of Confiscation.

PEMERIKSAAN | INSPECTION


70


Bahagian Penguatkuasaan Farmasi berperanan untuk memastikan semua produk farmaseutikal, tradisional dan kosmetik dalam pasaran adalah sah daripada segi pendaftaran dan notifikasi. Ia juga berfungsi untuk memastikan bahawa pengendalian rangkaian bekalan dan pemasaran, pengiklanan produk-produk kesihatan dan perkhidmatan perubatan dikendalikan dengan mematuhi peruntukan undang-undang yang dikuatkuasakan iaitu di bawah Akta Racun 1952, Akta Jualan Dadah 1952 dan Akta Ubat Iklan dan Penjualan 1956. Usaha ini dilakukan melalui aktiviti risikan dan operasi terancang, kawalan melalui sistem pelesenan berintegrasi, pemantauan beterusan dan bersepadu dan juga aktiviti seranta bersama agensi-agensi berkepentingan bagi menurunkan permintaan terhadap produk yang tidak selamat atau membahayakan. Bahagian ini turut bertanggungjawab bagi memastikan semua keluaran farmaseutikal dan produk penjagaan kesihatan yang berada di pasaran adalah berkualiti, selamat, berkesan.

Pharmacy Enforcement Division plays a pivotal role in ensuring that all pharmaceutical, traditional and cosmetics that are available in the market are genuine in terms registration and notification. It also acts to ensure that the link between supply and marketing, advertising of healthcare products and medical services is conducted in compliance with the provisions of the existing legislations in Poisons Act 1952, Sale of Drugs Act 1952 and Medicines Advertisement and Sale Act 1956. These activities are carried out through intelligence and operations, control of licensing and integrated monitoring and collaborative activities with stakeholders to reduce the demands for unsafe or hazardous products. Pharmacy Enforcement Division is also responsible for verifying that all pharmaceutical and healthcare products in the market are of high quality, safe and efficacious.

1. 0 PENGENALAN | INTRODUCTION


71

CAWANGAN RISIKAN DAN OPERASIINTELLIGENCE AND OPERATION BRANCH • Menjalankan risikan berdasarkan maklumat yang

diterima/diperolehi. • Menjalankan serbuan ke atas premis yang menjual/

membekal/menyimpan/mengilang produk-produk tidak berdaftar, kosmetik tidak bernotifikasi.

• Menjalankan serbuan ke atas premis yang menjual/membekal/menyimpan/mengilang racun, bahan psikotropik, bahan kimia dan ubat-ubat terkawal yang beroperasi tanpa lesen yang sah.

• Menjalankan aktiviti audit ubat-ubat terkawal.

• Conduct intelligence based on the information received/gathered.

• Conduct raids on the premises selling/supply/store/manufacture of unregistered products and un-notified cosmetics.

• Conduct raids on the premises selling/supply/store/manufacture of poisons, psychotropic substances, chemicals and controlled medicines operating without a valid licence.

• Conduct audits on controlled medicines.

CAWANGAN PELESENAN | LICENSING BRANCH • Memproses lesen/permit/kebenaran merangkumi

aktiviti penjualan, penggunaan, pengimportan dan pengeksportan bagi racun, dadah berbahaya, bahan psikotropik, bahan terkawal dan bahan kimia prekursor.

• Menjalankan pemeriksaan ke atas premis yang dilesenkan di bawah Akta yang dikuatkuasakan.

• Menyelaras dan memantau aktiviti saringan dan pemeriksaan pengimportan produk dan bahan-bahan yang dikawal di pintu-pintu masuk Kastam.

• Menyelaras dan memantau aktiviti pelesenan dan pemeriksaan di Cawangan Penguatkuasa Farmasi Negeri.

• Processing licences/permits/authorizations which cover the activity of sale, use, import and export of poisons, dangerous drugs, psychotropic substances, controlled substances and chemical precursors.

• Conduct inspection on the premises licenced under the acts in force.

• Co-ordinate and monitor screening and inspection activities on imported products and controlled substances at the entry points.

• Co-ordinate and monitor licensing and inspection activities at the state level.

CAWANGAN PERUNDANGAN | LEGISLATIONS BRANCH • Menjalankan dan mengawalselia aktiviti penggubalan

undang-undang melibatkan pewartaan, pindaan, kemaskini senarai racun dan pelantikan pegawai di bawah Akta-akta yang dikuatkuasakan.

• Memproses pengecualian khas bagi pengimportan keluaran tidak berdaftar bagi institusi kerajaan, swasta, pusat-pusat pengajian tinggi dan makmal-makmal penyelidikan.

• Memantau perjalanan aktiviti siasatan bagi kes-kes berkaitan keluaran farmaseutikal, racun dan bahan kimia yang dikawal di bawah Akta-akta yang dikuatkuasakan.

• Mengendalikan pendakwaan dan perbicaraan kes-kes di mahkamah berdasarkan Akta-akta yang dikuatkuasakan.

• Conduct and regulate the activities of legislations involves gazette, amendments, updates the list of poisons and appointment of officers under the acts in force.

• Process the application for special exemptions to import unregistered products received from government institutions, the private sector, institute of higher learning and research laboratories.

• Monitor the progress of inspection activities which involve pharmaceutical products, poisons and chemicals controlled under the acts in force.

• Conduct prosecution in the court in line with the acts in force.


72

CAWANGAN KAWALAN IKLAN | ADVERTISEMENT CONTROL BRANCH • Memproses permohonan kelulusan iklan ubat-ubatan

dan perkhidmatan kesihatan. • Memantau iklan yang disiarkan melalui media cetak

dan elektronik bagi memastikan peruntukan undang-undang sedia ada dipatuhi.

• Menjalankan siasatan bagi kes-kes berkaitan pengiklanan ubat-ubatan dan perkhidmatan perubatan.

• Mengumpul dan menyelaras statistik penguatkuasaan farmasi dan memantau aktiviti berkaitan kualiti dan inovasi penguatkuasaan farmasi.

• Menyelaras perancangan aktiviti dan latihan penguatkuasaan farmasi.

• Process the applications of products and medical services advertisements.

• Monitor advertisements advertised in the printed and electronic media to ensure compliance with the existing rules and legislations.

• Conduct investigation on cases involving advertisements of products and medical services.

• Compile and co-ordinate enforcement statistics as well as monitor the activities involving quality and innovation of Enforcement Pharmacy.

• Planning and co-ordinate the activities and training of Enforcement Pharmacy.

CAWANGAN KAWALAN FARMASEUTIKAL & PERLINDUNGAN PENGGUNAPHARMACEUTICAL CONTROL & CUSTOMER PROTECTION BRANCH • Menyelaras dan mengawalselia aktiviti meningkatkan

kesedaran pengguna mengenai penggunaan ubat-ubat berdaftar.

• Menyelaras dan memantau aktiviti kajian dan pembangunan (R&D) berkaitan penguatkuasaan farmasi.

• Menganalisa sampel-sampel produk yang terdapat di pasaran, yang disyaki melanggar peruntukan undang-undang yang dikuatkuasakan.

• Mengendalikan aduan berkaitan produk dan aktiviti penguatkuasaan farmasi.

• Menyedia dan menerbitkan bahan-bahan untuk kegunaan kempen berkaitan penguatkuasaan farmasi.

• Co-ordinate and monitor the activities to increase the consumer awareness regarding the usage of registered products.

• Co-ordinate and monitor Pharmacy Enforcement research and development activities (R&D).

• Conduct analysis on the sample of products available in the market, which is suspected of infringing the legal provisions in force.

• Handling complaints and enforcement activities related to pharmaceutical products.

• Prepare and publish materials related to the campaign for the Enforcement Pharmacy.


73

LEMBAGA IKLAN UBAT (LIU)MEDICINE ADVERTISEMENT BOARD (MAB) Lembaga Iklan Ubat (LIU) ditubuhkan di bawah Peraturan 2, Peraturan-peraturan Lembaga Iklan Ubat 1976. Urusetia LIU berperanan dalam memproses permohonan iklan ubat–ubatan. Selain itu, LIU juga memproses iklan-iklan perkhidmatan perubatan yang diberikan oleh hospital swasta, klinik swasta, klinik radiologi swasta dan makmal perubatan swasta. Ini bagi memastikan maklumat yang terkandung dalam iklan adalah fakta yang betul dan boleh disahkan. Ia tidak boleh keterlaluan,palsu,mengelirukan atau memperdayakan.

Bagi tahun 2016, LIU telah bermesyuarat sebanyak lima kali dan statistik seperti di Jadual 1 adalah jumlah iklan yang telah diproses sepanjang tahun 2016 dan Jadual 2 menunjukkan jumlah iklan yang telah diluluskan bagi tempoh 2013-2016.

Medicine Advertisement Board (MAB) was established under Regulation 2 of the Medicine Advertisements Board Regulations 1976. The MAB Secretariat plays a role in the processing of medicines advertisement. In addition, MAB also processes advertisements of medical services provided by private hospitals, private clinics, private radiology clinics and medical laboratories. This is to ensure that the information contained in the ad is accurate and verifiable. It should not be exaggerated, false, misleading or deceptive.

For 2016, MAB met five times and statistics provided in Table 1 is the number of advertisements that were processed during 2016 and Table 2 shows the number of advertisements that have been approved for the period 2013-2016.


Jadual 1: Permohonan Iklan untuk Tahun 2016.Table 1: Advertising Application for the Year 2016.

KeteranganCriteria

Permohonan Diterima

Application Received

DiluluskanApproved

Tidak Diluluskan

Not Approved

Tidak Perlu

KelulusanDoes Not Require

Approval

Permohonan Terbatal (Selepas Pemohon

Gagal Membuat Susulan ke Atas

Pertanyaan)Application Canceled (After the Applicant

Failed to Follow Up on the Question)

Yuran Dikumpul

(RM)Fee collected

(RM)

Iklan Produk UbatMedicines Advertisement

2,034 1,936 8 18 72 203,400

Iklan Perkhidmatan PerubatanMedical Services Advertisement

892 816 8 21 47 89,200

Jumlah | Total 2,926 2,752 16 39 119 292,600


74

Jadual 2: Kelulusan Iklan bagi Tahun 2013–2016.Table 2: Approved Advertisements for the Year 2013–2016.

Keterangan/Tahun | Criteria/Year 2013 2014 2015 2016

Jumlah permohonanTotal applications

2,562 2,735 2,739 2,752

Jumlah permohonan yang diproses dalam tempoh piagam pelangganTotal applications processed within client charter

2,317 2,594 2,466 2,321

Jumlah permohonan yang diproses di luar tempoh piagam pelangganTotal applications processed exceed client charter

245 141 273 431

Peratusan kelulusan permohonan dalam tempoh piagam pelanggan (Sasaran >90%)Percentage of approved advertisements within client charter (Standard >90%)

90.4% 94.8% 90.0% 84.34%

Mesyuarat LIU 1/2016 pada 19 Februari 2016 dipengerusikan oleh KPK YBhg Datuk Dr Noor Hisham Abdullah.MAB 1/2016 meeting on 19th February 2016 chaired by Director-General of Health YBhg Datuk Dr Noor Hisham Abdullah.

Mesyuarat LIU 1/2016 pada 19 Februari 2016 sedang berlangsung.LIU meeting 1/2016 on 19 February 2016 is being held.


75

Jadual 3: Jumlah Saringan Iklan yang Telah Dilakukan Sepanjang Tahun 2016 di BPF,KKM.Table 3: The Number of Ads That Have Been Monitored for the Year 2016 by PSD,MOH.

Iklan Media Cetak yang Disaring

Screened Ads in Print Media

Saringan InternetScreened Ads in the Internet

Saringan Media ElektronikScreened Ads in Electronic

Media (Programme/Talkshow/ Jingle Ads)

Jumlah SaringanNumber of ads screened

6,086 999 1,245

Jadual 4: Tindakan Iklan Keseluruhan Sepanjang Tahun 2016 di BPF,KKM.Table 4: Overall Number of Actions Taken in Year 2016 by PSD,MOH.

Peringatan/Amaran

Reminder/Warning

Tindakan Undang-undang

(Rujuk CPF Negeri)Legal Action

(Refer to CPF)

Rujuk Agensi Lain/ Cawangan Perisikan

& OperasiRefer to Other Agency

or Intelligence &Operation Branch

Tindakan Lain (Pemakluman/

Nasihat)Others Action

(Informed/Advisory)

JumlahTotal

251 28 285 4 568

PEMONITORAN IKLAN UBATMEDICINES ADVERTISEMENT MONITORINGPenyaringan iklan ubat dijalankan secara proaktif dan berkala ke atas pelbagai medium terutama melibatkan media nasional yang telah dikenalpasti oleh Cawangan Kawalan Iklan. Media yang terlibat ialah seperti akhbar, majalah, televisyen, radio, internet dan lain-lain. Selain itu, saringan juga dijalankan secara reaktif melalui maklumat atau aduan yang diterima daripada orang awam.

Penyaringan turut dijalankan di peringkat negeri oleh Unit Iklan di Cawangan Penguatkuasa Farmasi Negeri (CPF) yang memberi fokus kepada iklan-iklan ubat di peringkat tempatan.

Tujuan penyaringan iklan dijalankan ialah bagi memastikan semua iklan berkaitan perubatan yang dikawalselia di bawah Akta Ubat (Iklan dan Penjualan) 1956 adalah mematuhi undang-undang dan peraturan ini. Di samping itu, ia juga dapat memastikan maklumat dan informasi yang tepat sahaja yang disiarkan didalam iklan-iklan tersebut seterusnya memberi manfaat kepada pengguna untuk membuat pilihan.

Medicines Advertisement Monitoring is conducted regularly and proactively especially on the leading national media such as newspapers, magazines, television, radio, internet and others. In addition to that, reactive advertisement monitoring is also conducted whenever there is a complaint or intel from the public. Besides, local media advertisements monitoring has also been carried out at the state level by the Cawangan Penguatkuasaan Farmasi Negeri (CPF).

The objective of the advertisement monitoring is to ensure that all medical advertisements are compliant with the Medicines (Advertisement & Sale) Act 1956. Furthermore, the goal is to help consumers make choices based on accurate and reliable information with regards to medicine and medicinal related services.


76

LEMBAGA RACUN | POISONS BOARDLembaga Racun, selaku lembaga penasihat telah diberi kuasa untuk menjalankan penilaian terhadap pengkelasan ubat/bahan kimia dan seterusnya menasihati Menteri mengikut peruntukan-peruntukan yang terkandung di bawah Akta Racun 1952. Ahli lembaga yang telah bermesyuarat bagi kali ke-82 pada 21 Jun 2016 dan kali ke-83 pada 28 November 2016 memutuskan perkara-perkara seperti berikut:

The Poisons Board served as an advisory board, authorised to evaluate the classification of medicines / chemical substances and thereby to advise the Minister in accordance with the provisions stipulated under the Poisons Act 1952. The Board met for the 82nd meeting on 21st June 2016 and 83rd meeting on 28th November 2016 to decide on the followings:

i. PENGKELASAN BAHAN KIMIA BARU | CLASSIFICATION OF NEW POISONSAhli lembaga telah bersetuju dengan pengkelasan bahan kimia baru seperti yang dinyatakan dalam jadual di bawah:

The Board has agreed with the classification of new chemicals as shown in the table below:

Bil. Nama Ubat/Bahan Kimia Kumpulan 1 Pembrolizumab B2 Cerebrolysin B3 Panobinostat B4 Nivolumab B5 Silodosin B6 Luseogliflozin B7 Lenvatinib B8 Pirfenidone B9 Fimasartan B10 Pomalidomide B11 Umeclidinium B12 Palbociclib B13 Vedolizumab B14 Levetiracetam B15 Blinatumomab B16 Olaparib B17 Aclidinium bromide B18 Ezetimibe B19 Darifenacin C20 Pitavastatin calcium B21 Idarucizumab B22 Tetracaine B23 Toksin botulinum B24 Simeprevir B25 Citicoline B26 Alirocumab B27 Evolocumab B28 Ramucirumab B29 Cobimetinib B30 Cimicoxib B31 Rufinamide B32 Imidafenacin C33 Eptacog alpha B34 Afoxolaner B35 Gadolinium Based Contrast

Agents (GBCA)B

36 25B-NBoMe B dan bahan psikotropik

B and psychotropic

substance

37 25C-NBOMe B dan bahan psikotropik

B and psychotropic

substance

38 25I-NBOMe B dan bahan psikotropik

B and psychotropic

substance

39 AM-2201 (JWH-2201) B dan bahan psikotropik

B and psychotropic

substance

40 JWH-018 (AM-678) B dan bahan psikotropik

B and psychotropic

substance

41 3,4-Methylenedioxypyrovalerone (MDPV)

B dan bahan psikotropik

B and psychotropic

substance

42 Mephedrone B dan bahan psikotropik

B and psychotropic

substance

43 Methylone (3,4-Methylenedioxymethcathinone)

B dan bahan psikotropik

B and psychotropic

substance

44 N-Benzylpiperazine (BZP) B dan bahan psikotropik

B and psychotropic

substance


77

Selain itu, ahli lembaga juga telah memutuskan untuk mengawal produk bukan racun dalam bentuk suntikan sebagai Racun Kumpulan C di bawah Akta Racun 1952.

Besides, The Board has decided to control the non-poison parenteral products as Group C Poisons under the Poisons Act 1952.

ii. PENGKELASAN SEMULA RACUN | POISON RE-CLASSIFICATIONa. Memberikan pengecualian ke atas persediaan

makanan, ubat dan kosmetik yang mengandungi phosphorus daripada kawalan sebagai racun.

b. Memberikan pengecualian kepada Arbutin yang digunakan di dalam formulasi kosmetik bernotifikasi daripada kawalan sebagai racun di bawah butiran Hydroquinone.

c. Mengkelaskan Mitragynine sebagai Racun Kumpulan A bagi “All preparations unless in Group D” dan sebagai Racun Kumpulan D bagi “Preparations for laboratory use” dalam Jadual Pertama Akta Racun 1952.

a. Exemptions as poison for food, medicine and cosmetic preparations containing phosphorus.

b. Exemptions as poison for Arbutin used in notified cosmetic formulations classified under Hydroquinone.

c. Reclassification of Mitragynine as Group A Poison for “All preparations unless in Group D” and as Group D Poison for “Preparations for laboratory use”.


78


Bahagian Penguatkuasaan Farmasi telah mengadakan Persidangan Penguatkuasaan Undang-undang Inter-agensi Kebangsaan 2016 pada 5 hingga 8 September 2016 di Hotel Adya, Langkawi, Kedah. Persidangan ini dirasmikan oleh Dato’ Dr Haji Azman bin Haji Abu Bakar, Pengarah Bahagian Perkembangan Perubatan mewakili Yg Berhormat Timbalan Menteri Kesihatan.

Tema persidangan ini adalah ‘’Rangka Kerja Penguatkuasaan: Memerangi Penjualan Ubat Dalam Talian”.

Objektif-objektif persidangan adalah:1. Untuk mendapatkan gambaran mengenai perubahan

peraturan terbaru di kalangan agensi.2. Memperkukuhkan jalinan kerjasama dalam aktiviti

penguatkuasaan terhadap jenayah farmaseutikal di rantau Asia-Pasifik dan untuk mendapatkan gambaran tentang perubahan dalam peraturan dan penguatkuasaan dalam kalangan agensi.

3. Untuk membangunkan dan berkongsi kepakaran bagi mendapatkan kaedah yang paling berkesan dalam memerangi jenayah farmaseutikal.

4. Menggalakkan perkongsian pelbagai agensi antara penguatkuasaan farmasi bahagian, polis dan kastam serta agensi-agensi yang mengambil bahagian.

Persidangan Penguatkuasaan Inter-Agensi Kebangsaan 2016 telah dihadiri oleh 115 orang peserta. Peserta terdiri daripada pegawai-pegawai penguatkuasaan dari Bahagian Keselamatan dan Kualiti Makanan, Polis DiRaja Malaysia, Maritim Malaysia, penyertaan dari pihak regulatori dari Indonesia dan Filipina. Persidangan ini merupakan satu platform penting untuk mewujudkan rangkaian kerjasama antara pegawai-pegawai penguatkuasaan farmasi dengan agensi-agensi penguatkuasaan dalam dan luar negara.

Perkongsian pengalaman dan isu dibincangkan dalam 3 sesi plenari. Antara isu yang dibincangkan adalah:1. Pendekatan agensi antarabangsa dalam siasatan

internet.2. Kerjasama dalam menangani isu jenayah siber

farmaseutikal.3. Peranan undang-undang di Malaysia.

PERSIDANGAN PENGUATKUASAAN INTER-AGENSI KEBANGSAAN 2016NATIONAL LAW ENFORCEMENT INTER-AGENCY CONFERENCE 2016

The National Law Enforcement Inter-Agency Conference was held on 5th to 8th September 2016 at Adya Hotel, Langkawi, Kedah. This conference was officiated by Honourable Dato’ Dr Haji Azman bin Haji Abu Bakar, Director of Medical Development Division, representing the Deputy Minister of Health.

The theme of this year conference was ‘Enforcement Framework: Combating Illicit and Illegal Online Sales of Medicines’

The objectives of the conference are:1. To have an overview of the recent regulatory changes

among agencies.2. To strengthen collaboration in enforcement activities

concerning pharmaceutical crime in the Asia-Pacific region.

3. To develop and share expertise in combating pharmaceutical crime.

4. To promote a multi-agency partnership approach between pharmacy enforcement division, police, customs and in participating agencies.

National Law Enforcement Inter-Agency Conference 2016 was attended by 115 participants for examples officials from Food Safety and Quality Division, Royal Malaysian Police, Malaysian Maritime and delegates from Indonesia and Philippines regulators. This conference served as a platform to share experiences and enhance collaborations between local and foreign enforcement agencies.

Knowledge sharing and issues were discussed in three plenary sessions. Among the topics discussed were:1. Internet investigation: international approach.2. Pharmaceutical cybercrime: collaboration.3. The role of Malaysian’s law.


79

Persidangan ini diakhiri dengan pencapaian beberapa resolusi yang dipersetujui sebagaimana berikut:

RESOLUSI 1Untuk mewujudkan peraturan-peraturan bagi penjualan produk Farmaseutikal dalam talian. Cadangan untuk menggubal Peraturan-peraturan baru di bawah Akta Racun 1952 bagi urus niaga elektronik produk farmaseutikal.

RESOLUSI 2Penguatkuasaan Farmasi dicadangkan untuk mengeluarkan pensijilan untuk perniagaan farmasi dalam talian dan juga premis Farmasi yang menyediakan perkhidmatan farmasi dalam talian.

RESOLUSI 3Memperkukuhkan pemantauan penjualan ubat-ubatan secara atas talian yang melanggar peruntukan undang-undang oleh Seksyen Inteligens dan Forensik Siber (CiFORS).

RESOLUSI 4Mengukuhkan kerjasama dan perkongsian dengan semua pihak yang berkepentingan dalam memerangi jenayah siber farmaseutikal

RESOLUSI 5Latihan teknikal secara komprehensif oleh jurulatih kompeten/agensi siasatan jenayah siber dan juga cadangan untuk pegawai menjalani latihan sangkutan di makmal jenayah siber yang ditubuhkan dalam negara dan di peringkat antarabangsa.

RESOLUSI 6Kesedaran awam mengenai risiko membeli ubat-ubatan dalam talian melalui elektronik media-tv, radio dan media sosial seperti facebook, instagram, twitter dan lain-lain. Penglibatan yang berterusan dengan pihak berkepentingan menerusi dialog, forum dan latihan.

The conference ended with the achievement of several resolutions as follows:

RESOLUTION 1To set rules and regulations for online pharmacies. New regulations under poisons act 1952 on electronic transactions are suggested to be enacted.

RESOLUTION 2Enforcement to issue certification for genuine online pharmacies websites and established physical pharmacies providing online pharmacy services.

RESOLUTION 3Strengthening online monitoring of illegal websites and social media selling illicit medicines. This activity will be done by special cyber unit or section (CiFORS)

RESOLUTION 4Strengthening collaboration and partnership with all players in combating pharmaceutical cybercrime:

RESOLUTION 5Comprehensive technical training by a competent trainers/agencies on cybercrime investigation. It is suggested for officers to have an attachment at established cybercrime lab locally and internationally.

RESOLUTION 6Public awareness of the risk of purchasing medicines online through electronic media-tv, radio and social media such as Facebook, Instagram, Twitter, etc. Continuous engagement with stakeholders through dialogues, forum, training.


80

Upacara perasmian persidangan. | Conference opening ceremony.

Sesi bergambar pada hari perasmian. | Photo session during the opening ceremony.


81

Sesi forum bersama agensi swasta dan luar negara. | Forum session with the private and international agencies.

Peserta persidangan semasa sidang plenari. | Participants during the plenary session.


82

Bagi meningkatkan keberkesanan dalam mengawalselia iklan-iklan perubatan, pelbagai sesi dialog dan kerjasama serta lawatan kerja bersama-sama agensi berkepentingan lain seperti Pihak Berkuasa Tempatan, Lembaga Penapisan Filem, pihak media dan persatuan telah diadakan. Secara keseluruhan, sebanyak 41 sesi dialog dan engagement telah dihadiri oleh para pegawai di Cawangan kawalan Iklan sepanjang tahun 2016.i. Kerjasama dengan Pihak Berkuasa Tempatan diadakan

dengan memberi fokus kepada ‘Membanteras Iklan 3B Haram’ iaitu ‘Bunting, Banner, Billboard’. Aktiviti ini dijalankan di seluruh negara dan turut melibatkan pegawai dari Ibu Pejabat yang turut serta di lapangan.

SESI DIALOG DAN LAWATAN KERJA BERSAMA AGENSI BERKEPENTINGAN DIALOGUE SESSION AND WORKING VISIT WITH STAKEHOLDERS

In order to enhance the effectiveness in controlling medical advertisement, the Pharmacy Enforcement Department has taken the initiative to organise dialogues and engagement session with local authorities throughout the country, media companies and advertising associations. In conjunction to this, a visit to the Film Censorship Board has also been conducted. Overall, 41 dialogues and engagement sessions have been organised throughout the year 2016.i. Joint operations with local authorities in removing

illegal medical related advertisements (3B - Bunting, Banner and Billboard) was conducted throughout the country starting in the year 2016.

Aktiviti menurunkan iklan perubatan haram bersama-sama PBT yang diadakan di Melaka pada 16 Mac 2016.Joint operation with local authority in curbing illegal advertisement in Melaka was carried out on 16 March 2016.


83

ii. Dialog dengan pihak media telah diadakan dengan memberi penerangan dan mengadakan sesi soal jawab bersama-sama pihak media supaya dapat membantu meningkatkan kefahaman media dalam kawalan iklan perubatan.

ii. A dialogue session with the media has been carried out to disseminate information about the importance of good control of medicine related advertisement.

Dialog dengan stesyen televisyen berkenaan penyiaran iklan dalam segmen tajaan pada 15 November 2016.A dialogue session with the television stations had been conducted on 15th November 2016 which focuses on the

medicines related advertisement broadcast during sponsored segments.

Sesi dialog dengan Advertising Standards Authority Malaysia pada 23 Februari 2016.A dialogue with Advertising Standards Authority Malaysia was held on 23 February 2016.

iii. Dialog dengan persatuan agensi pengiklanan dan penyedia platform atas talian diadakan bagi memberi penerangan berkenaan kawalan iklan perubatan.

iii. A dialogue session with the advertising associations and the online platform providers has been organised to help them improve their knowledge in the control of medical related advertisement.


84

Sesi dialog bersama-sama penyedia platform atas talian pada 23 Mei 2016.A dialogue session with the online platform providers was held on 23 May 2016.

Lawatan kerja ke Lembaga Penapisan Filem pada 22 Mac 2016.Courtesy Visit to the Film Censorship Board on 22 March 2016.

iv. Lawatan kerja ke Lembaga Penapisan Filem turut diadakan bagi meningkatkan kerjasama dalam kawalan iklan perubatan disamping meningkatkan kefahaman proses kerja antara agensi.

iv. A visit to the Film Censorship Board was organised to enhance the collaboration in control of medicines advertisement and improving the understanding between the agencies.


85

DIALOG BERSAMA DENGAN SYARIKAT PENGEDAR UBAT-UBATAN (BAHAN TERKAWAL) DIALOGUE WITH DRUG DISTRIBUTORS (CONTROLLED SUBSTANCES)

Dialog bersama dengan syarikat pengedar ubat-ubatan (bahan terkawal) dan wakil industri farmaseutikal telah diadakan pada 3 Mei 2016 dan 7 Oktober 2016 di Bahagian Perkhidmatan Farmasi, KKM. Kedua-dua dialog ini telah melibatkan jumlah seramai 80 orang peserta termasuk wakil daripada semua Cawangan Penguatkuasaan Farmasi Negeri.

Dialog ini diadakan adalah bertujuan untuk meningkatkan interaksi dan kerjasama di antara Bahagian Penguatkuasaan Farmasi dengan syarikat-syarikat pengedar dan pihak industri farmaseutikal. Sesi dialog ini merupakan satu platform untuk menerangkan peraturan dan polisi berkaitan pelesenan serta mendapatkan input daripada semua pihak yang terlibat. Antara isu-isu yang telah dibincangkan termasuk isu-isu berkaitan syarat khas ke atas Lesen Racun Jenis A, pengendalian bahan terkawal, kuota bahan terkawal, penstoran racun dan hal-hal lain seperti penyelarasan format pelaporan transaksi pembekalan bahan terkawal.

Two dialogues with drugs distributors (controlled substances) and pharmaceutical industries were held at Pharmaceutical Services Division, MOH on May 3, 2016 and October 7, 2016. Both dialogues were attended by almost 80 participants, included representatives from all the State Pharmacy Enforcement Branches.

The main objective of these dialogues is to improve the interaction and cooperation between Pharmacy Enforcement Division and the distributor companies and pharmaceutical industries. It acts as a platform to make clear the rules and policies related to licensing and also to get input from all parties involved. Among the issues that have been discussed includes special terms and conditions of Type A Licence, regulation and quota of controlled substances, storage of poisons and other issues such as the coordination of monthly reporting format for supply transactions of controlled substances.


86

LAWATAN KERJA PINTU MASUK OLEH PENGARAH PENGUATKUASAAN FARMASI, KEMENTERIAN KESIHATAN MALAYSIAOFFICIAL VISIT TO ENTRY POINTS BY THE DIRECTOR OF PHARMACY ENFORCEMENT DIVISION, MINISTRY OF HEALTH


87

Lawatan kerja Pintu Masuk oleh Pengarah Penguatkuasaan Farmasi, Kementerian Kesihatan Malaysia (KKM) bersama pegawai-pegawai dari Bahagian Penguatkuasaan Farmasi, KKM telah diadakan di pintu masuk – pintu masuk terpilih di Malaysia. Tujuan program ini adalah untuk meninjau pelaksanaan aktiviti penyaringan dan pemeriksaan pengimportan di pintu masuk dan cabaran-cabaran yang dihadapi oleh pegawai penguatkuasa farmasi yang bertugas di lapangan.

Terdapat 6 (enam) pintu masuk yang telah dilawati oleh Pengarah Penguatkuasaan Farmasi sepanjang tahun 2016 iaitu:1. Pintu masuk Pulau Pinang, Kedah dan Perlis pada 18-

19 Mei 2016.2. Pelabuhan Klang di Selangor pada 1 Jun 2016.3. Pintu Masuk Johor pada 19 Julai 2016.4. Pintu Masuk Wilayah Persekutuan Labuan dan

Sarawak pada 18-19 Ogos 2016.5. Pintu Masuk Sabah pada 17 Oktober 2016.6. KLIA, Selangor pada 15 Disember 2016.

Lawatan kerja di setiap pintu masuk ini mendapat penerangan daripada pegawai-pegawai farmasi dan pegawai Jabatan Kastam Diraja Malaysia (JKDM) yang bertugas semasa lawatan kerja dijalankan. Daripada lawatan kerja ini menunjukkan kerjasama yang baik telah diberikan oleh pihak JKDM dalam membantu pegawai CPF menjalankan saringan dan pemeriksaan ke atas bagasi/bungkusan/konsaimen yang terlibat dalam pengimportan. Kerjasama yang baik ini penting kerana pihak farmasi hanya bertindak sebagai penasihat teknikal kepada pihak JKDM dalam kawalan pengimportan di pintu masuk Negara.

Official visits by the Director of Pharmacy Enforcement Division, Ministry of Health (MOH) and officers from Pharmacy Enforcement Division, MOH was held at the selected entry points in Malaysia. The purposes of these visits were to observed the implementation of the screening and inspection activities of the importation procedures at the entry points, and the challenges faced by law enforcement officers who served there.

Six (6) entry points were visited in 2016, namely:1. Entry Point of Penang, Kedah and Perlis on 18-19 May

2016.2. Port Klang in Selangor on June 1, 2016.3. Entry Point of Johor on July 19, 2016.4. Entry Point of Federal Territory of Labuan and

Sarawak on 18-19 August 2016.5. Entry Point of Sabah on October 17, 2016.6. KLIA, Selangor on 15 December 2016.

During the official visits, the officers were briefed by the pharmacy enforcement officers and also officers from the Royal Malaysian Customs (RMC). Good cooperation was given by the RMC to the pharmacy enforcement officers at the entry point, in terms of assisting them to do screening on luggage, parcels and consignments. This cooperation is essential, as the pharmacy enforcement only acts as the technical advisor to the RMC at the entry point.


88

SESI PEMAKLUMAN KEPUTUSAN KEMENTERIAN KESIHATAN MALAYSIA BERKAITAN DASAR RANG UNDANG-UNDANGBRIEFING SESSION OF THE MINISTRY OF HEALTH’S DECISION ON THE PHARMACY BILL

Satu sesi pemakluman keputusan Kementerian Kesihatan Malaysia berkaitan dasar Rang Undang-undang Farmasi (RUUF) kepada Stakeholders yang dipengerusikan oleh Ketua Pengarah Kesihatan telah diadakan pada 9 Mei 2016 bertempat di Dewan Serbaguna Aras 8, Blok E7, Kementerian Kesihatan Malaysia, Putrajaya. Tujuan sesi ini diadakan adalah untuk membentangkan keputusan KKM terhadap isu-isu dasar tertentu RUUF yang tidak mendapat persetujuan pihak berkepentingan semasa mesyuarat RUUF bersama stakeholders yang telah diadakan pada 30 November hingga 4 Disember 2015.

Seramai dua ratus (200) orang wakil daripada pelbagai pihak berkepentingan yang terdiri daripada wakil-wakil profesion farmasi, perubatan, profesion lain berkaitan dengan perubatan, persatuan industri farmaseutikal, persatuan pengguna dan juga Kementerian lain telah dijemput untuk menghadiri sesi pembentangan ini.

Sejumlah maklum balas dan cadangan telah diberikan terhadap setiap keputusan dasar RUUF yang dibentangkan oleh Pengarah Penguatkuasa Farmasi dan sesi pemakluman ini diakhiri dengan rumusan oleh Ketua Pengarah Kesihatan. Susulan daripada sesi pemakluman ini, satu mesyuarat bersama YB Menteri Kesihatan untuk membincangkan maklum balas dan cadangan berkaitan telah diadakan pada 13 Jun 2016.

A briefing session of the Ministry of Health’s decision on the Pharmacy Bill (RUUF) to the stakeholders chaired by the Director General of Health was held on the 9th May 2016 at the Dewan Serbaguna, Level 8, Block E7, Ministry of Health, Putrajaya. The objective of this session was to update the stakeholders of the ministry’s decision on certain policies in the bill which none consensus was reached among the stakeholders during the meeting of the RUUF with the stakeholders that was held on 30th November to 4th December 2015.

A total of two hundred (200) stakeholders were represented from the pharmacy profession, medical professions, and other health-related professions, pharmaceutical industry associations, consumer associations and other ministries who has been invited to attend this session.

A number of feedbacks and suggestions have been given to every decision pertaining to the RUUF policies presented by the Director of Pharmacy Enforcement Division and the briefing session was ended with a summary by the Director General of Health. Following this session, a meeting with the Minister of Health to discuss the feedbacks and suggestions given was held on 13th June 2016.

Dari kiri ke kanan: Pengarah Penguatkuasaan Farmasi, Pengarah Kanan Perkhidmatan Farmasi, Ketua Pengarah Kesihatan, Timbalan Ketua Pengarah Kesihatan (Penyelidikan dan Sokongan Teknikal) dan Penasihat Undang-

undang.From left to right: Director of Pharmacy Enforcement Division, Senior Director of Pharmacy Services, Director General

of Health, Deputy Director-General of Health (Research and Technical Support) and Legal Adviser.


89

BENGKEL PEMURNIAN RANG UNDANG-UNDANG FARMASI (RUUF) BERSAMA PENASIHAT UNDANG-UNDANG, KEMENTERIAN KESIHATAN MALAYSIAWORKSHOP TO HARMONIZE THE PHARMACY BILL (RUUF) TOGETHER WITH LEGAL ADVISOR, MINISTRY OF HEALTH

Satu bengkel pemurnian Rang Undang-undang Farmasi (RUUF) bersama dengan Penasihat Undang-undang, Kementerian Kesihatan Malaysia (KKM) telah diadakan selama empat (4) hari bermula dari 5 Disember hingga 8 Disember 2016 bertempat di Hotel Avillion Admiral Cove, Port Dickson. Seramai enam puluh lima (65) orang peserta dari setiap bahagian di bawah Program Perkhidmatan Farmasi, Cawangan Penguatkuasaan Farmasi Negeri, Agensi Farmaseutikal Farmasi Negara, Bahagian lain KKM, Peguam Kanan KKM serta agensi penguatkuasaan dari Kementerian lain telah dijemput untuk menghadiri bengkel ini.

Tujuan bengkel ini diadakan adalah untuk memurnikan draf RUUF agar selaras dengan dasar yang telah dimuktamadkan oleh Kementerian Kesihatan dan seterusnya menyediakan draf untuk dikemukakan kepada Jabatan Peguam Negara.

Sejumlah maklum balas dan cadangan telah dibentangkan di akhir bengkel kepada pihak pengurusan tertinggi Bahagian Perkhidmatan Farmasi dan secara keseluruhan, objektif bengkel ini telah dicapai dengan jayanya.

Semua maklum balas dan cadangan yang diberikan akan dikaji dan beberapa mesyuarat dan sesi perbincangan susulan dengan pihak yang berkaitan dirancang untuk diadakan bagi memastikan draf RUUF selaras dengan dasar Kementerian sebelum dikemukakan kepada Jabatan Peguam Negara.

A workshop to harmonize the Pharmacy Bill (RUUF) together with the Legal Advisor to the Ministry of Health (MOH) was held for four (4) days starting from 5th December to 8th December 2016 at Avillion Admiral Cove Hotel, Port Dickson. A total of sixty five (65) participants from each division of the Pharmacy Services Programme, State Pharmacy Enforcement Branch, National Pharmaceutical Regulatory Agency, other Divisions of MOH, Senior Federal Counsel of MOH as well as enforcement agencies from other ministries were invited to attend this workshop.

The objective of this workshop is to harmonise the RUUF draft with the policies that have been finalized by the MOH and subsequently prepare a draft to be submitted to the Attorney General’s Chambers.

A number of feedbacks and suggestions were presented to the top management of the Pharmacy Services Programme at the end of the workshop and the overall objective of the workshop was successfully achieved.

All feedbacks and suggestions given will be studied and several follow-up meetings and discussions with the relevant parties will be held to ensure that the RUUF draft is in line with ministry’s policies prior to submission to the Attorney General’s Chambers.

Perbincangan dalam kumpulan semasa bengkel.Group discussion during the workshop.


90

AUDIT SILANG HOSPITAL & KLINIK KESIHATAN KKMCROSS AUDIT IN HOSPITAL & HEALTH CLINIC, KKM

Audit ini dijalankan berikutan aduan-aduan yang diterima berkenaan penemuan ubat-ubatan Kementerian Kesihatan Malaysia (KKM) dijual di premis farmasi-farmasi swasta. Pemeriksaan audit ke atas fasiliti KKM dijalankan oleh Pegawai Penguatkuasa Farmasi untuk memeriksa sama ada tatacara dan prosedur pengendalian ubat-ubatan bermula dari proses penerimaan, penyimpanan, pembungkusan, pengeluaran dan pembekalan/pendispensan ubat di beberapa buah fasiliti terpilih adalah mengikut garispanduan dan peraturan yang ditetapkan di bawah perundangan farmasi yang berkuatkuasa.

Sebanyak 30 fasiliti Kementerian Kesihatan Malaysia (KKM) yang terdiri dari hospital dan klinik kesihatan Malaysia telah dipilih untuk diaudit. Audit tersebut melibatkan Stor Farmasi Utama yang merangkumi pesakit dalam, Farmasi pesakit luar, Farmasi satelit dan lain-lain unit/sub stor farmasi

Hasil audit mendapati sebanyak 26 fasiliti (86.7%) di mana kemudahan penstorannya samada stor utama/farmasi unit/sub stor farmasi TIDAK MEMATUHI keperluan prosedur/garispanduan dan peraturan yang dikeluarkan. Sebanyak 24 fasiliti [80.0%] mempunyai rekod/dokumen penerimaan dan pengeluaran ubat-ubatan samada di stor farmasi utama/farmasi unit/sub stor farmasi yang TIDAK MEMATUHI keperluan prosedur/garispanduan dan peraturan yang dikeluarkan dan sebanyak 10 fasiliti

The audit was conducted after receiving complaints that Ministry of Health medications were being sold at retail pharmacies. Audit inspection conducted by pharmacy enforcement officers to check whether the procedures of drugs control starting from receiving, storage, packaging, production and supply/dispensing at selected facilities comply to with the guidelines and regulations.

A total of 30 facilities the Ministry of Health (MOH), which consists of hospitals and health clinics Malaysia were selected for the audit. The audit involves Main Pharmacy Store, including Inpatient Pharmacy, Outpatient Pharmacy, Satellite Pharmacy and other unit/sub-store pharmacy.

The results of the audit showed that a total of 26 facilities (86.7%) with either the main stores/pharmacy unit/sub-store pharmacies DOES NOT COMPLY to the procedures/guidelines and regulations. A total of 24 facilities (80.0%) has a record/document of receiving and and issuing medicines from either the main stores/pharmacy unit/sub-store pharmacies DOES NOT COMPLY to the procedures/guidelines and regulations, and a total of 10 facilities (33.3%) does NOT COMPLY with the procedures/guidelines and regulations.

In addition, the audit found no procedures for disposal


91

[33.3%] mempunyai kemudahan penyimpanan ubat-ubatan yang tidak TIDAK MEMATUHI keperluan prosedur/garispanduan dan peraturan yang dikeluarkan di salah satu stor farmasi utama/farmasi unit/sub stor.

Selain itu, hasil audit yang dijalankan mendapati tiada prosedur pelupusan kotak kosong mengandungi hologram Meditag dijalankan di semua fasiliti yang diaudit. Pelupusan kotak-kotak kosong yang mengandungi hologram perlu dijalankan secara teliti untuk mengelakkan penyalahgunaan terhadap hologram tersebut.

of empty boxes containing a MediTag hologram at all facilities that have been inspected. Disposal of empty boxes containing a hologram must be done carefully to avoid misuse of the hologram.

JARINGAN OPERASI ANTARABANGSA OPERATION STORM STORM OPERATION NETWORKOperasi Storm adalah merupakan jaringan operasi antarabangsa yang melibatkan agensi penguatkuasa dari pelbagai negara dan agensi antarabangsa dalam memerangi produk-produk farmaseutikal counterfeit. Operasi ini melibatkan kerjasama agensi penguatkuasa dari negara-negara yang mengambil bahagian seperti pihak kastam, agensi regulatori dadah dan pihak polis. Operasi ini dikoordinasi oleh pihak INTERPOL, World Health Organization (WHO) dan World Customs Organization (WCO) yang mengendalikan mesyuarat perancangan dan program latihan. Objektif utama operasi adalah untuk membanteras aktiviti yang melibatkan pengilangan, pengedaran dan penjualan produk farmaseutikal counterfeit dan tidak sah dari segi undang-undang seperti ubat tidak berdaftar dan kosmetik tidak bernotifikasi. Antara aktiviti utama penguatkuasaan yang dijalankan adalah operasi serbuan, pemeriksaan premis, pemeriksaan pintu masuk, penyiasatan, pemantauan website dan aktiviti kesedaran pengguna.

Untuk tahun 2016, operasi STORM VII telah dijalankan pada 29 Feb–27 Mac 2016. Sepanjang tempoh operasi, pelbagai aktiviti penguatkuasaan telah dijalankan oleh semua cawangan penguatkuasa farmasi negeri dan melibatkan kerjasama agensi penguatkuasa lain seperti pihak Kastam, Polis DiRaja Malaysia (PDRM), Suruhanjaya Komunikasi & Mulltimedia (SKMM), Cyber Security Malaysia. Hasil keseluruhan Operasi Storm VII telah dibentangkan pada Operational Meeting of Storm Enforcement Network pada 19–23 April 2016 di Hanoi, Vietnam. Secara keseluruhan pada Ops Storms VII jumlah rampasan produk/kosmetik yang tidak mematuhi undang –undang adalah sebanyak 3,953,737 unit dengan nilai rampasan sebanyak USD1,697,413. Untuk Ops Storm VII 2016 jumlah rampasan produk meningkat sebanyak 59% berbanding jumlah rampasan untuk Ops Storm VI 2015.

Operation Storm is a multi-country operation combating counterfeit pharmaceuticals. This operation brought together Customs, Drug Regulatory Agencies and the Police of each participating country. In the run-up to the operation, INTERPOL, together with the World Health Organization (WHO) and the World Customs Organization (WCO), coordinated planning meetings and organised training session. The primary objective of the operation is to curb illegal activities involving the manufacture, distribution and sale of counterfeit pharmaceutical products and illegal such as unregistered medicines and cosmetics. Activities which are carried out by enforcement such as raids, inspections of premises, entry point inspection, investigation, websites monitoring and also consumer awareness.

In 2016, STORM VII was carried out on Feb 29 to March 27. During the operation, various enforcement activities conducted by all state pharmacy enforcement branches with the cooperation of other agencies such as the Customs, the Royal Malaysian Police (PDRM), Malaysian Communications and Multimedia Commissions (MCMC), and also CyberSecurity Malaysia. The result of the operation was presented in the Operational Meeting of Storm Enforcement Network on April 19–23, 2016 in Hanoi, Vietnam. Overall, the number of products/cosmetics being seized were 3,953,737 units with the confiscation of USD1,697,413. The number of product increased by 59% compared to the number of product seized in 2015 operation (Storm VI).

Operation Storm VI [2015] Storm VII [2016]

Overall Seized Quantity 2,486,896 Unit 3,953,737 Unit

Estimated Value (USD) USD1,117,930 USD1,697,413


92


93

JAWATANKUASA KERJA PENYELARASAN DAN PEMANTAPAN PENGUATKUASAAN KKM (JKPPP)I. Latihan Pemantapan Aktiviti Penguatkuasaan Agensi Penguatkuasa

Kementerian Kesihatan Malaysia. Enforcement Activities Enhancement Training, Enforcement Agency,

Ministry of Health Malaysia.

ii. Persidangan Penguatkuasaan Kementerian Kesihatan Malaysia 2016. Ministry of Health Enforcement Conference 2016.

Sebanyak 5 aktiviti latihan yang melibatkan penyampaian modul risikan dan operasi serbuan telah dijalankan dan melibatkan agensi penguatkuasaan KKM iaitu 3 sesi latihan bagi Bahagian Kawalan Kualiti Makanan yang telah dijalankan pada bulan April, Mei & Ogos 2016, 1 sesi latihan bagi Majlis Optik Malaysia yang telah dijalankan pada bulan April 2016 dan 1 sesi latihan bagi Bahagian Perubatan Tradisional dan Komplementari yang telah dijalankan pada bulan Jun 2016. Objektif utama aktiviti ini adalah bagi berkongsi pengetahuan berkenaan tugasan risikan & operasi serbuan yang telah menjadi bidang tugas utama Bahagian Penguatkuasaan Farmasi. Sambutan dari para peserta adalah amat menggalakkan di mana, aktiviti ini dicadangkan agar diteruskan di bawah Jawatankuasa Kecil Pemantapan Latihan Agensi Penguatkuasaan KKM.

A total of 5 training activities on intelligence and raid module was conducted involving MOH law enforcement agencies. Three training sessions were conducted for Food Quality Control Division in April, May and August 2016, one training session for the Malaysian Optical Council, in April 2016 and one training session for the Traditional and Complementary Medicine Division in June 2016. The main objective of this activity is to share knowledge of intelligence and raiding operations, which is the main task of the Pharmacy Enforcement Division. The response from the participants was very encouraging, and this activity is proposed to be continued under the Sub-Committee on Strengthening Enforcement Agency Training MOH.

Persidangan Penguatkuasaan Kementerian Kesihatan Malaysia 2016 telah diadakan pada 10 hingga 12 Mei 2016 bertempat di Intekma Resort & Convention Centre, Shah Alam. Persidangan dengan motto “Integrasi Pemacu Penguatkuasaan Berkualiti” ini adalah hasil usaha sama antara Bahagian Penguatkuasaan Farmasi, Unit Inspektorat & Perundangan, Kesihatan Awam dengan 7 (tujuh) entiti penguatkuasaan Kementerian Kesihatan Malaysia (KKM) di bawah Jawatankuasa Kerja Penyelarasan dan Pemantapan Penguatkuasaan KKM (JKPPP). Jawatankuasa Persidangan diketuai bersama oleh Tn. Hj. Sha’ari bin Abd. Rahman (Timbalan Pengarah Penguatkuasa Farmasi, Cawangan Risikan & Operasi) dan En. Muhammad Adam bin Abdullah (Unit Inspektorat & Perundangan, Kesihatan Awam). Persidangan telah dihadiri oleh 150 peserta daripada sembilan entiti penguatkuasaan KKM dari seluruh negara. Persidangan ini secara amnya adalah untuk membincangkan isu-isu penguatkuasaan bagi melindungi keselamatan dan kesihatan rakyat Malaysia. Persidangan ini juga berfungsi sebagai platform untuk berbincang, berkongsi serta bertukar pendapat bagi mewujudkan kesefahaman dan kerjasama antara entiti penguatkuasaan KKM, platform penting bagi mengenalpasti isu dan cabaran yang dihadapi dan seterusnya mencari penyelesaian untuk mempertingkatkan aktiviti penguatkuasaan.

The conference was held on May 10-12 2016 at Intekma Resort & Convention Center, Shah Alam. The conference with motto “Integration Drives Enforcement of Quality” was the result of collaboration between the Pharmacy Enforcement Division and the Inspectorate and Legal Unit, Public Health with seven (7) enforcement entities Ministry of Health (MOH) under the Working Committee on Coordination and Strengthening Enforcement of the Ministry of Health (JKPPP). This committee was co-chaired by Mr Haji Sha’ari bin Abd. Rahman (Deputy Director of Enforcement, Intelligence and Operations Branch) and En. Adam Muhammad bin Abdullah (Inspectorate and Legal Unit, Public Health). The conference was attended by 150 participants from nine MOH enforcement entities from all over of the country. The conference was to discuss enforcement issues to protect the safety and health of the citizens. The conference also serves as a platform to discuss, share and exchange ideas in order to create mutual understanding and cooperation between enforcement entities, to identify issues and challenges, and also to find solutions to improve enforcement activities.


94


95

Ahli Farmasi Berdaftar di Malaysia.Registered Pharmacist in Malaysia.

14,599

Nisbah Ahli Farmasi: PopulasiPharmacists: Population Ratio

1:2,185

20 Universiti dalam negara yang menawarkan program ijazah farmasi.Universities offering degree programme in pharmacy.


98


• Menguruskan permohonan pendaftaran dan pembatalan pendaftaran ahli farmasi dan pertubuhan perbadanan.

• Menguruskan permohonan akreditasi dan pengiktirafan bagi program ijazah farmasi di Institusi Pengajian Tinggi.

• Menguruskan permohonan kelulusan premis untuk latihan provisional.

• Menyelaras dan menggubal soalan Peperiksaan Kelayakan untuk Mengamal Farmasi bagi tujuan pendaftaran ahli farmasi.

• Menyedia dan memantau pematuhan kepada Garispanduan Kelulusan dan Pengiktirafan Program Farmasi bagi memastikan kualiti pelajar dan institusi yang menjalankan Program Ijazah Farmasi terpelihara.

• Manage applications for registration and deregistration of Pharmacists and Bodies Corporates.

• Manage applications for accreditation and recognition of pharmacy degree programmes in Higher Learning Institutions.

• Manage applications for approval of premises for provisional training.

• Coordinate and conduct Qualifying Examination for Registration as a Practicing Pharmacist for the purpose of pharmacist registration.

• Develop and monitor compliance of institutions to the Guidelines on Approval and Recognition of Pharmacy Degree Programme to assure the quality of graduates and the institutions offering pharmacy course.



99

Lembaga Farmasi Malaysia dianggotai oleh 18 orang ahli, yang terdiri daripada: • Ketua Pengarah Kesihatan Malaysia (ex officio); • Pengarah Kanan Perkhidmatan Farmasi (ex officio); • Lapan orang Ahli Farmasi Berdaftar dari sektor

perkhidmatan awam yang dilantik oleh Menteri Kesihatan Malaysia;

• Tiga orang Ahli Farmasi Berdaftar daripada Institusi Pengajian Tinggi (IPT) yang menawarkan program ijazah farmasi (dipilih dalam kalangan calon-calon yang dicadangkan oleh IPT) yang dilantik oleh Menteri Kesihatan Malaysia;

• Dua orang Ahli Farmasi Berdaftar bukan dari sektor perkhidmatan awam yang dilantik oleh Menteri Kesihatan Malaysia, dan;

• Tiga orang Ahli Farmasi Berdaftar bukan dari sektor perkhidmatan awam yang dicalonkan oleh persatuan-persatuan yang mewakili ahli farmasi di sektor swasta dan dilantik oleh Menteri Kesihatan Malaysia.

Demi membantu Lembaga Farmasi Malaysia melaksanakan fungsi dengan berkesan, tujuh (7) jawatankuasa telah ditubuhkan, iaitu:1. Jawatankuasa Teknikal Bersama.2. Jawatankuasa Peperiksaan Kelayakan untuk

Mengamal Farmasi.3. Jawatankuasa Teknikal Akreditasi Premis Farmasi.4. Jawatankuasa Pengiktirafan dan Pendaftaran Ahli

Farmasi.5. Jawatankuasa Teknikal Syarat Kelayakan Minimum6. Jawatankuasa Inkuiri.7. Jawatankuasa Latihan ‘Provisionally Registered

Pharmacist’ (PRP).

Pharmacy Board comprises of 18 members: • The Director General of Health ex officio; • The Director of Pharmaceutical Services ex officio; • Eight (8) registered pharmacists in the public service,

appointed by the Minister of Health; • Three (3) registered pharmacists from any higher

educational institution offering a course or programme in pharmacy, appointed by the Minister of Health;

• Two (2) registered pharmacists not in the public service, appointed by the Health Minister and;

• Three (3) registered pharmacists not in the public service, nominated by the association representing pharmacists in private practice, approved and appointed by the Minister.

In order to facilitate the Board, seven (7) committees are established with the following functions:1. Joint Technical Committee.2. Qualifying Examination for Registration as a Practicing

Pharmacist Committee.3. Accreditation of Pharmacy Premise Technical

Committee.4. Pharmacist Recognition and Registration Committee. 5. Minimum Entry Requirement Technical Committee. 6. Committee of Inquiry.7. Provisionally Registered Pharmacist (PRP) Trainning

Committee.


100


Tahun | Year Tahun Unjuran | Projection Year

0

5,000

10,000

15,000

20,000

25,000

2020201920182017201620152014201320122011201020092008200720062005

4,999 5,442 5,997 6,5947,298

8,0529,005

10,25211,372

12,29413,440

14,599

16,714

18,510

20,500

22,704

14,599 pada 31 Disember 2016

Bila

ngan

Ahl

i Far

mas

i | N

umbe

r of P

harm

acis

t

Tahun | Year

Rajah 1: Bilangan Ahli Farmasi yang Berdaftar (Tahun 2005-2016) dan Unjuran ke Tahun 2020.Figure 1: Number of Registered Pharmacists (Year 2005-2016) and Projection Into Year 2020.

Tahun | Year

Bila

ngan

Ahl

i Far

mas

i | N

umbe

r of P

harm

acis

t

0

1,000

2,000

3,000

4,000

5,000

6,000

2020201920182017201620152014201320122011201020092008200720062005

5,290

4,8714,533

4,1993,878

3,5923,282

2,9282,714

2,4632,303 2,185

1,935 1,777 1,632 1,499

Tahun | Year Tahun Unjuran | Projection Year

NISBAH KEPADA POPULASI=1:2,185Pada 31 Disember 2016

Jumlah Penduduk: 31.9 Juta

Rajah 2: Nisbah Ahli Farmasi: Populasi (Tahun 2005-2016) dan Unjuran ke Tahun 2020.Figure 2: Pharmacists: Population Ratio (Year 2005-2020) and Projection Into Year 2020.


101

Jadual 1: Senarai Universiti Dalam Negara yang Menawarkan Program Ijazah Farmasi.Table 1: List of Universities Offering Degree Programme in Pharmacy.

Bil.No.

InstitusiInstitution

ProgramProgramme

1 Universiti Sains MalaysiaUniversity Sciences of Malaysia

Sarjana Muda Farmasi (Kepujian)*Bachelor of Pharmacy (Hons)*

2 Universiti Kebangsaan MalaysiaNational University of Malaysia


3 Universiti Malaya University of Malaya


4 Universiti Teknologi MARAUniversity of Technology MARA


5 Universiti Islam Antarabangsa Malaysia International Islamic University Malaysia


6 Universiti UCSIUCSI University


7 Universiti Perubatan Antarabangsa Malaysia (IMU)International Medical University (IMU)

Sarjana Farmasi (program berkembar 2½+1 bersama Universiti Strathclyde, UK)Master of Pharmacy (twinning 2½+1 with University Strathclyde, UK)

Sarjana Farmasi (program berkembar 2+2 bersama Universiti Strathclyde, UK)Master of Pharmacy (twinning 2+2 with University Strathclyde, UK)


8 Universiti AIMST AIMST University


9 Universiti Nottingham Kampus Malaysia (UNMC)University Nottingham Malaysia Campus (UNMC)

Sarjana Farmasi program 2+2 setara dengan Universiti Nottingham, UK*Master In Pharmacy 2+2 similar programme of University of Nottingham, UK*

10 Kolej Universiti Sains Perubatan Cyberjaya (CUCMS) Cyberjaya University College of Medical Sciences (CUCMS)


11 Universiti Asia Metropolitan (AMU)#Asia Metropolitan University (AMU)#

Sarjana Muda Farmasi (Kepujian)4+0 bersama Universiti La Trobe, Australia*Bachelor of Pharmacy (Hons)4+0 with University La Trobe, Australia*

Sarjana Muda Farmasi (Kepujian)Bachelor of Pharmacy (Hons)

12 Universiti “Management & Science” (MSU)Management & Science University (MSU)


13 Kolej Universiti SEGiSEGI University College

Sarjana Farmasi program berkembar 2+2 bersama Universiti Sunderland, UK* Master of Pharmacy 2+2 twinning with University of Sunderland, UK*



102

Bil.No.

InstitusiInstitution

ProgramProgramme

14 Universiti Monash Kampus Malaysia Monash University Malaysia Campus

Sarjana Muda Farmasi (Kepujian) program setara dengan Universiti Monash, Australia*Bachelor of Pharmacy (Hons) similar programme of Monash University, Australia*

15 Universiti MAHSAMAHSA University

Sarjana Farmasi (program berkembar 2+2 bersama Universiti John Moores, UK)Master of Pharmacy (twining 2+2 with University of John Moores, UK)


16 Universiti Taylor Taylor’s University


Sarjana Farmasi 2+2 kerjasama dengan Universiti Cardiff, UK*Master of Pharmacy 2+2 in collaboration with Cardiff University, UK*

17 Kolej Universiti LincolnLincoln University College


18 Universiti Kuala Lumpur-Kolej DiRaja Perubatan Perak (UniKL-RCMP) Universiti Kuala Lumpur-Royal College of Medicine Perak (UniKL-RCMP)


19 Kolej Universiti Penjagaan Kesihatan KPJ KPJ Healthcare University College


20 Universiti Antarabangsa Quest PerakQuest International University Perak


* Diiktiraf oleh Lembaga Farmasi Malaysia. Fully recognised by Pharmacy Board Malaysia.

# Dahulu dikenali sebagai Kolej Universiti Sains Kesihatan Masterskill. Formerly known as Masterskill University College of Health Sciences.


103


Objektif bengkel ini adalah untuk menyemak semula buku log ‘Provisionally Registered Pharmacist’ (PRP) di sektor swasta. Bengkel ini telah dianjurkan oleh Lembaga Farmasi Malaysia bermula dari 19 hingga 21 Oktober 2016 di Hotel Allson Klana, Seremban dan telah melibatkan seramai 40 orang peserta yang terdiri daripada preseptor latihan PRP.

BENGKEL SEMAKAN SEMULA BUKU LOG PRPREVISION ON PRP LOG BOOKS WORKSHOP

The objective of this workshop is to revise Provisionally Registered Pharmacist (PRP) training log book in the private institutions. This workshop was organised by Pharmacy Board Malaysia and was held from 19th to 21st October 2016 at Hotel Allson Klana in Seremban. It involved a total number of 40 participants consisting of the PRP training preceptors.

MESYUARAT SEMAKAN SEMULA GARISPANDUAN KELULUSAN DAN PENGIKTIRAFAN PROGRAM IJAZAH FARMASI LEMBAGA FARMASI MALAYSIA REVISION ON THE GUIDELINES ON APPROVAL AND RECOGNITION OF A PHARMACY PROGRAMMEObjektif bengkel ini adalah untuk menyemak, mengemaskini dan memuktamadkan Garispanduan Kelulusan dan Pengiktirafan Program Ijazah Farmasi. Bengkel ini telah diadakan bermula dari 7 hingga 9 November 2016 di Hotel MS Garden, Kuantan, Pahang dan telah melibatkan seramai 30 orang perserta.

The objective of the workshop is to revise and finalise the Guidelines for Approval and Recognition of Pharmacy Degree Programme. This workshop was held from 7th until 9th November 2016 at MS Garden Hotel, Kuantan. A total of 30 participants attended this workshop.


104

BENGKEL ‘TRAINING OF PRECEPTORS’ KEPADA ‘PRINCIPAL PRECEPTOR’ DAN ‘MASTER PRECEPTOR’ LIBERALISASI LATIHAN AHLI FARMASI PROVISIONAL (PRP) 2016TRAINING OF TRAINERS WORKSHOP FOR PRINCIPAL AND MASTER PRECEPTORS LIBERALISATION OF PROVISIONALLY REGISTERED PHARMACIST (PRP) TRAINING 2016Bengkel ini telah diadakan sebanyak sembilan kali di Dewan Serai Wangi, Agensi Regulatori Farmasi Negara, Sabah dan Pulau Pinang. Objektif bengkel ini adalah untuk:i. Memberi panduan dan latihan kepada ‘Principal’ dan

‘Master Preceptor’ yang akan membimbing latihan PRP di fasiliti latihan liberalisasi, iaitu di farmasi komuniti, hospital swasta, industri farmaseutikal dan ‘Pharmaceutical Association of Malaysia’ (PhAMA).

ii. Memberi penerangan dan latihan secara terperinci tentang penggunaan dan pengisian buku log latihan PRP di sektor terbabit.

Training of Trainers Workshop for Principal and Master Preceptors Liberalisation of Provisionally Registered Pharmacist was held at Dewan Serai Wangi, National Pharmaceutical Regulatory Agency, Sabah and Penang. The objectives of this workshop are:i. To provide guidance and training to the Principal

and Master preceptors from liberalised training facilities i.e community pharmacies, private hospitals, the pharmaceutical industry and Pharmaceutical Association of Malaysia (PhAMA).

ii. To provide detailed information and training for the usage and filling of the training logbooks in the relevant sector.

No. Tarikh | Date Tempat | Venue

1 16 Mei 2016 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara



4 19 Julai 2016 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

5 20 Julai 2016 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

6 24 Julai 2016 Auditorium Kompleks Pentadbiran Kerajaan, Kota Kinabalu, Sabah

7 26 September 2016 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara

8 18 Oktober 2016 Bilik Gerakan, Bangunan Persekutuan, Pulau Pinang

9 14 Disember 2016 Dewan Serai Wangi, Bahagian Regulatori Farmasi Negara


105

BENGKEL SEMAKAN SEMULA CODE OF CONDUCT FOR PHARMACISTS AND BODIES CORPORATEREVISION ON THE CODE OF CONDUCT FOR PHARMACISTS AND BODIES CORPORATEBengkel Semakan Semula Code of Conduct for Pharmacists and Bodies Corporate Lembaga Farmasi Malaysia telah diadakan pada 20–22 September 2016 di Port Dickson, Negeri Sembilan. Seramai 39 orang peserta yang terdiri daripada ahli-ahli farmasi berdaftar dari pelbagai sektor farmaseutikal di Malaysia telah menghadiri bengkel ini.

Objektif utama bengkel adalah untuk menyemak semula Code of Conduct for Pharmacists and Bodies Corporate di bawah Lembaga Farmasi Malaysia serta mencadangkan langkah-langkah agar kod ini lebih jitu, komprehensif serta relevan untuk dijadikan rujukan dan panduan oleh semua ahli farmasi berdaftar di seluruh Malaysia.

The workshop was held on 20–22 September 2016 at Port Dickson, Negeri Sembilan. A total of 39 registered pharmacists from a variety of pharmaceutical sector in Malaysia attended this workshop.

The main objective of the workshop was to revise on the Code of Conduct for Pharmacists and Bodies Corporate as well as to make sure the codes were comprehensive and relevant as references and guidelines to all pharmacists in Malaysia.


106

BAHAGIAN REGULATORI FARMASI NEGARA (BRFN)THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA)

SAMPELSAMPLE99.93%

Sampel Pendaftaran dan Pemantauan Produk di Pasaran Dianalisa dalam Tempoh yang Ditetapkan.Registration Samples and Monitoring of Products in the Market Analyzed within the Stipulated Time.

Bilangan Produk Farmaseutikal, Tradisional, Suplemen Kesihatan dan Veterinar yang Masih Berdaftar.Number of Pharmaceutical Product, Traditional Product, Health Supplements and Veterinary Products which are Still Registered.

PRODUKPRODUCTS24,228 REGISTRATION

PRODUCT

PRODUKPRODUCTS155,367

Bilangan Produk Kosmetik yang Masih Bernotifikasi.Number of Cosmetics Products which are Still Notified.

Bilangan Pengilang, Pengimport & Pemborong.Number of Manufacturers, Importers & Wholesalers.

PEMBORONGWHOLESALERS1,334PENGILANG

MANUFACTURERS258 PENGIMPORTIMPORTERS445

Bilangan Clinical Trial Import Licence (CTIL) Dikeluarkan.Numbers of Clinical Trial Import Licence (CTIL) Issued.

PRODUKPRODUCTS285


108

BAHAGIAN REGULATORI FARMASI NEGARA (BRFN)THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA)

Bahagian Regulatori Farmasi Negara (BRFN), yang sebelum ini dikenali sebagai Makmal Pengawalan Farmaseutikal Kebangsaan, telah ditubuhkan pada Oktober 1978. Institusi ini telah ditubuhkan untuk melaksanakan kawalan kualiti ke atas produk farmaseutikal. Infrastruktur dan kemudahan institusi ini direkabentuk bagi memenuhi keperluan aktiviti kawalan dan pengujian kualiti yang dijalankan.

Bermula tahun 1985, BRFN bertanggungjawab untuk memastikan kualiti, keberkesanan dan keselamatan produk farmaseutikal melalui penilaian data saintifik dan ujian makmal. Sistem untuk memantau produk-produk di pasaran juga telah ditubuhkan. Sejak itu, BRFN telah memperluaskan kawalan kualiti dan kesemalatan ke atas produk-produk bukan preskripsi, tradisional, kosmetik, veterinari, bahan aktif farmaseutikal (API) dan seterusnya kawalan ke atas produk vaksin melalui aktiviti Vaccine Lot Release bermula tahun ini.

Dengan kepakaran dan kemampuan yang dimiliki, BRFN telah diberi pengiktirafan antarabangsa sebagai “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” pada tahun 1996. Pengiktirafan ini diberikan oleh World Health Organization (WHO) untuk sumbangan BRFN dalam bidang regulatori. Pengikhtirafan ini telah menarik minat agensi regulatori luar untuk menjalani latihan di BRFN. Selain itu, pengiktirafan ini telah meletakkan BPRN di platform antarabangsa dan meningkatkan kerjasama di antara BRFN dan agensi regulatori luar negara.

Di samping itu, BRFN telah diterima sebagai ahli ke-26 dalam Pharmaceutical Inspection Co-operation Scheme (PIC/S) pada 1 Januari 2002. Sejak itu, BRFN telah terlibat secara aktif dalam program Amalan Perkilangan Baik (APB) dan program Jaminan Kualiti Antarabangsa.

BRFN sentiasa berusaha dalam menaiktarafkan Sistem Pengurusan Kualiti. BPFK telah menerima pensijilan MS ISO 9001:2008 daripada SIRIM dan berjaya mengekalkannya sehingga kini. Selain itu, Pusat Kawalan Kualiti, BRFN telah memperolehi akreditasi MS ISO 17025:2005 di bawah Skim Akreditasi Makmal Malaysia (SAMM) pada tahun 2010.

Sejak penubuhannya, BPRN telah melalui pelbagai transformasi bagi memajukan institusi ini supaya menjadi institusi regulatori yang setanding dengan agensi regulatori antarabangsa. Dengan komitmen dan dedikasi semua kakitangan BPRN, BPRN bersedia untuk mengatasi cabaran pada masa hadapan dan akan terus memastikan bahawa ubat-ubatan di pasaran adalah selamat, berkualiti dan berkesan untuk kegunaan awam.

The National Pharmaceutical Regulatory Agency (NPRA), formerly known as the National Pharmaceutical Control Laboratory, was set up in October 1978. This institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities

Starting from 1985, NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through evaluation of scientific data and laboratory tests. A system to monitor products in the market was also established. Over the years, NPRA has extended the control of the quality and safety of non-prescription medicines, traditional products, cosmetics, veterinary products, active pharmaceutical ingredients (API) including the quality control of vaccine through Vaccine Lot Release activities which started this year.

In view of its technical expertise and training capabilities, NPRA has given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization (WHO) for NPRA’s contribution in the field of regulatory affairs. Apart from that, this recognition has placed NPRA on an international platform and enhanced cooperation between NPRA and other international regulatory agencies.

In addition to that, NPRA has successfully gained accession as the 26th member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on 1st January 2002. Since then, NPRA has been actively involved in international Good Manufacturing Practice (GMP) and Quality Assurance programmes.

NPRA is constantly striving towards upgrading its Quality Management System. NPRA has successfully obtained and retained the MS ISO 9001:2008 certification from SIRIM. Apart from that, NPRA has obtained MS ISO 17025:2005 accreditations for Centre for Quality Control under the Malaysian Laboratory Accreditation Scheme (SAMM) in 2010.

From the moment it was established, NPRA has gone through a series of transformation to advance itself as a regulator and to be on par with international counterparts. With the commitment and dedication of all NPRA staff, NPRA is well equipped to overcome future challenges and will continue to ensure that the medicines in the market are safe, of good quality and efficacious for public consumptions.



109

PENGARAH REGULATORI FARMASIDIRECTOR OF REGULATORY PHARMACY

• Aktiviti survelens pasca pendaftaran produk. Post registration surveillance activities.

• Farmakovigilans. Pharmacovigilance.

• Notifikasi kosmetik. Cosmetic notification.

Pusat Pasca Pendaftaran Produk& Kawalan Kosmetik

Centre for Post Registration of Products& Cosmetic Control

• Pemeriksaan ke atas tapak percubaan klinikal. Inspections of clinical trial sites.

• Pemeriksaan ke atas pusat kajian Bioequivalence. Inspections of Bioequivalence centres.

• Pengeluaran lesen import bagi ubat yang diimport serta kebenaran mengilang produk (CTX) untuk tujuan percubaan klinikal.

Issuance of import license to imported drugs for clinical trials as well as exemptions for manufacture of products for this purpose.

Pusat Kajian Produk BaruCentre for Investigational New Product

• Penilaian ke atas dossier untuk pendaftaran produk.

Evaluation of the dossier for product registration.

Pusat Pendaftaran Produk Centre for Product Registration

• Pengendalian sistem pendaftaran atas talian (QUEST) dan laman web rasmi BRFN.

Manages the on-line registration system (QUEST) and NPRA’s official website.

• Unit Helpdesk mengendalikan pertanyaan. The Helpdesk unit handles inquiries.

• Menyelaraskan aktiviti latihan. Coordinate training activities.

Pusat Pembangunan & Perancangan Strategik Centre for Development & Strategic Planning

• Pemeriksaan ke atas tapak pengilangan produk. Inspection on manufacturing sites.

• Pengeluaran lesen pengilang, pengimpot dan pemborong.

Issuance of manufacturers, importers and wholesalers licenses.

Pusat Komplians & Pelesenan Centre for Compliance & Licensing

• Tugasan pentadbiran dan kewangan. Administrative and financial tasks.

Pusat Pentadbiran Centre for Administration

• Pengujian kimia & mikrobiologi. Chemical & microbiological testing.

• Penilaian data validasi analisis.Analytical validation data evaluation.

Pusat Kawalan Kualiti Centre for Quality Control


110

2.0 MAKLUMAT TERKINI | LATEST INFORMATION

Tiada cukai barang dan perkhidmatan (GST) dikenakan ke atas ubat terkawal di dalam senarai Racun Kumpulan A, B, C, D di bawah Akta Racun 1952 yang berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD) dengan suffix ‘A’ pada hujung nombor pendaftaran produk berkuatkuasa 1 Januari 2016. Perkara ini telah diumumkan oleh Perdana Menteri Datuk Seri Najib Tun Razak dalam Bajet 2016. Senarai ubat mengandungi racun berjadual berkadar sifar boleh didapati di pautan http://gst.customs.gov.my/ms/rg/SiteAssets/gst_order/SENARAI_UBAT_SUFFIX%20A_20160116.pdf .

Selain tu, terdapat senarai produk berdaftar dalam Senarai Ubat Penting Kebangsaan (Suffix X dan Suffix N) yang diluluskan oleh Menteri Kewangan di bawah Cukai Barang dan Perkhidmatan (Pembekalan Berkadar Sifar). Senarai ini boleh didapati di pautan http://gst.customs.gov.my/en/rg/Pages/re_odr.aspx.

BRFN telah memberikan lanjutan tempoh masa sehingga 31 Disember 2016 untuk meletakkan suffix huruf ‘Z’ pada nombor pendaftaran untuk label produk-produk berkadar sifar.

UBAT BERKADAR SIFAR | ZERO-RATED MEDICINESAs announced by the Malaysian Prime Minister during the 2016 Government Budget, medicines zero-rated under the GST will be introduced in Malaysia with an effective date of 1st January 2016. Referring to the Goods and Services Tax (Zero-Rated Supply) (Amendment) (No. 2) Order 2015, all Scheduled Medicines i.e. medicaments under the Poisons List of Group A, B, C and D under Poisons Act 1952 which are registered under suffix ‘A’ by Drug Control Authority (DCA) will be zero-rated. This list can be downloaded online via the link http://gst.customs.gov.my/ms/rg/SiteAssets/gst_order/SENARAI_UBAT_SUFFIX%20A_20160116.pdf.

Besides that, there is also a list of registered product in the National Essential Medicine List (Suffix X and Suffix N) which is approved by the Ministry of Finance to be under the Goods and Services Tax (Zero-Rated Supply) Order 2014.This list can be downloaded online via the link http://gst.customs.gov.my/en/rg/Pages/re_odr.aspx.

As for the regulatory sides, the industry is given an extended period until 31st December 2016 to add suffix ‘Z’ at the end of the product registration number on the product label.

Kementerian Kesihatan Malaysia (KKM) telah memutuskan pelaksanaan yuran bagi perkhidmatan yang dijalankan oleh Bahagian Regulatori Farmasi Negara (BRFN) seperti berikut. Tarikh pelaksanaan yuran bagi perkhidmatan ini adalah pada 1 Januari 2016.

YURAN PERKHIDMATAN | PROCESSING FEESMinistry of Health (MOH) has decided the implementation of fees for services performed by the National Pharmaceutical Regulatory Agency (NPRA) as follows. The date of fee implementation for these services is 1st January 2016.


111

BIL.NO.

PERKHDIMATANSERVICES

YURANFEE

1. Pemprosesan Pengkelasan Produk Processing of Product Classification

RM300 setiap permohonanRM300 per application

2. Pemprosesan Permohonan Variasi Produk dan Tambahan Indikasi Processing of Product Variation & Additional Indication

Penilaian Penuh(A,X,H)Full Evaluation(A,X,H)

Penilaian Ringkas(N,T,H)Abridge Evaluation(N,T,H)

2.1 Minor Variation Prior Approval Minor Variation Prior Approval

RM150 setiap jenis permohonanRM150 per application


2.2 Major Variation (MaV)Major Variation (MaV)



2.3 Tambahan Indikasi Additional Indication

RM1,000RM1,000

Tidak berkenaanNot related

3. Pemprosesan Permohonan Pertukaran Pengilang Jenis IProcessing of Change of Site Type I

Farmaseutikal(A,X,N,H)Pharmaceutical(A,X,N,H)

Tradisional(T)Traditional(T)

RM1,000 setiap produkRM1,000 per product

RM100 setiap produkRM100 per product

4. Pemprosesan dan Pemeriksaan Pusat Kajian Bioekuivalens (BE) Tempatan Processing &Inspection of Local Bioequivalence (BE) Centre

4.1 Yuran Pemprosesan PermohonanProcessing Fee for Application

RM1,000 setiap permohonanRM1,000 for each application

4.2 Penilaian Dokumentasi Documentation Evaluation

RM1,000 setiap penilaian dokumentasiRM1,000 for each documentation

4.3 Pemeriksaan Penuh (Klinikal, Bioanalytical dan Method Validation)Full Inspection (Clinical, Bioanalytical and Method Validation )

RM1,000/pemeriksaan/hari bekerjaRM1,000/inspection/working days

4.4 Pemeriksaan Tambahan Tapak Klinikal/BioanalitikalAdditional Inspection for Clinical/Bioanalytical Site


4.5 Pemeriksaan Verifikasi Verification Inspection


4.6 Pemeriksaan “Triggered”Triggered Inspection


5 Pemeriksaan Amalan Makmal Baik ke atas fasiliti Kajian Bukan Klinikal di Malaysia Good Laboratory Practice Inspection for Non Clinical Trial facilities in Malaysia

5.1 PermohonanApplication

RM2,000 setiap permohonanRM2,000 each application

5.2 Penilaian Dokumentasi Documentation evaluation

RM2,000 setiap permohonanRM2,000 each documentation

5.3 Pra-pemeriksaan Pre-Inspection

RM2,000/hari/InspektorRM2,000/days/Inspector


112

BIL.NO.

PERKHDIMATANSERVICES

YURANFEE

5.4 Pemeriksaan Inspection

RM2,000/hari/InspectorRM2,000/days/Inspector

5.5 Verifikasi Verification


5.6 SurveilanSurveilance


5.7 Yuran Pakar Teknikal Techinical Specialist Fee


5.8 Sijil TahunanAnnual Certificate

RM2,000RM2,000

6. Aktiviti Penilaian Pelan Susun Atur PremisPremis Layout Evaluation

Permohonan Pelan BaruApplication of New Plan

Permohonan Pindaan PelanApplication for Plan Amendments

Semua jenis Pelan Susun Atur Premis Pengilang Produk Premis Layout Plan for All Type of Manufacturer

RM1,000 setiap Permohonan BaruRM1,000 per New Application

RM500 setiap Permohonan BaruRM500 per New Application

7 Pemprosesan Permohonan Sijil Indikasi dan Sijil Deklarasi Processing of Application of Certificate of Indication & Certificate of Declaration

RM50/setiap sijil yang dikeluarkanRM50/for each certificate issued

8 Pemprosesan Aktiviti Vaccine Lot ReleaseProcessing of Vaccine Lot Release

Jenis VaksinType of vaccine

Pemeriksaan Rangkaian Sejuk dan PenilaianLot Summary ProtocolCold Chain Inspection & Lot Summary Protocol Evaluation

Pemeriksaan Rangkaian Sejuk bagi Lot Summary Protocol yang pernah dinilaiCold Chain Inspection &Lot Summary Protocol Evaluation which has been evaluated

Semenanjung MalaysiaPeninsular Malaysia

8.1 Monovalent Monovalent

RM300/lot VaksinRM300/lot Vaccine

RM200/lot vaksinRM200/lot Vaccine

8.2 Polyvalent Polyvalent

RM500/lot VaksinRM500/lot Vaccine

8.3 CombinationCombination

RM1,000/lot VaksinRM1,000/lot Vaccine

Sabah dan SarawakSabah and Sarawak

8.4 Monovalent Monovalent



8.5 Polyvalent Polyvalent


8.6 CombinationCombination

RM1,300/lot vaksinRM1,300/lot Vaccine


113

PENDAFTARAN PRODUK | PRODUCT REGISTRATIONBahagian Regulatori Farmasi Negara (BRFN), bertanggungjawab untuk memproses permohonan pendaftaran untuk produk entiti baru kimia (NCE)/ubat-ubatan baru, biologik, preskripsi, bukan preskripsi, supplemen kesihatan, produk tradisional dan juga veterinar.

Pada 2016, sebanyak 1,268 produk telah didaftarkan daripada 2,054 permohonan terdiri daripada 57% produk tempatan dan 43% produk yang diimport. Kumulatif produk berdaftar sehingga Disember 2016 adalah 50,813 produk.

The National Pharmaceutical Regulatory Agency (NPRA) is responsible for processing registration applications for new chemical entities (NCE)/new drugs, biologics, prescription, non-prescription, health supplements, traditional as well as veterinary products.

In 2016, a total of 1,268 products were registered out of 2,054 applications comprised of 57% local products and 43% imported products. The cumulative number of registered products up to December 2016 is 50,813 products.


Jadual 1: Bilangan Produk Berdaftar, 2013-2016 | Table 1: Number of Registered Products, 2013-2016

Kategori | CategoryTahun | Year

2013 2014 2015 2016

Produk Preskripsi | Prescription Products 241 235 280 263

Produk Bukan Preskripsi|Non-Prescription Products 54 52 41 40

Produk Tradisional|Traditional Products 578 590 569 648

Supplemen Kesihatan|Health Supplements 85 128 236 238

Produk Veterinar|Veterinary Products 63 207 94 79

Jumlah | Total 1,021 1,212 1,220 1,268Sumber/Source: Bahagian Regulatori Farmasi Negara/National Pharmaceutical Regulatory Agency.

AKTIVITI PASCA PENDAFTARAN PRODUK PRODUCT POST REGISTRATION ACTIVITIESPemantauan produk berdaftar di pasaran dijalankan secara berterusan bagi memastikan produk berdaftar di pasaran tempatan mengekalkan keselamatan, keberkesanan dan kualiti keperluan. Pada tahun 2016, Program Pemantauan Adverse Drug Reaction (ADR) Malaysia telah menerima sebanyak 13,789 laporan, kira-kira 0.8% lebih tinggi berbanding tahun sebelumnya.

Monitoring of registered products in the market is carried out continuously to ensure that the registered products in local market maintain the safety, efficacy and quality requirements. In 2016, the Malaysian Adverse Drug Reaction (ADR) Monitoring Program had received a total of 13,789 reports, about 0.8% higher in compared to the year before.

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

Bila

ngan

Lap

oran

AD

RN

umbe

r of A

DR

Repo

rts

2013 2014 2015 2016

11,473 13,001 13,675 13,789

Rajah 1: Bilangan Laporan ADR yang Diterima, 2013-2016.Figure 1: Number of ADR Reports Received, 2013-2016.


114

Jadual 2: Bilangan Produk yang Disampel, 2013-2016. | Table 2: Number of Products Sampled, 2013-2016.

Kategori | CategoryTahun | Year

2013 2014 2015 2016

Produk Preskripsi | Prescription Products 786 731 592 462

Produk Bukan Preskripsi|Non-Prescription Products 140 234 201 151

Supplemen Kesihatan|Health Supplements 42 20 12 4

Produk Tradisional|Traditional Products 29 16 6 2

Produk Kosmetik | Cosmetics Products 25 22 41 19

Jumlah | Total 1,022 1,023 852 638Sumber/Source: Bahagian Regulatori Farmasi Negara/National Pharmaceutical Regulatory Agency.

Jadual 4: Bilangan Pemeriksaan Premis yang Dijalankan, 2013-2016 Table 4: Number of Premises Inspected, 2013-2016

Jenis Pemeriksaan | Type of InspectionsTahun | Year

2013 2014 2015 2016

Pemeriksaan GMP | GMP inspections 295 360 350 470

Kajian Plan Premis | Premise Plan Review 39 76 63 84

Panduan Teknikal | Technical Guidance 176 148 200 86

Jumlah | Total 510 584 613 640Sumber/Source: Bahagian Regulatori Farmasi Negara/National Pharmaceutical Regulatory Agency.

KOMPLIANS DAN PELESENAN | LICENSING AND COMPLIANCEPemeriksaan Amalan Pengilang Baik (GMP) ke atas pengeluar produk berdaftar dan kosmetik bernotifikasi memastikan pematuhan mereka terhadap keperluan GMP semasa manakala Good Distribution Practice (GDP) pemeriksaan memastikan pematuhan pengimport dan pemborong keperluan KDNK semasa. Terdapat 470 pemeriksaan GMP yang dijalankan pada tahun 2016. Perkhidmatan tambahan seperti panduan teknikal dan semakan pelan premis juga disediakan untuk pengilang.

Good Manufacturing Practice (GMP) inspection on the manufacturer of registered products and notified cosmetics is to ensure their compliance towards the current GMP requirements while Good Distribution Practice (GDP) inspection is to ensure adherence of importers and wholesalers to the current GDP requirements. There were 470 GMP inspections conducted in the year 2016. Additional services such as technical guidance and premise plan review were also provided to manufacturers.

Pada tahun 2016, 200 lesen pengilang, 430 lesen pengimport dan 1,203 lesen pemborong telah dikeluarkan.

In 2016, 200 manufacturer licenses, 430 importer licenses and 1,203 wholesaler licenses were issued.

Bila

ngan

Les

en y

ang

Dik

elua

rkan

Num

ber o

f Lic

ense

Issu

ed

Lesen PengilangManufacturer License

Lesen PengimportImporter License

Lesen PemborongWholesaler License

0

200

400

600

800

1,000

1,200

1,400

2016201520142013

263401

247 266200

430455

1,164 1,203

393

1,326

1,160

Rajah 2: Bilangan Lesen yang Dikeluarkan, 2013-2016.Figure 2: Number of License Issued, 2013-2016.

Sumber/Source: Bahagian Regulatori Farmasi Negara/National Pharmaceutical Regulatory Agency.


115

PENGUJIAN MAKMAL | LABORATORY TESTINGPengujian farmaseutikal & mikrobial dijalankan mengikut standard regulatori global. Tugas-tugas ini dijalankan oleh kakitangan yang cekap dan terlatih.

Pengujian produk dijalankan untuk tujuan pendaftaran bagi produk tradisional, untuk tujuan pengawasan bagi produk berdaftar dan kosmetik bernotifiaksi, sampel yang menyebabkan kesan advers (ADR) serta sampel aduan dan sampel penguatkuasaan.

Pharmaceutical & microbial testing is carried out in accordance with global regulatory standards. These duties are carried out by trained and competent personnel.

Product testing is carried out for the purposes of registration for traditional products, for the purpose of surveillance for registered products and notified cosmetic products, samples with adverse drug reactions (ADR) as well as complaint and enforcement samples.

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

2016201520142013

Gagal Ujian | Failed Testing Sampel yang Diuji | Samples Tested

Bila

ngan

Sam

pel |

Num

ber o

f Sam

ples

3,2923,487

3,2163,567

579263 326395

Rajah 3: Bilangan Sampel Diuji dan Bilangan Sampel Gagal Ujian, 2013-2016.Figure 3: Number of Sample Tested & Number of Failed Samples, 2013-2016.

Sumber/Source: Bahagian Regulatori Farmasi Negara/National Pharmaceutical Regulatory Agency.


116


Penganjur : BRFN & ISPE MalaysiaTempat : Hotel Bangi-Putrajaya, SelangorPenceramah : Pegawai PKP, Wakil ISPE

Peserta:Logistik/’Supply Chain Professionals’; ‘Transporters’, ‘Manufacturing Professionals’, ‘QC/QA Professionals’, Perunding, Pengurus Operasi, Pengurus Risiko Operasi , Academia dan Pelajar.

Objektif:Untuk meningkatkan pengetahuan dan pematuhan industri yang terlibat kepada keperluan garis panduan Amalan Pengedaran Baik (AEB).

GOOD DISTRIBUTION PRACTICE (GDP) FOR TRANSPORTERS | 1–2 MARCH 2016Organizer : NPRA & ISPE MalaysiaVenue : Bangi-Putrajaya Hotel, NPCBSpeaker : CCL officers, Representatives from ISPE

Participants:Logistics/Supply Chain Professionals; Transporters, Manufacturing Professionals, QC/QA Professionals, Consultants, Operations Managers, Operational Risk Managers, Academia and Students.

Objective:To improve the knowledge and compliance of the industry toward the requirement of Good Distribution Practice (GDP) guidelines.


117

Penganjur: Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI) dan Malaysian Association of Pharmaceutical Suppliers (MAPS) dan Bahagian Regulatori Farmasi Negara (BRFN).

Tempat : Hotel Eastin Petaling Jaya, SelangorPenceramah : Pegawai BRFNPeserta : Pegawai BRFN dan wakil industri

Objektif:Memberi penerangan kepada pihak industri berkaitan pendaftaran produk dan keperluan variasi produk ubat di Malaysia termasuk cabaran ketika menghantar permohonan pendaftaran produk, memahami keperluan pendaftaran produk dan memberi nasihat kepada pihak industri dalam menyediakan permohonan pendaftaran produk yang berkualiti agar mendapat kelulusan daripada Pihak Berkuasa Kawalan Dadah (PBKD) dalam masa yang berpatutan.

COLLABORATIVE REGULATORY TRAINING SEMINAR 2016: CHALLENGES & ISSUES WITH REGISTRATIONS AND VARIATION APPLICATIONS | 9-10 MARCH 2016

Organizer : Pharmaceutical Association of Malaysia (PhAMA), Malaysian Organisation of Pharmaceutical Industries (MOPI) and Malaysian Association of Pharmaceutical Suppliers (MAPS) in collaboration with the National Pharmaceutical Regulatory Agency (NPRA).

Venue : Eastin Hotel Petaling Jaya, SelangorSpeaker : NPRA officersParticipants : NPRA officers and industry representative

Objective:A platform for the industry to acquire a better understanding of the drug registration and variation requirements in Malaysia including the problem in drug registration submission, understanding registration requirements and advice for the industry for generating a high quality submission and obtain timely approvals from the Drug Control Authority (DCA).


118

Penganjur : Bahagian Regulatori Farmasi Negara (BRFN)Tempat : Best Western Hotel, Petaling JayaPenceramah : Pegawai BRFN & BPF

Peserta:Pegawai kerajaan daripada Afghanistan, Guinea, Arab Saudi, Mali, Tajikistan, Togo, The Gambia & Senegal.

Objektif:Fokus utama program ini adalah untuk memberi jaminan kepada negara luar terhadap kualiti, keselamatan dan keberkesanan produk farmaseutikal buatan tempatan serta produk import berdaftar yang berada di pasaran Malaysia. Selain itu, sejajar dengan aspirasi EPP 3: Malaysian Pharmaceuticals under the National Key Economic Area (NKEA) Healthcare, BRFN berharap peluang mengeksport produk farmaseutikal ke negara asing dapat dicapai.

TRAINING PROGRAMME FOR DRUG REGULATORY AUTHORITIES | 14–18 MARCH 2016Organizer : National Pharmaceutical Regulatory Agency (NPRA)Venue : Best Western Hotel, Petaling JayaSpeaker : NPRA & PSD officers

Participants:Government officials from Afghanistan, Guinea, Kingdom of Saudi Arabia, Mali, Tajikistan, Togo, The Gambia & Senegal.

Objective:To provide assurance to these foreign countries on the quality, safety and efficacy of locally manufactured and imported registered pharmaceutical products in the Malaysian market. Subsequently, in line with the aspiration of EPP 3: Malaysian Pharmaceuticals under the National Key Economic Area (NKEA) Healthcare, NPRA is hopeful that pharmaceutical product export opportunities will be attained in foreign countries.


119

Penganjur : Bahagian Regulatori Farmasi Negara (BRFN)Tempat : Dewan Anggerik, BPFKPenceramah : Pegawai PKP & PKK

Peserta:Pegawai kerajaan daripada 22 pusat pengumpulan darah di bawah program Fraksinasi Kebangsaan.

Objektif:Untuk meningkatkan pengetahuan dan pematuhan pusat-pusat yang terlibat kepada garis panduan Amalan Perkilangan Baik (APB).

NATIONAL BLOOD ESTABLISHMENT SEMINAR 2016 | 29-30 MARCH 2016Organizer : National Pharmaceutical Regulatory Agency (NPRA)Venue : Anggerik Hall, NPCBSpeaker : CCL & CQC officers

Participants:Government officers from 22 Blood Centers under the National Fractionation Programme.

Objective:To improve the knowledge and compliance of blood centers toward Good Manufacturing Practice (GMP) guidelines.


120

Penganjur: Jawatankuasa Teknikal Monograf Herba Malaysia (MHM) dengan kerjasama Bahagian Regulatori Farmasi Negara (BRFN).

Tempat : Pusat Kawalan Kualiti, BRFNPenceramah : Dr Noraida Mohamad ZainoorFasilitiator : Unit Fitokimia, Pusat Kawalan Kualiti

Objektif: • Untuk memberi pendedahan kepada pihak industri

tentang kepentingan ujian identifikasi bahan mentah herba.

• Untuk berkongsi pengalaman dalam menjalankan ujian identifikasi bahan mentah herba menggunakan teknik kromatografi lapisan nipis dan intrepretasi data.

MALAYSIAN HERBAL MONOGRAPH (MHM) THIN LAYER CHROMATOGRAPHY PRACTICAL TRAINING FOR INDUSTRY 2016 | 21 JULY 2016

Organizer: Malaysian Herbal Monograph (MHM) Technical Committee in collaboration with the National Pharmaceutical Regulatory Agency.

Venue : Centre for Quality Control, NPRASpeaker : Dr Noraida Mohamad ZainoorFacilitator : Phytochemistry Unit, Centre for Quality Control

Objective: • To give exposure regarding the importance of herbal

raw material identification to the industry. • To share experience in conducting identification test on

herbal raw material using thin layer chromatography technique and data interpretation.


121

Penganjur : BRFN & ISPE MalaysiaTempat : Hotel The Royale Chulan Damansara, SelangorPenceramah : Pegawai PKP

Peserta:Pengilang, Pengimport, Pengurus/Eksekutif Hal Ehwal Kawal Selia, Pemegang Pendaftaran Produk, Pemilik Produk.

Objektif: • Untuk menyebarkan maklumat mengenai keperluan

regulatori terkini berkaitan pemeriksaan Amalan Perkilangan Baik (APB) luar negara dan pengurusan perubahan oleh fasiliti berlesen.

• Untuk memberi panduan tentang cara permohonan pemeriksaan APB luar negara dengan BPFK.

• Untuk memberi peluang kepada syarikat dan BPFK untuk berkongsi isu-isu berkaitan pemeriksaan APB luar negara.

FOREIGN GMP REGULATORY INSPECTION AND MANAGING CHANGES OF LICENSED FACILITY | 26 OCTOBER 2016

Organizer : NPRA & ISPE MalaysiaVenue : The Royale Chulan Damansara Hotel, SelangorSpeaker : CCL & CQC officers

Participants:Government officers from 22 Blood Centers under the National Fractionation Programme.

Objective: • To disseminate information about the latest regulatory

requirements relating to foreign GMP regulatory inspections and management of changes to licensed facility.

• To provide guidance on how to make a Foreign GMP Inspection application with NPCB.

• To provide opportunities for the company and NPCB to share issues relating to foreign GMP inspections.


122

Penganjur: Jawatankuasa Teknikal Monograf Herba Malaysia (MHM).

Tempat: Hotel e-City, Subang Jaya.Penceramah: • Dr Ami Fazlin Syed Mohamed • Cik Chan Su Lyn • En. Mohd Nasrul Mohamad Noor • Tn. Hj. Ghazali Mansor.

Objektif:Untuk merangka pembangunan Farmakopia Herba Malaysia (FHM) yang menepati perundangan di Malaysia dan kemudiannya dapat digunapakai sebagai satu bahan rujukan utama terutamanya dalam pendaftaran ubat-ubat tradisional dan herba di Malaysia dan antarabangsa.

MALAYSIAN HERBAL PHARMACOPOEIA FRAMEWORK WORKSHOP 2016 1-3 DECEMBER 2016

Organizer: Malaysian Herbal Monograph (MHM) Technical Committee.

Venue: e-City Hotel, Subang Jaya.Speaker: • Dr Ami Fazlin Syed Mohamed • Ms Chan Su Lyn • Mr. Mohd Nasrul Mohamad Noor • Tn. Hj. Ghazali Mansor

Objective:To formulate the development of the Malaysian Herbal Pharmacopoeia (MHP) which conforms to legislation in Malaysia and can be used as a key reference especially in the registration of traditional medicines and herbs in Malaysia and internationally.


123

Penganjur: Jawatankuasa Teknikal Monograf Herba Malaysia (MHM) dengan kerjasama Bahagian Regulatori Farmasi Negara.

Tempat: Pusat Kawalan Kualiti, BPFK

Penceramah: • Cik Ooi Wei Yen • Pn. Mazli Muhammad • Dr Noraida Mohamad Zainoor • En. Dinash Aravind Radhakrishnan

Fasilitiator: Unit Fitokimia, Pusat Kawalan Kualiti.

Objektif: • Untuk memberi pendedahan kepada pihak industri

tentang kepentingan ujian identifikasi bahan mentah herba.

• Untuk berkongsi teknik dan pengalaman dalam menjalankan ujian identifikasi bahan mentah herba menggunakan teknik kromatografi cecair prestasi tinggi dan intrepretasi data serta membangunkan metodologi in-house HPLC.

MALAYSIAN HERBAL MONOGRAPH (MHM) HIGH PERFORMANCE LIQUID CHROMATOGRAPHY PRACTICAL TRAINING FOR INDUSTRY 2016 | 7-8 DECEMBER 2016

Organizer: Malaysian Herbal Monograph (MHM) Technical Committee in collaboration with the National Pharmaceutical Regulatory Agency.

Venue: Centre for Quality Control, NPCB

Speaker: • Ms Ooi Wei Yen • Mdm Mazli Muhammad • Dr. Noraida Mohamad Zainoor • Mr. Dinash Aravind Radhakrishnan

Facilitator: Phytochemistry Unit, Centre for Quality Control

Objective: • To give exposure regarding the importance of herbal

raw material identification to the industry. • To share technique and experience in conducting

identification test on herbal raw material using high perfomance liquid chromatography technique and data interpretation as well as to develop an in-house HPLC methodology.


124

KOLABORASI & PENGLIBATAN ANTARABANGSAINTERNATIONAL PARTICIPATION & COLLABORATION

KOLABORASI & PENGLIBATAN ANTARABANGSAINTERNATIONAL PARTICIPATION & COLLABORATION

1.0 MESYUARAT BILATERAL | BILATERAL MEETINGS

Berikutan isu-isu yang dibangkitkan semasa “2nd Malaysia-Thailand Joint Trade Committee (JTC)” berkaitan kemudahan proses pendaftaran, satu mesyuarat dua hala telah diatur di antara BPFK dan Thai FDA untuk membincangkan isu tersebut dengan lebih mendalam.

Dua pegawai daripada BRFN termasuk pengarah BRFN telah menghadiri mesyuarat tersebut yang diadakan pada 8 Ogos 2016 di pejabat Thai FDA di Nonthaburi, Thailand.

Perkara-perkara yang dibincangkan semasa mesyuarat itu termasuk, prosedur pendaftaran produk generik baru dan keperluan kajian BE di Thailand, klasifikasi produk farmaseutikal & peranti perubatan serta kerjasama teknikal di antara kedua-dua agensi pada masa hadapan.

MESYUARAT BILATERAL BRFN - FOOD AND DRUG ADMINISTRATION (THAI FDA), MINISTRY OF PUBLIC HEALTH THAILANDNPRA-FOOD AND DRUG ADMINISTRATION (THAI FDA), MINISTRY OF PUBLIC HEALTH THAILAND BILATERAL MEETING

Following the issues raised during 2nd Malaysia-Thailand Joint Trade Committee (JTC) on facilitation of registration procedures, a bilateral meeting was arranged between NPRA and Thai FDA to discuss the issue further.

Two officers from NPRA including the director of NPRA were present in the meeting which was held on 8th August 2016 at the Thai FDA office in Nonthaburi, Thailand.

Matters discussed during the meeting included, new generic product registration procedures and requirements of BE study in Thailand, classification of pharmaceutical products & medical devices as well as future technical cooperation between the two agencies.


126

Mesyuarat dua hala teknikal di antara BRFN dan HSA diadakan setiap tahun berikutan Memorandum Persefahaman (MoU) yang telah ditandatangani pada 28 Mac 2012 di Singapura.

Bagi tahun 2016, mesyuarat dua hala teknikal telah diadakan pada 16 Ogos 2016 di ibu Pejabat HSA di Singapura. Enam pegawai dari BRFN termasuk pengarah BRFN telah menghadiri mesyuarat ini.

Mesyuarat telah membincangkan maklumat regulatori terbaru daripada kedua-dua agensi serta kerjasama berterusan dalam bidang pendaftaran produk serta produk sel & gen terapi (CGTPs). Satu perbincangan khas mengenai vaksin denggi juga telah diadakan semasa mesyuarat.

MESYUARAT TEKNIKAL DUA-HALA BRFN–HSA NPRA–HSA TECHNICAL BILATERAL MEETING

A technical bilateral meeting between NPRA and HSA has been held annually following the Memorandum of Understanding (MoU) which was signed on 28th March 2012 in Singapore.

For the year 2016, the technical bilateral meeting was held on 16th August 2016 at the HSA headquarters in Singapore. Six officers from NPRA including the director of NPRA attended the meeting.

The meeting discussed regulatory updates from both agencies as well as the continuous cooperation and collaboration between the two agencies in the field of product registration and cell & gene therapy products (CGTPs). A special discussion on a dengue vaccine also took place during the meeting.

2.0 PENGLIBATAN BRFN DI DALAM KUMPULAN KERJA ASEAN NPRA’S PARTICIPATION IN ASEAN WORKING GROUPS

ASEAN Consultative Committee for Standards and Quality (ACCSQ) telah ditubuhkan pada tahun 1992 bagi memudahkan pencapaian objektif Perjanjian Perdagangan Bebas ASEAN. Pada tahun 2004, ACCSQ telah ditugaskan untuk menjalankan aktiviti-aktiviti yang berkaitan dengan penubuhan ASEAN Economic Community (AEC).

AEC dilancarkan pada 2015 dengan tujuan untuk mewujudkan pengeluaran asas dan pasaran tunggal di kalangan negara-negara ASEAN. Ini akan membolehkan pergerakan bebas barangan, perkhidmatan, buruh mahir dan pelaburan di kalangan 10 negara anggota ASEAN serta memudahkan aliran bebas modal. Pengharmonian peraturan-peraturan teknikal dan Mutual Recognition Agreements (MRA) adalah antara strategi yang akan digunapakai oleh AEC untuk mengurangkan kos perdagangan.

Melalui Bahagian Regulatori Farmasi Negara (BRFN), Malaysia mengambil bahagian secara aktif dalam tiga kumpulan kerja yang bertujuan untuk membangunkan skim pengharmonian produk farmaseutikal, ubat-ubatan tradisional dan supplemen kesihatan serta peraturan kosmetik di negara-negara ASEAN. Terdapat tiga kumpulan kerja di bawah ACCSQ iaitu - Pharmaceutical Product Working Group (PPWG), Traditional Medicines and Health Supplements Product Working Group (TMHSPWG) dan ASEAN Cosmetic Committee (ACC).

The ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed in 1992 to facilitate the accomplishment of the objectives of the ASEAN Free Trade Agreement. In 2004, the ACCSQ was tasked to undertake activities in relation to the establishment of an ASEAN Economic Community (AEC).

Launched in 2015, the AEC aims to eventually create a single market and production base within ASEAN countries. This will allow for the free movement of goods, services, skilled labor, and investment among the 10 ASEAN member nations, and facilitate the free flow of capital. Harmonization of technical regulations and mutual recognition agreements (MRA) are among the strategies that will be adopted by the AEC to reduce trade costs.

Through the National Pharmaceutical Regulatory Agency (NPRA), Malaysia actively participates in three product working groups which aim to develop harmonization schemes of pharmaceuticals, traditional medicines and health supplements as well as cosmetics regulations in ASEAN countries. There are three working groups under the ACCSQ – the Pharmaceutical Product Working Group (PPWG), the Traditional Medicines and Health Supplements Product Working Group (TMHSPWG) and the ASEAN Cosmetic Committee (ACC).


127

Berikut merupakan mesyuarat kumpulan kerja yang dihadiri oleh pegawai BRFN:

Below are the working group meetings attended by NPRA officers:

Bil.No.

Nama Mesyuarat Name of meeting

TarikhDate

TempatVenue

1. The Special Heads of Delegations (HOD) Meeting of the Traditional Medicines and Health Supplements Product Working Group (TMHSPWG).

14–15 Mac 2016 Bangkok, Thailand

2. The 23rd Meeting of the Pharmaceutical Product Working Group.

19–20 Mei 2016 Siem Reap, Cambodia

3. The 24th ASEAN Cosmetic Committee Meeting & Its Related Meetings.

23–27 Mei 2016 Hanoi, Vietnam

4. The 7th ASEAN Cosmetic Testing–Laboratory Committee.

25–26 Mei 2016 Hanoi, Vietnam

5. The 25th Meeting of Traditional Medicines and Health Supplements Product Working Group (TMHSPWG).

2–3 Jun 2016 Singapore

6. The Pharmaceutical Product Working Group (PPWG) Heads of Delegations Meeting.

18–19 Ogos 2016 Singapore

7. The 25th ASEAN Cosmetic Committee Meeting & Its Related Meetings.

15–18 November 2016 Brunei Darussalam

8. The 8th ASEAN Cosmetic Testing–Laboratory Committee.

17 November 2016 Brunei Darussalam

9. The 26th Meeting of ASEAN Consultative Committee for Standards & Quality Traditional Medicines and Health Supplement Working Group (ACCSQ TMHS PWG) and its related events.

28 November– 2 Disember 2016

Bangkok, Thailand

Mesyuarat Ke-25 Kumpulan Kerja Traditional Medicines and Health Supplements (TMHSPWG) (31 Mei–3 Jun 2016).The 25th Meeting of Traditional Medicines and Health Supplements Product Working Group (TMHSPWG) (31 May–3 June 2016).


128

Mesyuarat Ke-26 Kumpulan Kerja ASEAN Consultative Committee for Standards & Quality Traditional Medicines and Health Supplement Group (ACCSQ TMHS PWG) (28 November–2 Disember 2016).

The 26th Meeting of ASEAN Consultative Committee for Standards & Quality Traditional Medicines and Health Supplement Working Group (ACCSQ TMHS PWG) (28 November–2 December 2016).

3.0 BRFN SEBAGAI PUSAT KOLABORASI WHO BAGI KAWALAN REGULATORI UNTUK PRODUK FARMASEUTIKAL NPRA AS A WHO COLLABORATING CENTRE FOR REGULATORY CONTROL OF PHARMACEUTICALS

BRFN telah diberi pengiktirafan antarabangsa sebagai “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” pada tahun 1996. Pengiktirafan ini diberikan oleh World Health Organization (WHO) untuk sumbangan BRFN dalam bidang regulatori. Pengiktirafan ini telah menarik minat agensi regulatori luar untuk menjalani latihan di BRFN. Sepanjang 2016, BRFN telah menerima kunjungan lawatan daripada 77 orang pelawat antarabangsa daripada 19 negara.

Pada tahun 2016, BRFN telah memberi latihan kepada pegawai-pegawai dari agensi-agensi regulatori luar seperti Ghana FDA, Maldives FDA, National Medicine Quality Control Laboratory Republic of Sudan & Drug Administration of Vietnam. Skop latihan termasuk penggunaan IT dalam pendaftaran produk, aktiviti pengawasan pasaran, pemeriksaan Amalan Pengilangan Baik serta pengujian makmal untuk produk farmaseutikal, ubat tradisional dan kosmetik.

The NPRA has been given an international recognition as a “WHO Collaborating Centre for Regulatory Control of Pharmaceuticals” in the year 1996. This recognition is an acknowledgement from World Health Organization (WHO) for NPRA’s contribution in the field of regulatory affairs. This recognition has attracted foreign regulatory agencies to undergo training in NPRA. Throughout 2016, NPRA received 77 international visitors from 19 countries around the world.

In 2016, NPRA has given training to officers from other regulatory agencies such as Ghana FDA, Maldives FDA, National Medicine Quality Control Laboratory Republic of Sudan & Drug Administration of Vietnam. The scope of training includes the application of IT in product registration, market surveillance activities, Good Manufacturing Practice inspections as well as laboratory testing for pharmaceutical products, traditional medicines and cosmetics.


129

Selain daripada program-program latihan, BRFN juga aktif mengambil bahagian dalam Forum Serantau Pusat Kolaborasi WHO. Seorang pegawai BPFK telah menghadiri Forum Serantau Pusat Kolaborasi WHO Pasifik Barat kedua yang telah diadakan pada 28-29 November 2016 di Manila, Filipina. Forum ini berfungsi sebagai platform untuk menggalakkan perkongsian aktiviti setiap pusat WHO serta mengukuhkan rangkaian dan komunikasi antara semua CC WHO. Ini akan menggalakkan kerjasama inovatif untuk menyokong pencapaian Matlamat Pembangunan Mampan dalam bidang kesihatan & ubat-ubatan.

Apart from training programmes, NPRA also actively takes part in the Regional Forum of WHO Collaborating Centres. An officer from NPCB attended the 2nd Regional Forum of WHO Collaborating Centres in the Western Pacific which was held on 28-29 November 2016 in Manila, Philippines. The forum serves as a platform to promote and share activities of each WHO CC as well as strengthen the networking and communication between all WHO CC. This in turn will promote innovative collaboration to support the achievement of the Sustainable Development Goals in the field of health & medicines.

Peserta 2nd Regional Forum of WHO Collaborating Centres in the Western Pacific (28-29 November 2016).Participants from the 2nd Regional Forum of WHO Collaborating Centres in the Western Pacific (28-29 November 2016).


130

PENERBITAN & KAJIANPUBLICATIONS AND RESEARCH

PENERBITAN & KAJIAN | PUBLICATIONS AND RESEARCH

POLISI DAN GARIS PANDUAN PATIENT’S OWN MEDICINESPATIENT’S OWN MEDICINES POLICY & GUIDELINE

Program Patient’s Own Medicine (POMs) adalah satu program yang dilaksanakan sebagai salah satu langkah ke arah penjimatan ubat-ubatan di Kementerian Kesihatan Malaysia. Garispanduan POMs telah dibuat dan diedarkan sebagai panduan pengurusan POMs semasa kemasukkan pesakit ke dalam wad di fasiliti kesihatan KKM. Pada peringkat permulaan, program ini akan dilaksanakan di wad-wad perubatan am di semua hospital utama negeri dan hospital pakar major. Pesakit yang dimasukkan ke dalam wad perlu membawa ubat-ubatan yang telah dipreskrib sebelum ini atau dibeli sendiri untuk direkonsil oleh Pegawai Farmasi di wad tersebut. Ubat-ubat tersebut akan digunakan jika bersesuaian dengan keadaan klinikal pesakit semasa mendapatkan rawatan di hospital. Diharap program ini dapat mengoptimakan penggunaan dan mengelakkan pembaziran ubat-ubatan di fasiliti KKM.

Patient’s Own Medicine Program (POMS) is one of the programs implemented as one of the saving measures concerning drug purchasing cost in the Ministry of Health. Pharmacy Practice & Development Division has issued a Guideline for the management of POMS as a guide during the admissions to the wards in MOH health facilities. At the initial stage, the program will be initiated in the medical wards of all state hospitals and major specialist. Patients admitted to the wards need to bring along their prescribed medicines and pharmacists will reconcile these drugs in the ward. These drugs will be given to the patients according to their clinical condition and drug assessment. For patients at discharge, patients will only be supplied drugs recently prescribed by a doctor, and for medicines that should be continued in the future, the pharmacist will review the existing supply and make additional supplies if necessary. Hopefully, this program can optimise the drug utilisation and minimise the drug wastage.

GARIS PANDUAN PERKHIDMATAN TAMBAH NILAI FARMASI (VAS)PHARMACY VALUE ADDED SERVICES GUIDELINES

Satu garis panduan berkenaan pelaksanaan Perkhidmatan Tambah Nilai Farmasi (VAS) secara umum telah dikeluarkan pada 28 November 2016. Dokumen ini mengandungi panduan pelaksanaan VAS yang meliputi prosedur kerja VAS serta pelaporan yang diperlukan daripada pihak negeri berkaitan VAS.

A guideline on general implementation of the Value-Added Services was published on the 28th November 2016. The guide contains the work procedure for VAS and the reports that are required by each state.


132

GARIS PANDUAN PENGENDALIAN BAHAN PSIKOTROPIK DI DEWAN BEDAH FASILITI KESIHATAN KEMENTERIAN KESIHATAN MALAYSIA (KKM)

Garis panduan ini disediakan oleh Bahagian Perkhidmatan Farmasi KKM dengan kerjasama Perkhidmatan Anestesiologi KKM. Ia bertujuan untuk menyeragamkan proses dokumentasi dan memastikan penggunaan bahan psikotropik yang betul dan selamat. Satu pasukan kerja khas telah dibentuk yang melibatkan Bahagian Perkhidmatan Farmasi KKM, Bahagian Penguatkuasaan Farmasi KKM, Perkhidmatan Anestesiologi KKM dan Bahagian Kejururawatan KKM untuk memastikan garis panduan ini adalah praktikal dan memenuhi kehendak pengurusan dan perundangan semasa. Beberapa siri mesyuarat dan sebanyak dua kajian rintis telah dibuat di lima (5) buah hospital iaitu Hospital Kuala Lumpur, Hospital Tengku Ampuan Rahimah, Hospital Kajang, Hospital Selayang dan Hospital Sungai Buloh. Beberapa siri latihan kepada anggota kesihatan terlibat juga telah diadakan di empat (4) zon Semenanjung Malaysia bagi memberi penerangan berkaitan pelaksanaan garis panduan ini.

This guideline was developed by the Pharmaceutical Services Division MOH with cooperation from Anaesthesiology Services MOH. The primary purpose of this document is to standardise the documentation and to ensure suitable and safe use of psychotropics. A task force was formed which includes representatives from Pharmaceutical Services Division MOH, Pharmacy Enforcement Division MOH, Anaesthesiology Services MOH and Nursing Division MOH. A series of panel meetings and two (2) pilot study were conducted in five (5) major hospitals which are Hospital Kuala Lumpur, Hospital Tengku Ampuan Rahimah, Hospital Kajang, Hospital Selayang and Hospital Sungai Buloh. Pharmaceutical Services Division MOH and Anaesthesiology Service MOH also conducted a few training sessions in four (4) zone in Semenanjung Malaysia to facilitate the implementation of this guideline.

KAJIAN PEMANTAUAN HARGA UBAT | MEDICINE PRICES MONITORING SURVEY

Kajian ini bertujuan untuk mengukur harga ubat bagi 27 jenis ubat oleh WHO di sektor awam dan swasta bagi tahun 2011 hingga 2015 di Malaysia dengan menggunapakai metodologi World Health Organisation/Health Action International (WHO/HAI). Hasil kajian ini mendapati di sektor swasta, variasi harga ubat adalah lebih tinggi berbanding sektor awam dan variasi harga runcit adalah lebih tinggi berbanding harga borong. Ini menunjukkan terdapat perbezaan harga dan tiada harga yang seragam di sektor swasta. Purata harga perolehan sektor swasta adalah 4 kali lebih daripada sektor awam. Sementara itu, Median Price Ratio (MPR) di sektor awam adalah 1.83 hingga 2.19 kali berbanding International Reference Price (IRP) di mana menunjukkan perolehan ubat-ubatan yang cekap. Hasil kajian ini selaras dengan hasil kajian Malaysian Health System Research (MHSR) yang mendapati MPR harga perolehan sektor awam bagi sebahagian basket ubat-ubatan di Malaysia telah berkurang daripada 4.5 kali IRP bagi tahun 2010 kepada 2 kali IRP bagi tahun 2014 justeru menunjukkan terdapat penambahbaikan kecekapan perolehan di sektor awam.

The study aims to measure medicine prices of 27 core medicines from WHO in public and private sectors in Malaysia in the year 2011 to 2015 by using a standardised methodology developed by the World Health Organisation/Health Action International (WHO/HAI). The study revealed that in the private sector, the price variation was higher than the public sector and the variations of retail price were more than wholesale price indicating differential pricing and no standard price practised. Furthermore, average private sector procurement prices were four times more than the public sector. The median price ratio (MPR) in the public sector was 1.83 to 2.19 times compared to international reference price (IRP) which indicates an efficient procurement. This finding was consistent with the findings from the Malaysia Health Systems Research (MHSR) Study on public sector procurement prices for selected basket of medicines in Malaysia in which the average weighted MPR decreased between 4.5 times IRP in the year 2010 to 2 times IRP in the year 2014 suggesting improvement in the procurement efficiency.


133

Kajian kos ubat per preskripsi dijalankan setiap 2 tahun bagi pesakit luar di fasiliti kesihatan Kementerian Kesihatan Malaysia. Sejumlah 28,553 dan 28,211 sampel preskripsi bagi tahun 2012 dan 2014 daripada 80 hospital dan 114 klinik kesihatan terlibat dalam kajian ini. Hasil kajian adalah seperti rajah di bawah.

The study aims to measure medicine cost per prescription within out-patient settings of Ministry of Health Malaysia biannually. A total of 28,553 and 28,211 prescriptions were sampled among 80 hospitals and 114 health clinics in the year 2012 and year 2014 respectively. The result of the study as follows.

KAJIAN KOS UBAT PER PRESKRIPSISURVEY ON MEDICINES COST PER PRESCRIPTION

0

5

10

15

20

25

30

35

40

45

50

20142012

Acute per Visit Chronic per Visit Total per Visit Chronic per Month

Kos

Med

ian

| M

edia

n Co

st

5.67

40.39

14.02

18.65

5.88

45.94

15.47

19.91

Kos Ubat Per Preskripsi Berdasarkan Jenis Preskripsi, tahun 2012 dan 2014.Medicines Cost per Prescription per Visit and per Month by Type of Prescription, year 2012 and 2014.

KAJIAN KEBANGSAAN PENGGUNAAN UBAT DALAM KALANGANPENGGUNA DI MALAYSIAA NATIONAL SURVEY ON THE USE OF MEDICINES (NSUM)BY MALAYSIAN CONSUMERS

Diseluruh dunia, usaha untuk meningkatkan kualiti penggunaan ubat-ubatan dalam kalangan pengguna giat dilaksanakan. Usaha yang sama telah dijalankan oleh Bahagian Perkhidmatan Farmasi (BPF), Kementerian Kesihatan Malaysia (KKM).

Justeru, untuk mendapatkan data yang terperinci dan maklumat mengenai isu-isu berkaitan dengan ubat-ubatan dalam kalangan pengguna di Malaysia, satu kajian peringkat kebangsaan telah dijalankan selama 3 bulan (Jun–Ogos 2015) melibatkan 3,081 pengguna di seluruh negara. Hasil kajian tersebut menunjukkan bahawa:

Pengguna Malaysia menggunakan beberapa bentuk sediaan farmaseutikal, sebatian perubatan tradisional dan produk kecantikan dalam kehidupan harian mereka untuk tujuan kesihatan diri, kesejahteraan umum dan penampilan rupa. Daripada ini;

• 30.3% responden menggunakan ubat-ubatan untuk tujuan rawatan penyakit kronik; • 21.5-31.8% responden menggunakan vitamin, garam mineral dan makanan tambahan; • 7.9-16.8% responden menggunakan ubat-ubatan tradisional dalam bentuk minuman herba, herba yang telah

diproses dan belum diproses; dan • 10.9% responden menggunakan produk kecantikan.


134

Initiatives to improve consumer use of medicines are being implemented around the world with an effort to maximise health outcomes. Within this context, Pharmaceutical Services Division (PSD) Ministry of Health Malaysia (MOH) has developed a comprehensive strategy to promote rational medicine use among consumers.

In order to get in-depth data and information on issues related to medicines use among Malaysian consumers, a cross-sectional national survey for was conducted for three months (June-August 2015) which involved 3,081 consumers across the country. The study findings showed that:

Malaysian consumers were found to be using some form of pharmaceuticals, traditional health compounds and beauty products in their everyday life to manage their health, general well-being and appearance. Of these,

• 30.3% of the respondents were on chronic medications, • 21.5-31.8% of the respondents were using vitamins, minerals & supplements, • 7.9-16.8% of respondents were using traditional medicines in the form of herbal beverages, processed and

unprocessed herbs, and • 10.9% of the respondents were using beauty products.

Kajian ini juga mendapati bahawa;1. Doktor adalah tempat rujukan pertama apabila masyarakat mengalami masalah kesihatan. Lebih separuh daripada

responden (58.6%) memilih untuk berjumpa atau rujuk kepada doktor yang bekerja di sektor kerajaan.2. 75.2% daripada responden menganggap bahawa harga ubat adalah satu elemen penting yang perlu

dipaparkan pada label. Tambahan pula, 59.4% daripada responden menyatakan label harga ubat adalah faktor penting dalam mengekalkan kepatuhan ubat.

3. Walaupun pada satu bahagian dalam kajian ini menunjukkan kefahaman pengguna berkaitan ubat-ubatan semakin meningkat dan pengguna lebih sedar tentang isu keselamatan dan kawal selia ubat-ubatan, tahap kepatuhan ubat-ubatan masih menjadi suatu masalah, di mana 73.1% daripada responden mengaku terlupa untuk mengambil ubat-ubatan yang diberikan kepada mereka dan data ini dikaitkan dengan ketidakpatuhan ubat oleh pesakit.

4. 33.9% daripada pengguna dilaporkan berkongsi ubat-ubatan mereka dan situasi ini boleh mengundang masalah kesan perkongsian ubat-ubatan.

5. Individu yang telah mengambil bahagian dalam program ‘Kenali Ubat Anda’, majoritinya berpuas hati dengan aktiviti-aktiviti kempen yang telah dijalankan.

The study also found that;

1. Doctors were the respondents’ first point of reference when experiencing problems with health, with slightly more than half of them (58.6%) opted to consult a doctor in the government sector.

2. 75.2% of the respondents considered the price of medicine as an essential element to be displayed on the label. Furthermore, 59.4% of the interviewees rated price as a factor in maintaining medication compliance.

3. Although an increasing proportion of consumers were more aware of the safety and regulatory issues of medicines, compliance remained a problem, whereby 73.1% of the respondents were declared as non-compliant where they admitted forgotten to take their prescribed medication.

4. An emerging problem with sharing of medicines can be anticipated with as many as 33.9% of consumers reported to be sharing medications.

5. Of those who had participated in the ‘Know Your Medicines’ programme, a majority of the respondents were satisfied with the campaign activities.


135

Program pelatih farmasi adalah direka untuk memberi pendedahan latihan menyeluruh kepada pelatih untuk melaksanakan pelbagai tugas di perkhidmatan farmasi. Di Malaysia, latihan pelatih farmasi di fasiliti kesihatan awam telah wujud sejak tahun 2004 tetapi tidak pernah dinilai secara menyeluruh. Satu kajian kebangsaan telah dilaksanakan pada tahun 2016 untuk menilai tahap kepuasan dan persepsi pelatih farmasi (Provisionally Registered Pharmacists) terhadap latihan mereka di hospital dan klink kesihatan kerajaan. Dalam skala 1 hingga 5, didapati purata markah kepuasan kerja adalah sebanyak 3.32 (SD0.54). Faktor-faktor yang mempengaruhi kepuasan kerja adalah tanggapan keadilan di tempat kerja, tanggapan kompetensi diri selepas latihan setahun, kompetensi pengajar dan farmasi sebagai pilihan laluan kerjaya diri. Secara umumnya, pelatih farmasi berpuas hati dengan latihan farmasi di fasiliti kerajaan di Kementerian Kesihatan Malaysia. Langkah-langkah penambahbaikan yang dicadangkan adalah penilaian semula sasaran yang ditentukan oleh Lembaga Farmasi dan penilaian kompetensi pengajar.

The pharmacy internship program is designed to provide comprehensive training for interns to perform various roles in pharmacy practice. In Malaysia, the current internship program has been in place since the year 2004 in public health facilities but it has never been extensively evaluated. A national survey was conducted in the year 2016 to evaluate the satisfaction level and perception of intern pharmacists (Provisionally Registered Pharmacists) towards their internship training in government hospitals. On a scale of 1 to 5, the mean score of job satisfaction was found be 3.32 (SD 0.54). Factors that influence job satisfaction were found to be perceived fairness at the work place, perceived self-competence after one year of training, preceptors’ competence and pharmacy as a chosen career pathway. Intern pharmacists were fairly satisfied with the internship training in government facilities in Ministry of Health Malaysia. A review of the practicality of targets set by the Pharmacy Board and competency of the preceptors are warranted for further improvement.

KAJIAN KEPUASAN KERJA DI KALANGAN PEGAWAI FARMASIPROVISIONAL DI FASILITI KEMENTERIAN KESIHATAN MALAYSIATHE SATISFACTION AND PERCEPTION OF PROVISIONALLY REGISTERED PHARMACISTS IN MINISTRY OF HEALTH FACILITIES

Antibiotic Point Prevalence Survey telah dilaksanakan di hospital-hospital Kementerian Kesihatan Malaysia (KKM) yang terpilih pada 4 Oktober 2016, serentak dengan pelaksanaan Point Prevalence Survey for Healthcare Associated Infection Surveillance oleh Bahagian Perkembangan Perubatan, KKM. Sebanyak 14 hospital negeri dan 5 hospital tertier terlibat dalam kajian ini. Objektif kajian ialah mengukur prevalens pesakit di wad yang menerima rawatan dengan antibiotik.

Antibiotic Point Prevalence Survey was conducted at selected Ministry of Health (MOH) hospitals on 4 October 2016, simultaneous with the execution of Point Prevalence Survey for Healthcare Associated Infection Surveillance by Medical Development Division, MOH. 14 state hospitals and 5 tertiary hospitals participated in this survey. The objective of the study was to measure the prevalence of hospitalised patients prescribed with antibiotics.

ANTIBIOTIC POINT PREVALENCE SURVEY 2016


136

KAJIAN TECHNICAL EFFICIENCY | TECHNICAL EFFICIENCY STUDY

Kajian ini dilaksanakan dengan tujuan untuk mengukur ‘technical efficiency’ dalam perkhidmatan farmasi di hospital Kementerian Kesihatan Malaysia (KKM). Ia adalah indikator yang sering digunakan untuk mengukur prestasi organisasi dan mengukur tahap penggunaan sumber untuk menghasilkan output perkhidmatan berbanding organsisasi yang lain. Data-data yang digunakan adalah berdasarkan data-data statistik yang diterima setiap tahun. Data lain yang diperlukan dikumpul melalui pengkalan web. Kajian ini dianalisa menggunakan kaedah Data Envelopment Analysis untuk membandingkan relative technical efficiency. Perkhidmatan farmasi di hospital dianalisa mengikut 4 jenis kluster: Hospital Negeri/Daerah, Hospital Pakar Major, Hospital Pakar Minor dan Hospital Bukan Pakar. Skor technical efficiency yang dihasilkan oleh kajian ini dapat membantu pembuat polisi dalam pengurusan sumber manusia dan penetapan sasaran kerja untuk setiap unit di perkhidmatan farmasi. Langkah-langkah penambahbaikan boleh diambil dalam usaha mempertingkatkan lagi prestasi dan pencapaian perkhidmatan farmasi di hospital KKM.

The study aimed to measure the technical efficiency (TE) of Ministry of Health hospital pharmacy services in Malaysia. Technical efficiency is a common indicator to evaluate an organisation’s performance. It shows how well resources are used to produce the service outputs compared to similar organisations. The study uses primary and secondary sources. Panel data were gathered from the annual pharmacy statistics which were collected periodically. Variables that were not available will be collected through a web based system. Analysis of these data was conducted using Data Envelopment Analysis, a mathematical linear programming to measure the relative efficiency of these units. The hospital pharmacy was analysed based on 4 hospital categories: State/tertiary hospital, Major specialist hospital, Minor specialist hospital and Non specialist/District hospital. A set of technical efficiency score was produced that can be utilised to aid policy makers in human resources management and set targets of pharmacy services outputs for each unit. Further actions can be taken to improve the performance of the public hospital pharmacy services.


137

program farmasi - pharmacy.gov.my · letter from the director of pharmacy ... • issuance of...

Documents