PHARMACY PROGRAMMEANNUAL REPORT

LAPORANTAHUNANPROGRAM FARMASI

2 0 142 0 14

Untuk maklumat lanjut, sila hubungi:Bahagian Perkhidmatan Farmasi Kementerian

Kesihatan MalaysiaLot 36, Jalan Universiti,

46350 Petaling Jaya, Selangor Darul Ehsan,

MALAYSIA.Tel: 03 7841 3200

Faks: 03 7968 2222Laman web: www.pharmacy.gov.my

Diterbitkan pada Disember 2015Published on December 2015

For further inquiry, please contact:Pharmaceutical Services Division Ministry of Health, MalaysiaLot 36, Jalan Universiti, 46350 Petaling Jaya, Selangor Darul Ehsan, MALAYSIA.Tel: 03 7841 3200Fax: 03 7968 2222Website: www.pharmacy.gov.my

ISI KANDUNGAN CONTENTS

PENGHARGAAN ACKNOWLEDGEMENTS iv

VISI, MISI & OBJEKTIF VISION, MISSION & OBJECTIVES 1

PENGURUSAN TERTINGGI TOP MANAGEMENT 1

CARTA ORGANISASI ORGANISATIONAL CHART 1

PENGENALAN INTRODUCTION 1

SOROTAN 2014 HIGHLIGHTS 2014 2

PENCAPAIAN ACHIEVEMENTS 20

STATISTIK 2014 STATISCTICS 2014 32

JAWATANKUASA EDITORIAL EDITORIAL COMMITTEE 62

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI vii

PENGHARGAANACKNOWLEDGEMENTS

Jawatankuasa Editorial mengucapkan ribuan terima kasih kepada semua yang telah menyumbang kepada penerbitan laporan ini.

The Editorial Committee would like to thank all who have contributed to the publication of this report.

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 1

VISI, MISI & OBJEKTIFVISION, MISSION & OBJECTIVES

VISI VISION

Menerajui pengurusan berkualiti ke atas ubat-ubatan melalui tenaga kerja yang berdaya saing, sains dan teknologi bersesuaian dan perkongsian dengan semua pihak yang berkepentingan.

Leading in quality management of medicines through a competent workforce and appropriate science and technology development; in partnership with stakeholders.

MISI MISSION

Memastikan ubat-ubatan berkualiti untuk negara.

Ensuring quality medicines for the nation.

OBJEKTIF OBJECTIVE

Memastikan semua keluaran farmaseutikal dan produk penjagaan kesihatan yang berada di pasaran adalah berkualiti, selamat, berkesan dan dikawal mengikut undang-undang yang berkaitan serta digunakan secara rasional.

Ensuring all pharmaceutical and health products in the market are of quality, safe and efficacious, regulated according to relevant legislations and used rationally.

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI2

PENGURUSAN TERTINGGITOP MANAGEMENT

YBHG. DATO’ EISAH BINTI A. RAHMANPengarah Kanan Perkhidmatan Farmasi

Senior Director of Pharmaceutical Services

DR. SALMAH BINTI BAHRIPengarah Penguatkuasaan FarmasiDirector of Pharmacy Enforcement

PUAN ABIDA HAQ BINTI SYED M. HAQPengarah Amalan & Perkembangan Farmasi

Director of Pharmacy Practice & Development

ENCIK TAN ANN LINGPengarah Biro Pengawalan Farmaseutikal

KebangsaanDirector of National Pharmaceutical Control

Bureau

DR. NOUR HANAH BINTI OTHMANTimbalan Pengarah Dasar & Pengurusan Farmasi

Deputy Director of Policy & Pharmacy Management

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 3

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LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI4

PENGENALANINTRODUCTION

Program Farmasi Kementerian Kesihatan Malaysia (KKM) merupakan agensi utama yang bertanggungjawab memastikan ubat-ubatan adalah berkualiti untuk negara.

Program ini diketuai oleh seorang Pengarah Kanan yang bertanggungjawab ke atas empat bahagian utama iaitu Dasar dan Pengurusan Farmasi, Amalan dan Perkembangan Farmasi, Penguatkuasaan Farmasi serta pengawalan regulatori produk farmaseutikal, ubat tradisional dan juga produk kosmetik di Malaysia yang merupakan bidang kuasa Biro Pengawalan Farmaseutikal Kebangsaan. Kesemua aktiviti tersebut memainkan peranan penting dalam aspek-aspek yang berbeza tetapi mempunyai satu matlamat yang sama iaitu untuk memberikan perkhidmatan farmasi yang terbaik kepada orang ramai.

The Pharmacy Programme of the Ministry of Health (MOH) Malaysia is responsible in ensuring the quality of medicines for the nation.

The Programme is headed by a Senior Director who is responsible for four main activities namely Policy & Pharmacy Management, Pharmacy Practice & Development, Pharmacy Enforcement as well as the regulatory control of pharmaceutical products, traditional medicines and cosmetic products in Malaysia, which is under the purview of the National Pharmaceutical Control Bureau (NPCB). Although these activities are carried out through different approaches, they share the ultimate objective of providing the best professional pharmacy service to the public.

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 5

SOROTAN 2014 HIGHLIGHTS 2014

KURSUS DASAR UBAT NASIONAL (DUNas)MALAYSIAN NATIONAL MEDICINES POLICY AWARENESS COURSE

BENGKEL PENYEDIAAN GARIS PANDUAN PENGENDALIAN ORPHAN DRUGS WORKSHOP ON THE GUIDELINES ON THE MANAGEMENT OF ORPHAN DRUGS

BENGKEL VACCINE LOT RELEASEWORKSHOP ON VACCINE LOT RELEASE

BENGKEL PEMERIKSAAN BIOEKUIVALEN: ASPEK KLINIKAL DAN BIOANALITIKAL WORKSHOP ON BIOEQUIVALENCE INSPECTION: CLINICAL AND BIOANALYTICAL ASPECTS

KURSUS AMALAN KLINIKAL BAIK GOOD CLINICAL PRACTICE (GCP) COURSE

PROGRAM PUSAT TRANFORMASI LUAR BANDARRURAL TRANSFORMATION CENTRE PROGRAMME

MESYUARAT TEKNIKAL DUA HALA KE-3 DENGAN HEALTH SCIENCES AUTHORITY, SINGAPURA3RD TECHNICAL BILATERAL MEETING WITH HEALTH SCIENCES AUTHORITY, SINGAPORE

KARNIVAL FARMASI 2014THE PHARMACEUTICAL CARNIVAL 2014

KURSUS ‘1-DAY PAEDIATRIC UPDATES 2014’‘1-DAY PAEDIATRIC UPDATES 2014’ WORKSHOP

BENGKEL PENGURUSAN KESAKITAN: PRINSIP DAN AMALAN BAGI UBAT-UBAT TAHAN SAKITPAIN MANAGEMENT WORKSHOP: PRINCIPAL & PRACTICE OF PAIN MEDICINE

PERSIDANGAN CARDIOLOGY UPDATES KALI KE-3, 20143RD CARDIOLOGY UPDATES CONFERENCE 2014

KURSUS ASEPTIK BAGI PEGAWAI FARMASIASEPTIC COURSE FOR PHARMACIST

KURSUS PENGUKUHAN PROFESION PENOLONG PEGAWAI FARMASIBUILDING PROFESSION FOR THE PHARMACIST ASSISTANCE SHORT COURSE

PERSIDANGAN PENYELIDIKAN DAN PEMBANGUNAN FARMASI KEBANGSAAN KE-8, 20148TH NATIONAL PHARMACY RESEARCH AND DEVELOPMENT (R&D) CONFERENCE 2014

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI6

1. KURSUS DASAR UBAT NASIONAL (DUNas) MALAYSIAN NATIONAL MEDICINES POLICY (MNMP) COURSE

BilNo.

PerkaraSubject

TarikhDate

Bil PesertaNumber of Participants

1.

Kursus DUNas bagi Zon Tengah (Negeri Selangor, WP Kuala Lumpur / Putrajaya, Perak dan HKL)Central Zone MNMP Course(Selangor, Kuala Lumpur / Putrajaya, Perak and HKL)

21- 22/4/2014 35

2.

Kursus DUNas Zon Selatan (Negeri Melaka, Negeri Sembilan dan Johor)Southern Zone MNMP Course(Melacca, Negeri Sembilan and Johor)

21-22/5/2014 35

3.

Kursus DUNas Zon Timur(Negeri Kelantan, Terengganu dan Pahang)Eastern Zone MNMP Course(Kelantan, Terengganu and Pahang)

18-19/6/2014 35

4.Kursus DUNas Zon Utara(Negeri Pulau Pinang, Kedah dan Perlis)Northern Zone MNMP Course (Penang, Kedah and Perlis)

18-19/8/2014 35

5. Kursus DUNas Zon Sabah, Sarawak dan LabuanSabah, Sarawak and Labuan Zone MNMP Course 20-21/10/2014 35

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 7

Dasar Ubat Nasional (DUNas)

DUNas merupakan satu komitmen kerajaan yang melibatkan usahasama sektor awam dan swasta sejak tahun 2006. Objektif DUNas adalah untuk menggalakkan keperolehan yang sama rata dan penggunaan yang rasional ubat-ubatan penting yang berkualiti, selamat, berkesan dan mampu dimiliki bagi meningkatkan tahap kesihatan rakyat. Dasar ini mengutamakan matlamat jangka panjang dan sederhana yang telah ditetapkan oleh kerajaan. Rangka kerja DUNas disediakan oleh pelbagai pihak berkepentingan yang terdiri daripada wakil agensi kerajaan, badan profesional, industri, persatuan pengguna, ahli akademik dan organisasi bukan kerajaan.

DUNas telah memasuki penggal kedua (2013-2017). Kesedaran terhadap pengemaskinian pada dasar sedia ada dan perancangan strategi dan aktiviti DUNas Penggal Kedua telah dihasilkan melalui kursus-kursus yang diadakan di Zon Tengah, Selatan, Timur, Utara, dan Sabah, Sarawak dan Labuan sepanjang tahun 2014. Kursus-kursus tersebut telah melibatkan pegawai-pegawai farmasi dari setiap negeri. Matlamat kursus kesedaran adalah untuk melatih para peserta supaya dapat menyebarkan maklumat DUNas terkini kepada semua pengamal penjagaan kesihatan serta meningkatkan komitmen mereka ke arah pencapaian objektif DUNas.

Malaysian National Medicines Policy (MNMP)

MNMP is the government’s commitment involving the public-private sector engagement since year 2006. The objective of MNMP is to promote equitable access and rational use of safe, effective and affordable essential medicines of good quality towards achieving optimal health outcomes. The policy prioritizes the long term and the intermediate goal set by the government. The MNMP framework had been prepared by various stakeholders from the government agencies, professional bodies, industry associations, consumer associations, academicians and the non-government organisations (NGOs’).

The MNMP is now embarking its journey in the second phase (2013-2017). The policy had been reviewed with some amendments on the master plan and strategies. In order to have continuity from the previous phase, the awareness courses and training has been held in all zones throughout the country. It was attended by the representative pharmacists from all states. The purpose of conducting the courses was to train the participants as to disseminate the information of MNMP to the other healthcare providers as well as to encourage the commitments to match the MNMP objectives.

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI8

2. BENGKEL PENYEDIAAN GARIS PANDUAN PENGENDALIAN ORPHAN DRUGS WORKSHOP ON THE GUIDELINES ON THE MANAGEMENT OF ORPHAN DRUGS

Bengkel ini telah diadakan pada 2 hingga 4 Disember 2014 di Klana Resort, Seremban. Tujuan bengkel ini adalah untuk menyediakan Garis Panduan Pengendalian Orphan Drugs. Penyediaan garis panduan tersebut merupakan salah satu aktiviti di bawah strategi DUNas dengan matlamat meningkatkan keperolehan ubat penyelamat nyawa dan ubat orphan tanpa menjejaskan aspek keselamatan, kualiti dan keberkesanan. Seramai tiga puluh dua (32) peserta dari Bahagian Perkhidmatan Farmasi, hospital kerajaan, Bahagian Perolehan dan Penswastaan Kementerian Kesihatan, industri farmaseutikal, persatuan dan kumpulan wakil pesakit telah menjayakan bengkel ini.

Penghasilan garis panduan ini akan digunakan dan dijadikan rangka kerja dan panduan bersama oleh pelbagai pihak berkepentingan yang terlibat. Pengendalian ubat orphan yang diselaraskan secara cekap dan bersepadu dapat memanfaatkan pesakit serta membolehkan keperolehan ubat orphan dicapai secara berkesan.

Draf garis panduan telah dihasilkan di akhir bengkel yang berlangsung selama tiga hari ini. Usaha-usaha para peserta telah menghasilkan bab-bab yang berikut:

• Pengenalan, objektif, definisi ubat orphan

• Designasi dan pendaftaran ubat orphan

• Penyenaraian ubat orphan ke dalam formulari ubat

• Peruntukan dan perolehan ubat orphan

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 9

The workshop was held on 2nd to 4th December 2014 at Klana Resort, Seremban. The outcome was to prepare the Draft Guidance on Orphan Drugs. The Draft Guidance on Orphan Drugs is one of the activities under MNMP strategies with the aim to improve access of lifesaving and orphan drugs without compromising the safety, quality and efficiency aspects. A total of 32 participants from the Pharmaceutical Services Division, government hospitals, MOH Procurement and Privatization Division, pharmaceutical Industry, organisation and patient group representatives succeeded the workshop.

The Draft of this guideline has successfully being outlined as follows:

• Introduction, Objective, Definition of Orphan Drugs

• Designation and registration of orphan drugs

• Listing of the orphan drug in the MOH formulary

• Allocation and procurement of the orphan drug

The development of this Orphan Drugs Guideline will be used as a mutual framework and guidance by the stakeholders. The proper management of orphan drug will benefit patients who are the end user in having access to orphan drugs efficiently.

Workshop on the Guidelines on the Management of Orphan Drugs

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI10

3. BENGKEL VACCINE LOT RELEASE WORKSHOP ON VACCINE LOT RELEASE

Bengkel Vaccine Lot Release anjuran bersama Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) dan World Health Organisation (WHO) Malaysia telah diadakan pada 23 hingga 27 Jun 2014 di Hotel Armada, Petaling Jaya dengan penceramah daripada Kementerian Kesihatan Awam, Thailand. Sejumlah 25 orang peserta dari BPFK telah menghadiri bengkel ini.

Tujuan bengkel ini adalah untuk memberi latihan kepada pegawai-pegawai dari BPFK dalam aktiviti Vaccine Lot Release yang meliputi penilaian lot summary protocol, analisis statistik dan membuat keputusan.

The Workshop on Vaccine Lot Release was organised by the National Pharmaceutical Control Bureau (NPCB) in collaboration with World Health Organisation (WHO) Malaysia from 23 to 27 June 2014 at Armada Hotel, Petaling Jaya with guest speakers from the Ministry of Public Health, Thailand. A total of 25 participants from NPCB attended the workshop.

The objective of this workshop is to provide training to officers from NPCB on the Vaccine Lot Release activity which includes lot summary protocol review, statistical analysis and decision making.

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BPFK telah menganjurkan bengkel bertajuk Bioequivalence Inspection: Clinical and Bioanalytical Aspects pada 26 hingga 28 Ogos 2014 di Kuala Lumpur Convention Centre, Kuala Lumpur. Penceramah jemputan bagi bengkel ini adalah Dr. Arindam Dasgupta. Beliau merupakan seorang ahli farmakologi dari US Food and Drug Administration (US FDA). Seramai 50 orang peserta telah menyertai bengkel ini. Antaranya termasuk pegawai dari BPFK serta wakil dari pusat kajian bioekuivalen tempatan dan luar negara seperti Mesir, Indonesia, Singapura, Taiwan, Thailand dan Viet Nam.

The NPCB successfully organised a Workshop on Bioequivalence Inspection: Clinical and Bioanalytical Aspects at Kuala Lumpur Convention Centre, Kuala Lumpur on 26 to 28 August 2014. The guest speaker was Dr. Arindam Dasgupta, a pharmacologist from the Center for Drug Evaluation and Research, US Food and Drug Administration (US FDA). A total of 50 participants, including officers from NPCB as well as representatives from local and overseas bioequivelance (BE) centres such as Egypt, Indonesia, Singapore, Taiwan, Thailand and Viet Nam attended the 3-day workshop.

4. BENGKEL PEMERIKSAAN BIOEKUIVALEN: ASPEK KLINIKAL DAN BIOANALITIKAL WORKSHOP ON BIOEQUIVALENCE INSPECTION: CLINICAL AND BIOANALYTICAL ASPECTS

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI12

Empat puluh lima kursus GCP yang melibatkan sebanyak 2,174 orang peserta telah dianjurkan oleh Pusat Penyelidikan Klinikal, Kementerian Kesihatan Malaysia, institusi swasta dan universiti pada tahun 2014 di mana Pusat Kajian Produk Baru, BPFK memainkan peranan penting dalam memberi ceramah dan menyelaraskan peperiksaan GCP. Bermula pada tahun 2012, sijil untuk semua peserta yang lulus dalam peperiksaan GCP telah dikeluarkan oleh BPFK yang bertindak sebagai sekretariat kepada Jawatankuasa Penyelidikan Klinikal Kebangsaan (JPKK). Dengan ini, BPFK telah mengeluarkan sebanyak 1,811 sijil GCP termasuk bagi peserta yang lulus dalam peperiksaan ulangan dalam tahun 2014.

Forty five GCP courses which involved 2,174 participants were organised by the Clinical Research Centre, MOH, private institutions and universities in the year 2014 whereby the Centre for Investigational New Product (CINP), NPCB played an important role in giving lectures and coordinating the GCP examinations. Starting from the year 2012, the certificates for all participants who passed the GCP examination were issued by NPCB who acts as the secretariat to the National Committee for Clinical Research (NCCR). The NPCB issued a total of 1,811 certificates which included re-sit participants in the year 2014.

6. PROGRAM PUSAT TRANFORMASI LUAR BANDAR RURAL TRANSFORMATION CENTRE PROGRAMME

5. KURSUS AMALAN KLINIKAL BAIK GOOD CLINICAL PRACTICE (GCP) COURSE

Pusat Komplians dan Pelesenan, BPFK terlibat dalam menganjurkan latihan kepada industri untuk program Pusat Tranformasi Luar Bandar. Sebanyak tiga seminar telah dijalankan iaitu:

The Centre for Compliance and Licensing, NPCB was involved in organising training under the Rural Tranformation Centre (RTC) programme for the industry. Three seminars were conducted as listed below:

BilNo.

ZonZone

TarikhDate

LokasiLocation

Bilangan PesertaNumber of Participants

a) Zon TengahCentral Zone 2 - 3 September 2014 Pejabat BPFK,

Selangor 56

b) Zon SelatanSouthern Zone 28 - 29 Oktober 2014 M Suites Hotel,

Johor Bahru, Johor 44

c) Zon UtaraNorthern Zone 25 - 26 November 2014 Hotel Cititel Penang,

Pulau Pinang 46

Objektif seminar ini adalah:(i) Memberikan pendedahan kepada para peserta

berkaitan kawalan ubat tradisional dan produk kosmetik di Malaysia

(ii) Memberi kemahiran asas kepada para peserta membuat pendaftaran ubat tradisional dan notifikasi produk kosmetik di atas talian

(iii) Memberi kefahaman asas berkaitan keperluan Amalan Pengilangan Baik (APB) dan Amalan Edaran Baik (AEB)

The objectives of the training are:(i) To give exposure to the participants on matters

regarding regulatory control of traditional medicines and cosmetic products in Malaysia

(ii) To give basic knowledge to the participants on the online registration and notification process of traditional medicines and cosmetic products

(iii) To give basic understanding on matters regarding Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP)

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 13

7. MESYUARAT TEKNIKAL DUA HALA KE-3 DENGAN HEALTH SCIENCES AUTHORITY, SINGAPURA 3RD TECHNICAL BILATERAL MEETING WITH HEALTH SCIENCES AUTHORITY, SINGAPORE

Malaysia dan Singapura telah berjaya menandatangani Memorandum Persefahaman (MoU) berkaitan regulatori farmasi pada 28 Mac 2012.

Susulan daripada MoU tersebut, Mesyuarat Teknikal Dua Hala ke-3 telah diadakan di antara BPFK dan pihak Health Sciences Authority (HSA), Singapura pada 15 Ogos 2014 di Bahagian Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia, Petaling Jaya.

Delegasi dari kedua-dua buah negara telah mengadakan perbincangan secara berkumpulan yang meliputi aspek pendaftaran produk, penguatkuasaan farmasi dan Amalan Perkilangan Baik. Perbincangan tersebut membutirkan peranan kedua-dua institusi ini di dalam meningkatkan hubungan kerja sedia ada serta mengukuhkan kerjasama antara Malaysia dan Singapura dalam regulatori farmasi untuk faedah bersama.

On 28th March 2012, Malaysia and Singapore signed their first Memorandum of Understanding (MoU) related to pharmaceutical regulatory matters.

Following the signing of the said MoU, the 3rd

Technical Bilateral Meeting between NPCB and Health Sciences Authority (HSA), Singapore was held at the Pharmaceutical Services Division, Ministry of Health Malaysia, Petaling Jaya on 15th

August 2014.

Both delegations carried out a joint group discussion which covered the aspects of product registration, pharmacy enforcement and Good Manufacturing Practices. The discussion detailed the role of both institutions in enhancing the existing work relationship and strengthening the cooperation between Malaysia and Singapore in the pharmaceutical regulatory field for the benefit of both countries.

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Bahagian Penguatkuasaan Farmasi, Kementerian Kesihatan Malaysia telah menganjurkan Karnival Farmasi 2014 pada 1 November 2014 bertempat di Dewan Tunku Putra Kuala Nerang, Kedah. Karnival ini telah dirasmikan oleh Yang

Berhormat ADUN Kuala Nerang, Dato’ Badrol Hisham Bin

Hashim.

Objektif utama penganjuran karnival ini adalah untuk menyampaikan maklumat dan memberi kesedaran kepada masyarakat berkaitan penggunaan ubat berdaftar dan kawalan ubat-ubatan di Malaysia. Matlamat karnival ini adalah supaya masyarakat dapat mengenalpasti dan memahami ciri-ciri ubat berdaftar, cara penggunan ubat yang betul, risiko serta kesan penggunaan ubat tidak berdaftar sejajar dengan tema karnival ini iaitu “Pakat Mai Kenai Ubat”

Program ini juga bertujuan untuk memperkenalkan profesion farmasi yang meliputi aspek penguatkuasaan farmasi, klinikal, akademik dan farmasi komuniti kepada masyarakat setempat. Aktiviti seperti pemeriksaan kesihatan, pameran ubat-ubatan, pertandingan aktiviti rakyat, cabutan bertuah dan hadiah-hadiah menarik telah berjaya menarik 1,000 orang pengunjung yang terdiri daripada penduduk tempatan dan kawasan sekitar daerah Kuala Nerang untuk hadir.

8. KARNIVAL FARMASI 2014

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THE PHARMACEUTICAL CARNIVAL 2014

On 1st November 2014, the Pharmacy Enforcement

Division, Ministry of Health organised The Pharmaceutical Carnival 2014 at Dewan Tunku

Putra Kuala Nerang, Kedah. The carnival was officiated by the Honorable Assemblyman of Kuala Nerang, Dato’ Badrol

Hisham Bin Hashim.

The main objective of this carnival was to disseminate information and create awareness among the public on the use of registered medicine and drug control in Malaysia. In accordance with the carnival ‘s theme which was “Pakat Mai Kenai Ubat”, the aim of this carnival was to educate the public to identify the characteristic of registered medicines, enlighten them about the safe and correct usage of medicines and the risks of using unregistered medicines.

The program also aimed to introduce the profession of pharmacy, which includes the aspect of drug enforcement, clinical, academic and community pharmacy to the local community. Health screening services, medicine exhibitions, competitions, prize drawing and attractive prizes were given out during the carnival which attracted 1,000 visitors comprising of local residents and people who came from the other areas around Kuala Nerang.

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Satu kursus telah diadakan pada 11 September 2014 di Dewan Serai Wangi, BPFK mengenai penjagaan farmasi pediatrik. Pakar-pakar perunding dalam bidang masing-masing telah dijemput sebagai penceramah semasa bengkel tersebut. Seramai 51 peserta yang terlibat secara aktif dalam penjagaan pesakit pediatrik telah menghadiri bengkel ini.

This workshop is held on the 11th September 2014, at Dewan Serai Wangi, BPFK.

Various experts in the respective field were invited as speakers during the workshop. A total of 51 participants, who are actively involved in paediatric patient care, attended the workshop.

9. KURSUS ‘1-DAY PAEDIATRIC UPDATES 2014’ ‘1-DAY PAEDIATRIC UPDATES 2014’ WORKSHOP

Kursus ini bertujuan untuk:

i) Memperkenalkan kepada pegawai Farmasi pediatrik mengenai penyakit-penyakit biasa dalam bidang pediatrik ii) Mengemaskini rawatan farmakoterapi untuk pesakit pediatrikiii) Untuk menghuraikan kepentingan, keberkesanan dan kesan buruk rawatan

The objectives for this workshop are:

i) To provide peadiatric pharmacists with a review of common diseases in the field of paediatrics.ii) To update pharmacotherapy treatment for paediatric patientsiii) To elaborate the importance, efficacy and adverse effect of treatment

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Bengkel ini telah dijalankan pada 1 hingga 3 April 2014 di Hotel Hilton, Petaling Jaya. Objektif bengkel ini ialah:

i) Membantu peserta mengenalpasti patofisiologi, definisi dan jenis kesakitanii) Meningkatkan pemahaman pegawai farmasi terhadap pengurusan kesakitaniii) Mengaplikasi pengetahuan tentang pengurusan kesakitan terhadapn pesakit dalam situasi sebenar

Beberapa pakar perunding anaestesiologi dari Hospital Raja Permaisuri Bainun Ipoh & Hospital Selayang telah dijemput sebagai penceramah. Penceramah utama ialah Prof Dr. Roger Knaggs dari Department of Clinical Pharmacy Practice, University of Nottingham United Kingdom.

This workshop was held on the 1st until 3rd of April 2014 in Hilton Hotel, Petaling Jaya. The objectives for this workshop are:

i) To help the participants understand the pathophysiology, definition and types of painii) To improve pharmacists’ understanding on pain managementiii) To apply the knowledge of pain management on the treatment of patient in actual practise

A few consultant anaesthesiologists from Hospital Raja Permaisuri Bainun Ipoh & Hospital Selayang were invited as the speakers during the workshop. The main speaker was Prof Dr. Roger Knaggs who works in the Department of Clinical Pharmacy Practice, University of Nottingham United Kingdom.

10. BENGKEL PENGURUSAN KESAKITAN : PRINSIP DAN AMALAN BAGI UBAT-UBAT TAHAN SAKIT PAIN MANAGEMENT WORKSHOP: PRINCIPAL & PRACTICE OF PAIN MEDICINE

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Kumpulan profesional dari sektor kesihatan seluruh Malaysia telah berkumpul di Konferens Cardiology Updates kali ke-3, 2014 yang telah diadakan di Hotel Pullman Bangsar Kuala Lumpur pada 5 dan 6 Mei 2014.

Objektif konferens ini adalah:i) Memberikan maklumat terkini mengenai pengurusan pengakit kardiovaskularii) Menambahkan pengetahuan dalam pengurusan penyakit kardiovaskular untuk pesakitiii) Mendapatkan perkembangan terkini bagi pegawai farmasi khusus dalam bidang r awatan kardiologi

Kumpulan profesional kesihatan yang menyertai konferens ini diharapkan dapat menambah lebih pengetahuan dan mengaplikasikan semasa bertugas merawat pesakit.

Healthcare professionals from all over Malaysia who are responsible to manage patient with cardiovascular disease gathered at the 3rd

Cardiology Update conference held in Pullman Bangsar Hotel, Kuala Lumpur, from 5th to 6th of May 2014.

Objectives of this Cardiology Updates are:i) To provide updates on the latest management of cardiovascular diseaseii) To gain knowledge in the management of cardiovascular disease for the improved care of patients with cardiovascular diseaseiii) To obtain future insights of pharmacist specialised in cardiology

After the 2-day conference, healthcare professionals such as doctors, pharmacists, nurses and general practitioners were provided with knowledge on the latest management on cardiovascular disease and its pharmacotherapy. With this new knowledge and experiences gained during this conference, we hope it would help all the healthcare professionals who attended this conference are able to apply these new knowledge at their respective health care setting.

11. PERSIDANGAN CARDIOLOGY UPDATES KALI KE-3, 2014 3RD CARDIOLOGY UPDATES CONFERENCE 2014

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Kursus ini telah diadakan pada 31 Oktober hingga 2 November 2014 yang bertempat di Hotel Concorde Inn Sepang. Kursus ini melibatkan seramai lebih kurang 100 orang Pegawai Farmasi pelbagai gred yang bertugas di unit aseptik.

Tujuan kursus ini diadakan ialah:

i. Meningkatkan kefahaman mengenai konsep Amalan Penyediaan Baik – Good Preparation Practice (GPP) semasa menyediakan produk sterilii. Memantapkan kemahiran teknik aseptik di kalangan Pegawai Farmasi iii. Menyediakan satu platform untuk berkongsi pengalaman klinikal dalam mengendalikan isu penjagaan farmaseutikal berkaitan bidang kepakaran masing-masing (sokongan nutrisi, farmasi onkologi dan farmasi nuklear)

Pakar dalam bidang masing-masing telah dijemput sebagai penceramah di sepanjang bengkel diadakan.

12. KURSUS ASEPTIK BAGI PEGAWAI FARMASI ASEPTIC COURSE FOR THE PHARMACISTS

This course was done on the 31st of October until 2nd of November in Concorde Inn, Sepang. There were approximately 100 participants among pharmacists from all level who are currently working in the aseptic unit present in this workshop.

The objectives of this course are:

i. To increase understanding in the Good Preparation Practice while preparing the productsii. To improve aseptic techniqueiii. As a platform for the pharmacist from different unit of specialty (parenteral nutrition, oncology & nuclear) to share insights and experiences

The speakers were among the practising pharmacists in the subspecialty unit.

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Kursus ini telah diadakan pada 4 hingga 6 November 2014 yang bertempat di Institut KWSP, Bangi, Selangor. Kursus ini melibatkan seramai lebih kurang 60 orang Penolong Pegawai Farmasi yang bertugas di hospital dan klinik kesihatan.

Tujuan kursus ini diadakan ialah:

i. Meningkatkan pengetahuan dan kemahiran dalam kalangan para peserta berkenaan aktiviti-aktiviti farmasi yang dilaksanakan sama ada di klinik kesihatan mahupun hospital

ii. Menanam nilai-nilai positif supaya sentiasa mengutamakan fungsi dan peranan para peserta di tempat tugas masing-masing

iii. Memperkembangkan idea dan inovasi bagi memantapkan kualiti penyampaian perkhidmatan farmasi yang diberikan seiring dengan peredaran masa

Beberapa orang Pegawai Farmasi dan penolong Pegawai Farmasi yang mempunyai kemahiran di dalam bidang masing-masing telah dijemput sebagai penceramah di sepanjang kursus ini diadakan.

The course was held from 4th to 6th November 2014 at EPF Institute, Bangi, Selangor. The course involved approximately 60 pharmacist assistants who were currently working in the hospitals as well as the health clinics.

The aims of this course are:

i. Increase the knowledge and skills among the participants about the ongoing activities done in the hospitals or health clinics

ii. Cultivate positive values in order to prioritise the functions and roles and responsibilities

iii. To develop ideas and innovations for the improvement of quality of pharmaceutical care

A few pharmacists and pharmacist assistants who have expertise in their respective fields were invited as speakers during this course.

13. KURSUS PENGUKUHAN PROFESION PENOLONG PEGAWAI FARMASI BUILDING PROFESSION FOR THE PHARMACIST ASSISTANCE SHORT COURSE

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Persidangan ini telah dilaksanakan pada 10 hingga 12 Jun 2014 di Hotel The Grand BlueWave, Shah Alam. Persidangan dilaksanakan dengan kerjasama Persatuan Farmasi Malaysia. Persidangan telah dirasmikan oleh Yang Berhormat Datuk Seri Dr. S. Subramaniam, Menteri Kesihatan Malaysia dengan tema ‘Quality Research: Transforming Universal Excellence’. Sejumlah 80 dan 36 kajian telah dibentang secara persembahan oral dan poster oleh 107 orang pegawai farmasi yang mengambil bahagian. Jumlah kehadiran peserta persidangan ini adalah seramai 359 orang yang terdiri daripada pegawai farmasi dan penolong pegawai farmasi dari fasiliti-fasiliti Kementerian Kesihatan Malaysia.

14. PERSIDANGAN PENYELIDIKAN DAN PEMBANGUNAN FARMASI KEBANGSAAN KE-8, 2014 8TH NATIONAL PHARMACY RESEARCH AND DEVELOPMENT (R&D) CONFERENCE 2014

The 8th National Pharmacy R&D Conference was organised on 10th to 12th June, 2014 at Grand BlueWave Hotel, Shah Alam. It was a joint collaboration with Malaysia Pharmaceutical Society. The conference was officiated by Honourable Datuk Seri Dr. S. Subramaniam, Minister of Health Malaysia, with the theme ‘Quality Research: Transforming Universal Excellence’. There were 80 and 30 researches presented via oral and poster respectively by 107 pharmacists. A total number of 359 pharmacists and pharmacist assistants from Ministry of Health facilities had participated in the conference.

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PENCAPAIANACHIEVEMENTS

PELAKSANAAN AKTIVITI VACCINE LOT RELEASE DI MALAYSIAIMPLEMENTATION OF VACCINE LOT RELEASE ACTIVITY IN MALAYSIA

PEMBANGUNAN MONOGRAF HERBA MALAYSIADEVELOPMENT OF THE MALAYSIAN HERBAL MONOGRAPH

SKOP AKREDITASI MS ISO/IEC 17025:2005MS ISO/IEC 17025:2005 SCOPE OF ACCREDITATION

EKOSISTEM KONDUSIF SEKTOR AWAM (EKSA)PUBLIC SECTOR CONDUSIVE ECOSYSTEM (EKSA)

KOMPILASI PENYELIDIKAN DAN PEMBANGUNAN COMPILATION OF RESEARCH & DEVELOPMENT

PELABELAN HARGA UBAT PADA BUNGKUSAN PENDISPENSAN DI FARMASI KKMPRICE LABELLING OF DISPENSED MEDICINES IN THE MOH PHARMACIES

PANDUAN HARGA PENGGUNACONSUMER PRICE GUIDE

PHARMACY INFORMATION SYSTEM (PhIS DAN CPS)PHARMACY INFORMATION SYSTEM (PhIS AND CPS)

AKREDITASI PROGRAM IJAZAH FARMASIACCREDITATION OF PHARMACY PROGRAMME

KAJIAN NATIONAL SURVEY EXPLORING ON CONSUMER SATISFACTION & PERCEPTION TOWARDS MEDICINES DISPENSING SERVICESURVEY ON CONSUMER SATISFACTION & PERCEPTION TOWARDS MEDICINES DISPENSING SERVICE

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI24

Aktiviti Vaccine Lot Release telah mula dilaksanakan secara projek perintis dari 1 Julai 2014 hingga 31 Disember 2014 yang melibatkan vaksin-vaksin tertentu, contohnya Bacillus Calmette-Guérin (BCG), Diphtheria, Tetanus, Pertussis (DTP), Hepatitis B (HepB), Haemophilus Influenzae Type B (Hib), Polio dan Human Papillomavirus (HPV). Ini akan diikuti dengan pelaksanaan sepenuhnya bermula 1 Januari 2015. Aktiviti ini merangkumi penilaian dokumen Lot Summary Protocol dan pemeriksaan rangkaian sejuk ke atas setiap lot vaksin yang dibawa masuk ke Malaysia. ‘Guidance Document and Guidelines for Vaccine Lot Release in Malaysia’ telah diterbitkan dan digunapakai mulai 1 Julai 2014.

‘Guidance Document and Guidelines for Vaccine Lot Release in Malaysia’ telah

diterbitkan dan digunapakai mulai 1 Julai 2014.

A pilot study for Vaccine Lot Release was conducted from 1st July 2014 to 31 December 2014 which involved selected vaccines such as Bacillus Calmette-Guérin (BCG), Diphtheria, Tetanus, Pertussis (DTP), Hepatitis B (HepB), Haemophilus Influenzae Type B (Hib), Polio and Human Papillomavirus (HPV). This will be followed by the full implementation for all vaccines starting from 1 January 2015 onwards. This activity involves evaluation of Lot Summary Protocol and cold chain inspection on all lots of vaccines imported into Malaysia. The ‘Guidance Document and Guidelines for Vaccine Lot Release in Malaysia’ was published and enforced starting 1 July 2014.

The ‘Guidance Document and Guidelines for Vaccine

Lot Release in Malaysia’ was published and enforced starting

1 July 2014.

PENCAPAIANACHIEVEMENTS

1. PELAKSANAAN AKTIVITI VACCINE LOT RELEASE DI MALAYSIA IMPLEMENTATION OF VACCINE LOT RELEASE ACTIVITY IN MALAYSIA

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Pada tahun 2014, sebanyak 15 Monograf Herba telah diterbitkan, iaitu:

a) Persicaria minor (Huds.) Opiz (Kesum Leaves and Twigs)b) Moringa oleifera Lam. (Merunggai Leaves)c) Elaeis guineensis Jacq. Palma (Kelapa sawit leaves)d) Zingiber zerumbet L. Smith (Lempoyang rhizome)e) Piper sarmentosum Roxb. (Kadok Leaves)f) Clinacanthus nutans Lindau (Belalaigajah Leaves)g) Curcuma xanthorrhiza Roxburgh (TemuLawak rhizome)h) Sennaalata (L.) Roxb. (Gelenggang Leaves)i) Cosmos caudatus Kunth (Ulam raja leaves)j) Piper betle L. (Sireh leaves)k) Melasto mamalabathricum (Senduduk leaves)l) Gynura procumbents (Lour.) Merr (Sambungnyawa leaves)m) Tinospora crispa (L.) Hook. F & Thomson (Patawali stem)n) Zingiber officinale var. rubrum ( Haliabara rhizome)i) Ocimum basilicum (Selasih leaves)

In 2014, 15 Herbal Monographs were published as listed below:

a) Persicaria minor (Huds.) Opiz (Kesum Leaves and Twigs)b) Moringa oleifera Lam. (Merunggai Leaves)c) Elaeis guineensis Jacq. Palma (Kelapasawit leaves)d) Zingiber zerumbet L. Smith (Lempoyang rhizome)e) Piper sarmentosum Roxb. (Kadok Leaves)f) Clinacanthus nutans Lindau (Belalaigajah Leaves)g) Curcuma xanthorrhiza Roxburgh (TemuLawak rhizome)h) Sennaalata (L.) Roxb. (Gelenggang Leaves)i) Cosmos caudatus Kunth (Ulam raja leaves)j) Piper betle L. (Sireh leaves)k) Melasto mamalabathricum (Senduduk leaves)l) Gynura procumbents (Lour.) Merr (Sambungnyawa leaves)m) Tinospora crispa (L.) Hook. F & Thomson (Patawali stem)n) Zingiber officinale var. rubrum ( Haliabara rhizome)o) Ocimum basilicum (Selasih leaves)

2. PEMBANGUNAN MONOGRAF HERBA MALAYSIA DEVELOPMENT OF THE MALAYSIAN HERBAL MONOGRAPH

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Pada Oktober 2013, BPFK telah berjaya menambah skop akreditasi MS ISO/IEC 17025:2005 dari Jabatan Standards Malaysia untuk ujian penentuan kandungan Lovastatin di dalam produk traditional menggunakan High Performance Liquid Chromatography (HPLC).

Berdasarkan audit pemantauan yang dijalankan pada 6 Mac 2014, BPFK telah berjaya mengekalkan skop akreditasi berikut:

a) Penentuan arsenik, plumbum dan kadmium dalam produk tradisional dengan Graphite Furnace Atomic Absorption Spectrometry

b) Penentuan had merkuri dalam produk tradisional dengan Cold Vapour Atomic Absorption Spectrometry

c) Kontaminasi microbial dalam produk tradisional berdasarkan British Pharmacopoeia 2012 dan produk komestik berdasarkan metodologi in-house

d) Pengecaian kapsul dan tablet bagi produk- produk tradisional

e) Keseragaman berat untuk kapsul dan tablet bagi produk-produk tradisional

f) Penentuan plumbum dalam produk kosmetik dengan Graphite Furnace Atomic Absorption Spectrometry

g) Penentuan merkuri dalam produk kosmetik dengan Cold Vapour Atomic Absorption Spectrometry

h) Penentuan kandungan Hydroquinone di dalam produk krim kosmetik menggunakan HPLC

i) Penyaringan untuk identifikasi Arbutin dan Hydroquinone di dalam produk krim kosmetik menggunakan HPLC

MS ISO/IEC 17025:2005 SCOPE OF ACCREDITATION In October 2013, NPCB successfully extended the scope of accreditation of MS ISO/IEC 17025:2005 by the Department of Standards Malaysia for the detection and determination of Lovastatin in traditional products using High Performance Liquid Chromatography (HPLC).

Based on the surveillance audit conducted on 6 March 2014, NPCB managed to maintain the following accreditation scopes:

a) Determination of arsenic, lead and cadmium in traditional products using Graphite Furnace Atomic Absorption Spectrometry

b) Determination of mercury limit in traditional products using Cold Vapour Atomic Absorption Spectrometry

c) Microbial Contamination Test in traditional and cosmetic products based on the British Pharmacopoeia 2012 and in-house method respectively

d) Disintegration test for capsules and tablets in traditional products

e) Uniformity of weight for capsules and tablets in traditional products

f) Determination of lead in cosmetic products by using Graphite Furnace Atomic Absorption Spectrometry

g) Determination of mercury in cosmetic products using Cold Vapour Atomic Absorption Spectrometry

h) Determination of Hydroquinone in cosmetic cream products by using HPLC

i) Screening for the identification of Arbutin and Hydroquinone in cosmetic cream products by using HPLC

3. SKOP AKREDITASI MS ISO/IEC 17025:2005 MS ISO/IEC 17025:2005 SCOPE OF ACCREDITATION

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 27

BPFK telah berjaya mendapat pensijilan 5S dari Unit Pemodenan Tadbiran & Perancangan Pengurusan Malaysia (MAMPU) pada 17 Disember 2012. Pensijilan tersebut adalah untuk jangkamasa 2 tahun. Walaubagaimanapun, pihak MAMPU telah melakukan penjenamaan semula 5S kepada Ekosistem Kondusif Sektor Awam (EKSA) pada tahun 2013. Oleh itu, pada 27 November 2014, MAMPU telah menjalankan audit EKSA ke atas BPFK mengikut kriteria EKSA yang baru. Berdasarkan pengauditan yang telah dilaksanakan, BPFK telah dianugerahkan pensijilan EKSA yang berkuatkuasa dari 15 Disember 2014 hingga 14 Disember 2016.

NPCB successfully obtained the 5S certification from the Malaysian Administrative Modernisation and Management Planning Unit (MAMPU) on 17 December 2012. The certification was for a period of 2 years. However, in 2013, 5S was rebranded to the Public Sector Condusive Ecosystem (EKSA) by MAMPU. Therefore, on 27 November 2014, MAMPU carried out an EKSA audit on NPCB according to the new EKSA criteria. Based on the audit performed, NPCB was awarded the EKSA certification effective from 15 December 2014 until 14 December 2016.

Pada tahun 2014, Cawangan Pencegahan dan Kesedaran Pengguna (CPKP) telah menerbitkan Buku Kompilasi Penyelidikan dan Pembangunan Bahagian Penguatkuasaan Farmasi, Kementerian Kesihatan Malaysia. Kompilasi ini mengandungi 25 abstrak kajian dan 14 laporan penuh kajian yang telah dijalankan oleh cawangan-cawangan penguatkuasaan farmasi negeri serta bahagian penguatkuasaan farmasi. Dua Kajian 1Malaysia atau ‘multi-centred’ study iaitu Kajian 1Malaysia: Pola Penjualan Ubat-ubatan di Premis Perniagaan dalam Tanah Rancangan Felda dan Kajian 1Malaysia: Kewujudan Ubat Counterfeit di Rantaian Pembekalan Peringkat Pemborong Bukan Racun yang meliputi semua negeri di Malaysia turut dimasukkan di dalam kompilasi ini. Cawangan Pencegahan dan Kesedaran Pengguna (CPKP) berhasrat meneruskan aktiviti-aktiviti R&D secara proaktif untuk meningkatkan keberkesanan aktiviti penguatkuasaan yang dijalankan.

4. EKOSISTEM KONDUSIF SEKTOR AWAM (EKSA) PUBLIC SECTOR CONDUSIVE ECOSYSTEM (EKSA)

5. KOMPILASI PENYELIDIKAN DAN PEMBANGUNAN COMPILATION OF RESEARCH & DEVELOPMENT

In the year of 2014, the Consumer Awareness and Prevention Branch (CAPB) published a book titled ‘Kompilasi Penyelidikan dan Pembangunan Bahagian Penguatkuasaan Farmasi, Kementerian Kesihatan Malaysia’. The compilation comprises of 25 research abstracts and 14 full reports on the researches conducted by state pharmacy enforcement branches and the pharmacy enforcement division. Two multi-centred study titled ‘Kajian 1Malaysia: Pola Penjualan Ubat-ubatan di Premis Perniagaan dalam Tanah Rancangan Felda’ and ‘Kajian 1Malaysia: Kewujudan Ubat Counterfeit di Rantaian Pembekalan Peringkat Pemborong Bukan Racun’ involving every states in Malaysia were included in this compilation. CAPB wishes to continue all R&D activities proactively, to increase the effectiveness of the current enforcement practices.

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6. PELABELAN HARGA UBAT PADA BUNGKUSAN PENDISPENSAN DI FARMASI KKM PRICE LABELLING OF DISPENSED MEDICINES IN THE MOH PHARMACIES

Bahagian Perkhidmatan Farmasi telah memulakan aktiviti melabelkan harga pada bungkusan ubat-ubatan yang dibekalkan kepada pesakit di Farmasi Pesakit Luar sejak tahun 2012. Pelabelan harga ubat yang didispens dapat meningkatkan kesedaran pesakit terhadap kos ubat yang diperoleh dari fasiliti kerajaan dan seterusnya meningkatkan komplians penggunaan ubat-ubatan bagi mengelakkan pembaziran.

Hasil pemantauan pelaksanaan pelabelan pada Disember 2014 ke atas 139 buah hospital dan 707 klinik kesihatan mendapati 100% hospital dan 98.6% (697/707) klinik kesihatan telah menjalankan pelabelan (Jadual 1). Sebanyak 33 (23.7%) hospital dan 146 (20.7%) klinik kesihatan melaksanakan pelabelan bagi semua ubat-ubatan dalam inventori Farmasi Pesakit Luar. Secara purata, peratus ubat-ubatan dilabel harga di semua fasiliti adalah 70.5%. Antara sebab-sebab utama fasiliti-fasiliti KKM tidak mencapai peratus pelabelan 100% adalah i) tiada sistem IT untuk melabelkan harga ubat, ii) kekangan tenaga pekerja serta iii) kekurangan alat dan bahan untuk pelabelan.

Jadual 1: Bilangan fasiliti yang menjalankan pelabelan Tahun

  2012 2013 2014

Bilangan hospital 137 138 139

Bilangan klinik kesihatan 681 694 697

Since 2012, the Pharmaceutical Services Division has initiated medicines price labelling activity on packs of medicines dispensed to patients in the Outpatient Pharmacy. Labelling medicines prices on dispensed packs, enhances patients’ awareness of the costs of medicines obtained from the government facilities and subsequently boost patients’ adherence to medicines in order to prevent wastage.

A medicine price labelling monitoring survey conducted in December 2014 which included 139 hospitals and 707 health clinics shows that 100% hospitals and 98.6% (697/707) health clinics perform medicines price labelling (Table 1). A total of 33 (23.7%) hospitals and 146 (20.7%) health clinics labelled all medicines listed in the Outpatient Pharmacy inventory. On average, the percentage of medicines labelled with price in all facilities is 70.5%. The main reasons the MOH facilities did not achieve 100% are due to the i) absence of IT system for medicine price labelling ii) labor constraints and iii) lack of equipment and materials for labelling.

Table 1: The number of facilities performed medicines price labelling Year

  2012 2013 2014

Number of hospitals 137 138 139Number of health clinics 681 694 697

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 29

National Medicines Policy (NMP) emphasized on the importance of sharing medicines pricing information to the public, as a mean of reference, in order to obtain medicine in the private sector at the most affordable price. Since 2008, pricing information for controlled and OTC medicines in the public and private sectors has been gathered from the government facilities and voluntarily from the pharmaceutical industry, which initially was shared solely for internal use. However, since 2013, part of the drug pricing information has been uploaded to the pharmacy website for public use, using the term Consumer Price Guide (CPG). Pricing information for a total of 3526 and 2483 drugs was uploaded in 2013 and 2014 respectively.

Dasar Ubat Nasional (DUNas) menekankan pentingnya perkongsian maklumat harga ubat kepada orang ramai sebagai alat untuk rujukan bagi mendapatkan harga ubat-ubatan yang paling mampu milik di sektor swasta. Maklumat harga ubat-ubatan yang terdiri dari ubat terkawal dan OTC di sektor swasta dan awam telah mula dikumpul dari fasiliti kerajaan dan juga dari industri farmaseutikal secara sukarela dan dikongsi untuk kegunaan dalaman sahaja sejak tahun 2008. Walaubagaimanapun sejak tahun 2013 sebahagian dari maklumat harga ubat ini dengan menggunakan istilah Panduan Harga Pengguna (PHP) telah mula dimuat naik didalam laman sesawang farmasi, untuk kegunaan rakyat. Bagi tahun 2013 harga bagi 3526 jenis ubat telah dimuat naik manakala bagi tahun 2014 pula ialah sebanyak 2483 jenis ubat.

7. PANDUAN HARGA PENGGUNA CONSUMER PRICE GUIDE

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI30

8. PHARMACY INFORMATION SYSTEM (PhIS DAN CPS) PHARMACY INFORMATION SYSTEM (PhIS AND CPS)

Aktiviti pelaksanaan PhIS dan CPS telah dimulakan pada bulan Mac 2014 di Hospital Pakar Sultanah Fatimah, Muar dan Klinik Kesihatan Greentown. Fasiliti perintis menggunakan versi ‘online prescription’ yang melibatkan pembantu tadbir di kaunter pendaftaran, pegawai perubatan, anggota farmasi serta jururawat di wad. Pengurusan inventori bermula dari aktiviti perolehan, pengagihan stok dari stor utama ke substor dan unit-unit dari dalam dan luar fasiliti. Pada masa yang sama, aktiviti pengurusan perubahan, latihan penggunaan sistem, kerja-kerja melengkapkan infrastruktur rangkaian dan penghantaran perkakasan dimulakan secara berperingkat di Hospital Seri Manjung, Hospital Tanah Merah, Hospital Miri dan beberapa buah klinik kesihatan dalam daerah Kinta.

Pada tahun yang sama, kerja-kerja awal untuk peluasan projek telah dimulakan. Taklimat kepada semua penyelaras negeri diadakan pada bulan Februari 2014 diikuti dengan aktiviti lawatan tapak ke hampir 1,278 fasiliti pada bulan April hingga Disember 2014. Taklimat Pengurusan Perubahan kepada semua Ketua Jabatan di Jabatan Kesihatan Negeri juga diadakan bagi memastikan pelaksanaan diperingkat negeri mendapat kerjasama padu dari semua peringkat.

The commencement of PhIS and CPS was begun in March 2014 at Hospital Pakar Sultanah Fatimah, Muar and Greentown Health Clinic. These facilities which served as pioneers were using ‘online prescription’ based version and involving administrative assistants at registration counter, medical officers, pharmacy personnel and nurses in the wards. The inventory management system starting at initial stage of process from procurement activity, stock flow from main store to sub-store at pharmacy and also other units either intra- or inter-facility. At the same time, change-of-management activity, user training sessions, development of infrastructure for networking and supply of equipments were carried out staggeredly at Hospital Seri Manjung, Hospital Tanah Merah, Hospital Miri and a few health clinics in the district of Kinta.

In 2014, foundation works for expansion of this system was initiated. Briefings were delivered to all state co-ordinators in February 2014 This followed by visits to project site at 1,278 facilities from April to December 2014. In order to gain ultimate co-operation from entire levels of management, all heads of unit at state health departments were briefed on the change-of-management once PhIS and CPS are roll-out.

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 31

Lawatan | Visit Program | Programme Tarikh | Dates

TEMPATAN | LOCAL

PemantauanMonitoring

Sarjana Muda Farmasi, MAHSA UniversityBachelor of Pharmacy (Hons), MAHSA University

27-28 Februari 201427-28 February 2014

Sarjana Muda Farmasi, SEGi University Bachelor of Pharmacy (Hons), SEGi University

20-21 Ogos 201420-21 August 2014

Verifikasi Verification

Sarjana Muda Farmasi, Asia Metropolitan University (AMU) program 4+0 dengankerjasama University La Trobe, AustraliaBachelor of Pharmacy (Hons), Asia Metropolitan University (AMU) 4+0 programme in collaboration with University La Trobe, Australia

27 Mac 2014

27 March 2014

Sarjana Farmasi, University of Nottingham Malaysia Campus, program 2+2Master of Pharmacy, University of Nottingham Malaysia Campus, 2+2 programme

22 Mei 201422 May 2014

Sarjana Muda Farmasi, Asia Metropolitan University (AMU) program 4+0 dengankerjasama University La Trobe, AustraliaBachelor of Pharmacy (Hons), Asia Metropolitan University (AMU) 4+0 programme in collaboration with University La Trobe, Australia

6 November 2014

6 November 2014

Pengiktirafan ProvisionalProvisional Accreditation

Master of Pharmacy, Taylor’s University program 2+2 secara kerjasama denganCardiff University Master of Pharmacy, Taylor’s University, 2+2 programme in collaboration with CardiffUniversity

6-7 Januari 2014

6-7 January 2014

Sarjana Muda Farmasi, Taylor’s UniversityBachelor of Pharmacy (Hons), Taylor’s University

24-25 April 201424-25 April 2014

Pengiktirafan SemulaRe-accreditation

Sarjana Muda Farmasi, Universiti MalayaBachelor of Pharmacy (Hons), Universiti Malaya

22-23 Januari 201422-23 January 2014

ANTARABANGSA | INTERNATIONAL

Pengiktirafan PenuhFull Accreditation

Doctor of Pharmacy,Gulf University, UAEDoctor of Pharmacy,Gulf University, UAE

3-7 Februari 20143-7 February 2014

Sarjana Sains Farmasi (Program Farmasi Klinikal dan Komuniti),Institut Teknologi Bandung, IndonesiaMaster of Pharmacy (Clinical and Community Pharmacy Programme),Bandung Institute of Technology, Indonesia

17-21 Februari 2014

17-21 February 2014

Sarjana Sains Farmasi (Program Farmasi Klinikal dan Komuniti), Universiti Sumatera Utara, Medan, IndonesiaMaster of Pharmacy (Clinical and Community Pharmacy Programme), Universiti Sumatera Utara, Medan, Indonesia

3-7 Mac 2014

3-7 March 2014

Lembaga Farmasi Malaysia telah menjalankan sebelas lawatan pengiktirafan ke atas Program Ijazah Farmasi di dalam dan luar negara pada tahun 2014.Di dalam negara, lapan lawatan akreditasi telah dijalankan yang melibatkan dua lawatan pemantauan, tiga lawatan verifikasi, dua lawatan pengiktirafan provisional dan satu lawatan pengiktirafan semula di institusi tempatan. Manakala lawatan pengiktirafan program farmasi di luar negara dijalankan ke atas satu universiti di United Arab Emirates (UAE) dan dua universiti di Indonesia. Program ijazah farmasi yang terlibat ialah seperti berikut:

9. AKREDITASI PROGRAM IJAZAH FARMASI ACCREDITATION OF PHARMACY PROGRAMME

In 2014, Pharmacy Board of Malaysia had conducted eleven visits to institutions in the country and in overseas which offer pharmacy programme. In the country, eight visits were carried out and these involved two visits for the purpose of monitoring, three for verification, two for provisional accreditation and one for full accreditation. Visits to overseas which were aimed to accreditate pharmacy programmewere conducted on one university in United Arab Emirates (UAE) and two universities in Indonesia. Pharmacy prgrammes selected are as below:

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI32

Kajian ini bertujuan untuk menilai tahap kepuasan dan persepsi pengguna terhadap perkhidmatan pendispensan ubat oleh ahli farmasi di farmasi komuniti di Malaysia. Kajian ini dilaksanakan di sepanjang tahun 2014 dan peserta adalah daripada kalangan pengguna di seluruh Malaysia. Secara purata, hasil kajian mendapati tahap kepuasan pengguna terhadap pendispensan ubat oleh ahli farmasi di farmasi komuniti adalah tinggi. Kajian telah selesai dan laporan telah dicetak pada bulan Disember 2014.

10. KAJIAN NATIONAL SURVEY EXPLORING ON CONSUMER SATISFACTION & PERCEPTION TOWARDS MEDICINES DISPENSING SERVICE SURVEY ON CONSUMER SATISFACTION & PERCEPTION TOWARDS MEDICINES DISPENSING SERVICE

This survey was aimed to study consumer satisfaction and perception towards medicine dispensing services by pharmacists at community pharmacy in Malaysia. This study was conducted throughout theyear 2014 and participants were recruited among consumers in Malaysia. Finding shown that on average, level of satisfaction among consumers towards dispensing services by community pharmacy was high. Survey was completed and report was printed in December 2014.

STATISTIK 2014STATISCTICS 2014

PEMBANGUNAN SUMBER MANUSIA DAN MODAL INSANHUMAN RESOURCE AND HUMAN CAPITAL DEVELOPMENT

LATIHAN TRAINING

PERBELANJAAN FARMASEUTIKALPHARMACEUTICAL EXPENDITURE

PENCAPAIAN PRESTASI FARMASI PHARMACY PERFORMANCE ACHIEVEMENT

PERKHIDMATAN FARMASIPHARMACY SERVICES PENYENARAIAN UBAT KEMENTERIAN KESIHATAN MALAYSIAMINISTRY OF HEALTH DRUG LISTING

KESEDARAN TENTANG UBATMEDICINES AWARENESS

PENGUATKUSAAN FARMASIPHARMACY ENFORCEMENT

KAWALAN FARMASEUTIKALPHARMACEUTICAL REGULATORY

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI34

PEMBANGUNAN SUMBER MANUSIA DAN MODAL INSANHUMAN RESOURCE AND HUMAN CAPITAL DEVELOPMENT

Bilangan Pendaftaran oleh Lembaga Farmasi Malaysia, 2007-2014Number of Registrations by the Pharmacy Board of Malaysia, 2007-2014

Tahun 2008 2009 2010 2011 2012 2013 2014

Bilangan Ahli Farmasi Provisional yang didaftarkanNumber of Provisionally Registered Pharmacists

722 813 925 922 1208 1297 1223

Bilangan Ahli Farmasi Berpendaftaran Penuh Yang DidaftarkanNumber of Newly Full Registered Pharmacists

617 705 739 934 918 1085 864

Jumlah kumulatif Ahli Farmasi Berpendaftaran PenuhCulmulative Number of Fully Registered Pharmacists

6600 7301 8052 9553 10402 11380 12294

Bilangan Ahli Farmasi Berdaftar (Sementara) yang DidaftarkanNumber of Temporary Registered Pharmacists

0 5 6 1 15 13 3

TPC tamat tempohExpired TPC 0 1 1 4 7 0 9

Bilangan Pertubuhan Perbadanan yang didaftarkanNumber of Registered Corporate Body

43 48 48 44 57 68 99

Jumlah kumulatif Bilangan Pertubuhan Perbadanan yang didaftarkanCulmulative Number of Registered Corporate Body

768 816 864 908 965 1033 1132

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 35

Bilangan Jawatan Anggota Farmasi di Bahagian Perkhidmatan Farmasi,Kementerian Kesihatan Malaysia (2014)

Number of Posts for Pharmacy Personnel at Pharmaceutical Services Division,Ministry of Health 2014

Bilangan Jawatan Anggota Farmasi di Biro Pengawalan Farmaseutikal Kebangsaan (BPFK) 2014Number of Posts for Pharmacy Personnel at National Pharmaceutical Control Bureau (NPCB) 2014

PENGURUSAN

PEG. FARMASI

AMALAN & PERKEMBANGAN

PEN. PEG. FARMASI

PENGUATKUASAAN

LAIN-LAIN

105

90

75

60

45

30

15

0

300

25

200

150

100

50

0

Bila

ngan

Jaw

atan

/ Nu

mbe

r of P

osts

Bila

ngan

Jaw

atan

/ Nu

mbe

r of P

osts

PEN. PEGAWAI FARMASIPEGAWAI FARMASI LAIN-LAIN

90

2

18

76

5

17

28

2

45

258

79 72

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI36

Bilangan Jawatan Anggota Farmasi di KKM (2014)Number of Pharmacy Posts at MOH

Unjuran Nisbah Ahli Farmasi: Populasi (2005-2020)Projection of Pharmacists: Population Ratio (2005-2020)

Nisbah Ahli Farmasi: PopulasiPharmacists: Population Ratio

PEN. PEGAWAI FARMASI

PEGAWAI FARMASI

8,376

4,277

6000

5000

4000

3000

2000

1000

02004 2012

2928

2008

4199

2016

2083

2006

4871

2014

2463

2010

3592

2018

1817

2020

1628

2005

5290

2013

2714

2009

3878

2017

1939

2007

4533

2015

2259

2011

3282

2019

1717

2021

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 37

LATIHANTRAINING

BILANGAN LATIHAN YANG DIKENDALIKAN DALAM TAHUN 2014NUMBER OF TRAINING CONDUCTED IN 2014

Pelaksanaan Kursus dalam Negara BPF, KKMTraining Conducted Locally by PSD, MOH

TahunYear

Peringkat Ibu PejabatHeadquarters (HQ)

Peringkat Institusi & NegeriInstitutions & States

Bil. Kursus DijalankanNumber of Courses

Conducted

Bil. Pegawai MenghadiriNumber of Attendance

Bil. Kursus DijalankanNumber of Courses

Conducted

Bil. Pegawai MenghadiriNumber of Attendance

2013 71 3,046 288 12,568

2014 65 2,448 357 18,179

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI38

Pelaksanaan Kursus dalam Negara BPFKTraining Conducted Locally By NPCB

Jenis LatihanTypes of Training

Bilangan LatihanNumber of Training

(2013)

Bilangan Peserta Latihan

Number of Attendance

(2013)

Bilangan LatihanNumber of Training

(2014)

Bilangan Peserta Latihan

Number of Attendance

(2014)

KursusCourses 4 122 8 243

SeminarSeminars 1 54 4 184

Sesi CMECME Session 44 1810 60 1766

Sesi LatihanTraining Session 33 1338 124 1029

BengkelWorkshop 2 73 7 141

JUMLAHTOTAL 84 3397 203 3363

Pelaksanaan Kursus Luar Negara BPF dan BPFKOverseas Training Attended by PSD and NPCB Officers

TahunYear

Bilangan Kursus yang dihadiriNumber of Courses Attended

Bilangan PesertaNumber of Attendance

2013 (PSD) 12 21

2014 (PSD) 21 33

2013 (NPCB) 7 11

2014 (NPCB) 9 14

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 39

Senarai Universiti dalam Negara yang Menawarkan Program Ijazah FarmasiList of Universities Offering Degree in Pharmacy

Bil.No.

InstitusiInstitution

ProgramProgramme

1 Universiti Sains MalaysiaSciences University of Malaysia

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

2 Universiti Kebangsaan MalaysiaNational University of Malaysia

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

3 Universiti Malaya University of Malaya

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

4 Universiti Teknologi MARAUniversity of Technology MARA

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

5 Universiti Islam Antarabangsa Malaysia International Islamic University Malaysia

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

6 Universiti Kolej Sedaya Antarabangsa (UCSI)University College of Sedaya International (UCSI)

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

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

Sarjana Farmasi (Program Berkembar 2½+1 bersama Universiti Strathclyde, UK)Master of Pharmacy (Twining 2½+1 with University Strathclyde, UK)

Sarjana Farmasi (Program Berkembar 2+2 bersama Universiti Strathclyde, UK)Master of Pharmacy (Twining 2+2 with University Strathclyde, UK)

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

8Institut Perubatan, Sains dan Teknologi Asian (AIMST) Asian Institute of Medicine, Science and Technology (AIMST)

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

9 Universiti Nottingham Kampus MalaysiaUniversity Nottingham Malaysia Campus

Sarjana Farmasi Program 2+2 setara dengan Universiti Nottingham, UK*Master In Pharmacy 2+2 Similar Programme with University of Nottingham, UK*

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

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

11

Universiti Asia Metropolitan (AMU) (Kolej Universiti Sains Kesihatan Masterskill) Asia Metropolitan University (AMU) (as Masterskill University College of Health Sciences)

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

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

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI40

Bil.No.

InstitusiInstitution

ProgramProgramme

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

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

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

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 with Monash University, Australia

15

Akademi Sains Kesihatan Bersepadu Malaysia (MAHSA)Malaysian Allied Health Sciences Academy(MAHSA)

Sarjana Farmasi (Program Berkembar 2+2 bersama Universiti John Moores, UK)Master of Pharmacy (Twining 2+2 with University of John Moores, UK)

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

16 Kolej Universiti Taylor Taylor’s University College

Sarjana Muda Farmasi (Kepujian) - Program Francais 4+0 bersama USM)Bachelor of Pharmacy (Hons) 4+0 with USM As Franchised Programme

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

17 Kolej Universiti LincolnLincoln University College

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

18

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

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

19 Kolej Universiti Penjagaan Kesihatan KPJ KPJ Healthcare University College

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

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

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 41

PERBELANJAAN FARMASEUTIKALPHARMACEUTICAL EXPENDITURE

Perbelanjaan Ubat KKM, 2007-2014MOH Medicines Expenditure, 2007-2014

TahunYear

Jumlah Perbelanjaan(RM Juta)

Total Expenditure(MYR Million)

% Peningkatan berbanding tahun sebelumnya

% Increment over the previous year

2007 1,355.00 9.89

2008 1,510.00 11.44

2009 1,402.35 -7.13

2010 1,605.54 14.48

2011 1,767.61 10.09

2012 1,983.51 12.21

2013 2,200.43 10.94

2014 2,384.64 8.37

Perbelanjaan Ubat KKM Tahun 2014 berdasarkan Kaedah PerolehanMOH Medicines Expenditure In 2014 based on Types of Medicines Procurement

TahunYear APPL (RM) Kontrak KKM (RM)

MOH Contract (RM)Pembelian Terus & Sebutharga (RM)

Local Purchase & Quotation (RM)

2013873,527,943

(39.7%)

897,004,432

(40.8%)

429,898,594

(19.5%)

2014909,231,419

(38%)

946,225,383

(40%)

529,183,948

(22%)

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI42

PENCAPAIAN PRESTASI FARMASI PHARMACY PERFORMANCE ACHIEVEMENT

Pencapaian KPI pada Tahun 2014, Bahagian Amalan dan Perkembangan FarmasiAchievement for KPIs in 2014, Pharmacy Practice and Development Division

Bil. No.

Bidang Keterhasilan Utama (KRA)Key Result Areas (KRA)

Petunjuk Prestasi Utama (KPI)Key Performance Indicators (KPI)

Sasaran 20142014 Target 2014

1 Meningkatkan Kebolehcapaian Penjagaan Kesihatan

Increased Accessibility to Healthcare

Bilangan Klinik Kesihatan (dengan Pegawai Farmasi) yang menawarkan Perkhidmatan Tambah Nilai (VAS- Value Added Service) untuk mengambil ubat di farmasi kepada pesakit yang sedang menerima rawatan jangka panjang.

Number of health clinics (with pharmacist) offering Value Added Service (VAS) for the collection of medications at pharmacy by patients on long term treatment.

Tier 3: 530 klinik kesihatan (dengan pegawai farmasi)Tier 3: 530 health clinics (with pharmacists)

Tier 4: 100% klinik kesihatan (dengan pegawai farmasi)Tier 4: 100% health clinics (with pharmacists)

578

2 Meningkatkan Kebolehcapaian Penjagaan Kesihatan

Increased Accessibility to Healthcare

Peratus pesakit dengan preskripsi ulangan menggunakan Perkhidmatan Tambah Nilai (VAS- Value Added Service) bagi mendapatkan bekalan ubat susulan mereka.

Percentage of patients with repetitive prescriptions utilizing Value Added Service (VAS) in order to obtain following supply of medications

1.2 juta preskripsi susulan

1.2 million subsequent prescriptions

1,514,838(126.2%)

3 Meningkatkan Kebolehcapaian Penjagaan Kesihatan

Increased Accessibility to Healthcare

Peratus preskripsi didispens dalam tempoh 30 minit.

Percentage of prescriptions dispensed within 30 minutes

95% 97.35%

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 43

4 Kesedaran Kesihatan dan Gaya Hidup Sihat

Awareness to Health and Healthy Life Style

Peratus fasiliti farmasi yang menawarkan Perkhidmatan Klinik Kepatuhan Terhadap Ubat-ubatan (MTAC)

Percentage of pharmacy facilities offering Medication Therapy Adherence Clinic (MTAC)

4 MTAC:100% Hospital Utama 100% Main Hospitals

2 MTAC: 100% Hospital Pakar 100% Specialists’ Hospitals

1 MTAC: 100% Hospital Tidak Berpakar(dengan ≥ 4 PF) 100% Non- Specialists’ Hospitals (with ≥ 4 pharmacists)

1 MTAC: 210 Klinik Kesihatan (dengan ≥ 2 PF)210 Health clinics (with ≥ 2 pharmacists)

100%(14/14)

100%(39/39)

100%(76/76)

236

5 Kesedaran Kesihatan dan Gaya Hidup Sihat

Awareness to Health and Healthy Life Style

Peratus pesakit Diabetes MTAC yang patuh terhadap penggunaan ubat-ubatan.

Percentage of diabetic patients attending Diabetic Medication Therapy Adherence Clinic (DMTAC) adhering to their medications.

80% 88.19%(6404/7262)

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI44

Pencapaian Indikator QAP Bahagian Amalan dan Perkembangan Farmasi, 2011-2014Achievement for QAP Indicator, Pharmacy Practice and Development Division, 2011-2014

QAP Indikator QAPQAP Indicators

PiawaiStandard 2011 2012 2013 2014

QAP 1 Percentage of prescriptions wrongly filled and detected before dispensing to the total number of prescriptions counterchecked

0% 0.1079%(52,082 /48,262,364)

0.1213%(63,779 / 52,585,643)

0.1131%(69,960 / 61,881,329)

0.1111%(72,413/ 65,200,802)

QAP 3 Percentage of toxicity cases recommendations communicated within two hours to the requesting Doctor / Units to the total number of toxicity cases received

100% 99.41%(6,061 / 6,097)

99.74%(6,121 / 6,137)

99.85%(5,447 / 5,455)

99.65%(5188 / 5206)

QAP 4 Percentage of value of stocks disposed and written off to value of stocks handled annually

0% 0.017%(RM313,894.04 / RM1,835,623,759.89)

0.015%(RM328,502.84 / RM2,160,180,321.05)

0.004%(RM89,614.04 / RM2,293,475,101.78)

0.075%(RM1,797,515.91 / RM2,530,368,348.82)

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 45

PERKHIDMATAN FARMASIPHARMACY SERVICES

Bil.No.

Jenis PerkhidmatanTypes of Services

PencapaianAchievements

1 Perkhidmatan Kaunseling Ubat Medication Counseling Services

Jumlah pesakit menerima kaunseling individuTotal number of patients who reveived individual counseling

i. Pesakit Luar (Hospital) | Outpatient (Hospital | Hospital)ii. Pesakit Luar | Outpatient (Klinik Kesihatan | Health Clinic)iii. Kaunseling “Bedside” | Bedside Counselingiv. Discaj Wad | Discharge from Wardv. Farmasi Pesakit Dalam I Inpatient

1,134,718

319,663

486,009

NANA

428,211

2 Perkhidmatan Farmakokinetik KlinikalClinical Pharmacokinetics Services

Bilangan Assay | Number of Assays 170,494

3 Perkhidmatan Nutrisi Parenteral Parenteral Nutrition Services

i. Bilangan Hospital | Number of Hospitalsii. Bilangan Kes | Number of Casesiii. Bilangan Sediaan | Number of Preparations

4511,61387,555

4 Perkhidmatan Admikstur Intravena Intravenous Admixture Services

i. Bilangan Hospital | Number of Hospitalsii. Bilangan Sediaan | Number of Preparations

27300,896

5 Perkhidmatan Farmasi Onkologi Oncology Pharmacy Services

i. Bilangan Hospital | Number of Hospitalsii. Bilangan Kes | Number of Casesiii. Bilangan Sediaan | Number of Preparations

64106,682275,293

6 Perkhidmatan Pendispensan Ubat Pesakit Luar Outpatient Drug Dispensing Services

Jumlah Preskripsi Diterima Total Number of Prescriptions Received i. Hospital | Hospitals ii. Klinik Kesihatan | Health Clinics

Jumlah Preskripsi Susulan Didispen Melalui Perkhidmatan Tambah Nilai FarmasiTotal Number of Prescriptions dispensed through Value Added Services (VAS)

50,598,508

19,310,05631,288,452

1,513,478

7 Perkhidmatan Pendispensan Ubat Pesakit Dalam Inpatient Drug Dispensing Service

Jumlah Preskripsi DiterimaTotal Number of Prescriptions Received

Jumlah Preskripsi DiscajTotal Number of Discharged Prescription

18,792,514

1,179,022

8 Perkhidmatan Klinik Kepatuhan Terhadap Ubat-ubatanMedication Therapy Adherence Clinic

i. Bilangan MTAC Fasiliti Number of Facilities Offering MTAC Services

ii. Bilangan Pesakit yang Direkrut dalam Perkhidmatan MTAC bagi Lima Perkhidmatan MTAC Utama Number of Patients Recruited into Five Main MTAC Services

687

26,072

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI46

9 “Home Medication Review” (HMR) (bagi bidang Psikiatri, Strok dan Geriatrik)

i. Bilangan Fasiliti yang Menjalankan HMR Number of Facilities Conducting HMRii. Bilangan Pesakit yang Dilawati Number of Patients Visitediii. Bilangan Lawatan yang Dijalankan Number of Visits

126

3,954

7849

10 Methadone Methadone

Fasiliti Pendispensan Methadone Methadone Dispensing Facilities

i. Hospital | Hospitalsii. Klinik Kesihatan | Health Clinicsiii. AADKiv. Penjara

Bilangan Pendispensan MethadoneNumber of Methadone Dispensedi. Direct Observe Therapy (DOT)ii. Dose Bawa Balik (DBB) | Take-away dose

Jumlah pesakit Methadone menerima kaunseling individuTotal number of Methadone patients who received individual counseling

Bilangan intervensi ubahsuai dose Methadone yang dilakukan oleh Pegawai Farmasi MethadoneNumber of interventions in adjustment of methadone dose performed by Methadone Pharmacist

553145218

3,891,3551,496,865

40,042

39,995

11 Perkhidmatan Farmasi Nuklear Nuclear Pharmacy Services

i. Bilangan Hospital | Number of Hospitalsii. Bilangan Sediaan Kit-Based Number of Kit-Based Preparations iii. Bilangan Sediaan 18F-FDG Number of 18F-FDG Preparations

610,825

134

12 Sistem Unit Dos Unit Dose System

i. Bilangan Hospital Negeri HKL Number of State Hospitals & HKL ii. Bilangan Hospital Pakar Major Number of Major Specialists’ Hospitals iii. Bilangan Hospital Pakar Minor & Hospital Tidak Berpakar Number of Minor Specialists’ & Non-Specialists’ Hospitals

13

25

73

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 47

Kekuatan / Formulasi 5 29 16 9 6

Ubat Baru 28 44 35 34 27

Dikeluarkan 4 39 3 0 1

Entiti Kimia 768 779 802 821 834

Total 1496 1530 1578 1621 1652

PENYENARAIAN UBAT KEMENTERIAN KESIHATAN MALAYSIAMINISTRY OF HEALTH DRUG LISTING

MINISTRY OF HEALTH DRUG LISTING

Penyenaraian Ubat Dalam Formulari Ubat KKM, 2010-2014Drugs Listed into MOH Drug Formulary, 2010-2014

50

45

40

35

30

25

20

15

10

5

0

3000

2500

2000

15000

1000

500

0

Bila

ngan

Uba

t

2010 20122011 2013 2014

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI48

0 0

50 5

100 10

150 15

200 20

250 25

300 30

350 35

Perbandingan Ubat 327 222 271 221 191 187

39 30 41 38 35 27Drug Review

2009 2010 2011 2012 2013 2014

Bila

ngan

Akt

iviti

/ Num

ber o

f Act

ivitie

s

Aktiviti Penilaian FarmakoekonomikPharmacoeconomics Evaluation Activities

Perbandingan ubat: Bilangan ubat (Proforma B dan Proforma D) yang dibuat perbandingan dengan alternative sedia ada dalam Formulari Ubat Kementerian Kesihatan Malaysia (FUKKM).

Drug comparison: Number of drugs (Proforma B and Proforma D) compared with alternatives readily available in the Ministry of Health Drug Formulary.

“Drug review”: Bilangan ubat yang dibuat penilaian lengkap dari segi keselamatan, efikasi dan cost-effectiveness bagi ubat baru (Proforma D).

Drug review: Number of new drugs with a complete evaluation of safety, efficacy and cost-effectiveness (Proforma D).

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 49

KESEDARAN TENTANG UBATMEDICINES AWARENESS

MINISTRY OF HEALTH DRUG LISTING

Bilangan Aktiviti Penggunaan Ubat Secara Berkualiti (2012 – 2014)Number of Quality Use of Medicine (QUM) Activities (2012 – 2014)

Bilangan Duta Kenali Ubat Anda Yang Dilatih (2012 – 2014)Number of Trained ‘Duta Kenali Ubat Anda’ (2012 – 2014)

0

20

40

60

80

100

120

140 153 183

138

160

180

200

Tahun / Year

2012 2013 2014

Bila

ngan

Dut

a Ke

nali

Ubat

And

a

2584 2611

3376

0

500

1000

1500

2000

2500

3000

3500

4000

Bila

ngan

Akt

iviti

Tahun / Year

2012 2013 2014

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI50

Bilangan Ceramah,Pameran Pendidikan Dan Dialog 2012-2014The Number of Talks, Education Exhibition & Dialogues 2012-2014

Bilangan Pertanyaan Maklumat Ubat BPF, KKMNumber of Drug Information Enquires PSD, MOH

270000

280000

290000

300000

310000

320000

330000

340000

350000

Bila

ngan

Per

tany

aan

/ Num

ber o

f Enq

uire

s

Tahun / Year

2012

305889

299406

345269

2013 2014

0

250

500 482

637

90

595

762

82

685

937

148

750

1000

2012

Ceramah / Talks Pameran / Exhibition Dialog / Dialogue

2013 2014

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 51

PENGUATKUASAAN FARMASIPHARMACY ENFORCEMENT

PENDAKWAAN DAN PERUNDANGANPROSECUTION AND LEGISLATION

Statistik Pendakwaan 2014Prosecution Statistics 2014

CPF NEGERIBilangan

Kes Tertunggak

Bilangan Kes Baru

Daftar (Disebut Pertama

Kali)

Bilangan Kes

Minta Bicara

Bilangan Kes

DNAA

Bilangan Kes DNA

Bilangan Kes

Bersalah

Bilangan Kes

Mengaku Bersalah

Bilangan Kes

Selesai

Jumlah Denda (RM)

Bilangan Kes

Penjara

BPF, KKM 5 17 4 3 1 0 17 21 RM56,100 0

Perlis 4 22 1 0 0 0 23 23 RM76,300 0

Kedah 4 49 9 0 0 0 44 44 RM191,650 0

P. Pinang 6 84 12 3 0 0 81 84 RM375,800 0

Perak 4 84 1 8 0 0 73 81 RM121,900 0

Selangor 35 95 6 5 0 0 76 81 RM575,740 0

WP KL 5 125 11 14 2 0 105 121 RM474,800 0

N. Sembilan 4 32 1 5 1 1 28 35 RM96,800 0

Melaka 7 27 1 5 0 0 24 29 RM69,500 0

Johor 4 112 7 4 0 1 105 110 RM465,850 0

Pahang 15 52 4 3 0 0 66 69 RM108,823 0

Terengganu 0 62 2 3 0 0 59 62 RM114,200 0

Kelantan 7 88 8 9 0 2 75 86 RM104,250 0

Sabah 8 83 12 8 0 1 67 76 RM346,300 0

Sarawak 3 77 6 8 0 0 43 51 RM104,500 0

WP Labuan 0 3 0 0 0 0 3 3 RM11,300 0

Jumlah 111 1,012 85 78 4 5 889 976 RM3,293,813 0

Sumber : Cawangan Siasatan dan Perundangan, BPF, KKM

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI52

Statistik Penggubalan Undang-Undang 2012-2014Formulation of Law Statistics 2011-2013

BilNum.

AktivitiActivities

JumlahTotal

2012 2013 2014

1 Bilangan semakan undang-undangNumber of Reviews of Law 9 11 10

2 Bilangan perkara dalam pindaanNumber of Items in Amendmenta) Jadual Table 47 38 37b) Peraturan Regulation 7 13 55

3 Bilangan penerbitanNumber of Publications

a) Warta Gazette 3 5 5

b) Kad Kuasa Authority Card 88 101 85

c) Surat pemberian kuasa di bawah seksyen 6A Akta Ubat (Iklan dan Penjualan) 1956 A letter of authorization under section 6A of the Medicines (Advertisement and Sale) Act 1956

87 87 83

d) Surat kuasa di bawah S377(b) (Kanun Tatacara Jenayah) Authorization under S377 (b) (Criminal Procedure Code) 87 87 83

e) Surat kuasa di bawah seksyen 31(1) Akta Racun 1952A Letter of authorization under section 31 (1) of the Poisons Act 1952

87 92 87

f) Kad kebenaran memeriksa kad pengenalan JPN 1/12 Permission to check identification cards JPN 1/12 23 44 30

Bilangan pengecualian importNumber of import exemption

4

a) Hospital kerajaan Government Hospital - - -

b) Hospital swasta Private Hospital 1,715 1,626 1,511

c) Syarikat Company 40 39 38

5 Bilangan kebenaran import produk tidak berdaftarNumber of import permits for unregistered products 60 78 117

6 Bilangan pelepasan import di pintu masuk kastamNumber of import clearance at customs entry points 42 41 49

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 53

PELESENANLICENCING

Kawalan Pintu Masuk & PrekursorEntry Point & Precursor Control

Perbandingan Jumlah Eksport Prekursor Table II dari Tahun 2011 hingga 2014

90,000,000.00

80,000,000.00

70,000,000.00

60,000,000.00

50,000,000.00

40,000,000.00

30,000,000.00

20,000,000.00

20,000,000.00

KUAN

TITI

(kg)

0.00HCl

2014 41,001,019.8 76,351,705.4 18,381,962.7 1,224,939.39 29,434.79 4,055.24

4,691.32

2,073.57

5,802.30

28,780.17

53,897.20

531,598.80

44,989,809.6 44,989,809.6 26,007,767.6 926,903.69

41,122,616.8 41,122,616.8 21,855,809.4 1,066,204.18

43,700,374.5 43,700,374.5 23,231,646.0 945,730.72

2013

2012

2011

H2So4 Toluene MEK Acetone Ethyl Ether

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI54

Pelesenan Dan Kawalan BahanLicencing and Substances Control

Jenis Lesen / PermitType of Licence / Permit

Bil Lesen / PermitNumber of Licence / Permit

Fee Yang Dikutip (RM)Fee Collected (RM)

2012 2013 2014 2012 2013 2014

Lesen Racun Jenis APoison Licence Type A 3,819 4,197 5,104 PERCUMA

FREE OF CHARGE

Lesen Racun Jenis BPoison Licence Type B 1,811 1,875 2,027 181,100 187,500 202,700

Lesen Racun Jenis DPoison Licence Type D - - - - - -

Lesen Racun Jenis EPoison Licence Type E 35 33 33 3,500 3,300 3,300

Permit NaOHNaOH Permit 2,256 2,403 2,576 45,120 48,060 51,520

Permit PsikotropikPsychotropic Permit 395 397 408 39,500 39,700 40,800

Kebenaran import dadah berbahayaImport Authorization for Dangerous Drugs

184(9 percuma)

224(9

percuma)

211 (9

percuma)17,500 21,500 20,200

Kebenaran eksport dadah berbahayaExport Authorization for Dangerous Drugs

16 23 29 1,600 2,300 2,800

Kebenaran import bahan psikotropikImport Authorization for Psychotropic Substances

206(1 percuma)

224(1

percuma)

248 (4

percuma)20,500 22,300 24,400

Kebenaran eksport bahan psikotropikExport Authorization for Psychotropic Substances

30 28 29 3,000 2,800 2,900

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 55

Jenis Lesen / PermitType of Licence / Permit

Bil Lesen / PermitNumber of Licence / Permit

Fee Yang Dikutip (RM)Fee Collected (RM)

2012 2013 2014 2012 2013 2014

Jumlah & Fee Dikutip (RM)Total & Fee Collected (RM) 8,752 9,404 10,665 311,820 327,460 348,620

Jenis kelulusan / Type of Approval 2011 2012 2013 2014

Permit di bawah Perintah Kastam Permit under Custom Order

Larangan ImportImport Prohibition

432 384 428 428

Larangan EksportExport Prohibition

686 775 1,013 851

Obligasi di bawah Article 12, 1988 ConventionObligation under Article 12, 1988 Convention

Maklumbalas PENPEN Feedback

1,909 2,227 2,699 3,001

PEN dikeluarkanPEN Issued

717 761 947 783

Surat kebenaran Eksport Persediaan Mengandungi PrekursorLetter of Authorisation for preparation containing Precursor

TIADAnone

TIADAnone

TIADAnone

TIADAnone

Surat kebenaran Eksport Persediaan Mengandungi DextromethophanLetter of Authorisation for preparation Containing Dextromethorphan

40 18 11 10

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI56

SERBUAN DAN OPERASIRAIDS AND OPERATIONS

Jumlah Serbuan & Rampasan Tahun 2012-2014Total Number of Raids and Seizures 2012-2014

TahunYear

Jumlah SerbuanTotal Number of Raids

Jumlah Bil Perkara DirampasTotal Number of Seized Items

Jumlah Nilai Rampasan (RM)Value of Seized Items (RM)

2012 1177 25279 RM23,361,091

2013 1297 24331 RM43,451,832

2014 1317 23786 RM39,808,069

Jumlah Pemeriksaan & Rampasan Tahun 2012-2014Total Number of Inspections and Seizures 2012-2014

TahunYear

Jumlah PemeriksaanTotal Number of Inspection

Jumlah Bil Perkara DirampasTotal Number of Seized Items

Jumlah Nilai Rampasan (RM)Value of Seized Items (RM)

2012 13570 4567 RM355,650

2013 11632 3344 RM245,626

2014 13539 5176 RM479,379

Jumlah Konsainmen & Rampasan Tahun 2012-2014Total Number of Consignments and Seizures 2012-2014

TahunYear

Jumlah KonsaimenTotal Number of Consignments

Jumlah Bil Perkara DirampasTotal Number of Seized Items

Jumlah Nilai Rampasan (RM)Value of Seized Items (RM)

2012 3085 14811 RM2,619,048

2013 2691 10611 RM2,653,754

2014 4447 18371 RM4,392,055

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 57

JUMLAH SERBUAN DAN RAMPASAN 2012-2014TOTAL NUMBER OF RAIDS AND SEIZURES 2012-2014

RM23,361,091

RM43,451,832

RM39,808,069

RM50,000,000

RM45,000,000

RM40,000,000

RM35,000,000

RM30,000,000

RM25,000,000

RM20,000,000

RM15,000,000

RM10,000,000

RM15,000,000

RM0

30000

25000

20000

15000

10000

5000

0

2012

JUMLAH SERBUAN /NUMBER OF RAIDS

BIL PERKARA DIRAMPAS /NUMBER OF ITEMS SEIZED

NILAI RAMPASAN /VALUE OF SEIZED ITEMS

2013 2014

JUMLAH PEMERIKSAAN DAN RAMPASAN 2012-2014 TOTAL NUMBER OF INSPECTIONS AND SEIZURES 2012-2014

RM600,000

RM500,000

RM400,000

RM300,000

RM200,000

RM100,000

RM0

16000

14000

12000

10000

8000

6000

4000

2000

0

2012 2013 2014

RM355,650

RM245,626

RM479,379

JUMLAH PEMERIKSAAN / NUMBER OF INSPECTIONS

BIL PERKARA DIRAMPAS /NUMBER OF ITEMS SEIZED

NILAI RAMPASAN /VALUE OF SEIZED ITEMS

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI58

JUMLAH KONSAINMEN DAN RAMPASAN 2012-2014 TOTAL NUMBER OF CONSIGNMENTS AND SEIZUIRES 2012-2014

RM5,000,000RM4,500,000RM4,000,000RM3,500,000RM3,000,000RM2,500,000RM2,000,000RM1,500,000RM1,000,000

RM500,000RM0

20000180001600014000120001000080006000400020000

2012 2013 2014

RM2,619,048RM2,653,754

RM4,392,055

JUMLAH KONSAIMEN /NUMBER OF CONSIGNMENTS

BIL PERKARA DIRAMPAS /NUMBER OF ITEMS SEIZED

NILAI RAMPASAN /VALUE OF ITEMS SEIZED

PEMANTAUAN IKLAN

MONITORING OF ADVERTISEMENTS

TahunYear

Permohonan Diterima

Application Received

LulusApproved

Tidak LulusNot

approved

Tidak Perlu KelulusanDoes not Require Approval

TertangguhPending

Fee Dikutip (RM)Fee Collected

(RM)

2012 2,133 1,676 17 18 422 213,300

2013 2,562 1,929 18 8 - 256,200

2014 2,735 2,163 24 30 518 273,500

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 59

TahunYear

MediaBancTujuan khusus untuk pemonitoran media elektronik iaitu TV dan Radio (BPF sahaja)For the specific purpose of monitoring electronic media ie. TV and Radio (BPF only)

Jumlah Iklan dalam CD MediaBanc

Total Advertisement in MediaBanc CD

Jumlah iklan media elektronik sahaja yang berkaitan dengan farmasi

/ kesihatan / perubatanNumber of

advertisement in electronic media

related to pharmacy / health /medicine

Jumlah surat iklan media

elektronik sahaja yang menyalahi MASA 1956 atau tidak mematuhi

Garispanduan Iklan LIU

Number of warning letters issued for

elctronic media that violates MASA 1956

or fails to comply with MAB Advertisement

Guidelines

Jumlah Iklan Media Cetak yang Berkaitan Dengan

Farmasi / Kesihatan / PerubatanNumber of

advertisement in printed

media related to pharmacy/health/

medicine

Media cetak (Akhbar & Majalah)Printed Media

(newspaper &

magazine)

Media Elektronik

(TV & Radio)Elctronic

Media (TV & Radio)

2011 16,967 7,104 1,446 5 2,673

2012 16,236 7,071 1,566 17 2,311

2013 22,087 7,068 1,577 13 2,755

2014 22,032 6,334 1,523 8 2,949

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI60

KAWALAN FARMASEUTIKAL

Statistik untuk tahun 2014 Statistik untuk tahun 2013

Bilangan produk yang diluluskan untuk pendaftaran oleh Pihak

Berkuasa Kawalan DadahBilangan sampel yang diuji Bilangan produk kosmetik yang

dinotifikasi

1021 3487 77,9781212 3292 77,235

Bilangan Penilaian Protokol Dan Data Validasi

Bilangan Laporan Kesan Advers Ubat yang diterima Bilangan pembatalan notifikasi

691 13,001 7531030 11,473 743

Bilangan produk yang dibatalkan Bilangan pertanyaan yang diterima oleh Helpdesk BPFK

Bilangan pelawat yang diterima oleh BPFK

47 6117 25994 6084 389

Statistik untuk tahun 2014 Statistik untuk tahun 2013

BILANGAN PEMERIKSAAN YANG DIJALANKAN

Amalan Makmal Baik Amalan Klinikal Baik Pusat Kajian Bioekuivalens (BE) Tempatan

Pusat Kajian Bioekuivalens (BE) Luar

Negara

360 3 7 14295 4 5 8

BILANGAN LESEN YANG DIKELUARKAN

Lesen Pemborong Lesen Pengimport Lesen Pengilang Lesen CTIL* Lesen CTX*

1296 471 291 258 151324 429 272 344 12

Nota : *CTIL = Lesen Import Percubaan Klinikal *CTX = Permit Mengilang Produk Tidak Berdaftar

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 61

PHARMACEUTICAL REGULATORY

Statistics for the year 2014 Statistics for the year 2013

Number of products approved by Drug Control Authority from registration Number of samples tested Number of cosmetic

products notified

1212 3487 77,9781021 3292 77,235

Number of Evaluations of Protocol Analysis and Analytical Validation Data

Number of Adverse Drug Reaction (ADR) reports received

Number of notification cancellation

691 13,001 7531030 11,473 743

Number of products cancelled Number of enquiry received by NPCB’s Helpdesk

Numbers of visitors to NPCB

47 6117 25994 6084 389

Statistics for the year 2014 Statistics for the year 2013

NUMBER OF INSPECTIONS PERFORMED

Good Manufacturing Practice (GMP)

Good Laboratory Practice (GLP)

Local Bioequivalence Centre

Foreign Bioequivalence Centre

360 3 7 14295 4 5 8

NUMBER OF LICENSE ISSUED

Wholesaler license Import license Manufacturer license CTIL License* CTX License*

1296 471 291 258 151324 429 272 344 12

Note : *CTIL = Clinical Trial Import Licence *CTX = Clinical Trial Exemption

LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI62

JAWATANKUASA EDITORIALEDITORIAL COMMITTEE

BAHAGIAN DASAR DAN PENGURUSAN FARMASI (PENYELARAS)PHARMACY POLICY AND MANAGEMENT DIVISION (COORDINATOR)

Dr. Ramli bin ZainalBibi Faridha binti Mohd Salleh

Lau Ling WeiNurhafiza binti Md Hamzah

Izzati binti Mohd FarokNurul Islah binti Muzakir

BAHAGIAN AMALAN DAN PERKEMBANGAN FARMASIPHARMACY PRACTICE AND DEVELOPMENT DIVISION

Mary Chok Chiew FongMohd Azuwan Bin Mohd Zubir

BAHAGIAN PENGUATKUASAAN FARMASIPHARMACY ENFORCEMENT DIVISION

Zaimie binti MasrinSyazana Akmal binti Ahmad Kamal

BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAANNATIONAL PHARMACEUTICAL CONTROL BUREAU

Azlina binti IsmailSyuhadah binti Mohamed Hassan