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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
CARTA ORGANISASIORGANISATIONAL CHART
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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.
LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 11
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.
LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI 23
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.
LAPORAN TAHUNAN 2015BAHAGIAN PERKHIDMATAN FARMASI28
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