Parmaceutical & Health Legislation System and The Role of Komite
Farmasi Nasional (KFN) in Improving The Quality Of Pharmacy Personnel
Umi Athiyah
Member of National Pharmacy Committee (KFN)
Pharmacy Practice Act
51 2009
Decree 889 2011
Ministry regulation
1621 2011
To improve the quality of pharmacist and pharmacy technician in doing their pharmaceutical work in the
pharmacy facility
LEGAL PRINCIPLE
KOMITE FARMASI NASIONAL
Non-structural unit responsible to Ministry of Health through the
Directorate General of Pharmacy and Pharmaceutical Devices
Non-structural unit
responsible to Ministry of Health through the Directorate General of
Pharmacy and
Pharmaceutical Devices
KFN
Controlling and
Supervising Division
Sertification and
Registration Divisionon
Continuing Education and Training Division
ORGANISATION
STRUKTUR ORGANISASI KOMITE FARMASI NASIONAL
Drs. Purwadi, Apt, MM,ME
Ketua
Drs. Purwadi, Apt, MM,ME
KEANGGOTAAN DIVISI SERTIFIKASI DAN REGISTRASI
KEANGGOTAAN DIVISI PENDIDIKAN DAN PELATIHAN
BERKELANJUTAN
KEANGGOTAAN DIVISI PEMBINAAN DAN PENGAWASAN
Drs. Bambang Triwara, Apt, Sp.FRS Drs. Nurul Falah Eddy Pariang, Apt Dr. Tutus Gusdinar Kartawinata, Apt
Dr. Umi Athiyah, Apt, MS
Dr. Faiq Bahfen, SH Drs. Ahaditomo, Apt, MS
Dra. Augustine Zaini, Apt, M.Si
Dra. Suzana Indah Astuti, M.Si, Apt
Article 108 of Health Law 36/2009
• Pharmaceutical Practice to include compounding including quality control of pharmaceutical
product, safety, procurement, storage and
distribution of medicines, prescription services, drug information services and drug development, active ingredients and traditional medicines
should be done by health professional who have the expertise and liability in accordance with the law.
The Implication of articel 108
7
Pharmaceutical Practice as the practice stated in the Health
Law 36/09
Understanding of Expertise
Understanding of the
RESPONSIBILITY
Pharmaceutical Science and Technology Competence
Pharmacy Profession Competence
Adequate
Experience and Practice
Acknowledgement by the Government
system through
•Registration
•Practice licensed To include
Compounding including Quality
Control of Pharmaceutical Product, Safety, Procurement, Storage, Drug
Distribution, Prescription services , Drug
information services, Active ingredients, and
Traditional
medicines SOP of
Pharmaceutical Practice
Professional Product which is given in its characteristics
• Pharmacy is “the place” for pharmacist to practice their
pharmaceutical practices (stated since Pharmacy Practice Act 25/80)
• Health care facility that provide pharmaceutical services
• In accordance to Health Law 36/09 and Pharmacy Practice Act 51/09
• Pharmacist status as a subject of law that is responsible towards the services process
• Not the place of trading the medicines
THE DEFINITIVE STATUS OF THE COMMUNITY PHARMACY
THE COMMON PERCEPTION
• Entity, that actually do not have authority to sell medicines
• Community Pharmacy do “drug trading” of all drug category, i.e.
to become “panel” pharmacy
• Community Pharmacy develop into “franchise” status as a bussiness
• There are no “system“ that can control drug services both in community pharmacy and hospital pharmacy
• The lack of performing the health care scenario
What are stated in Health Law 36/2009 and Pharmacy Practice Act 51/2009
Understanding the context of reationship between
“pharmaceutical knowledge” with
“ pharmacy profession”
• Pharmaceutical Knowledge
(wikipedia),
The pharmaceutical sciences are a group of interdisciplinary areas of study involved with the design, action, delivery, disposition, and use of drugs
• The pharmaceutical sciences are further subdivided into several specific specialties, with four main
branches:
1. Pharmacology: the study of the biochemical and physiological effects of drugs on organisms.
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Subdivision of
“ Pharmaceutical Sciences ”
a) Pharmacodynamics: the study of the cellular and molecular interactions of drugs with their receptors.
b) Pharmacokinetics: the study of the factors that
control the concentration of drug at various sites in the body.
c) Pharmaceutical toxicology: the study of the harmful or toxic effects of drugs.
d) Pharmacogenomics: the study of the inheritance of characteristic patterns of interaction between drugs and organisms.
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Subdivision of “ pharmaceutical Sciences ”
2. Pharmaceutical chemistry: the study of drug design to optimize pharmacokinetics and pharmaco
dynamics, and synthesis of new drug molecules.
3. Pharmaceutics: the study and design of drug formulation for optimum delivery, stability, pharmacokinetics, and patient acceptance.
4. Pharmacognosy: the study of the physical, chemical, biochemical and biological properties of drugs, drug substances or potential drugs or drug substances of natural origin as well as the search for new drugs from natural sources.
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The Context of Pharmaceutical Knowledge
• As new discoveries advance and extend the
pharmaceutical sciences, subspecialties continue to be added to this list.
• Importantly, as knowledge advances, boundaries between these specialty areas of pharmaceutical sciences are beginning to blur
• The context of pharmaceutical knowledge is “ study” that have “dimention” not “limited”, in connection and contiuosly growing as the definition knowledge
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The concept and context of
“profession”
• A person having impressive competence in a particular activity.
[5]• Because of the personal and confidential
nature of many professional services and thus the necessity to place a great deal of trust in them,
• most professionals are held up to strict ethical and moral regulations.
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http://en.wikipedia.org/wiki/Professional
“ Form “ of the profession
• The professional owes a higher duty to a client,
often a privilege of confidentiality, as well as a duty not to abandon the client just because he or she may not be able to pay or remunerate the professional.
• Often the professional is required to put the interest of the client ahead of his own interests.
• A high standard of professional ethics, behavior and work activities while carrying out one's profession
• A professional is a person that is paid for what they do. http://en.wikipedia.org/wiki/Professional
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Health
( wikipedia)• The World Health Organization (WHO), in 1948, health was defined as "a state of complete
physical, mental, and social well-being and not merely the absence of disease or infirmity “ .
• In 1986, the WHO, in the Ottawa Charter for
Health Promotion, said that health is "a resource for everyday life, not the objective of living.
• Health is a positive concept emphasizing social and personal resources, as well as physical
capacities."
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THE FORMAT OF PHARMACIST
• Is the “ health professional ” ruled by Law and Act ( UU 36/09 and PP-51/09)
• Is a “ product of higher degree pharmacy
education ” designed to be competence in doing the “ pharmacy profession ”
• Profession work is “ to do ” many “ pharmacist
act ” in the process of pharmacotherapy, including the making of dosage form.
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Pharmacy “System ”
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Pharmacognosy
Physical Pharmacy
Pharmaceutics Pharmacology
Pharmaceutical Knowledge
Pharmaceutical Practice of Profession
The Product of Pharmacy Profession
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Pharmaceu tical
knowledge
“ Sistem ” Modern Pharmacy
+
THE NEW AND MODERN PHARMACEUTICAL SERVICE AND CARE
The application of the knowledge to improve health and to prevent and cure diseases.
SERVICE TO THE PATIENT
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PHARMACIST EXPLAIN AND DESCRIBE HOW
MEDICINE SHOULD BE USED BY THE PATIENT
Amlodipine J-URAI
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VASOCONSTRICTION VASODILATATION
CHANNEL Ca++
Voltage dependent
Blood vessels conformation
AMLODIPINE BESYLAT
A D M E
PHARMACOTHERAPEUTIC RESPONSE
The knowledge on Dosage form and Pharmaceutical Active Ingredients
The Nature of the Source
The nature of Health seeking behaviour
“Dosage Form” entity to heal
sickness DESEMINATION OF THE DOSAGE FORM KNOWLEDGE
KNOWLEDGE OF THE BODY RESPOND
TOWARDS INTERVENTION PRODUCTS
LIABLITY OF A DOSAGE
FORM
SICKNESS PHENOMENON EXPLAIN-
DESCRIBE, JURAI
UNDERSTANDING OF BODY RESPOND
DOSAGE FORM VARIATION
SICK BODY RESPOND
THE CONCEPT AND CONTEXTS OF PHARMACY
The Current and modern concept
CONCLUSION
• IMPROVING PHARMACY PERSONEL DEPEND ON:
– “HOW PHARMACY EDUCATION DESIGN “ – “ LAW ENFORCEMENT”
– “ PROFESSIONAL RESPONSIBILITY’
