ASPEK HUKUM

DALAM praktek
KEFARMASIAN

Dr. Wahyu Utami, MS., Apt

Pengertian - kontekstual
HUKUM :
•perlu ditetapkan untuk menjaga agar kehidupan
individu/sosial berjalan dg tertib, aman & nyaman
•ditetapkan oleh ‘penguasa’/pemerintah dan bersifat
mengikat, (berlaku utk semua orang yang ada dlm wilayah
teritori yang bersepakat), mendorong yang baik dan
melarang yang salah
•kaidah, patokan, ketentuan ttg suatu hal/peristiwa
tertentu
•keputusan yg ditetapkan hakim
 UU – PP – PerMen – dst…
The law is much more than a collection of mandates and
prohibitions.

It is a framework through which people in a society

resolve their disputes and problems in a way that does not
involve force and consistently yields results that are
acceptable to most of society.

It is a socially prescribed process through which people

declare their collective will and express their norms and
values.

This process of law accommodates the individual

differences of every situation, but it recognizes the need to
provide firm rules for people to follow as well.
Reasons to Regulate Medicinal Drugs

The government regulates medicinal drugs very heavily because

of the potential risks to users.
The concept of government regulation to protect people from
harming themselves through risky choices conjures up images
of an overbearing, paternalistic bureaucracy that forces people
to behave in prescribed ways.
If it can be assumed that people tend to act in their own self
interest by making decisions that will increase their personal
happiness (e.g. higher income, more free time, improved health
status), why does the government need to make decisions for
people?
Why not simply allow people to look out for themselves? One
possible answer is that the free market does not always act
efficiently to promote happiness-maximizing behavior.
Such market inefficiency often referred to as “market failure”
serves as justification for government regulation.

The following four types of market failures are relevant to drug

use:
1. Public goods
2. Externalities
3. Natural monopolies
4. Information asymmetry

-  Any legitimate government interference with a private

choice to use medicinal drugs will be based on one or more of
these identifiable market failures
In Pharmacy context…
the law that governs both the profession and the products
they distribute.

Understanding pharmacy law is critical to

understanding the profession.

Understanding requires that students

know some history behind the laws,

why they exist,
how they affect pharmacy practice, and subsequently
how to apply the law and
how to analyze whether there is a better approach.

 understand and critically analyze….

Profesi adalah
bidang pekerjaan yang dilandasi pendidikan
keahlian ttt

Profesional adalah
orang yang memiliki pekerjaan berdasarkan
keahlian yang memenuhi persyaratan
keilmuan dan kemampuan dibidang profesinya

Profesionalisme adalah
perwujudan aktif dari tindakan suatu
keahlian
Pharmacy law reflects
the history,
social policy, and
standards of practice
that have created and shaped the profession into
its current form
As we learn that
The law is seldom “black and white,” but rather
requires a considerable measure of reasoning and
analysis to reach a decision

To practice..
Pharmacist will need to understand and be able
to apply the laws

  Professional judgement
As health professionals,
pharmacists are highly regulated because the
slightest misstep in drug distribution or
pharmaceutical care could cost a life.

As custodians of the nation’s drug supply,

pharmacists are subjected to extensive regulation
because the products pharmacists control are held
to the most exacting standards of any consumer
product.
In most pharmacy practice situations,
the question of “What is legal?” can be addressed by answering
the question “What is best for the patient?”
Pharmacists may not always know the law, but they usually will
know what is best for the patient, and this knowledge is
ordinarily sufficient.
However,
sometimes situations are more complicated than this simplistic
approach would suggest.
Pharmacy laws have been drafted to describe the best general
approach to specific pharmacy practice situations.
They provide guidance for pharmacists by establishing rules that
reflect societal value choices. It is essential for pharmacists to
know these rules and how to use them.

  Rules – Roles - Responsibility

 Pharmacy law provides the rules, whereas government
agencies interpret and apply them.

Although pharmacy laws can describe basic

practice requirements, they cannot substitute for
good professional judgment.

Within this framework, pharmacists are free to

develop various strategies and exercise good
judgment.

It is not the role of law to dictate strategy and

professional judgment.

  Rules – Roles - Responsibility

PHARMACY PRACTICE and the LAW
NINTH EDITION . 2020
Richard R. Abood, BS Pharm, JD
What is the Pharmacist look like ?

What should the Pharmacist do ?

Who is the Pharmacist ?

• Pharmacist is one who is educated and licensed
to dispense drugs and to provide drug
information
• ---------------------- --- an expert on drugs
 PHARMACEUTICS 1

MEDICINE
DOSAGE FORM respon
EXPERT biologi

senyawa
drug
aktif APOTEKER target
farmasi
tujuan
MEDICINE terapi
BEST-USE
MANAGER

PHARMACOTHERAPY
 PHARMACEUTICS 1

QUALITY
respon
biologi
DOSAGE FORM
senyawa molecular target-
based drug drug
aktif delivery system
APOTEKER target
farmasi design RIGHT USAGE
tujuan
SAFETY
terapi

EFFICACY

PHARMACOTHERAPY
A Health Profession, as : APOTEKER
 Medicine Experts, and
 Medicine best-Use Manager

“ two in one “ hibrida keakhlian :

 keakhlian tentang obat mulai dari bahan baku
sampai menjadi sediaan farmasi yang memenuhi
persyaratan keamanan, khasiat atau
kemanfaatan dan mutu.
 keakhlian memandu (guidance-counseling-
advocate) penggunaan obat yang benar dan baik
oleh penderita sehingga tujuan terapi tercapai
PENDIDIKAN KEAHLIAN
PENGAKUAN
KEWENANGAN
PRAKTIK KEFARMASIAN
 Menjadi Apoteker Indonesia

Perguruan Organisasi Negara

Tinggi Profesi Pemerintah

Standar Pendidikan Standar Profesi Standar Kefarmasian

Standar Standar Kompetensi Gulidline of

Implementasi Apoteker Indonesia Practices
SPO
“BSNP”

KEAKHLIAN PENGAKUAN KEWENANGAN

Pendidikan Sertifikasi Praktik
Kompetensi
Elemen Kompetensi bagi Lulusan Pendidikan
Tinggi

-Seorang yang kompeten, harus mempunyai :

1. Landasan kemampuan pengembangan kepribadian
2.Kemampuan penguasaan ilmu dan ketrampilan
3.Kemampuan untuk berkarya ( know to do )
4.Kemampuan menyikapi dan berperilaku dalam berkarya,
mandiri, menilai dan mengambil keputusan secara
bertanggung jawab (to be)
5.Dapat hidup bermasyarakat dan bekerjasama , saling
menghormati dan menghargai nilai-nilai pluralisme dan
kedamaian (to live together)
License of Pharmacist

By the law & regulations of the country

in which the profession are applied

e.g; - Tenaga kesehatan adalah setiap orang yang

mengabdikan diri dalam bidang kesehatan
serta
memiliki pengetahuan dan atau ketrampilan
melalui pendidikan di bidang kesehatan yang
untuk jenis tertentu memerlukan kewenangan
untuk melakukan upaya kesehatan
 Pasal 1
Ketentuan umum
5. Apoteker adalah sarjana farmasi yang telah lulus sebagai Apoteker dan
telah mengucapkan sumpah jabatan Apoteker.
13. Apotek adalah sarana pelayanan kefarmasian tempat dilakukan praktek
kefarmasian oleh Apoteker.
Penjelasan PP.51
I. Umum
Tenaga Kefarmasian sebagai salah satu tenaga kesehatan pemberi
pelayanan kesehatan kepada masyarakat mempunyai peranan penting
karena terkait langsung dengan pemberian pelayanan, khususnya
Pelayanan Kefarmasian.
Pasal 35 Ayat (1)
Keahlian dan kewenangan Tenaga Kefarmasian dibuktikan dengan memiliki
surat izin praktik. Terhadap tenaga kesehatan di luar Tenaga Kefarmasian
juga dapat diberikan kewenangan melakukan Pekerjaan Kefarmasian yang
dilaksanakan sesuai dengan ketentuan peraturan perundang-undangan.
 Pasal 108
(1) Praktik kefarmasian yang meliputi pembuatan termasuk pengendalian
mutu sediaan farmasi, pengamanan, pengadaan, penyimpanan dan
pendistribusian obat, pelayanan obat atas resep dokter, pelayanan
informasi obat serta pengembangan obat, bahan obat dan obat
tradisional harus dilakukan oleh tenaga kesehatan yang mempunyai
keahlian dan kewenangan sesuai dengan peraturan perundang-
undangan.
(2) Ketentuan mengenai pelaksanaan praktik kefarmasian sebagaimana
dimaksud pada ayat (1) ditetapkan dengan Peraturan Pemerintah.
Pasal 203
Pada saat Undang-Undang ini berlaku, semua peraturan pelaksanaan
Undang-Undang Nomor 23 Tahun 1992 tentang Kesehatan dinyatakan
masih tetap berlaku sepanjang tidak bertentangan dengan ketentuan
dalam Undang-Undang ini.

UU 36/2009 ttg KESEHATAN PP 51 2009 PEKERJAAN KEFARMASIAN

 Keputusan–Tindakan Apoteker

pharmaceutics as Pharmacist
pharmaceuticals

Senyawa
Farmako Patient
Aktif
Terapi Client
Farmasi

• Drug Design • EDUCATION

• Delivery System • Prescribing • GUIDANCE
• Compounding • Recording • COUNSELING
• Manufacture • Care Plan • ADVOCATION
Lingkup tanggung jawab pelayanan kefarmasian
1.Menjamin ketersediaan obat dan alat kesehatan
yang dibutuhkan masyarakat
2.Menjamin obat yang diberikan berkualitas, aman,
efektif dengan memperhatikan hak azasi serta
keunikan individu
3.Menjamin setiap orang atau masyarakat yang
menggunakan obat atau alat kesehatan dapat
menggunakan dengan cara yang paling baik dan
benar.
4.Bersama tenaga kesehatan lain bertanggung jawab
dalam menghasilkan keluaran terapi
 FORMAT LAYANAN KEFARMASIAN

PRAKTEK
KEFARMASIAN

LICENSED CPOB
PHARMACIST
UU
Standar
Pelayanan

Kompetensi
KINERJA
PROFESION
AL YANG
TERUKUR
 PRAKTEK KEFARMASIAN

Ilmu …………… Farmasi

Etika …………… Komunikasi

Kepastian……………‘Hukum’
 The Seven
* Care Giver Stars of
Pharmacist
* Decision maker

* Communicator

* teacher
* Manager
* leader

* Long life learner

* RESEARCHER
 Terima kasih

teruslah bersemangat
dalam belajar