REGULASI OBAT YANG

MEMPENGARUHI PERESEPAN

Ida Prista Maryetty

Blok Pengobatan Rasional FK UII

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Definisi

z Regulasi/regulation
z Policy/kebijakan
z Inappropriate Prescribing

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Inappropriate prescribing

Inappropriate prescribing is a
manifestation of irrational drug use
behavior when drugs are not prescribed
in accordance with guidelines based on
scientific evidence to ensure safe,
effective and economic use

3
Factors underlying irrational use of
drugs
z Health System; unreliable supply,
availability of inappropriate drugs, etc.
z Prescribers
Internal factors: inadequate training,
inadequate continuing education,
inadequate objective drug information.
External factors: profit, peers
(colleague), patients.

4
(Factors underlying irrational use of
drugs, cont…)
z Dispenser, inadequate information
z Patient and community, beliefs,
inadequate information

5
Strategy to address irrational use of
drugs

z Educational
z Managerial
z Regulatory

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Why do we need regulations?

─ Drugs save lives and improve health

─ Access to quality essential medicines is
the right of every patient
─ Pharmaceuticals involve important risks
─ Pharmaceuticals involve many parties
─ Informal controls are insufficient

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Why do we need regulations (cont…)

─ To ensure the efficacy, safety, quality,

availability, accessibility, affordability,
sustainability and cost-effectiveness of
drugs
─ The limitation of resources
─ To protect patients from inappropriate
prescribing

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The effective regulations should meet the
following criteria

z Must clearly define the roles, responsibilities,

and rights of each party
z Creates administrative bodies to put rules
into practices, ex: national drug authority
(Indonesia; BPOM, Amerika; FDA)
z The drug regulatory agency must use its
authority to impose penalties when
necessary (withdrawal of drugs from the
market, etc)

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Regulasi yang dapat digunakan

z Sistem Kesehatan Nasional (SKN)

z Kebijakan Obat Nasional (National drug policy)
z Essential Drug Concept (INA; Daftar Obat
Esensial Nasional /DOEN)
z Limited drug list/formulary/formularium
z Standard treatment guidelines
z Generic Policy
z Drug registration

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Regulasi yang dapat digunakan
(cont…)

z Prescribing restriction
z Dispensing limitation
z Ethical criteria for medicinal drug
promotion (WHO)
z Drug Price Control

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Sistem Kesehatan Nasional (SKN)

Merupakan pedoman penyelenggaraan bidang

kesehatan di Indonesia, termasuk obat

Prinsip dasar; norma, nilai dan aturan pokok yang

bersumber dari falsafah dan budaya bangsa Indonesia

Mempunyai suprasistem (sistem penyelenggaraan

negara) dan subsistem

SKN berinteraksi dengan sisdiknas, sishankamnas,

sistem perekonomian nasional dan sistem nasional
lainnya

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Sistem Kesehatan Nasional (SKN),
cont…
Subsistem SKN
1. Upaya Kesehatan
2. Pembiayaan Kesehatan
3. Sumber Daya Manusia Kesehatan
4. Obat dan Perbekalan Kesehatan
5. Pemberdayaan Masyarakat
6. Manajemen Kesehatan

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Sistem Kesehatan Nasional (SKN),
cont…
Prinsip penyelenggaraan subsistem obat &…,
─ Pelayanan obat & … diselenggarakan secara rasional
dengan memperhatikan aspek mutu, manfaat, harga,
kemudahan akses serta keamanan bagi masyarakat
dan lingkungan

─ Tidak dipromosikan secara berlebihan dan

menyesatkan

─ Pemanfaatan tidak bertentangan dengan hukum,

etika dan moral

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Sistem Kesehatan Nasional (SKN),
cont…
─ Penyediaan mengutamakan obat generik
bermutu

─ Pelayanan obat di rumah sakit sesuai

formularium RS, sarana kesehatan
lainnya sesuai Daftar Obat Esensial
Nasional (DOEN)

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National Drug Policy

NDP is a guide for action. It is a document

specifying the goal sets by the government
for the pharmaceutical sector

Usually not a law

Need to be supported by appropriate legislation

to be enforceable

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National Drug Policy, cont…

Specific objectives of NDP differ among

countries, but the most common are
─ to make essential drugs available and
affordable
─ ensuring safety, efficacy & quality of
medicines, and
─ to promote rational use of drugs

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National Drug Policy, cont…

Indonesia: Kebijakan Obat Nasional (Konas),

tujuannya menjamin
1. Ketersediaan, pemerataan, dan
keterjangkauan obat, terutama obat esensial
2. Keamanan, khasiat dan mutu semua obat
yang beredar serta melindungi masyarakat
dari penggunaan yang salah dan
penyalahgunaan obat
3. Penggunaan obat yang rasional

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Konsep Obat Esensial

Obat esensial adalah obat terpilih yang

paling dibutuhkan untuk pelayanan
kesehatan, mencakup upaya diagnosis,
profilaksis, terapi dan rehabilitasi, yang
diupayakan tersedia pada unit pelayanan
kesehatan sesuai dengan fungsi dan
tingkatnya (rumah sakit, puskesmas, pos
obat desa)

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Konsep Obat Esensial, cont…

Merupakan pendekatan untuk

menyediakan pelayanan bermutu dan
terjangkau

Diwujudkan dengan Daftar Obat

Esensial Nasional (Indonesia; DOEN)

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Konsep Obat Esensial, cont…
Daftar Obat Esensial Nasional (DOEN)

─ Pertimbangan manfaat terhadap risiko dan

manfaat terhadap biaya

─ Berisi obat-obat yang paling menguntungkan

bagi pelayanan kesehatan dari segi kualitas,
keamanan, manfaat dan harga

─ Dievaluasi tiap 3 tahun, terakhir 2002

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Limited Drug List/Formulary

z Have been used since the early 1970s

z List of certain drugs
z Usually based on therapeutic class
z May differ among countries
z Drug based
z Aim at controlling costs and promote
rational use of drugs

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Limited Drug List/Formulary
z the main mechanism to prevent the use of
dangerous, ineffective and unnecessary
expensive drugs

z The listed drugs should be based on efficacy,

safety, availability, affordability and cost
effectiveness

z Examples; P-formulary, hospital formulary, WHO

formulary, British National Formulary, IONI, etc.

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Standard Treatment Guidelines
(STG)
z Treatment protocols, prescribing policies
z Assist prescribers in deciding on
appropriate treatment
z Disease centered, most common
diseases and complaints
z Indicate a treatment of choice

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Mengapa perlu STG?

z Penemuan obat baru

z Banyaknya pilihan obat untuk suatu

kondisi penyakit (Indonesia; sekitar
13.000 aitem obat)

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Generic Policy

Support the implementation of National Drug

Policy

Few countries have effectively implemented

generic policy with strong legislation and
incentives

Incentives for manufacturers, prescribers,

pharmacies

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Registrasi obat

Prosedur pendaftaran dan evaluasi obat

untuk mendapat izin edar

Merupakan elemen penting dalam regulasi

obat

Diatur dalam Kriteria dan Tata Laksana

Registrasi Obat dikeluarkan oleh Badan
POM (2003)

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Registrasi obat

Obat yang memiliki izin edar harus memenuhi

kriteria
a. Efikasi yang meyakinkan dan keamanan yang
memadai dibuktikan melakui uji preklinik, uji
klinik dan bukti lain
b. Mutu yang memenuhi syarat sesuai Cara
Produksi Obat yang Baik (CPOB)
c. Penandaan berisi informasi yang lengkap dan
obyektif yang dapat menjamin penggunaan
obat secara tepat, rasional dan aman

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Registrasi obat

Obat yang telah memiliki izin edar dapat dievaluasi

kembali ataupun dicabut izin edarnya

Evaluasi kembali dilakukan terhadap

1. Obat dengan risiko efek samping lebih besar
dibanding khasiat, terungkap setelah obat
dipasarkan (hasil post marketing surveillance)
2. obat dengan efektifitas tidak lebih baik dari
placebo
3. obat yang tidak memenuhi persyaratan
bioekivalensi/ketersediaan hayati

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Drug registration (cont…)

How does drug registration affect

prescribing
1. limits the types and numbers of
drugs available for prescribing
2. helps keep dangerous and
ineffective drugs on the market

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Prescribing Restrictions

z to cut down inappropriate prescribing

z Each institution has its own strategy to

restrict prescribing, such as; the use of
third-generation cephalosporins is
restricted to specialist prescribers, the
junior staff can prescribe such drug only
for 24-to-48 hours, etc

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Dispensing limitations

z To control wasteful or potentially

dangerous dispensing
z A system of three and five day limits
z Prepackaging drugs in unit-of use plastic
bags containing the minimum amount of
drug needed for one course of therapy
(South America)

z Exceptions must be built in to cover

chronic diseases and exceptional cases
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WHO Ethical Criteria for Medicinal
Drug Promotions
Objective
To support and encourage the
improvement of health care through the
rational use of medicinal drugs.

Constitute general principles for ethical

standard on drug promotions.

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WHO Ethical Criteria for Medicinal
Drug Promotions, cont…
Drug Promotions

Take place only with respect to drugs legally

available in the country

Should be in keeping with national health policies,

and in compliance with national regulations

Scientific data in the public domain should be made

available for prescribers

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WHO Ethical Criteria for Medicinal
Drug Promotions, cont…
Drug Promotions, cont…

Should not be offered to prescribers to

influence them in the prescription of drugs

Scientific and educational activities should not

be deliberately used for promotional purposes

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How do drug manufacturers affect
prescribing practices?
1. Prescribers: dinners, cash payments,
textbooks, meals, travel to attend
meetings, etc.
2. Patients: gifts, discounted merchandise

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WHO Ethical Criteria for Medicinal
Drug Promotions, cont…
Advertising

z Should be consistent with the approved scientific

data sheet

z Should usually contain

- the name of active ingredient(s), generic name
- the brand name
- content of active ingredient(s) per dosage form
- name of other ingredients known to cause problems
- approved therapeutic uses

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WHO Ethical Criteria for Medicinal
Drug Promotions, cont…
should usually contain (cont…)
- dosage form of regimen
- side-effects & major adverse drug reactions
- precautions, contraindications and warning
- major interactions
- name and address of manufacturer or
distributor
- Reference to scientific literature

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Drug Price Control

z Mempengaruhi peresepan secara tidak

langsung dengan mempengaruhi struktur
harga obat

z Mencegah promosi yang berlebihan kepada

prescribers

z Beberapa cara; regulasi harga, kebijakan

substitusi obat generik

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References and further readings

Badan Pengawas Obat dan Makanan (Badan POM), 2003. Kriteria dan Tata Laksana Registrasi
Obat. Badan POM, Jakarta.

Depkes R.I. 2006. Kebijakan Obat Nasional. Depkes R.I., Jakarta.

Departemen Kesehatan R.I. (Depkes R.I.), 2004. Sistem Kesehatan Nasional, Jakarta.

Depkes R.I. 2002, Daftar Obat Esensial Nasional. Depkes, Jakarta.

Quick, et. Al., 1997. Managing Drug Supply, 2nd edition, Management Science for Health,
Kumarian Press, Connecticut.

Weiss D. Laurence, …, Private Medicine and Public Health.

World Health Organization (WHO), 1988. Ethical Criteria for Medicinal Drug Promotion, WHO,
Geneva.

Weber J. Leonard, … Business Ethics in Healthcare; beyond compliance. Indiana University

Press, Bloomington&Indianapolis.

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