Endang Yuniarti, S.Si.,M.

Kes, Apt

Seleksi Obat di RS

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HOT TIPS..

Valuable medicine is
important, but a pharmacist
with a compassionate, tender
and humble heart is more
important.
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Rumah Sakit

 RS adalah institusi pelayanan kesehatan

yang menyelenggarakan pelayanan
kesehatan perorangan secara paripurna
(promotif, preventif, kuratif dan
rehabilitatif) yang menyediakan
pelayanan rawat inap, rawat jalan dan
gawat darurat.

(UU RI No 44 th 2009 ttg RS)

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Kefarmasian di RS

Bagian ke enam, pasal 15:

Pengelolaan alat kesehatan, sediaan
farmasi dan bahan habis pakai di Rumah
Sakit harus dilakukan oleh Instalasi
Farmasi sistem satu pintu
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Medicine use in Hospital

1. Selection and formulary management

by a multi-disciplinary committee
2. Prescribing by the physician
3. Procurement, storage, medication
order review, and preparation and
dispensing by the pharmacy
department
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Medicine use in Hospital

4. Medication administration by nurses

or both other health care
professionals
5. Monitoring the effect of medicines on
the patient by all members of the
health care team
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Expectations….

Patients, Financial
manager,
physicians, legal
Nurse counsels, and
risk managers
Health
care Government
administra and society
tors

To ensure that the highest-quality, most cost-effective

agents are available when needed to threat patient
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PMK NOMOR 72 TAHUN 2016

Pelayanan Kefarmasian di RS meliputi 2 (dua)

kegiatan:
1. Kegiatan manajerial berupa pengelolaan
sediaan farmasi, alat kesehatan, dan bahan
medis habis pakai
2. Kegiatan pelayanan farmasi klinik
Faktor pendukung:
a. Sumber daya manusia
b. Sarana
c. Peralatan
 Pengelolaan
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1. Pemilihan
2. Perencanaan kebutuhan
3. Pengadaan
4. Penerimaan
5. Penyimpanan
6. Pendistribusian
7. Pemusnahan dan Penarikan
8. Pengendalian
9. Administrasi
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PEMILIHAN
 The Drug and Therapeutic committee
(DTC), or
 Pharmacy and therapeutic committee
(P&T Committee), or
 The medicine and therapeutic committee
is solely responsible for approving policies
and procedures and monitoring practices
to promote safe and effective medicine
use.
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Functions of DTC:

1. Advising medical, administrative, and pharmacy

departments on pharmaceutical related issues
2. Developing pharmaceutical policies and procedures
3. Evaluating and selecting medicines for the
formulary and providing for its periodic revision
4. Identifying medicine use problems
5. Promoting and conducting effective interventions to
improve medicine use (including educational,
managerial, and regulatory methods)
6. Managing ADRs and medication errors
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Policies and Procedures

 Selection criteria of medications for hospital

formulary
 Management of the approved medicine list
or hospital formulary
 Ongoing (formulary) drug use review
 Adverse drug event reporting and
implementation of safe medication
practices
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Responsibilities

 Establishes and maintains the

formulary system
 Selects medications for formulary
inclusion by considering the relative
clinical efficacy, patient quality of life,
patient safety, and pharmacoeconomic
outcomes
 Evaluates medication use and related
outcomes
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Responsibilities
 Prevents and monitors adverse drug
reactions and medication errors
 Evaluates or develops and promotes use
of drug therapy guidelines
 Develops policies and procedures for
handling medications to include their
procurement prescribing, distribution, and
administration
 Educates health professionals to the
optimal use of medications
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Membership
should include representation from:
1. Medical staff (including representation
from each department)
2. Pharmacy (The chief pharmacist often
serves as the secretary)
3. Nursing
4. Hospital administration
5. Quality assurance staff and risk
management
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Membership

should have broad representation but be

sufficiently small and manageable to
conduct business efficiently: eight to
fifteen members.
The DTC may occasionally invite a
specialist to make a presentation or
provide advice on a particular issues
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Pharmacist Role

 Establish P&T committee meeting

agenda (as secretary)
 Analyze and disseminate scientific,
clinical and health economic
information regarding a medication or
therapeutic class for review by the P&T
Committee
 Conduct drug use evaluation and
analyze data
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Pharmacist Role

 Record and archive P&T Committee

actions (as secretary)
 Follow-up with research when
necessary
 Communicate P&T Committee decisions
to other health care professionals such
us pharmacy staff, medical staff, and
patient care staff.
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Factors Critical for Success of DTC

 Establish clear goals and purpose

 Obtain wide representation on the
committee—prescribers, nurses,
pharmacists, administration
 Permit no relationship of the committee or
committee members with pharmaceutical
manufacturers or suppliers
 Communicate all DTC information, policies,
procedures, recommendation, and actions
to staff
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Factors Critical for Success of DTC
 Obtain official status approved by the
administration (local hospital director and
regional health bureaus) with strong
management support— important issue
 Ensure the committee has a motivated,
respected, and dynamic chairperson and
members
 Develop support from medical and pharmacy
departments and local professional schools
 Ensure contextual incentives
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Examples of DTC Problems, Causes, and Solutions
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Examples of DTC Problems, Causes, and Solutions
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Examples of DTC Problems, Causes, and Solutions
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Examples of DTC Problems, Causes, and Solutions
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Examples of DTC Problems, Causes, and Solutions
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Formulary

A formulary manual is drug oriented and

contains summary drug information on a
selected number of medicines, sometimes
combined with practical prescribing and
dispensing information.
It is drug centered, and the information is
usually organized in therapeutic groups
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PMK 72 2016 – Formularium RS

 Formularium Rumah Sakit merupakan

daftar Obat yang disepakati staf medis,
disusun oleh Komite/Tim Farmasi dan
Terapi yang ditetapkan oleh Pimpinan
Rumah Sakit.
 Pemilihan obat berdasarkan kriteria yang
dikembangkan oleh KFT.
(p 15-16)
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SELECTION CRITERIA

1. Relevance to the pattern of prevalent disease

2. Proven efficacy and safety
3. Evidence of performance in variety of settings
4. Adequate quality, including bioavailability,
bioequivalence and stability
5. Favorable cost-benefit ratio in terms of the
total treatment cost
6. Preference for drug that are well known, with
good pharmacokinetic properties and
possibilities for local manufacture
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Bioavailabilitas

 Peraturan Kepala Badan Pengawas Obat

dan Makanan Republik Indonesia Nomor
HK.00.05.3.1818
 Persentase dan kecepatan zat aktif dalam
suatu produk obat yang
mencapai/tersedia dalam sirkulasi
sistemik dalam bentuk utuh/aktif setelah
pemberian produk obat tersebut, diukur
dari kadarnya dalam darah terhadap
waktu atau dari eksresinya dalam urine.
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Bioekivalensi
Dua produk obat disebut bioekivalen jika
keduanya mempunyai ekivelensi farmasetik
(mengandung zat aktif yang sama dalam jumlah
dan bentuk sediaan yang sama) atau merupakan
alternatif farmasetik (mengandung zat aktif yang
sama tetapi berbeda bentuk kimia –garam, ester,
dsb- atau bentuk sediaan atau kekuatan) dan
pada pemberian dengan dosis molar yang sama
akan menghasilkan bioavailabilitas yang
sebanding sehingga efeknya akan sama, baik
efikasi maupun keamanannya.
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Produk obat yang memerlukan uji ekivalensi

Dilakukan bila ada risiko bahwa perbedaan

bioavailabilitas dapat menyebabkan inekivalensi
terapi:
1. Produk oral lepas cepat yang bekerja
sistemik, bila memenuhi salah satu kriteria
berikut:
a. obat-obat yang memerlukan respon terapi
yang pasti, spt: anti tuberkulosis,
antiretroviral, antimalaria, antibakteri,
antihipertensi, antiangina, obat gagal
jantung, antiepilepsi, anti asma.
Produk obat yang memerlukan uji ekivalensi
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b. Batas keamanan/indeks terapi sempit: digoksin,

antiaritmia, antikoagulan, obat-obat sitostatik,
litium, fenitoin, siklosforin, sulfonilurea, teofilin.
c. Terbukti ada masalah dengan bioavailabilitas atau
bioekivalensi, misal: absorpsi bervariasi atau tidak
lengkap, eliminasi presistemik yang tinggi,
farmakokinetik nonlinier, sifat fisika kimia yang
tidak menguntungkan.
d. Eksipien dan proses pembuatannya diketahui
mempengaruhi bioekivalensi
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Produk obat yang memerlukan uji ekivalensi

2. Produk obat non oral dan nonparenteral yang

didesain untuk bekerja sistemik: sediaan
transdermal, suppositoria, permen karet nikotin,
gel testosteron dan kontrasepsi bawah kulit.
3. Produk obat lepas lambat atau termodifikasi yang
bekerja sistemik
4. Produk obat bukan larutan untuk penggunaan
nonsistemik
Produk obat yang tidak memerlukan uji ekivalensi
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1. Produk obat “copy” untuk penggunaan intravena

sebagai larutan dalam air yang mengandung zat
aktif yang sama dalam kadar molar yang sama
dengan produk pembanding.
2. Produk obat “copy” untuk penggunaan parenteral
yang lain (intramuskular, subkutan) sebagai
larutan dalam air yang mengandung zat aktif yang
sama dalam kadar molar yang sama dan eksipien
yang sama atau mirip.
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Produk obat yang tidak memerlukan uji ekivalensi

3. Produk obat “copy” berupa larutan untuk

penggunaan oral (termasuk sirup, eliksir,
tingtur atau bentuk lain selain suspensi)
4. Produk obat “copy” berupa bubuk untuk
dilarutkan, berupa gas, berupa sediaan
obat mata atau telinga, berupa obat
topikal, berupa larutan untuk
aerosol/inhaler/ nebulizer/semprot hidung.
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The formulary system

 The formulary has evolved beyond a list of

medications to a system that methodically
evaluates medications on an ongoing
basis for inclusion or exclusion,
establishes guidelines for optimal
medication use, and develops policies and
procedures for prescribing, dispensing
and administering medications in the
hospital
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The WHO Model Formulary

Each section of the formulary starts with a

comparative overview of various
therapeutic alternatives, while each
medication entry has information on use,
dosage, adverse effects, contraindications,
and warning.
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Information in a formulary manual

o Introductory information
o Basic Information for each drug
o Supplementary information on each drug
o Prescribing and dispensing guidelines
o General drug use advice (optional)
o Other component
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Basic information for each drug

1. Generic name, common synonyms, or

brand names
2. Dosage form(s) and strength (s)
3. Main indications (disease and conditions
for which a drug is given)
4. Pharmacology (may include
pharmacokinetic data)
5. Contraindications (reasons not to give the
drug)
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Basic information for each drug
6. Precautions (such as pregnancy, breast-
feeding, certain health conditions)
7. Side effects (major and minor, with estimated
frequency)
8. Dosage schedule (dosage form, frequency,
duration, pediatric dosage, dosage
adjustments for the elderly and for those with
renal or liver disease)
9. Instruction and warning
10.Drug, food, lab interactions (most common or
severe)
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Hospital Formularies

The hospital formulary is the cornerstones

of medication management in the hospital,
and it should be the principal concern of the
DTC.
Additional information presented in hospital
formulary manuals may include details of
recommended hospital procedures,
hospital antibiotic policy, and guidelines for
laboratory investigations and patient
management.
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Guidelines for hospital setting

• Limit the formulary list to conserve

resource
• Eliminate (limit) generic duplication
• Minimize the number of strengths stocked
for the same medication
• Select medications for the formulary
based on diseases and conditions treated
at the facility
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Guidelines for hospital setting

• Specify formulary medicines of choice for

common therapeutic indication. Medicines
of choice should be selected by
comparing efficacy, safety, toxicity,
pharmacokinetic properties,
bioequivalence, and pharmaceutical and
therapeutic equivalence. Cost
effectiveness and availability should be
primary considerations.
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Guidelines for hospital setting

• Include second-line alternatives to

medicines of choice as needed, but
minimize therapeutic duplication.
• Ensure that the hospital formulary
corresponds with any national or regional
standard treatment guidelines that have
been formally approved by the health
system
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Formularium Taiwan Hospital
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Formularium RS PKU

Berisi
kurang lebih 1300
merk obat

19% obat vital, 71%

obat esensial, dan
10% obat non esensial
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Formularium RS PKU, memuat informasi:

 Nama generic atau sinonim yang umum digunakan

atau nama dagang (maksimal 4 nama dagang
termasuk nama original)
 Bentuk sediaan dan kekuatan.
 Indikasi dan Kontra Indikasi
 Dosis dan aturan pemberian (frekuensi, durasi, dosis
anak-anak dan dosis pada lanjut usia dan pasien dgn
gangguan ginjal dan hati)
 Perhatian seperti kehamilan, menyusui atau kondisi
kesehatan yang khusus)
 Efek samping yang paling sering terjadi
 Interaksi baik dengan obat lain mupun makanan.
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Formularium RS PKU
..\..\PFT\a-Project New Formularium RS
PKU 2015\1. formularium PKU revisi 6 +
restriksi fornas edit baru - A5.pdf
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Formularium Nasional
..\..\S3 FK UGM\BIBLIOGRAFI\JKN
Indonesia\FORMULARIUM_NASIONAL.pdf
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e-formulary

On line
E-formulary

Formulary
database
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Promote formulary adherence

 Review and take action on all non formulary

medicine use
 Prohibit use or distribution of samples of non
formulary products
 Establish procedures and approved products
lists for therapeutic substitution
 Provide easy access to the formulary list
 Involved medical staff in all impending
formulary decisions
 Advertise and promote formulary changes
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Promote formulary adherence
If many non formulary medicines requests
come from a particular physician, or if requests
are frequent for a particular non formulary
medicine, the DTC should take actions, e.g
 Adding the medicine to the formulary, or
 Educating physicians on the rationale for
the non formulary status of the medicine, or
 Banning the medicine from use in the
hospital
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The Formulary System

 Drugs are added and deleted from the

formulary on a regular basis, but varies
among hospitals
 Formularies typically are updated every
12 to 18 months
 Loose-leaf formularies and those
maintained online can be updated
continuously in a timeline manner
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Notes

 Changing IV solutions, IV sets or other

nursing devices and educating all nurses
every year on the change is not feasible or
cost-effective and may increase medication
administration errors
 To minimize confusion and medication
errors, changing the source of drug products
in infrequent unless major economic
incentives exist
 Avoid LASA product (kejadian buvanest inj)
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References:
 Managing Drug Supply  MDS-3,
Managing Access to Medicines and Health
Technologies
 Permenkes RI No 58 th 2014
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References:
Pharmacy Management, Essentials for All
Practice Settings
Handbook of Institutional Pharmacy Practice
Manajemen Operasi
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Tugas untuk pertemuan berikutnya
Review buku manual DTC dari WHO,
presentasikan hasilnya dengan pembagian
sbb:
1. Kelompok 1: Introduction, hal 1-5
2. Kelompok 2: Struktur dan Organisasi
DTC, hal 6-11
3. Kelompok 3: Managing the Formulary
Process, hal 15-19
4. Kelompok 4: Managing the Formulary
Process, hal 19-23
Alhamdulillah
Mudah-mudahan bermanfaat
Matur nuwun..
Wassalam LOGO