CHOICE OF DRUGS AND

PHARMACEUTICAL PRODUCTS
 2

Choice of drugs and pharmaceutical products

• Approval of pharmaceutical products
• Safety, quality, and efficacy should be prerequisites for the
approval for sale of a pharmaceutical product.
• Number of drugs
• There are arguments for and against limiting the number of drugs
and pharmaceutical products.
• For various reasons some regulatory agencies, prepaid insurance
systems, and hospitals limit the number of drugs that can be
prescribed.
• A decision to limit the number of active substances and
pharmaceutical products requires a balance to be found between
several, sometimes conflicting, objectives.
 3

• The most important of these objectives is to establish a

drug supply system that satisfies the health needs of the
community and at the same time can respond to the health
needs of the individual.
• Whatever the extent of limitation of the number of drugs,
provision should be made to supply any approved
pharmaceutical product excluded from the limited list to
meet exceptional medical needs.
• The number of drugs and pharmaceutical products
selected will be Influenced by the need to maintain a drug
supply system of appropriate and manageable size in
terms of the human and financial resources needed to
monitor and control its operations effectively.
 4

Selection of essential drugs

• It provides a rational basis for :
• drug procurement at the national level
• establishing and meeting drug requirements at different levels
within the health care system
• As a first step, a process should be established for
selecting the drugs to be included in the essential drugs
list. Commonly a committee is set up which includes
experts in clinical medicine, pharmacology, pharmacy
 5

• Mechanisms should be established for consultation with

interested parties, including representatives of
professional bodies, pharmaceutical manufacturers, and
consumer and patient organizations.
• While such formal and informal consultation with
representative interests is needed to ensure that the
selection of drugs reflects broad policy objectives, the
process of drug selection by the experts should be carried
out independently.
 6

National Drug Selection Process: Thai example

1. Preparation of information
Information
Safety
Administration Score = D/ISAFE
Frequency
Efficacy
Drug expenditure/day

2. Consideration by national drug selection

committee
3. Consideration by national drug list
subcommittee
 7
Specific Working Groups for NLEM selection
- Reviewing evidences and generating evidence for ISafE scoring

The working group for coordination & consolidation of NLEM

- Gathering information and making recommendations to the subcommittee

weeks
The Subcommittee for Development of NLEM
- Setting criteria for drug selection and prioritizing those drugs for economic evaluation

weeks weeks

the next round

Sustaining for
Drugs listed on the top priority Drugs listed not on the top priority

The health economics The health economics

working group Drugs nominators working group
- Informing Non-profit organization - Rejecting to - Informing nominators to conduct
to conduct economic evaluation conduct the studies economic evaluation
weeks weeks
Non-profit organizations The health economics Drug nominators
-Conducting economic weeks subgroup weeks -Conducting economic
evaluation studies by -Assessing quality of the evaluation studies by
precisely observing the economic evaluation studies precisely observing the
national HTA guidelines national HTA guidelines
weeks
Revising studies Revising studies
Need some revisions
Re-conducting studies Re-conducting studies
Unacceptable quality
Acceptable quality

weeks
The health economics working group
Considering those economic evaluation studies and developing policy recommendation

weeks
The working group for coordination & consolidation of NLEM 7
The Subcommittee for Development of NLEM
 8
The UC benefit package development
•Policy
makers
•Academics
•Health
Professionals
•Healthcare
industry
•Civic groups
•Patient
associations
•Lay citizens

8
9
 10

Health Intervention and Technology Assessment Program (HITAP)

• A non-profit organisation established in Jan 2007

• An associate organisation with International Health

Policy Program, Ministry of Public Health, Thailand –
IHPP

• Responsible for appraising a wide range of health

technologies including pharmaceuticals, medical
devices, interventions, individual and community health
promotion and disease prevention
 11

Cost represents a major criterion in selection. In

comparing the costs of different drugs the following
elements should be taken into account:
• the cost of the treatment regimen rather than the cost of
the dosage form;
• the cost of treatment in relation to the savings made by,
for example, reduction in the need for surgery or
hospitalization; different rates of success of treatment
achieved, as a result of improved patient compliance,
reduced loss or waste achieved by using more stable
products.
 12

When several drugs are available with the same indication,

or when two or more drugs are therapeutically equivalent,
the aim should be to select the pharmaceutical product and
dosage form that provide the most favourable benefit/risk
ratio. Preference should be given to:
• the drugs that have been most thoroughly investigated;
• the drugs with the most favourable pharmacokinetic
properties, e.g. those that improve compliance or
minimize risk in various pathophysiological states ;
• the drugs, pharmaceutical products, and dosage forms
with the greatest stability or for which appropriate storage
facilities exist.
 13

• New drugs should be introduced into an essential drugs

list only if they offer distinct advantages over drugs
selected previously.
• If new information on drugs already in the list shows that
they no longer have a favourable benefit/risk ratio, they
should be deleted and replaced by safer drugs.
• For the treatment of certain conditions, non-
pharmacological forms of therapy or no therapy at all may
be preferable.
 14

• The essential drugs list should be updated at least every

second year and more often if necessary.
• Revision is likely to be needed because of advances in
drug therapy and in order to meet the needs of practice in
the light of clinical experience.
SUPPLY OF MEDICINE
• Procurement
• Local production
• Distribution and storage
 16
ALUR PENGADAAN OBAT
Permenkes No. 63 Tahun 2014

Komite Fornas Kemenkes Kemenkes

Usulan Harga Perkiraan Sendiri

Usulan Obat Penetapan
dan Jumlah Kebutuhan Obat
dari RS, Obat dalam
(Rencana Kebutuhan Obat) satu
Profesi, YLKI Fornas
tahun

Faskes Pabrikan LKPP LKPP

Pemesanan Obat Ketersediaan Kontrak dengan Pabrik Lelang Penetapan
oleh Faskes obat oleh Obat dan Distributor,
Penunjukkan
(Rumah Sakit, Pabrikan komitmen penyediaan
(dituangkan dalam e- Pabrikan sebagai
FKTP, Dinkes) melalui
katalog) pemenang
Distributor

Distributor Faskes Faskes BPJS Kesehatan

Pembayaran
Klaim INA
Pelayanan obat Penagihan klaim CBGs oleh
Distribusi Obat ke Pelayanan oleh
Faskes kepada peserta BPJS
oleh Faskes Faskes kepada Kesehatan
BPJS Kesehatan (Termasuk
Obat di
Ket : *Kecuali untuk obat kronis, obat rujuk balik dan obat non paket INA CBGs Dalamnya)*
17
 18

Data Realisasi E-Katalog Berdasarkan Anggaran Per Produsen

RKO Nasional
No Nama Industri (Rp) Realisasi (Rp) %

1 PT. ERELA 52,244,925,744 1,462,000,420

27,11
2 PT. WIDATRA BHAKTI 479,942,562,476 42,882,475,004
9
3 PT. HOLI PHARMA 291,447,391,695 21.564.756.177
7,40
4 PT. KIMIA FARMA 489,380,221,577 99,998,466,479
20
5 PT. SAMPHARINDO PERDANA 3,128,542,379 1,130.466.400 36,13

6 PT. YARINDO FARMATAMA 43,950,529,098 8.121.687.498

18,48
7 PT. NOVAPHARIN 74,932,642,686 15.489.473.665
20,67
8 PT. BERNOFARM 877,485,625,502 65,119,067,620
7
9 PT. ETHICA 13,091,680,331.13 611.779.540
5
10 PT. NUFARINDO 94,076,532 12.730.000
14
11 PT. PHAPROS 581.194.590.922 77,000,000,000
13
12 PT. PHYTO KEMO AGUNG 4,347,122,949.59 126,569,653
3
 19

LANJUTAN….

RKO Nasional
No Nama Industri (Rp) Realisasi (Rp) %

27,255,428,913 8,400,000,235
13 PT. MERSIFARMA 31
44,821,453,678 3,200,000,000
14 PT. DEXA MEDICA 7
330,634,109,342 56,000,000,000
15 PT. HEXPHARM 17
736,502,486 664.361.260
16 PT. IFARS 90,20
47,322,929,256 17.817.131.505
17 PT. PROMEDRAHARDJO 37,66
57,907,022,840 10,615,997,304
18 PT. RAMA EMERLARD 18
11,341,216,278 27,123,797
19 PT. SEJAHTERA LESTARI FARMA 0.2
1,600,000,000,000 189,000,000,000
20 PT. INDOFARMA 11.8
50,000,000,000 30,000,000,000
21 PT. MARIN LIZA 60
50,000,000,000 30,000,000,000
22 PT. LUCAS DJAYA 60
127.152.124.593 61.631.426.915
23 PT AFIFARMA 48,47
 20

Beban ganda kekosongan obat

Inefisiensi biaya pelayanan kesehatan & berkurangnya proteksi finansial
Di FKTP, kekosongan obat berhubungan dengan
meningkatnya rasio rujukan non-spesialistik (diagnosis
yang seharusnya bisa ditangani di FKTP namun dirujuk
ke RS)

Akibat: Inefisiensi biaya pelayanan kesehatan (biaya

INA-CBGs untuk diagnosis yang seharusnya dibiayai
kapitasi)
Sumber: Kajian Pemetaan Kompetensi Dokter di FKTP (BPJS Kesehatan 2015)

Di FKRTL, kekosongan obat menyebabkan peserta

harus mengeluarkan biaya tambahan untuk obat yang
biayanya seharusnya sudah tercakup dalam tarif INA-
CBGs

Akibat: Berkurangnya proteksi finansial peserta JKN-

KIS
Sumber: Kajian Biaya Tambahan yang Dibebankan ke Peserta BPJS Kesehatan di FKRTL (BPJS Kesehatan 2015)
feasibility studies are needed before local
production can be undertaken:
• the size of the domestic market, its purchasing power, and
the possibilities for the export of drugs to neighbouring or
other countries.
• the true foreign exchange costs, including hidden costs.
This will include costs of raw materials, packaging,
machinery and spare parts, technical assistance,
technology and licences, quality control equipment and
services, the distribution network.
• the highly skilled personnel needed are available locally
Criteria for storage
• adequate storage facilities ;
• adequate inventory control, including security;
• sufficient and appropriate transportation facilities and
maintenance service
• packaging material - standardization and labelling;
• quality surveillance ;
• education and regular training of staff,
• a management information system;
• drug utilization surveys.
Example of distribution patterns: