Transcript Rasionalisasi Obat Herbal

Rasionalisasi Penggunaan
Obat Herbal
Armen Muchtar
Departemen Farmakologi Klinik
RSUPN Dr Cipto Mangunkusumo
Dampak Industri Terhadap
Pelayanan Kesehatan
Masalah Obat Modern.
 Masalah Alat Kesehatan
 Masalah Obat Herbal
 Konglomerasi Sarana/Komersialisasi
Pelayanan

Latar Belakang Masalah Obat
Kemajuan teknologi/industri farmasi  drug
explosion  therapeutic jungle.
 Obat sebagai commodity dengan ciri
aggressive marketing: detailing, sponsorship,
incentives, hidden curriculum, disease
mongering, multi-level marketing, direct to
consumers advertising, consumer supporting
organization, fraud, bribery, dll.
 Industri farmasi kapitalistis: harga tak boleh
dikontrol, serahkan ke pasar; diberlakukan
masa patent  obat baru mahal.

Improper Conduct of US
Pharmaceutical Industries








Inflated government reimbursement for prescription
drugs.
Kickbacks to private insurers for favoring drug on
formularies.
Aggressively marketed drug for off-labeled indication.
Kickbacks to high-prescribing physicians.
False statement about safety.
False statement about drug efficacy to induce
prescription writing.
Holding continuing medical education meetings to induce
writing of un approved prescription.
Paid providers to induce prescription through payments
for training, consultation, or research.

Predominance role of commercial rather than
scientific source of drug information represents
a problematic area in healthcare delivery. In
the absence of mandatory postgraduate
education or recertification, pharmaceutical
advertising becomes the major source of
continuing medical education for physicians.
( Leighton Cluff), 1967)
The House of Commons: Committee Report on
the Influence of Pharmaceutical Industry
The influence of pharmaceutical industry
is enormous and out of control.
 The big pharma’s tentacles penetrate
much more widely, reaching patients,
health departments, regulators,
managers, researchers, medical
charities, academics, media, cares,
school children, and politicians.
( The Lancet, 2006)


The excessive influence of industry will
not be curbed unless and until all those
involved with drug companies take a
stand and question their relation with
them. Patient’s welfare will continue to
be vulnerable with health policies and
practices that are dominated by the will
of big pharmas.
(The Lancet, 2006)
Survai Masalah Penggunaan Obat
di Rumah Sakit

Those on medical wards of university hospital
received an average of 14 drugs during their
stay.
(Leighton Cluff, 1964)
 Hospitalized patients received an average of
15 drug administration per day.
( Mannase, 1989).
 Serious adverse drug events occurred in about
6.7% of hospitalized patients, or more than
100.000 deaths in US hospitals per year.
(Lazarou, 1998)
Masalah Obat
Excessive use: overuse, abuse, misuse
 Expensive: impoverishment/catastrophic
expenditure.
 Harmful: fatal/severe adverse drug
events.
 Too many: me-too drugs, copy drugs.
 Doubtful: placebo effect, marginal effect.

Jalur Pemecahan Masalah Obat
Penelitian.
 Pendidikan
 Pelayanan.
 Kebijakan dan regulasi
 Keprofesian

Instrumen Pemecahan Masalah
Obat







Registrasi obat.
Konsep dan implementasi uji klinik
Konsep dan implementasi obat esensial
Monitoring efek samping obat
Konsep dan implementasi penggunaan obat
yang rasional.
Universal insurance coverage and managed
care
Substitusi generik dan substitusi terapeutik






Hospital drug by-laws.
Ektensi disiplin ilmu: farmakologi klinik,
epidemiologi klinik/farmakoepidemiologi,
ekonomi kesehatan/farmakoekonomik, farmasi
klinik.
Clinical trial registry, Consolidated Standards of
Reporting Trial Statements (CONSORT).
Critical appraisal, meta-analysis, evidencebased pharmacotherapy, therapeutic guidelines.
Health Technology Assessment/Comparative
Effectiveness Study.
Konsep dan implementasi Patient Safety
Natural Products (NPs) in the World
Market




NP remedies are sold like pharmaceutical remedies;
they are widely available for purchase from
pharmacies, health-food stores, supermarkets, by mail
order, via the internet, and other retail outlets.
They are mostly produced by industrial/pharmaceutical
company, registered as food supplements, but
marketed as medicine.
They are aggressively marketed like conventional
medicine.
Herbal products are the most widely available NPs.
Regulation of NPs in UK

NPs are marketed as: 1) licensed NPs, 2) NPs
exempting from licensing, 3) unlicensed NPs sold as
food supplements.
 Many licensed NPs for minor self-limiting conditions
rely on bibliographic evidence to support efficacy and
safety.
 NPs exempting from licensing are those compounded
and supplied by practitioners on their own
recommendation, sold under their botanical name and
with no written recommendation for use.
 NPs that are industrially produced are required to hold
marketing authorization.
 Most NPs are sold as food supplement without making
medical claim.
Herbal Medicinal Products in
Germany

The use of plant drugs is an established
science. Herbal medicinal products known as
phytomedicine or phytotherapeutic agents are
prescribed in an evidence-based manner.
 Herbal medicinal products with documented
pharmacological activity and clinical efficacy
lie alongside conventional medicine. For
example, standardized senna preparation is
classified as conventional medicine.
Herbal Medicine in US





Most herbal products in the US are considered dietary
supplements.
They are marketed without prior approval of their efficacy and
safety by FDA.
The manufacturer of an herbal preparation is responsible for the
truthfulness of claims made on the label and must have evidence
that the claims are supported, but it does not require submission
of the evidence to FDA.
Under 1994 Dietary Supplement and Health Education Act
(DSHEA), the manufacturer is permitted to claim that the product
affects the structure or function of the body, as long as there is no
claim of effectiveness for the prevention or treatment of specific
disease.
If a concern about safety arises, the burden of proof lies not with
the manufacturer but with the FDA, which has to prove that the
product is unsafe.
Problems of the Use of NPs

Conflicting outcome of efficacy and safety due to
heterogeneity of active compounds, content
concentration, and processing of raw materials.
 Lack of/less validity in conducting clinical trials, so that
the results are considered as not reliable.
 Evidence of their quality, efficacy, and safety has not
been thoroughly assessed as applied to conventional
medicine.
 Frequently enough, NPs are adulterated by
microorganisms, toxins, pesticides, fumigation agents,
or drugs.
 The use of HM can pose serious adverse effects
(cardiotoxicity, hepatotoxicity, neurotoxicity,
hepatotoxicity, and drug interactions).
Improved and unimproved BPH
treated with Saw Palmetto

3139 men from 21 RCTs lasting for 4-48 weeks were
assessed. 18 trials were double-blinded and treatment
allocation concealment was adequate in 11 studies.
Compared with placebo, saw palmetto improved
urinary symptoms score, symptoms and flow measure
( Wilt et al, 2006)
 225 men over 49 years who had a moderate to severe
symptoms of BPH were randomly assigned to one
year of treatment with saw palmetto (2X160 mg) or
placebo. Saw palmetto did not improve symptoms or
objective measure of BPH ( Bent et al, 2006)
 This study raises the question about the variability of
botanical products; additional studies are needed to
reach fix conclusion ( Peola et al, 2006)
Instrument for the Critical Appraisal
of Trial of Herbal Medicine (HM)
1.
2.
3.
4.
5.
6.
7.
8.
The genus of test HM was stated.
The species of test HM was stated.
The plant part used to prepare the test HM was
stated.
How the test HM was processed/extracted was
described.
If the test HM was a commercial product, the brand
name was stated.
If the test HM was a commercial product, the name
of manufacturer was stated.
If the test HM was a commercial product, the lot
number was stated.
The name of the important chemical(s) of the test
HM was stated.
9. The amount of important chemicals of the test HM
was stated.
10. The test HM was analyzed for chemical content.
11. The dosage form of the test HM was stated.
12. The dose of the test HM was stated.
13. The frequency of administration of the test HM was
stated.
14. The route of administration of the test HM was stated.
15. The placebo or comparison treatment and the test
HM were matched in terms of taste, smell,
appearance, and dosing regimen.
16. The success of blinding was evaluated.
Proposed Research Strategy for HM
Folk experience of HM
hint or clue
↓ pharmaceutical study in GAP and CMP
Standardized pure compounds
↓ In vitro & in vivo pharmaco-toxicological study
Findings published in refereed journals
↓ CTs performed in GCP, Cochrane Reviews
Proved by EBM
New Application
New drugs
Chinese Herbal Medicine as a
resource of liver fibrosis treatment

Research has gone through three stages: 1)
clinical exploration, 1950s-1970s; 2)
experimental investigation (1970s-1990s); 3)
clinical trials and molecular studies (1990s
onward).
 Action mechanisms: inhibition of viral
replication, immunomodulation, anti-oxidation
and anti-inflammation, inhibition of fibrogenic
process.
 Efficacy: reverse liver fibrosis in CHB, reduces
DNA replication of HBV, lowers serum ALT,
reduces the incidence of HCC.

Safety: interstitial pneumonitis, fatal biliary
cirrhosis, hepatic veno-occlusive disease.
 Evidence against: two reviews did not
recommends the use of herbal medicine to
treat chronic liver disease.
 Conclusion: Strict quality control is critical for
pharmacological, clinical, and in-depth studies.
Experiments and clinical trials should be
carried out on the platforms that conform to
international standards.

Systematic reviews have found that
many clinical trials testing
complementary or alternative medicine
have major flaws, such as insufficient
statistical power, poor controls,
inconsistency of treatment or product,
and lack of comparison with other
treatments, with placebo, or with both.

Finding appropriate placebos or shams for
treatment such as acupuncture, chiropractic,
message therapy, or complex herbal mixture is
challenging.
 Complementary and alternative treatments
typically involved extended and intensive
interaction between the patient and the
practitioner, which greatly increase the
possibility of a placebo effect..
Various Expectation Effects Behind
the Placebo Response








Hawthorne effect: subjects respond to knowledge
being evaluated or observed,
Jastrow effect: subjects respond to explicit
expectation about outcome.
Pygmalion effect: evaluator expect therapeutic
benefit so they see it.
John Henry effect: subjects tend to emulate expected
outcomes
Halo effect: subjects respond to treatment novelty.
Experimenter effect: evaluator interpreted outcome
differently.
Socialization effect: other reporting apparent effect
influence the outcome.
Value effect: costs influence expected outcome.
Integrative vs Conventional
Medicine

Andrew Weil MD: Clearly there is a
dissatisfaction with conventional medicine….
I consider experience to be one of valuable
source of data – in my experience, many
patients use alternative methods because they
work. …….. Large numbers of patient have
found that there are treatment out of there that
their conventional medicine physicians do not
know about, did not advise them about, that
have worked for them in some cases after
conventional medicine has failed.

A.S Relman MD: Future in clinical practice will
depend on the application of new development in
science, biotechnology, molecular pharmacology, and
the use of clinical epidemiology based on analysis of
objective clinical data……. We need to see many
more controlled studies comparing standardized
herbal preparation with conventional pharmaceutical
before concluding that herbs have any special
advantage over conventional drugs and that herbal
therapy should be taught in medical schools.
(Arch Intern Med 1999;159:2122-2126)

At present, integrative medicine is largely
market-driven and spans the spectrum
from evidence-based practices that
benefit patients and carry little risk to
outright quackery, sometimes with
significant risk
Penyelengaraan Pengobatan Komplementer –
Alternatif di Fasilitas Pelayanan Kesehatan

Pelaksana pengobatan komplementeralternatif adalah dr/drg, serta tenaga
kesehatan lainnya yang teregistrasi dan
memiliki surat tugas/SIK-TPKA sesuai
ketentuan berlaku, memiliki sertifikat
kompetensi sesuai bidang keahliannya,
dan mendapat rekomendasi dari
organisasi profesi terkait.
Standard Pelayanan Medik Herbal

Standard Kompetensi: adalah kemampuan
minimal yang harus dimiliki oleh dokter
meliputi pengetahuan, keterampilan dan
perilaku, untuk dapat melakukan pekerjaan
secara efektif dalam bidang herbal, dan
mendapat sertifikasi dari Kolegium
Farmakologi Klinik.
 Dokter harus memperoleh rekomendasi dari
Perhimpunan Pengembang Kesehatan
Tradisional Timur (PDPKT) sebagai organisasi
seminat dibawah IDI, dan drg dari organisasi
profesinya.

BPOM telah mengeluarkan registrasi 24 obat
herbal terstandar dan 5 jenis fitofarmaka.
 PDPKTI berhasil memilih 30 jenis tanaman
berkhasiat dalam mengatasi berbagai macam
penyakit.
 Perlu suatu pelayanan medik herbal yang
berkualitas dan pelaksanaannya sesuai etika
kedokteran dengan prinsip manfaat dan
keamanan yang didasarkan pada pembuktian.