Rasionalisasi Obat Herbal.ppt

5/25/2018 Rasionalisasi Obat Herbal.ppt

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Rasionalisasi Penggunaan

Obat Herbal

Armen Muchtar

Departemen Farmakologi Klinik

RSUPN Dr Cipto Mangunkusumo


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Dampak Industri Terhadap

Pelayanan Kesehatan

Masalah Obat Modern.

Masalah Alat Kesehatan

Masalah Obat Herbal Konglomerasi Sarana/Komersialisasi

Pelayanan


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Latar Belakang Masalah Obat

Kemajuan teknologi/industri farmasi drugexplosiontherapeutic jungle.

Obat sebagai commodity dengan ciri

aggressive marketing: detailing, sponsorship,incentives, hidden curriculum, diseasemongering, multi-level marketing, direct toconsumers advertising, consumer supportingorganization, fraud, bribery, dll.

Industri farmasi kapitalistis: harga tak bolehdikontrol, serahkan ke pasar; diberlakukanmasa patent obat baru mahal.


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Improper Conduct of US

Pharmaceutical Industries

Inflated government reimbursement for prescriptiondrugs.

Kickbacks to private insurers for favoring drug onformularies.

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 paymentsfor training, consultation, or research.


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Predominance role of commercial rather than

scientific source of drug information represents

a problematic area in healthcare delivery. In

the absence of mandatory postgraduateeducation or recertification, pharmaceutical

advertising becomes the major source of

continuing medical education for physicians.

( Leighton Cluff), 1967)


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The House of Commons: Committee Report on

the Influence of Pharmaceutical Industry

The influence of pharmaceutical industryis enormous and out of control.

The big pharmas tentacles penetrate

much more widely, reaching patients,health departments, regulators,managers, researchers, medicalcharities, academics, media, cares,school children, and politicians.

( The Lancet, 2006)


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The excessive influence of industry willnot be curbed unless and until all thoseinvolved with drug companies take a

stand and question their relation withthem. Patients welfare will continue tobe vulnerable with health policies andpractices that are dominated by the will

of big pharmas.(The Lancet, 2006)


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Survai Masalah Penggunaan Obat

di Rumah Sakit

Those on medical wards of university hospitalreceived an average of 14 drugs during theirstay.

(Leighton Cluff, 1964)

Hospitalized patients received an average of15 drug administration per day.

( Mannase, 1989).

Serious adverse drug events occurred in about

6.7% of hospitalized patients, or more than100.000 deaths in US hospitals per year.

(Lazarou, 1998)


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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.


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Jalur Pemecahan Masalah Obat

Penelitian.

Pendidikan

Pelayanan. Kebijakan dan regulasi

Keprofesian


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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 managedcare

Substitusi generik dan substitusi terapeutik


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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, evidence-

based pharmacotherapy, therapeutic guidelines. Health Technology Assessment/Comparative

Effectiveness Study.

Konsep dan implementasi Patient Safety


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Natural Products (NPs) in the World

Market

NP remedies are sold like pharmaceutical remedies;they are widely available for purchase frompharmacies, health-food stores, supermarkets, by mailorder, via the internet, and other retail outlets.

They are mostly produced by industrial/pharmaceuticalcompany, registered as food supplements, butmarketed as medicine.

They are aggressively marketed like conventionalmedicine.

Herbal products are the most widely available NPs.


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Regulation of NPs in UK

NPs are marketed as: 1) licensed NPs, 2) NPsexempting from licensing, 3) unlicensed NPs sold asfood supplements.

Many licensed NPs for minor self-limiting conditionsrely on bibliographic evidence to support efficacy andsafety.

NPs exempting from licensing are those compoundedand supplied by practitioners on their ownrecommendation, sold under their botanical name andwith no written recommendation for use.

NPs that are industrially produced are required to holdmarketing authorization.

Most NPs are sold as food supplement without makingmedical claim.


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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 isclassified as conventional medicine.


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Herbal Medicine in US

Most herbal products in the US are considered dietarysupplements.

They are marketed without prior approval of their efficacy andsafety by FDA.

The manufacturer of an herbal preparation is responsible for thetruthfulness of claims made on the label and must have evidencethat the claims are supported, but it does not require submissionof the evidence to FDA.

Under 1994 Dietary Supplement and Health Education Act(DSHEA), the manufacturer is permitted to claim that the productaffects the structure or function of the body, as long as there is noclaim 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 theproduct is unsafe.


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Problems of the Use of NPs

Conflicting outcome of efficacy and safety due toheterogeneity of active compounds, contentconcentration, and processing of raw materials.

Lack of/less validity in conducting clinical trials, so thatthe results are considered as not reliable.

Evidence of their quality, efficacy, and safety has notbeen thoroughly assessed as applied to conventionalmedicine.

Frequently enough, NPs are adulterated bymicroorganisms, toxins, pesticides, fumigation agents,or drugs.

The use of HM can pose serious adverse effects(cardiotoxicity, hepatotoxicity, neurotoxicity,hepatotoxicity, and drug interactions).


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Improved and unimproved BPH

treated with Saw Palmetto

3139 men from 21 RCTs lasting for 4-48 weeks wereassessed. 18 trials were double-blinded and treatmentallocation concealment was adequate in 11 studies.Compared with placebo, saw palmetto improvedurinary 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 oneyear of treatment with saw palmetto (2X160 mg) orplacebo. 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 toreach fix conclusion ( Peola et al, 2006)


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Instrument for the Critical Appraisal

of Trial of Herbal Medicine (HM)

1. The genus of test HM was stated.

2. The species of test HM was stated.

3. The plant part used to prepare the test HM wasstated.

4. How the test HM was processed/extracted wasdescribed.

5. If the test HM was a commercial product, the brandname was stated.

6. If the test HM was a commercial product, the name

of manufacturer was stated.7. If the test HM was a commercial product, the lot

number was stated.

8. The name of the important chemical(s) of the testHM was stated.


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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 testHM were matched in terms of taste, smell,

appearance, and dosing regimen.

16. The success of blinding was evaluated.


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Proposed Research Strategy for HM

Folk experience of HM

hint or clue pharmaceutical study in GAP and CMPStandardized pure compounds

In vitro & in vivo pharmaco-toxicological study

Findings published in refereed journals

CTs performed in GCP, Cochrane ReviewsProved by EBM

New Application

New drugs


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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-oxidationand anti-inflammation, inhibition of fibrogenicprocess.

Efficacy: reverse liver fibrosis in CHB, reducesDNA replication of HBV, lowers serum ALT,reduces the incidence of HCC.


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Safety: interstitial pneumonitis, fatal biliarycirrhosis, hepatic veno-occlusive disease.

Evidence against: two reviews did not

recommends the use of herbal medicine totreat chronic liver disease.

Conclusion: Strict quality control is critical forpharmacological, clinical, and in-depth studies.

Experiments and clinical trials should becarried out on the platforms that conform tointernational standards.


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Systematic reviews have found that

many clinical trials testing

complementary or alternative medicine

have major flaws, such as insufficientstatistical power, poor controls,

inconsistency of treatment or product,

and lack of comparison with othertreatments, with placebo, or with both.


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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 thepossibility of a placebo effect..


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Various Expectation Effects Behind

the Placebo Response

Hawthorne effect: subjects respond to knowledgebeing evaluated or observed,

Jastrow effect: subjects respond to explicitexpectation about outcome.

Pygmalion effect: evaluator expect therapeuticbenefit so they see it.

John Henry effect: subjects tend to emulate expectedoutcomes

Halo effect: subjects respond to treatment novelty.

Experimenter effect: evaluator interpreted outcomedifferently.

Socialization effect: other reporting apparent effectinfluence the outcome.

Value effect: costs influence expected outcome.


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Integrative vs Conventional

Medicine

Andrew Weil MD: Clearly there is adissatisfaction with conventional medicine.

I consider experience to be one of valuablesource of datain my experience, many

patients use alternative methods because theywork. .. Large numbers of patient havefound that there are treatment out of there thattheir conventional medicine physicians do notknow about, did not advise them about, thathave worked for them in some cases afterconventional medicine has failed.


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A.S Relman MD: Future in clinical practice willdepend on the application of new development inscience, biotechnology, molecular pharmacology, andthe use of clinical epidemiology based on analysis of

objective clinical data. We need to see manymore controlled studies comparing standardizedherbal preparation with conventional pharmaceuticalbefore concluding that herbs have any specialadvantage over conventional drugs and that herbal

therapy should be taught in medical schools.

(Arch Intern Med 1999;159:2122-2126)


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At present, integrative medicine is largely

market-driven and spans the spectrum

from evidence-based practices that

benefit patients and carry little risk tooutright quackery, sometimes with

significant risk


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Penyelengaraan Pengobatan Komplementer

Alternatif di Fasilitas Pelayanan Kesehatan

Pelaksana pengobatan komplementer-

alternatif adalah dr/drg, serta tenaga

kesehatan lainnya yang teregistrasi dan

memiliki surat tugas/SIK-TPKA sesuaiketentuan berlaku, memiliki sertifikat

kompetensi sesuai bidang keahliannya,

dan mendapat rekomendasi dariorganisasi profesi terkait.


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Standard Pelayanan Medik Herbal

Standard Kompetensi: adalah kemampuanminimal yang harus dimiliki oleh doktermeliputi pengetahuan, keterampilan danperilaku, untuk dapat melakukan pekerjaan

secara efektif dalam bidang herbal, danmendapat sertifikasi dari KolegiumFarmakologi Klinik.

Dokter harus memperoleh rekomendasi dariPerhimpunan Pengembang KesehatanTradisional Timur (PDPKT) sebagai organisasiseminat dibawah IDI, dan drg dari organisasiprofesinya.


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BPOM telah mengeluarkan registrasi 24 obat

herbal terstandar dan 5 jenis fitofarmaka.

PDPKTI berhasil memilih 30 jenis tanaman

berkhasiat dalam mengatasi berbagai macampenyakit.

Perlu suatu pelayanan medik herbal yang

berkualitas dan pelaksanaannya sesuai etika

kedokteran dengan prinsip manfaat dan

keamanan yang didasarkan pada pembuktian.


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Rasionalisasi Obat Herbal.ppt

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