Rasionalisasi Penggunaan Obat Herbal Armen Muchtar Departemen Farmakologi Klinik RSUPN Dr Cipto Mangunkusumo
Dampak Industri Terhadap Pelayanan Kesehatan l Masalah Obat Modern. l Masalah Alat Kesehatan l Masalah Obat Herbal l Konglomerasi Sarana/Komersialisasi Pelayanan
Latar Belakang Masalah Obat Kemajuan teknologi/industri farmasi drug explosion therapeutic jungle. l 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. l Industri farmasi kapitalistis: harga tak boleh dikontrol, serahkan ke pasar; diberlakukan masa patent obat baru mahal. l
Improper Conduct of US Pharmaceutical Industries l l l l 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.
l 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 l The influence of pharmaceutical industry is enormous and out of control. l 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)
l The excessive influence of industry will not be curbed unless and until all those involved with drug companies take a stand 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) l Hospitalized patients received an average of 15 drug administration per day. ( Mannase, 1989). l 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) l
Masalah Obat l Excessive use: overuse, abuse, misuse l Expensive: impoverishment/catastrophic expenditure. l Harmful: fatal/severe adverse drug events. l Too many: me-too drugs, copy drugs. l Doubtful: placebo effect, marginal effect.
Jalur Pemecahan Masalah Obat l Penelitian. l Pendidikan l Pelayanan. l Kebijakan dan regulasi l Keprofesian
Instrumen Pemecahan Masalah Obat l l l l 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
l l l 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. l They are mostly produced by industrial/pharmaceutical company, registered as food supplements, but marketed as medicine. l They are aggressively marketed like conventional medicine. l Herbal products are the most widely available NPs. l
Regulation of NPs in UK l l l 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. l Herbal medicinal products with documented pharmacological activity and clinical efficacy lie alongside conventional medicine. For example, standardized senna preparation is classified as conventional medicine. l
Herbal Medicine in US l l l 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 l l l 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) l 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 (2 X 160 mg) or placebo. Saw palmetto did not improve symptoms or objective measure of BPH ( Bent et al, 2006) l This study raises the question about the variability of botanical products; additional studies are needed to reach fix conclusion ( Peola et al, 2006) l
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, 1950 s-1970 s; 2) experimental investigation (1970 s-1990 s); 3) clinical trials and molecular studies (1990 s onward). l Action mechanisms: inhibition of viral replication, immunomodulation, anti-oxidation and anti-inflammation, inhibition of fibrogenic process. l Efficacy: reverse liver fibrosis in CHB, reduces DNA replication of HBV, lowers serum ALT, reduces the incidence of HCC. l
Safety: interstitial pneumonitis, fatal biliary cirrhosis, hepatic veno-occlusive disease. l Evidence against: two reviews did not recommends the use of herbal medicine to treat chronic liver disease. l 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. l
l 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. l 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. . l
Various Expectation Effects Behind the Placebo Response l l l l 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 l 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.
l 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)
l 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 l 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. l Dokter harus memperoleh rekomendasi dari Perhimpunan Pengembang Kesehatan Tradisional Timur (PDPKT) sebagai organisasi seminat dibawah IDI, dan drg dari organisasi profesinya. l
BPOM telah mengeluarkan registrasi 24 obat herbal terstandar dan 5 jenis fitofarmaka. l PDPKTI berhasil memilih 30 jenis tanaman berkhasiat dalam mengatasi berbagai macam penyakit. l Perlu suatu pelayanan medik herbal yang berkualitas dan pelaksanaannya sesuai etika kedokteran dengan prinsip manfaat dan keamanan yang didasarkan pada pembuktian. l
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