1. 1. -Towards safety of herbal medication
2. 2. "Pharmacovigilance =( Pharmakon -drug ) + (Vigilance- to watch) The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems
3. 3. To improve patient care & safety in relation to medicines & all medical & para-medical interventions Patient Care To improve public health & safety in relation to the use of medicines Public Health Risk Benefit Assessment To contribute to the assessment of benefit, harm, effectiveness and risk of medicines To promote understanding, clinical training & effective communication to health professionals & the public Communication AIMS & SCOPE
4. 4. Pharmacovigilance in India: A Brief History
5. 5. NEED FOR PHARMACOVIGILANCE Humanitarian concern ADR May cause sudden death Promoting rational use of medicines and adherence Ethics:To know of something that is harmful to another person who does not know, and not telling, is unethical. ADRs: 4th Leading Cause of Death
6. 6. Adverse Drug Reactions (ADRs) Any response to a drug which is noxious and unintended and which occurs at doses used in man for prophylaxis, diagnosis or therapy Six Classifications of ADR Type A Type B Type C Type D Type E Type F (Augmented) (Bizarre) (Continuous) (Delayed) (Ending of Use) (Failure of Efficacy)
7. 7. 78,095 56,231 4,667 * 1 4 7 C E 2 5 8 % 3 6 / 9 0 + = STATISTICS 5% of adults are allergic to one or more medications 6 10% of ADRs result from a drug allergy 3% of hospital admissions are due to ADRs 28% of ADRs are preventable Drugs associated with ADRs: 29% analgesics, 10% sedatives, 9% antibiotics, and 7% antipsychotics. PGH: Antibiotics (35%), anti-TB meds (34%), anticonvulsants and ASA/NSAIDS (10% each)
8. 8. Herbalism Herbalism ("herbology" or "herbal medicine") is use of plants for medicinal purposes, and the study of such use. Plants have been the basis for medical treatments through much of human history, and such traditional medicine is still widely practiced today. The World Health Organization estimates that 80 % of the population of some Asian and African countries presently use herbal medicine for some aspect of primary health care.
9. 9. The use of herbal remedies is more prevalent in patients with chronic diseases such as cancer, diabetes, asthma and end- stage renal disease. Multiple factors such as gender, age, ethnicity, education and social class are also shown to have association with prevalence of herbal remedies use. Prevalence of use
10. 10. In India the herbal remedy is so popular that the government of India has created a separate departmentAYUSHunder the Ministry of Health & Family Welfare. The National Medicinal Plants Board was also established in 2000 by the Indian government in order to deal with the herbal medical system.
11. 11. Herbal preparations Herbal teas, or tisanes, are the resultant liquid of extracting herbs into water, though they are made in a few different ways. Infusions are hot water extracts of herbs, such aschamomile or mint, through steeping. Decoctions are the long-term boiled extracts, usually of harder substances like roots or bark. Maceration is the old infusion of plants with high mucilage-content, such as sage, thyme, etc. Tinctures are alcoholic extracts of herbs, which are generally stronger than herbal teas. Usually obtained by combining 100% pure with the herb. Extracts include liquid extracts, dry extracts, and nebulisates. Liquid extracts are liquids with a lower ethanol % than tinctures. Dry extracts are extracts of plant material that are evaporated into a dry mass.
12. 12. Safety A number of herbs are thought to be likely to cause adverse effects. Datura stramonium is a highly effective treatment for asthma symptoms when smoked, because it contains atropine, which acts as an antispasmodic in the lungs. However, datura is also an extremely powerful hallucinogen and overdoses of the tropane alkaloids in it can result in hospitalization or death.
13. 13. Examples of highly toxic herbs include: Poison hemlock and nightshade. They are not marketed to the public as herbs, because the risks are well known, partly due to a long and colorful history in Europe, associated with "sorcery", "magic" and intrigue. A case of major potassium depletion has been attributed to chronic licorice ingestion., and consequently professional herbalists avoid the use of licorice Black cohosh has been implicated in a case of liver failure. Examples of herbs where a high degree of confidence of a risk long term adverse effects can be asserted include ginseng, which is unpopular among herbalists for this reason, the endangered herb goldenseal, milk thistle, senna, against which herbalists generally advise and rarely use, aloe vera juice, buckthorn bark and berry, cascara sagrada bark, saw palmetto, valerian, kava, which is banned in the European Union, St. John's wort, Khat, Betel nut, the restricted herb Ephedra, and Guarana.
14. 14. Herbal Pharmacovigilance Some unwanted reactions due to herbs can be : (i) side effects (usually detectable by pharmacodynamics and often predictable) (ii) reactions occurring as a result of overdose, over duration, tolerance, dependence-addiction (detectable either by pharmacodynamics or pharmacovigilance) (iii) hypersensitivity, allergic and idiosyncratic reactions (detectable by pharmacovigilance), (iv) mid-term and long-term toxic effects including liver, renal, cardiac and neurotoxicity also genotoxicity and teratogenicity (detectable by in vitro and in vivo toxicological studies or by pharmacovigilance).
15. 15. The safety of herbal medicines has become an issue for the regulatory authorities, as serious effects have been reported, including hepatotoxicity, renal failure and allergic reactions The World Health Organisation, recognising the growing importance of the use of herbal medicines worldwide developed guidelines for the monitoring of herbal safety within the existing pharmacovigilance framework. Herbal medicines are traditionally considered harmless since these belong to natural sources. However, this is not true as there are several case reports of adverse reactions of herbal drugs mentioned in published literature. Systematic pharmacovigilance is essential to build up reliable information on the safety of herbal medicines for the development of appropriate guidelines for safe effective use.
16. 16. Herbs with suspected or known adverse effects HERBALDRUGS ADVERSEEFFECTS Ginkgo biloba Bleeding St. John's wort Gastrointestinal disturbances, allergicreactions, fatigue, dizziness,confusion, dry mouth,photosensitivity Ephedra (Ma Huang) Hypertension, insomnia, arrhythmia,nervousness, tremor, headache,seizure, cerebrovascular event,myocardial infarction, kidney stones. Kava( Pipermethysticum) Sedation, oral and lingual dyskinesia,torticollis, oculogyric crisis,exacerbation of Parkinson's disease,painful twisting movements of thetrunk, rash
17. 17. Herbs with Adverse Drug Interactions Herb Drug Adverse Effects Ginkgo biloba Drugs like Aspirin, warfarin, ticlopidine, clopidogrel, dipyridamole, garlic, vitamin E With aspirin -retards aspirin absorption Psyllium seed Coumarin derivates Retards absorption of drug Ephedra Caffeine, decongestants, stimulants May be additive in nature Feverfew Aspirin Additive effects
18. 18. Problems encountered with the use of herbal medicines and products. Some herbal products were found to contain 0.1 to 0.3 mg of betamethasone per capsule after some patients developed corticosteroid- like side effects. Owing to misidentification of the medicinal plant species, plant materials containing aristolochic acid were used for manufacturing herbal products, which caused severe kidney failure in patients in several countries. Reports have been received by drug safety monitoring agencies of prolonged prothrombin times, increased coagulation time, subcutaneous hematomas, and intracranial hemorrhage associated with the use of Ginkgo biloba. One of the most well-known traditionally used herbal medicines caused severe, sometimes fatal cases of interstitial pneumonia, when used in conjunction with interferon.
19. 19. List of the unapproved Ayurvedic medicinal products Karela tablets, produced by Shriji Herbal Products, India Karela capsules, produced by Himalaya Drug, India Karela capsules, produced by Charantia, UK (specifically batch #12011) Maha Sudarshan Churna powder, produced by Zandu Pharmaceuticals, Mumbai, India Maha Sudarshan Churna powder, D and K Pharmacy, Bhavnagar, India Maha Sudarshan Churna powder, produced by Chhatrisha, Lalpur, India Maha Sudarshan Churna powder, produced by Dabur India, New Delhi, India Safi liquid, produced by Hamdard-WAKF-Pakistan Safi liquid, produced by Hamdard-WAKF-India Yograj Guggul tablets, produced by Zandu Pharmaceuticals, Mumbai, India Sudarshan tablets, produced by Zandu Pharmaceuticals, Mumbai, India Shilajit capsules, produced by Dabur India, New Delhi, India
20. 20. Importance of Herbal Pharmacovigilance Some countries accept traditional, experience based evidence while others consider herbal remedies as dangerous or of questionable value. Medicinal herbs as potential source of therapeutics aids has attained a significant role in health care system all over the world for human beings not only in the diseased condition but also as potential material for maintaining proper health A major factor impeding the development of the medicinal plant based industries in developing countries has been the lack of information on the social and economic benefits that could be derived from the industrial utilization of medicinal plants. The monitoring the safety of herbal medicinal products, in the market or in the pipeline, will definitely go a long way in restoring the confidence of their safety
21. 21. CHALLENGES IN MONITORING THE SAFETY OF HERBAL MEDICINES: Regulation Quality assurance and control Safety monitoring of herbal medicines Recording and coding the identity of herbal medicines
22. 22. Specific challenges Unlike synthetic medicines, herbal medicines are typically chemically rich and complex products and not isolated single compounds. A number of factors can influence the qualitative and quantitative chemical profile including: Geographical origin climate, soil, photoperiod. Genotype. Parts of the plant leaves, stems, root, root bark, etc. Harvesting time (year, season, time of day) and conditions. Storage, processing, extraction. Combinations of herbs and/or processing of the combined herbs as medicines.
23. 23. ADR REPORTING
24. 24. Why report ADRs? To prevent drug-induced human suffering To avoid financial risks associated with unexpected risks
25. 25. Reports from Participating Hospitals Reports from Private Practitioners Report from Drug Mfr. Traders/ Outlets Reports on Clinical Investiga- tions Reports from Regulatory Authorities Reports from Intl ADR Centers BFAD ADR UNIT NADRAC WHO Collaborating Center Director - BFAD Secretary of Health - DOH ADR Monitoring System
26. 26. REPORTING SCHEME NADRAC (Trend Analysis) CASE Reporter Fills Out a Form Hospital Therapeutic Committees ADRMP Office (Central Database) WHO WHO
27. 27. How do we report ADRs? STEP 1 : Fill out the RED ALERT CARDS PGH FORM # P 60170 PGH ADVERSE DRUG SURVEILLANCE ALERT CARD (Clip this on chart front cover) Name of patient:___________________________________ Ward & Bed No.:__________________________________ Name of suspect drug:______________________________ Manufacturer:_____________________________________ Lot/ Code No.:__________ (Retain empty vial or container) Describe the reaction:_______________________________ _________________________________________________ _________________________________________________ Reporter: _________________________________________ (Please Print) PLEASE NOTIFY: CENTRAL BLOCK PHARMACY Loc. 3163 / 3170
28. 28. How do we report ADRs? STEP 2: Complete the ADR REPORT FORM The Resident - in - charge of the patient shall complete the necessary report of ADR circumstances.
29. 29. How do we report ADRs? STEP 3: Submit the red alert card and the ADR report form to the Central Block Pharmacy for proper referral. STEP 4: The Pharmacy will then compile the reports for review of the ADR Subcommittee and submission to the Bureau of Food and Drugs (BFAD).
30. 30. Pharmacist
31. 31. The WHO international drug monitoring program Under the WHO International Drug Monitoring Program, national pharmacovigilance centers designated by the competent health authorities are responsible for the collection, processing, and evaluation of case reports of suspected adverse reactions supplied by health care professionals (mainly spontaneous reporting by physicians of reactions associated with the use of prescribed medicines). The Program is described in two publications: Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance center.
32. 32. CONCLUSION This project aims to provide a comprehensive and critical overview of the current state of pharmacovigilance activities for herbal medicines at the national and global levels. It will explore in depth the challenges that pharmacovigilance of herbal medicines presents, consider relevant emerging issues and what steps could and should be taken to improve safety monitoring for herbal medicines in the future