Importance of Pharmacovigilance of Herbal Products

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This highlights the importance of Pharmacovigilance in herbal products.

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Herbal drugs “importance of regulatory affairs” Dr. R. K. Dixit, MD Professor Pharmacology & Therapeutics King George’s Medical University, Lucknow ..... Not all that is natural is harmless

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Herbal Medicinal Products “..vegetable pills have taken root in my nose. It was reddish before but now it is carroty” 29 November 2012 2 Herbal Drugs "Importance of Regulatory Affairs"

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Key Facts Herbal medicines are in use for thousands of years. A very large population depends on traditional medicine for primary health care. Herbal medicines are generating billions of dollars. Trend regarding relying on herbal products is growing. More than 100 countries have regulations for herbal medicines. 29 November 2012 3 Herbal Drugs "Importance of Regulatory Affairs"

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In India, around 25,000 herbal formulations are used. More than 1.5 million practitioners are using herbal products in India. More than 7800 manufacturing units are involved in the production of herbal products in India. 29 November 2012 4 Herbal Drugs "Importance of Regulatory Affairs"

21st Century:

21 st Century 21 st century is the century of Biology powered and propelled by scientific knowledge and technological expertise Three technologies namely Biotechnology Bioinformatics Herbal technology are going to be the most powerful elements that are crucial for welfare for the people of nations. 29 November 2012 5 Herbal Drugs "Importance of Regulatory Affairs"

Herbal technology:

Herbal technology All technologies for the manufacture of value added plant products can be called as herbal technology Herbal drugs and pharmaceuticals, Nutraceuticals , Designer foods or health foods Health drinks Cosmaceuticals Bio-control agents Bio-pesticides 29 November 2012 6 Herbal Drugs "Importance of Regulatory Affairs"

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THE INDIAN FLORA (ca 17500 species) 8000 species Ayurveda 900 sp. Unani 700 sp. Siddha 600 sp. INDIAN SYSTEMS OF MEDICINE Modern 40 sp. India’s strength in Herbal Technology 29 November 2012 7 Herbal Drugs "Importance of Regulatory Affairs"

Herbal Drugs:

Herbal Drugs Inclusions in Pharmacopoeia: Chinese Pharmacopoeia: has 647 traditional drugs. European Pharmacopoeia: has 152 crude drugs. Indian Pharmacopoeia: has 57 traditional drugs Inclusion in essential drug list: In India. - None In China.- 59 29 November 2012 8 Herbal Drugs "Importance of Regulatory Affairs"

Studies:

Studies 29 November 2012 9 Herbal Drugs "Importance of Regulatory Affairs"

Pharmaceutical Drugs From Herbs:

10 Pharmaceutical Drugs From Herbs Aspirin - White willow bark ( Salix alba ) Atropine - Belladonna ( Atropa belladonna) Artemesinin derivatives Cromolyn sodium - Khella ( Amni visnagu ) Cyclosporin - Cordyceps ( Cordyceps sp.) Digoxin - Foxglove ( Digitalis purpurea ) Morphine - Opium poppy ( Papaver somniferum ) Scopolamine - Jimson weed Taxol - Pacific Yew ( Taxus sp.) Theophylline - Tea shrub ( Camelia sinensis ) Vincristine - Periwinkle ( Vinca sp.) 29 November 2012 Herbal Drugs "Importance of Regulatory Affairs"

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Drugs Required for masses... ccessible ffordable ssured safety A 29 November 2012 11 Herbal Drugs "Importance of Regulatory Affairs"

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Do the herbal products fulfill these requirements ? 29 November 2012 12 Herbal Drugs "Importance of Regulatory Affairs"

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Accessible ? About 70% Indian population depends on alternative system of medicine. WHO 29 November 2012 13 Herbal Drugs "Importance of Regulatory Affairs"

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Affordable ? Herbal drugs are cheaper than allopathic drugs !! ?? 29 November 2012 14 Herbal Drugs "Importance of Regulatory Affairs"

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Assured safety ? Herbal drugs have been used in India for more than 4000 years. 29 November 2012 15 Herbal Drugs "Importance of Regulatory Affairs"

Why do people use herbal medicines?:

Why do people use herbal medicines? P oor accessibility to modern drugs C ost of drugs S hortage of physicians M yth that natural = Absolutely safe A DRs reported with modern medicine more than herbal preparations P lacebo effect C ultural & religious beliefs E ducational level 29 November 2012 16 Herbal Drugs "Importance of Regulatory Affairs"

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E thnic groups M ental comfort e.g. cancer, AIDS D isappointment with conventional Tt. F ear of safety L ack of effective treatments/cures P eer influence D esire to have control of one’s own health 29 November 2012 17 Herbal Drugs "Importance of Regulatory Affairs"

Problems Associated with Use of Herbal Medicines :

Problems Associated with Use of Herbal Medicines P otential for drug interactions M ultiple ingredients in one preparation D ifficult to identify ingredients L ess knowledge of ADRs or herbal drugs L ess disclosure by the patients ( 40% to 70% of patients do not inform physicians about use of alternative therapies) 29 November 2012 18 Herbal Drugs "Importance of Regulatory Affairs"

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D on't think that these are also drugs P reoccupied belief O ver the counter availability H ealth tonics and food supplements F alse but attractive claims by prescriber and manufacturers L ack of Good Manufacturing Practices (GMPs) 29 November 2012 19 Herbal Drugs "Importance of Regulatory Affairs"

Some Examples of Unsafe Herbal Therapies………..:

Some Examples of Unsafe Herbal Therapies……….. 29 November 2012 20 Herbal Drugs "Importance of Regulatory Affairs"

Ephedra sinica (mahaung) :

Ephedra sinica ( mahaung ) Anorexiant, Decongestant, 1% ephedrine Palpitations, MIs, death Drug interactions Theophylline, digoxin, caffeine Products containing ephedra accounted for 64% of all adverse reactions to herbs in the USA FDA announced ban on manufacturing dietary supplements that contain ephedrine and related alkaloids (12/30/2003) 29 November 2012 21 Herbal Drugs "Importance of Regulatory Affairs"

Kava Kava (Piper methysticum):

Kava Kava (Piper methysticum ) Anxiety, stress, sleep disorders Effective for short-term treatment of anxiety Kava Dermopathy : Photosensitivity and phototoxic Hepatotoxicity: liver failure FDA warning; removal from the market from USA Use no > 4 weeks No alcohol/sedating medications Caution when driving or operating machinery 29 November 2012 22 Herbal Drugs "Importance of Regulatory Affairs"

St. John’s Wort (Hypericum perforatum):

St. John’s Wort ( Hypericum perforatum ) Adverse Effects: Photosensitivity/Phototoxicity Insomnia , vivid dreams, headache, dizziness Drug Interactions: ( through induction of the Cytochrome P450 enzyme CYP3A4, but also CYP2C9 and induction of the P-glycoprotein (P-gp) efflux transporter) MAOIs, selective serotonin reuptake inhibitors (SSRIs), : Increased serotonin (Serotonin Syndrome) Cyclosporine : Decreased levels Warfarin : Decreased INR Oral contraceptives or hormone replacement therapy: 29 November 2012 23 Herbal Drugs "Importance of Regulatory Affairs"

Ginseng (Panax notoginseng):

Ginseng ( Panax notoginseng ) Adverse Effects: Nervousness, insomnia, excitation, palpitations, lowers blood glucose, alters immune function Ginseng abuse syndrome? (long-term use) Drug Interactions: Antidiabetics Warfarin 29 November 2012 24 Herbal Drugs "Importance of Regulatory Affairs"

Ginkgo biloba :

Ginkgo biloba Adverse Effects: Hypersensitivity reactions Gastrointestinal disturbances Spontaneous bleeding Drug Interactions: Anticoagulants Antiplatelets Ginkgo inhibits monoamine oxidase 29 November 2012 25 Herbal Drugs "Importance of Regulatory Affairs"

Pharmacovigilance Of Herbal Products:

Pharmacovigilance Of Herbal Products Any thing herbal is safe!!????? Adverse drug reactions (ADR) Drug-drug interactions Herb-Drug interactions Toxicity of the isolated ingredients 29 November 2012 26 Herbal Drugs "Importance of Regulatory Affairs"

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Assumption / Myth -Herbal drugs are absolutely safe Truth---Herbal drugs may cause significant ADRs and toxicities by Themselves or By producing drug interactions with the prescribed modern medicine Why Pharmacovigilance for herbal drugs? “Recently, Pharmacovigilance concerns have been widened to include herbals, traditional medicines, blood products, biological products, medical devices and vaccines" 29 November 2012 27 Herbal Drugs "Importance of Regulatory Affairs"

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Department of AYUSH , Ministry of Health and Family Welfare, Government of India, implemented a National Pharmacovigilance Program for Ayurveda, Unani, and Siddha systems of medicine, in order to systematically monitor adverse drug reactions (ADR). 29 November 2012 28 Herbal Drugs "Importance of Regulatory Affairs"

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Although a technical term equivalent to “pharmacovigilance” does not feature in Ayurvedic texts, the spirit of pharmacovigilance is vibrant throughout Ayurveda’s classical literature. Ayurvedic pharmacology ( Dravyaguna), pharmaceutics ( Rasa Shastra ) have clearly mentioned it’s importance . The Ayurvedic literature gives details of drug-drug and drug-diet incompatibilities. 29 November 2012 29 Herbal Drugs "Importance of Regulatory Affairs"

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According to Article 2 of the World Health Organization’s constitution, it is mandatory for its Member States “to develop, establish, and promote international standards with respect to food, biological, pharmaceutical and herbal products .” 29 November 2012 30 Herbal Drugs "Importance of Regulatory Affairs"

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In 1968 WHO initiated its Pilot Research Project for International Drug Monitoring. In 1997, WHO drew up the Erice Declaration , an international agreement signed by all member states to agree on uniform standards for reporting ADR’s. In 2002, India agreed to send all its ADRs arising from use of conventional medicine to WHO’s ADR Monitoring Centre in Uppsala, Sweden. “ To strive towards the highest ethical, professional, and scientific standards in protecting and promoting the safe use of medicines.” 29 November 2012 31 Herbal Drugs "Importance of Regulatory Affairs"

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November 2006, idea of pharmacovigilance program for traditional medicine began in Department of Clinical Pharmacology, B.Y.L. Nair Hospital, Mumbai. IPGTRA (Institute of Post Graduate Teaching and Research in Ayurveda ) Jamnagar took concrete steps sponsored by WHO Specialists in different fields (i.e. Physicians, Pharmacologists and Vaidyas , Hakeems ) worked hard under the guidance of WHO national office. The draft was finalized and released by Department of AYUSH. 29 November 2012 32 Herbal Drugs "Importance of Regulatory Affairs"

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On 29 September 2008 . IPGTRA was subsequently declared National Pharmacovigilance Resource Centre for ASU d rugs Since then India’s present ASU Pharmacovigilance program has been in operation. The program was reviewed on 21 January 2009 by the National Pharmacovigilance Consultative Committee for ASU drugs (NPCC-ASU). At present, besides the National Center in Jamnagar, 8 Regional Centers and 30 Peripheral centers are present. www.ayurveduniversity.com 29 November 2012 33 Herbal Drugs "Importance of Regulatory Affairs"

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The structure of India’s National Pharmacovigilance program for ASU drugs (NPP-ASU-2008) . What to report Reporting of all suspected drug related adverse events, including interactions with any other drugs or food. Reporting of seemingly insignificant or common adverse reactions may also be important. • Suspected events in the following categories (Must) (b) L ife threatening (real risk of dying) (a) D eath (c) H ospitalization (initial or prolonged) (d) D isability (significant, persistent, or permanent) (e) R equired intervention to prevent permanent impairment or damage. (f) C ongenital anomaly 29 November 2012 34 Herbal Drugs "Importance of Regulatory Affairs"

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Who can report Any health care professional Others can report through the physician under whom they have undergone treatment.) Where and How to report Reporting should be done in a prescribed format through pharmacovigilance center. 29 November 2012 35 Herbal Drugs "Importance of Regulatory Affairs"

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Direction of submitted information Information in the forms should be kept confidential Peripheral pharmacovigilance centers forward to regional pharmacovigilance centers where causality analysis is carried out. The information is then forwarded to the National Pharmacovigilance Resource Centre, where it is consolidated, analyzed, and forwarded to the Dept of AYUSH . 29 November 2012 36 Herbal Drugs "Importance of Regulatory Affairs"

Pharmacovigilance of Herbal Drugs :

Pharmacovigilance of Herbal Drugs The number of adverse reactions to Herbal drugs reported in the National Pharmacovigilance Program in India is Negligible Due to: The strong belief that Herbal medicines are safe. The lack of knowledge about the concept and importance of Pharmacovigilance in Herbal medicine 29 November 2012 37 Herbal Drugs "Importance of Regulatory Affairs"

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Year Herbal Product / ADR 1981 Aristolochic / carcinogen 1987 Vinca / immunotoxicity 1988 Echinacea (Kariyat) / anaphylaxis 1990 Pyrrolizidinic alkaloids / carcinogen 1991 Ginkgo biloba (Balkuwari) / anaphylaxis Rubia tinctorum (Manjishtha ) / genotoxicity ADR Reporting International achievements 1993 Teucrium chamaedris / hepatotoxic 1994 Sassafras albidum / genotoxic, carcinogen 1997 Cumarin / hepatotoxic 1997 Ginkgo / allergic reactions 1999 Chelidonium / hepatotoxic reactions 1999 Royal Jelly / allergic reactions / asthma 2000 Hypericum ( St. John's Wort ) / interactions) 2000 Kava-Kava / hepatotoxic 2001 Tussilago farfara / Pyrrolizidinic alcaloids 29 November 2012 38 Herbal Drugs "Importance of Regulatory Affairs"

Herbal References:

Herbal References Natural Medicines Comprehensive Database The Review of Natural Products The Professional’s Handbook of Complimentary and Alternative Medicine 29 November 2012 39 Herbal Drugs "Importance of Regulatory Affairs"

Herbal References:

Herbal References The United States Pharmacopeia and The National Formulary (USP-NF) Internet Reference The Natural Pharmacist WWW.tnp.com Herbs and Herbal Medicine Online International Bibliographic Information on Dietary Supplements Computer Access to Research on Dietary Supplements www.ods.od.nih.gov 29 November 2012 40 Herbal Drugs "Importance of Regulatory Affairs"

High Risk Users of Herbal Remedies:

High Risk Users of Herbal Remedies P oor overall health status (Compromised Renal, Hepatic, Pulmonary, Cardiac, Neurological, Immunity etc…) C hronic users S pecial Population (Elderly, Pregnant and Nursing women, Infants) 29 November 2012 41 Herbal Drugs "Importance of Regulatory Affairs"

Internet based reporting Vigi-base Online:

Internet based reporting Vigi -base Online 29 November 2012 42 Herbal Drugs "Importance of Regulatory Affairs"

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Take Home Messages… “ N atural” does not mean absolutely safe. T here is a need for a proper post-marketing surveillance program to observe quality, safety, and efficacy of herbal drugs. N ational pharmacovigilance Program for ASU Drugs. P harmacovigilance system success lies in its ability to prevent further adverse reactions on the basis of information received. 29 November 2012 43 Herbal Drugs "Importance of Regulatory Affairs"

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P ossible only when physicians are vitally alert to the onset or offset of any ADRs. P rioritize contributions to make the pharmacovigilance program for herbal medicines a success. P atients should be educated and encouraged to tell physicians, nurses, and pharmacists about herbal therapy use (documentation). H erbal-pharmaceutical interactions do occur L ack of standardization, L ack of quality control and regulation further increase chances. 29 November 2012 44 Herbal Drugs "Importance of Regulatory Affairs"

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Pharmacovigilance in herbal medicine is perhaps a less thought of concept as yet. However, we do not need “Herbal Thalidomide” to wake the Pharmacovigilance community. P hysicians, P harmacist, P aramedical, P atients, P olicy makers 29 November 2012 45 Herbal Drugs "Importance of Regulatory Affairs"

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