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how to avoid ADR of Ayurved medicines

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how to avoid ADR of Ayurved medicines

  1. 1. Dr Joban Modha MD PhD fellow (IOD, Fl. USA) Dept. of R.S.B.K. S.G.A.M. Gujarat Ayurved University Jamnagar Email: jkmodha@gmail.com SGAM/RSBK/Dr Joban K Modha
  2. 2. Why this workshop ?  To minimize ADRs  To minimize prescription errors  To avoid dispensing errors  To create awareness about ADRs  A contraindication is a specific situation in which a drug, procedure, or surgery should not be used because it may be harmful to the person. SGAM/RSBK/Dr Joban K Modha
  3. 3.  “Even a strong poison can become an excellent medicine if administered properly. On the other hand even the most useful drug can act like a poison if handled carelessly“ – Charak Samhita POISON MEDICINE
  4. 4. Dispensing Errors: The Numbers  98.3% accuracy in dispensing medications  Therefore, 1.7% inaccuracy rate  Over 3 billion medications dispensed per year  4 errors per day per 250 prescriptions filled  Over 51 million dispensing errors per year Flynn E, et al. J Am Pharm Assoc. 2003;43:191–200. SGAM/RSBK/Dr Joban K Modha
  5. 5. “Ghee or milk consumed when the digestive fire and metabolism is on a low ebb works like poison” (Viṣopamam) ( Astanga Hridayam; Shastri H, editor. Varanasi: Chaukhambha Samskrit Sansthan; 2011. p. 561.) SGAM/RSBK/Dr Joban K Modha
  6. 6. HEAVY METAL TOXICITY CONCERNS  The use of metallic preparations as single drugs or as ingredients in many Ayurvedic medicines has evoked concern and debate in the scientific and public forums in the recent times.  Some studies has warned that users of Ayurvedic medicines may be at risk for heavy metal toxicity and suggested that testing of Ayurvedic medicines for toxic heavy metals should be mandatory. SGAM/RSBK/Dr Joban K Modha
  7. 7. JAMA CONTROVERSY SGAM/RSBK/Dr Joban K Modha
  8. 8. SGAM/RSBK/Dr Joban K Modha
  9. 9. HEAVY METALS  A heavy metal is one with a specific gravity of 5gm cm-3 or more.  They are stable elements and cannot be metabolized by the body.  Some heavy metals such as zinc, copper, cobalt, chromium, iron and manganese are required by body in small measures.  These same elements can be toxic in larger quantities.  Heavy metals may enter the body in food, water, air, or by absorption through skin. SGAM/RSBK/Dr Joban K Modha
  10. 10. UNESCO SGAM/RSBK/Dr Joban K Modha
  11. 11. UNESCO SGAM/RSBK/Dr Joban K Modha
  12. 12. UNESCO SGAM/RSBK/Dr Joban K Modha
  13. 13. UNESCO/BBC SGAM/RSBK/Dr Joban K Modha
  14. 14. SGAM/RSBK/Dr Joban K Modha
  15. 15. SGAM/RSBK/Dr Joban K Modha
  16. 16. SGAM/RSBK/Dr Joban K Modha The king of poison The poison of kings
  17. 17. AyurVaidya’s take:  The heavy or toxic metals in elemental form are toxic but those in compound form i.e. Bhasma are safe for humans.  Bhasma are made from various metals, metal mixtures and alloys.  The way they are prepared, evaluated and therapeutically used leaves no doubt about their safety to the humans. SGAM/RSBK/Dr Joban K Modha
  18. 18. QUALITY CONTROL OF BHAMAS  PHYSICAL PARAMETERS Varitar Unnama Rekhapoornatva Shlakshnatvam  CHEMICAL PARAMETERS Varna Gatarasatvam Nishchandratva Apoonarbhavatva SGAM/RSBK/Dr Joban K Modha
  19. 19. SGAM/RSBK/Dr Joban K Modha
  20. 20. CURD TEST FOR TAMRABHASMA Most of the copper bhasma and other minerals having copper bhasma are in the form of CuO and CuS in final product. It is a test to check free copper metal, because when free copper reacts with lactic acid (one of the component of curd) copper salts are formed which gives blue colour and it is toxic in nature and produces nausea, vomiting because of free copper ions… 6/10 market samples of Tamra Bhasma could not clear the test SGAM/RSBK/Dr Joban K Modha
  21. 21. Easy tests to check Tamra Bhasma SGAM/RSBK/Dr Joban K Modha
  22. 22. SGAM/RSBK/Dr Joban K Modha
  23. 23. Drugs and Cosmetics Rules, 1945 [SCHEDULE-E(1) [Rule 161 (2)] List of poisonous substances - Ayurvedic Medicine I Drugs of vegetable origin  Ahipena: Papaver somniferum Linn.  Arka: Calotropis gigantea (linn.)R. Br. ex. Ait.  Bhallataka: Semecarpus anacardium Linn. F.  Bhanga: Cannabis sativa Linn.  Danti: Baliospermum montanum Mull. Arg.  Dhattura: Datura metal Linn..  Gunja: Abrus precatorium Linn. SGAM/RSBK/Dr Joban K Modha
  24. 24. Drugs and Cosmetics Rules, 1945 [SCHEDULE-E(1) [Rule 161 (2)] List of poisonous substances - Ayurvedic Medicine I Drugs of vegetable origin  Jaipala (Jayapala): Croton tiglium Linn.  Karaveera: Rerium indicum Mill.  Langali: Gloriosa superba Linn.  Parasika Yavani: Hyoscyamus inibar Linn.  Snuhi: Euphorbia neriifolia Linn.  Vatsanabha: Acontium chasmanthum Stapfex Holm.  Vishamushti: Strychnox nuxvomica Linn.  Shringivisha: Acontium chasmanthum Stapfex Holm. SGAM/RSBK/Dr Joban K Modha
  25. 25. Drugs and Cosmetics Rules, 1945 [SCHEDULE-E(1) [Rule 161 (2)] List of poisonous substances - Ayurvedic Medicine II Drugs of Animal Origin. Sarpa Visha Snake poison. III Drugs of Mineral Origin Gauripashana: Arsenic. Hartala: Arseno sulphide. Manahashila: Arseno sulphide. Parada: Mercury. Rasa Karpura: Hydrargyri subchloridum. Tuttha: Copper sulphate. Hingula: Cinnabar. Sindura: Red oxide of lead. Girisindura: Red oxide of mercury. SGAM/RSBK/Dr Joban K Modha
  26. 26. IF NOT –WHY?/IF YES-HOW?  Is It Applicable Universally ?  Are We Aware of Original References ?  Do We Know The Ingredients And Their Hypersensivity ?  Do We Are Confident Regarding Ayurvedic Prescriptions? DO OUR MEDICINES HAVE CONTRA INDICATOINS ? SGAM/RSBK/Dr Joban K Modha
  27. 27. SGAM/RSBK/Dr Joban K Modha
  28. 28. PRECAUTIONS TO AVOID ADRs Dosage form specific Formulation specific Disease specific Dose specific Doshic affinity Manufacturing method Anupana- Sahapana-Bala-Desha- Kala-Agni-Prakriti- Satwa-Satmya etc. Ref: Dr MS Krishnamurthy www.ayurblog.comSGAM/RSBK/Dr Joban K Modha
  29. 29. DOSAGE FORM SPECIFIC PRECAUTIONS TO AVOID ADRs Fresh Drug – Acute conditions (Psychological Setup), Children, Susceptible individuals (Garlic, Onion, Ajawain, Colour specific, Cow’s urine etc) Decoction – Children, women, poor mental ability, Minor sufferings, Non accustomed, Religious Tablets-Younger age group (size of tablet), Higher society, Extra awareness, Vomiting, Tastelessness, Constipation, Indigestion etc Powders-Younger age group, women, Nausea, Mental disliking Syrup-DM, Disliking towards Preservatives and colouring agents, Consistency specific SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  30. 30. DOSAGE FORM SPECIFIC PRECAUTIONS TO AVOID ADRs Asava-Arishta-Religious, Women, Nausea/ Susceptible, Paittic individuals, DM Avleha-DM, Gurutva, Indigestion Ghee and Oil- Gurutva, Indigestion and Nausea, Liver disorders, Renal insufficiency Rasoushadhis-Renal-Cardiac-Hepatic- Neurological-Pancreatic disorders SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  31. 31. Most popular Rasaushadhi in our practices  Aarogyavardhini Rasa  Bruhad or Laghu Suvarna Vasant Malini Rasa  Chandamarutham Ras  Chandraprabha Vati  Garbhpal Ras  Laxmivilas Rasa  Mahayograj Guggulu  Makardhwaja Rasa etc.  Panchamrita Parpati  Simhanada Guggulu  Swasakuthar Rasa  Tamra Bhasma  Tribhuvan Kirti Rasa  Trivanga Bhasma  Vaat Vidhvamsana Rasa  Yogaraja Guggulu http://apps.who.int/medicinedocs/pdf/whozip23e/whozip23e.pdf SGAM/RSBK/Dr Joban K Modha
  32. 32. FORMULATION SPECIFIC PRECAUTIONS TO AVOID ADRs Choorna- Sitopaladi, Talisadi-DM Avipattikara- Diarrhoea, DM Pushyanuga-Constipation Hingwashtaka-Leucorrhoea, Bleeding disorders, BPH, Constipation Shivakshara –Urinary incontinency, BPH Shatavari-Sore throat, Kaphaja Roga Haritaki- Garbhini SGAM/RSBK/Dr Joban K Modha
  33. 33. FORMULATION SPECIFIC PRECAUTIONS TO AVOID ADRs Tablets- Yogaraja guggulu-Constipation, Reduced urine output Gokshuradi and Punarnavadi- Diuresis, Sleeplessness Chitrakadi–Stomatitis Laghu sootashekhara – Constipation, mouth ulcer Rasnadi-Constipation Lashunadi-Constipation, Burning SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  34. 34. FORMULATION SPECIFIC PRECAUTIONS TO AVOID ADRs Leha- Shatavari-Sore throat, Cold, Cough, Asthama, Indigestion Chyavana prasha,Dashamula hareetaki- Mandagni, Constipation, Burning of the body, Non specific headache Pancha jeeraka guda-Excess appetite AmritBhallatak Rasayan: Paittik disorders, blood disorders Trivrit lehya-Ulceration Haridrakhanda rasayana-Dry skin, Vaatik P/P/V SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  35. 35. FORMULATION SPECIFIC PRECAUTIONS TO AVOID ADRs Asava-Arishta Lodhrasava, Saraswatarishta-DM Dashamula-Constipation Sariva,Usheera-Kaphaja disorders Kharjoora, Shreekhanda-DM Kutaja- Constipation,Vatic disorders Kumari no 1-Menorrhagia Ashoka-Constipation SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  36. 36. FORMULATION SPECIFIC PRECAUTIONS TO AVOID ADRs Ghrita and Taila- Kalyanaka- Menorrhagia Shatavari, Falaghrita- Cold, Sore throat Pinda taila- Internal administration Most Taila/Ghrita-Rhumatoid arthritis Maharaja prasarini-Burning chest SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  37. 37. Hepatic/ Biliary Disorders-Haratala, Manashila, Vatsanabha, Naga, Vanga, Dhattura, Hingula Anaemia- Constipatives, Hingula, Vatsanabha, Gandhaka, Navasagara Fever-Gastric irritants, Khadira-Ashoka-Lodhra- Arjuna-Bilva-Shilajatu Mouth ulcers-Haratala, Manashila, Dhattura, Hingula, Dashamula katutraya, Kanakasava, TBKR, A Bhairava Back ache-Sangrahi.. DISEASE SPECIFIC PRECAUTIONS TO AVOID ADRs SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  38. 38. DISEASE SPECIFIC PRECAUTIONS TO AVOID ADRs Male Sterility-Vatsanabha, Jayapala, Navasagara, Kshara, Lavana Head ache-Constipation, Dysuria, Irritant drugs Peripheral neuritis-Hingula, Manashila, Vanga Scanty menstruation-Chandrakala rasa, Bolabaddha rasa, Ashokarishta(mere) Menorrhagia-Formulations containing Manashila, Haratala, Jayapala, Hingu, Kumari, Shanapushpi SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  39. 39. DISEASE SPECIFIC PRECAUTIONS TO AVOID ADRs Eye disorders-Manashila, Naga, Vanga, Bhallataka Ear disorders-Unless specified oils(mridupaka),Acidic substances Tonsilitis-Shatavari yoga, Coolants to scalp, Ghrita preparations Cold, Cough, Asthama-milk products, Shatavari, Coolants, medicated Ghee –if not specified Cardiac diseases-Hingula, Vatsanabha, Jayapala, Dhattura Urinary calculi-Hingula, Tamra bhasma, Vanga, Naga, Dhattura  PCOD-Careful usage of irritants  Lactation-Anti diabetic, Sthoulyahara medicaments  Gynaeco-mastia- Galactogogues like Shatavari SGAM/RSBK/Dr Joban K Modha Ref: Dr MS Krishnamurthy www.ayurblog.com
  40. 40. BE CAUTIOUS while penning Yastimadhu, Kantakari Sarpagandha,Vidanga, Soma, Kutaja, Vacha, Parsik Yavani* Bilva, Dhattura, Vacha, Bakuchi, Bhallataka Trivrit, Danti, Sonamukhi, Katukarohini Vatsanabha, Vishatinduka Naga, Vanga, Tamra, Parada, Hingula, Haratala, Manashila Un known/Less known  *banned or restricted in US/UK/EU SGAM/RSBK/Dr Joban K Modha
  41. 41. Medicines which contains Manahshila  Shvaskuthar Ras (for asthma with cough and in remittent fever with cerebral complications).  Smriti Sagar Rasa (for psychotherapy).  Unmada Gajakesari Rasa (psychological disorders).  Externally, the paste of Mansil is applied on diseases of skin. e.g. hair removing creams or Switra related medicines. Test dose should be applied first.  Shilasinduraa SGAM/RSBK/Dr Joban K Modha
  42. 42. Medicines which contains Hartal  Hartal malham  Rasa Manikya-dose?  Hartal bhasma  Talsindura SGAM/RSBK/Dr Joban K Modha
  43. 43. Medicines which contains lead  Vaatvidhvansan Ras  Tribang Bhasma  Garbhapaal Ras SGAM/RSBK/Dr Joban K Modha
  44. 44. Medicines which contains Bhallataka  Bhallataka Rasayana:  Amrita Bhallataka Ghrita:  Sanjivani Vati:  allergic reactions like rash, itching and swelling  the antidotes: externally -coconut oil, rala ointment, ghee, coriander leaves pulp or butter mixed with Musta (Cyperus rotundus)  A cream of Shatadhauta can be administered. SGAM/RSBK/Dr Joban K Modha
  45. 45. Medicines which contains Gunja  Neelibhrungadi tailam  Sarivadi Vati  If not purified properly or if used in excess dosage than prescribed, it can cause severe vomiting and diarrhea.  Unpurified seed powder used over wounds or direct contact with blood can also produce toxic effects.  Roots – if used in excess dose can cause vomiting It is best to avoid Gunja or medicines containing it during pregnancy, lactation and in children below 5 years of age.  Antidote: There is no specific antidote for abrin poisoning, and treatment is mainly supportive with intravenous fluids and correction of electrolyte abnormalities. SGAM/RSBK/Dr Joban K Modha
  46. 46. Medicines which contains Ativisha:  Kutaj Ghan Vati  Chandraprabha Vati  Khadiradi Gutika  Rasnairandadi kashayam  Bal chaturbhadra Churna  Yogaraja guggul  May produce allergic reactions like skin rash, burning, itching and swelling  Overdose SGAM/RSBK/Dr Joban K Modha
  47. 47. Side effects of Guggulu preparations:  It should be used under observation in people who are suffering from hypertension or any serious illness of chronic origin, in pregnancy and during active severe bleeding.  It is not a single handed remedy in the mentioned disorders and shall need the support of co- prescriptions in the form of disease modifying formulations. SGAM/RSBK/Dr Joban K Modha
  48. 48. Are not alternative for other Guggulu preparations  Sinhnaad Guggulu contains Eranda Taila so the most common side effect occurs due to the purgative action of Simhanada Guggulu. Some people may experience loose stools. In high dosage, it can also cause diarrhea. Rarely, people have reported restlessness after taking it, which generally occurs with its high dosage  Yogaraja Guggulu contains Ativish, Hingu and Vacha.. So uses with caution in Ushna Kaal, Prakriti. It may lead to some rare side effects in some sensitive people.  Acidity  Heartburn  Burning sensation in abdomen SGAM/RSBK/Dr Joban K Modha
  49. 49. Medohar Guggulu is POSSIBLY SAFE and WELL TOLERATED with dosage less than 2 grams per day. But it contains Vidanga and other Ushnavirya Dravyas so heavy dosage may cause following side effects.  Heartburn  Dull headache (commonly associated with acidity and occurs in people with history of acidity, gastritis or ulcer)  Increase in appetite (it may not its side effects, as people feel it initially and after a few days it reduces itself)  Loss of appetite (it occurs in people with chronic gastritis or digestive troubles)  Medohar Guggul in pregnancy and lactation it is contraindicated as it has warm property, which means it produces heat in the body. SGAM/RSBK/Dr Joban K Modha
  50. 50.  Sushruta has explained Torticollis (neck stiffness) and yellowish discoloration of eyes, stools and urine as the toxic effect of Vatshanabhi.  The text book Rasaratna Samucchaya explains 8 stages of toxic effects of Vatsanabha. These stages refers to spreading of poison in different parts of the body. These stages are also dependent on level of toxicity and dosage of Vatsanabha.  1st stage – Twak Vikara – skin rashes,  2nd stage – Vepathu – tremors  3rd stage – Daha – burning sensation all over the body.  4th stage – Vikrata – deformity  5th stage – phenodgati – frothing  6th stage – skandha bhanga – drooping and wasting of shoulders.  7th stage – Jadyata – wasting and comatose of whole body.  8th stage – Marana – death. Evil effects of Vatsanabha SGAM/RSBK/Dr Joban K Modha
  51. 51. Antidotes for Vatsanabha poisoning:  The treatment for Vatsanabha is possible upto 5th stage only. – (Rasaratna Samucchaya) During Aconitum ferox toxicity due to over-dosage or usage without purification procedure, then ghee along with Tankana bhasma is given. Combination of Honey, ghee and bark of Arjuna (Terminalia arjuna) is also used as antidote.  Whenever Vatsanabha is used in any formulation, Tankana Bhasma (Borax calx) is always used in equal quantity. If used so, it will nullify all the toxic effects of Vatsanabha and hence there will not be any toxic effects. Example: Tribhuvana Kirti Ras – a potent Ayurvedic medicine used in fever, has both Vatsnabha and Tankana. SGAM/RSBK/Dr Joban K Modha
  52. 52. Vatsanabh yoga  Tribhuvan kirti ras  Agnitundi vati  Anand bhairav ras  Krimikuthar ras  Sanjivani vati  Sutshekhar ras  Shwaskuthar ras  Vaatvidhvamsan ras SGAM/RSBK/Dr Joban K Modha Agnitundi Vati- also contains Kupilu* *Break after 15 days/avoid in children
  53. 53. Ras atisevan/ Kshar atisevan  Single Prescription shouldn’t contain similar drug in more than 2 compounds…  E.g. “Ras”…Guduchi  Medicines containing kshar for oligospermia  Tikta ati ras sevan:  Neem  Guduchi  Vasa Lavana ras pradhan aushadh atisevan SGAM/RSBK/Dr Joban K Modha
  54. 54. Non sulfide form of mercury- Chandmarutam ras -Ras karpura SGAM/RSBK/Dr Joban K Modha
  55. 55. SARPAGANDHA  Sarpagandha side effects –  It is contra indicated in – Bronchial asthma, Duodenal ulcer, Hyperacidity, Renal disorders.  Because it stimualtes uterus, this herb should not be used during pregnancy.  It is not suitable to be used in cases of depression.  It is not ideal to use this in children and after delivery.  It is not ideal to take this medicine along with Digoxin, Levodopa. Special care is needed when it is administered along with other medicines for high BP. The combined effect may lower the BP to a great extent.  Its sleep enhancing effect may further increase if taken by an alcoholic. SGAM/RSBK/Dr Joban K Modha
  56. 56. Religious Sentiments SGAM/RSBK/Dr Joban K Modha
  57. 57. Poisons, which remain in the body for a long period of time and cause intractable diseases, are known as Garaviṣa. (Shastri H, editor. Varanasi: Chaukhambha Samskrit Sansthan; 2011. Astanga Hridayam; p. 902.) SGAM/RSBK/Dr Joban K Modha
  58. 58. SGAM/RSBK/Dr Joban K Modha
  59. 59. SGAM/RSBK/Dr Joban K Modha
  60. 60. SGAM/RSBK/Dr Joban K Modha
  61. 61. Dispensing Errors in the Work Area • Labels on bins and shelves  Separate by route of administration (external/internal/injectable, etc.) • Use auxiliary labels for externals – Amoxicillin oral suspension for ear infection thought by parents to be drops administered in child’s ear • Review published safety alerts for look-alike/ sound-alike drugs and frequent dispensing errors SGAM/RSBK/Dr Joban K Modha
  62. 62. Last sip…. A look into original classical references Knowledge of recipe and related ingredients Thinking before acting A thorough re-view/case study Faith and confidence Acceptance of truth Self limitation and limitation of science SGAM/RSBK/Dr Joban K Modha
  63. 63. THANK YOU SGAM/RSBK/Dr Joban K Modha

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