how to avoid adr of ayurved medicines
TRANSCRIPT
Dr Joban Modha MD PhD fellow (IOD, Fl. USA)
Dept. of R.S.B.K. S.G.A.M.
Gujarat Ayurved University
Jamnagar
Email: [email protected] SGAM/RSBK/Dr Joban K Modha
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
“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
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
“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
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
JAMA CONTROVERSY
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
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
SGAM/RSBK/Dr Joban K Modha
UNESCO
SGAM/RSBK/Dr Joban K Modha
UNESCO
SGAM/RSBK/Dr Joban K Modha
UNESCO
SGAM/RSBK/Dr Joban K Modha
UNESCO/BBC
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
The king of poison The poison of kings
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
QUALITY CONTROL OF BHAMAS
PHYSICAL PARAMETERS
Varitar
Unnama
Rekhapoornatva
Shlakshnatvam
CHEMICAL PARAMETERS
Varna
Gatarasatvam
Nishchandratva
Apoonarbhavatva
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
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
Easy tests to check Tamra Bhasma
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
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
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
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
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
SGAM/RSBK/Dr Joban K Modha
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.com SGAM/RSBK/Dr Joban K Modha
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
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
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
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
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
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
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
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
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
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
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
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
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
Medicines which contains Hartal
Hartal malham
Rasa Manikya-dose?
Hartal bhasma
Talsindura
SGAM/RSBK/Dr Joban K Modha
Medicines which contains lead Vaatvidhvansan Ras
Tribang Bhasma
Garbhapaal Ras
SGAM/RSBK/Dr Joban K Modha
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
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
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
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
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
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
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
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
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
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
Non sulfide form of mercury-Chandmarutam ras -Ras karpura
SGAM/RSBK/Dr Joban K Modha
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
Religious Sentiments
SGAM/RSBK/Dr Joban K Modha
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
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
SGAM/RSBK/Dr Joban K Modha
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
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
THANK YOU
SGAM/RSBK/Dr Joban K Modha