how to avoid ADR of Ayurved medicines

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.


“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.)


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.


JAMA CONTROVERSY



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.



UNESCO


UNESCO


UNESCO


UNESCO/BBC





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.


QUALITY CONTROL OF BHAMAS

PHYSICAL PARAMETERS

Varitar

Unnama

Rekhapoornatva

Shlakshnatvam

CHEMICAL PARAMETERS

Varna

Gatarasatvam

Nishchandratva

Apoonarbhavatva



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


Easy tests to check Tamra Bhasma



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.



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.



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 ?



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


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


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


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


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


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


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



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



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


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


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


Medicines which contains Hartal

Hartal malham

Rasa Manikya-dose?

Hartal bhasma

Talsindura


Medicines which contains lead Vaatvidhvansan Ras

Tribang Bhasma

Garbhapaal Ras


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.


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.


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


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.


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


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.


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


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.


Vatsanabh yoga Tribhuvan kirti ras

Agnitundi vati

Anand bhairav ras

Krimikuthar ras

Sanjivani vati

Sutshekhar ras

Shwaskuthar ras

Vaatvidhvamsan ras


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


Non sulfide form of mercury-Chandmarutam ras -Ras karpura


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.


Religious Sentiments


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.)





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


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


THANK YOU


Date post:	12-Apr-2017
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how to avoid ADR of Ayurved medicines

Health & Medicine