Question

Why pharmacovigilance in homoeopathy?

OR
What did you mean by pharmacovigilance? Describe it in view of Homoeopathy?
OR
What is pharmacovigilance? Why it is important/ helpful in homoeopathy?

Answer

A) *Definition (W.H.O.) =

Pharmacovigilance is the science of collecting, monitoring, researching, assessing

and evaluating information from healthcare providers and patients on the adverse
effects of medications, biological products, blood products, herbals, vaccines, medical
device, traditional and complimentary medicines.
The word “Pharmacovigilance” has two parts. The first
part or portion being the word ‘Pharmaco’ derives from the Greek word and term
‘Pharmakon’, which means Medical Substances and the concluding portion thereof
being ‘vigilance’ derives from the Latin term ‘Vigilia’, which means to keep watch.
Pharmacovigilance is an important and integral part of clinical research and it plays a
key role in the Healthcare System through assessment, monitoring and discovery of
interactions amongst drugs and their effects in human.

B) *Why in Homoeopathy?

The quality issues and safety concerns of Homoeopathic drugs have been raised from
various sources.
Ministry of AYUSH in the interest of public health to oversee the impact of ASU & H
[Ayurveda, Siddha, Unani & Homoeopathy] drugs consumed by the people from the
perspective of their safety profile.
It will also facilitate detection of potentially unsafe ASU&H drugs and misleading
advertisements for taking regulatory action against them.
The incidence of adverse drug effects is comparatively very less in homoeopathic
science hence very less inputs in pharmacovigilance from its side.
Entirely the AYUSH department deals with the practice of pharmacovigilance.

* Pharmacovigilance in view of homoeopathic science –

It deals with –
1.collecting,
2. monitoring,
3.researching,
4.assessing,
5.evaluating,

1 DR PARAG RAMESH BHAGWAT, H.O.D. HOMOEOPATHIC PHARMACY ,GOVT.H.M.C.,JALGAON.

 the information of adverse effects of medicine from healthcare providers and patients.
Considering the above things pharmacovigilance can be helpful and important in
homoeopathy in clinical trials.

*Why it is helpful in homoeopathy?

As stated above pharmacovigilance deals with the information of adverse effects of

medicines from their clinical and experimental uses.
1.The homoeopathic pathogenetic trial is intended to observe the effects of well-
regulated doses of drugs and medicines.
Where as in pharmacovigilance whatever the data is collected is out come of
hypersensitivity of the patient to that drug or due to incorrectly used drug.
Which yields sign and symptoms. That can become data for homoeopathic Materia
medica through its method of monitoring, researching, evaluating assessing method.

2.Pharmacovigilance helps in controlling the misuse of homoeopathic medicines by

medicos and non-medicos.

3.It restricts up to some extent over counter sale of irrational medicines.

4.Data from the pharmacovigilance helps in correcting the mistakes in future which
are observed with administration of particular drug in particular disease condition.

5. Due to handling of AYUSH, the pharmacovigilance in homoeopathy had become

more scientific, which helps in proving itself as more evidenced based scientific
system through its method of monitoring, researching, evaluating assessing method.

6. Pharmacovigilance is an important and integral part of clinical research and it plays

a key role in the Healthcare System through assessment, monitoring and discovery of
interactions amongst drugs and their effects in human.

All though the homoeopathic system is the safest system, the adverse reactions may
be seen in some cases where they are not used rationally.

*It is important in homoeopathic science to differentiate between adverse drug

reaction and the other aggravations in the homoeopathy while dealing with
pharmacovigilance-

Adverse Drug Reaction (ADR)

Adverse drug reaction is a response which is noxious and unintended, and which
occurs at doses typically used in humans for the preventive, or medicine for a
unhealthy condition, or for the change of physiological function. Less likely to occur
in the sick persons taking homoeopathic medications.
.

2 DR PARAG RAMESH BHAGWAT, H.O.D. HOMOEOPATHIC PHARMACY ,GOVT.H.M.C.,JALGAON.

 Aggravations in Homoeopathy
Aggravation is the increased intensity of the symptoms or worsening of the symptoms
or condition after the administration of medicine.

Homoeopathic aggravation: Hahnemann defined

Homoeopathic aggravation as the so-called homoeopathic aggravation, or rather the
primary action of the homoeopathic medicine that tend to increase somewhat the
symptoms of the original disease, for the first or few hours, which is definitely true
for diseases of a more acute character and of recent origin.” But the sick internally
feels well.

Medicinal aggravation: It denotes the appearance of new symptoms of the medicine

administered to the patient. When the medicine administered is not similimum.

Disease aggravation: It denotes the appearance of new symptoms belonging to the

sphere of disease due to its natural tendency to progress. Because the medicine given
is not similimum or of very low potency, which cannot control the natural course of
the disease. And hence the symptoms of disease increases.

Previously this part of pharmacovigilance was untouched part in homoeopathic

science. But due to the AYUSH the special centers are open at three different levels
where the adverse effects of any ASU& H medicines can be reported.

One should know-

What to report?
Where to report?
How to report?

Those centers to report pharmacovigilance are-

1-National,
2-Intermediary
3-Peripheral.

Possibilities of adverse drug reactions may be found more in cases where irrational
use of polypharmacy of homoeopathic medicines is done.

C) *Aims of pharmacovigilance =

1.To improve patient care and safety in relation to the use of medicines, and all
medical and paramedical interventions.
2.To improve public health and safety in relation to the use of medicines.

*The specific aims of pharmacovigilance are –

3 DR PARAG RAMESH BHAGWAT, H.O.D. HOMOEOPATHIC PHARMACY ,GOVT.H.M.C.,JALGAON.

 (a) to ameliorate patient suffering and safety in relation to the use
of medicines,

(b) identify problems related to the use of medicines

and communicate the findings in a timely manner,

(c)contribute to the assessment of benefit, harm, effectiveness

and threat of medicines, leading to the prevention of adverse
effects and maximization of benefit.

*Global aims of Pharmacovigilance =

“To Minimizes risks and maximize benefits” against use of Medicines and other
Interventions

1-To improve patient care safety.

2-To improve public health and safety.

3-To contribute to the assessment of benefit, harm, effectiveness and risk

4-To promote understanding, education and clinical training in pharmacovigilance and

its effective communication to health care professionals and the public.

.
D) *Objectives of Pharmacovigilance=

-To monitor adverse Drug Reactions/Events

-To develop the culture of documenting adverse effects for monitoring safety issue of
ASU & H Drugs.
-To establish a database of Adverse drug reactions/events(ADR/ADE) for evidence-
based recommendations towards clinical safety of ASU&H Drugs.
-Support the CDSCO (Central Drugs Standard Control Organization) to formulate
regulatory decisions for safety use of medicine.
-The surveillance of objectionable or misleading advertisements.
-To create awareness amongst the health care professionals about the key aspects of
pharmacovigilance.
-Communicate the findings with all key stakeholders.

E) *Challenges:

1)Self-medication-

4 DR PARAG RAMESH BHAGWAT, H.O.D. HOMOEOPATHIC PHARMACY ,GOVT.H.M.C.,JALGAON.

 -Patients takes drugs over the counter (OTC)prescribed by pharmacist, from
advertisements by the drug companies, available pamphlets.
-This leads to unknown adverse effects which usually goes unreported.
2)Web-based medication
-Web based information related to drugs and diseases without authenticity.
-It leads to the uncontrolled sale of medicines with questionable safety, efficacy and
quality.
3) Counterfeit drugs-
-Counterfeit drugs are underreported problem.
-It causes morbidity, mortality and loss of public confidence in medicines and health
structures.
4) Confounding illness-
-Incurable diseases with more advanced pathology like malignancy etc. may need
multiple drugs.
-The adverse effects which occur due to interaction between different drugs,
sometime does a problem in identifying the offending drugs.
5) Clinical trial monitoring-
-India is becoming hub for clinical trial in 21 st century.
-In most of the clinical trials, adverse drug reactions that happen due to the test drugs
goes unreported.
-ADR/ADE in clinical trials are not informed to the regulatory authority due to
personal interest or the fear of litigation.

F) *Hierarchy of pharmacovigilance programme set up-

Ministry of AYUSH has introduced new Central Sector scheme for promoting
pharmacovigilance of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H)
Drugs. Prime objective of the scheme is to develop the culture of documenting
adverse effects and undertake safety monitoring of Ayurveda, Siddha, Unani and
Homoeopathy drugs and surveillance of misleading advertisements appearing in
the print and electronic media.

The scheme intends to facilitate the establishment of three level of network:

1) National Pharmacovigilance Co-ordination centre (NPvCC)
2) Intermediary Pharmacovigilance centre (IPvC)
3) Peripheral Pharmacovigilance Centre (PPvC)

G) *REPORTING: Pharmacovigilance AYUSH

H) WHAT TO REPORT?
All suspected drug related adverse events and misleading advertisement in the
prescribed proforma.

WHO CAN REPORT?

5 DR PARAG RAMESH BHAGWAT, H.O.D. HOMOEOPATHIC PHARMACY ,GOVT.H.M.C.,JALGAON.

 Any health care professional can report suspected adverse drug events to the
concerned PPvCs/IPvCs.

WHERE TO REPORT?
Can be submitted to the nearby PPvCs/IPvCs

*Direct reporting to
www.ayushsuraksha.com

*Laws which related with pharmacovigilance-

The Drugs and Cosmetics Acts and Rules – 1940
Drugs and Magic Remedies Act and Rule – 1955 (Objectionable advertisement).
Medicinal and Toilet Preparation Act – 1955
Dangerous Drug Act – 1930, and Rules – 1957

6 DR PARAG RAMESH BHAGWAT, H.O.D. HOMOEOPATHIC PHARMACY ,GOVT.H.M.C.,JALGAON.