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Pharmacovigilance in Siddha System of Medicine:

Pharmacovigilance:

According to World Health Organisation (WHO) Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.


Adverse Drug Reaction (ADR):

An adverse drug reaction (ADR) is a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man. It concerns with the response of a patient, in which individual factors may play an important role, and that the phenomenon is noxious (an unexpected therapeutic response, for example, may be a side effect but not an adverse reaction).


Adverse Drug Reaction (ADR) in Siddha system of medicine:

Siddha therapeutic drugs are designed to treat and prevent diseases. Uniqueness in Siddha system of medicine is Siddha physicians are proficient to diagnose the disease, prepare the medicine and treat the patient. Adverse drug reaction may occur if the drug was not properly prepared or any improper schedule of drug intake. Adverse drug reaction is mentioned in Siddha text for specific drugs along with treatment in the term of Nanju Kurigunam and Nanju Murivu. Drug intake includes Dose, Duration, Season, Adjuvant and Pathiyam. Siddha physicians have to explain about the Dose, Duration of the drug intake, adjuvant, etc.


Patient's role in Pharmacovigilance:

If you observe any abnormal signs and symptoms (like skin itching, thickening, rashes, nausea, vomiting and diarrhoea) while taking Siddha treatment kindly inform it to your Doctor or the other Doctor of the department concerned/Hospital/Clinic immediately.


Siddha Physicians responsibilities in Pharmacovigilance:

What should be reported?

For new drugs report all suspected reactions, including minor ones. (In many countries drugs are still considered "new" up to five years after marketing authorization).

+ For established or well-known drugs-report all serious or unexpected (unusual) suspected ADRs;

+ Report if an increased frequency of a given reaction is observed;

+ Report all suspected ADRs associated with drug-drug, drug-food or drug-food supplements (including other system of medicine like (Allopathy) interactions;

+Report ADRs in special fields of interest such as drug abuse and drug use in pregnancy and lactation;

+ Report when suspected ADRs are associated with drug withdrawals;

+ ReportvADRs occurring from overdose or medication error;

+ Report when there is a lack of efficacy or when suspected pharmaceutical defects are observed.


Who can report?

Any health care professional may report suspected adverse drug events. The program does not accept reports from lay members of the public, nor others than health care professionals. Others can report through the physician under whom they have undergone treatment. Consumer may directly report to the concerned Peripheral Pharmacovigilance Centre (PPVC) / Intermediary Pharmacovigilance Centres (IPVC) or Physician.


Where and why to report?

It should be done in a prescribed format through the concerned Peripheral Pharmacovigilance centre (PPVCs)/Intermediary Pharmacovigilance centre (IPVC). As a health care professional it is the moral responsibility to safeguard the public health if any ADRs associated with use of medicine.


What happens to the submitted ADR FORM?

Information in the forms is to be handled in all confidentiality. Peripheral Pharmacovigilance Centers(PPVCs) forward the form to their Intermediary Pharmacovigilance Centers (IPvCs) where causality analysis is carried out. The information is then forwarded to the National Pharmacovigilance co-ordination Centre (NPVCC), where it is consolidated, statistically analyzed, and forwarded to the Ministry of AYUSH.

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