Dr Sai Nivas
Definition
A response to a drug that Is noxious and unintended, and which occurs at a dose normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
History
It started 169 years back, in 1848, Ms. Hannah Greener died of chloroform anesthesia before the removal of infected toenail. After investigation, it is found that she died of lethal arrhythmia or pulmonary aspiration.
In 1961, Dr McBride, suggested a connection between congenital malformation of babies and thalidomide, by observing the incidence of congenital disease rise from 1.5% to 20% in women who had taken thalidomide during pregnancy. This questioned the reliability of animal tests, behavior of industrial company, importance of monitoring drug after marketing.
This led to changes in system of pharmacovigilance and spontaneous reporting of adverse drug reaction become systematic, organized, regulated. In 1968, WHO program for international drug monitoring was instituted with 10 members. In 1992, European society of pharmacovigilance was funded, turned into the international society of pharmacovigilance (IsoP).
Importance in Homoeopathy
- Adulteration in the crude drug substances that are used for the preparation of the homoeopathic medicines, the adverse effect of the adulterants on the individual can be identified.
- The relationship of the remedies, only source of the knowledge about the remedy relations are the source books, pioneers of homoeopathy was keen on the drug relation and interaction with each other. But as the Materia medica is expanding, the new remedies have no literature in remedy relationship. This exercise helps us to collect the data base of relationship of remedies which can be used by future physicians.
- Interaction of the patient with the environment while under Homoeopathic medicines have lot of influence on cure, such that, avoiding aromatic oils while treatment, as mentioned in source books. But in this modern era, there are more exposure that affects the action of our medicines which should be studied and recorded.
- Growth of patent medicines in Homoeopathy through these years is exponential, the relation and interaction between the medicines added is not studied properly, such medicines are available in over the counter, whose effects on prolonged exposure should be recorded.
Mode of Homoeopathic prescription and ADE/ADR
Dr. Samuel Hahnemann in §273, Organon of Medicine, has strictly said “in no case under treatment is it necessary and therefore not permissible to administer to a patient more than one single, simple medicinal substance at one time.” In contrary to that, prescriptions like polypharmacy, mixture of medicines, patent medicines, multiple bio-chemic tablets etc. given for long duration.
ADR will not occur at all cases of wrong prescription, but overdosing, administration of multiple drugs for long duration, adulteration and contamination etc. always put threat for ADE/ADR in homeopathy.
The flow of information in the system shall be handled confidentially. This also facilitate documentation of adverse drug reaction. It helps to develop system wise database of adverse drug reaction and improve the clinical safety of the drugs.
The above data shows there is huge and robust infrastructure of Pharmacovigilance of ASU&H Drugs in India patronized by the government. So, there is a need of widespread publicity and awareness about this program among common mass, manufacturers, practitioners especially private practitioners etc. for increasing the reporting culture in this sector.
Reference:
- Gupta, S.K. (2011) Textbook of Pharmacovigilance. second. New Delhi: Jaypee Brothers Medical Publishers.
- Lamba, C.D. et al. (2020) “Evaluation of the modified naranjo criteria for assessing causal attribution of clinical outcome to homeopathic intervention as presented in case reports,” Homeopathy, 109(04), pp. 191–197. Available at: https://doi.org/10.1055/s-0040-1701251.
- Pharmacovigilance and homoeopathy: A review – semantic scholar (no date). Available at: https://www.semanticscholar.org/paper/Pharmacovigilance-and-Homoeopathy%3A-A-Review-Sonny/9522172323ca9044cefeda92e2b07d001ee76fc4 (Accessed: April 5, 2023). Gupta, S.K. (2011) Textbook of Pharmacovigilance. second. New Delhi: Jaypee Brothers Medical Publishers.
- Pharmacovigilance (no date) AyushSuraksha. Available at: https://www.ayushsuraksha.com/pharmacovigilance/ (Accessed: April 8, 2023).
Dr Sai Nivas
PG Scholar ,Father Muller Homoeopathic Medical College Mangaluru
Very nicely explained
I would like to add that study of pharmacology is very important for each practitoner and also knowledge of posology.