Background:
Long term use of a medicine without evidence of risk may indicate that is harmless, it isnot always definite how far one can rely on it as as assurance of innocuity. Preclinical toxicological studies can be undertaken to study safety of herbal medicines. In additional, side effects may be documented according to normal pharmacovigilance practices.
Additional link:
wahs 2012
Assessment of efficacy:
Citation of existing literature is sufficient to substantiate claims of benefits of herbal medicine being traditionally used. However, in case, any replacement addition, or deletion of traditionally used ingredients from herbal drugs product is made, or old product is markete for new indication, or traditional method of preparation is altered, the new herbal produc needs to be extensively investigared preclinically and clinically along with post marketing survelliance.
PHARMACOVIGILANCE
- Committee on Safety of Medicines/Medicines and Healthcare products Regulatory Agency’s (CSM/MHRA) ‘yellow card’ scheme for adverse drug reaction (ADR) reporting is the main method of monitoring the safety of herbal medicines in UK. (Barnes J, 2003)
- Prescription-event monitoring
- Use of computerised health-record databases.
- Modifications to existing methodology, patient reporting and greater consideration of pharmacogenetics and pharmacogenomics in optimising the safety of herbal medicines.
COLLECTION:
- Book : Dead and deduction . For download : death and deduction