Addressing the issue of the modus operandi to maximize the impact
Many plans and protocols, despite their proven benefits, face failures when are transposed to the situations different to the primary ones for which they were originally designed. A difference among needs, resources, and objectives warrants a revisit and subsequent indigenization of the plan to ensure its success in the local environment.
The idea of pharmacovigilance in Ayurveda also requires to be revisited in this spirit to underline its own needs, resources, and objectives. It is only then that the policy of implementation can be framed with a view to achieve the targets.
As the fundamental objective of pharmacovigilance is to ensure a safe medical practice by preventing drug-related harms to the patients, by increasing awareness and channelizing feedbacks, reporting of ADRs can be increased.
Contrary to the pharmacovigilance with conventional medicines, where a constant watch upon drug behavior is required, for drugs which are newly introduced and where there are no safety data available,[20
] in Ayurveda we need to work with known drugs which are in use for long periods and are believed to be safe when used as per the Ayurvedic
principles of their preparation and use. Pharmacovigilance in Ayurveda needs to identify contemporary causes for ADRs with Ayurvedic
medicines. A growing demand and subsequent exploitation of herbal drugs in general and Ayurvedic
drugs in particular however are posing some new and yet to be answered propositions. There are new proprietary medicines in the market, about which data are not available. There are suggestions that allow any herbal drug to be mixed up with a new drug which can be marketed without any clinical trial. There are extracts of the herbs being marketed without clinical trials. There are also new drugs not reported in Ayurvedic
classics. These issues are also required to be dealt in depth through pharmacovigilance in Ayurveda.
ADR reporting in pharmacovigilance of Ayurvedic medicines
The ADR reporting form developed by NPRC-ASU[21
] beautifully blends the need of Ayurveda with that of conventional ADR reporting practice as is envisaged by CDSCO in India.[22
] Obviously, this ADR form deals with various reasons of possible ADR peculiar to the current Ayurvedic
One of the important causes of ADRs to Ayurvedic
medicines is their deterioration upon storage. This is especially true for powders containing salts or sugar. Salt-containing powders are prone to liquifaction upon absorption of water and similarly sugar-containing powders adsorb water upon exposure and pose a threat of being contaminated with fungi.[23
] Drug dispensing in Ayurveda has also been a matter of great variation. Even if the drug is prescribed in milligrams or grams conventionally the doses are dispensed empirically through the use of spoons. Thus, the actual amount of a drug dispensed and thereby consumed in individual cases may not be precisely what was prescribed. Besides this a phenomenon called bulk dispensing also requires attention. At most state-run hospitals of Ayurveda, a lump sum amount of prescribed drugs is dispensed to the patient with an instruction to make required doses at their own as per the duration of therapy.[13
] Any inappropriate dose formation at home may lead to adversity where the reason for this is not really the drug but the way it was taken. Different sizes of vati
(tablet) preparations in Ayurveda and different formulations with the same name as described in different Ayurvedic
texts are another problem which need attention.
ADR reporting in Ayurveda should essentially address these situations, paying attention to the peculiarities characteristic of its practice style and therefore additions to the ADR reporting form are essential. NPRC-ASU (NPRC-Ayurveda, Siddha, and Unani) has worked in this direction by adding specific features in its ADR reporting form. Besides enquiring about drug dose, its indication, and the method of administration, it also enquires about dietary history, anupana, of the drug and also asks for collection of remains of the incriminated drug if can be made possible.
It is important that therapeutic procedures practised in Ayurveda should also be brought under the ambit of pharmacovigilance. Panchakarma, Ksharasutra, Rakta mokshana
are few such procedures. In these cases, the procedure-related harm needs documentation and discussion. It is heartening to note that a consensus has arrived to include adverse events caused by medical devices and therapeutic procedures under the purview of pharmacovigilance.[1
Causality analysis in Ayurveda
As discussed earlier, safe use of Ayurvedic medicine is entirely dependent upon its quality and appropriate uses. Any ADR therefore is an opportunity to learn about the possible causes. Causality analysis is one of the ways to find links between the drug in question and the adverse events that have occurred. From the Ayurvedic perspective, this causality analysis would be a definitive guide to find deficiencies in either drug quality or in its use.
Every ADR in Ayurveda should be analyzed in terms of drug properties (rasa, guna, virya, vipaka, and prabhava), the dose consumed singly or cumulatively, coadminstered drugs, herbs or food, prakriti of patient, vital status of the patient (sara pariksha), coexisting illness, pregnancy, lactation, and age (elderly or infancy).
The ADR reported and analyzed in Ayurveda may finally be reduced to two inferences: (1) Prakriti sama samaveta -- where the inference can be drawn by applying Ayurvedic principles of pharmacology, (2) Prakriti vishama samaveta -- where results cannot be drawn by applying the conventional Ayurvedic principles.
The latter example may come as a signal to Ayurvedic
pharmacovigilance and asks for a constant pharmacoepidemiologic monitoring to incriminated drug uses in diversified human population.[24