Basics Of Pharmacovigilance and the
Glossary of Terms
The nationwide programme under central sector scheme funded by Ministry of AYUSH, New Delhi for ASU & H drugs to establish and manage a data base of Adverse Drug Reactions (ADR) for developing system wise database of adverse drug reactions and evolving evidence based recommendations towards clinical safety of ASU & H Drugs. Besides this; the program also undertake surveillance of objectionable or misleading advertisements.
National Pharmacovigilance Coordination Centre (NPvCC)
It is a tertiary pharmacovigilance centre, acting as National Centre in the administrative structure of the program. Ministry of AYUSH, New Delhi has designated All India Institute of Ayurveda (AIIA), New Delhi as National Pharmacovigilance Coordination Centre (NPvCC).
Intermediary Pharmacovigilance Centres (IPvCs) for ASU & H Drugs
Secondary pharmacovigilance centres, acting as second level centres in the administrative structure of the program. Five National Institutes (National Institute of Ayurveda, Jaipur; Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar; National Institute of Siddha, Chennai; National Institute of Unani Medicine, Bengaluru; and National Institute of Homoeopathy, Kolkata) are designated as Intermediary Pharmacovigilance Centres.
Peripheral Pharmacovigilance Centres (PPvCs) for ASU & H Drugs
Primary pharmacovigilance centres. They are relatively smaller ASU & H colleges or institutions including. These are the first contact ADR data collection units. They would be identified and coordinated by IPvCs in consultation with NPvCC.
Designated in-charge of a particular participating pharmacovigilance centre
A healthcare professional involved in investigation of drug related adverse events.
Any person who suspects to have experienced / observed an ADR and informs any participating Pharmacovigilance centre about it.
A healthcare professional reporting ADR on the ADR form.
The process of overseeing drug related adverse events at the Pharmacovigilance centre participating in the Pharmacovigilance Program.
The process of providing ADR information by filling in the ADR form appropriately and forwarding the same to the appropriate level.
Process of informing by a notifier to any participating pharmacovigilance centre about the occurrence of a suspected ADR. The process may involve informing over telephone, in person, email, fax or any other means of communication-verbal or written. All notifiers must give their contact details.
Appropriate and adequate measures must be taken to keep track of the notifier. Any follow up action will be initiated on a notification only after the due verification of the notifier. If the notifier cannot be traced back, it will be recorded on the notification slip before closing the case.
A pre-designed structured form for communication of a suspected ADR by the notifier duly signed by him / her.
It’s the pre-designed structured form issued to record suspected ADR.
A systematic and independent examination (conducted by personnel, independent of the centre) of centre’s activities and documents to determine whether centre’s activities were conducted and the data were recorded, analysed and accurately reported according to the protocol and regarding performance of pharmacovigilance centre’s participation in Pharmacovigilance Program for ASU & H drugs.
In a confidential / secretive manner.
Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is related to the pharmacological properties of the drug.
Adverse Event / Adverse Experience
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment.
Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
WHO Technical Report No 498 (1972); ‘A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.
Unexpected Adverse Reaction
An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorization, or expected from characteristics of the drug.
Serious Adverse Event or Reaction
A serious adverse event or reaction is any untoward medical occurrence that at any dose
- results in death
- requires inpatient hospitalisation or prolongation of existing hospitalisation
- results in persistent or significant disability / incapacity is life-threatening