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 (NPCC).
Intermediary Pharmacovigilance Centres (IPvCC) 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 (PPvCC) for ASU & H Drugs
Primary pharmacovigilance centres. They are relatively smaller ASU & H colleges or institutions. These are the first contact ADR data collection units. They would be identified and coordinated by IPvCCs in consultation with NPvCC.
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 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 is 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.
Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is related to the pharmacological properties of the drug.
Comment: This is an old term and is broad enough to include both positive and negative effects of a drug apart from its main properties or indications. Some use the term as synonymous with ‘adverse reaction’, but the proposed definition will improve clarity of use of this term.
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.
Comment: This is a more recent term which some use interchangeably with ‘adverse reaction’, but, as indicated, it is better reserved for clinical phenomena occurring during drug treatment where causality cannot be or is not ascertained.