Pharmacovigilance in
Ayurved
What is Pharmacovigilance?
Pharmaco + Vigilance
•Pharmakon(Greek) - drug
• vigilare (Latin ) - to keep watch
Definition
Pharmacovigilance (PV) is defined as the science and activities
concerned with the
detection,
assessment,
understanding and
prevention of
Adverse Drug Reaction (ADRs) or any drug related problems.
WHO
What is ADR
“A response to a drug that is noxious and unintended and occurs at
doses normally used in man for the prophylaxis, diagnosis or therapy of
disease, or for modification of physiological function”
(W.H.O)
Many other issues relevant to PVG/ ADR
• Substandard medicines – Adulteration, Counterfeit Drugs
• Medication errors
• Lack of drug efficacy
• Medicines used for non-indicated disease conditions
• Abuse and misuse of medicines
• ADR arising out of interactions with other drugs, chemicals, food supplements etc.
• Modified Formulations
• Modified Processes – Extract / Active Principle
• Cultivation of medicinal plants with Lab. Generated species.
BRS- Moodabidri 2014 SEp 15 5
Why Pharmacovigilance?
Adverse Drug Reactions are among the top ten causes of mortality
(Lazarou J. et al., 1998)
The percentage of hospital admissions due to drug related events in
some countries is about or more than 10%.
(Bhalla et al, 2003; Imbs et al, 1999)
6
AIMS OF PHARMACOVIGILANCE …
• Early detection of unknown safety problems
• Detection of increases in frequency
• Identification of risk factors
• Quantifying risks
• Preventing patients from being affected unnecessarily.
Ultimate benefits of Pharmacovigilance
• Ayurvedic drug manufacturing industry will rise up….
• Quality products….
• Quality Ayurved Practice…
• Safety and assurance to the patients..
PVG IN AYURVEDA IN CONTEMPORARY ERA
National Pharmacovigilance
Programme for ASU (NPP-ASU)
The first National Consultative meet of
National Pharmacovigilance Programme for ASU Drugs
Was organized at
Dept. of AYUSH, Ministry of Health & F.W., New Delhi
on August 2008, sponsored by WHO.
Objectives –
Short-term objectives - To develop the culture of notification.
Medium-term objectives - To involve all professionals in the drug
monitoring and information processes.
Long-term objectives - To achieve operational efficiencies that would
make NPP for ASU drugs a benchmark for global drug monitoring
activities.
Process of Pharmacovigilance
Peripheral Pharmacovigilance Centre (Collection)
Regional Pharmacovigilance Centre (Causality Analysis)
Zonal Centre (Statistical Analysis)
National Pharmacovigilance Resource Centre (regulatory intervention)
WHO Monitoring Centre
NATIONAL PHARMACOVIGILANCE
PROGRAMME (ASU) – CURRENT NETWORK
NODAL AGENCY - Ministry of AYUSH, New Delhi
National Pharmacovigilance Co-ordination Centre (NPvCC) – AIIA, New
Delhi.
Intermediary Pharmacovigilance Centers (IPvCC) – NIA, Jaipur, IPGTRA,
Jamnagar for Ayurveda.
73 Peripheral Pharmacovigilance Centers (PPvC)
www.ayushsuraksha.com
Reporting Form for Suspected Adverse Reactions
National Pharmacovigilance Program for ASU & H
Drugs
Note:
Personal information will be kept confidential.
All suspected reactions are to be reported with relevant details.
Ay-AIIA Ay-NIA Ay-IPGT Un-NIUM Si-NIS Ho-NIH
Code of Peripheral Centre ADR Number / Year
1. Patient / consumer identification (please
complete or tick boxes below as appropriate)
Patient Initials: Patient Record Number (PRN)
Place of Birth
IP
D
/
O
P
D
Address: Age:
Village / Town: Sex: Male / Female / Others
Post / Via:
District / State:
Diagnosis: Constitution and Temperament:
2. Description of the suspected Adverse
Reactions
Date and time of initial observation
Description of reaction
3. Whether the patient is suffering with any chronic
disorders?
Hepatic Renal Cardiac Diabetes
Any Others (Specify, if others)
4. Addictions, if any? If yes, please specify:
5. H/O previous allergies / Drug reactions, if any: If yes, please
specify:
6. List of all ASU & H drugs used by the patient
during the period of one month:
Date of
Form / Route Any
Name of Manufacturer / Reason
Dose of Stopped / unwanted
the drug Batch no. Starting for use
administration Continued occurrences
7. List of other drugs used by the patient during
the period of one month:
Date of Any
Name Form / Route
Manufacturer / Reason unwanted
of the Dose of Stopped /
Batch no. Starting for use occurrence
drug administration Continued
s
8. Details of the drug suspected to cause ADR:
1. Name of the drug:
2. Manufacturing date and Expiry date (if available):
3. Remaining pack / label (if available):
4. Consumed orally along with (water / milk / honey / or any other)
5. Whether any dietary precautions have been prescribed?
6. If yes, please specify:
7. Whether the drug is consumed under medical supervision or used as
self medication.
8. Any other relevant information associated with drug use:
9. Management provided / taken for suspected
adverse reaction
10. Please indicate outcome of the suspected adverse
reaction (tick appropriate)
Recovered: Not recovered: Unknown: Fatal: If Fatal
Date of death:
Severe: Yes / No. Reaction abated after drug stopped or dose reduced:
Reaction reappeared after re administration of drug:
Was the patient admitted to hospital? If
yes, give name and address of hospital
11. Any abnormal findings of relevant laboratory
investigations related to the episode done pre and
post episode of ADR:
12. Particulars of ADR Reporter:
Please tick: Patient / Attendant / Nurse / Doctor / Pharmacist / Health worker / Drug
Manufacturer / Any others (please specify)
Name:
Address:
Telephone / E - mail:
Signature of the reporter:
Date:
Please send the completed form to: The centre
from where the form is received or to
The Coordinator, National Pharmacovigilance
Coordination Centre (NPvCC)
All India Institute of Ayurveda (AIIA), Mathura
Road, Gautam Puri,
Sarita Vihar, New Delhi - 110 076
E-mail: pharmacovigilanceayush@gmail.com,
ayush-pharmavig@aiia.gov.in
What to Report?
• All adverse reactions suspected to occur by ASU drugs alone or along with any
other drugs.
• All suspected drug interactions.
• Reaction to any other drugs suspected of causing
death
life threatening
hospitalization
disability
congenital anomaly
permanent impairment or damage
