Q1. What is Pharmacovigilance?
Pharmacovigilance, as defined by the World Health Organization, is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and complementary medicines, blood products, biologicals, medical devices and vaccines.
Q2. What is an Adverse Event (AE)?
An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Q3. What is an Adverse Drug Reaction (ADR)?
It is a noxious response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.
Q4. How does AE differ from an ADR?
An AR is characterized by the fact that a causal relationship between the drug and the event is suspected. This implies that there is a suspected relatedness to the administered drug.
Q5. What is a serious ADR or a Serious Adverse Event (SAE)?
A serious adverse event or adverse reaction is any untoward medical occurrence that at any dose:
- Results in death
- Is life-threatening
- Requires in patient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity or
- Is a congenital anomaly or birth defect
Q6. What is the difference between side effect and AE?
A side effect is any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug.
An adverse event or experience is defined as any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment.
Q.7 Who can report Adverse Drug Reaction?
All healthcare professionals including Clinicians, Dentists, Pharmacists, Nurses and Non-healthcare professionals (patients, consumers) can report ADRs.
Q.8 Why to report ADR?
As a healthcare professional and citizen of India its moral responsibility to report adverse reaction associated with pharmaceutical products to safeguard public health and help in improving patient safety.
Q.9. What type of Adverse Drug Reaction should be reported?
PvPI encourages reporting of all types of suspected adverse reactions with all pharmaceutical products irrespective of whether they are known or unknown, serious or non-serious and frequent or rare.
Q.10. What is Pharmacovigilance Programme of India (PvPI)?
The Central Drugs Standard Control Organisation (CDSCO), New Delhi has initiated a nation-wide pharmacovigilance programme under the aegis of Ministry of Health & Family Welfare, Government of India. The programme is coordinated by The Indian Pharmacopoeia Commission (IPC) located at Ghaziabad. The National Coordinating Centre (NCC) is operating under the supervision of Steering Committee to recommend procedures and guidelines for regulatory interventions in India.
Q.11. What is the scope of PvPI?
In order to gain a comprehensive safety profile of medicine, a continuous post-marketing monitoring system i.e. Pharmacovigilance is essential. In order to monitor the safety of medicine information from many sources are used for pharmacovigilance. These include spontaneous Adverse Drug Reaction (ADR) reporting mechanism; medical literature published worldwide, action taken by regulatory authorities in other countries, etc.
Q.12. How do we report ADRs through PvPI?
If there is any suspicion that an adverse event or adverse reaction has occurred, the health care professional attending to the patient, can fill up the suspected ADR form or patient suspects that he has experienced an ADR can report to the nearest ADRs Monitoring Centres (AMCs) under Pharmacovigilance Programme of India (PvPI). The details of AMCs are given in the website of IPC i.e. www.ipc.gov.in
Q.13. Is there a prescribed form to be used in making reports?
There is a prescribed form that can be used in making reports to AMCs which can be downloaded from the websites of IPC (www.ipc.gov.in) or CDSCO (www.cdsco.nic.in)
Q14. Can we report the listed events?
Yes. The listed events of medicines also can be reported.
Q.15. What are the minimum criteria for a valid ADR report?
The following minimum criteria must be met to make an ADR report valid:
- Patient identifier e.g., initials, or age or date of birth or sex
- Name of suspected medicinal product (s)
- Details of the suspected reaction
- Reporter details (name, profession, institution, contact details)
Q.16. What will happen after submitting the ADR?
The ADRs will be sent to WHO-Uppsala Monitoring Centre (UMC) for analysis and signal detection. Simultaneously ADRs are evaluated at NCC and the inferences are used to recommend regulatory body i.e. CDSCO to take necessary regulatory interventions, besides communicating risks to healthcare professionals and the public.
Q.17. Will there be any legal issue if I report ADRs?
No, there will not be any legal issues as the information will be used for drug safety.
Q.18. How AMCs are enrolled or to be enrolled under the fold of PvPI?
Medical Council of India approved institutions willing to participate in this programme should furnish the Letter of Intent forwarded by Head of the Institution and send to NCC. After examining the suitability the institute will be accepted as an AMC under PvPI.
Q.19. Whether NCC will provide financial support to the AMCs?
No., only logistic support and manpower shall be provided by NCC
Q.20. How can a consumer/healthcare professional report ADR?
Healthcare professionals can fill the “Suspected Adverse Drug Reaction Reporting Form” and consumers reporting form is available for consumers and send it to nearest the Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordinating Centre (NCC). You can directly mail the form to firstname.lastname@example.org or email@example.com. Toll free helpline (1800-180-3024) number can also be use to directly report an ADR.
Q.21. What are the timings to report an ADRs through helpline?
You can call on helpline number to report ADR on all working days (Mon-Fri) from 9:0AM-5.30 PM. If a call is not responded then one can drop a voice message on voice recording system.
Q.22. Is ADR reporting to NCC-PvPI is mandatory for Pharmaceutical companies?
Q.23. Off label ADRs should also be reported?
Yes, All the ADRs are medically important and should be reported.
Q.24. Where can I get information/ guidance on ADR reporting?
You can directly go to the link www.ipc.gov.in/PvPI/pv_home.htm and get all the information about ADR reporting. You can also call at toll free (1800-180-3024) helpline to ask any query related to ADR reporting.
Q.25. Can we report Vaccine related reports also?
Yes, vaccine related reports can also be reported in the same Suspected ADR form.
Q.26. Newsletter and other documents can be downloaded from the website?
PvPI e-newsletters can be downloaded from www.ipc.gov.in, under NAVIGATION, PvPI updates.
Q.27. Adverse Events due to medical devices can also be reported?
All the adverse events related to medical devices should be reported through Medical Device Monitoring Centres (MDMCs) under Materiovigilance Program of India (MvPI) to Sree Chitra Tirunal Institute of Medical Science And Technology (SCTIMST), Thiruvananthapuram - 695 011, Kerala. Phone: 91- 471 – 2340411, Fax: 91- 471 -2341814, Email: firstname.lastname@example.org. The institute is working as National Collaboration Centre for MvPI.
Q.28. Haemovigilance related ADR can also be reported here?
ADRs related to haemovigilance should be reported at Officer In-charge- HvPI & Scientist Grade-III, NIB, NOIDA at: email@example.com.
Q.29. Where can I get information on Regulatory related issues?
You can visit National Regulatory Agency (NRA) website www.cdsco.nic.in i.e. Drugs Controller General of India, Central Drugs Standard Control Organization (CDSCO) Head Quarter, FDA Bhawan, Kotla Road, New Delhi 110002. Phones: (Off.) 91-11-23236965 (D) Fax: 91-11-23236973. E-Mail: firstname.lastname@example.org