IPC identifies 24 institutions to carry out intensive ADR monitoring exercise
In its renewed bid to conduct studies related to specific
drugs and its adverse events, the Indian Pharmacopoeia Commission (IPC) has
identified 24 institutions to carry out intensive ADR monitoring exercise under
the Pharmacovigilance Programme of India (PvPI), according to a senior official
associated with the development.
IPC under the Union health ministry is the National
Coordination Centre (NCC) for PvPI.
IPC had earlier come out with draft guidelines focused on
targeted drugs and events as a part of intensive adverse drug reaction
monitoring exercise under PvPI so that action could be taken on specific drugs
involving adverse reactions.
“Stressing on the need for safe and efficacious drugs in the
country, the intensive ADR monitoring exercise is envisaged to generate adverse
drug reaction related events in real time and on scientific basis. The idea is
to integrate this exercise with our public healthcare system for drug quality
and hence patient safety”, according to scientific director IPC Dr G N Singh.
Considering the fact that data from spontaneous reporting of
ADRs have generally been mis-spelt, Union health ministry is also planning to
train institutions for undertaking specific projects on intensive ADR
monitoring.
The Union health ministry has also come out with suspected
ADR form for healthcare professionals and medicines side-effect reporting form
for consumers besides a toll free helpline number.
Centre has also tasked 250 ADR Monitoring Centres (AMCs)
existing in the country to establish clinical evidence between the drug and the
adverse drug reaction through a robust system of causality assessment.
Central Drugs Standard Control Organisation (CDSCO) in
collaboration with IPC has also started auditing healthcare institutions
through assessment on aspects like SOPs and causality assessment in order to
review the functioning of AMCs in the country.
The exercise was meant to generate awareness in medical
institutions to put in place effective surveillance system for detection of
ADRs.
CDSCO under the Union health ministry had initiated a
nation-wide PvPI in July 2010. PvPI leads with 0.82 points as per quality
completeness score of Individual Case Safety Reports (ICSR) as against the
global average of 0.55 accounted on a quarterly basis for a total of 150
countries including India which contribute to the global PvP database.
ICSR as part of ADRs are reported from all over the country
to NCC-PvPI, which also work in collaboration with the global ADR monitoring
centre (WHO-UMC), Sweden to contribute in the global ADRs data base.
IPC is also collaborating with CDSCO as a lot of data like
periodic safety update reports (PSUR) and post marketing surveillance data is
done by CDSCO based on market authorisation holders (MAH) reports submitted on
an ongoing basis.
IPC has also signed an MoU with NABH following which around
600 National Accreditation Board for Hospitals and Healthcare providers (NABH)
accredited hospitals have also started reporting ADRs as part of their
pharmacovigilance activities mandated by the government.
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