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#2948
pooja s wrote:
22 Nov 2018, 16:31
After an ADR is reported to CDSCO ,what procedure is followed to prevent future ADR's of the same nature?
After an ADR is reported to CDSCO, first they will analyze its nature (severity, seriousness, listedness etc.) at different levels.

As AEFI reporting has multiple steps involved the analysis/understanding of report starts at
district level which is later on moved to state level and finally reaches to central level discussion.

So based on assessment result, the action plan is decided. As we knew many of AEFI cases are classified as not-preventable reactions if it is vaccine related.

Hence, any immunization error related reactions the panel will develop the procedures in preventing the future AEFI. As it is a robust system it depends on the type of cases.
#2949
Shruthi8 wrote:
22 Nov 2018, 16:02
Can the expiry date of a vaccine be extended? If yes, on what basis and what are the possible consequences ?
To determine expiry date, vaccine's stability and potency data are required. manufacturers can submit the data and request for the extension date to respective regulatory authority which verifies the potency data. If vaccine's quality is not compromised, after regulatory authority approval, newly manufactured vaccines can be assigned with extended expiry date by manufacturers.
#2951
pooja s wrote:
22 Nov 2018, 16:31
After an ADR is reported to CDSCO ,what procedure is followed to prevent future ADR's of the same nature?
In India the post marketing ADR's are reported to PvPI (Pharmacovigilance programme of India ).Once the PvPI receives an ADR it undergoes assessment at different stages. In case of unlabelled ADR's they will be taken as a drug alert .The drug alert will be notified to the HCP'S in the PvPI database through an SMS .eg : Cefixime may cause skin hyperpigmentation is an alert released in April 2018 .

Once an alert is received the HCP's keenly watch for similar ADR's and report the same to PvPI, When enough evidence on the ADR is received the PvPI puts forth the details in the Signal panel meeting (that includes regulatory officials from CDSCO and PvPI ) .Further regulatory intervention like including the ADR in package insert,precautions and warnings in the package insert or withdrawal of the drug or particular batch will be made .This will leads to prevent similar ADR's in future .

Note : the drug alerts may be seen in the PvPI website also which is updates on monthly basis .
#2954
chris.vinod wrote:
22 Nov 2018, 15:27
If a patient is hypersensitive to an important vaccine, will that patient remain unvaccinated for that condition for lifetime?
If a person is allergetic or expreience IgE-mediated immediate hypersensitivity to vaccine, should be evaluated by an allergist/ dermatologist. It is important to identify the culprit allergen/ component of vaccine(egg, latex, yeast, gelatin) for all suspected anaphylactic events due to vaccines.
It is disturbing that the person should not be vaccinated further due to anaphylaxis. This practice is not recommended as it may results in inadequate immunization. after having thorough examination, patient can be given the vaccine in gradual doses under constant observation.
So finally to conclude, the approach of administration changes compared to conventional rather than skipping of further doses.
#2955
Gopika nair wrote:
22 Nov 2018, 15:22
What are the measures that could be taken to avoid coincidental event following vaccination?
Coincidental AEFI occurs when it occurs not due to vaccine product or immunization error related.

So we need to understand the pre-existing illness conditions, newly acquired illness, other exposures or spontaneously occurred conditions involved in the vaccination period.

Coincidental adverse events are majority times unrelated to vaccination.

However, sometimes events may be blamed on the vaccine by community because of
its close temporal association with immunization.

Therefore, these cases need to be investigated thoroughly in developing some measures to avoid in future.
#2957
Shefali Deo wrote:
22 Nov 2018, 15:25
A concept of “herd community”.Is it practiced in India? If Yes , then at what extent ? Also , are there any significant advantages of practicing herd community.
Herd immunity-better to consider as an achievement rather than a practice. If you vaccinate, you are protecting yourself and community around you. In fact, now this session however may contribute a little for herd immunity by creating awareness about vaccination significance.

As for advantages, we have eradicated small pox from the world- best example for herd immunity. Pneumococcal infections are more prominent in adults than in pediatrics. However vaccination in children reduced the risk of exposures in adults to pneumococcal infections.

In Indian Scenario, it is difficult to practice herd immunity, due to diversity, lack of awareness, high incidence of communicable diseases, importantly ineligibility for vaccination due to immuno-suppressive conditions like AIDS, cancer, Tuberculosis etc.,

We can hope for herd immunity by implementing better approaches and practice by educating ourselves and to public concerning significance of vaccination.
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