PharmD Info

Fish vaccination is a new technique to prevent fish related illness. What is the status of fish vaccination in India?

After an ADR is reported to CDSCO ,what procedure is followed to prevent future ADR's of the same nature?

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.

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.

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 .

annsandra96 wrote: ↑22 Nov 2018, 15:52 Is there any app for reporting vaccine safety?

In India, we have mobile app of 'ADR PvPI' for reporting ADRs/events which is developed by Pharmacovigilance Programme of India. Currently we do not have specific app for AEFI/ Vaccines related events. There is probability that we can expect in near future.

I have a question. What is this PvPI Toolkit ? What you do with that ?

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.

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.

Admin wrote: ↑24 Nov 2018, 10:25 I have a question. What is this PvPI Toolkit ? What you do with that ?

It is depository for resource materials, SOPs, newsletters, guidance documents which can be used for reference and updates by PvPI personnel.