Re: impact of PV on PE -day 2

[Guest guest]

Dear All,ICH classification of trials places PE & PV studies in Phase IV and till now it was rightly so. But NICE and FDA have now guidelines which require QoL and PE data right at the time of trial data submission for marketing approval. This is a big step forward as impact of a new drug or therapy in terms of monetary costs should be well known and also the information should be disseminated. 

Limiting PV studies to ADR reporting is not a good idea as the setup for these studies can also be used for establishing the therapeutic efficacy and DDI and FDI in actual populations. In todays time there is a need for integration across fields and we in Pharmacology need to grasp this fact as early as possible. Hence the need to familiarize ourselves with methods of Epidemiology, Statistics and related fields....

Best Regards,ArifOn Sun, May 16, 2010 at 7:42 AM, kunda gharpure <gharpurekunda@...> wrote:

 

hello,

Social and economic consequences of adverse drug reactions are considerable and there is a positive benefit of risk management – hence there is a need for monitoring adverse drug reactions.(Reiterating Anupama'scontribution)  Based on the available data, recommendations on product label amendments, product withdrawals and suspension, are formulated. PV plays a major role in pharmacotherapy decision-making, be it individual, regional, national or international level.

The purpose of the national pharmacovigilance programme is to collate data, analyze it and use the inferences to recommend interventions, besides communicating risks to healthcare professionals and the public, which is one of the mid term objectives of the policy.        

PV is not just about reporting cases to the regulatory authorities, the results should provide useful information which can be communicated to prescribers.

In practice, PV refers almost exclusively to the spontaneous reporting of adverse drug reactions to a central agency. Let us take a look at the other aims of PV

Aims of Pharmacovigilance 

Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.

Improve public health and safety in relation to the use of medicines.

Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.

Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

So now we see that one of the aims of PV is to encourage use of cost effective rational treatment in patients and improve public health.

Happy reading.

kunda

 

 

-- Dr. Arif HashmiJunior Resident - II,Dept. of Pharmacology,Govt. Medical College & Rajindra Hospital,Patiala, Punjab.0-956-904-7686drarifhashmi@...

[Guest guest]

hello,

In response to Arif's post I would like to state my experience. PE evaluation at the time of maketing approval will be an added tool to select rational drug. But how many company reps. tell you about the comparitive cost evaluation of a new drug vis-a-vis those already in the market?

kunda

hello,

Social and economic consequences of adverse drug reactions are considerable and there is a positive benefit of risk management – hence there is a need for monitoring adverse drug reactions.(Reiterat ing Anupama'scontribution) Based on the available data, recommendations on product label amendments, product withdrawals and suspension, are formulated. PV plays a major role in pharmacotherapy decision-making, be it individual, regional, national or international level.

The purpose of the national pharmacovigilance programme is to collate data, analyze it and use the inferences to recommend interventions, besides communicating risks to healthcare professionals and the public, which is one of the mid term objectives of the policy.

PV is not just about reporting cases to the regulatory authorities, the results should provide useful information which can be communicated to prescribers.

In practice, PV refers almost exclusively to the spontaneous reporting of adverse drug reactions to a central agency. Let us take a look at the other aims of PV

Aims of Pharmacovigilance

Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions.

Improve public health and safety in relation to the use of medicines.

Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use.

Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

So now we see that one of the aims of PV is to encourage use of cost effective rational treatment in patients and improve public health.

Happy reading.

kunda

-- Dr. Arif HashmiJunior Resident - II,Dept. of Pharmacology,Govt. Medical College & Rajindra Hospital,Patiala, Punjab.0-956-904-7686drarifhashmi@ gmail.com