What is Pharmacovigilance And Drug Safety?

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                                           What is PHARMACOVIGILANCE or DRUG SAFETY?

PHARMACOVIGILANCE- The other meaning for Pharmacovigilance is DRUG WATCH.

–  To detect assessment understanding and prevention of adverse effects and any drug related problems.

– To improve Public health and safety relation related to medicinal use.

(a)- Adverse Event (AE) – Unfavourable and Unintended Sign, like symptoms and disease associated with use of medicinal products.

(b)- Adverse Drug Reaction (ADR) – Response which is unintended or detects in regular dose.

(c)- Dechallenge – with drawl of drug till Adverse effect is gone.

(d)- Rechallenge –Again starting the medicine to the subject after adverse effects.

(e) Spontaneous report (SR)–Reporting by Healthcare or consumer to the company or the organization.

(f) Periodic Safety Update Report (PSUR) –All relevant New safety information is collected related to patient exposure to drug from appropriate source and determine where there any change will be made to product information to optimize the use of product. Benefit and risk analysis.

Responsibilities of Pharmacovigilance – Establishment and maintenance of all suspected adverse reaction which are reported to the personnel of marketing authority holder and then collected and correlated to accessible at least one point. Eg ADR, PSUR, Post authorization study report.

Methods – methods for managing reports to come to a conclusion –

(1) Passive surveillance – by analyzing spontaneous reports and case series.

(2)  Active surveillance – Sentinel Sites, Drug event monitoring, registries.

(3) Comparative observational studies – Cross section study, Case control study.

(4) Descriptive studies – Natural history of disease, Drug utilization study.

Pharmacovigilance in US –

Branches – (a) FDA

                     (b)Pharma Manufactures

                     (c) Academic/ nonprofit organization eg RADAR.

In AUSTRALIA – Therapeutic good Administration (TGA) control by 5 main process–

1) Pre market evaluation and approval of registered products intended for supply.

2) Development, maintenance, monitoring of system.

3) Licensing of GMP.

4) Post marketing monitoring through sampling and adverse event reporting.

In INDIA – National Pharmacovigilance advisory committee (NPAC)

Aim of NPAC – Monitoring adverse drug reaction on nationwide basis.

– ADR database analysis and report submit to international drug monitoring program for international collaboration on drug safety.

– Review PSUR submitted by pharmaceutical companies.

-PSUR expected to be submitted every 6 month for at least 2 years of marketing in india and annually for subsequently 2 years.

– maintain contact with international bodies in pharmacovigilance and exchange information on drug safety.

-base on data advisory committee to make label amendments, product withdrawl and suspension.

– provide information to end user through adverse drug reaction, drug alert, seminars.


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