[PRODUCT STANDARDS, MARKETING, AND SAFETY] National Policy Program on Pharmacovigilance

AO 2011-0009

National Policy Program on Pharmacovigilance is established by AO _________

pharmacovigilance

According to WHO (2006), ________ is the science and activities relating to the collection, detection, assessment, monitoring, understanding, and prevention of adverse effects or any other possible drug-related problems.

WHO (2006)

According to _________, pharmacovigilance is the science and activities relating to the collection, detection, assessment, monitoring, understanding, and prevention of adverse effects or any other possible drug-related problems.

● All pharmaceutical substances, including those used in clinical trials

● Tool for pre-marketing and post-marketing surveillance of ADE/ADR

● Ensures safety of pharmaceutical and related health products

Pharmacovigilance is the science and activities relating to the collection, detection, assessment, monitoring, understanding, and prevention of adverse effects or any other possible drug-related problems.

This includes:

Adverse Event (AE)

[ADVERSE EVENT VS ADVERSE DRUG REACTION]

Any untoward medical occurrence during drug use without causal relationship

Adverse Drug Event (ADE)

[ADVERSE EVENT VS ADVERSE DRUG REACTION]

Any untoward occurrence during treatment, may or may not be related

Adverse Drug Reaction (ADR)

[ADVERSE EVENT VS ADVERSE DRUG REACTION]

Noxious, unintended response at normal doses for prophylaxis, diagnosis, therapy

National Pharmacovigilance Program (NPVP)

[PHARMACOVIGILANCE]

Integral part of FDA pre-marketing and post-marketing surveillance

National Pharmacovigilance Center (NPVC)

[PHARMACOVIGILANCE UNITS]

This serves as the PRIMARY pharmacovigilance unit of the country.

National Pharmacovigilance Center (NPVC)

[PHARMACOVIGILANCE UNITS]

This coordinates the regional PV units.

National Pharmacovigilance Center (NPVC)

[PHARMACOVIGILANCE UNITS]

This functions as the IMPLEMENTING AUTHORITY of the National Pharmacovigilance Program (NPVP).

Regional Pharmacovigilance Units (RPVu)

[PHARMACOVIGILANCE UNITS]

These serve as SECONDARY pharmacovigilance units under the NPVC.

Regional Pharmacovigilance Units (RPVu)

[PHARMACOVIGILANCE UNITS]

These are usually located in large hospitals or medical colleges.

large hospitals or medical colleges

[PHARMACOVIGILANCE UNITS]

Regional Pharmacovigilance Units (RPVu) are usually located in________

Regional Pharmacovigilance Units (RPVu)

[PHARMACOVIGILANCE UNITS]

These function as DATA COLLECTION UNITS.

Peripheral Pharmacovigilance Units (PhPVu)

[PHARMACOVIGILANCE UNITS]

These operate at the FACILITY level, such as clinics, pharmacies, hospitals, and private practitioners.

Peripheral Pharmacovigilance Units (PhPVu)

[PHARMACOVIGILANCE UNITS]

These function as FRONTLINE DATA COLLECTION UNITS.

● ADR case reports

● Health advisories and warnings to healthcare professionals and the public

● Drug-drug incompatibilities (e.g., in ICU settings)

● Therapeutic inefficacy

● Defective medical devices

● Misoprostol used as an abortifacient

● Trans-mammary exposure via breast milk

● Off-label drug use

● Drug overdose

● Drug abuse and misuse

[PHILIPPINE PHARMACOVIGILANCE SYSTEM]

Focus Areas