ENSURING MEDICINESAFETY AND QUALITY–CASE STUDY FROMNIGERIA

Adeline OsakweHead NPC NAFDAC Nigeria

PHARMACOVIGILANCE FRAMEWORK, TOOLS AND GUIDELINES IN USE INNIGERIA

Nigerian National Pharmacovigilance Policy & Implementation

Frame Work

Abuja Sept. 2010

CONTENTS

• Regulatory Framework for pharmacovigilance system in Nigeria

• System structure and stakeholder coordination • Tools for post marketing safety and quality surveillance

• Information sharing on safety issues • Highlight of some regulatory actions taken as a result of pharmacovigilance activities.

REGULATORY FRAMEWORK FORPHARMACOVIGILANCE SYSTEM IN NIGERIA

Pharmacovigilance & NAFDAC Mandate:• The National Agency for Food and Drug Administration and Control

(NAFDAC) was established by Decree 15 of 1993 (as amended) now citedas Act Cap N1 laws of the Federal Republic of Nigeria 2004.

This mandate requires NAFDAC to ensure the quality, SAFETY and efficacy ofthe above named regulated products, hence, PHARMACOVIGILANCE

• National Medicines Policy (2005)

• Good Pharmacovigilance Practice Regulation (Draft)• Pharmacovigilance Policy (2010 Yet to be operationalized)

SYSTEM STRUCTURE AND STAKEHOLDER COORDINATION

National Pharmacovigilance

Centre(NPC)

National Pharmacovigilance

Centre(NPC)

Pharmacovigilance in Health Institutions

(DTC) 

Pharmacovigilance in Health Institutions

(DTC) 

Other Pockets of Pharmacovigilance

Activities

Other Pockets of Pharmacovigilance

Activities

Pharmacovigilance in Public Health Programs(PHP)

Pharmacovigilance in Public Health Programs(PHP)

ZonalPharmacovigilance

Centres (6)

ZonalPharmacovigilance

Centres (6)

National Drug Safety Advisory 

Committee(NDSAC)

National Drug Safety Advisory 

Committee(NDSAC)

Pharmacovigilance /Food & Drug Information 

Centre(PVG/FDIC)

Pharmacovigilance /Food & Drug Information 

Centre(PVG/FDIC)

PHARMACOVIGILANCE ACTIVITIES

• Awareness Creation/Advocacy Stakeholder’s Forum NCSC‐ Public Enlightenment & Sensitization Platform Use of IEC Materials

• Capacity Building of Healthcare Providers/MAH

• Surveillance of  Medicines• Signal Generation & Data Mgt

TOOLS FOR POST MARKETING SAFETY ANDQUALITY SURVEILLANCE

• Safety of Medicines in Nigeria‐ A Guide for Reporting and Detecting Adverse Drug Reaction

• Guide for Reporting ADRs to Marketed Drugs

• ICSR Form• Paper Based• Online Download

• SMS Short Code• Designed for Consumer Alert on Medicine Related Problems

INFORMATION SHARING ON SAFETY ISSUES

• Pharmacovigilnce/FDIC Newsletter• Public Alert Notice

• Print Media & Electronic Media

• Agency Sponsored Regular TV Programme• Feedback on Quality & Safety Issues

• Dear Healthcare Provider Letter

Drug Reason for Action Source Regulatory Action Taken Year Action Taken

ISOTAB® 20MG (ISOSORBIDE MONONITRATE)

Contamination of Product SRA {WHO} Targeted Alert Notice to HCP. Alert posted on Agency’s website and NPC’s newsletter

2012

Rosiglitazone Risk of congestive heart failure SRA {US FDA , EMA}

NRA Directed MAH to voluntarily withdrawproduct from circulation in Nigeria

2011

Tramadol Irrational Use & Increased Reports of ADRs

NPC database & Reports from Health Institutions

Reclassification of Drug From POM to Controlled Drug 

2012

Prevenar 13  AEFI reports of death from Prevenar 7 and insufficient evidence of efficacy and safety of Prevenar 13 in Nigeria

Japan RA Company directed to carry out phase IV study to ascertain safety and efficacy in the  reduction of the pneumococcal strains that are prevalent in Nigeria and  the compatibility of vaccine with the vaccines used in routine immunization in Nigeria.

2011

HIGHLIGHT OF SOME REGULATORY ACTIONS TAKENAS A RESULT OF PHARMACOVIGILANCE ACTIVITIES.THE NATIONAL INTELLIGENCE AGENCIES IN NIGERIA THROUGH THEIR NETWORK WORLD -WIDE SCAN FORREGULATORY ACTIONS TAKEN ON NAFDAC REGULATED PRODUCTS AND NOTIFY NAFDAC AND OTHER LOCALAGENCIES OF GOVERNMENT FOR APPROPRIATE ACTION IN THE INTEREST OF NIGERIAN CITIZENRY.THIS IS A MAJOR AND REGULAR INTERMEDIARY SOURCE OF INFORMATION FLOW OF REGULATORY ACTIONSTAKEN BY SRA AND OTHER RA GLOBALLY

HIGHLIGHT OF SOME REGULATORY ACTIONS TAKENAS RESULT OF PHARMACOVIGILANCE ACTIVITIES.

Drug Reason for Action Source Regulatory Action Taken Year Action Taken

Gentamycin280mg

Increased risk of ototoxicityand nephrotoxicity and increased risk of endotoxinreactions 

LocalResearcher

Deregistration of 280mg and mop up from circulation. Public Alert on action taken

2010

Teething Mixture

Contamination of product (My Pikin) with  diethylene glycol   resulting in death of children.Low benefit risk ratio

Local ICSR & Health facilities

Mop up of all affected batches of My Pikin & Ban of teething mixtures

2008 & 2009

CodeineContaining Cough syrups

Wide spread abuse of drug Anecdotal reports

Drug abuse campaign, reduction of quantities approved for manufacturing,

2011

Infusion Contaminated infusion localICSR & Health facility Report

Mop up of affected batches, manufacturer’s GMP re‐evaluated, Intervention in storage facility of HCI

2011

Dipyrone(Novalgin®, Analgin®) 

Toxic epidermal necrosis  Local ICSR & Health Facility Report

Banned in Nigeria  2005 

BABY RUKKAYA

2/08/2012 NAFDAC Phoecomelia Assessment

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THANK YOU, IMELA, ADUPE & NAGODE