PHARMACOVIGILANCE

• Aduroja Gideon
• Olabode Olakunle
• Taiwo Kolawole
OUTLINE

• A walk through history : Pharmacovigilance a necessity

• Introduction
• Importance of pharmacovigilance
• Who is involved?
• Regulatory Bodies
• Challenges and Shortcomings
• Conclusion
A WALK THROUGH HISTORY:
PHARMACOVIGILANCE A NECESSITY
A WALK THROUGH HISTORY:
PHARMACOVIGILANCE A NECESSITY

• The thalidomide crisis of the 1960s. This tragedy, in which thousands of babies

were born with congenital disabilities after their mothers took the drug
thalidomide during pregnancy, brought the issue of drug safety to the forefront
and led to the creation of regulatory systems for ensuring the safety of medicines

• First noted by Dr. McBride, an Australian doctor

DR MCBRIDE WROTE TO THE EDITOR OF THE
LANCET JOURNAL IN 1961
• The Vioxx scandal. Another tragic event that relates to
pharmacovigilance is the case of the anti-inflammatory drug Vioxx
(Rofecoxib). In 2004, a study showed an increased risk of heart
attack and stroke in patients taking the drug leading to the drug’s
withdrawal from the market. It was later estimated that the drug had
caused more than 27,000 heart attacks and sudden cardiac
deaths.
INTRODUCTION
INTRODUCTION

• What is pharmacovigilance”?
INTRODUCTION

Pharmacovigilance is the process of monitoring the safety of medicines

after they have been approved for use, including detecting, assessing,
understanding, and preventing adverse effects or any other drug-related
problems.
It is an ongoing process that involves collecting, analyzing, and
disseminating information about the safety of medicines, aiming to
improve patient care and public health
INTRODUCTION

• The main goal of pharmacovigilance is to promote the safe and effective

use of health products, in particular by providing timely information about
the safety of health products to patients, health-care professionals, and the
public

• It corresponds to Phase IV of drug development and occurs after a drug

has been approved for marketing
SALIENT FEATURES AND IMPORTANCE OF
PHARMACOVIGILANCE
• Phases of drug development : An overview
AN OVERVIEW OF DRUG DEVELOPMENT
IMPORTANCE OF PHARMACOVIGILANCE

• Although previous phases of drug development and clinical

trials have been concerned about safety of drugs in humans,
low-incidence drug effects, however, are not generally detected
before phase 4 no matter how carefully the studies are executed
• Pharmacovigilance is not redundant!!!
SALIENT FEATURES AND IMPORTANCE OF
PHARMACOVIGILANCE

Peculiarities of Pharmacovigilance/Post-marketing Surveillance include:

Many important drug-induced effects have an incidence of 1 in 10,000 or
less; thus are only observed when marketing have begun in the larger
population
Some adverse effects may become apparent only after long term dosage
e.g. certain uncommon/ idiosyncratic Adverse effects
SALIENT FEATURES AND IMPORTANCE OF
PHARMACOVIGILANCE

• Pharmacovigilance allows for special subpopulations (e.g.,

pregnant women, children, older people) that may not have
featured in the previous phases of drug development to be
observed.
• It occurs for a longer duration of time than other phases of drug
development
SALIENT FEATURES AND IMPORTANCE OF
PHARMACOVIGILANCE

It has no fixed duration. As such, many drugs continue their

develop­ment even after marketing
SALIENT FEATURES AND IMPORTANCE OF
PHARMACOVIGILANCE
•Pharmacovigilance never ends!!!
INVOLVED PERSONS AND REGULATORY BODIES

 Key stakeholders involved in pharmacovigilance include patients,

healthcare professionals, governments and pharmaceutical companies
 Among these stakeholders, healthcare professionals play the most
significant role
 Pharmacovigilance is a multidisciplinary approach that includes the
collaboration of multiple disciplines such as clinicians, pharmacists, nurses
and dentists
REGULATORY BODIES

• Regulatory authorities collect and maintain databases of adverse event reports and
analyse them systematically for new safety signals.
• Examples include:
• International regulatory bodies
 WHO- In response to the thalidomide disaster in 1961, the WHO initiated the
Programme for International Drug Monitoring (PIDM) and has an active WHO
Collaborating Centre for International Drug Monitoring (Uppsala Monitoring
Centre, Sweden), which promotes pharmacovigilance at the country level
REGULATORY BODIES

•  Eudravigilance- Founded In 2001. It Is The Official European Database For Managing

And Analyzing Information On Suspected Adverse Reactions To Medicines Which
Have Been Authorized For The Market Or Being Studied In European Clinical Trials
• US-FDA- Formed On June 30, 1906, And It Established That Drugs Must Be Pure And
Free Of Any Contamination.
• The FDA has Periodic Report Safety Reporting Requirements which includes a
Periodic Adverse Experience Report (PADER). This should be submitted quarterly for
the first three years after the US approval date and annually thereafter.
REGULATORY BODIES IN NIGERIA

• In Nigeria, Pharmacovigilance activities in Nigeria are coordinated by the National

Pharmacovigilance Centre (NPC) situated in the National Agency for Food and Drug
Administration and Control (NAFDAC—the drug regulatory agency in Nigeria
• Headed by Adeline Osakwe
ROLE OF NATIONAL PHARMACOVIGILANCE
CENTRE
• Serves as a repository for reporting Adverse drug reactions
• Liaises with other international groups such WHO, US-FDA etc. in improving drug
safety in Nigeria
• Seeks to increase public participation in drug safety
CHALLENGES AND SHORTCOMINGS FACING
PHARMACOVIGILANCE IN NIGERIA
• Underreporting of Adverse Drug Reactions
• Lack of skilled/ qualified man power
• Lack of sufficient funding
• Faulty/compromised penal system failing to prosecute defaulters
LIKELY SOLUTIONS

• Training and retraining of required Manpower

• Supply of sufficient funds
• Awareness campaign
• Digitalization to facilitate reporting of Adverse drug reactions and events E.g. The Med
Safety app launched by the National Pharmacovigilance Centre
• Proper remuneration of qualified persons for pharmacovigilance
• Constitutional backing and governmental will power to prosecute offenders
CONCLUSION

• Pharmacovigilance is of great importance in ascertaining the safety of pharmaceuticals in

humans, especially in larger populations and over a long period of time
REFERENCES

• Katzung and trevor pharmacology textbook

• KD Tripathi Pharmacology textbook
• : Kingsley Akarowhe, A Case Study of Pharmacovigilance in Nigeria: Challenges and
Solutions. 2020 - 10(1). AJBSR.MS.ID.001470. DOI: 10.34297/AJBSR.2020.10.001470.
• Pharmacovigilance/Post Marketing Surveillance Newsletter VOL. 14 No.2 2021
• WHO website
• ETC.
• Thank you for listening!!!