Module II

The Pharmacovigilance
System in Ghana
 Overview
• Legal basis of PV in Ghana
• Spontaneous Adverse Drug Reaction
and reporting AEFI Surveillance
system in Ghana
• Pharmacovigilance in Public Health
Programs (PHPs)
– Stakeholders in PHPs
•
Legal basis of PV in Ghana
Legal Basis for Pharmacovigilance

• Public Health Act, 2012 Act 851

–FDA’s mandates
•Part 6 :Tobacco Control;
•Part 7 :Food and Drugs;
•Part 8 :Clinical Trials
 Legal Basis for Pharmacovigilance
• Part 7, Public Health Act, 2012, Act 851
• Section 125 – Safety Monitoring (PV)
• Mandatory reporting by the Marketing Authorization
Holder (MAH)
• Subsection (2): the local representative
─ (a) shall monitor the safety of the product
granted marketing approval, and
─ (b) shall report an adverse effect or event to
the Authority during the period under which
the product is registered.
 Legal Basis for Pharmacovigilance
• Responsibility on the FDA
• Subsection (3): The Authority shall continually
monitor the safety of the products under this
Act by analysis of the “AE” reports and by any
other means and take appropriate regulatory
action when necessary.
 Legal Basis for Pharmacovigilance
• Section 142 – Penalties
─ (a) first offence, a fine of not less than ‘1000’ penalty units or to
a term of imprisonment not less than ‘6’ months, or to both
─ (b) subsequent offence to a fine of not less than ‘500’ penalty
units or to a term of imprisonment not less than ‘2’ years, or to
both
• Section 148 – Guidelines & Codes of Practice
1. Guidelines for Reporting Adverse Drug Reactions
2. Guidelines for Qualified Person for Pharmacovigilance (QPPV)
3. Guidelines for Safety Monitoring of Medicinal Products
4. Guideline for Conducting Pharmacovigilance Inspections
5. Guidelines for Surveillance of Adverse Events Following
Immunization in Ghana (in collaboration with the Expanded
Programme on Immunization)
The ADR and AEFI Monitoring System

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 Spontaneous ADR Reporting System
▪ Stakeholders
• FDA
– Continually monitor the safety of the products regulated
– Analyze adverse reactions reports submitted and take appropriate
regulatory actions
– Establish a Technical Advisory Committee (TAC) on Safety of Medicines
to;
– carry out causality assessment of adverse drug reaction reports
received
– recommend ways of improving the safety monitoring system in Ghana

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• Marketing Authorization Holder (MAH)
– Put in place pharmacovigilance measures to actively monitor the
safety of the products in clinical practice
– Nominate Qualified Persons for Pharmacovigilance (QPPV)
– Report adverse reaction reports to the FDA
 Spontaneous ADR Reporting System
▪ Stakeholders
• Healthcare Professionals
– Diagnose, manage and report all adverse
reactions
– Counsel patients on rational use of
medicines
– Serve as Institutional Contact Persons
(ICPs) within the Institutions
• Patients
– Inform health workers about medicines being used
– Copy with medicines and report all adverse reactions
directly or through the healthcare provider
 PATIENTS/GENERA
L PUBLIC

PRIMARY REPORTERS
•Doctors, Pharmacist, Nurses,
etc

ICPs RPOs

TECHNICAL ADVISORY SMD of FDA

COMMIITTEE

FDA SAFETY WHO DATABASE

DATABASE (SWS)

•ICPs-Institutional Contact Person

•RPOs-Regional PV Officers
•SWS-SafetyWatch System
•SMD-Safety Monitoring Department

SIGNAL GENERATION POSSIBLE

REGULATORY ACTION 13
AEFI Monitoring System
 AEFI Monitoring System
• Two systems for vaccine safety monitoring
Systems established in collaboration with
Expanded Programme on Immunization (EPI)
•Passive or Stimulated Passive AEFI
Monitoring System
•Active Monitoring System

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 Passive & Stimulated Passive Reporting
• Vaccinators and health care professionals are:
─ sensitized on the need to report
─ Informed to encourage mothers and caregivers to report any
observations after vaccination
─ Trained on how to complete AEFI forms (training of trainers)
• Reporting pathway is through the National EPI/GHS reporting pathway to
the National PV Centre (FDA)
• The Technical Advisory Committee (TAC) for Safety of Vaccines and
Biological products performs causality assessment (currently using the new
WHO Guidelines for Causality Assessment of AEFIs)
• Feedback on assessment to stakeholders
 Active Monitoring
• Special Monitoring System set up involving all stakeholders
• Vaccine- specific AEFI reporting forms
• Vaccine -specific training for health workers
• Resources are provided to focal persons to facilitate follow up
of vaccinees
• TAC/NEC meetings are scheduled pre, during and post (if
campaign mode)
• Specific end of monitoring reports written and shared with
stakeholders
 AEFI Monitoring Strategies
For all established vaccines
Immunization e.g. those used in the
campaigns/ Expanded Programme on
Newly introduced Immunization (EPI)
vaccines

During National
Immunization
Days (NIDs)

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Passive AEFI Surveillance System
Active AEFI Surveillance System
Reporting Adverse Drug Reactions &
Adverse Events Following
Immunization

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 How to Report ADRs & AEFIs
• Healthcare Professionals
─ Adverse Reaction Reporting Form
─ AEFI Reporting Form
─ Online Reporting System
• Patients
─ Blueform
─ Online Reporting System
─ Short code 4015
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 Provide Minimum Information

– Patient Details – Product Details

– Reaction Details • Product name
•Description of the • Dosage
reaction • Batch no.
•Outcome of the • Dose no.
reaction – Reporter Details
• Contact

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 [Link]@[Link].g
h

[Link]
AEFI REPORTING FORM

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Online Reporting
Online Reporting: Healthcare Professionals
 Online Reporting: Patient/Consumer
Patient / General Public Click here
 What to report
• All suspected reactions known or not that causes concern in
the patient and related to regulated products
– Drugs (allopathic/ herbals)
– Vaccines
– Cosmetics
– Household chemicals
– Blood and blood products
• Lack of efficacy/therapeutic failure
• Suspected defect
• Medication Error
• Suspected counterfeit
Examples of reportable events
Suspected counterfeits
Similar-looking labeling
Substandard & Pharmaceutical Defects
Substandard & Pharmaceutical Defects
 Known Serious ADRs:-Stevens-Johnsons syndrome
-Co-tirmoxazole

ARROW KOFI ANINI DR. [Link] 37

ADRs to Herbal Medicines
 When to Report
ADR AEFI

• Expedited Reporting • All AEFIs are to be reported

– All Serious Adverse Drug immediately to the next level
Reactions (including suspected when the reporter gets to
product quality issues) know of the event.
– within 7days • Serious AEFIs should receive
• All other Adverse Drug Reaction immediate attention and
should be reported within 28 reported within 24 hours
days.
Pharmacovigilance in Public
Health Programmes (PHPs)
 Public Health
•Science and art of preventing disease, prolonging
life and promoting health and efficiency through
organized community efforts.
•Charateristics of PHPs
─Prophylaxis : Vaccination, Seasonal Malaria
Chemoprevention (SMC)
─Treatment: ACTs for malaria, ARVs for HIV/AIDs
─Eradication: lymphatic filariasis, Leprosy
 PV and PHPs
Complementary functions for a common goal

PHPs PV
Reducing morbidity and Evaluating drug
mortality effectiveness and
safety

Improve patient and

communities health
and wellbeing
 Need to Monitor Products in PHPs
• Reduce harm and improve
effectiveness
• Improve acceptance and tolerance
• Detect effect on special populations
(e.g. Pregnant women and children)
• Identify possible therapeutic
failures (resistance, quality defects,
counterfeits)
• Identify misuse and abuse
Above all we want to be on top of things……
 The Role of PV in PHPs
• To detect, evaluate and prevent ADRs/AEFIs
related to
– Harm; Acceptance and tolerance; Misuse; Dependence;
Effect on pregnancy and children; Therapeutic failures
• Promote rational use of drugs in mass
treatment programmes (e.g. deworming
exercise, vaccination)
• Evaluate the impact of the programmes
• Improve acceptability of the programme
– Ensuring public confidence
 Existing Collaboration with PHPs
• Collaboration with EPI
– New Vaccines Campaign
– Gardasil Demonstration

• Effective Collaboration with the NMCP

– Cohort Event Monitoring of Antimalarials
• ACTs (Koforidua Regional Hospital)
• SP for IPTp (Police Hospital)

• PV sensitization for Yaws Eradication Programme, National

TB Control Programme, Expanded Programme on
Immunization

• Pharmacovigilance presentation to managers of all PHPs

during annual review meeting

• Cohort Event Monitoring of ARVs at four ART sites

Reports Received and Actions Taken
ADR Reports Received since 2005

Total reports = 2891

Feedback
 NPvC Contact Details
• Website: [Link]
• E-mail address: [Link]@[Link]
• Telephone numbers
– Landline: 0302 233200, 0302 235100
– Mobile: 0244 310297

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 THANK
YOU

Pharmacovigilance important
in every country!
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