This document discusses pharmacovigilance and adverse drug reactions. It defines pharmacovigilance as monitoring drug safety and adverse effects to identify hazards and prevent harm. Adverse drug reactions are unintended drug effects, while side effects are related to a drug's pharmacological properties. Reporting adverse reactions is important to minimize harm and economic costs. Healthcare workers should report all suspected adverse reactions using the national guidelines and tools, including a yellow form to document patient details and reaction severity. Online reporting is also available.

1. PHARMACOVIGILANCE
ENSURING SAFE USE OF
MEDICINES
By Dr. Maore Norah
30/4/2019

2. Objectives
By the end of this session participants will
be able to
–Define pharmacovigilance, adverse drug
reactions, and side effects
–Explain the rationale for Pharmacovigilance
–Discuss the roles and responsibilities of
health care workers in pharmacovigilance
–Discuss the tools for reporting in
pharmacovigilance

3. Embakasi East:Dr.Maore N
What do you see here? When did this happen first?

4. Defination of
Pharmacovigilance…
Pharmacovigilance is the science of collecting,
monitoring, researching, assessing and
evaluating information from healthcare
providers and patients on the adverse effects of
medicines, biological products, herbals and
traditional medicines, with the view to:
· Identifying new information about hazards, and
· Preventing harm to patients.”

5. Whats an Adverse drug reaction?
A response to a medicine which is noxious and unintended, and
which occurs at doses normally used in humans for the prophylaxis,
diagnosis or therapy of disease, or for the modification of
physiological function1.

6. What is a side effect…
– Any unintended effect of a pharmaceutical product occurring
at doses normally used in humans, which is related to the
pharmacological properties of the medicine

7. Ethambutol
– Side Effects
Headache, loss of appetite, upset stomach, or nausea/vomiting may
occur.
– ADR
Vision changes (such as blurred/decreased vision, color blindness), liver
disease (such as persistent nausea/vomiting, unusual
tiredness/weakness, severe stomach/abdominal pain, yellowing
eyes/skin, dark urine), numbness/tingling of arms/legs, toe/joint pain.

8. Why pharmacovigilance?
– To minimize harm
‘Drugs are double-edged weapons’
– do good
– do harm
– To control economic impact
….Adverse reactions are a cost of modern medical therapy…..
Goodman and Gilman, 1995

9. – Comparative safety of dolutegravir-based or efavirenz-based
antiretroviral treatment started during pregnancy in Botswana: an
observational study
Rebecca Zash, MD et al….
Findings
– Our analysis included 1729 pregnant women who initiated dolutegravir-
based ART and 4593 who initiated efavirenz-based ART. The risk for any
adverse birth outcome among women on dolutegravir versus efavirenz
was similar
– Conclusion : its safe to use DTG in PG…….Is This true for our population?
– DTG ADR to watch out for is (hypersensitivity and

11. Role of Clinician, Nurse,
laboratory and pharmaceutical
personnel…..
– prescribe the safest medicine among those of similar efficacy
– explain to the patient the nature, purpose and risks associated with the
treatment
– Collect important ADR related information that a patient may not reveal
to a doctor
– Inform clinicians of concerns in a patient’s vital signs and laboratory
reports
– Review of treatment charts and medication counseling to alert patients of
potential ADRs
– Report all suspected ADRs

12. National Pharmacovigilance
Guidelines and Tools

13. Guidelines for the National
Pharmacovigilance System in Kenya
Embakasi East:Dr.Maore N

14. Tools..
– Yellow form (PV 1) – Form for reporting suspected
adverse drug reactions
– White card (PV 4)-Alert card
– Pink form (PV 6)- Form for reporting poor quality
medicinal products

15. Embakasi East:Dr.Maore N
Identifiable patient
Identifiable reaction
Identifiable drug
Identifiable reporter

16. More space to fill in more
information and list more
drugs
Severity assessment
scale
Causality assessment
scale
Embakasi East:Dr.Maore N

17. Alert card
(front side)
Embakasi East:Dr.Maore N

18. Alert card
(back side)
Embakasi East:Dr.Maore N

19. PV 6 (PINK FORM)
FORM FOR
REPORTING POOR
QUALITY
MEDICINAL
PRODUCTS

21. • Demonstrate on online reporting ………
• The Kenya Pharmacovigilance Electronic
Reporting System (PV ERS)-
www.pv.pharmacyboardkenya.org
Module 5 Unit 3

22. Module 5 Unit 3

23. Module 5 Unit 3

24. Module 5 Unit 3

25. THANK YOU
“You need not be certain…
Just be suspicious”
Report all SUSPECTED
adverse drug reactions
Emabakasi East:Dr.Maore N