Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. a presentation in CME activities by Saad Specialist Hospital, KSA

1. BY: Ahmed Nouri
Clinical Pharmacist, internal medicine and cardiology
Pharmacovigilance

2. Outlines
What is Pharmacovigilance?
Drug Related Problems and ADRs
Why do we need Pharmacovigilance?
The concept of Pharmacovigilance system
Pharmacovigilance in KSA

3. What is Pharmacovigilance?
Pharmakon (Greek) – Medicine
Vigilare (Latin) – To keep watch
The science and activities relating to the detection, assessment, and
prevention of adverse drug reactions and other drug related
problems in humans
a type of continual monitoring of unwanted effects and safety
related to drugs post marketing.
The Importance of Pharmacovigilance, World Health Organization 2002

4. Aims of Pharmacovigilance
• Improve patient safety in relation to medications use.
• Encouraging the safe, rational and cost-effective use of drugs
• Detection of drug related problems at early stages.
• Promotion of understanding and education toward drug safety.

5. Pharmacovigilance
Safety
Drug Related
Problems

6. Drug Related Problems
• An event or circumstance involving drug therapy that
actually or potentially interferes with desired health
outcomes.
• In 1990, classified the DTPs into different categories
according to:
indication, effectiveness, safety, compliance.
Introduction to Health Care Delivery: A Primer for Pharmacists Strand et al1990

7. Drug Related Problems
1. Abuse/Misuse of medications
A. Unnecessary drug therapy.
Patient taking unneeded medications for his condition.
B. Wrong drug.
Patient taking medication that does not treat the patient's condition.
C. Additional drug therapy needed.
Patient needs more medication to treat his condition
D. Dosing
Sub-therapeutic dose , over-dose , dosage adjustment

8. Drug Related Problems cont.
2. Inappropriate adherence or compliance.
3. Medication Errors
Manufacturing or compounding, prescribing, transcribing,
dispensing, or drug administration.
4. Lack of efficacy
5. Adverse reactions.

9. ADR vs AE vs SE
• Adverse event
Harmful and undesirable effect to patients with no
direct causal relationship which may be related to
medications (by medication error, incorrect dosing or
an allergic reaction) or may result from other
interventions such as surgery or procedure.

10. ADR vs AE vs SE
• Adverse drug reaction
Any noxious and un-intended unexpected response to a
drug occurring with a direct causal relationship
between the event and the drug.

11. ADR vs AE vs SE
• Side effect
Imprecise term usually used to describe drug’s
unintended and expected effects within the
therapeutic range related to the pharmacological
properties.
e.g. antihistamines producing sedation

12. Side Effect Adverse Effect
can be both therapeutic or harmful. Harmful and undesirable.
Expected usually Not expected.
Do NOT hinder the main effect of the
drug.
can hinder the treatment and lead to
more complications
mild and self-resolving more severe and life threatening

13. CLASSIFICATION OF ADRS
(RAWLIN AND THOMPSON CLASSIFICATION)
Type A Augmented
Dose related – expected pharmacological effects
e.g. respiratory depression with opioids and bleeding with warfarin
Type B Bizarre
Non dose related – more serious – non expected
e.g. anaphylaxis with beta-lactam antibiotics
Type C Continuing
Dose and time related – related to cumulative drug use
e.g. osteonecrosis of the jaw with bisphosphonates
Type D Delayed
After the use of a medicine
e.g. Teratogenicity
Type E End of use
Due to withdrawal
e.g. Addisonian crisi after steroid withdrawal
Type F Failure Failure of therapy

14. Adverse Events
Medications Errors
Adverse drug reactions
Medication errors
that cause events
that are not ADRs
Medication errors
that do not cause
adverse events
ADRs from
medication
Errors

15. Why do we need
Pharmacovigilance?

16. Historical Background: Thalidomide Disaster
• 1956, Thalidomide was launched to the market.
• Prevention of nausea in pregnancy, hypnotic, morning
sickness
• 1960, Reports of fetal abnormalities (>20,000 cases )
ᴥ Severe birth defects in children of women who had been
prescribed this medicine during pregnancy. Phocomelia.

17. Phocomelia

18. Results of the tragedy
Change in drug regulations
• The disaster made many countries to introduce tougher rules
for the testing and licensing of drugs
• By 1965, thalidomide had been removed from the market.

19. 1. Insufficient safety evidence from clinical trials

20. 2. Protect patients from avoidable harm
• Studies found that of all ADRs, 70% are preventable
• Patients experienced ADRs (19%)
(59%) were avoidable

21. 3. To reduce healthcare expenses
• Costs related to the ADRs exceeded the cost of the medications
themselves in some countries.
• Patients with ADRs were hospitalized for an average 8 – 12 days longer
than other patients.
• Permanent disability may occur in 9.7% of patients with ADRs.
• Cost due to ADRs in EU: € 79 billions/year
Ref: Press Release from Brussels, 10 Dec 2008.

22. The Concept of
Pharmacovigilance
System

23. 1. Detection
• New drugs: report ALL suspected reactions including minor ones
• Well known drugs: report all serious, unexpected, unusual reactions.
• ADRs with generics that are not experienced with innovator products
• All suspected drug-drug, drug-food interactions
• ADRs associated with drug withdrawals
• ADRs due to medication errors
• ADRs due to lack of efficacy

24. 2. Reporting
Patients
Healthcare
Professionals
Pharmaceutical
industries
Regulatory
Authorities (SFDA)

25. 2. Reporting
A. Small scale
• any suspected ADR, DTP shall be reported.
• ADR reporting form (SSH-2056) in Saad Specialist Hospital
B. Large scale
Pharmaceutical companies play an important role in
gathering ADR reports on their own products.

26. 3. Investigations
• Proper History is required
• Establishing time relationship : Some response are quick /
delayed.
• Thorough physical examination with appropriate laboratory
investigations.
• Search literature for medicine suspected causing the ADR

27. 4. Actions
• Setting guidelines
• Package inserts
• Warnings
• Drug withdrawal from market

28. Drug withdrawal from market
Drug Year Reason
Lumiracoxib 2008 Hepatotoxicity
Aprotinin 2008 Kidney and cardiovascular toxicity
Tegaserod 2007 Cardiovascular ischemic events
Ximelagatran 2006 Hepatotoxicity
Valdecoxib 2005 Dermatology adverse events
Pemoline 2005 Hepatotoxicity
Rofecoxib 2004 Thrombotic cardiovascular events
Levomethadyl 2003 Fatal Arrhytmia
Rapacuronium 2001 Risk of fatal bronchospasm
Cerivastatin 2001 Rhabdomyolosis
Trovafloxacin 2001 Hepatotoxicity
Amineptine 2000 Hepatotoxicity, dermatological side effects, abuse potential
Cisapride 2000 Cardiac arrhythmias
Troglitazone 2000 Hepatotoxicity

29. Regulatory Authorities

30. WHO program for international
drug monitoring
• 1968, after the thalidomide disaster, the WHO set up its
International Drug Monitoring Program
• 1978 , Uppsala Monitoring Centre (UMC) in Sweden responsible
for the collection of data about ADRs from around the world
• Members submit reports of adverse reactions associated
with medicinal products to the WHO global database,
VigiBase

31. 124 countries have joined the WHO Program for International Drug Monitoring
(May 2016)

32. Yellow card scheme
• The main ADR reporting scheme in the UK collecting information on
suspected adverse drug reactions (ADRs).
• Introduced in 1964 after the thalidomide tragedy.
• It receives more than 20,000 reports of possible side effects
each year.
• In July 2015 a Yellow Card smartphone app was launched
for iOS and Android, allowing patients and healthcare workers to
report adverse reactions to medications.

33. Sentinel Initiative
• In May 2008, the U.S. Department of Health and Human
Services (HHS) and the U.S. Food and Drug Administration
(FDA) announced the launch of FDA’s Sentinel Initiative.
• A long-term program designed to build and implement a
national electronic system for monitoring the safety of FDA-
approved drugs and other medical products.

34. Pharmacovigilance
in KSA

35. Saudi Vigilance
• Saudi Food & Drug Authority (SFDA) established National
Pharmacoviglance Center (NPC)
• (NPC) was announced to be functioning in March 2009.
• Contribute in protection of public health by:
- Monitoring of the safety and quality of medicines
- Ensure healthcare professionals and patients have access
to up to date safety information about medicines

36. UMC membership

38. Reports facts
Total number of
reports received
1296 100%
ADRs 1126 87%
Herbals 17 1%
Cosmetics 14 1%
Medication Errors 39 3%
Product Quality 100 8%
Saudi Vigilance, 2014

39. • “Dying from a disease is sometimes unavoidable;
dying from a medicine is unacceptable.”
Lepakhin V. Geneva 2005
• “First, Do no harm” Hippocrates (460 –377 B.C.)
• PV improves patient care and drug safety.
• If you suspect an ADR..
Do not assume someone else will report it!
unacceptable

40. Thank You ..
Questions?
Ahmed Nouri