105th CCK Forum

1. Post Marketing
in Pharmaceuticals (Part - 1)
Obaid Ali & Roohi B. Obaid
105-CCK Forum at Regent Plaza, Karachi, 08 March 2020
Surveillance VigilanceVariations

3. 08 March 2020

4. Pharmacovigilance

5. Ability to see across

6. Ability to see across

7. Ability to see across

9. Behavior & mood
related changes
Approved for Asthma
Popular Drug
1998
2020

10. Behavior & mood
related changes
Approved for Asthma
Popular Drug
1998
2020
Suicide

11. Behavior & mood
related changes
Approved for Asthma
Popular Drug
1998
2020
Suicidal ThoughtsMontelukast

12. A widely used class of Antibiotics
Fluoroquinolones
Ciprofloxacin, Ofloxacin,
Moxifloxacin, Norfloxacin,
Levofloxacin etc.

13. Fluoroquinolones
July 2008
Tendinitis &
Tendon
Rupture
Aug 2013
Peripheral
Neuropathy
May 2016
Restricted
use for
certain
uncomplicat
ed infections
July 2016
Disabling
side effects
of tendons,
muscles,
joints,
nerves &
CNS
July 2018
Decrease in
blood sugar
& certain
mental
health side
effects

14. 09 per 100,000
300 per 100,000
Aortic
Aneurysm
Dec 2018

17. I've been on Wellbutrin for
several years and things were
fine and dandy, but once I was
switched I started
experiencing headaches,
anxiety, depression and
sleeplessness',
People who had never
been suicidal were all of a
sudden reporting suicidal
thoughts.
Which drug we
are talking
about?
2012

22. Omeprazole
Lansoprazole
Pantoprazole

25. Surveillance

26. • Mix up
• Child resistant caps
• Less quantity
• Wrong label
• Discoloration
• Chipping
• Broken edges
• Empty pockets in blister
• Sticking
• Material release from within the tablet
etc.
Quality Issues: Tablets

27. • Caps locking problem
• Disintegration
• Dissolution
• Uniformity of weight
• Content uniformity
Quality Issues: Capsules

28. • Particles
• Metal flakes
• Glass pieces
• Microbial growth
• Fibers
• Fungi growth
• pH problem
Quality Issues: Injectables

29. • Microbial Growth
• Crystallization
• Less volume
Quality Issues: Syrups

30. • Caking
• Microbial growth
• Dissolution
• pH disturbed
Quality Issues: Suspensions

31. • Phase separation
• Microbial growth
• Moldy smell
• Leakage from container
Quality Issues:
Creams/Ointments

32. • Label color
• Shape of secondary packaging
Quality Issues: Cosmetic

33. Complaints, GMP Violations,
Published Studies, Returned or
Recalled Goods, Potent Products,
First Generics
4000 drugs in
10 years
1.1%
found deviated

34. Thanks