CCK Discussion Forum on "Recall Affairs & NDMA Emergence"

1. Recall
Fundamentals, Situation
& Scenario Analysis
CCK- Forum
Sunday, Oct 6th Karachi
Lecture
1

3. It reflects the views and understanding of presenter
& may not be construed to represent the views or
policies of organization or association to which
speaker has ties
Documents of US-FDA & Review Scientific
Articles are used to construct presentation
Disclaimer
Reference

4. Recall

5. Recall
Re call

6. An effective method of removing
defective product …
It is not limited to drugs but their
promotional literature too
Recall

7. If a drug is not of correct quality as authorized in
registration documents
It will be reported …
Severity of consequences will be assessed…
Recall will be initiated
Recall

8. When it is initiated?

9. Company discover a problem
Inspector identify potential
Reports appear
Other Govt. agencies approach
Recall

10. Voluntary Recall
Non-voluntary Recall
Recall

11. Requested Recall
Ordered Recall
Govt.

12. Notification
Monitoring
Auditing
Termination
Company Acts

13. Discussion,
Request ,
Order &
Announcement
Gathering
further
information
Approach
concerned
areas
Offers
guidance
Monitor &
Termination
Government Discharges

14. Recall Strategy
Depth of Recall
Public Warning
Effectiveness of Recall

15. Recall Knock
Up to Patient level
Up to Retailer level
Up to Distributor level

16. Distributor Pharmacies Patient

17. Is classification of recall
necessary?

18. Is classification of recall
necessary?
Yes
Response time
&
Methodology
will be different for
different classes

19. An effective method of removing
defective product …
It is not limited to drugs but their
promotional literature too
Recall

20. If a drug is not of correct quality as authorized in
registration documents
It will be reported …
Severity of consequences will be assessed…
Recall will be initiated
Recall

21. If extensive unexpected ADRs emerge &
establish …
It will be reported …
Severity of consequences will be assessed…
Withdrawal or label change will be initiated
Withdrawal

22. Any new information that
emerge & may influence the
judgment of benefit risk
concluded on previously
submitted applications
Reporting Obligations

23. The risk to patient health
The extent of the quality defects in terms
of batches & market distribution
Impact on market
Root cause of defect
Immediate or long term CAPA
Assessment of Defect

24. Product pose a
serious life
threatening risk
Class 1
Immediate
Medicines & Healthcare product Regulatory Agency

25. Product pose a
serious life
threatening risk
Defect could harm
the patient but not
life threatening
Class 1 Class 2
Immediate 48 hours
Medicines & Healthcare product Regulatory Agency

26. Product pose a
serious life
threatening risk
Defect could harm
the patient but not
life threatening
Defect is unlikely
to produce harm
Class 1 Class 3Class 2
Immediate 48 hours 5 days
Medicines & Healthcare product Regulatory Agency

27. Product pose a
serious life
threatening risk
Defect could harm
the patient but not
life threatening
Defect is unlikely
to produce harm
No threat to patient
safety
Class 1 Class 4Class 3Class 2
Immediate 48 hours 5 days
Alert
advice
Medicines & Healthcare product Regulatory Agency

28. Reasonable probability to see the
serious adverse health consequences
or death
Class I Response Time
US Food and Drug Administration

29. Reasonable probability to see the
serious adverse health consequences
or death
Class I Response Time
Temporary or medically reversible
adverse health consequences
or remote probability of
serious adverse health
Class II Response Time
US Food and Drug Administration

30. Reasonable probability to see the
serious adverse health consequences
or death
Class I Response Time
Temporary or medically reversible
adverse health consequences
or remote probability of
serious adverse health
Class II Response Time
Not likely to cause adverse
health consequencesClass III Response Time
US Food and Drug Administration

31. The product involves minor
or no violation---- Withdrawal

32. Distributor Pharmacies Patient
Class
I
Class
III Class
II

33. Lets rearrange to connect

34. Label mix up on a life saving drug?
A drug that is under strength & not subject
for use to treat life threatening condition
A drug that has mistake in label in terms of
English or demographic data
A
B
C

35. A drug that is under strength & not subject
for use to treat life threatening conditionA I or II or III

36. A drug that is under strength & not subject
for use to treat life threatening conditionA I or II or III

37. Label mix up on a life saving drug?B I or II or III

38. Label mix up on a life saving drug?B I or II or III

39. A drug that has mistake in label in terms of
English or demographic dataC I or II or III

40. A drug that has mistake in label in terms of
English or demographic dataC I or II or III

41. Label mix up on a life saving drug?
A drug that is under strength & not subject
for use to treat life threatening condition
A drug that has mistake in label in terms of
English or demographic data
A
B
C
I or II or III
I or II or III
I or II or III

42. Discussion on Scenarios

43. Mix up of
Glimepiride
tablet
1 mg & 2 mg

44. Scenario A
If Glimepiride 1 mg tablet
was labeled Glimepiride 2 mg
A

45. Scenario B
If Glimepiride 1 mg tablet
was labeled Glimepiride 2 mg
If Glimepiride 2 mg tablet
was labeled Glimepiride 1 mg
A
B

46. Scenario A & B
If Glimepiride 1 mg tablet
was labeled Glimepiride 2 mg
If Glimepiride 2 mg tablet
was labeled Glimepiride 1 mg
A
B

47. Scenario A & B
A B

48. Scenario A & B
A
B

49. Mix up of
Paracetamol tablet
250 mg & 500 mg

50. Scenario - A
If Paracetamol 250 mg tablet
was labeled Paracetamol 500 mg
A

51. Scenario B
If Paracetamol 500 mg tablet
was labeled Paracetamol 250 mg
B
If Paracetamol 250 mg tablet
was labeled Paracetamol 500 mg
A

52. Scenario A & B
If Paracetamol 500 mg tablet
was labeled Paracetamol 250 mg
B
If Paracetamol 250 mg tablet
was labeled Paracetamol 500 mg
A

53. Scenario A & B
A B

54. Scenario A & B
B
A

55. Mix up of
Tablet Metformin 500 mg
&
Tablet Mefenamic Acid
500 mg

56. Scenario - A
If Metformin 500 mg tablet
was labeled Mefenamic acid 500 mg
A

57. Scenario B
If Mefenamic acid 500 mg
tablet was labeled Metformin 500 mg
B
If Metformin 500 mg tablet
was labeled Mefenamic acid 500 mg
A

58. Scenario A & B
If Mefenamic acid 500 mg
tablet was labeled Metformin 500 mg
B
If Metformin 500 mg tablet
was labeled Mefenamic acid 500 mg
A

59. Scenario A & B
A B

60. Scenario A & B
B
A

61. Mix up of
Tablet Losartan 25 mg
&
Tablet Loratadine 10
mg

62. Scenario - A
If Losartan 25 mg tablet
was labeled Loratadine 10 mg
A

63. Scenario B
If Loratadine 10 mg tablet
was labeled Losartan 25 mg
B
If Losartan 25 mg tablet
was labeled Loratadine 10 mg
A

64. Scenario A & B
If Loratadine 10 mg tablet
was labeled Losartan 25 mg
B
If Losartan 25 mg tablet
was labeled Loratadine 10 mg
A

65. Scenario A & B
A B

66. Scenario A & B
A
B

67. Mix up of
Tablet Simvastatin 20 mg
&
Tablet Atorvastatin 20
mg

68. Scenario - A
If Simvastatin 20 mg tablet
was labeled Atorvastatin 20 mg
A

69. Scenario B
If Atorvastatin 20 mg tablet
was labeled Simvastatin 20 mg
B
If Simvastatin 20 mg tablet
was labeled Atorvastatin 20 mg
A

70. Scenario A & B
If Atorvastatin 20 mg tablet
was labeled Simvastatin 20 mg
B
If Simvastatin 20 mg tablet
was labeled Atorvastatin 20 mg
A

71. Scenario A & B
A B

72. Scenario A & B
BA

73. Thank You