The First Eastern Mediterranean Region/Arab Countries Meeting of Pharmacovigilance
The First Eastern Mediterranean Region/Arab Countries Meeting of Pharmacovigilance
Supplement
Tables
Table 2: Reports for Health Products (Morocco)
Health Products and Widening PV Scope / Number (%) of ReportsDrugs (since 1989) / 26695 (73.28)
Vaccines (since 1999) / 2686 (7.37)
Drugs used during Pregnancy and Breastfeeding (since2000) / 374 (1.02)
Herbal Medicines (since 2000) / 2724 (7.50)
Medication Errors (since 2004) / 1123 (3.08)
Cosmetics (since 2008) / 918 (2.52)
Medical Device (since 2010) / 590 (1.62)
Anti-TB Drugs (since 2013) / 650 (1.78)
HIV/AIDS Drugs (since 2013) / 436 (1.20)
Antiepileptic Drugs (since 2013) / 99 (0.27)
Antidiabetic Drugs (2014) / 68 (0.18)
Anti-Cancer Drugs (2014) / 65 (0.17)
From 1989 to June 2014
Table 3: Cumulative Workload (since establishment to 30/09/2014) (Egypt)
ICSRs / 6739Newsletters / 69
PSURs / 893
RMPs / 389
DDPS/PSMF / 225
Recalls / 1
DHCPC / 285
Withdrawals / 14 (APIs) = 82 (Brands)
PV committee / 98 meeting = 2014 decisions
Safety Reports / 3042
Training to MAHs / 50 (involved 1471 trainees)
Training to HCPs / 311 (involved 6514 trainees)
Meetings & Scientific conferences / 86
International communications With DRAs / 183
PASS / 5
ICSRs: Individual Case Safety Reports; PSURs: Periodic Safety Update Reports; RMPs: Risk Management Plans; DDPS/PSMF: Detailed Description of the Pharmacovigilance System/ Pharmacovigilance System Master File; DHCPC: Dear Health Care Professional Communication; PV: Pharmacovigilance; MAH: Marketing Authorisation Holders; Health Care Professionals; Drug Regulatory Authorities; PASS: Post-Authorisation Safety Surveillance
Table 4: Total ICSRs and Communications (since establishment to 30/09/2014) (Egypt)
Pharmacovigilance / Medical Device Vigilance department / Biocides Vigilance department / Alexandria Satellite Centre / Cairo Satellite Centre / Sohag Satellite Centre / Total
Yellow cards / 3497 / 397 / 2822 / 23 / 6739
Pink cards / 66 / 1 / 67
Blue cards / 27 / 1 / 28
White card (Quality report) / 1 / 20 / 1 / 89 / 18 / 4 / 133
Total / 3498 / 86 / 28 / 486 / 2841 / 28 / 6967
Communications
In / 4147 / 674 / 247 / 205 / 102 / 41 / 5519
out / 3162 / 1151 / 260 / 345 / 168 / 56 / 5262
Cumulative work load since establishment to 30/09/2014
Table 5: JFDA Activities (Jordan)
Activities / 2013 / 2014HCP training lectures / 7 / 2
Industry training / 1 / 2
Reports received / 85 / 140
Reports sent to WHO / 39 / 92
MENA workshops / 2 / 1
(updating PV guidelines) Arab league members / Started / Approved
HCP: Health Care Professional; WHO: World Health Organisation; MENA: Middle East and North Africa; PV: Pharmacovigilance
Table 6: JFDA Regulatory Actions during the First 6 Months of 2014 Due to Safety or Efficacy Issues (Jordan)
DDL dissemination / 48 > letterLabel update / 108 > updates
Recall / 2
Pending & Withdrawals / 2
PSUR & RMP reviewing / 54 +24
DDL: Dear Doctor Letter; PSUR: Periodic Safety Update Report; RMP: Risk Management Plan
Table 7: Department of Collection and Analysis of AEs (Tunisia)
Year / Consultations / Folders / Pregnancies1990 / 82 / 58 / 00
1995 / 922 / 405 / 38
2000 / 1819 / 731 / 190
2007 / 3875 / 1539 / 404
2008 / 4194 / 1852 / 398
2009 / 4721 / 1944 / 385
2010 / 4789 / 1975 / 400
2011 / 4542 / 1987 / 379
2012 / 5255 / 2135 / 386
2013 / 5223 / 2026 / 401
Table 8: Reporting Facts (Kingdom of Saudi Arabia)
Report Type / Number (%)Total number of reports / 76,649 (100)
ADRs / 75,486 (98.5)
Medication errors / 796 (1)
Product quality / 367 (0.5)
ADRs: Adverse Drug Reactions
Table 9: Actions by Advisory Group (Saudi Arabia)
Actions Taken / Number (%)Labelling Update / 32 (26)
Circulars / 19 (16)
DHCPLs / 18 (15)
Drug Withdrawal / 9 (7)
Others / 44 (36)
DHCPLs: Dear Health Care Professional Letters
Figures
Figure 3: Adverse Drug Reaction reports (Jordan)
Figure 4: Number of Safety Reports (Oman)
Figure 5: Trend Analysis Plot for the Number of Safety Reports (Oman)
Figure 6: Vertical versus Integrated Systems
Figure 7: Different Types of Vigilances
OTC: Over The Counter
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