Pharmacovigilance in Saudi Arabia. Ali Alshahrani B.Sc.Pharm, National pharmacoviglance Center Saudi FDA

Transcription

1 Pharmacovigilance in Saudi Arabia Ali Alshahrani B.Sc.Pharm, National pharmacoviglance Center Saudi FDA

2 Drug Regulations Strategic Imperatives 1. Design IND application approval process 2. Design NDA approval process 3. Re-engineer current drug approval process 4. Establish cosmetics listing database and regulation 5. Establish post-marketing surveillance program 6. Develop port of entry inspection presence 7. Support implementation of an agency wide communication plan 8. Updating of existing guidelines and regulations 9. Establish department for licensing of pharmaceutical institutions 2

3 Established Saudi Food & Drug Authority (SFDA) National Pharmacoviglance Center (NPC) 3

4 Mission To contribute in protection of public health through monitoring of the safety and quality of medicines and to ensure healthcare professionals and patients have access to up to date safety information about medicines. 4

5 NPC Objectives Improve patient safety in relation to the use of medicines. Detection of ADRs at an early stage. Detection of increase in frequency of known ADRs. Prevention of adverse drug events, if possible. Promotion of understanding, education and training in Pharmacovigilance. Encouraging rational and more effective use of medicines. Liaison with international centers. 5

6 Strategy Strategic plan was to establish NPC including the following: To build an infrastructure for NPC: Staffing, qualifications, and expertise. Reporting Forms Database Advisory committee Connecting large hospitals to reporting system Ensure all MAHs submit the required ADR reports & PSUR 6

7 Strategy Cont d To enhance awareness and reporting culture Work shops, newspapers, media, and the presence in public events. Implementing PV guidelines QPPV, ICSRs, and PSURs 7

8 Saudi PV Guideline PV Guideline: Roles of MAHs. Roles of QPPV. Expedited reporting in Saudi Arabia and internationally. PSURs. 8

9 Pharmacovigilance In KSA The National Pharmacovigilance Centre (NPC) was announced to be functioning in March

10 UMC Membership 10

11 Organizational Structure Pharmacovigilance & Crisis Management Directorate National Pharmacovigilance Center (NPC) Cosmovigilance Crisis Management Medication Error Data entry Signal detection Data entry Drugs Risk analysis Risk analysis and Signal detection Cosmetics PSURs Inspection 11

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13 Who Reports To The NPC? Healthcare Providers Public Drug Industries Doctors Nurses Pharmacists Citizens, residents. Different disciplines and backgrounds. QPPV 13

14 What Has Been Reported To NPC? All suspected ADRs that might be related to use of medicines, vaccines, herbal products and cosmetics. Medication Errors Counterfeiting Quality Issues Packaging & Labeling Errors Therapeutic Failure 14

15 Reporting Methods Used Online Reporting Form Paper-based Reporting Form Verbal Reporting & Other reporting means Telephone Fax Prepaid Mail 15

16 Paper-based reporting forms If in doubt fill the form out! 16

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20 Database 20

21 Signal Detection Tool 21

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23 PV Coordinators Northern region = 5 Central region = 18 Eastern region = 12 Western region = 19 Southern region = 8 62 Coordinators have been recruited 23

24 37 Workshops have been conducted >4000 HCP have received training about PV and ADR reporting 24

25 PV Workshops Across Saudi Arabia Regions No. of workshops Central 14 Western 13 Northwestern 4 Eastern 6 Total 37 25

26 Reporting Facts REPORTS TYPE # % Total number of reports received % ADRs % Herbal (traditional) products 17 1% Cosmetics 14 1 % Medication Errors 39 3 % Product Quality 100 8% 26

27 ADR Reports By Type Of Reporter % % 20% 16% 4% 0 Physician Pharmacist Other HCPs MAHs Public Reporter

28 ADR Reports By Seriousness 30 % 70 Serious ADRs Non-serious ADRs 28

29 Suspected vs Unsuspected Products Suspected products 1585, (49%) Unsuspected products 1651, (51%) 29

30 Suspected Products By Pharmacological Group anti-infective agents Analgesics / pain killers Cardiovascular drugs CNS agents GI drugs Miscelleneous Hypnotics / anxiolytics Antidepressents Anticoagulants/antiplatelets Antineoplastic agents Corticosteriods Earl Nose /Ophthalmic preparations Diagnostic Agents Hormones Muscloskeletal agents Antidiabetics Antihypercholesteremia Elctrolyte / fluids Anesthetics Immunosuppresants Respiratory drugs Antihistamines vitamines Genito-urinary disorders Blood derevatives Vaccines No. of suspected products

31 ADR Reports By System Organ Class (SOC) SOC No. of events Reproductive system and breast disorders 1 Surgical and medical procedures 1 Social circumstances 2 Neoplasms benign, malignant and unspecified (incl cysts and 7 polyps) Ear and labyrinth disorders 8 Hepatobiliary disorders 17 Immune system disorders 20 Infections and infestations 24 Musculoskeletal and connective tissue disorders 26 Blood and lymphatic system disorders 30 Renal and urinary disorders 34 Metabolism and nutrition disorders 36 Eye disorders 51 Cardiac disorders 77 Investigations 87 Injury, poisoning and procedural complications 90 Psychiatric disorders 120 Respiratory, thoracic and mediastinal disorders 134 Gastrointestinal disorders 137 General disorders and administration site conditions 204 Nervous system disorders 301 Skin and subcutaneous tissue disorders 311 Vascular disorders 649 Total 2,332 31

32 ADR Reports By SOC Vascular disorders Skin and subcutaneous tissue disorders Nervous system disorders General disorders and administration site conditions Gastrointestinal disorders Respiratory, thoracic and mediastinal disorders Psychiatric disorders Injury, poisoning and procedural complications Investigations Cardiac disorders Eye disorders Metabolism and nutrition disorders Renal and urinary disorders Blood and lymphatic system disorders Musculoskeletal and connective tissue disorders Infections and infestations Immune system disorders Hepatobiliary disorders Ear and labyrinth disorders Neoplasms benign, malignant and unspecified (incl Social circumstances Surgical and medical procedures Reproductive system and breast disorders

33 PV Advisory Committee Multidisciplinary team Provide independent evaluation of safety concerns 33

34 Activities Of PV Adv. Co. 15 meetings Actions taken ranged from labeling update to revoking of drug marketing authorization Examples of actions taken: - Withdrawal of Sibutramine - Suspension and then withdrawal of Rosiglitazone 34

35 Periodic Safety Update Reports Evaluation Actions taken ranged from labeling update to submission of risk minimization plan. Action, 18 Submitted, 163 Reviewed,

36 Success Stories 36

37 Staff Training 22 training courses have been attended. Targeted trainings include: Pharmacoepidemiology Pharmacovigilance Risk management Signal detection MedDRA coding 37

38 Overseas Postgraduate Education 1 holding PhD degree 3 holding Msc degree From UK 3 Bsc in pharmacy 5 doing postgraduate studies abroad (4 in USA for Pharm D, 1 in Australia for Msc) 38

39 Challenges Underreporting! Main reasons are: People are not aware of existing system Complicated reporting Process Lack of motivation 39

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