Minimum Information Model for Reporting

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1 Minimum Information Model for Reporting Dr. H. Sefiani - Pr. R. Soulaymani Bencheikh 1

2 Background WHO created the Department Safety and vigilances with ambition to integrate all Health Vigilances that allow the interplay various safety issues affecting patients 2

3 3

4 Reporting cornerstone of any vigilance system It is important to Collect as many reporting cases as possible (Quantity) Capture information on AEs in a structured manner and to the highest possible quality standards to: Enable causality assessment and preventability evaluation Build an efficient database Support accurate detection and analysis of signals Put in place Risk Minimisation Actions 4

5 Tools Terminologies, taxonomies and procedures should be harmonized To optimize communication To share data across systems To minimize the risks of inefficient use of resources especially for developing countries 5

6 Problematic Product used by patient: numerous and complex vigilance systems Each vigilance develop its own system: Specific reporting form Specific information Data collection, data extraction Dissemination Feedback 6

7 7

8 Old version: too long and not adapted to all Medicinal Products 8

9 Specific reporting forms: numerous 9

10 Limits For vigilance systems: Conception and production of several reporting forms Separated vigilances without any coordination Duplicated systems: logistic, distribution and availibility For reporters Several reporting forms Several interlocutor 10

11 Underreporting and lack of informations 11

12 Proposed Solution Adapting reporting form to satisfy reporters and to enhance the performance of the Pharmacovigilance System 12

13 Intergrated approach Reporting form with minimal common informations Global data base Global analysis Share informations for the consolidated learning around a patient safety incident 13

14 How?? Analysing the overlaps, redundancies and synergies across reporting and vigilances systems Creating model that will allow the seamless convergence of information 14

15 Standard reporting form Patient (report Id) AE/Incident Medicinal product: suspected and concomittent Context /circumstances Reporter (to have more information) 15

16 Invariable data Patient s data Name or initials Age or Date of Birth Sex Weight Origin: urban /rural Profession Relevant medical history Incident/AE data (Yes/No) Clinical description - Severity Date of onset End date Actions taken Outcomes Reporter Name Function : public / health professional Address, phone or . 16

17 Health products Variable Data Context/circomstances Medicines, vaccines and combined oral contraceptives Diagnostic radiology products Biological products Medical devices Dietary products and food additives Herbals Homeopathic products Cosmetics products Veterinary products Normal conditions of use Medication errors Treatment failure Drug-drug interactions Dependance Resistance Abuse, misuse Intoxications Toxicomany Defectiveproductsor counterfeit products 17

18 Health products Variable Data Context/circomstances Medicines, vaccines and combined oral contraceptives Diagnostic radiology products Biological products Medical devices Dietary products and food additives Herbals Homeopathic products Cosmetics products Veterinary products Normal conditions of use Medication errors Treatment failure Drug-drug interactions Dependance Resistance Abuse, misuse Intoxications Toxicomany Defectiveproductsor counterfeit products Before and After marketing Authorization, During medical practice and pharmacoepidemiolgical studies 02/10/2014 WithFirst or EMR/arab without meeting harm 18

19 Common Items for all Health products Name: brand and commun Indication/ reason for use Dose Route Duration : Start and stop date Action taken (withrawn, dose reduced ) 19

20 Vaccine Batch number Dose number (1st, 2nd..) Site of administration Vaccination session (public or private..) AEFI category Herbals Medical devices Cosmetics 02/10/2014 First EMR/arab meeting 20

21 Herbals Vernacular name Common name Part of herb Type of extraction Type of preparation Cosmetics Reason of use Dose (raw material) 02/10/2014 Vaccines First EMR/arab meeting Medical devices 21

22 Medical devices Brand name Model Type Batch number Location of use The user or manipulator Name and address of the manufacturer Incident (with or without harm) Vaccines Incident category Herbals 02/10/2014 First EMR/arab meeting Cosmetics 22

23 Cosmetics Site of application Time of application Reason of use Expery date Herbals Medical devices Vaccines 02/10/2014 First EMR/arab meeting 23

24 Reporting Form in Practice Hard/paper version, must be Unique Attractive, Simple Targeted information requested Short (1 page) Space for answers Possibility to contact reporter for specific items 24

25 National Pharmacovigilance Centre REPORTING ADVERSE EVENTS OF DRUGS AND OTHER HEALTH PRODUCTS Patient Name: Age: Gender M / / F / / Unknown/ / Weight (Kg): If pregnant, gestation term: Locality/city: Phone number: Adverse(s) events(s) Clinical and paraclinical description of adverse event: Relevant medical history Current medical condition: Comorbidities: Previous history of allergy: yes / / No/ / Unknown / / If yes, please specify which drug: Date of start of reaction: / / / / Date of end of reaction: / / / / Occurrence delay: Hours / / Days / / Months / / Relevant laboratory test: Differential diagnosis eliminated: Action taken: Drug withdrawn / / Dose reduced / / Treatment of reaction (Please specify): Other: Seriousness: Hospitalization / / Prolonged hospitalization / / Outcome: Favorable / / Sequelae / / Not recovered / / Death / / Unknown/ / Drugs and other health products administered by patient Name and form Suspected/ concomitant drug Dosage and route of administration Batch number Date of therapy start Date of therapy end Indication Status of dispensing and use(*) Action taken (**) Please specify if it is: (*) Medical prescription: 1 Self medication: 2 Medication error: 3 Defective product: 4 Drug interaction: 5 (**) Drug withdrawn: a Dose reduced: b Dose increased: c Dose not changed: d Unknown: e If vaccine: Number of administration: Setting of administration: Public sector /_/ Private sector /_/ Vaccination drive /_/ If herbal medicine: Quantity: Part used: Preparation: Infusion / / Decoction / / Soaking / / Other / / Rechallenge with drug or health product: Yes / / No / / Which one : Reccurence of adverse event: Yes / / No / / Please describe: Reporter Name: Tel: Postal address: Physician / / Specialist Dentist / / Pharmacist / / Nurse / / Other healthcare professional: Workplace: Teaching hospital / / Public sector / / Private sector/ / City:. Receive more information about this reporting: Yes / / No / / First EMR/arab meeting Signature To be transmitted by Post / Phone / Fax or 02/10/

26 Reporting Form in Practice Paper version Attractive, Simple Targeted informations requested Short (1 page) Space for answers Specific form should be available at the PV center Electronic version More exhaustive, but selective Attractive, Simple to fill Common data: first page Links for specific data Maximum: 10 min 26

27 Electronic version 27

28 Possible link for all specific data vaccines Herbals Cosmetics Medical devices Diagnostic radiology Biological products - Name of vaccine - Batch number - Dose number - Site of administration - Vaccination session - AEFI category - Vernacular name - Common name - Part of herb - Type of extraction - Type of preparation - Reason of use - Dose (raw material) - Name of product - Site of application - Time of application - Reason of use - Expery date - Manufacturer - Commercial name - Model - Type - Batch number - Location of use - the user or manipulator - name and address of the manufacturer - Incident Dietary products Homeopathic Veterinary 28

29 TERATOVIGILANCE DRUGS HERBAL COSMETIC Simple form Single form Single window/count 29

30 Future Vigilances delema Facilitate reporting act for reporters Built Pharmacovigilance performance As complete as possible As polyvalent as possible Integration of vigilances Facing challenges: Not duplicate systems: Rationalize resources Coordination between partners in Vigilances Harmonizing terminologies and definitions Developing a global system for vigilance 30

31 Thank you 31

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