Lareb update. Linda Härmark, apotheker-epidemioloog Hoofd Innovatie en Projecten PPN vergadering 14 mei, 2019

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1 Lareb update Linda Härmark, apotheker-epidemioloog Hoofd Innovatie en Projecten PPN vergadering 14 mei, 2019

4 College ter Beoordeling van geneesmiddelen Inspectie Gezondheid en Jeugd Patiënten MAH Rijksinstituut voor volksgezondheid en milieu Lareb Zorgverleners European Medicines Agency Wereldgezondheidsorganisatie Universiteiten en onderzoeksinstellingen Geneesmiddelenketen CCMO, CBG, Lareb, IGZ, RIVM, ZIN

5 Ga naar Vul de code #H859 in

7 Outline Spontane rapportage (geneesmiddelen en vaccins) Lareb Intensive Monitoring Geneesmiddelgebruik rondom de zwangerschap WHO Collaborating Centre

8 Rechtstreeks aan Lareb Via industrie

9 Uitdagingen Aantal meldingen van zorgverleners nemen niet toe Aantal meldingen van MAH nemen toe Totaal aantal meldingen neemt toe

10 Reporting tools Webformulier gebruikersvriendelijker maken Nieuwe manieren van melden, WEB-RADR app Integratie in huisartsen systemen

11 Registers (ziektespecifiek) Lareb werkt met 4 verschillende registers samen - DREAM-RA: rheumatoid arthritis - SpA-Net : spondyloarthritis and arthritis psoriatica - RUBRIC: therapy-refractory IMID's - MS-register: MS Gegevens over bijwerkingen worden uitgewisseld en Lareb maken hiervan een ICSR

12 Registers (ziektespecifiek) Uitdagingen - De prioriteit van registers is efficacyen niet toxiciteit - Heterogene data collectie - Moeilijk om data te delen - Harmonisatie van data elementen noodzakelijk om data uitwisseling tussen verschillende partijen mogelijk te maken

13 13

15 Follow up van meldingen Hoe ervaren jullie de procedure om follow up te vragen bij Lareb?

16 Is more alwaysbetter? Meer meldingen Signaaldetectie anders inrichten?

19 Hoe hebben jullie jullie signaaldetectieprocessen veranderd afgelopen periode?

21 Hoe gaan jullie om met duplicate detection? EV duplicate detection vs eigen duplicate detection?

22 Signaldetection Case-by case review Statistical signal detection - Niet alleen afhankelijk van disproportionaliteit (ROR)

23 Signals Discussed during signal detection meeting Lareb- Medicines Evaluation Board Lareb disseminates to the MEB in a continuous manner: - Signals - Overviews(i.e. for new chemical entities, Media attention) - Letters which inform the MEB immediately about urgent safety issues Signals discussed at MEB can result in different actions, among others: - Inclusion ADR in SmPC - Dear Health Care Professional Letters - Discussion in PRAC

24 Lareb-RIVM Sinds 2011 is het beheren van het Rijksvaccinatieprogramma en het bewaken van bijwerkingen van de vaccins gescheiden Direct informeren bij bijzondere vaccine meldingen Delen van signaleringen

25 Lareb-IGJ Lareb is verantwoordelijk voor de bijwerkingen bewaking van doorgeleverde bereidingen en named patient use (artsenverklaring) en rapporteert signalen en overviews aan IGJ

26 Outline Spontane rapportage (geneesmiddelen en vaccins) Lareb Intensive Monitoring Geneesmiddelgebruik rondom de zwangerschap WHO Collaborating Centre

27 Lareb Intensive Monitoring Prospective cohort study Variousinclusioncriteria - e.g. specific drug use, special patient group Various recruitment methods - e.g. pharmacy dispense, specialist doctors, patient organizations Web-based questionnaires at different points in time Patient is the source of information

28 Lareb Intensive Monitoring Improve pharmacotherapy and manage expectations - Type of ADE - Course ADE - Treatment ADE - Recovery ADE (when, management etc.) - Burden ADE - Impact ADE - Risk factors - Etc. etc.

29 LIM projects Korte beschrijving Partners Status NControl NOACs (ZonMW) Inclusion method that matches daily practice in pharmacy setting Several aspects(including ADEs) use of NOACs Service apotheek Mosadex Finished Ongoing Monitor biologicals (ZonMW) Developmentof a nationalmonitor forearlydetectionof safety issues regarding the use of biologicals Diverse ziekenhuizen DREAM Ongoing UPGx PREPARE Study (H2020) Dosageadaptationsof medicationbasedon pharmacogenetic profile and the occurence of ADRs LUMC Ongoing Influenza-LIM Yearly monitoring influenza-vaccination -- Ongoing BRIMM (ZonMW) Development of aninfrastructureforregister primarycare; web-basedpatientquestionnaires linkedtogp data overactive bladder first use case Nivel Pilot phase MenACWY vaccination Monitoring of the introduction(switch) to the MenACWY vaccinationfor14 monthsand14 yearsoldchildrenin the Netherlands RIVM Ongoing StatinsandPCSK9 inhibitors Severalaspects(includingADEs) useof statinsandpcsk9 inhibitors In preparation

30 Monitor biologische geneesmiddelen Ontwikkeling en opzet van een nationaal veiligheidsmonitoringssysteem voor biologische geneesmiddelen door middel van een Landelijke Intensive Monitoring systeem.

Monitor biologische geneesmiddelen Inclusion of patients in the hospital Biologic drugs used and combination therapy Bimonthlyquestionnaires (5-15 minutes

31 Monitor biologische geneesmiddelen Inclusion of patients in the hospital Biologic drugs used and combination therapy Bimonthlyquestionnaires (5-15 minutes dependingon numberof ADRs) What kind of ADRs are experienced? Is ADR is still current? Contact moments with health care professionals Burdenof theadr (1-5) Andsoon

32 Partners

33 Monitor biologische middelen

34 Monitor biologische middelen

36 Patients perspectives on burden of ADRs Patiënten met Crohnof colitis ulcerosa geincludeerd door IB- DREAM

37 Patients perspectives on burden of ADRs Patiënten met reumatoïde artritis

38 Monitoring MenACWYvaccin Introductie Men ACWY vaccin 14 maanden prik 14 jaar prik (nieuw) In kaart brengen van het bijwerkingenprofiel na vaccinatie met nieuwe meningokokkenvaccin

39 Monitoring MenACWYvaccin Ouders ontvangen uitnodiging voor het onderzoek via het RIVM Deelname registreren Invullen vragenlijsten Analyse

40 Outline Spontane rapportage (geneesmiddelen en vaccins) Lareb Intensive Monitoring Geneesmiddelgebruik rondom de zwangerschap WHO Collaborating Centre

Teratology Information Service To provide up-to-date safety information on exposures during conception, pregnancy and lactation To enable informed decision making by healthcare

41 Teratology Information Service To provide up-to-date safety information on exposures during conception, pregnancy and lactation To enable informed decision making by healthcare professionals and their patients To prevent congenital malformations and other adverse pregnancy outcomes, and To prevent unnecessary anxiety and terminations of wanted and healthy pregnancies

Pregnancy drug register The Netherlands ± 170.

45 Pregnancy drug register The Netherlands ± births/ year Estimates vary;± 70% uses prescribed drugs Sufficient information to make an evidence-based decision about use during pregnancy is available for <10% of drugs Adam et al. 2011; 157: Bakker et al. 2006;113(5):559-68

46 Pregnancy drug register Aim: Obtain insight into medication use among pregnant and breastfeeding women and into the potential effects on maternal and fetal health. Thereby, providing in a step towards translation of daily practice with drug exposure in pregnancy and breastfeeding into actionable knowledge.

47 Data collection: schedule Online consent, followed by questionnaire 1 (as early in pregnancy as possible) Questionnaire 2 (gestational week 17; skipped if enrolment was after week 20) Questionnaire 3 (gestational week 34) Questionnaire 4 (8 weeks after expected date of birth) Questionnaire 5 (26 weeks after expected date of birth) Questionnaire 6 (52 weeks after expected date of birth)

48 Data collection: content Type of data: Current pregnancy Obstetric history Maternal health Medication use Delivery + child s health Breastfeeding Lifestyle factors + demographics The Dutch data collection for the European Registry of Antiepileptic Drugs and Pregnancy (EURAP)is embedded in pregnant. Participants that use AEDs are asked permission to share their data with EURAP and receive some extra questions regarding their disease (e.g. occurrence of insults and type of epilepsy).

49 Future directions Large scale implementation Initial steps are taken to integrate sending of the digital invitation for pregnant in the midwifes digital practice information systems and thereby embed pregnant within the routine of perinatal care in the Netherlands. Exploreextension of data collectionon long term outcomes, like (neuro)developmental milestones Explore extension of data collection on severity of maternal disease Questionnaire in multiple languages Project: Paternal exposure (immunosuppressive drugs)

51 Slide courtesy of Ida Niklson

52 Slide courtesy of Ida Niklson and Miriam Sturkenboom

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