Lareb Intensive Monitoring

Lareb Intensive Monitoring May 14, 2014 UMC pharmacovigilance course Linda Härmark, PharmD, PhD Head Reporting department www.lareb.nl

Outline Why intensive monitoring? Lareb Intensive Monitoring Pregabalin study Developments

Why? EPAR Remicade www.ema.europa.eu

Missing information about ADRs Frequency in real life Time course of ADRs Risk factors for ADRs Quality of life

Aim To gather knowledge about ADRs, such as frequency, type, time course, risk factors and impact of quality of life in order to improve pharmacotherapy and to optimise patient adherence.

How? Cohort based on first prescription in the pharmacy Patient as source of information Web-based questionnaires Multiple questionnaires

Pharmacy 1 st dispensing signal Registration Questionnaire LIM-database Automated process Analysis

The pharmacy One patient, one pharmacy Computer signals a first prescription Patient is informed about the LIM study

Questionnaires Patient characteristics Drug use ADRs Quality of life Extra questions (risk factors)

Questionnaires Number of questionnaires per study is flexible Timing of questionnaires is flexible Collection of longitudinal data

Data ADRs are coded with a meddra LLT Analysis

Drugs New chemical entities (NCE s) Drug whose safety are being discussed More than one drug can be monitored Length of the study depends on the drugs being monitored

Drugs monitored with LIM Type of drugs Anti-diabeticdrugs (GLP-1 agonist, DPP-4 inhibitors, SGLT-2 inhibitors) DOACs Drugs Bydureon Byetta Eucreas Forxiga Galvus Janumet Januvia Jentadueto Komboglyze Onglyza Trajenta Victoza Eliquis Pradaxa Xarelto Valdoxan

Outline Why intensive monitoring? Lareb Intensive Monitoring Pregabalin study Developments

Pregabalin Neuropathic pain Epilepsy Generalised Anxiety Disorder

Pregabalin

Pharmacy Patient Lareb 1 st prescription signal Registration Questionnaire 2 weeks Questionnaire 6 weeks Questionnaire 3 months Questionnaire 6 months Coding Analysis

Patient characteristics 1373 participants 58 % female Average age 54.5 years Range 11-89 years Off label use

Indication Neuropathic pain 1134 Pain 22 Fibromyalgia 20 Herpes zoster 16 Epilepsy 11 Back pain 11 Dystrophy 10

1373 participants 897 (65%) fills in one or more questionnaires 728 (81%) reports at least one ADR

Signal New association Interactions Information about latencies Information about recovery Information about frequencies

Palpitations Aphasia Oedema Confusional state Muscle spasms Oedema peripheral Abdominal pain upper Paraesthesia Insomnia Euphoric mood Psychomotor hyperactivity Flatulence

Signals Headache frequency higher than SmPC Withdrawal not always necessary for recovery Abdominal pain Not mentioned in the SmPC Suicidal ideation Hypoglycaemia

Longitudinal Monitoring 2 weeks 6 weeks 3 months 6 months

Outline Why intensive monitoring? Lareb Intensive Monitoring Pregabalin study Developments

From drugs to vaccines Different inclusion point Same methodology Solicited events

Influenzavaccine 2013/2014 Inclusion at the general practitioner 3 questionnaires 5, 15 and 30 days post vaccination In total 1500 participants from 80 GP offices Analysis is ongoing

Neisvac-C LIM

NeisVac-C NeisVac-C is produced by Baxter Change in production site from Beltsville USA to Orth, Austria MAH requested to perform a PMS study where the safety of the two vaccines was compared in a non-inferiority study with pyrexia as the primary endpoint

NeisVac-C Distribution arrangements with NIP Invitation letter send to parents Inclusion at baby clinics Three questionnaires Analysis

Further developments Secondary care From drug to groups Collaborations with others

l.harmark@lareb.nl