Lareb Intensive Monitoring
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1 Lareb Intensive Monitoring May 14, 2014 UMC pharmacovigilance course Linda Härmark, PharmD, PhD Head Reporting department
2 Outline Why intensive monitoring? Lareb Intensive Monitoring Pregabalin study Developments
3 Why? EPAR Remicade
4 Missing information about ADRs Frequency in real life Time course of ADRs Risk factors for ADRs Quality of life
5 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.
6 How? Cohort based on first prescription in the pharmacy Patient as source of information Web-based questionnaires Multiple questionnaires
7 Pharmacy 1 st dispensing signal Registration Questionnaire LIM-database Automated process Analysis
8 The pharmacy One patient, one pharmacy Computer signals a first prescription Patient is informed about the LIM study
9
10 Questionnaires Patient characteristics Drug use ADRs Quality of life Extra questions (risk factors)
11 Questionnaires Number of questionnaires per study is flexible Timing of questionnaires is flexible Collection of longitudinal data
12 Data ADRs are coded with a meddra LLT Analysis
13 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
14 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
15 Outline Why intensive monitoring? Lareb Intensive Monitoring Pregabalin study Developments
16 Pregabalin Neuropathic pain Epilepsy Generalised Anxiety Disorder
17 Pregabalin
18 Pharmacy Patient Lareb 1 st prescription signal Registration Questionnaire 2 weeks Questionnaire 6 weeks Questionnaire 3 months Questionnaire 6 months Coding Analysis
19 Patient characteristics 1373 participants 58 % female Average age 54.5 years Range years Off label use
20 Indication Neuropathic pain 1134 Pain 22 Fibromyalgia 20 Herpes zoster 16 Epilepsy 11 Back pain 11 Dystrophy 10
21 1373 participants 897 (65%) fills in one or more questionnaires 728 (81%) reports at least one ADR
22
23 Signal New association Interactions Information about latencies Information about recovery Information about frequencies
24 Palpitations Aphasia Oedema Confusional state Muscle spasms Oedema peripheral Abdominal pain upper Paraesthesia Insomnia Euphoric mood Psychomotor hyperactivity Flatulence
25 Signals Headache frequency higher than SmPC Withdrawal not always necessary for recovery Abdominal pain Not mentioned in the SmPC Suicidal ideation Hypoglycaemia
26 Longitudinal Monitoring 2 weeks 6 weeks 3 months 6 months
27
28
29 Outline Why intensive monitoring? Lareb Intensive Monitoring Pregabalin study Developments
30 From drugs to vaccines Different inclusion point Same methodology Solicited events
31 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
32 Neisvac-C LIM
33 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
34 NeisVac-C Distribution arrangements with NIP Invitation letter send to parents Inclusion at baby clinics Three questionnaires Analysis
35 Further developments Secondary care From drug to groups Collaborations with others
36
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