Download 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
1st dispensing
signal
Registration
Questionnaire
Automated
process
LIM-database
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
Drugs
Anti-diabeticdrugs
(GLP-1 agonist, DPP-4
inhibitors, SGLT-2 inhibitors)
Bydureon®
Byetta®
Eucreas®
Forxiga®
Galvus®
Janumet®
Januvia®
Jentadueto®
Komboglyze®
Onglyza®
Trajenta®
Victoza®
DOACs
Eliquis®
Pradaxa®
Xarelto®
Valdoxan®
Outline
• Why intensive monitoring?
• Lareb Intensive Monitoring
• Pregabalin study
• Developments
Pregabalin
– Neuropathic pain
– Epilepsy
– Generalised Anxiety Disorder
Pregabalin
Pharmacy
1st prescription
signal
Patient
Lareb
Registration
Questionnaire
2 weeks
Questionnaire
Coding
6 weeks
Questionnaire
3 months
Questionnaire
6 months
Analysis
Patient characteristics
– 1373 participants
– 58 % female
– Average age 54.5 years
– Range 11-89 years
• Off label use
Indication
–
–
–
–
–
–
–
Neuropathic pain
Pain
Fibromyalgia
Herpes zoster
Epilepsy
Back pain
Dystrophy
1134
22
20
16
11
11
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
[email protected]