Methods in Pharmacovigilance
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1 Methods in Pharmacovigilance Dr. Linda Härmark, PharmDepidemiologist Head Innovation, Netherlands Pharmacovigilance Centre Lareb
2 How can you monitor the safety of drugs after registration?
3 Post marketing surveillance Hypothesis generation Hypothesis confirmation
4 Hypothesis generation Spontaneous Reporting Intensified ADR Reporting Targeted Reporting Cohort Event Monitoring
5 Hypothesis confirmation Case control studies Cohort studies Randomized Clinical Trials Meta-analysis
6 Spontaneous reporting system A system to monitor the safety of all medicines on the market Voluntary submission of ICSRs by health professionals, pharmaceutical manufacturers and patients to the national pharmacovigilance centre
7 Spontaneous reporting system Requires two initial steps: A reporter 1. suspects that an undesirable medical event may have been caused by exposure to a medicine 2. reports the suspicion to the national pharmacovigilance centre
8 report data entry coding & Assessment signal detection signal Database
9 What to report? Create awareness for reporting You can report You should report
10 What to report? Serious ADRs* (mandatory/not mandatory) Severe ADRs New drugs Unknown (unlabelled reactions) ADRs in vulnerable groups (children, pregnant women, elderly) * fatal, life threatening, causing permanent disability, prolonging hospitalisation or medically significant
11 MHRA Reporting Reminder
12 What to report? Create awareness for reporting You can report You should report
13 Covers the whole population Includes all medicines Pros with spontaneous reporting Continual monitoring throughout life cycle of a medicine Detects signals of new, rare or serious ADRs
14 Most commonly used method Pros with spontaneous reporting Easiest method to establish Least labour intensive Relatively inexpensive
15 Inherent underreporting Captures only suspected ADRs Cons with spontaneous reporting Reporting bias Seriousness, severity New medicine Advertising of product Publicity of specific ADR
16 Denominator unknown Cons with spontaneous reporting Difficult to detect delayed ADRs ADRs with high background incidence
17 Pacurariu et al, Drug Safety 2014
18 Hypothesis generation Spontaneous Reporting Intensified ADR Reporting Targeted Reporting Cohort Event Monitoring
19 Intensified spontaneous reporting To enhance ADR reporting of specific medicines in early post marketing phase Extension of Spontaneous Reporting Programme
20
21 Hypothesis generation Spontaneous Reporting Intensified ADR Reporting Targeted Reporting Cohort Event Monitoring
22 Targeted spontaneous reporting Intensified ADR Reporting within a defined cohort
23 Targeted Reporting Specific ADR All ADRs Specific Medicine(s) Specific Clinics Specific Population
24
25 Targeted Reporting Specific Population
26 TSR Uganda Specific population: Patient with HIV infection
27 Targeted Reporting Specific Clinics Specific Population
28 TSR Uganda Specific population: Patient with HIV infection Specific clinics: Regional Pharmacovigilance Centres of Masaka and Mbale
29 Targeted Reporting Specific Medicine(s) Specific Clinics Specific Population
30 TSR Uganda Specific population: Patient with HIV infection Specific clinics: Regional Pharmacovigilance Centres of Masaka and Mbale Specific medicines: Tenofovir
31 Targeted Reporting All ADRs Specific Medicine(s) Specific Clinics Specific Population
32 TSR Uganda Specific population: Patient with HIV infection Specific clinics: Regional Pharmacovigilance Centres of Masaka and Mbale Specific medicines: Tenofovir Specific ADRs: Renal toxicity
33 Côte d Ivoire Targeted Spontaneous Reporting Kenya Lao PDR Viet Nam
34 Pros with TSR Can utilise existing ADR reporting infrastructure Targets specific medicines of interest Possible to implement monitoring programme that targets specific issue of concern (ADR, medicine, patient group) Captures useful information (less background noise ) Denominator known
35 Cons with TSR Under reporting remains a problem Captures only suspected ADRs or known toxicities May limit reporting only to specific ADRs Relies on diagnostic capability of reporter
36 Hypothesis generation Spontaneous Reporting Intensified ADR Reporting Targeted Reporting Cohort Event Monitoring
37 Cohort Event Monitoring (CEM) To gather more information on the safety profile of a new chemical entity in early postmarketing phase Observational cohort study design Patients enrolled into cohort and actively followed up during treatment to record all adverse events (not just suspected ADRs).
38 Cohort T=1
39 Cohort Event Monitoring (CEM) Characterise known reactions Detect signals of unrecognised reactions Identify interactions with other medicines and TCAMs Detect inefficacy of medicine Assess safety in pregnancy & lactation Identify risk factors for ADRs
40 Lareb Intensive Monitoring Frequency in real life Time course of ADRs Management of ADRs Risk factors for ADRs Quality of life/severity
41 Lareb Intensive Monitoring 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.
42 Lareb Intensive Monitoring Cohort based on first prescription in the pharmacy Patient as source of information Web based questionnaires Multiple questionnaires in time
43 Pharmacy 1 st dispensing signal Registration Questionnaire LIM-database Automated process Analysis
44 The pharmacy One patient, one pharmacy Computer signals a first prescription Patient is informed about the LIM study
45
46 Questionnaires Patient characteristics Drug use ADRs Quality of life
47 Questionnaires Number of questionnaires per study is flexible Timing of questionnaires is flexible Collection of longitudinal data
48 The drug 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
49 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
50 Pregabalin study Neuropathic pain Epilepsy Generalised Anxiety Disorder
51
52 Pregabalin study Neuropathic pain Epilepsy Generalised Anxiety Disorder Questionnaires at 2 weeks, 6 weeks, 3 months, 6 months
53 Pregabalin study 1373 participants 58 % female Average age 54.5 years Range years - Off label use
54 Pregabalin study Neuropathic pain 1134 Pain 22 Fibromyalgia 20 Herpes zoster 16 Epilepsy 11 Back pain 11 Dystrophy 10
55 1373 participants 897 (65%) fills in one or more questionnaires 728 (81%) reports at least one ADR
56
57 Signal New association Interactions Information about latencies Information about recovery Information about frequencies
58 Palpitations Aphasia Oedema Confusional state Muscle spasms Oedema peripheral Abdominal pain upper Paraesthesia Insomnia Euphoric mood Psychomotor hyperactivity Flatulence
59 Signal Headache - frequency higher than SmPC - Withdrawal not always necessary for recovery Abdominal pain - Not mentioned in the SmPC Suicidal ideation Hypoglycaemia
60 2 weeks 6 weeks 3 months 6 months
61
62
63 Developments Vaccines Other inclusion points
64
65 PV methods spectrum Spontaneous Reporting Intensified ADR Reporting Targeted Reporting Cohort Event Monitoring Denominator unknown Denominator unknown Denominator known Denominator known Suspected ADRs All medicines Suspected ADRs Specific medicines Suspected ADRs/Specific ADRs Cohort specific medicines All events Cohort specific medicines Essential minimum reporting Early postmarketing phase of new drugs Profile of ADRs for a specific medicine in a specific popn Post marketing surveillance of a new chemical entity WHO Programme for International Drug Monitoring UK/EU Black Triangle Scheme Profile of ADRs for a specific medicine in a specific popn CEM of new antimalarials (ACTs)
66 Method Medicines Population Reports Spontaneous Reporting All medicines, life-cycle of product All exposed individuals but denominator unknown All ADRs Intensified ADR Reporting Specific medicines All exposed individuals but denominator unknown All ADRs Targeted Reporting Specific medicines Defined cohort All ADRs Specific ADRs Cohort Event Monitoring Specific medicines Defined cohort All Events
67 Which method? A new drug is introduced to the market, A. A has a new mechanism of action compared to other drugs on the market. How would you monitor the safety of A? Why?
68 Which method? A new drug is introduced on the market, B. B is an ACE inhibitor indicated as treatment of hypertension and heart failure. How would you monitor the safety of this drug? Why?
69 Which method? There is emerging evidence that drug C, which is used in the treatment of HIV, can cause hepatitis. You want to know more about this ADR. Which method would you choose? Why?
70 Which method? Drug D is a biological drug recently introduced to the market. How would you monitor the safety of D? Why?
71 Which method? Drug E will be introduced into a public health programme, but its safety in this population is not well known. How would you monitor the safety of E? Why?
72
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