Transcript Data Management in Pharmacovigilance
Sanjeev Miglani MD COO and Scientific Director CIDP Biotech India
International Conference and CME workshop on Pharmacovigilance Systems and Rational Use of Drugs: An integrated approach ; 27 Nov 2010
Overview
Importance of Pharmacovigilance
Source of ADRs
Triage
Case Processing
Different PharmacovigilanceSoft Wares
Pharmacovigilance
Collection of the information Processing in a Database Medical Evaluation, Analysis and Signal Detection Reporting
Importance of Safety Monitoring
Capture of Complete safety data
Regulatory agencies becoming proactive
Ethical requirements
Serious consequences due to Non compliance
SOURCE OF REPORT
Spontaneous Reports
U nsolicited communication by a healthcare professional or consumer to a company, regulatory authority or other organization that describes one or more ADRs in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.
Literature
Each MAH is expected to regularly screen the worldwide scientific literature by accessing widely used systematic literature reviews or reference databases.
The frequency of the literature searches should be according to local requirements
A copy of the article might be requested by the local regulatory authority to accompany the report.
Solicited Sources
Solicited reports are those derived from organized data collection systems, which include clinical trials, registries, post-approval named patient use programs, management other patient programs, support surveys of and disease patients or healthcare providers, or information gathering on efficacy or patient compliance.
Contractual Agreements
The marketing of many medicines increasingly takes place through contractual agreements between two or more companies, which may market same product in the same or different countries/region.
Arrangements vary considerably with respect to inter-company communication and regulatory responsibilities.
Regulatory Authority Sources
Individual serious unexpected ADRs originating from foreign RAs are subject to expedited reporting to other authorities by each MAH.
Re-submission of serious ADR cases without new information to the originating RA is not usually necessary, regulation.
unless otherwise specified by local
Call Centers
A centralized office used for the purpose of receiving and transmitting a large volume of requests by telephone.
They provide service to pharmaceutical companies with a complete post-marketing surveillance solution including adverse event monitoring and reporting; drug information services; and product complaint management.
TRIAGE OF CASES
Once the complaint is received at PV department of a company, it must be properly classified for processing.
The initial triage should be to determine whether the report needs urgent processing in order to be transmitted to the RAs, or business partners.
Experienced and qualified personnel should always supervise triage
Triage should cover, at the least, the following:
ADRs PQCs associated with ADRs
PQCs Medical Inquiries legal
ADRs can further be triaged using the following criteria:
Serious or non serious
Expected or unexpected
Causality (Specially for SAEs from Clinical Trials)
The minimum information required for reporting purposes is
:
An identifiable patient the name of a suspect medicinal product an identifiable reporting source, and, an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship.
Case Processing
Data entry into safety database Medical coding QC review Medical review
Data Entry:
For user friendliness, the front end of these software are made in such a way that end user can enter data very easily and more accurately.
These systems generally require additional mandatory fields like date of receipt of ADR, Source Country, type of source.
Once the case with minimum information for reporting is entered, the case is saved
Information can be divided into following fields,
Subject (data related to subject like name or initials, height, weight, gender, age ,pregnancy etc)
Suspect Drug (data relate to suspected medicinal product like name, start date, end date, duration of exposure, formulation, dose and dosage form, indication etc), Event (which includes fields like, reporter’s verbatim, company’s verbatim, MedDRA terms, event onset date, event end date, etc).
Reporter’s information may include (reporter’s name, contact address, phone number, e-mail id, whether reporter is a Health care professional or not, secondary or tertiary reporter, etc),
Reportability or submission fields may include country where the case is reportable, schedule of reports, including due date of submission, etc)
Narratives
The objective of the narrative is to summarize all relevant clinical and related information The narrative should serve as a comprehensive, stand alone “medical story”.
The information should be presented in a logical time sequence; ideally this should be presented in the chronology of the patient’s experience, rather than in the chronology in which the information was received.
MedDRA
Coding of: – Adverse events – Medical history – Signs and symptoms – Diagnoses – Physical examination data – Laboratory tests
WHO-DD
The WHO Drug Dictionaries consist of medicinal product names - both proprietary and nonproprietary - from more than 90 countries.
All drugs in the WHO Drug Dictionary and the WHO Drug Dictionary Enhanced are classified according to the Anatomical Therapeutic Chemical classification – ATC.
FOLLOW-UP INFORMATION
All efforts should be made to seek additional information for good assessment of case
The priority of cases for follow-up should be as follows:
Serious and unexpected,
Serious and expected, and
Non-serious and unexpected
In addition to seriousness and expectedness as criteria, cases “of special interest” also deserve extra attention as a high priority
QC Review
After Data entry, a drug safety specialist reviews the data entry against the source documents and reviews the case narrative.
A clear methodology on the quality check should be developed
Follow-up information should be requested when the initial case is incomplete or unclear.
Medical Review
The medical review should generally cover the medical content of the case with particular attention paid to the narrative, the suspect and concomitant drugs (including dosages), the past medical history, and coding.
The review should also include, but is not limited to, the following considerations:
•Is a diagnosis possible? •Have the relevant diagnostic procedures been performed? •Were alternative causes of the reaction(s) considered? •What additional information is needed?
.
Tracking and Metrics
It is critical that all cases reports be tracked The tracking of cases should base on the workflow step Each drug safety specialist and manager should be aware of status of all the cases The manager can reallocate cases or other work to ensure that the time-critical cases are handled appropriately.
Similarly, non expedited cases that need to be completed for aggregate reports should be tracked so that they are completed by the time of data lock
.
Line Listings: Example
Ctry Mnf Ctrl # Srce Sex AgeYr Dose Treatme nt dates Onset React ion Outcome Comment s Gastric disorders
CLINI00 IND HCP M 24 50mg 25 to 27 Aug 2009 25 AUG 2009 Abdominal pain Recov ered Hospitalised.
Hepatic disorders
951114 USA LIT F 41 25mg 26 to 29 August 2009 26 AUG 2009 Elevated LFTs, swollen abdomen, Unkno wn Abnormal on ult rasound liver, gallbladder, pancreas.
Vigiflow
Safety data Base is hosted by the Uppsala Monitoring Center Internationally recognised standards –E2B report format –WHO-ART and ICD or MedDRA –WHO Drug Dictionary One server installation –maintained in UMC
Oracle's Argus Safety suite
Oracle Argus Affiliate:
local affiliates and among partners, lowering risk from unanticipated reporting delays. Oracle Argus Interchange: Electronic exchange Oracle Argus Reconciliation: SAE reconciliation Oracle Argus Dossier: Periodic safety update report Oracle Argus Insight: Multidimensional analysis of drug safety data. It can generate preformatted filterable safety reports Oracle Argus Perceptive: an integrated solution for signal management.
Aris G Safety Soft ware Suite
ARISg™: Used for the Collection, coding, Assessment and Reporting of Adverse events data ARISj™: Japanese pharmacovigilance system agXchange ESM™: Electronic exchange
agXchange IRT™:
Inbound receipt and triage of ADRs
agConnect™:
Clinical safety reconciliation system
agComposer™:
Comprehensive periodic and aggregate reporting system
agSignals™:
Advanced signal detection and data mining system