Reports to Regional Centres come from several sources:
SOURCE AND MANAGEMENT OF REPORTS
Reports
to Regional Centres come from several sources:
·
Spontaneous reports sent by healthcare profes-sionals.
Prescribers and pharmacists are legally required to report immediately serious
or unex-pected ADRs to their Regional Centre. However, other healthcare
professionals (nurses, physiother-apists etc.) can also report these ADRs.
There is an official form for reporting ADRs to Regional Centres (cerfa n 10011∗01). However, centres usually have their own forms (commonly
devised) on to which the information is transferred, and in which raw data
(e.g. photocopies of lab tests or hospital discharge letters) can be stored.
·
Reports gathered during clinical rounds: since the Regional
Centres are in reference (tertiary care) hospitals, the appropriate departments
(internal medicine, haematology, dermatology, hepatology, for instance) can be
regularly visited or contacted for hospitalised drug-related cases. These depart-ments
sometimes have ‘drug staffs’ where drug-related problems can be discussed with
the team from the Department of Pharmacology. In addi-tion, pharmacy students
in the clinical wards are often used as pharmacovigilance relays.
·
A large number of reports come from the requests for
information by health professionals, that is the drug information centre
activity. Though a fair number of these questions concern pre-emptive
information (what can I prescribe this pregnant women with this condition?),
about half concern new medications and suspected drug reactions, usually under
the form ‘has this ever been reported before?’ These actually usually
correspond to a specific patient, the prescriber asking the Centre for help in
solving a diagnostic problem, where a drug may possibly be involved. The
dialogue that ensues between the pharmacologist and the clini-cian will usually
help solve the problem. Since the interaction occurs early, the pharmacologist
can suggest further action, such as diagnostic tests, or drug dechallenge,
which will improve the case’s information content. In this interaction, the
clin-ician receives help for a specific problem, and the Regional Centre
receives a case with better information (Moore, 2001).
This
activity is viewed as a service rendered to local healthcare professionals,
making them more willing to call and report. This will also have an influence
on the type of reports retrieved, since physicians are more likely to call in
for unusual, severe or unexpected events than for well-known ones, which after
all is the main objective of spontaneous reporting systems.
After
assessment of causality using the French imputation method (see below) (Begaud et al., 1985),
reports
are input to the national pharmacovigilance database at the Regional Centre.
Mean time from receiving the case to input is a few days, with priority given
to serious reports, which are identified as such in the database. Centres are
required to report all seri-ous reactions to the Agency within 15 days. At any
time, every Centre can access the complete database, which is located in the
Pharmacovigilance Unit of the Agency.
Though
there are no automated alerting processes functioning routinely on the database
at this time, it is customary when a new report comes in, espe-cially if it
concerns a recently marketed drug, or if the event is serious and unexpected,
to query the base for similar cases, possibly using the case–non-case approach
(Moore et al., 1993, 1997; Montastruc
et al., 2000), to generate some
measure of reporting dispro-portionality that could be indicative of an
impending problem. Serious reports are automatically retrieved from the
database at the Agency on a daily basis and forwarded from the Agency to the
relevant MAH, and in the case of centrally authorised products to the European
Medicines Agency (EMEA) as required by the European pharmaceutical legislation.
Pharmaceutical
companies also have to comply with the European legislation, including 15-day
transmis-sion of serious ADRs occurring on French territory to the Agency, and
the submission of Periodic Safety Update Reports (PSURs) according to defined
peri-odicity. Reports from industry are received at the Agency, and input
manually to a separate database, which can for the moment be accessed only at the
Agency. In accordance with the new European requirements (Regulation (EC) No
726/2004), elec-tronic transmission of ADRs will become manda-tory in November
2005. In order to be compliant with ICH standards for electronic reporting of
ADRs, AFSSAPS is currently setting up a new pharmacovig-ilance database. This
new single database will receive ADRs from pharmaceutical companies and
Regional Centres and will contain all previously recorded case reports.
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