Alerts can arise from individual case reports at the regional level, because of the number or nature of the reports or because of reporting disproportionality.
ALERT MANAGEMENT
Alerts
can arise from individual case reports at the regional level, because of the
number or nature of the reports or because of reporting disproportionality.
Alerts may also originate from other European competent authorities through the
Rapid Alert System or from FDA alerts, from literature data or any other
source. Possible domestic alerts are reviewed within the Technical Committee
for attribution.
The
Technical Committee is presided by the Chair-man of the National
Pharmacovigilance Commis-sion, and includes a representative of each Regional
Centre (usually its director). The Pharmacovigi-lance Unit of the Agency
ensures the secretariat of both the National Commission and the Technical
Committee.
During
each committee meeting, current problems are reviewed, results of ongoing investigations
are presented, methodological matters broached, and new investigations decided
upon and attributed. Whenever it is decided that a problem should be
investigated, a Centre is designated to take responsibility for the
investigation as ‘Rapporteur’. This can be an ‘unof-ficial investigation’ or an
‘official investigation’. In the former case, the Rapporteur Centre looks at
all cases reported to the Centres, and at other sources of information, to
recommend whether the alert is or is not worthy of official investigation. If
not, it is usually shelved, or kept under distant surveillance in case it
reactivates. The MAH is not formally involved in unofficial investigations.
An
official investigation can be initiated because of an alert (at the national or
European level), or can be systematic in the case of a new drug class, for
instance, or if specific problems are anticipated when a drug is put on the
market. The rules for these official investigations are outlined in the Good
Pharmacovig-ilance Practices, which have been revised recently to take into
account the recent scientific and tech-nical developments of pharmacovigilance
activities. It should be used as a reference document to define the roles and
responsibilities of interested parties. This document is available on the
AFSSAPS’ website: www.afssaps.sante.fr.
When
an official investigation is decided upon, the marketing authorisation holders
concerned are informed and instructed to make contact with the designated
Rapporteur Centre. The cases reported to the Regional Centres and to the MAH
are pooled. Duplicates are identified and resolved. All cases are reviewed
together by the MAH and the Centre, with the help of external experts as
necessary, and causal-ity is reassessed, using more specific criteria, such as
those devised in consensus conferences, national or Council for International
Organizations of Medical Sciences (CIOMS)-supported. The population expo-sure
to medication is estimated from sales data, or from more precise data if
available, resulting in report-ing rates, usually given in number of cases
reported per treatment-months of product sold. This estima-tion is done for the
various levels of causality and seriousness. Additionally, indications of risk
factors such as age, concomitant diseases or medication are looked for.
The
assessment report written by the Rapporteur Centre on the investigation is sent
to the MAH for comments, and presented to the Technical Committee. The
Technical Committee ensures that the investi-gation has been carried out
properly, validates it or not and submits it for examination to the National
Commission, usually after a consultation meeting with the MAH, where the MAH’s
proposals or comments are discussed.
The
National Pharmacovigilance Commission is composed of representatives of health
authorities and research bodies, clinicians, toxicologists, pharmacol-ogists,
pharmacists, representatives of consumers and patients associations, and a
representative of the phar-maceutical industry. It can be supplemented and
guided as needed by invited experts. The Rapporteur Centre presents the
assessment report, in the pres-ence of the MAH representatives, who are invited
to comment and make their proposals. These are then discussed, first in the
presence, then in the absence of the MAH. The National Pharmacovigilance
Commis-sion provides advice to the General Director of the Agency on the
measures to be taken to prevent, reduce or eliminate drug-related risks. In the
case of centrally authorised products, the Commission’s recommendation is
forwarded to the Committee for Medicinal Products of Human Use (CHMP) of the
EMEA and other Member States for possible further action.
The
French pharmacovigilance system provides an active participation at the
European level which relies on a close co-operation between Member States
ensur-ing a common evaluation and management of safety concerns.
These
processes are relatively similar to the European processes, except that there
seems to be greater interaction and co-operation with the MAHs. This is built
into the system, and may be related to the fact that many of the industry
pharmacovig-ilance personnel have been trained in the Regional Centres. In
addition there are many programmes to enhance industry-regional centre
communications, such as commonly organised training courses, and yearly
workshops. In fact, the industry is a recog-nised part of the French
Pharmacovigilance System, which has been officially designated as including the
Agency, its Pharmacovigilance Unit and the Commis-sions it harbours, the
Regional Centres and the Indus-try Pharmacovigilance Departments.
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