Alert Management

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Chapter: Pharmacovigilance: Spontaneous Reporting - France

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 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:

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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