Source and Management of Reports

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Chapter: Pharmacovigilance: Spontaneous Reporting - France

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 1001101). 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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