Source And Management Of Reports

Reports to regional centres come from several sources:

• Spontaneous reports sent by healthcare professionals. There is no official form for reporting ADRs to Regional Centres. 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 hospitals, the appropriate departments (internal medicine, haematology, dermatology, hepatology, for instance) can be regularly visited or contacted for hospitalised drug-related cases. These departments sometimes have "drug staffs'' where drug-related problems can be discussed with the team from the Department of Pharmacology. In addition, 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, i.e. 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 clinician 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 clinician 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 for causality using the French imputation method (see below) (Begaud et al., 1985), reports are input to the national pharmaco-vigilance 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 serious 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, especially 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 (Montastruc et al., 2000; Moore et al., 1993, 1997), to generate some measure of reporting disproportionality 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 Evaluation Agency (EMEA) as required by European regulations.

Pharmaceutical Companies

Pharmaceutical companies also have to comply with the European regulations, including 15-day transmission of serious ADRs occurring on French territory to the Agency, and the submission of Periodic Safety Update Reports (PSURs) according to defined periodicity. 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. The whole database system is presently being overhauled to provide electronic data transfer to and from industry, in order to avoid manually re-entering data or sending reports.

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