Recommendations

The working group formulated a total of 65 proposals relating to general principles of good safety information and the what, when, how, where and who (responsibilities) for CSIs. A selection of the most useful principles is given below.

What?

* The CSI should be determined by the needs of healthcare professionals in the context of a regulatory and legal environment.

* Include what is practical and important to enable the prescriber to balance risks against benefit and to act accordingly.

* Avoid including events, especially minor events, that have no well-established relationship to therapy.

* There is a legal duty to warn but this must be balanced against the need to include only substantiated conclusions in the CSI.

* The CSI should include important information which physicians are not generally expected to know. (The converse is also true.)

When?

* As soon as relevant safety information becomes sufficiently well established it should be included in the CSI.

It was not possible to define this more precisely but the working group introduced the concept of "threshold". This is dependent on the quality of information available and the body and strength of the evidence according to the 39 criteria (plus two additional ones subsequently identified) in the ranking exercise described above. Situations in which the threshold should be lowered were identified. In general, information should be added sooner whenever it is likely to help the physician make a differential diagnosis related to an adverse event, spare extra tests, lead to the use of a specific targeted test or facilitate early recognition of an event. Similarly, the threshold should also be lowered if the ADR is medically serious or irreversible, if good alternative drugs are available, a relatively trivial condition is being treated, or the drug is being used for prophylaxis.

How?

* Keep ADRs identified in the initial CSI (premarketing experience) separate from those identified subsequently.

* ADRs should be listed by frequency in body system order.

* Whenever possible, an estimate of frequency should be provided, expressed in a standard category of frequency.

While the working group recognised that precise frequency rates can only be obtained from studies and are limited to the more common reactions, it was agreed that estimates of frequency in a standard format should be provided whenever possible. Although it is difficult to estimate incidence on the basis of spontaneous reports due to the uncertainties in estimating denominator and the degree of under-reporting, the group recommended the standard frequencies shown in Table 25.3.

Table 25.3. CIOMS III standard frequencies.

Incidence

Standard frequencies

Very commona

>1/10 (10%)

Common (frequent)

>1/100 and <1/10

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