Info

IMPORTANT: PLEASE INDICATE ANY EVENTS REPORTED TO CSM OR MANUFACTURER "This enables i'OV m itfentify the patient in any future carraspauilenee catleerning this reparl

Figure 26.1 Green form.

IMPORTANT: PLEASE INDICATE ANY EVENTS REPORTED TO CSM OR MANUFACTURER "This enables i'OV m itfentify the patient in any future carraspauilenee catleerning this reparl

Figure 26.1 Green form.

Table 26.1. Reports for which additional information is sought.

• Medically important adverse events reported during pre-marketing development

• Medically important events reported during postmarketing in other countries (for products launched elsewhere before the UK)

• Events considered to be possibly associated with the product during the PEM

• All pregnancies

• Any deaths for which the cause is not known or which may be related to the medication

• Reports of overdose and suicide given in Table 26.2, are derived from the mean 52% of returned green forms which provide clinically useful data.

PEM collects event data and does not ask the doctor to determine if any particular event is due to an adverse drug reaction (ADR). If, however, the doctor does consider the event to be an ADR or he has completed a yellow card (a spontaneous ADR report) regarding the event, then he is asked to indicate this on the green form.

Further details of the methodology of PEM, including the methods of data coding, computerisation, and analysis, have been provided in a number of publications (Inman, 1978b; Free-mantle et al., 1997; Mann et al., 1997).

Table 26.2. List of 78 completed studies.
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