Decisionmaking And Risk Management

The objective of the EU competent authorities is to take regulatory actions which are justified by scientific evidence, and allow users to make informed decisions and to use medicines safely. Sometimes the balance of risks and benefits will be sufficiently clear to allow firm recommendations (such as contraindications), whilst in other situations less directive advice will be warranted.

The types of action which may be taken vary according to potential means of preventing the adverse reaction. In particular, hazards may be minimised by targeting the drug at patients least likely to be at risk of the ADR and by specifically contraindicating it in patients with identifiable risk factors. Dose and duration of treatment are often important issues since the risk of many hazards is related to one or both of these parameters. It is quite common for dosage regimens to change during the post-marketing period in response to safety concerns and many drugs have been initially recommended at doses higher than necessary. In re-evaluating dose in response to a safety concern, consideration is also given to the evidence of efficacy at lower doses.

The identification of a new ADR or the accumulation of important new evidence about a recognised reaction leads to a need to make changes to the product information, and hence to vary the marketing authorisation(s). Variations to marketing authorisations on safety grounds may be proposed by the competent authority or pharmaceutical company. Regardless of who proposes the changes, there is exchange of information and discussion between the parties before a variation is submitted in order to facilitate rapid implementation. When the competent authorities and companies are in agreement about the nature and impact of a drug safety issue, changes can be made on a voluntary basis by the marketing authorisation holder. However, if the companies do not agree about the actions required, then the competent authorities may exercise compulsory powers. Exceptionally, when the issue has urgent public health implications the authorities may act rapidly, without a right of appeal by the company, to immediately withdraw the product(s) from the market by suspension of the authorisation(s) or to change the product information.

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