Communication Of Benefitrisk Information

Currently, the emphasis of communication is on deciding whether a drug should be available or not and communicating that information, and the provision of official information in summaries of product characteristics (SPCs) and their equivalents, or in formularies. Decisions are made by regulators and the industry and their professional advisers as a result of a debate that is not transparent to consumers in most countries. Medicines are somewhat different from most other consumer products, in so far as patients generally do not have the ability, either because of lack of knowledge or insight, to make good choices about their own treatment. The question then arises as to whether health professionals, as learned intermediaries, have the correct or sufficient information on the benefits and risks of drugs from information that is readily available during clinical practice, e.g. reference books and SPCs.

Patient information leaflets are now promoted by some authorities, such as the EU and industry. These moves seem reasonable, but there must be a review of their effectiveness.

Communication to health professionals on adverse reactions needs to give some idea of their likelihood, severity and possible outcome to be useful to a clinician, and, of course, their patients. Little of this information is made available, nor is the level of certainty made clear on the evidence for most reactions.

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