- All > Medicine Access and Rational Use > Rational Use
- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- Keywords > advertisement and promotion
- Keywords > Good Prescribing Practice (GPP)
- Keywords > inappropriate use
- Keywords > medicines use - patterns and trends
- Keywords > mésusage - prescription hors AMM
- Keywords > off-label uses - prescriptions
- Keywords > pharmaceutical advertisements
- Keywords > pharmaceutical promotion
- Keywords > proper use
- Keywords > safety
(2013; 93 pages) [French]
The off-label uses of a drug have always existed: between 15 and 20% of all prescriptions are reported in the literature, even more in certain areas such as pediatrics, gerontology, or and oncology. Up to 78% of physicians have prescribed drugs for off-label uses according to a recent survey. If those are sometimes justified, recent incidents have shown failures in the whole chain of the drug industry involving many actors: from manufacturers, that sell the medicine to the authorities granting the marketing authorization and reimbursement, to prescribers and pharmacists, not to mention the more or less informed patients who seek and demands results.
In addition, studies show that drugs were involved in 40% of avoidable serious adverse effects. The definition of "avoidable" or "preventable" is "would not have occurred if the treatment had been in line with management considered satisfactory" or "situation that deviates from procedures or outcomes expected in a normal situation and that is or would be a potential source of harm." If medication errors are the most common causes of these unwanted side effects, off-label uses also contribute to them. However, the figures raise the question of the poorly managed uses of the drug...
Among all the provisions that concern the management of prescriptions for the proper use of drugs, there is one about the advertising of medicinal products to healthcare professionals. Indeed, since the budget for marketing and publicity represents approximately 23% of the pharmaceutical companies revenue, and the average yield in additional sales per dollar invested in pharmaceutical advertising was 8.34 USD in 2004, it has been established that the promotional efforts (advertising, sales representatives, congresses, medical journals ..) could have a negative impact on medical prescriptions going against health requirements, as was the situation in the Mediator case: thus, an a priori control of advertising has been restored.
We will consider the merits of this measure regarding both the off-label prescriptions and the misuses.