Uso de medicamentos a largo plazo
DEFINITION OF LONG-TERM USE
The CPMP has already defined long-term use in its carcinogenicity guidelines as ‘where the medicine is likely to be administered regularly over a substantial period of life, i.e., continuously during a mini mum period of six months or frequently in a n intermittent manner so that the total exposure is similar’.
Medicinal product therapy may therefore be classified as:
1. occasional, e.g., the infrequent use of an analgesic for occasional toothache or headache, the prescription of an antibiotic unlikely to be repeated, or an anaesthetic gas. This is not long-term use;
2. intermittent use, e.g. an antibiotic regularly prescribed for chronic bronchitis, or regular use of an analgesic for dysmenorrhoea;
3. prolonged use }
4. life-long use } e.g., treatment of epilepsy, hypertension, rheumatoid arthritis, or heart failure.
Categories 3 and 4 are considered as long-term use and will be applied to any medicinal product when current medical practice is likely to bring the medicinal product into one of these categories, irrespective of any particular recommendation of the company concerned. Whether 2 constitutes long-term use in the sense of the present note for guidance will depend upon the circumstances of the case, especially the nature of the disorder, but also the risks thought to be involved and the novelty of the compound. The examples given are illustrative and not meant to be an exclusive list.