[Unlicensed and off label usage of some drugs in obstetric practice].
Off label usage refer with prescribing of some drugs outside indications licensed by the regulatory organs of the country or is in conflict with the product information. During pregnancy there are cases, when the health of the mother is a priority and the obstetrician has no alternative, except off label using the medication. The examples, which we show, include usage of different drugs in Bulgaria with their unlicensed indications, age group, dosage and duration of the curing course. Unlicensed usage is not illegal, because of necessity to meet the special needs of the patient. Such prescribes can not be accepted as an experiment, if there are based over publications in scientific magazines or/and presented in international congresses and consensuses. That question is covered by EC Pharmaceutical Directive 89/341 EEC.
Bozhinova
S
S
Tsvetkov
D
D
D002031:Bulgaria; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D017723:Drug Utilization Review; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D009774:Obstetrics / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D010818:Practice Patterns, Physicians' / Q000639:trends
D004364:Pharmaceutical Preparations