The use of unlicensed and "off-label" medicines in children is widespread. Between 50-80% of the medicines currently administered to children have neither been tested nor authorized for their use in the paediatric population which represents approximately 25% of the whole European population. On 26 January 2007, entered into force the European Regulation of Paediatric Medicines. It aims at the ...

It is difficult to draw up a list of medicines that are essential for infants and children. It is clear, however, that many of the medicines used appropriately to treat infants and children are not licensed for such use.1 The medicines concerned may be used outside the terms of their product license, ie, used off-label, or unlicensed for use in children at any age.2 Off-label use appears to be ...

BACKGROUND Medications are frequently prescribed outside their regulatory approval (off-label) by physicians particularly where appropriate therapies are not available. However, the risk/benefit ratio of drugs in off-label use needs to be critically appraised because it may differ from approved on-label usage. Therefore, an extensive exploration of current evidence on clinical data is well-advi...

Introduction Despite their limited licensed indications, anti-IL1 agents are often used in real-life practice for an increasing number of diseases. A national survey to record the off-label use of this class of therapeutics in France was started in January 2011. The survey is coordinated by the French National Reference Centre for Auto-inflammatory Diseases, under the aegis of the “Club Rhumati...

Over the last decades, an increase in antipsychotic (AP) prescribing and a shift from first-generation antipsychotics (FGA) to second-generation antipsychotics (SGA) among youth have been reported. However, most AP prescriptions for youth are off-label, and there are worrying long-term safety data in youth. The objective of this study was to assess multinational trends in AP use among children ...

OBJECTIVE To develop a practitioner led definition of a prescribing error for use in prevalence/incidence studies in paediatric practice. DESIGN A two stage Delphi technique was used to obtain the views of a panel of expert health professionals working in the hospital paediatric setting. The extent of their agreement on a definition of a prescribing error, and on 40 scenarios that might be cl...

China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe...

OBJECTIVE To examine off-label use and costs of antihypertensive drugs in children by using a national sample of prescription claims. METHODS We conducted a cross-sectional study using the 2002 Medstat MarketScan Database, a national sample of outpatient prescription claims of children <or=18 years old enrolled in private, employer-sponsored health plans. Our main outcomes were off-label use ...

Given the highly political nature of abortion in the United States, the provision of medical abortion with mifepristone (Mifeprex®) and misoprostol has always occurred under a unique set of circumstances. The Food and Drug Administration-approved regimen requires clinicians to administer the mifepristone in the office and also requires women to return to the office for the misoprostol. In the U...