Chronic noncancer pain includes a heterogeneous group of disorders and is often refractory to treatment. Cannabis products have historically been used for chronic pain and are attracting renewed pharmaceutical interest. Nabilone is a synthetic cannabinoid licensed in Canada for the treatment of severe nausea and vomiting associated with cancer chemotherapy. We have used nabilone off-label for t...

The scope of this study is to review the legal aspects of off-label prescription in Brazil compared to the US regulatory environment, to verify whether or not it derives from the structure of the current administrative regulatory process. It involved a bibliographic study in English and Portuguese in public databases of legislation, articles, books and dissertations using the key words 'off-lab...

OBJECTIVE To evaluate patterns of antipsychotic use. DESIGN, SETTING, AND MEASUREMENTS: We used nationally representative data from the IMS Health National Disease and Therapeutic Index to describe outpatient antipsychotic use. The primary outcome was the volume of visits where antipsychotics were used for specific indications (treatment visits). We also quantified use without U.S. Food and Dru...

Peyronie's disease is a disfiguring and psychologically devastating disease, which continues to pose a significant clinical conundrum to the attending doctor. Many forms of therapy have been trialled but results have been inconsistent at best. Non-surgical therapy revolves around oral, intralesional and shockwave therapies. The focus of this paper is on intralesional agents, their evolution and...

PURPOSE To estimate the prevalence of off-label and unlicensed prescribing during 2008 at a major paediatric teaching hospital in Western Australia. METHODS A 12-month retrospective study was conducted at Princess Margaret Hospital using medication chart records randomly selected from 145,550 patient encounters from the Emergency Department, Inpatient Wards and Outpatient Clinics. Patient and...

BACKGROUND Children are frequently prescribed medication 'off-label', meaning there has not been sufficient testing of the medication to determine its safety or effectiveness. The main reason this safety knowledge is lacking is due to ethical restrictions that prevent children from being included in the majority of clinical trials. OBJECTIVE The objective of this paper is to investigate wheth...

BACKGROUND Anecdotal evidence suggests that transcatheter aortic valve implantation (TAVI) is being used beyond pre-market label indications. METHODS To assess the frequency and outcomes associated with "off-label" use of TAVI, we conducted a retrospective study, examining adherence to patient selection criteria in 63 patients undergoing implantation with the 18F CoreValve ReValving System (C...

OBJECTIVES Our main objective was to evaluate the longer-term safety and efficacy of drug-eluting stents (DES) in off-label indications as compared with bare-metal stents (BMS). BACKGROUND DES are frequently implanted in patients with off-label indications. However, the longer-term safety and effectiveness of DES among patients with off-label indications are not well understood. METHODS Pro...

BACKGROUND/AIMS To compare the clinical outcomes of 'on-label' and 'off-label' drug-eluting stents (DESs) over a 5-year follow-up period. METHODS A total of 929 patients that underwent percutaneous coronary intervention with DESs were enrolled. Patients were divided into two groups according to on-label (n = 449) and off-label (n = 480) indications. Off-label use was defined as implantation o...

OBJECTIVE To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications. METHODS Chart audit in neonatal intensive care units of two institutions in Chandigarh, India. RESULTS Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% pres...