Post-marketing surveillance is needed for off licence use of drugs in children

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منابع مشابه

Off-label use of drugs in children.

The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, including more than 500 labeling changes. However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in ...

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Post-marketing surveillance of buprenorphine.

PURPOSE This study was undertaken to evaluate the adverse consequences of recently introduced higher strength (0.4 and 2.0 mg per tablet) buprenorphine in Indian market. Buprenorphine, a partial opiate agonist and antagonist, is an emerging alternative to methadone as an agent for long-term treatment of opiate dependence. METHODS The current investigation was conducted through a multi-centric...

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Off licence and off label prescribing in children: litigation fears for physicians.

So-called "off label" and unlicensed prescribing refers to the use of medicines outside of the indications for which they are licensed by national regulatory bodies. Off label prescribing is quite common in children, as most drugs are developed only on the basis of trials with adults. Nevertheless, physicians and hospitals can be wary of using medicines in this way for fear of litigation if adv...

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Patients' motives for participating in active post-marketing surveillance.

PURPOSE Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, ...

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Post Marketing Surveillance on Propranolol and Atenolol Tablets Manufactured in Iran

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ژورنال

عنوان ژورنال: BMJ

سال: 2003

ISSN: 0959-8138,1468-5833

DOI: 10.1136/bmj.326.7391.712/a