Strategy to address innovative off-label medication use in China: grading management

Dear Editor, The off-label use of medication is an important part of medical practice worldwide.Off-label medication use enables clinicians practicing to become more knowledgeable about treatment alternatives.Off-label medication use may lead to innovative new uses of old medications and new therapeutic advances, particularly when approved treatments have failed.Off-label use of medication can vary from being experimental or innovative or controversial to standard practice and even state-of-the-art treatment.So off-label use of medication carries a higher risk for the patient and the practitioner than its registered use.Awareness remains an issue in many conditions for both patients and prescribers, but unfortunately, abuse and overpromotion continue too frequently, so extra care should be taken.For example, since more than 35 years, the international medical scientific community tries to solve the problem of the off-label use of pediatric drugs.But the detailed analysis of the problem shows not only a still remaining lack of medical knowledge, but also persistent weaknesses in the ethical, legal, medical, pharmacological, and political practices that surround the phenomenon of off label use in pediatrics [1].So off-label use has become a worldwide problem.The key to solving this problem is how to regulate offlabel promotion.Off-label prescribing is legal in the USA and in many other countries.Zhang et al. reported in their study that seven countries had laws related to off-label medication use: American, Germany, Italy,