Study On Status And Countermeasures Of Drug Off-label Use

ObjectiveThe study stays focused on the analysis of the status and stewardship circumstance of off-label use of drug, which may offer background reference for the management to a national strategic level.ContentsThis paper introduced the concept, classification and legal standing of off-label use of drug. Drawing on analysis on its status and legal nature, with the knowledge cognition of off-label drug use in a specialized hospital, the analysis provides a series thinking of exsiting problems of off-label drug use facing stewardship circumstance, then put forward corresponding management countermeasures.MethodsThis study defined the off-label drug use and identify the legal standing of it by means of literature review; a questionnaire survey was conducted to look into medical staffs’ comprehension about off-label use; we conducted a field survey and consultation to understand the current status of off-label use in a specialized hospital finding the management deficiencies, off-label use’s risks and stewardship circumstance; finally, the management proposals were provided by the qualitative analysis.ResultsThe concept and the reasons of off-label use in medical practice can be listed as follows. Off-label use of drug is one that fails to conform to the drug instruction which was approved by regulatory authority, and off-label use of drug is truly be influenced by many factors. The present state of off-label use of drug in the selected hospital is as follows. Data were collected from1134patients.738patients had received at least one off-label use drug, accounting for65.08%of the total.The legal nature of off-label prescribing in medical practice, according to diagnosis and treatment standard, is rational administration of drug. And doctors’rational prescribing behavior should be protected by law.Many clinicians still have no clear thoughts about the legality of off-label use in the selected hospital. About41.18%of subjects thought that doctors have no right to prescribe off-label use of drug;35.29%of subjects considered that off-label use of drug is a violation of law; and29.41%advocated that off-label use should be prohibited.The hospital has poor capacity in off-label use management. For example, lack of related management system, ineffective implement of informed consent, and the weak role of the medical prescription evaluation.At present, doctors are facing a complicated stewardship circumstance, which gives a severe challenge to drug off-label use. Diagnosis and treatment standards are not good enough to serve the clinical practice, administrative departments still have different opinions on drug off-label use, and the judgment of the judicial organs is influenced by many other factors.ConclusionsIt is rational and necessary that drug off-label use should be widely used in clinical practice, but population still have a lack of understanding of drug off-label use; and supervision and guidance of drug off-label use should be strengthened to avoid irrational administration of drug.There is a severe challenge to drug off-label use. The diagnosis and treatment standards are not good enough to serve the clinical practice, administrative departments still have different opinions on drug off-label use, and the judgment of the judicial organs is influenced by many other factors, which raise the risk of drug off-label use.Working out the practical diagnosis and treatment standard can improve the level of clinical use of drugs and ensure safe drug usage.The effective implement of informed consent is the effective means to reduce the occupational risk of drug off-label use.SuggestionsThe legal status of drug off-label use should be clarified by the authority, and the guidelines for drug off-label use should be issued.Establish a multi-channel fund-raising relief system of adverse drug reaction, in which proper compensation for the accidental damage is available.Set up clinical diagnosis and treatment standardsconsidering medicines, demands of clinical therapy and drugs’ information of safety and effectiveness acquired by medical practice.Establish an effective mechanism of doctor-patient communication, to ensure patients’ right to know the truth and to make decisions in the course of treatment.