Off-label prescribing is an integral part of contemporary medicine. Many patients benefit when they receive drugs or devices under circumstances not specified on the label approved by the Food and Drug Administration (FDA). An off-label use may provide the best available intervention for a patient, as well as the standard of care for a particular health problem. In oncology, pediatrics, geriatrics, obstetrics, and other practice areas, patient care could not proceed without off-label prescribing. 1 When scientific and medical evidence justify off-label uses, physicians promote patients' interests by prescribing products off label.Off-label prescribing can also harm patients, however. The potential for harm is greatest when an off-label use lacks a solid evidentiary basis. A 2006 study examining prescribing practices for 169 commonly prescribed drugs found high rates of off-label use with little or no scientific support. 2 Researchers examining off-label use in U.S. children's hospitals concluded, "[W]e still have incomplete knowledge about the safety and efficacy of many medications commonly used to treat children across a range of drug classes and clinical diagnoses." 3 More than half the respondents in a survey of academic medical centers reported that innovative off-label prescribing raised concerns in their institutions, such as lack of data, costs, and unfavorable risk-benefit ratios.4 When substantial uncertainty exists about off-label applications, patients are at risk of receiving harmful or ineffective treatments.Legal authorities recognize physicians' discretion to prescribe products off label. 5 In the existing regulatory framework, once the FDA approves a product for marketing, physicians may prescribe it for indications or patient populations not included on the label. They may also prescribe drugs at dosages or using methods of administration not specified on the label. 6 Omission from the approved label does not mean that the FDA disapproves of an off-label use, it simply indicates that the agency has not reviewed that use. Of course, like other parts of medical practice, off-label prescribing can lead to malpractice liability if it fails to conform to accepted standards of care. 7 In a perfect world, all uses of drugs and devices would be supported by solid research. The existing regulatory system fails to impose this high standard, however, and the private sector often lacks incentives to conduct rigorous evaluations of off-label uses. In the current situation, the medical community has primary responsibility for determining when off-label prescribing is appropriate for patients. But appropriate off-label prescribing can be challenging for physicians today, because of time pressures, information overload, and the involvement of industry in research and education about off-label uses.Responsible off-label prescribing requires physicians to: (1) evaluate whether there is sufficient evidence to justify an off-label use; (2) press for additional information and research when NIH Public Access
Pediatricians commonly face vaccine refusal that they perceive to be due to parent safety concerns. In response, many pediatricians say they would discontinue care for families refusing some or all vaccines. This willingness to dismiss refusing families is inconsistent with an apparent ambivalence about newer, yet recommended, vaccines. The practice of family dismissal needs further study to examine its actual impact on vaccination rates, access to care, and doctor-patient relations.
Background The American Academy of Pediatrics recommends that pediatricians become knowledgeable in and comfortable with providing palliative care. Objective The study goals included: determining the extent of training, knowledge, experience, comfort and competence in palliative care communication and symptom management of pediatric residents and fellows; obtaining residents’ and fellows’ views on key palliative care concepts; identifying topics and methods for palliative care education; and identifying differences in responses between residents and fellows. Design/Methods In academic year 2006–2007 pediatrics residents and fellows completed a survey on: training, experience, knowledge, competence, and comfort in delivering palliative care; palliative care practices; and suggestions for delivering palliative care education. Results Fifty-two (60%) and 44 (62%) residents and fellows respectively completed the survey. Residents and fellows described none to moderate levels of training, experience, knowledge, competence and comfort in palliative care. Most respondents said they would benefit from more formal palliative care training. Respondents identified discussing prognosis, delivering bad news, and pain control as the three most important areas of needed education. Learning about supporting families spiritually and emotional support for physicians were among the least important educational areas identified. Respondents recommended delivering education via observation, bedside teaching, and participation in multidisciplinary groups. Conclusions Efforts to improve education in pediatric palliative care are needed. A palliative care team could facilitate palliative care education through engaging trainees in “real-life” interactions. The role of physicians in providing spiritual support and the need for educating physicians in obtaining emotional support for themselves merit further investigation.
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