Clinical Prescribing (and Off-Label Use) in a Second-Best World

ArticleinMedical care 48(4):285-7 · February 2010with8 Reads
DOI: 10.1097/MLR.0b013e3181d60408 · Source: PubMed
  • [Show abstract] [Hide abstract] ABSTRACT: "Off-label" in relation to the use of medication means that a medicine is used in another way or for indications other than those specified in its conditions of registration and reflected in its labelling. The off-label use of medication accounts for an estimated 21 per cent of drug use overall and is an important part of mainstream, legitimate medical practice worldwide. In South Africa, legislation prohibits the dissemination of information regarding the off-label use of medication. There are diverging views on whether pharmaceutical companies should be allowed to distribute scientific publications on off-label uses of approved drugs. Current policy in the United States of America (USA) eases restrictions on the dissemination of information of this nature. The prohibitions existing in South Africa, however, are more comparable with those in European countries. After analysing the different legal positions on the issue, it is submitted that pharmaceutical companies should not be allowed to disseminate information on off-label uses, but that the regulatory authority play an active and leading role in providing the latest, objective medical and scientific information, as well as guidelines on the off-label use of medication. Other related recommendations are also made.
    Article · Mar 2011
  • [Show abstract] [Hide abstract] ABSTRACT: To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes. The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts. Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.
    Full-text · Article · Jan 2012
  • [Show abstract] [Hide abstract] ABSTRACT: Empirical research has proven the influence exerted by the medical industry on physicians' decision-making. Physicians are the gatekeepers who determine how money is spent within the healthcare system. Hence, they are the target group of powerful lobbies in the field, i.e. the manufacturers of medical devices and the pharmaceutical industry. As clinical research lies in the hands of physicians, they play an exclusive and central role in launching new medical products. There are many ethical problems involved here: physicians may develop a mindset of entitlement; biased decisions may put patients at risk; academic interests and research activities will no longer be free if they are influenced considerably by financial incentives; fair resource allocation may be restricted. An aspect that has been neglected so far is the administrators' involvement as they not rarely expect physicians to acquire external financial resources from industry as benefits often lie with the institutions. To "protect" physicians from undue sway may be in the best interest of patients in order to guarantee a fair allocation of resources and to prevent the application of technologies (and medications) that would not have been used according to current standards of care. The latter may and obviously does put patients at risk. On the other hand, medico-industrial relations are of great importance. A considerable part of medical progress is driven by private industry. Yet, any co-operation between those who care for patients and industry ultimately has to serve the patient. Hence, strong policies to guide conduct are sorely needed. The following points are held to be pivotal in order to secure ethical conduct: (1) professional codes of ethics; (2) a stronger academic attitude amongst medical staff, (3) rules of transparency for medico-industrial relations including online disclosure and limiting scale of payments, (4) establishing rules (and laws) that ban unethical conduct and mandate vigorous surveillance of adherence to guidelines.
    Full-text · Article · Mar 2012
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