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Philosophy, Prescriptions, and Politics

Douglas R. Bess, MD
JAMA. 1980;243(6):525-527. doi:10.1001/jama.1980.03300320017013.
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Philosophy  SINCE the 1960s, the complex topic of so-called "substitution, drug product selection, or generic dispensing"1 has evoked much stürm und drang ("storm and stress") in both lay and professional articles. To the detriment of patient, physician, and pharmacist, the issue of generic substitution has been more obfuscated with rhetoric than enlightened by fact. Even exactly what is debated is often unclear, as "positions have had time to harden into symbolic and rigid polarities: Free Enterprise vs. Government, Big Business vs. Consumer Groups, and—especially today—Quality Assurance vs. Cost Containment."2Basic concepts of pharmacokinetics (the study of the absorption, distribution, metabolism, and excretion of a drug) have been reviewed elsewhere3 and will not be covered in this article. The reader, however, is strongly urged to acquaint himself with the basic concepts of bioavailability—such as disintegration and dissolution rates, single-dose and steady-state study designs, blood concentration-time curves, and the


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