Pharmaco-legal considerations in the clinical use of decongestants

Abstract

Thanks to changes in the health care environment, pharmacists are no longer viewed as merely dispensers of pharmaceuticals. They are now required to render judgments concerning patient therapy based on legal mandates directed at accuracy, efficiency, and quality of care. Moreover, pharmacists' decisions and actions are governed by legal requirements for patient counseling, drug therapy monitoring, and drug substitution. A number of these requirements stem from the federal Omnibus Budget Reconciliation Act of 1990 legislation relating to Medicaid, which mandates expanded responsibilities for pharmacists. For the past decade, however, state regulations have governed risk-assessment and risk-management responsibilities with regard to physicians and pharmacists. The original antisubstitution laws, which were exceptionally restrictive, have been replaced by newer regulations clearly defining pharmacists' legal responsibilities regarding drug substitution. These regulations address patient consent, cost savings, Orange Book standards, and delayed-release dosage forms. All of them have considerable impact on the dispensing of decongestants by pharmacists.