PHARMACO-LEGAL CONSIDERATIONS IN THE CLINICAL USE OF DECONGESTANTS

Thanks to changes in the health care environment, pharmacists are no l onger viewed as merely dispensers of pharmaceuticals. They are now req uired to render judgments concerning patient therapy based on legal ma ndates directed at accuracy, efficiency, and quality of care. Moreover , pharmacists' decisions and actions are governed by legal requirement s for patient counseling, drug therapy monitoring, and drug substituti on. A number of these requirements stem from the federal Omnibus Budge t Reconciliation Act of 1990 legislation relating to Medicaid, which m andates expanded responsibilities for pharmacists. For the past decade , however, state regulations have governed risk-assessment and risk-ma nagement responsibilities with regard to physicians and pharmacists. T he original antisubstitution laws, which were exceptionally restrictiv e, have been replaced by newer regulations clearly defining pharmacist s' legal responsibilities regarding drug substitution. These regulatio ns address patient consent, cost savings, Orange Book standards, and d elayed-release dosage forms. All of them have considerable impact on t he dispensing of decongestants by pharmacists.