Abstract: A method for restricted distribution of a drug to a patient while minimizing the occurrence of adverse side effects. The method restricts access to the drug by preventing distribution to certain patients for whom the drug may be contraindicated. The method permits a prescription to be filled by a pharmacy only after the pharmacy has received an approval for release of the prescription. Generation of the prescription approval depends on registration of a prescriber, pharmacy and patient in a central database, and the determination that the risk is acceptable that the patient will experience an adverse side effect. The database contains a patient profile that may include additional patient-specific health-related information that is probative of the risk that an adverse side effect is likely to occur if the patient is exposed to the drug. Based in part on the information in the patient profile, the registered prescriber makes a determination as to the patient's risk of adverse side effects.