Subject


The normal distribution channel for antiviral prescription drugs is from the manufacturer to a wholesaler to the dispensing retail pharmacy. Current law and rule do not allow the Department of Health to transfer antivirals (received from the Strategic National Stockpile, or, “public health antivirals”) from the Department to retail pharmacies, unless there is a shortage of antivirals or a distribution delay. There is no shortage or delay, but at the present time only a barrier arising from the high cost of antivirals (approximately $100 for a 5-day treatment course). Several major pharmacy chains have agreed to dispense antivirals, without cost, to persons bearing a valid prescription but lacking ability to pay for these antivirals (an effective “shortage” if antivirals are unaffordable). One exception to the prohibition against the wholesale distribution of prescription drugs is for “emergency medical reasons.” The Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, contains a provision in Section 499.003(53)(b)2., F.S., for the “emergency medical reasons” exemption to the prohibition against the wholesale distribution of prescription drugs by health care entities if the distribution is conducted in accordance with the rules established by the department. Rule authority is found in Section 499.05(1)(i), F.S., to implement an emergency medical reason exemption. The emergency rule provides the mechanism to allow the Department of Health to transfer public health antivirals to licensed Florida retail pharmacies willing to dispense those antivirals without cost to ill persons with a prescription for the same, so that Florida residents and visitors have access to treatment for the novel influenza regardless of inability to pay. County Health Departments are authorized under current rule to accept a patient’s oral representation of inability to pay. Subsection 64F-16.003(3), F.A.C. Department of Health will suggest that licensed retail pharmacies may choose to apply this standard regarding ability to pay.