7653802, 64FER09-1 - Florida Administrative Rules, Law, Code, Register

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Notice: 7653802

Notice of Emergency Rule

Department:

DEPARTMENT OF HEALTH

Division:

Division of Family Health Services

Overview

RULE:

64FER09-1

Wholesale Distribution of Prescription Drugs - Exceptions and Specific Distributions Authorized

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE:

Influenza, commonly called “the flu” is an infection of the respiratory tract caused by the influenza virus. On June 11, 2009, the WHO Director-General Dr Margaret Chan issued a statement raising the level of pandemic influenza alert to Phase 6, beginning the 2009 Influenza Pandemic, stating: “This particular H1N1 strain has not circulated previously in humans. The virus is entirely new. The virus is contagious, spreading easily from one person to another, and from one country to another. . . Spread in several countries can no longer be traced to clearly-defined chains of human-to-human transmission. Further spread is considered inevitable.”
On April 26, 2009, Acting HHS Secretary Charles Johnson determined that a nationwide Public Health Emergency existed, with potential to affect national security. On June 19, 2009 the HHS Secretary further issued a federal PREP Act declaration identifying the pharmaceuticals Tamiflu and Relenza as “covered countermeasures” to address the threat of or actual human influenza that results from the infection of humans with highly pathogenic avian influenza A viruses including the swine H1N1 virus. On June 25, 2009 the HHS Secretary issued a PREP Act declaration similarly identifying the 2009 H1N1 vaccines as a “covered countermeasure” for that same purpose, and, on July 14, 2009 the FDA issued an Emergency Use Authorization letter expanding uses of Tamiflu for treatment and prophylaxis of influenza. Finally, following her confirmation by the Senate as Secretary of HHS, on July 24, 2009 Secretary Kathleen Sebelius renewed that Public Health Emergency declaration.
On May 6, 2009 CDC released guidance for antiviral treatment of influenza in certain high-risk groups, stating, “A person who is at high-risk for complications of novel influenza (H1N1) virus infection is defined as the same for seasonal influenza at this time.”
&#9679;	Children younger than 5 years old. The risk for severe complications from seasonal influenza is highest among children younger than 2 years old.
&#9679;	Adults 65 years of age and older.
&#9679;	Persons with the following conditions:
&#9679;	Chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological (including sickle cell disease), neurologic, neuromuscular, or metabolic disorders (including diabetes mellitus);
&#9679;	Immunosuppression, including that caused by medications or by HIV;
&#9679;	Pregnant women;
&#9679;	Persons younger than 19 years of age who are receiving long-term aspirin therapy;
&#9679;	Residents of nursing homes and other chronic-care facilities.
&#9679;	On the same date, CDC stated that no person should be denied treatment with antivirals due to inability to pay. The identical position was announced the preceding day, May 5, 2009, by the Florida Department of Health regarding access to treatment.
In May 2009 the Department of Health received 25% of Florida’s allocation of Strategic National Stockpile antivirals to treat persons ill with influenza, and another 25% is arriving this week. Dispensing by retail pharmacies is the most expeditious way to get antivirals to ill persons who need them, particularly since the influenza is impacting schoolchildren – many of whom participate in the School Lunch Program, a need-based program.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES:

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.

SUMMARY:

This emergency rule authorizes the transfer of public health antivirals from the Department of Health to licensed retail pharmacies, for dispensing to persons unable to pay for antivirals.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS:

Rebecca Poston, R.Ph., Director, Drugs, Devices & Cosmetics Program, Department of Health, 4052 Bald Cypress Way, Bin #C-04, Tallahassee, Florida 32399-1703

PRINT PUBLISH DATE:

9/25/2009 Vol. 35/38

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://www.flrules.org/gateway/ruleno.asp?id=64FER09-1&PDate=9/25/2009&Section=4

REFERENCE MATERIALS:

No reference(s).

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