Public Anti-Viral Stockpile Distribution for H1n1 Infection

1. Public Anti-Viral Stockpile Distribution for H1n1 Infection Sanford D. Zelnick D.O., M.S. Medical Director Volusia County Health Department

2. Goals • To assure availability and delivery of anti-viral medications to those who need them, regardless of ability to pay • To define a process for order and re-supply of anti-viral medications

3. Who should be treated • The CDC has identified the same high risk groups for treatment that are recommended for treatment with seasonal flu. • Children younger than 5 years old. The risk for severe complications from seasonal influenza is highest among children younger than 2 years old. • Adults 65 years of age and older. • Persons with the following conditions: • Chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, hematological (including sickle cell disease), neurologic, neuromuscular, or metabolic disorders (including diabetes mellitus); • Immunosuppression, including that caused by medications or by HIV; • Pregnant women; • Persons younger than 19 years of age who are receiving long-term aspirin therapy; • Residents of nursing homes and other chronic-care facilities. http://www.cdc.gov/h1n1flu/recommendations.htm, Accessed 23 September 2009

4. Treatment • Hospitalized patients are not specifically mentioned, but are indicated for any priority group patient that is hospitalized, particular for respiratory disease and more so if they are deteriorating, if the diagnosis is at all unclear etc.. • Information on specific formulations of anti-viral medications and their use is at: http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm

5. Anti-Viral Supply and Demand • Anti-viral medications will be made available through the following mechanisms: • Retail Pharmacies: • Florida Anti-Viral Stockpile • Strategic National Stockpile

6. Retail Pharmacies • Discussions are underway between the Bureau of Statewide Pharmaceutical Services and several large retail chains to participate. Local pharmacies are also encouraged to participate.

7. Florida Anti-Viral Stockpile • The Florida Department Of Health (FDOH) Bureau of Statewide Pharmaceutical Services (BSPS) has stockpiles of selected medications: • 900,000 doses of Tamiflu or Relenza in adult (capsule) or pediatric suspension to treat patients

8. Strategic National Stockpile • The Department of Health and Human Services has established a stockpile of anti-viral medications as part of their pandemic influenza preparedness efforts. • As of September 10, HHS has allocated 2,533,259 doses to Florida. • The VCHD currently has 2,929 treatment courses of Tamiflu for adults (2,929 bottles of 10, Tamiflu 75 mg)

9. Anti-Viral DistributionVCHD Clients • VCHD will prescribe antiviral medication to our clients: • Patients enrolled in primary care MediPass • Obstetrical patients under our care

10. Anti-Viral DistributionNon-VCHD Clients • Retail Pharmacies: • Under 64-F12.01 (1)(j)FAC, DOH may partner with local retail pharmacies to dispense public stockpile anti-viral medications without ability to pay (and without charge either to the patient or DOH) according to the administrative rule cited above. • For large pharmacy chains, this transfer will of medication will be accomplished between the BSPS and you through a centralized agreeement • For pharmacies that are not part of a larger chain, a Memorandum of Agreement will be sent to pharmacies that want to participate for signature • This is a one-way transfer of anti-viral medications…there is no way for you to return unused product. However, we have the right to request unused medication from you, if the need arises • For retail pharmacies that are not part of a large chain, a memorandum of agreement has been established for this purpose. You will also be supplied by the BSPS

11. Anti-Viral DistributionNon-VCHD Clients • Hospitals and Private providers (closed pharmacies, dispensing physicians): • Under F.S. 465.019(2)(b) and with the Emergency Public Health Declaration dated 9.1.09 hospital or other institutional pharmacies (closed pharmacies) may dispense a course of pharmaceutics in times of shortage with a valid prescription at no charge to the patient or to the DOH. • The same terms and conditions that apply to retail pharmacies apply to closed pharmacies • A Memorandum of Understanding (MOU) has been accomplished for this purpose

12. Anti-Viral Record Keeping and RecoveryRetail Pharmacies • As outlined in the MOU, retail pharmacies must maintain and be able to immediately produce for inspection, all records of the movement or transfer of all public asset anti-viral medications transferred to it. • Records to maintained include but are not limited to: • A perpetual inventory itemizing drugs received and drugs dispensed by prescription number or administered by patient identifier • This must be submitted to the DOH quarterly

13. Anti-Viral Record Keeping and RecoveryClosed Pharmacies and Private Providers • The same record keeping responsibilities apply, however, they are required to provide to the VCHD weekly an accounting of public asset anti-viral medications which were dispensed.

14. VCHD Points of Contact • Mr. Charles Honaker at 386-274-0764.

15. How To Participate • Sign up at www.volusiahealth.com

16. Questions?