Florida Antiviral Product Availability Survey - Time Sensitive
Florida Temporarily Lifts Restrictions on Wholesaling of Antivirals
FDA Suggest Holding Short Dated Antiviral Medications
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Florida Antiviral Product Availability Survey
The Florida Pharmacy Association has been working with state government on the issues surrounding the H1N1 virus outbreak. According to the Center for Disease Control there are 642 laboratory confirmed cases of H1N1 influenza (swine flu) infections in the United States. Five cases have been confirmed in Florida with 2 deaths (both in Texas). Forty one states have reported active cases. More current information on H1N1 is available on the CDC web site at http://www.cdc.gov/h1n1flu/.
The Center for Disease Control has published the following information on their web site:
Antiviral drugs are prescription medicines (pills, liquid or an inhaler) with activity against influenza viruses, including swine influenza viruses. Antiviral drugs can be used to treat swine flu or to prevent infection with swine flu viruses. These medications must be prescribed by a health care professional. Influenza antiviral drugs only work against influenza viruses -- they will not help treat or prevent symptoms caused by infection from other viruses that can cause symptoms similar to the flu. There are four influenza antiviral drugs approved for use in the United States (oseltamivir, zanamivir, amantadine and rimantadine). The swine influenza A (H1N1) viruses that have been detected in humans in the United States and Mexico are resistant to amantadine and rimantadine so these drugs will not work against these swine influenza viruses. Laboratory testing on these swine influenza A (H1N1) viruses so far indicate that they are susceptible (sensitive) to oseltamivir and zanamivir.
Members have reported to the FPA that there has been some issues with the availability of these drugs. To help respond to questions from the Department of Health and the Governor's office we ask that you take a moment to respond to this very important survey. Please respond only once. The survey will take only about 2 to 3 minutes. Please feel free to forward this message to other pharmacies. The more responses that we receive the better information that we can provide to the state. Enter here for the survey link.
Florida Temporarily Lifts Restrictions on Wholesaling of Antivirals
The Florida Department of Health has lifted pedigree requirements for the wholesaling of Tamiflu and Relenza into this state. That order dated May 1, 2009 reads as follows:
State of Florida
Department of Health
Declaration of Public Health Emergency
Department of Health
Declaration of Public Health Emergency
As a consequence of confirmed cases of Swine Influenza A (swH1N1) in Broward and Lee Counties, the potential for the disease to further spread throughout the State of Florida, and after consultation with Governor Charlie Crist and public health officials witnin the Department of Health, I, Ana M. Viamonte Ros, M.D., MPH, State Surgen General, pursuant to the authority vested in me under section 381.00315(1)(b), Florida Statutes, do hereby determine that a public health emergency exists in the State of Florida involving swH1N1 that has the potential to result in substantial injury or harm to the public health.
In order to protec the public health, I hereby suspend the pharmaceutical pedigree requirements under section 499.01212(1), Florida Statutes, as applicable to the wholesale distribution of the prescriptions drug Tamiflu and Relenza needed to cope with this emergency.
In accordance with section 381.00315(1)(b), Flroida Statutes, this Declaration shall remain in effect for sixty days unless amended, rescinded, or renewed with the concurrence of the Governor.
Ana M. Viamonte Ros, M.D., MPH
State Surgeon General
State Surgeon General
The Department of Health also temporarily lifted Florida wholesale permitting requirements for the distribution of Tamiflu and Relenza. To view that order go to this link.
In an additional supplemental emergency order the Department of Health also lifted the restriction of the dispensing of Tamiflu and Relenza to clients of facilities with a class II institutional pharmacy permit. That order can be viewed through this link.
In an additional supplemental emergency order the Department of Health also lifted the restriction of the dispensing of Tamiflu and Relenza to clients of facilities with a class II institutional pharmacy permit. That order can be viewed through this link.
Pedigree requirements on Tamiflu and Relenza has also been temporarily suspended. To view that order enter here.
FDA Suggests Holding Short Dated Antiviral Medications
http://www.fda.gov/h1n1flu/default.htm
During this public health emergency, the Food and Drug Administration (FDA) has issued Emergency Use Authorizations that expand access to medical products that may become necessary. Two antiviral treatments covered by Emergency Use Authorizations, Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included in many emergency stockpiles. All companies, U.S. states and localities, and other organizations with Tamiflu and Relenza that are approaching, or past, the labeled expiration date, are urged to consider keeping it while the U.S. Department of Health and Human Services evaluates options, including those that may allow for their use if needed during this 2009 H1N1 flu virus outbreak. These organizations are also urged to contact the FDA’s Emergency Operations Center with information on how much Tamiflu and Relenza in their stockpiles is at or approaching expiration. This information should be reported to:FDA’s Emergency Operations Center 301-443-1240.
FDA Suggests Holding Short Dated Antiviral Medications
http://www.fda.gov/h1n1flu/default.htm
During this public health emergency, the Food and Drug Administration (FDA) has issued Emergency Use Authorizations that expand access to medical products that may become necessary. Two antiviral treatments covered by Emergency Use Authorizations, Tamiflu (oseltamavir) and Relenza (zanamivir), may already be included in many emergency stockpiles. All companies, U.S. states and localities, and other organizations with Tamiflu and Relenza that are approaching, or past, the labeled expiration date, are urged to consider keeping it while the U.S. Department of Health and Human Services evaluates options, including those that may allow for their use if needed during this 2009 H1N1 flu virus outbreak. These organizations are also urged to contact the FDA’s Emergency Operations Center with information on how much Tamiflu and Relenza in their stockpiles is at or approaching expiration. This information should be reported to:FDA’s Emergency Operations Center 301-443-1240.
This statement is not directed to individual patients who already have these two products in their homes. Individuals with these products should continue to follow the directions from their doctor, pharmacist or other health care professional.
April Journal Posted on the FPA Website
April Journal Posted on the FPA Website
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Members of the FPA are reminded that the April Journal has been published on pharmview.com. To view the journals you will need to have your member number and password on hand. Articles in this journal include the following:
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July 8-12, 2009
119th Annual Meeting and Convention Offering: General and consultant recertification CE (Hours TBD) Also offering: 2 hours of Florida approved medication errors  Renaissance Resort at World Golf Village 500 South Legacy Trail St. Augustine, Florida 32092 Phone: (888) 740-7020 or register directly on-line through this link (use code: Florida Pharmacy Association) Room Rate $129.00 Plus Tax Deadline for room reservation - June 15, 2009 (or until block is full) - Register early as the rooms may not last!!  August 9-12, 2009
26th Annual Southeastern Gatherin' Offering: General and consultant recertification CE (Hours TBD)
Also offering: 2 hours of Florida approved medication errors.  Village of Baytowne WharfSandestin Golf and Beach Resort 9300 Emerald coast Parkway Destin, Florida 32550 Phone (800) 320-8115 Room Rate: From $179.00 plus tax Deadline for room reservation - July 17, 2009 (or until block is full) September 12 - 13, 2009
Regulatory and Law Conference Reviewing laws and rules related to F.S. 465, 893, 499, 64B16 and the Code of Federal Regulations applicable to the practice of Pharmacy Offering: General and consultant recertification CE
Also offering: 2 hours of Florida approved medication errors  Hyatt Regency Bonavenure250 Racquet Club Road Weston, Florida 33326 Phone (954) 616-1234 Room rate: $125.00 plus tax Deadline for room reservation - August 28, 2009 (or until block is full) Pharmacist CE at SEA
Sailing September 20 - 27, 2009 Aboard Royal Caribbean's Freedom of the Seas Ports of Call: Port of Canaveral, Coco Cay, St. Thomas, St. Maarten and return to Port Canaveral Preferred cabins go early so make your reservations as soon as possible.  Participating States: Ohio Pharmacists Association, Kentucky Pharmacists Association, Deleware Pharmacists Society, South Carolina Pharmacy Association, Minnesota Pharmacists Association and Alaska Pharmacists AssociationCome and network with your colleagues from other states. Florida Pharmacy Association
Mid-Year Clinical Conference Sheraton Orlando North October 10 - 11, 2009 For more information visit our web site at
http://www.pharmview.com/ 
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