2009 Bills Related to Pharmacy
Senate Bills:
SB42: To amend Section 20-2-23 of the Code of Alabama 195, relating to Schedule I controlled substances, to list salvia divinorum and Salvinorin A.
DEAD
SB47: Under existing law, after October 1, 2009, the sale of any product containing ephedrine or pseudoephedrine is prohibited and subject to criminal penalties unless the product is manufactured so that the ephedrine or pseudoephedrine cannot be extracted to be used in the production of methamphetamine. This bill would delete this provision.
Enacted 2009-283
SB130: This bill would prohibit smoking in places of employment and public places.
DEAD
SB155: Under existing law, certain public contracts are exempt from the competitive bid process. This bill would exempt purchases from health industry joint purchasing organization contracts within or without the State of Alabama by any hospital or campus medical facility operated by a state educational institution or an educational institution receiving state funds, including pharmacies and pharmacy clinics, veterinary clinics and hospitals, medical teaching clinics and health care clinics, and services operated for the state provided that opportunity is given minority owned businesses.
DEAD
SB257: Currently, departments and agencies that are subject to the Alabama Sunset Law are subject to review every four years. This bill would require such departments (including the State Board of Pharmacy) to be reviewed every eight years.
DEAD
SB259: This bill would set term limits for the Alabama House and Senate members.
DEAD
House Bills:
HB25: It is illegal to possess, use, or sell drug paraphernalia, as defined. This bill would include certain glass tubes to the list of items identified as paraphernalia.
Enacted by the Legislature and awaiting signature by Governor
HB49: This bill would make it a specific crime of burglary in either the first or second degree, depending upon the controlled substances involved, for a person to knowingly and unlawfully enter or remain unlawfully in a medical facility and to commit or attempt the theft of a controlled substance based on the schedule of the controlled substance.
DEAD
HB107: This is a sunset bill which continues the Alabama State Board of Pharmacy based upon their review.
Enacted by the Legislature and signed by the Governor, Act 2009-36
HB163: Under existing law, minors may give effective consent for certain medical, dental, health, or mental health services. This bill, to be known as the “Parents Consent and Access to Medical Information and Services Act,” would give the parent or legal guardian of a child authorization to consent for services and access to all medical, dental, health, or mental health records of an unemancipated minor.
DEAD
HB212: This bill would prohibit the cloning of human beings.
DEAD
HB270: Under current sales tax law, medicines prescribed by a physician and subsequently filled by a licensed pharmacist are exempt from sales taxation. This bill would exempt over the counter medications from city, county, and state sales taxes.
DEAD
HB284: Under existing law, a certificate of need is required for a new institutional health service. This bill would repeal that law.
DEAD
HB299: Under existing law, a resident under the age of 21 who is receiving long term care nursing services under the Medicaid program in a long term care nursing facility for juveniles is required to be transferred to another long term care nursing facility when the resident reaches age 21. This bill would allow them to continue to receive the services in the facility where the resident is residing after the resident turns 21.
DEAD
HB338: Under existing law, there is no requirement to report torture or cruelty to an animal. This bill would require certain persons (including pharmacists) to report torture or cruelty to an animal.
DEAD
HB340: This bill would provide a property owner limited immunity from civil liability in defense of his or her self, others, and their property.
DEAD
HB346: This bill would allow the Board of Pharmacy to adopt rules imposing non-disciplinary administrative penalties for certain violations, provide for the renewals of licenses of assistant pharmacists, provide further for biennial licenses for the manufacture or sale of precursor chemicals, allow the board to own real property, allow the board to hire more drug inspectors, and allow the board to electronically provide each registered pharmacist with a copy of the rules and regulations.
Enacted by the Legislature and awaiting signature by Governor
HB475: To amend Section 20-2-23 of the Code of Alabama 195, relating to Schedule I controlled substances, to list salvia divinorum and Salvinorin A.
DEAD
HB484 Controlled substances, prescribing by physician assistants, registration certificate required, regulated by State Board of Medical Examiners, Secs. 20-2-60 to 20-2-69, inclusive, added; Secs. 20-2-214, 20-2-217 am’d.
Enacted 2009-489 05/07/2009
HB538: This bill would allow federally qualified health care centers (FQHCs) and public health facilities and departments to compound and dispense prescriptions, excluding controlled substances, at one location and courier the medication to clinics for patient pick-up.
Enacted by the Legislature, awaiting the signature of the Governor
HB567: This bill would provide that prescription drugs would be exempt from business license taxes based on gross receipts.
DEAD
Resolutions:
HJR38: Requests the Auburn University School of Pharmacy to provide courses in retail pharmacy practice.
DEAD
U.S. Representative Jo Bonner Gets New Committee Assignments
After joining the influential House Appropriations Committee last year, U.S. Representative Jo Bonner, (R)Mobile, has gotten new subcommittee assignments.
For this Congress, Bonner, who is beginning his fourth two-year term, will join the Commerce, Justice, and Science subcommittees as well as the Labor, Health, and Human Services panel. In return, Bonner will give up his seats on the financial services and legislative brand subcommittees.
Shelby Indicates He Will Run Again
U.S. Senator Richard Shelby, (R) Tuscaloosa, has indicated he will seek a fifth term next year. Shelby, first elected to the Senate in 1986, will be 76 by the time of the November 2010 elections. An avid fundraiser, he has amassed almost $13.3 million in his campaign account according to his most recent Federal Election Commission report.
Alabama Pharmacy Association Goes to Capitol Hill
May 11-13, 2009 and June 16-17, 2009
The Alabama Pharmacy Association (APA) is teaming up with the National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS) to educate Members of Congress and their staff about the importance of pro-pharmacy policy and the need for healthcare reform!
Individuals from all aspects of pharmacy, including student pharmacists and their faculty, are invited to attend both the NCPA 41st Annual Legislative Conference and the 1st Annual RxIMPACT Day on Capitol Hill. These events will review the secrets of influential communication, explain how to effectively engage in the political process, and most importantly, provide the unique opportunity to meet with Members of Congress and their staff to discuss important pharmacy issues.
Your participation demonstrates that Alabama’s practitioners are dedicated to advancing pharmacy and quality patient services. The more individuals in attendance at these annual events, the more Capitol Hill will understand pharmacy and welcome our positions on important health policy issues.
“Your involvement is critical to influencing policy outcomes at a time when the healthcare reform debate is surfacing,” said Alabama Pharmacy Association President David Darby, RPh about the events scheduled for May 11-13, 2009 and June 16-17, 2009 in Washington, D.C. “We need member involvement in events like these on Capitol Hill to ensure pharmacy is at the decision-making table. Remember, you are either at the table, or you’re on the menu!”
While Darby is registered to attend the events along with Alabama Pharmacy Association Executive Director Louise Jones, the two leaders are hopeful others from the state will plan to attend these important events.
Both conferences will include scheduled appointments with Alabama’s Congressional Delegates. Alabama attendees will conduct these visits as a group allowing you an opportunity to meet with each of this state’s Representatives and Senators and their staff to discuss issues important to your pharmacy practice. Appointments with Members of Congress will be scheduled as follows:
NCPA Legislative Conference Visits– May 13th & possibly the morning of May 14th
RxIMPACT Visits - June 17th
To read more about the RxIMPACT event, please visit http://www.nacds.org/wmspage.cfm?parm1=6245 or contact Heidi Ecker via email at hecker@nacds.org or telephone at 703-837-4121.
To read more about the NCPA 41st Annual Conference on National Legislation and Government Affairs event, please visit www.ncpanet.org/calendar or contact NCPA at 800-544-7447.
Please contact Louise Jones at ljones@aparx.org or by phone at (334) 271-4222 with any questions about these conferences.
(back to top)
News You Can Use
CMS Announces Course of Action to Identify Protected Classes of Prescription Drugs
The Centers for Medicare & Medicaid Services (CMS) announced an interim final rule that makes sure beneficiaries with conditions such as epilepsy, mental illness, and depression will not be discouraged from enrolling in any Part D plan, nor experience any interruptions in their drug therapy. The public comment period for this rule closes on March 17, 2009.
In June 2005, CMS directed that Part D formularies include all or substantially all drugs in the following six drug classes: Antidepressant; Antipsychotic; Anticonvulsant; Immunosuppressant (to prevent rejection of organ transplants); Antiretroviral (for the treatment of infection by retroviruses, primarily human immunodeficiency virus (HIV); and Antineoplastic (only those chemotherapy drugs that are generally are not covered under Medicare Part B).
The interim final rule notifies Part D plans that they must continue to provide coverage of these drugs in 2010, consistent with the policy already in place.
The rule also codifies in regulation a provision of the Medicare Improvements for Patients and Providers Act (MIPPA) with respect to the identification and coverage of protected drug categories and classes under the Part D program.
For contract years 2011 and beyond, CMS plans to consider whether any modifications are necessary to the existing six classes currently protected, whether under CMS’s existing administrative authority or under MIPPA. Should CMS decide that modifications are necessary, CMS will propose these modifications through a rulemaking process that provides for meaningful public comment.
The regulation was published on Jan. 16, 2009, and may be viewed at http://www.gpoaccess.gov/fr/browse.html. Click “Go” next to where 2009 appears in the year selection box for “Back Issues (HTML Only).”
Medicare Clarifies ‘Negotiated Prices’ Under Part D
On January 6, 2009, CMS released a regulation revising Medicare’s definition of negotiated prices by requiring drug plan sponsors under Part D to use the amount paid to a pharmacy as the basis for determining cost sharing for beneficiaries and for reporting a plan’s drug costs to CMS. The negotiated prices are the costs for prescription drugs that are reached through direct negotiation between the Part D sponsor or an intermediary contracting organization such as a pharmacy benefit manager (PBM) and the pharmaceutical manufacturer. The change is effective January 1, 2010.
CMS currently allows Part D sponsors that contract with a PBM to report to the agency the amount paid to the PBM (the lock-in price) or the amount the PBM paid to the pharmacy (the pass-through price). Under the new rule, any difference between the price paid by the plan to the PBM and the price paid by the PBM to the pharmacy must be reported as an administrative cost. This requirement helps ensure that sponsors’ administrative costs are not included in the drug costs used to determine how much the beneficiary will pay, as well as reinsurance and risk corridor payments made by CMS. This will also create a uniform definition of drug costs for all Part D sponsors.
“For patients whose plan used the lock-in model, this regulation will reduce what they pay at the pharmacy counter because their copayment will no longer be based on a higher negotiated price,” said CMS Acting Administrator Kerry Weems. “The current lock-in approach also moves beneficiaries through the Part D benefit more quickly, bringing them to the ‘coverage gap’ sooner than under the pass-through pricing model.”
The May 16, 2008 proposed rule also proposed similar revisions and additions to the definition of negotiated prices under the Retiree Drug Subsidy (RDS) program. The final rule does not finalize the changes proposed for RDS, but invites comments on several policy options.
This rule also codifies earlier guidance to plan sponsors about using Best Available Evidence (BAE) to determine an enrollee’s eligibility for extra help through the Part D Low-Income Subsidy program. The BAE policy will continue to help protect low-income beneficiaries, and pharmacies, from unnecessary co-payments at the point of sale.
(Part D policy details)
(more research facts)
(additional Part D tip sheets)
WellPoint Medicare Advantage and Prescription Drug Plan Contracts Enrollment Suspended
CMS suspended marketing and enrollment for WellPoint Medicare Advantage and Prescription Drug Plan contracts, effective January 12, 2009. With these imposed sanctions, WellPoint will not be able to market several of its Medicare Advantage and Prescription Drug Plans and will not be able to enroll new beneficiaries.
Beneficiaries currently enrolled in WellPoint sponsored plans will continue to receive the same health care services and prescription drug coverage they have now. They will not lose any Medicare coverage.
Beneficiaries who have questions should first contact WellPoint. If they have additional questions, they should contact 1-800-MEDICARE or their specific plan.
Beneficiaries who have had difficulty getting services from WellPoint may have a special opportunity to enroll in a different Medicare plan.
If they would like to learn more, they should contact 1-800-MEDICARE and explain their situation. The customer service representative will explain the next steps.
WellPoint has served as the Medicare Part D Prescription Drug Program’s safety net “point-of-sale” (POS) contractor, paying claims for Low-Income Subsidy (LIS) beneficiaries that have not yet been enrolled into a Part D plan. WellPoint will continue to pay these claims under the terms of its contract with CMS. This process has been used successfully by over 100,000 LIS beneficiaries in 2008 without a problem, and we are fully confident that the POS prescription process will continue to work effectively and seamlessly for beneficiaries at the pharmacy counter.
In the past, WellPoint also has been permitted to enroll many of these individuals into one of their plans, but this activity is being suspending as part of the sanction. WellPoint will notify CMS of any beneficiaries handled through the POS process so they can be enrolled into a non-WellPoint plan in the beneficiary’s region that has a premium at or below the LIS benchmark premium amount (in other words, a zero-premium plan for individuals receiving the full subsidy.). This is consistent with the approach used in areas where WellPoint has no zero-premium plan.
Background: The sanctions were imposed because of widespread and continued failures by WellPoint to properly administer their contracts in accordance with CMS requirements. Many of these failures have been reported by WellPoint.
WellPoint’s compliance problems include but are not limited to failures in the following areas: enrollments and disenrollments; benefits administration, (including determining premiums, co-pays, administering the benefit for LIS eligibles); grievances and appeals; marketing; claims processing; coordination of benefits; billing, and meeting call center and customer service requirements.
CMS has been actively monitoring information received from the CMS Complaints Tracking Module (CTM) and from WellPoint about reports of beneficiaries who cannot access Part D drugs when they go to buy their medicines at the pharmacy counter because of system failures. This analysis is part of the risk assessment that CMS continually conducts and led to the actions taken against WellPoint. In addition, CMS has been reaching out to affected Medicare beneficiaries to make sure their problems have been satisfactorily resolved. Although new problems should be prevented due to the enrollment suspension along with active efforts by WellPoint; CMS is continuing to monitor and follow up with these issues by reaching out directly to beneficiaries.
DMEPOS Accreditation Deadline Reminder
As a reminder, a pharmacy’s deadline to submit a complete accreditation application to the accreditation organizations (AOs) was January 31, 2009. If an enrolled DMEPOS supplier did not meet this requirement, CMS cannot ensure that the AOs will be able to accredit them by the September 30, 2009 deadline. Proof of accreditation must be submitted to the National Supplier Clearinghouse (NSC) by the end of September. The NSC will revoke a DMEPOS supplier’s billing privileges on October 1, 2009. Please refer to the 4th Quarter 2008 APA Journal for full details of this requirement. (DMEPOS accreditation fact sheet)
CMS Issues Final Rule Requiring Surety Bonds for DMEPOS Suppliers
CMS has issued a final surety bond regulation, required by the Balanced Budget Act of 1997, that makes certain suppliers of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) post a $50,000 surety bond. Existing suppliers must comply with this requirement by October 2, 2009 while newly enrolling suppliers must meet this requirement by May 4, 2009. This requirement was due in part to the large number of improper and potentially fraudulent payments to medical equipment suppliers for furnishing medical equipment and devices to people with Medicare. The 2007 Medicare error rate report found approximately $1 billion in improper payments for medical equipment and supplies.
The surety bond requirement is designed to limit the Medicare program risk from fraudulent equipment suppliers and help to ensure that only those suppliers who remain in the program furnish items to Medicare beneficiaries that are considered reasonable and necessary from legitimate DME suppliers.
Suppliers who have had certain adverse legal actions imposed against them in the past may also be required to post a higher bond amount. All newly enrolling suppliers that meet the requirements of the rule will be required to have a surety bond before they can enroll in the Medicare program. More information about the new regulation can be found at www.cms.hhs.gov/MedicareProviderSupEnroll.
While this regulation requires most suppliers to obtain a surety bond, some companies or organizations that supply these items are exempt from the surety bond requirement, including certain physicians and non-physician practitioners, physical and occupational therapists, state-licensed orthotic and prosthetic personnel, and government-owned suppliers. Pharmacies are not exempt.
New Rules for How Medicare Pays Suppliers for Oxygen and Oxygen Equipment
CMS has announced new oxygen payment rules and supplier responsibilities required by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The new rules permit the supplier to retain ownership of oxygen equipment after receiving payment for furnishing oxygen and oxygen equipment for 36 continuous months. The rental payment covers the equipment, contents, maintenance, and supplies and accessories such as tubing or a mouthpiece. After the 36-month payment period, the supplier is required to continue furnishing the equipment, supplies, accessories, and contents and is responsible for ensuring the equipment is in good working order for any period of medical need for the remainder of the five year reasonable useful lifetime of the equipment. There will be no additional Medicare payment for the equipment, supplies, accessories, or repairs for the remainder of the reasonable useful lifetime as Medicare’s payments during the 36-month rental period cover all of these costs. However, after 36 months, Medicare will pay for oxygen contents for gaseous or liquid oxygen equipment. Also, Medicare will pay for one in-home, routine maintenance and servicing visit for oxygen concentrators and transfilling equipment every six months during 2009 only, beginning six months after the end of the 36-month rental period. This payment will be made if the supplier visits the beneficiary’s home, performs any necessary maintenance and servicing, and inspects the equipment to ensure that it will function safely for the next six months. These changes are effective for services provided on or after January 1, 2009.
Clarification of CMS’ Requirement for Part D Fraud, Waste, and Abuse Training
CMS has received hundreds of phone calls and emails from Part D Sponsors and their first tier, downstream, and related entities about the fraud, waste, and abuse training requirement that became effective January 1, 2009.
Quick facts about the requirement:
1) It is the Part D Sponsor’s responsibility to provide their first tier, downstream, and related entities with the appropriate training;
2) This training requirement became effective January 1, 2009. Since this is a yearly requirement, each Sponsor has from January 1, 2009 to December 31, 2009 to meet this requirement; and
3) Any training completed prior to January 1, 2009 will not count for the 2009 requirement.
4) All persons in the pharmacy who come in contact with Part D recipients need to be trained. That includes, but is not limited to, pharmacists, pharmacy technicians, and cashiers.
5) The training that is currently available on the CMS Med-Learning Network for Fraud, Waste, and Abuse is NOT intended to satisfy the Part D requirement.
6) This requirement could be cumbersome for first tier, downstream, and related entities because these entities often contract with multiple Part D Sponsors.
The final rule entitled, “Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes,” FR Doc. 07-5946 (72 FR 68700 through 68741), published December 5, 2007, updated the compliance plan requirements for Medicare Advantage (MA) organizations and Part D Sponsors. Specifically, the compliance regulation states that a compliance plan, which must include measures to detect, correct, and prevent fraud, waste and abuse, must consist of training, education, and effective lines of communication between the compliance officer and the organization’s employees, managers, and directors, as well as first tier, downstream, and related entities. This change clarifies that MA organizations and Part D Sponsors need to apply these training and communication requirements to all entities they are partnering with in the MA and Part D programs, not just the direct employees within their organizations.
MA organizations and Part D Sponsors are responsible for ensuring that all employees (including managers and directors) and the first tier, downstream, and related entities are provided appropriate training. MA organizations and Part D Sponsors must either provide the training directly to all of its employees (including managers and directors) and first tier, downstream, and related entities or provide the appropriate training materials to its employees (including managers and directors) and first tier, downstream, and related entities and ensure that the training has been taken. First tier, downstream, and related entities, including pharmacies, should not develop their own training. The first tier, downstream, and related entities can administer the training if the materials are provided by the Sponsor.
Complete details on this regulation can be found at: http://edocket.access.gpo.gov/2007/07-5946.htm
Self-Certification for Sale of Pseudoephedrine - Training Required Yearly by DEA
Recently, pharmacists have been receiving notice from the Department of Justice concerning self certification for the sale of pseudoephedrine. This is a reminder that each pharmacy needs to do a self certification if they are selling pseudoephedrine. Information is on the DEA/Office of Diversion Control web page, which can be found at: http://www.deadiversion.usdoj.gov/meth/index.html. Scroll down on this page to find the “Required Training and Self Certification” portion. Once the training has been completed, a copy should be made of the certificate and close attention paid to the expiration date at the bottom. No renewal notices will be sent, but recertification is required as soon as the certificate expires. A copy of the certificate should be kept on file in the pharmacy. Every pharmacy will have a different date depending on the date of their original certification.
Latest Health Debit Card Developments
The Internal Revenue Service has extended the deadline on when Flexible Spending Account and Health Reimbursement Arrangement debit cards may not be used at pharmacies unless the store has an Inventory Information Approval System (IIAS) or at least 90 percent of the store’s gross receipts for the prior tax year qualify as medical care expenses. The original deadline of January 1, 2009 has been extended to July 1, 2009.
Primary Changes and Updates in the 2008 ACIP Recommendations
Note: On December 19, 2008, the Center for Disease Control (CDC) issued Interim Recommendations for the Use of Influenza Antivirals for the 2008-09 Season.
The 2008 recommendations include five principal changes or updates:
• Beginning with the 2008-09 influenza season, annual vaccination of all children aged five to 18 years is recommended. Annual vaccination of all children aged five to 18 years should begin in September or as soon as vaccine is available for the 2008-09 influenza season, if feasible, but annual vaccination of all children aged five to 18 years should begin no later than during the 2009-10 influenza season.
• Annual vaccination of all children aged six months to four years (59 months) and older children with conditions that place them at increased risk for complications from influenza should continue. Children and adolescents at high risk for influenza complications should continue to be a focus of vaccination efforts as providers and programs transition to routinely vaccinating all children.
• Either TIV or LAIV can be used when vaccinating healthy persons aged two to 49 years. Children aged six months to eight years should receive two doses of vaccine if they have not been vaccinated previously at any time with either LAIV or TIV (doses separated by four or more weeks); two doses are required for protection in these children. Children aged six months to eight years who received only one dose in their first year of vaccination should receive two doses the following year. LAIV should not be administered to children aged less than five years with possible reactive airways disease, such as those who have had recurrent wheezing or a recent wheezing episode. Children with possible reactive airways disease, persons at higher risk for influenza complications because of underlying medical conditions, children aged six to 23 months, and persons aged more than 49 years should receive TIV.
• The 2008-09 trivalent vaccine virus strains are A/Brisbane/59/2007 (H1N1)-like, A/Brisbane/10/2007 (H3N2)-like, and B/Florida/4/2006-like antigens.
Oseltamivir-resistant influenza A (H1N1) strains have been identified in the United States and some other countries. However, oseltamivir or zanamivir continue to be the recommended antivirals for treatment of influenza because other influenza virus strains remain sensitive to oseltamivir, and resistance levels to other antiviral medications remain high.
FDA Issues Rule on Labeling Requirement for Reporting Side Effects
The Food and Drug Administration (FDA) has issued a final rule that will require the side effects labeling of certain drug products to include a toll-free number for reporting adverse events. The rule took effect November 28, 2008, but won’t be enforced until July 1, 2009.
The new labeling must state, “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088”.
Pharmacists and other authorized dispensers may distribute this statement in one of five ways:
• On a sticker attached to the unit package, vial, or container of the drug product
• On a preprinted pharmacy prescription vial cap
• On a separate sheet of paper
• In consumer medication information
• In the appropriate FDA-approved Medication Guide that contains the side effects statement (view 800 side effects rule)
CMS Delays Ban on Faxed Prescriptions
Deadline Moved to Jan. 1, 2012
Physicians who participate in Medicare and depend on computer-generated faxes to transmit prescriptions to pharmacies can breathe a collective sigh of relief. CMS has extended its deadline for banning faxed prescriptions by three years, moving the Jan. 1, 2009, deadline to Jan. 1, 2012.
The deadline change is included in the 2009 Medicare Physician Fee Schedule final rule announced by CMS on Oct. 30. According to CMS' press release, the agency reversed its position "in the interest of patient care and safety and to encourage prescribers and dispensers to adopt e-prescribing."
Although many physicians initiate prescriptions through their electronic health record, or EHR, systems, their computers actually generate a fax to the pharmacy.
Had the deadline been imposed on Jan. 1 of next year, many physicians might have reverted back to paper-based prescriptions.
E-prescribing offers proven benefits to physicians, including reductions in medication errors, a reduced call burden from pharmacies and electronic access to formulary information.
(read the CMS press release) |
Swine Flu Situation Update: A Pandemic is Declared
On June 11, 2009, the World Health Organization (WHO) raised the worldwide pandemic alert level to Phase 6 in response to the ongoing global spread of the novel influenza A (H1N1) virus. A Phase 6 designation indicates that a global pandemic is underway. As of 07:00 GMT, 12 June 2009, 74 countries have officially reported 29,669 cases of influenza A(H1N1) infection, including 145 deaths.
NOTE: The CDC cautions that the most recent illnesses and reported death suggest a pattern of more severe illness associated with this virus in the U.S. The CDC notes further that most people in the U.S. will not have immunity to this new virus, and as it continues to spread - more cases, hospitalizations, and deaths are expected in the coming days and weeks.
NOTE: The number of state health department confirmed cases may be higher than the CDC reported numbers. This is due to the fact that the CDC reviews the states' results before confirming a case.
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Inventory Levels:
Inventory is being monitored by HHS, and there is a procedure in place for state officials to request information regarding inventory levels.
APA has requested information from McKesson, Cardinal, Smith Drug, and Amerisource regarding their inventory levels of Tamiflu and Relenza. We will post this data and ordering information to our website as it becomes available. We will also be providing you with information on resources/suppliers for face masks.
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Facts about Swine Flu
Strain: Influenza A (H1N1)
Infectious Period:
1 to 3 days before onset to 3 to 9 days after onset of illness
Symptoms:
Fever
Lethargy
Loss of appetite
Runny nose
Coughing
Sore throat
Nausea
Diarrhea
Vomiting
No unusual cases of swine illness have been identified in the impacted areas of the United States; however, the U.S. Department of Agriculture, working with industry, is closely monitoring the situation. Swine influenza cannot be transmitted through consumption of pork products, although some consumer hesitancy may occur.
ALABAMA DEPARTMENT OF PUBLIC HEALTH PRESS RELEASE
CONTACT:
Jim McVay, Dr.P.A.
800-252-1818
334-201-8660
CDC now recommends implementation of measures that focus on keeping all students, faculty and staff with symptoms of influenza out of schools and child care facilities during their period of illness when they are potentially infectious to others.
Students and faculty with influenza-like illness should stay home and not attend school or go into the community except to seek medical care for at least seven days, even if symptoms resolve sooner. The child with symptoms should return to school or day care only after being well for at least 24 hours. Students or staff who appear to have influenza-like illness at arrival or become ill during a school day should be isolated promptly in a room separate from other students and sent home.
The Alabama Department of Public Health does not recommend cancelling large group events based on concerns of H1N1 influenza. Individuals should try to curtail the spread of influenza by realizing the virus is circulating in the population. Individuals who are ill should not attend group
events to avoid spreading the virus to others. Persons with underlying medical conditions which would put them at greater potential risk are also advised to avoid group events.
At-risk groups of persons with medical complications of A H1N1 infections include:
• Children less than 5 years old;
• Persons aged 65 years or older;
• Children and adolescents (less than 18 years) who are receiving long-term aspirin therapy and who might be at risk for experiencing Reye syndrome after influenza virus infection;
• Pregnant women;
• Adults and children who have chronic pulmonary, cardiovascular, hepatic, hematological, neurologic, neuromuscular, or metabolic disorders;
• Adults and children who have immunosuppression (including immunosuppression caused by medications or by HIV);
• Residents of nursing homes and other chronic-care facilities.
Prescription antiviral drugs such as Tamiflu and Relenza provide effective treatment and should be taken within the first 48 hours of illness. All persons are reminded to follow these precautions:
• Cover your cough or sneeze with a sleeve or tissue.
• Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand sanitizers are also effective.
• Avoid touching your mouth, eyes and nose with your hands.
• Try to avoid close contact with sick people.
• If you get sick, stay home from work or school and limit contact with others to avoid infecting them. Patients experiencing severe symptoms, such as difficulty breathing, should call their health care provider.
The symptoms of H1N1 influenza are similar to the symptoms of traditional influenza and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with H1N1 influenza. Ill persons should voluntarily
isolate themselves from others for seven days after they experience symptoms. Close contacts should limit their contact with others for a period of seven days from the time they were exposed.
The incubation period from the moment of exposure to H1N1 influenza until symptoms develop is two to seven days. Individuals are infectious to others one day before until seven days after symptoms develop. Persons who develop symptoms of respiratory illness should contact their medical provider who can arrange for tests to determine whether the disease is due to H1N1 flu.
For information about H1N1 influenza, please visit www.adph.org.
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Pharmaceutical Manufacturing Status
Updated on: 4/29/2009 11:19:36 AM
Pharmacies and wholesalers may be reporting low inventory on their shelves due to this outbreak of swine flu coinciding with the end of the flu season. As a result, it may take a few days for supply to meet the increased demand. To meet the increased demand, distributors and manufacturers are ramping up their operations. However, there is no shortage on the manufacturers' level but merely an issue of product working its way through the pharmaceutical supply system.
Preparation of reference strains from which manufacturers can make viral seeds for vaccine production: A/CA/04/09 virus received by FDA and is currently being germinated. More information regarding the status of this process will be available by Wednesday, April 29.
Discussions on vaccine clinical trials and manufacturing are on going with BARDA, NIH and manufacturers.CDC/BARDA/FDA developing commercial scale vaccine production strategy; anticipate 12-16 week production timeline from receipt to seed virus.
The current influenza vaccine is not expected to protect against the outbreak. The strain is also resistant to two of the four antiviral drugs licensed in the United States for treatment of influenza, amantadine and rimantadine. The strain, however, is sensitive to oseltamivir (trade name Tamiflu) and zanamivir (trade name Relenza). The CDC has developed a genetically matched “seed stock” for the strain, which would be needed if vaccine production is necessary.
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Government Status
Updated on: 4/29/2009 4:35:26 PM
The World Health Organization (WHO), the Global Alert and Response Network (GOARN), and the Centers for Disease Control and Prevention (CDC) have sent experts to Mexico to work with health authorities.
The CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization. This includes deploying staff domestically and internationally to provide guidance and technical support.
The CDC has also activated its Emergency Operations Center to coordinate this investigation and is working with BARDA/FDA on development of vaccine candidates. The CDC is assisting public health authorities in Mexico by testing specimens and providing epidemiological support.
As part of our pandemic preparedness efforts, the Government has purchased 50 million treatment courses of antiviral drugs -- oseltamivir and zanamivir – for the Strategic National Stockpile.
According to DHS Congressional Testimony on April 29 at 10am ET, "currently the U.S. out of the 50 million courses of anti-viral medication on hand, 6 million courses are dedicated for containment, and 44 million for treatment. 25% (11 million courses) of the states ' allotments of these stockpiled anti-virals, Tamiflu and Relenza, are being released. While there is a priority placed on states that have confirmed cases of this flu, as well as on border states, all states have access to these extra resources. Resources are already being deployed to several states and DHS expects all of the 11 million courses will be deployed by May 3. These federal resources augment the roughly 23 million courses that states themselves have stockpiled".
During the HHS press conference on April 29 at 11am,the CDC's Dr. Bresser stated that New York City, and the States of New York and Indiana had received their full stockpile allotments.
CDC’s Division of the Strategic National Stockpile (SNS) is releasing one-quarter of its antiviral drugs, personal protective equipment, and respiratory protection devices to help states respond to the outbreak,particularly prioritizing the states where we already have confirmed incidents of swine flu.
In addition, the Department of Defense has procured and strategically prepositioned 7 million treatment courses of Tamiflu. In addition, the Department of Defense has procured and strategically prepositioned 7 million treatment courses of Tamiflu.
At the federal level, the Department of Justice (DOJ) has established legal federal authorities pertaining to the implementation of a quarantine and enforcement. Under approval from HHS, the Surgeon General has the authority to issue quarantines necessary to prevent the introduction, transmission or spread of communicable diseases.
Two websites have begun monitoringreported (both confirmed and suspected) swine flu cases around the world. It is important to note that these are UNOFFICIAL SOURCES and SHOULD NOT BE TAKEN AS FACT.
http://outbreaks.globalincidentmap.com/home.php
http://maps.google.com/maps/ms?hl=en&ie=UTF8&oe=UTF8&msa=0&msid=106484775090296685271.0004681a37b713f6b5950
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Transportation
Updated on: 4/28/2009 10:32:27 AM
CDC recommends that U.S. travelers avoid all nonessential travel to Mexico and HHS / DHS / DOT are evaluating border exit screening. However,the CDC does not recommend closing the border as an effective public health measure at this time and airport security in the United States is maintaining the usual levels of precautionary screening and raising awareness for travelers coming to/from affected areas.
The European Union's health commissioner has urged Europeans on Monday to postpone nonessential travel to the United States or Mexico due to swine flu.
Some countries are reportedly increasing border surveillance, however, Anne Schuchat of the U.S. Centers for Disease Control and Prevention has said that “with infections in many different communities as we’re seeing, we don’t think that containment is feasible . . .we are not at a point where we can keep this virus in one place.”
Significant economic impacts are only expected if a decision is made to limit the movement of people and goods between the United States and Mexico, which would result in significant cascading economic impacts. According to the Bureau of Transportation Statistics, in 2008, close to three million truck containers crossed the border, in addition to approximately 22,000 train passengers, 3 million bus passengers, 80 million personal vehicles, and 44 million pedestrians.
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Alabama Medicaid Continues Preferred Status for Swine Flu Drugs
4/29/09 – The Alabama Medicaid Agency has taken steps to ensure that Medicaid-eligible recipients can quickly access two anti-viral medications used to combat swine flu by extending the preferred status of Tamiflu® and Relenza® until further notice.
Preferred status allows physicians to prescribe either of the two brand-name medications without obtaining prior approval. Both drugs have been on preferred status during the flu season which normally ends on April 30.
“In light of the recent declaration of a National Public Health Emergency related to the swine influenza outbreak, we want to ensure that children and adults who need either of these medications can access them beyond the typical flu season,” said Medicaid Medical Director Robert H. Moon, M.D.
More than 700,000 people, primarily children, are eligible for coverage of the flu medications by Alabama Medicaid.
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Alabama Department of Public Health Prepares
In preparation for possible pandemic flu, the Alabama Department of Public Health purchased 700,000 courses of antivirals and will receive additional courses and personal protective equipment this week. The department also has 1 million masks which will be distributed if needed.
Any samples identified as probable cases will be forwarded to the Centers for Disease Control and Prevention for confirmation. If a possible case is identified the health care provider and families of the individual will be contacted for appropriate follow-up. Contacts will be identified and referred for appropriate evaluation. See Alabama case information in the Situation Update Section of this post.
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CDC Health Advisory
Distributed via Health Alert Network
April 25, 2009, 3:00 EST (03:00 PM EDT)
CDCHAN-000281-2009-04-25-ALT-N
Investigation and Interim Recommendations: Swine Influenza (H1N1)
CDC, in collaboration with public health officials in California and Texas, is investigating cases of febrile respiratory illness caused by swine influenza (H1N1) viruses. As of 11 AM (EDT) April 25, 2009, 8 laboratory confirmed cases of Swine Influenza infection have been confirmed in the United States. Four cases have been reported in San Diego County, California. Two cases have been reported in Imperial County California. Two cases have been reported in Guadalupe County, Texas. Of the 8 persons with available data, illness onsets occurred March 28-April 14, 2009. Age range was 7-54 y.o. Cases are 63% male.
The viruses contain a unique combination of gene segments that have not been reported previously among swine or human influenza viruses in the U.S. or elsewhere. At this time, CDC recommends the use of oseltamivir or zanamivir for the treatment of infection with swine influenza viruses. The H1N1 viruses are resistant to amantadine and rimantadine but not to oseltamivir or zanamivir. It is not anticipated that the seasonal influenza vaccine will provide protection against the swine flu H1N1 viruses.
CDC has also been working closely with public health officials in Mexico, Canada and the World Health Organization (WHO). Mexican public health authorities have reported increased levels of respiratory disease, including reports of severe pneumonia cases and deaths, in recent weeks. CDC is assisting public health authorities in Mexico by testing specimens and providing epidemiological support. As of 11:00 AM (EDT) April 25, 2009, 7 specimens from Mexico at CDC have tested positive for the same strain of swine influenza A (H1N1) as identified in U.S. cases. However, no clear data are available to assess the link between the increased disease reports in Mexico and the confirmation of swine influenza in a small number of specimens. WHO is monitoring international cases. Further information on international cases may be found at: http://www.who.int/csr/don/2009_04_24/en/index.html
Clinicians should consider swine influenza infection in the differential diagnosis of patients with febrile respiratory illness and who 1) live in San Diego or Imperial counties, California, or Guadalupe County, Texas, or traveled to these counties or 2) who traveled recently to Mexico or were in contact with persons who had febrile respiratory illness and were in one of the three U.S. counties or Mexico during the 7 days preceding their illness onset.
Patients who meet these criteria should be tested for influenza, and specimens positive for influenza should be sent to public health laboratories for further characterization. Clinicians who suspect swine influenza virus infections in humans should obtain a nasopharyngeal swab from the patient, place the swab in a viral transport medium, refrigerate the specimen, and then contact their state or local health department to facilitate transport and timely diagnosis at a state public health laboratory. CDC requests that state public health laboratories promptly send all influenza A specimens that cannot be subtyped to the CDC, Influenza Division, Virus Surveillance and Diagnostics Branch Laboratory.
Persons with febrile respiratory illness should stay home from work or school to avoid spreading infections (including influenza and other respiratory illnesses) to others in their communities. In addition, frequent hand washing can lessen the spread of respiratory illness.
CDC has not recommended that people avoid travel to affected areas at this time. Recommendations found at http://wwwn.cdc.gov/travel/contentSwineFluUS.aspx will help travelers reduce risk of infection and stay healthy.
Clinical guidance on laboratory safety, case definitions, infection control and information for the public are available at:http://www.cdc.gov/swineflu/investigation.htm.
• Swine Influenza A (H1N1) Virus Biosafety Guidelines for Laboratory Workers: http://www.cdc.gov/swineflu/guidelines_labworkers.htm
• Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection in a Healthcare Setting: http://www.cdc.gov/swineflu/guidelines_infection_control.htm
• Interim Guidance on Case Definitions for Swine Influenza A (H1N1) Human Case Investigations: http://www.cdc.gov/swineflu/casedef_swineflu.htm
Morbidity and Mortality Weekly Reports Dispatch (April 24) provide detailed information about the initial cases at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm58d0424a1.htm
For more information about swine flu: http://www.cdc.gov/swineflu
Additional information is also available by calling 1-800-CDC-INFO (1-800-232-4636)
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