Today, I’ll be covering the following information: What is an antiviral medication? Brief Overview of Clinical Guidelines Differences between Antiviral Medication & Vaccine Strategic National Stockpile Overview State Stockpile -Overview -Access -Distribution -Reporting Supply Chain Disruption Key Points Considerations
I know you have seen this slide already in the Regional Medical Director presentation. I bring it up again for context and to re-emphasize that antiviral medications are one component of an overall plan to assist in the control of an influenza outbreak. Antiviral medications are medications that have activity against influenza viruses, including the novel H1N1 influenza virus Antiviral medications can be used for treatment or prevention of novel H1N1 influenza virus This medication is not appropriate for everyone. The most current treatment guidance found at www.texasflu.org will outline for providers the appropriate use of antiviral medications. It is important to remember that this medication should only be used when prescribed by a health care provider. For these reasons and others, the non-pharmaceutical intervention strategies that have been discussed, such as hand washing, will continue to be a key method of protection until and even after a vaccine is available
This slide provides a brief overview of the clinical guidelines for prescribing antiviral medications. Please note, these are the current recommendations. Clinical guidance may change based on changes in the epidemiology of the novel H1N1 influenza- please visit www.texasflu.org regularly to check for changes in clinical guidance. Treatment Antiviral medications need to be used within 48 hours of the onset of symptoms in order to have maximum effectiveness from the medication. Antiviral medications should be targeted to high risk groups identified by the CDC. Current high risk groups are: Pregnant women, children, adults with chronic diseases (such as asthma, COPD, and diabetes) Healthcare providers should follow guidance from DSHS found at www.texasflu.org Antiviral medications can sometimes be used for preventive treatment in limited situations.
There has been a lot of information about antiviral medications and vaccine here and in the news. I want to quickly explain the differences between antiviral medication and vaccine. #1 Antiviral medications are primarily used to treat influenza are used in specialized cases to prevent Vaccines are used to prevent influenza #2 Taking antiviral medication does NOT build immunity in your body. Getting the novel H1N1 influenza vaccine DOES help your body build its own immunity. #3 Antiviral medications only offer you protection from novel H1N1 influenza while you are taking them. Once your body uses the vaccine to develop immunity to the novel H1N1 influenza virus, your body has lasting protection against the virus. #4 There is a finite amount of antiviral medication available. The amount of antiviral medication is not enough to serve everyone. The CDC is planning to have enough vaccine for anyone who wants it.
The Strategic National Stockpile, also called SNS, is a federal government stockpile of medicine and medical supplies available to states for public health emergencies upon request by state officials. For pandemic influenza response, Texas receives a finite amount of antiviral medications from the SNS. The CDC allocated materials from the SNS for each state for pandemic influenza response. The allocation includes a limited supply of antiviral medications (approximately 3.2 million for Texas), personal protective equipment (PPE), and ventilators. The SNS Includes two types of antiviral medications - Tamiflu and Relenza
I described the SNS, and now I want to describe the state stockpile for Texas. This state stockpile includes materials that we have received from the SNS because they become a state asset once received. The state stockpile consists of: Purchases made with federal preparedness funds (federal grants for preparedness activities) Funds from state legislature specifically to purchase antiviral medication for the state stockpile Materials from Strategic National Stockpile or SNS There is a limited and finite amount of antiviral medications. In total, there are approximately 4.75 million courses of Tamiflu and Relenza antiviral medications in the Texas state stockpile. This number includes antiviral medications from all sources- state purchased and federal SNS assets for Texas.
In general, routine channels for obtaining antiviral mediations will still be used. While the state stockpile contains a significant amount of antiviral medications, it does NOT have enough medication to cover every person or every need. Due to these resource limitations, it is necessary to target the materials to specific needs. There are three primary uses for the state stockpile listed here, and I am going to speak about each.
The routine channel for accessing antiviral medications for patients is shown above. The process are shown here is: Health care provider determines if a prescription is appropriate. Health care provider writes a prescription for the antiviral medication. Patient takes the prescription to his/her pharmacy to be filled. Pharmacist fills the prescription.
Most individuals will be able to continue to obtain antiviral medications through routine channels which I described on the last slide. There are, of course, individuals who would not be able to fill that prescription due to cost, lack of insurance or being underinsured. For those individuals, the state stockpile can be used, but for the most part the routine process is still in place. The mechanism to access the state stock is based on a partnership between DSHS and chain pharmacies, independent pharmacies, and Federally Qualified Health Centers (FQHC’s) and Community Health Centers. Federally Qualified Health Centers and Community Health Centers. are community-based organizations that provide primary care and preventive care services to persons of all ages, regardless of their ability to pay.
The process as shown here is: Healthcare provider determines if a prescription is appropriate. Healthcare provider writes a prescription The Healthcare provider identifies if state stock is needed to fill the prescription. Patient takes prescription to the pharmacy their healthcare provider refers to them to. Pharmacist fills prescription from the state stockpile for low or no cost based on the patient’s need. Let me explain a few additional details about this mechanism: 1. Healthcare providers will be advised from public health sources on how to write prescriptions that can be accessed from the state stockpile when appropriate and on what pharmacy to refer patients. Healthcare providers will receive this information from DSHS and professional associations. 2. The DSHS goal is to have participating pharmacies statewide. DSHS is currently working with chain pharmacies, independent pharmacies, and Federally Qualified Health Centers (FQHC’s) and Community Health Centers (CHC’s) to create access throughout the state. Pharmacy partners are selected based on geography, population served, and epidemiology of H1N1.
Use #2 of the state stockpile is Public health measures needed for outbreak control. Local health departments would be providing antiviral medications to address public health outbreaks or as a stop-gap measure when routine supply channels break down. For example, this summer we had a few residential summer camps that experienced a novel H1N1 influenza virus outbreak. These were very special closed settings, where all campers and all staff live and work onsite and do not leave the site . In some very specific settings such as these residential camps, antiviral medications can help contain novel H1N1 influenza outbreaks. In containing an outbreak in this residential camp setting, we prevent campers and staff from leaving at the end of the camp week and taking the virus with them to hundreds of communities all across the state.
Health care entities also have routine channels for obtaining necessary medications, shown above. This process usually involves health care entities tracking their supplies, placing an order with their routine supplier, receiving supplies from the routine supplier, and using the supplies to treat patients.
For health care entities too, there are times when this routine channel may break down. There may be small supplier breakdowns in a health care setting and the health service region can help to meet those immediate needs. Use #3 of the state stockpile is for when a break down in routine health care supplies occurs. These entities should follow routine channels for requesting medications [insert region specific information about process here].
This slide shows how DSHS will distribute antiviral medications across the state. DSHS will work with chain pharmacies, independent pharmacies, and FQHCs/CHCs across the state to help uninsured and underinsured people access medications . 1.In general, each county served by a chain will only be served by one chain in that county and all stores of that chain within the county will have state stock *For large counties (such as Dallas, Harris, Tarrant, Bexar, etc.) will probably have more than 1 chain pharmacy *DSHS is heavily emphasizing chain pharmacies because of their ability to perform distribution tasks to supply their stores 2. Counties that do not have chains but do have independent pharmacies will be served by one or more independent pharmacies in their county. *All independent pharmacies that are located in a county without a chain will be asked to participate in the antiviral 3. Counties with no pharmacies, approximately 30 in the state, will be served by the pharmacy in a neighboring county that currently serves that county with its pharmacy needs 4. FQHCs/CHCs will provide antiviral medications to their patients, as we know their patients are more likely to need state stock Partner pharmacy locations are being finalized now. Pharmacy partners are selected based on geography, population served, and epidemiology of H1N1. DSHS will distribute antiviral medications for use in public health measures to Local Health Departments. Should supply chains break down temporarily or for a longer period, DSHS will supply healthcare systems such as hospitals, with antiviral medications.
Usage Reporting DSHS will track state stock antiviral medication usage and inventory levels. Entities receiving state stock of antiviral medications will be required to report individual usage data and inventory levels to DSHS on a regular basis through an electronic system.
Again, I just want to summarize that there are three primary purposes for the state stockpile. Used for uninsured or underinsured individuals who have been identified as needing these medications by a health care provider and who otherwise wouldn’t be able to afford these medications. Used for outbreak control by local health departments and health service regions when necessary as a public health measure. (such as the camp setting) Used to meet immediate health care entity needs due to routine suppliers not being able to meet those needs.
It is important to note that in a large supply breakdown, in a worst case scenario, supply channels could become completely unavailable. If this happens, the state will need to review epidemiological information at the time (who is affected by the disease) and current treatment guidance to determine the appropriate allocation of the remaining stockpile. This may include attempts to address continuity of critical infrastructure (electricity, water, etc.) if this has not already been addressed through vaccination.
I’d like to wrap up with a few key points I hope you’ll remember and take with you after the conference today: Antiviral medications are only appropriate in specific circumstances There are a finite number of antiviral medications available Healthcare providers determine appropriateness of antiviral medication for patients Healthcare providers should make their decisions based on the guidance found at www.texasflu.org Antiviral medications are not a substitute for vaccine. Seek seasonal influenza vaccine as soon as that vaccine is available Antiviral medications are just one component for controlling a novel H1N1 influenza virus outbreak Non-pharmaceutical interventions (hand washing, social distancing, staying home from work/school when ill) are key elements to reduce transmission
As you participate in the conference today, especially in the Rehearsal of Concept exercise this afternoon, please be thinking about these considerations. DSHS will be doing the following regarding antiviral medications for a novel H1N1 influenza response: Manage state stock antiviral medication distribution (allocate, process orders, ship) Coordinate with stakeholders (healthcare providers, pharmacy partners, etc.) regarding state stock antiviral medication distribution Provide clinical treatment guidance at www.texasflu.org Track and report state stock antiviral medication usage Local Communities should be planning to do the following in their communities for a novel H1N1 influenza response: Healthcare providers should use the clinical guidance listed at www.texasflu.org Communities should use non-pharmaceutical interventions (handwashing, staying home when sick, etc.) to reduce transmission Ensure coop plans do not rely on long-term antiviral medication prophylaxis for healthcare workers and first responders Entities who receive state stock antiviral medications report on usage of this medication
Texas Pandemic Influenza Regional Conference Antiviral Medication Distribution Texas Department of State Health Services (DSHS) And Texas Division of Emergency Management (DEM) August and September, 2009
Must be used within 48 hours of onset of symptoms for maximum effectiveness
Should be targeted to high risk populations
Pregnant women, children, adults with chronic diseases (such as asthma, COPD, and diabetes)
Patients hospitalized due to novel H1N1 influenza
Healthcare providers should follow guidance from DSHS found at www.texasflu.org
Antiviral medications can sometimes be used for preventive treatment in limited situations
Antiviral Medication Brief Overview of Clinical Guidelines Page
Antiviral Medication Differences between Antiviral Medication and Vaccine Page Antiviral Medication Vaccine Primarily used to treat influenza, specialized use for preventing influenza Used to prevent influenza Does not build immunity in your body Helps your body build its own immunity You are only protected from influenza while you are taking the medication if used for prevention Once your body develops immunity, you have lasting protection Finite amount of medication, not enough to serve everyone CDC plans to have enough for anyone who wants it
Q What is the Strategic National Stockpile? A The Strategic National Stockpile (SNS) is a federal government stockpile of medicine and medical supplies available to states for public health emergencies upon request by state officials
For pandemic influenza response, Texas receives a finite amount of antiviral medications from the SNS.
The SNS includes two types of antiviral medications – Tamiflu and Relenza.
Antiviral Medication Strategic National Stockpile Overview Page
Q What is the State Stockpile? A A stockpile of antiviral medication DSHS purchased from federal preparedness funds and state legislature funds & antiviral medication received as the Texas portion of the federal Strategic National Stockpile
The state stockpile includes materials received from the SNS
The state stockpile has a finite amount of antiviral medications that need to be used strategically
The state stockpile includes two types of antiviral medications - Tamiflu and Relenza
Antiviral Medication State Stockpile Overview Page
There are three primary purposes for the state stockpile:
Individuals who cannot access medication through routine channels
Public health measure needed for outbreak control
Routine supply channels breakdown
Antiviral Medication State Stockpile Overview Page
Healthcare provider determines if an antiviral is appropriate Healthcare provider writes prescription Pharmacist fills prescription Access to Antiviral Medications for Patients Routine Channel for Patients Antiviral Allocation and Distribution Routine Channels for Access to Medication for Patients Page
Uninsured and underinsured may not utilize routine channels due to cost
DSHS created a mechanism to serve these patients through the state stockpile where patients can access medication at low or no cost based on the patient’s need
This mechanism uses a pharmacy distribution network that includes:
Retail chain and independent pharmacies
Community Health Center (CHC) / Federally Qualified Health Center (FQHC) pharmacies
Antiviral Allocation and Distribution Access to State Stock Medication for Patients Page
Healthcare provider determines antiviral is appropriate Healthcare provider writes prescription Health Care Provider refers patient to a pharmacy that has state stock Access to State Stock Antiviral Medications for Specific Patients Healthcare provider identifies state stock is needed Pharmacist fills prescription from state stock Antiviral Allocation and Distribution Access to State Stock Medication for Patients Page
Local health departments addressing public health outbreak control can access the state stockpile if local supplies are nearing or at depletion.
The local health department should contact the health service region to make this request.
Antiviral Medication Public Health Measures to Address Outbreak Control Page
Antiviral Allocation and Distribution Routine Supply Channel for Health Care Entities Access to Antiviral Medications for Health Care Entities Medication supply runs low Order from supplier Treat patients Routine Channel for Health Care Entities Page
If routine supply channels break down, the Health Service Region has a mechanism to provide supplies to health care entities. Access to Antiviral Medications for Health Care Entities Medication supply runs low Order from supplier Treat patients Routine Channel for Health Care Entities Antiviral Allocation and Distribution Routine Supply Channel for Health Care Entities Page
Chain Pharmacies Independent Pharmacies FQHCs / CHCs DSHS Local Health Departments Uninsured/ Underinsured Populations Healthcare Systems DSHS Health Service Region Antiviral Allocation and Distribution Distribution System for State Stock Antiviral Medication Page