1. What is the cost for a course of the antivirals under both options?
The subsidized price for Tamiflu is $14.43. The subsidized price per course for Relenza is $16.29. Texas has approximately 2.3 million courses available at these subsidized rates. If orders placed by governmental entities and by DSHS for the state stockpile exceed the subsidized courses available, governmental entities will have the option of purchasing antivirals at the regular contract price of $19.24 for Tamiflu and $21.72 for Relenza. The regular wholesale price for either is approximately $50 per course.

Example:
Green Health Department decides to purchase enough Tamiflu to treat 1,000 people.
The subsidized price for 1,000 treatment courses of Tamiflu would be $ 14,430.
The regular wholesale price for 1,000 courses would be about $50,000.

2. Will the contracts with manufacturers be renewed after the 12/31/07 end date?
We don’t know at this time, but the current federal contract states that prices can be re-negotiated at the end of the contract period, so that option is there. However, in a year there may be new and better antivirals on the market since a number are in the pipeline.

3. What are the storage and handling requirements for the antivirals?

• These products must be stored in a controlled temperature range of 59 to 86 degrees Fahrenheit (°F), preferable at or near 77°F.
• Area must be free of pests/varmints and have controlled humidity, with little or no light except during routine checks or during use.
• Storage area should have limited access to authorized individuals only, with location in compliance with state and federal requirements for prescription drug products. Location would include a licensed pharmacy or other site under the authority of a licensed health practitioner or his/her agent.
• Authorized personnel must have 24/7 access.
• A backup power source is desirable.
  

4. What is the shelf life of the antivirals, and will the Shelf Life Extension Program apply to them?
The shelf life of Tamiflu and Relenza is 5 years.

The federal Shelf Life Extension Program (SLEP) permits a longer approved shelf life for federally owned medications. Drugs in the SLEP have to be kept under very controlled conditions. Samples from each manufacturing lot in each location are sent in periodically for testing to assure that the drug is still effective. One issue with the SLEP program is the expense. Given the high price of testing, the amount of any lot number that is stored in any one location must be large enough to justify the cost.

At this point the SLEP is not available for antivirals on the federal contract, but CDC is looking into that option for states. There has been one conference call with CDC and ASTHO on this subject. The exact cost of testing isn’t known at this time.

5. Do we need to order, store, and distribute the antivirals under the direction and supervision of a physician or pharmacist?
Yes, under Texas state law. Any non-health department purchasers must have a physician who is willing to order the antivirals for employees. A physician, pharmacist, or registered nurse can sign for medication delivery.

6. Is there a program to replace these meds as they expire or is it a one time purchase and when they expire that's the end of the program?
This is a one-time purchase at this point. As DSHS and local health departments plan for storage of antivirals purchased under the contract, replacement to avoid expiration is an important consideration. We need to consider options where rotation of stock might be possible. Even at a cost for this service, it will save replacement costs in the long run.

7. What is expected of local health departments/ health authorities?
The responsibility for the local health departments is to coordinate with entities in their jurisdictions desiring to purchase under the contract. They will need to assure that each purchaser has an appropriate physician signature for purchase, from a currently licensed Texas physician. They will also need to confirm that there is a responsible physician, nurse, and/or pharmacist to accept delivery of the medications, supervise their storage, and ensure the appropriate environment. Local health departments must also collaborate with their preparedness partners.

8. What are the responsibilities of the physician who signs for the medications for non-health department purchasers?
The physician must sign the order request, including his/her Texas license number. The physician must be willing to write a standing order describing how the antivirals will be distributed among the employees and take responsibility for that administration, which can be done by a registered nurse or pharmacist.

9. If there is not a method to replace this stockpile as meds expire, why would local communities not be allowed to set up a system where they use the stockpiled drugs during non-pandemic times and replace them with drugs with longer expiration dates. This seems like a logical approach to avoid the wasting of medications and taxpayer dollars.
Whether we are able to do this has not been determined yet, but does make sense. The question has been posed to CDC. The option of rotation may be available in the future if the right relationships can be developed with pharmacies or distribution centers with which we have contracts for vaccine and other public health medications.

10. Please give more information on the 80/20 ratio determination and/or attach the reference providing more detailed information.
We are seeking more detailed information on the decision. We do know that the National Vaccine Advisory Committee (NVAC) to DHHS recommended that ratio. However, purchasers can choose any ratio they want to meet their communities’ needs. Tamiflu is an oral medication; Relenza is an inhaled powder. In addition, Relenza requires more storage area.

11. How many antiviral courses is DSHS purchasing and how will they be allocated? Will my decision to purchase or not affect my allocation?
DSHS has purchased approximately 144,000 courses of antivirals with CDC Cooperative Agreement funds. Texas will have reserved in the StrategicNational Stockpile approximately 3.3 million courses (federally funded) that will be sent to Texas for pre-positioning in the event that a pandemic is imminent. The state has not yet decided how much additional antiviral medication to purchase.

12. What if I don’t sign a contract now?
You have until November 2007 to make a decision about purchasing under the existing subsidized federal contract.

Texas is limited to approximately 2.3 million courses at the subsidized rate.. The amount of subsidized courses available for local purchase will be limited to the number of courses remaining after DSHS purchase. The orders for subsidized courses placed and paid first will have precedence. The remainder will be filled at the full contract price.

13. What if I don’t buy any antivirals?
Decisions on allocation and distribution of federal and state funded antivirals have not been made at this time. Antivirals will likely be allocated according to epidemiological factors during a pandemic; for example, if one age group is disproportionately severely affected by the virus, more of the antivirals may be designated for that group. However, population would also be considered. If one county had more of the affected population group than another, more might be allocated to that county. If all populations are affected equally, allocation may be per capita. Geographic concentration of the infection may be another factor to be considered.

15. What are other local governments doing? Other states?
We don’t have that information about local governments. Other states are making decisions just as we are. Private and public entities can contract directly with manufacturers to purchase antivirals without state or federal involvement.

16. We don’t have a local pandemic plan yet. How does that affect us with respect to purchasing antivirals?
Locals who receive preparedness funds must have pandemic plans prior to December 31, 2006 as a requirement of pandemic influenza supplemental funding round 1. Those entities that do not receive preparedness funds must coordinate with local preparedness partners including the DSHS Health Service Regions.

17. Will ordering off this contract remove millions of dollars of antivirals from circulation in the private sector?
No, the drug manufacturers have committed to fill the orders for the private sector. They are increasing capacity to meet the increasing demands from oth sectors.

18. If we buy medications from this contract, who in our community can use them? employees? their families? Also, how can they be used?For preventive treatment? Only for those who are already ill? Or are these local decisions, not mandated by the state or federal government?
At this time, medications bought under this contract must be used for treatment, but that would include preventive treatment and outbreak control. They cannot be used for season flu. In addition, they may not be released or used until a pandemic is imminent, as determined by CDC.Otherwise, at this time, the use of these locally purchased medications and the persons for whom they can be usedare local decisions. These decisions should be made in coordination with local preparedness planning.

19. How can I find out more about pandemic influenza activities in my area?
Contact your DSHS Health Service Regional (HSR) office or local Health Department (LHD). In recent months, HSRs and LHDs have met to discuss pandemic influenza planning and funding use. They will be able to help you determine how your plans and any order you submit would fit into other local and regional plans.

20. Are these antivirals for use with the seasonal flu?
These antivirals are for use as treatment in the event of an avian flu (pandemic), not for seasonal flu.

21. Should we purchase some level of product to be used for his first responders, police, fire, EMS?
This is one reason for the offer to allow local government entities to access this federal contract. Local government officials should make the decision about what is best for their locality.

22. What are the storage requirements?
A local hospital would be an ideal place to store the product as it will have a Class C pharmacy, security, controlled temperature and humidity, and 24/7 availability. As long as the drug cache is handled under the purview of a practioner (MD or their designee) it could be at some other location that complies with the aforementioned criteria for drug storage. (This could be a warehouse, pharmacy, physician's office, but not limited to just these.)

22. How will these meds be monitored? Is that the responsibility of the region?
There is no existing or planned program to monitor the meds in the possession of the governmental agencies that purchase them; but a future audit or inventory is possible depending on the actions or instructions of the CDC.

The Eligible Applicant is responsible for monitoring. See bullet 2 on either contract. Storing with entities that can ensure safety and monitoring is important in your planning. Fees for these services should be considered. Also review Q & A questions 3, 4, 5, and 6.

23. How will Local Health Departments know if the antivirals are being used as ordered by the CDC; and if they aren’t, is that against the law?
Use of the antivirals outside of CDC guidelines would be a violation of the contract signed by the purchaser.

24. I understand that there are 10 capsules @ 75 mg each with each course of Tamiflu and 20 powder packages per unit of Relennza. How many people can be treated with 1 Course of both the Tamiflu and Relenza?

The 10 capsule pack of Tamiflu 75mg constitutes one course of drug or enough for one patient to have 5 days of treatment, taking one capsule twice a day. This course can also be used for prophylaxis at a dose of one capsule per day for 10 days.

Relenza comes with 20 powder packets per carton and is sufficient for one course of drug also, providing one patient with 5 days of treatment. The dosage is two packets twice daily or a total of 4 packets daily for 5 days. There is no prophylaxis dosage recommended for Relenza.

25. On the information you provided, the third bullet, you state that " this contract must be signed and returned to DSHS and payment must be received no later than November 1, 2007. Funds must be received by DSHS before your antiviral order can be placed." Does this mean we have up until November 1, 2007, to pay?
Yes, funds do not need to be sent with the signed contract but may be sent any time before November 1, 2007.

26. Does that also mean that if we wait until November 1 2007 that the order will not be processed until then?
Your order will not be processed until funds have been received. Once we have received your funds we can place your order. Funds must be received by November 1, 2007, to take advantage of this subsidized price.

27. Is this something that will be coordinated through each region even if we have a local health department and LHA?
The LHD coordinates local response. For jurisdictions without LHDs, the HSR serves in that capacity.

28. Also, is the LHA responsible for requesting these drugs for whoever chooses to participate?
No, LHDs are not involved in the ordering process. The Eligible Applicant submits order to DSHS. See paragraph 2 and bullet 4 both on page 1 of the Contract to Purchase. Also Q & A questions 7 and 8 might help.

29. I was also asked about storage and if each individual is responsible for that, or do they need to be stored within a local pharmacy or at the health department?
The Eligible Applicant is responsible. See bullet 2 on page 1 of the contract.

30. How will these meds be monitored? Is that the responsibility of the region? How will we know if they are not being used as ordered by the CDC and if they aren’t, is that against the law?
The Eligible Applicant is responsible for monitoring. See bullet 2 on the contract. Storing with entities that can ensure safety and monitoring is important in your planning. Fees for these services should be considered. Also review Q & A questions 3, 4, 5, and 6.

31. May Pan Flu grant funds be used for stockpiling antivirals?
Antiviral purchases are not allowed with pan flu funds. CDC base funds may be utilized for the purchase of antivirals with advance approval by CDC.

32. Who are considered eligible applicants for the subsidized rate for purchase of antivirals?
State agencies and local governments.

33. Since the health of family members will affect the ability of a state employee to perform duties in the event of a flu pandemic, can we include family members of state employees in our order? I assume that the employee would need to pay for the cost of family members.
With regard to purchase of antivirals for the family members, they should consult Government Code Chapter 607 which allows this, but only for the family members of certain first responders, and only when the first responder is actually exposed to a disease (see below). I think it is appropriate that each agency or local government consult their own attorney on how to interpret this, but there is no authority to prophylactically administer the vaccine to family members. With regard to payment, as a state agency, you would need to determine what is legally allowable under your state funding. Asking the employee to pay for medication for family members is an option, but the money would have to be available at the time the order is placed.

34. Which is more effective: Tamiflu or Relenza?
We don't know which one will be more effective in the event of a pandemic-- or whether they will be effective at all. It is also possible that by the time of a pandemic, better antiviral medications may have been developed and approved. The CDC and DHHS Pandemic Influenza websites have additional information about antivirals.
http://www.cdc.gov/ or http://www.pandemicflu.gov/

35. Is it possible for a non-participating Local Health Department with an approved Health Authority to purchase pandemic influenza antivirals via methods indicated in Dr. Bell’s letter of 11/02/06 and Dr. Lakey's letter of July 30, 2007?
All governmental entities are eligible to contract with us to purchase the antivirals. As a non-participating LHD, you are considered a governmental entity.

36. We are an office of lawyers and associated staff. Did you indeed intend to extend this offer to agencies that do not have custody of or responsibility for other persons, e.g., TDCJ or TYC?
All governmental entities were extended this offer.

37. According to the contract, the antivirals will not be released for usage until the pandemic health emergency is declared by federal and/or state officials. Does that mean that the antivirals are warehoused elsewhere and not sent to us until the emergency is declared?
Your order is shipped to you once payment has been received.

38. I have interpreted the documents and contract to say that they will be shipped basically upon order and we may be be required to store them for several years.
The antivirals will be shipped to the place you specify. The antivirals purchased with this contract are intended for use during a pandemic and not for seasonal use; therefore they should not be released from your storage for use by your staff until the public health emergency is declared.

39. What are the routine requirements for these antivirals? In addition, how much space is required for, say, 120 courses of either Tamiflu or Relenza?
Storage and distribution will be your responsibility. The antivirals can be stored in an air conditioned location, optimal 77 degrees F, but can vary between 59 and 86 Degrees F. This is the standard for most air conditioned locations. Lighting would only be a problem if the actual medications, capsules or powder were exposed. Both are in sealed packaging. Regarding space, Tamiflu will requre about 1 cubic foot per case of 88 cartons. Relenza about the same but for only 16 units per case. So Tamiflu would need 2 square feet 12 inches high. Relenza about 7.5 square feet or less than 3 square feet one case high.

40. Our agency has no health care professionals on staff, nor any business relationship with any health care professionals. How is it envisioned that we would involve the requisite health care professionals, should we decide we want to participate in the offer?
You may contact the Health Authority in Travis County at the Austin-Travis County Health and Human Services (Dr Adolfo Valadez). They may be able to assist you in receiving and distributing the antivirals. If you are interested in purchasing these antivirals, the Department of State Health Services will work with your regarding this requirement.

41. What is our agency's liability under this program? For example, who's liable if they're stored improperly, lose effectiveness, and someone is injured or killed as a result of receiving improperly stored medication? Who's liable if they're not administered properly? The agency or the health care professional who administered it? Who's liable if the medications don't work or are tainted?
There are a variety of scenarios but generally the agencies liability should be slight. There are clear guidelines for storing and using the antivirals and if these guidelines are violated you should obtain expert advice before using the product. Congress has provided liability protection to those involved in administering "Pandemic and Epidemic Products" see Public Law 109-148 ("Division C-Public Readiness and Emergency Preparedness Act") for details.

42. Would a state university be eligible to purchase from this contract? If so, may the antivirals be sold for at least what we paid for them, if the CDC has declared the pandemic flu in our area?
Yes you are eligible to purchase from this contract as you are a governmental entity. Normally if someone purchases something they are free to dispose of it as they see fit. But in this case they are agreeing to follow CDC guidelines on use of product, and selling it might be a violation depending on who they sell it to, the purchaser's use of the product, and the content of CDC guidelines. As to selling the product at a profit, nothing in the contract prevents this, but it certainly contravenes the purpose of this program which was to make the antivirals available to those who need them most at the lowest possible price.

43. Are we able to purchase Tamiflu at pediatric doses?
Roche confirmed that pediatric suspension of Tamiflu is not included in the contract. They did say, however, that work is being done with powder formulations that can be incorporated into flavored syrups.

We speculate that there will be something more definite in the near future

44. Can CDC Preparedness funds be used to purchase antivirals?
At this time, CDC does not allow pandemic influenza round 1 and 2 and Cities Readiness Initiative (CRI) funds to be used to purchase antivirals. Public Health Emergency Preparedness (or base funds) can be used but only after CDC has given approval for purchase. Once a contractor has submitted a contract specifying the amounts to be ordered, a request will be forwarded to CDC for approval. Once approved, the contractor will be notified that a contract amendment will be completed to obtain those funds.

45. How can private, non-profit hospitals coordinate with their local health departments or Region re the purchase of antivirals? If the local health departments/Region do not get involved in the actual purchase by entities in their jurisdiction, and the private non-profit is not eligible to directly purchase, then how do we (the Region or LHD) coordinate with these entities regarding their purchase of antivirals?
Based on documents received from federal level partners “the intent behind the appropriation of this contract is not to provide purchasing opportunities for private sector use. The intent is for states (and the areas that comprise the states) to treat the general public with antiviral drugs in the absence of vaccine in a declared pandemic.“ Texas has interpreted this to mean that we are unable offer this opportunity to the private sector at this time. If this directive changes, we will inform you. Letters were sent to public hospitals and asked to coordinate with their local health departments or Region. Private, non-profit hospitals were not sent this letter.

Questions about this program can be answered by local health departments or by sending an email to

List of local Health Departments:
Full Service
Non-participating
Health Service Regions

Last updated November 14, 2007