ARCHIVED: Addendum: The Management of the National Antiviral Stockpile: Options Report

Addendum (June 19, 2009)

The emergence of the novel H1N1 flu virus (human swine flu) virus in Canada in April 2009 led to preparation for the potential use of antivirals from the National Antiviral Stockpile (NAS) and the potential need for surge capacity by the National Emergency Stockpile System (NESS).   Although there was no federal/provincial/territorial decision to formally deploy the NAS to respond to the novel virus, some jurisdictions used antivirals from their stockpiles in their public health response based on local considerations and respective triggers for deployment. There were several antiviral stockpile management issues that arose that deserve mention in this Addendum. The key issues were the purchase of additional antivirals, early conversion of bulk oseltamivir into capsules, prepositioning of antivirals in remote communities and clarification of the triggers for release of the NAS. On June 11, 2009 a Phase 6 pandemic was declared by the World Health Organization which has implications for the NAS since the trigger for release of antivirals from the national stockpile is a Phase 6 declaration (Annex E, CPIP).  We conclude this Addendum with recommendations for F/P/T consideration to promote timely and optimal preparedness for a more significant draw from the F/P/T antiviral stockpiles.   

New Antiviral Purchases

In response to the outbreak, some provinces and territories decided to purchase additional antivirals to supplement the National Antiviral Stockpile (NAS) in their jurisdiction, and/or to escalate their purchase plans to address recent composition recommendations or to address expiring stocks they currently held in the NAS.  On April 29, 2009 PHAC made a decision to purchase from GSK an additional 5.7 M doses of zanamivir (Relenza^R) to supplement existing stocks in the National Emergency Stockpile System (NESS).  These antivirals are intended for surge capacity for the provinces and territories at the time of a pandemic and are expected to be delivered in mid to late July, 2009.  Since that time, P/Ts have raised concerns about the lack of zanamivir availability in the private market (pharmacies and hospitals) due to sales restrictions imposed by GSK.  In response to concerns expressed by PHAC, however, GSK has subsequently reviewed and revised its internal policy and expects to be able to obtain additional quantities of zanamivir to address shortages in the hospital / pharmacy market. PHAC has advised GSK of its willingness to delay receipt of up to 2.5 million doses of zanamivir for diversion to the private market if that will expedite availability to that market, and PHAC will work with GSK to facilitate equitable distribution within those jurisdictions with an identified short supply using GSK’s existing distribution network.   

Bulk Oseltamivir

In April 2009, PHAC also made a decision to proceed early with the process of placing its NESS supply of bulk oseltamivir, stored in Switzerland, into capsules.  Since this process takes 6 months from the time it is requested to the time the capsules are shipped, it was deemed prudent to ensure this supply would be available in advance of a pandemic for surge capacity for the P/Ts.  These capsules are expected to be delivered in the fall.  There are some jurisdictions (i.e. MB) that have elected to convert their supply of bulk into capsules earlier than originally planned.  Some jurisdictions (i.e. ON, NL) are maintaining their original schedule for conversion as it was slated for the early winter and they expect existing supplies to be sufficient until then. Other jurisdictions did not purchase bulk. 

Pre-positioning of Antivirals

Since antiviral treatment is recommended within 48 hours of the onset of symptoms, some remote and isolated communities may desire a stockpile to be pre-positioned in advance of an influenza pandemic.  For example, the decision to pre-position antivirals early in the H1N1 outbreak was made by the Yukon for 13 rural communities.  Other jurisdictions (i.e. QC, ON, SK, NB, MB, NL, BC) have also pre-positioned or deploy antivirals in remote or auxiliary depots to facilitate rapid access. 

Clarification on the Use/Triggers of the NAS and NESS

The release of Annex E “The Use of Antiviral Drugs During a Pandemic” in the Canadian Pandemic Influenza Plan occurred during the outbreak.  Annex E defines the purpose of the NAS and NESS stockpiles and their intended uses.  The outbreak underscored the need for clarification regarding who the stockpiles are intended for (eligibility) and triggers/mechanisms for use.  It was agreed that the NAS is intended for use by all Canadians, including First Nations on-reserve and federal populations (inmates, federal employees, etc), provided the stockpile was being used for purposes consistent with F/P/T policies as outlined in the Plan and its annexes and the Policy Recommendations on the use of Antivirals for Prophylaxis.  The NESS antivirals are intended for surge capacity in support of P/T efforts to manage pandemic/avian influenza.   The allocation of antivirals from the NESS and the mechanism for this request requires further discussion. 

Outstanding Issues:

• All F/P/T governments have inventory management capacity for monitoring the quantity of antivirals stockpiled in the NAS and the NESS.  There is a need to assess the current ability for a real-time (rapid) monitoring of the quantity of remaining antivirals and to what level (i.e. at the depot, at the regional level, local or distribution site) this monitoring currently extends.  Information about the rate of depletion of antivirals stockpiled in NAS will help determine whether and when there might be shortages, and whether adjustments are necessary to national recommendations for the use of antivirals based on epidemiology and scientific evidence.  This information is also essential to help inform the NESS on its allocation of antivirals to the P/Ts for surge.  
• In collaboration with the P/Ts, PHAC is in the process of determining an equitable allocation strategy for antiviral distribution of the NESS to P/Ts as their respective NAS stocks are depleted.  The implementation plan for equitable distribution of Relenza to the private market where there exists a short supply is being developed by GSK.  
• The existing stockpile contains antivirals that are close to expiry.  F/P/T governments are in the process of making decisions on how to manage these expiries (either replacing, holding and stability testing, or exchanging). 
• Some jurisdictions are planning to, or have purchased additional antivirals and/or powder for liquid suspension for those unable to swallow capsules.  Historically, this has not been a national stockpile recommendation due to its shorter shelf-life and bulky storage requirements.
• The lack of availability of Relenza® in the private market for treatment of seasonal influenza was a concern expressed by P/Ts, as was the inability to obtain diskhalers for Relenza® as a separate stockpiled item.  The need for additional diskhalers (they are currently supplied one diskhaler/treatment course of Relenza) was raised by one province since they may be required in certain circumstances, such as to replace lost or damaged diskhalers.  Other jurisdictions may have similar demands for additional diskhalers.
• It became apparent during the H1N1 outbreak that the need for national engagement related to the agreed upon use and management of the national stockpiles, and monitoring of international use/practices is important and should continue. In this Report, the Task Group recommends that an ongoing F/P/T network or committee continue to address stockpile management best practices and inventory control issues.  However, the mandate of the AVSMTG has reached an end according to its Terms of Reference. 

 AVSMTG Recommendations for Short-Term Planning:

1. That the ability to rapidly monitor the rate of depletion of the NAS and the NESS  be established as soon as possible, with a plan to roll-up information to the national level developed by the fall of 2009.  A scan of existing mechanisms and agreement on a simple process for national reporting will be completed by members of the Antiviral Stockpile Management Task Group.
2. That the mandate of the Antiviral Stockpile Management Task Group be extended for another year to continue to address emerging issues regarding the antiviral stockpiles, such as implementation of the national antiviral strategy (i.e. deployment), identification of the trigger for release of the stockpiles and communications issues in the context of the current H1N1 pandemic.
3. That F/P/T governments continue to collaborate and work towards ensuring adequate supply of antiviral stockpiles and preparation for rapid deployment, to include, but not limited to:
   1. determine the immediate need for purchases of antivirals to replace expiring stock and/or to purchase antivirals to meet national targets (i.e. amantadine)
   2. ongoing assessment of current and future storage capacity
   3. consider the early  conversion of bulk oseltamivir powder to capsules
   4. consideration by P/Ts to purchase powder for liquid suspension oseltamivir for use in the short-term (NT and NU have made purchases).
   5. work with manufacturers and jurisdictions who have signed on to the Exchange Program offer to determine ability to  continue with the Program and the agreed upon timelines
   6. position any remaining antivirals nearing expiry to be used first
   7. consider the prepositioning of antivirals (type, quantity) in remote and isolated communities
   8. confirm that there are adequate supplies of Relenza® in the private market to meet current clinical requirements, and ensure equitable distribution to jurisdictions with short supply
   9. further explore the option of purchasing diskhalers separate from the drug for jurisdictions wishing to stockpile an additional quantity.
   10. conduct ongoing assessment (at the P/T and national level) of the status (quantity) of the NAS
   11. other emerging stockpile management issues