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1 message found.


Medical Material Quality Control Message

MMQC-19-1557


Message Number: MMQC-19-1557
Released On: 22-Mar-19
Message Class: Informational
Material Type: Vaccine
MMQC\MMI Reference: MMQC-18-1648
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

GlaxoSmithKline (GSK) Shingrix Vaccine Shortage/Additional Guidance


Reason / Information:

Informational / Vaccine / Action Required - This message was previously published as MMQC-18-1648, updated to reflect new guidelines and requirements. Defense Health Agency Immunization Healthcare Branch (DHA-IHB) and Defense Health Agency Medical Logistics (DHA-MEDLOG) are providing Medical Treatment Facilities (MTF's) with additional instructions and guidance due to the continued high demand for GSK's Shingrix vaccine, it is anticipated that order limits and shipping delays will continue throughout 2019.

NOTE: Limitations in supply are not due to any manufacturing issues, product recalls, or safety concerns. Shingrix vaccine is being released by the manufacturer based on historical ordering patterns and based on current projected supply availability. At midyear, GSK plans to reevaluate allocation targets based on available supply.


Disposition / Instructions:

Actions to be taken:

1) DO NOT utilize the normal holding orders process described in the current Statement of Work Pharmaceutical Prime Vendor Contract.

2) Effective 25 March 2019, all MTF's that have an allotment allocation will begin utilizing the new DHA-MEDLOG and Defense Logistics Agency-Troop Support (DLA-TS) Shingrix Vaccine web order application to place holding orders for the Shingrix Vaccine. This will allow DHA-IHB, DHA-MEDLOG, and DLA-TS to track and adjust product allocations to ordering MTFS's, in conjunction with, Prime Vendor (PV), AmerisourceBergen. If the web ordering site is not utilized, MTF's will not receive the requested shingrix vaccine.

3) The DHA-MEDLOG/DLA-TS Shingrix web order application can be accessed via https://info.health.mil/bus/medlog/ops/Pages/MEDLOG_Shingrix.aspx

---Shingrix Vaccine allocations to the PV will be made every two weeks, based on the cutoff date posted on the web ordering site.

---Shingrix web order application will display cutoff dates on the dashboard under announcements. No orders will be processed after the cutoff date. The Shingrix web order application will display the date for the next ordering period.

---MTF's must complete an offline non-submit request within Defense Medical Logistics Standard Support (DMLSS) and print the DD Form 1155. Ensure that the "Non-submit" indicator is checked.

---DHA-MEDLOG has provided step-by-step instructions which will assist the MTF's in placing a holding order via the web ordering application. (See attachment on Message under Additional Documentation/Attachment )

4) MTF's are responsible for monitoring the status of their active holding orders previously submitted, as well as, to place subsequent holding orders if vaccine demand exists.

5) MTF's can only place holding orders via a customer ordering account (non-credit).

---Full or partial order's that have been confirmed as delivered, the PV will deduct the $25 flat fee per order from the customers credit account.

---If no vaccine has been delivered, the PV may not deduct the flat fee from the MTF credit account.

6) Shingrix vaccine orders can be held on backorder, under this process, for 180 days. If Shingrix vaccine does not become available and does not ship within the outlined timeframe, then the PV will cancel the order and send an EDI 855, Purchase Order (PO) Cancelled.

7) The cost associated for a holding order's will be determined at the time of the order confirmation, EDI 855, PO Acknowledged.

---To ensure pricing accuracy, the PV will not generate the EDI 855 until the product has been received from GSK.

---The EDI 855, must be sent and received prior to the EDI 856, Advanced Shipment Notice, which is prior to shipping, to the MTF's.

8) MTF's may cancel the holding order after they have notified the PV, AmerisourceBergen, via the appropriate customer service email listed below: Ensure to include on the subject line "holding order cancellation".

---CONUS: DoDCustomerCARE@amerisourcebergen.com

---OCONUS: DODOCONUS@amerisourcebergen.com

9) MTF's should also include in the cancellation email, all pertinent information such as, ordering account number and PIID number. AmerisourceBergen may decline to cancel an line item, if the order is in process.

10) MTF's are encouraged to utilize the ???Backorder Report??? located in AmerisourceBergen, PassPort portal.

---MTF's will then be able to track all holding orders placed.

---For more details on the ???Backorder Report??? refer to the AmerisourceBergen PassPort portal ???Use the Reporting Tools??? under the ???How Do I??????? section.

11) Prioritization of patients is not recommended at this time. Decisions to prioritize should be based upon MTF's practice and patient needs.

12) To replenish supply and for continued coverage of beneficiaries, MTF's may schedule individuals who need a second dose to return at the six (6) months time frame after the initial dose.

---Shingrix vaccine dosing schedule is two (2) doses, with a second dose administered two (2) to six (6) months after the initial dose.

If there are any questions or concerns with regards to the DHS-MEDLOG/DLA-TS Shingrix web order application, contact DHA-MEDLOG at 301-619-4033, DSN 3434-4033.


Item Information:

NSN (FSC-NIIN): 6505 - NS1
NDC: 58160081912
Nomenclature: SHINGRIX VIAL KITS
UI: KT
Manufacturer: GLAXOSMITHKLINE
Distributor:

LOT / SN:
All

NSN (FSC-NIIN): 6505 - NS2
NDC: 58160082311
Nomenclature: SHINGRIX VIAL KITS (10 KT OF 1EA )
UI: CS
Manufacturer: GLAXOSMITHKLINE
Distributor:

LOT / SN:
All

Service/Additional Instructions:



POC Contact Information:

US AIR FORCE
Email: usaf.detrick.afmoa.mbx.sgmp-scs-alerts@mail.mil
Phone (COMM): 301-619-4183
Phone (DSN): 343-4183
Fax: 301-619-2557

US ARMY
Email: usarmy.detrick.medcom-usamma.mbx.doc@mail.mil
Phone (COMM): 301-619-4198
Phone (DSN): 343-4198
Fax: 301-619-4468

US NAVY
Email: usn.detrick.navmedlogcomftdmd.list.mmqc@mail.mil
Phone (COMM): 301-619-3085
Phone (DSN): 343-3085
Fax: 301-619-2473

USAMMC-E
Email: usarmy.rheinland-pfalz.medcom-usammce.list.dtd-quality-assurance@mail.mil
Phone (COMM): 011-49-6331-86-7118/7181
Phone (DSN): 495-7118
Fax: 6218

Additional Message Recipients:

Please ensure dissemination of this information to the following:

Command Channels
Immunization Clinics
Medical Log Officers
Medical Staff
Pharmacy Officers
Supply Officers
Supported Activities/Centers
Vaccince Shot Teams

Message Dissemination Authorization

AF Activities will take action as prescribed in AFMAN41-209, Medical Logistics Support, Chapter 7. For MAJCOMS & NGB ??? This Msg has been transmitted to all designated subordinate medical activities

See Army Regulation (AR) 40-61, 28 January 2005, Chapter 4, and The Department Of The Army Supply Bulletin (SB 8-75-11) For Applicable Policies and Procedures.

DODD 5105.22 and DODD 6025.13

Additional Documentation / Attachments


*** END OF MESSAGE ***