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1 Health Alert Netwrk Tri-Cunty Health Department Serving Adams, Arapahe and Duglas Cunties Phne 303/ Fax 303/ Richard L. Vgt, M.D. Executive Directr The pages that fllw cntain infrmatin critical t prtecting the health f yur patients and the citizens f Clrad. Number f pages including cver: 8 Subject: Update Additinal Prducts Recalled in Assciatin with Multi-state Hepatitis A Outbreak Message ID: 6/28/2013 4:30:00 PM Recipients: HAN Cmmunity Members. Frm: TRI-COUNTY HEALTH DEPARTMENT Adams, Arapahe and Duglas Cunty, Clrad Recipient Instructins: Tri-Cunty Health Department is frwarding yu the attached HAN. Yu may have already received this bradcast if yu are n the CDPHE distributin list, hwever, we wanted t ensure yu did nt miss this imprtant infrmatin. N respnse is required. =========================================================================== Yu have received this message based upn the infrmatin cntained within ur Health Alert Netwrk Ntificatin System. If yu have a different r additinal r fax address that yu wuld like us t use, r if yu want t be remved frm the list, call

2 HEALTH ALERT NETWORK BROADCAST MESSAGE: :10 FROM: CO-CDPHE SUBJECT: HAN Update Additinal Prducts Recalled in Assciatin with Multi-state Hepatitis A Outbreak RECIPIENTS: Lcal Public Health Agencies, Emergency Departments, Infectin Cntrl Practitiners, Infectius Disease Physicians, Clinical Labratries RECIPIENT INSTRUCTIONS: Lcal Public Health Agencies -- please frward this HAN in its entirety n t health care prviders and pharmacies (as much as pssible) in yur jurisdictin. Health care prviders please distribute widely in yur ffice. This message can als be fund n Health UPDATE fr Clrad Health Care Prviders June 28, 2013 UPDATE: Additinal Prducts Recalled in Assciatin with Multi-state Hepatitis A Outbreak ****Health care prviders: Please distribute widely in yur ffice**** KEY POINTS: This UPDATE prvides updated infrmatin t the HAN Alerts that were distributed n May 31 and June 4, The fllwing infrmatin and clarificatin is included: Outbreak update: CDC, FDA, and multiple western states and lcal public health agencies cntinue t investigate an utbreak f cases f hepatitis A assciated with frzen berry mix cnsumptin. As f June 28, 2013, 25 cases have been cnfirmed in Clrad. FDA has identified a single large lt f pmegranate arils (seed casings) imprted frm Turkey that is assciated with cnfirmed cases f hepatitis A virus (HAV) infectin in the multistate utbreak. Pmegranate arils frm this implicated lt are reprted t have been incrprated int multiple prducts in additin t the Twnsend Farms Organic Antixidant Blend frzen berry mix that was recalled n June 3. On June 27, 2013, Wdstck Frzen Organic Pmegranate Kernels distributed by Scenic Fruit Cmpany was vluntarily recalled ( because f the ptential fr hepatitis A cntaminatin; additinal prduct recalls are anticipated. At this time, there are n cases f HAV infectin knwn t be assciated with the Wdstck prduct, nr ther prducts ther than the Twnsend Farms Organic Antixidant Blend. The risk f cntracting HAV infectin frm the Wdstck prduct r ther prducts that might cntain pmegranate arils frm the implicated lt is currently unknwn. Regarding pst-expsure prphylaxis (PEP): Althugh the risk f hepatitis A infectin assciated with cnsuming the Wdstck prduct is nt knwn, persns wh cnsumed this prduct within the preceding 14 days shuld cnsider btaining pst-expsure prphylaxis (PEP) t prevent hepatitis A infectin. Recmmendatins t health care prviders t determine if PEP is warranted are unchanged frm previus recmmendatins fr this utbreak except fr cnsideratin f the Wdstck prduct in additin t the Twnsend Farms Organic Antixidant Blend and Harris Teeter Organic Antixidant Berry Blend frzen berry mix. These recmmendatins, and an updated screening tl and flw chart are included in this update. The recmmendatins fr immune glbulin are expanded t include persns aged 75 years and lder. Suspect cases f hepatitis A shuld be reprted t the state r lcal public health department immediately (CDPHE can be reached at during business hurs r after hurs). Page 1 f 7

3 BACKGROUND INFORMATION: UPDATE - Current Situatin: The Clrad Department f Public Health and Envirnment (CDPHE), Clrad lcal public health agencies, and multiple ther state health departments are wrking with the Centers fr Disease Cntrl and Preventin (CDC) and the United States Fd and Drug Administratin (FDA) t investigate an utbreak f hepatitis A infectins. CDC, FDA, and multiple western states and lcal public health agencies cntinue t investigate an utbreak f cases f hepatitis A assciated with frzen berry mix cnsumptin. As f June 28, 2013, 25 cases have been cnfirmed in Clrad. FDA has identified a single large lt f pmegranate arils (seed casings) imprted frm Turkey that is assciated with cnfirmed cases f HAV infectin in the multistate utbreak. Pmegranate arils frm this implicated lt are reprted t have been incrprated int multiple prducts in additin t the Twnsend Farms Organic Antixidant Blend frzen berry mix. On June 27, 2013, 5,091 cases (61,092 eight unce bags) f Wdstck Frzen Organic Pmegranate Kernels distributed by Scenic Fruit Cmpany were vluntarily recalled because f the ptential fr hepatitis A cntaminatin. Wdstck Organic Pmegranate Kernels are sld in eight-unce (227 gram) resealable plastic puches with UPC Cde Specific cding infrmatin t identify the prduct can be fund n the back prtin f these puches belw the zip-lck seal. The fllwing lts are subject t this recall: C 0129 (A,B, r C) 035 with a best by date f 02/04/2015 C 0388 (A,B, r C) 087 with a best by date f 03/28/2015 C 0490 (A,B, r C) 109 with a best by date f 04/19/2015 In Clrad, recalled lts f this prduct were distributed between February 2013 May 2013 t the fllwing retail lcatins: Albertsn s lcatins in Clrad Springs, Denver, Frt Cllins, Grand Junctin, Luisville, Nrthglen, Thrntn; Alfalfa s in Bulder; B and F Superfds in Nederland; Bamb Market and Market n the Muntain in Steambat Springs; Clark s Market in Aspen; Dn s Market in Pania; Gunnisn Vitamin & Health; Llita s in Bulder; Mile High Organics in Denver; Muntain Naturals in Wdland Park; Nature s Oasis in Durang; Nature s Pantry in Buena Vista; Nch Vegan Market in Denver; Peppercrn in Bulder; Sunshine Market in Salida; Village Market Edwards, and Vitamin Cttage lcatins thrughut the state. The vluntary recall ntice, including lt numbers f implicated prducts and prduct pictures, can be fund n the FDA website: Additinal recalls f ther prducts cntaining pmegranate arils frm the implicated lt are anticipated. At this time, there are n cases f HAV infectin knwn t be assciated with the Wdstck prduct, nr ther prducts ther than the Twnsend Farms Organic Antixidant Blend. The risk f cntracting HAV infectin frm the Wdstck prduct r ther prducts that might cntain pmegranate arils frm the implicated lt is currently unknwn. Additinal infrmatin is being cllected n hepatitis A cases t determine whether illness is assciated with expsures t any f the additinal recalled prduct(s). Infrmatin abut Hepatitis A: Hepatitis A infectin is caused by the hepatitis A virus. Incubatin perid: days, with an average f 28 days. Signs and symptms: Acute nset f fever, fatigue, lss f appetite, nausea, vmiting, abdminal pain, dark urine, clay-clred stl, diarrhea, jint pain, jaundice. Infected yung children typically have mild illness r are asymptmatic. Infected lder children and adults are typically symptmatic and >70% have jaundice. Duratin f illness: Usually less than 2 mnths, althugh 10%-15% f symptmatic persns have prlnged r relapsing disease fr up t 6 mnths. Transmissin: Infected persns shed the virus in their stl 2 weeks prir t the nset f symptms until up t 10 days after jaundice r symptm nset. Persn-t-persn transmissin ccurs thrugh the fecal-ral rute. Cmmn-surce utbreaks and spradic cases can ccur frm ingestin f fecally cntaminated fd r water. Diagnsis: Serlgical test fr IgM antibdy t hepatitis A virus in persns with cmpatible signs and symptms. Additinal diagnstic infrmatin can be fund n the next page f this alert. Page 2 f 7

4 Pst-expsure prphylaxis (PEP): Persns wh may have been expsed t hepatitis A virus and have never received hepatitis A vaccine and d nt have a previus histry f hepatitis A infectin can receive PEP within 14 days f the expsure t pssibly prevent infectin. PEP cnsists f a single dse f single antigen hepatitis A vaccine r immune glbulin (IG). PEP is nt effective if received greater than 14 days after expsure. Mre details abut PEP can be fund in this alert. Disease cntrl cnsideratins: Persns with suspected r cnfirmed hepatitis A infectin shuld be advised nt t handle r prepare fd fr thers. Cases wh are fdhandlers (such as at a restaurant) r wrk in health care settings shuld be excluded frm wrk fr seven days after nset f jaundice. Additinal infrmatin abut hepatitis A can be fund n CDC s website: RECOMMENDATIONS / GUIDANCE: Hepatitis A testing and diagnsis: Health care prviders are encuraged t cnsider and test fr hepatitis A in patients wh have signs and symptms cnsistent with hepatitis A (i.e., acute nset f jaundice, abdminal pain, fever, nausea, fatigue, lss f appetite, dark urine, diarrhea), especially if they have a histry f expsure t Twnsend Farms Organic Antixidant Blend, Harris Teeter Organic Antixidant Berry Blend frzen berry mix, r Wdstck Frzen Organic Pmegranate Kernels. Fr symptmatic persns, health care prviders shuld rder serlgic tests fr hepatitis A virus IgM antibdy, ften included as part f an acute hepatitis panel. This test is available at cmmercial clinical labratries. In additin t serlgic tests fr hepatitis A virus, health care prviders shuld rder a liver functin panel. Testing is nt recmmended fr asymptmatic persns, EVEN IF THEY CONSUMED THE IMPLICATED PRODUCTS, as false-psitive hepatitis A IgM antibdy results cmmnly ccur if testing is dne in persns wh are unlikely t have disease. Pst-expsure prphylaxis (PEP): Public health is making the fllwing PEP recmmendatins fr the current utbreak situatin. These recmmendatins are slightly different than the standard CDC hepatitis A PEP recmmendatins because there is currently a shrtage f immune glbulin. T assist health care prviders in determining if PEP is warranted, a screening frm and flw chart are included at the end f this alert. PEP is recmmended fr persns wh meet all f the fllwing criteria: The persn ate any f the fllwing: Twnsend Farms Organic Antixidant Blend Harris Teeter Organic Antixidant Berry Blend Wdstck Frzen Organic Pmegranate Kernels, frm any f the fllwing lts: C 0129 (A,B, r C) 035 with a best by date f 02/04/2015 C 0388 (A,B, r C) 087 with a best by date f 03/28/2015 C 0490 (A,B, r C) 109 with a best by date f 04/19/2015 If the persn des nt knw which lt f the Wdstck prduct they cnsumed, then still cnsider PEP. The persn ate the prduct(s) within the last 14 days. The persn des nt have a previus histry f hepatitis A diagnsis r hepatitis A vaccinatin. At least ne dse f hepatitis A vaccine, at least ne mnth befre expsure, is cnsidered prtected against hepatitis A. The persn has nt had jaundice (yellw skin r eyes) r dark urine (like tea r cla) within the last tw mnths (these persns shuld be evaluated fr hepatitis A infectin). PEP using hepatitis A vaccine: A single dse f single antigen hepatitis A vaccine is recmmend fr persns aged 6 mnths 75 years wh d nt have a severe immune cmprmising cnditin, severe r chrnic liver disease, r ther cntraindicatins t vaccinatin. The efficacy f cmbined hepatitis A virus / hepatitis B virus vaccine (e.g. Twinrix) fr PEP has nt been evaluated. Special cnsideratins fr infants: Infants between 6 mnths and 12 mnths f age wh receive a single dse f single antigen hepatitis A vaccine fr pst-expsure prphylaxis will still require the rutine 2 dse series f hepatitis A vaccine starting at 12 mnths f age r greater if lng-term immunity is desired. Pregnant wmen and breastfeeding mthers: Pregnant wmen and breastfeeding mthers may be given the hepatitis A vaccine fr PEP. Because the hepatitis vaccine is prduced frm inactivated virus, the theretical risk t the fetus is lw; neither inactivated r Page 3 f 7

5 live-virus vaccines administered t lactating wmen affect the safety f breastfeeding fr wmen r their infants. If the health care prvider des nt have hepatitis A vaccine available, patients can be referred t the lcal public health agency in the cunty where they reside. Sme pharmacies and travel clinics may als have hepatitis A vaccine available (such as Walgreens, Safeway, Take Care Clinics, King Spers, Cstc, and A Little Clinic). Cntact infrmatin fr Clrad lcal public health agencies can be fund at: Main%2FCBONLayut&cid= &pagename=CBONWrapper Vaccine Dsage: Hepatitis A dsage infrmatin can be fund n the tables n the next page f this alert. Fr the purpse f PEP, nly ne dse is needed. Fr lng term immunity, a secnd dse is recmmended 6 t 12 mnths fllwing the first dse. Vaccine Cntraindicatins: Severe allergy t vaccine cmpnent r fllwing prir dse. Bth vaccines cntain aluminum. Havrix cntains the preservative 2-phenxyethyanl. Mderate r severe acute illness, at the health care prvider s discretin. Vaccine Adverse Events: Injectin site cmplaints (i.e., pain, redness, swelling) 20% - 50% f recipients. Systemic reactins uncmmn less than 10% f recipients. Recmmended Dses f Havrix Hepatitis A Vaccine Grup Age Dse (EL.U.) Vlume N. Dses Schedule* Children and Adlescents 1 18 years mL 2 0, 6 12 Adults 19 years 1, ml 2 0, 6 12 Recmmended Dses f VAQTA Hepatitis A Vaccine Grup Age Dse (U) Vlume N. Dses Schedule* Children and Adlescents 1 18 years mL 2 0, 6 18 Adults 19 years ml 2 0, 6 18 *Mnths: 0 represents timing f the initial dse; subsequent number(s) represent mnths after the initial dse. PEP using immune glbulin (IG): There is currently a shrtage f IG. Select lcal public health agencies in Clrad have been prvided with the very limited amunt f IG that is currently available. Patients wh need IG shuld be referred t the lcal public health agency in the cunty where they reside. Cntact infrmatin fr Clrad lcal public health agencies can be fund at this website: Main%2FCBONLayut&cid= &pagename=CBONWrapper A dse f IG is recmmended fr the fllwing persns: Persns less than 6 mnths f age Persns aged 75 years and lder Severely immuncmprmised persns Persns with severe r chrnic liver disease Persns with ther cntraindicatins t vaccinatin IG shuld be given t any pediatric patient regardless f age wh is at high risk fr severe hepatitis A disease, including thse wh are immuncmprmised r have severe r chrnic liver disease. If IG is nt immediately available, health care prviders shuld cnsider administering hepatitis A vaccine. Reprting suspect cases t public health: Hepatitis A is a 24-hur reprtable cnditin in Clrad. Health care prviders shuld reprt suspect cases f hepatitis A prmptly t CDPHE ( during business hurs, r after hurs; secure FAX ) r yur lcal public health agency. Page 4 f 7

6 Recmmendatins fr the general public: Peple may still have Twnsend Farms Organic Antixidant Blend, Harris Teeter Organic Antixidant Berry Blend frzen berry mix, r Wdstck Frzen Organic Pmegranate Kernels in their freezers. These prducts shuld nt be cnsumed and shuld be dispsed f in the trash. Peple wh ate Twnsend Farms Organic Antixidant Blend, Harris Teeter Organic Antixidant Berry Blend frzen berry mix, r Wdstck Frzen Organic Pmegranate Kernels in the past 14 days shuld cntact their health care prvider t discuss the need fr hepatitis A vaccine r immune glbulin. If a persn des nt have a health care prvider, they shuld cntact their lcal public health agency. Persns wh have cnsumed Twnsend Farms Organic Antixidant Blend, Harris Teeter Organic Antixidant Berry Blend frzen berry mix, r Wdstck Frzen Organic Pmegranate Kernels greater than 14 days ag shuld watch fr signs and symptms cnsistent with hepatitis A infectin. In this situatin, hepatitis A vaccine r immune glbulin will nt be prtective against disease. FOR MORE INFORMATION: General infrmatin abut hepatitis A - CDC website: Fr the General Public: Infrmatin abut hepatitis A and the current utbreak: Clrad Health Emergency Line fr Public Infrmatin (CO-HELP) Fr Health Care Prviders: Questins abut the current utbreak r pst-expsure prphylaxis guidelines: CDPHE Cmmunicable Disease Epidemilgy Sectin r yur lcal public health agency; Questins abut hepatitis A vaccine: CDPHE Immunizatin Prgram - Nicle Ortiz Page 5 f 7

7 Name Screening Tl fr Hepatitis A Pst-Expsure Prphylaxis (PEP) Fllwing Expsure t Pmegranate Seeds in: Twnsend Farms Organic Antixidant Blend frzen berries OR Harris Teeter Organic Antixidant Berry Blend frzen berries OR Wdstck Frzen Organic Pmegranate Kernels* TO BE COMPLETED BY MEDICAL OFFICE / PUBLIC HEALTH SCREENING STAFF Date f Birth Age Sex Address City/State/Zip Phne/Hme Phne/Cell Expsure: Did yu eat any f the prducts listed abve? Yes N Nt sure If yes, did yu eat any f them in the last 14 days? Yes N Nt sure If persn cnsumed a prduct but nt within the past 14 days, s/he will nt be eligible fr PEP. Cunsel persn n symptms f hepatitis A and ask t cntact prvider if they develp symptms. Discntinue screening and d nt administer PEP. Immunity: Have yu ever been diagnsed with hepatitis A? Yes N Nt sure Have yu ever received the hepatitis A vaccine? Yes N Nt sure If yes: When? Hw many dses? 1 2 Nt sure Have yu received an immune glbulin (IG r gamma glbulin) sht in the last 3 mnths? Yes N Nt sure If yes: When? If persn said yes t any f the abve immunity questins, s/he will T need PEP. A previus histry f hepatitis A diagnsis r hepatitis A vaccinatin (at least ne dse f hepatitis A vaccine, at least ne mnth befre expsure, is cnsidered prtected against hepatitis A). Discntinue screening and d nt administer PEP. Recent illness: During the past tw mnths have yu had: Dark urine (like tea r cca-cla) Yes N Nt sure Yellw skin r eyes Yes N Nt sure If persn said yes t these symptms questins, s/he shuld be evaluated by health care prvider t determine if he pssibly has hepatitis A befre administering prphylaxis. If jaundice and/r dark urine, cnsider rdering liver functin panel and acute hepatitis panel (including hepatitis A IgM). Suspect Hepatitis A cases shuld be reprted t CDPHE ( ) r lcal public health within 24-hurs. Suspect Hepatitis A cases shuld be cunseled t stay hme frm wrk if they wrk in high risk ccupatins (fd service, healthcare, r childcare) and nt prepare fd fr anyne. Eligibility fr prphylaxis: A persn is eligible fr PEP (vaccine r IG) if all f the fllwing criteria are met: 1. The persn ate ne f the prducts listed abve. 2. The persn ate the prduct within the last 14 days. 3. The persn des nt have a previus histry f hepatitis A diagnsis r hepatitis A vaccinatin. At least ne dse f hepatitis A vaccine, at least ne mnth befre expsure, is cnsidered prtected against hepatitis A. 4. The persn has nt had jaundice (yellw skin r eyes) r dark urine (like tea r cla) within the last tw mnths. Eligible fr prphylaxis: Yes N If eligible fr prphylaxis, administer ne dse f single antigen hepatitis A vaccine (T Twinrix) t persns at least 6 mnths f age. Pregnant r breastfeeding wmen can receive vaccine. IG shuld be reserved fr the fllwing persns: under 6 mnths f age; 75 years r lder; diagnsed with severe r chrnic liver disease; severely immune cmprmised; r has ther cntraindicatins t receiving vaccine. Prphylaxis given: Yes N If yes, type given: IG [Patient Weight: Dse: ] adult vaccine pediatric vaccine Date given: Injectin Site: Lt Number: Administered by: Clinic Name: Please return cmpleted frm t CDPHE at fr data cllectin. *Lts C 0129 (A, B, r C) 035 with a best by date f 02/04/2015, C 0388 (A, B, r C) 087 with a best by date f 03/28/2015, C 0490 (A, B, r C) 109 with a best by date f 04/19/2015. If persn des nt knw which lt they cnsumed, then still cnsider PEP. Page 6 f 7

8 HEPATITIS A POST-EXPOSURE PROPHYLAXIS (PEP) ALGORITHM fr persns expsed t Twnsend Farms Organic Antixidant Blend frzen berries OR Harris Teeter Organic Antixidant Berry Blend frzen berries OR Wdstck Frzen Organic Pmegranate Kernels * Persn cnsumed ne f the prducts listed abve Histry f 1 r mre hepatitis A vaccine dses r physician diagnsed hepatitis A N vaccine r immunglbulin needed Persn cnsumed ne f the prducts listed abve mix in the last 14 days Histry f severe allergic reactin t a vaccine cmpnent; dcumented severe/chrnic liver disease; severely immune cmprmised; less than 6 mnths ld; 75 years r lder Nte: Pregnant and breastfeeding wman can receive vaccine Give IG. May need t refer t lcal public health agency. Give Hepatitis A vaccine Persn cnsumed prducts, but mre than 14 days ag D nt vaccinate. If develp signs and symptms, see prvider D nt vaccinate. Dispse f remaining prducts in hme *Lts C 0129 (A, B, r C) 035 with a best by date f 02/04/2015, C 0388 (A, B, r C) 087 with a best by date f 03/28/2015, C 0490 (A, B, r C) 109 with a best by date f 04/19/2015. If persn des nt knw which lt they cnsumed, then still cnsider PEP. Page 7 f 7