THANK YOU, DR. TEMTE, AND
GOOD MORNING.
YOU MAY BE FAMILIAR BY THIS
POINT WITH THE ONGOING UPDATE OF
OUR TOME, THE GENERAL REMGTSS OF
IMMUNIZATION HANDLING, TODAY
WE'RE GOING TO GIVE YOU A BRIEF
UPDATE OF WHERE WE'RE AT AND GO
OVER ONE OF THE CURRENT SECTIONS
THAT WE'RE WORKING ON.
LET'S SEE.
THERE WE GO.
AS YOU RECALL, THE GENERAL
RECOMMENDATIONS ARE PUBLISHED IN
AN MMWR HARD COPY EVERY THREE TO
FIVE YEARS, AND THESE
RECOMMENDATIONS ADDRESS A BROAD
RANGE OF CLINICAL PRACTICE
ISSUES THAT ARE RELEVANT TO GOOD
VACCINATION POLICY, CLINICAL
VACCINATION POLICY FOR MULTIPLE
VACCI
VACCINES.
THERE ARE SPECIFIC TOPICS THAT
ARE NOT PERTINENT TO ANY ONE
VACCINES, BUT TO VACCINE
IMMUNIZATION PRACTICE IN
GENERAL.
THIS IS THE CURRENT ISSUE, AND
THESE ARE THE TOPICS THAT ARE
COVERED IN THE GENERAL
RECOMMENDATIONS AND TODAY WE'LL
BE UPDATED YOU ON THE REVISIONS
THAT WE PROPOSE FOR THE STORAGE
AND HANDLING OF IMMUNOBIOLOGICS.
THE NEXT MEETING WE'LL PROVIDE
INFORMATION ON INFORMATION
SOURCES AND WE MAY BE ABLE TO
COMPLETE OUR PROPOSED PROVISIONS
AT THAT TIME, BUT I DO ENCOURAGE
THE ACIP MEMBERS, LIAISONS AND
OTHERS, TO PLEASE READ THE
DOCUMENTS, LOOK AT THE PROPOSED
REVISIONS AND GIVE US YOUR
FEEDBACK.
WE VERY MUCH APPRECIATE HEARING
FROM YOU.
I ALSO WANT TO TURN YOUR
ATTENTION TO A PUBLICATION WHICH
IN THEIR GUIDELINES AROUND THE
VACCINATION OF IMMUNOCOMPROMISED
HOSTS AND THIS TOPIC IS ALSO
ADDRESSED, BUT THE GUIDELINES GO
INTO A LOT MORE DETAIL AND
PROVIDE GUIDANCE FOR CLINICIANS
BASED ON A VARIETY OF LEVELS OF
EVIDENCE FROM HIGH QUALITY, DOWN
TO EXPERT OPINION, ON VARIOUS
AREAS, SOME OF WHICH ARE NOT
ADDRESSED BY ACIP, AND WE HAVE
SOME CONFLICTING RECOMMENDATIONS
THERE, SO IT WOULD BE VERY
HELPFUL IF YOU HAVE THE
OPPORTUNITY TO TAKE A LOOK AT
THE IDSA PRACTICE GUIDELINES SO
THAT WHEN WE DISCUSS THIS AT THE
NEXT MEETING, IF YOU'VE GOTNOW,E
US AWARE OF THOSE.
AT THIS POINT, I'M GOING TO TURN
IT OVER TO DR. KROGER.
I JUST WANT TO TAKE A MINUTE TO
THANK ANDREW, AGAIN, FOR ALL HIS
HARD WORK IN REVISING THESE
GUIDELINES AND LEADING OUR WORK
GROUP THROUGH THESE PROCESSES
AND MY ACIP COLLEAGUES AND TO
ALL THE LIAISONS.
WE VERY MUCH APPRECIATE YOUR
CAREFUL READING AND REVIEW OF
THESE GUIDELINES AND YOUR
VALUABLE INPUT.
IT'S BEEN VERY, VERY HELPFUL.
THANK YOU VERY MUCH,
DR. DUCHIN, AND THANK YOU TO
ACIP FOR ALLOWING THE GENERAL
HANDLING SECTION OF THE GENERAL
RECOMMENDATIONS.
SO THIS IS AN OUTLINE OF THE
AREAS COVERED IN THE 2011
GENERAL RECOMMENDATIONS
DOCUMENT.
IT'S BRIEF.
IT GOES INTO STORAGE
TEMPERATURES, THE RANGES THAT
ARE APPROPRIATE FOR VARIOUS
VACCINES, STORAGE UNITS, PROPER
TEMPERATURE MONITORING
PRACTICES, THE RESPONSE TO AN
OUT-OF-RANGE TEMPERATURE
READING, THEN THERE'S AN
EXTENSIVE DISCUSSION OF
EXPIRATION DATES AND WINDOWS AND
MULTI-DOSE VILES.
THAT'S THE 2011 DOCUMENT.
I WANT TO POINT OUT SINCE THE
GENERAL RECOMMENDATIONS WAS
PUBLISHED IN 2011, THE CDC's
STORAGE AND HANDLING TOOL KIT,
WHICH IS POSTED ON CDC's
WEBSITE, HAS BEEN EXTENSIVELY
REVISED.
NOW, THIS TOOL CONTAINS BEST
PRACTICES INFORMATION FOR BOTH
PUBLIC AND PRIVATE PROVIDERS,
AND REALLY CONTAINS VERY, VERY
PRECISE, EXHAUSTIVE DETAIL ON
THE FOLLOWING TOPICS, WHICH I
SHOW AS STRIKEOUT ON THIS SLIDE,
SO STORAGE UNITS, TEMPERATURE
MONITORING, EXPIRATION DATES AND
WINDOWS, AND MULTI-DOSE VIALS.
THERE IS AN EXTENSIVE DISCUSSION
IN THE STORAGE AND HANDLING TOOL
KIT AND I SHOW YOU AN IMAGE OF
THE FIRST PAGE OF THE TOOL KIT
AND THE WEBSITE WHERE IT CAN BE
FOUND.
YOU WILL NOTE IN THE DRAFTS THAT
THE ACIP MEMBERS HAVE DRAFTS OF
THE GENERAL RECOMMENDATIONS
CHAPTER.
THEY WILL ALSO SEE EXTENSIVE
STRIKEOUT, BECAUSE THE GENERAL
WORK GROUP FEELS LIKE THESE
TOPICS ARE ADEQUATELY COVERED IN
THE TOOL KIT AND REALLY DON'T
NEED TO BE IN THE ACIP
RECOMMENDATIONS.
IT'S COVERED IN TWO PLACES.
I WILL QUICKLY PROVIDE SOME
BREAK -- SOME BACKGROUND AS TO
WHAT IS IN THE TOOL KIT.
THERE'S -- IN THE GENERAL, I
WILL TALK ABOUT THE MAJOR TOPICS
COVERED JUST BY WAY OF SAYING
THESE ARE BEST PRACTICES.
AND THEY BREAK DOWN TO EQUIPMENT
CONSIDERATIONS FOR STORAGE UNITS
AND THERMOMETERS, MAINTAINING
THE COLD CHAIN, ROUTINE STORAGE
AND HANDLING PRACTICES,
INVENTORY MANAGEMENT, EMERGENCY
PROCEDURES FOR PROTECTING
VACCINE INVENTORIES.
BASICALLY, A BULLETED LINE LIST
IN THE GENERAL RECOMMENDATIONS
WITH A REFERENCE TO THE WEBSITE
THAT I SHOWED YOU ON THE LAST
SLIDE.
NOW, YOU KNOW, JUST TO GO INTO A
BIT MORE DETAIL, WHAT ARE --
WHAT'S IN THESE SECTIONS?
JUST BY WAY OF SOME EXAMPLES,
THERE'S SPECIFIC RECOMMENDATIONS
FOR THE TYPE OF STORAGE UNIT
UNDER EQUIPMENT CONSIDERATION.
OF COURSE, WE KNOW NOT STAND
ALONE OR SINGLE REFRIGERATORS
ARE PREFERRED.
THERE ARE DETAILS ABOUT THE
TYPES OF THERMOMETERS YOU SHOULD
USE WITH THEIR TEMPERATURE
PROBES ENCASED IN A GLYCOL
COVER.
THERE IS A DISCUSSION IN THE
TOOL KIT, OR LISTING OF THE
REQUIRED TEMPERATURES FOR BOTH
FROZEN AND INACTIVATED VACCINES,
SO THAT'S IN THE TOOL KIT.
THERE ARE DISCUSSIONS OF
PRACTICES, POSITIONING OF THE
VACCINE, LABELING OF TRAYS AND
CONTAINERS, DISCUSSION OF
INVENTORY MANAGEMENT, HOW YOU
USE AND INTERPRET THE EXPIRATION
DATES THAT ARE LISTED ON THE
VIALS, AND LASTLY, EMERGENCY
PROCEDURES FOR PROTECTING
VACCINE INVENTORIES,
SPECIFICALLY HOW YOU TRANSPORT
VACCINES TO OFF-SITE FACILITIES,
THE TOOLS YOU NEED TO USE TO
MAINTAIN AND REQUIRE
TEMPERATURES.
A LOT OF DISCUSSION AND THERE'S
EVEN MORE THAN THIS.
THERE'S A DISCUSSION OF VACCINE
PERSONNEL STAFFING, A DISCUSSION
OF THE ACTUAL HANDLING OF THE
VACCINE, WHICH IS IN THE STORAGE
AND HANDLING TOOL KIT, AND AS
YOU KNOW, THE GENERAL RECS HAS
ITS ADMINISTRATION SECTION WHICH
DISCUSSES SOME VACCINE HANDLING
ISSUES.
BECAUSE IT'S IN THERE, WE FELT
WE COULD DELETE THIS INFORMATION
FROM THE GENERAL RECS, SO YOU
CAN SEE THOSE CORRESPONDING SUB
HEADERS HAVE BEEN DELETED FROM
THE GENERAL RECS DRAFT THAT YOU
HAVE.
STORAGE AND HANDLING TOOL KIT IS
CDC CLEARED, REPRESENTED BEST
PRACTICES FOR BOTH PUBLIC AND
PRIVATE.
IT'S HAR MONOIZED WITH THE
VACCINE FOR CHILDREN
REGULATIONS, WHICH ARE DESCRIBED
IN THE OPERATIONS MANUAL.
SO WHAT ARE WE GOING TO RETAIN
IN THE ACIP GENERAL
RECOMMENDATIONS?
WELL, WE WANT TO KEEP, EVEN
THOUGH THIS IS ALSO IN THE TOOL
KIT, WE WANT TO KEEP THE TABLE
OF TEMPERATURE RANGES, SIMILAR
TEMPERATURE CUTOFFS ARE
PUBLISHED IN THE STORAGE AND
HANDLING TOOL KIT.
AS I MENTIONED, ALSO IN THE
TEXTBOOK VACCINES.
WHAT'S UNIQUE IN THE GENERAL
RECOMMENDATIONS, THERE IS A
DESCRIPTION OF THE TYPES OF
VACCINES, THE CATEGORIES THAT
CORRESPOND TO THE SPECIFIC
TEMPERATURES YOU SHOULD USE.
WE BREAK DOWN VACCINES WITH THE
FOLLOWING LABELS --
NONINJECTABLE VACCINES, AND THAT
TABLE IS ON PAGE 5 OF YOUR
DRAFT, AND WHEN I TALK ABOUT THE
DRAFT, I'M REFERRING
SPECIFICALLY TO THE DRAFT THAT
HAS ALL OF THE MARKED CHANGES ON
IT, SO IT'S PAGE 5 IS AN EXAMPLE
OF THAT TABLE.
I'LL SHOW YOU A SLIDE IN A BIT.
NOW, WE'RE GOING TO CONTINUE
USING THESE LABELS.
WE DECIDED TO ADD SOME LANGUAGE
TO THE GENERAL RECOMMENDATIONS
ABOUT THESE CATEGORIES.
OF COURSE, YOU KNOW, FOR THE
ALUMINUM ADJAVENTED VACCINES,
THE DESCRIPTION IS LESS WELL
DESCRIBED FOR VACCINES, SO WE DO
MAKE SIMILAR RECOMMENDATIONS FOR
THE STORAGE OF THESE VACCINES
AND, BY THE WAY, THE
REFRIGERATION TEMPERATURE IS 35
THROUGH 46 DEGREES FARENHEIT, 2
THROUGH 8 DEGREES CELCIUS FOR
THESE VACCINES, THE
NON-LYOPHIL
NON-LYOPHIL
NON-LYOPHILIZED VACCINES.
FOR VACCINES THAT ARE
LYOPHILIZED, THEY DON'T NEED TO
BE FROZEN, THEY CAN BE FROZEN.
ONE EXCEPTION, SHOULD NOT BE
STORED BELOW 35 DEGREES
FARENHEIT.
THE FOURTH BULLET, THESE SHOULD
BE KEPT FROZEN AND FROZEN MEANS
MINUS 58 DEGREES FARENHEIT
THROUGH 5 DEGREES FARENHEIT.
OTHERWISE, THE VACCINE VIRUS
WILL DEGRADE.
FOR THE NONINJECTABLE VACCINES,
THERE'S NOT REALLY A CLEAR
MECHANISM THAT APPLIES TO ALL IN
THAT CATEGORY.
IT'S GENERALLY STANDARD
PRACTICE, STANDARD THAT THEY ARE
NOT RECOMMENDED TO BE FROZEN,
NOT TO BE STORED BELOW 35
DEGREES FARENHEIT.
THERE ARE SOME INJECTABLE
VACCINES THAT WE KNOW THAT THE
DOSE CAN BE COUNTED IF THEY DO
HAPPEN TO BE -- THEY DO HAPPEN
TO BE FROZEN AND FOUND TO BE
ADMINISTERED, THE LIVE INFLUENZA
VIRUS WAS AN EXCEPTION TO THAT.
SO THAT'S IN THERE STILL.
DESCRIPTION OF THE TYPES OF
VACCINES.
RESPONSE TO OUT OF RANGE
TEMPERATURE READING.
THIS IS A SECTION THAT IS NOT
SPECIFICALLY COVERED IN THE TOOL
KIT, AND SO WE DO WANT TO MAKE
SURE WE MAINTAIN THIS IN THE
GENERAL RECOMMENDATIONS.
THERE'S SOME DUPLICATION OF
HAVING A PLAN AHEAD OF TIME,
THAT IS IN THE TOOL KIT,
PRACTICES SUCH AS MARKING THE
VACCINE DO NOT USE, SEEING IF
THE TEMPERATURE DEVIATION HAS A
SOLUTION, RESOLVABLE SOLUTION
SUCH AS THE DOOR LEFT OPEN, WAS
THE STORAGE UNIT UNPLUGGED, SO
THERE IS SOME OF THAT
INFORMATION THAT'S STILL IN
THERE.
MOVING THE VACCINE TO AN
ALTERNATE SITE.
ONE OF THE IMPORTANT ISSUES, IF
VACCINE IS FOUND TO BE STORED
OUT OF RANGE, IS TO CONTACT THE
STATE OR LOCAL HEALTH DEPARTMENT
OR THE MANUFACTURER TO DETERMINE
IF THE VACCINE IS VIABLE.
THIS IS NOT NEW LANGUAGE.
THIS WAS IN THE 2011 GENERAL
RECOMMENDATIONS.
WE ARE GOING TO KEEP THAT
LANGUAGE.
IF THE DOSES HAVE ALREADY BEEN
ADMINISTERED AND THEN FOUND TO
HAVE BEEN KEPT OUT OF
TEMPERATURE, WE DO MAKE A
SPECIFIC STATEMENT TO CONTACT
THE STATE AND LOCAL HEALTH
DEPARTMENT, SO MAKE SURE THAT AT
A MINIMUM, THAT ENTITY IS
CONTACTED, STATE AND LOCAL
HEALTH.
PUBLIC HEALTH.
AND SO SOME OF THE LANGUAGE THAT
WE ARE GOING TO HAVE IN THIS
SECTION I'VE REPLICATED ON THIS
SLIDE.
AS A GENERAL RULE, VACCINES THAT
HAVE BEEN STORED AT
INAPPROPRIATE TEMPERATURES
SHOULD NOT BE ADMINISTERED
UNLESS PUBLIC HEALTH AUTHORITIES
OR THE MANUFACTURER DETERMINED
IT IS SAFE TO DO SO.
ON PAGE 3 OF YOUR DRAFT, LINE
28, THAT'S POSITIONED IN A
SECTION WHERE WE JUST TALK ABOUT
DISCOVERY OF VACCINE IN THE UNIT
KEPT OUT OF RANGE.
THEN WE HAVE THE SENTENCE, "IF
SUCH VACCINES HAVE ALREADY BEEN
ADMINISTERED, VACCINE EXPOSED TO
INAPPROPRIATE TEMPERATURES THAT
IS INADVERTENTLY ADMINISTERED
SHOULD GENERALLY BE REPEATED.
CLINICIANS SHOULD CONSULT STATE
OR LOCAL HEALTH DEPARTMENTS IN
THESE SITUATIONS.
CONSULTATION WITH THE CDC IS
AVAILABLE WHEN NECESSARY."
AND THAT'S PAGE 3, LINE 31 OF
THE DOCUMENT.
THE LANGUAGE HAS BEEN TWEAKED A
LITTLE BIT.
I CAN TELL YOU THAT, AGAIN, THE
STANDARD IS THAT INADVERTENT
VACCINE ADMINISTERED SHOULD
GENERALLY BE REPEATED.
IF CDC IS FIRST CONTACT FROM A
PROVIDER, AND WE'RE TALKING
ABOUT HUNDREDS OF DOSES HAVING
BEEN ADMINISTERED, THE STATE AND
LOCAL HEALTH DEPARTMENTS, PUBLIC
HEALTH, WILL BE CONTACTED IN
THAT SITUATION, AS WELL.
JUST A BIT MORE ON THE TABLE OF
STORAGE TEMPERATURES AT THE END
OF THE DOCUMENT.
WE'VE ADDED MANHIBRICS TO THE
TABLE.
WE HAVE ADDED THE TEMPERATURE
FOR ALL VACCINES, WHICH IS
NEGATIVE 58 DEGREES FARENHEIT,
OR THE EQUIVALENT NEGATIVE 50
DEGREES CELCIUS.
THIS IS A CHANGE THAT'S ALREADY
IN THE TOOL KIT AND IT'S A
CHANGE MANY OF YOU ARE FAMILIAR
WITH.
PROBABLY IS NOT A BIG DEAL.
MOST STORAGE UNITS CANNOT EVEN
REACH TEMPERATURES THIS LOW.
WE HAVE TO PUT IT IN THERE, AND
IT'S VERY, VERY IMPORTANT,
BECAUSE IT INVOLVES ISSUES OF
TRANSPORT THAT ARE NOT GOING TO
BE COVERED IN THE GENERAL RECS,
BUT ARE IN THE TOOL KIT.
TRANSPORT ON DRY ICE CAN CAUSE
VARIATIONS IN TEMPERATURE THAT
COULD REACH AS LOW AS NEGATIVE
58 DEGREES FARENHEIT, THEREFORE,
WE DON'T RECOMMEND DRY ICE FOR
TRANSPORT, THE IDEA BEING ALSO
TEMPERATURES THIS LOW CAN BE
DAMAGING BECAUSE THEY MIGHT
AFFECT THE VACCINE ITSELF OF THE
RUBBER VIAL.
SO THAT'S ONE OF THE ISSUES, AS
YOU'LL SEE, THERE IS SOME
WORDING IN YOUR DRAFT ON THIS.
ALSO WITH THE TABLE OF STORAGE
TEMPERATURES, WE'VE REMOVED
ENTIRELY ONE OF THE COLUMNS, A
COMMENTS COLUMN.
IT USED TO CONTAIN INFORMATION
ON LIGHT SENSITIVITY, WHAT DATA
THERE IS ON THE DEGREE OF
THERMOSTABILITY.
WE FELT WE COULD GET RID OF THIS
INFORMATION.
AS LONG AS WE REFER TO THE FDA,
AS WELL AS -- AND PACKAGE
INSERTS, SO WE'VE REMOVED THAT
TABLE COMPLETELY, BECAUSE REALLY
THERE IS A LOT OF DETAILED
INFORMATION NOW AND IT CAN
EASILY BE FOUND ON CDC's WEBSITE
AND FDA's WEBSITE.
SO HERE'S A SNAPSHOT OF WHAT THE
TABLE LOOKS LIKE.
I DO NOT HAVE THE HEADERS ON THE
SLIDE, BUT THE LEFT-HAND COLUMN
IS THE VACCINE, THE MIDDLE
COLUMN IS THE VACCINE ITSELF,
THE TEMPERATURE RANGE, AND THE
RIGHT-HAND COLUMN IS THE STORAGE
RANGE.
THAT'S WHAT THE THREE COLUMNS
ARE, AND FOR VACCINES, WE HAVE
THE LOWER CUTOFF NOW OF NEGATIVE
58 DEGREES FARENHEIT.
WE'VE UPDATED OUR TEMPERATURE
LOGS, AS WELL, THE FIGURES IN
THE BACK OF THE SECTION.
WE HAVE ONE FOR REFRIGERATOR
STORAGE, ONE FOR FREEZER
STORAGE.
THESE ARE BORROWED FROM THE
IMMUNIZATION ACTION COALITION,
WE PREFER SEPARATE UNITS NOW, SO
MAKES SENSE TO HAVE SEPARATE
LOGS, SEPARATE PIECES OF PAPER
TO TAPE TO THE REFRIGERATOR OR
WHATEVER.
THEY'VE BEEN TWEAKED A BIT SO
THAT IT'S HARDER FOR A PROVIDER
TO CHECK A BOX OFF WHEN THE
TEMPERATURE'S OUT OF RANGE AND
THEN IGNORE IT AFTER THAT, WHICH
EMPHASIZES THE NEED TO TAKE
IMMEDIATE ACTION.
HERE IS WHAT THE TEMPERATURE LOG
LOOKS LIKE FOR REFRIGERATORS,
AND YOU CAN SEE THAT THERE IS --
OH, WE HAVE -- IT'S KIND OF HARD
TO SEE ON THE SLIDE, I GUESS,
BUT ABOUT FOUR ROWS DOWN,
THERE'S A SPECIFIC ROW-TO-LOG
SPECIFIC TEMPERATURES OVER TIME.
WE NOW HAVE A RECOMMENDATION TO
RECORD THAT TWICE A DAY, SO
THAT'S NOW ON THIS LOG, AND WE
HAVE, AS MENTIONED, THE
ACCEPTABLE TEMPERATURES FOR
REFRIGERATED VACCINES WITH
REALLY A BIG RED LINE AT THE
BOTTOM.
YOU HAVE GONE TOO LOW, YOU NEED
TO DO SOMETHING.
AND HERE IS THE CORRESPONDING
TEMPERATURE LOG FOR FREEZERS
WITH THE BIG PURPLE LINE AT THE
TOP, IF YOUR TEMPERATURE GETS
TOO WARM, YOU NEED TO DO
SOMETHING.
SO THAT'S THE NEW TEMPERATURE
LOG.
SO THAT'S BASICALLY IT.
I'LL LEAVE SOME TIME FOR
DISCUSSION AND I'D LIKE TO THANK
THE GENERAL RECOMMENDATIONS WORK
GROUP, LIAISON REPRESENTATIVES,
ACIP MEMBERS AND CONSULTANTS FOR
THEIR HELP IN MAKING THESE
CHANGES.
>> THANK YOU, DR. KROGER.
OPEN IT UP FOR ANY QUESTIONS OR
COMMENTS.
DR. RUBEN?
>> I HAD A QUESTION ABOUT THE
MULTIDOSE VIAL.
I GUESS THAT'S COMING OUT OF THE
GENERAL REC IN FAVOR OF THE
OTHER DOCUMENTS.
THE SPECIFIC QUESTION WAS, AT
OUR HOSPITAL AT LEAST, WHEN WE
ENTER A MULTIDOSE VIAL AFTER 30
DAYS IT EXPIRES, DOESN'T MATTER
WHAT THE EXPIRATION DATE ON THE
VIAL COMES FROM.
I DON'T KNOW WHERE THAT COMES
FROM, OR IF IT'S A GENERAL
PRINCIPLE CLINICIANS USE, OR,
YOU KNOW, HOW THAT CONFLICT IS
RESOLVED IN OTHER PLACES.
>> RIGHT.
SO THE ISSUE IS, IT'S KIND OF AN
INVENTORY ISSUE IN READING THE
EXPIRATION DATE ON THE VIAL.
THAT IS SOMETHING THAT IS IN THE
TOOL KIT AND IS NOT IN THE
GENERAL -- NOT BE MENTIONED IN
DETAIL IN THE GENERAL RECS
ANYMORE.
ONE OF THE FIRST ORGANIZATIONS
TO REALLY POST A LOT OF THIS
INFORMATION ABOUT THE 30-DAY
OPEN RULE.
THERE ARE CERTAIN VACCINES FOR
WHICH THE PACKAGE INSERT STATES
A LONGER PERIOD OF TIME
MULTIDOSE VACCINES THAT NEED TO
BE ENTERED AND RECONSTITUTED.
BUT FOR THE MOST PART, MOST OF
THE VACCINES THAT ARE IN USE ARE
SINGLE-DOSE VIALS THAT HAVE THAT
30-DAY RECOMMENDATION ON IT, SO
WE DON'T FEEL THAT'S GOING TO BE
TOO BIG OF AN ISSUE, AND THE
DETAILS WILL BE IN THE STORAGE
AND HANDLING TOOL KIT.
>> QUESTION BACK HERE.
DR. KRISTINE HAHN.
I HAD TWO QUESTIONS.
ONE IS ON THE RESPONSE TO THE
TEMPERATURE INCIDENT.
OR THE OUT OF RANGE TEMPERATURE.
IT SAYS THAT IT SHOULDN'T BE
ADMINISTERED UNLESS IT'S
DETERMINED TO BE SAFE TO DO SO,
I'M WONDERING IF THAT SHOULD SAY
SAFE AND EFFECTIVE, BECAUSE
REALLY, THE CONCERN IS MORE
ABOUT LOSS OF EFFICACY USUALLY
THAN A SAFETY CONCERN.
I JUST MADE THAT COMMENT.
I THINK THAT IS DEFINITELY AN
ADDITION THAT WE CAN MAKE.
I'LL MAKE SURE IT DOESN'T
REPLICATE, GET TOO REDUNDANT
WITH THE LANGUAGE.
THAT'S DEFINITELY A CHANGE THAT
CAN BE MADE.
>> AND MY SECOND COMMENT WAS ON
THE TABLE, AND I KNOW WE'RE ONLY
SEEING A PORTION OF THE TABLE,
TEMPERATURES REFER TO DULLUENT
TEMPERATURES, AND I WONDER
WHETHER IT COULD BE CONFUSING TO
PEOPLE, THAT THIRD COLUMN WHERE
THERE'S PROMINENT LANGUAGE ABOUT
THE TEMPERATURE RANGE, AND I
WONDER IF PEOPLE MIGHT
MISINTERPRET THAT AS BEING THE
VACCINE TEMPERATURE RANGE,
WHETHER IT SHOULD BE SEPARATED
MORE CLEARLY OR SOMETHING.
I THOUGHT GLANCING AT IT,
SOMEBODY COULD MISINTERPRET THAT
POSSIBLY.
CAN WE GO BACK TO THE -- 14
IS A GOOD ONE.
SO THIS IS A SNAPSHOT BASICALLY
OF THE TABLE.
I GUESS WE HAVE THE TOP HEADER
OF THE ENTIRE TABLE, WHICH
CONTAINS ALL OF THE VACCINES,
WILL INDICATE WHAT THESE COLUMNS
STAND FOR, WHETHER WE CAN DO
SOME FORMATTING, WE'LL LOOK INTO
THAT.
WE'LL BE CLEAR THAT THIS
INFORMATION IS THE DILUENT AND
THE OTHER INFORMATION IS THE
VACCINE.
>> MS. HAYES?
TO ADDRESS DR. RUBEN'S
CONCERN, I'M FAIRLY CERTAIN IT'S
A JOINT COMMISSION REQUIREMENT
IN A HOSPITAL YOU HAVE TO
DISCARD SOMETHING AFTER 28 DAYS
AND I FEEL IN THE OUTPATIENT
SETTING, THAT PROBABLY DOESN'T
APPLY.
THANK YOU FOR THAT COMMENT.
>> NOT SURE IF YOU'RE THE BEST
PERSON TO RESPOND TO ANDREW, OR
IF IT SHOULD GO TO DR. MOORE,
BUT JUST A GENERAL QUESTION IN
TERMS OF VSC SITES AND NON-VSC
SITES, THE THOUSANDS OF CLINICS
ACROSS THE COUNTRY THAT HOUSE
VACCINES.
WHAT TYPE OF ONGOING TRAINING
AND SCRUTINY DO THESE SITES GET?
I THINK OFTENTIMES THE VACCINE
IS A HUGE AMOUNT OF THEIR
THROUGHPUT COST, BUT I'M CURIOUS
HOW DO WE TRANSLATE THE
RECOMMENDATIONS INTO ACTION?
SURE.
KELLY MOORE WITH AIM.
SO IMMUNIZATION PROGRAMS WORK
WITH THE VSC PROVIDERS VERY
CAREFULLY.
WE HAVE EXTENSIVE TRAINING USING
CDC MATERIALS AND WE ARE
EXTREMELY APPRECIATIVE OF THE
NEW MATERIALS THAT HAVE COME OUT
THAT FINALLY GIVES US A LOT OF
DETAILED-SPECIFIC INFORMATION.
WE HAVE ONLINE MODULES PEOPLE
CAN DO ON THEIR OWN AND
REQUIREMENTS TO UNDERGO
EDUCATION AND STORAGE AND
HANDLING ANNUALLY THAT HAVE JUST
NOW STARTED TO KICK IN, SO WE DO
SITE VISITS AT LEAST EVERY OTHER
YEAR, IF NOT MORE OFTEN WITH
THEM AND FOCUS A LOT ON STORAGE
AND HANDLING.
ONCE OUTSIDE THE PROGRAM,
HOWEVER, THERE'S NO INVOLVEMENT
DIRECTLY OF PROGRAMS IN
SUPERVISION OF THOSE INVOLVED IN
IMMUNIZING PEOPLE OUTSIDE THE
PROGRAM.
BUT THERE ARE TOOLS NOW
AVAILABLE FOR THEM TO GO ON
THEIR OWN TO ACCESS THROUGH THE
CDC WEBSITE, LIKE YOU CALL THE
SHOTS OR PRODUCED BY CALIFORNIA.
SO THERE ARE RESOURCES
AVAILABLE, BUT IT'S UP TO THEM
TO SEEK THOSE OUT.
>> AND AS A FOLLOWUP, DO WE HAVE
ANY IDEA OF THE PERCENTAGE OF
SITES THAT ARE VSC VERSUS NOT?
WELL, AMONG PEDIATRIC
PRACTICES, I DON'T HAVE SPECIFIC
NUMBERS, BUT MOST PEDIATRIC
PRACTICES PARTICIPATE.
A GOOD NUMBER OF FAMILY
PHYSICIANS, BUT OUTSIDE OF THAT,
WHEN YOU GET INTO THE ADULT
ARENA, PHARMACIES, ADULT
PROVIDERS, THEN THAT WOULDN'T BE
REALLY A BIG PLAYER.
THANK YOU.
>> THE VSC PROVIDERS ARE ALSO
PROVIDING VACCINES TO PUBLICLY
INSURED PEOPLE AND THERE ARE
OVER 40,000 VSC PROVIDER SITES.
WE'VE ALSO MADE EFFORTS TO MAKE
IT CLEAR THAT PHARMACIES CAN BE
VSC PROVIDERS IF THEY FOLLOW THE
REQUIREMENTS, SO WE'VE TRIED TO
EXPAND IT, BUT STRICTLY, WE'RE
NOT DOING SITES TO THE
ADULT-ONLY PROVIDERS.
THERE ARE OTHER OVERSIGHT GROUPS
POTENTIALLY, BUT NOT US.
THANK YOU.
AND I THINK AS AN ADDITIONAL
FOLLOWUP THROUGH DR. FOSTER, MY
IMPRESSION IS, BECAUSE
PHARMACIES ARE USED TO
MAINTAINING INVENTORY AT
APPROPRIATE TEMPERATURES AND SO
ON, THAT'S NOT AS MUCH OF A
CONCERN IN MY MIND AS IT WOULD
BE IN THE PRIVATE ADULT PRACTICE
THAT HAS SOME INVENTORY, BUT
DOESN'T PARTICIPATE IN VSC.
STORAGE AND
HANDLING QUITE CAREFULLY.
I WOULD SAY ON THE AVERAGE,
THOUGH, I'M NOT SURE THAT
100% -- I KNOW NOT 100% IS
ALL OF
THE RULES, THINGS LIKE THE
REFRIGERATOR, FREEZERS, AND
THOSE TYPES OF ISSUES.
IT HAS BEEN DISTRIBUTED TO THE
PHARMACISTS OUT THERE, BUT
STILL, THIS IS MORE OF A
CORPORATE DECISION IN MANY OF
THE PLACES WHAT THEY DO, BUT
THEY HAVE NOT REALLY BEEN
ENFORCED ON THAT.
SOME ARE DOING IT, SOME ARE NOT.
AS FAR AS REGULAR STORAGE, THEY
DO HAVE OTHER MEDICATIONS.
IT IS MONITORED QUITE WELL.
IT IS A REQUIREMENT.
>> ANY OTHER QUESTIONS,
DISCUSSION?
OKAY.
OH.
>> JUST MAKING AN ADDITIONAL
COMMENT THAT, YOU KNOW, A COUPLE
YEARS AGO, THE OFFICE OF
INSPECTOR GENERAL REVIEWED THE
STORAGE AND HANDLING IN THE
VACCINES FOR CHILDREN PROGRAM
AND FOUND A NUMBER OF CONCERNS.
YOU KNOW, WE ISSUED CORRECTIVE
ACTION PLAN AND MUCH OF THE
TRAINING AND TOOL KIT YOU'RE
HEARING ABOUT IS A RESULT OF
THAT RESPONSE.
I'M TOLD THERE'S BEEN A HUGE
UPTICK IN ACCESSING THE TOOL KIT
AND THE TRAINING, NOT THROUGH
JUST WHAT WE'RE PUSHING, BUT
ADDITIONAL ONES, SO I THINK THE
WORKS THE PROGRAMS BOTH AT CDC
AND THE STATES HAVE BEEN DOING
IS SHOWING UP IN USE OF THE
TRAINING MATERIALS.
THANK YOU.