Arizona Pediatric Emergency Preparedness Sue Moravec PharmD Chief Pharmacy OfficerAVP Pharmacy Services May 23 rd 2017 Disclosure Nothing to disclose Except Planning Pediatric Drug Shortage ID: 616970
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Slide1
Planning For Scarce Pediatric Pharmaceutical Resources
Arizona
Pediatric Emergency
Preparedness
Sue Moravec, PharmD
Chief Pharmacy Officer/AVP
Pharmacy Services
May 23
rd
, 2017Slide2
DisclosureNothing to disclose
Except….Slide3
Planning Pediatric Drug ShortageSlide4
Drug Shortage Overview
Right
NOW!
Sodium Bicarbonate, D50
Electrolytes
K
Phos
, Na
Acet
,
Calcium Cl, Cal GluconateAll Emergency SyringesEpi, Norepi, AtropineRocuronium, VecuroniumLidocaineFentanyl, Morphine
Sample email from FridaySlide5
Drug Shortage Overview
Epi,Atro,Bicar,Dex,Cal,Lido
Lido,Fent,Roc,Vec,AtrSlide6
Drug Shortage Overview
Drug shortage is a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.
ASHPSlide7
Drug Shortage Overview
Drug shortages are of
particular concerning emergency care settings
where providers must rapidly treat ill and injured patients.
For most medications, substitutes exist, but may
not be as effective
, and may have
more side effects
, and providers are
inexperienced
in using them, which could lead to increase errors such as dosing or interactions Slide8
Drug Shortage Overview
Utah Emergency MDs 2016
One-third of all drug shortages are within the scope of emergency medicine
(1789)
Shortages of drugs with no substitute grew 125%
From 2008-2014, emergency medicine
drug shortages
rose by 435%
(23 to 123 drugs)
Life-saving or high acuity shortage drugs increased 393
% * (2017 – more)Slide9
Drug Shortage Overview
True reasons around shortages remains unknown.
Multiple disease states
Infectious disease, analgesia, toxicology, critical care
Around 40% of drug shortages affect emergency care
Health Human Services Emergency Care Coordination
6. Median shortage time is about 9 monthsSlide10
Causes
#1 reason Manufacturing difficulties
Hospira syringes
AGAIN! glass
Stricter FDA –due to black market
OLD buildings
Alternatives
– Supply/Demand
Sodium Bicarbonate -> Sodium
Acetate
Normal Saline -> Conc. NACL vials/Sterile Water BagsRaw materials shortageFentanyl*Recalls (*sometime your first hint to a shortage)Business/economic pressures (generics)“One assembly line”Slide11
Consequences
Finger pointing – Manufacturers -> Distribution -> rising prices
Incomplete disclosure of drug
shortages
2017 – New transparency regulation
Difficulties in determining inventories in real-time
Buyers – watching internet
Difficulties associating shortages with clinical outcomes in a population
Clinical
Adjustments
Sub optimal therapiesPoor outcomesSlide12
Consequences
Emergency
/ Critical Care Protocols
(all change)
Shortage of anesthesia drugs
/ PAR levels
Lots of errors, miss-dosing, look
alikes
, delay in care
Angry MDs / Clinicians / Administration
Psychological consequenceStaff -> patientsOncology shortagesCOSTS!!!! Major financial burdenIV DiphenhydramineIV Compazine Slide13
Pediatric
Pharmacokinetics
They are NOT ‘little
adults’ (dose by kg)
Extremely vulnerable – ABC - *A - respiratory
ADME - pharmacokinetics
Absorption
Shorter GI, Skin, Respiratory, IV
Distribution
Lipid drugs – rapid absorption, Water based-rapid eliminationMetabolismIn general ‘faster’ –antibioticsExcretionMore age related / renal function / hydrationSlide14
Pediatric
Pharmacokinetics
Even the FDA says so ..
Some doses are higher
Some are lower
Alternatives / substitutions – need to be evaluated --- especially different routes of adminSlide15
Countermeasures
FDA
–
allowing
a lot
foreign products
NS/IV from Mexico/Spain (Baxter
)
*no bar code, look different, tubing
Homework… check vials.. India
Communication (be proactive)SBAR –weekly, now 2x Action Plans Alternative sizes, vials, strengths, doses System to notify – act quickly Frequent updates help reassureSlide16
CommunicationSlide17
CommunicationSlide18
Countermeasures
Collaborations within / outside
Regulations - Track
/
trace – Banner/
Abrazo
/Dignity
“Emergency Protocol”
Allowing for extending outdates – 3-6 month
Allowing Multi-dose vials or SDV more than once
PropofolGray market (black market)Compounding CentersRaw materials / powdersRegulations – Do your homework!Slide19
Black Market
Google location!
4.5 / 5 Yelp
Groupons
Some don’t have street view
Check FDA / State Board Slide20
Countermeasures
Proactively update most used protocols
D50 – 10% Dextrose, Oral, Gels, Tablets (PR)
Adjust thresholds – Remove give ½ amp
Disaster
drills/exercises should include
practice
in estimation of dosages for pediatric patients.
Many “visual” signs –
Peds
chartsNeed updated with alternativesSlide21
Countermeasures
Collaboration with nursing, physicians, EMS, pharmacy - (different routes, doses)
Preferred Pediatric Emergency – usually have good committees – increase frequency
Compounding “own” syringes *risky
Restrict drugs to high risk populations
Prepare long term plan
Access CDC stockpile Slide22
Countermeasures
Definitely see frequent product changes
Prepare to have different vials / strengths
Prepare to have different colored syringes - IMS
Prepare to have lower PAR levels
Pediatrics
Key is parents – communication
Awareness
Education – professional,
KNOW your pharmacy teamSlide23
Planning Pediatric Drug ShortageSlide24
Resources
ASHP Drug Shortages Website https://www.ashp.org/shortages
FDA Drug Shortage Website http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
CDC Vaccine Shortage and Delays Website http://www.cdc.gov/vaccines/vac-gen/shortages/
Product Manufacturers
CDC / Emergency Prep
Moving TargetSlide25
Questions
Thank you