Planning For Scarce Pediatric
Pharmaceutical Resources
Arizona Pediatric Emergency Preparedness
Sue Moravec, PharmD
Chief Pharmacy Officer/AVP Pharmacy Services
May 23rd, 2017
Disclosure
• Nothing to disclose
• Except….
Planning Pediatric Drug
Shortage
Overview
Causes/Consequences
Pediatric Concerns
Planning/Countermeasures
Summary
Drug Shortage Overview
Right NOW!
• Sodium Bicarbonate, D50
• Electrolytes
– K Phos, Na Acet,
– Calcium Cl, Cal Gluconate
• All Emergency Syringes
– Epi, Norepi, Atropine
• Rocuronium, Vecuronium
• Lidocaine
• Fentanyl, Morphine
Sample email from Friday
Drug Shortage Overview
Epi,Atro,Bicar,Dex,Cal,Lido
Lido,Fent,Roc,Vec,Atr
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.
ASHP
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
Drug Shortage Overview
Utah Emergency MDs 2016
1. One-third of all drug shortages are within the
scope of emergency medicine (1789)
– Shortages of drugs with no substitute grew 125%
2. 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)
Drug Shortage Overview
3. True reasons around shortages remains
unknown.
4. Multiple disease states
– Infectious disease, analgesia, toxicology, critical
care
5. Around 40% of drug shortages affect
emergency care Health Human Services Emergency Care Coordination
6. Median shortage time is about 9 months
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 Bags
• Raw materials shortage
– Fentanyl
• *Recalls (*sometime your first hint to a shortage)
• Business/economic pressures (generics)
– “One assembly line”
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 therapies
– Poor outcomes
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 consequence
– Staff -> patients
– Oncology shortages
• COSTS!!!! Major financial burden
– IV Diphenhydramine
– IV Compazine
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
elimination
– Metabolism
• In general ‘faster’ –antibiotics
– Excretion
• More age related / renal function / hydration
Pediatric Pharmacokinetics
• Even the FDA says so ..
• Some doses are higher
• Some are lower
• Alternatives / substitutions – need to be
evaluated --- especially different routes of admin
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 reassure
Communication
Communication
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
– Propofol
• Gray market (black market)
• Compounding Centers
– Raw materials / powders
– Regulations – Do your homework!
Black Market
Google location!
4.5 / 5 Yelp
Groupons
Some don’t have street view
Check FDA / State Board
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 charts
– Need updated with alternatives
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
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 team
Planning Pediatric Drug Shortage
Education Drug Shortages
Collaborative Committees
Proactively Update Protocols/charts
New Thresholds/Care Plans
Alternatives/Substitutions
Safety First! – Sterility, Errors, Practice
Resources
• ASHP Drug Shortages Website
https://www.ashp.org/shortages
• FDA Drug Shortage Website
http://www.fda.gov/Drugs/DrugSafety/DrugShort
ages/default.htm
• CDC Vaccine Shortage and Delays Website
http://www.cdc.gov/vaccines/vac-gen/shortages/
• Product Manufacturers
• CDC / Emergency Prep
Moving
Target
QUESTIONS
Thank you