1. Planning For Scarce Pediatric Pharmaceutical Resources
Arizona Pediatric Emergency Preparedness
Sue Moravec, PharmD
Chief Pharmacy Officer/AVP Pharmacy Services
May 23rd, 2017

2. Disclosure
Nothing to disclose
Except….

3. Planning Pediatric Drug Shortage
Overview
Causes/Consequences
Pediatric Concerns
Planning/Countermeasures
Summary

4. Drug Shortage Overview
Right NOW!
Sample from Friday
Sodium Bicarbonate, D50
Electrolytes
K Phos, Na Acet,
Calcium Cl, Cal Gluconate
All Emergency Syringes
Epi, Norepi, Atropine
Rocuronium, Vecuronium
Lidocaine
Fentanyl, Morphine

5. Drug Shortage Overview
Epi,Atro,Bicar,Dex,Cal,Lido
Lido,Fent,Roc,Vec,Atr

6. 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

7. 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

8. 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 , emergency medicine drug shortages rose by 435% (23 to 123 drugs)
Life-saving or high acuity shortage drugs increased 393% * (2017 – more)

9. 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 months

10. 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”

11. 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

12. 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

13. 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

14. 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

15. 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

16. Communication

17. Communication

18. Countermeasures Collaborations within / outside “Emergency Protocol”
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!

19. Black Market Google location! 4.5 / 5 Yelp Groupons
Some don’t have street view
Check FDA / State Board

20. 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

21. 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

22. Countermeasures Definitely see frequent product changes Pediatrics
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

23. Planning Pediatric Drug Shortage
Education Drug Shortages
Collaborative Committees
Proactively Update Protocols/charts
New Thresholds/Care Plans
Alternatives/Substitutions
Safety First! – Sterility, Errors, Practice

24. Resources ASHP Drug Shortages Website https://www.ashp.org/shortages
FDA Drug Shortage Website
CDC Vaccine Shortage and Delays Website
Product Manufacturers
CDC / Emergency Prep
Moving Target

25. Questions
Thank you