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! Sample email 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

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 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)

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

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 “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!

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 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

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/DrugShortages/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