18.5 Formulary & Inventory Management, Drug Shortages, Antidote Stocking & Clinical Decision Support
Key Takeaways
The 2018 expert consensus on antidote stocking recommended 44 antidotes, 23 of them immediately available on patient arrival and 14 more within 1 hour, plus a hospital-specific hazard vulnerability assessment.
ASHP's 2018 shortage guidelines combine an operational assessment, a therapeutic assessment, prioritization of patients, clear communication and safety checks on substitute products.
The Joint Commission's 2026 goals require hospitals to standardize and limit drug concentrations, communicate shortages and follow written substitution protocols.
Clinicians override about half to nearly all medication alerts, so alerts should be tiered so that only high-severity, high-specificity warnings interrupt workflow.
In an external validation published in 2021, a widely used proprietary sepsis prediction model had an AUC of 0.63 and missed about two-thirds of sepsis cases, which shows predictive tools need local validation before use.
18.5 Formulary & Inventory Management, Drug Shortages, Antidote Stocking & Clinical Decision Support
Note
Exam scope: 2025 outline subtopics 3A5 (Formulary and Inventory Management, e.g., automated dispensing cabinets, medication shortages, antidote inventory) and 3A6 (Informatics and Clinical Decision Support Systems). Automated dispensing cabinet safety features and smart pumps are covered in Section 14.1, and disaster stockpiles in Section 14.3.
Formulary Management for the ED
The Pharmacy and Therapeutics (P&T) committee decides which drugs are on the formulary, based on efficacy, safety, cost and how well a product fits the workflow. For the ED, workflow fit matters a lot:
- Ready-to-administer products: premixed infusions, prefilled syringes and bar-coded unit doses reduce compounding and errors at the bedside.
- Standard concentrations, required by The Joint Commission's 2026 National Performance Goals (NPG.14.02.01). One concentration per drug simplifies smart pump libraries and order sets.
- Kits and trays: rapid sequence intubation kits, code trays standardized across units, a pediatric resuscitation system organized by weight or color, and thrombolytic kits with dosing charts.
- Restricted drugs: antimicrobial or high-cost restrictions should allow ED first doses when delay is dangerous, followed by approval.
- Therapeutic interchange: P&T-approved automatic substitution within a class, such as proton pump inhibitors.
- Medication use evaluations collect data on how a drug is used against approved criteria, and the results feed back into the formulary, order sets and education (Section 18.6).
Formulary decisions balance purchase price against the total cost of care. For example, a bolus thrombolytic can save nursing time and avoid infusion errors even if it costs more.
Inventory Management
| Concept | Meaning | ED application |
|---|---|---|
| Par level | The target quantity restocked at each refill | Set from usage data and refill frequency; review after formulary or practice changes |
| ABC analysis | "A" items are a small share of products (often 10 to 20%) that make up most of the spend (often 70 to 80%) | Manage high-cost items such as antivenom, digoxin immune fab and thrombolytics tightly |
| First-expired, first-out (FEFO) | Use the soonest-expiring stock first | Prevents waste of rarely used antidotes |
| Inventory turns | Annual purchases divided by average inventory | Higher turns mean less money tied up, but too few units risk running out |
| Automated dispensing cabinet profiling | Items available by override, without pharmacist review, are limited to defined emergency drugs | The override list follows ISMP guidance and the hospital's NPG.14.01.01 review policy |
Emergency supplies must be standardized, sealed and checked after every use: crash carts, malignant hyperthermia supplies wherever triggering agents are used, and pediatric resuscitation stock.
Drug Shortages
Why Shortages Happen
Shortages are concentrated in older, low-margin sterile injectables. Causes include manufacturing and quality failures, few manufacturers, business discontinuations, raw material problems and demand surges. ASHP recorded an all-time high of more than 320 active shortages in early 2024. Examples that disrupted EDs include:
- IV fluids after Hurricane Helene damaged a major manufacturing plant in 2024
- Benzathine penicillin G, for which FDA allowed temporary importation
- Prefilled emergency syringes, such as sodium bicarbonate, dextrose 50% and epinephrine
Managing a Shortage (ASHP 2018 Guidelines)
- Operational assessment: confirm the shortage, the stock on hand and in the supply chain, usage rate and expected duration. Find the days of supply remaining.
- Therapeutic assessment: identify alternatives, including other products, concentrations, routes and drugs, and their safety differences.
- Conservation and prioritization: restrict the drug to the most critical indications, using ethical allocation criteria approved by leadership, not decisions made at the bedside. Use smaller vials or dose rounding, and switch IV to oral where possible.
- Communication: tell prescribers, nursing and the EHR team. Update order sets, pump libraries and ADC labels. The Joint Commission requires shortage communication and written substitution protocols (NPG.14.02.01).
- Safety: a substitute with a different concentration or container is a major error risk. Add alerts, separate storage and labels, and double checks.
- Other sources: registered 503B outsourcing facilities, compounding within USP standards, and FDA-authorized temporary importation.
Antidote Stocking
The 2018 Expert Consensus
Dart and colleagues (Annals of Emergency Medicine, 2018) reviewed 45 antidotes for hospitals that provide emergency care:
- 44 were recommended for stocking.
- 23 should be immediately available, which in most hospitals means stocked where they can be given when the patient arrives.
- 14 more should be available within 1 hour of the decision to treat, which allows pharmacy storage with a reliable delivery process.
- Every hospital should complete a formal antidote hazard vulnerability assessment that considers local industry, agriculture, snake species, transport times and nearby hospitals.
Quantity Problems
Several antidotes are needed in large amounts, and the ED pharmacist should calculate whether one severely poisoned patient could be treated with the stock on hand:
| Antidote | Why quantity matters |
|---|---|
| Crotalidae antivenom | Initial control can require 10 or more vials, with maintenance doses later (Section 9.3) |
| Digoxin immune fab | Acute ingestions may need 10 or more vials (Section 9.1) |
| Pyridoxine | A 5 g dose from 100 mg/mL vials is 50 mL (Section 9.4) |
| Glucagon (beta-blocker toxicity) | Boluses of 3 to 10 mg followed by an infusion can use up an ED's stock of 1 mg kits within hours (Section 8.5) |
| Fomepizole, hydroxocobalamin, high-dose insulin, lipid emulsion | Expensive or bulky; need a defined location and a plan for restocking |
Share stock regionally under agreements, coordinate with the poison center, and review expiration dates and quantities at least once a year.
Informatics and Clinical Decision Support (CDS)
Types of CDS in the ED
- Alerts: drug-drug interaction, allergy, dose range, duplicate therapy and kidney dosing alerts.
- Order sets: sepsis, stroke thrombolysis, DKA, RSI and massive transfusion, with weight-based calculators and default doses.
- Calculators and nomograms: acetaminophen nomogram, CrCl, ideal body weight and infusion rates.
- Dashboards and timers: sepsis bundle clocks, time to thrombolysis, ED boarding lists.
- Worklists: rapid diagnostic results (Section 12.3) and culture callbacks (Section 14.2).
Alert Fatigue
Studies report that clinicians override about half to nearly all medication alerts, most of which are clinically irrelevant. Overridden important alerts then cause harm. Practical steps:
- Tier alerts by severity. Only high-severity, high-specificity alerts should interrupt (hard stops are reserved for near-absolute contraindications). Show the rest passively.
- Use patient-specific logic: kidney function, weight, current labs and indication.
- Monitor override rates and reasons, and retire or redesign alerts with very high override rates.
- Follow the "five rights" of CDS: the right information, to the right person, in the right format, through the right channel, at the right time in the workflow.
Weight, Data Quality and Downtime
- Record weight in kilograms only and mark whether it was measured or estimated. A wrong weight in the EHR spreads into every weight-based dose.
- Avoid free-text orders that skip dose checking, and be careful when copying forward old notes.
- Keep downtime procedures current: paper order forms, printed dosing references and recent medication administration records.
Predictive Analytics and AI
Predictive models are only as good as their validation. In a 2021 external validation, a widely used proprietary EHR sepsis model had an AUC of 0.63, missed about two-thirds of sepsis cases and generated many false alerts. Before using any predictive or AI tool, hospitals should validate it on local data, check its performance across patient groups, and monitor for drift and alert burden afterward.
The ED has 4 days of 8.4% sodium bicarbonate prefilled syringes left, and the supplier gives no release date. Which first-line response is most consistent with ASHP shortage guidelines?
Remove sodium bicarbonate from every order set without communication
Use leadership-approved criteria, label alternatives and update order sets
Replace syringes with vials of a different concentration, with no extra safeguards
Let each physician decide case by case who receives the remaining syringes
A rural hospital is reviewing its antidote inventory. According to the 2018 expert consensus on antidote stocking, what should guide the hospital's specific stocking decisions beyond the published list?
Do a formal antidote hazard vulnerability assessment for the area
Stock the minimum quantity on the product label for one adult dose
Rely entirely on the regional poison center to supply antidotes
Stock only antidotes used at least once in the past year
An ED's drug interaction alerts are overridden 94% of the time, and a pharmacist finds a serious interaction alert that was overridden without review. What is the best informatics response?
Tier alerts by severity, interrupt only for high-severity pairs, and track overrides
Turn off all interaction alerts in the ED to remove distraction
Require a free-text reason for every alert override before signing the order
Convert every interaction alert into a hard stop that requires a pharmacist
Sections you finish are checked off in the contents.