18.4 Healthcare Regulations & Standards: FDA, REMS, Bar Coding, DEA, CMS, EMTALA, The Joint Commission, NIOSH & USP

18.4 Healthcare Regulations & Standards: FDA, REMS, Bar Coding, DEA, CMS, EMTALA, The Joint Commission, NIOSH & USP

FDA Safety Tools

• Boxed warnings: the strongest labeling warning for serious or life-threatening risks.
• Drug Safety Communications: alerts about new safety findings, label changes or market actions, such as the 2025 withdrawal of andexanet alfa in the US (Section 10.1).
• MedWatch: the voluntary reporting system for healthcare professionals and patients (Form 3500). Manufacturers must report adverse events they learn about (Form 3500A).
• VAERS: the vaccine adverse event reporting system, run jointly by CDC and FDA. Vaccine providers must report certain events listed in the reportable events table.

Risk Evaluation and Mitigation Strategies (REMS)

FDA requires a REMS when labeling alone cannot ensure that a drug's benefits outweigh a serious risk. A REMS may include:

• A Medication Guide or communication plan
• Elements to assure safe use (ETASU): certified prescribers, certified pharmacies or settings, dispensing only in certain healthcare settings, documented lab results, patient monitoring or a registry
• An implementation system

REMS programs removed in 2025: clozapine (FDA stopped expecting participation in February 2025 and eliminated the program in June 2025) and the autologous CAR-T cell therapies (June 2025). The underlying risks remain in the labeling.

ED implications: REMS-restricted products may not be stocked or orderable on short notice. Know how to obtain or substitute them, and never dispense a REMS-restricted product outside its rules.

Bar Code Medication Administration (BCMA)

FDA's 2004 bar code rule requires a linear bar code containing the National Drug Code (NDC) on most prescription drug labels and on OTC drugs commonly used in hospitals. BCMA checks the patient's wristband against the drug's bar code and the active order at the bedside, confirming the right patient, drug, dose, route and time.

• In a landmark before-and-after study (Poon, 2010), BCMA with an electronic administration record reduced non-timing administration errors by about 41% and potential adverse drug events by about half.
• ED barriers: verbal orders during resuscitation, overrides, bedside-prepared syringes without bar codes, and patients without wristbands.
• Common workarounds that defeat BCMA: scanning a copy of the wristband taped to a computer, or scanning one vial and giving another. Pharmacy should track scanning compliance, investigate workarounds as system problems, and supply bar-coded labels for ED-prepared products.

DEA and Controlled Substances in the ED

CMS Conditions of Participation and EMTALA

Hospitals must meet the Medicare Conditions of Participation (CoPs) to bill Medicare. Accreditation by The Joint Commission or another approved accreditor confers "deemed status."

• 42 CFR 482.25 (Pharmaceutical services): pharmacy directed by a qualified pharmacist; drugs stored securely; expired drugs removed from use; drug administration errors, adverse reactions and incompatibilities reported; controlled-substance abuses and losses reported; drug information available to staff.
• 42 CFR 482.23(c): drugs are given according to orders from authorized practitioners. Verbal orders are used rarely and authenticated promptly.
• Standing orders (42 CFR 482.24): allowed when approved by the medical staff, nursing and pharmacy, based on evidence, and documented and authenticated in the record. Examples include anaphylaxis, hypoglycemia and triage protocols.

EMTALA (Emergency Medical Treatment and Labor Act, 1986)

EMTALA applies to Medicare-participating hospitals with emergency departments. Anyone who comes to the ED requesting care must receive:

1. A medical screening examination to determine whether an emergency medical condition exists, regardless of insurance or ability to pay. Insurance questions must not delay screening or treatment.
2. Stabilizing treatment, or an appropriate transfer: the receiving hospital accepts the patient, records go with the patient, transport is qualified, and the physician certifies that the benefits of transfer outweigh the risks.

For the pharmacist, needed emergency drugs cannot be withheld or delayed because of cost or coverage.

The Joint Commission: 2026 National Performance Goals

Under Accreditation 360 (effective January 1, 2026), the National Patient Safety Goals were replaced by 14 National Performance Goals. Goal 14 covers medication management:

Other goals relevant to ED pharmacy include Goal 1 (correct patient identification and communication of critical results), Goal 4 (assessment of health-related social needs, Section 18.3), Goal 6 (pain management and safe opioid prescribing, including prescriber and pharmacist access to the prescription drug monitoring program) and Goal 8 (reducing suicide risk). The Sentinel Event Policy still expects a comprehensive systematic analysis and action plan after a sentinel event (Section 14.1).

Under long-standing Joint Commission medication management standards, a pharmacist prospectively reviews medication orders. The exceptions are when a licensed practitioner controls ordering, preparation and administration, or when a delay would harm the patient in an urgent situation. These exceptions cover much of resuscitation care.

NIOSH, USP <800> and USP <797>

• NIOSH List of Hazardous Drugs in Healthcare Settings (2024): reorganized into two tables. Table 1 lists drugs that carry manufacturer special handling information or meet the definition of a carcinogen; Table 2 lists other hazardous drugs. ED examples include methotrexate, misoprostol and several antiseizure and hormonal drugs.
• USP <800> sets containment, PPE and handling requirements for hazardous drugs (Section 14.1). It is enforceable when adopted by a state or board of pharmacy. An assessment of risk allows alternative containment for some dosage forms that are not antineoplastic.
• USP <797> (2023 revision) immediate-use compounded sterile preparations:
  • May be prepared outside a cleanroom using aseptic technique.
  • May involve no more than 3 different sterile products.
  • Administration must begin within 4 hours after preparation starts.
  • Must be labeled unless the person who prepared it administers it immediately.
  • Examples include bedside dilution of push-dose vasopressors and reconstitution of emergency antibiotics.
• ISMP Safe Practice Guidelines for adult IV push medications: use commercially available ready-to-administer products when possible, do not dilute unless the label or a protocol requires it, never draw medication from a prefilled syringe into another syringe, and label every syringe that is not immediately administered.