Pharmacy Regulations on Injectable Medications

Injectable Medication and Pharmacy Practice

• Injectable Medication Definition: Approved by the Federal Food and Drug Administration for mental health and substance use disorder treatment.
• Certified Pharmacy Intern: Defined under Education Law §6806; must meet requirements in section 63.4(d) and obtain a certificate of administration as per section 63.9(a)(3).

Certification and Administration Authority

• Certified Pharmacist Authority: Can administer injectable medications if trained as per Education Law §6801(3) and holds a certificate of administration.
• Patient-Specific Orders: Administration requires a valid prescription or patient-specific order.
• Competency Maintenance: Pharmacists must continue to stay competent regarding populations served and medications used.

Delegation and Supervision

• Non-Delegation Rule: Certified pharmacists cannot delegate the administration of injectable medications, except to certified pharmacy interns under immediate supervision.
• Patient Consent: Certified pharmacy interns must obtain patient consent for administration; if consent is refused, the pharmacist will administer the medication.

Pre-Administration Responsibilities

• Initial Dose Verification: Pharmacists must confirm the patient has received an initial dose and is eligible for maintenance treatment, with documentation of eligibility from the prescriber.
• Patient Information: Must inform the patient of common side effects, drug interactions, and injection site reactions both orally and in writing.
• Contraindication Assessment: Pharmacists are responsible for assessing any contraindications before administration.
• Emergency Preparedness: Must have anaphylaxis treatment agents and related supplies available.
• Consent Documentation: Must obtain and document written consent from the patient or their legal representative.
• Adverse Reaction Instructions: Patients should receive written instructions on managing adverse reactions or contraindications.
• Privacy: Administration must occur in a private area to ensure patient confidentiality.

Reporting Procedures

• Prescriber Notification: Pharmacists or their designees must notify the prescriber within five days after administration; if the scheduled medication is missed, this must be reported within 72 hours.
• Documentation: All notifications and communications must be recorded in the patient's medication profile.
• Adverse Reaction Reporting: Pharmacists are obliged to notify the prescriber immediately in the event of side effects or adverse reactions.

Anaphylaxis Treatment

• Anaphylaxis Medication Administration: Certified pharmacists trained under Education Law §6801(3) can administer medications for treating anaphylaxis to patients receiving injectable medications.
• Standards Compliance: Administration must follow specific standards, procedures, and reporting requirements outlined in section 63.9(b).

Professional Judgment

• Refusal of Administration: Pharmacists may refuse to administer injectable medications if, in their professional judgment, it could endanger the patient's health due to potential adverse effects or interactions.