24 Del. Admin. Code §§ 2500-14.0

Current through Register Vol. 27, No. 12, June 1, 2024

Section 2500-14.0 - Administration of Injectable Medications, Biologicals and Adult Immunizations

14.1 Purpose. The purpose of this section is to implement provisions relating to the training, administration, and documentation of injectable medications, biologicals, and adult immunizations by pharmacists, registered interns and pharmacy students pursuant to 24 Del.C. Ch. 25 relating to Pharmacy. Certified pharmacy technicians may only administer adult immunizations pursuant to the training, administration and documentation requirements set forth in subsection 19.2.3.

14.2 Educational Requirements

14.2.1 In order to administer injectable medications, biologicals, and adult immunizations a licensed pharmacist, a registered intern or a pharmacy student shall complete a Board approved academic and hands-on practical curriculum and maintain a current Cardio-Pulmonary Resuscitation (CPR) certificate acceptable to the Board of Pharmacy. CPR certification must be obtained through a CPR course for health care providers and the course must have a hands-on, skills check component.

14.2.1.1 An approved academic and practical curriculum includes, but is not limited to, disease epidemiology, vaccine characteristics, injection technique, emergency response to adverse events, and related topics.

14.2.1.2 Pharmacists successfully completing the above education and practical training shall notify the Board. The Board will record the successful training in Board database systems. The pharmacist's license shall include the notation that such licensee has completed the training for the administration of injectable medications, biologicals and adult immunizations.

14.2.2 A licensed pharmacist, registered intern or pharmacy student may only administer injections consistent with public health and safety and in a competent manner consistent with the academic curriculum and training completed.

14.2.3 Continued competency shall be maintained and available for Board inspection.

14.2.3.1 A minimum of two hours (0.2 C.E.U.) of the thirty hour requirement for continuing education for licensed pharmacists, every licensure period, must be dedicated to this area of practice. To be relieved of this requirement, the licensee must notify the Board, in writing, that he or she is no longer administering injectable medications, biological and adult immunizations.

14.2.3.2 A minimum of two hours of continuing education every two years for registered interns and pharmacy students must be dedicated to this area of practice.

14.2.4 Documentation of the satisfactory completion of the proper academic and practical training requirements shall be listed in a policy and procedures manual available for inspection by the Board of Pharmacy. Maintaining such documentation shall be the responsibility of the pharmacist-in-charge.

14.3 Practice Requirements

14.3.1 The pharmacist-in-charge must maintain a manual with policies consistent with OSHA (Occupational Exposure to Bloodborne Pathogens) and procedures for dealing with acute adverse events.

14.3.2 The administration of injectable medications, biologicals and adult immunizations by registered interns and pharmacy students must be directly supervised by a licensed pharmacist who is approved for injectable administration.

14.3.3 The pharmacist, registered intern, or pharmacy student, before administering an injectable medication, biological, or immunization, must counsel the patient and/or the patient's representative about contraindications and inform them in writing in specific and readily understood terms about the risks and benefits. A signed copy of the patient's consent shall be filed and available for inspection by the Board of Pharmacy.

14.3.4 The pharmacist, registered intern, or pharmacy student must document all injections made and have such documentation available for inspection by the Board of Pharmacy. Documentation shall include:

14.3.4.1 Patient's name, address, phone number, date of birth, and gender.

14.3.4.2 Medication or vaccine administered, expiration date, lot number, site of administration, dose administered.

14.3.4.3 Date of original order and the date of administration.

14.3.4.4 The name of the prescribing practitioner and the pharmacist, registered intern, or pharmacy student administering the dose.

14.3.5 The pharmacist, registered intern, or pharmacy student must document fully and report all clinically significant adverse events to the primary-care provider and to the Vaccine Adverse Event Reporting System (VAERS) when appropriate.

14.3.6 The pharmacist, registered intern, or pharmacy student shall provide documentation to each person receiving immunizations and shall report to the Immunization Vaccination Registry.

14.3.7 All documentation and records required by this Regulation must be maintained for a period of not less than three years and available for inspection by the Board of Pharmacy.

14.4 Administration of medications includes injectable medications, biologicals and adult immunizations pursuant to a valid prescription or approved protocol approved by a physician duly licensed in this State.

24 Del. Admin. Code §§ 2500-14.0

3 DE Reg. 431 (09/01/99)
17 DE Reg. 653 (12/1/2013)
18 DE Reg. 707 (3/1/2015)
21 DE Reg. 989 (6/1/2018)
26 DE Reg. 64 (7/1/2022)
26 DE Reg. 768 (3/1/2023) (Final)