Delaware News: Board Regulation 14 Review - Administration of Injectable Medications

June 1, 2009 5:00 PM Topics: Prescriptions

Published in the June 2009 Delaware State Board of Pharmacy News

The Delaware State Board of Pharmacy has received a number of questions regarding the rules and requirements for the administration of injectable medications. As a review, please see the following Regulation 14 in its entirety. The purpose of this regulation is to implement provisions
relating to the training, administration, and documentation of injectable medications, biologicals, and adult immunizations by pharmacists, pursuant to 24 Del.C. Ch. 25 relating to pharmacy.
14.1 Educational Requirements
14.1.1 In order to administer injectable medications, biologicals, and adult immunizations a licensed pharmacist shall provide proof that the following requirements have been satisfied:
14.1.1.1 The satisfactory completion of an academic and practical curriculum approved by the
Board of Pharmacy which includes, but is not limited to, disease epidemiology, vaccine characteristics, injection technique, emergency response to adverse events, and related topics.
14.1.1.2 A current Cardio-Pulmonary Resuscitation (CPR) certificate acceptable to the Board
of Pharmacy.
14.1.2 A registered pharmacist may only administer injections consistent with public health and safety and in a competent manner consistent with the academic curriculum and training completed.
14.1.3 Continued competency shall be maintained. A minimum of two hours (0.2 C.E.U.) of the thirty hour requirement for continuing education, every licensure period, must be dedicated to this area of practice.
14.1.4 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 a policy and procedures manual shall be the responsibility of each registered pharmacist administering injections.
14.2 Practice Requirements
14.2.1 The pharmacist must maintain a manual with policies consistent with OSHA (Occupational Exposure to Bloodborne Pathogens) and procedures for dealing with acute adverse events.
14.2.2 Prescriptions and/or physician-approved written protocols will be maintained and available for inspection by the Board of Pharmacy.
14.2.3 The pharmacist, 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.
14.2.4 The pharmacist must document all injections made and have such documentation available for inspection by the Board of Pharmacy. Documentation shall include:
14.2.4.1 Patient’s name, address, phone number, date of birth, and gender.
14.2.4.2 Medication or vaccine administered, expiration date, lot number, site of administration,
dose administered.
14.2.4.3 Date of original order and the date of administration(s).
14.2.4.4 The name of the prescribing practitioner and the pharmacist administering the
dose.
14.2.5 The pharmacist must document fully and report all clinically significant adverse events to the primarycare provider and to the Vaccine Adverse Event Reporting System (VAERS) when appropriate.
14.2.6 The pharmacist shall provide documentation to each person receiving immunizations and when appropriate to the Immunization Section of the Department of Health and Social Services so the names of those individuals can be added to the Vaccination Registry.
14.2.7 All documentation and records required by this Regulation must be maintained for a period of not less than three years.
14.3 Classes and Indications of Approved Medications.
Classes of medications shall include injectable medications, immunizations, and biologicals contained in the list of Approved Drug Products with Therapeutic Equivalence Evaluations or drugs under clinical study when administered in accordance with indications approved by the Food & Drug Administration.
14.4 Authorization. Only those registered pharmacists meeting the requirements of this Regulation shall administer injectable medications, biologicals, and adult immunizations. The Board of Pharmacy shall maintain a current list of those pharmacists so authorized.
It is the responsibility of each registered pharmacist to maintain his or her current status on such list.
3 DE Reg. 431 (9/1/99)