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Delaware News: Pharmacy Regulation Amendments
Published in the December 2009 Delaware State Board of Pharmacy Newsletter
The Delaware State Board of Pharmacy, in accordance with 24 Del. C. §2509, amended pharmacy regulations associated with Pharmacist Licensure Requirements, Pharmacy Requirements, Dispensing, Pharmaceutical Services in Nursing Homes Automated Pharmacy Systems, Storage and Dispensing of Medical Gases, Technicians: Qualifications, Training, and Duties, and Specialty Institutional Pharmacy Licenses.
The following are some of the amendments pertaining to technicians and specialty institutional pharmacy licenses. For a complete review of all the amendments made, please see our Web site at http://regulations.delaware.gov/AdminCode/title24/2500.shtml.
19.0 Technicians: Qualifications, Training, and Duties
19.1 Qualifications and Training
19.1.1 Pharmacy Technicians shall successfully complete a training program. Training shall begin immediately upon initiation of employment and be completed within 90 days. Once training is commenced the technician in training may work in the pharmacy under the direct supervision of a pharmacist or a trained technician.
19.1.1.1 The pharmacist-in-charge is responsible for ensuring proper training of all supportive personnel. The actual training may be delegated to a pharmacist or other trained supportive personnel.
19.1.1.2 The areas of training required are to be determined by the pharmacist-in-charge and will be appropriate to the practice site and responsibilities assigned to the technicians. Training should be a minimum of 10 hours of didactic training in the following areas:
19.1.1.2.1 general drug and dosage form knowledge
19.1.1.2.2 medical terminology
19.1.1.2.3 pharmaceutical calculations
19.1.1.2.4 prescription labeling requirements
19.1.1.2.5 general filling/dispensing responsibilities
19.1.1.2.6 patient profile record system requirements
19.1.1.2.7 requirements for patient
counseling
19.1.1.2.8 confidentiality
19.1.1.2.9 safety practices
19.1.1.2.10 inventory functions
19.1.1.2.11 knowledge of applicable State and Federal Statutes and Regulations
19.1.1.2.12 other site-specific parameters
19.1.1.3 The general content of the training program must be maintained in the policy and procedure manual.
19.1.1.4 Documentation of successful training in specific areas by oral or written evaluation will be maintained and will be available for inspection by the Board of Pharmacy.
19.1.1.5 Supervision. Supportive personnel must be supervised by a registered pharmacist who will be responsible for the activities of these persons.
19.1.2 Certified pharmacy technicians must be at least 18 years of age, successfully complete a certified training program approved by the Board of Pharmacy or successfully pass the PTCB [Pharmacy Technician Certification Board] Exam or other national technician certification exam approved by the Board of Pharmacy. Only certified pharmacy technicians may assist the pharmacist by reconstituting oral solutions and contacting the prescriber or their agent to obtain refill authorization or other patient or prescription information of a non-clinical nature, or assisting the pharmacist with compounding.
19.2 Allowed Activities
19.2.1 Except in emergency situations for short periods where staff is unavailable only pharmacy technicians and certified pharmacy technicians may assist the pharmacist or deliver prescriptions in the pharmacy to a patient or the patient’s agent.
19.2.2 Pharmacy technicians and certified pharmacy technicians may carry out any pharmacy-related duty assigned to them by their supervising pharmacist except for those activities specifically excluded by 24 Del.C. §§2507(b) and 2502(19).
20.0 Specialty Institutional Pharmacy Licenses
20.1 Specialty institutional pharmacies are those institutional pharmacies which provide specialized pharmacy services restricted in scope of practice and designed to provide certain health care pharmacy services that are not generally obtainable from other pharmacy permittees. Specialty institutional pharmacies include but are not limited to short term or primary care treatment modalities that have pharmacies on site such as outpatient chemotherapy centers, primary treatment centers, free standing emergency rooms, rapid in/out surgical centers and certain county health programs.
20.2 Labeling and record keeping requirements shall be kept in accordance with Regulation 9.9 through 9.13.
