24 Del. Admin. Code §§ 2500-12.0

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

Section 2500-12.0 - Pharmaceutical Services in Health Care Facilities/Programs

12.1 Definition of Health Care Facilities/Programs:

A health care facility/program means any organization, other than a nursing home or hospital, which is licensed or certified by the State to provide a physical environment for patients in which health care services are a component. These facilities/programs include, but are not limited to:

12.1.1 Assisted Living Facilities (Title 16 Administrative Code 3225)

12.1.2 Group Homes (AIDS)

12.1.3 Group Homes (Mental Health)

12.1.4 Neighborhood Homes (DD)

12.1.5 Rest Residential

12.1.6 Intensive Behavioral Support and Educational Residence

12.1.7 Clinics

12.1.8 Residential Child Care Facilities and Day Treatment Programs

12.1.9 End Stage Renal Disease Treatment Centers

12.2 Requirements. Any health care facility/program in which pharmaceutical services are provided must comply with all State and Federal laws regarding drug storage, labeling, recordkeeping, and security. Only health care personnel authorized by law to handle medication may have access to medication areas.

12.2.1 Any pharmacist providing contractual pharmaceutical services to the Health Care Facilities/Programs will be responsible for providing information to the staff as may be appropriate or required to ensure safety, understanding and compliance with policies and procedures pertaining to pharmacy-related activities and concerns. The written policies and procedures which shall be provided include, but are not limited to:

12.2.1.1 Policies and procedures that pertain to the pharmacy services provided for the contracted health care facility/program.

12.2.1.2 Policies governing appropriate security and storage of medications.

12.2.1.3 Policies and procedures necessary to insure the safe use, administration, control and accountability of all drugs throughout the Health Care Facility/Program in compliance with State and Federal laws.

12.2.1.4 Policies and procedures outlining the destruction of wastage for all medications.

12.2.1.5 Procedures to follow if a pharmacy dispensing error has occurred.

12.2.2 The pharmacist shall make inspections of each Health Care Facility/ Program and related drug storage areas at least annually. The inspections may be more frequent if required by other state laws or depending on the contractual agreement with health care facilities/programs. At the discretion of the pharmacist a pharmacy support person may assist with the inspection under the direct supervision of a pharmacist.

12.2.2.1 Inspections must include, but are not limited to, documentation of the following:

12.2.2.1.1 Medication storage area(s) (59 to 86 degrees Fahrenheit) and refrigerator temperatures (36 to 46 degrees Fahrenheit);

12.2.2.1.2 Security of all drugs/devices meeting all the requirements of State and Federal laws and regulations;

12.2.2.1.3 Proper labeling, including any accessory or cautionary instructions;

12.2.2.1.4 Proper expiration dating;

12.2.2.1.5 Cleanliness;

12.2.2.2 Copies of these inspection reports must be maintained at the facility and the pharmacy provider for two years.

24 Del. Admin. Code §§ 2500-12.0

17 DE Reg. 990 (4/1/2014) (Final)