PHA 573 - Central Fill Student October 2024 Central Fill Regulations

Central Fill, Remote Order Entry, Retail with Home Health Care, Outpatient Clinic and Others Learning Objectives ========================================= - Describe the steps involved in the central fill and the remote order entry prescription process. - Describe th...

Central Fill, Remote Order Entry, Retail with Home Health Care, Outpatient Clinic and Others Learning Objectives ========================================= - Describe the steps involved in the central fill and the remote order entry prescription process. - Describe the processes utilized by retail - Describe the outpatient clinic pharmacy prescription process - Describe the practitioner dispensing of drugs - Describe the process used to dispense drugs under the authority of a job description or nurse protocol Central Filling Regulations (480-10A) ------------------------------------- - ###### Definitions - Originating Pharmacy - Central Fill Pharmacy - Dispensing Pharmacy Central Filling Regulations (480-10A) ----------------------------------------------------------- - ###### Licensing and Contracting - Retail license - DEA registration - Central Fill Pharmacy must be "authorized" to fill on - Contractual relationship - Common owner - Shared dispensing responsibility Central Filling Regulations (480-10A) ------------------------------------- - ###### Policies and Procedures - Any retail pharmacy using or providing central fill services must have policies and procedures on file and make available to GDNA upon request 1. Description of activities in the filling process performed by each pharmacy 2. Responsibilities and accountabilities of each pharmacy 3. List of names, addresses, phone numbers, license/registration numbers for pharmacies participating in central fill 4. Guidelines to protect confidentiality and integrity of PHI, maintenance of records to identify names, initials, ID codes, and specific activities of each pharmacist involved in the central fill process Central Filling Regulations (480-10A) ----------------------------------------------------------- - ###### Transmission - Originating pharmacy must have minimum required patient information and Rx order requirements **[before]** sending prescription to central fill pharmacy - May be transmitted electronically from originating pharmacy to central fill, including via fax Central Filling Regulations (480-10A) ------------------------------------- - Transmission to Central Fill (going OUT) - All transmission **records going OUT** must include: 1. **[CENTRAL FILL]** on face of prescription, if it's a hard copy 2. Name, address, phone, GA Pharmacy license number, DEA number (if controlled), of the **[Central Fill pharmacy]** to which the Rx has been transmitted to 3. Number of refills already dispensed and number of refills remaining 4. Name of **[Originating Pharmacy pharmacist]** transmitting 5. Date of transmittal Central Filling Regulations (480-10A) ----------------------------------------------------------- - ###### Central Fill receipt records - All transmission receipt records coming IN must include: 1. All of the information required to transmit out PLUS... 2. Name, address, phone number, GA Pharmacy license number, DEA registration (if controlled), of the **[Originating Pharmacy]** transmitting the prescription Central Filling Regulations (480-10A) ------------------------------------- - ###### Labeling - Label affixed to container/vial by Central Fill must have: 1. Date of fill/refill 2. Originating Pharmacy names, address, phone \# 3. Central Fill Pharmacy's unique identifier 4. Rx Number (serial number of the prescription) 5. Patient name 6. Prescriber's name 7. Supervising physician's name (if applicable) 8. Expiration date of drug dispensed 9. Directions for use and any other cautionary statements required Central Filling Regulations (480-10A) ----------------------------------------------------------- - #### Information Systems and Record Keeping - Originating and central fill pharmacies **MUST** share common electronic files or have appropriate technology to allow secure access - Originating pharmacy responsible for PDMP compliance Central Filling Regulations (480-10A) ------------------------------------- - #### Information Systems and Record Keeping - Originating Pharmacy **MUST** have RPh/intern/extern or PhT sign for receipt of all prescriptions received FROM Central Fill Pharmacy - Date of receipt - Method of delivery - Name of Originating Pharmacy employee accepting - RPh on duty at Originating Pharmacy **MUST** verify receipt of all controlled substances Central Filling Regulations (480-10A) ----------------------------------------------------------- - ###### Patient Counseling and Patient Notification - Responsibility of the **Originating Pharmacy pharmacist** - Central Fill Pharmacy **CANNOT** provide patient - **BEFORE** sending prescription to Central Fill pharmacy, Originating Pharmacy **must notify patients** that this may/could occur - Patients have right to "opt out" of central fill services - Notification can be through signage that is clearly visible and readable by the public ##### Retail Pharmacy Requirements for Remote Prescription Drug Order Processing (480-36) - ###### Definitions - Remote prescription drug order process - Primary dispensing pharmacy - Secondary remote entry pharmacist ##### Retail Pharmacy Requirements for Remote Prescription Drug Order Processing (480-36) - ###### Primary Dispensing Pharmacy Requirements - Licensed as a retail pharmacy in GA - Physically located in GA - Must have same owner or have written contract describing scope of services and responsibilities and accountabilities of each party ##### Retail Pharmacy Requirements for Remote Prescription Drug Order Processing (480-36) - Personnel and Supervision - Primary dispensing pharmacist - Must be physically present during business hours - Responsible for obtaining and recording patient biographical information, medication history, drug allergies, etc. - Secondary remote entry pharmacist - Responsible for supervising all pharmacy activities and - **[EXCLUDES:]** compounding, preparation, dispensing, and counseling - **[INCLUDES]**: Rx data entry verification and drug regiment review ##### Retail Pharmacy Requirements for Remote Prescription Drug Order Processing (480-36) - ###### Record Keeping - Common electronic files or technology allowing for sufficient information to process a non-dispensing task - Records MUST identify each RPh/PhT involved in each task of remote processing and RPh verification - Rxs processed by secondary RPh must be separately identified and retrievable at the request of GDNA - Records must be kept for 2 years ##### Retail Pharmacy Requirements for Remote Prescription Drug Order Processing (480-36) - ###### Patient Counseling - Responsibility of primary dispensing pharmacist - Secondary remote entry pharmacy CANNOT provide - ###### Patient Notification of Remote Order Processing - Must notify patients their Rxs may be processed by an offsite pharmacist/pharmacy. - Signage at least 3" high - "Remote Order Processing Utilized Here" Retail Pharmacies Providing Home Health Care Services (480-21) ------------------------------------------------------------------------------------ - ###### Definitions - Retail Pharmacy providing Home Health Care - Outpatient - Compounded, Sterile Parenteral Products Retail Pharmacies Providing Home Health Care Services (480-21) -------------------------------------------------------------- - ###### Personnel - Pharmacist-in-charge - Supportive Personnel - Secretarial Personnel - Staffing Retail Pharmacies Providing Home Health Care Services (480-21) ------------------------------------------------------------------------------------ - **Physical Requirements** - Space - Equipment - laminar airflow hood or class 100 clean room - sink with hot/cold running water - equipment for light/dark field examination - appropriate disposal containers - Class II vertical flow biological safety cabinet if chemo is prepared - refrigerator/freezer with thermometer - Supplies - disposable needles and syringes - disinfectant cleaning solutions and handwashing agents - disposable lint free paper towels - appropriate filtration equipment - disposable masks and sterile gloves - References -- Handbook on Injectable Drugs or Kings' Guide to Parenteral Admixtures Retail Pharmacies Providing Home Health Care Services (480-21) -------------------------------------------------------------- - ###### Prescription Drug Orders - Written or verbal - Filing system - New order requirements, when course of therapy - Minimum prescription order requirements Retail Pharmacies Providing Home Health Care Services (480-21) ------------------------------------------------------------------------------------ - ###### Prescription Drug Orders - Patient Profile - Labeling - Delivery Service Retail Pharmacies Providing Home Health Care Services (480-21) -------------------------------------------------------------- - ###### Records Required - Patient Profile - Prescription records - Pharmacy inventories - Biennial controlled substance inventory - Policy and Procedure manuals - Training manuals Retail Pharmacies Providing Home Health Care Services (480-21) ------------------------------------------------------------------------------------ - ###### Patient Care Guidelines - Primary Care Provider - Patient Counseling - Pharmacist-Patient relationship - Patient monitoring Retail Pharmacies Providing Home Health Care Services (480-21) -------------------------------------------------------------- - ###### Quality Control - Must be documented, ongoing quality control programs that monitor personnel performance, equipment, and facilities - Hood certification - End Product Sampling - Bulk Compounding - Expiration Dates Outpatient Clinic Pharmacies (480-33) =========================================================== - ###### Definitions - Outpatient clinic - Outpatient clinic pharmacy - Outpatient - Standard ward inventory - Outpatient prescription Outpatient Clinic Pharmacies (480-33) ===================================== - ###### Clinic Pharmacy Licensure - Pharmacy licensure application requirements and - Not authorized to dispense refills on prescription drug orders - Nothing prohibits an outpatient clinic from applying for a retail pharmacy license Outpatient Clinic Pharmacies (480-33) =========================================================== - ###### Personnel - Pharmacist-in-charge - Secretarial and clerical personnel Outpatient Clinic Pharmacies (480-33) ===================================== - ###### Absence of a Pharmacist - After hours cabinets - Pharmacy access - Emergency kits Outpatient Clinic Pharmacies (480-33) =========================================================== - ###### Physical Requirements - Space - Reference materials - Poison Control - Equipment - CII Storage - Unattended areas Outpatient Clinic Pharmacies (480-33) ===================================== - Drug Distribution - Identification up to the point of administration - Receipt of prescription drug order - Transaction records - Labeling - Perpetual Inventory Outpatient Clinic Pharmacies (480-33) =========================================================== - ###### Accountability of controlled drugs - Proof of use forms must be used and include: - Drug name, strength, and dosage form - Dose - Name of prescriber (first and last name) - Given and last name of patient (first and last name) - Date and time of administration - Signature of administering individual (first initial and last - Documentation by two signatures of destruction of all unused portions - Proof of receipt of medication - Date medication was issued and date that proof of use form Outpatient Clinic Pharmacies (480-33) ===================================== - ###### Records Required - Patient profile / patient chart - Proof of use forms for controlled substances - Reports of suspected / known ADRs - Inventories of night cabinets, E-Kits, standard ward inventory - Pharmacy inventory - Biennial controlled substance inventory - Alcohol and flammables reports Outpatient Clinic Pharmacies (480-33) =========================================================== - ###### Medications from Outside Sources Brought in By Patients - Cannot be administered unless precisely identified - Must be pursuant to a practitioner's prescription - If not administered, must be returned to an adult member of patient's immediate family or store by pharmacy and returned to patient upon departure Outpatient Clinic Pharmacies (480-33) ===================================== - ###### Inspections by PIC - Occurs at least once a month - Verify drugs are dispenses by licensed RPh only - Personnel are properly supervised - Proper storage of drug inventory - Distribution and administration of controlled - Reference materials readily available - Policies and procedures are being followed Outpatient Clinic Pharmacies (480-33) =========================================================== - ###### Inspections by GDNA - Occurs at least once every two years - Covers all aspects of management and operation of outpatient clinic pharmacy to verify compliance Practitioner Dispensing of Drugs (480-28) ========================================= - ###### Definition - Physician, dentist, podiatrist, or veterinarian dispensing - ###### General Requirements - Must comply with the same record-keeping, labeling, packaging, and storage requirements as pharmacies - ###### Notice of Intent to Dispense - Practitioner must file notice of intent to dispense with Practitioner Dispensing of Drugs (480-28) =============================================================== - ###### Prescription Records - Prescription drug order required for each drug - Patient name and address; drug name, strength, and quantity; directions for use; date of issuance; prescribers signature; DEA, if applicable - **MUST** document on prescription drug order dispensing - No transfers to another prescriber or pharmacist - Must keep dispensing records for two (2) years Practitioner Dispensing of Drugs (480-28) ========================================= - ###### Invoice Requirements - Schedule II invoices kept separately from Schedule III, - Schedule III, IV, or V invoices must be stamped with red - Must maintain biennial controlled substance inventory - Prescription drug orders filed using two- or three-file Practitioner Dispensing of Drugs (480-28) =============================================================== - ###### Labeling Requirements - Date of dispensing - Serial number - Patient Name - Prescribing practitioner's name - Dispensing practitioner's name, address, telephone - Drug name and strength - Directions for use - Drug expiration date ### Dispensing of Drugs Under Authority of Job Description or Nurse Protocol (480-30) - ###### Definitions - Dispensing procedure - Written document signed by a RPh and practitioner that establishes the appropriate manner under which drugs may be dispensed under authority of a nurse protocol or job description - Job description - Document signed by a licensed practitioner that describes the - Nurse protocol - Document that is mutually agreed upon and signed by a nurse and licensed physician where the physician delegates to the nurse the authority to perform certain medical acts ### Dispensing of Drugs Under Authority of Job Description or Nurse Protocol (480-30) - ###### Submission of Dispensing Procedure for Board Review - Any RPh who signs a dispensing procedure must submit - ###### General Requirements - Anyone dispensing drugs must comply the same record keeping, labeling, packaging, and storage requirements imposed as pharmacies ### Dispensing of Drugs Under Authority of Job Description or Nurse Protocol (480-30) - ###### Labeling Requirements - Date filled - Serial number - Patient name - Prescribing practitioner's name - Name and address of facility where drugs were - Drug name and strength - Directions for use - Expiration date