Remote Pharmacy Practices Quiz

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Questions and Answers

What is excluded from the responsibilities of a secondary remote entry pharmacist?

Prescription data entry verification

Patient counseling (correct)

Supervising pharmacy activities

Drug regimen review

Which of the following must be recorded in the remote prescription processing documentation?

Patient's medication history

Names of each pharmacist and pharmacy technician involved (correct)

Prescription dispensing time

Cost of each prescription

How long must records of remote prescription processing be kept?

3 years

2 years (correct)

Indefinitely

1 year

Who is responsible for patient counseling in a pharmacy setting?

Primary dispensing pharmacist Signup and view all the answers

What must be communicated to patients regarding their prescriptions processed remotely?

Their prescriptions may be processed by an offsite pharmacist/pharmacy Signup and view all the answers

Which information is required to be included in the transmission receipt records coming into the Central Fill pharmacy?

Name and address of the Originating Pharmacy Signup and view all the answers

What must the label affixed to the container by the Central Fill pharmacy contain?

The unique identifier of the Central Fill Pharmacy Signup and view all the answers

In regards to patient notification before sending prescriptions to Central Fill, what right do patients have?

To opt out of central fill services Signup and view all the answers

What is the primary responsibility of the Originating Pharmacy regarding the Prescription Drug Monitoring Program (PDMP)?

To ensure compliance with PDMP regulations Signup and view all the answers

Which is NOT a requirement for a Primary Dispensing Pharmacy in Georgia?

It must offer 24/7 service Signup and view all the answers

Who is responsible for providing patient counseling at the time of dispensing?

The pharmacist on duty at the Originating Pharmacy Signup and view all the answers

What information must be recorded by the pharmacist during remote prescription drug order processing?

Patient's medication history and drug allergies Signup and view all the answers

Which information does the Originating Pharmacy need to verify upon receiving controlled substances from the Central Fill Pharmacy?

Receipt of the controlled substances by a pharmacist Signup and view all the answers

What additional information must be included in the records that the Central Fill must keep?

The method of delivery and date of receipt Signup and view all the answers

What is indicated as a requirement for the Central Fill Pharmacy regarding its operation with the Originating Pharmacy?

To utilize common electronic files or secure access technology Signup and view all the answers

What is a requirement for a central fill pharmacy to fill prescriptions on behalf of an originating pharmacy?

They must be part of a common ownership structure. Signup and view all the answers

Which of the following must be included in transmission records going to a central fill pharmacy?

CENTRAL FILL noted on the face of the prescription. Signup and view all the answers

Which of the following is NOT a responsibility of pharmacies that participate in central fill services?

Conducting health screenings for patients. Signup and view all the answers

What type of pharmacy is responsible for originating the prescription before it is sent to a central fill pharmacy?

Retail pharmacy. Signup and view all the answers

In which format can prescriptions be transmitted to a central fill pharmacy?

Electronically, including via fax. Signup and view all the answers

What is one of the requirements for retail pharmacies utilizing central fill services regarding their procedures?

Policies and procedures must be available upon request. Signup and view all the answers

What key information is a central fill pharmacy NOT required to maintain according to the policies concerning central filling?

Patient's complete medical history. Signup and view all the answers

Which aspect of the central fill process involves ensuring the integrity and confidentiality of patient information?

Policies and procedures on file. Signup and view all the answers

What is the minimum height for signage indicating home health care services?

3 inches Signup and view all the answers

Which piece of equipment is essential for preparing compounded sterile parenteral products?

Laminar airflow hood Signup and view all the answers

Who is ultimately responsible for overseeing a retail pharmacy providing home health care services?

Pharmacist-in-charge Signup and view all the answers

What is a requirement for prescription drug orders in home health care services?

Verbal orders must be documented Signup and view all the answers

What is required for patient monitoring in home health care?

Standardized assessments and records Signup and view all the answers

In outpatient clinic pharmacies, what oversight occurs at least once a month?

Inspections by the pharmacist-in-charge Signup and view all the answers

What is a requirement for accountability of controlled drugs in outpatient clinics?

Proof of use forms must be completed Signup and view all the answers

What must labeling requirements for practitioner dispensing include?

Prescriber’s name and directions for use Signup and view all the answers

What document is essential for defining a dispensing procedure under a nurse protocol?

Written document signed by a RPh and practitioner Signup and view all the answers

What is necessary when medications are brought in by patients from outside sources?

They must be accompanied by a practitioner’s prescription drug order Signup and view all the answers

Which aspect is NOT part of the ongoing quality control programs?

Sales tracking Signup and view all the answers

What should a practice do if a girl insists on a medication dispensed without proper identification?

Encourage the patient to return with proper identification Signup and view all the answers

What is the primary role of secretarial personnel in retail pharmacies providing home health care services?

Providing support with administrative tasks Signup and view all the answers

Study Notes

Central Filling Regulations

Central Filling - a process where a prescription is filled by a pharmacy that is not the originating pharmacy.
Originating Pharmacy - the pharmacy where the prescription is initially written.
Central Fill Pharmacy - the pharmacy that fills the prescription.
Dispensing Pharmacy - the pharmacy that dispenses the filled prescription to the patient.
Licensing and Contracting - Both central fill and originating pharmacies must have a retail license, DEA registration, and be "authorized" to fill prescriptions
- This authorization can be through a contractual relationship between the two pharmacies or through common ownership.

Central Filling Processes

Policies and procedures - All retail pharmacies that use central fill services must have policies and procedures on file.
- These policies and procedures must outline the activities in the filling process, responsibilities of each pharmacy, contact information for the pharmacies, protection of PHI, and proper record keeping.
Transmission - The originating pharmacy must have minimum required patient information for the prescription before sending it to the central fill pharmacy.
- All prescriptions transmitted to central fill must include:
  - Indication that it is a central fill
  - The name, address, phone, GA Pharmacy license number, DEA number of the central fill pharmacy
  - Number of refills already dispensed and remaining
  - Name of the originating pharmacy pharmacist transmitting the prescription
  - Date of transmittal.
Central Fill Receipt - All receipts at the central fill pharmacy must include the information listed above, plus the name, address, phone number, GA Pharmacy license number, and DEA registration of the originating pharmacy.
Labeling - The label affixed to the container by the central fill pharmacy must include:
- Date of fill or refill
- Originating Pharmacy’s name, address, and phone number
- Central Fill Pharmacy’s unique identifier
- RX number
- Patient name
- Prescriber's name
- Expiration date of drug dispensed
- Directions for use, along with any other cautionary statements required.

Central Filling Information Systems and Record Keeping

Originating and central fill pharmacies must share common electronic files or have technology to allow secure access.
The originating pharmacy is responsible for PDMP compliance
Originating Pharmacy MUST have RPh, intern, extern, or PhT sign for receipt of all prescriptions from the central fill pharmacy.
- This must include the date of receipt, method of delivery, and the name of the pharmacy employee accepting the delivery.
RPh on duty must verify receipt of all controlled substances.

Central Filling Patient Counseling and Notification

Responsibility for patient counseling falls upon the originating pharmacy pharmacist on duty at time of dispensing.
Central Fill Pharmacy CANNOT provide patient counselling.
Originating Pharmacy must notify patients BEFORE sending a prescription to the central fill pharmacy.
- This can be done through signage that is clearly visible and readable by the public.
- Patients have the right to opt out of central fill services.

Remote Prescription Drug Order Processing

Remote prescription drug order processing is a process where a prescription is filled by a pharmacy that is not physically located at the same site as the patient.
Primary Dispensing Pharmacy - The pharmacy where the prescription is initially written and where the patient picks up the prescription.
Secondary Remote Entry Pharmacist - The pharmacist that enters the prescription information into the primary dispensing pharmacy’s system.
Requirements for Primary Dispensing Pharmacy:
- Licensed as a retail pharmacy in GA
- Physically located in GA
- Must have the same owner or a written contract outlining the responsibilities of each party.

Remote Prescription Drug Order Processing Personnel and Supervision

Primary Dispensing Pharmacist - Must be physically present during business hours and is responsible for patient information, medication history, drug allergies, etc.
Secondary Remote Entry Pharmacist - Is responsible for supervising all pharmacy activities and the accuracy of prescriptions involved in remote processing, excluding compounding, preparation, dispensing, and counseling.
- The secondary entry pharmacist is responsible for RX data entry verification and drug regiment review.

Remote Prescription Drug Order Processing Record Keeping

Primary and secondary pharmacies must have common electronic files or technology that allows for sufficient data transfer for non-dispensing tasks.
All records must identify each RPh, PhT, intern, and extern involved in each task and the RPh verification.
Rxs processed by the secondary RPh must be separately identified and retrievable at the request of GDNA.
Records must be kept for 2 years.

Remote Prescription Drug Order Processing Patient Counseling and Notification

Patient counseling is the responsibility of the primary dispensing pharmacist.
Secondary remote entry pharmacy CANNOT provide patient counseling.
Patients must be notified that their Rxs may be processed by an off site pharmacist or pharmacy.
- This must be done through a clear sign that is at least 3 inches tall and states “Remote Order Processing Utilized Here”.

Retail Pharmacies Providing Home Health Care Services

Retail Pharmacy providing Home Health Care Services - A retail pharmacy that provides home health services, such as compounding sterile parenteral products.
Outpatient - A patient who is not admitted to a hospital or other healthcare facility.
Compounded, Sterile Parenteral Products - Medications that are prepared by a pharmacist for a specific patient, and are sterile and meant to be injected.

Retail Pharmacies Providing Home Health Care Services Personnel

Pharmacist-in-charge
Supportive Personnel
Secretarial Personnel

Retail Pharmacies Providing Home Health Care Services Physical Requirements

Space - Enough space for compounding and storage.
Equipment - Must include equipment for light/dark field examination, a laminar airflow hood or class 100 clean room, a sink with hot and cold running water, disposal containers, a refrigerator/freezer with thermometer, disposable needles and syringes, disinfectant cleaning solutions and handwashing agents, lint-free paper towels, filtration equipment, disposable masks, and sterile gloves.
Supplies - Must include all supplies listed under equipment.
References - Must include the Handbook on Injectable Drugs or Kings’ Guide to Parenteral Admixtures.

Retail Pharmacies Providing Home Health Care Services Prescription Drug Orders

Written or verbal prescription drug orders can be accepted.
Prescriptions must be filed in a system that allows them to be easily retrieved.
When the course of therapy is not indicated, new orders must be obtained.
Orders must meet minimum requirements as outlined by the state.

Retail Pharmacies Providing Home Health Care Services Patient Profiles, Labeling, and Delivery Services

A patient profile must be established for each patient that receives home health care services.
Labels must contain the necessary information for each prescription.
Delivery service must be provided for all prescriptions.

Retail Pharmacies Providing Home Health Care Services Required Records

Patient profiles
Prescription records
Pharmacy inventories
Biennial controlled substance inventory
Policy and procedure manuals
Training manuals

Retail Pharmacies Providing Home Health Care Services Patient Care Guidelines

Patients must have a primary care provider.
Patient counseling must be provided for all medications dispensed.
Pharmacists must establish and maintain a relationship with each patient receiving home health care services.
A system for patient monitoring must be in place.

Retail Pharmacies Providing Home Health Care Services Quality Control

There must be documented, ongoing quality control programs that monitor personnel performance, equipment, and facilities.
Hood certification must be updated regularly.
Programs must include end product sampling, bulk compounding protocols, and proper expiration date tracking.

Outpatient Clinic Pharmacies

Outpatient Clinic - A healthcare facility that provides medical care to patients who are not hospitalized.
Outpatient Clinic Pharmacy - A pharmacy that is located in or serves an outpatient clinic.
Outpatient - A patient who is not admitted to a hospital or other healthcare facility.
Standard ward inventory - A list of medications that is typically kept on hand in a hospital or healthcare facility.
Outpatient Prescription - A prescription that is filled for a patient who is not hospitalized.

Outpatient Clinic Pharmacies Licensure

An outpatient clinic pharmacy must have a pharmacy license.
An outpatient clinic pharmacy is not authorized to dispense refills on prescription drug orders.
An outpatient clinic is permitted to apply for a retail pharmacy license.

Outpatient Clinic Pharmacies Personnel

Pharmacist-in-charge
Secretarial and clerical personnel

Outpatient Clinic Pharmacies Absence of a Pharmacist

A system for after hours cabinets must be in place if the pharmacy is not staffed.
A policy for access to the pharmacy after hours should be established.
An emergency kit must be readily available for situations requiring immediate access to medications.

Outpatient Clinic Pharmacies Physical Requirements

Space - Enough space for compounding and storage.
Reference materials - Must include up-to-date materials related to patient care and pharmacy practice.
Poison Control - There must be a plan for accessing poison control in an emergency.
Equipment - It must include the necessary equipment for compounding, dispensing, and storage of medications.
CII Storage - Appropriate storage for Schedule II drugs is a must.
Unattended areas - All unattended areas must be secured to prevent unauthorized access.

Outpatient Clinic Pharmacies Drug Distribution

Drug identification from prescription to administration is a must.
All prescriptions must be received and documented.
Transaction records must include all necessary information for each prescription.
Labeling must be correct and complete.
Perpetual Inventory - A system of inventory tracking must be in place to ensure that medications do not expire before use.

Outpatient Clinic Pharmacies Accountability for Controlled Drugs

A Proof of Use form must be used for all controlled drugs dispensed.
- This form must include the drug name, strength, dosage form, dose, name of prescribing practitioner, given and last name of the patient, date and time of administration, signature of the administering individual, and documentation of destruction of all unused portions.
- There must be documentation of receipt of the medication and the date the medication was issued.
All proof of use forms must be returned to the pharmacy upon administration.

Outpatient Clinic Pharmacies Required records

Patient profiles/patient charts
Proof of use forms for controlled substances
Reports of suspected/known ADRs
Inventories of night cabinets, E-Kits, and standard ward inventory
Pharmacy inventory
Biennial controlled substance inventory
Alcohol and flammables reports

Outpatient Clinic Pharmacies Medications from Outside Sources Brought in By Patients

Patients are not allowed to bring medications from outside sources to administer unless the medication can be precisely identified.
Medications from outside sources can only be administered pursuant to a practitioner's prescription drug order.
Medications brought in from outside sources that are not administered must be returned to an adult member of the patient's immediate family or stored by the pharmacy and returned to the patient upon departure.

Outpatient Clinic Pharmacies Inspections by the PIC

Inspections by the PIC must occur at least once a month.
The PIC must verify:
- Drugs are only dispensed by a licensed RPh
- All personnel are properly supervised
- Proper storage of drug inventory
- The distribution and administration of controlled substances is adequately documented.
- All reference materials are readily available.
- All policies and procedures are being followed.

Outpatient Clinic Pharmacies Inspections by GDNA

Inspections by GDNA occur at least once every two years.
Inspections must cover all aspects of the management and operation of the outpatient clinic pharmacy to ensure compliance.

Practitioner Dispensing of Drugs

A practitioner, such as a physician, dentist, podiatrist, or veterinarian, who dispenses medications to their patients must comply with certain regulations.
General Requirements - Practitioners must comply with the same record-keeping, labeling, packaging, and storage requirements as pharmacies.

Practitioner Dispensing of Drugs - Notice of Intent to Dispense

Practitioner must file a notice of intent to dispense with the respective licensing board.

Practitioner Dispensing of Drugs - Prescription Records

A prescription order is required for each drug dispensed.
- This must include the patient's name and address; drug name, strength, and quantity; direction for use; date of issuance; prescribers signature; DEA, if applicable.
Prescription drug orders must include the dispensing prescriber's signature and the date filled or refilled.
Practitioners dispensing drugs cannot transfer prescriptions to other prescribers or pharmacists.
Practitioners must keep dispensing records for 2 years.

Practitioner Dispensing of Drugs - Invoice Requirements

Schedule II invoices must be kept separately from Schedule III, IV, and V invoices.
Schedule III, IV, and V invoices must be stamped with red “C” stamp.
A biennial controlled substance inventory must be maintained.
Prescription drug orders must be filed using a 2 or 3-file system.

Practitioner Dispensing of Drugs - Labeling Requirements

Labels must include the date of dispensing; serial number; patient name; prescribing practitioner’s name; dispensing practitioner’s name, address, and telephone; drug name and strength; directions for use; and drug expiration date.

Dispensing of Drugs Under Authority of Job Description or Nurse Protocol

Dispensing procedure - A written document that outlines the manner in which drugs can be dispensed by a nurse under the authority of a nurse protocol or a job description.
Job Description - A written document signed by a licensed practitioner that outlines the duties of a physician's assistant.
Nurse Protocol - A written document that is mutually agreed upon by a nurse and licensed physician that delegates the authority to perform certain medical acts to the nurse.

Dispensing of Drugs Under Authority of Job Description or Nurse Protocol - Submission for Board Review

Any registered pharmacist that signs a dispensing procedure must submit it to the Board for review.
General Requirements - Everyone dispensing drugs must comply with the same record keeping, labeling, packaging, and storage requirements as pharmacies.

Dispensing of Drugs Under Authority of Job Description or Nurse Protocol - Labeling Requirements

Labels must include the date filled; serial number; patient name; prescribing practitioner’s name; the name and address of the facility where the drugs were dispensed; the drug name and strength; directions for use; and the expiration date.

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Description

Test your knowledge on the responsibilities and regulations of a secondary remote entry pharmacist. This quiz covers essential aspects such as documentation requirements, patient counseling, and communication related to remote prescription processing.