Lecture 20 - Indiana Administrative Code 1 Flashcards
What is the Indiana Administrative Code?
A list of rules written and reviewed by the Indiana Board of Pharmacy, which have the force of law in the state of Indiana
What does it mean when a pharmacist is present in a pharmacy?
-Physically present in the area specified as the dimensions of the pharmacy in the relevant pharmacy permit application
-A pharmacist must be physically in a pharmacy as outlined by the pharmacy permit, but that this requirement does not impact the larger practice of pharmacy
How does a pharmacist supervisor meet the requirement of being within reasonable visual and vocal distance?
Being physically present within the licensed permitted area or by a means that provides for adequate supervision of technicians as individually approved by the board
What is supervision as defined by Indiana Administrative Code?
-Oversight and management by a managing pharmacist, pharmacist in charge, or qualifying pharmacist of another individual’s work or work product
-Individuals practicing pharmacy must be directly supervised either through a direct line of sight and hearing, or via technological means that allow a supervisor to adequately ensure quality of care and patient services
-This is focused on management in the pharmacy, pharmacists in non-management roles are only responsible for what happens under them when they are on duty
What is pharmaceutical care?
Includes, but is not limited to, dispensing legend drug product and delivery of cognitive services
What would be a cognitive service?
Any service outside of dispensing
What is a real-time online database?
A database that is continuously updated in real time and allows users to share and store patient information and interface with each other in a secure environment over the internet or an intranet
What is an unlicensed person?
-Someone who is not HIPAA trained
-Someone who does not hold a valid license, certification, permit, or registration issued by the board
What are unlicensed people prohibited from doing?
They cannot perform any pharmacy dispensing functions related to legend drugs in the pharmacy
What happens when a pharmacist’s license is displayed by a company and they no longer work there?
That license may be revoked
What must someone complete to be a licensed pharmacist in Indiana?
-Complete a college or school of pharmacy curriculum, including a minimum of 1500 hours of practical experience
-Submit an application as required by the Board (this is required for your authorization to test for the NAPLEX and MPJE)
-Take and pass the NAPLEX and MPJE in English
What happens when an applicant fails one of the exams?
-They must complete a new application
-If they fail after two attempts, they must appear before the board for consultation and to receive written permission from the board to retake it
-Maximum of 5 attempts
What happens if someone cheats or frauds the exam?
Board can refuse licensure or revoke license if is already issued
What must a pharmacist do if they want to apply for a pharmacist license in Indiana, but they are already a pharmacist in another state?
-Complete an application for license transfer on nabp.pharmacy
-Pass the Indiana law exam (MPJE)
-If not actively participating in the 12 months prior to the application, then they have to take the NAPLEX again
What happens when the board determines that the pharmacy has not met the requirements of the law?
They must correct the issue so that it does meet the requirements within 30 days of notification
What must a pharmacy do if they want to operate somewhere that will be open beyond when the pharmacy is open?
-They must file an application with the board and abide by the closing hours outlined in the application
-This is specific to category 1 and three permits
When may a prescription department be locked while the remainder of the pharmacy remains open to the public?
-There are reasonable barriers in place that prevent easy and/or quick access to legend drugs
-The prescription department, if not completely enclosed from floor to ceiling and locked, is secured and monitored by an electronic monitoring device
-Any violation or breach of the secured area is recorded and reported to the board within 72 hours
-If monitored electronically, backup power must be provided and capable of continuing for no less than 36 hours
-The electronic monitoring system be activated or inactivated only by key or combination
What must a pharmacist do when they have a pharmacy open without a pharmacist on duty?
-Maintain a record stating any hours that the pharmacy was open for business without a pharmacist on duty if those hours vary from the hours listed on the application
-This record must be maintained in the pharmacy and available to the board for examination for not less than 2 years from the date of the last entry in the record
What laws must pharmacists follow?
-Cannot sell controlled substances in bad faith or in unusually large amounts within an unusually short period of time to the same individual
-Cannot sell counterfeit products
-Cannot aid or abet the practice of pharmacy by a person not licensed
-Cannot practice in a manner as to amount to incompetency or negligence
When returning and reselling a product, what does it mean when a medication is “properly stored and securely maintained”?
Medication must have been under the control of licensed nursing personnel the entire time
What is required on a prescription label?
-Name, address, and telephone number of the establishment from which the drug was sold
-The date the prescription was filled
-The prescription number (serial number)
-The name of the prescriber
-The name of the patient, and if an animal, the species of the animal and the owner’s name
-Directions for use as contained in the prescription
-The name of the drug (trade or generic or both)
What is a pharmacy technician prohibited from doing?
-Any duty required by law to be performed by the pharmacist
-Provision of advice to a prescriber or other health care provider
-Provision of advice to a patient regarding interpretation of a prescription or information contained within the patient profile
-Dispensing prescription drug information to the patient
-Receipt of a verbal prescription from a prescriber
-Final check on all aspects of a completed prescription
What must a pharmacy technician do?
-Wear identification clearly stating that the person is a pharmacy technician while on duty
-Identify themselves verbally in any telephonic or electronic communication as a pharmacy technician
How much CE must a pharmacist complete to maintain their license?
-30 hours of CE each biennium
-CE biennia run from January 1st of even-numbered years through December 31st of the following odd-numbered year
-The pharmacist may use hours completed from a succeeding biennium and apply them to the previous biennium