Lecture 20 Flashcards
(21 cards)
Reasonable visual and vocal distance
“by a pharmacist 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.”
Supervision
“…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…”
Focused on management in the pharmacy; pharmacists in non-management roles are only responsible for what happens under them when they are on duty
Pharmaceutical Care & Cognitive Services
Pharmaceutical care:. The term includes, but is not limited to, dispensing legend drug product and delivery of cognitive services.
Cognitive services: Examples include MTM, patient counseling, drug interaction review, collaborative practice, Medication error reduction
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.”
Unlicensed Person
Someone who is not HIPAA trained and does not hold a valid license, certification, permit, or registration issued by the board
Unlicensed persons cannot perform any pharmacy dispensing functions related to legend drugs in the pharmacy
Pharmacists’ Certificate
Licensure must be “conspicuously displayed
If a pharmacist’s licensure is displayed by a company, and the pharmacist no longer works there, that license may be revoked.
Examination and Experience Requirements
Complete a college or school of pharmacy curriculum, including a minimum of 1,500 hours of practical experience
Submit an application as required by the Board (this is required for your authorization to test (ATT) for the NAPLEXTM and MPJETM)
Take and pass the NAPLEX and MPJE in English
Licensure Reexamination and Fraud
Must complete a new application if you fail the NAPLEX or MPJE
if you fail the exam after 2 tries you must appear before the board for consultation and to receive written permission from the board to sit for the exam again.
Maximum of 5 attempts for naplex and MPJE
Any misrepresentation made in the application, or fraud perpetrated in the examination is sufficient for refusal of licensure or revocation if licensure is already issued.
Reciprocity
This section deals with being licensed in Indiana after being licensed in another state. Pharmacists meeting this criteria must complete the following:
1.Complete an application for license transfer on the nabp.pharmacy
2.Pass the Indiana law examination (MPJETM)
3.If not actively practicing in the 12 months prior to the application, a practical examination (NAPLEXTM)
Drugstores, Pharmacies, Apothecary Shops
IC 25-26-13-18 discussed some requirements for each pharmacy, and 856 IAC 1-6.1 expands on that, requiring the qualifying pharmacist to decide what additional fixtures, facilities, and equipment is needed by the pharmacy to operate in compliance of the law.
If the board determines that pharmacy has not met the requirements of IC 25-26-13-18, it will notify the qualifying pharmacist, and the issue must be corrected within 30 days of notification
Pharmacy Department Closed
Specific to Category I and Category IIIpermits
Pharmacy must file an application withthe board and abide by the closing hours outlined in the application
A pharmacy’s prescription department can stay secured while the rest remains open if:
Barriers prevent easy access to legend drugs
It’s locked or electronically monitored
Breaches are reported to the board within 72 hours
Backup power for monitoring lasts at least 36 hours
Only a key or combination can activate/deactivate the system
Record of hours open without a pharmacist on duty
The pharmacist shall 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.
must be made in ink
Must keep record in pharmacy and available to the board for examination for no less than 2 years for the date of the last entry in the record
Violations and Penalties
IC 35-48-1-1 through IC 35-48-4-14, 21 USC § 801 through 21 USC § 1191, 21 USC § 301 through 21 USC § 392, or IC 25-26-13-1 through IC 25-26-13-29 (and in effect, all of IC 16-42)
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
Resale of Returned Substances
856 IAC 1-21-1 reviews IC 25-26-13-25(k) and adds more stipulations:
For a medication to have been properly stored and securely maintained, the medication must have been under the control of licensed nursing personnel the entire time.
If dispensed in a unit dose pack, it must meet U.S.P standards to be redispensed
Any repackaged medication shall be labeled with an expiration date of one year, or the manufacturer’s expiration date, whichever is earlier.
Prescription Labeling (856 IAC 1-23)
1.Name, address, and telephone number of the establishment from which the drug was sold
2.The date the prescription was filled
3.The prescription number (serial number)
4.The name of the prescriber
5.The name of the patient, and if an animal, the species of the animal and the owner’s name
6.Directions for use as contained in the prescription
7.The name of the drug (trade or generic or both) in compliance with IC 16-42-22
Pharmacy Technician Prohibited Tasks
A pharmacy technician is prohibited from performing:
1.Any duty required by law to be performed by the pharmacist
2.Provision of advice to a prescriber or other health care provider
3.Provision of advice to a patient regarding interpretation of a prescription or information contained within the patient profile
4.Dispensing prescription drug information to the patient
5.Receipt of a verbal prescription from a prescriber
6.Final check on all aspects of a completed prescription
Pharmacy Technician Identification
The public must be able to identify a pharmacist from a pharmacy technician while engaged in the provision of care. As such, the pharmacy technician shall:
1.Wear identification clearly stating that the person is a pharmacy technician while on duty
2.Identify themselves verbally in any telephonic or electronic communication as a pharmacy technician.
Continuing Professional Education (CE or CPE)
All pharmacists who are renewing a license must complete 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.
If a pharmacist fails to complete 30 hours during a CE biennium, they may use hours completed during a succeeding biennium and apply them to the previous biennium. If this action occurs, the hours used for the previous biennium cannot count for any other biennium.
CE and Licensure
CE Biennium: January 1, 2024 – December 31, 2025
Licensure Biennium: July 1, 2024 – June 30th, 2026
The two biennium are offset by 6 months, which allows for a CE catch-up window from January 1, 2026 – June 30th, 2026, to make up any CE deficit
CE stipulations
Of the 30 total hours of CE required:
No more than ¹⁄₅ of the total hours may be business, management, or computer courses
At least ⁴⁄₅ of the total hours must be pharmacy practice related
At least ½ of the total hours must be ACPE approved
If initial licensure occurs within a biennium, you should accrue 1.25 hours CE for each month you are licensed from the date of licensure to the end of the biennium*
*If licensed in the last 6 months of the biennium, no CE required for the biennium
