Kentucky Law Review

The Legislative ruling bodies of Pharmacy in Kentucky, as opposed to the Administrative Agencies.

(Hint: there’s 2)

US Congress & Kentucky Legislature

The Administrative Agencies of Pharmacy Law in Kentucky

(Some may be more significant, Bonus points if you know which)

the FDA, DEA, CMS, CDC

the KY BoP, Cabinet for Health & Family Services, OIG

The Administrative Agency the determines Drug Control in Kentucky

OIG (Office of Inspector General)

The number of members who sit on the Kentucky Board of Pharmacy

(Bonus points if you know who appoints them & how many are required to be Pharmacists)

The Board consists of SIX members, who are appointed by the Governor (thank you daddy Beshear).

Five members shall be pharmacists, while one is a citizen at large.

Term duration for members of the Kentucky BoP

(Coincidently, it is equal to the number of times the BoP is required to meet per year)

Board members serve FOUR YEAR terms, and may be reappointed once.

The BoP is required to meet at least FOUR times per year.

The utmost purpose of the Kentucky Board of Pharmacy

To Protect the PUBLIC by Regulating the PROFESSION

Duties of the BoP

(What the Board is authorized to do, there’s a lot, like seven things)

• Set time & place for examinations, at least two per year

• Approve approved colleges of pharmacy (not necessarily accredited)

• Promulgate administrative regulations pertaining to pharmacists, interns, techs, pharmacies, wholesalers & manufacturers

• Schedule & conduct hearings

• Issues & renew licenses

• Investigate complaints

• Employ an executive director (whom shall be a pharmacist)

Tell me about Complaints made to the Board

(Who can place them? What does the Board do about them? Who can action be taken against?)

Complaints can be in about any form and come form any source

(Oral, Electronic, Written, from Layman, Customer, RPh, Law Enforcement)

Upon receipt of a complaint, the Board SHALL instruct its staff to conduct an investigation.

Action may be taken against: a pharmacy, a PIC, a pharmacist, a technician, and depending on the issue an intern.

What forms of disciplinary action can the Board issue?

(Hint: I’m thinking of Six)

• Suspension of license (temporary)

• Revocation of license (Permanent/Lifetime)

• Probation

• Restrictions on license

• Fines

• Additional CE requirements

So you broke the rules and now have a violation on your record (frowny face), how long until you may request the Board for expungement?

Are there exceptions to expungement?

Expungement may be requested after THREE YEARS,

however, expungement cannot be granted for violations involving Controlled Substances (Abuse, Diversion, or Theft).

What is PRN, what is it for, and what is the benefit of PRN?

The Pharmacists Recovery Network

PRN assists Pharmacists, Technicians, and Interns impaired by drugs, alcohol, mental illness, or physical incapacity.

• You must voluntarily withdraw or limit practice as directed by PRN consultant (who shall be a licensed pharmacist), and comply with all requirements of Rehab/Detox program

• May self-report and remain unknown to the Board, wherein disciplinary action cannot be taken solely for impairment (so long as no errors were made/reported)

When does the Pharmacists license expire in Kentucky

The Pharmacist License expires ANNUALLY on February 28th of each year

(some bonus not worthy of its own flashcard: the pharmacist’s license must be displayed conspicuously at the primary practice site, and the pocket license must always be in the possession of the licensee when practicing)

Pharmacists may dispense medications in Kentucky, but are they permitted to Administer medications?

Yes, don’t be silly

Talk to me about CE requirements

How many Hours are required? and In what time frame?

Are there dates associated with this time frame?

How long must records of CE be kept?

Are there requirements for what the CE should review?

(Bonus if you know the hour:CEU ratio)

15 Hours of CE are required each YEAR

The time period for which is March 1st to February 28th

Records of CE must be kept for 3 YEARS

For the years 2023 to 2028, one hour of CE must review the opioid epidemic

(1 hour = 0.1 CEU, so 1.5 CEU [or 15 hours] are required each year)

What is the minimum period of Internship for Pharmacy Interns in Kentucky

(and How many of these hours may be obtained via work or research?)

The minimum period of internship is 1,500 hours, a maximum 400 of which may be obtained via work or research.

What duties can Pharmacy Interns complete?

All Pharmacist duties (counseling, immunization, opinion on medication, etc.) with the exception of Final Verification

What duties can Graduate Interns complete?

Graduate Interns, as with non-graduate interns, may complete all delegable pharmacist tasks, which excludes Final Verification.

How many Interns may one Preceptor supervise?

(and are there exceptions to this rule?)

A preceptor may supervise only one intern at a time, unless supervising additional interns as part of a community rotation/experience.

Responsibilities of the Pharmacist-in-Charge

(Hint: there’s Six)

• Quality assurance

• Procurement, storage, safety, security, and disposition of drugs & providing pharmacy services

• Ensuring proper licensure of subordinate Pharmacists/Interns/Techs

• Making and filing reports required by law

• Notifying the Board within 14 calendar days of changes in PIC, other pharmacists, or in pharmacy hours

• Responding to Board identified violations/deficiencies

For what amount of time must the PIC be physically present at the practice site?

The PIC must be physically present at least 10 hours per week

(with the said, a facility can go up to 14 days w/o a PIC on site)

Describe the Pharmacist’s Duty to Report & Duty to Self-Report

Duty to Report - things that you SEE, i.e., the conviction of a felony, pharmacist incompetence, fraud/deceit in obtaining a license, diversion or illegally distributed drugs, physical or mental disability (whether caused by drugs/alcohol/ or not), or violation of a Board order.

Duty to Self-Report - things that you DO, namely felony conviction (not merely limited to drugs tho) and must be within 30 days of that conviction.

What Law requires Pharmacists to perform DUR, maintain comprehensive patient medication records, and offer patient counseling?

OBRA 90 :)
(Some notes on this point: the offer to counsel may be made by any designee of the Pharmacy, i.e., by a delivery person for medication delivery, but must be completed by the pharmacist. Additional, in the hospital setting, counseling only needs to be provided for discharge medications)

Describe the retrievability of patient records within the pharmacy

Patient records shall be readily retrievable, meaning immediately in this context.

What information shall the patient record include (for DUR purposes?)

(Hint: Seven-ish items)

• Patient’s full name

• Address & Phone number

• Age or Date of birth

• Gender

• List of all Rxs obtained in the previous 12 months

• Known (chronic) disease states

• Drug allergies

Patient counseling shall include what information

(Hint: Six items)

• Drug name

• Dosage form

• Route of administration

• Proper storage

• “Common AND clinically significant” adverse effects

• Interaction or Contraindications

True or False:

Patient records and counseling are confidential, and considered protected health information.

FALSE; while patient records are confidential, counseling is not.

What form of documentation is required for counseling, and how long must these records be kept?

Documentation is required only for refusal of counseling, records of which must be kept for ONE (1) YEAR.

What disease states must be reported to the local health department?

(Hint: One big one*, six not so big ones)

• Tuberculosis*

• Measles

• Cholera

• E. coli

• Rabies

• Rubella

• Diphtheria

What vaccinations can be administered by Pharmacists/Interns/Techs, and to whom may they be administered to?

All CDC recommended vaccinations, to individuals at least 5 years of age

(Note that those administering vaccinations must be BLS/CPR certified)

What is the minimum age requirement for Pharmacy Technicians?

16 years of age

Describe the supervision requirements for Certified and Non-certified Technicians

Certified technicians require only general supervision (a pharmacist is on the premises)

Non-certified (registered) technicians require immediate supervision (direct visual and physical supervision)

Describe the duties (& limitations there of) of Certified and Non-certified Technicians

All Tech Duties must be non-judgmental

(i.e., counting/pouring medication, data entry, stocking medication, compounding, offer counsel, certify med carts filled by another technician, receive diagnostic orders in a nuclear pharmacy)

Certified Technicians may also complete delegable pharmacist tasks, excluding those that require judgement (i.e., counseling, DUR, Rx interpretation, Final verification, Receiving new Rxs)

• so this may include filling automated dispensing cabinets without barcode technology (because non-certified can with barcodes).

Technicians CANNOT Transfer Prescriptions*

What is the RPh to Technician Ratio in Kentucky?

There isn’t one :) the law also does not indicate the number of techs a pharmacist may supervise at one time

When does the Technician registration expire in Kentucky?

Technician registration expires ANNUALLY on March 31st of each year

What is required to be included within a Board Authorized Protocol

(Hint: 5 items)

• Criteria for identifying eligible patients

• List of medications approved for pharmacist prescribing/dispensing

• Care plan for monitoring patients

• Patient education

• Duration of protocol

A patient is identified as eligible for your pharmacies tobacco cessation protocol, for which you prescribe and dispense NRT in the form of nicotine patches.

In what time frame does this patient’s PCP need to be notified of this med change?

If a patient has a PCP, they must be notified of therapy changes within TWO (2) business days.

A permit/license is required to operate a pharmacy (obvi),

but when does the pharmacy permit expire?

The permit (/license) must be renewed ANNUALLY, with an expiration date of June 30th of each year.

Describe the retrievability of records for Out-of-State pharmacies

(think mail-order that does business in Kentucky)

Records shall be readily retrievable, meaning within 48 hours in this context.

Out-of-State pharmacies that do business in Kentucky are required to have a PIC who is licensed in which state?

(Hint: this is an easy one)

Out-of-State pharmacies that do business in Kentucky are required to have a PIC who is licensed in Kentucky :)

Pharmacies in Kentucky are required to have certain reference materials on site, which fall into a number of categories.

Please name each Required Category of Reference Material

(No hints for this one because it’s a little important)

Category I - Pharmacology

Category II - Drug Interactions

Category III - Drug Product Composition

Category IV - Laws and Regulations

* note that an internet source is not suitable for these resources, which must be accessible without an internet connection.

During what time frame (in relation to pharmacy hours of operation) can pharmacy telework be done, and by whom?

Pharmacy telework in Kentucky can only be done by an individual licensed or registered in Kentucky, and only during pharmacy hours of operation (as the individual must be reachable by the Pharmacist)

Describe Permanent Closure

(Duration of closure, Notice & Record requirements)

Permanent Closure is permanent, meaning cessation of business operations indefinitely.

A THIRTY (30) day notice must be put in place PRIOR to closure and left in place for THIRTY (30) days AFTER closure.

Additionally, a FIFTEEN (15) day written notice must be supplied to the Board, DEA, and CHFS.

Records (of closure? all pharmacy records?) must be maintained for TWO (2) years.

Describe Involuntary Closure

(Duration of closure & Notice requirements)

Involuntary - no desire for closure (can result from acute illness, death, natural disaster, etc.)

Written notice of closure must be supplied to the Board within FIVE (5) days of closure.

The premises may be maintained for up to SIXTY (60) days, however if no prescriptions are dispensed in this time, the Board may seize all medication stock.

Describe Voluntary Closure

(Causes [there is one highlighted in review] & Duration of closure)

Causes - any reason that is not Permanent or Voluntary, deviation from posted hours of operation for over FIVE (5) consecutive days is highlighted.

Failure to resume normal operations within SIXTY (60) days will result in permanent closure and medication stock confiscation by the Board (SHALL).

What is to be done with the Pharmacy Permit upon permanent closure?

Upon permanent closure, the Pharmacy Permit must be returned to the Board

There is one activity that is permitted during Temporary Pharmacy Closure, What is it?

Deposition of prescriptions into the Pharmacy

How long must Daily Printouts/Logs be retained?

The Daily Log must be retained for FIVE (5) years

What are the Labeling Requirements for Central Fill Packaging

The Name & Address of both the Central Fill facility and Primary Pharmacy are required

Describe Charitable Pharmacies

(Really just three things that make them unique)

• They may only dispense Legend drugs, but not Controlled Substances

• They may not charge any fees for services/prescriptions

• They may accept medications for distribution in unbroken original packaging

PIC of an Institutional Pharmacy

the “Director of Pharmacy”

How often should automated dispensing cabinets be checked?

At least monthly

What references related to what subjects are required to be available within the institutional pharmacy?

(Slightly different from Community Requirements)

• Drug Identification

• Toxicology

• Drug Interactions

• Parenteral Drug Compatibility

• Microbiology

How long must records of medications in Hospice or Home Health Agencies be maintained?

(Physical possession by home health agency, legal possession by pharmacy)

Records of medications must be maintained for FIVE (5) years

Drug inventory for storage in home health agencies is limited to what agents?

(Hint: 8 items)

• Sterile Water for irrigation or injection

• Sterile Saline for irrigation or injection

• Heparin flush

• Diphenhydramine injection

• Epinephrine injection

• Glucagon

• Flu vaccine

• Pneumococcal vaccine

How long must records of medications within an automated pharmacy system in a residential hospice facility be maintained?

Records must be maintained for FIVE (5) years

A DEA registrant pharmacy may not employ whom?

Any person who has been convicted of a felony related to controlled substances (unless the DEA issues a waiver)

Return of damaged, unsalable, or recalled medications may only be made to who?

(Hint: there’s three)

• The original manufacturer

• A third party returns processor

• A reverse distributor

What is required for the Sale of a Pharmacy?

(Hint: 5 items)

• The Seller’s Pharmacy Permit must be returned to the Boards

• The Buyer must obtain a new Pharmacy permit

• A complete CS inventory must be completed by the outgoing & incoming PICs

• A pre-opening inspection must be completed by the Board

• A list of all pharmacy staff must be provided to the Board

Describe the requirements for a Pharmacy Audit

(For the Auditor, 4 items highlighted)

• The Pharmacy to be audited must have a 30 days notice

• Documentation/record-keeping expectations cannot exceed Board requirements

• Audits may not go back more than TWO (2) years

• If an audit will require professional/clinical judgement, it must be completed by a licensed pharmacist

What form is to be completed in the event of theft of controlled substances, and to who is this form to be sent to?

Form 106 is for theft of CS, and should be provided to the Board, DEA, CHFS, and KASPER

How long must Prescription Records be maintained?

Prescription Records must be maintained for FIVE (5) years

How long must Controlled Substance inventory records be maintained, and can they be stored off-site?

Controlled Substance inventory records must be maintained for FIVE (5) years, with at least the last TWO (2) years of records stored on-site

In what instance may a pharmacist interchange a medication due to a formulary compliance rejection?

1) The “Preferred Product” must be within the same therapeutic class as the originally prescribed medication, and 2) the prescriber must be notified within 24 hours (in writing, but a Fax works)

What are the limitations placed on Emergency Refills?

Emergency refills may only be for a 72 hour supply and can only be provided once for a maintenance medication

(Note: no emergency refills for CS)

Describe “PRN/ad lib” prescription refills

The prescription can be filled for a maximum of ONE (1) YEAR

What is required to be recorded for OUTGOING prescription transfers?

(Hint: 4 items)

• Name of the Receiving RPh

• Date of the transfer

• Name & Address of the Receiving Pharmacy

• DEA number for CS Rxs

What is required to be recorded for INCOMING prescription transfers?

(Hint: 5-ish items)

• Original written date & last fill date

• Date of issue

• Number of remaining refills

• Original number of authorized refills

• Name of the Transferring RPh

(this is in addition to the information required for OUTGOING transfers)

How long must records of Prescription Transfers be maintained?

Transfer records must be maintained for FIVE (5) years

True or False:

Controlled Substance Prescriptions can be transferred by both Pharmacists and Pharmacy Interns

False; CS transfers must be completed by a Pharmacist, Interns may transfer non-controlled substance prescriptions only.

What is the purpose of a Prescriber Invoice, and what information should be included on this invoice?

(Hint: 6 items)

An invoice is used by prescribers to purchase medications/devices for office use (as Kentucky does not recognize “For Office Use” Prescriptions)

The Invoice should include:

• Name of both parties involved

• Drug names & quantities

• Date of drugs received

• Form 222 if CII included

• Signature of both parties

• Copy for each party involved (for records)

True or False:

A Pharmacist is permitted to change the dosage form of a prescribed medication

True & False; loaded question, a pharmacist may change the dosage form of a Controlled Substance prescription without provider approval, all other prescriptions require provider approval for dosage form interchange.

Describe Adulteration of a drug

A drug is adulterated if it is filthy, putrid, decomposed, contaminated, poisonous, wrong strength or mixed or packaged in a way that reduces its quality or strength.

(i.e., an antibiotic suspension that was reconstituted with too much/little water)

Describe Misbranding of a drug

A drug is misbranded if the package fails to have information required by law, if the labeling is not prominently displayed, if there is not “habit forming” label for certain CS, if there are inadequate instructions for use, if the drug is dangerous to health is used as directed by the label, if imitating or using the name of another drug.

(i.e., no pharmacy name on label, “take as directed” unless per package insert or in specific instances such as per coumadin clinic)

What should the Beyond Use Date be for unit dose packaging?

The BUD for unit dose packaging is either: Six months from packaging date, the manufacturers expiration date, or 25% of the time remaining between the date of packaging and the original expiration date, whichever is shortest.

What are the labeling requirements for unit dose packaging?

(Hint: 5-ish items)

• Name & Strength of medication

• Beyond use date

• Manufacturer name

• Lot number

• Number of units per container

(NDC is recommended, but not mandatory)

What law requires safety caps to be used on prescription medications, and what are the exceptions to this law?

The Poison Prevention Packaging Act requires safety caps to be used for all prescription bottles except:

• Nitroglycerin sublingual tablets

• If a patient provides a blanket request for non-safety caps

• If a provider requests a single prescription to have non-safety caps

In what instance can a pharmacy accept a dispensed legend drug for resale or reuse?

A dispensed legend drug can be accepted for reuse if:

• it is under 14 days since dispensing

• does not require refrigeration, and

• has an intact safety seal

Describe the distinctions between the different classes of medication recall

Class I - reasonable possibility of death or serious adverse effects, requires medications to be taken back from patients

Class II - risk is remote or effects are temporary or reversible

Class III - unlikely to cause adverse health consequences

What are the labeling requirements for Prescription Medication labels

(Hint: 10-ish items)

• Pharmacy name, address, and telephone number

• Patient name

• Drug name & strength

• Quantity

• Directions for use

• Date of fill

• Expiration date

• Pharmacist name or initials

• Prescriber name

• Refill information

What are the labeling requirements for Stock Medication bottles

• Brand name (if Branded product)

• Generic name

• strength

• Quantity

• Ingredients per tab/cap/tsp

• manufacture name & address

• expiration date

• Lot number

• package insert

• storage/temperature requirements

• C-II/IV if controlled

• Required warnings

• NDC number

How long does a patient have to pick-up a filled prescription for Accutane until the prescription is void?

SEVEN (7) days for women with potential to become pregnant

THIRTY (30) days for men or women who cannot become pregnant

What factors determine if a medication is considered “Hazardous”

(Hint: 5 items)

• Teratogenicity

• Carcinogenicity

• Reproductive toxicity

• Organ toxicity

• Genotoxicity

Who determines the need for REMS programs, and who is responsible for creating and implementing those programs?

The FDA determines the need for REMS programs, while the drug manufacturer is responsible for creating and implementing the program

Once removed from the Shortage List, how long may a 503B pharmacy sell a compounded shortage product?

A 503B pharmacy may sell a compounded product for SIXTY (60) days after it is removed from the shortage list before sales must cease.

What designation is required to be put on a Medicaid prescription in order for a Branded product to be dispensed without substitution?

“Brand Name Medically Necessary” must be put on the prescription blank in order to avoid generic substitution for Medicaid prescriptions. “DAW1”, “DNS”, or “Do Not Sub” are not sufficient.

What are the Orange & Purple Books?

Orange Book - Brand to generic equivalence; unless approved in the Orange book, all drugs are non-interchangeable

(“Approved Drug Products with Therapeutic Equivalence Evaluations”)

Purple Book - biologic to biosimilar equivalence

What are the criteria for designating a drug a Controlled Substance?

(Hint: 5 items)

• Actual or relative potential for abuse

• State of current scientific knowledge

• Risk to public health

• Immediate precursor to a Controlled Substance

• History and current pattern of abuse

Factors designating C-I

• High potential for abuse

• No accepted medical use

Factors designating C-II

• High potential for abuse

• Accepted medical use

• Abuse may lead to severe dependence

Factors designating C-III

• Potential for abuse less than C-I or C-II

• Accepted medical use

• Abuse may lead to moderate to low physical or high psychological dependence

Factors designating C-IV

• Low potential for abuse relative to C-III

• Accepted medical use

• Abuse may lead to limited physical or psychological dependence relative to C-III

Factors designating C-V

• Low potential for abuse relative to C-IV

• Accepted medical use

• Abuse may lead to limited physical or psychological dependence relative to C-IV

A Pharmacist may NEVER add or modify what aspects of a C-II prescription?

• The Name of the Patient

• The Name of the Controlled Substance (excluding generic substitution)

• The Signature of the Prescriber

A Pharmacist may add or modify what aspects of a C-II prescription with prescriber approval?

• The Date of Issue (may be ADDED, but not CHANGED)

• Drug strength

• Quantity/Quantity check-mark box (only in conjunction with change in strength, total quantity must not exceed original authorized)

• Directions for use

• Practitioner’s name (printed, NOT signature)

(also refills for III-IV, not applicable to C-II)

A Pharmacist may add or modify what aspects of a C-II prescription without prescriber approval?

• Dosage form

• Patient address

• Practitioner’s address

• Practitioner’s telephone number

• Practitioner’s DEA number

Where must Schedule II stock bottles be kept within the pharmacy?

C-II stock can be kept either 1) all together if locked in a substantially constructed & securely locked safe, or 2) spread through out the prescription drug area.

When may a C-II prescription be partially dispensed?

Three instances:

1) If the pharmacy is unable to supply the full amount of the Rx. The remaining portion must be filled within 72 hours, or the Rx is void and a new one must be obtained.

2) For a patient who is in a long-term care facility or who is terminally ill. The total dispensed quantity shall not exceed the quantity prescribed, and there can be no dispensing beyond 60 days of issuance of the Rx.

3) At the request of a prescriber or patient who is not in a long-term care facility or terminally ill, so long as the total dispensed quantity does not exceed the quantity prescribed, and there can be no dispensing beyond 30 days of issuance of the Rx.

C-II Prescription Requirements

(Form, Refills, Expiration, Transfers)

• Can be written or electronic***

(Kentucky requires all CS to be electronic as of 2021, but prescribers can get waivers and renew them annually, so who knows, and can be faxed for long-term care facilities/hospice patients/parenteral narcotics to be compounded)

• C-II Rxs cannot be refilled

• Valid only for SIXTY (60) days from the date of issue

• A little gray on the transfer bit, maybe just once, or “forwarded” to a pharmacy with a shared system, so long as it has never been filled

C-III/V Prescription Requirements

(Form, Refills, Expiration, Transfers)

• Can be written, electronic, oral, or faxed

(oral & faxed require RPh signature)

• Maybe have up to FIVE (5) refills

• Valid for 180 days from the date of issue

• May be transferred once, unless it is within a shared system, then as many times as there are refills so long as it has been filled once

What is the quantity limit for a Controlled Substance Prescription?

Loaded Question, Opioids for acute pain are limited to a THREE (3) day supply, however there are many exceptions, one of which is just if the prescriber thinks they need more :/

Additionally, certain prescribers are limited by their scope, such as:

APRN - 3 day supply with exceptions for ADD/ADHD drugs if certified in mental health (30 days) & hydrocodone combo products (30 days)

OD - 72 hour supply hydrocodone combo products, no other C-IIs

Other than that, most third parties will limit day supply to 90 days, but there is no maximum quantity in state or federal law.