Louisiana MPJE Review - 2024

Area 2/2.2: Conditions under which the pharmacist or pharmacy intern participates in the administration of drugs in the management of patients' therapy

- Pharmacist/ pharmacy intern license in active status (restricted status allowed; interns can only do MA when supervising Rph is credentialed)

- Certificate program that meets CDC training guidelines and accredited by ACPE or JA

- 20 hours of training and experience in specific content areas as outlined by the board (p.16)

- Life safety AHA BLS course or ACLS - health professional course

- Maintain 1 hr of CE per year

- Retain evidence of training and continuing competency

- Report immunizations to state registry within 72 hours of administration

- Sufficient staffing to administer the medication, supervise staff, and monitor the patient afterwards

- Adequate supplies and equipment and P&P to facilitate emergency management of anaphylactic reactions

Area 2/2.2: Conditions under which the technician participates in the administration of drugs in the management of patients' therapy

-Tech license in active status (restricted status allowed; tech can only do MA when supervising Rph is credentialed)

- Certificate program that meets CDC training guidelines and accredited by ACPE or JA

- 6 hours of training and experience in specific content areas as outlined by the board (p.29)

- Life safety AHA BLS course or ACLS - health professional course

- Maintain 1 hr of CE per year

- Retain evidence of training and continuing competency

Area 2/2.3: Requirements regarding counseling

- At a minimum, the pharmacist should be convinced that the patient is informed of the typical drug information: name, indication, directions for use, duration, side effects, storage, self-monitoring, refills, and missed doses

- Rph shall not use written information alone to fulfill counseling requirement

- RPh shall counsel face-to-face when possible and by alternative methods when needed

- RPh shall counsel patients discharged from hospitals but counseling not required for inpatients where a licensed HCP is authorized to administer medications

- RPh shall maintain appropriate patient-oriented drug information materials

- No one can solicit or encourage blanket waivers for patient counseling, but nothing prohibits the patient or caregiver from declining patient counseling

Area 2/2.4: Returning or reusing drugs

- In a hospital, unused drugs may be returned to the pharmacy for re-dispensing

- When a patient returns dispensed drugs to a pharmacy for disposal, the pharmacy shall inform the patient of disposal mechanisms

- If pharmacy accepts previously dispensed drugs from the patient, the pharmacy shall quarantine the products and comply with proper disposal of controlled substances, non-hazardous and hazardous controlled substances

- Drug dispensed to a patient shall not be accepted for return, exchange, or re-dispensing after the drugs have left the pharmacy premises where they were dispensed

- Drugs not adulterated or misbranded may be donated to charitable pharmacy or correctional facility

Area 2/2.5: Regulations and agencies regarding pharmacy practice

Agencies:

Food and Drug Administration (FDA)

Drug Enforcement Administration (DEA)

The Joint Commission (TJC)

State Board of Pharmacy (BOP)

National Association of the Boards of Pharmacy (NABP)

Louisiana Department of Health

Regulations:

- Louisiana Revised Status (La. R.S.).. Laws

- Louisiana Administrative Code (LAC) .. Regulations by BOP

- Code of Federal Regulations (CFR)

Area 2/2.5: Regulations and agencies regarding pharmacy practice- Overall authority

R.S. 37 §1163: The chapter is to promote, preserve, and protect the public health, safety, and welfare by and through effective control and regulation of the practice of pharmacy, licensure, certification, permitting, registration, control. and regulation of all persons in and out the state that sell drugs or devices to consumers or patients or assist in the practice of pharmacy within this state.

The board is responsible for the control and regulation of the practice of pharmacy, including enforcing regulations

Primary role of the FDA

protecting the public health by ensuring safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation

Wiley Act- Pure Food and Drug Act

- Accurate product labeling. No food or drug label could be false or misleading

- Ingredients used in the drugs met the standards as defined in the USP and NF

- No adulterated or misbranded drugs could be sent through interstate commerce

Food, Drug, and Cosmetic Act

- Manufacturer must prove the safety of the drug before it could be marketed and FDA could conduct inspections and apply penalties

- Adequate directions for safe use

- List of all ingredients must be on the label

- All product claims had to be accurate

- Food, drug, supplement, cosmetics, devices defined

- Adulteration and misbranding defined

Durham-Humphrey Amendment

- Distinction made between OTC and prescription drugs and the labeling requirements were differentiated

- Rx only= federal law prohibits dispensing without a prescription

Kefauver-Harris Amendment

Resulted out of thalidomide children malformations

- Manufacturers must prove drug is safe and effective before it can be approved and manufacturers must continue to report serious side effects after drug is on the market

- Individuals must give informed consent before enrolling in clinical trials

- CGMPs must be used for manufacturing

- FDA given oversight to regulate advertisement of RX drugs and FTC regulates advertisement of OTC drugs

Controlled Substances Act

- Controlled substances defined and categorized into 1 of 5 schedules based on relative potential for abuse

- Closed system for manufacturing, distributing, and dispensing drugs to reduce drug diversion

- DEA enforces the CSA

Poison Prevention Act

Child-resistant packaging for drugs and a number of household substances

Drug Listing Act

- Each rx drug had a unique NDC

Federal Anti-Tampering Act

- Federal crime to tamper with OTC product

- OTC products must have tamper-resistant features

- Exempt products: skin products, insulin, lozenges, and toothpaste

Orphan Drug Act

- Orpgan drug treats a disease that affects less than 200k people and there is no expectation that the sales with recover research and development

- Incentives and tax credits to manufacturers

- 7 years of market exclusivity

Hatch-Waxman Act

- Streamlined generic approvals and grant patent protection to drug innovators

- Generic application filed through ANDA or 5O5b2 application

- 5 years of market exclusivity to new brand name drugs

Prescription Drug Marketing Act

- Prohibits reimportation of drugs

- Sale of drug samples and coupons prohibited

- Patients cannot bring drugs into the U.S from other countries unless the quantity is 90 day supply or less and an effective treatment for a serious condition is not available in the U.S

- Blocked hospitals from reselling drugs they purchased at a discount for profit

- Strict limit on percent of drugs that hospital pharmacies can resell

Omnibus Budget Reconciliation Act OBRA 90

- Rph must perform prospective DUR and counseling for all medicaid beneficiaries before dispensing

- Retrospective DUR program to look for patterns of fraud, abuse, overuse, and medically unnecessary cre

DSHEA Act

-Adulteration and misbranding prohibited but FDA approval not needed prior to marketing for supplements

- Must have disclaimer: "This statement has not been evaluated by the food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease

- Address nutrient deficiency, support health, or be linked to body functions

FDA Modernization Act

- Registry required for clinical trials

- FDA can charge manufacturer fees to expedite the drug review process, including fast track designation

Drug Addiction Treatment Act 2000

- Permitted physicians to prescribe and dispense controlled substances in an office-based setting to treat opioid use disorder

FDA Amendments Act

Risk Evaluation and Mitigation Strategy program was established to ensure benefits of drugs outweigh the risks

Biologics price competition and innovation act

- This act established generic approval pathway for biologics - or better known as, biosimilars

-Purple Book to view biologic interchange information

Affordable Care Act

- Increased access to care, reducing cost, and improving quality through collaboration and accountability

- Integrated Care Models

- Care Transition Programs

- Improvements to MTM with Medicare Part D

- Hospital value-based purchasing (payment based on quality of care, not quantity)

Drug Quality and Security Act

-Compounding Quality Act to regulate compounding

- Distinction between 503a and 503b outsourcing facilities

- Track and trace requirements with Drug Supply chain security act to prevent counterfeit drugs from entering the market and records of transaction information must be kept for 6 years from pharmaceutical suppliers

Pregnancy and Lactation Labeling Final Rule

- Lettering categories are no longer used

- Three categories include: pregnancy, lactation, and females and males of reproductive potential

Comprehensive addiction and recovery act (CARA)

- Funding for prevention and education in response to the opioid epidemic

- C2s could be partial filled at the request of the patient or prescriber but must be filled within 30 days from the date of issue

Health Insurance Portability and Accountability Act - Definition and regulation

- Protect the privacy of patient's protected health information (PHI); PHI includes the medical record, healthcare provided, payment for providing care (hospital bill), and when associated with health information: name, address, birthdate, and SSN

- Ensure patient information is secure whether the information is electronic, verbal, or written

- HCPs must have documented HIPAA training

- Violation of HIPAA can result in fines and imprisonment

- Covered entities of where PHI can be shared: HCPs, facilities where health care is provided, insurance companies

- PHI can be shared with the patient, HCPs caring for the patient, for payment purposes, research purpose (limited data set), law enforcement, DEA, FDA, pharmacy board inspectors for public health purpose or abuse concern; otherwise HCP must receive patient's written authorization

- Minimum neccessary information standard

- Incidental disclosures are unavoidable and acceptable

Area 2/2.5 - Protecting patient and health record confidentiality

State Regulations

- All services provided shall be performed in a setting which insures patient privacy and confidentiality

- Disposal of PHI must protect confidentiality

- Adequate security and safeguards against unauthorized access to confidential information, including on communication devices

- P&P that includes security and patient confidentiality

- Prescription and other patient healthcare information shall be maintained in a manner that protects the integrity and confidentiality of such information

Federal regulation for notice of privacy practices

-Site specific notice on policies to protect PHI and with whom information can be shared

- Notice in simple language and the patient's rights to their own information; list DHHS for complaints and discuss privacy concenrs

- Privacy notice placed in a prominent location within the pharmacy

- Notice given to the patient on the first day of service, when requested, when there are changes and make good faith to obtain patient's written acknowledgement of receiving the notice

- Services can still be provided if patient refuses to sign

- Signed disclosure must be kept for 6 years, separate from other signatures

Area 3/3.1: Responsibilities for determining whether prescriptions/drug orders are issued for a legitimate medical purpose, and within all applicable restrictions

A prescription, in order to be effective in legalizing the possession of legend drugs, shall be issued for a legitimate medical purpose by one authorized to prescribe the use of such legend drugs. (RS 40:1060.14)

Corresponding responsibility rests with the pharmacist to ascertain that a prescription was issued for a legitimate medical purpose in the usual course of professional practice

Legitimate medical need includes the prevention of the transmission of communicable diseases

Area 3/3.2: Transferring prescription/drug order information between pharmacies by authorized personnel- controlled requirements

- C3-5 transfer allowable on a one-time basis unless, the pharmacies share a real-time, online database, unlimited transfer

- Controlled drugs transferred between two pharmacists

- Transferring pharmacist must: invalidate prescription and record which pharmacy it was transferred to (name, address, DEA), rph receiving the rx, date of transfer, transferring rph name

- Receiving rph must record: reason for transfer, information required for controlled susbstance (name, address of pt, drug name, strength, dose, quantity, directions, name, address, and dea of prescriber), original date and refills, original dispense date, refills remaining and date and location of previous refills, pharmacy name, address, dea registration, rx number from which the prescription was transferred, name of transferring rph, pharmacy info for original fill

- Maintain original and transferred prescription for a period of two years from the date of last refill

Area 3/3.2: Transferring prescription/drug order information between pharmacies by authorized personnel- non-controlled requirements

- May be transferred up to the maximum number of refills

- Transferring rph, intern, or certified tech shall invalidate rx, record name and address of the pharmacy it was transferred to and the rph receiving the rx, date of transfer and name of rph transferring (Same as controlled substances, except DEA not required)

- Receiving rph shall record all information as required for controlled substances except DEA number

- Maintain original and transferred prescription records for a period of two years from the date of last refill

Area 3/3.3: Prospective drug utilization reviews

- A rph shall review the patient record and each prescription presented for dispensing and recognize: drug over-utilization or under-utilization, therapeutic duplication, drug-disease contraindications, drug-drug interactions, inappropriate dose or duration, drug-allergy interactions, or clinical abuse/misuse and upon recognizing any of the situations, take appropriate actions

- Positive identification of prospective DURs

- OBRA 90 requires prospective DUR for all medicaid beneficiaries

Area 3/3.3: Prospective drug utilization reviews - requirements for reporting to PMP and accessing PMP data

- Each dispenser shall submit to the board information regarding each prescription dispensed for a controlled substance or drug monitored by the program (butalbital, promethazine in oral formulation, gabapentin), no later than the next business day after the date of dispensing

- If dispenser is unable to submit prescription by electronic means, he may apply to the board for a waiver and the board will determine the format and frequency. waiver expires one year after date of issue

- Must submit prescriber info (name and DEA), patient information, or if animal, client name and animal species, prescription information, drug information (including NDC), and dispenser information

- Patient info includes: name, address, dob, identification number, gender, species

- Rx info includes: identification number, date of issuance and fulfillment, number of refills, and refill number, and method of payment

- Drug information includes: NDC, quantity, and days supply

- Dispenser info includes DEA or NPI

- Board must retain PMP info 5-10 years

Area 3/3.3: Prospective drug utilization reviews- accessing PMP data

The following persons can access PMP:

- Persons that prescribe or dispense controlled substances or drugs of concern for purpose of providing care of verifying records

- Designated representatives from pharmacies and prescribers, Medicaid, the board, medical examiner, substance abuse counselor, epidemiologist, PMP in other states

- Prescribers and dispensers get automatically registered (not veterinarians) as a participant and must authenticate their identity, board verifies valid license (DEA), and issues credential to access PMP

- Those approved for access are responsible for enabling and disabling access privileges for delegates, as well as supervision

Area 3/3.4 - Exceptions to dispensing or refilling prescriptions/drug orders

- Prescription from Electronic questionnaire but no valid physician-patient relationship, no fill

-no refill on C2

- refills exhausted or expired prescription

- no refill instructions= no refills

- Prescription refills authorized by the prescriber shall not be dispensed in the absence of a patient, or hIs agent's request or approval. This does not apply to residents of LCTF

Area 3/3.5: Labeling of dispensed drugs in hospital pharmacy

Identifies:

- Patient name and location

- Drug name and strength

- Medication dose

Compounded and sterile medications shall also be labeled with expiration or beyond-use-date, the initials of the preparer, and the rph performing final check

Area 3/3.5: Labeling of dispensed drugs in nuclear pharmacy

immediate container:

-radiation symbol

- "caution- radioactive material"

- rx control number

- name of radionuclide

- amount of radioactive material contained

Outer container:

- radiation symbol

- "caution- radioactive material"

- name of radionuclide

- chemical form

- amount of material

- liquid volume

- calibration time and date for the amount of radioactivity contained

Area 3/3.5: Labeling of dispensed drugs - general prescription drugs

-Pharmacy name, address, and phone

- Rx number

- Prescriber

- Patient name

- Date dispensed

- Drug name and strength

- Directions for use

- RPh name or initials

- Cautionary aux labels if applicable

Area 3/3.5: Labeling of dispensed drugs - prepackaged drugs

Drug name, dose, strength, quantity, storage requirements, pharmacy prepackage number that corresponds to: manufacturer, manufacturer lot, date of preparation, pharmacists initials, and expiration date according to USP

Area 3/3.6: Packaging of dispensed drugs

Unit-dose: properly labeled to show identity of generic, strength, lot, and expiration

Suitable container, labeled for subsequent administration

New container and closure, glass containers only need new top

Child-resistant unless drug does not require C-R packaging

Marijuana products: only in a secure, light-resistant container

Pill/MedPak

Area 3/3.5: Labeling of dispensed drugs - investigational drugs

"For investigational use only"

Area 3/3.5: Labeling of dispensed drugs - vet drugs

- Same as prescription label

- Client name and animal species

- "Federal law restricts this drug to use by or on the order of a licensed vet"

Area 3/3.7: Drug product conditions prohibiting dispensing

-Final check incorrect: verify source of container, prescription medication, and rx label against rx form

-Adulterated or misbranded drugs

-Adulterated drugs are contaminated medicinous substances having deleterious foreign or injurious materials which fail to meet safety, quality, and/or purity standards; unlawful to have in inventory or to dispense

-Misbranded drugs have a false or misleading label, do not bear name and address of the manufacturer and does not have an accurate statement of the quantities of active ingredients, without accurate monograph, or meeting the qualifications of misbranding as noted in the FDCA (lack of Poison Prevention packaging, incomplete labeling of additives, PPI not provided with oral contraceptives or estrogen-containing products, etc.)

Area 3/3.8: Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products - Dispensing or administration

-Label should not be misbranded

- If the label is missing: principal display, statement of identity, drug facts, directions for use, quantity, expiration, or manufacturer info, it is misbranded

Area 3/3.8: Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products- Labeling of non-prescription drugs and devices

Label should include:

- Principal display panel

- Statement of identity

- Drug facts panel

- Directions for use

- Quantity

- Expiration date

- Name and address of manufacturer

Drug facts panel includes: active and inactive ingredient, purpose, use, warning, directions, other information, and contact information

Specific labeling for Ca, Mg, K, Na

If an electrolyte contains an amount equal or greater to the threshold, the label must state the amount

Ca: 20mg, Mg: 8mg, and K/Na: 5mg

Warning statements ("typically ask a doctor before use") must be issued at greater than these daily dose thresholds

Ca: 3.2g

Mg: 600mg

K: 975 mg

Na: 140mg

Area 3/3.8: Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products - Packaging and repackaging of non-prescription drugs and behind-the-counter products

PPPA allows manufacturers to package one-size of OTC drugs in a non-CR container as long as the same product is also available in a C-R container

Packages must have warning: "this package is for households without young children" or "package not child-resistant"

Effervescent acetaminophen and aspirin powder does not require C-R packaging

OTC that requires C-R packaging: Tylenol >1gm per package, select NSADIs, iron with 250mg of elemental iron, diphenhydramine with >66mg/package, lopermide, minoxidil topical, and any otc products that were previously Rx only

Area 3/3.8: Requirements for the distribution and/or dispensing of non-prescription pharmaceutical products, including controlled substances and hazardous drugs- Dispensing-restricted, non-prescription drugs

- Pseudoephedrine, ephedrine and phenylpropanolamine and their transactions must be kept behind the counter or in a locked cabinet

- All sales recorded in a log book (NPLEx)

- Federal or state ID required for purchase

- No more than 3.6 grams in 1 day, 9grams in 30 days, and 7.5 grams in a 30-day period for each mail-order purchase

-Pharmacies must self-certify compliance with attorney general

- Must be 18 to purchase dextromethorphan

Area 4/4.1: Ordering and acquisition, including maintenance and content of such records

All records kept and maintained for 2 years and produced within 72 hours

Content: PIC is responsible for maintaining

- a record of all drugs procured, the quantity received, and the name, address, and wholesale distributor licensure number of the person from whom the drugs were procured

Area 4/4.1: Distribution, including maintenance and content of such records

All records kept and maintained for 2 years from most recent transaction and produced within 72 hours

Content:

- Positive identification of who entered rx, DUR, dispensing, and administration

- Electronic recordkeeping system, backed up once per day

- Patient profile with RX/ drug orders

- Log of changes

- a record of drugs dispensed

- records of drug orders and records relating to the practice of pharmacy

- Records of all drugs compounded or prepackaged for use only within a healthcare facility

- Record of the distribution of drugs to patient care areas held for administration

- a log any changes made in the drug record

Area 4/4.2: Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling, and reporting - Non-dispensing requirements for operations of pharmacies or practice settings

Issues related to space, equipment, advertising and signage, security (including temporary absence of the pharmacist), policies and procedures, libraries, and references (including veterinary), and the display of licenses.

Area 4/4.2: Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling, and reporting - Possession, storage, and handling of non-hazardous drugs

bulk drug substances/excipients, and devices, including controlled substances Investigational new drugs, repackaged or resold drugs, sample pharmaceuticals, recalls, and outdated pharmaceutical products.

Area 4/4.2: Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling, and reporting - Training, possession, handling, storage, and disposal of hazardous drugs

1.8.1 Requirements for appropriate disposal of hazardous materials

1.8.2 Requirements for training regarding hazardous materialsReverse distributors, quarantine procedures, comprehensive safety programs, and Material Safety Data Sheets

1.8.3 Environmental controls addressing the proper storage, handling, and disposal of hazardous materials Ventilation controls, personal protective equipment, work practices, and reporting

When is the red "C" waived for recordkeeping of C3-5, to be considered readily retrievable

Pharmacy employs and ADP or electronic record system which permits identification by prescription number, prescriber name, patient name, drug dispensed, and date filled

Area 4/4.2: Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling, and reporting - Allowing non-pharmacist personnel access to drugs

Controlled substance storage areas shall be accessible only to a absolute minimum number of specifically authorized employees.

When it is necessary for others to pass through controlled substance storage areas, the licensee shall provide for adequate observation of the area by an employee specifically authorized in writing

Listed under investigational drugs

- the rph shall ensure the development of a central reposiiory for the maintenance of essential information and the dissemination of that information to all personnel tasked with procurement, storage, dispensing, or administration

Area 4/4.2: Recordkeeping in compliance with legal requirements, including content, inventory, maintenance, storage, handling, and reporting -Requirements for conducting controlled substance inventories

Every inventory record are required to be kept and available for at least 2 years from inventory

Complete and accurate record of all controlled substances on hand on the date the inventory is taken and shall be maintained at the registered location

C2 inventory shall be kept separate and controlled substance inventory shall include date, names of substances, dosage forms, strength, quantity, or volume in each container and number of containers.

Substances on hand (in possession, ordered not yet invoiced, store in a warehouse, in possession of employees)

Inventory taken at the beginning or close of business. Initial inventory required at opening and at least every two years. Pharmacies shall take a new inventory every year and new inventory on the following occasions:

- New PIC

- Discovery of any loss or theft

- Departure of PIC

- Permanent closure

For opened containers:

- C2s get exact count

- C3-5, estimate count unless the container holds more than 1000 tablets or capsules

4.3 - Delivery of drugs

Outside packaging should not have any identifying marks indicating the contents and the inner labeling must include the information required

P&P should be established to ensure patient receives meds, it has not become adulterated, delivery verification unless waived, temperature-controlled packaging, etc.

Controlled substances may be delivered if the pharmacy is registered or exempt with DEA. Packaging standards for controlled substances include: prescription label contains name and address of dispenser, the inner container is marked and sealed and placed in outer container, and the outside wrapper or container is free of markings that could indicate the contents.

Nuclear pharmacy: area for delivery and receipt of materials requiring after-hours handling by non-pharmacy personnel shall be separate from dispensing area

Marijuana pharmacy: each pharmacy shall offer home delivery to paitents in each zip code within its region once per month

Nonresident/mail order pharmacy requires a licensed pharmacist in good standing in the state he practices; shall have toll-free number for counseling

4.4 - Conditions for permitted or mandated product selection

The pharmacist shall not select an equivalent drug product when the prescriber prohibits interchange by:

- DAW

- Brand Necessary or Brand Medically for rx's reimbursable by medicaid

- Oral rx prescriber indicates a specific brand name

- Electronic prescription: brand medically necessary, dispense as written, DAW

- If the prescriber has not prohibit equivalent drug interchange, the pharmacist may select an equivalent drug product (SAME A rating as in Orange Book), provided the patient has been informed of and has consented to the proposed cost saving interchange

- For interchangeable biological products (use purple book), the pharmacist shall communicate to the prescriber within 5 days of the dispensing date the specific product dispensed to the patient, name of the product and manufacturer unless, the prescriber prohibited interchange, no product rated interchangeable, or the product dispensed is a refill and has not changed from prior fill

4.5 - Compounding sterile preparations

Comply with section 503A of the FDCA and USP Chapter 797

- Critical areas exposed to sterile drugs must be ISO5 or less than 3520 particles per cubic meter

- Must occur in a PEC (sterile hood like LAFW) that is in a SEC (buffer room) or in a CAI (glovebox) in a segregated compounding area

- PEC is ISO5, SEC is ISO7, and anteroom (where garbing and handwashing occur) is iso 8 for positive pressure buffer area and iso7 for negative pressure buffer area (hazardous products)

- BUD sterile products: Immediate use risk in no PEC , 4 hours bUD; Category 1 in SCA: 12 hours room temperature and 24 hours fridge; Category 2: PEC in clean room: 1-45 days at room temperature, 4-60 days fridge, 45-90 days frozen; Category 3: includes sterility testing which allows products to last 60-180 days unless an ingredient expires earlier

- Personnel training required and competency demonstrated at least every 12 months in technique, cleaning, and sterile drug preparation

- Environmental monitoring: SEC and CSP storage areas checked at least daily; buffer room must be <20 degrees Celsius or 68F and humidity 60% or less; fridge 2-8C and freezer -25 to -10C

- Air and surface testing: airborne sampling every 6 months, surface sampling every 30 days for classified areas and areas touched frequently tested at the end of shift before cleaning

- Air pressure testing checked once daily and confirms difference in pressure and that airflow is unidirectional

Compounding hazardous preparations

Comply with section 503A of the FDCA and USP Chapter 800

- Containment hoods required

- SDS required which provides guidance on drug-specific safety information, PPE required, and procedures for first aid and clean up

- Typical hazardous drugs include: chemo, warfarin, seizure drugs, colchicine, hormones, transplant drugs

- Harzard communication program which is basically a P&P and the list of hazardous drugs must be maintained and reviewed every 12 months or whenever a new drug is stocked or used

- C-PECS must be at least one meter part and no particle generating activities during sterile products

- Air must be externally ventilated in CPEC and CSEC through HEPA filtration with 30 air changes per hour, if nonsterile hazardous drugs: air can be externally exhausted or passed through 2 hepa filters in a series with 12 ACPH

- trace waste in yellow container and bulk waste in black container

- at minimum two pairs of chemo gloves and two shoe covers for compounding and cleaning, one pair for receiving hazardous drugs, n95 respirator for most HD compounding

- Spill kits near receiving

- Compounding records include the master formulation which is the recipe and the compound record which shows all the steps, products used, and the staff that prepared the product

4.5 - Compounding non-sterile preparations

Comply with section 503A of the FDCA and USP Chapter 795

- Clean secure space with proper lighting and ventilation, in room or ambient air, separate from dispensing area and ingredients stored off the floor

- BUD assigned based on Aw. Aw =0.6, 14 days in fridge, preserved= 35 days; Aw<0.6= liquids 90 days and nonaqueous forms: 180 days

4.6 - Centralized prescription processing or central-fill pharmacy dispensing

Requirements

- Same owner or written contract that outlines service as to be provided and responsibilities and accountabilities of each pharmacy in compliance with regulation

- Share a common electronic file

- All drugs that have been dispensed by a remote dispenser shall bear a label containing an identifiable code for a complete audit trail

- P&P required for on-site and remote dispensers for reference by all personnel

-P &P to include compliances with laws, maintaining records to identify responsible rph in dispensing and counseling, mechanism for tracking the order during each step, mechanism to identify on the prescription label all pharmacies involved, and adequate security to protect confidentiality and integrity of patient information

- Remote pharmacy processing still requires a pharmacist to be on-site, especially if there are more than 100 occupied beds in a hospital

- Remote pharmacist shall have the same access as on-site pharmacist and be trained

- Both pharmacies shall have appropriate technology to access required patient information

- P&P identify responsibilities, protect PHI, and maintain appropriate records to identify each rph performing services, the specific services, and the date of services

- Remote pharmacies can process orders when there are privacy and security controls, the pharmacist does not engage in receiving orders, and no dispensing information is duplicated downloaded or removed from the dispensing information system

4.7 - Requirements for the registration, licensure, certification, or permitting of a practice setting or business entity

Pharmacy permit application shall be completed by owner of pharmacy and PIC with appropriate fees and application expires one year after receipt

Application submitted 30 days prior to opening, on-site inspection, and permit issued and LA CDS License issued if requested

Requirements for the renewal or reinstatement of a license, registration, certificate, or permit of a practice setting

Renewal: pharmacy permits renewed by December 31st each year

Requirements for an inspection of a licensed, registered, certified, or permitted practice setting

The board may inspect any licensed facility or location of a licensed person including pertinent records for the purpose of determining compliance with the requirements of the law book and federal laws and regulations

Classifications and processes of disciplinary actions that may be taken against a registered, licensed, certified, or permitted practice setting

Due process disciplinary hearings

Upon receipt of a written complaint, board shall initiate and conduct an investigation

Violations committee determine the nature and disposition of the violation and then it is directed to the committee for informal or interlocutory hearing or special counsel for administrative hearing

Sanctions must be sufficient to remedy the problem

The board may place under seal all drugs or devices that are owned by or in possession, custody, or control of a licensee at the time his license is suspended or revoked for a licensee's failure to timely renew his license

Qualifications, scope of duties, limitations, and restrictions of duties, or conditions to practice for pharmacist-in-charge

- Active Louisiana Rph license, active pharmacy practice

for a minimum of 2 years under any jurisdiction in the U.S.

- Present and practicing at the pharmacy 20 hours per week or 50% of normal business hours

-PIC is responsible for complete supervision, management, and compliance with all laws and regulations pertaining to the practice of pharmacy, which includes accountability for any violation occurring within the prescription department supervised by a pharmacist-in-charge

- PIC responsible for implementing P&P manual, proper maintenance of all prescription records and capacity to produce required records, implementation of a recall procedure, P&P to ensure discontinued or outdated drugs or removed from pharmacy inventory

- PIC shall sign an affidavit indicating understanding and acceptance of duties and responsibilities of PIC

- PIC shall not hold a PIC position at more than one pharmacy permit unless approved by the board

Qualifications, scope of duties, limitations, and restrictions of duties, or conditions to practice for pharmacist

RPhs must be licensed and registered with the BOP

- A pharmacist on duty at all times

Scope: Prospective Drug Utilization Review, patient counseling, make a reasonable effort obtain, record, and maintain patient information, counsel the patient face-to-face when appropriate, cognitive services, Collaborative Drug Therapy Management as defined in protocol registered with the board

Qualifications, scope of duties, limitations, and restrictions of duties, or conditions to practice for non-pharmacist personnel

Technicians/ technician candidates assist the pharmacist

Tech candidates shall not receive any verbal prescription orders, give or receive verbal transfers, interpret rx orders, compound high-risk sterile preparations, counsel patients, or administer medications

Techs shall not release a verbal rx order for processing until it is reduced to written form and initialed by tech and supervising pharmacist, interpret prescription orders, or counsel patients

Pharmacy-intern may complete any task of the pharmacy under the supervision of a licensed pharmacist, but may not identify as the pharmacist, sign any document which is required to be signed by the pharmacy unless the preceptor cosigns the document, and intern may not independently supervise techs or tech candidates

All pharmacy staff must be registered or licensed with the board

the ratio of staff to pharmacists on duty shall not exceed 4 to 1 in any variable in any given time and pharmacy interns on rotation to pharmacists shall be no more than 3 to 1

Qualifications, examinations, internships, maintaining pharmacist competency, and renewals of licensures, registrations, or certifications

- Pharmacist must be 21 and of good moral character, apply for license by reciprocity or licensure by examination of passing NAPLEX and MPJE, have received 1740 hours from COP, background check

- Must obtain CPE and submit renewal application yearly before December 31st

- 15 hours of CPE each year with 3 live hours, no live hours then Rph must obtain additional 5 hours

- 1 hour CPE in sterile compounding, 1 hr in medication administration, 5 hours in nuclear pharmacy

Classifications and processes of disciplinary actions

- Complaint received and investigated

-Disposition of offenses shall be determined by conducting informal hearings, interlocutory hearings, (5 day summon), or referring matter to special counsel for formal hearing by full board

- Notice summons issued to respondent 30 days prior to hearing with name, address, location, allegation, authority, citation, and supporting documents

- Sanctions are issued based on nature of violation, degree of knowledge of violation, scope of circumstances, honesty of respondent, prior sanctions, cooperation, and sufficiency of the sanction to remedy the problem

- Disciplinary actions can include fines, restriction, suspension, probation, revoked licenses, and/ or imprisonment

Reporting to and participating in programs addressing the inability to practice with reasonable skill and safety

No one in the practice of pharmacy shall be impaired

Impairment is a condition that causes an infringement on the ability of a person to practice pharmacy sufficient to pose a danger to the public. It may be caused by, alcoholism, substance abuse, mental illness, or physical illness

-Any staff member that knows another staff member is impaired shall notify the board of the fact ASAP

- Staff would be subject to medical evaluation

- Impairment committee oversees complaints, investigates complaints, and reviews impaired or allegedly impaired persons practicing in pharmacy and makes recommendations to the board. Recommendations may include agreement by impaired person to mandatory surrender of license that prohibits pharmacy practice, entering approved treatment monitoring program, and application for reinstatement after completing program, requirements by the board, and receiving post-treatment evaluation from a board-approved addictionist

Requirements for drug uses, limitations, or restrictions

- a prescription or chart order is the lawful authority for a patient to acquire a prescription drug from a pharmacy

- the patient's lawful authority to obtain the drug conveyed by the prescription shall continue to exist until the expiration date or when the total quantity authorized has been dispense

-Rph are permitted to fill prescriptions for off-label indications but should do due diligence with researching the use

Scope of authority, scope of practice, limitations or restrictions of practice, and valid registration of practitioners who are authorized to prescribe, dispense, or administer drugs

-A prescription may be issued by a practitioner with valid prescriptive authority, valid state professional license and issued for a legitimate medical purpose

-A Rx can be prepared for the signature of the prescriber

-A pharmacist can issue a prescription when authorized by law, rule, standing order, or practice agreement

- Controlled substances can only be prescribed by physicians, dentists, PAs, APRNs, optometrists, or medical psychologists

- Controlled substances shall be dispensed by pharmacists but can be dispensed by physicians, dentists, and veterinarian's to his own patients, same requirements apply with procurement and storage

- Valid DEA registration: First letter typically A,B,F,G M (mid level practitioner), P (manufacturer or narcotic treatment program) second letter first letter of prescriber's last name, add 2,4,6 number and multiply by 2, then add that result to the sum of the 1st, 3rd, and 5th number. The last number in the sum should match the 7th number in the DEA, aka check digit

Requirements for issuing non-controlled prescriptions/drug orders

- Rx may be issued by a practitioner with valid prescriptive authority and can be prepared by presciber's agent but must be signed by prescriber

- Rx shall have prescriber name, licensure designation, address, phone number, patient name, date, name of drug, strength and quantity, directions, signature, refill instructions

- Issued orally, on written form 4inx5in with a single printed signature line and prescriber's info (max 4 orders with DAW check box), written in ink, indelible pencil, typewriter, or printed on computer paper and signed, issued by fax with non-fading image, and issued by electronic means

- multiple c2 prescriptions may be issued for up to 90 day supply and include date and date to be filled

Requirements for issuing controlled prescriptions/drug orders

A prescription for a controlled substance may be issued only be a practitioner who is authorized by law to prescribe controlled substances and includes the following:

- Physician, dentist, veterinarian, physician assistant, advanced practice registered nurse, an optometrist or a medical psychologist

- valid licensed from state professional agency

- valid DEA

- issued for a legitimate medical purpose by an individual acting in the usual course of his practice

- no detoxification or maintenance treatment unless the drug is on the approved FDA list

- each rx dated, and signed;

- exemptions from DEA registration: hospital prescribers must provide special internal code number assigned to him or provide branch of service and service identification number

- Written prescriptions on 4x5 form, clear identification of prescriber, address and phone number, no more than 4 orders on script, pre-printed check box for DAW, and a single printed signature line

Authority limitations of practitioners' ability to authorize refills

- No C2 Refills

- C3/C4: max 5 refills and expires 6 months from date of issue

- C5 drug can be refilled without limitation if so indicated at the time issued subject to the one-year expiration date

- A prescription for a drug not a controlled substance, medical device, medical gas, or DME may be refilled without limitation subject to one-year expiration

- When all refills on the original have been dispensed, then authorization form from the prescriber shall be obtained prior to dispensing, a new prescription shall be prepared, and it shall be issued a different prescription number