Nebraska MPJE - 2024

Who are the BOP board members?

5 members (including 4 actively practicing pharmacists)

At least 1 practices in a hospital

1 public member

Is the BOP a separate entity or under another organization/department?

Under the Department of Health and Human Services

Who Chairs the BOP?

Annually the board selects a chairperson, vice-chairperson, and secretary from its own membership

How are BOP members selected?

Appointed by the state Board of Health or a state association or society may submit a list to the Board of Health for consideration

How long do Board Members serve?

5 years; cannot serve more that 2 consecutive full terms

Who can attend meetings?

Open to the public

Pharmacist: Who can apply?

Graduate from accredited pharmacy program

Be of good moral character and at least 19 years old

Foreign graduates must pass equivalency exam from the board

Pharmacist: # of CE hours for renewal?

30 hours every 24 months

Pharmacist: Special CE requirements?

None

Pharmacist: Exam Requirements

NAPLEX

MPJE

Pharmacist: Documents required for application

New:

Documentation of pharmacy degree

Documentation of 1500 internship hours

Copy of birth certificate or driver's license

Transfer/Reciprocity:

Documentation of degree

Application for transfer of pharmaceutic licensure

Copy of birth certificate/driver's license

Pharmacist: Renewal period?

January 1st of each even numbered year

Pharmacy Intern: Who?

Student currently enrolled in accredited pharmacy school or graduate of an accredited pharmacy program serving their internship

Pharmacy Intern: Preceptor required?

May compound and dispense drugs and fill prescription only in the presence of and under the immediate supervision of a licensed pharmacist

Pharmacy Intern: License Expiration

15 months after graduation or at the time of professional licensure, whichever comes first

Pharmacy Intern: Temporary Educational Permit

TEP is issued to a pharmacy graduate who is not yet licensed as a pharmacist but is serving in a supervised education program at an accredited hospital or clinic in Nebraska

Cannot exceed one year but can be renewed for no more than 5 one-year periods

Technician: License/Registration required?

Yes

Technician: Who can apply?

18 years of age

High school diploma or equivalence

Have never been convicted of any non-alcohol, drug-related misdemeanors or felonies

Technician: CE renewal requirements?

None

Technician: Requirements?

Must be certified by a board approved or national pharmacy technician certification program

Technician: Renewal period?

Expire on January 1st of each odd-numbered year

Storage of Prescription Hard Copies

Paper Schedule II shall be maintained at the registered location in a separate prescription file

Paper Schedules III, IV, and V: Stored either in a separate file or in a way that they are readily retrievable from the other prescription records

Locking of storage area for drugs and hard copies

Must be maintained in a secure location

Must storage be on site? Time?

Not specified other than all original hard copies of all prescriptions dispensed must be maintained by the pharmacy for 5 years from the date of dispensing

Emergency Preparedness

Pharmacy must have plans in place that address:

How the pharmacy will provide for the storage of drugs, devices, and biologicals at the proper

temperature

How the pharmacy will provide for the disposal of drugs, devices, and biologicals if the pharmacy

determines their potency, efficacy, or safety has been adversely affected

How the pharmacy will secure the drugs, devices, and biologicals from the public; and

How the pharmacy will maintain patient records and inventory records

Signing Requirements

Not specified requirements for counseling, hours, or for PIC change

Sign Requirements for Closures

The PIC of practitioner is responsible for notifying patients of that pharmacy that they will need to seek service elsewhere through advertisement, written notice, or other such means of notification

Notifying Board: Changes of Ownership

PIC must notify Dept of HHS within 15 days

Notifying Board: Changes to PIC

1 Business day

Notifying Board: Changes in Address

Licensee must notify DHHS in writing 15 days prior to moving

Notifying Board: Parkinson's Disease report

Semi-annual report including name, address, and SSN for whom the drugs were prescribed and the name and address of the prescriber

Notifying Board: Environmental Changes

Notify within 24 hours of any changes to the environment which will adversely affect the potency, efficacy, safety, or securing of the drugs, devices, of biologicals in the pharmacy

Notifying Board: Quality Assurance Reports

PIC annually submits Pharmacy Quality Assurance Report form and the Dept will conduct inspections

Remote Order Entry Pharmacists

Must be located in the United States

Maintain adequate security and privacy

May be linked to more than one hospital/LTC facility/pharmacy where services are provided

Have access to each patient's medical information

Automated Dispensing Cabinet in LTC Facilities

A PIC of a pharmacy licensed under the Health Care Facility Licensure Act shall annually license the LTC automated pharmacy in whice the automated medication cabinet is located

Must include:

Name and location of pharmacy

FDA registration number of the pharmacy, then the LTC automated pharmacy will get its own FDA # for renewal

Location of LTC automated pharmacy

Name of PIC

An inspection of the LTC pharmacy will take place

Separate applications/licenses for each LTC location

Same prescription/verification/record keeping policies enforced; keep records for 5 years

Inventory transferred to LTC automated cabinet excluded from the licensed pharmacy's drug sales revenue

Packaging of drug dispensed from automation must include:

Name and Address of LTC automated pharmacy

Prescription number

Name, strength, dosage form

Name of resident

Name of prescriber

Date of filling

Directions for use

Must RPh be on-site?

Pharmacy shall not be open without a pharmacist physically present

Access to the pharmacy is not permitted unless a pharmacist is on the premises

Emergency Medication Box

Drugs for immediate therapeutic needs

Must be provided and sealed with tamper evident seals from pharmacy

Stored in medication room or secured area

Exterior labeled:

For emergency uses only

List of drugs: Name, strength, quantity, route, and expiration

Name, address, telephone number of supplying pharmacy

Drug packaging shall include:

manufacturer/distributor name, lot number, drug name, strength, dosage form, NDC, route, and expiration

Repackaged drugs should include calculated expiration date (1 year from repackaging or manufacturing expiration, whichever is first)

Inspected by pharmacy ever 30 days or after reported use

Documentation of inspection and receipt of medications retained by LTC facility for 5 years

Removal of drugs:

Notify pharmacy within 24 hours

Counted to inventory of pharmacy until used

Mail Order Allowed?

Yes

License required for mail to other states?

Must have at least one pharmacy employed that has an active Nebraska license

Owning Pharmacy: License

$625 for initial license and renewal expiring July 1st every year

Anyone may apply, do not need to be RPh but must have a PIC

No specific time frame but anticipated opening date included on initial application

Transfer of Pharmacy Ownership

Must notify DHHS 15 days before pharmacy is sold, leased, discontinued, or moved to a new premises

RPh to Technician/Intern Ratio

1:3

Compounding Rules

Follow USP 795 and 797

Shall not compound a drug that is a copy of an approved drug unless there is a drug shortage as determined by the board or unless a patient has an allergic reaction to the approved drug

Behind the Counter: Sales of Controls

No sale of Schedule V controls without prescription

Behind the Counter Requirement for products available for purchase

All products containing ephedrine, phenypropanolamine, or pseudoephedrine must be stored behind a counter not accesible to customers or in a locked case that requires employee assistance to access

Dispensing behind the counter medications requirements

Electronic submission to NPLEx before completing the sale:

Name, age, address of person purchasing

Name and quantity of product purchased

Date and time of purchase

Name or initials of staff selling product

Type of ID, entity that issued ID, and ID number

Must be 18 years and have valid form of identification

Staff selling must be 18 or older

Dispensing of Needles/Syringes

May be sold with no rules/regulations/logging requirements

Pseudoephedrine Limits

3.6g/day

9g/30 days

Collaborative Practice Aggreements

Pharmacist shall notify board of any practice agreement at initiation of the agreement and at any changes to the parties/protocols of the agreement

Notification to BOP and board of healtch care practitioner containing names of pharmacists and providers included in agreement

Members of agreement must sign/date the document every 2 years; agreement is active once signed by all listed in agreement

CPA ceases at:

Death of pharmacist or practitioner

Loss of license by either party

Disciplinary action limiting the ability to practice by either party

Individual decision by either party to terminate the agreement

Interns may participate in the agreement without being written in if under the supervision of the pharmacist party in the agreement

Pharmacists' Rights to Refuse Dispensing

Pharmacists or intern may refuse to dispense a prescription, no specific conditions mentioned

Nuclear Pharmacy

Pharmacist certified by a specialty board whose certification process has been recognized be an agreement state or the US nuclear Regulatory Commission. Candidates of certification must:

Graduated from accredited pharmacy program or passed the Foreign Pharmacy Graduate Exam

Hold a current, active license

Provide evidence of 4,000 hours of training/experience in nuclear pahrmacy. Academic training may be subsituted for no more than 2,000 hours

Pass examination in nuclear pahrmacy

Completed 700 hours in a structured educational program

Remote Dispensing Pharmacy

Separate license for remote pharmacy and a pharmacy but same PIC, a pharmacy cannot act as both

Must be located 10 driving miles or more from nearest pharmacy at initial licensure

Can employ a technician as long as real-time audiovisual communication is performed by pharmacist of licensed pharmacy; dispensing by technician cannot take place if remote communication is down

Pharmacist responsible for DUR, final verification, supervision of remote dispensing, and must attempt to counsel on all new prescriptions

Monthly visits by PIC

Central fill allowed

Unused Medications from Jails/Community Health Centers/LTC facilities

Can be returned to the pharmacy the correctional facility ahs a contract through for credit and redispensing for another prisoner

Pharmacy makes decision to accept return

Must have been stored properly

Must be returned unopened in original container

May not be controlled substance

Controlled Medications for Veterinary Use

Reported through the PDMP still

Maintaining Original Hard Copies

Keep for 5 years from dispensing date

Must include:

All information required for prescription

Prescription serial number

Date of Initial filling

Quantity dispensed

If an emergency verbal Schedule II "authorization for emergency dispensing" must appear on the face of the prescription

Requesting Records

Released only to:

Patient or caregiver of the patient or others authorized by the patient or his/her legal representative

A physician treating the patient

Other physicians/pahrmacists when, in professional judgement of the pharmacist, such release is necessary to protect the patient's health or well-being

Other persons or governmental agencies authorized by law to receive such information

Requirements for Reporting ADRs

Form FDA 3500 should be used by healthcare professionals and consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care of product quality issues

Reporting Licensure Violations

Must report within 30 days of occurence

Duty to report incompetent, gross negligent, or unprofessional conduct

Impaired or disabled person

Ability to practice imparied by alcohol, controlled substances, mind-altering substances, or physical, mental, or emotional disability

Reviewing Patient Profile Prior to Dispensing

Make reasonable effort to obtain and record/maintain records of:

name, address, telephone number, date of birth, and gender of patient

History of significant disease, known allergies, and drug reactions

Comprehensive list of relevant drugs and devices used by the patient

Any comments of the pharmacist relevant to the patient's drug therapy

Drug Utilization Review Checking Requirements

Therapeutic duplication

Drug-disease contraindications

Drug-drug interactions

incorrect drug dosage or duration of drug treatment

Drug-allergy interactions

Clinical abuse or misuse

Definition of Adulterated

If its strength or purity falls below the professed standard of quality under which it is sold or was tested by the United States Pharmacopeia and The National Formulary

Definition of Misbranded

1) an imitation or offered for sale under the name of another article

2) it is labeled to deceive (ex:illegal drugs put in place of foreign drug)

3) packaging or label bears or contains any statement, design, or device regarding the curative or therapeutic effect, which is false or fraudulent

FDA Class I Recall

Serious adverse health consequences or death

FDA Class II Recall

Temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

FDA Class III Recall

Not likely to cause adverse health consequences

Red Book

Drug Pricing

Orange Book

Therapeutic Equivalence

Yellow Book

International Travel Vaccines

Green Book

Animal drug products

Pink Book

Vaccine preventable diseases

Purple Book

Biological products

USP 795

Non-sterile compounding

USP 797

Sterile compounding

USP 800

Hazardous Drug Handling

Requirements of a Valid Prescription

Patient Name

Name of drug/device/biologic

Strength of drug/biologic (if applicable)

Dosage form of drug or biologic

Quantity

Directions of use

Date of issuance

Number of refills authorized

Prescriber's name

Prescriber's signature (if written)

What can RPh Correct/Change/Add to Prescription

May call and clarify/take new verbal authorization for any prescription

For CII can NOT change the patient name, name of medication, or prescriber's signature

What can non-RPh staff Correct/Change/Add to Prescription

Interns can do everything pharmacist can

Technician cannot perform any evaluation or necessary clarification of a medical order or perform any functions other than strictly clerical functions involving a medical order

Substituting Drugs from prescription

Can dispense quivalent drug product or an interchangable biologic product in place of brand-name except when:

Prescriber designates that selection is not permitted by specifying in the prescription (DAW, no production selection NDPS, brand medically necessary BMN, no generic substitution, or notated when receiving oral prescription)

A patient or designated representative or caregiver instructs otherwise

Substituting Biologics

Communicate within 3 days after dispensing the biological product

Communication not required if there is no interchangeable product or if it is a refill prescription not changed from the product dispensed in prior filling

LTC quantity

Shall be 60 days supply unless otherwise limited by prescriber

Fax Prescriptions

Allowed for all prescriptions

CII script can only be faxed if:

It is to be compounded for parenteral administration for home infusion

For patient in hospice care (must have "hospice patient" written on it)

For a resident of a LTC facility

Electronic Prescriptions

Must contain all of the same prescription requirements

Can be all control levels

RPh can make changes same as written prescription

Phone Prescriptions

Must have all necessary components of prescription

Must be verbalized from employee or agent of prescriber to a pharmacist or intern

Technicians can ONLY take refill authorizations

Transferring Prescriptions: Transferring Pharmacy Requirements

Indicate void on record of prescription

Indicate that prescription has been transferred

Record the following:

Name, address, and DEA # of pharmacy (if controlled)

Name of receiving pharmacist or intern

Name of the transferring pharmacist or intern

Date of transfer

Maintain records for 5 years from date of transfer

Transferring Prescriptions: Receiving Pharmacy Requirements

Transferred Prescription Includes:

Date of issue of original prescription

Date of original dispensing

Original # of refills authorized

Refills remaining

Date and location of last refill

Name, address, DEA # of transferring pharmacy (if controlled)

Name of transferring pharmacist or intern

Original prescription number

Date of transfer

Indicate on record that prescription is transferred

Record any information normally required on a new prescription

Maintain records for 5 years from date of transfer

Who can transfer prescriptions?

Pharmacists or interns, not technicians

How many times can a prescription be transferred?

Pharmacies sharing real-time database: as many times as there are refills

Pharmacies not sharing: only once

Information required on prescription label

Name, address, telephone number of pharmacy or practitioner

Name of patient

Date of filling

Prescription serial number

Name of prescriber

Directions for use

Name of drug/device/biologic (unless instructed to omit by the prescriber)

Strength

Quantity

Dosage form

Any cautionary statements

Child safety caps

Follows poison prevention packaging act

Expiration/Beyond use date for dispensed or repackaged drug

Date of manufacturer/distributor's package or one year from date of repackaging, whichever is earlier

Requirements for Counseling

Verbal offer to counsel must be made prior to dispensing or delivery

Must occur unless one of the following is documented:

Drug/device.biologic is being administered by a health care professional credentialed by the DHHS to a resident of a hospital or LTC facility

Patient or caregiver refuses to be counseled

Pharmacist determines counseling could harm or injure the patient

Prescriber designates "contact before counseling" or words similar, in which pharmacist would contact prescriber prior to counseling and may use his/her professional judgement regarding counseling following consultation with the prescriber

Required topics to cover with counseling

Include but not limited to:

Name and description of drug/device

Route of administration, dosage form, dose, and duration of therapy

Special directions and precautions for preparation, administration, and use by patient or caregiver

Common side effects, adverse effects, or interactions and therapeutic contraindications that may be encountered, including avoidance, and the action required if such effects, interactions, or contraindications occur

Techniques for self-monitoring drug therapy

Proper storage

Prescription refill information

Action to be taken in the event of missed dose

Drug/Device Disposal

Can be collected by pharmacy for disposal

May be returned to a pharmacy in response to a recall

Shall not be returned to inventory

Cancer/Immunosuppressant Drug Donations

Cancer and immunosuppressant drug repository programs

Conditions for accepting:

Unopened, not expired, not adulterated or misbranded

Must be able to be kept at room temp (59-86 F)

Form for donating:

Name of cancer drug

Quantity of drug

Name of person whom the drug was originally prescribed for

Relationship between donator and who was prescribed for

Signature of donator

Date signed

Must maintain logbook with all information above plus:

Lot/Expiration

Prescriber

Name to who distributed

Date distributed

Date of destruction of expired drug

If fee was charged

Participant Registry:

Name

Address

Phone number

Whether participant is physician's office, pharmacy, hospital, free clinic

What can a pharmacist not change on a CII prescription?

Patient name

Drug prescribed

Prescriber

Picking up controlled substances

Must request ID unless personally and positively known to pharmacy

Annual controlled inventory

Submitted yearly to the Board

Maintain copy of inventory report for 5 years

Name, address, DEA number, date and time inventory taken, and signature of person responsible for taking inventory

Separated into Schedules I and II from III, IV, and V

Separate DEA registration requirements

Required at each place where controlled drug is manufactured, distributed, or dispensed

Only exception is Emergency drug boxes

PDMP requirements

Submit the following electronically:

Patient name, address, phone number, gender, DOB

Patient identifier (driver's license, ID number, etc)

Name and address of dispensing pharmacy

Date prescription issued

Date filled

Number of refills authorized

Prescription number

NDC of medication

Strength of medication

Quantity and day's supply

Prescriber DEA or NPI

Veterinarians must also report to PDMP if they dispense

Submitting CII Prescriptions

Must be digitally signed and transmitted

Can only be fax or hand written if:

Compounded for home infusion use

For hospice patient (must have "hospice patient" written on it)

For a LTC resident