Delaware State Law (MPJE)

When should controlled substance inventories be completed? Who is responsible? How long should the inventory records be kept?

biennially and within 24 hours of a change in PIC

Performed before or after business hours (not during)

PIC is responsible; records should be kept for 2 years minimum and include who was involved, and when it was taken

How long should prescription records be kept? Who is responsible?

At least 3 years; PIC is responsible

includes prescriptions, transfers in/out, and vaccine adminisration

How long must records of CS orders/invoices be kept? Who is responsible?

at least 2 years; PIC is responsible

How often should PMP submissions be completed

daily at minimum

DEA form 106

report of theft or loss of controlled substances

What actions should a PIC take after theft of a CS

tell the DE "Office of Controlled Substances" and inform the DEA within 1 day, then submit DEA form 106

How often should PICs complete pharmacy self-inspections

Annually by Feb 1st of each year

Must also perform a self-inspection within 30 days of becoming the PIC

How long should pharmacy self-inspection forms be kept

3 years

A PIC must notify the board within ___ days of termination as the PIC

10

How long does a new PIC (who has never been a PIC in DE) have to appear before the board

90 days

How much experience is necessary in order for a pharmacist to serve as a preceptor?

2 years

How long do ALL licensees (pharmacists/techs/interns) have to inform the Board of a home address change?

within 10 days of the change

What is the maximum pharmacist to tech ratio

there is no maximum ratio; pharmacist must simply ensure there is proper supervision that ensures patient safety

How long after employment do techs have to complete a training program

90 days

What duties can non-certified pharmacy techs carry out?

performance of dispensing functions, such as filling, labeling, and stocking of drugs

What duties can certified pharmacy techs perform

- dispensing functions, as filling, labeling, and stocking

- administration of vaccines

- reconstitution of oral solutions

- non-sterile and sterile compounding

- contacting prescriber for a refill authorization

T or F: a certified pharmacy tech may not perform sterile compounding

false; they can perform both sterile and non-sterile

Pharmacy technicians may NOT...

- certify prescriptions

- perform DURs

- provide drug info that requires clinical/technical knowledge

- counsel patients

- receive a new verbal Rx order without recorded backup

- contact prescriber about a prescription drug order interpretation or therapy modification

- transfer prescriptions

How many techs must be on duty at all times when a pharmacy is open for business?

at least one

A certified tech must obtain __ hours of CE on ___ during each renewal cycle

2 hours of CE on vaccines

How many hours of practical experience are required for licensure

1500

How long do pharmacy interns have to notify the board of a change in preceptor

10 days

What duties can interns perform

essentially all of the same duties as a pharmacist, EXCEPT

- oversight of technicians

- final verification of a prescription

How often is pharmacist license renewal

September 30th of even-numbered years (biennial)

Pharmacist CE requirements

30 hours per biennial licensure period, with the following requirements:

- 2 hours related to medication safety/errors

- 2 hours related to CS or the detection of abuse or illegal use of CS

- 2 hours related to vaccines/injectables (if applicable)

NEWLY LICENSED (1st biennial period): only required to obtain 1.25 hours per month

T or F: CE hours may be permitted to carry-over from one period to another

FALSE. never allowed

Felony or misdemeanor: failure to keep CS records (order forms, invoices, statements, etc)

misdemeanor (but pretty much anything else to do with CS is a felony)

Felony or misdemeanor: violation on the proper storage or sale of pseudoephedrine

misdemeanor

Felony or misdemeanor: unlawful distribution of a CS

felony

Felony or misdemeanor: using a false DEA registration number

felony

Felony or misdemeanor: acquiring a CS by misrepresentation or forgery

Felony

Felony or misdemeanor: furnishing false CS info on an official application

felony

Felony or misdemeanor: theft of a CS

felony

Felony or misdemeanor: administering a steroid for the purpose of increasing human performance in sport/game

felony

Felony or misdemeanor: unlawful disclosure of PMP info

felony

T or F: pharmacists that fail to submit CS dispensing info into the PMP will be subject to discipline

true

What violations of the Delaware Pharmacy Act or Board rules may lead to suspension or revocation of license?

- practicing incompetently or negligently

- being convicted of a crime related to pharmacy

- abusing drugs

- having license disciplined in another jurisdiction

- inability to practice with reasonable skill/safety due to mental/physical impairment

- dispensing outdated product

- charging third party for more expensive drug than what was dispensed

- improperly altering content of a prescription or prescription records

- circumventing patient counseling requirements

- dispensing meds without proper authorization

- falsifying affidavit

T or F: the Board always takes formal disciplinary actions on pharmacists who have violated the DE Pharmacy Act

FALSE. they may choose to counsel a pharmacist on a violation rather than taking formal disciplinary measures

When might the board summarily suspend a license BEFORE a hearing?

if there is a danger to public health/welfare

T or F: Pharmacists are not mandated reporters of child abuse or neglect

FALSE. they are mandated reporters and must report any known or suspected incidences

What must a pharmacist do if their license has been disciplined by another state's board?

report to the DE board

What must a pharmacist do if they have been convicted of a crime related to pharmacy

report to the DE board

An impaired pharmacist may enter a treatment program WITHOUT disciplinary action if...

no complaint has been filed against him/her and no guilty plea has been made

if there IS a complaint against the RPh, the Board can CHOOSE whether to discipline the RPh or defer (and possibly ultimately dismiss) the discipline if a treatment program is completed

An impaired pharmacist partaking in a treatment program must do the following

- MAY NOT engage in the practice of pharmacy

- must sign a release so that records of treatment & progress in the program are released to the Board

- continue to make progress and complete the program (if not, disciplinary action may be pursued)

- submit to random drug/alcohol screenings

- pay for all costs related to the program

T or F: impaired pharmacists entering a treatment program are entitled to confidential care

FALSE. must sign a release form allowing the Board to monitor your records for progress

Pharmacists in DE are required to report any healthcare provider (including themself) who has...

- engaged in conduct that would constitute grounds for discipline

- the inability to practice with reasonable skill and safety due to incompetence, mental illness, physical illness, or drug/alcohol abuse

T or F: Online survey-based prescription issuance is considered sufficient for an established patient-prescriber relationship

FALSE; insufficient

T or F: Telehealth visits for prescription issuance is considered sufficient for an established patient-prescriber relationship

TRUE

All hard-copy prescriptions must be issued on...

tamper-resistant prescription forms that prevent unauthorized copying, modifications/erasing, or ability to counterfeit

When do pharmacists filling prescriptions assume corresponding liability

- if its not properly prepared

- not issued for a legit purpose

- out of the prescribers scope

T or F: A PA prescribing controlled substances puts the DEA number of their supervising physician on the prescription

FALSE. the PA must use their own name & DEA number

T or F: It is acceptable to fill CS prescriptions received from out-of-state prescribers

true, so long as the Rx meets all other normal DE requirements

What must any prescriber that prescribes CS include on the Rx?

their own DEA number

T or F: APRNs and PAs may prescribe all controlled substances

true, as long as it remains within their scope of practice

also, PAs must be delegated by a supervising physician

Optometrist CS prescription requirements

must obtain a Controlled Substance Registration (CSR) and then can prescribe SELECT CS for eye-related issues only!

- CIIs containing hydrocodone only for a max of 72 hour supply

- CIII, CIV, and CV with a max limit of a 72 hour supply

- oral steroids are limited to a single 6-day Medrol dose pack

What prescriber must obtain a Controlled Substance Registration (CSR)

optometrist

T or F: Dentists can prescribe all CS

true, but only for teeth/mouth related issues

T or F: A veterinarian can prescribe for a human

FALSE, vets can NEVER prescribe for humans. animals only.

Requirements to be included on ALL prescriptions under DE law

- patient name & address

- prescriber name, address, phone #, degree classification

- prescriber's signature (may be electronic)

- prescriber license number

- date of issuance

- drug name, strength, dosage form, & quantity

- directions for use

- number of refills allowed

- electronic only: date of transmission & name of intended pharmacy

What patient-related info must be on a prescription under DE law

name and address

T or F: date of birth must be on a prescription under DE law

FALSE

What prescriber info must be on a prescription under DE law

- name

- address

- telephone number

- degree classification (MD, DO, PA, etc)

- signature (physical or electronic)

- license number

- date of issuance

- date/time of transmission & name of intended pharmacy

What drug-related info must be on all prescriptions under DE law

- name

- strength

- dosage form

- quantity

- directions for use

- number of refills allowed

How long is a non-CS presciption valid to be filled

up to 1 year after the date of issuance

What is DE's rule for electronic vs physical prescriptions

all prescriptions (non-CS and CS) must be issued electronically, with some exceptions (technology failure, prescriber waiver, veterinarian, etc).

However, an RPh is not required to verify that an exception is in place if a patient brings a physical copy.

Emergency refill requirements

- non-CS med that is essential for continuation of therapy for a chronic condition

- supply dispensed is minimum needed for the emergency period

- Rx was originally dispensed at this same pharmacy

- prescriber is notified of the emergency fill and it is documented in the patient profile

- the prescription hasn't been emergency filled before

T or F: an emergency fill can be done more than once for the same Rx

false

When can a CS be issued as a verbal order and what are the requirements

EMERGENCY situations only!

- the quantity may not exceed what is needed for the emergency period

- the RPh must immediately reduce the verbal to writing

- the prescriber must deliver a written/electronic Rx to be delivered to the pharmacy within 7 days to cover for the emergency dispensing

What is the quantity limit for a CII prescription

up to 100 dosage units or up to a 31-day supply (whichever is greater)

How long is a CS prescription valid?

CII and CIIIs become void if not dispensed within 7 days of the date of issuance, UNLESS

- prescriber utilizes a "do not fill until" comment)

- terminally ill or LTCF patients have 60 days

CIII and CIV prescriptions expire 6 months after issuance

When can a faxed CII prescription serve as the original copy?

only for patients in hospice, patients with a terminal illness, or if the drug is to be compounded for direct patient administration by a HCP

CS refill limits

CII- no refills

CIII, IV, and V- 5 refills

Days supply limit on initial opioid prescriptions for acute pain

initial Rx for acute pain opioids should only be for a 7 days supply maximum

prescribers can override this for situations such as hospice, active cancer treatment patients, terminally ill patients, hospitalized inpatients, or those with terminal illness -> in general, if an opioid Rx for acute pain is issued for > 7 days supply, the RPh should question the prescriber

What information should NEVER be altered by a pharmacist on a CS prescription

patient's name, drug name, or the prescriber's name/signature

(NAME NAME NAME rule)

What information is permissible to be altered by a pharmacist on a CS prescription WITHOUT CONSULTING THE PRESCRIBER

RPh can add the patient's address and the dosage form

What information is permissible to be altered by a pharmacist on a CS prescription AFTER FIRST CONSULTING THE PRESCRIBER

RPh can make additions/edits to the patient's address, drug strength, drug quantity, and directions for use

T or F: a prescriber can issue an Rx to obtain stock of CS for their own dispensing to patients

FALSE

Requirements for pharmacists to prescribe hormonal contraceptives

- must complete approved training program and refer the patient to HCP upon dispensing

- must have patients complete a self-screening risk assessment

- must provide patient with a copy of the visit and a written record of the drug prescribed

To what ages can pharmacists administer vaccines?

patients age 3 and older

What requirements are necessary for pharmacists to partake in vaccine administration

- completion of a Board-approved training program and a current CPR certification

- must obtain 2 hours of CE related to vaccines during each 2yr cycle

- must counsel the patient & obtain their consent

- must provide a VIS to patient prior to administration

- must report any AEs to VAERs

- must document vaccine administration to DelVAX within 72 hours of administration

Requirements for consultant pharmacists at nursing facilities

- notify Board within 10 days of taking the role

- monthly inspections of all drug storage areas

- review the drug regimen of each patient on a monthly basis

When must counseling be offered for prescriptions

new prescription or if changed from previously

T or F: counseling supplements like videos and print-outs cannot replace the face-to-face counseling offer on a new or changed Rx

true

T or F: telepharmacy counseling on a new Rx or newly changed Rx is acceptable if the patient is not physically in DE

FALSE. patient must be present in DE and provide informed consent

How is counseling offered/provided on a delivered Rx?

written/printed info and the pharmacy's phone number must be included within the package

What patients do NOT need to be offered counseling for new or changed drugs

Inpatients of a hospital

What must be done if a patient declines counseling on a new or changed Rx

pharmacist must document that the offer was made within the patient profile

What is the time limit for redispensing a drug that has been returned to shelf from will call and therefore never reached the patient

within 1 year from the original date of dispensing

Rules for accepting returned drugs

- in general, pharmacies may not accept returned drugs from patients UNLESS it is for the purpose of disposal only

- if a non-CS was packaged in an unopened manufacturer's unit dose or with a tamper-proof seal and held in appropriate conditions by a HCP, it may be accepted for return and redispensing

Within what time period must nursing facilities return an unused, unopened product to a pharmacy for redispensing

within 72 hours of the drug being discontinued

CLIA waivers allow "test and treat" by pharmacists for...

influenza, strep, COVID, lice, ringworm, athlete's foot

T or F: Pharmacists may dispense naloxone without a Rx to patients in need

true

When/to who can a pharmacist release patient information

- to another provider who is actually providing care to the patient

- required legally (law enforcement inquiry, etc)

Pharmacies must give patients a notice of ______ before serving them

privacy practices

A pharmacist is responsible for refusing to fill an Rx if....

- they believe it was not issued for a legitimate medical purpose

- it was issued outside of a valid patient/prescriber relationship

- it was issued outside of the scope of the prescriber

CII transfer requirements

unfilled CIIs that were issued electronically may be forwarded/transferred to another pharmacy electronically only (may not use verbal or fax transfers)

CIII-CV transfer requirements

may be transferred one time only unless it is within the same chain (shared online database), at which point the Rx may be transferred up to the maximum refills permitted by law and authorized on the Rx

Required steps to transfer an Rx out

- void current Rx in the computer

- record date of transfer

- document name, address, and phone of receiving pharmacy

- document name/initials of receiving pharmacist (or intern if non-CS)

- if its a CS, must document DEA # of the pharmacy

When transferring in a prescription, the following must be recorded..

- word "transfer"

- date of issuance

- date of original fill

- number of original refills

- number of valid refills remaining

- date of last fill

- Rx number

- pharmacy name/address/phone

- if its a CS, the DEA number of the pharmacy and the pharmacist's name

T or F: PMP logins can be shared amongst pharmacy employees

FALSE. RPhs, interns, and techs can all access PMP but via their own logins