CPJE law

An underserved location is one that does not have a pharmacy within ______ (distance).

10 miles

Supervising pharmacy and the remote site must be within _____ (distance) of each other

150 miles

In telepharmacies, controlled substances must be stored separately. All management of controlled substances, such as filling, dispensing, and taking deliveries must be captured on video. Video recordings must be kept at least _____ (time).

120 days

A pharmacist from the supervising pharmacy must travel to the remote/ telepharmacy site and conduct an inspection of the pharmacy at least _____ (frequency).

once a month

Opioids are limited to a ____ (time) supply for initial prescriptions for Medicare Part D patients if the patient has not received an opioid in the last _____ to _____ (time)

7 day supply; 60-90 days

PIC can supervised up to _____ (number) pharmacies as long as they are within _____ (distance) of each other.

2 pharmacies; 50 driving miles

Any change of PIC is reported by the pharmacy & the departing PIC to the board in writing within _____ (time).

30 days

PIC must complete a _____ (frequency) self-assessment form for their pharmacy before _____ (date) of each _____ (odd/even?) numbered year

biennial (every other year)
July 1
Odd (ex: Before July 1, 2017, then again before July 1, 2019)

An additional PIC self-assessment form must be completed within _____ (time) if a NEW PERMIT is issued, when the pharmacy has A NEW PIC, or when the pharmacy MOVES TO A NEW LOCATION.

30 days

Each PIC self-assessment form will be kept in the pharmacy for _____ (time).

3 years

If the pharmacy has only 1 pharmacist on duty, the pharmacist can leave for a break and meal periods for up to _____ (time)

30 minutes

While the pharmacist is away (not inside the pharmacy), only _____ (type) medications that the pharmacist has already checked and which do not require patient counseling can be dispensed.

refill

A new law in 2018 _____ (allows/ phohibits?) a community pharmacy from requiring a pharmacist to WORK ALONE.

prohibits

Under SB 493, all registered pharmacists (RPhs) can provide the following servies after meeting certain training requirements:
(6 things)

1. administer drugs & biologics
2. furnish self-administered hormonal contraceptives
3. Furnish travel medications
4. Furnish prescription nicotine replacement products
5. Independently initiate & administer immunizations (per CDC as long as patients are 3 y/o or OLDER)
6. Order and interpret tests

In order to ensure that pharmacists are up-to-date with new drug changes & treatment guidelines, _____ (time) of continuing education (CE) must be completed during each 2-yr license period.

30 hours

For license renewals on or after July 1, 2019, at least _____ (time) of pharmacy laaw and ethics must be included for each renewal.

2 hours

Pharmacy license expires on the _____ (first or last?) day of the pharmacist's BIRTH MONTH

last day

The first _____-year license cycle is EXEMPT from CE requirements since the pharmacist is considered up-to-date.

2

The certificate of completion of pharmacist CEs must be kept for _____ (time)

4 years

A pharmacist can supervise _____ interns at any one time.

2

Ratio of Pharmacist to Technician (COMMUNITY)
1 pharmacist: _____

1 technician

Ratio of Pharmacist to Technician (COMMUNITY)
>1 pharmacist --> _____ technicians for each ADDITIONAL pharmacists
2 pharmacists: _____ technicians
3 pharmacists: _____ technicians

2
3
5

Ratio of Pharmacist to Technician (Inpatient)
1 pharmacist: _____ technician per each pharmacist

2 technicians

A pharmacist can only supervise _____ technician TRAINEE at a time, and only for up to 120 hours.

1

A pharmacist can supervise _____ clerks at a time

unlimited

Clerks _____ (can/ connot?) put drugs on the shelf and give patients their prescriptions at the point of transaction.

CAN

Any prescriber that prescribes for controlled substances must be registered w/the _____ (organization). Pharmacists should not fill a prescription if the practitioner is not prescribing w/in his/her SCOPE OF PRACTICE.

DEA

Prescriptions from DECEASED prescribers: If a valid prescription was written when the prescriber was living, the prescription is considered valid untill _____ & no more than _____ (time) from the written date for CONTROLLED substances & _____ (time) for UNCONTROLLED substances (whichever comes 1st).

refills are gone
6 months- controlled
1 year- uncontrolled

A prescription must have the following information:

Pt name
Address of pt
Name & quantity of drug/ device
Directions for use
Date of issue
Prescriber info (stamped, typed, or written by hand/ typeset)- Name, address, & telephone number, prescriber's license classification, prescriber's DEA number (if controlled substance is prescribed)
Condition or purpose of prescribed drug (if requested by the pt)
Prescriber signature

If the prescription is written by a veterinarian for a controlled substance for an animal, it must state the _____ of animal & the _______ of the owner or person having custody of the animal.

kind
name & address

Prescriptions must be kept in the pharmacy for _____ (time)

3 years

Stop dispensing prescriptions for NON-CONTROLLED drugs after _____ (time) from the issue date (even if the Rx has more refills lefts).

1 year

All CONTROLLED drugs expire _____ (time) from the date of issue.

6 months

There is _____ refill limit for schedule V drugs

no refill limit

Refills for schedule III and IV drugs are limited to a maximum of _____ refills within _____ (time) and all refills COMBINED cannot exceed _____-day supply. The original fill is NOT A REFILL and is NOT included when determining if _____-day supply limit has been exceeded.

5
6 months
120
120

There is _____ refill that can be given for schedule II drugs

0

PRN refills are ONLY acceptable for _____ (non-controlled/ controlled?) substances. PRN refills should not be refilled past _____ (time) from the date of issue

non-controlled
1 year

If a non-controlled Rx has a PRN refill and is written for 30d supply, how many refills can you give to the pt?

11 refills (remember the 1st fill is not considered a refill)

If a non-controlled Rx has a PRN refill and is written for 90d supply, how many refills can you give to the pt?

3 refills (remember the 1st fill is not considered a refill)

It is allowed to dispense up change Rx to 90d supply of a NON-CONTROLLED, NON-PSYCHIATRIC drug when the initial Rx specified a shorter time period (ex 30d supply) as long as the following requirements are met:
1. The pt has completed an initial _____-day supply of the drug w/ no neg effects, or the pt previously received the same medication w/ a 90d supply.
2. Total quantity dispensed (including the refills) DOES NOT EXCEED the amount authorized on the Rx.
3. The pharmacist notifies prescriber about 90d supply change.

30d

A pharmacist cannot dispense a greater quantity supply of drug (ex: from 30d supply to 90d supply) if:
1. Prescriber hand written or orally indicates "_____" or words similar to that
2. Prescriber indicates that dispensing the initial amount is MEDICALLY NECESSARY

No change to quantity

At pt's request AND with a VALID Rx that states _____-supply, the pharmacy MUST dispense up to _____- supply of a self-administered hormonal contraceptive (ALL AT ONE TIME) (self-admin hormonal contraceptive includes pill, patch, ring, injection)

12 month (for both answers)

Who can be involved in an Rx transfer from one pharmacy to another?

Pharmacists, Intern pharmacists

When a BRAND name is dispensed, the brand name should be listed on the Rx label. Manufacturer's name _____ (is/ is not?) required because the brand name _____ (can/ cannot) be used to identify the manufacturer.

is not
can

When a GENERIC name is dispensed, the Rx label _____ (must/ must not?) include:
1. The generic name
2. "GENERIC NAME FOR [insert brand name equiv] to indicate the brand name drug equivalent to the dispensed generic drug
3. The generic drug manufacturer.
There are often multiple manufacturers of the same generic drug.

must

Each of the following items (and onlt these 4 items) must be clustered into ONE AREA of the label that comprises at least _____% of the label. Each item must be printed in at least a _____ font sized sans serif typeface and listed in the FOLLOWING ORDER: (4)

50%
12
1. Name of pt
2. Name and strength of drug
3. Directions for use of drug
Condition or purpose of drug (if written in Rx)

Which drug classes can impair a person's ability to operate a vehicle or vessel and the pharmacist should warn the pt about this huge side effect and be included as a warning in the axiliary label:

Muscle relaxants
Antipsychotic drugs w/ CNS depressant effects
Anti deppressants w/ CNS depressant effects
Antihistamines
Motion sickness agents
Antipruritics
Antinauseants
Anticonvulsants
Antihypertensive agents
Controlled substances w/ CNS depressant effects
Anticholinergic agents that may impair vision

Which drug classes pose a substantial risk of side effect(s) in combo w/ ALCOHOL and pharmacist must then include a warning on the prescription label:

disulfiram (ex chlorpropamide, flagyl)
MAO inhibitors
Nitrates
Antidiabetic agents (insulin, SFU due to risk of hypoglycemia

Prospective Drug Utilization Review (DUR) vs Retrospective DUR

Prospective DUR: evaluating pt's med profile PRIOR to dispensing
Retrospective DUR: evaluating pt's med profile AFTER drug is dispensed

A pharmacist must keep med profiles on all pts who have Rxs filled at the pharmacy except when pharmacist feels that the pt will NOT come back to the pharmacy. Each profile must be kept for at least _____ (time) from the date when the LAST Rx was filled

1 year

There are 3 types of written info that can be provided to the pt:

Consumer Medication Information (CMI) leaflets
Patient Package Inserts (PPIs)
Medication Guides (MedGuides)

When should CMI be given to pt's?

For each new Rx

Is CMI FDA approved?

No

When should PPI be given to pt's

For every Rx (old and new)

In institutionalized setting (hospital/ long-term care facility), PPI must be given to patient _____ (before/ after?) administration and every _____ (time) thereafter.

before
30 days

Is PPI FDA approved?

Yes

When should MedGuides be given to pts?

Every Rx fill (old and new)
Can also be given if pt/ caregiver asks for it

Is MedGuides FDA approved?

Yes

What does REMS mean?

Risk Evaluation and Mitigation Strategy
It ensures that the benefits of certain drugs and biologics outweigh the risks

Thalidomide
What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

Thalomid REMS Program (prev called STEPS program)
Risk: Severe birth defects
Requirement: Negative pregnancy test required prior to dispensing EACH prescription

Isotretinoin
What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

iPledge Program
Risk: Severe birth defects
Requirement: Negative pregnancy test required prior to dispensing EACH prescription

Clozapine
What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

Clozapine REMS Program
Risk: Neutropenia; Agranulocytosis
Requirement: Monitor ANC

Qsymia
What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

Qsymia REMS Program
Risk: Severe birth defects
Reuirement: MedGuide reuired, healthcare training program, dispensed only through certified pharmacies

ER/LA opioids (Avinza, Butrans, Dolophine, Duragesic, Exalgo, Hysingla ER, Kadian, Methadose, MS Contin, Nucynta ER, Oxycontin, Zohydro ER, Hysingla)

What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

ER/LA Opioid Analgesics REMS Program
Risk: High abuse potential, life-threatening respiratory depression
Requirement: MedGuide required and prescribers must complete approved CE and must counsel on pts

Saxenda
What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

Saxenda REMS Program
Risk: Medullary thyroid carcinoma, risk of acute pancreatitis

Addyi
What is the Risk? What is the REMS requirement for the med to be approved for dispensing?

Addyi REMS Program
Risk: Hypotension and syncope due to an interaction W/ ALCOHOL
Reuirement: No alcohol use while taking Addyi. All REMS participants must be trained and pts must be properly counseled.

Patient counseling must include at least the following items:

Directions for use and storage
Importance of compliance w/ directions
Precautions and relevant warnings (common/ severe SEs and drug interactions)

If a prescription is MAILED or delivered, there must be a _____ (written/ verbal?) notice that a pharmacist is available if the pt has any questions and a telephone # that the pt can call.

written

Incidental disclosures (ex: accidently overheard when counseling a patient at a pharmacy or when discussing pt's care during medical rounds) _____ (are/ are not) a HIPPA violation.

are not

The Orange Book uses 2-letter code system to indicate whether or not a generic drug is therapeutically equivalent to the branded drug.

An AB rated generic drug is _______ (therapeutically/ NOT therapeutically? ) equivalent to the reference listed drug (RLD), which is the branded drug that the generic manufacturer submitted to the FDA.

If the first letter is B, such as BB rated drug, the formulation is _____ (therapeutically/ NOT therapeutically) equivalent.

AB rated: therapeutically equiv
B_ rated: NOT therapeutically equivalent

Substitution _____ (is/ is NOT) permitted between long- acting and short-acting forms of a medication with the same chemical ingredients (Ex: LA form of clonidine that is indicated for ADHD (Kapvay) to be interchanged with IR clonidine)

Substitution _____ (is/ is NOT) permitted between combination drug products and multiple single- agents (Ex: Combo drug isosorbide dinitrate/ hydralazine (BiDil) to be interchanged with 2 indiv drugs as seperate drugs)

Both answers: is NOT

Substitution _____ (is/ is NOT) permitted by the pahrmacist between different formulation with same active ingredients of equivalnet strength and duration of therapy as the prescribed drug when the change will improve patient compliance. (Ex: 1/2 tab Bactrim DS for a child to be interchanged with 5mL/dose pediatric suspension to the child's parents.

is

What is a biosimilar?

A biological product that has highly similar structure and function to the reference product and has no significant difference in safety and effectiveness from the reference product.

What is a biosimilar to filgrastim (Neupogen)?

Filgrastim-sndz (Zarxio)

What is a biosimilar for infliximab (Remicade)?

Infliximab-dyyb (Inflectra)

A biosimilar _____ (is/ is NOT) automatically interchangable with the reference product. A biosimilar must prove that it would have the same clinical effect as the reference product in any given patient in order to be considered interchangable.

is NOT

Drugs can be pre-counted or repackaged from a stock container (which is larger) into smaller quantities suitable for dispensing. The repackaging should be done according to the Current Good Manufacturing Practices (CGMPs), and the drugs must be properly labeled with at least the following information: (7 things)

Name of drug
Strength
Dosage form
Manufacturer's Name
Lot #
Expiration Date
Quantity per repackaged unit

If a MD is unable to create a written order, MD can make a verbal order instead. If a nurse is involved, the nurse can enter the order for MD, NOTE PRESCRIBER'S NAME AND SIGN the order. The MD then has _____ (time) to physically or electronically COUNTERSIGN the order.

48 hours

A copy of the chart order for NON-CONTROLLED substances must be kept at the hospital for at least _____ (time).

3 years

A copy of the chart order for CONTROLLED substances must be kept at the hospital for at least _____ (time).

7 years

The board has created a type of specialty license for the hospital pharmacy to perform centralized packaging for the pharmacy's hospital & 1 or more general acute care hospitals under COMMON OWNERSHIP & located within _____ (distance) radius of each other

75 mile

Hospital Dose Packaging: Label for each unit dose medication produced by a centralized hospital packaging pharmacy must contain all of the following: (7 things)

Name of medication
Quantity of each active ingredient
Date medication was prepared
Beyond use date
Special storage or handling requirements
Lot or control #
Name of centralized hospital packaging pharmacy

Hospital Dose Packaging: Label should include beyond use date which is no later than either of the following: (2)

1 year from date of the drug was repackaged
Expiration date on manufacturer's container

Drug supplies for use of medical emergencies must be immediately available at each nursing unit or service area. The hospital drug supply must be inspected by a pharmacist, intern, or technician at least every _____ (time). Records for inspections must be kept for at least _____ (time). Irregularities found should be reported within _____ (time) to the PIC and the director or chief executive officer of the healthcare facility.

30 days
3 years
24 hours

Dispensing Blood Clotting Products for Home Use: Each provider of blood clotting products for home use must:

1. Maintain 24/7 on-call service everyday of the year.
2. Have the ability to obtain all FDA-approved blood clotting products in multiple assay ranges & vial sizes
3. Supply all necessary ancillary infusion equipment & supplies with each prescription, as needed
Ship the prescribed blood clotting products & ancillary infusion equipment & supplies to the pt w/in 2 business days.

A mobile pharmacy during a federal/state/local emergency must cease activity within _____ (time) after the emergency is over.

48 hours

All actions related to test ordering, interpretationm and management, including changes in drug treatment, must be documented within _____ (time) in a system accessible to the healthcare team members (Ex: electronic Health Record (EHR))

24 hours

Higher the gauge, the _____ (thicker/ thinner?) the needle

thinner

Vaccination: What is the length of the needle for IM injection? What is the angle?

1 inch
1.5 inch if W >200lbs or M > 260lbs
90 degree angle

Vaccination: What is the length of the needle for SC injection? What is the angle

5/8 inch
45 degree angle

In California, pharmacists can independently administer routine immunizations to anyone greater than or equal to _____ years old

3 years old

A pharmacist _____ (can/ cannot?) administer epinephrine or diphenhydramine by injection to treat severe allergic reaction

Can

Pharmacists and interns who initiate and administer vaccines must:
Complete a CDC or ACIP-approved immunization training program
Maintain basic life support certification
Complete ONE HOUR of continuing education on immunizaitons and vaccines every _____ (time).

2 years

Pharmacist must notify each patient's PCP within _____ (time) of the administration of any vaccine.

14 days

What are the two types of oral emergency contraception?

Levonorgestrel- OTC; best to take within 3d (can take within 5d but less effective in day 5)
Ulipristal (Ella)- Rx only best to take within 5d

Which oral emergency contraceptive does the purchaser need to be 17 y/o or older?

2-tablet levonorgestrel products

When dispensing naloxone to pt, pt counseling _____ (can/ cannot?) be waived.

Cannot

California pharmacists can furnish naloxone w/o an Rx pursuant to a protocol as long as they follow these steps:
1. Complete _____ (time) of CE on the use of naloxone or equivalent curriculum-based training from board-recognized school of pharmacy.
2. Ask if the recipient uses opioids or knows someone who does.
3. Ask if the recipient has a known naloxone hypersensitivity.
4. When dispensing naloxone to pt, pt counseling _____ (can/ cannot?) be waived.
5. Provide board-approved Fact Sheet. With the pt's permission, the pharmacist must notify the patient's PCP that naloxone was furnished.
6. Keep records of furnishing the naloxone for 3 years.

1 hour
Cannot

Under protocol, pharmacists can furnish prescription NRT (including inhaler & nasal spray) by following these steps:
1. Complete a minimum of _____ (time) of an approved CE program specific to smoking cessation therapy & NRT or equiv curriculum approved by BOP.
2. Complete ongoing CE focused on smoking cessation therapy every _____ (time).
3. Reviews the pt's current tobacco use & past quit attempts.
4. Asks pt a series of screening questions:
- Pregnant or planning to be pregnant? --> DNG
- Heart attack w/in past 2 wks? ---> Furnish w/ caution
- Hx heart palpitations, arrhythmia ---> Furnish w/ caution
- Hx of allergic rhinitis? ---> Avoid nasal spray
- Diagnosed with temporal mandibular joint (TMJ) dysfunction? ---> Avoid nicotine GUM
5. Counsel pts on therapy and refers to smoking cessation support.
6. Notify PCP of the medications provided. Records of furnishing the NRT are kept for 3 years.

2 hours
2 years

Furnishing Self-administered Hormonal Contraceptives (PO, patch, ring, injectable): pharmacists who participate in this protocol must have completed at least _____ (time) of a BOP-approved continuing education program specific to self-administered hormonal contraception, application of the US Medical Eligibility Criteria (USMEC) for contraceptive use, and other CDC guidance on contraception.

1 hour