CPJE Law 2023: High Yield

Pharmacy Record Keeping

Most items are kept 3 years. However, (1) items is kept 7 years. Name it.

7 years

-Hospital chart orders for controlled substances

Pharmacy Record Keeping

Most items are kept 3 years. However, (1) item is kept 6 years. Name them.

6 Years

-HIPAA acknowledgement

Pharmacy Record Keeping

Most items are kept 3 years. However, (1) item are kept 4 years. Name it.

4 years:

CE Certificates

Pharmacy Record Keeping

Most items are kept 3 years. However, (2) items are kept 2 years. Name them.

2 Years:

(1) Pseudophed Sales Log

(2) DEA CS Biennial Inventory

Pharmacy Record Keeping

Most items are kept 3 years. However, (2) items are kept 1 year. Name them.

1 year:

(1) Patient med profile

(2) Med error/ QA forms

Per CA law, what is considered EMERGENCY CONTRACEPTION that pharmacist can furnish?

Plan B
Ella
High dose COC

Expiration date: Prescription Bottle vs Unit Dose

RX bottle: 1 year
Unit Dose: 6 months

On CA security prescriptions, what items need checkboxes?

(1) Drugs Quantity
(2) Refills
(3) "Do Not Sub"
(4) Prescriber -- if multiple prescriber on pad

What are the 4 critical items on RX bottle?

(1) Patient name

(2) Drug n ame/strength

(3) Directions for Use

(4) Indication, if on original prescription

Investigation of pharmacy medication error must begin within ____ days of the error occuring?

2 days

Centralized Hospital Packaging:

Hospitals must be under common ownership and within ____ mile radius

75 miles

Telepharmacy/remote dispensing

Distance between remote site and supervising pharmacy: ______

150 miles

If one PIC oversees 2 pharmacies, the distance between the pharmacies cannot be more than _____ miles

50 driving miles

All outpatient RX records are kept for ____ years

3 years

503A vs 503B

503A:
-Trad compounding
-Requires individual RX
-Regulator: BOP

503B:
-Outsourcing compounding
-No individual RX
-Regulator: BOP + FDA

What are limits to CS prescribing for OPTOMETRIST and NATUROPATHIC DOCTOR?

Optometrist:

(1) Only schedule 2-4, cannot prescribe schedule 5

(2) codeine and hydrocodone --> max 3 day supply

Naturopathic

(1) only schedule 3-5, cannot prescribe schedule 2

Pharmacist to intern

1:2

Pharmacist to tech

(retail vs hospital)

Retail:

-first pharmacist = 1 tech

- Every other pharmacist = 2 tech

Hospital

- 1 pharmacist: 2 tech

How to report loss/theft of controlled substance to DEA and BOP

Report to DEA: within 1 days

AND

Report to BOP:

-Cause = general loss = 30 days

-Cause = theft = 14 days

When must you report vaccine or travel med furnishing to PCP?

Within 14 days

When does PIC self-assessment have to be performed?

Within 30 days:

- New PIC

- New pharmacy permit

- Change to pharmacy location

After that, every odd numbered year before July 1

Form 222 vs CSOS

When myst supplier report transaction to DEA?

222: END OF MONTH

CSOS: 2 BUSINESS DAYS

DEA Triplicate Forms: what do colors mean

Copy 1 = BROWN = where the drugs come from

Copy 2 = GREEN = DEA

Copy 3 = BLUE = where the drugs are going

What pre-printed prescriber info must be on CS Security Pad?

Pre-Printed on CS Prescription

-Name

-License Type (MD, DO, PA, etc)

-License Number

-DEA number

What is the only time a faxed RX can be the original for Schedule 2 prescription?

Patients at SNF/LTC, Hospice, Home Health

Multiple sequential RX for schedule 2 drugs:

Prescribers can write multiple sequential RX at one time but cannot exceed total ____ day supply

90 days

What buprenorphine formulations are used for PAIN vs OPIOID TX?

PAIN: Monotherapy

OPIOID TX: Monotherapy + Combo w/ naloxone

When is pharmacist license expiration date?

Last day of your bday (JANUARY) every 2 years

General CE requirements?

30 hours of CE every 2 years
(2 hours must be law/ethics)

When furnishing contraception, what 3 papers must be given to patient

(1) FDA birth control guides
(2) PPI
(3) Fact sheet w/ admin instructions

What drugs are used for end of life?

Secobarbital (SECONAL)

Pentobarbital (NEMBUTAL)

What standards do 503A vs 503B facilities follow?

503A: USP

503B: USP + CGMP

503A vs 503B: interstate distribution?

Interstate Distribution

503A: only up to 5% of total sales

503B: Yes, unlimited

Age limit to receive vaccines?

Must be at least 3 YEARS OLD

To dispense blood products

(1) Must have 24 hours phone line and respond to calls within _____
(2) Must ship blood product and equipment within _____

(1) 1 hour
(2) 2 business days

Drug Take Back

If STARTING/STOPPING new program, must notify BOP within ____ days

30 days

Drug Take Back

If there has been theft/tampering, must notify BOP within

14 days

Drug Take Back

Inform board every _____ about service and location

Annually

How many pharmacies per one PIC?

2 pharmacies within 50 driving miles

How often does PIC self-assessment have to be done?

#1 = Self-assessment within 30 days

-New permit

-New PIC

-Pharmacy location change

#2 = Every ODD YEAR on July 1st

What is requirement for OD prescribing? What change to their license?

Certified by board of OD
Have "T" at end of license

What is requirement for ND prescribing? What change to license?

Furnishing number = "NDF" before license number

Name 3 exemption from child resistant packaging?

(1) SL NTG
(2) Oral contraception
(3) Hormone replacement

How often are medguides given?

Dispensed to patient = ALL FILLS

Dispensed to providers = First time only

What are 4 things are required in counseling?

(1) Directions for use

(2) Direction for storage

(3) Importance of adherence

(4) Precautions

Task Frequency: PIC self assessment

Every odd numbered year before July 1

Task Frequency: Complete hospital drug supply inspection?

Monthly

Task Frequency: CA required schedule 2 inventory

Q3 months

Task Frequency: DEA Biennial Complete CS Inventory

Q2 years

Task Frequency: 30 hours of CE

Every 2 years (except first cycle)

How to report CS loss (to CA BOP)

General loss: 30 days

Suspected theft: 14 days

How to report CS loss (to DEA)

ASAP within 1 day

Pharmacy Reporting: Submitting dispensing data to CURES

within 1 day

Pharmacy reporting: med error investigation

within 2 days

Pharmacy reporting: Prescriber did NOT provide physical RX for emergency Schedule 2 V/O within 7 days

144 days, report to CA Bureau of Narcotics

Pharmacy reporting: Bankruptcy

ASAP

Pharmacy reporting: impairment of licensee

14 days

Pharmacy reporting: schedule 2 inventory by new PIC

30 days

Pharmacy reporting: change in pharmacy address, name, PIC, or permit type

30 days

Can you fill OUT OF STATE controlled substance prescription?

Schedule 2: Yes but can only be delivered by mail

Schedule 3-5: Yes, can be picked up or delivered

DEA Form 41

Record of destroyed CS

DEA Form 106

report of theft or loss of controlled substances

DEA 222

Paper ordering for schedule 1-2 drugs

DEA 510

Registration form for bulk chemical manufacturers and distributors

DEA 363

Registration form for narcotic treatment programs (OTP)

DEA 225

Registration for:
- Manufacturers
- Distributors
- Researchers
- Analytical laboratories
- Importers
- Exporters

DEA 224

Registration of a

-pharmacy

-hospital

-practioner (MD/DO, PA, etc)

-teaching institute

Dextromethorphan OTC restrictions

+18 YO
Government ID

Pseudophed Purchasing Restrictions

(1) Per Day:
(2) Per 30 day:

(1) Per Day: 3.6g

(2) Per 30 day: 9g

Prescription Transfer Rules

Non-Controlled: unlimited

Schedule 2: No transfers
Schedule 3-5: one transfer, unless shared database

Refill Limits

Non-Controlled: unlimited refills

Schedule 2: 0 refills

Schedule 3-4: Up to 5 refills in 6 months (Total of all refills cannot exceed 120-day supply)

Schedule 5: unlimited refills

How long is prescription valid?

Non-Controlled: 1 year

Controlled Schedule 2-5: 6 months

Patient access to medical records:
-Access must be granted within ___ days
-Copies must be given within ___ days

-Access must be granted within 5 business days

-Copies must be given within 15 business days

If you need to recall a COMPOUNDED drug that you made, when do you notify:

(1) Patient/prescriber
(2) CA BOP

(1) Patient/prescriber: within 12 hours

(2) CA BOP: within 24 hours

How to inventory opened CS bottles?

Schedule 1-2: Exact count always

Schedule 3-5

- Bottle > 1000 tablets = exact count

- Bottle < or = 1000 tablets = estimate

For furnishing of ___, ____, and____

counseling CANNOT be waived

Naloxone

PREP
PEP

To furnish ____, ____, and _____

Pharmacist need two CE hours

(1) Nicotine replacement
(2) Vaccine
(3) Travel meds

To furnish ____, ____, and _____

Pharmacist need one CE hour

(1) Emergency contraception
(2) Self-admin contraception
(3) Naloxone