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Time limit requirement for Keeping Record:
Hospital pharmacy chart orders for controlled substances
7 years
Time limit requirement for Keeping Record:
Patient acknowledgement of HIPAA
6 years
Time limit requirement for Keeping Record:
Transaction information, history, and statement for most prescription drugs (required under Drug Supply Chain Security Act)
6 years
Time limit requirement for Keeping Record:
Certificate of completion for Continuing Education
4 years
Time limit requirement for Keeping Record:
Community or clinic pharmacy prescriptions
3 years
Time limit requirement for Keeping Record:
Hospital pharmacy chart orders for non-controlled drugs
3 years
Time limit requirement for Keeping Record: Controlled susbtance inventories
3 years
Time limit requirement for Keeping Record:
DEA forms 222, CSOS records, power of attorney forms
3 years
Time limit requirement for Keeping Record: Purchase invoices for all prescription drugs
3 years
Time limit requirement for Keeping Record:: Self-assessment forms
3 years
Time limit requirement for Keeping Record: Documentation of the return of drugs to wholesaler or manufacturer
3 years
Time limit requirement for Keeping Record: Documentation of transfers or sales to other pharmacies, licensees, & prescribers
3 years
Time limit requirement for Keeping Record:: Theft and loss reports of controlled substances (DEA forms 106)
3 years
Time limit requirement for Keeping Record: Sale logs of pseudoephedrine and ephedrine
3 years
Time limit requirement for Keeping Record: Patient medication profiles
1 year
Time limit requirement for Keeping Record:: Medication error/quality assurance reports
1 year
Reporting requirements: Change of pharmacist address/name/email
within 30 days
Reporting requirements: Change of pharmacist-in-charge, owners, or corporate officers
within 30 days
Reporting requirements: changes in pharmacy permit
within 30 days
Reporting requirements: theft by a licensee or impairment of a licensee
within 14 days
Reporting requirements: loss/theft of controlled drugs
Report to DEA immediately (one business day). Report to California Board of Pharmacy within 30 days.
Reporting requirements: bankruptcy, insolvency, receivership
immediately
Frequency of pharmacy operation: Completion of self-assessment form
Every odd-numbered year before July 1. Within 30 days when new pharmacy permit/change in PIC/change in pharmacy location.
Frequency of pharmacy operation: Controlled substances inventory (all schedules)(federal requirement)
every 2 years
Frequency of pharmacy operation: Pharmacist continuing education (30 hrs)
every 2 years except first cycle
Frequency of pharmacy operation: Inventory of Alprazolam 1 and 2 mg, Tramadol 50 mg, Promethazine/Codeine 6.25 mg/10mg per 5 mL
every year
Frequency of pharmacy operation: Schedule II controlled substances inventory (state requirement)
every 3 months
Frequency of pharmacy operation: Medication error investigation
Within 2 days of error
Frequency of pharmacy operation: Submitting dispensing data to CURES
within 1 business day of dispensing any schedule II - V drug
To be a licensed as a pharmacist, a candidate must have completed how many hours of pharmacy practice experience?
1500 hours of pharmacy practice experience
When must all licensees join the board's email notification list?
Within 60 days of becoming licensesd
How many hours of continuing education do all registered pharmacists need? Frequency?
30 hours of CE during each two-year license period
How many hours of continuing education do advanced practice pharmacists need? Frequency?
10 hours of CE per cycle in addition to the 30 hours per licensed period
What activities are pharmacy clerks allowed to complete? What are they NOT allowed to complete?
Type a prescription label and enter prescription information into a computer. Request and receive refill authorizations. Put medications back on the shelf and give prescriptions to patients. They are NOT allowed to pull drugs from shelf or fill prescriptions.
if pharmacist suspects another pharmacist is impaired at work, they must report to board within
Within 14 days
Inventory records of schedule II drugs must be kept ____ from all other controlled substances. There [is/is not] a requirement to submit a copy of the inventory to the DEA?
Separate; NOT a requirement
True/false: Inventory should be performed during business hours
FALSE
What documentation is required for pharmacies to store records off-site? Where is this documentation kept?
Waiver granted by the board; kept in the pharmacy
Prescription records are kept for total three years. Prescriptions for non-controlled substances must be kept at the pharmacy for at least ______ After that, the prescriptions can be stored offsite for another _____.
1 year, 2 years
2 multiple choice options
Prescription records are kept for total three years. Prescriptions for _____ must be kept at the pharmacy for at least 2 years. After that, the prescriptions can be stored off-site for another year.
controlled substances
2 multiple choice options
______ is needed to bill Medicare for Durable Medical Equipment
Detailed Written Order (DWO)
True/false: Medicare does not accept PRN refills.
TRUE
If deliveries are made to a hospital pharmacy to through a central receiving location, the drugs or devices must be delivered to the licensed pharmacy premises within _________ day following the delivery.
Within one working day
Adulteration
Drug quality compromised
Misbranding
Incorrect or missing information on the label
How often are hospital drug supplies inspected by a pharmacist/intern/technician?
Every 30 days at least
Which types of drugs are assigned a beyond-use-date?
Repackaged or Resold drugs
Drug Recall
When a drug is removed from the market because it is defective or potentially harmful. Issued by FDA or the drug manufacturer.
True/false: The FDA mandates that the pharmacy contact the patient on drug recalls.
False
In a class I recall, the _________ is responsible for determining which patients received the drug & notifying each __________. The _______ must decide whether to inform the patient.
Pharmacist; patient's prescriber; prescriber
Class I recall
There is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Class II recall
use or exposure will cause temporary/reversible adverse health consequences, or where proability of harm is remote (ie possibility of particles in vials)
Class III recall
Use of or exposure is NOT likely to cause adverse health consequences
When drug recalled is a compounded product, pharmacy or outsourcing facility must contact the recipient if?
- use of or exposure to compounded drug can cause serious adverse health effects or death
- recalled drug was dispensed or is intended for use in California
How quickly must pharmacies notify recipient and board of pharmacy of issuing a recall?
12 hours
For a recall on a compounded product from an outsourcing facility, recent must be notified within?
24 hours
If pharmacy is made aware that patient has been harmed by a compounded product prepared by the pharmacy, the pharmacy must report event to what program? How quickly for non-sterile products? How quickly for sterile products?
FDA Medwatch program
Within 72 hours for non sterile products
Within 12 hours for sterile products prepared in a hospital
Immediately for sterile products prepared by all other pharmacies
If an outsourcing facility is made aware that patient has been harmed by a compounded product prepared by the facility, the facility must report event to what program? How quickly?
FDA Medwatch program
Within 15 calendar days
FDA's Flush List examples
Buprenorphine
Diazepam rectal gel
Fentanyl-containing products
Hydrocodone-containing products
Hydromorphone
Methadone
Methylphenidate transdermal system (Daytrana patch)
Morphine
Oxycodone-containing products
Oxymorphone
Tapentadol
Each person licensed by the BOP are "mandated reporters" of child abuse, elder abuse, and neglect. A report should be made when there is a reason to believe that a child/elder is a victim of abuse or neglect. The mandated reporters must phone law enforcement or protective services as soon as they can and prepare & send a written report within _____ working days or _____hrs of receiving the information concerning the incident. Failure to do so is a misdemeanor, punishable by up to 6 months in county jail &/or fine of $1,000.
Within 2 working days; 36 hours of receiving information
Dispensed drugs with an Estrogenic component must include?
Package insert with risks vs. benefits associated with use of such medications
Definition: Poison Prevention Packaging Act of 1970
Place ORAL (only) prescriptions meds in child-resistant safety containers
What are some exceptions to the Poison Prevention Packaging Act of 1970?
NTG SL tab
Colestipol powder
Erythromycin ethylsuccinate granules for oral suspension
Oral contraceptives
Ordering of Schedule II controlled substance requires
DEA Form 222
How long must paper or electronic controlled substance records for based on federal standards?
2 years
3 multiple choice options
How long must paper or electronic controlled substance records for based on state standards?
3 years
3 multiple choice options
____ hours of the total CE hours must be on Law and Ethics from a course provided by the Board of Pharmacy
2 hours on Law & Ethics
3 multiple choice options
____ hours of the total CE hours must be on Cultural Competency & Humility from a course provided by the Board of Pharmacy
1 hour on cultural competency & humility
How long must you retain CE ceriticates?
4 years
What is REMS? Purpose?
REMS: Risk Evaluation & Mitigation Strategy
Restricted access to meds that have shown serious side effects, teratogenicity, or potential for abuse
REMS: Bosentan (TRACLEER) for Pulmonary HTN
Safety concern?
Hepatotoxicity/Teratogenic effects
REMS: Subutex & Suboxone
Safety concern?
Abuse potential
REMS: Clozapine (CLOZARIL)
Safety concern?
Neutropenia & aplastic anemia
REMS: Isotretinoin (ACCUTANE)
Safety concern?
Teratogenic effects
REMS: Natalizumab (TYSABRI)
Safety concern?
PML
REMS: Zyprexa Relprevv
Safety concern?
Post injection delirium/sedation
REMS: Sodium Oxybate (XYREM)
Safety concern?
Overuse, abuse, addiction potential
REMS: Thalidomide (THALOMID)
Safety concern?
Teratogenic effects
REMS: Bosentan (TRACLEER)
Enrollment?
Prescriber & Patient
3 multiple choice options
REMS: Subutex & Suboxone
Enrollment?
Prescriber Certification
3 multiple choice options
REMS: Clozapine (CLOZARIL)
Enrollment?
Prescriber & Pharmacy
3 multiple choice options
REMS: Isotretinoin (ACCUTANTE)
Enrollment?
Prescriber/Patient/Pharmacy
3 multiple choice options
REMS: Natalizumab (TYSABRI)
Enrollment?
Prescriber/Patient/Pharmacy
REMS: Zyprexa Relprevv
Enrollment?
Prescriber/Patient/Pharmacy
REMS: Sodium Oxybate (XYREM)
Enrollment?
Prescriber & patient
REMS: Thalidomide (THALOMID)
Enrollment?
Prescriber/Patient/Pharmacy
REMS: Bosentan (TRACLEER)
Program requirements?
Monitoring of liver function
Monitoring of pregnancy every month
REMS: Subutex & Suboxone
Program requirements?
Special DEA number used (opioid dependence)
REMS: Clozapine (CLOZARIL)
Program requirements?
Clozaril National Registry
Check WBC every 2-4 weeks
REMS: Isotretinoin (ACCUTANE)
Program requirements?
iPLEDGE (2 pregnancy tests + 2 birth control)
REMS: Natalizumab (TYSABRI)
Program requirements?
Must complete pre-infusion patient checklist
REMS: Zyprexa Relprevv
Program requirements?
Zyprexa Relprevv Patient Care Program
REMS: Sodium Oxybate (XYREM)
Program requirements?
Distribution to patient monitored
REMS: Thalidomide (THALOMID)
Program requirements?
S.T.E.P.S. Program (Rx has authorization number)
Definition: Market withdrawal
The firm removes the product from the market and/or corrects a minor violation
Definition: Medical device safety alert
Unreasonable risk of substantial harm
What is the Board of Pharmacy?
Agency authorized to enact rules & regulations pertaining to the practice of pharmacy
True/False: Pharmacy Board Inspector must be an RPh
False
2 multiple choice options
Any person /entity served with a citation may appeal to the Board in writing within
30 days
The board must be notified within _____ days for:
change of ownership, address or name/pharmacist-in-charge/pharmacy permit/theft/diversion/drug loss
30 days