*Module 1: PP1 Law Review Flashcards
Who owns and created the NAPLEX and MPJE?
National Association of Boards of Pharmacy
How many hours and questions are the NAPLEX and MPJE?
NAPLEX: 6 hours 225 Q
MPJE: 3 hours 120 Q
What is the accrediting body for schools of pharmacy?
Accreditation Council for Pharmacy Education (ACPE)
What is a dose?
Amount of drug taken at one time
What does frequency involve?
Time
What is the total daily dose?
How much a patient takes in one day
What is the max daily dose?
The highest amount a patient should take in one day
What is the duration of therapy?
How long a patient should be treated
What is the target dose?
Dose that achieves the ‘targeted effect’
What does Medicare billing require?
Specific directions (no PRN on its own), Specific quantity, Correct day supply, ICD-10 (diagnosis) code
When is PRN allowed?
When PRN is used in part of a definite max day limit
What has the FDA said regarding boxes of insulin?
Health care professionals should dispense the pens to a single patient in the original sealed carton.
What is the general ratio of drops per mL?
20 drops per 1 mL
18 drops per 1 mL
How are sprays or inhalations often billed?
Based on total weight of the container but some stores bill based on number of boxes
Nebulized medications are dosed in ____________ and billed based on __________.
Strength/mL
Total mL in the package
For nebulized medication, you focus on the ________ to calculate day supply.
Unit dose ampules
What trumps day supply?
Expiration dates for medications that expire a certain amount of time once opened/stored under certain conditions
The insurance wants ______ numbers for day supply.
Whole
What is the FDA responsible for?
- Drug approval process
- Drug manufacturing and distribution
- Drug safety aspects
- OTC labeling
Within the FDA, who is responsible for drug safety aspects?
Center for Drug Evaluation and Research
What are the responsibilities of the Federal Drug Enforcement Administration (DEA)?
- Places drugs into schedules (in collaboration with FDA)
- Prevents and prosecutes diversion
- Enforcement of Controlled Substance Act (CSA)
What are the responsibilities of state boards of pharmacy?
- Grant and revoke licenses
- Revisions of laws
- Create specific rules to follow in response to laws that are passed
What are the responsibilities of the Department of Health and Human Services (DHHS)?
- Overseeing all areas of ‘health’ (including FDA and CMS)
What are the responsibilities of the Centers for Medicare and Medicaid Services (CMS)?
- Oversees federal and state funded insurance programs
- Sets standards to follow to receive reimbursement
What is the Federal Trade Commission (FTC) responsible for?
OTC advertising regulations
What does NIOSH do?
Maintains the list of hazardous drugs
What governing agency is responsible for the P-list chemicals?
EPA
Who appoints the members of the Board of Pharmacy?
Governor and Senate
The governor may remove a member of the BOP for?
Neglect of duty, incompetence, official misconduct
What does the BOP consist of?
- 5 members who are licensed pharmacists
- 2 citizen members who are not licensed and do not perform any service related to pharmacy
What is the term of appointment for the BOP?
5 years
Members of the BOP may not serve more than _____ consecutive FULL terms.
2
True or false: members must reside in WV during appointment.
True
Members automatically forfeit membership if?
Convicted of felony
Are board of pharmacy members compensated?
Yes, they also receive expense reimbursement
What is the minimum amount of annual meetings the BOP has?
2
Does the board of pharmacy = inspectors?
No
What is probation?
License is restricted for a specific amount of time
What is suspension?
License is inactivated but may be reinstated if conditions are met
What is revocation?
License is taken away
What is surrender?
Individual agrees to voluntarily give up license
What is reinstatement?
License has lapsed (or suspended or revoked) but is returned to active status
What is restriction?
Restriction on where a pharmacist may practice or what the pharmacist may handle
BOP can require a licensee or registrant to pay up to _________ per day PER VIOLATION.
$1000
What may the BOP require for payment for proceedings?
May require licensee, registrant, or permittee to pay costs of proceeding—this is different than ‘fines’
BOP may require attendance at certain ______ or other trainings.
CE
True or false: BOP may choose to refuse to renew a license or registration.
True
What is reprimand?
Public documentation; this does not mean there is any restriction on the license/registration
What is supervised practice?
BOP may only allow the pharmacist to practice under supervision; this is a form of restriction
What are reasons the WV BOP may take disciplinary action against a licensee?
All: illegally sharing HIPAA, unprofessional conduct, committing practice-related fraud, falsifying pharmacy documents, failing to report disciplinary action to another state board, violating state or federal pharmacy practice laws, failing to report other pharmacy staff who are unable to practice competently and safely.
Under what circumstances may the WVBOP deny or refuse to renew, suspend, restrict or revoke a pharmacist’s license?
Obtaining a board authorization by fraud, being convicted of a felony, unprofessional conduct, intentional violation of a lawful order, having had license evoked or suspended in another jurisdiction, aiding unlicensed practice, endangering public health, incapacity, violation of laws, committing fraud, disciplinary action taken by another state, failure to report discipline, failure to report adverse judgement.
Disciplinary actions by the BOP are open to the public and published in the ___________ newsletter.
Quarterly
What is pharmacy fraud?
Occurs when the pharmacist, technician, or intern knowingly fills the wrong prescription, or the wrong amount, to gain financially.
Some examples of ways fraud is committed include?
- Drug diversion
- Bribery
- Automatic refills
- Switching drugs
- Billing schemes
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
Who must comply with HIPAA?
Healthcare facilities, insurance companies, healthcare professionals
What does Protected Health Information (PHI) include?
- Past, present, or future physical or mental health
- The provision of care
- Payment of care
- Info that can identify the patient
With whom can we share protected health information?
The patient, healthcare professionals caring for the patient, entities for payment or operation, law enforcement with a warrant, and authorized individuals.
If a request for PHI is not related to the outlined indications, what must you have?
Written authorization from the patient detailing who the PHI can be shared with, the purpose, expiration date, right to remove authorization, and the patient’s signature.
We must attempt to limit the amount of PHI shared to the _________ to accomplish the intended purpose.
Minimum necessary
Exceptions to the minimum necessary rule include?
- Treatment
- When patient has signed an authorization
- Disclosures for payment
Pharmacists are held to the _______ of professional conduct.
Highest standards
According to the WV Rules of Professional Conduct, the pharmacist recognizes the responsibility to the public in?
- Providing pharmacist care
- Providing safe storage of drugs
- Providing safe handling of drugs
- Dispensing drugs and devices
- Providing information on drugs and devices to other healthcare specialists
No person practicing pharmacy shall engage in conduct which _________ nor shall he or she _________
Tends to reduce the public confidence in the ability and integrity of the profession of pharmacy, or endangers the public health, safety and welfare.
The pharmacist shall _________ before dispensing, if there is any doubt that the prescription order is not legal or correct.
Hold a conference with the prescriber
What shall pharmacy personnel not do?
- Attempt to diagnose
- Dispense coded prescriptions
- Make false or misleading advertising
- Purchase, accept, compound, dispense products that they do not deem to be therapeutically reliable
- Promote a drug that tends to be used in excess
- Provide prescribers with prescription blanks that bear the name of the pharmacy or pharmacist imprinted
- Enter in an agreement that exploits the patient.
WV intern licenses expire on ______ each year and Ohio intern licenses expire on _______ each year.
June 30
September 15
How often must intern licenses be renewed in WV, OH, KY?
WV: annually for up to 6 years from original date of issuance
OH: every 2 years
KY: valid for 6 years
What an intern CANNOT do in WV?
- Transfer prescriptions for controlled substances
- Dispense Schedule V without prescription
- Possess keys/codes to the pharmacy or safe
- Complete the final check on prescription
What are the record keeping requirements of PSE?
- Name of purchaser
- Address of purchaser
- Signature of purchaser
- Name of product purchased
- Quantity of product purchased
- Total weight in grams of PSE
- Date and time of purchase
- Type of ID provided and ID number
In WV, persons purchasing PSE and Ephedrine must be at least _____ years old.
18
Who is permitted to sell PSE?
RPh, Interns, Registered Techs
What must be offered with each PSE/Ephedrine purchase?
Counseling
OTC purchases are reported to the __________ for PSE products.
Real time tracking database
Where do prescription PSE/ephedrine purchases show up?
Controlled Substance Monitoring Program (CSMP)
Pseudoephedrine purchases in WV must be reported to the CSMP how frequently?
Monthly
What must be kept in the pharmacy for you to immunize?
A copy of your CPR card and immunization training certificate
Pharmacists must report the ADRs they deem significant to what 4 places?
- VAERS
- BOP
- DHHR Office of Epidemiology and Prevention Services
- Patient’s PCP
A record of immunization must be sent to WVSII within ________ days of immunization.
30
In addition to the PCP, a record of immunization must be sent to _____________ provider within 30 days of immunization.
WV Statewide Immunization Information (WVSII) database
A pharmacist may immunize a person aged 3 through 17 if…
- The patient has written, informed parental consent
- Having no contraindications to receiving the vaccine
- We have informed the patient/caregiver of the importance of well-child visits
In West Virginia, Immunization records must be maintained for _____ years.
5
WV Registered Tech and trainees may not?
- Receive verbal prescription orders
- Interpret and evaluate RX orders
- Sell drug products
- Interpret patient medication records
- Perform drug regimen reviews
- Deliver RX to patient before the final check
- Communicate info that pharmacist considers significant
- Handle transfers
- Perform acts involving discretion or independent professional judgment
- Do anything that is not specified in the written protocol
- Have keys/codes to CS safe or pharmacy
True or false: Technicians are allowed to weigh or measure specific ingredients for compounding provided that the quantities are verified by the pharmacist.
True
What is the purpose of the Controlled Substance Act?
Oversight and management of meds with addiction and abuse potential
What is the closed system of CS distribution?
To limit the number of people involved with controlled substances
What is the purpose of the DEA?
Prevent diversion and abuse while ensuring an adequate, uninterrupted supply of medications
Who must be registered with the DEA?
- Dispensers (pharmacies & individual prescribers)
- Distributers
- Manufacturers
- Reverse distributors
- People conducting research
- Operating treatment programs
- Performing chemical analysis
- Importing
- Exporting
What does a DEA number consist of?
First 2 characters or alphabetical followed by 7 digits
What are the possible first letters of DEA number for physicians, dentists, veterinarians?
A, B, F, G
What is the first letter of DEA number for mid-levels such as PAs or APRNs?
M
What are the possible first letters of DEA number for distributors?
P, R
What are the steps to check DEA number validity?
- Add 1st, 3rd, 5th
- Add 2nd, 4th, 6th and multiply by 2
- Add sum of 1 and 2
- Determine if the last digit in the sum corresponds with last digit of the DEA license
You need a new DEA registration if you?
Have change of address
Who assigns DEA numbers?
Each state
What form do you register for a new DEA number?
224
What form is used to renew all chain pharmacies at once?
224B Affidavit
Pharmacy renewal with DEA is how often?
Every 3 years
What is the first step in the DEA number calculation?
6th and multiply by 2
What is the second step in the DEA number calculation?
Add sum of 1 and 2
What is the third step in the DEA number calculation?
Determine if the last digit in the sum corresponds with the last digit of the DEA license
When do you need a new DEA registration?
If you have a change of address
How often is pharmacy renewal with DEA required?
Every 3 years
How often is the pharmacy license renewed with BOP in WV?
Annually
What is the term for the shared responsibility in prescribing controlled substances?
Corresponding responsibility
For what can pharmacists be prosecuted?
Filling purported prescriptions
What is the description of Class 1 drugs?
Not known to have medicinal value, high abuse potential
List 5 Class 1 drugs.
Heroin, LSD, PCP, peyote, marijuana
What is the description of Class 2 drugs?
High abuse potential but also have medicinal use. Abuse may lead to severe physical/psych dependence.
Class 2 drugs include various ______ and ______.
- opiates
- stimulants
List 5 Class 2 drugs.
Cocaine, morphine, fentanyl, amphetamines, methamphetamines
Describe Class 3 drugs.
Less abuse potential than C2s; with medical use. Abuse may lead to moderate or low dependency.
List 4 Class 3 drugs.
Lower doses of C2s, anabolic steroids, testosterone, buprenorphine
Describe Class 4 drugs.
Lower abuse potential than C3; has medical use.
List 2 Class 4 drugs.
Benzodiazepines, ‘Z’ drugs non-benzo sedative hypnotics
Describe Class 5 drugs.
Low potential for abuse and dependency.
List 4 Class 5 drugs, including 2 that are Class 5 in WV but not federally.
Pseudoephedrine, Gabapentin, codeine cough medications, anti-diarrheal products that contain an opiate
Who decides what schedule a controlled substance medication is in?
The US Attorney General
What does OBRA ‘90 state about drug utilization review (DUR) for reimbursement?
The RPh must perform a prospective drug utilization review (DUR) to be reimbursed for Medicaid services.
Who must do a retrospective review after the medication has been dispensed according to OBRA ‘90?
State
What must patient profiles include?
Name, address, phone, DOB, gender, medication list, disease state info, allergies/intolerances & reactions, social history
How often must we make a reasonable effort to keep patient profiles updated?
Each time a med is dispensed
What information must a prescription contain about the prescriber?
Name, address, phone number, DEA # if applicable, NPI #, prescriber signature
What must be included on prescriptions for animals?
Name of animal, species, owner’s name
What else must be on the prescription aside from prescriber info?
- Patient name
- Patient address
- Date written
- Drug name
- Drug quantity
- Directions for use
In WV, how long are Non-Controlled substance prescriptions valid from date of issuance?
12 months
In WV, how long are C3-C5 prescriptions valid from date of issuance?
6 months or 5 refills, whichever comes first
In WV, how long are C2 prescriptions valid from date of issuance?
90 days, 0 refills
Which classes of controlled substances can be verbally prescribed and prescribed via fax?
C3-C5
What must be documented for verbal prescriptions?
- Name of caller
- Date and time of call
- Hand-written initials of the receiver
What must be documented for electronic prescriptions?
- Name of intended pharmacy
- Name of person transmitting the prescription
- Phone number of the prescriber office
- Date and time of transmission
In WV, what changes can a pharmacist make to controlled substance prescriptions?
With verification or after consultation with the prescriber, RPh can make basically any change except for patient name, drug prescribed, prescriber signature.
What are the prescribing authority limits for PAs and APRNs?
- No schedule 1 meds
- Up to 3-day supply of C2 narcotics
- No other limits
What are the requirements for picking up a controlled substance?
- Person must be 18 or older
- Must provide valid government issued photo ID
- Must show photo and DOB of person picking up the medication
Are scripts from other countries valid in WV?
Scripts from other countries are not valid; scripts from other states are valid if written in accordance with that state’s laws.
What must be documented when transferring prescriptions between pharmacies?
• Original RX date written
• Original # RF
• Date original RX was dispensed
• Number of refills remaining
• Date of last fill
• Original RX number
• Pharmacy info: name, address, DEA number
• Date and time of transfer
• First and last name of RPh giving transfer & of RPh receiving the info
• Write transfer on RX at receiving pharmacy
How many times can C3-5 drugs be transferred?
Once
What are the rules for maintaining records of transfers?
- 5 years from date of last fill
- 1 year on site
- Other 4 years available within 72 hours of request
What Dispensing Pharmacy info must be on the label of the dispensed prescription?
- Name and store #
- Address
- Phone
- Rx #
- Name/initials of dispensing RPh
What else must be on the label aside from Dispensing Pharmacy info?
- Name of patient
- Name of prescriber
- Date filled
- Refills remaining
- Directions for use
- Drug and strength
- Drug quantity
- Manufacturer or Distributor’s name
- BUD
- Caution statements
- Auxiliary info
- Federal ‘Transfer Warning’
