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North Carolina Pharmacy Practice Act

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Question
Answer
Describe dispensing   prep/packaging an rx drug/device and labeling the container with information required by state and federal law. filling or refilling drug containers is dispensing, so is providing quantities of unit dose prescription drugs  
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Define the practice of pharmacy   1-interpreting and evaluating drug orders, 2-dispensing and labeling rx drugs and devices, 3-safely storying drugs and devices, 4-maintaining proper records, 5-controlling pharmacy goods/services  
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who is responsible for enforcing the practice act?   the NCBOP is responsible for enforcing the laws of the practice act  
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What is the makeup of the board?   6 members, each serving 5 year terms, one shall be a public member not a health care provider or married to one. max of 2 consecutive 5 year terms. must reside in north carolina in order to vote.  
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When must new techs register with the board?   must register within 30 days of finishing training program  
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What are requirement to hire a tech from a PM standpoint (3 things)   1-must be enrolled/have HS diploma 2-PM notifies board w/in 30 days of date of hire 3-PM provides training program (completed within 180 days of hire; only required 1x)  
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What is the RPh:tech ratio?   any more than 2:1 tech:RPh requires approval from the board. addt'l techs must be PTCB cert.  
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When do licenses expire?   Annually on 12/31. can renew beginning 12/1. 60 day grace period 1/1-3/1.  
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How many days allowed before change of address/employment required?   30 days to report change of address or employment  
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Timeframe when board requires appearance and submitting of evidence that RPh can practice pharmacy?   Greater than or equal to 5 years of non-renewal  
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Time in which PM must notify the board about changes in personnel?   30 days notice of personnel changes  
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Are out of state pharmacies required to register with the board?   Yes, annual reg req'd. must be current in the state where they reside  
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What is requirement of out of state pharmacist?   agree in writing on a form approved by the board to be subject to the jurisdiction of the board  
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What must be conspicuously posted in a pharmacy?   PM license, Pharm permit, current renewals.  
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What must be readily available in a pharmacy?   license / last renewal of staff pharmacist  
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How can a provider ensure no substitution permitted?   sign DAW line, write DAW, or verbally state no substitution  
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what are the requirements for NTI drugs?   refilled using only the same drug product by the same manufacturer that was last dispensed. even new rx's which continue therapy. PT/Presc must both allow override  
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When do rx's expire?   legend refills do not expire, rx's marked prn expire after 1 year  
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What are rules about nurses dispensing in public health clinics?   Nurses can dispense legend (not controlled drugs) from an approved formulary; dept must register with BOP; PM/other shall review dispensing records weekly  
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Can a person who presents legal written request of rx records receive them w/o being the patient?   Yes, so can prescribers/RPh's who are treating the pt, even if not same prescriber.  
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What is the board's disciplinary authority?   issue a letter of reprimand, suspend/revoke/refuse renewal of a license, may require remedial education, apply for an injunction  
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are free clinics allowed to resell drugs?   No, only allowed to charge a handling fee not to exceed medicaid price.  
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How many months must donated drugs be unexpired in order to donate?   Must be unexpired for 6 months minimum  
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Are quality assurance programs required for community pharmacy?   Yes, a process must exist for the continuous reduction in medication errors.  
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How are med errors reported to the board in the case of a complaint?   within 10 days of notice of the complaint, the pharmacy shall compile list of med errors for the previous 12 months within 10 days  
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Auditing rights (4)   14 days notice of an on-site audit; clerical errors are not fraud; no more than 1 audit per calendar year, unless misrepresentation is suspected; no extrapolation  
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PA prescribing limits and rx req's (4)   1-licensed in NC 2-NCMB # on written rx's 3-written policy with a physician 4-compounding/dispensing must occur under supervision of RPh  
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Nurse practitioner prescribing limits (3)   Similar to PA; 1-NCMB gave ID # which appears on rx's 2-written agreement with a physician 3-dispense/compound under supervision of a pharmacist  
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Clinical pharmacist prescribing limits   CPP implement predetermined drug therapy; NCMB given ID# to appear on rx's;  
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difference between a CS and CS analogue   CS includes immediate precursors; CS analog means a look alike drug; schedule I CS analogues shall be treated like C-I drug  
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Name 2 CIV's and 2 CV's   CIV's-Eszopiclone (Lunesta) and Zaleplon (Sonata) CV's-Pregabalin (lyrica) and diphenoxylate with atropine (lomotil)  
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Name 2 schedule 6 drugs   marijuana and THC  
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Can schedule 5 drugs be dispensed without an rx?   Yes, page 36 of practice act, person must be 18y/o with reasonable medical use. Remember the 5 refill/6 month limit does not apply to CV's  
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Whose ID must be presented in order to dispense a CII rx?   The ID of the person picking up the rx must be present. does not apply to inpatient rx's or rx's given to employees of a hospice company  
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What ID's are allowed for II's and select III's (narc)?   drivers license, NC ISSUED state ID, Military ID card, Passport  
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What are the reporting requirements for II's and select III's?   must report pickups within 72 hours and keep a record of pickups for 3 years  
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Which officials are allowed to inspect rx records?   page 37, auth'ed federal and state inspectors. employees of the NCDOHHS.  
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pseudoephedrine limits for NC?   only be sold in blister packs, to a patient >=18 y/o, stored and sold behind the pharmacy counter  
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What are the record keeping requirements for NC pseudoephedrine?   maintain a record for 2 years and must be available w/in 48 hours. new law requires electronic submit to National Precursor Log Exchange (NPLEx) as part of a sale  
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PSE package limits /day /month?   3.6 g or 2 total packages per day. 9g or 3 total packages per 30 days.  
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PSE limits do not apply to...   liquids, gels, or pediatric products. prescription PSE.  
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can an individual access his own controlled substance record?   Yes, if he requests so. Others: SBI, Pharmacists, Prescribers, licensing boards.  
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What are the Health Care ID laws in NC?   When providing health care, ID including individual's name and license/certification held. abbreviations are acceptable. not required if prov. can be readily ID'ed by being in the provider's office.  
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if a hospital pharmacy is not open 24/7, what are the requirements for dispensing? (4)   1-dispense NMT 24h supply from a formulary 2-prepackaged by the pharmacy 3-MD/PA/NP must initial the label and sign the dispense book 4-pharmacist verifies book weekly  
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Can a II-V have a preprinted rx pad?   Nope, preprinting rx pads of II-V is prohibited  
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What are the dispensing limitations for dronabinol and nabilone?   Must only be dispensed for antiemetics in cancer chemo.  
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what warning label must appear on tranq/sedative meds?   the consumption of alcoholic beverages may be harmful to your health  
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How are rx insurance cards regulated by the BOP?   states each plan shall issue a uniform rx card. must contain address and phone number. new card required within 12 months of a change in the coverage. must contain electronic verification like barcode or magnetic strip.  
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When must an early refill be covered by an rx plan?   page 55, when a declared state of emergency exists in the county where the insured resides. must request refill within 29 days of declaration  
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What about health benefit plans excluding a pharmacy?   "any willing provider" states that terms of benefit plan may not favor one pharmacy over another or require mail order services. 60 days notice must be given to pharmacies when a new plan is added  
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