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NC Pharmacy Laws
North Carolina Pharmacy Practice Act
| 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 |
| 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 |
| who is responsible for enforcing the practice act? | the NCBOP is responsible for enforcing the laws of the practice act |
| 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. |
| When must new techs register with the board? | must register within 30 days of finishing training program |
| 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) |
| 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. |
| When do licenses expire? | Annually on 12/31. can renew beginning 12/1. 60 day grace period 1/1-3/1. |
| How many days allowed before change of address/employment required? | 30 days to report change of address or employment |
| Timeframe when board requires appearance and submitting of evidence that RPh can practice pharmacy? | Greater than or equal to 5 years of non-renewal |
| Time in which PM must notify the board about changes in personnel? | 30 days notice of personnel changes |
| 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 |
| 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 |
| What must be conspicuously posted in a pharmacy? | PM license, Pharm permit, current renewals. |
| What must be readily available in a pharmacy? | license / last renewal of staff pharmacist |
| How can a provider ensure no substitution permitted? | sign DAW line, write DAW, or verbally state no substitution |
| 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 |
| When do rx's expire? | legend refills do not expire, rx's marked prn expire after 1 year |
| 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 |
| 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. |
| 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 |
| are free clinics allowed to resell drugs? | No, only allowed to charge a handling fee not to exceed medicaid price. |
| How many months must donated drugs be unexpired in order to donate? | Must be unexpired for 6 months minimum |
| Are quality assurance programs required for community pharmacy? | Yes, a process must exist for the continuous reduction in medication errors. |
| 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 |
| 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 |
| 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 |
| 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 |
| Clinical pharmacist prescribing limits | CPP implement predetermined drug therapy; NCMB given ID# to appear on rx's; |
| 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 |
| Name 2 CIV's and 2 CV's | CIV's-Eszopiclone (Lunesta) and Zaleplon (Sonata) CV's-Pregabalin (lyrica) and diphenoxylate with atropine (lomotil) |
| Name 2 schedule 6 drugs | marijuana and THC |
| 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 |
| 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 |
| What ID's are allowed for II's and select III's (narc)? | drivers license, NC ISSUED state ID, Military ID card, Passport |
| 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 |
| Which officials are allowed to inspect rx records? | page 37, auth'ed federal and state inspectors. employees of the NCDOHHS. |
| pseudoephedrine limits for NC? | only be sold in blister packs, to a patient >=18 y/o, stored and sold behind the pharmacy counter |
| 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 |
| PSE package limits /day /month? | 3.6 g or 2 total packages per day. 9g or 3 total packages per 30 days. |
| PSE limits do not apply to... | liquids, gels, or pediatric products. prescription PSE. |
| can an individual access his own controlled substance record? | Yes, if he requests so. Others: SBI, Pharmacists, Prescribers, licensing boards. |
| 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. |
| 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 |
| Can a II-V have a preprinted rx pad? | Nope, preprinting rx pads of II-V is prohibited |
| What are the dispensing limitations for dronabinol and nabilone? | Must only be dispensed for antiemetics in cancer chemo. |
| what warning label must appear on tranq/sedative meds? | the consumption of alcoholic beverages may be harmful to your health |
| 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. |
| 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 |
| 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 |
Created by:
nickh88
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