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SC State Laws

Pharmacy Laws for SC

QuestionAnswer
Which two agencies regulate pharmacy in SC? LLR/BOP and DHEC Bureau of Drug Control
What is SC Code of Law Title 40, Chapter 43 called? SC Pharmacy Practice Act
Who is responsible for making regulations? For making Laws? State agency makes regulations, but has to be approved to be a law by state Legislature.
What are the 4 primary functions of the BOP? 1) Permit facilities 2) License Pharmacists 3) Register Techs 4) Register Interns
What is the purpose of the Pharmacy Practice Act? To promote, preserve, and protect the public health, safety and welfare... (PPA 40-43-10)
What is the structure of the BOP? Currently, 8 members (but may be 9 members by next year). 6 are RPhs from congressional districts, 2 members are appointed by Governor (1 layperson, 1 pharmacist at large)
How long is a term in the BOP? 6 years, with up to 2 consecutive terms. May be longer if filling a position mid-term, or if governor hasnt appointed new member.
Laws establish the ___ requirements of pharmacy practice. Minimum; you probably will exceed these guidelines to have good quality of care.
What are the 10 responsibilities of the BOP? 1) Practice of Pharmacy 2) Sale/dispensing drugs/poisons/devices 3) Supervision of interns/externs 4) Investigate violations 5) Min requirement of permits 6) Confine drugs to Rx status 7) Seize dangerous drugs/devices 8) Promulgate regulations
What are the 10 responsibilities of the BOP? (continued) 9) License, register, permit 10) Adopt rules of conduct
How often does the BOP inspect facilities? Biennial (every 2 years)
What are the inspections for, and who are the inspectors? Inspectors are pharmacists. They are looking for compliance to BOP regulations.
What disciplinary powers does the BOP possess? They can cancel, fine, suspend, revoke, or restrict authorization to practice. Fine can not exceed $500, unless otherwise stated. They also have other "resonable" actions deemed necessary and appropriate by BOP.
What is the most common punishments? 1) Reprimand or letter of caution (public or private) 2) Fine (usually up to $500) 3) Probation (with conditions) Revocation of license is rare, but for extreme violations.
What is the Code of Ethics? The American Pharmaceutical Assoc. Code of Ethics are adopted as the SC Code of Ethics. There are 8 statements.
What are 5 examples of Unprofessional Conduct? 1) Circumvent counseling requirments 2) Violate patient confidentiality 3) Sell drugs/devices for illegal use 4) Sell without a Rx 5) Incomplete records
What happens (punishment) if you violate the Pharmacy Practice Statues? 1) misdemeanor for violations of any provision 2) In most cases, a $500 fine for each offense, or up to 2 years imprisonment, or both. There are provisions for civiil penalties up to $10,000 3) Unprofessional conduct
What are the 4 types of licenses that may be seen in a pharmacy? 1) Pharmacist 2) Technician 3) Interns 4) Facility permit
If you are a floating RPh, what should you carry with you? You should have your wallet card with you at all times, while working.
What are the practical experience requirements to receive your Pharmacist liscense? 1) 1500 hours of practical experience (500 from work, 1000 from school rotations) 2) Experience must be supervised by licensed RPh 3) Experience can't be more than 40hrs/wk 4) Intern is responsible for paperwork to BOP 5) Must have an intern liscense
Explain the requirements to maintain your Pharmacist license. 1) Annually renew liscense by April 30th; application/fee must be sent by April 1st 2) CE requirment of 15 hours annually; 6hrs must be live, 50% of credit must be drug therapy/pt management; hours must be accredited by ACPE or CME I)
What happens if you are audited for CE hours by BOP? 10% of license holders will be audited; will have to show proof of 15 hours completion by time you submitted your application. So if you submit on March 28, but you finish your hours on March 29, you will be in trouble.
What are the 3 types of Pharmacist liscense, and explain them. 1) Active 2) Inactive: not actively engaged in pharmacy; to become reinactivated, complete 15 hours of CE 3) Lapsed: not renewed by May 1st; will require fees, law exam, and a lot of CE hours, depending on length of lapse
Explain the requirements to maintain a technician license. 1) Registration expires ANNUALLY on June 30th. 2) 10 hours of CE annually; 4 live hours, ACPE and CME I
What are the 5 requirements to be a State Certified Technician. 1) 1000 hours of experience 2) Complete BOP-approved course 3) High school diploma/equivalent 4) Pass PTCB exam 5) Annual CE requirement of 10 hours
Explain the classification of a Pharmacy (facillity) permit. 1) This permit is required for direct pt care/dispensing 2) Facility dispenses legend drugs/devices to patients 3) Has to have a Pharmacist-in-charge (PIC)
Explain the classification of a Non-dispensing Drug Outlet (facillity) permit. 1) Is a permit to store drugs; no direct dispensing to pt 2) Administer & store drugs 3) SubCategories: FQHC (federally qualified health center), Detention Centers, EMS 4) Has a Consultant Pharmacist (once a month min)
What is the exception to having a Consultant Pharmacist for a Non-dispensing Drug Outlet permit? Don't need a Consultant Pharmacist if facility only manufactures, wholesales, and distributes drugs/devices.
Explain the classification of a Medical Gases/Legent Devices (facility) Permit. 1) For Durable Medical companties, oxygen 2) Dispense by prescription order 3) Has an Consultant RPh or appointed
Explain the classification of a Non-Resident Pharmacy (facility) permit. 1) Is needed in order to sell, distribute, dispense in SC 2) Mail order pharmacies, manufacturers/compounding
How do you obtain a BOP permit? 1) Each physical location must be permitted. 2) Permits expire ANNUALLY: June 30th (also the day when techs have to reapply for license) 3) Written application for a new permit must be submitted to BOP at least 45 days BEFORE the opening of the facility
Are registration/permits transferable? NO! If ownership or location changes, you have to get a new permit
What is the civil penalty for not displaying the original copy of the permit? $50
When do you have to apply for a new permit (3 situations)? 1) Change of ownership 2) Change in pharmacy name 3) Change in location
Explain the 10 Day Rule of when you have to notify the BOP. 1) Leaving or Starting a Job 2) PIC Change 3) Consultant Pharmacist change 4) Address change (facility or person) 5) Permanent closing of facility 6) Name changes (marriage, divorce, etc)
What are the requirements for a Pharmacy facility? 1) Sufficient Size 2) Maintain area for patient counseling; has reasonable privacy 3) Maintain current drug references materials 4) Update drug monographs QUARTERLY 5) Update product information QUARTERLY 6) Update new development information QUARTER
When you update product information, what specifically needs to be updated? 1) Legend status 2) Controlled Substance schedule 3) Available strengths, dosage forms, package sizes
When you update new development information, what specifically needs to be updated? 1) Drug therapy 2) Investigational agents 3) New products or changes
What are 7 References to keep on hand in the pharmacy? 1) Pharmacy Practice Act 2) Controlled Substances Act 3) Drug Act 4) BOP Newsletter 5) Equivalent Drug Product Evaluations 6) Facts & Comparisons 7) Patient-oriented information (monographs)
Can these references be electronic? Yes, these can be stored electronically; but you need to be able to access them quickly.
What sort of storage/shelving/etc is required? 1) Storage- at proper temperatures 2) Sink with Hot & Cold water 3) Pharmacist on duty when open 4) Secure pharmacy with barriers 5) Sign stating "Pharmacy Dept closed, pharmacist not on duty" 6) Necessary equipment/supplies
Describe the area/equipment needed for compounding/dispensing Rxs? 1) Ventilation/lighting 2) Orderly inventory 3) Separte outdated/damaged stock 4) Refrigerated stock 5) Labeled compounded materials 6) Compounding-only area 7) Clean instruments; designated sink for compounding 8) Good hygiene!
What is a Wholesale Distributor? A Person engaged in wholesale distribution of prescription drugs/devices
What are some examples of a Wholesale Distributor? 1) Manufacturers 2) Repackagers 3) Retail pharamcies, if appropriate 4) Warehouses of manufactures, wholesalers, chain drugs
What does a "Wholesale Distributor" NOT include (3 things)? 1) Intracompany sales 2) Group-purchasing organization 3) Emergency medical reasons
Explain an intracompany sale? Is a transaction or transfer between 2 divisions under the same ownership and control of a coporate entity; Ex: transfer between 2 CVS locations
Explain a group-purchasing organization? An example would be independent pharmacies joining together to get a better price.
Explain an emergency medical reason? The transfer of legend drugs by a pharmacy to another pharmacy to alleviate a temporary shortage; may only be less than 5% of the total legend drug sales for both parties in a 12 month period
How quickly must a wholesale distributor notify the BOP of permit changes? 30 days
What are the facility requirements to be a wholesale distributor? 1) Suitable size with adequate storage areas 2) Quarantined area for damaged/out of date 3) Clean and orderly conditions 4) Free from infestation 5) Secure from unauthorized entry 6) Controlled access from outside 7) Outside perimeter well lighted
What are the facility requirements to be a wholesale distributor? (continued) 8) Limited access 9) Alarm system; Security system
Describe what types of records a wholesale distributor must maintain? How long do they have to be kept? 1) Records for receipt/distribution/disposition that includes: source, identity/quantity/dates 2) Must be maintained for 2 years
What are some policies and procedures of a wholesaler facility? 1) Oldest stock distributed FIRST 2) Procedure for recalls & withdrawals must be able to deal w/: Fed/state action, manufacturer voluntary actions, replacement with new product for public health/safety 3) Outdated drugs are segregated from other drugs
What are some requirements for Mail Order Pharmacies? 1) Be permitted in SC 2) Report location, names of officers/pharamcists 3) Comply with laws 4) Annually provide copy of inspection report 5) Records must be maintained
Does a pharmacist working in a mail order pharmacy permitted in SC, need a SC license? No, unless the pharmacist is engaged in the practice of pharmacy in SC (physically in SC)
What is the max ratio of pharmacists to techs in a mail order pharmacy? 1 Pharmacist to 2 Techs
What is the minimum Hours of Operation for a Mail order pharmacy? 6 days or 40 hours/week
What is the contact information requirement for mail order pharmacies? 1) Toll free service number for patients 2) Number prsent on label
Describe the paitent record system needed for a pharmacy? 1) Maintained by all pharmacies for each patient 2) Be able to immediately retrieve Rx history
What is the minimum requirement for a patient's record? 1) Full name 2) Address/telephone number 3) Age/DOB 4) Gender 5) Rx within past 2 years (Drug, refills, dispensing RPh, Prescriber) 6) Comments on patient/drug therapies
Is the patient record a legal document? Yes! So don't put anything in it that you don't want the patient to read
What types of medical information is necessary patient information? 1) Allergies 2) Drug reactions 3) Idiosyncrasies related to health care 4) Diagnoses 5) Other medications
Describe the requirements for Records for Dispensing 1) Ready/Retrievable within 24 hours (non-CS) 2) Includes dates/quantities, serial number, dispensing RPh, drug name/manufacturer 3) Maintained for 2 years from original date or date of last activity
What are some policies and procedures needed for Automated Systems? 1) Ouput documentation 2) System interruptions (scheduled or unsched) 3) Backup file procedures/maintenance- outline process 4) Audit procedures: assign personal codes, access responsibilities 5) Quality assurance mechanism: data entry validation
What are some policies and procedures needed for Automated Systems? (continued) 1) Refill-by-Refill audit trail that includes: print out for any drug, ID prescriber/patient/RPh, Dates/quantities, serial number
How quickly do centralized Rx records need to be able to send requested printouts? Within 72 hours
How quickly do you have to report a loss of data or breach for automated systems? Within 72 hours
Who can be employed in a pharmacy? 1) PIC 2) Consultant RPh 3) RPh 4) Registered Techs 5) State Certified Techs (CPhT) 6) Interns/Externs 7) Clerical staff #1-6 have to be permitted by BOP!!
What is the definition of a Pharmacist-in-Charge? A pharmacist licensed in SC who *ACCEPTS responsibility for the operations of a pharmacy* in conformance with all laws pertinent to the practice of pharmacy and the distribution of drugs and who *is in full & actual charge of the pharmacy & personnel*
Who needs a PIC? What do they do at a pharmacy? 1) Every permit holder needs a PIC; may be part-time 2) PIC is in charge of policies/procedures, record keeping systems, notify BOP of changes, file required reports, respond to BOP violations, sign/renew pharmacy permit, ensures proper license/registrat
Can a person be PIC at more than one location? No, you can only be the PIC at one location. However, the BOP may make an exception if you live in a rural area.
What policies/procedures is the PIC responsible for at an Institution? 1) Provision of drugs in absence 2) Authorized access 3) Night cabinet inventory list 4) Stop-order policy
What is an consultant pharmacist? A pharmacist licensed in SC who acts as a consultant for a permit holder OTHER than a pharmacy or an institution.
True or False? Every permit holder issued by BOP requires a consultant pharmacist. Generally true, but there are a few exceptions. Pharmacies (they have PIC instead), Wholesalers, and Oxygen-only facilities don't need a consultant pharmacy (bc there is no administration of meds to pt)
What do you have to do to be the Consultant pharmacist? Agree in writing to assume responsibilities (& notify the BOP w/in 10 days); signs/renew permit application.
What policies/procedures does the consultant pharmacist need to establish/implement? 1) Drug recordkeeping system (what & how its used) 2) Recalls (at patient level) 3) Remove outdated/adulterated drugs 4) Employee duties (who's allowed to do what with the meds)
What other duties does the consultant pharmacist have? 1) Drug Information Resource (provide info, be available by phone) 2) Monthly inspections for compliance (look at all pt charts monthly) 3) Monthly patient record review (document review and advise physician)
What are some duties of a registered Technician? 1) Provide effective, appropriate, and safe pharmacy services 2) Prepare Rxs 3) Handle legend drugs 4) Compound and mix medications
What specifically can a Tech do to prepare a Rx? 1) Receive orders (only State techs can accept new Rx orders) 2) Refill requests 3) Initial order interpretation 4) Rx entry 5) Maintain unit dose carts/cassettes (but be checked by RPh) **Techs can NOT call or clarify orders with MD***
What specifically can a tech do when handling legend drugs? 1) Check for outdates 2) Accept/stock shipments 3) Process for returned credit 4) Stock automatic dispensers
What specifically can a tech do to compound and mix medications? 1) Mix with water to activate 2) Prepare IV solutions 3) Repackage bulk medications **If compounding, they should have CE that covers compounding**
What is the definition of a (State) Certified Pharmacy Technician? An individual who is a registered pharmacy technician and who has completed the requirements set forth in 40-43-82(B).
What 4 additional duties do State Certified Techs have? 1) Receive/initiate verbal orders 2) Conduct non-CS Rx transfers (CS Rx transfers have to be between 2 RPh) 3) Check technician's medication refill 4) Check repackaging #3-4 is only in institutional settings
What is the max employment ratio of pharmacist, techs, and certified techs? 1 pharmacist: 3 technicians; as long as 2 of these technicians are state certified.
In an institutional pharmacy, what is the employment ratio of pharmacist: techs? Have to hire at ratio of 1:3, but the daily operational ratio is determined by PIC, so can exceed this ratio
What types of positions do NOT count into the employment ratio? 1) Clerical support 2) Interns/externs 3) Technician students on rotation
What is the ratio of pharmacists to interns/externs? 1 pharmacist for 1 intern/extern
What is a definition of an extern? When a pharmacy student is working somewhere for school credit; non-paid position; doesn't apply to pharmacist:tech ratio
What is a defintion of an intern? When a pharmacy student is working somewhere for experience (non-school); is a paid position; applies to employment ratio
What are the duties of an intern/extern? 1) Interpret orders 2) Select drug/device 3) Counsel 4) Drug regimen reviews 5) Pharmacy care 6) Receive orders *Basically do the same thing as a pharmacist, but under their supervision*
What is considered clerical duties? *This is not covered in Practice Act* 1) Enter basic info 2) Order inventory 3) Billing 4) Nonprofessional inquiries (not refills) 5) Process sales transactions
What is the definition of a practitioner? Anyone authorized by law to diagnose and prescribe drugs and devices
Who may write a prescrition in SC? 8 people 1) Physician (MD) 2) Dentist (DMD, DDS) 3) Osteopath (DO) 4) Podiatrist (DPM) 5) Veterinarian (DVM) 6) Nurse practitioner (NP, CNP) 7) Optometrist (OD) (Opthalamist is a MD) 8) Physician Assistant (PA)
What drugs are optometrist limited to prescribing? 1) Anesthetics 2) Antihistamines 3) Antimicrobials 4) Antiglaucoma 5) OTC drugs
Describe what schedules an optometrist can prescribe. They can prescribe CIII-V analgesics (not Class II); the Rx can only be for a 7 day supply or less
How long can an optometrist prescribe a topical steroid for? 21 day supply or less
What types of nurses have prescriptive authority? 1) Nurse practitioner (NP) 2) Certified nurse practitioner (CNP 3) Certified registered nurse anesthetist (CRNA)
Nurse practitioners shall perform *delegated medical acts*. What does delegated medical acts include? 1) Diagnosing 2) Treating 3) Prescribing 4) Identify need for referral
What are the standards for prescriptive authority for nurse practitioners? 1) Shall comply with all state and fed laws 2) Within the speciality of the NP (written protocol) 3) May prescribe CIII-CV, if registered by DHEC
Can you receive a telephone (oral) Rx order from a nurse practitioner? Yes you can.
What is the required form for Rx for NPs? 1) Include the NPs *AND* Physician's name, address, phone 2) Complies with all Rx laws 3) Must designate specific number of refills 4) Any drugs or devices prescribed (document in patient record)
What gives nurses prescriptive authority? The Nurse Dispensing Act (40-33-30)
What does the Nurse Dispensing Act say? Under the guidance of an RPh and direction of an MD, registered nurses may dispense drugs for the treatment of TB, VD< maternal and infant care, crippled children, family planning, immunization and other public health programs (DHEC establishes policies)
When is a physician's assistant able to prescribe? May prescribe if certified by Board of Medical Examiners
Describe what drug schedules a PA can prescribe? CIII-CV controlled substances, if registered by DHEC. Can NOT prescribe CIIs.
What is the definition of a prescription? 1) Oral or written order 2) Legitimate medical purpose 3) W/in the practiioner's scope of practice 4) Given individually for specific pt 5) Directly from the prescriber or prescriber agent to pharmacist or pharmacist's agent
What is a chart order? Lawful order from a practioner for a drug or device for *patients of hospital or extended care facility*
What is required for a Rx Drug order? 1) Pt info (name, address) 2) Prescriber info (name, contact info, degree, liscense #, DEA # if applicable) 3) Date of issue (CS: Date/signed on date of issue) 4) Drug info (name, strength, dosage form, quantity, directions for use)
Is their a requirement for refill amount? No there is not. However, remember that NPs have to specify refills.
How many signatures lines must be present on a Rx? There must be 2 lines; dispense as written (on left) and substitution permitted (on right)
Describe what counts as an accptable prescriber signature. Original signature only! No stamps or printed.
Can non-controlled drugs have preprinted Rx? Yes, but only 1 drug/set of instructions.
Can a CS drug have preprinted Rx? No!
For a non-CS with PRN refills, how long is the Rx good for? 2 years date of issue. Technically, the prescription never expires, but you should be using your clinical judgement.
For a CS with PRN refills, how long is the Rx good for? PRN=5 refills or 6 months; no refills unless indicated.
True or False? For out-of-state Rx, you should follow SC laws? True! The SC laws are always what you follow, no matter where the Rx is from.
Can you fill a Rx in a SC pharmacy for a CII written by a NP from NC? No, because NPs in SC can't write CIIs.
Describe Electronic Prescribing? 1) Routing compnay registers with BOP 2) Rx format meets all requirements of 40-43-86(E); generic substitution instructions must be clear 3) Must maintain integrity/confidentiality of Rx/pt info 4) Pharmacy can NOT incentivize e-prescribers
What is required on a e-prescription? 1)Rx IDs transmitter & recipient 2) Pharmacy of patient's choice 3) Secure prescriber signature and digital code 4) There should be a pt-practitioner relationship
True or False? You can NOT e-prescribe controlled substances in SC @ this time? True
What are the 5 duties of the pharmacist when practicing pharmacy? 1) Rx drug orders (Interpret, evaluate, dispense) 2) Participate in selection, admin, reviews, research 3) Pharmacy care; drug therapy management 4) Compound and labeling, safe storage of drugs/devices 5) Control pharmacy and personnel
What is the definition of administer? The direct application of a drug or device *by practioner's lawful order* to the body of a patient by injection, inhalation, ingestion, topical application, or any other means.
What is the defintion of Drug therapy management? The practice of pharmacy that involves the expertise of the pharmacist in a *Collaborative effort with practioner* to ensure the highest quality health care services for patients.
What are the 7 duties of a pharmacist (include, but not limited to..)? 1) Interpret and evaluate medical orders 2) select drug/device 3) Counsel patient 4) Review drug regimens 5) Provide pharmacy care 6) Receive orders 7) Supervise techs
What is Drug Regimen Review include (but is not limited to)? Evaluation of Rx drug orders and pharmacy records for: allergies, therapy CIs, reasonable prescriptions, duplication of therapy, interactions (drugs, food, disease, ADR), and proper utilization.
What is the purpose of reviewing a patient record? 1) Promoting therapeutic appropriateness by identifying: 2) Over/under utilization 2) Duplicate Tx 3) Disease CI 4) Drug interactions 5) Incorrect dose or duration 6) Allergies 7) Abuse/misuse
If you recognize an issue while reviewing a patient record, what should you do? The pharmacist shall attempt to avoid/resolve the problem, and contact practitioner if necessary.
Created by: brookshiree2