SC MPJE
What must be written on an Emergency CII prescription?
"authorization for emergency dispensing" and you must have oral authorization from PRESCRIBER and not his/her agent
How much is the penalty for for failure to display a permit?
$50
BOP fines may not exceed ___ unless otherwise specified by the Board
$500 they may also cancel, fine, suspend, revoke, or restrict authorization to practice.
What are the CE requirements for pharmacy technicians?
(10 hours of ACPE or CME 1 CE per year) and 4/10 hours must be live
What is required on a CS prescription?
- Must be dated and signed on date issued - Patient's full name -Patient's address (PO box address OK, not prefer - Drug name - Drug strength - Dosage form - Quantity - Directions - Prescriber's name - Prescriber's address and DEA # - Manual signature (DOB not required) can be written in pen, typewritten, or indelible pencil
What is NOT permitted to be changed on C-II prescription? (3)
- Patient name - Prescribed medication (except for generic) - Prescriber's signature (can't add or take verbal order for C-II) - OR DATE CHANGES
Certified Pharmacy Technician duties (community vs institution)
- Receive/Initiate verbal phone orders for non-controlled substances -Conduct Rx NonCS 100transfers Institutional Setting: Check a technician's medication refill Check a technician's repackaging
Dietary Supplement Health Education Act (DSHEA) Products may be marketed without ____. Products do not have to be proven ___. T/F: required to manufacture under GMP. T/F:May make structure/function claims on labels if statements do not indicate product will diagnose, cure, treat, or prevent disease
- proof of efficacy -safe -False -True
What must be on the label of the emergency kit?
- that it is an emergency drug kit for use in emergencies only - List of drugs contained - name, strength, quantity of contents -name, address, phone # of supplying pharmacist
Equivalent drug product (pharmaceutical equivalence)
-(drug products that contain the same active ingredients, are of the same dosage form and route of administration, and are formulated to contain the same amount of active ingredient and to meet the same or compendial or other applicable standards) -a drug product which has the same established name and active ingredients to meet the same compendia or other applicable standards -may differ in characteristics such as shape, scoring configuration, packaging, excipient (including colors, flavors, preservatives), and expiration time
What happens if a 222 form is lost or stolen?
-Fill out another form; prepare statement w/ serial # and stating order not rec'd, order form lost; - Put Copy 3 of 1st order & statement w/ Copy 3 of the new order; also, attach statement to Copy 1 & 2 of new order form to supplier -REPORT loss or theft of used or unused forms to the DEA and include serial number
What must a prescription contain?
-Full name of patient -Address of patient - Prescriber name, address, telephone*, degree classification - "license number, and Drug Enforcement Agency registration number of the prescribing practitioner where required by law" -Date of issuance -Name, strength, dosage form**, quantity of drug prescribed -directions -# of refills (if left blank, it = zero refills) - signature (no stamps) - two lines for sig (dispense as written or sub allowed) except when electronic rx or out of state or US gov issued rx
Misbranded (5)
-If the labeling is false or misleading in any manner -Manufacturers: Missing name/location of manu, packer, or distributer Quantity of contents is not present All required info is not prominent inadequate directions for use/warnings (OTC) ingredients missing look alike container or product violates the PPPA (poison preventative packaging act)
After consultation with a prescriber, what can be changed on a CS prescription?? (5)
-Patient address -Drug strength -Drug quantity -Drug directions -Dosage form
Procedures in case of loss, theft of CS in hospital: small amounts and recurring shortages
-Small amounts (single dose) must be reported to responsible supervisor official--> investigation should be made--> copy of report of investigation signed by responsible supervisor must be filed w/ hospital CS records - recurring shortages: thorough investigation --> complete report must be done and sent to administrative authority of hospital and copy of report + theft report must be submitted to DHEC
Ordering using Form 222:
-Submit 1 & 2 pages to supplier; retain 3rd copy; -Supplier records number of containers on Copies 1 & 2 (the supplier can partially fill, but must send remaining CS within 60 days); -Shipped to purchaser at location on form -Supplier retains Copy 1, sends Copy 2 to DEA at end of month (partial fill complete) -Purchaser (CVS) will record on copy 3 what they received and date it
What information does the receiving pharmacy need? (CVS to Walmart) What info does Walmart need?
-document "transfer" on Rx - date of issue and Rx number - Date/time of transfer - Transferring pharmacy name/address and DEA if CS - Name of RPh at CVS - Manufacturer or brand name of drug dispensed
Clerical duties
-enter patient information in profile (name, phone number, insurance, address, DOB) -order pharmaceuticals -perform billing functions -non-professional telephone inquiries -process RX sales transaction (CV non-rx sales after pharmacist signs book, CMEA covered products) cannot sell pseudoephedrine products UNLESS that person has been trained (Meth act)
Technician to RPh ratio: 1:1 2:1 3:1 4:1 how many techs must be state certified?
0; 0; 1; 2 can't be in charge of more than 2 non-certified technicians at a time
What is the mail order RPh:tech ratio?
1 RPh: 2 techs If the state in which the facility is located does not establish, by statute or regulation, a ratio describing the number of auxiliary personnel that a pharmacist may supervise, or otherwise define the role of the pharmacist in the compounding and dispensing of prescription drugs, then that facility may not allow a pharmacist to supervise more than two pharmacy technicians at any time in the compounding and dispensing of prescription drugs. (PPA)
What is the technician: RPh ration?
1 RPh: 4 Technicians (2 state certified)
CE credit for pharmacists and techs: what is required?
1 hour related to monitoring Rx for controlled substances
What is the Intern: RPh ratio?
1 intern: 1 RPh
DHEC registration is good for
1 year
How long are their terms? (7 congressional pharmacists) and (2 at-large)??
1) 6 years or until their successors are appointed with two term limits 2) Continuously with the appointing governor
What must be on a the label of every prescription or legend drug? could be any
1) Caution: Federal law prohibits dispensing without prescription 2) "Caution: Federal law restricts this drug to use by, or on the order of, a licensed _____" 3) RX only
Required supplies in the area where vaccines are administered
1- current copy of Immunization protocol 2- supply of most current federal VIS for vx being administered, or electronic access to them 3- Aqueous epi USP(1:1000), in amps, vials, or prefilled (epipens). If epipen, need at least 4 adult epipens 4- Benadryl- IV (50mg/mL) and PO (25mg) 5- syringes: 1mL, 3mL, 22g and 25g, 1" and 1.5" needles for epi and benadryl 6- alcohol swabs and bandages 7- BP device or stethoscope and sphygmomanometer (with peds, adult, and XL cuffs) 8- adult and ped size pocket masks w one-way valve 9- flashlight w xtra batteries (to examine mouth and throat) 10- time-keeping device w second counter 11- telephone access 12- equip to enable to sit or lie down if AE to vax, such as mat or reclining chair
Tamper-resistant pad must contain all of the following: (3)?
1. 1 or more industry-recognized features designed to prevent unauthorized copying, erasure or modification of information, and use of counterfeit rx forms
1. CV must not be more than _____ mL ( or ____ oz) to same purchaser in any given ___-hour period 2. Age at least ____ 3. Requires ____ 4. Bound book that contains what information prior to dispensing? 5. Prescription is or is not required? 6. Ex. of CV
1. 120 mL (4 oz); 48 hour 2. 18 years 3. ID (if not known to pharmacist) 4. Name/address of purchaser, name and quantity of CS purchased, date of each purchase, name/initials of pharmacist 5. Nope 6. NMT 200 mg codeine per 100 mL or 100 g; NMT 100 mg dihydrocodeine per 100 mL or 100 g; NMT 100 mg opium per 100 mL or 100 g "Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance, nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance, may be dispensed at retail to the same purchaser in any given 48-hour period" DEA CSA but use 120ml for any control V bc it's from SC CS and it's more strict
Obtaining BOP permits: When must a new permit application be submitted to the BOP? What must occur in addition? When do permits expire?
1. 45 days prior to opening 2. Facility must pass BOP inspection 3. Each location must be permitted 4. No registrations/permits are transferable 5. Annually on June 30th
NIOSH has 3 categories:
1. Antineoplastic HD 2. Non-antineoplastic HD 3. Drugs w/ reproductive tox
What are the duties of the PIC?
1. Assures all pharmacists, techs, interns employed within the pharmacy are currently licensed, certified, or registered and that interns/techs wear proper ID while on duty 2. Files any necessary reports 3. Responds to the board regarding any violations 4. Notifies the BOP immediately of: - change of employment of PIC (within 10 days) - change of PIC status (within 10 days) -Change of pharmacy ownership, pharmacy address (within 10 days) -Permanent closing of the pharmacy (within 30 days of intent to close/ and 10 days of closing) - Making sure everyone is current on registrations, certifications, and licesures - establishes/implements appropriate policies and procedures they also sign the pharmacy permits and renewals (along with permit holder. So the PIC and owner both sign permit renewals?)
System is down, how do you record refills of CIII-CVs?
1. Auxiliary procedure insures refills are authorized by original Rx order 2. Max number of refills have not be exceeded 3. Approp. data is retained for on-line data entry
How many files do you keep CS prescriptions? (in SC)
1. CII separate 2. CIII-CV separate 3. non-controls (federally allows the use of 2 files, all controls and all nonCS. or CIIs and then the rest CS with non. but need big rec C for all other CS mixed with nonCS) but SC requires 3 separate files
After filling a CS, RPh must document what? (3)
1. Date of original fill 2. Initials of pharmacist- handwritten 3. Quantity dispensed
Partial fill of a CII for LTC/terminally ill patient?
1. Document on prescription - terminally ill or LTCF patient -Date of partial fill -quantity dispensed -authorized quantity remaining -identification of dispensing pharamcist (Rx remaining valid for up to 60 days)
FQHC section in PPA does not prevent a licensed practitioner from dispensing a drug/device for a patient of an FQHC if:
1. Drug dispensed by FQHC is properly labeled 2. Patient is given a choice of receiving the drug from the FQHC or another provider 3. As it pertains to an FQHC without a retail pharmacy, it must maintain a FQHC permit and monthly shall conduct/submit BOP self inspections and maintain written checklists Also must designate pharmacist as a consultant pharmacist to be responsible: signing new/renewal application along w/ FQHC permit holder, agrees in writing the duties of CP, and performs/maintains written quarterly inspections Must notify BOP of consultant pharmacy change within 10 days
Controlled substance Rx label requirements dispensed directly to ultimate user...? (9) So an MD dispensing a CS to the patient
1. Drug name 2. Drug quantity (different**) 3. Name and address of dispenser 4.Name of ultimate user (patient name) 5. Directions for use 6. Date of dispensing 7. Cautionary statement 8. Federal statement 9. serial number (at the discretion of the dispenser) no strength req? no patient address req? No practitioner shall directly dispense more than a thirty-one day supply. (DHEC)
What circumstances would partial fill of CII be an option?
1. If the patient requests it-- all remaining qty will be VOID 2. If the pharmacy does not have enough --- must get the rest in within 72 hours or a new Rx is required 3. Patient may have terminal illness or be in LTCF--- rest of partial fill is good for 60 days after issuance date
When would you have to do inventory for CS other than May 1? (2)
1. If you get a new PIC 2. When a non-controlled drug turns into controlled drug, change of schedule
Unprofessional Conduct:
1. Intentionally circumventing patient counseling 2. Violating confidentiality 3. Selling drugs/devices for illegal use 4. Selling drugs/devices without prescription 5. Maintaining incomplete records
7-point label for OTC drug; if anything is missing from the label what is it?
1. Name of product 2.Name/address of manufacturer, packer, distributor 3.Net contents of package 4.Established name of all active ingredients and certain inactive ingredients 5.Name of any habit-forming drug present 6.Cautions/warnings to protect the consumer 7.Adequate directions for use MISBRANDED !
What are the citations and associated costs? 1. Failure tot display permit 2. Failure to display intern certificate or possess wallet card 3. Pharm tech working without a registration 4. Pharm tech working with lapsed registration 5. Pharmacy operating out of RPh: tech ratio
1. PIC- $50 2. PIC and Intern- $25 3. PIC- $500 4. PIC- $500 5. PIC- $500
What must be reported to the SCRIPTS database? (12 things)
1. Patient name 2. Patient address (city, state, zip) 3. Patient DOB 4. Date prescription was issued 5. NDC of drug dispensed 6. Quantity dispensed 7. Approx. # days supplied 8. Prescription # 9. Status- new Rx or refill 10. Date dispensed (not filled) 11. Prescriber's DEA number 12. Dispenser DEA number (not prescriber name, address, phone numer. no phone numbers at all. no name of person who picked up)
What are the 4 types of permitted facilities?
1. Pharmacy- requires PIC 2. Non-dispensing drug outlet- Authorized to administer and store legend drugs (includes clinics, wholesalers, manufacturers, distributors); requires consultant pharmacist (exceptions: facility only manufactures, wholesales, and/or distributes) 3. Medical gases/legend devices- requires consultant pharmacist unless supplying only oxygen. 4. Non-resident pharmacy- facilities located outside of South Carolina whose primary business is mail order; authorized to sale, distribute, or dispense legend drug/devices in this state. but FQHC without a retail pharmacy also need a permit.- need a consultant pharmacist who is exempted??
Who can prescribe CS substances in SC? (7)
1. Physicians (MD, DO) 2. Dentist (DMD) 3. Podiatrist (DPM) 4. Vets (DVM) 5. Optometrists (OD) 6. NP 7. PA
Registered Tech duties (4)
1. Provide effective, appropriate, and safe pharmacy services 2. Prepare prescriptions -Receive written prescription or medication orders -Receive verbal refill requests -Initial interpretation of orders -Enter Rx information into patient profile -Select appropriate drugs/devices -Fill/maintain unit dose carts -Change unit dose medication cassettes 3. Handle legend drugs -Check for drug outdates -Accept/Stock drug shipments -Process/Discard medications for returned credit -Stock automatic dispensers 4. Compound and mix medications -Mix drugs in dry form with water to activate -Prepare IV solutions -Repackage bulk medications
What is a state-certified technician authorized to do? (4)
1. Receive and initiate verbal telephone orders 2. Conduct one-time prescription transfer 3. Check another technician's refill of medications if the medication is to be administered by a licensed health care professional in an institutional setting i.e Tech-check-tech 4. Check a technician's repackaging of medications from bulk to unit dose in an institutional setting
What must be logged when a CS is dispensed?
1. Rx number 2. Date Rx filled 3. Number and ID type 4. Initials of person obtaining/recording info
What are required pharmacy references to be kept on hand?
1. SC PPA 2. SC CSA and regulations 3. SC Drug Act 4. Equivalent Drug Product Evaluations 5. Facts and Comparisons 6. Board of Pharmacy Newsletter 7. Patient-oriented information Drug equivalency and Facts&Comparisons can be online
FQHC with a permitted retail pharmacy:
1. The pharmacy must be permitted 2. the FQHC pharmacist may be the consultant pharmacist for the FQHC's affiliated delivery sites
CII Prescriptions: exceptions to written order signed by prescriber? (2)
1. Verbal order for EMERGENCY fill only--- followed up of written Rx within 72 hours or you must contact DHEC (DEA CS says 7 days instead of 72 hours...) (no quantity dispense limitation specified but should be limited to cover emergency period) Prescriber must write "authorization for emergency dispensing" on the Rx and send within 72 hours. 2. Fax is accepted as original Rx for those on/in home infusion, LTCF, hospice, narc to be compounded(so home infusion, right?) - written, signed, "voided" rx maintained in patient's medical record
All locations must have a DEA registration except ____ (4)?
1. Warehouses by registrants for storage, the CS can't be distributed directly from there. 2. Practitioner's office that only prescribes (not administered, stored, or dispensed from there. Practitioner registered at another location) 3. Common carriers (freight delivery company) 4. Office where sales are only solicited, made etc (no samples or displays allowed)
What procedures are put in place to monitor output of compounded prescriptions?
1. capsule weight variation 2. adequacy of mixing 3. clarity 4. pH of solutions 5. Procedures to prevent microbial contamination when meds are purported to be sterile
NIOSH is a drug identified as what? (6)
1. carcinogenic 2. Teratogenic or development toxicity 3. genotoxic 4. Reproductive tox in humans 5. Organ tox at low doses (10 mg/day humans) or <1mg/kg/d in anmals 6. new drugs that mimic existing HD drugs in structure or tox only need to have one of them
What exceptions does the requirement for labeling CS not apply to?
1. carton or wrapper in which the stock bottle come in if the symbol is see through 2. if the container is too small, the box or package must have it on there 3. clinical research where there are blinding/double blinding studies 4. exporting from the US
What is not included in the tech: rph ratio?
1. clerical employees (running cash register, patient info data entry) 2. Externs/Interns (1:1 ratio)
What is reported on Scripts?
1. daily CS dispensed on days open for business Controls II-IV (not C-V) 2. zero dispensing reported too Dispenser does not include: hospital pharmacy (inpatient or dispensing for discharge) practitioner who administers wholesale distributor Reporting exceptions: dispensing for VA outpatient (DHEC presentation says VA and IHS do report??) most LTC/assisted living methadone clinic ER (if < 48hour supply) veterinarian (if <5 d supply or <31 d of phenobarb) " a licensed hospital pharmacy that distributes controlled substances for the purpose of inpatient hospital care or dispenses prescriptions for controlled substances at the time of discharge from the hospital; or up to a 48 hour supply in a licensed institutional or hospital emergency room/department"- SCRIPTS doc on DHEC web says this so then why would the lecture freaking say that VA and IHS do report??? I'm hoping it's a type and supposed to say "don't" report.
For a partial fill of a CII for a terminally ill or LTC patient, what must be recorded on the back of the prescription?
1. date of partial fill 2. quantity dispensed 3. remaining qty authorized to be dispensed 4. ID of dispensing pharmacist
Partial fill of a CII by a pharmacy? (3)
1. document quantity dispensed on face of prescription 2. remaining quantity must be dispensed within 72 hours 3. no further quantity may be supplied beyond 72 hours without a new prescription
What are the 3 most common pharmacy issues?
1. drug diversion 2. med errors 3. pharm tech issues
Labeling of CS prescription bottle: (10)
1. drug name, qty, date of filling, pharmacy name/address, rx number, name of patient, prescribing practitioner, directions for use, cautionary statements (federal too)
Storage of CS inventory: 2
1. either dispersed throughout stock of non-controlled substances 2. CII-CVs may be stored in secure cabinet
Who do not count in the RPh:Tech ratio?
1. externs, interns (but can 1:1 ratio b/w pharm:intern) 2. clerical support 3. technician students and externs on rotation
What are the three exclusions from inspection?
1. financial data 2. sales data other than shipping data 3. pricing data
prn refills for non-CS is PRN refills for CS
1. for 2 years 2. 5 refills or 6 months, whatever comes first
A practitioner must check PMP before writing a scheduled II prescription for everyone except whom?
1. for a hospice-certified patient 2. for a RX that does not exceed a 5-day supply 3. An established patient w/ chronic condition-- except they must check every 3 months 4. practitioner approving the administration of a CII 5. Skilled nursing facility, nursing home, community residential care facility, or assisted living facility in which the meds are properly stored and monitored 6. If unable to access PMP -- must document
In order to be a CERTIFIED technician in SC, what are the requirements?
1. have a high school diploma or equivalent 2. worked for 1000 hours as a registered pharm tech under the supervision of a licensed pharmacist 3. has completed BOP approved pharm tech course 4. pass the national pharm tech certification board exam and has maintained current cerfitication (PTBC) d. fulfilled CE requirements (10 hours of ACPE or CME 1 CE per year) and 4/10 hours must be live
What constitutes an emergency fill for a CII? (3)
1. immediate administration is necessary for proper treatment 2. No appropriate alternative tx in another schedule is available 3. It is not reasonably possible for prescriber to provide written Rx to give to patient before dispensing ex: cancer patient needs pain meds to get him through the weekend.
Compounding logs require (5)?
1. ingredients, amounts, methods, equipment (same as formula) 2. date of compounding 3. date of expiration 4. assign batch/lot number 5. list all ingredients including lot number and exp. date for each
Who is authorized to dispense or administer narcotics at a narcotic treatment program to the patient? (4)
1. licensed practitioner 2. RN under direction of licensed practitioner 3. LPN under direction of licensed practitioner 4. pharmacist acting under a prescription or an order issued by the licensed practitioner
Who needs to register with DHEC annually for CS handling? (12)
1. manufacturing CS 2. distributing CS 3. dispensing CS 4. Conducting research w/ CS II-IV 5. Conducing research w/ CS I 6. narcotic tx programs CII-CV-- but employees/practitioners in the program do not need a separate registration, only locations separate from the main program that house narcotics 7. conducting chemical analysis w/ CS I-V 8. importing CS 9. exporting CS 10. compounder 11. conducting instructional activities w/ CS II-V 12. automated storage machines in LTCF
An FQHC without a retail pharmacy:
1. must maintain a FQHC permit and monthly shall conduct/submit BOP self inspections and maintain written checklists Also must designate pharmacist as a consultant pharmacist to be responsible: signing new/renewal application along w/ FQHC permit holder, agrees in writing the duties of CP, and performs/maintains written quarterly inspections 2. must certify w/ the board it made a good faith effort w/ an existing retail pharmacy within 5 miles of FQHC meaning that they were not able to reach an agreement with the existing retail pharmacy 3. the existing pharmacy would have provided Rx drugs to all FQHC patients at the same cost, convenience, and efficacy as offered by the FQHC
A pharmacy does not have to be inspected as non-sterile (503A) if what?
1. reconsititue/mix per labeling of medication 2. make less than 20 compounds of an oral or topical product using 5 or less non-hazardous API over any 30-day period Must keep formulas/logs though API's need cert of analysis (COAs)
Distribution of CS: A practitioner (or pharmacy) who is registered to dispense CS may distribute their stock to another practitioner (or pharmacy) (without being registered as a 'distributor') provided what 4 things?
1. the other practitioner is also registered to dispense CS 2. Proper records are kept 3. DEA form 222 is used for Schedule I or II 4. Total number of CS dosage units distributed must not exceed 5% of all CS dispensed in 12 month period
Keep vaccine records for __ years if 18+ or __ years if <18
10 years and 13 years
What is the breakdown of NDC code?
10-digits 12345 -- MFG 0678-- ID drug 91 -- ID package
How many hours does a technician need to be certified by the board? Other requirements? (5)
1000 hours + must have completed a Board of Pharmacy approved technician course High school diploma or equivalent Pass the National Pharm Tech Certification Board CE requirements
One-time emergency refill of NON-CS may occur after attempting to reach prescriber for a ____ day-supply and can only be done once in a ____ period. What kind of medication can it be? Within ____ days, PCP must be contacted.
10; 12 month period Essential medication: non controlled and for continuation of therapy or maintenance of life 10 days (but exam may still have 3-day supply, since recently increased)
What needs to be reported to the BOP within ___ days?
10? Pharmacists: employment, personal name or address, and PIC changes Pharm techs: employment, personal name or address
You need a prescription for an influenza vaccine if the person is less than ____ years old.
12
DHEC registration is valid for how long? Does each location need a separate registration? Who is the registrant? When do you re-register?
12 month; yes; PIC; within 60 days of expiration date
Airflow hood must be certified _____and each time _____.
12 months by certified technician each time it moves location (to a new pharmacy etc)
How long does a pharmacy have to notify DHEC of pharmacy transfer if going out of business?
14 days and must take complete inventory when going out of business (or bought out) the receiving pharmacy must fill out DEA form 222 for C-IIs
Expiration dates for water containing oral products and water containing topical/dermal products no water containing
14 days; 30 days 6 months
What is the SC pharmacist annual CE requirements?
15 hours total: ACPE or CME I 6 hours LIVE; 50% total hours must be in patient management or drug therapy 1 hour must include PDMP monitoring
What are the RPh CE requirements? total hours Live hours Excess carry over ____? Who is exempt CE requirements?
15 total hours (ACPE or CME) 6 hours live 9 hours non-live 50% of total hours (7.5 hours) must be in drug therapy or patient management 1 hour must be related to monitoring rx for CS Must have annual vaccination or compounding CE if doing that 1 year Pharmacists are exempt from CE requirements for their first renewal period following initial registration (and "may be granted by the board for pharmacists enrolled in an approved pharmacy postgraduate degree program. Application must be made to the board and a current official transcript must be submitted to the board.) sooo residents??
In a state of emergency, the pharmacist may dispense one-time emergency refill up to ___ day supply When does the pharmacist contact the PCP What must be written on the face of the Rx What kind of medications can be filled?
15; within 15 days; Emergency refill essential medications- no CS
You need a prescription for any vaccine other than influenza if the person is less than ___ years old.
18
Shurman Antitrust Act
1890
Pure Food and Drug Act
1906
What did the Pure Food & Drug Act do?
1906; prohibited interstate commerce of misbranded or adulterated food, drinks, drugs did not regulate cosmetic products or medical devices
Harrison Narcotics Act (year____) and what did they control?
1914; distribution/usage of narcotics The controlled substance act of 1970 repealed the Harrison Narcotic Act
Food Drug and Cosmetic Act (FDCA)
1938
Durham-Humphrey
1951
Kefauver-Harris (drug efficacy)
1962
Controlled Substance Act
1970
Poison Prevention Packaging Act
1970
Federal Anti-Tampering Act
1982
Federal anti-tampering act
1982
Orphan Drug Act
1983
Waxman-Hatch (Price comp and patent-term restoration)
1984
Prescription Drug Marketing Act
1987
Prescription Drug Marketing Act ____ (Dingle Bill)
1987
Dietary Supplement Health and Education Act (DSHEA)
1994
HIPPA (Health Insurance Portability & Accountability Act)
1996 (SC level)
FDA Modernization act
1997
In an institution, employment ratio is __ RPh : ___ techs, however daily operating ratio is determined by ___
1: 3; PIC
How long do you maintain 222 forms and related documents?
2 years
How long is a nonCS prescription good for in SC?
2 years
How long must original and transferred prescription drug order be maintained? Control records must be readily available within ___ Non-CS " within ___
2 years from date of last refill controls- 1 hour NonCS- 24 hours (SC PPA)
How long must written PE logs be kept?
2 years, then can be destroyed
A pharmacist may manufacture (without registering to be a manufacturer) an aqueous or oleaginous solution or solid dosage form containing a narcotic CS in a proportion not exceeding ___% of the complete solution, compound, or mixture
20
CMEA : combat meth epididemic act all need CMEA sales certification if selling pseudoephedrine/ephedrine products over the counter and need to complete online training and self certification after training (yearly)
2005 (but signed in 2006)
Drug Quality and Security Act
2013
Withdrawal treatment for narcotic addiction (using methadone) shall not exceed ____ days in length and shall not be available to any drug dependent person more than once every _____ months.
21 days; 6 months
DEA forms: 224: 225: 363:
224: pharmacies 225: manufacturers or research 363: narcotic treatment programs all good for 36 months (3 years)
Records for dispensing must be readily retrievable within ____ for a Non-CS. For a CS, how long should it be?
24 hours; 1 hour SC CS- readily retrievable: Certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some other manner visually identifiable apart from other items appearing on the records; when the term is not applicable to data processing systems, the term also means that a registrant is able to produce controlled substances records in a timely manner (usually within one hour) and that such records are segregated, sorted, or filed in such a manner that the controlled substances information may be derived from the material within a reasonable time (usually with a few hours) by an inspector
a person volunteering at a free med clinic and doing pharm technitian duties may register as a pharm tech without paying or filing with the board. this special resgistration is kept at the free med clinic for __ years
3
Can compound for anticipated rx if have history/routine, but cant exceed ___ months of anticipation
3 months
Dingle bill: how long do drug manufactures/distributors keep sample requests for?
3 years
What is the max amount of ephedrine, pseudoephedrine, or phenylpropanolamine a retailer may sell in any single day either in a nonprescription product or combination of non-prescription products?
3.6 g/day
Wholesale distributor permits- any changes must be made to the BOP within ______.
30 days (vs 10 days for other smaller (pharmacies)
iPLEDGE: max day supply of isotretinoin? How many days after issuance of Rx must it be dispensed? What must be dispensed with each Rx?
30 days supply; 7 days of potential child-bearing women; 30 days for men or women not of child-bearing potential Isotretinoin medication guide
Reporting to the BOP. report within 30 working days when: report within 10 working days when:
30 days to report: -theft or loss of drugs or devices (also notify DEA and DHEC); -conviction of any employee of any state or federal drug law. 10 days to report: - permanent closing (Upon permanent closing a permittee shall return the permit to the board within thirty days) - change of ownership, management, location (address), consultant pharmacists, or pharmacist in charge of a pharmacy; - change in employment of pharmacists or pharmacy technicians within a pharmacy permitted by the board; - disasters, accidents, destruction, or loss of records required to be maintained by state or federal law. - pharmacist or pharmacy technician who changes his mailing address - pharmacists or tech changes employment - change in PIC - change in consultant pharmacist civil penalty of not more than one hundred dollars upon any individual who fails to comply with the rules as provided in this section
Prescriptions for CS in Schedule II with the exception of trans-dermal patches, must NOT exceed a ___ day supply
31
Inside hoods (PECS): ISO Class ___
5
The SC BOP meets how many times a year and when?
5 times; JAN, MAR, JUN, SEPT, NOV
"emergency medical reasons" includes the transfer of legend drugs by a licensed pharmacy to another licensed pharmacy or a practitioner licensed to possess prescription drugs to alleviate a temporary shortage, except that the gross dollar value of the transfers may not exceed ___ percent of the total legend drug sales revenue of either the transferor or the transferee pharmacy during a consecutive ____ period
5%, 12 month
Which can sell compounds for office use only? 503A or 503B?
503B
CIII-V prescriptions are good for
6 months (C-II rx only good for 90 days)
Media-fill test every ___ months when handling HD
6 months. yearly for non HD/others tests
No prescription for a CS listed in schedule III, IV, or V shall be filled or refilled more than ____ months after the date on which prescription was issued and no such prescription may be refilled more than ___ times. (whichever comes first)
6 months; 5 times
HIPAA privacy notice records should be maintained for ______ from the date of signature of last date of Rx dispensed
6 years
How long is a CII prescription good for for a LTC/Terminally ill patient after a partial fill?
60 days from date of issue (what about before a partial fill? still 60 days or 90d??) " Schedule II prescriptions for patients in an LTCF or terminally ill patients are valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication" DEA CSA So valid for only 60 days
How much is something considered a poison?
60 grains or less
How many congressional districts are in SC?
7 - these pharmacists must live in their district
Cleaning of airflow hood should be used with and should be done how often?
70% isopropyl alcohol every 8 hour shift but if you're making something, MUST clean with 70% IPA and even before each batch, after each spill, beginning of each shift etc
Physicians in ER rooms may dispense legend drugs in order to meet the immediate needs of the patient. The amount dispensed may not exceed an amount equal___
72 hour supply
What is the max amount of ephedrine, pseudoephedrine, or phenylpropanolamine a retailer may sell in a 30 day period either in a nonprescription product or combination of non-prescription products?
9 grams
How many people make up the state board of pharmacy?
9 members (7 elected pharmacists from each of the congressional districts) + 2 at-large (one lay member + 1 hospital pharmacist)
Prescriptions for CS in Schedules III through V, inclusive, must not exceed a ___ day supply.
90 (C-II rx only up to a 31 day supply)
Prescriptions for Scheduled II substances must be dispensed within ___ days of the date of issue, after which time they are void.
90 days
Maintenance treatments is dispensing narcotics for periods >___ in the treatment of individuals depending on heroin or morphine-like substances
> 21 days
Mail order pharmacists must provide what to the BOP every year?
A copy of most recent inspection report from its state with their yearly SC permit renewal
What is a permit consultant pharmacist?
A pharmacist licensed in this State who acts as a consultant for a permit holder other than a pharmacy must notify BOP of change of consultant pharmacists within 10 days
lapsed license renewal
A pharmacist whose license has lapsed for three years or less may reinstate his license by applying to the board, submitting proof of completion of fifteen hours of acceptable continuing education for each year the license has been lapsed, and paying the renewal fee and any applicable penalty A pharmacist whose license has lapsed for more than three years and who has been actively practicing pharmacy in another state may reinstate his license by applying to the board, submitting evidence of at least one thousand hours of out of state employment in the practice of pharmacy within the last three years, official verification of a current license in another state, proof of completion of sixty hours of acceptable continuing education, and paying the renewal fee and any applicable penalty A pharmacist whose license has lapsed for more than three years and who has not been actively practicing pharmacy in another state may reinstate his license by applying to the board, demonstrating to the board evidence of at least one thousand hours of practice under the on site supervision of a pharmacist licensed in this State (???), successfully passing the Multistate Pharmacy Jurisprudence Examination, submitting proof of completion of sixty hours of acceptable continuing education, and paying the renewal fee and any applicable penalty. the board does not issue temporary licenses
PPPA: blanket approvals ?
A prescriber nor pharmacist can give blanket approval ---only a patient can. A prescriber can give approval for ONE Rx (refill only) and not every medication.
Automated systems should be capable of producing (5)
A refill-by-refill audit trail Print out for any drug Identify prescriber, patient, pharmacist Dates of dispensing and quantities Serial number
Patient records should include at a minimum and the pharmacist should make a good faith effort to obtain:
A. Full name of patient. B. Address and telephone number of patient. C. Patient's age or date of birth. D. Gender. E. All prescription drug orders within past 2 years at that pharmacy. F. Comments relevant to patient and/or drug therapies. G. Allergies, drug reactions, and/or idiosyncrasies. H. Chronic conditions and/or disease states. I. Other medications including over-the-counter medications.
We have adopted which code of ethics
APhA Code of Ethics
DEA Number verification... How do you do the math? BB1234563 What do the BB mean?
Add the 1st, 3rd, 5th # together Add the 2nd, 4th, 6th # together, then mult. by 2 Add both sums together Last digit above should be DEA last digit!!! First letter either is A, B, F, or M. A= before 1985 B= after 1985 F= physician M= mid level (PA,NP,OD) Second letter is last name.
Sterile Comp. Facility requirements
Adequate washing facility -hot and cold water -germicidal soap -warm air blower or non-shedding single use towels -eye wash station -class 100 laminar airflow hood -walls, ceilings, floors, counter-tops are NONPOROUS and do not produce matter
Class 100 environment
An atmospheric environment which contains < 100 particles 0.5 microns in diameter per cubic foot of air
Designated pharmacist
An individual currently licensed by the Board of Pharmacy in this State who certifies internship training
Any person or entity who engages in CS activity in SC must obtain a registration how often and by whom?
Annual; DHEC and must register with DEA
Med guides are required for which classes of medications ? for new and each refill
Antidepressants/SSRIs NSAIDs PPIs ADHD FQ TZDs Anticoagulants/Warfarin
When does the pharmacist license expire?
April 30
Pharmacist license expires when? When must a renewal be postmarked by? By what date is a license lapsed if the above is not done?
April 30th; April 1st; may 1
Drug or medicine- MD, PT, C
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals
Manufacturing control compounds
As an incident to a distribution under § 1401, a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound, or mixture -DHEC
How large must the CS symbol be on the container?
At least twice as large as the largest text on the container
Patient package inserts (PPIs) were targeted towards _____ medications, but should be placed in the prescription bag with every ____ and ____ for a community pharmacy. Institution: when do they need to add PPI? Who else does this PPI requirement apply to?
BC; initial fill and refill Prior to first administration and every 30 days after Anyone who dispenses drugs; LTCF, hospital pharmacies
When must a pharmacist renew license in order to be active ?
BEFORE APRIL 1, and if not postmarked before april 1, must pay $50 (online- submit before midnight on april 1st)
HD may only be compounded in
BSC and CACI. May not be prepared in laminar airflow workbench or a compounding aseptic isolator
Centralized prescription records must send requested printout within ______? Loss of data must be reported to the Board of Pharmacy within _____. (for automated systems)
Both 72 hours (in PPA)
Enforcement of the CSA in the state level is done by
Bureau of Drug Center, DHEC
BOP has a sister agency known as ____, which is affiliated with ______in an analogous relationship that the BOP has with ___.
Bureau of Drug Control (similar to SC's local DEA); DHEC; LLR
After receipt by the compounding facility, packages of ingredients that lack a supplier's expiration date cannot be used after one year unless either appropriate inspection or testing indicates that the ingredient has retained its purity and quality for use in CSPs (compounded sterile product)
But it also says: For components that do not have expiration dates assigned by the manufacturer or supplier, a compounder shall label the container with the date of receipt and assign a conservative expiration date, not to exceed three years after receipt of the component based on the nature of the component and its degradation mechanism, the container in which it is packaged, and the storage conditions So I guess it's 3 years unless it's for a sterile product, then it's just 1 year?
marijuana LSD (Lysergic acid diethylamide) Heroin
C-I
Modafanil (Provigil)- narcolepsy Midazolam (versed) Fospropofol (Lusedra) Phenazepam Zaleplon (Sonata) Zolpidem (Ambien) Carisoprodol (Soma)- muscle relax Alprazolam (Xanax) Barbital Chlordiazepoxide (Librium)- anxiety/sleep/withdraw Clobazam (Onfi)- seizures Lennox-Gastaut syndrome Diazepam (Valium) Meprobamate (Equanil, Miltown)- anxiety Pentazocine HCL and APAP (Talacen)- PO Pentazocine HCL and ASA- PO Pentazocine HCL and Naloxone (Talwin Nx)- PO Pentazocine (Talwin)- PO Phenobarbital (Luminal) Phentermine (Adipex-P)- weight loss "lams and pams" = benzodiazepines Sleep: Zaleplon (sonata), Zolpidem (ambien), Eszoplicone (Lunesta) propoxyphene (Darvon® and Darvocet -N 100®) a CIV narcotic alprazolam (Xanax®) clonazepam (Klonopin®) clorazepate (Tranxene®) diazepam (Valium®) lorazepam (Ativan®) midazolam (Versed®) temazepam (Restoril®) and triazolam (Halcion®)
C-IV
Pregabalin (Lyrica) Lacosamide (Vimpat)- seizures Pyrovalerone (MDVP? bath salts?) NMT 2.5 mg diphenoxylate and not less than 25 mcg atropine sulf. (Lomotil) Brivaracetam (Briviact)- seizures APAP with codeine elixir Phenergan with codeine Dihistine- DH (Codeine, Chlorpheniramine, pseudoephedrine) "cough syrups" - dispensed as Rx or OTC cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC® and Phenergan with Codeine®)
C-V
Remifentanil Racemorphan Secobarbital Piminodine Phenmetrazine Phenazocine **Pentazocine (injection only) opium poppy/poppy straw Levorphanol Dihydrocodiene Diphenoxylate Oripavine Thebaine Dronabinol (Syndros) -LIQUID narcotics include morphine and opium. hydromorphone (Dilaudid®) methadone (Dolophine®) meperidine (Demerol®) oxycodone (OxyContin®, Percocet) fentanyl (Sublimaze® or Duragesic®) hydrocodone (Norco, Vicodin, Lorcet, Lortab) morphine (MS contin) codeine opium stimulants include: amphetamine (Dexedrine®, Adderall®) methamphetamine (Desoxyn®) methylphenidate (Ritalin®). Other schedule II substances include: cocaine, amobarbital (Amytal)- sedative glutethimide- sedative pentobarbital (Nembutal Sodium)- sedative& anticonvuls
CII
Labeling of CII and CIII-CVs do not apply when administered to an ultimate user who is institutionalized given what?
CII- not more than 7 day supply is dispensed at one time CIII-CV - not more than a 30 day supply or 100 unit doses (whichever is less) is dispensed at one time
Anabolic steroids such as oxandrolone (Oxandrin), Depo-Testosterone** Buprenorphine combination products containing less than 15 milligrams of hydrocodone per dosage unit (Vicodin) Ketamine (ketalar) - anesthetic Dronabinol (marinol)- CAPS Chlorphentermine- weight loss Lysergic acid Methyprylon Nalorphine(Lethidorne, Nalline)- opioid withdrawal Phendimetrazine (Adipost, etc)- weight loss Sulfonmethane (Sulphonal)- hypnotic APAP w codeine (not more than 90 milligrams of codeine) per dose. not the liquid. benzphetamine (Didrex®)- weight loss phendimetrazine (Adipost)- weight loss Butalbital(Fiorinal, not fioricet) (b/c of the ratios but not listed under SC, so not sure if it applies) SODIUM OXYBATE (XYREM)- narcolepsy but GHB (date rape drug) is CI, but GHB products like Xyrem are CIII Pentobarbital, secobarbital, and amobarbital become C-III when combined with nonCS (such as aspirin) or when suppository
CIII
Apap w/ codeine Benzos Carisprodol (soma) Diphenoxylate/atropine (lomotil) Dronabinol (marinol) Tramadol (ultram) Pregabalin (lyrica) Lacosamide (vimpat) Zaleplon (Sonata)
CIII CIV CIV CV CIII CIV CV CV CIV
What are the special considerations for an NP to prescribe CS?
CIII-CV only NP can't write PRN refills, they must designate specific number of refills
Optometrist controlled substance prescribing:
CIII-V analgesics Only CII exception: Hydrocodone combo products 7 day or less supply Topical steroids limited to 21 or less day supply
Which CS are required to be reported to the SCRIPTS program?
CS II, III, IV (not C-V)
Outsourcing facilities
Can compound "for office use only". only way allowed. No rx needed for bulk compounding for office use. Can do sterile compounding
What are the special considerations for an optometrist to prescribe CS?
Can only prescribe CIII - CV only and limited to 7 days supply *except they can prescribe hydrocodone combo products and limit to 21d supply of topical steroids
What must all oral medications be dispensed in? (PPPA)
Child-resistance containers
What was the child resistance test? children and adults?
Children under 5 were given 5 minutes to open up a package. If they could not open it, they were shown how to and given another 5 minutes. The package is considered to be child-resistant if not more than 20% of 200 children tested could open up the package. Adults aged 18-45 years were given 5 min to open and properly close the package. If 90% of 100 could open and close the child-resistant package, it passed!
Buffer room: ISO Class ___ But for HD it needs to be ISO Class ___
Class 7 positive pressure Class 7 NEGATIVE pressure (and separate from ante room)
Ante room: ISO Class ___ But for Hazardous it needs to be ISO Class ___
Class 8 positive pressure. Class 7 positive pressure (and must be separate)
All cytotoxic solutions must be compounded in _______? It must be certified how often?
Class II BSC; 12 months or when moved. per PPA
What duties can a certified pharmacy tech do? (4 things) Community vs Institution
Community 1. receive and initiate verbal telephone orders 2.conduct one time prescription transfers Institution 1. check a technician's refill of medications if the medication is to be administered by a licensed health care professional in an institutional setting 2.check a technician's repackaging of medications from bulk to unit dose in an institutional setting
Compounding Vs. Manufacturing?
Compounding is when the quantity made is sufficient enough to fulfill the prescribers written order Compounded drugs are not commercially available FDA approved products Dosage forms are not sold to third parties or other pharmacies Ingredients must meet official standards. Pharmacy may advertise it does compounding but may not solicit business for specific products. Interstate distribution is no more than 5% of total Rxs filled by that pharmacy
Adultered (composition)
Contains in whole/part any filthy, putrid, or decomposed substance Has been prepared, packaged, or held under unsanitary conditions Has been manufactured under conditions that do not meet GMP standards Contains unapproved color additives strength differs purity falls below standard reducing quality or strength by mixing or substituting drug PCN powder gets on next drug from dirty counting tray
What is CSOS?
Controlled Substance Ordering System -can't share CSOS passwords -can only be used by person that it was issued to and also signed by their power of attorney person(looked up on DEA CS act and web) - if share password, DEA takes it away and will have to go back to paper ordering.
If a physician passes away, how long are controlled and non-controlled prescriptions active for?
Controlled-- Must be voided Non-controlled- 90 days
Drug Facts Label 1999
Created standard order 1. active ingredients 2. purpose 3. uses 4. warning 5. directions 6. other info-- drug facts 7. inactive ingredients
Sterile compounding area: What do you clean daily? weekly? monthly?
DAILY: countertops, hoods, floors swept, equipment wiped, utensils cleaned, trash discarded Weekly: floors mopped Monthly: shelves cleaned/sanitized, refrigerator cleaned and freezer, cabinet exteriors cleaned Air sampling: q 6 months
What is required at the bottom of each Rx for prescriber signature?
DAW and substitution permitted lines (left, right respectively)
Bureau of Drug Control is equivalent to SC's local ___?
DEA
What forms must be filled out after a CS has been missing/stolen? How long do you have to notify ?
DEA Form 106 regarding such loss of theft and should be mailed or faxed to DHEC/DEA 30 days to file form. But must contact DEA by writting and DHEC (verbal?) within 24 hours also contact BOP (within 30 days in PPA) Form 106 not filled out for accidental spillage.. use form 41 instead
What form do we fill out for a destroyed CS?
DEA Form 41 (submitted by the registered reversal distributor to the DEA)
Inventory of Drugs Surrendered for Disposal? (form?)
DEA form 41
Dispense
DEA lecture - "in SC a pharmacist will not administer or dispense...only fill and authorize a prescription" ....??? pharmacists not required to register with DEA bc they don't distribute or dispense. The pharmacy does.
DEA Form 223
DEA registration form. need to post cert on the wall
Controlled substance act is administered by _____? What do they regulate? (7)
DEA; buying inventorying prescribing dispensing storing using destroying
NP to prescribe CS must be registered with
DHEC
If a CS is missing, destroyed, or stolen, who does the PIC report to?
DHEC/DEA and BOP
Bureau of drug control --> _____ BOP--> ____ under the _______ umbrella?
DHEC; LLR; SC legislature
Dispensing compounds: what is required?
Date of dispense Prescription must have lot number
Distribute
Delivery of a drug or device other than by administering or dispensing
What is DHEC?
Dept. of Health and Environmental Control
What are these items? an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article
Devices
Which bill restricts sales/purchase/trade of drug samples?
Dingle bill (1987)- Prescription Drug Marketing Act
Administer
Direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means
SC OBRA-90 penalty
Disciplinary action or suspension, revocation, denial or refusal to renew permit by the pharmacy board; imposition of a fine by the BOP Misdemeanor convition for any violation a civil action brought by the LLR resulting in a fine no more than $10K
"The transfer of possession of one or more doses of a drug or device by a licensed pharmacist or person permitted by law, to the ultimate consumer or his agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient"
Dispense
SCRIPT Penalties
Dispensers who fail to report will be subject to a two thousand ($2,000) dollars fine and/or two (2) years imprisonment. Authorized users who knowingly disclose their account user information or breach confidentiality of the information will be subject to a ten thousand ($10,000) dollars fine and/or ten (10) years imprisonment.
Prescription Drug Marketing Act 1987 (Dingle Bill) This bill was enacted to prevent what? ____ What did it do? (5)
Drug diversion from normal distribution channels; Proper storage/maintenance of distribution records Restricts resale of drug products by hospitals Wholesalers must be state licensed Companies must be registered in their state restricts sale, purchase, or trade of Rx samples
Phase II of clinical trials test what?
Drug effectiveness and dosing (LIMITED EFFICACY AND SAFETY)
Phase III of clinical trials test what?
Drug effectiveness compared to control group (FULL EFFICACY AND SAFETY)
Repackaging--> unit dose. Label must include
Drug name Route of administration (if other than oral) Strength/volume control number/expiration date special storage A log book must be maintained identifying the repackager, the name of the drug, the lot number, the manufacturer, the facility control number, the expiration date, the quantity, and the initials of the pharmacist
cytotoxic agent
Drug that has the capability of killing living cells
Under what act do Rx bottles must have legend: "caution: federal law prohibits dispensing without a prescription?"
Durham-Humphrey Amendment 1951
What is the expiration date of the emergency kit?
Earliest date of expiration of a drug or device supplied in the kit -- supplying pharmacist must replace expired drug/device
What is the function of the Bureau of Drug Control?
Enforcing the SC Controlled Substances Act which closely parallels the Federal CS Act of 1970
What are the duties of a consultant pharmacist?
Establish/implement P/P 1. recordkeeping system for drugs (purchase, sale, possession, storage, safekeeping, return of drug) 2. drug recalls 3. removal of outdated/adulterated drugs 4. supervise duties of employees: sale, storage, compounding, distribution, procurement 5. Drug info resource and be available by phone for questions. 6. Monthly inspections for compliance w/ P&P 7. Monthly patient record review 8. Sign new and renewal permit application along with permit holder
How do your record CS inventory?
Exact counts of CIIs Exact counts of >1000 count Estimated count of CIII-CVs Whole numbers only Must record time (either beginning or end of business day) Who completed inventory.
Extern vs intern
Extern= rotation student Intern= working under licensed pharmacist to work towards license
(T/F)? Compounding includes mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling?
FALSE
(T/F)? Intracompany sales is an example of a whole sale distributor
FALSE
T/F: counseling is still required even if the patient refuses it
FALSE- must document patient refusal to be counseled /if counsel occurs
PPPA: T/F- For refills, you can use the same bottle?
FALSE- unless it's glass. Any plastic containing part must be replaced for refills. Bottle and cap if plastic. If glass bottle, and plastic cap, must replace cap.
T/F: Emergency fill for CIII-CVs are allowed.
FALSE-- must get new prescription or verbal order-- only CIIs (exceptions) and essential non-CS allowed
T/F: A controlled substance (III-V) on file is eligible to be transferred.
FALSE; once it's in the database, it must be filled at that pharmacy for the first time prior to transferring refills
T/F: you can have legend drugs in your facility if you are in the process of being permitted/have sent in your application
FALSE; the BOP must inspect and you must receive your pharmacy permit before your facility can have legend drugs
Which act added legend requirement "Rx Only"
FDA Modernization Act 1997
FDA enforces what? What do they approve?
FDCA- seize any adulterated or misbranded drug, food, cosmetic with court approval Approve new drug entities Approve drug package insert labeling
Which form must be used when any CS is sold, transferred, or returned to suppliers?
FORM 222
What is a non-dispensing drug outlet permit ?
Facility that administers and/or stores legend drugs and include clinics, wholesalers, manufacturers, 3PLs and distributors
T/F: mail order pharmacists must be licensed in SC if they are dispensing medications from another state.
False
T/F: A separate registration is required for CS if they are NOT being manufactured, distributed, or dispensed by a person?
False--- ex. warehouses that just store narcs do not need a registration unless they are distributing from that building; an office used by where sales are made or supervised but not distributed as samples or act as a distribution site; practitioner office where no supplies of CS are maintained and he/she does not dispense nor administer but prescribes
Faxed CS must include...?
Fax of a written, signed Rx. Include: Name, address, phone of prescriber Intended pharmacy Time/date of transmission
How can changes reported be made to the BOP?
Fax, mail, or online
FQHC
Federally Qualified Health Center
What form do pharmacies need to fill out to register for DEA? Renewal? When does initial registration expire?
Form 224, (224a is renewal; 36 months (3 yrs)
What assures pharmaceutical safety/quality?
GMP- good manufacturing practices
USP <800> <797> <795>
Hazardous drugs sterile non-sterile
HIPAA
Health Information Portability and Accountability Act
What are the exemptions for practitioners for a CS rx?
Hospital DEA + numerical suffix (name- stamp, type, printed) for residents -military -PHS (public Health services?) practitioner (must include service/agency and service # (stamp, typed, printed) - VA
What symbol is used for the following: Schedule I Schedule II Schedule III Schedule IV Schedule V Does the word "schedule" have to be on each bottle
I or C-I II or C-II III or C-III IV or C-IV V or C-V No
RECALLS: Class I, II, III what action must be taken?
I: serious adverse health consequence-- death possible ACTION: must get rid of pharmacy stock and notify patients II: temporary or reversible effects, remote prob of serious effects ACTION: remove pharmacy stock III: Drug product unlikely to cause adverse heath consequence ACTION: none
What's the difference between Pentazocine lactate (Talwin) in state vs federal?
INJECTION: it is a CII in SC and CIV per federal; oral dosage forms are CIV in both Pentazocine: for pain. often given before/after surgery
Pharmacist investigator reports finding of complaints to ___
IRC (investigational review committee)
What is the IRC made of? (4 things)
IRC- investigational review committee 1. two professional members chosen by BOP 2. BOP administrator 3. Pharmacist investigator 4. Attorney from LLR Office of disciplinary counsel
Faxed C-II
In order to expedite the filling of a prescription, a prescriber may transmit a schedule II prescription to the pharmacy by facsimile. The original schedule II prescription must be presented to the pharmacist and verified against the facsimile at the time the controlled substance is actually dispensed. The pharmacist must make sure the original document is properly annotated and filed with the records that are required to be kept. (In DEA CSA)
ISO 5 ISO 7 ISO 8
International Organization for Standardization ISO 5: atmospheric environment that contains fewer than 3,520 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100 ISO 7: 352,000; 10,000 ISO 8: 3,520,000; 100,000
Intern/Extern Duties
Interpret/Evaluate Medical Orders Participate in drug/device selection Provide patient counseling Perform drug regimen reviews Provide pharmacy care Receive phone/verbal orders
How to complete 222 form?
It is a Triplicate form Prepared and executed by purchaser (typed, pen,or inedible pencil); One item per line ONLY Number of lines used should be documented at bottom; Name and address of supplier entered; Signed by authorized person (power of atty); PA- filled w/ executed forms
What is the quantity limit for an emergency CII fill?
It is limited to the amount adequate to treat the patient during the emergency period
What did the Shumarn Antitrust act do?
It's to prevented monopolies, so it stops: Price setting Boycotting And saying you can only buy one thing with another ("you can only buy aspirin if you also buy tylenol from us")
When are pharmacy technicians to renew licenses by? BEFORE _____
July 1
When is a pharmacy technician registration valid from?
July 1 to June 30 of each calendar year
Full implementation of USP 800 due by
July 2018?
When is the renewal deadline for all mail order pharmacies out-of-state and all facilities located within this State engaging in the manufacture, production, sale, distribution, possession, or dispensing of prescription drugs or devices?
June 1
When do technician registration expire? Annual CE requirements? Total hours/ live hours Excess hours? Exemptions?
June 30th 10 total hours -4 live hours -1 hour for CS PMP -CE for compounding if doing that Excess hours can be carried over for 1 registration year Exemption same as pharmacist- first renewal period (and also if enrolled in a pharmacy technician program)
What created GMP?
Kefauver-Harris Amendment
Chart order
Lawful order from a practitioner for a drug or device for patients of a hospital or extended care facility, or such an order prepared by another person and signed by a practitioner either immediately or at another time, issued for a legitimate medical purpose within the practitioner's course of legitimate practice and including orders derived on behalf of a practitioner from a practitioner approved drug therapy management
Controlled substances can be transferred between whom?
Licensed pharmacists
Selling to Optometrists:
Licensed pharmacists may sell pharmaceutical agents, other than controlled substances as defined in Section 44 53 110, to optometrists who are diagnostically certified by the South Carolina Board of Examiners in Optometry for diagnostic purposes in the practice of optometry in accordance with Section 40 37 105(A). For these purposes, "pharmaceutical agent" means anesthetics, mydriatics, cyclopegics, miotics, dyes, and over the counter drugs. Licensed pharmacists may sell pharmaceutical agents, other than Schedule I and Schedule II controlled substances as defined in Section 44 53 110, to optometrists who are therapeutically certified by the South Carolina Board of Examiners in Optometry for diagnostic and therapeutic purposes in the practice of optometry in accordance with Section 40 37 105(B). Soooo can only sell C3-C5 if they're therapeutically certified and not just diagnostically certified...? -___-
Online pharmacy reporting
MONTHLY report to DEA of the total quantity of each controlled substance that the online pharmacy has dispensed the previous calendar month (esp if >100 scripts or >5000 dosage units combined dispensed. This report is due on or before the 15th day of the following month. For example, an online pharmacy would submit its report for the month of January no later than February 15th
Non-resident pharmacy permit is basically _____. What are they authorized to do?
Mail order sale, distribute, dispense legend drugs/devices in SC
Formulas/logs maintained either ____ or _____ Formulas must include: (5)
Manually/electonically 1. ingredients 2. amount 3.method 4. equipment 5. special info regarding sterile comp
Production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, or from bulk chemicals, and includes any packaging or repackaging of the substances or labeling or relabeling of its container, if these actions are followed by the promotion and marketing of the drugs or devices for resale to pharmacies, practitioners, or other persons
Manufacturing
When is CS inventory conducted? How long do you keep records? Can you do CS inventory on another day? Does each registered location need to do CS inventory?
May 1 every year; 2 years; Yes, but you must notify DHEC; Yes;
When is the annual CS inventory due?
May 1; Registrants must be certain to record the date of the inventory and whether the inventory was taken at the opening or the close of the business day. Inventory records must be maintained for two years in a readily retrievable manner. DEA only required CS inventory every 2 years but SC requires annually. inventory all need to be taken when change PIC separate C2 inventory from C3-5 need EXACT counts for CI & CII estimated counts for CIII-CV (exact if >1000 ct bottles) need to take inventory of certain product when schedule of the product changes.
Difference between mechanical error and intellectual error
Mechanical error= dispensing the wrong drug/misfills Intellectual error= counseling the patient
OBRA requires to counsel for ____ patient, but state requirement to counsel on all _____ Rx
Medicaid; New
Terminally ill patient has an RX for CII. What must be on that rx?
Medical diagnosis of terminal illness
Failure to distribute PPI (patient package insert) is considered what?
Misbranding
How long must a mail order pharmacy be operational?
Must be open 6+ days a week or 40 hours a week and must provide toll-free service for patients in which number is on their prescription label
Controlled Rx with NO DATE OF ISSUE??
Must contact the prescriber Must document correct date of issue and communication with prescriber
What is the notification requirement for reporting a permanent closing of a facility to the BOP?
Must notify BOP within 30 days of intent to close and then within 10 days of closing)
Therapeutic equivalence
Must show pharmaceutical equivalence for which bio-equivalence has been demonstrated AND are expected to have the SAME clinical effects + safety profile when administered to the patient under the same labeling considerations same effectiveness and same toxicity same drug salt=same drug
Does a college or university athletic dept that dispenses prescription drugs or devices need to have a PIC? or be have a permit by the BOP?
NO
Does a permitted facility supplying only oxygen, a wholesaler, or pharmacy require a consultant pharmacist?
NO no to wholesaler bc they don't dispense and no to pharmacy bc they have a PIC
Can you change the date of a CS?
NO, you must get a new prescription. If it is a CIII-CV, you may get a verbal order from physician. But for C-II will need to get a new non-verbal Rx.
Mid-level practitioners:
NP PA Optometrists medical psychologists ? nursing home? ambulance services? doctors of oriental medicine? neuropathic physician? euthanasia technitians? animal shelter? homeopathic physician? registered pharmacist? (Not in SC obvi) Examples of MLPs include, but are not limited to, nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists, physician assistants, optometrists, ambulance services, animal shelters, euthanasia technicians, nursing homes, and homeopathic physicians.
503a is what? 503B is what?
NS compounding facility (regular pharmacy, regulated by BOP state) outsourcing facility- mix btw comp. and manufacturer that complies with GMP, oversight by the FDA. and supplies products to hopsitals/pharmacies w/o Rx. w/o going under FDA approval/scrutiny (?)
Counseling
Name and description of medication Dosage form, dosage, route, duration of tx special directions and precautions for preparation, administration, and use by the patient techniques for self-monitoring drug tx action taken if miss dose proper storage refill information adverse effects and side effects
Labeling Parenteral Solution
Name of solution volume of solution Patient's name Rate of infusion ** Bottle sequence number (or other sys control method) Name and quantity of additives Date of prep BUD and time Ancillary precaution labels Identity of preparer and checking RPh
NIOSH
National Institute for Occupational Safety and Health
New BOP permit when:
New name, new address, new ownership
What are some exceptions to the PPPA? (7 medications)
Nitroglycerin-SL Isosorbide dinitrate (SL/chew < 10 mg) ASA/APAP: effervescent/granules Potassium suppl: unit dose Aerosol containers (inhalers) BC in dialpacks Anhydrous cholestyramine or colestopol packets Erythromycin gran/tabs Iron if contains less than 250mg elemetal iron per package.
Does the SC Pharmacy Practice Act have a mandatory error reporting clause?
No
Per the dingle bill, can a company ship drugs between states without being registered in the state from which they are being shipped?
No
Refills for CIII-CV: what's the earliest a CS can be refilled?
No sooner than 48 hours, but carry over time should not accrue between fills
SC's Implementation of OBRA 90: Does signing a counseling form constitute an offer? Can the technician or cashier offer counseling to the patient? Do you have to offer counseling on refills? Prescription transfers? OTC products?
No to all.
Does a pharmacist need to register him/herself to get a DEA number?
No, if working in a registered establishment
Do you need approval from Medicaid patients to dispense generic?
No, it is already deemed they have consented to substitution as part of the enrollment
Are prescriptions required for CS in floor stock at a hospital?
No, the request for CS appears on the perscriber's orders which must be signed by physician -administration recorded via the MAR - verbal/telephone orders permitted if absolutely necessary. but physician must verify order within 72 hours.
One time emergency fills are done for what type of medications and for how many days? How many times can it be done? Does the prescriber need to be contacted ?
Non-controlled, essential drugs (BP etc); 10 days; only once in a 12 month period for that medication; prescriber contact attempt should be done prior to e-fill, and they should be contacted within 10 days (may still be 3 days, bc fairly new increase)
Can a member of the board serve more than 2 successive terms?
Nope
If a physician own's his/her own practice, and is dispensing medications, is a pharmacy permit required?
Nope
SC's OBRA-90 - institutional setting --> required?
Not required for inpatients or ED where other health care professionals are authorized to administer the drug;
Labeling of samples: required or not required? It's required for nonCS when: what's the qty in mL or day supply?
Not required unless it is a CS; Required if more than 120 dosage units or 30 day supply of drug in solid form; more than (240mL) 8 oz in liquid form and if not in manufacturers original packaging, physician must label it like normal Rx
OBRA
Omnibus Reconciliation Act 1990
How often does DHEC do drug inspections? who do they inspect?
Once every 3 years*****; all practitioners/registrants who manufacture, dispense, or distribute controlled substances must be registered by DHEC and DEA
How many facilities can a pharmacist be PIC of??
Only 1 at a time without written permission from the board
Who is notified when the emergency kit is opened and who can refill it?
Only the supplying pharmacist on the emergency kit
What type of medications can an Optometrist prescribe? Limit of days supply for CS and topical steroids
Optometrist; oral or topical applied anesthetics, antihistamines, antimicrobials, antiglaucoma, OTC drugs; No medications may be administered IV or injection May prescribe controlled substance analgesics in Schedules III, IV, V in a 7-day or less supply and C-II only hydrocodone-combo products Topical steroids - no more than 21 day supply
Pharmacist currently licensed in the state who accepts responsibility for the operation of a pharmacy in conformance with all laws pertinent to the practice of pharmacy and the distribution of drugs and who is in full and actual charge of the pharmacy and personnel.
PIC
PIC or Consultant Pharmacist? Community pharmacy Hospital Pharmacy Non-dispensing drug outlet-whole saler Medical gases/legend devices-oxygen only Medical gases/legend devices* FQHC without retail pharmacy Non-resident pharmacy EMS
PIC PIC Neither Neither Neither*- duties must be carried out by medical director, resp. therapist, RN or consultant pharmacist Consultant- FQHC PIC Neither
Partial fill for CIII-V is different.
Patient can come back and get remainder of C-III at anytime. but before 6 months*** ex: alprazolam 1mg po 1 TID #90 patient requests #45 they can come back any time to get the remainder as long as it doesn't exceed #90 in 30 days. they have 6 months since the rx was written to get the rest (when the rx expires)
In order for a patient to be administered a CS in a hospital, what must occur beforehand?
Patient must be physically examined by physician in ER or outpatient facility
Generic consent, blanket authorization accepted?
Patient must consent to receive generic substitution. blanket authorization not acceptable. must consent for every generic substitution (except Medicaid. they all req generic subs)
Prescription Drug order requirements (18 things)
Patient name, address Prescriber: name, address, tele, degree, license #, DEA if required, and if mid-level, supervising physician's info also required, date of issuance, Name/strength/dosage form/quantity of drug/directions; # refills, and signature with DAW on left and Substitution permitted on right (UNLESS Medicaid script which does not require)
TREATMENT Investigational New Drug is used for whom?
Patients not enrolled in clinical trials who have life threatening illness for which there is no cure to receive IND -tx protocols must be submitted -AIDS, some cancers, ALZ, Parkinson's
What is a wholesale distributor? what are examples?
Person engaged in wholesale distribution of prescription drugs/devices; Manufacturers Repackagers Own-label distributors Private-label distributors Retail pharmacies (that conduct wholesale distribution) Warehouse: - manufac. -distributors -chain drugs -wholesale
Transferring prescriptions: who can do it?
Pharmacist, intern/extern (non-CS), and state certified tech (non-CS) Must get authorization from RPh
What is title 40; chapter 43 called?
Pharmacy Practice Act of SC
Labeling of prescriptions by filling/refilling: What is oddly not required by federal/state law but prob by insurance?
Pharmacy name/address** Rx (serial number) Name of prescriber Name of patient Date of filling Drug dispensed and strength (if mult. strengths are available) Brand and Generic name if dispensing generic ("generic for") and also manufac. (??) Directions of medication Initials of dispensing RPh Any special cautionary statement Quantity is not required, but usually automatically put there and refills are not required. But quantity is required for control labels Pharmacy phone number only req on label if from mail order
Who is authorized to receive data from SCRIPTS? (8)
Practitioner/pharmacist who certifies request is for purpose of providing Tx for bona fide patient Individual requests their own information (pharmacists cant give them a print out. have to go through DHEC to get it) LLR representative involved in investigation of designated person Local, state, federal law enforcement directly involved in investigation of designated person SC DHHS regarding Medicaid program recipients Properly convened grand jury pursuant to subpoena issued for records Personnel of Drug Control for administration and enforcement of program Qualified personnel involved in research/education
Identification requirement
Prescriptions for a controlled substance in Schedules II-V may not be filled unless the dispenser knows the recipient or requires proper identification and notes the identification source on the prescription or log documenting the following: i. Rx number ii. Government issued photo ID: Type, state/entity, number iii. Verify picture with person iv. Initials of employee collecting ID information
Brand Name
Proprietary or trade name placed upon a drug, its container, label, or wrapping at the time of packaging
What do you do to the unused 222 forms if you d/c business, change name, or address?
RETURN UNUSED 222 FORMS
What information does the transferring pharmacy need? (CVS to Walmart) What info does CVS need?
Record date of transfer Record name/address of receiving pharmacy (walmart) Record name of pharmacist at walmart Any remaining refills at CVS must be void Record pharmacy's DEA too if a CS transfer
wholesalers
Records kept at a central location apart from the inspection site and not electronically retrievable must be available for inspection within two working days of a request by an authorized official of any governmental agency charged with enforcement of this chapter
Transferring CS: Records must reflect transfer from one ____ to another? They must be readily retrievable Kept for ____ years Purchasing CS: Invoice records must indicate ____/_____ are recieved How do you separate the CS invoices?
Registrant; two; date/quantity; CIIs are always kept separate CIII-CVs can be kept separate or within non-controls
Federal Trade Commission (FTC)
Regulates advertising issues (for supplements)
What is the protocol for dispensing of Naloxone?
Reporting is voluntary
OBRA 90's Title IV Requirements
Requires all states to establish patient counseling standards applicable to Medicaid patients by Jan 1, 1993 as a condition to receiving drug reimbursements from Medicaid --> most states have expanded patient counseling requirements to apply to all patients Drug Utilization Review
Fair Packaging and Labeling Act
Requires consumer products in interstate to be properly labeled (including OTC)
Kefauver-Harris Amendment: FDA had authority to regulate _______. Required _______ in clinical investigations. Reporting of _______. Creation of ______.
Rx drug advertisements; informed consent; adverse drug reactions GMP
For buprenorphine: Physicians (not PAs or NPs) must have waiver from ___. must also obtain a special DEA# that starts with an ___.
SAMHSA X Both DEA and XDEA must be on prescription. physicians may have up to 100 patients (only 30 the first year) pharmacies don't have any restrictions for dispensing buprenorphine. except for laws applying to C-IIIs.
No federal limits on the quantity of CS prescribed.
SC does have the limitations.
795
SC pharmacists not req to be in full compliance with it?
DEA/DHEC registration renewal. SC must be renewed___, but federally mst be renewed___
SC: annually on or before April 1st Federally: every 3 years
What is the CS tracking system called in SC?
SCRIPTS
What are some examples of restricted distribution programs?
STEPS- thalidomide (leprosy, cancers. Baby limbs) IPLEDGE: isotretinoin (acne) Clozaril National Registry- agranulocytosis. Blood work results to pharmacy w/in 7 days. TIPS: tikosyn (gone 2016) EPASS- exjade PPL- Lotronex (alosetron. Women w IBS) TAP- Bosentan (Tracleer) for PAH (hepatox, fetal) FOSAMAX- alendronate (gone?) IRESSA- Gefitinib Xyrem Success- Sodium Oxybate REACH- sorafenib (Nexavar)
Phase I of clinical trials test what?
Safety- drug toxicology (PK) ADVERSE EFFECTS INDA submitted before phase I
Amphetamines, codeine (by itself), hydromorphone, meperidine, methadone, morphine, oxycodone
Schedule II
In a state of emergency, a RPh licensed in another state can dispense to those in SC if what?
They can prove current licensure in their state, and are engaged in legitimate relief effort during emergency situation
(T/F)? "Federal law prohibits dispensing without prescription"
True
(T/F)?: A drug includes articles, other than food, or nonprescription vitamins intended to affect the structure or a function of the human body or other animals
True
503B can do sterile and non sterile products: T/F
True
A CII that is to be compounded into a parental, SQ, intra-muscular, IV or intra-spinal medication to a patient in a home infusion can be transmitted via fax. The written, signed Rx shall be maintained in the medical record of the patient. T/F
True
NPs must be BON recognized NP, Clinical NP, or Certified RN Anesthetist in order to prescribe
True
T/F: A controlled substance in Schedule V, which is not a prescription drug as determined under the Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail
True
T/F: A registrant may not employ anyone, who has access to CS, who has been convicted of a felony offense relating to controlled substances, without a waiver from DHEC and the DEA
True
T/F: Alternate forms of patient information may be used to supplement patient counseling when appropriate.... therefore written instruction does not meet your statutory duty to counsel
True
T/F: CIII-CV prescriptions can be written, faxed, or received by telephone?
True
T/F: Compounding does NOT include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling
True
T/F: Daily printouts verified, signed by each individual who filled Rx that day (think costco when filling CS)
True
T/F: In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted.
True
T/F: Individuals (researchers), manufacturers, distributors, exporters, narcotic treatment programs, dispensing locations (pharmacies) must be registered by DEA in order possess controlled substances
True
T/F: Schedule 1 drugs have no accepted medical use, high abuse potential, lack of info on safety of their use, even under med supervision
True
T/F: Schedule IV drugs have an accepted med use, lower abuse abuse potential, physical and psycho dependence
True
T/F: The partial filling of a prescription for a controlled substance listed in schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription)
True
T/F: Transferring is permissible as many times as there are authorized refills between two licensed or permitted pharmacies, but may be delegated to intern/extern or state certified tech. For nonCS
True
T/F: any transfer of CS-II from one registrant to another requires Form 222
True
T/F: breakage, damage, or spillage is not a "loss" (theft)
True
T/F? A consultant pharmacist can consult at one or more locations.
True (unlike PIC that can only be a PIC at one location)
T/F: Schedule V exempt narcs--accepted medical use, low abuse, limited physical and psycho dependence
True (diphenoxylate w/ Atropine); -NMT (not more than) 200 mg codeine/100 mL or gm -NMT 100 mg dihydrocodeine/100 ml or mg (evenly divisible by 5)
T/F: emergency kits must be stored in secured areas to prevent unauthorized access, and to ensure a proper environment for preservation of the drugs within them
True (they can have controls in them)
T/F: Pharmacies: gross dollar value of the transfers may not exceed five percent of the total legend drug sales revenue during a consecutive twelve-month period of the transferor or the transferee
True or else they would have to register as a whole sale distributor
T/F: FQHC pharmacist may be PIC at more than one pharmacy and need not be physically present at the pharmacy to serve as its PIC
True'
A CII can be dispensed by a pharmacist pursuant to: a. written prescription b. e-script T/F
True, True
T/F: pharmacist can refill OTC without prescriber authorization What are exceptions?
True; 1. dose requested is more than recommended on label 2. prescriber limited refills on original prescription 3. drug is CV where refills must be designated by prescriber 4. individual state has set time limit for refillsl
A CII can be faxed for a patient enrolled in a hospice care program certified and/or paid for by Medicare(?) or hospice program which is licensed by DHEC. The Rx shall be kept as a written, signed, and void in their medical records. What must the practitioner or his/her agent put on the prescription? T/F
True; Note on the Rx the patient is a hospice patient
T/F: it is unlawful to dispense CS from hospital stock to employees T/F: physician cannot obtain CS for his/her own office from hospital inventory
True; True
T/F: a non-dispensing drug outlet facility requires a consulting pharmacist UNLESS the facility is engaged in __, ___, or ___.
True; manufacturing, distributing, or wholesaling
T/F: Preprinted blanks are prohibited for controlled substances? How does preprinted blanks work for non-controlled subst?
True; must be one drug & one set of instructions per page
T/F: Samples are barred from retail pharmacies What are allowed instead? Institutions are allowed samples Are they stocked with normal drug stock and how do they keep track of where the samples go?
True; starter packs (altho not considered samples); True; stocked separately from other medications; disposition is precisely recorded and are licensed prescriber requested
A CII that is faxed to a pharmacy for a LTC patient shall be kept as a written, signed, and void in their medical records. Does this include residents of community residential care facilities or assisted living facilities? T/F?
True;NO, only LTC
Durham-Humprey Amendment established what? (what year too) What does it allow as well?
Two classes of drugs: prescription- under medical supervision and OTC (non-prescription)- without medical supervision; 1951 Verbal orders and refills Expiration or beyond use dating
SC's Implementation of OBRA 90
Upon receipt of a prescription drug order for a new medication and following review** of the patient's pharmacy record, the pharmacist shall personally* offer counseling to the patient or the patient's agent - in person, or by telephone - Patient counseling is not required for inpatients or emergency department patients of a hospital or institution where other licensed health care professionals are authorized to administer the drug.
What is the protocol for administration of vaccines?
Vaccinating pharmacist must complete yearly CE
When does a pharmacist license become lapsed??
When it has not been renewed before MAY 1
If a DEA special agent or compliance investigator or an inspector from DHEC requests a copy of a refill-by-refill audit trail for any CS, how soon do you have to send it?
Within 48 hours (per DEA CSA)
Are all inspectors at the BOP pharmacists?
YES- true
Transfer of CS: Shared database: - Can an Rx be transferred multiple times? -If receiving an Rx from an unshared database, can another pharmacy within that database fill the Rx? Unshared database: - Once you transfer it to another pharmacy, can the other pharmacy share transfers within its database?
Yes No No NonCS- can be transferred anywhere as long as there are refills left
Can other pharmacists have authority to order CS?
Yes, as long as they have power of attorney--- the PIC will add individual obtaining authorization
Can the follow up prescription of an emergency CII be hand delivered or mailed?
Yes, both. MUST be postmarked within 72 hours.
Medical gases/Legend devices permit- requires a consultant pharmacist?
Yes, except in the case where O2 is only being issued.
Generic substitution: is it required to get prescriber and patient authorization? Is blanket authorizations acceptable?
Yes, prescriber must authorize either by signature or verbally; Patient must authorize each time (each refill) whether they want generic or brand No, it is not acceptable
Can you dispense compounds to licensed prescriber? If so, what must be set in place and what must be on compound?
Yes; contract btw pharmacist and prescriber in order to sell them products Contract must specify that compounds are intended for "office use only" and lot numbers/exp dates must be maintained and readily available in patient chart IN CASE of a RECALL A prescription for an individual patient for each administration of the drug shall not be required. Institutional pharmacies may order and store compounded preparations, both sterile and nonsterile, from compounding pharmacies in anticipation of patient orders based on the existence of a pharmacist/patient/practitioner relationship for regularly observed prescribing patterns. A chart order from a practitioner will be required for administration in an institutional facility
What do you do if you partial fill a CII for a normal person?
You must void all remaining quantities. The person either gets all the medication or some. He/she cannot come back for the rest.
Long term care facility:
a nursing home, retirement care, mental care, or other facility or institution, which provides extended health care to resident patients. (not registered with DEA. keep controls that are already dispensed to the ultimate user)
Nonresident pharmacy
a pharmacy located outside SC
Automated Dispensing Systems (ADS)
a retail pharmacy allowed register at the site of the LTCF and store controlled substances in an ADS (if state permits, does SC?) drugs in the ADS are counted as pharmacy stock keep all records required for those additional registered sites at the retail pharmacy/ central location
Methadone and its salts are restricted to? (3)
a. tx, maintenance, detox programs b. hospital for analgesia, pertussis, detox tx c. retail pharmacy for analgesia
A- rated, B-rated, AB-rated
a= bioequivalent b= not equivalent ab= meets necessary bioequivalence requirements sub numbers need to match too. AB1=AB1 but does not equal AB2
What is an A-NDA?
abbreviated NDA: -encourages generic development -require proof of similar properties to innovator's drug
What is a rare disease? Orphan Drug Act provides ?
affects <200,000 people in the US incentives (tax/licensing) to promote research, approval, marketing of drugs for rare diseases
The Division of Diversion Control monitors:
all aspects of the legitimate manufacture and distribution of controlled substances.
Personnel must be trained in compounding, handling, and destroying cytotoxic agents and informed of risks, how often? ____ Documentation required ___
annually for both
NP and PA
are midlevel practioners and so are Clinical nurse practitioner specialist (CNS) and Certified nurse- midwife (CNM), nurse anesthetist (CRNA), advanced practice registered nurse (APRN)
How often are inspections done by the BOP inspectors?
biennial - every 2 years
Keep vet meds order forms separate (222 form)
carfentanil, etorphine HCL, diprenorphine
DEA penalties: failure to follow refulations related to recordkeeping, security of controlled subs and listed chemicals, and unlawful distribution may result in
civil fine of $10,000 up to $25,000 per violation loss of authority to handle CS, and/or imprisonment
If practitioner practices in two different locations but in the same state then that second office is not required to have different DEA number if the practitioner is only prescribing at that different location (not dispensing, administering, and if no controls in that office) but yes if practicing at different locations in different states
confusing. but its in §1301.12 Separate registrations for separate locations
Biological Safety Cabinet
containment unit suitable for the preparation of low-to-moderate risk agents where there is a need for protection of the product, personnel, and environment
PA may prescribe if
crtified by the board of medical examiners
CMEA sales limit:
daily: 3.6 g 30 days: 9 g Mail/shipment: 7.5 g
Examples of misbranding?
deals w labeling Mixing lot numbers Labeling Rx with trade name but dispensed generic Refilling Rx w/o authorization of prescriber Labeling Rx with one strength, but dispensed another strength missing "warning- may be habit forming" when appropriate missing "caution: federal law prohibits dispensing w/o prescription" if legend drug offered for sale under another name
Potential IRC actions includes?
dismissal letter of caution disciplinary actions per resolution guidelines referral to full board for hearing
Scheduled Listed Chemical Product (SLCP)
ephedrine, pseudoephedrine, or phenylpropanolamine (not sold anymore. only to animals with rx) products must be kept behind the counter or in locked cabinets.
How often does FDA inspect manufacturers?
every 2 years
Airflow hood must be certified every ___ per PPA, but every ___ months per USP 797
every 6 months certification with date must be attached to the front of the food ppa says hood must be recertified everytime the hood is moved (locations, not moved from wall to wall in same facility) pressure in rooms checked every work shift or continuously
long term care, regulated by:
federal and state
Form 104
filled out when surrender DEA registration
What are the special considerations for a PA to prescribe CS?
for CII only: Oral dose: initial is limited to 72 hr supply; any subsequent rx authorization must be in consultation with and upon patient exam/evaluated by supervising physician, and must be documented in patient's chart. subsequent rxs may be up to 31 day supply Parenteral dose for CII in hospital, ER/outpatient departments affiliated with hospitals: written medical order may not exceed a one-time administration w/i 24 hr period
DHEC inspectors
get trained like police officers. Have statewide police powers, carry firearms, can execute and serve warrants, can investigate, can seize property, can ARREST without warrants for offenses committed in their presence.
T/F: A pharmacist may not serve as PIC unless ___?
he/she is physically present in the pharmacy a sufficient amount of time to provide supervision and control
Licenses/registration/certificates must be placed where?
in a public view--- original copies only
Storing invoice records vs dispensing records
invoice records: C-2 kept separately C3-5 can be separate or mixed with nonCS dispensing records: must have 3 files 1- C2 2- C3-5 3- NonCS
What is the medication error rate limit for long-term care?
less than or equal to 5%
CMEA: Logbook and photo ID does not apply to single sales of ___? Exclusions also do not apply to what?
less than or equal to 60 mg If a MD prescribes it IT says that purchaser must provide a photo ID and sign a logbook and enter his or her name, address, date, and time of sale (DEA CSA)
Dispensing CV is limited to ____. Age limit May not purchase again within ____
liquid; 18 (I think federally is 16?); 48 hour period
A SC registered pharmacist (may/may not) dispense a CS prescription if the pharmacist knows or should have known the Rx was issued (with/without) a valid patient-practitioner relationship
may not; without
Compounding pharmacist must have CE education... how many hours do they need? Can a pharmacy tech help with compounding-- if so, do they need CE credit too?
minimum 6 hours initial and then 4 hours each year Yes
Prescription and inventory records
need to be readily available (kept at registered location)
USP 797 requires cleaning hoods every 30 minutes with STERILE 70% IPA alcohol, at begining of every shift, before each new batch, and after every spill. But SC PPA-->
only require cleaning q 8 hours with non-sterile 70% alcohol. need to document cleaning performed, date, time, initials and kept 2 years.
BOP permit:
permits expire June 30th but you must submit the renewal application by June 1st!! if not then a $50 penalty. If permit is not renewed by July 1st- considered lapsed. Pharmacy may not operate with a lapsed permit. "A permit renewal application, including the required fee, must be submitted to the board before June first. If not postmarked before June first, a penalty of fifty dollars must be assessed. For permits not renewed by the expiration date, the board may charge an additional ten dollars a day until the permit is reinstated. A permit which has not been renewed before July first is a lapsed permit. A permit holder who allows a site to operate with a lapsed permit is in violation"
Dispensing of biological product
pharmacist must inform prescriber of the biological product name dispensed and manufacturer within 5 days (not needed for refills if dispense same product, or when dispensed in-patient)
Phase IV is what?
post-marketing testing (NDA submitted before phase IV)
Who has to register with IPLEDGE to be able to handle isotretinoin?
prescribers pharmacies patients wholesalers**
ryan haight online consumer protection act 2008
prohibited online sell of CS unless the online pharmacy holds a modification of DEA registration authorizing it to operate as an online pharmacy. Patient still required at least one in person medical evaluation or telemedicine. A pharmacy website is exempted from the Ryan Haight Act's definition of an "online pharmacy" if its Internet facilitated activity relating to controlled substances is limited to filling new and/or refilling prescriptions for controlled substances in schedules III, IV, or V. and not required to get a modification of its DEA registration authorizing it to operate as an online pharmacy. soooo pretty much they would only need a special modification of its DEA registration if its also going to be filling C-IIs online?
SCRIPT delegates
provider/pharmacists can have 3 delegates under account to look up reports in SCRIPTS (technician can be a delegate)
Which copy of 222 form is kept by purchaser (ie cvs), supplier, and DEA?
purchaser: copy 3 (blue) supplier: copy 1 (brown) DEA: copy 2 (they get it at the end of the month) (green)
If PE is lost/stolen, one must:
reports should be made orally to the local DEA Diversion Field Office. and a written report of losses must be filed within 15 days after the pharmacist becomes aware of the loss or theft
FDA Modernization Act 1997- Encouraged what? Pharmacies compounding are exempt from what?
research for new uses of drugs; GMP standards
FDCA of 1938 stated that no marketing until proven _____. Drugs prior to 1938 are known as ________. What are examples ?
safe; grandfathered; Digoxin, Levothyroxine, NTG, Phenobarbital
What is required for detox/maintenance treatment for DEA? (methadone clinic). but not req if methadone used for pain.
separate/special registration is required (DEA form 363, and approved by SAMHSA) physicians who is not separately registered to conduct narcotic treatment programs may still administer (NOT prescribe) narcothic drugs to relieve acute withdrawl symptoms may administer not more than a day's medication for max of 3 days. NP and PA's can't register for special permit
Inactive license --> active (so retired pharmacists wanting to go back to work) need to:
submit a renewal application to the board (before April 1st) 30 hours of CE (15 hrs must have been done the year immediately preceding the renewal application. So I guess only 15 of the 30 could be carry over credits)
What is an S-NDA?
supplement NDA: -change in labeling/packaging of already marketed drug -change in manuf. location -change in synthesis of drug -change in production procedure of drug ex. adding dosage form, tablet strength, new therapeutic use to original drug
T/F: all complaints are investigated by the BOP
true
T/F: drugs must be removed from emergency kits only pursuant to a valid medical order
true
T/F: Pharmacist (only) may dispense opioid antidote pursuant to written prescription or standing order by a prescriber or by state protocol The pharmacist must contact who after it's been dispensed?
true; PCP
T/F: Schedule III drugs have a current med use, less abuse than I and II, mod to low physical dep, _____ psycho dep.
true; high
How long are CS records kept?
two years
What is the notification requirement for reporting a PIC change of employment, change of PIC status, change of pharmacy ownership/pharmacy address?
within 10 days
How long must changes be reported to the BOP?
within 10 days of the change Leaving/starting a job PIC change consultant pharmacist change address change (facility or person) permanent closing of pharm (30 days before and then 10 days before) When get married too apparently, prob bc of name change?
In the case of temporary technical difficulties, how many days do you have to report to the National Association of Drug Diversion Investigators the purchasers information (DOB,time/date, name, address, ID type, ID number and amt of PE)?
within 3 business days of each business day that the electronic log was not operational
When must a CS be returned to the pharmacy in a hospital if it has not be administered to the patient?
within 72 hours after order is d/c
Enteral
within or by way of intestines
How long does a PIC have to correct any violations and respond to the inspector?
~14 days
What happens if a pharmacy tech does not renew by the due date?
Shall immediately cease practice and refrain from performing any duties as a pharmacy technician. He/she must go before the board
Investigational NDA
Submitted before testing on humans (done before 4-test phases) FDA has 30 days to approve/disapprove Safety determined by animal testing
Buprenorphine
Suboxone, Subutex, Zubsolv dispensed for maintenance of detox of opioid addiction
Methadone distribution in NTP moved from FDA to
Substance Abuse and Mental Health Services Administration (SAMHSA) 2001
SC more stringent laws with filling, quantity. than federal
T
T/F: each location must have a different DEA registration
T
(T/F) In order for you to be licensed in the state of SC if originally from another state, your original license must remain active in order for your SC license to be valid.
TRUE
(T/F): A permit is required for the sale, distribution, possession, or dispensing of drugs bearing the legend "Caution: Federal law prohibits dispensing without a prescription"
TRUE
(T/F): A pharmacist whose license has been denied, revoked, suspended, or restricted for disciplinary purposes is not eligible to be registered as a pharmacy technician
TRUE
(T/F)? A device must bear the label: "Caution: Federal law restricts this device for sale by or on the order of a ___________", the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device
TRUE
(T/F)? The actual sales transaction and delivery of a drug or device is not considered dispensing and the administration is not considered dispensing.
TRUE
(T/F)? The purpose of this chapter is to promote, preserve, and protect the public health, safety, and welfare by and through the effective control and regulation of the practice of pharmacy; the licensure of pharmacists; the licensure, permitting, control, and regulation of all sites or persons, in or out of this State, that distribute, manufacture, possess, or sell drugs or devices within this State, as may be used in the diagnosis, treatment, and prevention of injury, illness, and disease of a patient or other individual.
TRUE
T/F: BOP meetings are open to the public
TRUE
T/F: It is legal to fax a Schedule II prescription for patients residing in LTC facilities and/or hospice patients?
TRUE
T/F: No person may operate a pharmacy without a PIC
TRUE
T/F: SC regulates pharmacy technicians and includes national certification in their region
TRUE
T/F: Schedule II drugs have an accepted med use, high abuse potential, severe physical and psychological dependence
TRUE
T/F: The Bureau of Drug control inspectors/investigators are all SC-licensed pharmacists who are also commissioned as state law enforcement officers.
TRUE
T/F: inspections are unnanounced
TRUE
T/F: all emergency kits must be sealed and provided by a pharamcist
TRUE (can be kept in a LTCF, and institutional practices without institutional pharmacy)
T/F: A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner.
TRUE, but only for CIII-CV
T/F: SC does not accept state sponsored CE (ie NC offers 5 hours of CE for acting as a preceptor)
TRUE, must be ACPE-accredited or CME I
T/F: There must be an administrator of the BOP who must be a pharmacist licensed in the state of SC AND who must be the chief drug inspector
TRUE--> Lee Ann Bundrick
T/F: New/refill prescriptions must be in child-resistant closures? Are there exceptions?
TRUE; 1. prescriber specifies none to be used (for one rx only) 2. patient indicates they do not want it (single request or blanket) 3. drugs are maintained/administered by heath professionals
Tamper resistant vs tamper evident
Tamper resistant is used to resist access to the product (safety seal) Tamper evident describes a feature to make it easy to detect that it has been accessed
What was the Federal Anti-Tampering act?
Tamper-resistant packaging of OTC products/ cosmetics to provide barriers-to-entry against intentional contamination ex. safety seals
pharmaceutical alternatives
Tetracycline HCL, 250mg capsules vs. tetracycline PHOSPHATE complex, 250mg capsules; quinidine sulfate, 200mg TABELTS vs. quinidine sulfate, 200mg CAPSULES SC law says therapeutically equivalence with same dosage form
Kefauver-Harris Amendment was created as a results of what? What did medications have to show? ____ and _____
Thalidomide defects; safe and effective** label requirements for manufactures and dispenser to the patient?
What reference should be used to determine therapeutic equivalence?
The Orange Book
Deliver or delivery
The actual, constructive, or attempted transfer of a drug or device from one person to another
Patient's records and who can see them?
The patient Pharmacist/personnel authorized Prescriber BOP/DEA inspectors Not spouses technically..
Who is responsible for choosing to get child-resistant packaging? How is that documented? What does this test for?
The patient; on prescription (written waiver if blanket approval) or on prescription specifically); test whether the Rx will enter a home
DEA registration Exemption
The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service, or Bureau of Prisons, who is authorized to administer, dispense, or prescribe, but not to procure or purchase controlled substances in the course of his or her official duties. Such officials must follow procedures set forth in 21 C.F.R. part 1306 regarding prescriptions, but must also state the branch of service or agency (e.g., "U.S. Army" or "Public Health Service") and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his or her Social Security identification number. If federal government practitioners wish to maintain a DEA registration for a private practice, which would include prescribing for private patients, these practitioners must be fully licensed to handle controlled substances by the state in which they are located.
What's required on a CS stock bottle?
The symbol designating the schedule in which such controlled substance is listed