MPJE

Practitioners are indicated by the letter _____ as the first letter in a DEA #

"A"

No substitution if written Rx states:

"Brand Medically Necessary" or "No Substitutions"

cautionary statement required for all controlled drugs (CII-CIV)

"CAUTION: Federal law prohibits transfer of this drug to any person other than the patient for whom it is prescribed"

Side effects statement

"Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088"

Statement that must be provided to consumer when pharmacy dispenses an Rx

"If you have a concern that an error may have occurred in the dispensing of your prescription you may contact the Department of Consumer Protection, Drug Control Division, by calling (Phone#)"

Mid-level practitioner's DEA numbers start with the letter "__"

"M"

Signage regarding substitution of generic drugs and biological products

"This pharmacy may be able to substitute a less expensive drug product or interchangeable biological product which is therapeutically equivalent to the one prescribed by your doctor unless you do not approve"

biosimilar product

"no clinically meaningful differences" from reference product for safety, purity, and potency as demonstrated through PK and PD studies

_____ multi dose vials = 1 unit

#1

____ suppositories = 1 unit

#10

_____ single dose ampules, tubexes, or other single dose package forms = 1 unit

#10

_____ tablets or capsules = 1 unit

#100

For "cause", DCP may assess civil penalties $$ up to:

$1,000/violation (cumulative)

Nonlegend Drug permit renewal fee (LATE)

$10

Non-legend drug permit Renewal Fee

$100

Pharmacy Technician Registration Fee (New)

$100

Pharmacist who permits someone else to use their license is subject to:

$100 fine and disciplinary proceedings

What is the fine for selling non legend drugs without a permit?

$100-$500

Pharmacist License Fee (Renewal)

$120

Pharmacist License Fee (renewal) if lapse <3 years and not working in state

$120

Permit to sell non-legend drugs (fee)

$140

Pharmacy License Renewal fee

$190

Late notice of ownership/name/location change for non-legend permit

$20

Retirement status fee

$20

Pharmacist License Fee (new)

$200

Pharmacist License fee (renewal) if lapse >5 years

$200

Temporary permit to practice pharmacy fee

$200

Marijuana producer license application fee

$25,000

Change in corporate officers (late fee)

$50

Change in name, ownership, management (late fee)

$50

Pharmacy Technician Registration (renewal fee)

$50

Pharmacy Intern Application Fee

$60

Change in corporate officers Fee

$60 each

Pharmacy License Fee (new)

$750

Change in name, ownership, management

$90

Label requirements for emergency stock at SNF's

(same as stock bottles in pharmacy) drug name and strength expiration date lot number manufacturer

Packaging standards for mailing controlled substances:

- inner container marked and sealed and placed in a plain outer container or securely wrapped in plain paper -if controlled substance consists of prescription medicines, the inner container is also labeled to show the name and address of the pharmacy, practitioner, or other person dispensing the prescription -the outside wrapper or container is free of markings that would indicate the nature of the contents

Faxed prescription record must contain (non control)

- name of receiving pharmacy -If for LTC pt, name of sending facility -If hospice- Rx must note it is for a hospice pt -"This prescription order is valid only if transmitted by means of a facsimile machine"

HD list must be maintained by entity and reviewed every ______

-12 months -when new agent or dosage form is used by entity

To qualify for CDTM, pharmacist must be one of the following:

-BS with 10 years of experience, or PharmD -certified by Board of pharmaceutical specialties or commission of certification in geriatric pharmacy -credentialed in disease state management by National Institute for Standards in Pharmacist Credentialing -in a pharmacy residency accredited by ASHP -successfully completed disease state management certification program approved by ACPE

Surfaces to be wiped during environmental sampling include:

-C-PEC interior and equipment within -pass-through chambers -staging or work areas near C-PEC -Areas adjacent to C-PECs (eg: floor directly under, dispensing area) -Areas immediately outside HD buffer room and C-SCA -Patient administration areas

Pt may use palliative marijuana in CT if:

-CT resident -diagnosed with "debilitating medical condition" ->18 years of age (or emancipated minor or minor with consent from parent/legal guardian who will have control) -has written certification from physician

Controlled Substances Initial Inventory Requirements (Federal)

-Date of inventory -whether taken at beginning or close of business day -Name of each controlled substance inventoried -Finished form of each (eg: 10 mg tablet) -Number of dosage units of each finished form in commercial container (eg: 100 tablet bottle) -Number of "finished" containers of each finished form (eg: four 100 tablet bottles) -Count --If CII- exact count --If CIII-CV- estimated count unless container holds more than 1,000 tabs/caps- if so then exact count needed ****CT REQUIRES EXACT COUNTS OF ALL CONTROLLED SUBSTANCES- NO ESTIMATING

Retail, outpatient hospital pharmacies, and prescribing dispensers must electronically report within 1 business day to DCP the following info on all CII-CV prescriptions dispensed:

-Dispenser ID and Rx number -Date filled -New or refill, and number of refills authorized (if any) -Drug name, NDC number, and amount dispensed -Days supply dispensed -Patients: ID number, first and last name, address including zip code, DOB, gender -date Rx issued, number of refills authorized, DEA number of prescriber -type of payment (cash, insurance)

HIPAA documentation and record retention

-HIPAA privacy policies and procedures -NoPP -disposition of complaints -any other: actions, activities, designations that the privacy rule requires to be documented

Exceptions to minors controlling health decisions or records

-HIV and STD testing and care -Abortion counseling -Family planning/mature adolescent -Inpatient psych care 16 and 17 years old -Outpatient counseling under special circumstances -substance abuse treatment -If emancipated (qualified as an adult)

List of controlled substance records that must be maintained:

-Official order forms (DEA 222) -Power of Attorney authorization -receipts and invoices for CIII-CV drugs (separate from other records) -All inventory records, including initial and annual inventories -Report of theft or significant loss on DEA form 106 -Inventory of drugs surrendered for disposal (DEA Form 41) -Records of controlled drugs transferred between pharmacies -DEA registration certificate -Self certification certificate and logbook of scheduled listed chemical products (SLCPs) -Proof of Use Sheets for CS dispensed from floor stock

Prescription Record Requirements

-Patient's full name -Patient's Address -date prescription issued by prescriber -Name of medication -Dosage form of med -Strength of med (if applicable) -quantity of medication -directions for use -Required cautionary statements -Number of times Rx can be refilled -Prescribers name (if written Rx must be manual signature) -Prescribers Address -Date Rx filled/refilled on face or back of prescription -Serial number (Rx #) -Dispensing Pharmacist's initials -retail price of generic substitute IF CONTROLLED also need: -prescribers DEA# -Patient's age OR adult/child

Prescription label requirements

-Pharmacy Name/Address -Patient's full name -Drug name (unless prescriber says no) -Strength of medication (if applicable) -Quantity dispensed -Directions for use - Required cautionary statements -Expiration date -Serial number of Rx (Rx#) -date prescription dispensed (refilled) - if CIII or CIV- date initially filled AND refilled -Prescribers full name

Prescribing Practitioners in CT

-Physician (MD)- eg: psychiatrist, ophthalmologist -Osteopath (DO) -Dentist (DDS) -Podiatrist (DPM) -Veterinarian (DVM) -Certain nurses: APRN, CRNA, Nurse midwife (APRN) -Physician Assistant (PA) -Optometrist (OD)- but NOT nonemergency oral glaucoma meds -Pharmacist (BS, PharmD)- opioid antagonist, collaborative drug therapy management

Anti-methamphetamine Federal Law Requirements

-Product must be kept behind counter or in locked cabinet (no direct access by consumer/purchaser) -pharmacy must contain logbook (electronic or paper) -purchaser must show valid ID and sign log book -seller must train personnel and self-certify to US Attorney General that sales personnel have been trained

Not allowed to prescribe in CT:

-RN -Psychologist (PhD, PsyD) -EMT/Paramedic -Chiropractor (DC) -Optician - no drugs, just design fit and verify eyeglasses -Naturopathic physician (ND)

Physician and APRN issuing written certification for palliative use of marijuana must

-active CT license, DCP controlled substance registration, and DEA registration for CII -registered with and have access to PDMP -bona fide physician-patient relationship -conducts assessment and develops treatment plan, including an in person physical exam -diagnosis the DMC -benefits outweigh risks of palliative marijuana -determine that Rx drugs are not in best interest for treatment of DMC -be available for follow ip care and treatment -explain potential risk and benefits of PUM -may not issue for self, family members, employees or co-workers

Full-faced cartridge-type respirator or powered air purifying respirator (PAPR) should be worn when:

-addressing HD spills larger than a spill kit can contain -deactivating/,decontaminating/cleaning under C-PEC work surface -airborne exposure to HD powders or vapors if known or suspected

USP <800> applies to:

-all healthcare personnel who handle hazardous drug preparations -all entities that (with respect to HDs) - store, prepare, transport, administer

Cleaning and disinfecting ISO 5 (PECs) occurs:

-at the beginning of each work shift -before each batch is prepares -every 30 minutes during continuous compounding periods of individual CSPs -whenever there are spills -when surface contamination is known or suspected

Transferring pharmacist records (controlled substance)

-cancel Rx and write "VOID" on the FACE of the prescription -on the back of the Rx, write the name of the name, address, and DEA# of the receiving pharmacy, and the name of the receiving pharmacist -Date of transfer and name of transferring pharmacist

When can someone other than the authorized ultimate user possess controlled substances?

-common carriers or warehousemen (while engaged in lawful transport and storage) -public officers/employees performing official duties -temporary and incidental possession by employees/agents of persons lawfully entitles to possess controlled substances -if possession is for purpose of aiding public officers in performance of official duties

DEA Form 222 Unfilled/Lost

-complete new order form -prepare statement that includes first order form's serial # and date, and verify that original order was never received -attach the statement to the new order form and keep a copy of the statement with copy 3 of the first and new order forms

If compounding sterile pharmaceuticals, nonresident pharmacy sending to CT must:

-comply with USP <797> -if dispensing is not pt specific, must submit manufacturing license or FDA registration -have 24/7 toll-free phone # -disclose sterile compounding to DCP -10 days to provide DCO with notice of any disciplinary action, advisement, warning by state/federal agency or accrediting body

Document non-control refill data by either:

-daily printout, made within 72 hours after dispensing, which is verified and signed by dispensing pharmacist as soon as possible after receipt or- electronic record, but pharmacists name/initials is presumed to be dispensing pharmacist

Quality assurance review of prescription errors must include:

-date of review and name/title of person performing it -pertinent data and information relating to error -documentation of notification of prescriber and patient -recommended changes to policy, procedure, or systems

HIPAA Authorization to disclose must include:

-description of the information to be used/disclosed -Name of CE authorized to make disclosure/use -Name or identification of person to whom requested disclosure/use is to be made -purpose of the use/disclosure -expiration date/event -signed and dated by patient (or personal representative, with description of authority to act for patient) -Required statements

USP 800 gown requirements

-disposable and shown to resist permeability by HDs -be closable in the back , have long sleeves, with closed plastic or knit cuffs, no seams or closures that allow HDs to penetrate -change every 2-3 hours or immediately after spill -do not wear in other areas after used to handle HDs Required when: compounding HDs administering injectable antineoplastic HDs deactivating/decontaminating HD areas

exemptions for telephone consumer protection act

-emergencies -health care message made by, or on behalf of, a HIPAA CE or its BA

Self certification of SLCP regulated seller

-employees engaged in the sale of SLCPs have been trained regarding provisions of CMEA -records of training are being maintained -sales to individuals do not exceed 3.6 grams of ephedrine, pseudoephedrine or PPA in a single day -for mobile retail vendors and mail order distributors, sales to an individual in a 30-day period may not exceed 7.5 grams -non-liquid forms are packaged as required -regulated sellers store SLCPs behind the counter or in a locked cabinet -Mobile retail vendors store SLCPs in a locked cabinet -regulated sellers properly maintain a written or electronic logbook -the logbook information will be disclosed only to federal, state, or local law enforcement and only to ensure compliance with title 21 of the US Code or to facilitate a product recall

C-SEC for compounding must be :

-externally ventilated -physically separate from other non-HD prep areas -at least 12 ACPH for non sterile compounding -at least 30 ACPH for sterile compounding -negative pressure relative to all adjacent areas

USP <800> requires the following elements in areas where HD compounding will take place:

-eye wash station readily available -surface of ceilings, walls, floors, fixtures, shelving, counters, and cabinets must be smooth, impervious, free from cracks and non shedding -If C-PECs used for sterile and non sterile compounding are in the same room, they must be at least 1 meter apart -HD sterile compounding areas must have "fixed walls"

New SCP, or starting sterile compounding after 2014 must:

-file addendum to pharmacy license Application with DCP -not start sterile compounding until DCP inspects and approves

Nonresident pharmacy who wants to compound sterile preparations must:

-file addendum w/ DCP that includes sterile compounding -Provide written proof of passed state agency inspection where non resident pharmacy is located (must provide copy of most recent inspection report every 2 years) -no compounding for sale/delivery into CT until receipt of approval from DCP

Other PPE required by USP 800

-hair covers -show covers -sleeve covers -eye and face protection

Physical Security for controlled substances (federal)

-in a locked cabinet -dispersed throughout the non-controlled stock to deter theft -an electronic alarm is recommended

Central fill pharmacy receiving the Rx information from the retail pharmacy must:

-keep a copy of the transmitted information (electronic or fax), including name, address and DEA# of transmitting retail pharmacy -keep a record of the transmitted Rx received, including date of receipt, RPh filling Rx, dates of fill/refill -keep record date filled Rx was delivered to retail pharmacy (including delivery method- private, common or contract carrier)

naloxone and standard of care/immunity

-licensed healthcare professionals who may legally prescribe naloxone may prescribe or dispense to any individual and not be civilly or criminally liable for subsequent use of opioid antagonist -licensed healthcare professional may administer opioid antagonist to treat or prevent overdose and not be civilly or criminally liable for administration -good samaritan acting in good faith and with reasonable care may administer and not be civilly or criminally liable for administration

Retail pharmacy transmitting Rx to central fill pharmacy must:

-mark original Rx as "central fill" with name, address, and DEA# of central fill pharmacy, RPh transmitting, and date of transmittal -ensure that all required info is transmitted -for CIII-CV, indicate refills already dispensed and remaining -maintain original Rx for at least 3 years from last refill (in CT) -keep record of receipt of filled Rx (including date, delivery method, name of employee who accepted delivery)

Environmental Sampling (ES)

-measurement of total number of airborne particles -Certification of ISO 5, 7, and 8 environments (every 6 months and whenever PEC or room is relocated, altered, or major service is performed) -pressure differential monitoring (continuous or at least daily) -Air sampling (every 6 months and in response to identified problems) -surface sampling- done on a periodic basis

For central fill pharmacy to be able to fill controlled substance prescriptions for a retail pharmacy:

-must have contract or common owner with retail pharmacy -must maintain required CD records, reflect all CS dispositions -Must meet same CS security requirements as retail pharmacy

Patient Counseling points

-name and description of medication -dosage form, dose, route, duration -special directions/precautions for preparation, administration and use of drug -common severe side effects, interactions and contraindications/precautions - self monitoring techniques -proper storage -refill information - action to be taken if dose missed

Written protocol for pharmacist administration of vaccines must include:

-name of healthcare provider authorized to order or prescribe drugs -name of pharmacist authorized to administer vaccines -types of vaccines to be administered -procedures, decisions criteria and plan to be followed by administering pharmacist, including when to refer patient to physician -procedures for emergency situations -record keeping /documentation procedures

PHI is de-identified if all of the following are removed:

-names, telephone numbers, fax numbers -all geographic subdivisions smaller than a State, except for the initial 3 digits of a zip code -all elements of dates (except year) directly related to patient, including birth date, admission date, discharge date, date of death and all dates for those over 89 (including year), except that such ages and elements may be aggregated into a single category of age 90 or older -electronic mail addresses, URLs, IP address numbers -SS#, medical record #, health plan beneficiary #, account #, certificate/license #, vehicle identifiers and serial # -Biometric identifiers, including finger and voice prints, full face photographic images and any comparable images -any other unique identifying number, characteristic, or code

Which HDs may be stored with Non-HD inventory

-non antineoplastic HDs -reproductive risk only HDs -final dosage forms of antineoplastic HDs

Application for dispensary facility license must include:

-permission of background checks of applicant and its backers -blueprint of proposed facility -proposed facility manager -location -financial statement -services and products to be offered -controls against diversion, theft, or loss of product -documentation that applicable state/local building, fire, zoning, and ordinances will be met

Pharmacist may prescribe opioid antagonist if:

-pharmacist is trained and certified by DCP-approved program -prescribing is done in good faith -pharmacist provides training in the administration of the antagonist to the person to whom the drug is dispensed -pharmacist maintains records of dispensing and training

Adulterated Drugs

-prepared, packed, or held in conditions where it may have been contaminated -exposed to a container that may have contaminated it -manufactured under conditions that do not conform to current CGMP -also any drugs that contain an unsafe color additive, or of their strength, quality and purity differs from standards, unless stated on the label

Pharmacist may substitute oral, tablet or liquid dosage forms if:

-prescriber is not reasonably available for consultation; and -prescribed drug does not use a unique delivery system; and -the form dispensed has the same strength, dose, and dose schedule; and -the form dispensed is therapeutically equivalent to the drug prescribed must inform pt and prescriber at the earliest reasonable time

Deactivating, decontaminating, cleaning and disinfecting written procedures must specify:

-procedures -agents used -dilutions (if used) -frequency -documentation requirements

Pharmacy logbook for OTC ephedrine/pseudoephedrine/PPA

-product name and quantity sold (entered by seller) -name and address of purchaser (either seller or teller may enter, but other must verify) -date and time of sale (either seller or purchaser may enter, but other must verify)

If discontinuing use of computer system, must:

-provide 30 day advance written notice to DCP -provide up to date hard copy printout of the last 3 years of prescriptions -make hard copy records available to any nearby pharmacy if discontinuation is because the pharmacy is closing

CII Emergency Dispensing Requirements

-quantity limited to amount adequate to treat during the emergency period -Rx order immediately reduced to writing -if prescriber unknown, must make reasonable effort to determine if legitimate -Written Rx authorizing emergency dispensing must be mailed or delivered within 72 hours (CT) postmarked within 7 days (federal) must be signed by prescriber and state "AUTHORIZATION FOR EMERGENCY DISPENSING" -Written authorization Rx must immediately be attached to written oral script -is prescriber fails to deliver written authorization, pharmacist must contact DEA/Drug Control

Marijuana dosage forms allowed to be manufactured

-raw material -cigarettes -extracts, sprays, tinctures or oils -topical applications, oils, or lotions -transdermal patches -baked gods -capsules or pills

Spill kits must be located:

-readily available in areas where HDs are routinely handled -where HDs are prepared/administered in non-routine healthcare area

USP <800> states PPE must be worn when handling HDs, including the following activities:

-receipt (unpacking) -storage -transport -compounding -administration -deactivation/ decontamination, cleaning and disinfecting -spill control -waste disposal

CII perpetual inventory

-reconciled on monthly basis -records kept on premises -maintained separate from other records -arranged by date -kept for 3 years

Dispensary distribution is limited to:

-registered QP -primary caregiver -DPH licensed hospice or inpatient care facility with DCP approved protocol for handling/distribution of marijuana -laboratory -organization engaged in DCP approved research program

USP <800> facility requirements

-signage at entrance -restricted access -designated areas for HD handing- receipt and unpacking, storage, non sterile compounding, sterile compounding -HD area must be located away from break rooms and refreshment areas -negative pressure in certain HD areas relative to adjacent areas

Immediate Use CSPs

-simple transfer <3 commercially manufactured non hazardous products -<2 entries into any container -compounding is continuous and complete in <1 hour -aseptic technique is used -Administered <1 hour from start of compounding -Labeled (1 hour BUD) if not immediately and completely administered

Patient-Specific written protocol for CDTM must including:

-specific drugs managed by pharmacist -terms and conditions to initiate, modify or discontinue -lab tests that may be ordered by pharmacist -drugs that may be administered by pharmacist

Pharmacy rewards- HIPAA Authorization

-specific uses/disclosures of PHI allowed -whether PHI will be disclosed to 3rd parties, or if it will no longer be protected after disclosure -which 3rd parties will have PHI -how authorization may be revoked -that consumer may have copy of signed authorization

exceptions to electronic transmission of controlled substances

-temporary technological/electrical failure (eg: power outage) -impractical for pt to obtain electronically transmitted Rx and delay would adversely impact patient BUT limited to 5 day supply (eg: overnight ED visit) -Rx will be dispensed by out of state pharmacy -Use of electronic transmission would negatively impact patient care (eg: compounded. complicated) - prescriber does not have the technological capacity to issue e-scripts

Shoe covers are required when:

-there is potential exposure to HD residue -2 pairs when compounding HDs must be immediately disposed

PHI may be shared between CEs/BAs about a common patient for:

-treatment -or, subject to the minimum necessary rule : for business operations of one or the other, or for payment

CDTM agreement with physician includes:

-types of prescriptive authority decisions pharmacist is allowed to make -pts who are eligible for treatment -types of disease/drug/drug categories involved -procedures, decision criteria, plans and guidelines for therapeutic decisions -required training -plan for periodic review, feedback and QA -procedures for documenting prescribing decisions

Anti-methamphetamine Federal Law Requirements (mail order pharmacy)

-verify pt's identification before shipping -7.5 gram monthly sales limit (different than 9 g limit)

Prohibited marijuana products

-when combined with alcohol (except ethanol based tinctures with alcohol level approved by DCP or <0.05% w/v), dietary supplements or any drug -beverage or confectionary -obscene or indecent, encourages recreational use, or use other than for DMC, or is customarily associated with persons <18 years

Receiving pharmacist records (CIII-CV)

-write "transfer" on face of prescription record -issue date of original Rx -original number of refills authorized on original Rx -date of original dispensing -Number of valid refills remaining -Date and LOCATIONs of previous fills -transferring pharmacy's name, address, DEA#, and original Rx # -Receiving pharmacist's name

A practitioner who is not DATA-waived and not part of NTP/OTP may dispense buprenorphine to initiate SUD detox or maintenance but is limited to administering ________

1 dose/day for a max of 3 days

Single dose containers in worse than ISO 5 may be used up to ______ after puncture

1 hour

BUD for immediate use CSPs

1 hour from start of compounding

Immediate Use BUD

1 hour room temperature

If C-PECs for sterile and non sterile compounding are in the same room, they must be located ______ apart

1 meter

_____ liquid= 1 unit

1 pint

Prescriptions for needles are valid for _______

1 year, but seller must confirm with prescriber at 6 months if there is still need

3 categories of hazardous drugs

1. Antineoplastics 2. Non antineoplastic HDs 3. HDs that primarily pose reproductive risk

2 parts to collaborative drug therapy management

1. CDTM agreement with CT licensed physician 2. patient-specific written protocol

5 methods for drug disposal from practitioner- registrants inventory

1. on-site method 2. reverse distributer 3. return or recall (if CI or CII, use DEA form 222) 4. DEA request for assistance (DEA Form 41) prior to disposal 5. if regularly disposing controlled substances, by single request to DEA, with conditions

_____ powder, crystal, flake, or granule = 1 unit

1/8 oz

Any changes in name, owner, management, officers/directors must be submitted within _______

10 days

Corporation who holds pharmacy license must notify commission of change in directors or officers within _____

10 days

Palliative marijuana: report to DCP within ______ of alarm activation or police response, security breach, security system failure of >8 hours duration

10 days

SCP must notify DCP ______ of remodel or relocation of a cleanroom

10 days in ADVANCE

SCP must notify DCP _______ of upgrade or non-emergency repair of HVAC or PEC

10 days in ADVANCE

Late fee for renewal of RPh, pharmacy or non legend drug permit

10% off fee (min: $10, max: $100)

Phase II Clinical Trial

100's of patients tests EFFICACY

Phase III Clinical Trial

1000's of patients continual safety and efficacy testing

Storage room for antineoplastic HDs that will be manipulated and API HDs must have _______ ACPH

12 ACPH

Low risk w/ 12 hour BUD, BUD

12 hours at room temp or refrigerator

Competency assessment of USP 800 should occur every _______

12 months

Pharmacy license must be submitted ___ days before the next meeting of the Commission of Pharmacy

15

CE hours breakdown

15 hours/year contact hour= 50-60 min 5 hours must be LIVE 1 hour must be LAW

Number of required CE credits/year

15/year

How many intern hours required in CT to complete pharmacist application?

1500 hours

Unscheduled closing of pharmacy may not occur more than:

18 times in 365 days or 2 times in a 30 day period (no consecutive days of closing)

You must be _____ years old to purchase CV OTC products

18 years

How old must a patient be for a pharmacist to administer a vaccine?

18 years and older (adults only)

How old must you be at the time of pharmacist application?

18 years old

Pharmacist Duty to counsel medicaid patients: DUR of drugs dispensed in the last ______ days

180 days (6 months)

Other controlled substance: penalty

1st offense: $25,000 fine/7 years 2nd offense: $100,000 fine/15 years

Narcotic or hallucinogenic substance: penalty

1st offense: $50,000 fine/15 years 2nd offense: $100,000 fine/30 years 3rd offense: $250,000 fine/30 years

License must be renewed every ___ years

2

Registrant disposal of controlled substances always requires ____ employees to transport/witness

2

After a prescription error, QA review must take place within _____ of when error is discovered

2 business days

Of the active pharmacists on the commission, ___ must be community pharmacists and ___ must be institutional pharmacists

2 community (1 independent, 1 retail) 1 institutional (hospital)

Sterile compounding pharmacies are limited to a ______ day supply when providing to prescribers for administration to prescribers patients

2 weeks (14 day supply)

License renewal period

2 years from Feb 1-Jan 31 (even years)

If license lapsed or not held >2 years, how many CE hours must be completed before renewal

2 years worth 30 hours/10 live/2 law

How many hours of practice under a collaborative agreement must an APRN practice before they can prescribe independently?

2,000 hours (and 3 years)

Phase I Clinical Trial

20-80 patients tests SAFETY

FDA and Trading Partners must be notified or suspect/illegitimate drugs within ______

24 hours

If any recall issued for drug/device, _______ to provide DCP names of CT residents who received delivery

24 hours

Written or verbal order for CII in a hospital must be countersigned within _____

24 hours

Multi-dose containers BUD

28 days after initial puncture (unless otherwise specified by manufacturer)

Tech: Pharmacist Ratio (Retail pharmacy)

2:1 * if one of the techs is certified, ratio can be 3:1

Tech: Pharmacist Ratio (Institutional outpatient pharmacy)

2:1 *up to 3:1 with demonstrated need + petition

Schedule III drugs are TYPICALLY divisible by "____"

3

CII inventory records must be kept for ______

3 years

How long must faxed prescriptions be kept for?

3 years

Maintain counseling records for:

3 years

Retain CE records for ___ years

3 years

Rx for needles must be kept on file for _______

3 years

retention period for marijuana records

3 years

e-prescribing records for controlled substances in CT must be kept for _____ years

3 years (federally: 2 years)

Controlled substance records must be kept for _______

3 years (CT retention period)

OTC sale restrictions of pseudoephedrine, ephedrine, and PPA

3.6 grams daily 9 grams monthly (does not apply to Rx sales or OTC sales of <60 mg of pseudoephedrine)

C-SEC must have at least ______ ACPH for sterile compounding

30 ACPH

Non sterile compounding pharmacies are limited to a _____ day supply when providing the prescribers for administration to prescribers patients

30 day supply

SCP onsite inventory of CSPs may not exceed _______

30 day supply

How far in advance must written notice be sent to DCP if starting use, changing system, or discontinuing computer system?

30 days

How many days after a pharmacy posts notice to the public can they reduce their scheduled hours

30 days

If an online pharmacy wishes to change its internet website address, it must notify the DEA _____ days prior

30 days

Maximum hospital order of CIII-CV substances is:

30 days

Once an IND has been submitted the FDA has ____ days in which to decide whether the investigational drug is suitable for testing

30 days

If a patient requests to only receive 20/30 oxycodone tablets, how long do they have to receive the other 10?

30 days from the issue date of the Rx

CE requirements for retired pharmacists wishing to renew license

30 hours; 10 must be live

Prescriber's with a CSAT waiver for treating addiction may treat ___________ patients at one time

30, 100, or 275 - DEA certificate will say how many

Pharmacy must be open for ______ hours/week

35 minimum

Tech: Pharmacist Ratio (community pharmacy if IV, unit dose, bulk compounding/dispensing)

3:1

Tech: Pharmacist Ratio (Institutional Inpatient Pharmacy)

3:1 * up to 5:1 with demonstrated need + petition

Tech: Pharmacist Ratio (Institutional satellite pharmacy)

3:1 * up to 5:1 with demonstrated need + petition

CV OTC products

4 fl oz Stokes Expectorant 4 fl oz of Brown Mixture 8 fl oz of any mixture that contains camphorated tincture of opium or opium equivalent not to exceed 16.2 mg of opium in 1 fl oz No more than 48 dosage units containing opium No more than 24 dosage units if other controlled substance

Board of Physicians term length

4 years or until successor is appointed

When working/volunteering in CT pharmacy, interns may have no more than ______ hours/week apply toward requirement

40 hours/week

How long can the pharmacy manager be gone for before they are replaced?

42 days

If purchasing CV OTC product, ______ hours have to have passed before you can purchase the same product again

48 hours

Records of QA review for prescription errors must be made available to DCP within _____ of request

48 hours

When drug control requests records, must be able to make 3 years of printed information available within _____ of the request

48 hours

Within ____ hours of dispensing a substituted biological product (including refills, unless same as last fill) , document name and manufacturer or product dispensed to pt and notify prescriber

48 hours

Schedule V drugs are TYPICALLY divisible by "____"

5

There are ___ actively practicing pharmacists on the Commission in CT

5

Dispensary change of employment, name or home address must be reported to DCP within _______

5 business days

Any administrative or legal action against SCP by state/federal regulatory agency or accreditation entity must be reported to DCP within ________

5 business days of receipt of notice of start of action

If an Rx for a controlled substance is written in an overnight ED, how many days may the script be written for?

5 day supply

Copy of recertification to DCP after remodel, relocation, upgrade or repair within _______ days after recertification approval

5 days

How long do you have to notify DCP if the pharmacy manager has been gone for >16 days?

5 days

Opioid supply for minors is limited to _____ days

5 days

Pharmacists and technicians must report change of Name or Home Address to DCP within ____

5 days

A dispensary facility may employ no more than _____ dispensaries at one time

5 dispensaries (unless DCP approves more) -one must be designated dispensary facility manager (and cannot be changed without DCP approval)

How many refills are allowed on a CIII-CIV Rx?

5 refills

Marijuana producer license renewal period

5 years

Flavoring agents added must be no more than ____% of the total weight of the product

5%

If distributing >____% of all controlled substances distributed within a calendar year to another pharmacy, the pharmacy must register as a distributer

5%

Retail and Hospital are both _____ pharmacies

503A pharmacies

Single dose containers in ISO 5 may be used up to ______ after puncture

6 hours

Partial fills for CIII-CIV must be within ______ of the Rx issue date

6 months

Recertification of ISO classifications is performed every _______

6 months

Expiration date of CIII-CIV

6 months from the issue date OR original +5 refills (whichever comes first)

According to USP <795>, BUD for non aqueous preparations

6 months or earliest expiring API

HIPAA Record Retention

6 years

Investigation records for suspect drugs must be kept for how long?

6 years

Keep records of product identified as illegitimate for ______

6 years

Once an NDA is submitted, the FDA has ___ days to decide whether to file for review

60 days

If the pharmacy receives a CII script for a patient that is terminally ill or in a LTC facility, and a partial fill is requested, the Rx is good for _____ days

60 days must also note "LTCF pt" or "terminally ill" on Rx

How many commissioners are there in CT?

7 commissioners: 5 full time pharmacists 2 public members

Adults receiving opioids for the first time may receive a _____ day supply

7 day

Maximum hospital order of CII substances is:

7 days

Practitioner may prescribe a ______ supply of controlled substances for self/family member in an emergency

72 hour supply

What is the max supply that can be given for an emergency, non control prescription?

72 hour supply

Pharmacist Manager must report unscheduled closing to DCP within _______

72 hours

Theft, loss, or unauthorized destruction of controlled substances must be reported to DCP within _______

72 hours

When substituting biological products, pharmacists must inform prescriber of substitution within ______

72 hours

written or verbal order for a CIII-CV in a hospital must be countersigned within ________

72 hours

If the pharmacy runs out of a CII medication and has to give the patient a partial, how long do they have until they must dispense the remainder?

72 hours *if they cannot complete the filling within 72 hours, must notify prescriber

Score required to pass MPJE and NAPLEX?

75 (scaled)

How many members in the Board of Physicians?

8 board certified physicians (or surgeons) at least 1 must be board certified pediatrician

How many digits in a DEA#?

9 2 letters, 6 numbers, 1 check digit

For refill reminder to not be considered marketing, must be a drug/biologic currently prescribed (within the last ______ days), or its generic

90 days

Supply limit for "multiple prescriptions" rule

90 days

What is the max quantity patients can receive for their medications at one time?

90 days supply

Which USP chapters are mandatory?

<1000

How many needles requires a prescription?

>10 needles requires a prescription

Online pharmacies must report actual amount of controlled substances dispensed in the preceding month if the actual amount is >_____ Rx's filled or >_______ dosage units dispensed

>100 Rx's >5,000 dosage units if below threshold: report as "negative"

When to report pharmacy manager absence:

>16 consecutive days (report within 5 days) >42 days (immediate notice to DCP and person is no longer manager for that pharmacy)

Drug Control

A division of the DCP charged with inspecting and reporting violations of Connecticut's Pharmacy Practice Act, and other law

Off-label prescribing

A drug is prescribed to treat conditions other than those approved by the FDA.

When a new drug is developed, testing on animals occurs in which phase A. preclinical B. clinical C. Post marketing

A. Pre clinical

Biological Products apply to A. humans only B. animals only C. both

A. humans only

ANDA

Abbreviated New Drug Application

Schedule III Substances

Abuse potential less than CI and CII but more than CIV and CV Moderate/low physical dependence or HIGH psychological dependence currently accepted medical use Eg: (THINK: Strength divisible by 3) Codeine or dihydrocodeine: <1.8gm/100mL or <90 mg/dose (eg: Tylenol w/ codeine #3) Dihydrocodeinone or ethylmorphine: <300mg/100 mL or <15 mg/dose Opium <300 mg/100mL or <25 mg/dose Morphine combined with active non-narcotic ingredients : <50 mg/100mL or <50 mg/100gm (eg: paregoric) Buprenorphine to treat opioid addiction (suboxone, subutex, buprenex) *Anabolic steroids ketamine dronabinol

How to check DEA#

Add 1st, 3rd, and 5th digit= x Add 2nd, 4th, and 6th digit= y multiply by 2 (2y) Add them together (x+2y) this should match the last digit (7th digit) in the DEA#

Pharmacy Commission Powers and Responsibilities

Administer and enforce the Pharmacy Practice Act May issue subpoenas May administer oaths

Emergency Refills (non control)

Allows refill of non-controlled prescription without prescriber authorization if: -unable to contact prescriber after reasonable effort -failure to refill might result in interruption of therapeutic regimen or create pt suffering -pt/representative informed that prescription is being dispensed without authorization -prescriber informed at earliest reasonable time that authorization is required for future refills -Authorized refill quantity must not exceed 72 hours

Ryan Haight Online Pharmacy Consumer Protection Act

Amended CSA to address "online pharmacies" valid prescription for online dispensing of controlled substances requires at least one in-person medical evaluation of the patient

What drugs are not subject to assessment of risk?

Any HD API Any HD antineoplastic that requires manipulation

Opioid Drug

Any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability

USP <1079>

Any drug product storage area should be clean, cleanable, and free from pests Smoking, drinking, and eating should not be permitted in any drug product storage/hold areas

Who can apply for pharmacy license or its renewal?

Anyone, does not have to be pharmacist

If pharmacy wants to reduce scheduled hours

Apply to DCP Have an inspection If approved, cannot implement until 30 days after: public notice is posted manager files notice of hours with DCP

Orange Book

Approved Drug Products with Therapeutic Equivalence Evaluations

Can a physician prescribe controlled substances to their animal?

Are they a veterinarian? If not, then it is not in their scope of practice

AoR

Assessment of Risk

Entity can perform ________ on HDs to determine if containment requirements do not apply or may be relaxed

Assessment of risk

Cheating will ban the applicant from examination for how long?

At least 1 year

If applying for reciprocity, applicants must have practiced for:

At least 1 year in the last 5 years OR licensed by exam within the past 12 months

How many times/year does the Board of Commissions meet?

At least 6

Who is responsible for BA HIPAA fines?

BA is directly responsible

Order must be verified by a pharmacist (before/after) tech begins dispensing process

BEFORE

No substitution on telephones (oral) Rx if:

BNS/NS in pharmacists handwriting (or in e-record) Time Rx received Name of person giving authorization to pharmacist

C-PEC examples

BSC, CACI

Purple Book

Biological products and bio similar interchangeables

BLA

Biologics License Application

Who reviews and recommends additions to list of debilitating medical conditions?

Board of Physicians

Commission of Pharmacy

Board that advises and assists DCP in adopting regulations to enforce CT's drug and pharmacy statutes

BA

Business Associate

BAA

Business Associate Agreement

If a controlled substance is lost, stolen, or destructed without authorization, must report to CT DCP by _______ within _______

By email within 72 hours

GHB is listed as a schedule _____ depressant

CI

CT does not allow schedule ______ drugs in emergency kits

CII

Methadone is a schedule ____ drug?

CII

Connecticut requires 3 separate files of prescription records:

CII CIII-CV All non controlled drugs

Expiration date of CII?

CII's do not have an expiration date, it is up to the pharmacist to use professional judgement as to if the patient still needs to Rx

A pharmacy may distribute what schedule controlled substances to correctional or SNF medical director (who has valid DEA & CT controlled substances registration) for "emergency stock" at the facility?

CII, CIII, CIV, CV ****CT DOES NOT ALLOW CII IN EMERGENCY KITS

Faxed prescriptions (Control) from LTC facility & hospice

CII- faxed, non fading= original Rx CIII-CIV: Fax, non fading= original Rx

Faxed prescription (control) from non LTC facilities

CII: handwritten original needed before dispensing CIII-CIV: fax, non fading = original Rx

Suboxone is a schedule _____ drug

CIII

Xyrem (sodium oxybate)

CIII used to treat narcolepsy REMS program

What control schedules are NOT restricted when prescribing through telehealth without an in person visit?

CIV, CV, and non controls

CRNA exception to prescribing authority

CRNA prescribing during surgery may do so only if physician medically directing the prescriptive activity is physically present

In order for a prescriber to offer addiction treatment with CIII, CIV or CV substances, they must have a ____ waiver

CSAT Waiver known as DATA-waived practitioner

Epidiolex is a schedule ______

CV *FDA approved cannabidiol

MedWatch Program

Can report product problems and/or adverse events -Voluntary for healthcare professionals and consumers -Mandatory for IND Reporters, manufacturers, distributers, importers, and user facilities (devices)

If performing AoR, divide entity's HD list into two categories

Category 1: No AoR allowed -HD antineoplastics requiring manipulation -HD API -any HD where risk cannot be assessed (eg: HD investigational drug) Category 2: alternative/relaxed containment requirements -final dosage forms of antineoplastic HDs that do not require manipulation other than counting or repackaging -Non antineoplastic HDs -HDs that are reproductive risk only

CSAT

Center for Substance Abuse Treatment

NTP/OTP must be approved and certified by ________

Center for Substance Abuse Treatment (CSAT) which is part of SAMHSA

What is the most serious drug recall classification?

Class I Recall

Anabolic steroids are class _____ substances

Class III

Refrigerator/Freezer Temps

Cold Place: <46F or 8C Fridge: 35-46F or 2-8C Freezer: -25 to -10C

CDTM

Collaborative Drug Therapy Management

CMEA

Combat Methamphetamine Epidemic Act

In CT, who designates controlled substances?

Commissioner of Consumer Protection

Who has the power to override the Board of Commission decisions?

Commissioner of Consumer Protection

Who selects the chairperson of the board of physicians?

Commissioner of DCP

Graduates of foreign pharmacy schools are eligible to sit for licensure if they:

Comply with requirements for temporary permit Submit proof of 1500 hours of equivalent experience submit proof of date/place of birth Pass tests for written and spoken English Provide proof of US citizenship Pass Foreign Pharmacy Graduate Equivalency Examination (FPGEE) Appear for personal interview with commission of pharmacy

CPMRS

Connecticut Prescription Monitoring and Reporting System CT's prescription drug monitoring program

C-PEC

Containment Primary Engineering Control protects worker and environmental exposure when HDs handled directly

C-SEC

Containment Secondary Engineering Control the room or area where the C-PEC is located

CSOS

Controlled Substances Ordering System

Any healthcare provider who bills electronically is considered a ______

Covered entity (CE)

A new sterile compounding pharmacy cannot start compounding until _____ inspects and gives approval

DCP

Dispensary facility licensed by _____

DCP

Drug Control Agents are employees of:

DCP

Nonresident pharmacy must register with ______ before sending drugs or medical devices into CT

DCP

Qualifying patient must register with ______ for palliative marijuana

DCP

Manufacturers and wholesalers must register with _____ to operate in CT

DCP exception: manufacturer that is registered with the FDA need only file copy of FDA registration with DCP to operate - this does not include sterile compounding pharmacies

Prescriber who does not have ability to write e-scripts for controlled substances must obtain ______

DCP registration waiver

Which agency enforces the Controlled Substance Act (CSA)?

DEA (DOJ)

A practitioner who will prescribe controlled drugs in CT must have 2 separate forms (federal and CT specific)

DEA Form 224 (federal) Controlled Substance Registration (CT)

DEA Form for Narcotic Treatment Program

DEA Form 363/363a

Special order form for CI and CII is called_______

DEA form 222

Retail pharmacy may act as central fill pharmacy and does NOT need separate:

DEA registration inventories records

Generally, in CT, a minor (<18 yo) [does/does not] control his/her own health decisions or records

DOES NOT

Producers of marijuana are licensed by ______

DPH

Dispensaries are licensed by ______

DPH -the dispensary is the CT licensed pharmacist

In DQSA, title II= _______

DSCSA (Drug Supply Chain Safety Act)

Pharmacists must report the following information to DCP within 5 days of commencing work, or changing place of employment

Date of commencement/change Name of employer Address of practice location Type of practice

DCP

Department of Consumer Protection

DPH

Department of Public Health

Hospitals are regulated by:

Department of Public Health (DPH)

DSS

Department of Social Services

DCP is mandated to issue a report for disciplinary action about:

Disciplinary action against any person with a controlled substance registration Sanctions imposed by DCP (Commission) against a pharmacy or pharmacist

Exempt from labeling requirements of CT-FDCA if drug is dispensed "on a written or oral prescription" of an authorized prescriber if the label contains

Dispensers name and place of business Serial number (Rx #) Date of fill/refill Prescriber's name Patient's name

DATA

Drug Addiction Treatment Act

Pharmacies are regulated by:

Drug Control Division of DCP

DQSA

Drug Quality and Security Act

DSCSA

Drug Supply Chain Safety Act

Preclinical (Drug approval process)

Drug developed Animals Tested IND application/review

Drugs repackaged in a pharmacy, should have labels that include:

Drug name Drug strength Lot number manufacturer expiration date

When dealing with CIII-V prescriptions, a pharmacist may not add or change:

Drug name (except to substitute generic) Patient name prescriber name

Upon contact with and verbal permission directly from prescriber, a pharmacist may change what on a CII prescription?

Drug strength Dosage form Quantity Directions for use must document: change was authorized date/time change authorized initials of pharmacist making change

What type of respirator is required when unpacking HDs not contained in plastic?

Elastomeric half-mask

EDI

Electronic Data Intermediary

How often must the DEA Form 224a be renewed?

Every 3 years (registration period is 36 months)

If license not held for 5 years, no renewal unless:

Exam required by commission Application fee paid ($200) Exam Fee paid ($190) Renewal fee paid ($120)

T/F: A pharmacist with a suspended/revoked license can become a technician

FALSE

T/F: A technician may obtain refill request for a controlled medication

FALSE

T/F: Pharmacies are allowed to accept samples

FALSE

T/F: Technicians may accept an oral order for a new prescription

FALSE

T/F: Technicians may consult patients on their medications

FALSE

T/F: pharmacists can accept meds for return to stock

FALSE If a medication has left the pharmacy counter with a patient, assume it is contaminated

T/F: if a prescriber is not DATA-waived and not part of NTP/OTP, they may prescribe buprenorphine for SUD detox

FALSE they may dispense 1 dose/day up to 3 days but NOT prescribe

T/F: BUD and expiration date are the same

FALSE Expiration dates are: -established by commercial manufacturer and based on equations -specific to particular formulation, container, and storage conditions -descriptive of chemical and physical stability BUDs are: educated guesses that are documented

T/F: ampules may be used up to 6 hours after opening if opened in ISO 5 environment

FALSE ampules must be discarded after opening and not stored for any amount of time

T/F: Pharmacies must get a non legend drug permit

FALSE Pharmacies, by virtue of their pharmacy premise license, are not required to get a permit to sell non legend drugs

T/F: A pharmacist may dispense methadone for maintenance or detox to a patient?

FALSE can dispense for pain management cannot dispense for maintenance or detox

T/F: a pharmacy may distribute CII substances to another pharmacy

FALSE (CIII-CV only)

T/F: APRN must include name of collaborating physician on prescription

FALSE - it is allowed but not required

T/F: A pharmacist can fill a script written for 30 days of a CIV with 3 refills as a 90 day supply?

FALSE, pharmacist may refill for a greater quantity than the initial quantity prescribed if the drug is NOT a controlled drug

T/F: When writing a written order, prescriber may use stamp to sign

FALSE- must have prescribers actual signature (use of stamp not allowed)

Prescription Drug User Fee Act

FDA collects fees from manufacturers to fund drug approval process

Phenylpropanolamine (PPA)

FDA considers PPA unsafe for human consumption, so its only proper use is Rx Only for veterinary purposes

T/F: Health Plan CE must obtain acknowledgement of NOPPs by patient

False Health Plan CE does not need acknowledgement -needs only to be distributed to named insured, and resent at least every 3 years

T/F: communicating about Medicare/medicaid to a patient is considered marketing?

False communications about government sponsored programs are an exception to the HIPAA marketing rule

misbranded drug

False or misleading labeling, Incorrect or incomplete labeling, Misleading advertising

If a prescription is faxed in, when does the pharmacist need the handwritten original before dispensing?

Faxed in CII from a non-LTC facility

What months does the Commission NOT meet?

February, July, December

manufacturer label

Federal Law Requirements 1) Name of manufacturer/packer/distributor 2) Address 3) Name of the drug 4) Net quantity (weight, quantity or dosage units in package) 5) Weight of each active ingredient in each dosage unit-->mEqs if electrolyte replacement Tx!!! 6) Fed legend "Rx only" 7) Non oral route must be specified 8) Special storage directions if appropriate 9) Manufacturer's lot# or control# 10) Expiration date

Good Manufacturing Practices

Federal guidelines that must be followed by all entities that prepare and package medication or medical devices

Federally, marijuana is a class _____ in CT, marijuana is a class _____

Federally: Class I CT: Class II

"Filling-new" prescription: online pharmacy

Filling a CIII-V script for a person if the pharmacy has previously dispensed the controlled substance to the patient- other than by means of the internet- pursuant to a prescription and the pharmacy contacts the prescriber to ask for a new prescription of the same medication and the prescriber determines there is a legitimate medical purpose for issuance of the prescription

Fines regarding failure to keep required controlled substance records:

First offense: $500 fine Subsequent offense(s): $1,000 fine/30 days Intentional Failure: First offense: $3,000 fine/2 years Subsequent offense(s): CLASS C FELONY ($10,000 fine/10 years)

FDAMA

Food and Drug Administration Modernization Act

FDCA of 1938

Food, Drug & Cosmetic Act (1938)

Form required to purchase/transfer CI and CII Controlled Substances

Form 222

Will DCP disclose to the public if a pharmacist has a substance abuse problem?

Generally no because they want people to get the help that they need

HIPAA Privacy Rule

Generally, a CE may not use or disclose PHI (or ePHI) without the patient's authorization Exceptions: to the patient for treatment for payment, healthcare operations (minimum necessary) uses and disclosures with an opportunity to agree or object incidental use/disclosure if reasonable safeguards are adopted public health and safety

GMP

Good Manufacturing Practices

Sensitive topics for HIPAA disclosure

HIV, mental health, substance abuse treatment

HIPAA

Health Insurance Portability and Accountability Act

Schedule II Substances

High potential for abuse that may lead to severe psychological/physical dependence Currently accepted medical use Eg: Narcotics (morphine, codeine, hydrocodone, benzhydrocodone, opium extracts, hydromorphone, methadone, meperidine, oxycodone, fentanyl, Stimulants (amphetamine, methamphetamine, methylphenidate) other: cocaine, pentobarbital, amobarbital, secobarbital, immediate precursor to fentanyl

Schedule I Substances

High potential for abuse that may lead to severe psychological/physical dependence NO currently accepted medical use in the US Eg: Heroin LSD ecstacy psilocybin bath salts

HPUS

Homeopathic Pharmacopeia of the United States

Microbial action should be taken if fingertip samples in ISO _____ should >3 CFU

ISO 5

Microbial Action Levels (Air samples)

ISO 5: >1 ISO 7: >10 ISO 8: >100

Microbial Action Levels ( Fingertip sample)

ISO 5: >3 CFU ISO 7: N/A ISO 8: N/A

Microbial Action Levels (Surface sample)

ISO 5: >3 CFU/plate ISO 7: >5 CFU/plate ISO 8: >100 CFU/plate

What is the penalty for violation of Pharmacy Practice Act

If no other penalty provided by statute, violation is considered a Class D felony Up to $5,000/violation Imprisonment up to 5 years/violation CUMULATIVE for each separate offense

When is partial dispensing of a CII medication allowed?

If the pharmacy is out of stock- must dispense remainder within 72 hours of partial, otherwise notify prescriber or if requested by prescriber or patient, may fill partial(s) up to amount of the Rx, but only up to 30 days from ISSUE DATE or if the pt is terminally ill or LTC inpatient, but only up to 60 days from issue date

When can an APRN prescribe controlled drugs?

If under written collaborative agreement with a CT licensed physician, collaborative agreement must specify level of CII and CIII that can be prescribed After 3 years and 2,000 hours of practice under a collaborative agreement, APRN may practice independently

BUDs based on risk level and <797>

Immediate Use: -room temp: 1 hour -fridge: N/A -frozen: N/A Low risk w/ 12 hour BUD: -room temp: 12 hours -fridge: 12 hours -freezer: N/A Low Risk -room temp: 48 hours -fridge: 14 days -freezer: 45 days Medium Risk -room temp: 30 hours -fridge: 9 days -freezer: 45 days High Risk -room temp: 24 hours -fridge: 3 days -freezer: 45 days

Unused Order forms lost/stolen

Immediately report to DEA/CT Drug Control Give serial #'s of lost/stolen forms If found later, notify DEA/Drug Control

To dispense using the internet, must have a valid prescription from a prescriber who has done a ________ evaluation

In person

When dispensing samples, prescriber must personally dispense the drug EXCEPT....

In the ED, licensed nurse may dispense under prescriber's supervision

Receiving Pharmacist's Records for transfers (non-control):

Indicate that Rx was transferred Name of transferring pharmacy and pharmacist original issue date and dispensing date Rx # on original Rx Number of refills authorized on original Rx complete refill record on date of transfer Number of valid refills remaining

Valid Photo ID pickup does NOT apply in which 2 settings?

Institutional setting LTC facility

Cosmetic

Intended to be: rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body For cleansing, beautifying, promoting attractiveness, or altering the appearance

Dietary Supplement

Intended to supplement the diet Contains 1 or more dietary ingredient intended to be taken by mouth is labeled on the front panel as being a dietary supplement

IND

Investigational New Drug

A drug is a prescription only if:

It's not safe for use except under supervision of practitioner because of its toxicity, potentially harmful effect, or method of use

If a prescription for a control is faxed in from which 2 facilities does the fax count as original Rx (no written copy required)

LTC facility or hospice

HIPAA Privacy Rule

Law that regulates the use and disclosure of patients' protected health information (PHI) in any format or media -paper, electronic, spoken word, video

3 branches of government

Legislative, Executive, Judicial

CSP Microbial Contamination Risk Levels

Levels assigned based on potential for risk of harm to patients based on the compounding process -immediate use -Low risk -Low risk w/ <12 hr BUD -Medium risk -High risk

Schedule V Substances

Low abuse potential relative to CIV currently accepted medical use Abuse may lead to limited physical/psychological dependence (primarily preparations containing limited quantities of certain narcotics generally for antitussive, antidiarrheal and analgesic properties) THINK DIVISIBLE BY 5 Eg: Lyrica (pregabalin) Cough preparations with <200 mg/100mL (or 200 mg/200gm) codeine (eg: phenergan w/ codeine) antidiarrheal preparations with <200 mg/100 mL or <200mg/100gm opium or <2.5mg diphenoxylate+<25 mcg atropine (eg: lomotil)

Class III substances have ______ physical dependence and _____ psychological dependence

Low/moderate physical High psychological

Lyrica is a schedule _____ Neurontin is a schedule ______

Lyrica (pregabalin) is schedule V Neurontin (gabapentin) is NOT scheduled

Emergency CII (may/may not) be filled by central fill pharmacy

MAY NOT

FDA approval for same indications and conditions of use as reference product if biological product has same:

MOA route of admin dosage forms strength

Sterile compounding pharmacies that dispense CSP's without a prescription or patient-specific order are considered :

Manufacturers

Compounding vs Manufacturing

Manufacturing: FDA regulation requires specific labeling; cGMP; drug approval process Compounding: regulated by the states as practice of Pharmacy

Class II Drug Recall

May cause a temporary reversible adverse affects; Little likelihood of serious adverse affects

Medicare Prescription Drug Improvement and Modernization Act of 2003

Medicare Part D established

MMA

Medicare Prescription Drug, Improvement, and Modernization Act

MPJE

Multistate Pharmacy Jurisprudence Examination

USP 800 glove requirements

Must be: -chemotherapy gloves -in compliance with ASTM standard D6978 -powder free Gloves: -must be inspected for defects prior to use -should be changed every 30 minutes -must be changed if torn, punctured or contaminated -should be worn for handling all HDs -must be worn when unpacking HDs Wear 2 pairs of gloves if: -Compounding any HD -administering antineoplastic HD -deactivating/ decontaminating / cleaning / disinfecting HD areas or equipment

______ respirators offer no protection against gases/vapors, and little protection against splashes

N95

documentation of pharmacist tech initial and continuing training must include:

NAME of person receiving training DATE of training (initial and continuing) General description of TOPICS SIGNATURES of both technician and pharmacist manager

Difference between NDA and ANDA

NDA requires: Animal studies, clinical studies, bioavailability ANDA requires: Bioequivalence

DEA Form 224

NEW application to dispense controlled medications for Retail pharmacy, hospital/clinic, practitioner, teaching institution, or Mid-level practitioner

________ list of antineoplastic and other hazardous drugs in healthcare settings

NIOSH

Does CT prohibit sale of OTC cough meds containing dextromethorphan (DM) to minors?

NO

In CT, can non legend drugs be sold in vending machines?

NO

Can a practitioner prescribe themselves or their family members controlled substances?

NO CII-CIV (there are some exceptions) CV is ok

Can a psychologist prescribe drugs in CT?

NO, only a psychiatrist can

ALWAYS high risk category when

NON STERILE -compounding with non sterile raw materials -putting sterile products into non sterile container

According to USP <795>, BUD for water containing oral formulation

NTE 14 days- must be stored at controlled cold temperature

According to USP <795>, BUD for water containing topical/dermal, mucosal liquid, semisolid

NTE 30 days

CV OTC record book must contain:

Name and address of purchaser name of product purchased quantity of product purchased date of sale time of sale initials of pharmacist

Pharmacy may provide prescription blanks to prescribers, but they may NOT contain

Name of Pharmacist Name of Pharmacy

Transferring pharmacist records (non- control):

Name of pharmacy transferred to Date of transfer cancellation of original Rx

NTP

Narcotic Treatment Program

Methadone for maintenance or detox must be dispensed under separate DEA registration as a ________

Narcotic Treatment Program (NTP) or Opioid Treatment Program (OTP)

NABP

National Association of Boards of Pharmacy

NDA

New Drug Application

Are soaps considered cosmetics?

No

Can a pharmacy operate without a pharmacist present?

No

is dextromethorphan a controlled drug?

No

Since marijuana is a CII in CT, is a prescriber allowed to provide product samples to patients?

No No samples contains marijuana can be provided unless product is FDA approved

HIPAA Privacy Rule

No disclosure of patient's personal information without patient's consent

How many times can a non-controlled Rx be transferred?

No limit

Opioid supply limit for substance abuse treatment

No limit

How soon before a DEA Form224a expires may it be renewed?

No more than 60 days before current expiration date

Are drugs repackaged into stock bottles for pharmacy use considered misbranded?

No, as long as they contain the required label information

Does the FDA initiate drug recalls?

No, but they can order a recall and make the companies do them

Does a practitioner for the US military require a DEA#?

No, however, if they are engaged in private practice, than must have his/her own DEA registration

Can pharmacy accept controlled meds for destruction?

No, must direct patient to police station which usually has a waste disposal program

If a doctor writes a new prescription for 30 days supply, can the pharmacist fill 90 days on the first fill?

No, the pharmacist may REFILL for greater quantity than initially prescribed if refill is made after the original quantity is dispensed (plus other factors)

If a pharmacy wants to increase their scheduled hours, do they need permission from DCP?

No, they can increase hours whenever they want, but have to notify DCP no more than 5 days after change

Who must get a permit to sell non legend drugs?

Non pharmacies Must obtain permit from Pharmacy Commission

NAPLEX

North American Pharmacist Licensure Examination

NoPPs

Notice of Privacy Practices

Pharmacy preceptor may supervise how many interns at one time?

ONE

What dosage forms can be substituted for each other by a pharmacist ?

ORAL tablet or liquid

Non-legend drugs

OTC

Patient Protection and Affordable Care Act

Obamacare

OBRA 90

Omnibus Budget Reconciliation Act of 1990

Which kind of eye doctor can/cannot prescribe drugs in CT?

Ophthalmologist- can prescribe Optometrist- cannot prescribe nonemergency oral glaucoma meds Optician- cannot prescribe

OTP

Opioid Treatment Program

PA rx's must contain:

PA's signature, name, address, and license number must print and sign name on all orders

Primary caregiver may be responsible for one one QP at a time unless:

PC is parent, guardian, conservator or sibling of each

De-identified records are no longer _______

PHI

Poison Prevention Packaging Act

PPPA - requires use of child resistant packaging for prescription drugs, OTC, household chemicals, and hazerdous materials - some drugs are exempt from child proof packaging --> OTC drugs with the proper labeling not for children and in big enough packages

Chapter 420F

Palliative use of marijuana in CT

camphorated tincture of opium

Paregoric

When dealing with CII prescriptions, a pharmacist may not change or add:

Patient Name Name of drug (except substituting with generic) Name of prescriber Date of issuance

CII Prescription: Pharmacist may add or change ______ without permission from the doctor

Patient age/birthdate Patient address

Omnibus Budget Reconciliation Act (OBRA)

Patient counseling

Consent to release HIPAA information must be documented

Patient/agents name date nature of records or info released

Who is authorized to dispense a prescription?

Pharmacist Pharmacy intern under supervision of pharmacist temporary-permit- pharmacist

Who has authority to deactivate alarm in pharmacy?

Pharmacist only

Who may apply for/receive a dispensary license?

Pharmacist only

Epilepsy/seizure drugs substitution

Pharmacist to give notice to both patient and prescriber AND get written consent from prescriber if filling Rx using diff manufacturer/distributer "any substitution any time can cause seizures"

All drug control agents are:

Pharmacists

Who is responsible for training pharmacy technicians?

Pharmacy Manager

Drug Trial Post Marketing

Phase IV Clinical Trial

PPPA

Poison Prevention Packaging Act

Phase IV Clinical Trial

Post-marketing, continue assessing therapeutic value and monitor less common adverse events

Only persons granted _______ by registrant may complete a Form 222

Power of Attorney

Pharmacy Ownership by physician/family

Prescribing practitioner and his/her non pharmacist spouse and dependent children may NOT have ownership or investment interest in a pharmacy exceptions: Had interest prior to July 1 1993 Inherited interest prescriber not required to maintain malpractice insurance interest is in investment securities held in publicly traded corporation if <0.5% of corporations total issued shares

PDUFA

Prescription Drug User Fee Act

Business Associates must observe _______ to extent CE would need to

Privacy Rule, Security Rule, and Breach Rule

Telephone Consumer Protection Act

Prohibits telephone solicitations using automated dialing systems or a pre-recorded voice or unsolicited faxes absent express written permission

PHI

Protected Health Information

NOPP Revision

Provider-CE does not need to resend amended NOPP- just replace the old one and move on Health Plan-CE needs to redistribute per schedule of NoPP update

Biological products are approved under the:

Public Health Service Act

When substituting biological products, refer to the ______ book for therapeutic equivalency

Purple Book

DEA Form 224a

RENEWAL Application to dispense controlled medications for retail pharmacy, hospital/clinic, practitioner, teaching institution, or mid-level practitioner

Assessment of Risk

Recognizes that some HDs have dosage forms that do not present "risk of direct occupational exposure" -containment requirements may not apply must consider: -HD type -dosage form -risk of exposure -packaging -manipulation

Power of Attorney

Registrant may authorize other people to obtain and execute Form 222 for CI and CII ordering Must be kept in the pharmacy at all times does NOT have to be submitted to the DEA

Schedule IV Substances

Relative to CIII- low abuse potential that MAY lead to psychological/physical dependence currently accepted medical use **BENZO's, Z's

DEA Form 106

Report lost/stolen controlled substances

How soon must theft/significant loss of controlled substances be reported? and to whom?

Report to DEA within one business day on DEA Form 106 CT- also required to report to DCP. No specific form. DCP prefers EMAIL. within 72 hours

REMS

Risk Evaluation and Mitigation Strategy

High Risk CSP BUD

Room temp: 24 hours Fridge: 3 days Freezer: 45 days

Medium risk CSP BUD

Room temp: 30 hours Fridge: 9 days Freezer: 45 days

Low risk CSP BUD

Room temp: 48 hours Fridge: 14 days Freezer: 45 days

Information to verify a practitioners DATA-waiver is found at:

SAMHSA website

Food, Drug, and Cosmetic Act of 1938

Safe according to directions Labeling with adequate directions Established the Food and Drug Administration (FDA) within the department of Health and Human Services (HHS)

SDS

Safety Data Sheet

In CT, marijuana is a schedule ____ substance

Schedule II

Examples of the Z drugs and their schedule

Schedule IV Z drugs: eszopiclone (Lunesta), zaleplon (Sonata), zolpidem (Ambien)

Lomotil is a schedule _____ drug

Schedule V

Controlled Substances Act

Schedules of controlled substances

Food and Drug Administration Modernization Act of 1997 (FDAMA)

Section 503A- prohibited pharmacists from soliciting prescriptions for, and advertising, compounded drugs -in 2002, supreme court ruled FDAMA's 503A to be unconstitutional restriction on commercial speech

SAMHSA

Substance Abuse and Mental Health Services Administration

T/F: Amyl nitrate is a controlled substance

TRUE

T/F: Prescriptions for all schedules (CII-CV) may be transmitted electronically (including fax) between the retail pharmacy and the central fill pharmacy

TRUE

T/F: If a CII Rx is partially filled, the amount dispensed must be noted on the face of the Rx

TRUE if there is no notation, it is assumed that the total amount was dispensed

TCPA

Telephone Consumer Protection Act

If a pharmacist changes the strength of a medication on a CII prescription after speaking with the doctor, he/she must document:

That the change was authorized Date/time that change was authorized initials of pharmacist making the change

Who appoints the Commission Board?

The governor

Who must notify DCP if there is a change in pharmacy manager?

The pharmacy AND the pharmacist

If there is a change in pharmacy manager:

The pharmacy must notify DCP of change and immediately enroll a new manager (fee required) The pharmacist who ceases being the pharmacist-manager must also notify DCP

Flavoring agent may be added to the prescription product by the pharmacist if:

The prescriber, patient, or patient's agent requests it or if acting on behalf of a hospital

Class III drug recall

The product is not likely to cause adverse reaction

Class I Drug Recall

There is a strong likelihood that the product will cause serious adverse affect or even death

3PL

Third-party logistics provider

Biologics Price Competition and Innovation Act

This act establishes generic approval pathway for biologics (BLA) shown to be biosimilar

Per DSCSA Requirements, dispensers must only accept drugs that have:

Transaction history Transaction information Transaction statement

TPO

Treatment, Payment & Operations

T/F: Any SCP and hospital that does sterile compounding must have a policy and procedure manual

True

T/F: PPPA applies when dispensing veterinary drugs

True

T/F: Pharmacies, pharmacists and nurses (who are NOT APRNs) are not required to register under the Controlled Substances Registration in CT

True

T/F: Pharmacy license must be posted in a retail pharmacy

True

T/F: a separate DEA Form 224 is required for each pharmacy (even if chain or commonly owned)

True

T/F: moving location of pharmacy terminates the license

True

T/F: pharmacist or person holding pharmacy license must disclose the price of legend drug upon request of prospective purchaser

True

T/F: In CT, a nurse midwife has prescriptive authority

True, in CT a nurse midwife is an APRN

Pharmacy technicians MAY:

Type Rx label enter Rx into computer Enter information into pt file retrieve medications from stock place medications in container place label on container prepare nursing home med cards reconstitute oral liquids obtain REFILL authorization for NON-CONTROLLED drugs compound medications for dispensing

The CSA gives ______ power to determine which drugs will be controlled substances

US Attorney General

USP-NF

United States Pharmacopeia/National Formulary

What day of the month is the commission meeting?

Usually the 3rd wednesday in the month

Qualifying practitioners for treating addiction will have an additional DEA number that starts with the letter "____"

X

If the doctor says not to give a package insert to a patient, but the patient wants it anyways, should you give it to them?

YES Dispenser must provide medication guide when product is dispensed EXCEPT prescriber may instruct dispenser to not provide med guide BUT if patient asks for information, dispenser must provide medication guise despite prescriber instruction

How many refills are allowed on CII ?

ZERO

Interchangeable product

a biosmiliar that has also shown it is expected to produce the "same clinical result"

Refrigerated antineoplastic HDs must be stored in

a dedicated refrigerator within a negative pressure area

Notice of Privacy Practices

a document that informs patients of their rights as outlined under HIPAA Must include: -How a CE may use and disclose an individuals PHI -The patients rights regarding PHI and how the patient may make a complaint -The CE's duties regarding the PHI, including a statement that the CE is required by law to maintain the privacy of PHI -Whom the patient may contact for more information about the CE's policies

Counterfeit Drug

a drug which, or the container or labeling of which bears trademark, trade name, or other identifying mark, imprint, or device or any likeness thereof of a drug manufacturer, processor, packer, or distributor (other than the actual ones) without authorization and thus is falsely representing itself

Controlled substance definition (CT)

a drug, substance or immediate precursor in schedules I to V, inclusive of the CT controlled substance scheduling regulations adopted pursuant to section 21a-243

statute

a general law passed by a legislative body

regulated sellers store SLCPs in __________

a locked cabinet or behind the counter

Opioid antagonist may be dispensed to:

a person at risk, or family, friend or other person in a position to assist person at risk of overdose

New oral prescriptions must be communicated directly to:

a pharmacist

20% rule

a pharmacist is permitted to compound CII-V aqueous, oleaginous or solid dosage form containing a controlled substance up to 20% of complete solution, compound, or mixture Must be for specific patient or order If CII- order must be written

Nonresident pharmacy

a pharmacy that is located outside of particular state that mails, ships, or delivers prescriptions to patients inside that particular state

Telehealth provider may prescribe CII or CIII (other than an opioid) without an in-person examination for treatment of _________ or __________

a psychiatric disability or substance use disorder

Biological Product

a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins Prevention, treatment, or cure of disease or condition in human beings

prescription error

act or omission of clinical significance relating to the dispensing of a drug that results in or may reasonable be expected to result in injury to or death of a patient

HIPAA Security Rule

addresses only PHI in electronic format (ePHI)

USP <800> says CSTD are required when _______ antineoplastic HDs

administering *not required when administering non-antineoplastic HDs *not required to be used in compounding

DEA Form 224b

affidavit for chain pharmacy renewals

prescription label

affixed to dispensed drug or device

regulation

aka: administrative law more detailed law created by administrative agency

wholesaler

aka: distributer entity that sells or supplies to other wholesalers, manufacturers, distributers, hospitals, prescribers, pharmacies, governments agencies, clinics or other authorized entities

______, _______ and _____ are specifically excluded from controlled substance classifications

alcohol, caffeine and nicotine

In DQSA, Title I 503A states:

all pharmacy sterile compounding be done in accordance with USP <797> *refers to any pharmacy that does compounding that is state licensed- including hospitals

In what setting can an APRN prescribe?

all practice settings

Central Fill Pharmacy

allowed by state contractual relationship or common owner only retail pharmacy delivers to ultimate user pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user. Central pharmacy shall be deemed authorized to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a contractual relationship providing for such activities or share a common owner

Emergency "kits"

allows a non pharmacist (usually a nurse) to dispense in an institution when a pharmacist is not available but it must be: an emergency reviewed by nursing supervisor or physician prior to administration recorded by pharmacist (when they become available)

Governor's Declaration of Emergency

allows hospital pharmacies, pharmacies and DCP registrants - with prior DCP approval- to transfer CONTROLLED DRUGS to another pharmacy, registrant, or DCP registered location gives DCP authority to develop biannual list of strategic prescription drugs for public health preparedness

Classifications of controlled substances

amphetamine-type barbiturate-type cannabis-type cocaine-type hallucinogenic morphine-type other stimulant and depressive substances

How often must pharmacy license be renewed?

annual application with fee for renewal

How often must controlled substance inventories be performed in CT?

annually

How often must dispensary license be renewed?

annually

Manufacturer and wholesaler license is issued how often?

annually and by location

When must CT controlled substance inventory be completed?

annually within 4 days of the first day of May

Opiate

any drug or substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable or conversion into a drug having such an addiction-forming or addiction-sustaining liability

What is a HIPAA Business Associate (BA)

any entity that, on behalf of a covered entity of on behalf of another BA: creates, receives, maintains, or transmits PHI maintains includes physical and virtual storage vendors (egL box storage facilities and cloud services) even if they do not view or access PHI

Protected Health Information (PHI)

anything a covered entity of business associate knows about a patient because of the covered entities relationship with the patient *the relationship is the trigger

HIPAA marketing rule

anytime a CE (or BA) received financial remuneration from a third party in exchange for making a communication to a patient about the third party's product or service *not permitted without pt authorization

SCP must notify DCP of emergency repair _______

as soon as repair commences

How often must Health Plan CE NOPPs be sent to patients?

at least every 3 years

Within CDTM, pharmacist must report patient's drug therapy management to physician _______

at least every 30 days

How often should quality assurance evaluations be done for tele pharmacy

at least once per calendar quarter

How often does the Board of Physicians meet?

at least twice a year for public hearings and to evaluate petitions to add to list of debilitating medical conditions

ADS

automated dispensing system

A rated products (Orange Book)

bio equivalent and "therapeutically equivalent" to brand name/reference product

Hours of operation font:

block letters >0.5" tall

SCP must report any known violation or noncompliance with viable and nonviable environmental sampling testing per USP <797>, when?

by the end of the next business day after discovery

Debilitating conditions

cancer, glaucoma, HIV, AIDS, Parkinson's, MS, epilepsy or uncontrolled seizure disorder, cachexia, wasting syndrome, Crohn's disease, PTSD, cerebral palsy, CF, terminal illness requiring end-of-life care -anything else designated by DCP regulation

"B" rated products _____ be substituted for one another

cannot

When filling, central fill pharmacy must affix label to the package showing retail pharmacy name and address and a unique identifier (________) that indicated the Rx was filled at the central fill pharmacy

central fill pharmacy DEA#

Federal definition of "device" states that MOA must not be:

chemical or metabolic

CSTD

closed-system transfer device protect from occupational exposure or environmental release of HD during compounding or administration

Adulterated: think....

composition

Registered pharmacy intern may:

compound dispense perform pharmacy services only is pharmacist is present

2 pairs of chemotherapy gloves must be worn when:

compounding HD administering antineoplastic HDs cleaning/disinfecting/decontaminating HD areas or equipment

Head and hair covers required when:

compounding or there is potential exposure to HD residue

Risk category classification is determined by _______

compounding personnel (pharmacist)

Where must the pharmacy manager's name be posted in the pharmacy?

conspicuously within the prescription department so that patients/customers can see

Technicians may NOT:

consult with patient/practitioner about Rx or medical record identify, evaluate, interpret, or clarify a prescription interpret clinical data perform professional consultations verify a prescription order determine generically or therapeutically equivalent drugs

If person is not known to pharmacist, must ask for ID before picking up what kind of drug?

controlled substance (all schedules)

Deodorant: cosmetic or drug?

cosmetic

CE

covered entity

Combat Methamphetamine Epidemic Act of 2005

created a new class of regulated products called "Scheduled Listed Chemical Products" (SLCPs) SLCP contains pseudoephedrine, ephedrine, or phenylpropanolamine (PPA)

In DQSA, Title I 503B: _________

creates new entity known as "outsourcing facility" -facility that must follow cGMP when it compounds

Controlled drug records must be documented either:

daily printout, made within 72 hours after dispensing, which is varied and signed by dispensing pharmacist as soon as possible after receipt or- Bound log book or separate file signed by dispensing pharmacist on the date of dispensing (but no later than the pharmacists first work date after the dispensing)

CII inventory filed by ______

date

DS

dietary supplement

"refilling": online pharmacy

dispensing a CIII-V in accordance with valid refill instructions and does not include issuance of a new prescription for a controlled substance that the individual was previously prescribed

Maintenance Treatment

dispensing of a narcotic drug, in excess of 21 days, for the treatment of dependence upon heroin or other morphine-like drugs

CE requirements in first year of licensure

do not apply

Patient [does/does not] need to consent to collaboration with a pharmacist

does not physician must have PHYSICIAN/PATIENT relationship with the patient

Upon contact with and verbal permission directly from prescriber, a pharmacist may change what on a CIII-CV prescription?

dosage form dosage strength quantity directions for use issue date (not the same as CII- this could not be changed)

antiperspirant: cosmetic or drug?

drug

Record of emergency stock controlled substances for distribution in SNF must include:

drug name, form, strength and quantity date distributed MEDICAL DIRECTOR'S name and DEA#

DUR

drug utilization review

2 factor identification for ______

e-prescribing controlled drugs

If SCP initiates a recall of cSP dispensed on patient- specific prescription/order notify:

each patient (or caregiver), prescriber and DCP within 24 hours

If SCP initiates a recall of cSP not patient-specific, notify:

each purchaser, DCP and FDA by the end of the next business day

Manipulation of HDs

eg: crushing tablets, opening capsules

How often is air pressure measured?

either continuously or daily

ePHI

electronic PHI

Telepharmacy

electronic technology to allow pharmacist to supervise technician in dispensing of sterile products

CT prescriber ordering controlled substances to be filled in a CT pharmacy, must transmit the prescription ________

electronically

e-prescribing records for controlled substances must be retained ______

electronically

CII/CIII Medications >1000 units in a hospital must be kept in a _______

enclosed masonry room or equivalent

manufacturer

entity that prepares, synthesizes, compounds, packages, repackages, or labels under a trademark any drug, device or cosmetic

How often is air sampling performed?

every 6 months as part of recertification and in response to identified problems

Commissioner of DCP is ________ of board of physicians

ex-officio member

T/F: A physician may issue written certification for palliative marijuana use for a co-worker

false

T/F: a pet counts as an immediate family member

false

T/F: unscheduled pharmacy closings can occur on consecutive days

false

T/F: HDs may be stored on the floor

false do not store ANY HDs on the floor

T/F: A C-PEC is required when counting tablets and capsules

false not required for handling final dosage forms that dont produce particles, aerosols or gasses

T/F: a licensed practitioner may verbally authorized medication to be dispensed to a non hospital patient from hospital emergency department

false this law is OUTDATED direct pt to the right setting of care (eg: 24 hour pharmacies/urgent cares) insurance will not reimburse this kind of dispensing by hospitals

The second letter of a DEA# indicates?

first letter of last name

Medical Protocol standing order for opioid antagonist

for dispensing opioid antagonist - must be FDA approved -intranasal or auto injection only -dispense to person at risk, or family, friend or other person in position to assist person at risk -pharmacy must provide DCP with copy of each medical protocol standing order agreement

If entire premises is not licensed as a pharmacy, the pharmacy department must:

have approved partitions be completely secured/locked when CLOSED or pharmacist is NOT PRESENT conspicuously display the pharmacy department HOURS on the main entrance Make 24 hour access to pharmacy available to a PHARMACIST not imply the entire premise is a pharmacy on its signs for the pharmacy allow direct access to the pharmacy department by patients

Covered Entity (CE)

health care providers who conduct certain standard administrative and financial transactions in electronic form, including doctors, clinics, hospitals, nursing homes, and PHARMACIES. Any health care provider who bills electronically Health plans healthcare clearinghouses

Licensee

holder of the pharmacy license

Conversion factor of ephedrine/pseudoephedrine/PPA HYDROCHLORIDE

hydrochloride = 0.82

Satisfactory assurances

if a CE receives from a requesting party a written statement and accompanying documentation demonstrating that the party requesting the info has made a good faith attempt to provide written notice to individual, and the notice included sufficient evidence about the litigation or proceeding and the time for the individual to raise objections to the court has elapsed and no objections were filed or the objections have been resolved

CII Emergency

immediate administration is necessary no appropriate alternative is available written prescription not reasonable possible prior to dispensing eg: sickle cell pts who go into crisis

Mobile retail vendors store SLCPs _______

in a locked cabinet

DCP may disclose information received through filed reports or investigations when:

in a proceeding about licensure or right to practice where the commission votes in favor of disciplinary action against a pharmacist/pharmacy related to DISPENSING ERROR if the commissioner considers such info to be in the interest of public health

In a retail pharmacy, all CII medications must be stored:

in a safe/vault *unless pharmacy licensed before 1975

In what cases can a practitioner prescriber CII-CIV substances for immediate family members or self?

in an emergency where no other qualified prescribing practitioner is available, they can prescribe, dispense, or administer up to 72 hour supply animal in the residence emergency must be documented

Personnel of reproductive capability must confirm ______ that they understand the risks of handling HDs

in writing

Marijuana inventory schedule

initial, weekly and annual inventory

Gowns are required when administering _________ HDs

injectable antineoplastic

Device

instrument, apparatus and contrivances including their components, parts or accessories intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals intended to affect the structure or function of body of humans or other animals

Presence of _____ or ______ is considered "adequate security" during momentary absence of pharmacist

intern or technician

Dosage forms of opioid antagonist that a pharmacist may dispense under medical protocol standing order

intranasal or auto-injector (no IM with syringes and vial)

Written certification of debilitating condition

issues by physician or APRN on form approved by DCP valid for 1 year

Prescription Records

kept at the pharmacy as record of authorization to dispense prescribed drug or device

records of QA review must be kept for ______ and filed by ________

kept for 3 years filed by DATE

Misbranded: think...

label

Grandfathered Drugs

levothyroxine, digoxin, nitroglycerin, phenobarbital

Prescribing Practitioner

licensed individual who is authorized to issue a prescription WITHIN THE SCOPE of the individuals practice

Low risk level with 12 hour BUD

low risk level CSPs compounded where PECs cannot be located within an ISO class 7 clean room/buffer area under certain conditions: -CSP prepared under physicians order for specific patient -Administration must commence within 12 hours of preparation, or as recommended by manufacturer, whichever is earlier NO HAZARDOUS DRUGS

Administration of HDs that requires _______- personnel must wear appropriate PPE and use a plastic pouch to contain any dust generated

manipulation such as crushing tablets or opening capsules

Sterile compounding pharmacy that dispenses CSP's without a prescription or patient- specific medical record is considered a _______ in CT

manufacturer

Trading partners

manufacturers, wholesalers, repackagers, and dispensers

Opioid Agonist

medication that binds to the opiate receptors and provides relief to individuals in treatment for abuse of or dependence on an opioid drug

If manufacturer label is missing the lot # or control #

misbranded

If an oral emergency CII order is made, how many days later must the practitioner send in the script?

must be mailed or delivered within 72 hours (CT law) postmarked within 7 days (federal)

CII Perpetual Inventory

must be reconciled on monthly basis must be kept on premises maintained separate from other records filed by date maintained for at least 3 years

Opioid Antagonist

naloxone hydrochloride or any other similarly acting and equally safe drug approved for the FDA for the treatment of drug overdose

APRN prescription form MUST contain

name, address, and phone of APRN

Detoxification Treatment

narcotic drug is dispensed in decreasing doses, not exceeding 180 days, to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug, with the ultimate goal of bringing a patient to a narcotic drug-free state

If C-PEC provides any of the ______ pressure in the room, it must operate continuously

negative pressure

How often do drug control agents inspect/investigate retail pharmacies?

no less than every 4 years

Qualifying patients may have _______ primary caregivers at any time

no more than 1

QP may posses how much marijuana at one time?

no more than the amount reasonably necessary to ensure uninterrupted availability for a period of ONE MONTH

Antineoplastic and API HDs must be unpacked in a designated area that has _______ air pressure

normal/neutral or negative

B rated products (Orange Book)

not bioequivalent

USP <800> standards must be incorporated into entity's ___________

occupational safety plan

Annual report of marijuana dispensed providing data to DCP on types, mixtures, dosages must occur when?

on or before January 1st

Healthcare provider CEs must make sure that NOPPs are made available to patient when?

on or before the first visit -attempt to obtain an acknowledgement

How many times can a controlled med (CIII-CV) be transferred?

one time except for pharmacies sharing real-time, online database may transfer up to the maximum number of refills lawfully authorized by the prescriber

How much information may a CE release in response to an order from a court?

only as much as the order allows

Dietary supplements must be _____ (route)

oral

Ways of prescribing medications

oral written electronic

Package insert required with which medications

oral contraceptives, estrogen

Report child (<18 yo) abuse or neglect within:

oral report within 12 hours; written report within 48 hours to DCF

CV medications may be sent in by:

oral, written, e-prescription

accepted forms of CIII-CIV prescriptions

oral, written, e-prescription

OTC

over the counter

For e-prescribing controlled drug, prescriber must have at least 2 of the following 3 authentication factors:

password or PIN biometric data hard token

SCP may supply patient- specific CSPs only to:

patient practitioners hospital or healthcare facility licensed by DCP

Pharmacist not required to provide counseling or gather information when:

patient refuses counseling patient is unable to provide information requested

________, ________, or ________ are needed before a CE (or BA) may release a record in response to a subpoena

patient's authorization, court order, or "satisfactory assurances"

Exceptions to HIPAA release (no consent required)

patient, prescriber (or patients agent), 3rd party payer, government agency with statutory authority, valid subpoena, entity with written agreement to access data that does not identify specific individuals

How often is surface sampling performed?

periodically

Pharmacist must offer in person to discuss the drug being dispensed and to counsel the client on their usage except when:

person obtaining the prescriptions is other than the person on the prescription form or the pharmacist determines it is appropriate to make such offer in writing

De-identification

person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods determines risk is very small that info could be used alone or in combo to identify an individual - documents the methods and results of the analysis

If technology malfunctions during sterile compounding my technician, there shall be no distribution of CSP unless pharmacy:

personally reviews and verifies that the CSP process by the tech was accurate or when technology is restored, the pharmacist uses it to confirm the tech took all proper steps

Who must manage a pharmacy?

pharmacist

Documentation of pharmacist tech training is done by ________

pharmacy manager

Who may write a written certification for diagnosis of debilitating condition in CT?

physician or APRN who diagnosed the debilitating condition exception: APRN cannot issue written certification for glaucoma

Provider-CE NOPP location

posted in clear and prominent location at site of service -if a summary is posted, the full NOPP needs to be right there to pick up -on the CE website

Pharmacy Manager must:

practice at the pharmacy full time be designated as the pharmacy manager may not manage more than 1 pharmacy at a time

No substitution on electronic Rx if:

prescriber selects DAW code on EHR

Exceptions for opioid drug supply limits:

prescribers professional judgment for treatment of acute medical condition chronic pain pain associated with cancer diagnosis palliative care

Prescription Drug Labeling is also known as:

prescribing information package insert professional labeling

Legend drugs are also known as ________ drugs.

prescription drugs

Healthcare professionals and consumers should NOT report ________ to MedWatch

problems with vaccines, tobacco, investigational drugs, dietary supplements, veterinary consumers

"AB" rated products (Orange Book)

product meets "necessary bioequivalence" requirements and may be substituted

_______ do not need to be labeled when dispensed by the prescribing practitioner

professional samples

DQSA Title 1: _________

quality compounding act

Converting from base --> salt

quantity of base/conversion factor = quantity of salt

Converting from salt --> base

quantity of salt * conversion factor = quantity of base

Drug

recognized in the USP-NF, HPUS, or any supplement to them intended for the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals

DEA Form 41

record destruction of controlled substance inventory by a registrant

Exceptions to HIPAA marketing rule

refill reminders (specifically defined) in person face-to-face communication (email and phone calls are NOT face to face) communications that promote health communications about government sponsored programs

Report Elderly (>60 yo) abuse or neglect within:

report to DSS within 72 hours

Report abuse or neglect of person with intellectual disability (or ward of DSS) within:

report to DSS within 72 hours

Medicaid stance on generic substitution

requires generic substitution if prescriber did not specify, in WRITING, "no substitution" or "brand medically necessary" if oral script: written certification from prescriber required within 10 days

Track and trace laws do NOT apply to:

samples and veterinary drugs

Marijuana facilities must cultivate pharmaceutical grade product in [indoor/outdoor] facility

secured indoor facility

Antineoplastic HDs that will be manipulated and all API HDs must be stored:

separately from non HDs negative pressure room externally ventilated with at least 12 ACPH

If a CE receives a subpoena for medical records that is signed by a lawyer, the CE [should/should not] produce the records

should not, unless..... the court also receives: court ordering production, or a HIPAA "qualified protective order" thats been entered in the lawsuit, or a HIPAA compliant authorization from the pt that authorizes the disclosure demanded by the subpoena

When can a retail or hospital pharmacy distribute CIII-CV medications to another pharmacy?

small quantities can be distributed if: for "immediate" needs of patient <1 ounce powder/ointment <16 ounces liquid <100 tabs/caps, suppositories, or injectables

If patient is under 18, may NOT provide which marijuana dosage forms?

smoked, inhaled, vaporized

Department of Consumer Protection

state agency in CT that is responsible for enforcing the state drug laws

If C-PEC is used for ______ compounding, it must operate continuously

sterile

Class II BSC is used for ______ compounding

sterile (can use for non sterile also)

Substitution of drugs requires the same:

strength, dose, dosage form, quantity

Drugs exempt from PPPA

sublingual nitroglycerin unit dose potassium supplements oral contraceptives in special dispensers medrol DosePak

Conversion factor of ephedrine/pseudoephedrine SULFATE

sulfate= 0.77

Who is responsible for supervising pharmacy technicians?

supervising pharmacist

"direct supervision" of technicians means:

supervising pharmacist is physically present and conducts in-process and final checks

Legal possession of a narcotic requires __________

that it be kept in the container that was used to deliver it to the ultimate user

Dispense

the acts of processing a drug or device for delivery or for administration for a patient pursuant to a prescription (what happens from the time the prescription is received to before the patient actually gets the med) DOES NOT INCLUDE THE ACTS OF DELIVERING A DRUG TO A PATIENT OR ADMINISTERING THE DRUG TO THE PATIENT

If multiple prescriptions are issued for a CII medication, the prescriber must provide written instructions for _____ on each Rx

the earliest date on which the pharmacy may fill Rx

HIPAA allows PHI to be shared with certain friends and family without an authorization, with the consent of the individual but only when......

the friend/family is assisting the individual with healthcare, health insurance, or payment needs

Controlled substances may be mailed if:

the mailer or the addressee is a DEA registrant the mailer or the addressee is exempt from DEA registration

Optometrist may dispense controlled substances only if:

there is no charge <72 hour supply

Optometrists in CT may prescribe:

topically administered agents Orally administered agents, including antibiotics, antihistamines, antivirals (but not if treating systemic infection) it is outside scope of practice to prescribe "nonemergency oral glaucoma meds"

T/F: SLCP self certification can be done online

true

T/F: technicians must wear a name tag identifying them as a tech

true

Rx life of a CV

unlimited refills CT does not restrict life of Rx to 6 months or +5 refills as it does for CIII-CIV

Temporary permits to practice pharmacy last for how long?

until licensure in CT or 3 months, whichever is shorter (Commission may authorize a one time, 3 month extension)

Pharmacy rewards program

when a retailer offers store credits, discounts, or other health benefits in exchange for filling Rx's with the retailer

eye and face protection must be worn

when working outside of C-PEC and there is a risk of spills/splashes or waste materials

CT's Controlled Substances Registration Act

who is required to register in CT to distribute, dispense, administer, or conduct research with respect to controlled substances

Written certification of "brand medically necessary" is required in a prescribers handwriting for a medicaid patient ____ days after filling a telephoned prescription

within 10 days

How soon much a pharmacist inform a prescriber that they dispensed a 90 day supply instead of a 30 day supply as written?

within 48 hours of the refill

Fax is a subset of a ______ order

written

CII prescriptions may be received in what form?

written or e-prescription

Dispensary license must be renewed every ______

year

Does CT allow multiple Rx's on CII's?

yes

Is partial dispensing allowed on CIII-CIV medications?

yes

Can a hospital pharmacist relabel and dispense a parenteral medication?

yes, if it did not leave control of the pharmacy

Can a pharmacy accept returned meds for destruction?

yes, if the medication is a non controlled substance

Can CII prescriptions be transferred to another pharmacy?

yes, if the original, unfilled electronic Rx is transferred

Can optometrists prescribe controlled substances?

yes- including orally administered analgesic agents used for purpose of alleviating pain caused by diseases or abnormal conditions of the human eye or eyelid

Kefauver-Harris Amendment of 1962

• Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval

Durham-Humphrey Amendment of 1951

• Created a distinction between "OTC" and "Legend Drugs". • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs".