How soon must loss, theft, or unauthorized destruction of controlled substances be reported? - correct answer CT: 72 hours (to Commissioner of Consumer
... [Show More] Protection/DCP)
Federal: 24 hours (DEA Form 106)
Who is the "commissioner" - correct answer Commissioner of Consumer Protection
How many members are on the Commission of Pharmacy, and who are they? - correct answer 7 members: 5 full-time pharmacists and 2 members of the public (at least 2 pharmacists from retail: 1 from independent and 1 from chain; at least 1 pharmacist from hospital)
How often does the Commission of Pharmacy meet? - correct answer at least 6 times per calendar year at the office of commission, and at other times when a chairperson or a majority of the commission deems necessary
the commission should keep a record of its proceedings
How often should the commissioner inspect each retail pharmacy? - correct answer not less than once every 4 years
What are the 5 requirements for a pharmacist LICENSE? - correct answer 1) submitted a written application on a form approved by the department
2) graduated from a school of pharmacy approved by the commission
3) has professional experience as a pharmacy intern
4) successfully passed any examinations required by the commissioner
5) eighteen years of age or older
The Department of Consumer Protection shall issue a temporary permit to practice pharmacy to an individual who: - correct answer -practices under the direct supervision of a licensed pharmacist
-has an application for reciprocity on file with the commission
-is a licensed pharmacist in good standing in a state from which the state's board of pharmacy grants similar reciprocal privileges to pharmacists
-has no actions pending against their license
When will a TEMPORARY permit to practice pharmacy expire? - correct answer at the time the individual with the temporary permit is licensed as a pharmacist in this state, or not later than three months from the date of issuance of the temporary permit, whichever occurs first
(the commission may authorize one three-month extension of the temporary permit)
What is the fee for issuance of a pharmacist license?
When does a license to practice pharmacy expire?
How do you renew your pharmacist license? - correct answer $200
biennially (biannually)
completion of an application
payment of $120
completion of CE credits
Pharmacies are to be supervised and managed by a pharmacist. What are the requirements of the pharmacy manager? - correct answer -must be licensed in CT full-time
-must be full-time at the store where acting as pharmacist manager
-may not manage more than 1 pharmacy at a time
-may be, but does not have to be the supervising pharmacist
-name should be displayed for public viewing
-if there is a change in position, the DCP must be notified of the change and immediately enroll a new manager
-pharmacy must report the absence of a pharmacist manager if:
>16 days (must be reported to the commission within 5 days)
>42 days (they are deemed ceased to be pharmacy manager; immediately enroll new pharmacy manager)
-new first-time manager must conduct an interview with the commission first
-($90 fee for change in pharmacy management; $50 late fee added if late)
What is a "continuing education unit" (CEU)? - correct answer ten contact hours of participation in accredited CE
What is a "contact hour" (CE)? - correct answer 50-60 minutes of participation in accredited continuing professional education
What are the pharmacist continuing education requirements? - correct answer -at least 15 CE credits per year
-at least 5 annual CE credits have to be live
-at least 1 annual CE credit has to be on drug law
What is the fee for filing notice of a chance in name, ownership, or management of a pharmacy?
What is the late fee for failing to give such notice? - correct answer $90
$50 plus the fee for notice
What is the fee for issuance of a pharmacy license?
When do pharmacy licenses expire?
What is the fee for renewal? - correct answer $750
annually
$190
What is the fee for registration as a pharmacy intern? - correct answer $60
What is the fee for application for registration as a pharmacy technician?
What is the fee for renewal of registration as a pharmacy technician? - correct answer $100
$50
Three requirements/descriptions of pharmacy technicians - correct answer 1) must be registered or certified with DCP to work as a pharmacy technician
2) does not include persons not engaged in dispensing/compounding of medications (i.e. store clerks)
3) must wear name tag that clearly identifies their roles
No legend drug may be dispensed or sold at retail except: - correct answer -in a pharmacy
-by a hospital to an employee of the hospital when prescribed by a practitioner for the employee or for the employee's spouse or dependent children
-by a hospital to a retiree of such hospital or the retiree's spouse
Tech DO's in CT (10): - correct answer 1) type Rx label
2) enter Rx into computer
3) enter information into patient file
4) retrieve medications from stock
5) place medications in container
6) place label on container
7) prepare nursing home medication cards
8) reconstitute oral liquids
9) obtain REFILL authorization for non-controlled drug
10) compound medications for dispensing
Tech DON'Ts in CT (7): - correct answer 1) accept oral order for new prescription
2) consult with patient/practitioner about prescription or medical record
3) identify, evaluate, interpret, or clarify a prescription
4) interpret clinical data
5) perform professional consultation
6) verify a prescription order
7) determine generically or therapeutically equivalent drugs
Tech ratio in community retail pharmacy - correct answer 2:1
3:1 if one tech is certified
(pharmacist can refuse to supervise 3 techs, but refusal must be in writing given to the manager)
Tech ratio in COMMUNITY IV, unit dose, or bulk compounding/dispensing pharmacy - correct answer 3:1
(pharmacists can't refuse to supervise 3 techs in this setting)
Tech ratio in institutional outpatient pharmacy - correct answer 2:1
(can be up to 3:1 with demonstrated need + petition)
Tech ratio in institutional inpatient pharmacy - correct answer 3:1
(can be up to 5:1 with demonstrated need + petition)
Tech ratio in institutional satellite pharmacy - correct answer 3:1
(can be up to 5:1 with demonstrated need + petition)
Documentation of pharmacy tech training must include: - correct answer -NAME of the person receiving training
-DATES of training
-general description of TOPICS
-SIGNATURES of both technician and pharmacy manager
-(change in pharmacy manager? new manager must review and sign documentation of tech training)
Dispensing of legend drug or devices pursuant to Rx only: - correct answer -gives authority to pharmacist (and intern under supervision) to dispense based on a prescription
-allows technician (under direct supervision) to assist in dispensing
-prevents a pharmacist whose license is suspended or revoked from being a technician
-does not prevent a prescriber from dispensing drugs to his/her own patients if within scope of practice
T/F A prescriber can DISPENSE drugs to his/her own patients - correct answer True (if within scope of practice)
What is an emergency "kit"? Under what circumstances can an emergency kit be used? - correct answer An emergency kit allows non-pharmacist (i.e. nursing supervisor or physician) in an institution to dispense drugs when a pharmacist is not available
MUST be:
1) an emergency
2) reviewed by nursing supervisor or physician prior to administration
3) recorded by RPh
(CT Pure Food and Drug Act addresses labeling requirements)
Emergency stock at a SNF is technically distributed to whom? - correct answer medical director who has valid DEA & Connecticut controlled substances registration
Two ways to order CIIs - correct answer 222 (triplicate order form)
CSOS (electronic order system)
Where is the Power of Attorney application kept? - correct answer - on record in the pharmacy
- (it does NOT go to the DEA)
What to do if an UNFILLED (written on but not received) 222 order form is lost - correct answer -must complete second (new) form
-must prepare STATEMENT that includes first order form's serial number & date, and verify that original order was never received
-attach the statement to the second order form and keep a copy of statement with Copy #3 of the first and second order forms
What to do if an UNUSED (not written on) 222 form is lost or stolen - correct answer -immediately report to DEA/CT Drug Control
-give serial numbers of lost/stolen forms
-if found later, notify DEA/CT drug control
T/F A starter pack given to a retail pharmacy is considered a sample - correct answer F (starter packs given to retail are NOT samples)
What is a prescription drug sample? - correct answer a unit of drug intended not to be sold but rather to promote the sale of the drug
Requirements of prescription drug samples (5) - correct answer 1) samples may be distributed ONLY to practitioners licensed to prescribe or to pharmacies of hospitals or health care entities -this does NOT include retail pharmacies
2) samples must be requested by the practitioner, in writing, on a form that includes the necessary information by law
3) the practitioner must make the request EACH time (no standing orders)
4) recipient must execute a written receipt for the delivery of the samples
5) the receipt must be returned to the manufacturer or wholesaler
6 requirements a Dispenser must do (wholesaler stuff): - correct answer 1) use licensed/registered Trading Partner to purchase prescription drugs
2) quarantine & investigate "suspect" products
3) keep investigation records for suspect drug 6 years
4) identify & remove "illegitimate" products
5) notify FDA and Trading Partners within 24 hours
6) keep records of product identified as illegitimate for 6 years
What does "suspect" drug product mean? - correct answer there is REASON TO BELIEVE the product is counterfeit, diverted, or unsafe
What does "illegitimate" drug product mean? - correct answer CREDIBLE EVIDENCE shows that the product is counterfeit, diverted, or unsafe
What are the Dispenser accept/transfer/regulator requirements?
("pedigree" requirements of Prescription Drug Marketing Act of 1987; Drug Supply Chain Act of 2013; Title II of Drug Quality and Security Act) - correct answer Accept: dispensers must accept ONLY rx drugs that have transaction information, transaction history, and transaction statement ("pedigree" information)
Transfer: provide the transaction information, transaction history, and transaction statement (this is for transferring back to wholesaler; this history INCLUDES information received from upstream Trading Partners)
Regulators: for recalls & investigations of suspect products, provide transaction information, transaction history, and transaction statements to regulators
Requirements for pharmacy-to-pharmacy distribution of controlled substances (CT law) - correct answer retail or hospital pharmacy *may distribute "small quantities"* of CS to another pharmacy if:
- C-III through C-V only (no C-II)
- for "immediate needs of patient"
- ≤1 ounce powder/ointment
- ≤16 ounces liquid
- ≤100 tablets/capsules, suppositories, or injectables
Who may a pharmacy (acting as distributor without being registered as a distributor) distribute controlled substances to? (what 2 parties) - correct answer - another pharmacy
- a registered practitioner for the purpose of general dispensing by the practitioner to patients
4 requirements for pharmacy to act as a distributor (to another pharmacy/registered practitioner) - correct answer 1) the pharmacy/practitioner receiving controlled substances is registered with the DEA to dispense
2) the distribution and receipt are recorded on both ends
3) if it is for CII: the distributing pharmacy documents transfer on DEA Form 222 (or CSOS)
4) *the total number of dosage units for all controlled substances distributed does not exceed 5% of all controlled substances dispensed in a calendar year* (if >5%, must register as a distributer)
Controlled substances may be mailed if either - correct answer the mailer or the addressee is a DEA registrant
the mailer or the addressee is exempt from DEA registration
3 packaging requirements for mailing a *controlled substance* - correct answer 1) the inner container is marked and sealed and placed in a plain outer container or securely wrapped in plain paper
2) if the mail consists of prescription medicines, the inner container is also labeled to show the *name and address* of pharmacy/practitioner/or other person dispensing the prescription
3) the outside wrapper or container is free of markings that would indicate the nature of the contents
The Prescription Drug Marketing Act of 1987 prohibits the sale, purchase, or trade of prescription drugs purchased by HOSPITALS except: - correct answer - own use (the hospital's patients)
- sales or purchases to Nonprofit Affiliates and those of common control
- sales or purchases for Emergency Medical Reasons
- dispensing prescription drugs pursuant to prescriptions for employees, spouses/children of employees, and retirees
Reimportation of prescription drugs is illegal EXCEPT for: - correct answer manufacturers importing in small quantities, if they are not approved in the US and are needed to treat serious illnesses in the US
an individual patient may reimport, on their person, an FDA approved drug from Canada in a quantity NOT TO EXCEED a 90-day supply, in its original container
CSA allows for 50 dosage unit limit to be personally transported, in original container, and declared at customs
1 unit of a controlled substance medication is: - correct answer 100 units or capsules
1 pint of liquid (16 oz)
1/8 oz of powder, crystal, flake, or granule
1 multi-dose vial
10 single-dose vials, tubexes, or other single-dose package form
10 suppositories
Schedule I Controlled Substances - correct answer highest abuse potential
no currently accepted medical use in the US
lack safety information
heroin, marijuana (federal), methaqualone, MDMA, LSD, mescaline, psilocybin
Schedule II Controlled Substances - correct answer high abuse potential with severe psychological or physical dependence liability;
have accepted medical use
narcotics: morphine, codeine, hydrocodone, opium, hydromorphone, methadone, meperidine, oxycodone, fentanyl
stimulants: amphetamine, methamphetamine, methylphenidate
other: cocaine, amobarbital, secobarbital, pentobarbital, glutethimide, immediate precursor to fentanyl
marijuana (in CT)
phencyclidine (PCP)
Required records that must be maintained by a pharmacy (11) - correct answer DEA Form 222 or CSOS (executed and unexecuted)
DEA Form 106 (reports of theft or significant loss)
DEA Form 41 (inventory of drugs surrendered for disposal)
Power of Attorney authorization to sign order forms
receipts and/or invoices for schedules III, IV, and V controlled substances
ALL inventory records of controlled substances, including initial and biennial inventories, dated as of beginning or close of business
records of controlled substances distributed (to other registrants, returns to vendors, to reverse distributors)
records of controlled substances dispensed
records of transfers of controlled substances between pharmacies
DEA registration certificate
self-certification certificate and logbook (as required under the Combat Methamphetamine Epidemic Act)
4 standards for approved safe - correct answer - minimum of a B Burglary Rate
- equipped with a relocking device
- weight of 750 pounds or more or rendered immobile by being securely anchored to a permanent structure of the building
- adequate interior space to store all controlled substances required to be kept within the safe
Manufacturer, wholesaler, distributor, importer, exporter *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII <250 units in an approved safe
CII ≥250 units in a vault
CIII-CV in an approved vault
*know 4 standards for approved safe* (separate question)
Retail licensed pharmacy *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII <150 units in a completely enclosed locked wood or metal cabinet
*pharmacies that are new or relocated after 1/1/1975 should store ALL CII in approved safe*
CII ≥150 units in approved safe
CIII-CV stored in approved safe, locked wood or metal cabinet, or dispersed throughout stock (not bunched together)
*know 4 standards for approved safe* (separate question)
Practitioner (MDs, dentists, veterinarians, osteopaths, podiatrists) *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII *AND* CIII ≤15 units in a wood or steel cabinet
CII *AND* CIII >15 units in an approved safe
*Veterinarians*: CII *AND* CIII ≤40 units in a steel or wood cabinet (for barbituate-type used solely for animal anesthesia or animal euthenasia)
CIV-CV stored in a steel or wood cabinet *OR* in a securely safeguarded location
Laboratory (*other than hospital clinical laboratory*) secure storage of controlled substances (CI-CV, various quantities) - correct answer *CI-CII* stock stored in an approved safe
^except CII barbituates ≤10 units used *solely* for sedative or anesthetic effect on animals stored in an approved safe *OR* separate secured locked location
CIII-CV in an approved safe *OR* separate secured locked location
Hospital pharmacy *SECURE* storage of controlled substances (CII-CV, various quantities) - correct answer CII *AND* CIII <150 units in a locked wood or metal cabinet
CII *AND* CIII ≥150 units but <1000 units in an approved safe
CII *AND* CIII ≥1000 units in an enclosed masonry room with a vault-type steel door; must be equipped with a "day gate"
*completely enclosed masonry rooms contructed after 1/1/1975 must be equipped with an electrical alarm system*
CIV-CV stock stored in a secure location within the pharmacy prescription compounding area or drug room
*Hospital Clinical Laboratories*: CII-CIII in approved safe
*Hospital Clinical Laboratories*: CIV-CV kept in a separate secure locked location
*know 4 standards for approved safe* (separate question) [Show Less]