CT MPJE
How much will a person with the intention of fraud/ misleading be fined?
$1000 or imprisonment for 1 year or both
What is the fee to renew a Wholesaler license? What is the fee to renew a Manufacturer license?
$190 Manufacturer 5 licensed pharmacist/chemists- $285 6-10: $375 >10: $945
satelitte pharmacy
3:1 may grant 5:1
If a vault is accessed frequently and needs to be left open, this is required.
Day gate which is self closing and self locking
Drug dependence:
Mean a psychoactive substance dependence on drugs as that condition is defined in the most recent edition of Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association.
Where should the name of the pharmacy manager be posted?
The name of the pharmacist manager shall be conspicuously posted within the prescription department of a pharmacy, or in immediate proximity to it.
what are the types of controlled drugs
amphetamine, barbiutate, cannabis, cocaine, hallucinogenic, morphine, other stimulant, depressant drugs
what are the rules on no substitution (DAW)?
for medicaid need to specify the basis, write brand medically necessary (cannot be preprinting) need to get a rx in handwritting 10 days after communication for a medicaid patient
DEA form 224c
form required for application for modification of registration for online pharmacies
What must technicans be before starting?
must be registered or certified with the department
What is the CE requirements for a retired pharamcist to become active?
must get 30 hours of CE, 10 live, and apply for and receive a license before becoming active
if a sterile compounding area is going to be changed when should you notify the commission
within 10 days
vending machines
no drugs can be sold this way
how many days should you review an error
no later t han 2 business days from the error
when can something be dispense d from the emergency room?
no pharmacy in 5 miles can give 24 hour supply (not controlled substancees)
If an oral emergency CII order is made, how many days later must the practitioner send in the script?
72 hours mailing or delivery of the script (CT) 7 days by federal
When giving an emergency day supply to a patient, how much can you give them?
72 hours worth (3 day supply).
fee nonresident pharmacy certificate of registration
750 renewal- 190
what usp governs non sterile compunds
795
what is the USP that sterile pharmacy needs to follow
797
If a physician specifically does not want to substitute the brand version of the medication, he/she must have in his/her handwriting _______________________.
"BRAND MEDICALLY NECESSARY" ***If the patient is a Medicaid or ConnPACE (CT medicaid) recipient, such practitioner must specify why the brand is medically necessary in comparison to generic.
Legend drugs bear this statement:
"CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT A PRESCRIPTION" OR "RX ONLY"
Each pharmacy shall display a sign concerning reporting of prescription error in conspicuous location visible to consumers. The sign must be 8" high and 10" in length (minimum) and the font must be readable to consumers. It shall have the following statement:
"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 Department of Consumer Protection telephone number" **This statement must also be found on receipt or in the bag or other similar packaging
Each pharmacy must have this sign about generic medication in block letters not less than one inch in height:
"THIS PHARMACY MAY BE ABLE TO SUBSTITUTE A LESS EXPENSIVE DRUG PRODUCT WHICH IS THERAPEUTICALLY EQUIVALENT TO THE ONE PRESCRIBED BY YOUR DOCTOR UNLESS YOU DO NOT APPROVE"
Any non-pharmacy that sells non-legend drugs without a permit from the commission or inappropriately labels/packages non-legend drugs not in accordance with state/federal law will be fined:
$100- $500
Patients in CT who use Marijuana must:
- Resident of CT - Diagnosed with medical condition -18 years or older ( if minor must be in control of parent who is control of marijuana and paraphernalia) - Has written certificate from physician ***physicians can't give samples of marijuana unless FDA has approved the product
A retail pharmacy or pharmacy within a licensed hospital may distribute "Small quantities" of CIII, CIV or CV controlled substances to another pharmacy provided from the immediate needs of a patient. What is considered small quantities?
- one ounce of a powder or ointment -16 ounces of a liquid -100 units of tablets, capsules, suppositories or injectables
90 day supply
-1st fill is original QTY -Refill doesn't exceed total prescribed QTY or 90 days -Prescriber hasn't prohibited change -Drug is not controlled -Inform prescriber ASAP and within 48 hours of refill
A drug can be repackaged without being considered a misbranded considering it indicates what on the label?
-Drug name and strength -Lot Number -Manufacturer -Expiration Date **So when putting medication back into stock this information must show, everything else can be blacked out or ripped off.
A pharmacist or any person holding a pharmacy license can advertise price of any legend drug sold at retail via prescription from practitioner as long as:
-Advertisement clearly states price and how long that price remains in effect and shall not contain any statement indicating that the advertised price is subject to change without notice. -Pharmacist must disclose price of any legend drug to any prospective purchaser.
Cosmetic:
-Article intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any of its parts for cleansing, beautifying, promoting attractiveness or altering the appearance -articles intended for use as a component of any such articles, except that such term shall not include soap
What should be on the label of the outer container (radiation shielding) for radio-pharmaceutical medications?
-Name of the pharmacy and address -Name of the prescribing practitioner -Date dispensed -Radioactivity, calibration time/date -RX Number -Name of the procedure -Name of radionuclide/chemical form -Dosage unit -Expiration time -Standard Radiation symbol and "Caution Radioactive Material" *if solid, number of items/weights *if gas, the number of ampoules or vials *Patient name if for therapeutic use must have or has "For Physician Use +/- only"
What should the inner container of the radiopharmaceutical to be dispensed be labeled with?
-Name of the radio-pharmaceutical -Serial Number -Standard radiation symbol -"Caution: Radioactive Material" Don't need procedure details/expiration date! Interesting
When retrieving a prescription of a controlled medication that was phoned in, what information is necessary?
-RX number -The name and address of the patient -Date of issuance -Prescriber name, address, DEA # -Name, Strength, dosage form, QTY of medication -Total number of refills authorized For refills this additional information is needed: -Date of refill (and first date dispensed) -Name/Initial of pharmacist for each refill Total number of refills dispensed to date
What equipment is needed in a Nuclear pharmacy? (6 things)
-Radioactive detecting and measuring equipment -Radioactive shielding -Refrigerator -Equipment appropriate for QA testing -Equipment for decontamination or accidental spills -Equipment for compounding and dispensing sterile parenteral radiopharmaceuticals.
Sterile Compounding Requirements regarding remodels: Must notify DCP of below changes how quickly? -Remodel or relocation -Upgrade/ non urgent repair -Emergency repair (and recertification?) -Violation of environment -Legal action
-Remodel or relocation: 45 day written notice +plan -Upgrade/nonurgent repair: 45day written notice +plan -Emergency repair: Max 24 hours after repair (recertification)--> within 5 days of approval -Violation of environment: by end of next business day -Legal action within 5 days of notice
How many years pass before you cannot renew your license?
5 years
When transferring a RX what must the receiving pharmacist do? Noncontrolled and controlled
-Write "transfer" in pharmacy record -Pharmacy name and RPh -Original date RX and dispensing date -RX number -Original number of refills and remaining refills -Dates/location of pharmacy medication was refilled Controlled substance transfer -Pharmacy name, address and DEA # -Date of transfer
Initial application fee for registrant for controlled substances is :
20 dollars for biennial registration and renewal there after is 40 dollars biennial.
How many interns can an intern preceptor have at a time?
1
How long is a tech license good for?
1 year **Then it needs to be renewed with a fee
Documentation of the fact that refill information entered into the computer each time a pharmacist refills an original prescription order for CIII-CV is correct must be done by:
1. A separate hard-copy printout of controlled substance RX order refill data for each day. Each RX printout shall be reviewed by the pharmacist who refills the prescription and sign the document the same manner as he would sign a check or legal document. This document shall be filed separately for a period of 3 years from the dispensing date. This printout of the controlled substance prescription order must be provided by each pharmacy using a computerized system within 72 hours of the date on which the refill was dispensed and must be verified and signed by the pharmacist (which must be done during that work period). 2. The pharmacy shall maintain a bound logbook or separate file which each pharmacist involved in such dispensing shall sign (must be done during that work period).
How much is a pharmacist lisence?
200
The Commission is responsible for regulations including (but not limited to):
1. Concerning the licensing of any pharmacist/pharmacy 2. Specifying various classes of pharmacy licenses, including but not limited to limited to, licensed for infusion therapy, nuclear pharmacies. 3. Creation and Maintenance of prescription records 4. Concerning registration and activities of pharmacy interns, registered pharmacy techs and certified pharmacy technicians. 5. Storage and retrieval of prescription information for non-controlled substances, including refills by pharmacists through the use of electronic data processing systems or other system for the efficient storage and retrieval of information 6. The operation of institutional pharmacies 7. Activities of pharmacy techs in pharmacies and institutional pharmacies, including ratios of registered pharmacy techs and certified pharmacy techs to pharmacists in pharmacies and institutional pharmacies.
fee temporary permit to practice pharmacy
200
What is the minimum information needed to be registered as a wholesaler?
1. Name, address and telephone number 2.Business name to be registered 3. Name, address, telephone number of all contact persons for all facilities used by the registrant for the storage, handling and distribution of prescription drugs 4. Type of ownership (self, partnership, corporation) 5.Name of owner and operators (including name and title if corporation/partner etc.) 6. Must indicate the type of drugs distributing (controlled, legend, OTC etc.)
If a pharmacy is discontinuing a data processing system what should be done (3 things)?
1. Notify DCP in writing at least 30 days prior to discontinuing the system 2. Provide an up-date hard-copy printout of all prescriptions stored in the automated system for the 3 years preceding as part of the final records of that pharmacy prior to a change over to a manual system 3. Make provisions for these records available to any nearby pharmacy in the event that the pharmacy closes.
fee pharm tech
100 renewal 50
All prescriptions for controlled drugs shall include:
1. name an address of the patient, or the name address of the owner of an naimal and the species of the animal 2. whether the patient is an adult or child or specific age 3. the drug/preparation and the quantity 4. Direction of use 5.name and address of the prescriber 6.Date of issuance 7. DEA # of practitioner
renewal of pharmacist license for someone who has not had one for 5 years
200+190
In the case of a hospital pharmacy what quantity of controlled medication may be destroyed at one time?
10 Units worth In the case of hospital pharmacies where small quantities of less than 10 controlled substance units are involved on any separate occasion.
How many days after a cooporation changes officers or directors does one need to tell the commission?
10 days
When to notify Commission of change in officers? (Corporation holds pharmacy license- AKA Walgreens)
10 days
How many days does a Pharmacy license holder have to notify the commissioner of changes in pharmacy ownership or change in name of the pharmacy?
10 days **if late must pay late fee
A prescription is required if purchasing more than _______ syringes.
10 plus RX good for 1 year (**So without a RX can sell up to 10 syringes) **The pharmacist/seller must confirm with the physician every 6 months thereof if the patient continues to buy to see if it being used for an actual medical issue.
What is considered a Unit: How many tablets or capsules? __________ pint of liquid __________ ounces of a powder, crystal, flake or granule ________ multiple dose vial ________ suppositories __________ single dose ampules, tubexes, dosettes, hyporettes or other single dose package forms for injection whether powder or in solution.
100 tablets or capsules 1 1/8 ounce of powder, crystal, flake or granule 1 10 10
fee permit to sell nonlegend drugs: Fee for renewal of permit to sell nonlegend drugs:
140 100 **late fee for failing to notify commission change of ownership, name or location for nonlegend permit is: $20
How many CE are needed to renew a license?
15 yearly (900 mins) 5 live (300 mins)- meaning a live presentation 1 on law (60 mins)- pharmacy/drug law starts when you first renew **completed not less than 15 contact hrs/year (900 mins) of accredited continuing education in the previous calendar year immediately preceding expiration of the license. **Notice 15 CE must be done yearly even though pharmacist license is renewed every other year (biennial).
Applications for new pharmacy licenses and applications for the relocation of a pharmacy shall be made at least _______ days prior to the next _____________ of the commission.
15, scheduled meeting
If a pharmacist manager is absent from the pharmacy for more than ___________ days, the licensee shall report such an absence to the commission within _________ days following the 16 consecutive day absence, along with the name of the pharmacist designated as new pharmacy manager.
16 days, 5 days
Max number of unscheduled closings of pharmacy allowed? When to notify DCP?
18 days in 365 day timeframe 2 days in 30 day period (NONE consecutive) Notify DCP within 72 hours
At what age is an individual considered an adult?
18 years old
Once an application for a new drug is sent to the commissioner it will become effective ________________days after filed, except if the commissioner finds the drug not safe/effective for use or find the labeling inappropriate, he/she can deny the application.
180 days
DEA form 224/224a
224: initial registration as DISPENSER 224a: Renewal registration form as DISPENSER
When a non-controlled drug is scheduled I-V how long will it be in that schedule until it can be changed?
240 days
What is the maximum techs to supervising pharmacy ratio in an outpatient pharmacy?
2:1 (max 3 if granted by commission)
ratio in outpatient pharmacy
2:1- can grant permission for 3:1
How long should Quality Assurance records be stored for?
3 years
how long do you need to keep the audit trail from prescriptions electronically transmitted
3 years
how long do you need to maintain the records of signed refill history
3 years
how long to error reports need to be kept
3 years
how long to keep prescriptions?
3 years
how long do you need to hold onto error reports and how soon do you need to release them if you are asked
3 years 48 hours
How long do you hold onto CE forms?
3 years (at least) Pharmacist must hold certificates of approved CEU for a period of not less than 3 years after the date on which the license was renewed.
What is the minimum period of contact for which a CEU can be awarded?
A CEU can't be granted for learning events that are less than one hour in length.
Dispensing outpatient facility
A facility operated by a corporation or muncipality which provides medical services to patients on an outpatient basis and which maintains stock of drugs for dispensing of drugs on a regular basis to patients for use off the premises.
What should Nuclear pharmacist do with radioactive material not intended for drug use?
A nuclear pharmacist may transfer to authorized persons and US Nuclear Regulatory Commission licensed medical practitioners' radioactive material not intended for drug use. A nuclear pharmacy may also furnish radiopharmaceuticals and other drug products for office use to these practitioners for individual patient use. Nuclear pharmacies may redistribute US FDA approved radioactive drugs if the nuclear pharmacy does not process the radioactive drugs in any manner nor violate the product packaging. Drugs dispensed in this manner are not subject to the labeling requirements.
Revocation or suspension of non-legend drug permit
A permit to sell non-legend drugs maybe revoked or suspended by the commission for any violation.
What 3 conditions constitutes a pharmacist the ability to given emergency medication to a patient without authorization from physician for a refill?
A pharmacist may exercise his professional judgment in refilling a prescription that is NOT a controlled drug without authorization of the prescribing practitioner provided: (MAX of 72hr supply when out of refills) 1. Unable to reach practitioner after reasonable effort 2. Failure to refill the prescription might result in an interruption of a therapeutic regimen or create pt suffering 3.The pharmacist informs the pt or rep of the pt at the time of dispensing that the refill is being provided without such authorization and informs the practitioner at the earliest reasonable time that authorization of the practitioner is required for future refills. ***Prescriptions maybe refilled once pursuant to this subsection for a quantity of drug not to exceed a 72 hr supply.
When retrieving prescription information, the following information should be given: A. Original prescription number B. DEA of Prescribing physician C. Full name of patient and address of patient D. Date and location of refills E. Quantity prescribed and Quantity dispensed In a refill history what additional information is needed?
A, C, E (no sig required, or location of refills) This is the following information that must be given: 1.Original RX number 2.Date of issuance of RX 3.Full name and address of patient 4.Name and address of prescribing practitioner 5. Name, Strength, Dosage form, Quantity (prescribed and dispensed) 6. Total number of refills authorized by physician ______________ 7. The date of the refill 8. Name and initial of each pharmacist for each refill 9. Date the RX was dispensed (not issued) 10. Total number of refills dispensed (not the number of refills authorized as stated above).
Which of the following is considered a drug? A. Antiperspirant B. Deodrant
A. Antiperspirant is a drug, Deodorant is is not a drug it used to cover up smell.
Devices:
A. For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals B. Affect the structure or any function of the body of humans or animals but does not mean contact lenses.
Drug:
A. an article recognized in the official USP, Homeopathic pharmacopoeia of the US or Official National Formulary B. Article intended to diagnose, cure, mitigate, treat or prevent disease C. An article other than food intended to affect the structure or any function of the body of humans.
Hypodermic needles include: A. Needles/syringes B. Intravascular device C. indwelling catheters D. Anti-neoplastic agents
ABC Hypodermic needles and syringes means needles, syringes and any other types of intravascular device including but not limited to indwelling catheters and introducers, except that needles which are specifically used to administer anti-neoplastic agents.
Adults getting opioid for first time outpatient day supply limit? Minor limit?
Also applies to Tramadol even though schedule 4! Adults: 7 days Minor: 5 days Exception: Truama/splint and head brace in bones etc- the professional may make judgement for longer. Up to prescriber to determine how many to give.
If a product contains unsafe or unapproved color additive it is considered ________________(Adulterated/misbranded?)
Adulterated
DEA form 224b
Affidavit for chain renewal - chain operates under single registration
Amyl nitrate is a (Controlled/noncontrolled)
Amyl nitrate is designated as a controlled drug but not a controlled substance (scheduled substance)
How should refills of prescriptions for schedule III, IV, V controlled substances be stored?
An automated data processing system may be used for the storage and retrieval of refill information. Any such computerized system shall provide on-line retrieval for a period of at least 6 months from the date the last recorded dispensing via visual display device or hard copy printout of original prescription order information for all prescriptions including those prescription orders which are currently authorized for refilling.
Satellite Pharmacy
An extension of an inpatient pharmacy which provides decentralized pharmaceutical care to persons in specific locations including but not limited to specific patient care areas, nursing units, operating rooms and critical care units.
Electronic questionnaire:
Any form of electronic format that requires personal, financial or medical information from a consumer or patient.
Who is considered a Nuclear pharmacist?
Any pharmacist who holds a current pharmacist license issued by the commission and: 1. Has a current board certification as a nuclear pharmacist by the Board of Pharmaceutical specialties 2.Identified as an authorized nuclear pharmacist on US Nuclear Regulatory commission or agreement state license that authorizes the use of radioactive material in the practice of nuclear pharmacy.
Radiopharmaceutical
Any drug that exhibits spontaneous disintegration of unstable nuclides with the emission of nuclear particles or photons and includes any non-radioactive reagent kit or radionuclide generator or eluates derived therefrom, which is intended to be used in preparation of any such substance. The term includes, but is not limited to, positron-emission tomography agents, any biological product, including but not limited to blood formed element, antibody or peptide, that is labeled with a radionuclide or solely intended to be labeled with a radionuclide.
Pesticide chemical:
Any substance which, alone, in chemical combination or in formulation with one or more other substances is an "economic poison" and which is used in the production , storage or transportation of raw agricultural commodities.
Sterile Pharmaceuticals
Any dosage form of a drug, including but not limited to, parenterals (injectables, surgical irrigants and opthalmics), devoid of viable microorganisms
On what day does a Pharmacy license expire?
August 31st
What is the Eligibility of Examination for citizens in the US? A. Must be over 18 years B. Graduated from school/college ACPE approved C. At least 1000 hours of practical experience D. Must have worked in retail and must have hours approved by commission
B. Applicants must have graduated from school/college accredited by ACPE and approved by commission and has had at least 1500 hours of practical experience.
Which of the following are devices? A. Popsicle Stick B. Tongue depressor/compressor C. Stethoscope D. Toothbrush
BCD Although A is similar to B, A popsicle stick is not considered a device. ***You can look up device classifications on the FDA product classification section.
Applicants for registration can be classified as: A. Ambulatory B. Practitioner C. Clinic D. Hospital E. Others
BCDE
Bureau for Narcotics is called:
Bureau of Narcotics and Dangerous Drugs, US Department of Justice or its successor agency.
What are some conditions Marijuana is used for?
Cancer, glaucoma, HIV, AIDS, Parkinsons, MS, Spinal cord damage, seizure, epilepsy, wasting syndrome, PTSD, cystic fibrosis, terminal life
Gamma-hydroxybutyric (GHB) AKA Xyrem- Sodium Oxybate
C3 only dispensed by specially certified pharmacies
Who inspects a pharmacy prior to approving it?
Commissioner of Consumer Protection
This pharmacy is licensed in storage and dispensing of legend drugs/devices and from which related pharmaceutical care services are provided, primarily to non-institutionalized patients living in a community setting. What type of pharmacy is this?
Community pharmacy
Non-sterile Compounding Pharmacy must comply with USP#? How much product can they supply to prescriber?
Comply with USP 795 and give max 30 day supply
What happens to pharmacy deliveries while the pharmacist is not there?
Deliveries from manufacturers, wholesalers or other drug distributors of legend drugs, controlled substances, legend devices and products whose sale is limited to pharmacies or shall be carried out by or under the supervision of a pharmacist, shall be [stored in a secure locked area until such time the pharmacist is present in the pharmacy.]
So if a patient has concern about error in dispensing who do they call?
Department of Consumer Protections
Collaborative protocols must be available for inspection by these two departments:
Department of Public Health Department of Consumer protections
Main treatment uses authorized in the state of CT for Marijuana use is:
Glaucoma and CINV
What must the prescribing practitioner do after faxing the prescription?
He/she must destroy the prescription immediately or mark it/control it in a manner that prevents the use of such form to obtain controlled substances other than as authorized by these regulations.
when can you have a 3:1 ratio
IV and other sertile prep if one of the 3 is certified
What does the Commission take into consideration when designating a class/classes?
It will consider the portion of the business that the class of service represents as it relates to the total business of the pharmacy.
On what day does a Pharmacist's license expire?
January 31st
If a check given to the commissioner of consumer protections bounces, how much is the permittee fined?
Maybe fined $20
Difference between Legend and non-legend drugs?
Legend drugs would require a prescription and will have "Rx ONLY" or "CAUTION: Federal law prohibits dispensing without a prescription." Non-legend drugs means a drug which does not require dispensing by prescription and is OTC.
A Manufacturer must have a licensed ________ or ___________ supervising all manufacturing/compounding. This individual must be found qualified by the Commissioner.
Licensed pharmacist or chemist
Who must be notified prior to statement of loss/theft of controlled substances is sent to the commissioner of consumer protections?
Local authorities
License of wholesale/manufacturer are based on _____________ of registration.
Location
Methadone for maintenance/detox
Must be a Narcotic Treatment Program (NTP) or Opioid Treatment Program (OTP)
Within how many days does an individual who holds a non-legend permit supposed to tell the commission if there is a change in ownership, change in name or location of the store?
Must notify commission in 5 days
Can OTC drugs or non-legend drugs sold via a vending machine?
NO
Is soap considered a cosmetic product?
NO
Can you transfer CII scripts?
NO only CIII, CIV and CV scripts can be transferred out
The pharmacist manager shall be responsible for maintaining written record documenting the initial and continuing training of pharmacy technicians and it shall contain the following information:
Name of the individual that is being trained Date the training occurred Topics covered Name of the individual supervising the training Signature of pharmacy manager and the trainee ***If changing pharmacy manager, new manager has to review it and sign it. The pharmacist manager shall assure the continued competency of pharmacy technicians through continuing in-service training designed to supplement initial training.
Who give the accreditation of immunization training program?
National Center for Disease Control Prevention (CDC) or ACPE
(T/F)This sign protects the pharmacist from any potential suit made by a purchaser.
Neither the failure to instruct by the purchaser not the fact that a sign has been posted shall be a defense on the part of a pharmacist against a suit brought by the purchaser.
Can a hospital given a 24 hr emergency supply of controlled medication if no pharmacy is available in 5 mile radius form emergency room?
No
Can nonlegend drugs be sold in a vending machine in CT?
Nope!
Central fill pharmacy in CT?
Nope, not allowed
How often does the commission check a pharmacy?
Not less than once every 4 years
In CT does RPh HAVE to review pdmp (CPMRS)?
Not required, RPh MAY review, but not required Prescribers are REQUIRED to review at least every 90 days and if C5 can check annually
In how many days should the registrant notify the commissioner of any changes in data to the registration issued or on data required on the registration?
Notify the commissioner 30 days of any changes in the information or data required after registration is issued.
How often is a regulatory action report created by the Department of consumer protections?
Once every 3 months
When is the vault or safe allowed to be open?
Only when required items need to be removed/replaced. **Vaults if used frequently and left open will require day gates ***If a manufacturing process cannot be completed at the end of a working day, the processing area or tanks, vessels or bulk containers containing the controlled substance must be securely locked inside an area or building which affords adequate security.
Required drug label for prescriber dispensing
Patient name Prescriber's name & address Dispensing date + Instructions for use Cautionary statements required by law (if any)
Who should be notified prior to substitution of a medication?
Patient or the patient's agent
What is a regulatory action report?
Report created by the Department of Consumer Protections which indicates: 1. Any disciplinary actions taken by the department on anyone with controlled substance registration. 2. Any Sanction by the Commission of Pharmacy against any pharmacy or pharmacist. **Such a report shall contain reasons for any such action or sanction and shall be posted on the website of the department.
How many people on the commission of pharmacy? And what are there positions?
Seven appointed by governor nominated by CPA or other pharmacy organizations -Five pharmacists -Two public members -Two- retail -One independent one chain -One- hospital
If there is any vacancy on the commission it shall be filled by who?
The Governor
Dispense:
The act of processing a drug or device for delivery or for administration for a patient pursuant to a prescription consisting of: A. Comparing the directions on the label and prescription B. Selection of drug/device from stock to fill the Rx C. Counting, measuring, compounding or preparation of the drug or device D. Placing the drug/device in proper container E. Affixing the label to the container F. Addition to a written prescription of any required notations. **Dispense does not include delivery/administration.
Who has the power to extend CE time period or waive the requirement based on certain circumstances?
The commission (who then tells the department of consumer protections to renew the license)
Aside from pharmacist license what else can the department provide?
The department can issue a document suitable for display indicating that the individual has been issued a certificate of license to practice pharmacy.
When dispensing drugs to individuals eligible for benefits, offer in person to discuss the drugs to be dispensed and to counsel the client on their usage. What if someone other than the person whose name is on the prescription is picking up the prescription?
The pharmacist if he/she determines it is appropriate to make such offer can do so in writing. Any such written offer shall include an offer to communicate with the client either in person at the pharmacy or by telephone.
NO pharmacist/pharmacy shall reveal any records or info concerning the nature of pharmaceutical services rendered to a patient without the oral or written consent of patient or patient's agent. If the patient gives consent orally what should the pharmacist do?
The pharmacist shall promptly record in writing or electronic data form, the oral consent by listing the: patient's name or name of patient's agent, date and nature of record/info released.
Aside from licensee who else must notify the commission if a pharmacy manager is absent for 16 days consecutively?
The pharmacist who ceases management of the pharmacy shall also immediately notify the commission of this fact.
Who assigns and records a serial number to each prescription?
The pharmacy when it fills it.
If controlled substances are lost/destroyed through breakage of the container or other accident other than in transit what must be done? What if the loss/destruction is happened via transit (or theft)?
The registrant shall make a signed statement as to the kinds and quantity of controlled substances lost or destroyed and the circumstances involved. This statement shall be forwarded to the commissioner of consumer Protection. A copy of this statement shall be kept by registrant. If by theft or in transit, the consignee (buyer) and consigner (if within the state) who is the seller shall forward a signed statement to the commissioner which will include facts and details of lost/stolen/destroyed substances and must indicate that local authorities were notified.
The commissioner or his/her agent has the right to enter into any establishment within the state to investigate and examine food, drug, devices and cosmetics and take a sample or specimen at reasonable times. Where are these samples tested?
The samples shall be submitted to the agricultural experiment station or the laboratory services section of the Department of Public Health for examination.
(T/F) A pharmacy license shall be conspicuously posted within the pharmacy.
True
How long do temporary permits last?
Until they get a real license or 3 months Can authorize a 3 month extension
Biomedical Waste
Untreated solid waste which requires special handling **Treating biomedical waste means changing the character/composition of any biomedical waste so it is rendered waste non-infectious, non-injurious, safer for storage, transport and reduce in volume.
What is needed on a radiopharmaceutical records?
Upon receiving an order for a radiopharmaceutical, a nuclear pharmacy shall immediately reduce the prescription to writing or record the order in an automated data system. The written or electronic record shall contain: -Institution and prescribing practitioner/agent Name -Pt Name (only needed if therapeutic or biologic product [blood]) -RX number -Date of dispensing and calibration time -Identity of person dispensing -Name of radiopharmaceutical -Dose/Quantity -Specific Instructions -Name of procedure
Which medical professional can have an additional 25 U of CII/CIII stock of barbiturate type medications to be locked in steel or wood cabinets?
Veterinarians. In the case of veterinary practitioners an additional 25 U of controlled substance CII/CIII stock of barbiturate type, for use solely for animal anesthesia or euthanasia maybe stored in a locked substantially constructed steel or wood cabinet.
Must pharmacy technicians wear name tags all the time?
Yes
How often does a pharmacy license expire?
Yearly
Can a prescribing practitioner dispense own prescriptions of his own patients when authorized within the scope of his/her own practice?
Yes
Can anyone apply to the commission for a permit to sell non-legend drugs?
Yes
Can you transfer unfilled controlled substance? C2-C5?
Yes, if it was an electronically received RX. Transferring Pharmacy -Name address and phone number of pharmacy -Name and license # of pharmacist Receiving pharmacy -All required transfer info of RX -Name of pharmacy -Issue date, transfer date and any refills
what happens with training if the pharmacy manager leaves
a new manager should review the document of training and sign it
what must a pharmacy do if they want to compound
add an addendum to their application for pharmay license
Written prescriptions must
be written in ink or in indelible pencil or by typewriter. NO duplicate, carbon or photographic copies and no printed or rubber stamped orders.
side effects statement
call your doctor for medical advice about side effects. you may report side effects to FDA at 1-800 FDA 1088 must be clear single, easy to read style type
what consistutes a drug being deemed adulterated?
consists of any filthy purtrid or decomposed substance, has been produce packed or held in insanitary conditions, if it is a drug and its contianing is composed by any poisonous or deleterious substance, contains a coloring additive which is unsafe within the meaning of section, stored contary to cautionary label statements, not been manufacturer in accordance with good manufacturing practices, if the drug differs in strength, qunality or purity falls below the standards, mixed or packed therewich so as to reduce its quality or strength
what needs to be included on the record of the error
data and dates of quality assurance review, names and titles of persons performing the review pertinent data and other info related to the prescription error reviewed documentation of the patient and prescribing practioner contact reuqired findings and determinations generated by the quality assurance review recommended changes to pharmacy policy, procedure, systems and processes
In any complaint, information or indictment or action/ proceeding the burden of proof lies on the ____________
defendant
how is the complaint for an embargo written to contain
description of the article, name of the place where the article is located, name of the person in whose possession or custody the article was found, state as tot he manner in which the article is adultered or misbranded or the characteristics which render its distribution or sale illegal
If you fail to renew a license, permit or certificate/registration the fine can be:
equal to 10% of the renewal fee (not less than $10 and not more than $100)
Before denying, suspending, revoking or refusing to renew a registration or before issuing a letter of reprimand or placing a registrant on probationary status, the commissioner shall afford the applicant or registrant an opportunity for _______________
hearing
embargo
if an article is suspected of veing in violation it can be embargoed. Within 21 days the embargo should be removed or item confiscated, cannot remove the item until it has been passed, neither the comissioner nor the state is held liable for damages because of the embargo if there was probable cause for the embargo
Who does not need to show an ID when picking up a controlled substance?
institutional setting, long term care, assited living, known to the pharmacist
what needs to be on a bottle for it not be be misbranded?
label, name, strenght, lot, manufacturer, expiration
how many days before you need to go a new pharmacy manager
manager is absent for more than 16 consecutive days need to get a new name within 5 days following the 16th days of absence >42 days (immediate notice to DCP and RPH is no longer enrolled as pharmacy manager)
If a pharmacy decides it wants to stop business it can sell all its stock to:
manufacturer, distributor, practitioner, wholesaler or pharmacy but for CII drugs it may only be sold on such written order as is required by the Federal Controlled Substance Act.
store rewards program
must provide writting summary of terms and conditions
what does the radiation sheild need to be labeled with
name and address of pharmacy name of prescriber date of dispening prescription number caution- radioactive material procedure radionuclide and chemical form amount of radioactivity and calibration time expiration time dosage units number of items or weight number of ampoules or vials patient name or for physican use
what needs to be recorded for a transfer?
name and address of prescriber, date of prescription, name dose stength, quantity, name and address of patient, animals need the name and address of owner and species, directions, cautionary statments, number of refills
what info do you need to get to get the pricing data for a patient
name, dose, quantity
how many days can the pharmacy be emergency closed
not closed more than 18 times in 365 days or more than 2 times in a 30 day period (non-consecutive)
Who can have the words pharmacy on their building?
only someone who has a pharmacy if not- class D misdemeanor
who can you provide records to
patient, dr, pharmacist, agent for dr, third party payors, governmental agentcy, subpoena, written aggreement to access database where youcannot specify individuals
Define "Practice of of nuclear pharmacy"
patient-oriented service that embodies the scientific knowledge and professional judgement required to improve and promote health through the assurance of the safe and efficacious use of radiopharmaceuticals and other drugs.
Prescription record requirements, non controlled drug
patients name & address (animal species + owner name & address) prescriber name & address date RX issued + filled name of med/strength/QTY/directions/refills cautionary statements serial number RPh initials retail price of generic substitute
How can you advertise prices?
period during which the price is in effect, cannot change without notic, disclose pice to any prospective purchaser
what needs to be documented for a transfer?
transfer and names of transfering, date of issuance, rx number, date first dispensed, number of refills on original, complete refill record, number of refills remaining
Administer:
Direct application of a drug device to the body of a patient or research subject by injection, inhalation, ingestion or any other means.
how many needles are you allowed to sell
10 without rx
Once the pharmacy hours have been approved by the commission, the pharmacy can reduce hours if: 1. Pharmacist manager files notice of reduced hours with DCP at least __________ days to change 2. The pharmacy posts a conspicuous notice the public at least ______ days to change
30 days
how many day supply of sterile product can be in inventory
30 days
how soon before starting training does a tech need to be registered
30 days
Any pharmacy instituting an automated data processing system needs to let the Department of Consumer protections know at least how many days in advance?
30 days prior
how many hours does the pharmacy have to be open?
35
What is the maximum tech to supervising pharmacy ratio in an inpatient pharmacy or satellite pharmacy?
3:1 (max 5 if granted by commission)
inpatient pharmacy ratio
3:1 can grant 5:1
A wholesaler can: 1. Dispense 2.Distribute 3. Sell 4. All of the above
4
According to the Federal Track and Trace (DSCSA) how long to maintain records of "suspect products"?
6 years Once removed notify the FDA and Trading Partners of illegitimate product within 24 hours
fee pharmacy intern
60
fee for change in directors or coporation holding pharmacy license
60 $50 additionally if it is 10 days late
How many days from the permit effect date can a permittee get his/her money back via application to commissioner?
60 days
In a hospital if the physician wants to give a patient CII medication how many days worth can be given? How about for CIII- CV medications how long can it be written for?
7 days 30 days **if the physician wants to continue the CII medication, they can extend it for another 7 days by signing or initialing of the order by the prescriber
How many people are in the Commission of Pharmacy?
7 people (5 RPH [2-community, 1 hospital], 2 public elected officials] - appointed by governor
how many day supply are you allowed to give an in emergency for a non refill?
72 hours
Any theft, loss or unauthorized destruction must be reported within ___________ hours to commission of consumer protection.
72 hours DEA 106 form is used to report theft DEA 41 to surrender drugs and return to DEA
how soon after emergency closing do you need to report it
72 hours after closing
What can the commission do to prevent a person from continuing violations?
The commission may apply to the Superior Court for and the court may, upon hearing and for cause shown, grant a temporary or permanent injunction enjoining any person from violating. The commission also may apply to the Superior Court for, and the court shall have jurisdiction to grant, a temporary restraining order pending a hearing.
How many classes of pharmacies are there?
The commission shall approve a pharmacy for licensure in one or more of the following (6) classes: Community, Infusion, Specialty, Nuclear, Long-term care, Specialized drug pharmacy (also sterile and non-sterile compounding pharmacies)
Who exercises general supervision over the operations of the commission?
The commissioner
if you want a license reinstated what must you submit
a notarized letter and supporting documentation attesting to the related work experience in their occupation or profession from the time he or she let license lapse
enzyme
a protein that catalyzes chemical reactions of other substances without being destroyed or altered upon completion of such reactions
what is a permit to sell nonlegend drugs
apply to the commission for permit change in leadership, must notify in 5 days cannot transfer permit
(T/F) NO person shall be subject to the penalties for having violated adulterated/misbranded products if he/she establishes a guaranty or undertaking signed by and containing the name and address of the person residing in this state from whom he received the article in good faith, to the effect that such article is not adulterated or misbranded.
True ***So if someone sells you a product claiming it is not adulterated or misbranded you maybe not entitled to these penalties.
A pharmacist can administer a vaccine:
if conducted pursuant to an order of a licensed health care provider and if the pharmacist has successfully completed an immunization training program.
what does it means in a emergency situation?
immediate administration of the controlled substance is necessary for proper treatment of the intened ultimate user no appropriate alternative treatment is available not reasonably possible for the prescribing practioner to provide a written prescription to be presented
inactive license
license that is issued to a retired pharmacist which license does not authorize the retired pharmacist to practice pharmacy and on which the word inactive is printed or stamped Basically retired pharmacist who cannot practice and has inactive on the face of the license.
where can you supply the side effects statement?
new and refills sticker on the package, preprinted pharmacy cap, separate sheet of paper, medication information, FDA approved medication guide
how soon after discovering a sterile compounding violation do you need to tell the comission
next business day
what happens if telepharmacy technology goes down?
no produce can be dispensed unless the pharmacist can personally review the verify accuracy, can confirm the proper steps were taken
how soon after do you need to appeal the class
not more than 30 days after the notice of classification
exemption from prescription requirements
not necessary for drug contraining not more than 200mg of codeine per 100ml or 100 grams that also includes one or more nonnarcotic ingrediate
what must you do if you are getting a new computer system
notifiy the commission 30 days before getting it need to provide a hardcopy printout for 3 years prior to change over make these records available to a nearby pharmacy if the pharmacy is closing
how often does telepharmacy need to be reviewed?
once a year quality assurance evaulation must be available for review and inspection by department of consumer protection and public health
how are techs trained
one the job and related education manager retains- name of individual, date of training, description of topics covered, name of supervising person, signiture of that recieving training and pharmacist manager
Prescription record- controlled
patients name & address (animal species + owner name & address) prescriber name & address date RX issued + filled name of med/strength/QTY/directions/refills cautionary statements serial number RPh initials retail price of generic substitute Patient age OR adult/child DEA number Electronically or "wet" signature
What is the fine/punishment for someone who removes any tag or other appropriate marking affixed to an article which has been embargoed or condemned without the permission of the commissioner or his agent?
penalty of up to $500 for each offense
retired pharmacist
pharmacist who is at least 62 years old and no longer actively engaged in the practice of pharmacy
how can you reduce the amount of hours the pharmacy is open?
pharmacy manager files notice of reduction with department of consumer protection at least 30 days proir to change and posts a notice to the public 30 days priot to such reduction of hours
what should a equipment and supply should be in a nuclear pharmacy
radiation detection radiation shiedling quality assurance testing refridge materials for decontamination of accidental spills compounding and dispensing sterile products USP or remington the science and practice of pharmacy current rules and regulations of nuclear regulatory commiission or agreement state
what can technicians NOT do
recieve new rx verbally from practioner, consult, identification, evaulation or clarlification, consult with practioner, interpret clinical data, verify prescription, determine generically and therapeutically equivalent drugs
How many times a year does the Commission of pharmacy meet?
6 times/year
Side Effects Statement
"Call your doctor for medical advice about side effects. You may report effects to FDA at 1-800-FDA-1088"
Hair-dyes must have the following statement on it:
"Caution- This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness" ***Preliminary test meaning skin test first (the product should have directions for preliminary testing)
Business which is not a pharmacy is prohibited from using words, displays or symbols indicating it is a pharmacy: What are some prohibited advertising words? What is the punishment? Are there any exceptions?
"Drug store", "pharmacy", "apothecary", "Drug", "Drugs", "medicine shop" or any combination of such terms or symbols Fined up to $200 or imprisoned for 30 days or BOTH **Exception: This does not apply to any person that provides pharmacy-related services directly to pharmacies/practitioners and does not offer such services and drugs or medical services directly to the public.
What information should be given to department (department of consumer protections) when a pharmacist commences the practice of pharmacy or changes the pharmacist's place of employment? (4 things) What time period must this information be given in?
-Date of commencement -Name of Pharmacist's employer -Address of practice location -Type of practice Within 5 days
When recording a Quality assurance review what should be documented?
-Date of when the Quality assurance review occurred. -Names and title of person performing the review -Pertinent data relating to the prescription error -Documentation that the pt and prescriber was notified -Findings and Determinations generated -Recommended changes to pharmacy policy, procedure
What needs reported to PDMP for controlled substance?
-Dispenser ID number -Original Date, filled date & Rx Number -New or Refill, and # of refills authorized -Drug name & NDC number & QTY & Days supply -Patient name & address, DOB, gender -DEA number of prescriber -Type of payment (cash, insurance) -Patient's ID number
Storage of medication (for wholesalers)
1. All drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with USP/ National Formulary 2. If there are no specific storage requirements, the drug may be held at "controlled" room temperature. 3. Need documentation of proper temperature and humidity adherence
Pharmacies which have received approval from the commission to operate when the prescription department is closed (CVS, Walgreens etc) shall comply with the following requirements: **There are 3 requirements
1. All entrances to the Pharmacy must have one-half inch Block letters. 2. All Advertising for a specific pharmacy shall clearly state hours of operation of the prescription department. 3. Advertising should also state: "The services of a pharmacy may not be available at all times when stores are open"
Who can manufacturers and wholesalers sell any drugs to?
1. Another manufacturers or wholesalers 2. Hospitals 3. Institution with full-time pharmacist 4. Nursing home 5. Physician 6. Podiatrist 7. Dentist 8. Optometrist 9. Veterinarian 10. Licensed pharmacy 11. Store with permit to sell non-legend meds
Who can appeal decisions of commission of pharmacy?
1. Any person holding a license, permit or registration who has been disciplined by the commission 2.Anyone who has been refused a license, permit or registration, or refused a renewal of a license or permit
What particular areas/spaces should a radioactive pharmacy have?
1. Area to prepare and dispense radiopharmaceutical preparations 2. Area to ship and receive deliveries 3. Area for storage and radioactive waste decay areas
A pharmacy student must register as a pharmacy intern when?
1. At the time of commencing employment or service under supervision of a pharmacist. 2.After completing 2 years of college and is enrolled in a professional program at a school/college of pharmacy accredited by ACPE and approved by the commission or has graduated from an ACPE accredited school or if applicant graduated from foreign school must have passed a proficiency test for written and spoken English and a foreign pharmacy graduate equivalency examination.
What is considered an adulterated drug/device?
1. Consists wholly or partly filthy or putrid or decomposed substances 2. produced, prepared, packed or held under insanitary conditions. 3. If drug and its container is composed of any poisonous or deleterious substance which can be injurious to health 4. If it the drug bears/contains a coloring additive/food coloring which is unsafe or unauthorized 5. If drug has been stored kept or held in conditions contrary to the cautionary label statement on the package or contrary to recommendations within the official compendium (ex: Drug supposed to refrigerated but it is not) 6. If drug/device is not manufactured in accordance with good manufacturing practices as defined by the Federal Food and Drug Acts 7. If it represents itself as a known drug (official compendium) but differs in strength, quality or purity falls below the set standard. Even if it doesn't known drug, its strength, quality is not as it purports to be. Other reasons: -Does not meet cGMP standards or made in place that does not have cGMP standards -active ingredient is substituted or its strength decreased by mixing with another substance -OTC drug that is not packaged in tamper resistant container -If compounded does not meet PET standards -
A non-resident pharmacy shall be approved by the commission upon a few requirements:
1. Disclose annually in a report to the commission the location, name and titles of all principal corporate officers, if applicable, and all pharmacists who are dispensing drugs or devices to residents of this state. A nonresident pharmacy shall file additional report within 30 days after change in office, corporate officer or pharmacist. 2. Needs to submit a statement that it complies with the directions and requests for information from the licensing agency/regulatory from the state it is located in and comply with all requests made by commission of CT. 3. Maintain at all times a valid unexpired license, permit/registration and be compliant with the law. 4. Also needs to submit a copy of the most recent inspection report from the licensing agency of the state it is located in before receiving a certificate/registration from the department. 5. Must be open at least 6 days/week for a minimum of 40hrs/week 6. Must provide a Toll free number to facilitate communication between patients in this state and the nonresident pharmacy. This number must be affixed on the container of drugs dispensed to patients.
Anyone who is selling misbranded/adulterated products or disseminating them will be:
1. Injunction proceeding which is a permanent or temporary restraint 2. Imprisoned not more than 6 months or fined not more than $500 or both, if the violation happens after the conviction the person can be imprisoned 1 year or fined $1000 or both (this also applies to anyone who is fraud or misleading)
How should documentation of the fact that refill information entered into the computer each time a pharmacist refills an original RX order for non-controlled substance is correct must be provided by the pharmacist in what way?
1. He/she must provide a separate hardcopy printout of non-controlled substance prescription order refill data for each day. The pharmacist must verify that the data is correct and sign the document. The document must be saved for 3 years from the dispense date and should be able to retrieve when necessary. Although stored for 3 years it should be visually available for 6 months from the last recorded dispensing if computerized.
A drug is misbranded if:
1. If label does not have name, place or manufacturing/distribution 2. Fails to have accurate quantity 3.Fraudulent or exaggerated claims 4.Omission of pertinent info (ex: No "RX ONLY") 5.Inconspicuous printing: (ex: generic name is in the front and is in half the font size of the brand name-it should be equivalent) 6.The drug is recognized in the official compendium but does not conform to the compendium labeling (ex: missing statement to refrigerate this medication) 7. It is labeled as another drug 8. Drug is dangerous to use as its currently labeled 9. It does not contain an identifier as required under the Drug supply Safety Act *****A drug is not considered misbranded when repackaged by a pharmacy into stock packages for use within the pharmacy if properly labeled with: -drug name, strength, quantity, LOT #, Manufacturer and expiration (if any)
Misbranded cosmetics:
1. If labeling is false or misleading in any particular way. Any statement on the label of such cosmetic directly/indirectly implying endorsed or recommended by any federal/state agency is misleading (unless such agency has approved the statement prior to use) 2. It must have label of name/place of business of the manufacturer, packer or distributor, an accurate statement on quantity of contents in terms of weight and numerical count. 3. info or statements required must appear on label must be placed conspicuously and must be understood by the ordinary individual. 4. Its container must not be so made, formed or filled as to be misleading.
The commission may deny, revoke or suspend a certificate of registration as a nonresident pharmacy for conduct which causes serious bodily or psychological injury to a resident of CT if the commission has referred the matter to the licensing agency of the state where the non-resident pharmacy resides and the agency fails to:
1. Initiate an investigation in 45 days 2. Complete the investigation in 120 days of referral 3. Resolve the referral through formal agreement, settlement or decision in 180 days 4. Initiate disciplinary proceedings when the licensing agency of the non-resident pharmacy determines it is necessary.
When destroying controlled substances in hospital pharmacies what must be done?
1. It must be destroyed in a manner that would make it nonrecoverable 2. It must be done by a CT licensed pharmacist while another CT licensed pharmacist acts as a witness. 3. Need to maintain a separate record of each destruction indicating the: -date & time -manner of destruction -type, strength, form and quantity *It must also have the signatures of the pharmacist destroying and witnessing.
What are some requirements for prescriptions sent via fax?
1. It must contain the name of the pharmacy sent to and the facility it was sent from. 2. It must state: "This prescription is valid only if transmitted by means of a facsimile machine". 3. The document must be non-fading and durable (for at least 3 years). If the document is not non-fading /durable the document must be reduced to writing, photocopied or converted into an individual hard copy printout.
A licensed manufacturer or licensed wholesaler may sell hypodermic needles and syringes only to the following:
1. Licensed manufacturer, licensed wholesaler or licensed pharmacy 2. Physician, dentist, veterinarian, embalmer, podiatrist, scientific investigator licensed to practice 3. Person in charge of a care-giving institution (college or scientific institution which is care-giving) 4. Person in charge of a licensed or registered laboratory 5. Farmer only for use on farmer's animals or poultry 6. Business authorized to purchase hypodermic needles but only for legitimate industrial or medical use 7. Needle and syringe exchange program **Aside from the stated individuals/organizations stated above, everyone else must have a prescription from a practitioner if buying more than 10 needles/syringes
Hypodermic needles and syringes in a quantity of ten or less without a prescription may be provided or sold at retail only by the following:
1. Licensed pharmacy only by a licensed pharmacist or under his direct supervision. 2. By a needle exchange program established by a health care facility or licensed health care practitioner.
Prohibited acts:
1. Misbranding or adulteration of any food , drug, device or cosmetic 2. Sale of any misbranded of adulterated product 3. The receipt in interstate commerce of any of adulterated/misbranded product, and the sale thereof in such commerce for pay or otherwise 4. The introduction or delivery for introduction into interstate commerce of any: violated food, new drug 5. Dissemination within the state of CT in any manner or by any means or through any medium of any false advertisement 6. The refusal to permit entry and the taking of a sample or specimen or the making of an investigation. 7. Forging, counterfeiting, simulating or falsely representing or without proper authority, using any mark, stamp, tag, label or other identification device authorized or required by regulations 8. The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of a food, drug device or cosmetic or the labeling of the product or the doing of any other act with respect to the product is a violation ***Basically anything unauthorized to the label is considered a violation, adulteration, misbranding
If a pharmacy decided to discontinue a system what must be done?
1. Notify the commission 30 days prior to discontinuing the system. 2. Make hard copies up to 3 years available 3. Make records to be available to a nearby pharmacy.
Written policies and procedures of wholesalers:
1. Oldest approved stock of a drug product is distributed first 2. Must have procedure for handling recalls and withdrawals of drugs requested by US FDA or other federal/state agencies. 3. Must have procedure to ensure wholesale is prepared for and is able to handle any crisis that affects security or operation of any facility (Strike, fire, flood, natural disasters) 4. Procedure to ensure that outdated drugs shall be segregated from other drugs and returned to manufacturer or destroyed (documentation of either should be kept for 3 years). 5. In the case wholesalers are also pharmacies, these procedures apply to the legend drugs available.
When substituting a medication what two things should be written on the prescription by the pharmacist (including oral/electronically transmitted) ?
1. On the FACE of the prescription write the brand name of substituting drug. If no brand name, write generic. 2. Also on the FACE of the script record the retail price of the drug substitution.
What characterizes "physician-patient relationship"?
1. Patient makes a medical complaint 2. Patient provides medical history 3. Patient receives physical examination 4. logical connection existing between the medical complaint, the medical history, the physical examination and any drug prescribed for the patient.
The commissioner of consumer protections in consultation with the department of public health will set regulations for pharmacist to follow for vaccine administration:
1. Pharmacist can immunize after successfully completing an immunization training program 2. Basic requirements of training including pre-administration education and screening, vaccine storage/handling, SUBQ vaccines, Record keeping, vaccine safety, resuscitation, basic cardiac life support and ADR event. 3. Identify qualifying training programs, which are accredited by the CDC, ACPE or other national accrediting body. 4. Establish system of control and reporting
Department of consumer protection shall, upon authorization issue a temporary permit to an individual:
1. Practices under the direct supervision of a licensed pharmacist 2. Has application for reciprocity on file with the commission 3. Is a licensed pharmacist in good standing in a state or jurisdiction from which such state's pharmacy board or commission of pharmacy grants similar reciprocal privileges to pharmacists licensed in this state. (meaning a pharmacist moving to another state will provide similar privileges to pharmacists coming from CT). 4. Has no actions pending against such individual's license with any state's pharmacy board or commission of pharmacy.
Non-controlled drug maybe transferred orally or electronically between pharmacies provided:
1. Practitioner has authorized prescription to be refilled 2. Pharmacist transferring the prescription cancels the original and records: name of pharmacy transferred and date 3. Receiving pharmacies shall write transfer on the prescription, name pharmacy and pharmacist transferring, Date of issuance, Original prescription number, Date original prescription was first dispensed, number of refills authorized by the original prescription and the complete refill record for the prescription as the date of the transfer, the number of valid refills remaining as of the date of the transfer. P.S- more information should be recorded between both pharmacies (it is discussed in earlier slides).
What are some effective controls against diversion?
1. Prescribing, dispensing or administering of controlled substances only after a proper medical evaluation 2. Maintaining a controlled substance record keeping and security requirements 3. Adequate security of prescription blanks to prevent theft 4. Regular monitoring of patients with conditions who are using controlled substances for a prolonged period of time. 5. Refraining from knowingly prescribing controlled substances for persons abusing or using it for dependency. 6.Compliance with all state and federal statues and regulations concerning controlled substances.
No place of business maybe operated as a pharmacy unless a pharmacy license has been issued for the place and unless it is under the direct supervision of a pharmacist EXCEPT that the commissioner, shall adopt regulations, when a pharmacy may remain open for business when a pharmacist not present and directly supervising:
1. Prescription department must be closed and properly secured when pharmacist is not present. 2. The prescription department will keep minimum number of hours of operation (35hrs/week) 3. Meet all security requirements of the prescription department (alarms, walls etc.) 4.Physical security of all legend drugs (safe, vault, locked cabinet, alarms etc) 5. Has an actual prescription department as defined
Prescriptions for CIII, CIV, CV controlled substances can be transmitted by a prescribing practitioner or his agent to a pharmacy by means of a fax machine if:
1. The fax prescription is clearly containing the name of the pharmacy to which the fax is being transmitted and the name of the facility from which it is transmitted and if the prescription is written for an inpatient of a chronic or convalescent nursing home or a rest home with nursing supervision. 2. It must state: "This prescription is valid only if transmitted by means of a fax machine". 3.The Fax prescription can only be an actual script if maintained as an actual prescription only if it will remain non-fading and durable for a minimum amount of time for record keeping. ****If the document will not remain non-fading or durable, the prescription transmitted by fax machine shall be reduced to writing, photocopied or converted to an individual printout.
When counseling what information is discussed?
1. The name and description of the drug 2. dosage form, dosage route of administration and duration of drug therapy 3. special directions and precautions for preparation and administration 4. Common side effects and interactions 5. technique for self-monitoring drug therapy 6. proper storage 7. prescription refill info 8. what to do if missed dose.
A pharmacist in a hospital pharmacy or nursing home pharmacy may relabel and dispense to a registered inpatient, parental medication, except controlled substances, dispensed for another registered patient if the following criteria are met:
1. The original medication order is discontinued 2. The medication is in an unopened tamper-evident package 3. Medication is not expired 4.Original patient is not charged for the medication 5. upon receipt of the medication by the facility from the licensed pharmacy, it is processed through the hospital's pharmacy or nursing home pharmacy,
What must be done when there is change in ownership of the pharmacy or change in the name of the pharmacy?
1. The person whom a pharmacy license has been issued shall immediately notify the commission of a change in ownership of the pharmacy and a change in name of the pharmacy. **Notice will be accompanied with filing fee. ***Anyone who does not notify the commission of these changes will be required to pay a late fee.
What are a few criteria that should be met for store/business that contains a pharmacy (so not the whole premise of the business is devoted to sale of medicine)? **7 criteria's Hint: Imagine CVS/Walgreens
1. The pharmacy itself will be separated and partitioned (approved by commission) to prevent public from having unauthorized or illegal access to drugs/medical devices. 2. It should be made in a way that it is completely locked/closed when pharmacist is not present 3.The Hours of operation of the pharmacy should be displayed at entrance of store/business. 4. Access should be available to authorized pharmacist 24hrs daily. 5. There should be exterior and interior signs indicating where and what is the pharmacy. 6. There should be a door admitting public directly into the pharmacy from outside the building. 7. If there is no direct door admitting public directly the pharmacy shall be located in an area which is approved by the commission and which provides for convenience and ease of access to patients.
What two factors (or more) does the commission take into considering when licensing a pharmacy in regards to the entire premise?
1. The primary nature of the business and the type of products sold, especially the relationship of the products sold to the practice of pharmacy 2. The percentage of the floor space of the business devoted to the sale of drugs, medical devices and other health related products.
In order for Hospitals to accurately reflect the manner in which electronic drug records are currently maintained at the hospital, what must be done?
1. The types of drug records maintained on the electronic system. 2. Hospital's patient population and physical location 3. The specific types of electronic identifiers which shall be unique to an individual and shall be controlled in a secure manner. 4. The manner in which the access to the electronic drug record system is controlled (General level of access into the system, the mechanism by which hospital identifies all individuals who accessed the system, user's level of access) 5. The method by which individual electronic identifiers allowing access to the system are issued, maintained and terminated which should include a specific group/individual responsible for maintaining or terminating electronic identifiers, the procedure to maintain/terminate, the method of establishing uniqueness and security of the identifiers. 6. The recover procedure of data reconstruction if system experiences downtime 7.Procedure for backup data storage if there is destruction of electronic drug records 8. Method to detect and prevent unauthorized user/alterations of the data. 9. How is the data being kept confidential
In a Nuclear pharmacy these 2 references/rules should be kept: (possible 3 references)
1. USP National Formulary and/or 2. Remington: The science and practice of Pharmacy 3. Rules/Regulation of Nuclear Regulatory Commission or agreement state
Examination of materials (for wholesalers) To make sure there is no delivery of drugs that have been damaged in storage or held under improper conditions a few things must be done:
1. Upon receipt each outside shipping container shall be visibly examined for identity and to prevent the acceptance of contaminated drugs or drugs that are otherwise unfit for distribution. 2. Each outgoing shipment shall be carefully inspected for identity of the drug products and to ensure that there is no delivery of drugs that have been damaged ***Drugs that are outdated, opened, damaged, misbranded or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Even if the medication casts doubt on the integrity of the medication, it must be either examined or otherwise destroyed/returned.
Who is considered a Nuclear Pharmacy technician?
1. Works directly under the supervision of a nuclear pharmacist 2. Currently registered as a pharmacy technician 3. Must have successfully completed a nuclear pharmacy tech training program by an accredited college program or equivalent company sponsored program approved by the commission 4.Must be listed as an "Authorized user of Radioactive material" on the nuclear pharmacy's US Nuclear Regulatory commission or agreement state license.
A pharmacist or pharmacy may provide pharmacy records to the following people:
1. patient 2. practitioner, pharmacist or another practitioner currently treating the patient 3. Practitioner's agent 4. Third party payors 5. Any governmental agency with statutory authority to review or obtain information. 6. Any individual, state or government agency with a subpoena. 7. Any individual, corporation or partnership that has written legal agreement to access pharmacy's database provided the info accessed does not identify specifically the individuals/patients.
Information received by the department through filed reports or inspection shall not be disclosed publicly in such a manner as to identify the individuals or institutions except:
1. proceeding involving the question of licensure or the right to practice 2. Proceeding where the commission has voted in favor of formal disciplinary action against pharmacist/pharmacy licensed, when such disciplinary action is related to an error in the dispensing of medication. **Nothing under this law prohibits the commissioner from disclosing information gained through the inspection of pharmacies and outlets holding permits for the sale of non-legend drugs if the commissioner considers such disclosure to be in the interest of public health. Now in spite of non-disclosure, the commissioners Consumer Protections and Public Health (and authorized agents) can: 1. Exchange information relating to a license or registration issued by their representative agencies OR 2. Exchange investigative information relating to violations with each other, with Chief State's Attorney and with agencies charged with the enforcement.
What security requirements need to be implemented for Electronic data intermediaries? What security measures need to exist to keep information confidential?
1. select and execute security measures 2. Physical safeguard from intrusion 3. Protect and control confidential patient information 4.Prevent unauthorized access to data when transmitted over communication networks or when data physically moves from one location to another using media (ex: CD, removable drives etc) 5. authenticate the sender's authority and credentials to transmit prescription 1. Encryption technology 2. Control on employee access 3. Protect from unauthorized users 4.Permanent deletion of patient information (when deleted)
When developing collaborative practice protocol what needs to be established?
1. specific drug or drugs to be managed by pharmacists 2. the terms and conditions under which drug therapy maybe implemented, modified or discontinued 3. Conditions and events upon which the pharmacist is required to notify the physician 4. lab tests that maybe ordered (so limited) ***All activities performed by the pharmacist in conjunction with the protocol shall be documented in the patient's medical records.
CIII and CIV can only be valid for how many months?
6 months and it cant be refilled more than 5 times *CII can't be refilled at all.
When obtaining information from a medicaid patient, data about drugs and devices dispensed in the last __________ days are needed.
180 days
how many days after the a new drug application will it become effective
180 days - give a hearing to see if the drug is safe and effective
Fee for pharmacist license exam
190
fee for pharmcy license renewal
190
Any person who manufactures, distributes, sells prescribes, compounds, transports with intent to sell, dispense, possesses, offers, administers substance which is a hallucinogenic substance other than marijuana, or a narcotic substance, except as authorized will be:
1st offense- prison 15 years and/or fine $50,000 2nd offense- " 30 years and/or fine $100,000 subsequent- "30 years and/or fine $250,000
Of the members in the Commission how many must be working full time in retail and how many must be working as pharmacists in hospital?
2 in retail(chain, independent) and 1 in hospital
if a pharmacy supplies sterile compound to a practioner's office, how many days supply can they supply
2 weeks
If you have 2 years in which your license lapsed, how many CE do you need?
2 years worth- 30 in the two year period prior to the year of application for renewal **A pharmacist submitting an application for renewal of a license to practice pharmacy, whose license has lapsed and who has not held a license authorized by the commission and issued by the department for more than two years shall submit a statement signed under the penalty of false statement that the pharmacist has satisfactorily completed the requirements (15 CE/year) prior to the year of the application for renewal. So it is required that each pharmacist do 15 CE per year before renewing pharmacist license every other year.
On what days is data of all dispensed controlled medications transmitted to the DCP? What if the transmission day falls on a holiday?
20th day of the month (for prescriptions dispensed between 1st and 15th of that month) and on the 5th of the following month for prescriptions dispensed between the 16th and last day of the month. If it falls on a holiday, the pharmacy shall transmit the information the next workday (according to the State of CT)
Seizing products in violation If the commissioner or his authorized agent find or has probable cause to believe that a product in violation, (food,drug, cosmetic) is offered for sale or intent for sale, whether it is in the hands of common carrier or any other person, the commissioner may affix to such product/article an appropriate marking and shall be embargoed (seizure/ban). Within __________ days after an embargo has been placed on any article/product it shall be removed by the commissioner or a summary proceeding for the confiscation of the article shall be instituted by the commissioner.
21 days ***No person shall remove or dispose of such embargoed article by sale or otherwise without the permission from the court. If the embargo is removed by the commissioner or the court, neither the commissioner nor the state shall be held liable for damages because of such embargo if the court find that there was probably cause for the embargo.
Wholesalers shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records include the source of the drugs, including the name and principal address of the seller, address from where it was shipped, identity and quantity of the drug received, distributed or disposed of and the dates of receipt and distribution. ***If wholesaler is also a pharmacy no records shall be required to be maintained for the receipt or distribution of OTC drugs. Wholesalers must keep records on site or electronically available for_____ years at inspection site. If not at inspection site it must be made available within __________days.
3 years, 2 days.
Any computerized system shall have the capability of producing a printout of any refill data, for a _________ year period following the last date the medication was __________. The printout shall be produced within ___________ hours upon request and shall include the following:
3, dispensed, 48 Name of physician & patient, Name of medication, Dosage form, Strength, quantity
at what point has a manager ceased to be the manager
42 consecutive days immedialy enroll the name of the new manager ceased manager must also notify the commission
Applications for license or permits shall be submitted to the department at least ______ days prior to date on which the examination.
45
How long does a pharmacy have to provide the commissioner with refill by refill audit trail data?
48 hours
how soon after a request is made for a print out of refill data does it need to be provided
48 hours
how soon after requesting an error report do you need to give it to the commission
48 hours
Of the members in the Commission how many must be full time pharmacists?
5 ***The other 2 people shall be public members
It is the responsibility of a registrant who ceases to practice or who goes out of business to notify the Commissioner in writing __________ days before such occurrence.
5 days
how soon after sterile recertification do you need to tell the comission
5 days
A pharmacy intern has how many days to notify commission of certain changes in the internship training? What are some changes that the commission should be notified about?
5 days Change in preceptor, Commencement, cessation of supervision, Change in place, Change in hours of supervision
If a patient requires medication to be initiated immediately and the services of a licensed pharmacy are not available within ________ mile radius of a hospital emergency room, a person associated with such hospital authorized to dispense medication can dispense up to ________ supply of medication excluding _________. Who authorizes this order?
5 miles, 24hr supply, control medications licensed practitioner
contact hours
50-60 minutes of participation in CE (60 mins really) **so essentially 500-600 contact hours will make up 1 CEU (which is 10 contact hours)
how long does an online system need to be able to retriave a non controlled rx
6 months
Records or info collected or maintained of collaborative practice must be kept for _________ (from the date it was created).
6 months **This data collected shall not be subject to subpoena or introduced into evidence in any judicial proceeding except as otherwise specifically provided by law.
When an emergency controlled medication is called in, how long does the practitioner have to send the written/signed prescription to the pharmacist? What if it is not sent within that time period?
72 hrs if CII (federal law says post marked within 7 days) If it is not received, the pharmacist must notify the DEA/ CT Drug Control Note: The qty dispensed should be the amount needed during the emergency period
Issuance fee for "pharmacy" license
750
fee for change in name, ownership or management of pharmacy
90 $50 additionally if it is 10 days late
If there is theft/burglary in a pharmacy how long does the pharmacy have to set up extra safeguard including approved vault, approved safe, separate locked cage area, locked room or enclosure, locked wood cabinet?
90 days ***180 days if a hospital pharmacy
In licensed hospitals, mental health hospitals, metal retardation facilities, training schools, correctional institutions, juvenile training/youth services, educational institutions, health maintenance organizations, hospital drug rooms, hospital satellite pharmacies and hospital clinical laboratories, how should CII/CIII be stored? How about CIV and CV?
<150 U CII/ CIII should be stored in constructed locked metal and wood cabinet 150-999U CII/CIII shall be stored in safe 1000 or more Units of CII/CIII shall be stored in a completely enclosed masonry room or equivalent equipped with a vault-type steel door with horizontal or vertical locking bolts, having a 3 tumbler combination lock and relocking device. If this room is frequently opened, it must be equipped with a day gate which is self-closing/locking or the vault type steel door must be equipped with a key locking device or equivalent. The room must be equipped with an electrical alarm system which will transmit signal directly to central station protection company of unauthorized entry. CIV and CV should be stored in a secure location within the pharmacy prescription compounding area or drug room. In a hospital clinical laboratory CIV and CV shall be kept in a separate secured locked location.
Counterfeit substance:
A controlled substance which or the container or labeling which, without authorization bears the trademark, trade name or other identifying mark, imprint, number or device or any likeliness thereof, of a manufacturer, distributor or dispenser other than the person who in fact manufactured, distributed or dispensed the substance.
Legend device/Legend drug: **must have what written when dispensed
A. "RX ONLY" IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC ACT B: "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN"
Drugs:
A. An article recognized in the official USP, official Homeopathic pharmacopeia of the US or official National Formulary, or any supplement to any of them B. An article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals C. An article, other than food, intended to affect the structure or any function of the body of humans or any other animal D. An article intended for use as a component of any article specified in this subdivision, but does not include a device.
New drug:
A. Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the condition prescribed, recommend or suggested in its labeling
Natural food
A. Food which has not been treated with preservatives, antibiotics, synthetic additives, artificial flavoring or coloring. B. Which has not been processed in a manner that make such food significantly less nutritive. Processing of food by extracting purifying, heating, fermenting, concentrating, dehydrating, cooling or freezing shall not, of itself, prevent the designation of such food as "natural food".
When dispensing prescriptions for medicaid recipients, the pharmacist or designee of the pharmacist shall make reasonable effort to obtain, record and maintain information regarding this patient: What information is needed?
A. Name, address, telephone #, DOB, Age, Gender B. Individual history including disease states, allergies, drug reactions C. Comprehensive list of drugs and devices dispensed by the pharmacy within the last 180 days D. Pharmacist's comments relevant to individual's drug therapy
A pharmacy technician must be under "direct supervision" of a supervising pharmacist. What does "direct supervision" in this context mean?
A. Pharmacist must be present in the area or location where the pharmacy tech is performing routine drug dispensing functions. B. Conducts in-process and final checks on the pharmacy tech performance.
No electronic data intermediary shall operate without the approval of the Commissioner of Consumer protections. They must apply and will be approved on the basis:
A. Provide procedures to be sued for transmission and retention of prescription data B. Provide mechanisms to be used by a intermediary to safeguard the confidentiality of such data.
Mobile medication carts shall be substantial construction and shall incorporate the following features:
A. Separate, lockable, non-removable drawer or compartment for storage of all controlled substances B. The key which locks the controlled substance drawer or compartment shall be different from keys to all other locking devices on each cart. Keys shall not be interchangeable between carts. Controlled substances should have its own drawer on the cart. C. Locking mechanisms which will secure the entire contents of the cart without requiring the use of a key ***All controlled substance medications shall be inventoried when received and immediately placed into the controlled substance drawer or compartment within the mobile cart. Quantities of patients'-controlled substance meds stored within the mobile cart shall be limited to the minimum quantities necessary to provide for normal efficient operation and shall be promptly removed for proper disposition when no longer needed by the patient.
Which of the following signs is appropriate for a business to indicate the location of the pharmacy in the premise? A. Apothecary B. Drug store C. Pharmacy D. Medical shop
ABC (all of those are appropriate)
Pharmacy technicians are not allowed to do which of the following: A. Receive new prescription orders verbally from a prescribing practitioner or the practitioner's agent B. Get authorization for Refills C. Perform any identification, evaluation, interpretation or needed clarification of a prescription. D. Interpret the clinical data in a patient medication record system E. Fill medications from the Safe
ACD Techs are not allowed to do (8 things) 1. Receive new scripts verbally from a prescribing practitioner or agent 2. consult with a patient or the patient's agent regarding medication or regarding medical info in patient's records 3. identify, evaluate or interpret or needed clarification of a prescription 4. consult with prescribing practitioner any medical info pertaining to the patient's prescription 5. Interpret clinical data 6. perform professional consultation with prescriber, nurses or other healthcare professional 7. verify RX prior to its release for patient use 8. Determine generically and therapeutically equivalent drug products to be substituted for brand name drug products.
A collaborative drug therapy management agreement may authorize a pharmacist to: A. Implement drug therapy B. Change Diagnosis C. Modify the drug therapy D. Administer drugs E. Order associated lab tests
ACDE A collaborative drug therapy management agreement may authorize a pharmacist to implement, modify or discontinue a drug therapy that has bee prescribed for a patient, order associated labs and administer drugs all in accordance with patient-specific written protocol.
What are volatile Substances: Designated as controlled substances that said chemical substances or compounds containing chemical substances that when breathed, inhaled, sniffed or drunk can induce a stimulant, depressant or hallucinogenic effect to CNS: To the extent that those who have inhaled, consumed, etc or under the influence of these substances shall be deemed to be psychologically dependent on the substance. ***Medical treatment rather than criminal sanction shall be afforded to individuals who breathe, sniff, drink these substances. Any other illicit use of these substances are illegal.
Acetone, Toluol, tricholoroethylene, isopropanol, methanol, ether, methyl, cellosolve acetate, toluene, hexane, butyl alchol, benzene, methyl ethyl ketone, cyclohexanone, pentochlorophenol, ethyl acetate, methyl isobutyl ketone, trichloroethane and dichlorodifluroromethane
What needs to be given for a pharmacy license?
Applicant/owner- name and address Pharmacy- name, address Pharmacist manager- name, address & license number
A pharmacist must offer counseling unless the patient denies it or inability of the patient to accept counseling or refusal by the patient to give information. This information should be documented and kept on record for how long?
At least 3 years
How long shall pharmacies keep all written prescriptions and the record of oral and electronically-transmitted prescriptions in numerical order in suitable file for?
At least 3 years
How often must a pharmacist report to a physician regarding the patient's drug therapy management?
At least every 30 days.
When should an applicant (in this case practitioners renewing registration) renew his/her registration to the Commissioner?
At least one month prior to the expiration of his/her current registration. **All practitioners, hospitals, clinics or other authorized persons or facilities wishing to prescribe, administer or dispense controlled substances shall obtain a certificate of registration issue by the commissioner of consumer protection. No controlled substances shall be prescribed, administered or dispensed until such regulation has been approved by the commissioner.
Who will have access to controlled medications that are stored in a secure safe place?
Authorization should be given by registrants only to the minimum number of employees absolutely essential for efficient operation.
Opium controlled product classes
Belladonna/opium- C2 Tincture of opium- C2 (25 times more potent than Paregoric) Opium combination (Paregoric)- C3 Opium combination (Parepectolin)- CV
Schedule I drugs: High abuse potential and NO currently accepted medical uses. Also lacks accepted safety for use under medical supervision:
Benzethidine, Heroin, GHB, Lysergic Acid, LSD, Ecstasy (MDMA), psilocybin
C4 products
Benzos, tramadol, propoxyphene, butorphanol, petazocine (Talwin), Ambien, phentermine
Biennial vs Biannual?
Biennial- every other year Biannual- twice a year
Example of Drug Paraphernalia:
Bong, spoons, masks, pipes, metal bowls, cigarettes, wrappers, vials, chillers, kits Any equipment, product and materials of any kind which is used or designed for planting, propagating, cultivating, growing, harvesting, manufacturing, compounding, converting, producing, processing, preparing, testing, analyzing, packaging, repackaging, storing, containing or concealing or ingesting inhaling or otherwise introducing into the human body any controlled substance
A pharmacy shall be open at least _________ hours per week, except as otherwise authorized in regulations concerning classes of pharmacies. A. 20 B. 60 C. 35 D. 45
C. 35 hrs/week
Lyrica and Lomotil CV RX requirements
C5 does not expire (C3-C4 expires in 6 months)
In Laboratories (other than hospital clinical laboratories) how many CI/CII U can be stored?
CI and CII controlled substance stock shall be stored in approved safe except where CII stock of the barbiturate type is used solely for its sedative or anesthetic effect on animals and not more than 10 controlled substance units are stocked.
In the case of practitioners (including medical doctors, dentists, veterinarians, osteopaths and podiatrists) how should CII and CIII medications be stored?
CII and CIII meds, up to 15 U shall be stored in a locked cabinet in a securely safeguard location. **If over 15 U then must be stored in an approved safe.
DATA Waived pracitioners
Check with SAMHSA to verify prescriber is DATA-waived since they won't have an X DEA number. May tx 30, 100, 275 pts at one time Center for Substance Abuse Tx (CSAT)- they provider waiver.... file a notice of intent (NOI) with no training Must give med guide with buprenorphine
Records of interstate shipment:
Carrier engaged in interstate commerce, and persons receiving food, drugs, devices or cosmetics in interstate commerce or hold such articles so received, shall, upon the request of an authorized representatives of the commissioner, permit such representative, at reasonable time, to have access to an to copy all records showing the movement in interstate commerce of any food, drug, device or cosmetic.
Non-resident pharmacy may not advertise its services in CT unless it has a _________ Can a Resident of CT advertise a non-resident pharmacy?
Certificate or registration from DCP NO
If you grow marijuana what level misdemeanor is this? What if you sell (intent to deliver or manufacture with intent to deliver) marijuana?
Class C misdemeanor Class A misdemeanor **Possession of marijuana for what ever intent (store, grow, use) ***Any person who violates (meaning grows or sells) or is within 1500 feet of real property comprising of public or private elementary or secondary school and who is not enrolled as a student in such school shall be imprisoned for a term of 1 year in addition to the misdemeanors stated above.
Electronic data intermediary shall file application for approval of its system with the ____________on a form prescribed by the department. The form shall contain the following information: What shall the request contain?
Commission Shall contain: 1. Name and address of the applicant 2. Business status of the applicant (sole, partnership, corporation etc.) 3. description of type of electronic data system to use including security safeguard, how it will safeguard patient info, retention and retrieval capabilities of the system. *The commission may also ask for a protocol that describes in detail the applicant's intended plan of operation.
Within what time period should ___________(DCP/Commission) be notified if a pharmacist or registered pharmacy technician's name or address has been changed?
Commission, Within 5 days
Who issues the registration of Manufacturer and wholesaler? Any exceptions?
Commissioner NO wholesaler or manufacturer shall operate as such until he has received a certificate of registration issue by the commissioner, which certificate shall be renewed annually Exceptions: 1. Manufacturer located outside the state of CT 2. Registered with the FDA as manufacturer who files with the commissioner.
What can the commissioner make public?
Commissioner from time to time may publish reports summarizing all judgments, decrees and court orders and disseminate information regarding food, drugs, cosmetics etc as he/she deems necessary in the interest of public health and protection of the consumer against fraud.
Who determines requirements for minimum security and safeguard standards for storage and handling of controlled substances for each registrant?
Commissioner of Consumer Protection
The purchase, possession, control and use of hypodermic needles and syringes need to be authorized by the ____________ following a written statement (has 5 clauses):
Commissioner of Consumer Protections, it will be under the commissioners discretion whether the business meets the following requirements. 1. The business needs the needles for operation/business 2.No alternative device/tool can be used in place of hypodermic needles 3. Can only have a certain quantity of these needles 4. These needles should be safeguarded and must have an inventory control system. 5. Access to these needles are limited to only those employees who have a legitimate need to handle these devices in the normal course of business.
How shall the commission bring about proceedings for embargoed products?
Commissioner shall bring a complaint to the supreme court. The complaint shall include: 1. Description of the article/product embargoed 2. Name of the place the product is located 3. Name of the person who is in possession or in custody of 4. Statement as to the manner in which the article is adulterated or misbranded or the characteristics which rendered its distribution or sale illegal. ***Upon the filing of the verified complaint, the court shall issue a warrant directed to the proper officer to seize and take in his possession the article in the warrant and summon the person named in the warrant. ***The hearing upon the complaint shall be at the time and place specified in the warrant, which time shall not be less than 5 days or more than 15 days.
What will happen if commissioner or agent of commissioner finds meat, seafood, poultry, vegetable or food in unsound or contains any filthy, decomposed or putrid substance that maybe poisonous or deleterious to health?
Commissioner shall condemn or destroy the same or in any other manner render the same unsalable as human food. **Don't keep dirty gross food in the pharmacy or working area
How often shall commissioner inspect each retail pharmacy?
Commissioner shall inspect each retail pharmacy at least once in 4 years.
If a violation is found during an inspection what happens?
Commissioner will notify the owner of factory, warehouse or establishment who has the right to a hearing which will be mailed to him within 15 days of the original inspection. The owner can contest to the violation and proceed with the hearing, requesting the hearing in writing 15 days from the date of receipt of the notice. The cost of all reinspection necessary to determine compliance with any such provision shall be $40/hr and shall be charged to the owner, except if the first reinspection following the original indicates compliance with the provision, no charge shall be made. However if in reinspection violation is seen, the commissioner may suspend or revoke the license of such establishment after hearing and notice is conducted.
Needles after use should be: A. Resheathed B. Broken/Bent C. Removed from the syringe D. Thrown as it is
D ***Although resheathing is not required, injectable equipment having self-contained secondary precautionary type sheathing devices may be utilized in accordance with its manufacturer's directions, and resheathing may occur when technical procedure involved request resheathing as part of that procedure. So some needles maybe manufactured that way.
What to do with theft/loss of pseudophedrine?
DEA Form 107 within 15 days
What order form is used to get CII medications?
DEA Form 222
Electronic data intermediary:
Entity that provides the infrastructure that connects the computer system or other electronic devices utilized by prescribing practitioners with those used by pharmacies in order to facilitate the secure transmission of electronic prescription orders, refill authorization requests, communications and other patient care information.
Epilepsy Seizures
Epilepsy- neurological condition characterized by recurrent seizures Seizures- Disturbance in the electrical activity of the brain
Generic name:
Established name designated in the official USP National Formulary, official Homeopathic pharmacopeia of the US or official US Adopted Names.
How often does a Pharmacy license expire?
Every year **Pharmacist license expires every 2 years.
When practitioners renew their registration they must include their title of profession practice (MD, Dentist, Osteopath or podiatrist etc.)
Ex: Ph.D, Director, Director of pharmacy, Administrator, President, Manager
Class IV: Relative to CIII low abuse potential that may lead to limited physical/psychological dependence. Has current accepted medical use:
Examples: Narcotics: Propoxyphene (Darvon, Darvocet), butorphanol (Stadol) and pentazocine (Talwin- NX) Benzodiazepines: Alprazolam (Xanax), Clonazepam (Klonopin), Clorazepate (Tranxene), Diazepam (Valium), Lorazepam (Ativan), Flurazepam (Dalmane), Halazepam (Paxipam), Midazolam (Versed), Orazepam (serax), Prazepam (verstran), Temazepam (Restroil), Triazolam (Halcion), Clobazam (ONFI), Estazolam (Prosom), Quazepam (Doral), Temazepam (Restoril), Tetrazepam, Zaleplon (Sonata), Zolpidem (Ambien), Eszopiclone (Lunesta) Carisoprodol (Soma) *muscle relaxant Stimulants: Cathine, Diethylpropion (Amfepramone), Mazindol, Modafinil, Pemoline (Cylert), Phentermine (Adipex, Fastin, Pro-fast, Suprenza, Lomaira), Pipradol Fenfluramine (Pondimin)- This is a dangerous drug that was once prescribed to patients in combination with Phentermine under the brand name Fen-Phen for weight loss but cause heart valve problems mainly due to the Fenfluramine. other: Barbital, phenobarbital (Luminal), chloral hydrate, ethchlorvynol (placidyl), Chlordiazepoxide (Librium), Ethinamate, meprobamate (Miltown, Mbtab), methohexital (Brevital), phentermine, diethylpropion, Pemoline (Cylert), Mazindol (Sanorex), Sibutramine (Meridia)
(T/F) CII- CV controlled substances in small quantities intended for emergency use only, may be stored within an emergency drug kit or on emergency crash carts equipped with disposable locking or sealing device.
False only CIII-CV can be put in emergency cart.
(T/F)Prescriber name is required on controlled medication labels but not on non-controlled medication labels
False! Prescriber name is required on both but prescriber address is only required on controlled medication labels.
(T/F) Only a Nuclear pharmacy shall receive a licensed to operate a Nuclear pharmacy.
False! A Nuclear Pharmacist or one who employs a nuclear pharmacist. **The license to operate a nuclear pharmacy shall be effective only if the pharmacy also holds appropriate federal and state licenses and permits to possess and distribute radioactive materials. Copies of all documents should be kept and be available to the commission when needed. **They should also maintain records of acquisition, inventory and disposition
(T/F) If a pharmacy wants to increase its hours it must notify the DCP 10 days in advance before doing so.
False! If increasing hours notice DCP within 5 days after such change.
(T/F) Only the patient can deposit original written prescriptions, prescription containers for refill, written request for Rx Refill into the drop box during hours when the pharmacy is closed.
False! Patient or his/her agent
(T/F) The meetings of the commission are private and recording or other personnel are not allowed.
False, The commission shall keep a record of its proceedings. Such record shall be made available to the public upon request and shall contain the name and licensed number of any pharmacy/pharmacist that the commission has recommended formal disciplinary action against. A copy of any such record, certified by the commissioner, shall be admitted as evidence in any civil or criminal action in lieu of the record.
(T/F) CEU earned in one calendar year can be carried forward into the next calendar year for the purpose of fulfilling the subsequent year's accredited continuing professional education requirements for license renewal. Ex: Doing 20 Contact hours 1st year, so the 2nd year have 5 contact hours already
False, It does not carry over. Just do the 15/year
(T/F)Can a pharmacy technician in a pharmacy or institutional pharmacy may dispense medication under the direct supervision of a pharmacist.
False, they may "Assist in dispensing"
(T/F)If a wholesale operates in more than one location it is necessary to be registered in all these locations.
False. If more than one location only need a single registration unless distribute controlled substances.
What to do if you are a pharmacy that wants to start doing sterile compounding?
File addendum to pharmacy license application to include sterile compounding DCP will inspect premises and pharmacy waits for approval
A Pharmacist who permits use of pharmacist certificate/temporary permit/ display document to be used by an unlicensed person for unlawful use shall be:
Fined $100 and subject to disciplinary proceedings
Any pharmacy that fails to furnish or keep records, statements or info will be:
Fined $500 on first offense and $1000 and/or 30 days of Prison for every violation of not keep records afterwards. ***If the person, agent, pharmacy etc is not keeping records on purpose it will be fined up to $1000 dollars and/or 2 years in prison. Subsequent violations on purpose will be $10,000 and/or 10 years in prison
What is the penalty for violation of Pharmacy Practice Act?
Fined no more than $5000 or imprisoned not more than 5 years or both. **Each instance of patient contact or consultation that is in violation of any provision shall be a separate offense **Failure to renew in a timely manner any license issued under said sections is not a violation for purposes of this section.
In general, special and long-term hospitals there shall be separate proof of use sheet for controlled drugs which are not dispensed or administered directly to patients from the hospital's pharmacy but are administered or dispensed from each ________.
Floor stock (technically it can also come from hospital pharmacies) ***so for these meds, require a separate proof of use sheet.
How are CIII- CV stock securely kept in manufacturer, wholesalers, distributors, importers/exporters vs in a Licensed pharmacy.
For manufacturers, wholesalers etc, should be kept in approved vault, safe w/ electrical alarm system, separate locked caged area. In licensed pharmacy should be stored in safe or substantially constructed locked metal/wood cabinet or dispensed throughout stock within the pharmacy prescription compounding area (this can only be done if no loss, theft or diversion has occurred in the pharmacy).
HIPPA:
Health Insurance Portability and Accountability Act
What act dictates that pharmacy is responsible to insure the confidentiality of information?
Health Insurance Portability and Accountability Act of 1996
what does a pharmacy intern get when providing the application and fee to the commission?
ID number and card shall be issued by the commission to the applicant.
Schedule ____ to ______ can be called over the phone
III- V ***In an emergency, a practitioner may call-in a prescription for a Schedule II controlled substance by telephone to the pharmacy, and the pharmacist may dispense the prescription provided that the quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. The prescribing practitioner must provide a written and signed prescription to the pharmacist within seven days(federal) 72 hours (CT). Further, the pharmacist must notify DEA if the prescription is not received.
Prescriptions for CII maybe transmitted by a prescribing practitioner or his agent to a pharmacy by means of a fax machine provided the original written, signed prescription is provided to the pharmacist for review prior to the actual dispensing of the controlled substance, EXCEPT:
If CII is to be compounded for paternal IV, IM, SQ or intraspinal infusion fax can be accepted as the original prescription. If in a LTC facility fax or hospitc can act as the original prescription
What if the commissioner finds the violations minor, what can he do instead of reporting to the State attorney?
If he/she finds the violation minor and fixable, he can send written notice or warning.
Adulterated cosmetics:
If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual; provided this provision shall not apply to coal-tar hair dye.
False advertisement of food, drugs, devices, and cosmetics
If it is misleading in any particular way and has any statement either directly or indirectly implying that the product is recommended or endorsed by any agency of the federal/state government (unless agency has approved the statement prior to use).
Can a long term care pharmacy have automated dispensing machine in a SNF?
If protocol is approved by DCP. No regulations for operating APDMs at this time.
What if during the hearing they find that the product/article is not in violation?
If the article seized is not injurious to health is properly packed, marked, branded or other wise brought into compliance, its sale would not be prohibited, the court may order the article delivered to the owner upon the payment of the costs of the proceedings and the execution and delivery to the state department.
In law jargon when they stay "Notwithstanding" what does that mean?
In spite of the fact of
What statement needs to be on pharmacy bag/receipt to be given to patient?
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#)
What must be done with controlled substances if a wholesaler, manufacturer or laboratory licensed by the commissioner of DCP has license revoked or suspended?
If you lose license and do not reapply within 30 days, need to surrender controlled substances to Commissioner of DCP.
Do patients in nursing homes, long care facilities or hospitals need to be counseled?
No
What is the tech to supervising pharmacist ratio in a community pharmacy?
In retail its 2:1 but can have 3:1 if one of the techs is certified. Pharmacist can refuse 3:1 but the refusal must be in writing from pharmacist to pharmacy manager.
What should be done during a (computerized) system down time?
In the event that a pharmacy experiences a computerized system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation refills of CIII- CV controlled substances. The auxiliary procedure must ensure that refills are authorized by the original prescription order and that all the appropriate data is retained for online data entry as soon as the computer system is available for use again.
What vaccines are provided by the pharmacist?
Influenza, Pneumococcal, Meningococcal, Herpes Zoster (shingles), Tetanus, Pertussis **Any vaccine included on CDC's Adult immunization schedule
who does DCP provide this collected prescription evaluation to?
Investigators/law enforcement agencies Civil/Criminal purposes Practitioners (educational purposes criminal/civil) Practitioners and Pharmacists for drug therapy monitoring and management. Public or private entities for statistical research or educational purposes (provided that the privacy/confidentiality of the patient info is not compromised).
Does hair dye include eyelash/eyebrow dye?
No
What is a Reagent kit?
It is a something used to perform one or more designated diagnostic tests or procedures. They maybe for laboratory or personal use. It must be a sterile and pyrogen-free reaction vial containing non-radioactive chemicals, including, but not limited to, complexing agent, reducing agent, stabilizer, or dispersing agent.
In a hospital unwated partial or individual doses of controlled substances are discarded by?
It is discarded by Nursing personnel, a record of each such destruction must be made indicating the date and time of each such destruction; the name, form, strength and quantity of Controlled Substance destroyed; the signature of the nurse destroying the Controlled Substance, and the signature of another nurse who witnesses such destruction. In other than hospital location, an authorized person may witness such destruction.
What is Quality assurance program and what is the purpose?
It is implemented to identify and prevent prescription errors by collecting data in response to a prescription error to assess the cause an any contributing factors such as system or process failure. Each pharmacy shall use the findings of its quality assurance program to develop pharmacy systems and workflow process designed to prevent prescription errors.
What is the schedule of Marijuana currently?
It is now CII in CT (it was previously CI) ***Federally it is CI though
When disposing undesired, excess, unauthorized, obsolete or deteriorated controlled substances who and how should it be destroyed?
It must be transferred to a person or firm registered under the Federal Controlled Substance Act and authorized to possess such controlled substances providing all state and federal required procedures are complied with. In hospital pharmacy must be done with 2 pharmacists If legally possessed by a person for his/her own personal use due to medical condition, destroy the substance in a way nonrecoverable. By a surrender of the controlled substance without compensation of the controlled substance to the Commissioner of DCP.
If a pharmacy closes temporarily or permanently what are done with the prescription records and what must be done?
It needs to make all its prescription records immediately available to a nearby pharmacy and post a notice of this availability on the window or door of the closed pharmacy. **This does not apply to a hospital pharmacy.
Prescription error:
Mean an act or omission of clinical significance relating to the dispensing of a drug that results in or may reasonably be expect to result in injury or death of a patient.
Where are appeals returnable for decisions by the commission to discipline a person licensed to practice pharmacy or registered as a pharmacy intern, tech or to refuse to register a person as pharmacy intern or tech shall be made returnable to: An appeal of a decision by the commission to discipline the holder of a pharmacy license or the holder of a permit to sell non-legend drugs or to refuse a persons's application for such a license or permit shall be made returnable to:
Judicial district in which the person resides, if the person does not reside in CT then in the district of New Britain. Judicial district in which the building person's or store is located, for which the license or permit was sought or in which it was suspended or revoked.
C5 products
Limited quantities of certain narcotics (antitussive, antidiarrheal and analgesic) Lyrica, Robitussin AC, diphenoxylate/atropine
This type of pharmacy, wherein legend drugs and legend devices are stored and dispensed to patients or residents of licensed nursing homes, rest homes, homes for the aged, or other supervised residential facilities and from which related pharmaceutical care services are provided.
Long-term care pharmacy (this includes pharmacies located both inside and outside of such facilities but does not include those that are part of licensed hospital).
What should be done with this information on past medical history and drug use?
MTM should be done. Prior to dispensing the pharmacist shall undertake a review of drugs in the last 180 days to check for: A. Duplication of therapy B. Contraindication with disease state C. Drug interaction with drug or allergy D. Clinical abuse or misuse **Such a review is based upon standards of American Hospital Formulary Service Drug Information, USP Drug information, American Medical Association Drug evaluation and the peer-reviewed medical literature.
Neglect and Abuse Reporting
Mandatory within 72 hours But if child then oral report needed within 12 hours and written report in 48 hours
An industrial, research or other professional experience program established by a school of pharmacy accredited by ACPE, how many maximum hours can an intern work in this subdivision for rotations?
Max 400 hours.
What if not DATA waived practitioner?
Max of 1 dose may be given up to 3 days while pending referral for a treatment program for maintenance detox (NTP or OTP)
Unit dose drug distribution system:
Means a drug distribution system used in a hospital or chronic and convalescent nursing home in which drugs are supplied in individually labeled unit of use packages, each patient's supply of drugs is exchanged between the hospital pharmacy and drug administration area or, in the case of a chronic and convalescent nursing home between a pharmacy and the drug administration area, at least once each twenty-four hours and each patient's medication supply for this period is stored within a patient-specific container, all of which is conducted under the direction of a pharmacist licensed in CT and in the case of a hospital, directly involved in the provision and supervision of pharmaceutical services at such hospital at least 35 hrs/wk
Dispensing:
Means acts of processing a drug for delivery or administration pursuant of a prescription: A. Comparing directions on the label with the directions on the prescription B. Selection of drug from stock to fill the prescription C. Counting, measuring, compounding or preparation of drug D. Placing drug in proper container E. Affixing the label on container F. Addition to a written prescription of any required notations.
What is Quality assurance procedure (in Nuclear pharmacy)?
Means all activities necessary to assure the quality of the process used to provide radiopharmaceutical services, including authentication of the product history, internal test assessment, and maintenance of all required records.
nonresident pharmacy:
Means any pharmacy located outside the state of CT which ships, mails or delivers, in any manner, legend devices or legend drugs into this state pursuant to a prescription order.
Abuse of drugs:
Means the use of controlled substances solely for their stimulant, depressant or hallucinogenic effect upon the higher functions of the CNS and not as a therapeutic agent prescribed in the course of medical treatment or in a program of research operated under the direction of a physician or pharmacologist.
Compound:
Means to combine, mix or put together two or more ingredients pursuant to a prescription and includes the preparation of drugs or devices in anticipation of prescriptions based on routine, regularly-observed prescribing patterns.
What is an appropriate description of a "safe" that can be used to keep controlled medications as per Regulations of CT state agencies?
Minimum of B Burglary Rate equipped with relocking device. It has to weight atleast 750 lbs and immobile by securely anchored to a permanent structure of the building. There should be adequate interior space to store all controlled substances kept within the safe.
If a pharmacist has never been a pharmacy manager (specifically in CT) previously what must be done before he can work as a pharmacy manager?
Must interview before the commission. ***If its difficult to schedule an interview before starting work as pharmacy manager, the pharmacist shall appear at the first commission meeting held after the date the pharmacist commences work as a manager.
New drugs
NO person shall sell, deliver, offer to sell any new drug unless application of new drug has been approved. Unless such drug has been tested and has been found to be safe for use and effective in use, there has been filed with the commissioner an application. It must have full reports of investigation which has been made to show whether or not such drug is safe and effective for use. It must have a full statement on the composition of the drug. It must have full description of the method used in and facilities and controls used for, the manufacture, processing and packing of the drug. ***This does not apply to drugs solely for investigation use by experts for scientific training and experience to investigate the safe/effectiveness of the drug. ***Also does not apply to drugs sold in the state at any time prior to the enactment of this chapter.
Is CSOS the same as ARCOS?
NO- ARCOS is the Automated Reports and Consolidated ordering system which manufacturers and distributors are required to use to record their annual inventories.
When applying for or renewing a pharmacy license what information is necessary on application?
Name and Address of the applicant and owner of the pharmacy Name and street and mailing address of the pharmacy Name, address and license number of the pharmacist who manages the pharmacy **Commissioner may ask for other information necessary for the department to carry out its duties.
When transferring a RX what must the transferring pharmacist do? Noncontrolled and controlled
Name of pharmacy and date of transfer Cancel original RX unless within chain pharmacy Controlled substance transfer -Write void on the FACE of paper RX or note if electronic RX -Pharmacy name, address and DEA # -Date of transfer -Receiving RPh's name and license number
What are the 3 ways a prescription can be transmitted to a pharmacy?
Oral, written, electronically
Schedule II drugs: High abuse potential, severe psychological/physical dependence. Although there are medically accepted uses of these medications:
Narcotics (opium, opiates, opioids)- morphine, codeine, hydrocodone (vicodin), opium extracts, hydromorphone (Dilaudid), Methadone (Dolophine), Meperidine (Demerol), Oxycodone (oxycontin) and Fentanyl (Sublimaze, Duragesic), Dextrorphan, Nalbuphine, Alfentanil (Alftenta), Hycodone, Levorphanol (Levo-Promoran), Remifentanil (Ultra), Sufentanil (Sufenta), Tpentadol (Nucynta) Stimulants: amphetamine (Dexedrine, Adderall), methamphetamine (Desoxyn) and methylphenidate (Ritalin, Daytrana, Concerta, Metadate, Methylin), Phenmetrazine, Lisdexamfetamine (Vyvanse) Other: cocaine, pentobarbital (Nembutal), Secobarbital (Seconal), Glutethimide (discontinued), Amobarbital (Amytal), Glutethimide, Nabilone (Cesamet) *****MARIJUANA is now CII
Can a pharmacist whose license is under suspension or revocation act as a pharmacy technician?
No
Can you relabel and dispense Controlled substances?
No
Who can sell non-legend drugs?
No legend drugs may be sold at retail except at a pharmacy or at a store that has obtained from the commission a permit to sell non-legend drugs.
Illegal obtaining or supplying of drugs. Forged label
No person shall obtain, produce, administer, manufacture, possess or falsely assume the title of a authorized individual to obtain an illegal/misbranded medication. No person shall make or utter any false or forged prescription or false or forged written order No person shall affix any false or forged label to package or receptacle contain any drug
Will a publisher, radiobroadcaster, advertising agency or any other agency dissemination of advertising, except the manufacturer, packer, distributor or seller be subject to the advertising misbranded/adulterated products?
No, unless he has refused, on the request of the commissioner, to furnish the name and address of the manufacturer, packer, distributor, seller or advertising agency in the US, who caused him to disseminate such false advertisement.
This type of pharmacy has legend drugs, in the form of radiopharmaceuitcals, and legend devices are stored prepared or dispensed and from which related radiopharmaceutical care services are provided.
Nuclear pharmacy
In care-giving institutions and correctional or juvenile training institutions in "EMERGENCY" situations, when the pharmacist is not available, the prescription shall be reviewed by the ___________ or a ___________ before administration of the drug or device and recorded with the pharmacist in its original form or a copy thereof.
Nursing supervisor, physician
When a corporation renews or files for a pharmacy license, it shall include on the application the names of the ___________ of the corporation.
Officers/directors
Official Compendium:
Official USP, Official Homeopathic pharmacopeia of the US, Official National Formulary (or any supplements to any of them)
What can be placed in the drop box when pharmacy is closed?
Original written prescriptions, prescription containers for refill, written request for prescription refill.
How many CII orders can be written on a CII prescription?
Only 1
Who is the only one that can deactivate the alarm system in a pharmacy?
Only a pharmacist. KEYS and Access code to alarm system shall be controlled in such a manner so as to prevent access to the prescription department by other than authorized pharmacy personnel. Alarm has to be activated and operated separately from any other alarm system at the pharmacy.
Who is the only person that can order CII medications?
Only person granted power of attorney by registrant may complete Form 222 Registrant is authorized by the commission is someone who is not a convicted felon, was not denied registrant before or revoked.
Can a pharmacy be a dispensary?
Only pharmacies can apply for/receive dispensary license but dispensary is not the same as pharmacy
Who can accept prescirptions?
Only the pharmacy, cannot be another person who gives it to a pharmacy
The quantity of controlled substances stocked by any registrant shall be determined for security purposes by totaling the number of controlled substances units currently on hand. What if you have partial containers of controlled medications? What if you have larger or smaller package sizes?
Partial containers of controlled substances shall be considered as being full when determining the total quantity of controlled substance stock. Larger Package sizes shall be counted according to the number of controlled substances units they contain (ex: package size 200 capsules = 2 U Package sizes less than a full controlled substance unit shall be counted as the fraction of a unit which the package size contains. (ex: package size 50 capsules= .5 U)
What cannot be changed on a C2 RX?
Patient's name Name of drug (unless approved generic) Date issued prescriber's signature
A physician and patient must have a valid ___________ relationship to be able to prescribe controlled medications. (T/F) Electronic questionnaire is considered a valid relationship.
Patient-physician, False In the absence of a documented patient evaluation that includes a physical examination, any request for a controlled substance issued solely on the results of answers to an electronic questionnaire shall be considered outside the context of valid practitioner-patient relationship and NOT be a valid prescription.
Wholesaler/Distributor:
Person who supplies drugs, medical devices, or cosmetics or cosmetics prepared, produced or packaged by manufacturers other other wholesalers, manufacturers, distributors, hospitals, practitioners, pharmacies, federal, state or municipal agencies, clinics or other person 1. retail pharmacy or pharmacy within licensed hospital which supplies to another such pharmacy of both controlled and noncontrolled substances stocked to provide immediate need of patients pursuant to a prescription. 2. Pharmacy within a licensed hospital which supplies drugs to another hospital or an authorized practitioner for research purposes. 3.Retail pharmacy which supplies a limited quantity of a noncontrolled/controlled substance for emergency stock to a practitioner who is a medical director of a chronic and convalescent nursing home, or a rest home with nursing supervision.
Who should be trained on using hypodermic needles?
Personnel involved in the handling and disposal of hypodermic needles and syringes shall be informed of the potential health and safety hazards and trained in the appropriate handling and disposal procedures. Each facility shall monitor staff performance for adherence to the established handling and disposal procedure Policy for disposal of these wastes by a health care facility shall be available for review by the Department of Health services or the Commissioner of Consumer protection.
What information should be reported to the DCP when transmitting info CII-CV medications?
Pharmacy DEA # DEA of Prescriber Pt name and address Birthdate Gender Date RX filled RX#, Drug name, NDC, QTY, Day supply, refills Date prescription written Prescription origin code Payment code (Cash or Third party) New refill code **Notice this is all information that is written up when registering a patient
Who must notify the commission each time the pharmacy has an unscheduled closing within ________ hours after the closing?
Pharmacy Manager, 72 hours
Who must apply to the commission for permission to close the prescription department (pharmacy) during specified hours? What happens after applying?
Pharmacy manager of pharmacy Once applied, the commission shall request that the commissioner of Consumer protections inspect the pharmacy for compliance. Upon confirmation from the Commissioner of consumer protections. Once confirmed, the commission will grant permission of the pharmacy hours. **A record of such application and its approval shall be maintained on file by the commission.
A pharmacist may require a valid ______________ prior to releasing controlled substance to any person not known to such pharmacist. ***This does not apply in a institutional setting or long-term care facility, including but not limited to an assisted living facility or hospital.
Photographic ID
The commission may refuse to authorize temporary permit, refuse to issue renewal of a license to practice or operate a pharmacy or registration of a pharmacy intern or tech, and may revoke or suspend a license if the applicant or holder of the license has a condition including but not limited to:
Physical illness, loss of skill or deterioration due to the aging process, emotional disorder or metal illness, abuse or excessive use of drugs or alcohol that would interfere with practice. **The commission may not violate the provisions of section 46a-73 or 42 USC section 12132 of the Federal Americans with Disabilities Act.
If a prescription error does occur who are the first people to be notified?
Physician and Patient. The pharmacist shall communicate to the patient and prescribing practitioner the methods of correcting the error and reducing the negative impact of the error on the patient. **If the patient is deceased or unable to fully comprehend the notification of the error, the pharmacist shall notify the patient's caregiver or appropriate family member.
What conditions can patients possess marijuana?
Physician may supply marijuana (with license and authorization from Department of Consumer Protections) to patients for the treatment of glaucoma or side effect of chemotherapy (CNIV) ***No person outside the state of CT shall sell or supply controlled substances /marijuana within this state (CT) without first obtaining a license to do so from the Commissioner of Consumer Protection, provided no such license shall be required of a manufacturer whose principal place of business is located outside this state and who is registered with the FDA
Schedule V: Low abuse potential relative to CIV (Consists primarily of preparations containing limited quantities of certain narcotics- generally for antitissive, antidiarrheal and analgesic purposes). Abuse may lead to limited physical/psychological dependence (Lean, Purple drink)
Pregabalin (Lyrica) Cough Preparations w/ </= 200mg/100ml (or 200mg/200g) codeine (Robitussin AC, Phenergan w/Codeine) Antidiarrheal preparation </= 200mg/100ml or 200mg/ 100gm opium (Parepectolin) Others: </= 100mg/ 100 ml or 100g of dihydrocodeine </= 2.5 mg of diphenoxylate per unit dose </=2.5 mg of atropine sulfate per unit dose
What are things on Prescription record (Rx itself) not needed on RX label?
Prescriber address (technically its needed if its a controlled medication) Dosage form of Medication Retail price of generic substitution Dispensing pharmacist initials
What is in a prescription Record? (non-controlled) What are the additional things necessary on controlled scripts?
Pt's Name + Address (If pet, species and owner's name) Date the RX is issued Drug name Dosage form/Strength/Quantity/Directions/Refills Cautionary statements Prescriber's name (Also prescriber's signature) Prescriber's address RX Serial number Date Script is filled/refilled on face/back of script Retail price of generic substitute Dispensing pharmacist's initials For controlled: Need Prescriber DEA# and Age of patient (or indication of adult/child) ****Prescriber signatures are necessary if the medication is controlled or if the script is written.
Anyone who tries to prescribe, dispense, administer, sell etc. any controlled substance to an 18 year old and if the violator is at least 2 years difference in age (older):
Punishment will be 2 years in prison in addition to any other violation/term. 3 years if giving to elementary/secondary school, licensed child day care center. ***if you hire/persuade or induce a person younger than 18 to do business, punishment will be 3 years in prison.
How many days after a prescription error must a Quality assurance review be done?
Quality assurance review should be done immediately but no later than two business days from the date the prescription error is discovered.
Student who graduated from foreign schools need the following to be eligible to sit for examination (for license): A. Birth certificate with date and location B. FPGEE C. TOEFL D. US citizenship/Visa permit employment E. Proof of 1500 hours of practical experience
Requirements include: -Documentation of date/place of birth -TOEFL and FPGEE (min score of 55) -Proof of US citizenship/ Visa working permit -Proof of 1500 hours practical experience Appearance before the commission for a personal interview prior to the commencement of the practical experience.
If a pharmacy has less than 150 Units of CII medication how should it be stored?
Schedule II stock, if less than 150 Units a constructed completely enclosed locked wood or metal cabinet shall be used for storage of all CII meds. If 150 Units or more, a approved safe shall be used .
All facilities at which drugs are stored, warehoused, handled, offered, marketed or displayed shall: 1. Be of suitable size and construction to facilitate cleaning, maintenance and proper operations 2. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment and security conditions 3.Have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded or adulterated or that are in immediate or sealed, secondary containers that have been opened 4. Be maintained in a clean and orderly condition 5. Be free from infestation by insects, rodents, birds or vermin of any kind.
Security: 1. All facilities operated by wholesalers shall be secure from unauthorized entry. 2. Access from outside the premises shall be kept to a minimum and well controlled 3. The outside perimeter of the premises shall be well lighted 4. Entry into areas where drugs are held shall be limited to authorized personnel 5. All facilities shall be equipped with an alarm system to detect entry after business hours 6. All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electric records.
An automated data processing system (computer) may be used for the storage and retrieval of refill information. Any such computerized system must provide on-line retrieval for a period of at least ___________months from the date of the last recorded dispensing via visual display device or hard-copy printout of original prescription ordering information for all prescriptions.
Six months
This type of pharmacy provides specialized legend drugs and legend devices which are stored and dispensed and from which related pharmaceutical care services are provided including, but not limited to, those relating to the treatment of diabetes, hemophilia and infertility
Specialized pharmacy
Who does the commissioner report any violations to?
State attorney or assistant state's attorney of the Superior court
What chapter of United States Pharmacopeia is 1. Sterile compounding 2. Non-sterile compounding? 3. Hazardous drugs?
Sterile compounding- USP 797 Nonsterile compounding- USP 795 Hazardous drugs- USP 800
Schedule III drugs: Less abuse potential than CI or CII but greater than CIV or CV. Currently has accepted medical use. Moderate/low physical dependence or high psychological dependence.
Stimulants: Bezphetamine (Didrex), phendimetrazine (Bontril, Melfiat, Obezine), Chlorphentermine, Clortermine, Ketamine ****Suppository forms of Amobarbital, Secobarbital, Pentobarbital Buprenorphine (suboxone, Subutex) Nalorphine ****</= 1.8g codeine/ 100ml or </= 90 mg codeine/dose (ex: Codeine w/ APAP, Aspirin, Ibuprofen, Fioricet etc.)-----Remember if the number is divisible by 3 then its a CIII drug. Both 1.8 and 90 are divisible by 3. Dronabinol (Marinol) Anabolic steroids- oxadrolone (oxandrin), Cholorotestosterone, Clostebol, Androxy, Mesterolone, Methenolone, Methyltestosterone, Mibolerone, Nandrolone (Deca-Durabolin, Hybolin Decanoate), Oxymetholone (Anadrol 50), Stanozolol (Winstrol), Testolactone (Teslac), Testosterone (Androderm, Testim, Fortesta, Androgel), Chorionic gonadotropin. **Any substance that contains 15mg of barbiturate long/ intermediate acting (this includes in combination with 188mg aspirin, 375 mg salicylamide, 70mg phenacetin/acetanilid/acetaminophen ***Any substance with 15mg short acting barbiturate containing 307 mg aspirin, 614 mg salicylamide, 106mg APAP/ Phenacetin
Where should needles/syringes be located?
Stored in a manner so as to be available to authorized personnel and not be openly available to customers or patients.
C3 products
Suboxone, ketamine, paregric, codeine or dihydrocodeine (APAP with codeine), Anabolic steroids (oxadrolone-Oxandrin), dronabinol
No person shall sell any food, drug or cosmetic at an auction unless ________________
Such person has notified the commissioner of consumer protection, in writing, of such sale. Such notice shall be given at least 7 days prior to such sale and said commissioner shall inspect such food, drug or cosmetic and prohibit the sale of the same if its found to be unfit for human use. ***This does not apply to the sale of food by any church, parent teacher association, charitable organization or any organization of any political party.
Who submits the applications for injunction/ restraint on behalf of the Commission?
The Attorney General **An application to the Superior Court shall be brought by the Attorney General.
Does the commissioner have the power to destroy drug paraphernalia?
The Commissioner can seize the paraphernalia and shall record all the paraphernalia received and disposed of, showing exact kinds and quantities of the paraphernalia, the persons from whom received. The commissioner can destroy it once authorized by the court.
Who determines competency requirements for a pharmacist to enter protocol based collaborative drug therapy management agreement:
The Commissioner of Consumer Protection, in consultation with the commissioner of Public Health.
What happens if you don't renew your registration?
The Commissioner of Consumer protections will notify the FDA and administrative action will be taken by the commissioner resulting in denial, surrender or revocation of a registration or the limitation of the controlled substance schedules of a registration.
Who appoints the members of the commission of Pharmacy?
The Governor **Members are selected from lists of individuals nominated by the Connecticut Pharmacists Association or by other professional associations of pharmacists or pharmacies.
Does the ID have to be returned to the commission?
The ID number and card shall become void and shall be returned to the commission if the pharmacy intern does not complete the requirements for graduation from, or terminates enrollment at, an accredited and approved school or college of pharmacy.
What happens if they find that in fact there is a violation during the hearing?
The article shall be confiscated and disposed of by destruction or sale as the court may direct and the proceeds of any sale, less the legal costs and charges, shall be paid into the state treasury.
If an automated system malfunctions or there is a destruction of the data bank, what should be done?
The automated data processing system shall be capable of being reconstructed in the event of a computer malfunction or accident resulting in the destruction of the data bank.
Anesthesia (licit vs illicit)
The breathing, inhalation, sniffing or drinking of anesthesia for medical or dental purposes under the direction of a physician, dentist or osteopath acting in the course of his professional practice, is determined to be a LICIT and not in contravention of these regulations.
How should the pharmacy start the process of requesting the commission to modify its class/classes?
The pharmacist manager shall submit a written request to the commission which documents: 1. The specific regulation for waiver 2. The reason for the request 3. Description of alternative measures employed 4. Relevant information that will assist the commission on evaluating the request. 5. Additional info requested by the commission that will help them Upon approving or denying the request the pharmacy manager will be notified.
How should the patients be notified of an unscheduled closing?
The pharmacy shall implement procedures to notify patients of the pharmacy who need prescriptions dispensed where these prescriptions, including refills, can be obtained immediately. Such procedures may include, but are not limited to, telephone system messages and conspicuous signs. **If a pharmacy is not required to post its hours of operation but has unscheduled closing, it needs to notify patients of the unscheduled closing.
(T/F) A person practicing as a pharmacist, pharmacy intern or tech shall at all times have available for inspection by an inspector of the department a current certificate of license or temporary permit to practice pharmacy or a current registration to act as a pharmacy intern or pharmacy tech.
True
How long can the pharmacy be closed for if unscheduled?
The prescription department of a pharmacy shall not be closed more than one consecutive calendar day for unscheduled closings. Not more than 18 times in a 365 day period. No more than 2 times in a 30 day period (non-consecutive days)
How should C4-C5 be stored in laboratories?
These medications should be stored separately from other drugs and substances in an separate secure locked location only accessible to a few authorized people. **In labs, controlled substances in the process of testing may only be used for testing and must be returned immediately to storage after use.
What if the prescription is phoned in or sent electronically where the physician can't indicate in their own hand writing: "BRAND MEDICALLY NECESSARY"?
There will be no generic substitution and a written certification in the practitioner's handwriting bearing the phrase "BRAND MEDICALLY NECESSARY" shall be sent to the dispensing pharmacy no later than 10 days after the date of communication.
The following medications can only be sold in retail: Legend drugs/devices, injectable/indigestible antibiotics or biological, Sulfonamides and their compounds, injectable corticosteriods, camphorated tincuture of opium (exceptions?) Violation of this will be.....
These maybe sold at retail only by: A licensed pharmacy In limited circumstances by a hospital if to hopsital's: employees, employee's spouse or dependent children, Retiree or the retiree's spouse on hospital's retirement/pension plan. **Violation of this will be fined $100-$500.
Who are inspectors?
They are employed by the Commissioner of Consumer Protections to inspect all pharmacies and other places in which drugs and devices are or may be dispensed or retailed, and to report any violations, inclusive or other laws relating to drugs and devices and violations of laws regarding pharmacy licenses, non-legend drug permits, licenses of pharmacists and supervision of pharmacy interns and pharmacy techs. Called Drug Control
In a hospital, clinic, infirmaries how long does physician have to send in scripts after giving oral order?
They must send in a written order for CII in 24 hrs and all other controlled meds (CIII-CV) must be given in within 72 hrs.
Paregoric 2mg/5mL: Can someone get this filled without an RX? How to document sale?
This is a C3 BUT can be sold as a C5 if given in low quantity CV OTC quantity limit is 8 FL Oz with max 16.2mg of opium in 1 fluid ounce. Paragoric has 16mg in 30mL which means pt can have 8 ounces of Paragoric without a RX. Name and address of purchaser Name and QTY sold Time and date of sale No sale again within 48 hours to same purchaser
(T/F) A pharmacist may substitute a therapeutically equivalent-generic drug (unless pt/prescriber requests otherwise) w/ the same strength, quantity, dose and dosage form. When the practitioner is not available for consultation the prescribed drug does not have a unique delivery system technology, the pharmacist may substitute an oral tablet, capsule or liquid form as long as it has same strength, dose and dose schedule/ therapeutically equivalent. **The pharmacist shall inform the pt or a representative of the pt, and the practitioner at the earliest reasonable time.
True
(T/F) A prescription dispensed by a pharmacist shall bear upon the label the name of the drug in the container unless the practitioner writes "DO NOT LABEL" on the prescription or so indicates via phone/electronically.
True
(T/F) Medication can be used for investigation of controlled substance by a researcher or scientist wherein documentation of necessity of use of such controlled substances is maintained.
True
(T/F) NO license shall be granted to any person who has, within 5 years of the date of application, been convicted of a violation of any law of the US, or any state relating to a controlled drug.
True
(T/F) No non-resident pharmacy shall engage in the business of shipping, mailing or delivering legend devices/drugs in the state of CT unless such non-resident pharmacy has been issued a certificate of registration by the commission and has paid the fee.
True
(T/F) No person shall act as a pharmacy technician unless registered with, or certified with, the department.
True
(T/F) One or more pharmacists licensed may enter into a written protocol based collaborative drug therapy management agreement with one or more physicians licensed.
True
(T/F) Only Pharmacy may accept prescription for dispensing.
True
(T/F) The Commission may compel attendance of witnesses and the production of documents by subpoena and may administer oaths. If a person refuses or fails to appear, testify or produce any document when so ordered, a judge of the Superior court may, upon application of the commission, make such order as may be appropriate.
True
(T/F) The commissioner shall inspect correctional and juvenile training institutions and care-giving institutions throughout the state with respect to handling of drugs, shall report violations of law and make recommendations for improvements in procedure to the authority responsible for the operation of the institution.
True
(T/F) When moving to a new location, the pharmacy license is terminated and must be renewed.
True
(T/F) Wholesalers and manufacturers shall permit the commissioner or his authorized representatives to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedure, at reasonable times and in a reasonable manner.
True
(T/F)A nuclear pharmacy can only dispense radioactive pharmaceuticals only upon receipt of an order from a licensed practitioner or the practitioner's agent, or from a person authorized by the US Nuclear Regulatory Commission or agreement state agency to possess such radiopharmaceuticals.
True
(T/F)CII scripts should be filed separately from all other controls
True
(T/F)Electronic data intermediaries may archive copies of of only that electronic data related to such transmissions necessary to provide for proper auditing and security of such transmission. Such data shall only be maintained for the period necessary for auditing purposes. Electronic data intermediaries shall maintain patient privacy and confidentiality of all archived information as required by state and federal law.
True
(T/F)In order to enter into a written protocol based collaborative drug therapy management agreement, such physician shall have established a physician-patient relationship with the patient. Each patient's collaborative drug therapy management shall be governed by a written protocol specific to that patient established by the treating physician in consultation with the pharmacist.
True
(T/F)Pharmacy should only substitute the medication if it cost saving for the purchaser, if it is not, then it can't be done. The pharmacy must let the purchaser know how much was saved.
True
(T/F)Radioactive drugs approved by the FDA maybe redistributed by Nuclear Pharmacies and do not subject to specific labeling requirements.
True
(T/F)Refills shall be recorded on the front/back of the original prescription.
True
(T/F) In Hospital patient care areas/hospital nursing home stations, Schedule II controlled substances in small amounts not exceeding the quantity necessary for efficient operation kept at any specific individual area or location shall be stored in a locked substantially constructed non-portable and immobile metal cabinet or metal container within another separate locked enclosure.
True **Keys shall not be the same for each of these locks and such keys shall be kept on two separated key rings or holders. ***CIII- CV can be stored with the CII
(T/F) Cancellation is not required from a transferring pharmacy which electronically access the same prescription records and utilize the same computer or other electronic prescription transfer system.
True (Ex: Walgreens pharmacy --> walgreens)
(T/F) If the applicant or licensee if a person other than the pharmacy manager, the applicant or licensee may designate an individual as an agent to attend the meeting with the commission on behalf of the licensee/applicant.
True (both applicant [or agent] and Pharmacy Manager need to be present)
(T/F) The Quality Assurance records must absolutely be kept in the pharmacy to be readily available to all pharmacy personnel and the department.
True but it can also be kept outside the pharmacy and should be available for inspection by the department within 48 hours on request.
(T/F) Fax is not considered the actual prescription but only a record of transmission of the C2 RX order
True- just a record of transmission (MUST get original RX before DISPENSING) *Unable to dispense C2 until the original RX is reviewed *UNLESS to be compounded for direct administration, or LTC facility/hospice (NOT GROUP HOME)
(T/F) The breathing, inhalation, sniffing or drinking of anesthesia for medical or dental purposes under the supervision of a physician or dentist is determined licit purpose and not in contravention.
True.
(T/F) A protocol should be established for vaccine administration by a healthcare provider with a pharmacist or pharmacy.
True. Written protocol should include: Practitioner who authorized immunization, Pharmacist who administered, Type of immunization, procedures to refer patient to physician, procedure during emergencies and record keeping of immunizations.
A sterile compounding pharmacy may provide compounded products to practitioners of medicine, osteopathy, podiatry, dentistry, or veterinary medicine to administer to their patients in the course of their professional practice either personally or under their direct and immediate supervision, except that the quantity of such compounded products shall be limited to a ___________ supply.
Two week
What does FDA stand for?
US Food and Drug Administration
Up to how many units of CII medications can be stored in a safe, before it would be more appropriate to use a vault?
Up to 250 U of CII can be stored in Safe, more than that should be stored in vault
How are vaccine related adverse effects reported? What about for regular drugs?
VAERS (Vaccine adverse event reporting system) and FAERS.
Can a retail pharmacy or a pharmacy in a hospital considered a wholesaler?
Yes if they are distributing medication to authorized people/organizations
When ordering CII meds it must be done through Triplicate order form or electronically through the controlled substance order system (CSOS)
When paper form is used, ordering registrant keeps one copy and two copies are sent to registered supplier. When the supplier fills the order, it keeps one copy and send the other copy to the DEA.
Can the commissioner of Consumer protections change a schedule of a drug?
Yes, he/she may change the schedule in which a substance classified as a controlled substance I to V of the controlled substance scheduling regulation is placed. The commissioner shall submit a list of all schedule changes to the chairmen and ranking members of the join standing committee of the General Assembly. ***Remember if there is any inconsistency between federal and state control or law, the more stricter law the one to abide by.
Can interns do out of state practical experience programs?
Yes but they must be approved by the appropriate licensing agency in the state wherein the experience is attained.
Can pharmacy interns dispense medication?
Yes but under the supervision of a pharmacist **Also anyone holding a temporary permit. Both pharmacist and pharmacy interns can take prescriptions in.
Responsible persons in Wholesale
Wholesalers need to establish and maintain a list of officers, directors, managers and other persons in charge including their duties and summary of their qualifications.
Therapeutically equivalent:
Will provide essentially the same efficacy and toxicity when administered to an individual in the same dosage regimen.
When to notify DCP if there is administrative or legal action by government regulatory agency or accreditation entity?
Within 10 days of getting notice
If a Pharmacist in collaborative practice decides to discontinue therapy in what time period must he/she notify the physician?
Within 24 hrs
Can the commissioner of consumer protection limit the schedules for which the practitioner is registered?
Yes
When inspecting, can commissioner or agent enter any vehicle being used to transport or hold food, drugs, devices or cosmetics in interstate commerce?
Yes
Can a non-legend permit holder sell non-legend veterinary drugs?
Yes Nothing in the Pharmacy Practice Act prohibits a non-legend drug permit holder from selling non-legend veterinary drugs.
Is a Pharmacy intern adequate enough security if a pharmacist leaves the pharmacy momentarily?
Yes Pharmacy intern or pharmacy technician is adequate security. If the Tech and Intern can supervise entry of people. If the tech/intern also leave, then the pharmacy must be closed both physically and electronically (use of alarm).
Can a pharmacist refuse 3 techs in a community pharmacy?
Yes but must have it in writing to the pharmacy manager.
Can interns compound and dispense drugs/devices?
Yes but only when a pharmacist is physically present in the pharmacy or institutional pharmacy and personally supervising such compounding, dispensing or delivery.
Can a permittee get refunded for a permit?
Yes, the commissioner of consumer protections may refund to any permittee the fee paid by him, provided application for such refund shall be made not later than 60 days after the effective date of the permit.
Can a pharmacy technician get authorization for refills?
Yes. Pharmacy technician can communicate with a prescribing practitioner or his agent to obtain an authorization for the renewal of an existing prescription for a drug other than a controlled substance that can no longer be refilled as long as: - the supervising pharmacist is aware of an authorization refill is being requested - The prescription is exactly the same as the previous with no changes to anything -All refill authorizations obtained by the pharmacy tech are reviewed by the supervising pharmacist.
Label
a Display of written, printed or graphic matter upon the immediate container of any article, provided a requirement made by or under authority of this chapter that any information or other word or statement appear on the label shall not be considered to be complied with unless such information or other word or statement also appears on the outside container or wrapper, if any, of the retail package of such article, or is easily legible through the outside container or wrapper.
areas of nuclear pharmacy
adeuqate space radiopharmaceutical preparation and dispensing area, radioactive material shipping and receiving area, radioactive matieral storage ages, radioactive waste decay area secured from entry by unauthorized personnel maintain recoreds
what drugs are exclused from controlled drugs/substances
alcohol, nicotine, caffeine
non resident pharmacy
annually tell names, title of officers and pharmacists dispensing drugs file report in 30 days of change in office have to tell for sterile products must have license copy of inspection telephone number notify of disciplanary action in 10 days recall- must send a list to the comission in 24 hours of names of people with them
what vaccines can be given
any adult 18 or older need immunization training, define program (education, screening, storage, handling, SC, IM admin, recordkeeping, safety, cardiopulmonary resucitation, life support, ADE reporting, CDC or ACPE accredided, control and reporting
controlled substances
any drug that is listed schedule II, III, IV, V of the federal controlled substance act or implementing regulations must be dispensed by prescription only
how does the pharmacy need to be constructed
area of pharmacy is completely separated from other business, need to be secured and locked if the pharmacist is not present, hours on the outside of the business, access by pharmacist provided 24 hours daily, signs cannot imply entire business is a pharmacy, can have a door leading directly to the pharmacy,
Institutional pharmacy:
area within a care-giving institution or within a correctional/juvenile training institution commonly known as a pharmacy, that is under the direct charge of a pharmacist and in which drugs are stored and dispensed.
drug
article recognized by the official US pharmacopoeia, intended for the use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals, intended to affect the structure of any function of thebody, any substance or preparation except soaps intended for external or internal use in the cure, mitigation, treatment, remedy or prevention of disease or ailment in man or other animal
Any person who tries to sell/deliver a non-controlled substance representing it as a controlled substance will be:
guilty of Class D felony
what does a pharmacist need to do to qualify for a collaborative therapy management agreement
bachelor of science degree in pharmacy with 10 years of clinical experience or PharmD certification by board of pharmaceutical specialties certification by comission of geriatric pharmacy credential in disease state management from national institute for standards in pharmacist credentialing pharmacy residency completion of disease state management certification from ACPE
how can a pharmacy be approved in a class
can be in multiple classes cannot do anything unless they are registered in that class more classes does not mean more fees
what do you need to do when giving a transfer away?
cancel rx, name of pharmacy to transfer, date of transfer,
what are the rule about substituting with anti epilepsy
cannot provide prior notice to patient and dr, obtains written conset
electronic questionnarie
cannot be used to dispensed controlled substances, the patient must have a physical exam
prices for manufacturers wholesale list price
cannot sell for price below the manufacturers wholesale list price per dozen
what warning needs to be on all controlled substances?
caution federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed can also be the spanish version
what are the requirements for prescriptions via fax
clearly contain the name of the pharmacy where the fax is going and the name of the facility tranmitting this presciption is valid only if transmitted by means of facsimiile machine the paper needs to be non fading and durable for the minimum amount of time required for the maintenance of prescription records
If there is any changes that need to be made to a wholesaler registration it must be notified to _____________ in ________days.
commissioner, 30 days
what are things a tech can do
communicate with the practioner for a refill of an existing prescription for a drug other than a controlled substance have to have pharmacist aware of this, need to be the exact same rx, need to be reviewed by the pharmacist after
what are the classes of pharmacy
community, infusion therapy, long term care, nuclear, specialized drug pharmacy, specialty pharmacy
sterile product
compounded manipulated or otherwise prepared under sterile conditions during the dispensing process, not attended for self administration but used in hospital or office based locations
nuclear pharmacist
has board certification as nuclear pharmacist, indentified as an authorized nuclear pharmacist on a US nuclear regulatory comission or agreement state license that authorizes the use of radioactive material in the practice of nuclear pharmacy
legend device
device that is required to be dispensed pursuant only to a prescription or is restriction to use by prescribing practioners, required to bear the legends -RX only in accordance with guidelines established in the federal food, drug and consmetic act -caution- federal law restricts this device for use by or on the order of a licensed veterinarian
who is in charge of telepharamcy?
director of pharmacy in hospital
certificate of continuing education units
document issued to a pharmacist by an organization which offered accreditied CE which A. Certifies the pharmacist has completed a specified number of CEUS B. and bears the name of the organization, title of the program, date when program was conducted, number of units, signature of director
how can prescriptions be left when the pharmacy is closed?
drop box, one way container and cannot be retreived from the outside can be taken from inside by pharmacist or designee only at times when the pharmacist is present in the pharmacy
collaborative practice agreement protocol
drugs managed by pharmacist, when a drug may be implemented, modified, or discontinued, must notify of discontinuation, mod, or implement to md in 24 hours, condition in which to notify dr, labs must report ot dr every 30 days
electronic technology or telepharmacy
each step involved in the dispensing of a sterile product is verifed through use of a bar code tracking system and documented by photos which are recorded and preserved
Accredited continuing professional education
education designed to maintain professional competence in the practice of pharmacy and which is provided by an organization approved by the commission Such educations include: A. Social/economic/behavioral/legal/administrative aspects of health care B. Properties and actions of drugs and dosage forms C. Etiology, characteristics, therapeutics and prevention of the disease states D. Pharmaceutical monitoring and management of patients E. Other areas of information unique to specialized types of professional pharmacy practice.
what are the places to get intern hours
empolyment not more than 40 hours a week, college, out of state approved by licensing agency in the state the experience is acquired, research (400hr max)
what do you need to tell the commission if you want to use needles
essential need for such devices no devices or tools as alternative maintain quantity essential for normal operatives security safeguards and inventory control systems to detect loss access to stock is limited to those who need to access
how can you refuse to have 3:1
except for IV and sterile product prep, unit dose and bulk compounding you can put into wirting the refusal
what is the requirements for new drugs
full reports on the safe for use and effectiveness for use full list of articles used as components of drugs full statement of composition of drug full description of the methods used in labeling to be used for the drug
What does the pharmacy manager need to be?
full time basis only can manage one store notify the comssion every time it changes immediately notify of change in manager have 10 days to notice of change in ownership
how do you notice the pharmacy personnel of an error
give a copy of the quality assurance program to each pharmacist employed at the pharmacy
what do you need to do if a pharmacy is moving
go to a comission meeting, square footage of area, total square foot of business, size prescription department, location of areas used a storerooms, size of prescription counter, location of department sink and fridge, controlled drug safe, location of toilet, size of patient counseling areas
what is the flavoring agent regulations
good manufacturing principles, minimum quanityt to produce effect, meets standards, inert and produces no effect, not greater than 5% of total weight of the product
Controlled Substance schedules
grouping of drugs, schedules 1 through 5, promulgated under the Code of Federal Regulation.
The commissioner of consumer protections shall adopt regulations to implement quality assurance program which will require pharmacies to:
implement a quality assurance program that describes in writing policies and procedures to be maintain in such pharmacy. Such policies shall include directions from communication a prescription error to a practitioner, patient or caregiver of patient/ family member if patient is deceased or unable to fully comprehend the communication. Such communication shall describe methods of correcting the prescription error or reducing the negative impact of the error on the patient.
what needs to happen if there is an emergency closing
implement procedures to notify patients where these can be obtained (phone or signs), cannot be closed for more than 1 day (must notify DCP within 72 hours)
what is considered misleading or misbranded on a drug
implying the product is recommended or endorsed by any agency unless the agency has approved the statement should contain the name and place of the manufacturer, dosage form, name and place of business of the packer or distributor, quanity, weight, measure or numerical count if it contains something habit forming, it needs to say "warning may be habit forming" read this highlighted section
how do rx need to be stored?
in numerical order with an assigned serial number
how can you increase the hours a pharmacy is open?
increase the hours and send notice department of consumer protection not later than 5 days after such change
drug retailer
individual, firm, or corporation engaged wholly or partially in retail drug trade
This type of pharmacy provides parental, enteral and infusion therapies.
infusion pharmacy
What are the legend devices or drugs that cannot be sold except at a pharmacy?
injectable or ingestible antibiotics, inj biologics, sulfonamides, inj or PO corticosteriods, camphoarted tincture of opium
When do you not need to give a side effect statement?
inpatients in hospital, healthcare facility under order of practioner, supervised home health care
Who besides a pharmacist can dispense meds in an emergency?
institutional pharmacy nursing supervisor or physician before administration recorded with the pharmacist in its original form or a copy of a presciring practioner can always dispense when it is their own patient in their scope of practice
Interstate commerce:
means any and all commerce within the state of CT
what are the rules about MTM
medicaid patient obtain- name, address, phone, birth, age, gender, PMH, alleriges, list of meds in last 180 days, comments of drug therapy
How long should records of quality assurance regulations and reports of prescription errors be kept? If the Commissioner wanted to inspect these records/prescription errors how long does pharmacy have to provide it?
minimum of 3 years 48 hrs
what should be discussed in offer to counsel
name and description of drug, dosage form, route, duration, special directions and precautions, ADE, techniques for andmistrations, storage, refill, action if missed dose does not apply to nursing home keep records of offer to counsel for 3 years
what needs to be on a radiopharmaceutical prescription
name of institution and practioner date of dispending and calibration time of the radiopharmaceutical name of the procedure name of radiopharmaceutical dose or quantity of radiopharmaceutical prescription number specific instriuction person dispensing the prescription order patient name
what needs to be on a refill printout
name of prescriber, name of patient, name dose strenght quanitity of drug, date of dispensing for each refill, name of dispensing pharmacist, number of the original prescription order
what does the inner counter of radiopharmaceutical need to be labeled with
name of radiopharmaceutical serial number of prescription radiation symbol caution radioactive material
Prescription label- non controlled
pharmacy name and address, patient name, name of medication/strength/QTY/directions cautionary, expiration, serial number, date dispensed, prescribers name ***Pharmacist shall label the prescription container with the name of the dispensed drug product. If the dispensed drug product does not have a brand name, the prescription label shall indicate the generic name of the drug dispensed along with manufacturer or distributor.
prescription label- control
pharmacy name and address, patient name, name of medication, strength, quantity, directions, cautionary, expiration, serial number, date filled (and refilled for CIII and CIV), prescribers name (and prescriber address) cautionary- federal law prohibits transfer of this drug to any person other than the patient for whom it is prescribed **Controlled medications require prescriber address on the label where has non-controlled does not require prescriber address.
who can a manufacturer sell needles to?
pharmacy, practionioner, care giving institution, college or science lab, farmer, business for industrial or medical use, exchange program
Dosage form:
physical formulation or medium in which the product is intended, manufactured and made available for use, including but not limited to: tablets, capsules, oral solutions, aerosol, inhalers, gels, lotions, creams, ointments, transdermals and suppositories etc. **Specific formulation helps with release, targeting, systemic absorption or other delivery of a dosage regimen in the body.
how do hours of operation need to be posted
posted at all entrances, all advertising needs to state the hours of operation of the prescription department, ads with multiple pharmacies can contain "the servies of a pharmacist may not be available at all times when the stores are open"
who can add flaoring?
prescriber, hospital,
A prescription maybe refilled only upon the written, oral or electronic-transmitted order of a _________________
prescribing practitioner
Who cannot have owenership of pharmacies?
prescribing practitioner, spouse of prescribing practitioner except if they are a pharmacist, or dependent of a prescribing practitioner
reciprocity requirements
qualified to get licensed in current state, graduate of pharmacy school, reisdent of CT or indicated to practice pharmacy in CT, 1 year of practice or has taken an exam in the last 12 months, pass the pharmacy law exam, appearing before comission, current state grants reciprocity
in vitro nucleic acid techniques
recombinant deoxyribonucleic acid techniques that use vector systems and techinques involving the direct introduction into organisms of heretitary materials prepared outside the organisms such as microinjection, macroinjection, chemoporation, electroporation, microencapsulationg, and liposome fusion
how do you record when a drug is substituted
record on the face of the rx the brand name of the drug and the generic name and manufactuer record on the face of the rx the retail price of the drug product substituted
Where can non legend drugs or devices be sold?
retail pharmacy, hopsital for an employee spouse or child, hospital to a retiree
how does the pharmacy need to be protected when closed?
securely lockes, alarm system, only pharmacist can deactivate alarm system
what does a electronic data intermediary need to include
security measures, physical safeguards, protect and control confidential patient info, prevent unauthorized access to the data, autheniticate the sender's authority and credentials to transmit a prescription
retail drug trade
selling to the consumer, not for the purpsoe of resale, of any form of drugs, medicines, cosemtics, toilet prep, etc
what needs to be in the pharmacy to warn of erros
sign- 8x10- if you have a concern that a error may have occured in the dispensing of your prescription you may contact the department of consumer protection, drug control division by calling # needs to be on the rx bag, receipt or similar packaging
what needs to be on a written prescription
signature, address of dr, date of rx, name, dosage, stength, quantity, name and address of patient, direction, cautionary statnents, refills
what is in the content of a patient protocol for a collaborative practice agreement
specific drugs or drugs to be managed terms and conditions under which drug therapy may be implemented, modified, or discontintued conditions and events that pharmacists is required to report to physican labs tests that can be ordered drugs that can be administered
What if you need additional time for CE?
submit a waiver in writing with the license renewal application. If a pharmacist cant comply with the requirements for CE due to illness, incapacity or other extenuating circumstances he/she may apply for a waiver to extend the time. It must be in writing and must be given with license renewal application. The department shall then forward it to the commission who will waive the requirement and renew the license or extend the time for compliance while renewing the license. The pharmacist must then comply with CE requirements in the time period or his/her license will be suspended/revoked.
what are the rules on name tags
techs must clearly identify themselves as tech
continuing education unit
ten contact hours of participation in accredited CE Yearly requirement: 1.5CEU/year, 15 contact hours/year
Locations of licensed practitioner
the State of Connecticut, any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States
what must be in a collaborative practice agreement
types of prescriptive authority- initiaion, continuation, modification patients who are eligible types of disease, drugs, drug catergories invovles there are no limits on disease states or conditions procedures, decisiones, plans or gluidlines when making therapeutic decisions required training plan for periodic review, feedback, and quality assurance procedures for documenting prescribing decisions
In industrial health facilities, educational institutions, clinics, summer camps and other institutions how many units of CII/CIII can be stored in a wooden/metal cabinet? How about CIV and CV?
up to 15 units or less of CII/CIII can be stored in a locked metal/wood cabinet. If more than 15 Units then store in safe CIV or CV substance stock shall be stored in a separate secure locked location or with CII an CIII in wood/metal cabinet or safe if over 15 U.
what are the rules regarding needle disposal
used needles should be placed intack into puncture resistant containers put containers close to where you are using the needles one way container to prevent spillage container should be secure at all times containers should be stored in designatve area accessible to only authorized personnel
nuclear pharmacy technicians
works under nuclear pharmacist, currently registered as tech with the department, complete nuclear pharmacy training program, listed as authorized user of radioactive materials on US nuclear regulatory comission
