CSA things and FDCA Flashcards
Practice of Pharmacy Defined
- Interpreting, evaluating prescription orders, compounding, dispensing, labeling, drug selection, administering vaccine, participating in DUR, proper and safe drug storage, maintenance of proper records, consulting with patients & practitioners, operating & managing a pharmacy … and performance of drug therapy management pursuant to a written collaborative practice agreement with one or more physicians who have an established physician-patient relationship.
Key points of the FDCA What did it establish? What definitions did it expand on? What must ___ contain?
New drugs cant be marketed until they are approved for safety by the FDA for use under labeled conditions. Labeling must contain adequate directions for use Expanded definitions of adulterations and misbranding Grandfathered drugs were drugs pre 1938
Types of Licenses
What is important to note about them?
- Active
- License by exam or score transfer
- License by reciprocity (pharmacist is already licensed in another state)
- Inactive- Failure to do CE
- Voided license failure to pay license renewal fee
- Neither an inactive nor voided license allows the holder to legally practice.
Parenteral Product prep
7 requirements
What applies and what is more strict?
- Laminar flow hood or other suitable aseptic environment, annually certified
- Aseptic work area
- Nearby sink
- Current Iv incompatibility/stability reference
- P and P manual
- USP 797 applies and is more strict
- Labeling for IV
Dietary Supplement Health and Education Act DSHEA - What did it Mandate the FDA to do? - What do these product require? - When can a DS be removed? - What are developed?
Mandates FDA to regulate DS as special type of food (in contrast to a drug) - Products do not require pre-market approval - FDA can only take action to remove DS from the market after establishing the product to be adulterated (unsafe) or misbranded (labeling is false or misleading) - GMPs are developed by the manufacturers for all precesses, packaging, labeling, and holding of products - Dont follow that=adulteration
Administer
Who can do it?
If the patient is?
When can a pharmacist?
What if the patient doesnt have a primary care provider?
How are records kept?
- Practitioner or pursuant to the lawful direction of practitioner
- The patient under supervision of practitioner
- A pharmacist authorized in K.S.A 65-1635a amendments thereto
- Must complete immunization training
- Influenza vaccine to persons 6 years old or older and other vaccines to persons 12 years old or older pursuant to a vaccination protocol
- On or after July 1st 2020 immunizers must report the immunization to the state registry maintained by KDHE
- (a) A pharmacist or a pharmacy student or intern who is working under the direct supervision and control of a pharmacist may administer influenza vaccine to a person six years of age or older and may administer vaccine, other than influenza vaccine, to a person 12 years of age or older pursuant to a vaccination protocol if the pharmacist, pharmacy student or intern has successfully completed a course of study and training, approved by the accreditation council for pharmacy or the board, in vaccination storage, protocols, injection technique, emergency procedures and recordkeeping and has taken a course in cardiopulmonary resuscitation (CPR) and has a current CPR certificate when administering vaccine. A pharmacist or pharmacy student or intern who successfully completes such a course of study and training shall maintain proof of completion and, upon request, provide a copy of such proof to the board. (b) All vaccinees will be given a written immunization record for their personal files. The administering pharmacist or pharmacist supervising an administering pharmacy student or intern shall promptly report a record of the immunization to the vaccinee’s primary care provider by mail, electronic facsimile, e-mail or other electronic means. If the vaccinee does not have a primary care provider, then the administering pharmacist or pharmacist supervising an administering pharmacy student or intern shall promptly report a record of the immunization to the person licensed to practice medicine and surgery by the state board of healing arts who has entered into the vaccination protocol with the pharmacist. The immunization will also be reported to appropriate county or state immunization registries, except that if the person vaccinated or, if the person is a minor, the parent or guardian of the minor, objects to the report, the report shall not be made.
Nonresident Pharmacies
Where must they be register
Who is the PIC?
What about the pharmacists working there?
How must this pharmacy be available?
Each pharmacy shall be currently licensed or registered in good standing in the state in which it is located.
- Each pharmacy shall provide and maintain, in readily retrievable form, the record of a satisfactory inspection conducted within the previous 18-month period by the licensing entity of 116 the state where the pharmacy is located. If no such inspection record is readily available, the record of a satisfactory inspection conducted at the expense of the pharmacy within the previous 18-month period by a third party recognized by the board to inspect may be accepted.
- The pharmacy shall maintain an incoming toll-free telephone number for use by Kansas customers to facilitate personal communication with a pharmacist with access to patient records. (1) This service shall be available during normal business hours for at least 40 hours and six days per week
DEA form used by pharmacists to report theft or significant loss.
DEA form 106
The maximum amount of codeine (mg) per 100ml or 100g combined with one or more active, non‐narcotic ingredients to be scheduled as a CV.
200 mg
Losing your license
- What are the ground for it? 3 types
- What does the board have the authority to do?
- Unprofessional conduct: (1) Fraud in securing a registration or permit; (2) intentional adulteration or mislabeling of any drug, medicine, chemical or poison; (3) causing any drug, medicine, chemical or poison to be adulterated or mislabeled, knowing the same to be adulterated or mislabeled; (4) intentionally falsifying or altering records or prescriptions; (5) unlawful possession of drugs and unlawful diversion of drugs to others; (6) willful betrayal of confidential information under K.S.A. 65-1654, and amendments thereto; (7) conduct likely to deceive, defraud or harm the public; (8) making a false or misleading statement regarding the licensee’s professional practice or the efficacy or value of a drug; (9) commission of any act of sexual abuse, misconduct or exploitation related to the licensee’s professional practice; or (10) performing unnecessary tests, examinations or services which have no legitimate pharmaceutical purpose.
- Professional Incompetency: (1) One or more instances involving failure to adhere to the applicable standard of pharmaceutical care to a degree that constitutes gross negligence, as determined by the board; (2) repeated instances involving failure to adhere to the applicable standard of pharmaceutical care to a degree that constitutes ordinary negligence, as determined by the board; or (3) a pattern of pharmacy practice or other behavior that demonstrates a manifest incapacity or incompetence to practice pharmacy.
- Board can- require licensee to submit to mental or physical examination or a drug screen or any combination
- or to get fingerprinted and to submit a national criminal health check.
A registrant transferring a pharmacy business operation to another registrant must notify the nearest DEA office at least ______ days before the date of the proposed transfer.
14 days
Quantity of drug a pharmacist may dispense to a patient on a CII emergency prescription.
Enough for the emergency period, not limited to a specific number of doses
Pharmacist Scope of Practice
- Determined by?
- Who has independent prescribing? 5
- Who can do stuff under protocol?
- What can a kansas pharmacist do? 3 things
- MD’s, DOs, DDS’s, DVM’s, podiatrists
- PAs and APRN can as well under protocol
- Pharmacist cant but they can:
- Vaccinate under a signed protocol with age and vaccine limitations
- Enter to a signed collaborative drug therapy management arrangement
- Sign a state-wide protocol to dispense naloxone (Emergency Opioid Antagonist protocol)
The minimum age of individuals allowed to purchase CV‐OTCs in Kansas.
18
Number of times a CII prescription can be transferred.
0
Collaborative Drug Therapy Management
- What is it?
- What is the physicians responsibilty
- What shouldnt be construed?
- • Means “a practice of pharmacy where a pharmacist performs certain pharmaceutical-related patient care functions for a specific patient which have been delegated to the pharmacist by a physician through a collaborative practice agreement
- Physician is responsible for patient care following initial dx and assessment and direction/supervision of the pharmacist • “Nothing in this subsection shall be construed to permit a pharmacist to alter a physician’s orders or directions, diagnose or treat any disease, independently prescribe drugs or independently practice medicine and surgery.”
Length of time a pharmacist has to verify accuracy of the computer record for filling/refilling of CIII and CIV prescriptions.
72 hours
Medical Care facility (hospital) pharmacies
Who can obtain drugs from the pharmacy for inpatient use?
What quantity of drugs may be supplied for ER outpatient use?
Requires Checks of? How often?
- Responsibilities of Pharmacist in Charge (68-7-11)
- Procedure requirements for inpatient service and ER outpatient service when a pharmacist is NOT on premises
- Who can obtain drugs from the pharmacy for inpatient use?
- What quantity of drugs may be supplied for ER outpatient use? A) An interim supply of prepackaged drugs shall be supplied to an outpatient only by a designated registered professional nurse or nurses pursuant to a prescriber’s medication 112 order when a pharmacist is not on the premises and a prescription cannot be filled. The interim supply shall be labeled with the following information:(i) The name, address, and telephone number of the medical care facility; (ii) the name of the prescriber. The label shall include the name of the practitioner and, if involved, the name of either the physician’s assistant (PA) or the advanced registered nurse practitioner (ARNP);
- Required checks of drug records and conditions of drug storage [68-7-11(e)]
- How often?
The interim supply shall be limited in quantity to an amount sufficient to supply the outpatient’s needs until a prescription can be filled
) The pharmacist-in-charge of the medical care facility pharmacy shall maintain documentation of at least quarterly checks of drug records and conditions of drug storage, in all locations within the facility, including nursing stations, emergency rooms, outpatient departments, and operating suites
- Pre-packaging requirements [68-7-11(h)]
So your licensed What about it?
What happens if you fail to register?
- License must be displayed conspicuously visible to the public- where you are practicing
- Can get a duplicate if you lose the original or its destroyed
- Reinstatement after 3 consecutive year lapse. Upon failure of a pharmacist to renew a registration under the provisions of K.S.A. 65-1632 for three consecutive years or more, the board shall require the applicant to take a written or oral examination prior to reinstatement. Upon satisfactory completion of that examination and compliance with the provisions of K.S.A. 65-1632, the applicant shall be entitled to a renewal of registration if no grounds exist for denying the renewal.
- Reciprocating to another state
Length of time a Kansas pharmacy must keep controlled substance records.
5 years from the date of the last entry
The allowable number of refills for phentermine prescribed for treatment of obesity in Kansas.
0
health departments and private not for profit family planning clinics
What can they have? and do?
PIC responsibilities:
- What do they need to develop?
- What do they need to perform and how often?
- Assure adherence to?
- Records of?
- • May store and distribute non-controlled drugs approved for a formulary
- PIC responsibilities
- Develop policies & procedures for distribution and control of drugs
- Perform and document quarterly checks of drug storage conditions and drug records
- Assure adherence to prepackaging procedures & label requirements
- Adequate records of drug distribution by nurse(s) maintained
Allowable time to complete a partial fill for CII for a patient residing in a LTCF.
Within 60 days of the date of issue.
Drug Efficacy Study Implementation Project (DESI) - What was the Objective? - What happened in 2006?
- Evaluate OTC and Rx drugs for efficacy that were approved between 1938 and 1962 - Removing unapproved drugs from the market.
What can registration for a pharmacy also include and what dont you have to do?
The issuance of a registration for any pharmacy shall also have the effect of permitting such pharmacy to operate as a retail dealer without requiring such pharmacy to obtain a retail dealer’s permit. On evidence satisfactory to the board:
- That the pharmacy for which the registration is sought will be conducted in full compliance with the law and the rules and regulations of the board;
- that the location and appointments of the pharmacy are such that it can be operated and maintained without endangering the public health or safety; and
- that the pharmacy will be under the supervision of a pharmacist, a registration shall be issued to such persons as the board shall deem qualified to conduct such a pharmacy.
Collaborative Drug therapy Management CDTM advisory committee
How many members and from where?
What is the purpose?
- 7 members from BOP and Board of Healing Arts
- Purpose: promote consistent regulation and enhance coordination among boards with jurisdiction over licensees involved in collaborative drug therapy management.
- advise and make recommendations to the Board of Pharmacy and Board of Healing Arts on matters relating to collaborative drug therapy management
Maximum amount of pseudoephedrine base that may be sold to a purchaser in a day
3.6 g (base)
Board Disciplinary Actions
- Who files a petition?
- Board and ______ can enter into what?
- What can be scheduled?
- What else can be scheduled
- There is an opportunity for?
- Enter board and licensee may enter into stipulations
- A hearing can be scheduled
- A formal hearing can be scheduled
Automated drug delivery systems
What are the PICs responsibilities? 5
How often should it be checked for accuracy?
- maintain the system
- Assuring the stocking, accounting and dispensing is accurate
- Assuring confidentiality
- Limit loading and unloading to R.PH, intern or tech
- Security maintanence
- Inspected for accuracy at least monthly and it is the PIC responsibility
Allowable number of times and/or length of time a pharmacist may refill a CIII or CIV prescription, if authorized.
5 x or 6 months whichever comes first
A PIC must notify the Board in writing within _________ of ceasing to serve as PIC.
5 days
Medical Care Facility Pharmacy
- Need adequate what?
- Supervise and train?
- preparation of?
- What type of medication review?
- Check whaaaa?
- What can a tech check? 5 things
- What does the checking tech need?
- Has a current?
- Has either one of the following
- Experience for how long? Plus
- Or?
- And has to take what?
- Adequate drug information references
- Supervision and training of technicians
- P & P for preparation of IV’s
- 7-day “after-the-fact” review of medication orders (68-7-11(l)) -Each medication order shall be reviewed by a pharmacist within seven days of the date it was written
- Security
- Tech-check-Tech requirements (68-7- 11(q)) • Note the technician requirements—-
- Except with regard to drugs that have not been checked for accuracy by a pharmacist after having been repackaged, prepackaged, or compounded in a medical care facility pharmacy, a pharmacy technician in a medical care facility may check the work of another pharmacy technician in filled floor stock, a crash cart tray, a unit dose cart, or an automated dispensing machine if the checking pharmacy technician meets each of the following criteria: (1) Has a current certification issued by the pharmacy technician certification board or a current certification issued by any other pharmacy technician certification organization approved by the board. Any pharmacy technician certification organization may be approved by the board if the board determines that the organization has a standard for pharmacy technician certification and recertification not below that of the pharmacy technician certification board; (2) has either of the following experience levels: (A) One year of experience working as a pharmacy technician plus at least six months experience working as a pharmacy technician in the medical care facility at which the checking will be performed; or (B) one year of experience working as a pharmacy technician in the medical care facility at which the checking will be performed; and (3) has successfully completed a written training program and related examination designed by the pharmacist-in-charge of the medical care facility pharmacy to demonstrate competency in accurately checking whether floo
Allowable time to complete a partial fill for CII for an ambulatory patient.
Within 72 hours of the first partial fill
Confidentiality
Priviledged comi
The confidential communications between a licensed pharmacist and the pharmacist’s patient and records of prescription orders filled by the pharmacist are placed on the same basis of confidentiality as provided by law for communications between a physician and the physician’s patient and records of prescriptions dispensed by a physician. Nothing in this subsection shall limit the authority of the board or other persons, as provided by law, from inspecting the book or file of prescription orders kept by a pharmacy or firm performing any duty or exercising any authority as otherwise provided by law.
CE
How many hours?
What are some restrictions to the CEs that can count?
What needs to be furnished?
Within ___ days of completion?
When can you carry over hours?
- Thirty clock-hours of continuing education shall be required for renewal of a pharmacist license during each licensure period. Continuing education clock-hours may be prorated for licensure periods that are less than biennial at a rate of 1.25 clock-hours per month.
- Continuing education programs shall not include in-service programs, on-the-job training, orientation for a job, an education program open to the general public, a cardiopulmonary resuscitation (CPR) course, a basic cardiac life support (BCLS) course, emergency or disaster training or direct experience at a healthcare facility under a code blue, testing out of a course, and medical school courses
- Each provider shall furnish a certificate of completion to the licensee for each continuing education program that the licensee has successfully completed. Each certificate shall be in a format approved by the board and shall include the following: (A) The licensee’s name; (B) the title and date of the approved continuing education program; (C) the name of the provider, D) the number of continuing education clock-hours approved by the board; (E) the number of continuing education clock-hours completed by the licensee; (F) the approved program number issued by the board; and (G) the provider’s dated signature, certifying program completion
- Within 30 days of completion, each licensee shall submit to the board proof of completion of any approved continuing education program not reported to the ACPE-NABP CPE monitor service. No credit shall be given for any certificate of completion received by the board after the June 30 expiration date of each licensure period.
- A licensee shall not be allowed to carry forward excess clock-hours earned in one licensure period into the next licensure period
- The required continuing education shall be obtained in the two-year licensure period ending on the June 30 expiration date of each license.
Minimum required equipment
- Equipment and supplies to compound in good repair and available in sufficient quanitity to meet the needs of practice
- Note this requirement is for other than medical care facility pharmacy
Pharmacy Interns or Students
- Who do they register with?
- What must be displayed
- How many hours?
- Once they are registered?
- How many interns can a preceptor supervise?
- When you get newly employed what do you have to do and what time frame
- What if you move?
- Must register with the board
- Must display registration at work
- Must get 1740 preceptor supervised hours
- Once registered have to get them within 6 years
- Preceptor can only supervise 2 interns
- Within 30 days of getting a new job need to tell the board
- Must tell board within 30 days of moving, changing email, or legal name.
DEA form used to report disposal or destruction of CS.
DEA form 41
Patient medication profile requirements
5 things and how long do they need to keep them?
- Pt name and address
- Prescriber name
- Initial date of dispensing Rx number
- Drug name, strength and quantity dispensed
- Name of dispensing pharmacist
- Drug allergies or sensitivities
- Retain 5 years from date of last entry
Registration as a pharmacy: what type of pharmacies are included?
When does it need to be renewed?
What must be displayed?
When open?
Designate?
- Retail pharmacy non-resident pharmacies and hospital pharmacies (termed medical care facility pharmacies)
- Renew with the board of pharmacy annually (expires on june 30th)
- Display the registration
- Have a pharmacist on duty when open
- Designate a PIC
Pharmacy Functions in Refilling
- How can they be refilled?
- Fill all scripts with strict conformity of direction except? 4 exception
- Rx cannot be refilled more than authorized or after one year following the date of issuance whichever is first
- Except:
- Providing a 3 monts supple of rx drug that is not a CS or psychotherapeutic drug if sufficient number of refills to do so
- Dispense a 7 day emergency refilling
- Exercise brand substitution brand exchange if in compliance with the orange book
- Exercise biologic exchange if in compliance with the purple book
Length of time in which a pharmacy must notify the local DEA Diversion Field Office after discovery of a theft or significant loss of a CS
Within one business day
Script transfer and Faxing
How can control substances be transferred?
What can pharmacy interns do?
- CS must be between two licenses pharmacists
- Interns can transfer non CSs
Number of days a physician may administer methadone to a patient while waiting for admission to a narcotic treatment program.
3 days, one day at a time
How frequently must a community pharmacy submit dispensing data to KTRACS?
Within 24 hours of being dispensed unless exempted or filling a zero report
Durham Humphrey Amendment to the FDCA - What did it differentiate? - What did prescription drugs have to carry? - This was in order to comply with what?
Differentiation between OTC from prescription (legend) drugs - Required prescription drugs to Carry “Caution federal law prohibits dispensing without a prescription or RX only - This was in order to comply with adequate directions for use.
Allowable number of times and/or length of time a Kansas pharmacist may refill a CV prescription, if authorized.
5 x or 6 months whichever is first
Resposibility of PIC
- Assure that tech training?
- What is reviewed and when?
- What needs to be available and why?
- Notifies board of?
Ratio to pharmacists
- Two scenerios
- Assure the tech course of training addressess specific topics designed for the pharmacy
- Training course is annually review
- Documentation of training must be provided for inpection
- PIC tells the board when the effective date of tech employement is
- 2:1 or 3:1 if two have current certification by the pharm tech certification board.
Home Health Agencies and Hospice
May handle and store specific drugs identified by written protocol with a pharmacy and approved by the PIC. • Quarterly checks required by PIC • Allowable drugs: • Sterile water and saline for injection or irrigation • Heparin flush • diphenhydramine injection • epinephrine injection
The controlled substance schedule of oral diphenoxylate with atropine.
CV
CQI Procedures
- If the pharmacist is aware of an Incident?
- WHos responsible for prepare the report and how do you report it?
- How long is the report retained for and when must you be able to provide it to the board?
- Reports are? Except?
- Pharmacists aware of an incident must report it to PIC as soon as practical
- Involved pharmacist and PIC are responsible for preparing the report
- Complainant’s name, address, age, phone number
- Name of each employee involved & license number
- Date of incident & date of report
- Pharmacist’s description of incident
- Prescriber’s name and whether contacted
- Signatures of all involved employees
- Report retained for 5 years and available to board within 3 business days, if requested
- Reports non-discoverable except by the board of pharmacy
The length of time a DEA “Dispenser” registration is valid.
3 years
Requirements for electronic data storage systems
7
What must you be able to reproduce and in what time frame.
- Daily back up is performed
- Maintain a written rx on file
- Have a numerical system for rx ID
- Maintain a written or electronic daily log
- Store each active pt profile
- Document that pharmacist is responsible for each authorization refill
- ID on a daily basis the pharmacist fill Rxs
- Able to reproduce all information in the system in written form within 72 hours of being requested
What are the 3 categories of option claims that a DS can have?
- Structure/function claims-
- But the manufacturer needs to be able to substantiate these claims are truthful and not misleading
- Need to notify FDA within 30 days of making the claim
- But must conatin disclaimer that it isnt evaluated by the FDA -
- Health Claims
- relationship of DS to a disease or condition
- this is generally not permitted unless the FDA has promulgated a regulation re: conditions and labeling
Nutritional Support Claims- highlight nutritional attributes of a product.
Pharmacist licensure
- How old do you have to be?
- Graduate where?
- Complete a minimum of?
- What do you have to pass and what score?
- What may be required?
- When might you have to notify the board
- 18 years old
- Board approved school
- Once year of preceptor supervised 1740
- Pass NAPLEX and MPJE with 75
- May need to get finger printed and criminal background check
- Notify board within 30 days of changing residential address or email address
Incident reports in other than a med care facility
68-7-12b
Retail dealer
means a person selling at retail non-prescription drugs which are prepackaged, fully prepared by the manuf. for use by the consumer. Shall NOT include: • controlled substances • legend drugs • drugs administered by injection
Vaccination protocol
- What is it?
- How long is it valid?
- Written physician approved policies and procedures for record keeping, reporting and adminitering vaccines
- No greater than 2 year validity.
Utilization of Unused meds
What is the objective?
What are the donating entities?
What is a qualifying center or clinic?
Donated meds are considered?
Read study guide
- To make available unused medications to medically indigent (voluntary)
- Donating:
- LTCF, mail service pharmacies, hospital pharmacies
- Qualifying center or clinic mean indigent health clinic federally qualified health center, or community mental health center.
- Donating meds are not considered resold
The maximum amount of codeine (mg) per dosage unit combined with one or more active, non‐narcotic ingredients to be scheduled as a CIII.
90 mg
Indigent health clinic, Federally-qualified health center (65-1648)
• Supervised by PIC • RN or PA approved by the PIC shall be in charge of distribution and control of drugs • No regulations yet
Kefauver Harris - What proof did we need? - What did it establish? - Increased controls over? - What did it give the FDA the authority to do?
Required proof of efficacy prior to marketing - Established current GMP requirements - Increased controls over clinical investigations (informed consent) - Gave FDA authority over Rx drug advertising.
Additional responsibilities of the PIC
Maintain written P and P that Address?
4 things
- Function of all personell
- Control and accountability of drugs in compliance with fed/state law
- Documentation of reportable incidents
- Maintenance of records of dispensing, prepackaging, and compounding
Prescription Label Requirements
What needs to be on it?
What drugs need and Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed.
II, III, IVs
Prescription drug labels what schedules need this sticker
