Law All (S18-W)
What does the *Orange* book include?
*All FDA-approved drug products* (NDA, OTC, ANDA) *Products that have been discontinued or had their approvals w/drawn for reasons other than safety or efficacy* *Therapeutic equivalence evals for MULTI-SOURCE products* -compares generic products to RLD's/brand drug(s)
How does KS define the *Practice of Pharmacy*?
*Interpreting, evaluating* Rx orders, *compounding, dispensing, labeling, drug selection, administering* vaccine, participating in DUR, proper and safe drug storage, maintenance of proper records, operating and 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
Where do *states* have the authority to regulate?
*Intra*state (issues of professional practice) (In areas not delegated to the federal government)
When should the DEA be notified about changes to a registration?
*Modify* (e.g. location change) *Terminate* *Transfer business to another registrant*
Patient-directed labeling includes?
*PPIs* (patient package inserts) *CMI* (consumer medication info) *MedGuides* *REMS* (risk evalu & mitigation strategies)
What can be done to prepare or manage DEA inspections?
*Proactively prepare* (maintain, review, and update CS polices and procedures) *Examine agent(s)' credentials, obtain business cards, and ascertain the purpose* *Take detailed notes of what was said, done and suggested* during inspection *Answer questions asked but do not speculate* (silence is preferable than incriminating statements) *Request for final discussion or exit interview w/ inspectors*
How can a Rx drug be switched OTC status?
*SNDA* (approved by FDA) FDA may create or amend an OTC monograph Manufacturer may petition FDA to make the switch
How much codeine is considered *CIII*?
*≤1.8 g* per 100 mL *≤90 mg* per dosage unit w/ 1 or more active non-narcotic ingredient
How much morphine is considered *CIII*?
*≤50 mg* per 100 mL *≤100 g* w/ 1 or more active, non-narcotic ingredients in recognized therapeutic amounts
# of times a *CII* prescription can be transferred
0
The allowable # of refills for phentermine prescribed for tx of obesity in KS.
0
# of times a *CIII, CIV, or CV* prescription (with refills) can be transferred in KS if pharmacies do not share real-time computer system
1
How many times can a *plastic CR container & lid* be used for dispensing?
1
How many times can a CIII-CV prescription be transferred?
1
Schedule? Heroin
1
Schedule? Marijuana
1
Schedule? Mescaline
1
Schedule? Peyote
1
What FDA *number*classification of a new drug indicate *a new molecular entity*?
1
Which copy of DEA 222 form? Supplier's copy
1
Which human clinical trail phase determines *safety* and detect *adverse effects*?
1
When a pharmacy orders CII drugs via DEA Form 222, which of the triplicate form(s) is/are sent to the supplier?
1 & 2
What copies of DEA 222 form is mailed to supplier?
1 and 2
BUD? *immediate* risk *sterile* compounds stored at *room temp*
1 hour
Refusing a FDA inspection can lead to?
1 year in prison and/or up to $1000 fine
BUD? Repackaging of non-sterile multiple-unit and solid and liquid single-unit containers
1 year or expiration date on manufacturers' container (whichever is earliest) unless there is stability data (must not exceed manufacturer's expiration date)
Case: A large hospital pharmacy employs 20 pharmacists and 35 techs. The PIC would like to decrease the amt of time pharmacists spend checking the accuracy of tech work so would like to initiate a tech-check-tech program. *What the legal experience requirements in order for techs to participate in tech-check-tech?*
1 yr tech work in the medical care facility at which the checking will be performed *OR* 1 year tech experience PLUS 6 mos experience working at facility at which the checking will be performed *plus* Successfully completing a written training program and exam to demonstrate competency
How long will it take for new drugs classified as *S*?
10 months
How long is an NDC?
10 or 11 digits
DEA form used by pharmacists to report theft or significant loss
106
DEA form? Must be submitted when a CS loss occurs
106
Pharmacist may sell no more than ____ mL or ____ doses of codeine-containing CV OTC in ___ hours.
120; 24; 48
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
BUD? *Low* risk *sterile* compounds when *refrigerated*
14 days
In the absence of stability info, what is the maximum BUD for *non-sterile* compounds of *water-containing oral* formulations?
14 days when stored at controlled cold temps (2°-8°C or 36°-46°F)
How many preceptor-supervised clocked hours of experience is required in KS for pharmacist interns or students?
1740
The minimum age of individuals allowed to purchase *CV-OTCs* in KS.
18 years
What is required to be purchase *guaifenesin w/ codeine* OTC (CV)?
18 yo ID (if RPh does not know them)
How old must a person be to purchase ephedrine, PSE or phenylpropanolol products OTC?
18 yo (KS)
Some Rx drugs are said to be "grandfathered" onto the market. This means they must have been on the market prior to?
1938
When did the *FDCA* get enacted?
1938
When did Durham-Humphrey Amendment get added to the FDCA?
1952
When did the Kefauver-Harris Amendment get added to the FDCA?
1962
How many interns can a preceptor supervise at one time?
2
How many witnesses are required for POA statement?
2
Schedule? Amphetamine
2
Schedule? Amphetamine/dextroamphetamine
2
Schedule? Belladonna extract & opium suppositories
2
Schedule? Cocaine
2
Schedule? Codeine (uncombined)
2
Schedule? Fentanyl
2
Schedule? Hydrocodone
2
Schedule? Hydrocodone combination products
2
Schedule? Hydromorphone
2
Schedule? Levorphanol
2
Schedule? Lisdexamfetamine
2
Schedule? Meperidine
2
Schedule? Methadone
2
Schedule? Methamphetamine
2
Schedule? Methylphenidate
2
Schedule? Morphine
2
Schedule? Nalbuphine
2
Schedule? Opium tincture
2
Schedule? Oxycodone (uncombined)
2
Schedule? Oxycodone combination products
2
Schedule? Oxymorphone
2
Schedule? Pentobarbital
2
Schedule? Secobarbital
2
Schedule? Tapentadol
2
What FDA *number*classification of a new drug indicate *a new salt or ester form*?
2
Which copy of DEA 222 form? DEA's copy
2
Which human clinical trail phase determines *efficacy* of the drug and the *dosages* at which efficacy occurs?
2
Transfer of CS prescriptions is communicated between?
2 licensed pharmacists
An immunization protocol is valid for no longer than what period of time?
2 years
How long are technicians registrations good for?
2 years
How long is a *vaccination protocol* valid for?
2 years
How long must CS records be kept per *federal* law?
2 years
The license of a KS pharmacist is valid for what period of time?
2 years
What is the statute of limitations in KS for malpractice lawsuits?
2 years (but no longer than 4 y beyond time of the act if not ascertainable initially)
CS Rx storage method? All CS file, all non-CS file
2-file method
CS Rx storage method? CII file, All other CS + non-CS file
2-file method
How many hours of CE must a technician complete and in what timeframe?
20 q 2 years
The maximum amt of codeine (mg) per 100 mL or 100 g combined with 1 or more active, non-narcotic ingredients to be scheduled as a *CV*.
200
What title of the CFR houses the *drug-related* regulations?
21
DEA form used to order *CII* substances
222
DEA form? Used if registrant is using reverse distributor to dispose or destroy CIIs
222
What DEA form must be used to distribute *CII* drugs?
222
What DEA form must be used to purchase *CII* drugs?
222
DEA form used to register for CS dispensing.
224
What DEA form is used to apply for registration for CS?
224
To apply to the DEA for registration as a "Dispenser", a person must complete DEA form ___. If granted, the registration remains in effect for how long?
224; 3 years
What DEA form can be used by corporations to register w/ DEA?
224b
Per KS law, what is the limitations on dispensing for an *optometrists*?
24 h supply or minimal quantity necessary until Rx can be filled by RPh (lenses not included)
BUD? *High* risk *sterile* compounds stored at *room temp*
24 hours
What is the ratio of techs to RPh?
2:1 3:1 (If 2 are certified)
How many phases of human clinical trials are there for a new drug?
3
Schedule? APAP w/ codeine tablets (>200 mg/100 mL or grams)
3
Schedule? Buprenorphine
3
Schedule? Buprenorphine, naloxone
3
Schedule? Butalbital w/ APAP, caffeine and codeine
3
Schedule? Butalbital w/ ASA, and caffeine
3
Schedule? Butalbital w/ ASA, caffeine, and codeine
3
Schedule? Codeine combinations (containing not >90 mg/dose)
3
Schedule? Methyltestosterone
3
Schedule? Paregoric
3
What FDA *number*classification of a new drug indicate *new form or formulation*?
3
Which copy of DEA 222 form? Purchaser's copy
3
Which human clinical trail phase *tests for safety and efficacy*?
3
How long does a pharmacy have to retrieve an *incident* report and make it available to the BOP if requested?
3 business days
BUD? *High* risk *sterile* compounds when *refrigerated*
3 days
# of days a physician may *administer* methadone to a patient while awaiting for admission to narcotic tx program
3 days (1 at a time)
How long are *dispenser* registrations valid for?
3 years
The length of time a DEA "dispenser" registration is valid.
3 years
CS Rx storage method? CII file, CIII-CV file, non-CS file
3-file method
Maximum amount of pseudoephedrine base that may be sold to a purchaser in a day
3.6 g (base)
Combat Methamphetamine Epidemic Act: Limitation per *day* of ephedrine, PSE, or phenylpropanolamine
3.6 grams of base product (regardless of transaction number)
A pharmacist must pass an exam w/in ____ days of becoming a PIC.
30
A pharmacist intern must notify the KS SOP of a change in residential or email address w/in what time period?
30 days
How long can a pharmacy operate w/o PIC in KS?
30 days
In the absence of stability info, what is the maximum BUD for *non-sterile* compounds of *water-containing topical/dermal and mucosal liquid and semisolid* formulations?
30 days
It is a violation of the KS Practice Act to operate a pharmacy w/o a PIC after what period of time?
30 days
What is the day supply limit of CS prescribed for obesity?
30 days
BUD? *Medium* risk *sterile* compounds stored at *room temp*
30 hours
What size of *ipecac* syrup can be sold as OTC?
30 mL
Schedule? Alprazolam
4
Schedule? Butorphanol tartarte
4
Schedule? Carisoprodol
4
Schedule? Chloral hydrate
4
Schedule? Clobazam
4
Schedule? Clonazepam
4
Schedule? Diazepam
4
Schedule? Diethylpropion
4
Schedule? Eszopiclone
4
Schedule? Lorazepam
4
Schedule? Meprobamate
4
Schedule? Midazolam
4
Schedule? Pentazocine
4
Schedule? Phenobarbital
4
Schedule? Phetermine
4
Schedule? Temazepam
4
Schedule? Tramadol
4
Schedule? Triazolam
4
Schedule? Zalephon
4
Schedule? Zolpidem
4
What FDA *number*classification of a new drug indicate *new combo of compounds*?
4
How long can someone serve on the KS board of pharmacy?
4 years/term (max: 2 terms)
DEA form used to report disposal or destruction of CS.
41
DEA form? Should be used for dropped tablets, spilled or crushed CS
41
DEA form? Used if registrant wants to dispose or destroy their CS themselves
41
BUD? *High* risk *sterile*compounds when frozen (≤10°C)
45 days
BUD? *Low* risk *sterile* compounds when frozen (≤10°C)
45 days
BUD? *Medium* risk *sterile*compounds when frozen (≤10°C)
45 days
BUD? *Low* risk *sterile* compounds stored at *room temp*
48 hours
How many times can a Schedule *III, IV, and V* be refilled?
5
Per KS law, PIC of *drugstores* must notify BOP in *writing* w/in how many days of *ceasing* to serve as PIC?
5
Schedule? APAP w/ codeine *elixir*
5
Schedule? Codeine combinations (≤200 mg/100 ml)
5
Schedule? Diphenoxylate w/ atropine
5
Schedule? Ezogabine
5
Schedule? Lacosamide
5
Schedule? Pregabalin
5
Schedule? Promethazine w/ codeine
5
What FDA *number*classification of a new drug indicate *essentially duplicates another drug*?
5
How long does a pharmacist have to report to the prescriber if there was a product exchange on a biological product?
5 business days
How long does a pharmacist have to submit in *CPA (collaborative practice agreement)* to the board?
5 business days (after signing)
A PIC must notify the Board w/in ____ of ceasing to serve as a PIC.
5 days
A pharmacist must submit a copy of his/her signed emergency opioid antagonist protocol to the Board w/in what period of time of signing it?
5 days
Per KS law, within what timeframe must *each registrant* notify BOP in *writing* of any *change in majority ownership*?
5 days after the change
A pharmacy must retain its Naloxone dispensing records for what period of time?
5 years
How long must CS records be kept per *Kansas* law?
5 years
How long must a pharmacist be practicing in KS to qualify to be on the board?
5 years
How long must an *incident report* be retained?
5 years
Per Kansas law, how long must CS records be kept?
5 years
How long must emergency CII fills records be kept for?
5 years (KS) 2 years (fed)
Length of time a KS pharmacy must keep controlled substance records.
5 years from date of last entry
Per KS law, how long must pt med profile be kept for?
5 years from date of last entry
A pharmacy may distribute what % of the total CS units it distributes and dispenses in a year w/o having to register as a distributor?
5%
Schedule? Guaifenesin w/ codeine liquid or syrup
5-OTC (if allowed by state law)
Schedule? Ephedrine (compound, mixture, or preparation containing any detectable amount)
5-OTC (KS)
Schedule? Pseudoephedrine (compound, mixture, or preparation containing any detectable amount)
5-OTC (KS)
Which section of title I of DQSA (Drug quality and security act)? *Traditional compounding* must meet certain conditions and describes conditions under which compounding human drug products are exempt from sections of the FDCA requiring *compliance w/ cGMP, labeling w/ adequate directions for use, and FDA approval prior to marketing*
503A
Allowable # of times and/or length of time a KS pharmacist may refill a *CV prescription*, if authorized.
5x or 6 mo (whichever comes first)
Allowable # of times and/or length of time a pharmacist may refill a *CIII or CIV prescription*, if authorized
5x or 6 mo (whichever comes first)
Per Kansas law, how refills are allowed for CIII to CV rx?
5x or 6 months from date of issue (whichever comes first)
What FDA *number*classification of a new drug indicate *product previously market by same firm*?
6
CII prescription is valid for ___ from its date of *issue*
6 months
How long is Schedule *II, III, IV, and V* prescription good for?
6 months
How long will it take for new drugs classified as *P*?
6 months
How long are *CII* prescriptions valid for?
6 months (KS)
Per Kansas law, how long is CII rx valid for?
6 months from date of issuance
What is the expiration date for partial refills of *CIII-V*?
6 months from date of issuance
In the absence of stability info, what is the maximum BUD for *non-sterile* compounds of *non-aqueous* formulations?
6 months or earliest expiration date of any active pharmaceutical ingredient (whichever is earlier)
BUD for Compounded non-sterile preparations? Non-aqueous formulations
6 months or expiration date of any active ingredient whichever is earlier
Per HIPAA, how long must records be kept for?
6 years (from last entry)
Per KS law, what date does a *pharmacy* registration expire?
6/30
Allowable time to complete a partial fill for CII for a patient residing in a *LTCF*
60 days
Allowable time to complete partial fills on a *CII* prescription for a patient diagnosed *terminally ill*
60 days
How long is a completed DEA 222 form valid for?
60 days
How long can CII partial fills be dispensed for terminally ill or LTCF patients?
60 days from issue date
A pharmacy may partially fill a C-II med for a pt diagnosed as terminally ill for a maximum of ____ days form ____ date.
60; issue
Per KS law, how many days can a pharmacist dispense for an *emergency* refill?
7
How many members are on the *collaborative drug therapy mgmt* advisory committee?
7 (From BOP and Healing Arts)
Time a pharmacist has to obtain the original prescription form a physician for an emergency CII
7 days
Combat Methamphetamine Epidemic Act: Limitation within *30 day* if purchase ephedrine, PSE, or phenylpropanolamine by mail order
7.5 gram of base product
Technicians registered after ____ must pass PTCB or ExCPT exam before next renewal.
7/1/17
Allowable time to complete a partial fill for CII for an *ambulatory patient*
72 h
Electronic data storage must be able to reproduce all info in written form w/in?
72 h
Length of time a pharmacist has to verify accuracy of the computer record for filling/refilling of *CIII/CIV* prescriptions.
72 h
Per KS law, within what timeframe must a *new* PIC conduct a CS inventory after starting as PIC?
72 h
W/in ___ after beginning to function as a PIC, the PIC shall conduct a CS inventory
72 h
When must a partial fill for *CII* be completed by?
72 hours of partial fill (must notify prescriber if not completed)
What is the minimum score to pass Naplex or MPJE?
75
What chapter of the USP/NF addresses *non-sterile* preparations for pharmaceutical compounding?
795
What chapters of the USP/NF are pharmacy related?
795, 797, 800
What USP chapter addresses sterile compounding and is more strict than KS law?
797
What chapter of the USP/NF addresses *sterile* preparations for pharmaceutical compounding?
797
Following the initial CS inventory, a registrant must conduct the next CS inventory within what time frame?
8-12 mos after
What chapter of the USP/NF addresses *handling hazardous drug* for pharmaceutical compounding?
800
BUD? *Medium* risk *sterile* compounds when *refrigerated*
9 days
Maximum amount of pseudoephedrine that can be sold to a purchaser in 30 days.
9 g (base)
Combat Methamphetamine Epidemic Act: Limitation per *30 day* period of ephedrine, PSE, or phenylpropanolamine
9 gram of base product
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
Maximum # of days supply that may be prescribed and dispensed on multiple CII prescriptions.
90 days
What chapters of the USP/NF are enforceable by FDA under the FDCA?
<1000
How much codeine need to be in combination are considered schedule *3*?
>200 mg/100 mL or grams
What amount of codeine in *antitussives/expectorants* are considered *CIII*?
>200 mg/100 mL or grams
What letter represents drugs that *are* substitutable in the *Orange* book?
A
What are the steps in Board disciplinary actions?
A petition is filed by one of several entities Board & licensee may enter into *stipulations* A *hearing* may be scheduled A *formal hearing* may be scheduled Opportunity for appeal
What letter(s) in a DEA # designates an *individual practitioner*?
A, B, F, G
Per KS law, what type of *oral drugs* may be prescribed by an *optometrist*?
ABX (bacterial, viral) Antihistamines Analgesics Steroids Anti-glaucoma Other drugs w/ clinically accepted ocular uses
Drug(s)? Schedule 5
APAP w/ codeine elixir Codeine combo (≤200 mg/100 ml) Diphenoxylate w/ atropine Ezogabine Lacosamide Pregabalin Promethazine w/ codeine
Drug(s)? Schedule 3
APAP w/ codeine tablets Buprenorphine Buprenorphine, naloxone Butalbital w/ ASA and caffeine Butalbital w/ ASA, caffeine, and codeine Butalbital w/ APAP, caffeine and codeine Codeine combinations (≤90 mg/dose) Methyltestosterone Paregoric
Type of practitioner? May not dispense drugs other than samples pursuant to protocol
APRN
Type of practitioner? May prescribe non-controlled or CS pursuant to written *protocol* authorized by a responsible physician
APRN
Type of practitioner? Written prescriptions must include: -Name, address and phone # of *practice location* for prescriber -Name, address and phone of responsible physician -Signature of prescriber followed by credential -Be from class of drugs prescribed pursuant to protocol -DEA # of prescriber
APRN
When should pharmacists aware of an *incident* report it to the PIC?
ASAP
What are the steps to verifying a DEA #?
Add 1st, 3rd, and 5th number together Add 2nd, 4th, and 6th numbers and multiply by 2 Add step 1 to 2 (last digit of sum should be the last digit in DEA#)
What did the *PDMA* do? (Prescription drug marketing act)
Address problems of drug diversion by: -Place controls over prescription drug sampling -Place restrictions on resale of prescription drugs by hospitals & other HC entities -Require state licensing of drug wholesalers -Limit re-importation of exported US produced drug to original manufacturer
Term? The direct application of a drug, whether by injection, inhalation, ingestion or any other means, to the body of a pt or research subject by: -Practitioner or pursuant to the lawful direction of supervisor -pt or research subject at the direction and in the presence of the practitioner -RPh
Administer
Per Secure and Responsible Drug Disposal Act: Retail pharmacies, hospitals or clinic pharmacies may voluntarily become authorized collectors and:
Administer *mail-back* programs Maintain *collection receptables* w/in pharmacy Manage a collection receptable at a *LTCF*
If presented, entry/inspection must be permitted by the registrant?
Administration Inspection Warrant
What allows the DEA to inspect during regular business hours (which does NOT mean at the convenience of the owner)?
Administration Inspection Warrant
What may be obtain by DEA if registrant consent for inspection was withheld or withdrawn from an inspection?
Administration Inspection Warrant
What are the 2 main FDCA violations?
Adulteration Misbranding
What provided addl funding to fight fraud and integrate data from CMS and other federal programs?
Affordable Care Act
What *can* be changed on a *CII* prescription?
After consulting with prescriber: Add a date (if no date); Drug strength, quantity, SIG Add pt's address, DEA# Select dosage form if one not written
Exceptions to DEA registration requirement include?
Agents or employees of a registrant acting w/in scope of employment & licensed by state (individual practitioners employed by a hospital, *pharmacists*) Officials of law enforcement, armed services, Coast guard, PHS, Bureau of Prisons authorized to prescribe, dispense or administer (may NOT purchase CS)
What drugs did the Kefauver-Harris Amendment apply to?
All drugs made since 1938
Drug(s)? Schedule 4
Alprazolam Butorphanol tartrate Carisoprodol Chloral hydrate Clobazam Clonazepam Diazepam Eszopiclone Lorazepam Meprobamate Midazolam Pentazocine Phentermine Phenobarbital Temazepam Tramadol Triazolam Zaleplon Zolpidem
Drug(s)? Schedule II
Amphetamine Amphetamine/dextroamphetamine Belladonna & opium suppositories Cocaine Codeine (uncombined) Fentanyl Hydrocodone Hydrocodone combination products Hydromorphone Levorphanol Lisdexamfetamine Meperidine Methadone Methamphetamine Methylphenidate Morphine Nalbuphine Opium Tincture Oxycodone (uncombined) Oxycodone combination products Oxymorphone Pentobarbital Secobarbital Tapentadol
Per KS law, what are CIII drugs?
Anabolic steroids Not *>1.8 g of codeine per 100 mL* or *>90 mg per dosage unit* w/ one or more active non-narcotic ingredient Not >50 mg of morphine per 100 mL or per 100 grams w/ one or more active, non-narcotic ingredient
Per KS law, how often must *pharmacy* renew w/ BOP?
Annually
Which law? Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal health care program business
Anti-Kickback Statute
Term? Used to describe a product approved under a NDA by an innovator (brand) company and who, in the face of pending generic competition repackages the product and markets it as a generic under another label
Authorized generic
Tips on how to stay out of trouble and avoid common sources of liability include?
Avoid factors associated w/ dispensing errors -Evaluate work area; use a systems approach Execute your professional duties (counsel) Avoid 'unprofessional conduct' -Convey to each pt that you have concern and respect for them Take all errors seriously -Never alter the facts to make it sound less like a problem Document, document, document -clear, concise, correct, clinically relevant Carry personal malpractice insurance
What letter represents drugs that *are not* substitutable or inequivalent in the *Orange* book?
B
Per KS law, obesity is defined as?
BMI ≥ 30 or ≥ 27 w/ other risk factors
Term? Date after which a dispensed product should no longer be used
BUD (beyond use date)
Drug? Exempt from CR packing if ≤12.6 mg of drug per package
Betamethasone
What are some examples of *Medicare Fraud*?
Billing for non existent Rxs, brand name drug when generic is dispensed, rx dispensed but never picked up Splitting rxs in order to receive addl dispensing fees Drug diversion Steering a pt to a Part D plan if it benefits their pharmacy
What act defined *biologicals* and amended the Public Health Service Act to create a pathway for products to demonstrate they are *biosimilar* or *interchangeable* w/ already licensed products?
Biologics Price Competition and Innovation Act
Case: A woman stopped by her local community pharmacy to pick up her husband's prescription shortly after the store opened. She was handed a bagged prescription by an individual working behind the counter. When she requested to talk with the pharmacist, she was told that the only scheduled pharmacist had called to say she would be late. If you feel the situation does pose a legal problem, what regulatory entity do you think has jurisdiction over the situation?
Board of Pharmacy (state)
What are specific labeling requirements for *Ipecac*?
Boxed emergency use legend Keep out of reach of children Dosage: 1 tablespoon (15 mL) in persons over 1 year of age
Term? Impermissible use or disclosure of info that compromises security or privacy of PHI
Breach
The FDA considers which of the following factors to be crucial in determining whether a product is considered to be a "drug" under the FDCA? a. whether the product is chemical entity b. whether the product is safe and effective c. whether the manufacturer claims that the product will treat a disease d. whether the purchaser intends to use the product to treat a disease
C
Heroin
C-I
Marijuana
C-I
Mescaline
C-I
Peyote
C-I
Amphetamine (Adderall)
C-II
Amphetamine and Dextroamphetamine (Adderall)
C-II
Belladonna extract & opium suppositories
C-II
Cocaine
C-II
Codeine (uncombined)
C-II
Fentanyl (Duragesic)
C-II
Hydrocodone combination products
C-II
Hydromorphone (Dilaudid)
C-II
Levorphanol (Levo-Dromoran)
C-II
Lisdexamfetamine (vyvanse)
C-II
Meperidine (Demerol)
C-II
Methadone (Dolophine, methadose)
C-II
Methamphetamine (Desoxyn)
C-II
Methylphenidate (Ritalin, concerta, quillivant, methylin, daytrana)
C-II
Morphine (MS Contin)
C-II
Nalbuphine (Nubain)
C-II
Oxycodone (Oxycontin, Roxicodone)
C-II
Oxycodone combination products
C-II
Oxycodone with Acetaminophen (Percocet, Endocet)
C-II
Oxymorphone (Opana)
C-II
Pentobarbital (Nembutal)
C-II
Secobarbital (Seconal)
C-II
Tapentadol (Nucynta)
C-II
hydrocodone
C-II
hydrocodone/acetaminophen (Norco, Vicodin, Hycet, Xodol)
C-II
opium tincture
C-II
APAP with codeine tablets (tylenol # 3)
C-III
Buprenorphine (Buprenex, Subutex)
C-III
Buprenorphine with Naloxone (suboxone)
C-III
Butalbital, ASA, and Caffeine (Fiorinal)
C-III
Butalbital, ASA, caffeine, and codeine (Fiorinal w/ codeine, Ascomp)
C-III
Butalbital, Acetaminophen, Caffeine, and codeine (Fioricet with codeine)
C-III
Codeine combination containing no > 90 mg/dose
C-III
Codeine combinations > 200 mg/100 mL or grams
C-III
Methyltestosterone (android)
C-III
Paregoric (camphorated opium tincture)
C-III
Alprazolam (Xanax)
C-IV
Butorphanol tartrate (Stadol)
C-IV
Carisoprodol (Soma)
C-IV
Choral hydrate (somnote)
C-IV
Clobazam (Onfi)
C-IV
Clonazepam (Klonopin)
C-IV
Diazepam (Valium)
C-IV
Diethylpropion (Tenuate, Durad)
C-IV
Eszopiclone (Lunesta)
C-IV
Lorazepam (Ativan)
C-IV
Meprobamate (Miltown)
C-IV
Midazolam (Versed)
C-IV
Pentazocine (Talwin)
C-IV
Phenobarbital (Luminal)
C-IV
Phentermine (Adipex-P)
C-IV
Temazepam (Restoril)
C-IV
Tramdol (ultram)
C-IV
Triazolam (Halcion)
C-IV
Zaleplon (Sonata)
C-IV
Zolpidem (Ambien)
C-IV
APAP with codeine elixir
C-V
Codeine combinations (≤ 200 mg/100 mL)
C-V
Diphenoxylate with Atropine (Lomotil)
C-V
Ezogabine (Potiga)
C-V
Lacosamide (Vimpat)
C-V
Pregabalin (Lyrica)
C-V
Promethazine with Codeine
C-V
What schedule of controls are exempt from the transfer label requirement?
C-V
guaifenesin/codeine liquid or syrup (Cheratussin AC)
C-V OTC
Pseudoephedrine (Sudafed) - compound, mixture, or preparation containing any detectable amount
C-V OTC (KANSAS)
Ephedrine - compounding, mixture, or preparation containing any detectable amount - ephedrine inj. Is RX
C-V OTC (kansas)
Where are *federal final* regulations published?
CFR (Code of Federal Regulations)
Schedule? Records must be maintained *separately* from all other records
CI to CII
Schedule? A special DEA form is NOT required to purchase these from supplier
CIII to CV
Schedule? Records must be *readily retrievable*
CIII to CV
Schedule? Computer system may be used as alternative to a "hard-copy" system for refills
CIII-CV
Schedule? Partial fills are permitted - quantity of partial fill must be recorded in same manner as refills - on back of paper Rx or on other appropriate document
CIII-V
Which type of Patient-directed labeling? Left to the private sector and is not regulated by the government
CMI
Per Kansas law, what type of written information cannot be supplement for verbal counseling?
CMI (supplemental forms of pt info)
Document? May *NOT* authorize a pharmacist to administer flu vaccine except pursuant to the vaccine statutes/regulations
CPA (collaborative practice agreement)
Document? Must detail methods, procedures, decision criteria the RPh uses to perform, document, and communicate w/ the physician regarding CDTM
CPA (collaborative practice agreement)
Document? Must be signed and dated by each physician and pharmacist --> RPh must send a copy to the Board w/in 5 business days and must be reviewed and updated ≤2 years
CPA (collaborative practice agreement)
___ prohibits importation of CS unless importer is registered and has DEA permit/authorization.
CSA
Schedule? Per KS law, narcotic drugs containing non-narcotic active drug(s); any compound, mixture, or prep. containing the following drugs, or their salts [calculated as the free anhydrous base or alkaloid - fed CSA]
CV
What must pharmacist provide regarding MedWatch?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
What did OBRA'90 cause?
Changes in state by state practice standards Expanded pharmacist responsibilities
When is a *SNDA* required?
Changes in the product's: -production procedures -Manufacturing location -Labeling -Packaging
What key information need to be extracted for a civil case?
Characters Issue Rule Analysis Conclusion
What is required in the *NDA* process?
Chemistry Manufacturing Controls Labeling Testing *Animal studies Clinical Studies Bioavailability*
What is required in the *ANDA* process?
Chemistry Manufacturing Controls Labeling Testing *Bioequivalence*
Drugs? Pre-1938 drugs that are not listed in the *Orange* book
Chloral hydrate Hydromorphone Magnesium Sulfate Digoxin Thyroid Phenobarbital Quinine
Drug? Exempt from CR packing if up to 5 g/packet
Colestipol
Per KS law, KS pharmacists may enter into a signed ________ management arrangement.
Collaborative drug therapy
Term? 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*
Collaborative drug therapy mgmt
Examples of future cases and liability include?
Collaborative practice agreements MTM PMP (Ktracs) Employment disputes EHR Provider status Immunization Sterile compounds HIPAA
What act? Requires employers to *self-certify* annually on DEA's website and maintain documentation that each selling employee is trained to sell ephedrine, PSE< and phenylpropanolamine products
Combat Methamphetamine Epidemic Act
What must be included in an *incident report*?
Complainant's name, address, age, phone # Name of each employee involved & license # Date of incident & date of report Pharmacist's description of incident Prescriber's name and whether contacted Signatures of all involved employees
What does renewing a KS pharmacist license require?
Completion of Board-furnished application Payment of a fee Completion and documentation of CE (30 hours)
What is Title I of the *DQSA*? (Drug quality and security act)
Compounding Quality Act
What standards are including USP *795* for non-sterile compounding?
Compounding facilities and equipment Categories of compounding and compounding process Stability criteria and BUD Compounding documentation and quality control Personnel responsibilities
What must be done if unpermitted use or disclosure of *unsecured* PHI occurs?
Conduct risk assessment to determine if it is a breach -If so, notify affected individuals by method required by regulation
What is considered *adulteration* by the FDCA?
Consists of filthy, putrid, decomposed substance or is prepared/packaged, held under unsanitary conditions Preparation, packaging, and holding fails to meet GMP standards Purports to meet USP/NF standards, but fails to meet them Contains unsafe additives
What agency enforces the PPPA?
Consumer Product Safety Commission
Drug products are considered *pharmaceutical* equivalent if?
Contain the same active ingredient(s) Same dosage form Identical in strength or concentration Same route of administration
What drugs are not allowed to be sold by *retail dealers*?
Controlled substances Legend drugs Drugs administered by injection
Issues of product supply chain security include?
Counterfeiting Diversion Cargo theft Importation of unapproved or substandard drugs
Per KS law, what are required references for *drugstores*?
Current KS laws Texts -Toxicology -Pharmacology -DI -Pt focused drug reference -Drug equivalencies -Medical dictionary May include internet sources (annually updated)
What allows qualifying prescribers to prescribe CS III, IV, V opioids approved for drug addiction?
DATA
Who determines the manufacturing quotas CI and CII?
DEA
Who has the authority to schedule substances?
DEA HHS Attorney general of US
Who administers the CSA?
DEA (under the dept of justice)
What form must a physician use to obtain CII drugs for *office use* from another registrant?
DEA 222
Other records required for CS drugs?
DEA 222 forms POA forms DEA registration certificate Self-certification certificate and PSE logbook CV OTC sales logbook
Records? Must be kept at the registered site
DEA 222 forms (paper) Prescriptions (paper) Inventory records
What need to be turn in with *terminate* registration request to the DEA?
DEA certificate of registration Unused "voided" 222 forms Explanation of disposal or transfer of all CS
What should the DEA present to pharmacy to do an inspection?
DEA credentials Notice of Inspection (Form 82)
What initiative? Objective: Evaluate drugs (OTC and RX) for *efficacy* that were marketed b/w 1938 and 1962
DESI
What department is the *FDA* a component of?
DHHS (Dept of Health and Human Services)
What dept can enact regulations in HIPAA?
DHHS (dept of health and human services)
What act? Addresses issues with compounding quality in pharmacies and issues of product supply chain security
DQSA (Drug quality and security act)
What act? Creates a new section *503B*: sterile compounders may elect to become an *outsourcing facility*
DQSA (Drug quality and security act)
What act? Re-enacts *503A* of the FDCA and establishes national standards for compounding
DQSA (Drug quality and security act)
The FDCA amendment defines "dietary supplment", what health statements a supplier may make and what labeling is required is referred to as:
DSHEA
Law/Act/Amendment? Mandates the FDA to *regulate DS as a special type of food* (in contrast to a drug)
DSHEA 1994 (dietary supplement health and education act)
What type of advertising does not have any federal specific regulations?
DTC (Direct to consumer)
What are the 3 major areas of OBRA'90?
DUR (drug use review) Demonstration projects Rebates
Per KS law, requirements of *Electronic data storage systems* include?
Daily back-up Maintain written Rx on file Numerical system for Rx identification Maintain a written or electronic daily log Store each active pt profile Document that RPh is responsible for accuracy of the info entered and each authorized refill (daily) Reproduce all info in system in written form w/in 72 h
In addition to the non-controlled label requirements, what are federal requirements to be included on C-II to C-V prescription labels?
Date of initial dispensing Transfer label: "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" (except for C-V prescriptions)
In addition to the non-controlled label requirements, what are state requirements to be included on C-II to C-V prescription labels?
Date of initial filling
What is required on the back of *CIII, IV* script that has been refilled?
Date refilled Quantity Pharmacist initials
What is the objective of the PPPA?
Decrease childhood poisoning
What area of OBRA'90? Goal: determine through scientific studies whether the outcomes of patient care improve and the costs decrease when pharmacists are paid to provide DUR services to patients, whether the drug is dispensed or not
Demonstration projects
Per KS law, who can obtain drugs from the pharmacy for inpatient use if there is not a pharmacist on duty?
Designated persons (charge nurse)
Term? Objective to achieve an opioid drug-free state through use of decreasing doses
Detoxification
What are the functions of a consulting pharmacist in LTCF per KS law?
Develop policies and procedures Assure proper control and accountability for emergency kit
What did the FDCA address?
Development Production Marketing
What does the Durham Humphrey Amendment add to the FDCA?
Differentiated b/w OTC and Rx drugs Required specific labeling for Rx-only drugs Allowed provisions for receipt of oral prescriptions and refilling of prescriptions
What consequences can result from a single violative act by a pharmacist?
Disciplinary action by state boards Regulatory action by federal agencies Malpractice lawsuit (negligence) Criminal penalties
What are some examples of mistakes made that can be reason for professional malpractice?
Dispensing the wrong drug Labeling w/ wrong directions Dispensing to wrong patient Failing to counsel or counseling in error
What are some potential issues of handling controlled substances in LTCF?
Disposal Nurse as agent of the prescriber Conflict of interest
How may a *defendant* succeed (win) a malpractice lawsuit?
Disproving any of the elements or proving an affirmative defense 1. statute of limitations 2. Comparative (contributory) negligence
Conditions required for re-packager to use BUD label of 1 year or manufacturer expiration date (whichever is earliest) include?
Dosage forms are packaged and stored at temp of ≤25°C and plastic material used in packaging must afford better protection against moisture than *polyvinyl chloride*
What does DESI stand for?
Drug Efficacy Study Implementation Project
What does *PTRA* stand for?
Drug price competition and patent term restoration act
What does title *II* of the DQSA address? (Drug quality and security act)
Drug supply chain security (tract and trace)
What is Title II of the *DQSA*? (Drug quality and security act)
Drug supply chain security act
What drug info is required to be reported to KTracs on Schedule II-IV as well as drugs of concern?
Drug, dosage, frequency, number, day's supply Identifying info about prescriber and dispenser Identifying info about patient
What type of drugs cannot have reminder ads?
Drugs w/ BBWs
What are "potential" problems that can be detected by a pharmacist doing a screening before dispensing?
Duplicate therapy Drug-disease contraindications Drug-drug interactions Incorrect drug dosage or duration of treatment Drug-allergy interactions Clinical abuse/misuse
A formal legal distinction b/w prescription and OTC drugs came into existence w/ the enactment of what FDCA amendment?
Durham-Humphrey
Which FDCA amendment? Allowed provisions for receipt of oral prescriptions and refilling of prescriptions
Durham-Humphrey
Law/Act/Amendment? Differentiated OTC drugs from prescription (legend) drugs
Durham-Humphrey Amendment
Law/Act/Amendment? Required prescription drugs to carry "Caution: federal law prohibits dispensing w/o a prescription" or *Rx only*
Durham-Humphrey Amendment
Requirements for *multiple CII* prescriptions include?
Each prescription is issued for legitimate medical purpose Prescriber provides written instructions on each Rx (other than the 1st one if indicated for immediate fill) indicating the earliest date the Rx may be filled Issuance is permissible under state law Quantity of all the prescriptions does not exceed a *90 day* supply
What did the 5th reauthorization of the PDUFA include?
Early notification by manufacturers of potential drug shortages
What can be considered as *harm* in a malpractice lawsuit?
Economic and/or non-economic (emotional, pain, suffering)
What part of the DUR process? Goal: improve the way that medications are used
Educational Programs
What formulation(s) of *ASA and APAP* is exempt from CR packaging?
Effervescent tablets with ≤15% of drug Unflavored powder forms in unit doses (≤15.4 grains of ASA or 13 grains of APAP per unit dose)
What are the 3 options for storage of CS prescriptions?
Electronic searchable file(s) 3-File method 2-file methods
KS requirements: registration w/ Board required for everyone manufacturing, distributing or dispensing CS except for?
Employee of any ... Dispenser of any CS if the employee is acting in the usual course of employment Pharmacies already registered w/ Board to dispense and distribute drugs Any person licensed by the state board of healing arts and board of vet examiners Members of the Native American Church using peyote for bona fide religious ceremonies
What are the benefits of the PDUFA?
Enables: -FDA to hire more reviewers -Decreases NDA/ANDA review time -Increase FDA overseas manufacturing inspections
Quantity of drug a pharmacist may dispense to a patient on a *CII* emergency prescription.
Enough for emergency period (not limited to specific # of doses)
What drug quantity can be dispensed for *emergency CII* scripts?
Enough for the emergency period
Per KS law, what quantity of drugs may be supplied for ER outpatient use when there is not a pharmacist on duty?
Enough until pharmacist comes in
What is considered "scheduled listed chemical products"?
Ephedrine PSE Phenylpropanolamine
Per KS law, minimum required equipment for *drug stores* include?
Equipment and supplies to compound (in good repair and available in sufficient quantities to meet the needs of practice)
Per KS law, what is required for *incident reports* in *other than* a medicare care facility (hospital) pharmacy?
Establish a CQI (continuous quality improvement) program -Document reportable incidents -Conduct at least quarterly meetings w/ PIC
What should be done if a DEA 222 form is lost?
Execute new form Execute statement noting serial #, date lost, list of drugs on lost form, and fact drugs were not received Retain copies #3 together (lost, new) w/ statement
Drug(s)? Controlled substances allowed by Kansas law to be given as samples to physicians
Ezogabine Lacosamide Pregabalin (non-narcotic cns depressants)
T/F A drug would be considered misbranded if its manufacture did not conform to required cGMP.
F (adulterated)
T/F Rx drugs that have been dispensed to the final customer can be resold, re-dispensed or distributed by a licensed pharmacist.
F (cannot)
T/F Prescriptions can be picked up from a drop station that is a not a registered pharmacy.
F (cannot)
T/F The pharmacy may refuse service to any patient that refuses to sign the "Notice of Privacy Practices"
F (cannot)
T/F HIPAA prohibits the pharmacy form sending refill reminder info to the pt w/o their written authorization.
F (exception)
T/F Tech registration do NOT have to be displayed in the pharmacy.
F (have)
T/F Hospitals are not required to comply with PPI regulations and are, therefore, not required to provide PPIs to inpatients.
F (initial fill and q 30 days)
T/F Dispensing from prescription copies are permitted.
F (not)
T/F The source that lists biological products, including biosimilar and interchangeable products, is the Orange book.
F (purple)
T/F PIC is a federal concept.
F (state)
T/F The presence of an NDC # on the label or labeling of a prescription drug indicates that the drug has received an approved NDA
F (used for tracking)
T/F PHI relates to individual's past and present physical or mental health only; genetic information
F (& future)
T/F Per KS law, pharmacists cannot exercise brand substitution even if listed in Orange Book.
F (Can)
T/F Federal law requires that hospitals have a PIC
F (KS law)
T/F Supplemental written information can be a substitute for verbal counseling.
F (cannot)
T/F Pharmacies can deny treatment if acknowledgement of Notice of Privacy Practices is refused.
F (cannot)
T/F KS pharmacists have independent authority to prescribe.
F (do not)
T/F A collaborative practice agreement permits a pharmacist to alter a physician's order or directions, dx or treat any disease, independently prescribe drugs or independently practice medicine and surgery.
F (does not)
T/F CE hours carry over
F (does not)
T/F Electronic supervision in hospital pharmacies does not require application to the BOP
F (does)
T/F Pharmacist may be electronically connected to only 1 pharmacy at a time for electronic supervision.
F (multiple)
T/F Executive secretary is a member of the board.
F (not)
T/F A pharmacist can be a PIC at more than 1 full time pharmacy. (Full time = pharmacy services total ≥30 h/week)
F (only 1)
T/F Patient authorization is required to release PHI for all marketing purposes.
F (refill reminder)
T/F Healthcare practitioner's scope of practice, including prescribing authority, is determined by federal law.
F (state)
T/F Not able to fill out-of-state prescriptions including from US territories (PR, VI)
F (can)
T/F Authorized generics can be found in the Orange book
F (cannot)
T/F CII can be transferred from pharmacy to pharmacy.
F (cannot)
T/F Can fill out-of-country prescriptions
F (cannot)
T/F Community pharmacies can request for prescription drug samples
F (cannot)
T/F Consumers generally can legally purchase CS from foreign internet suppliers and have them shipped into the US - even with valid prescription.
F (cannot)
T/F Pharmacies that are authorized collectors can co-mingle their inventory w/ these returns.
F (cannot)
T/F POA need to be notarized
F (does not)
T/F Preparations in aerosol containers intended for inhalation therapy is not exempt from CR packaging
F (is)
T/ F Partial fills for *CIII-CV* prescriptions, quantity dispensed for all partials may exceed total quantity prescribed (face quantity + refill quantity)
F (not)
T/F BUDs and expiration dates are the same
F (not)
T/F CR packaging is the same as tamper resistant.
F (not)
T/F There is a quantity limit per single CS script
F (not)
T/F PPPA is an amendment to the FDCA.
F (not)
T/F Pharmacies can use the same CS registration for all their sites.
F (separate)
T/F Biosimilars = generics
F (≠)
Outsourcing facilities will be inspected by ____ according to risk-based schedule.
FDA
What agency enforces regulations over advertising of *Rx drugs*?
FDA
Who grants *exclusivity*?
FDA
Who maintains *MedWatch*?
FDA
Who maintains the FAERS (Adverse Event Reporting System)?
FDA
Who regulates the content and form of commercial prescription drug labels and labeling?
FDA
What act? Created a fast track approval process for drugs treating serious or life-threatening diseases or conditions
FDAMA (FDA modernization act)
What act? Objectives: -make the drug approval process more efficient and timely -Expanded manufacturers' use of off label and drug economic information -Changed the "legend" requirement to *Rx only* -Clarify the parameters of pharmacy compounding
FDAMA (FDA modernization act)
What act? Provided incentives to conduct pediatric drug studies
FDAMA (FDA modernization act)
What act? Renewed the PDUFA
FDAMA (FDA modernization act)
Law/Act? Intent: protect consumers from adulterated and misbranded foods, drugs, cosmetics, or devices
FDCA
What agency enforces regulations over advertising of *OTC drugs*?
FTC
Which act? OIG may exclude providers that violate it from participating in Medicare and other federal programs
False Claims Act
Which act? Prohibits *knowingly* submitting a false or fraudulent claim for approval or payment to the govt
False Claims Act
Where are *federally proposed* regulations published?
Federal register
Where are final monographs for OTC drugs published?
Federal register
Where are *manufacturing quotas* published and how often?
Federal register (annually)
Reasons to get on the OIG exclusions list?
Felony conviction relating to health care fraud, or controlled substance
What identifies active ingredients, generally recognized as safe and effective, for OTC products?
Final monograph
Records? May be kept centrally
Financial and shipping records (if DEA notified) Electronic refill records
What cannot be inspected, reviewed, or be completed by the DEA during an inspection?
Financial, sales, pricing data, or personal records Patient charts Interview witnesses (including registrant or employees)
What must be documented on a new or refill Rx order?
First *and* last names of *transmitting* agent
Per KS law, PIC must maintain written P&P that addresses?
Functions of all personnel Control and accountability of drugs in compliance with fed/state law Documentation of reportable incidents Maintenance of records of dispensing, prepackaging and compounding (labeling)
What were developed by the manufacturers for all processes, packaging, labeling, and holding of products and failure to comply is adulteration?
GMPs
What falls under the scope of refill reminder exception in HIPAA?
Generic options Adherence
What formulation(s) of *erythromycin ethylsuccinate* is exempt from CR packaging?
Granules for oral suspension and oral suspensions ≤8 g of the equivalent Tablets ≤16 g of drug/package
What are exceptions to reselling of the PDMA? (Prescription drug marketing act)
Group purchasing for own use Sales/purchases among hospital under common control or to nonprofit affiliates Sales/purchases for emergency medical reasons or to alleviate temporary shortage
Drug(s)? Schedule 5-OTC (if allowed by state law)
Guaifenesin w codeine liquid or syrup
What standards of practice must *inpatient* pharmacy services meet? (Medicare regulations)
Guidelines on handling/labeling UD drugs, repackaging Outdated products; stop orders Quality assurance programs Drug formulary system
Which act? Objective: Develop national standards for electronic health care transactions (National data transaction and code sets)
HIPAA
Which act? Objective: Eliminate job-lock and minimize disruptions in treatment cause by patients changing insurance and providers (seamless care through use of electronic data)
HIPAA
Which act? Objective: Protect the *security and privacy* of health data
HIPAA
Which act? Objective: Reduce health care costs
HIPAA
Which act? Objective: Require national provider identifier (NPI) numbers
HIPAA
Which act? Pharmacies must distribute *Notice of Privacy Practices* to new patients
HIPAA
Which act? Requires pharmacies to identify a privacy office and train the pharmacy staff on privacy
HIPAA
What is required from the physician for *emergency CII* scripts?
Hard copy w/ manual signature w/in 7 days of fill
Who are registrants prohibited from employing persons in positions that have access to CS if the person?
Has been convicted of felony related to CS Had a DEA registration denied or revoked Has surrendered a DEA registration for "cause"
Type of facility? PIC responsibilities: -Develop polices and procedures for distribution and control of drugs -Perform and document *quarterly* checks of drug storage conditions and drug records -Assure adherence to prepackaging procedures and label requirements -Adequate records of drug distribution by nurse(s) maintained
Health depts & private not-for-profit family planning clinics
Term? Intentionally deceiving, providing false statements of material fact in any application for benefit or payment, purposely billing for services never provided, or misrepresentation in order to obtain an unauthorized benefit
Healthcare fraud
Type of facility? May handle and store specific drugs identified by written *protocol* w/ a pharmacy and approved by the PIC
Home health agencies and Hospices
Type of facility? PIC performs quarterly checks for adequate storage and expiration dates Allowable drugs: -Sterile water and saline for injection or irrigation -Heparin flush -Diphenhydramine injection -Epi injection
Home health agencies and Hospices
What dispensing info are exempt from reporting to KTracs?
Hospital pharmacy dispensing to inpatient hospital care Hospital outpatient ER dispensing an interim quantity that does not exceed a 48 h supply
What type of drugs require *child-resistant* (CR) packaging?
Human *oral* prescription drugs (some exceptions) Most OTCs and some hazardous household substances
Which recall class? Cause reasonable probability of serious adverse health/death - drug should not be dispense
I
Which of the following employee ratios is(are) legally acceptable in KS when one pharmacist is working? I. 1 non-certified, 2 certified, 1 intern, 1 clerk II. 2 non-certified, 2 interns, 1 clerk III. 2 non-certified, 1 certified
I and II only
Which of the following pharmacies is not operating w/in KS BOP regulations? I. Lin's pharmacy allows a relief pharmacist w/ an inactive KS license to work an evening shift. II. Drugs R Us Community pharmacy donates their unused, non-controlled drugs to a nearby indigent healthcare clinic that serves as a 'qualifying center' III. Bill's pharmacy hired a newly licensed PharmD grad to serve as PIC
I and II only
In the case of Oyler v. Hy-Vee, a tech transcribed a phoned-in prescription in error by writing once daily MTX instead of metalozone. Unfortunately, the RPh failed to catch the error and when the pt's husband picked up the med, he was given no addl pt education. The pt used the MTX daily as instructed on the label and died less than a month later from the drug's effect. The family filed a lawsuit against the pharmacy. *What is this case an example of?* I. Civil II. Criminal III. Administrative
I only
Tax-free alcohol may be purchased and legally used by which of the following? I. Hospital pharmacies for compounding medications for inpatients II. Community retail pharmacies for compounding medications for outpatients III. Hospital pharmacies for compounding rx meds for pts treated in am care clinics off premises.
I only
Under which of the below conditions would a drug likely be considered a "new drug" according to the definition in the FDCA? I. The drug is a new combo of 2 formerly approved drugs II. The drug was prescribed for a condition not indicated on its approved labeling III. The drug was not manufactured in accordance w/ cGMP.
I only
What are the different schedules of CS?
I, II, III, IV, V, V-OTCs, SLCP (listed chemical products)
What can *methadone* be used for detox or maintenance?
IF pt is enrolled in OTP
Schedule? Cannot be refilled
II
Which recall class? Cause temporary or medically reversible adverse health consequences
II
Pharmacies must provider pts w/ the Medwatch statement with each new and refill prescription. Pharmacies may use use which of the following methods to distribute this info to pts? I. Oral counseling II. In patient med info distribute by the pharmacy III. on a preprinted vial cap
II and III only
The CS schedule of a prescription containing not more than *50 mg of morphine* per 100 mL or per 100 g combined with one or more active non-narcotic ingredients
III
The controlled substance schedule of buprenorphine S.L.
III
Which recall class? NOT likely to cause adverse health consequences
III
Schedule? Refills: no more than 5 times or 6 months after the date of issue (whichever comes first)
III IV
Schedule? Total # of refills must be retrievable
III IV
Which of the following statements is *accurate*? I. Primary function of a BOP is to lobby the state of legislature on behalf of the pharmacy profession II. FDA issues guidance documents that are legally enforceable by the agency III. Federal agencies issue regulations that specify the details and requirements necessary to implement statutes
III only
What must be submitted to the FDA by drug sponsors following animal studies and to begin human clinical trials?
IND (Investigational New Drug Application)
Who approves the IND?
IRB (Institutional Review Board)
When is CR packaging not required for LTC inpatients?
If meds are administered by healthcare provider and not in multidose vial
When are *MedGuides* required to be provided to patients?
If patient requests for it In outpatient setting each time drug is dispensed If specified as part of REMS
When can a prescriber not certified through OTP administer methadone in a hospital inpatient?
If pt is being treated for an illness or dx outside of detox or maintenance
Criteria to qualify for *emergency CII* prescriptions?
Immediate administration is necessary No alternative is available Not reasonably possible for the prescriber to present a written Rx
Per Kansas law, how can verbal counseling be given?
In person or by telephone
What doesn't approved CE include?
In-service Job training or orientation CPR BCLS Emergency/disaster/code blue training Public education Testing out of a course
Why should pharmacy be regulated?
Incentivize provision of products for public good Minimize harm to public Promote efficiency in "natural monopolies" Information asymmetry
KS regulation *Utilization of Unused meds*, what locations are *qualifying centers or clinics* to receive donated unused meds?
Indigent health care clinics Federally qualified health center Community mental health center
Type of facility? Supervised by PIC *RN* or *PA* approved by PIC shall be in charge of distribution and control of drugs No regulations yet
Indigent health clinic, federally qualified health center
What is required of the seller when selling a pharmacy business?
Inform DEA at least 14 days prior to the sale Transfer all CII drugs by use of DEA Form 222 form(s)
Per KS law, what must a pharmacist do in regards to substituting biological products (purple book)?
Inform pt of the interchange Maintain a record of the product dispensed Communicate to the prescriber w/in *5 business days* following dispensing the product name and manufacturer dispensed
When should inventory checks be completed for CS?
Initial Annually (biennial) Newly controlled substances
What products may not be legally sold via vending machine in KS?
Injectable drugs Rx drugs Drugs that contain ephedrine, poisons, alkaloids
Type of facility? Must be supervised by pharmacist or practitioner: -Must develop/approve training training and supervision of personnel in providing drugs and controlling drugs -Maintain at least *quarterly* review of drug records, storage conditions for all drugs -Develop P&P for documenting reportable incidents -Assure drugs dispensing for use outside the institution are adequately labeled
Institutional drug room
Type of facility? Site where *prescription only* drugs are stored and from where they are dispensed or administered E.g. providing drug needs from *jail, juvenile detention center* inmates, college students, *inpatient hospice*
Institutional drug room
Who can preform inspections of Automated drug delivery systems?
Intern Tech RPh
What serves as records of CIII to CV purchase?
Invoice Packing slips
Who is responsible for preparing the *incident report*?
Involved RPh and PIC
What is the manufacturer's responsibility for Class I and Class II recalls?
Issue written recall notices
When can an *approved* drug become a *new* drug?
It contains a new substance It is a new combo of approved drugs The proportion of ingredients is changed A new use is intended The dosage, method, duration of administration or application is changed
What date requires that immunizers must report the immunization to the state registry maintained by KDHE?
July 1, 2020
What date does a KS pharmacist license expire?
June 30th
Federal law allows pharmacists to refill Schedule V scripts as many times as the prescriber authorizes. KS law, however, limits CV to 5 refills. Which law should a KS pharmacist follow?
KS (most strict)
Federal or Kansas Law? Adequate directions for use
Kansas
Federal or Kansas Law? Beyond use date
Kansas
Federal or Kansas Law? Brand or generic name; manufacturer or distributor
Kansas
Federal or Kansas Law? Contents in terms of weight, measure or numerical count
Kansas
Federal or Kansas Law? Drug strength
Kansas
Federal or Kansas Law? Full name of patient
Kansas
Federal or Kansas Law? Name, address & phone # of dispensing pharmacy
Kansas
Federal or Kansas Law? Necessary aux labels and storage instructions, if needed
Kansas
Where are *Kansas regulations* published?
Kansas register
The amendment to the FDCA that requires that drugs be proven effective before marketing is called the?
Kefauver-Harris
Law/Act/Amendment? Gave FDA authority over prescription drug advertising
Kefauver-Harris Amendment
Law/Act/Amendment? Established cGMP (current manufacturing practice requirements)
Kefauver-Harris Amendment
Law/Act/Amendment? Increased controls over clinical investigations (i.e., informed consent)
Kefauver-Harris Amendment
Law/Act/Amendment? Required proof of *efficacy* prior to marketing
Kefauver-Harris Amendment
Type of facility? Requires *consulting pharmacist* to develop policies and procedures and assure proper control and accountability for emergency kit
LTCF
What is a *hybrid* patient setting often covered by govt programs (medicare/medicaid)?
LTCF
Per KS regulation *Utilization of Unused meds*, who can be *donating* entities of unused meds?
LTCF Mail service pharmacies Hospital pharmacies
Exceptions to *CII partial fill* limitation include?
LTCF patients Terminally ill patients
Case: A pharmacist received a call from a physician who ordered ibuprofen 600 mg for a patient but instructed the pharmacist to label the drug as oxycodone. *Why would doing this violate the FDCA misbranding rules?*
Label is false or misleading It is offered for sale under the name of another drug It is an imitation of another drug
Case: A pharmacist received a prescription for a brand-name drug and legally substituted a generic drug. The pharmacist labeled the dispensed generic drug using the brand-name drug name. *Why would this be a misbranding violation of the FDCA?*
Label is false or misleading Is offered for sale under the name of another drug
Misbranding violations for prescriptions containers include?
Label must not be false or misleading Drug dispensed must not be an imitation drug Drug must not be sold under the name of another drug Packaging and labeling must conform to official compendia standards If it s a drug liable to deterioration, it must be packaged and labeled appropriately Must be packaged in conformance with PPPA
What is considered *misbranding* by the FDCA?
Labeling is false or misleading Fails to meet label/labeling requirements Fails to provide "adequate directions for use" or "adequate info for use" Packaging or labeling violates Poison Prevention Packaging Act Dispensing or refilling a "Rx" drug w/o authorization Imitation of another drug or sold under the name of another drug
Per KS law, requirements of *parenteral product preparation* include?
Laminar flow hood or other suitable aseptic environment (annually certified) Aseptic work area Nearby sink Current IV incompatibility/stability refereance P&P manual
What are the branches of the government?
Legislative Executive (administrative agencies) Judicial
Low, med, high risk or immediate? Reconstitution of a *single-dose vial, single preparation of a small volume parenteral, single large volume IV replacement fluids with no more than 3 components*
Low
What are the CSP risk categories used for BUD?
Low Low w/ <12 hr bud Medium High Immediate
CSP risk category? Compounding location: *ISO Class 5 PEC segregated from other operations*
Low w/ <12 hr BUD
CSP risk category? Reconstitution of a single-dose vial, single preparation of a small volume parenteral, single large volume IV replacement fluids with no more than 3 components, *non-hazardous preparations only*
Low w/ <12 hr BUD
CSP risk category? Compounding location: *ISO Class 5 PEC, ISO Class 7 buffer area, ISO Class 8 ante area*
Low, medium
What letter(s) in a DEA # designates a *midlevel practitioner*?
M
Per KS law, who have *independent prescribing* authority?
MD DO DDS DVM Podiatrists
What state does not have a drug tracking system?
MO
Case: A large hospital pharmacy employs 20 pharmacists and 35 techs. The PIC would like to decrease the amt of time pharmacists spend checking the accuracy of tech work so would like to initiate a tech-check-tech program. *What filling functions are technicians allowed to check?*
Machine fill Crash cart fill Floor Stock Automated dispensing machines Unit dosing
What are the benefits of *stare decisis*?
Maintains a system of stable laws providing predictability and continuity Ensures laws more accurately reflect the morality and expectations of the community
PIC responsibilities of Automated drug delivery systems include?
Maintenance Assuring stocking, accounting, and dispensing accuracy Security maintenance Loading and unloading
What is the objective of KS regulation *Utilization of Unused meds*?
Make available unused meds to medically indigent (voluntary)
What are the objectives of the *FDAMA*? (FDA modernization act)
Make drug approval process more efficient and timely Expanded manufacturers' use of off-label and drug economic information Changed the legend requirement to Rx only Clarify the parameters of pharmacy compounding
What information may be *omitted* from pre-packaging or repackaging labels if suitable records are kept?
Manufacturer Lot # Date repackaged Initials of RPh/Tech
What does the NDC identify?
Manufacturer Product Trade package size
What activities require registration with the DEA?
Manufacturing Distributing Reverse distributing *Dispensing schedules II-V or instructing* Conducting research w/ CS I Conducting research with CS II-V Conducting a narcotic treatment program Conducting chemical analysis with CS Importing CS Exporting CS
Per KS law, what is the scope of practice for *technicians*?
May *package*, do *manipulative, repetitive or nondiscretionary tasks related to Rx processing*
Which type of Patient-directed labeling? Given for drugs that pose a "serious and significant concern" that is not an oral contraceptive or estrogen product
MedGuide
Which type of Patient-directed labeling? Is not required to provide to inpatients (at FDA discretion)
MedGuide
Which type of Patient-directed labeling? Must be provided if *patient (or patient's agent) requests it*
MedGuide
Which type of Patient-directed labeling? Must be provided if *specified as part of REMS*
MedGuide
Which type of Patient-directed labeling? Must be provided in *outpatient setting each time drug is dispensed*
MedGuide
What procedures may be required for high risk to benefit ratio drugs by the FDA?
MedGuides Communication Plan (informed consent, protocols, specialized training) Elements to Assure Safe Use (ETASU) Distribution limitations
What is a voluntary reporting system for healthcare providers?
MedWatch
Order the following drugs in order of highest to lowest abuse potential. Ezogabine Methyltestosterone Butophanol
Methyltestosterone Butophanol Ezogabine
Term? An individual practitioner other than a physician, dentist, veterinarian, or podiatrist who is licensed, registered, or otherwise permitted to dispense a CS in the course of professional practice. Ex. ARNPs, PAs, nurse anesthetists, nurse midwives
Mid-level practitioner
Case: A pharmacist received a prescription for a brand-name drug and legally substituted a generic drug. The pharmacist labeled the dispensed generic drug using the brand-name drug name. *What part of the FDCA did the pharmacist violate?*
Misbranding
What are the requirements for *non-resident* pharmacies?
Must be registered in state located Designate a KS licensed RPh as non-resident PIC All other RPh must be licensed in the state where practicing Must have 800 # Min hours: 40 hr-6 days/wk
What does the DQSA require pharmacies to do?
Must develop a procedure outlining what pharmacy personnel should do when unpacking received drug orders Must be able to provider upon request lot-level product tracing info (transaction hx, hx an statement) for 6 years
What must the *plaintiff* prove for malpractice (negligence)?
Must prove all elements to succeed: -Duty of care -Breach of duty -Harm or injury -Causation
What is the *standard* of pharmacist's duty?
Must use that degree of care that a reasonable and prudent pharmacist would use under similar circumstances
Restrictions regarding the display of dietary supplement publications include?
Must: - not be false or misleading - include balanced publications - be physically separate from the actual product
Term? FDCA established the pre-marketing drug approval process
NDA (new drug application)
What is each OTC and prescription drug product assigned?
NDC
What serves to facilitate automated processing of drug claims and drug distribution?
NDC
What are federal label requirements for *parenteral products* prescription containers?
Name & Address of dispenser Serial # of prescription Date filled Name of prescriber Name of patient Directions for use (including precautions)
What are state label requirements for *parenteral products* prescription containers?
Name & Address of dispenser Serial # of prescription Date filled Name of prescriber Name of patient Directions for use (including precautions) *Name & Quantity of each drug and additive* *Expiration date (BUD)* *Prescribed flow rate* *Storage info, if applicable* If dispensed in a medical facility: - date and time of addition of additive(s) - name or initials of person who prepared
What are federal label requirements for *non-controlled* prescription containers?
Name & Address of dispenser Serial # of prescription Date filled Name of prescriber Name of patient Directions for use (including precautions) MedWatch statement
Per KS law, what must be on a Rx written by an *optometrists*?
Name & address of prescriber License registration # Name & address of pt in addition to other legally required rx info
Federal requirements for prescription container labels include?
Name and address of dispenser Serial # of Rx Date of Rx issuance or date filled Name of prescriber Name of patient Directions for use (including precautions as indicated on the Rx) MedWatch statement
What does OBRA'90 require to be part of the counseling provided to patients?
Name and description of med Dosage form, dosage, route, duration Special directions/precautions Common and severe SE, contraindications, and ways to prevent them or what to do when they occur Techniques for self-monitoring Storage Refills Missed doses
Per KS law, what is required on written Rxs prescribed by *ARPN*?
Name, address and phone # of *practice location* for prescriber Name, address and phone of responsible physician Signature of prescriber followed by credential Be from class of drugs prescribed pursuant to protocol DEA # of prescriber
Per KS law, what is required on written Rxs prescribed by *PA*?
Name, address, and phone # of supervising physician Name, address and phone # of the prescriber Signature and credential of prescriber DEA # of prescriber (if applicable)
What are Kansas label requirements for *non-controlled* prescription containers?
Name, address, phone # of dispensing pharmacy ID # of the prescription Date prescription filled refilled Name of the prescriber Full name of patient Adequate directions for use BUD Brand name or generic name; manufacturer or distributor Drug strength Contents in terms of weight, measure or numerical count Necessary auxiliary labels and storage instructions, if needed (must be typed or printed)
What must be documented for *guaifenesin w/ codeine* OTC (CV) sales?
Name/address of purchaser Name/quantity of drug Date of purchase Name/initials of dispensing RPh (bound book)
When can a *CII* be retained as a "hard copy"?
Narcotic parenteral pain Patient in LTCF Narcotic treatment for pt enrolled in hospice care (medicare certified)
Type of practitioner? Formulary approved pursuant to a written protocol w/ a physician
Naturopaths
Type of practitioner? Prohibited from prescribing CS or Rx drugs except those on the formulary
Naturopaths
Per Kansas law, when must the RPh or pharmacy student/intern personally offer to counsel each patient/pt agent?
New RX dispensed Once yearly on maintenance meds RX refills (if RPh deems appropriate)
Per KS law, when is a pharmacist required to *personally offer to counsel*?
New Rx Annually on maintenance Refills (when appropriate)
Is CR packaging required for *inpatients*?
No
Case: Sandy is a PIC at Heartland Pharmacy. Can her pharmacy participate in *Utilization of Unused Medications* program?
No (community pharmacies do not qualify)
Is the patient legally required to *sign* a request for non-CR packaging?
No (but recommended esp if blanket waiver)
Per KS law, what is the expiration date for emergency kits for LTCF?
No greater than 1 year from date of filling
Maximum # of doses (quantity) that may be prescribed and dispensed on a *single* CII prescription.
No limit
When is a new drug classified as *priority*?
No other effective drug available More effective or safe than drugs currently used Important advantages: greater convenience, reduced SE, or improved tolerance or usefulness in special pops
Per KS law, what type of drugs are *PA* able to prescribe?
Non-controlled and CS under a written *agreement* w/ a supervising physician
Requires *CR packaging* or not? Birth control
Not
Requires *CR packaging* or not? Duragesic 12 mcg/h (fentanyl patch)
Not
Requires *CR packaging* or not? Effer-K 20 mEq tablets (unit dose)
Not
Requires *CR packaging* or not? Estraderm
Not
Requires *CR packaging* or not? Flonase
Not
Requires *CR packaging* or not? Medrol dose pak
Not
Requires *CR packaging* or not? Nitro-Bid
Not
Requires *CR packaging* or not? Nitro-Dur (transdermal patches)
Not
Requires *CR packaging* or not? PredniSONE 1 mg tablet in 100 tablets container
Not
Requires *CR packaging* or not? PredniSONE 5 mg tablets (21 tablet package container)
Not
Requires *CR packaging* or not? Prempro
Not
Requires *CR packaging* or not? Questran (cholestyramine powder) unit dose
Not
Requires *CR packaging* or not? Rheumatrex Dose Pak
Not
Requires *CR packaging* or not? SL NTG tablets
Not
Requires *CR packaging* or not? Z-Pak
Not
Per KS law, what is the limit for *codeine* to be considered a CIII?
Not >1.8 g per 100 mL or >90 mg per dosage unit (combo)
Per KS law, what is the limit for *morphine* to be considered a CIII?
Not >50 mg per 100 mL or per 100 mg (combo)
What must pharmacies post in a prominent, visible location in the pharmacy (and on website)?
Notice of Privacy Practices
How should a *transfer business to another registrant* request for a DEA registration be made?
Notify area DEA special agent at least *14 days prior* to transfer with specifics via certified mail (receipt requested) or in person
How should a *terminate* request for a DEA registration be made?
Notify nearest DEA office (return DEA certificate, unused "voided" 222 forms, & explanation of disposal or transfer of all CS)
What office enforces HIPAA?
OCR (office of civil rights)
What was established by *statute* to identify and eliminate fraud, waste, and abuse in US Dept of Health and Human Service programs?
OIG (office of inspector general)
Who can *exclude practitioners convicted of Medicare and Medicaid related crimes from participation in the programs*?
OIG (office of inspector general)
What drugs are approved through the *Monograph Approval* process?
OTC
What type of samples are not covered by the *PDMA*? (Prescription drug marketing act)
OTC
When does the registration year end for *techs*?
Oct 31
Who can request prescription drug samples?
Only licensed prescribers or pharmacies of hospital or health care entities
When can CS inventory be completed during business hours?
Opening or closing of business (must be noted on record)
Type of practitioner? May *prescribe, administer, or dispense topical pharmaceutical drugs or oral drugs* for exam, dx, and tx of ocular conditions and any insufficiencies or abnormal conditions of the human eye and its adnexae
Optometrists
Type of practitioner? Prescription must include: -Name & address of prescriber -License registration # -Name & address of pt in addition to other legally required rx info
Optometrists
What type of drugs require that a *PPI* is given to the patient?
Oral contraceptives Estrogen products not intended for contraceptives
What lists *approved drug products w/ Therapeutic equivalence evaluations* but is not an official US compendium?
Orange book
What is considered *shared* services in KS?
Order *filling* Order *processing*
What is the purpose of a *Power of attorney*?
Order authority if registrant on 224 is not available
What are the PIC responsibilities for *veterinary medical teaching hospital pharmacy* (KSU)?
P&P Storage, maintenance of Rx meds Packaging, distribution, adequate safety
Per KS law, who identifies the drugs in an emergency kit at a LTCF?
P&T committees
Type of practitioner? May dispense *Rx drugs if pharmacy services are not readily available and quantity does not exceed amount necessary for 72 hr supply*
PA
Type of practitioner? Written prescriptions must include: Name, address, and phone # of supervising physician Name, address and phone # of the prescriber Signature and credential of prescriber DEA # of prescriber (if applicable)
PA
Type of practitioner? May prescribe Non-controlled and CS under a written *agreement* w/ a supervising physician
PA
Per KS law, who may prescribe drugs under *protocol or practice agreement w/ a prescriber*?
PA APRN
What professions are mid level practitioners?
PA APRN RPh (some states)
What act? Limit *re-importation* of exported US produced drugs to original manufacturer
PDMA (Prescription drug marketing act)
What act? Objective: address problems of *drug diversion*
PDMA (Prescription drug marketing act)
What act? Place *restrictions on resale* of prescription drugs by hospitals & other HC entities
PDMA (Prescription drug marketing act)
What act? Places controls over *prescription drug sampling*
PDMA (Prescription drug marketing act)
What act? Prohibits the sale, purchase, or trade of prescription drugs that have been purchased by a hospital, healthcare entity, or charitable organization w/ some exceptions
PDMA (Prescription drug marketing act)
What act? Require *state licensing* of drug wholesalers
PDMA (Prescription drug marketing act)
What act? Wholesalers must be licensed by the state and wholesaling is defined as distributing drugs to anyone other than the consumer
PDMA (Prescription drug marketing act)
Law/Act/Amendment? Authorizes FDA to collect fees from brand-name, generic device and biosimilar manufacturers
PDUFA 1992 (Prescription Drug User Fee Act)
Term? Identifies the individual or could reasonably be expected to identify the individual
PHI
Automated drug delivery systems: Who is responsible for maintenance of the system?
PIC
Automated drug delivery systems: Who is responsible for security maintenance?
PIC
Automated drug delivery systems: Who is responsible for stocking, accounting and dispensing accuracy?
PIC
Case: Upon routine inspection, it was discovered that a pharmacist refilled several APAP #3 prescriptions 3 times more than the 5 authorized refills. When this was called to the pharmacists attention, he said that the pharmacy software program was at fault. He said he had contacted the software vendor about the problem but the vendor was having difficulty identifying and repairing the glitch. Who is responsible for pharmacy compliance with relevant laws?
PIC
Per KS law, who is responsible for checks of drug records and conditions of drug storage in medical care facilities (hospital)?
PIC
Per KS law, who is responsible to list procedure requirements for *inpatient* service and *ER outpatient* service when a pharmacist is *NOT* on duty?
PIC
Per KS law, who must conduct a CS inventory prior to leaving employment of a drugstore?
PIC
Who is responsible to assure that tech training courses addresses specific topics designed for pharmacy?
PIC
Who is responsible to ensure that a licensed pharmacist is on duty at all times that the pharmacy is open?
PIC
Who is responsible to the Board for compliance with laws? (but does not relieve other RPhs from compliance)
PIC
Who must notify the BOP of the effective date of technician employment?
PIC
Requirements of *Medical Care Facility (hospital) Pharmacies) include?
PIC Procedure for pharmacies services when RPh not there Checks of drug records and drug storage Pre-packaging requirements Adequate drug info references Supervision and training of techs P&P for IV prep 7-day "after-the-fact" review of med orders Security Tech-check-tech requirements
Which type of Patient-directed labeling? Required for estrogen products not intended for contraception and restricted to prescription (including fixed combinations w/ other drugs; not limited to oral)
PPIs
Which type of Patient-directed labeling? Required for oral contraceptives
PPIs
Which act? Objectives: - speed up approval process of generics - Make list of bioequivalent drugs (Orange book) - Grant manufacturers incentives to continue R&D - Codify ANDA process (abbreviated NDA)
PTRA or Waxman-Hatch
A pharmacist can honor a *blanket* request to use non-compliant packaging for all of a patient's medications by whom?
Patient (not prescriber)
What *cannot* be changed on a *CII* prescription?
Patient name Drug Prescriber name Date (if one is written)
What is the purpose of the *REMS* program?
Patient safety; ensure the drug benefits outweigh the risks
Per KS law, non-controlled Rxs can only be refilled how many times?
Per authorized on Rx or up to 1 year after the date of issuance (whichever comes first)
Who is authorized to sign a DEA 222 form?
Person who signed 224 or POA
Per KS law, registration (or permits) are required for?
Pharmacies (resident) Non-resident pharmacies Health depts and family planning clinics Home-Health and hospices Indigent health clinics, federally qualified health center Institutional drug rooms Research/Teaching Institution Retail dealers Wholesalers (distributors) Manufacturers
Per KS law, who is able to receive a *new* prescription order?
Pharmacist or pharmacy intern
Per Kansas law, who must comply with OBRA'90?
Pharmacist or pharmacy intern or student
What are some examples of laws that conflict between state and federal?
Pharmacy compounding Prescription validity Use of marijuana for medicinal and recreational purposes
Case: Sandy Lee is the PIC of Heartland Community Pharmacy (open: 50 h/week), but Sandy only schedules herself to work 30 h/week. Recently a small family planning clinic opened for local residents and the director contacted Sandy about serving as the PIC for the facility. *Under what conditions can she legally do so while remaining PIC of the pharmacy?*
Pharmacy services <30 h/wk
What is considered full time pharmacy operation?
Pharmacy services provided for *≥30 h/week*
What standards are including USP *797* for sterile compounding?
Physical facilities and equipment Microbial contamination risk levels Expiration and BUD Sterility testing Compounding for animal patients
Defenses to malpractice claims include?
Plaintiff fails to prove any one of the 4 elements Defendant is able to prove affirmative defenses -Comparative (contributory) negligence of the plaintiff -Statute of limitations
What do cGMP standards address?
Plant & equipment requirements Raw material requirements Personnel control Production & packing control Documentation and record keeping Quality assurance and control
Other types of practitioners that are able to prescribe drugs include?
Podiatrists Naturopaths Dentists
What information is required to be on a CS prescription?
Prescriber name and address Pt full name and address Date issued Drug name, strength, dosage form, quantity, sig Refill info Prescriber name (manually signed) DEA #
OTC prescriptions are usually refillable without authorization except if?
Prescription calls for a dose higher than recommended on the commercial label Prescription has refill directions (must follow them) Prescription is for a C-V, CSA requires refills to be authorized by the prescriber
Case: The patient, Maria, presented a prescription for tamoxifen to the pharmacist, Ellis. The pharmacist entered the prescription into the computer as Tambocor and misfilled it on 3 occasions. Ellis knew that the pt's physician was an oncologist and that Tambocor was a heart medication. Despite testimony indicating that the writing on the prescription was illegible, Ellis did not call the physician to clarify. What would be the probable intent of the remedy?
Prevent future similar conduct by the defendant Compensate the plaintiff for the harm
What are addl label requirements of IV drugs?
Product name(s), additive(s), quantity Expiration date Flow rate Storage conditions (if applicable)
Drugs of concern include?
Products containing all three: *butalbital, APAP, caffeine* Any preparation containing any detectable quantity of ephedrine or PSE and is exempt from being reported to the statewide electronic system for sale of methamphetamine precursors Promethazine w/ codeine Gabapentin
What type of drugs are NOT included in the *Orange* book?
Products not reviewed and approved for safety and effectiveness (pre-1938 drugs) DESI drugs (1938-1962)
Per the Combat Methamphetamine Epidemic Act, what must be identified in the *logbook* for ephedrine, PSE and phenylpropanolamine sales?
Products purchased by name Quantity sold Name, address, signature of purchaser Date and time of the sale Seller must determine that purchaser ID and signature match
What is the purpose of the *collaborative drug therapy mgmt* advisory committee?
Promote consistent regulation and enhance coordination among boards w/ jurisdiction over licensees involved Advise and make recommendation to the BOP and Board of Healing Arts on matters relating to collaborative drug therapy mgmt
What do administrative agencies do?
Promulate rules and *regulations* that define and detail statutes Administer and enforce both statutes and regulations Interpret and hold hearings regarding statutes and regulations (adjudicate)
What part of the DUR process? Performed by the pharmacist and includes screening before dispensing, patient counseling, and pharmacist documentation of relevant info
Prospective Review
What are the 3 parts of the DUR process?
Prospective review Educational Programs Retrospective Review
Drug(s)? Schedule 5-OTC (KS)
Pseudoephedrine Ephedrine (compound, mixture, or preparation containing any detectable amount)
Per KS law, what drugs cannot be filled a 3-month supply if not written for 3-months?
Psychotherapeutic CS
What are exceptions to *Minimum Necessary* PHI disclosures?
Pt Regarding the tx of pt w/ other providers involved in the tx When authorized by pt When required by DHHS for compliance and enforcement purposes When required by law
When is CR packaging required for LTC inpatients?
Pt is in assisted living and have multidose container at bedside
What *cannot* be changed on a *CIII-CV* prescription?
Pt name Drug (except generic) Prescriber's signature
Per KS law, what is required in *patient med profile*?
Pt name and address Prescriber's name Initial date of dispensing and Rx # Drug name, strength, quantity dispensed Name of dispensing RPh Drug allergies or sensitivities
When is a *MedGuide* required to be provided in *outpatient setting and drug is being dispensed directly to patient*?
Pt requests it Each time drug is dispensed First dispensing MedGuide materially changed Drug is subject to ETASU REMS
When is a *MedGuide* required to be provided in *outpatient setting when drug dispensed to healthcare professional for administration to patient*?
Pt requests it First dispensing MedGuide materially changed Drug is subject to ETASU REMS
What are the 4 types of market failure relevant to drug use?
Public goods Externalities Natural monopolies Information asymmetry
What records are required for CS drugs?
Purchased Dispensed Distributed Returned Destroyed Lost or stolen Inventoried (on hand)
What act *prohibited the adulteration and misbranding of foods and drugs in interstate commerce*?
Pure Food and Drug Act (1906)
What book enables user to make substitution decisions for biologicals?
Purple
What book lists *biological* products, including any *biosimilar* and *interchangeble* products under the reference product?
Purple
What is required on the *face* of paper RX or other appropriate document for *partial* fills of *CII*s?
Quantity Date of partial fill ID of RPh filling
According to DQSA, what must a pharmacy due if they receive a suspicious product?
Quarantine product while investigating and if illegitimate, notify immediate trading partners and FDA
How often are checks of drug records and conditions of drug storage in medical care facilities (hospital) required?
Quarterly (usually done monthly)
What program allows the FDA to require variety of procedures for drugs with high risk to benefit ratio?
REMS
Which type of Patient-directed labeling? Mandated for provider/patient education for use of certain seriously toxic drugs
REMS
Which type of Patient-directed labeling? May require *ETASUs* (elements to assure safe use)
REMS
Automated drug delivery systems: Who can load and unload?
RPh Intern Tech
What is required on a cancelled CII script?
RPh name or intern and preceptor names
Requirements to use a Computer system may be used as alternative to a "hard-copy" system for CIII-CV refills include?
RPh verification of accuracy on either hard-copy printout or bound book or file Dated and signed w/in 72 h Capable of producing printout of any refill data to user pharmacy w/in 48 h if kept centrally Back-up system
What is required on a CS prescription label?
RX # Date of initial filling Date filled or Refilled Pt name Prescriber Adequate directions for use Name of drug/manufacturer - strength- contents BUD Federal transfer (CII-IV)
What is a common use of *SNDA*?
RX to OTC status
What is the pharmacist role in *filling* Rx?
Read and interpret (Rx, pt records) Identify in the record what RPh verified the accuracy of the Rx Make reasonable effort to ensure that any Rx is issued for a *legitimate medical purpose* by an *authorized prescriber* Select drug products Perform drug regimen reviews Personally offer to counsel each *new* Rx, annually on maintenance, and refills (prn) Supervise techs & delegate non-judgmental functions only
What area of OBRA'90? Requires manufacturers to provide pharmaceuticals to Medicaid at their "best price," the lowest price @ which they sell the product to any customer (pays medicaid the difference b/w AMP and "best price")
Rebates
What can the DEA inspect, copy and verify during inspections?
Records, reports, required forms, equipment and CS May collect samples (usually will leave receipt)
What is required to be put on CIII-CV if using 2-file storage method?
Red C (at least 1 inch high in lower right hand corner of rx)
What are the objectives of HIPAA?
Reduce health care costs Develop national standards for electronic health care transactions (National data transaction and code sets) Require NPI numbers Protect the security and privacy of health data Eliminate job-lock and minimize disruptions in treatment caused by patients changing insurance and providers
What are some examples of recent pharmacy litigation?
Refusal to fill Compounding Collaborative practice agreements
Who submits Form 41 to DEA for the disposal or destruction?
Registrant Reverse distributor (if used)
Methods for disposal or destruction of CS from inventory include?
Registrant requests permission from DEA Registrant uses reverse distributor
How does the FDA enforce the FDCA?
Regulation and issuance of guidance documents
What are the 3 titles of the CSA?
Rehab programs Registration and distribution of controlled substances Importation and exportation of controlled substances
What factors do extent of pharmacist's duty depend on?
Relationship b/w provider and pt *Foreseeability of harm* Decisions of judgement v. non-judgement
Per KS law, registered pharmacies must?
Renew annually w/ BOP Display registration RPh on duty when open Designate PIC
What should be done if a DEA 222 form is stolen?
Report to nearest DEA office stating serial # of stolen forms and/or date of issuance Must notify DEA if found
Term? Preventable medication error involving a prescription and resulting in any of the following: -Pt received wrong drug -Pt received incorrect drug strength -Pt received incorrect dosage form -Drug being received by wrong pt -Inadequate or incorrect packaging, labeling or directions -Dispensing of drug to a patient in a situation that results in or has the potential to result in serious harm to the pt
Reportable incident (incident)
How can a *modify* request for a DEA registration be made?
Request in writing or online (if approved, a new certificate will be issued)
Requires *CR packaging* or not? Exalgo 8 mg tablets in 100 tablet bottle
Requires
Requires *CR packaging* or not? Liquid formulations of medications
Requires
Requires *CR packaging* or not? MethylPREDNISolone 4 mg tablets in 100 tablets bottle
Requires
Requires *CR packaging* or not? NTG extended release capsules
Requires
Requires *CR packaging* or not? Potassium Chloride Oral Solution, USP
Requires
HIPAA: Must provide patient with own PHI and ___ disclosures when pt requests
Restrict
What does *ETASUs* need to include?
Restricted distribution Limited access Provider training Monitoring
Per KS law, what must register as a pharmacy?
Retail (drug stores) Non-resident Hospital (medicare care facility)
Term? Means a person selling at retail non-prescription drugs which are prepackaged, fully prepared by the manufacturer for use by the consumer
Retail dealers
What part of the DUR process? Usually completed by state DUR board made of physicians, nurses, pharmacists, etc and recognizes "ideal" drug therapy and determines whether actual meds used conforms to the ideal
Retrospective Review
What are conditions when a pharmacy (dispenser) may act like a supplier?
Returning CIIs to wholesaler, manufacturer, or reverse distributor Selling a pharmacy business requires the seller Distributing CII drugs b/w DEA registrants
CQI quarterly meetings with the PIC include?
Review all incident reports since last quarter Establish steps to prevent recurrences Create a meeting report that includes attendees, incident reports reviewed, description of steps taken/to be taken to prevent recurrences
Case: Following graduation from KU Pharmacy School, Sam Greene became licensed in both KS and MN and moved to Minneapolis to work for a national chain pharmacy. He had practiced for 5 years w/o any disciplinary problems when he became involved with an internet operation and dispensed prescriptions that were based on the patient completing an internet questionnaire. The MN Board of Pharmacy after due process, revoked his license to practice. KS revoked their license also. *Can the revocation be for all time?*
Revocation shall be for all time, except that at any time after the expiration of *one year*, application may be made for reinstatement of any license (65-1627f)
What must a pharmacist review to assign a BUD for compounded *sterile* preparations?
Risk categories (Low, Med, High) Related storage and use limitations
Requirements to be exempt from *CII* partial refill limitations?
Rx Face: terminally ill or LTCF Rx Back: date, quantity dispensed, remaining quantity to be dispensed, ID of dispensing pharmacist Limitation: 60 days from issue date
Per KS law, what type of drugs can *PA* dispense?
Rx drugs if pharmacy services are not readily available and quantity does not exceed amount necessary for *72 hr supply*
Which act? Objective: To prevent illicit sales of CS over the internet by "rogue" web sites, while allowing the use of electronic communications for prescribing and dispensing CS for legitimate medical purposes
Ryan Haight Online Pharmacy Consumer Protection
Who enforces the *Addiction Treatment, Opioid treatment programs (OTPs)?
SAMHSA (substance abuse and mental health services administration)
What formulation(s) of *NTG* is exempt from CR packaging?
SL
What formulation(s) of *isosorbide dinitrate* is exempt from CR packaging?
SL and Chewable in strengths ≤ 10 mg
"Briefing" (analyzing) a case is similar to?
SOAP
Drug products are considered *therapeutically* equivalent if when compared they are?
Safe and effective Pharmaceutically equivalent Bioequivalent (rate and extent of absorption) Adequately labeled Comply with cGMPs
What is the objective of *OBRA'90*?
Save money by improving quality of drug therapy and patient outcomes
Which act? Purpose: Disposal of CS returned from ultimate users or LTCF on behalf of their patients
Secure and Responsible Drug Disposal
Per CSA, how can CS be stored in pharmacies (including hospital)?
Securely locked, substantially constructed cabinet Dispersed among non-CS stock
What can healthcare providers report to MedWatch?
Serious Adverse events Product Quality Problems Medication and Device Use errors
What should the RPh's documentation do?
Serve as reminder to RPh Provide reference for other RPhs in same pharmacy Contain info for surveyors who need to record what was done and connect that action w/ an outcome if possible Show enforcement officials that OBRA'90 requirements are met
How do KS shared services differ from federal central fill regulations and which one should be followed?
Shared services can be sent directly to pt but central fill does NOT allow that Federal (most strict)
Per KS law, how can KS pharmacists dispense Naloxone?
Sign a *state-wide protocol*
Per KS law, how can KS pharmacists vaccinate?
Signed *protocol* (age and vaccinations limitations)
Prescriber qualifications for DATA include?
Special education Special DEA#
What are the objectives of the *Waxman-Hatch or PTRA act*?
Speed up approval process of generics Make list of bioequivalent drugs (Orange book) Grant manufacturers incentives to continue R&D Codify ANDA process (abbreviated NDA)
State or federal? Determines the scope of practice of pharmacist
State
State or federal? Prohibits a pharmacist from dispensing a generic product that is not considered bioequivalent according the FDA (Orange book)
State
Case: Upon routine inspection, it was discovered that a pharmacist refilled several APAP #3 prescriptions 3 times more than the 5 authorized refills. When this was called to the pharmacists attention, he said that the pharmacy software program was at fault. He said he had contacted the software vendor about the problem but the vendor was having difficulty identifying and repairing the glitch. What entity has jurisdiction over this situation?
State board (most likely)
What may duty and its breach be established by?
Statutes and regulations Previous court cases Expert witness(es) Code of ethics
Per KS law, what type of drugs are allow in *Home health agencies and Hospices*?
Sterile water and saline for injection or irrigation Heparin flush Diphenhydramine injection Epi injection
What ways can the MedWatch statement be distributed?
Sticker attached to container Pre-printed Rx vial cap Separate sheet of paper Consumer med info FDA approved MedGuide
What claims can be made by *dietary supplement's* labels?
Structure/function claims Health claims Nutritional support claims
What does the board have the authority to require of licensees?
Submit to mental and physical exam or a drug screen or any combo Fingerprinted and submit to a state and national criminal history record check
What types of product quality problems can be reported to MedWatch?
Suspect counterfeit Contamination, instability Poor packaging, labeling Defective components Therapeutic failures
T/F A pharmacy may share or discuss PHI w/ a language interpreter employed by the pharmacy w/o written pt authorization.
T
T/F A single violative act by a pharmacist may result in consequences in all 3 legal divisions
T
T/F All branches of govt can make laws
T
T/F Board may limit, suspend, revoke or deny renewal of tech registration on same grounds as those of a RPh.
T
T/F Breach of HIPAA may result in both civil fines and criminal penalties (up to 10 y in jail)
T
T/F CSA authorizes DEA to inspect "controlled premises" (pharmacy)
T
T/F CSA requires that a pharmacy must be registered for each different activity (e.g. research vs dispensing)
T
T/F Community pharmacies must provide pts w/ a PPI for every new and refilled prescription written for oral contraceptives and estrogen products.
T
T/F Electronic supervision still require that the pharmacist verify each order before dispensing.
T
T/F Failure of a community pharmacy to provide a required PPI constitutes a misbranding violation.
T
T/F If no harm, then no compensation in malpractice lawsuits.
T
T/F Incident reports are non-discoverable except by the BOP
T
T/F KS law permits pharmacist to provide a 3-mo supply of Rx drugs that is not a CS or psych drug if sufficient refills are remaining to do so
T
T/F MedGuides are required for scheduled medications
T
T/F Medical care facilities (hospital) must follow pre-packaging requirements
T
T/F Medroxyprogesterone acetate tablets are exempt from CR packaging
T
T/F Optometrists can be a DEA registrant
T
T/F PHI may be electronic, paper and oral forms
T
T/F Pancrelipase preparations are exempt from CR packaging
T
T/F Per HIPAA, pt that pay cash for RXs can prevent the pharmacy from disclosing the info to their insurer.
T
T/F Per KS law, Priviledged communications b/w RPh and pt is on the same basis as b/w physician pt
T
T/F Pharmacist must document each dispensing of Naloxone. (record prescriber either as RPh or protocol physician)
T
T/F Registrant may withhold consent or withdraw consent of inspection
T
T/F Techs must pass one or more exams w/in time specified and pay registration fee.
T
T/F To be on the board of pharmacy, a pharmacist need to be appointed by the governor.
T
T/F To prove *proximate* causation each link must be foreseeable; unforeseeable event ("superceding cause") breaks the causality chain
T
T/F Wholesale distributors must register with the state.
T
T/F With electronic supervision, pharmacist may supervise only 1 student or tech in a hospital pharmacy at one time.
T
T/F Anything incriminating said by registrant during inspection may be used against them
T
T/F Donated meds are not considered "resold"
T
T/F Ipecac syrup is *NOT* ipecac fluid extract.
T
T/F Must request modification of an existing pharmacy registration to operate as an online pharmacy (no additional fee)
T
T/F Per KS law, pharmacists may exercise biological product exchange if in compliance with state law.
T
T/F Registrations may be denied, suspended, or revoked.
T
T/F about HIPAA Unless the pt consents to receiving the pharmacy's "Notice of Privacy Practices" electronically, the pharmacy must provide them with a paper copy on the first day they receive service.
T
How can CS be disposed of in LTCF?
Take back programs Automated drug delivery systems
Case: Pharmacy tech Anderson has overseen the unit-dose packaging for several years at the local Heartland hospital and always carefully labels and documents the packaging. Today, one of the pharmacy students instructs her that omitting the date of repackaging is not legally acceptable. The tech disagrees. *Which person is correct?*
Tech (if documented somewhere else)
Per KS law, who is able to receive a *refill* order?
Tech (if authorized by RPh) Intern RPh
Drugs? Is part of the REMS program
Thalomid Lotronex ER/LA opioid drugs
Per KS law, when is a pharmacist not required to report info about biological products dispensed to prescriber?
There is no interchangeable product for the one prescribed A refill is not changed from the prior product dispensed
What does federal law require for LTCF?
Timely pharmacy services Consultant pharmacist who oversees drug distribution, record keeping, reconciliation and monthly drug regimen review Drugs labeled in accordance w/ state and fed laws Drugs stored properly to maintain drug integrity and assure security
What act? Enable verification of the legitimacy of the drug product down to package level Enhance detection and notification of illegitimate products in the drug supply chain Facilitate more efficient recalls of drug products Include drug manufacturers, wholesale drug distributors, repackagers, third party logistic providers, and pharmacies
Title II: Drug Supply Chain Security Act
What act? Outlines process to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the US over 10 years
Title II: Drug Supply Chain Security Act
Why did "Caution: federal law prohibits dispensing w/o a prescription" or *Rx only* become a requirement?
To comply w/ "adequate directions for use" requirement of FDCA
Per HIPAA, when can a covered entity permitted to use and disclose PHI, w/o an individuals authorizations?
To the individual For tx, payment and health care operations (must limit PHI to *minimum necessary*)
DTC guidance allows brief summary of risks as long as "adequate provision" for obtaining info included?
Toll free # Internet webpage address Referral to concurrently available print info Referral to health care provider
Term? Violation of a duty imposed by law on an individual based upon a relationship to another individual. (e.g. health care professional to a patient)
Tort
Per KS law, what texts are required in *drug stores*?
Toxicology Pharmacology DI Pt focused drug reference Drug equivalences Medical dictionary
What is required on a *faxed* CS prescription?
Transmitter's phone, time & date of transmission, ID of pharmacy to receive Name of individual transmitting, if other than physician Complies w/ all federal and state RX requirements
What do drug ads require?
True statement (drug name, ingredients) Brief statement (SE, CI, effectiveness) *Fair balance*
Exceptions to requirement of pt authorization for release of PHI include?
Tx of individual Face to face Case mgmt or care coordination To direct or recommend alternative tx, therapies, healthcare providers, or settings of care
CSA requires registration by?
Type of activity Type and schedule of CS registrant is allowed to handle
Who grants *patents*?
US patent and trademark office
FDA *Traditional* compounding guidelines states that drug product is compounded in *compliance with _____ chapters using ______ bulk drug, FDA-approved drug, or other approved listed substances.
USP USP/NF
What provides *standards of quality, strength, purity, packaging, labeling, compounding (sterile, non-sterile, BUD and expiration date)*?
USP/NF
Who regulates if narcotics can be mailed or not?
USPS (plain wrapper, no indication that it is narcotic on the outside)
Initiative? Created in 2006; FDA began new efforts to remove unapproved rugs from the market
Unapproved Drugs Initiative and the Prescription Drug Wrap up
What formulation(s) of *potassium supplements* is exempt from CR packaging?
Unit dose (effervescent tablets, liquid, powered) packets ≤50 mEq/unit dose
What criteria is needed to exempt *ASA and APAP oral powder* forms from CR packaging?
Unit doses that contain ≤15.4 grains of ASA or 13 grains of APAP per unit dose and dose not contain other substances to the provisions of the act
What type of previously dispensed meds can be re-dispensed?
Unit-dose that only contain 1 med and never reached the pt and is still intact
How can a license be lost (revoked)?
Unprofessional conduct (65-1626) Professional incompetency Others (65-1627)
Schedule? Federal: may refill as authorized
V
Schedule? Kansas: no more than 5 times or 6 months after the date of issue, whichever comes first
V
The controlled substance schedule of oral diphenoxylate with atropine.
V
What does the Ryan Haight Online Pharmacy Consumer Protection Act require?
Valid prescription (legitimate purpose and practitioner has conducted at least 1 in person pt eval) Online pharmacy w/ modified DEA registration for internet business
What can compensation from a malpractice lawsuit cover?
Verifiable damages (medical expenses, lost employment, lost wages or subjective damages of emotional injury, pain and suffering Punitive damage caused by: -cover ups -extreme carelessness -failure to follow standard precedures -reckless, wanton conduct
What does VIPPS stand for?
Verified pharmacy practice sites
Per KS law, how can drugs be distributed in LTCF?
Via prescription Traditional, unit-dosed, and/or automated drug delivery system
What provision of the False Claims Act entitles a portion of the award (5-25%) to be given to the person who notified authorities of the violation?
Whistle blower (qui tam lawsuits)
Per Kansas law, what alternative forms of patient information be provided to supplement verbal counseling?
Written Info Leaflets Pictogram labels Video programs Auxiliary labels on RX vials
What does OBRA'90 require to be documented by the pharmacist?
Written record that contains pt info including *name, address, DOB, phone #, pt hx, list of meds, devices and RPh impression of pt's drug therapy*
What are reportable incidents?
Wrong drug Wrong strength Wrong dosage form Wrong patient Inadequate or incorrect packaging, labeling or directions Dispensing of drug to a pt in a situation that results in or has the potential to result in serious harm to the pt
What letter does the DATA DEA # start with?
X
Case: Sandy Lee is the PIC of Heartland Community Pharmacy (open: 50 h/week), but Sandy only schedules herself to work 30 h/week. Recently a small family planning clinic opened for local residents and the director contacted Sandy about serving as the PIC for the facility. The county health dept also contacted Sandy and asked her to serve as the PIC. *If the health dept offers pharmacy services no greater than 15 h/wk, can Sandy be the PIC there too?*
Yes
Pre-marketing approval needed? Rx drugs
Yes (IND, NDA, ANDA, SNDA)
Case: Following graduation from KU Pharmacy School, Sam Greene became licensed in both KS and MN and moved to Minneapolis to work for a national chain pharmacy. He had practiced for 5 years w/o any disciplinary problems when he became involved with an internet operation and dispensed prescriptions that were based on the patient completing an internet questionnaire. The MN Board of Pharmacy after due process, revoked his license to practice. *Can the revocation of his license in MN serve as the basis for revoking his Kansas license?*
Yes (65-1627)
Pre-marketing approval needed? Devices
Yes (class III)
A manufacturer marketed an oral suspension w/ a dietary supplement as the active ingredient. The product labeling claimed that the product would cure gastroenteritis infections cause by campylobacter. *Which statement about product is correct? The FDA will likely consider this product to be a:* a. drug, b/c the manufacturer is making a disease claim b. dietary supplement b/c the active ingredient is a herbal c. dietary supplement b/c it makes a structure/function claim d. drug b/c purchasers will intend to use the product to treat an upset stomach
a
Which statement(s) about drug recalls is(are) correct? a. Pharmacists are responsible for knowing which drug products have been recalled b. Drug recalls are divided into 4 classes based on their potential for harm c. Class I recalls are the least serious.
a
It was discovered during an audit that RPh Smith intentionally billed Medicare Part D for brand-name CS when she actually dispensed generic products for those prescriptions. If Smith did do this, which of the following is accurate? a. Her action will likely be considered fraud by violation of the False Claims act b. If the pharmacist tech acted as a "whistleblower" to Smith's billing activity, the tech could receive some portion of the fines levied against the RPh c. The pharmacist may be placed on the OIG exclusion list
a, b, c
The FDA ordered a drug manufacturer to implement a REMS. A REMS can require: a. distribution of a MedGuide b. completion of specialized training or experience by prescribers c. pts enrolled in a registry
a, b, c
*Prescription drug sampling* must follow procedures for?
accountability (including inventory, reporting of losses)
Type of pharmacist license? License by exam or score transfer
active
Type of pharmacist license? License by reciprocity
active
What are the different types of licenses?
active inactive voided
Actual or proximate causation? Prove that defendant pharmacist's conduct was a substantial factor in plaintiff's harm
actual
Per the FDCA 1938, labeling must contain?
adequate directions for use
Type of law? Deals with disputes b/w: *society and licensed* individuals
administrative
Type of law? Involves: *violation of statutes and/or regulations governing a license*
administrative
Type of law? Objective: *Compliance*
administrative
Type of law? Burden of proof: *preponderance of evidence*
administrative civil
Who does the executive branch assigns the responsibility of administering and enforcing statutes to?
administrative agencies
Which govt branch? Create *regulations* (laws) through a formal procedure that includes public announcement and comment (notice and rulemaking)
administrative agencies (executive branch)
What definitions did the FDCA 1938 expand?
adulteration misbranding
When can the FDA take action to remove a dietary supplement from the market?
after establishing the product to be adulterated (unsafe) or misbranded (labeling is false or misleading)
What can *RPh* dispense methadone for?
analgesic only (not for detox or maintenance)
How often is the CFR updated?
annually
How often must the PIC review the training course for technicians?
annually
Per Kansas law, how often should a CS inventory be completed?
annually (at least 8 months after prev one)
Per Kansas law, how often must a CS inventory be completed?
annually (no sooner than 8 mos since the last one)
If a RX is written for *generic* drug, what drugs can be substituted for it?
any
When should a *CPA (collaborative practice agreement)* be reviewed or updated?
at least q 2 years
Term? A mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls and maintains all transaction information
automated dispensing system
What is the pharmacist's responsibility regarding recalls?
be aware of them
Registrant may seek an employment waiver and must be granted ___ hiring.
before
Where are *SLCP* stored?
behind counter or in locked cabinet
Term? Products made from living organisms and include viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, blood components, and derivatives used to treat or cure, prevent or diagnose diseases and medical conditions
biologicals
Term? Means that the biological product is highly similar to the reference product not withstanding minor differences in clinically inactive components and that there are no clinically meaningful differences in terms of safety, purity, and potency of the product
biosimilar
Brand or generic drug requirement? Chemistry
both
Brand or generic drug requirement? Controls
both
Brand or generic drug requirement? Labeling
both
Brand or generic drug requirement? Manufacturing
both
Brand or generic drug requirement? Testing
both
Federal or Kansas Law? Date of prescription issuance or date filled (or refilled)
both
Federal or Kansas Law? Name of prescriber
both
Federal or Kansas Law? Serial # of the prescription (RX #)
both
Brand or generic drug requirement? Animal studies
brand
Brand or generic drug requirement? Bio*availability*
brand
Brand or generic drug requirement? Clinical studies
brand
What is easy to prove in cases of errors in filling or dispensing?
breach
What type of ads require "adequate provision" of info?
broadcast
Drug(s)? Used for drug addiction under DATA
buprenorphine SL, buccal film Buprenorphine/naloxone
Outsourcing facilities must comply with _____ and report serious ADEs
cGMP
What provides extensive standards for drug manufacturing?
cGMP
There must be a _____ b/w the breach of duty and the harm or injury that occurred (a chain of events).
causal link
Term? A pharmacy which is permitted by the state in which it is located to prepare CS orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user (must share common owner or have contractual relationship)
central fill pharmacy
Type of pharmacy? Cannot receive CS rx directly from patient and cannot mail meds directly to pt (everything must go through community pharmacy)
central fill pharmacy
What type of techs can do the tech-check-tech?
certified
Type of law? Deals with disputes b/w: *individuals*
civil
Type of law? Involves: *injury to a person(s) by another person(s)* (e.g., injury to patient or customer by a pharmacist or technician)
civil
Type of law? Objective: *compensation for harm*
civil
What type of law deal with disputes b/w individuals or organizations?
civil
Case: The patient, Maria, presented a prescription for tamoxifen to the pharmacist, Ellis. The pharmacist entered the prescription into the computer as Tambocor and misfilled it on 3 occasions. Ellis knew that the pt's physician was an oncologist and that Tambocor was a heart medication. Despite testimony indicating that the writing on the prescription was illegible, Ellis did not call the physician to clarify. If the case was litigated, would it be likely done as a criminal, administrative or civil case?
civil and possibly administrative if Board knows about it
What is *professional malpractice* also classified as?
civil law
Legal term? To turn into law
codify (codification)
What is the purpose of civil lawsuits?
compensation and deterrence
Under KS law, if a PIC quits, the pharmacy must hire another PIC w/in 30 days. When a KC hospital pharmacy failed to rehire a PIC w/in 30 day period, the BOP fined the pharmacy $1000 plus $20 each day that the pharmacy was in violation. What is the primary purpose of *administrative* disciplinary actions*?
compliance
Term? Articles intended to be *rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body ... for cleansing, beautifying, promoting attractiveness, or altering the appearance and intended for use as a component of any such articles; excepting soap*
cosmetic
In order to dispense *naloxone*, a pharmacist must ____ in person or they cannot dispense it.
counsel
Term? A CS which, or the container or labeling which, w/o authorization bears the trademark, trade name, or other identifying mark ... of a manufacturer, etc, other than the person who manufactured, etc. the substance
counterfeit substance
Type of law? Burden of proof: *beyond a reasonable doubt*
criminal
Type of law? Deals with disputes b/w: *society and individuals*
criminal
Type of law? Involves: *criminal statutes*
criminal
Type of law? Objective: *punishment*
criminal
How often is the Federal Register updated?
daily
What is BUD defined as?
date after which a dispensed product should no longer be used
Legal term? An individual, company, or institution sued or accused in a court of law
defendant
Who is the party that caused the harm or damage also called a 'tortfeasor'?
defendant
FDA *Traditional* compounding guidelines states that drug product has not been identified by FDA by regulation to present ____ ____ __ _______ that effect safety and effectiveness of the product.
demonstrable difficulties for compounding
Term? Instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article
device
Term? Intended to affect structure or function of the body...which does not achieve any intended purpose through chemical action.. or dependent upon being metabolized ... to achieve its purposes
device
Term? Intended for ingestion means (taken by mouth) in capsule, tablet, liquid, powder, softgel, or gelcap form
dietary supplement
Term? May *NOT* be intended for diagnosis, cure, mitigation, treatment, or prevention of disease .. and remain a dietary supplement
dietary supplement
Term? Products intended for ingestion, supplement the diet and contain one or more of the following: -vitamin, mineral, herb, botantical, amino acid
dietary supplement
OTC labels requires "adequate ____ or use" (public use)
directions
Cause of action begins when the plaintiff discovers the injury is called?
discovery rule
Term? An individual practitioner, institutional practitioner, *pharmacy or pharmacist* who dispenses a CS
dispenser
A pharmacy registered as a _____ may manufacture or distribute to other practitioners an aqueous or oleaginous soln or solid dosage form containing a narcotic substance in a preparation NOT exceeding ____ of the complete product.
dispenser 20%
What do *community pharmacies, hospital pharmacies, & teaching institutions* register as?
dispensers
A pharmacy registered as a *dispenser* may sell other registrants *without* registering as a ______ as long as the total # of dosage units distributed does *not* exceed ____ of the total units of CS distributed and dispensed in one calendar yer.
distributor 5%
KTracs: Do or don't? Contact us if you have questions
do
KTracs: Do or don't? Discuss the reports with patients
do
KTracs: Do or don't? Notify us when your delegates quit so that we lock their access
do
KTracs: Do or don't? Post patient notification posters (link on left side of this page)
do
PIC must have _____ of tech training available for inspection.
documentation
Partial fill ____ refill
does not equal
KTracs: Do or don't? Put your patient's reports in their charts/files
don't
KTracs: Do or don't? Query anyone except your own patients
don't
KTracs: Do or don't? Query prospective employess
don't
KTracs: Do or don't? Share reports with other pharmacists and prescribers
don't
KTracs: Do or don't? Show your patients their reports
don't
Term? (other than food) intended to affect structure or function of the body
drug
Term? Intended for use as a *component* of an item in one of the 3 categories
drug
Term? Intended to *diagnose, cure, mitigate, treat or prevent disease* in man or animal
drug
Term? Recognized in *official compendium*
drug
Term? *Hypodermic syringes*, needles, and other objects used or intended for use in parenterally injecting CS into the human body are included in the definition
drug paraphernalia
When can the FDA mandate a *REMS*?
during or after approval process
When are PPIs required to be given for oral contraceptives or estrogen products in *community* setting?
each fill (new or refill)
When must inventory be completed for *newly controlled substances* be completed?
effective date of scheduling (published in Federal Register)
What type of CS prescriptions? DEA allowed in 2010 -Created by a prescriber and processed by a pharmacy that *both* use applications that meet all DEA requirements and specifications that assure prescription authenticity and security -before any application may be used it must be reviewed, tested, and determined to meet all requirements by a third-party
electronic
Drug? Exempt from CR packing if ≤8 g of equivalent/package in granules for oral suspension & oral suspension
erythromycin
Exact or estimated count? CIII, CIV, and CV in containers of 1000 or *less*
estimated
How often must a pharmacist license be renewed?
every 2 years
Per federal law, how often must a CS inventory be completed?
every 2 years (biennial)
How often does the PDUFA need to be renewed?
every 5 years
Exact or estimated count? CII - CVs in containers of *more* than 1000 doses
exact
Patents or Exclusivity? Gives manufacturer time to retain the market share
exclusivity
Which govt branch? Administers and enforces statutes
executive
Which govt branch? Develops *administrative* law
executive
Which govt branch? Enforces law
executive
Outsourcing facilities are ______ from FDA drug approval requirements
exempt
Type of standard for pharmacist duty? Counseling, MTM, catching interactions, allergies, monitoring therapy, collaborative practice
expanding
Type of standard for pharmacist duty? Responsibility to perform addl professional functions
expanding
What *exists when the production or consumption of a good affects someone who does not fully consent to the effect and when the costs of a good are not fully incorporated into the consumer price*?
externality
Federal or Kansas Law? Directions for use, including precautions, as indicated on the prescription
federal
Federal or Kansas Law? Medwatch statement
federal
Federal or Kansas Law? Name & address of dispenser (pharmacy)
federal
Federal or Kansas Law? Name of patient, if stated
federal
Refusal of Administration Inspection Warrant can result in?
fine and jail sentence
When are PPIs required to be given for oral contraceptives or estrogen products in *inpatient* setting?
first fill and every 30 days
Term? Articles used for food or drink for man or other animals Chewing gum Articles used for components of any such article
food
What is a test of *proximate* causation?
foreseeability
Brand or generic drug requirement? Bio*equivalence*
generic
What are drugs pre-'38 called?
grandfathered
What drugs were exempted from safety requirement of the FDCA 1938?
grandfathered (pre-'38)
_______ purpose is to clarify laws or regulations, to explain how compliance with the laws and regulations may be achieved and to outline review and enforcement approaches.
guidance documents
What board regulates *amphetamine* law?
healing arts
Type of DS label claim? Relationship of a DS to a disease or condition
health
What is the purpose for state regulations?
health and welfare of citizens
Who are commercial prescription drug labels and labeling directed to?
healthcare professionals
Drug(s)? Schedule 1
heroin marijuana mescaline peyote
CSP risk category? *CSPs prepared from bulk, nonsterile components or in final containers which are not sterile*; preparations must be terminally sterilized before administration
high
CSP risk category? BUD: -Rm Temp: *24 hours* -Refrigerated: *3 days* -Frozen: *45 days*
high
CSP risk category? Compounding location: *ISO Class 5 PEC, ISO Class 7 buffer area, ISO Class 7 ante area*
high
FDA *Traditional* compounding guidelines state that the drug product is compounded for _______ based on the receipt of a valid _______.
identified patient prescription
When can a DS label say it benefits a nutrient deficiency?
if it discloses the US prevalence
When can a manufacturer market one size of OTC product in non-compliant (non-CR) package?
if labeled appropriately
_____ of the law provides no defense.
ignorance
What type of acts are excluded from personal malpractice insurance coverage?
illegal
CSP risk category? *Emergent* use preparations such as epidurals prepared by anesthesia for immediate injection or infusion, diagnostics, any non-hazardous preparations that might cause harm due to delays in administration
immediate
CSP risk category? Compounding location: *medication prep areas should be clean, uncluttered, and functionally separated*
immediate
CSP risk category? Does not require garbing to compound
immediate
CSP risk category? BUD: -Rm Temp: *1 hour* -Refrigerated: n/a -Frozen: n/a
immediate
Type of pharmacist license? Failure to do CE
inactive
What should be documented in a patient's record when an amphetamine is prescribed, administered, sold or dispensed?
indication or what the drug is being used
Term? A physician, DDS, DVM, or other individual licensed, registered, or otherwise permitted, by the US or the jurisdiction in which he/she practices, to dispense a CS in the course of professional practice, but does *not* include a pharmacist, a pharmacy, or an institutional practitioner
individual practitioner
What does pharmacy ligation serve to do?
inform practitioners of practice expectations
What pharmacy action if required if the physician fails to meet his or her requirements for emergency CII fills?
inform the DEA
Patient's waiver of counseling must be an ____ waiver.
informed
Notice of Inspection must be _____ and ______.
informed voluntary
Type of CS inventory? Need to be completed on date person first engages in dispensing CS
initial
What must all changes to a *CII* script have?
initials, date, time
Outsourcing facilities pay a user fee for FDA _____.
inspections
What type of DTC advertising is exempt from "adequate provision" for obtaining info requirement?
institutional
Term? A *hospital* or other person (other than an individual) licensed, registered, or otherwise permitted by the US or the jurisdiction in which it practices, to dispense a CS in the course of professional practice, but does not include a pharmacy
institutional practitioner
Drug? Exempt from CR packing if ≤10 mg strengths for SL and chewable forms
isosorbide dinitrate
Which govt branch? May adjudicate civil lawsuits regarding obligations/contracts b/w two or more people (e.g., professional malpractice)
judicial
Which govt branch? May interpret statutes and regulations (adding to the body of common law)
judicial
Which govt branch? Develops *common or case* law
judicial
Which govt branch? Interprets law
judicial
What has *persuasive* authority and may be limited by prior decisions of superior courts?
judicial opinions
What from the judicial branch establish enforceable rules?
judicial opinions (decisions and interpretations)
Violation of the *Anti-Kickback Statute* must be ___ and ____ and carries ___ and ___/____ penalties.
knowing; willful criminal, civil/administrative
Label or labeling? Is the written, printed, or graphic matter *on* the immediate container
label
Label or labeling? Includes *all* labels and other written, printed, or graphic matter on any article, container, wrapper, or *accompanying* such article
labeling
If the expiration date is listed as month/year, what day does the drug expire?
last day of month
What does professional malpractice enforce?
legal accountability
Which govt branch? Develops *statutory* law
legislative
Which govt branch? Makes/develops law
legislative
A prescription for a CS to be effective must be issued for a _______ by an individual practitioner acting in the usual course of his professional practice. The responsibility for proper prescribing and dispensing is upon the prescribing practitioner, but a ____ rests with the pharmacist who fills the prescription.
legitimate medical purpose corresponding responsibility
Per KS law, who are transfer *controlled substances* prescriptions?
licensed *pharmacists*
FDA *Traditional* compounding guidelines states that drug products are compounded by *licensed pharmacists or physicians* in _____ quantities based on hx w/in established provider/patient relationship.
limited
CSP risk category? BUD: -Rm Temp: *48 hours* -Refrigerated: *14 days* -Frozen: *45 days*
low
CSP risk category? BUD: -Rm Temp: *12 hours* -Refrigerated: *12 hours* -Frozen: n/a
low w/ < 12 hr BUD
Term? Objective to treat an opioid dependent individual with stable opioid agonist therapy for a period in excess of 21 days
maintenance
It is the *intention* of the _____ that determines what an article will be classifed as: food or drug.
manufacturer
What establishes production ceilings?
manufacturing quotas
What restricts the manufacture and procurement of CI and CII substances to DEA-registered manufacturers?
manufacturing quotas
How long can a prescriber not certified through OTP *administer* not prescribe methadone for while enrolling in OTP?
max 3 days (1 day at a time)
Drug? Exempt from CR packing if ≤600 mg of drug per package
mebendazole
Hospital *in-patients* received medications pursuant to?
medication orders
CSP risk category? *Batched* syringes, TPN, ophthalmic preparations made from sterile products, pooled admixtures, *batch*-compounded preparations w/o bacteriostatic additives, preparations made using automated compounders or other automated devices, elastomeric pumps
medium
CSP risk category? BUD: -Rm Temp: *30 hours* -Refrigerated: *9 days* -Frozen: *45 days*
medium
What drug/strength is restricted to OTPs and may not be used for pain management?
methadone 40 mg
Drug? Exempt from CR packing if ≤84 mg of drug per package
methylPREDNISolone
Case: A pharmacist received a call from a physician who ordered ibuprofen 600 mg for a patient but instructed the pharmacist to label the drug as oxycodone. *What part of the FDCA will be violated if the pharmacist does it?*
misbranding
Refilling w/o express authorization is a ______ violation.
misbranding
What type of violation is *failure to dispense in CR package* considered?
misbranding
Failure to comply with product tampering regulations may result in?
misbranding and/or adulteration
If a PPI is not given to a patient, what type of violation is it?
mislabeling
In order to be an *authorized collector*, the DEA requires _____ of registration.
modification
Each resident of a LTCF must have their drug regimen reviewed by a consultant RPh at least how frequently?
monthly
How often does the pharmacist have to do a medication review for each pt in LTCF?
monthly
How often must the contents of Automated drug delivery systems be inspected for accuracy?
monthly
Labels of ______ Rx drugs dispensed to patients must comply with *USP/NF standards & FDCA, CSA and state laws*.
multi-dose
How many times can a *glass bottom* CR container and lid be used?
multiple times but lid can only be used once
Term? includes opiates, cocaine, coca leaves
narcotics
What occurs when the *fixed costs of providing a good are high relative to the variable costs, so the average cost declines over the time that the good is provided*?
natural monopoly
Term? A drug that is not generally recognized by qualified experts as *safe and effective* for use under the conditions recommended in the drug's *labeling*
new drug
What type of drug may not be marketed w/o FDA approval?
new drug
FDCA 1938, _____ may not be marketed until approved for ____ by FDA for use under labeled conditions.
new drug safety
Pre-marketing approval needed? Cosmetics
no
Pre-marketing approval needed? Dietary supplements
no
Pre-marketing approval needed? Food
no
Per Federal law, what is the limit for refills for *CV* scripts?
no limit
If a prescription does not contain indication of refills, what is it considered?
no refill
Non-sterile formulation? BUD: *6 months or earliest expiration date of any active pharmaceutical ingredient (whichever is earlier)*
non-aqueous
Non-controlled, parenteral or controlled prescription? Federal Label requirements: Name & Address of dispenser Serial # of prescription Date filled Name of prescriber Name of patient Directions for use (including precautions) MedWatch statement
non-controlled
Per KS law, what type of drugs are *ARPN* able to prescribe?
non-controlled and CS pursuant to written *protocol* authorized by responsible physician
Per KS law, what type of drugs can *health depts & private not-for-private family planning clinics* store and distribute?
non-controlled approved for formulary
Per KS, what type of prescriptions can pharmacy *interns* transfer?
non-controlled prescriptions
What should also be done if CS are stolen?
notify the police
Type of DS label claim? Highlight nutritional attributes of a product
nutritional support
What can amphetamines *not* be prescribed or dispensed to treat?
obesity
What does OBRA'90 require to be made to patients/caregivers and varies with state law as to when (new and/or refills)?
offer to discuss
Required or omit if suitable records are kept for Pre/repackaging labels? Date repackaged
omit
Required or omit if suitable records are kept for Pre/repackaging labels? Lot #
omit
Required or omit if suitable records are kept for Pre/repackaging labels? Manufacturer
omit
Required or omit if suitable records are kept for Pre/repackaging labels? Repackager (RPh or tech initials)
omit
Per Kansas law, when are RPhs required to place a BUD?
on labels of non-sterile and sterile repackaged and compounded packages
Term? Person, entity, or internet site, whether in the US or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet. The term includes, but it not limited to, a pharmacy that has obtained a modification of its registration that currently authorizes it to dispense CS by means of the internet
online pharmacy
If a RX is written for *brand* drug and prescriber indicates no sub preference, what drugs can be substituted for it?
only drugs with the same TE code
Who submits a *SNDA*?
original manufacturer that submitted the original NDA
What type of drug is *sufficiently safe and effective to be marketed by the # of patients who need them is so small that it is not commercially feasible to market*?
orphan drugs
Term? A facility at one geographic location that engages in sterile compounding, elects to register w/ the FDA, and is subject to some compounding constraints and inspection requirements
outsourcing
Non-controlled, parenteral or controlled prescription? Federal Label requirements: Name & Address of dispenser Serial # of prescription Date filled Name of prescriber Name of patient Directions for use (including precautions)
parenteral
Patents or Exclusivity? Protects the manufacturer/inventor --> allows them to make profit and prevent other manufacturers from making product
patents
Outsourcing facilities may or may not receive _______ prescriptions and may or may not be a ______.
patient-specific pharmacy
Term? Any individual, corporation, government or governmental subdivision or agency, partnership, association or other legal entity
person
CS? Exempt from control when used in bona fide religious activities by Native American Church
peyote
Term? Any pharmacist licensed by a State to dispense CS, and shall include any person (e.g. pharmacist intern) authorized by a state to dispense CS under the supervision of a pharmacist licensed by such State
pharmacist
Who can dispense *guaifenesin w/ codeine* OTC (CV)?
pharmacist only
Who is responsible for checking if the dropper provided with oral suspensions of drugs is CR?
pharmacists
Who must do the actual counseling per OBRA'90?
pharmacists
Per KS law, who supplies the *emergency kit* to LTCF?
pharmacy
What establishes a *minimum standard* of professional behavior?
pharmacy law
Post-marketing surveillance allows the FDA to require manufacturers to complete ______ studies.
phase IV
In a *collaborative practice agreement*, who is responsible for pt care following initial dx and assessment and direction/supervision of the RPh?
physician
Legal term? AKA petitioner; the party that initiates the lawsuit
plaintiff
Who is the injured party?
plaintiff
FDA can require manufacturers to provide REMS with their product due to?
post-marketing surveillance
Drug? Exempt from CR packing if ≤50 mEq per unit dose
potassium supplements
What formulation(s) of *anhydrous cholestyramine* is exempt from CR packaging?
powder form
What formulation(s) of *colestipol* is exempt from CR packaging?
powder up to 5 g per package
Term? A physician, dentist, veterinarian, scientific investigator, *pharmacy*, *hospital*, or other person licensed, registered, or otherwise permitted... to distribute, dispense..administer.. a controlled substance (CS)
practitioner
Federal laws may be written to _____ state law if the laws are in conflict.
pre-empt (override)
Dietary supplement do not require ____ approval.
pre-market
Drug? Exempt from CR packing if ≤105 mg of drug per package
predniSONE
Term? An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g. an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription)
prescription
What does the letter P mean in classification of new drugs?
priority
Who puts together the USP/NF?
private independent organization
Outsourcing facilities must provide _____ and _____ info to the FDA.
production sales
What is usually the result of *unintentional mistakes*?
professional malpractice
What requires a plaintiff to prove that defendant failed to practice to a standard of care that caused damage or harm?
professional malpractice
Why is liability insurance a necessity?
professional malpractice
Legal term? To proclaim or declare something officially; to publicize that law or regulation is in effect
promulgate
Actual or proximate causation? Limits the scope of liability to the party whose misconduct most directly caused the harm
proximate
What are goods that are those *necessary and beneficial commodities that private entities will not supply b/c there is no incentive for a private entity to provide them*?
public goods
How frequently must a community pharmacy submit a zero dispensing report to KTRACS?
q 7 days
FDA classification of new drugs determines ___ through NDA process.
rate
Term? That certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records
readily retrievable
*Electronic supervision* means pharmacist supervision in _____ of a tech or pharmacy student working in a KS medical care facility pharmacy.
real-time
OBRA'90 requires that RPh make a ______ to document.
reasonable
FDA *Traditional* compounding guidelines states that drug product is not compounded ____ or in _____ amounts if it is essentially a copy of commercially available drug product(s).
regularly inordinate
Legal term? A rule having the force of law issued by an administrative agency
regulation
Statute or regulation? Detail and implement statute
regulation
Statute or regulation? Source: agency -easier to enact and change
regulation
Statute or regulation? Violation may result in administrative penalties and may not exceed authority of the statute
regulation
What ads are exempt from the following requirements? True statement (drug name, ingredients) Brief statement (SE, CI, effectiveness) *Fair balance*
reminder
Required or omit if suitable records are kept for Pre/repackaging labels? Aux labels if necessary
required
Required or omit if suitable records are kept for Pre/repackaging labels? BUD
required
Required or omit if suitable records are kept for Pre/repackaging labels? Brand or generic name
required
Required or omit if suitable records are kept for Pre/repackaging labels? Drug strength and quantity
required
What does pharmacy law address when adverse outcomes occur?
responsibility accountability liability
Per KS law, what type of drugs can *APRN* dispense?
samples pursuant to protocol only
DQSA allows FDA inspections for the purpose of?
sampling, recalls, manufacturing, repackaging and compounding
CIII to CV invoices or packing slips should be filed ____ from general business files or make "readily retrievable*
separately
Per KS law, what type of barbiturates are CII?
short-acting (schedule change if combined w/ non-CS drugs or in suppository form)
Term? A product which identifies itself by a common name or slang associated w/ CS and indicates on its label or promotional material that it stimulates the effect of a CS
simulated controlled substance
What type of drug source will *NOT* have a *TE* code assigned to it?
single source
Drug? Exempt from CR packing if ≤264 mg per package
sodium fluoride products
What formulation(s) of *sucrase* is exempt from CR packaging?
solution in glycerol and water
What does the letter S mean in classification of new drugs?
standard
What means to *'abide by decided cases'*
stare decisis
What are NOT considered samples?
starter paks
What are provided to pharmacies free of charge, but not intended to be free for consumers and not packaged as such?
starter paks
If a compounder elects not to register as an *outsourcing* facility, who will have oversight over them?
state
What law commonly reference the *Orange book*?
state
What level of government determines who has authority to prescribe?
state
What entity regulates *503A* pharmacies?
state boards of pharmacy
Legal term? A written law enacted by a legislature
statute
Statute or regulation? Source: legislature -Difficult to enact and change
statute
Statute or regulation? Violation may carry criminal penalties
statute
What type of law do *legislative* branches (both state and federal) make?
statutes
Type of DS label claim? How product affects organs/systems of the body
structure/function
Type of DS label claim? Allowed by FDA if: Manufacturer can substantiate claims are truthful/not misleading Manufacturer must notify the FDA w/in 30 days of making the claim Label must contain a disclaimer: This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease
structure/function
What is a SNDA?
supplemental new drug application
What type of alcohol can *hospitals* obtain to compound with?
tax-*free* 95% ethyl alcohol
What type of alcohol can *community* pharmacies obtain to compound with?
tax-*paid* 95% ethyl alcohol
What law should pharmacists follow if state and federal laws conflict?
the most strict (as long as it does not cross state line)
What are OTC drugs evaluated on by the FDA?
therapeutic category
What does the *Ietter* FDA classification of a new drug indicate?
therapeutic potential
FDA inspections must be at a reasonable ___, manner and reasonably limited.
time
What are malpractice cases classified as within civil law?
torts
Type of standard for pharmacist duty? *Learned intermediary doctrine* -Argument: physicians are in the best position to choose appropriate meds and advise pts of risks of tx -Has contributed to establishing an error-free practice environment
traditional
Type of standard for pharmacist duty? A technical responsibility to fill and dispense accurately
traditional
What type of government does the US have?
tripartite
________ Rx drugs must comply with *FDA Compliance policy Guide and state law*.
unit-dosed
FDA *Traditional* compounding guidelines states that drug product has not been withdrawn from the market b/c it was deemed ____ or _______.
unsafe not effective
Per KS law, drug store references may include internet sources if?
updated annually
How are mid-level practitioners able to prescribe?
using protocols or collaborative practice agreements
Document? Written physician - approved policies and procedures for recordkeeping, reporting and administering vaccines
vaccination protocol
Type of pharmacist license? Failure to pay license renewal fee
voided
Length of time in which a pharmacy must notify the local DEA diversion Field Office after discovery of a theft or significant loss of CS.
w/in 1 business day
When must the DEA be notify about significant loss of CS?
w/in 1 business day of loss discovery
How frequently must a community pharmacy submit dispensing data to KTRACS?
w/in 24 h of being dispensed unless exempted or filing a zero report
When must dispensing info on schedule II-IV and drugs of concern be submitted?
w/in 24 h of dispensing
How long does a technician have to notify the board of *new employer* of changing jobs?
w/in 30 days
When should the board be notified of a change in residential address, email address, or legal name?
w/in 30 days
When should the board be notified when new employment is obtained?
w/in 30 days
How long does a pharmacist have to notify the BOP if discontinuing the *emergency opioid antagonist statewide protocol*?
w/in 30 days of stopping
Once registered as an intern, when must all required hours be completed by?
w/in 6 years
A drug wholesaler, acting as a supplier, has how much time to complete a DEA Form-222 before it becomes invalid?
w/in 60 days of date of issue
Non-sterile formulation? BUD: *14 days when stored at controlled cold temps (2°-8°C or 36°-46°F)*
water-containing oral
Non-sterile formulation? BUD: *30 days*
water-containing topical/dermal and mucosal liquid and semisolid
When is a *MedGuide* required to be provided in *inpatient* setting?
when pt requests for it
What is defined as distributing drugs to anyone other than the consumer?
wholesaling
The FDA rates the therapeutic potential of some new drug applications as a "P". This rating indicates that the drug?
will receive priority review
How long does a pharmacist have to submit in signed *emergency opioid antagonist statewide protocol*?
within *5 days* of signing
How must the BOP be notified if there is a PIC change or change in majority ownership of a drugstore?
writing
Pharmacies must make a good faith effort to obtain ____ acknowledgement of Notice of Privacy Practices.
written
Prescription drug samples require _____ request and receipt.
written
Scripts for obesity can be continuously dispense or prescribe for a pt if?
wt loss ≥5% of initial weight during the initial 90 days of tx using CS
How many times can a Schedule *II* be refilled?
zero
Per KS law, what is the limit for *diphenoxylate* to be a *CV*?
≤ 2.5 mg and not less than 25 mcg of atropine sulfate per dosage unit
Per KS law, what is the limit for *codeine* or any of its salts per 100 mL or 100 g to be a *CV*?
≤ 200 mg
What day supply exempts an outpatient ER from reporting to KTracs?
≤ 48 h
What is the limit for *predniSONE* for exemption from CR packaging?
≤105 mg/package
How many grains of *APAP* can be in a unit dose of powder to be exempt from CR packaging?
≤13
BUD for Compounded non-sterile preparations? Water-containing oral formulations
≤14 days when stored at controlled cold temperatures (2°-8° C or 36°-46°F)
What criteria is needed to exempt *effervescent ASA and APAP* oral products from CR packaging?
≤15% of drug per tablet Oral LD50 in rates >5 g/kg body weight Releases ≤85 mL of carbon dioxide per grain when placed in water
How many grains of *ASA* can be in a unit dose of powder to be exempt from CR packaging?
≤15.4
What is the limit for *sodium fluoride* products to be exempt from CR packaging?
≤264 mg per package
BUD for Compounded non-sterile preparations? Water-containing topical/dermal and mucosal liquid and semisolid formulations
≤30 days
What is the limit for *potassium chloride* for exemption from CR packaging?
≤50 mEq/unit dose
Per KS law, what is the quantity limit for PA to dispense?
≤72 h supply
What is the limit for *methylPREDNISolone* for exemption from CR packaging?
≤84 mg/package
Per KS law, who can a pharmacist give vaccines, other than the flu, to
≥ 12 yo
Per KS law, who can a pharmacist give a flu vaccine to?
≥ 6 yo
How long must records of Naloxone dispensing be kept for?
≥5 years
What is considered a passing score on the PIC exam?
≥85%