Juris Exam 1, Juris Kahoot, MPJE ty coral, MPJE, MPJE Review - NY-2018 C
Medicaid prescriptions have to be filled within how many days?
- 60 if non-controlled
Non-resident Pharmacy Establishments: criteria for licensure
- 600 Rxs/yr or $10,000/yr - must: - be licensed and in good standing in state of origin - maintain records in a form as dictated by NYS - Suppply info if requested by NYSED - Comply with all laws, rules, and regulations in state of origin *and* NYS - complete an application and pay a *triennial* fee
How many sets of forms are included in DEA Official Order Form books?
- 7 - can order 6 at a time unless their need exceeds the limit of 6
What medication can a pharmacist dispense without a prescription?
- 7 day starter pack of HIV PEP under a standing order
*Reporting Requirements* change of SP
- 7 days
*Reporting Requirements* auction
- 7 days prior to auction
Orders for prn controlled substances in an institutional setting are good for how many hours and how many administrations?
- 72 hours - 1 administration can be given anytime within the 72 hours period
% of all health care premiums rule
- 80-85% of preimums are spent on health care services and health care quality improvement - if insurance companies do not meet these goals (cause profits or costs are too high), they must provide rebates to customers
NYS BOP contains how many pharmacists? How many public representatives?
- 9 - must be licensed in NY for 5 years - 2 public rep
Pharmacies operating inside a general merchandise establishment must be enclosed by a permanent partition of at least how tall?
- 9 ft 6 in - or floor to ceiling if ceiling hieght is less than 9 ft 6 in
Restoration of a Recovated License
- >3 years after revocation, an application for restoration may be made - applicant bears complete burden of proof - peer panel - competency, remorse, public safety
Patient retaliation
- A covered entity may not retaliate, discriminate against, or intimidate any individual who files a complaint
Who handles CE credit?
- Accredidtation Council for Pharmacy Education (ACPE)
Exceptions to One Drug Per Blank Rule
- Article 28 facilities: (hospitals, nursing homes) - mental health hospitals - developmental centers
Misbranding or Adulteration: a pharmacist puts back into stock a cough syrup that was in the will call section for 3 weeks. He pours it back into the stock bottle.
- Both! Misbranding if the bottle has a different Lot # than the original syrup.
Misbranding or Adulteration: An intern reconstitutes an antibiotic in 20 mLs less water than what the instructions call for.
- Both! You changed the potency!
Which of the following is NOT required to be electronically prescribed? a. controls b. non-controls c. medical devices d. behind-the-counter medications e. syringes
- behind the counter medications
USP 795
Non-sterile compounding
LPA written rx non controlled requirements
ONYS rx blank - name, address, phone of PA - name of supervising phys. - also on other forms of rxs - all other legal info - rx does NOT need to be countersigned
all rxs written in NYS must be written on.. whats the exception?
ONYSRx blanks nursing homes: patient specific Rx form
LPA written controlled rx
ONYSRx blanks - LPA DEA #, starts w/M - LPA blanks or supervising phys. blanks - must have supervising MD name imprinted on blank
what must exposure plans be modeled after?
OSHA bloodborne pathogens and hazards communications standards - yearly follow up and training
what rxs can be FAX to FAX w/medicaid?
OTC non controls
what process has the 3 categories of OTC products?
OTC review process
what is excluded from the orange book/therapeutic equivalence rating system?
OTCs diagnostic aids nutritional supplements devices
What if the cover Rx after an emergency CIII-CV order comes in with refills?
Okay! Refills are good, and fulfills the emergency order.
qualified privilege rx authority
PA NP Midwife certified optometrists CDTM pharmacists
if a PBM claim was retroactively denied for a clerical, typographical error, computer error...
PBM will pay if was properly and correctly dispensed - unless pattern of error
in order for a pharmacy application to accept eRxs...
PHA meets all application requirements - must meet all set by DEA the Rx is in conformity w/laws
what else is looked at in phase 1?
PK pharmacology
you can't change quantity on CS/non CS rx without contacting...
PR
according to the FDA, what happens if the PR dies?
PR-patient relationship is broken and PR can no longer overee the pts use of the med
what must be done in an EMERGENCY when there is no less expensive substitute in stock?
RPH may dispense brand name drug at brand prices
what should be done if there is a therapeutic problem w/Rx or DDIs?
RPH must contact pt via phone or face to face b4 dispensing and offer 8 step counseling
counseling if drug is substituted?
RPH must get ok from prescriber RPH must contact pt by phone or in person - make 2 documented attempts to contact, 48 hours after mailing/delivering
what needs to happen in regards to delivery/mail order and counseling?
RPH/intern must counsel pt or person acting on behalf - face to face - phone number, toll free CANT BE DONE BY UNLICENSED PERSONNEL written offer to counsel
who can sign protocols allowing pharmacists to immunize?
MD/NP only
where are pregnancies with isotretinoin reported to?
MEDWATCH + iPledge
what are 5 federal reporting programs?
Medwatch medmarx ISMP iPledge STEPS
know the lowest price act patient's right to know drug prices act
Trump in 2018 prevents gag clause that kept pharmacists from being able to discuss cash prices w/patients who have rx insurance - private insurance - medicare in 2020
what is the only thing a pharmacy NEEDS to have to prevent incidental disclosure of PHI?
ask other pts to stand back while serving ppl
what is the purpose behind the food and drug administration amendments?
assures safe use of products, practitioners are trained and certified in their respective areas, lab testing, monitoring of patients
in a pharmacy when do you need to report change of ownership?
at least 6 weeks
who can pharmacists immunize?
any one 18+ 2-18 y/o for flu ONLY
who can purchase plan B?
any person regardless of age, gender
pregnancy warnings update applies to...
any products approved on or after june 30th 2015 - previous ones to gradually phase in
partial filling
anything less than the number of dosage units prescribed by PR
what safeguards do covered entities need for PHI?
appropriate administrative, technical, physical safeguards to protect privacy of PHI
therapeutic equivalent
approved by FDA as safe and effective pharmaceutically equivalent bioequivalent adequately labeled manufactured with current GMPs
what is the role of the FDA regarding food?
approves new additives monitor safety of dietary supplements monitor content of infant formulas and medical foods biotech, dietary supplements, food ingredients, packaging, labeling, nutrition
what are the exceptions to one drug per rx blank?
article 28 facilities - general hospital: medical order - nursing homes - RHCF mental health hospitals developmental centers PATIENT SPECIFIC RX FORM
when must verbal rxs be phoned in by a licensed professional?
article 28 facilities - general hospitals - nursing homes - RHCF mental health facilities developmental centers
what should the pharmacist do if receiving a written/verbal rx indicating it was originally sent over electronically?
check records to make sure eRx was not received/dispensed - if received both, void one
what should the pharmacist do if receiving a written/verbal rx indicating it was sent to another pharmacy?
check with that pharmacy to see if filled - if yes, void paper - if no, void eRx
who doesnt have to sign the notice of privacy?
children under 18
what class medical device is a tampon?
class 2 b/c toxic shock
what are the classes of product recall?
classes 1-3 - depends on how far the product has been distributed, consumer or user level
in order to write rxs, NPs need...
collaborative agreement + protocol w/physician or collaborative relationships (experienced NPs)
who has the authority to issue a state wide non patient specific order in the event of flu outbreak?
commissioner of health
who regulates implementation of free language assistance program?
commissioner of health
if biologic was substituted what does the RPH need to do w/in 5 business days?
communicate to PR: - name/strength/manu.
how do pharmacists become immunizers?
complete APHA course complete CPR course - not online or virtual pay fee keep up w/BBP training
hard token
cryptographic key that is stored in a special hardware device rather than general purpose computer
what defines biologic products?
derived from a living system, natural sources or recombinant technology
what is phase 1 of the drug approval process?
determines human pharmacologic actions - absorption - metabolism/elimination - dosage - acute SEs
what is phase 2 of the drug approval process?
determines usefulness of product for which it is intended
where can CDTM pharmacists do stuff?
diagnostic centers treatment centers hospital out pt nursing home that has onsite pharmacy
what can be different but can still be considered pharmaceutically equivalent?
different size different shape
max number of unlicensed personnel assisting a pharmacist
2
Handbook refigerator temperatures
2 - 8 degrees Centigrate 36 - 47 degrees Fahrenheit - (must know)
what are the requirements of iPledge?
2 forms of BC used 2 negative pregnancy tests 1 month before starting, 1 negative pregnancy test every month during use, and 1 negative pregnancy test 1 month after use
Drug Development: *Phase 4*
6.) Phase IV - after the drug hits the market - looks at large populations - confirm safety, efficacy, and other indications - compare several "me-too" products
medicaid rxs have to be filled within
60 days of date written
non resident pharmacies criteria for licensure
600 rxs or 10000 per year
in a pharmacy when do you need to report change of SP?
7 days
who are all state boards required to report discipline to?
NABP
CPE monitor program..
NABP and ACPE electronic system for monitoring CE completion - pharmacists and techs required
what organization published the federal register or CFR?
NARA: national archives and records administration
what was the purpose of the OTC review process?
evaluate the safety and effectiveness of OTC drug products - withdrawal of OTC products from market - concern with effectiveness and safety
how often are GMP inspections done?
every 2 years
NYS requires pharmacy techs to be registered. T or F?
false
The State Board of Pharmacy is an independent rule making body: T or F?
false
To be licensed as a pharmacist in NY state a person must be a US citizen or a "Green" card holder: T or F?
false
Training for immunization privilege cannot be applied to pharmacist's CE requirement. T or F?
false
licensed practical nurses can prescribe all medications except controlled substances. T or F?
false
the executive secretary of the pharmacy board is a voting member of the board. T or F?
false
what are examples of unaccepted medicaid claims?
false claims, submitting or causing to be submitted claims for: - unfurnished medical care, services, supplies - an amount in excess of established rates or fees - medical care, services, supplies at a frequency that is not medically necessary - amounts substantially in excess of usual charges/costs to general public
RPH renewal of license
every 3 years
a printout of all rxs filled/refilled needs to be how often?
every day
what is an investigational new drug form?
exemption given to pharmaceutical companies for the transportation of new drugs across state lines
what must PRs do in regards to substitution w/oral rxs?
expressly state whether substitution is allowed or not - cannot be filled otherwise make part of written record
can drugs w/different dosage forms be bioequivalent?
no only products that have their ratings w/in their dosage form category are considered bioequivalent
do business courses count as CE?
no - content needs to be approved by BOP
can PBMs require pharmacists to charge a copayment higher than the amt. reimbursed?
no - prohibits clawbacks that reduce adjudicated cost
if the rx is written DAW, can the pt or RPH choose the brand name?
no - will need a new rx or telephone order
if patient comes in requesting 3/5 refills be filled, do you fill it?
no, need authorization to do so
what kind of rx can a patient have a copy of?
non controlled only
LPA verbal rx for what stuff?
non controls CS emergency oral RXs for benzos oral rxs for syringes
what is an abbreviated new drug application?
not as long as NDA not as complete as NDA SHOW DRUG WORKS THE SAME AS BRAND NAME - for generic drugs
drugs labeled "B" or BC, BN, BT, BX
not therapeutically equivalent to others require further FDA investigation/review
DSHEA requires what of a manufacturer of a dietary supplement bearing a health claim?
notify FDA no later than 30 days after first marketing the supplement
what notice does a retail price list need to have?
notify your pharmacist and PCP of all meds you are taking and how to avoid harmful interactions
can pharmacies sell to other providers, hospitals or pharmacies?
only if registered as wholesaler or repacker
faxed rx requirements
only fax to fax faxed rxs must be on prescriber's blank and signed beforehand
when can automatic dispensing machines be used?
only for emergency dispensings in nursing homes
can you mail foreign rxs?
only if you: - are registered with SED as a manufacturer or wholesaler - FDA approval to export - receive permission from other country
when is a follow up for medicaid rx drugs not required?
only non controls: - oral - faxed - w/wo refils
what samples can be given?
only what a provider is allowed to prescribe
medicaid OPRA
ordering, prescribing, referring, attending rx requirements for unlicensed residents, interns, foreign-trained physicians in training
how are samples dispensed?
original packaging
what can't optometrists prescribe?
outside scope injections syringes/needles controls
when can covered entities disclose/use PHI?
own privacy officer another healthcare provider for treatment another covered entity or provider for payment activities
serial number "NNN..."
fax from nursing home
who supports medicare?
federal
which law (federal vs state) is chosen when a conflict arises?
federal always prevails
what determines what drugs are legend drugs?
federal food drug and cosmetic act
what does the veterinary legend say?
federal law restricts this drug to use by or on the order of a licensed vet
what is the NYS vaccines for children program?
federally funded, provides vaccines at no cost for eligible children - pharmacy can only bill for administration but get vaccines for free
new pregnancy labeling category 3
females and males of reproductive potential - must include info about pregnancy testing, contraception, infertility related to drug
what must the PR do when can issue Rxs electronically?
file information with DOH - ASAP
records, orders, Rxs that are maintained electronically shall be available to the department upon request in what format and where?
hardcopy at the premises where licensed activity is conducted
drugs rated "AB"
have been tested and proved problems between drugs have been resolved meet bioequivalence requirements
what must the RPH accepting the transfer need to record?
have hard copy or electronically marks refill transfer on hard copy or electronically keeps copy for 5 years - HIPAA says 6 yrs dates of original and most recent filling or transfer of original rx transferring pharmacy's name, address, rx number name of transferring RPH name of pharmacist receiving
what can states do with regard to legend drugs?
have stricter status not lessor
what happens if an employee misuses PHI?
have to punish them - must have policy in place for this document all instances
USP 800
hazardous drugs - new update in december 2019
who developed HIPAA and HITECH?
health and human services office of civil rights
what gave the FDA the ability to regulate biosimilars?
health care reform
Which of the following are NYS pharmacists not allowed to administer? Hepatitis A vaccine Meningococcal vaccine Pertussis vaccine Diphtheria vaccine?
hepatitis A
new pregnancy labeling category 2
lactation - provide info about the use during breastfeeding: amt drug in breast milk + potential SEs to baby - sections on: risk summary, clinical considerations, data
what is looked for in phase 4?
large populations confirm safety, efficacy, other indications compare me too products
what references are mandatory to have in the pharmacy?
law references
when determining whether to impose discipline charges, authorities consider violations: Laws only Rules only Regulations Only Laws, rules, & regulations?
laws, rules, regulations
class 1 medical device
least regulation b/c pose least risk to user - needles, scissors, gloves etc general controls pre market notification
what are veterinary drugs classified as?
legend non legend
Methadone short term detoxification treatment
may not exceed 30 days
food and drug modernization act of 1997
may use investigational drugs outside of controlled clinical studies to treat pts w/serious or life threatening diseases for which no comparable therapy is available
when did PRs become required to prescribe electronically?
march 27th, 2016
what supply can you fill of a foreign Rx?
max 3 mo supply
who can provide CEs?
must be approved by commissioner of department of education currently approved by ACPE as sponsors some are not ACPE approved - cant use these for states unless approved there
Medicare Modernization Act of 2003
part A: - hospitalization - mandatory upon retirement, free part B: - physician services - optional for retirees, paid from social security part C: medicare managed care - possibly lower cost/more services part D: - medicare rx drug coverage - rx coverage thru private insurance plans - thru managed care plans - deductibles and copays
what pharmacies does limited english proficiency apply to?
part of a group of 8 or more pharmacies located in NYS any pharmacy that delivers most of rxs through USPS or other service
biologics price competition and innovation act 2010
part of affordable care act allowed pathway to introduce biosimilars into US market
Laws
passed by a government body citing what is legal and illegal
are first aid courses acceptable CE?
no
are pharmacies liable for mistakes made from contractors who interpret?
no
can RSA's prescribe?
no
can SPs supervise more than one pharmacy?
no
can a PBM prohibit or penalize a pharmacist/pharmacy from disclosing to an individual the cost of the rx to the individual or availability/cost of therapeutic equivalent?
no
can a covered entity retaliate against a patient that filed a complaint?
no
can a technician compound in a community setting under supervision of RPH?
no
can a technician make IVs in a hospital?
no
can controlled rxs be transferred?
no
can credits from one 3 year period be carried over to the next?
no
can insurance companies ask for rx copies?
no
can midwives prescribe anabolic steroids?
no
can retail pharmacies be given samples?
no
can samples be purchased or offered for sale?
no
can you fill a Rx that an MD from out of state writes in your store from his script pad and shows ID?
no
can you give samples of CS in NYS?
no
can you have more than one drug per rx blank?
no
do inmates have a right to notice of privacy practice?
no
does NYS require a specific statement on an Rx copy?
no
fax backs and failover faxes
no
is a prescriber's name stamp a substitute for a signature?
no
is entering into the professional assistance program an admission of guilt?
no
is name of collaborating phys. required on midwife rx?
no
is signing the OPD investigation report an admission of guilt?
no
is there a limit on the number of refills that can be authorized?
no
samples of CS?
no
sell samples?
no
systems providing for the electronic transfer of rxs shall not infringe upon...
patient freedom of choice of pharmacy
do out of state rx's need to meet substitution law requirements? when else doesnt it apply?
no dispensing by practitioners
what classifies a drug as "new" under the Durham-Humphrey amendment?
drug that has not been shown to be safe for use in self medication under terms of an effective NDA limited to rx dispensing
medicaid only pays for what?
drugs and DME found on the list of medicaid reimbursable rx drugs
what does FDA breakthrough therapy do?
enhanced approval process similar to fast track but skips steps in approval process
what does an FDA priority review do?
enhanced approval that speeds approval process
what is the mission of the FDA regarding food?
ensures safe, free of contaminants, chemicals and other harmful substances
how does the RPH need to communicate the biologic substitution info to PR?
entry in interoperable electronic medical records system OR fax, electronic transmission or other means OR phone if the above not available
Combat Methamphetamine Epidemic Act of 2005 drugs in question
ephedrine pseudoephedrine phenylpropanolamine
filling
equal to number of dosage units prescribed by PR
legal rights attached to prescription
patient has a right to have order refilled if authorized and according to law right to a copy of a non controlled rx RPH cannot disclose info and maintain confidentiality
where can records of immunizations be kept?
patient medication profile separate form that is retrievable format available to DOH and pt
what are the critical elements of drug labels?
patient name directions for use (full sentences) drug name and strength
pt consent and CDTM
patient needs to be informed of right to opt out of CDTM patient or representative needs to consent and it needs to be noted on medical record nobody is required to participate in this
who can be counseled?
patient or person authorized to act on behalf of pt who presents Rx
other than ONYSRx blanks, what can nursing homes write Rxs on?
patient specific rx form
pharmacists have to notify who when giving immunizations?
patients PCP by fax or electronic NYS registry annual pharmacist immunization survey
where does it need to be indicated when a PR is using an exception to eRxs?
patients health record
what forum is included under USP/NF?
pharmacopeial forum
what must be done if a pharmacy ceases to use an application service provider?
pharmacy ensures that provider transfers any records - in a format that can be read, displayed, printed for the BNE
where are reporting requirements for a pharmacy kept?
pharmacy handbook
PBMs and appeals
pharmacy has 30 days from when claim submitted to appeal PBM has to send electronic message acknowledging the receipt of appeal - 7 days for determination - if accepted, adjustment made - if not accepted, PBM has to send NDC # of therapeutic equivalent purchasable drug
what ppl are exempt from pharmacist to unlicensed ratio?
ppl responsible for placing unit dose meds into carts in a hospital - approved unit dose system - not performing all other tasks
what does the pharmacy need to provide in store for immunizations?
private area for administration clearly visible CDC adult immunization schedule - ACIP recommendations
what kind of entity had the highest number of HIPAA HITECH violations?
private practices
what did the omnibus budget reconciliation act do ?
required that drug manufacturers sell their drugs to medicaid at the best price available to any other purchaser - become part of medicaids preferred drug list
what is the purpose of a new drug application?
safety and effectiveness of product labeling appropriate ensure strength, identity, quality, purity
The responsibility of informing a patient that a generic product is being prescribed rests with: Anyone in a prescriber's office The prescriber, personally A member of the pharmacy staff A pharmacist, personally?
the prescriber personally
DEA form 41
to destroy controlled substances
drugs rated "AT"
topical products
serial number is required to be captured on all rxs when submitting a claim to medicaid for a rx that has been...
transferred - "TTTTTTTTT"
CE hours in trimester and quarterly of Pharm D. courses
trimester = 15 CE quarterly = 10 CE
Because of the answer to questions 2, the test on Thursday will cover commissioner's regulations and regents rules: T or F?
true
Exercising undue influence on patients on the promotion of the sale of drugs is prohibited: T or F?
true
Failure to number prescriptions consecutively and filing them may constitute unprofessional conduct charge: T or F?
true
Regulations of the Commissioner carry the same weight/effect as NYS law for discipline purposes? T or F?
true
Rules and regulations clarify and expound upon laws, carry the same weight: T or F?
true
definition of drug samples
units of drug that are intended to promote the sale of the drug and not intended to be sold
what is the potential jail sentence for violation for personal gain or malicious intent?
up to 10 years
what is the potential jail sentence for violation under false pretenses?
up to 5 years
what is the potential jail sentence for violation unknowingly or with reasonable cause?
up to one year
in order for pharmacies to give flu vaccine to children..
update standing order for pediatrics must be pediatric CPR certified report to NYSIIS or CIR (NYS) vaccines for children program
what must the covered entity provide the individual with the right to restrict HPI and what needs to be done when requested?
use and disclosure for privacy officer other ppl picking up rxs need to document these
what must the practitioner do to e prescribe?
use eRx application that meets all requirements by DEA Rx is in conformity w/federal CSA
what can optometrists do with phase 1 certification?
use/recommend all NON rx/OTC for ocular disease - oral OR topical - agents must be approved by FDA
what is prohibited when vaccinating a pregnant pt or children <3?
vaccines containing more than trace amts. of thimerosal - no more than 0.5 mcg mercury per 0.5 mL dose flu cant contain more than 0.625 mcg mercury per 0.25 mL dose
when are pharmacies exempt from counseling?
vendor to nursing homes
which form of rxs have the highest rates of medication errors?
verbal - misinterpretation
NABP DMEPOS accreditation
verification of licensure - all licenses of personnel and establishment confirmation of policies and procedures on site survey of facility
when can you dispense both drugs on an rx blank?
verified by prescriber issuing rx if not, can still dispense but not CS
are coupons allowed to be taken for CS?
yes
are signing and transmission of Rxs distinct actions?
yes
can NPs give verbal Rx? samples? CS rxs?
yes
can RN counsel at discharge?
yes
can RNs immunize?
yes
can an agent or employee of the prescriber electronically create and electronically transmit the e Rx to the pharmacy?
yes
can different lots of the same biologic product from the same company not be exact?
yes
can medicaid contract w/mail order at any time?
yes
can pharmacies be waived if experiencing undue burden from free language program?
yes
can pharmacists emergency treat anaphylaxis?
yes
can you have more than one intern per RPH?
yes
can you have more than one tech per RPH if tech is PTCB certified?
yes
coupons of CS?
yes
do parent, guardian, loco parentis have the authority to act on behalf of the minor?
yes
do you need to ask pts if they want counseling w/refills?
yes
do you need to have a policy/procedure on hand for PHI breaches?
yes
do you need to indicate who signed the rx if there is more than one prescriber?
yes
does the 2 factor PR authentication constitute the PR signing the rx?
yes
if pt refuses to give RPH health info, can rx still be filled?
yes
if your daily log is electronic do you need to be able to see the scanned rx?
yes
is it a felony for a PR to give their password for eRx's to someone else?
yes
is it mandatory to eprescribe all rxs?
yes - all controlled and non controlled
if pt refuses to sign notice of privacy, do you still treat them?
yes - go thru reasonable means to obtain signature from them
can a covered entity disclose PHI if there is suspected healthcare fraud/abuse?
yes - if each entity has had a relationship with the individual
does DAW have to be in the prescriber's own handwriting if written rx?
yes - if electronic, need code
do you have to have the notice of privacy practices displayed? if so, where?
yes -pharmacy area - website
LPAs syringes
yes w/wo DEA number
*Reporting Requirements* change of ownership
- 6 weeks
what must EPT rxs have in the body of the Rx?
EPT
who regulates OTC items and their advertising?
FTC
How long do syringe prescriptions need to be kept on file?
- 5 years
Records for poison sales must be kept for how long?
- 5 years
Pharmacies used for training pharmacy interns have one intern per how many prescriptions per year?
- 5000
How long must HIPPA consent forms be kept for?
- 6 years
Expiration of DEA orders
- 60 days
what amt. of fine per HIPAA violation can be faced from state attorney general?
$100-$50,000 max: $25K - $1.5 mill.
when do pharmacies need to have employee education about false claims recovery in regards to medicaid?
$5,000,000 rule - pharmacies that bill medicaid for more than 5 mill per year
Official NYS prescription forms may be cancelled by the commissioner by notifying the prescriber how long before the cancellation?
- 6 months
How long to pharmacists have to report immunizations to the registry?
- 14 days
How many doses can methadone patients take home in months 10-12?
- 6 unsupervised doses per week
Direct to Consumer Advertising
- "Brief summary" - Fair balance - true statement - in consumer language that is easily understood
Pharmacy requirements: References
- "reference resources" as may be necessary to carry on the practice of pharmacy - not just limited to books - CDs, Internet, etc. - law references are still mandatory
"unlawful" criminal sale of a controlled substance
- "unlawful" when done in other than in good faith and in the course of professional practice
Security features of NYS prescriptions
- "void" appears if copied, scanned, or physically altered - heat-sensitive ink in the Pharmacist Test Area on the front will turn blue when rubbed - heat-sensitive ink in the Secure Standard Register will turn from orange to yellow when rubbed
Medicare Part D Initial Coverage Limit
- $3750
Medicare Part D deductible
- $405
Medicare Part D donut hole max
- $5000
*Medicare Part D* wants pharmacy records maintained for...
- *10 years* from the date of receipt or creation
The *BNE* wants pharmacy records maintained for...
- *5 years* from the date of receipt or creation
The *NYSBOP* wants pharmacy records maintained for...
- *5 years* from the date of receipt or creation
*HIPAA* wants pharmacy records maintained for...
- *6 years* from the date of receipt or creation
*Medicaid* wants pharmacy records maintained for...
- *6 years* from the date of receipt or creation
E-Prescribing Provisions
- *Mandatory* e-prescribing of *all* prescriptions after March 27th, 2016 - "optional," by federal law - Pharmacies are *not* required to *take* medications electronically - if your pharmacy wants to accept controlled eRxs, system must be approved by DEA (with a notifcation sent to the BNE)
Food Drug and Cosmetic Act
- *defined* adultered, misbranded - directions required - gave FDA more rights to inspect factories, and regulate cosmetics and medical devices - fast track approval for serious or life threatening conditions - sulfanilamide tragedy, diethylene glycol used as a solvent --> people died - *safety*
Persons entitled to issue verbal orders for CS
- *federal* gov't says nurses and agents of practitioner can do this - *state* law says only the prescriber can do this - nursing home or hospital or wherever!
*Revocation/Suspension*
- *licences* are for *life* - can be surrendered/revoked - *registrations* are *renewed*
"B" rated products
- *not therapeutically equivalent* to others - require further investigation by FDA
Pure Food and Drug Act
- *prohibited* adultered and misbranded drugs - recognized USP/NF - *PURE*
Self Defense Spray Device Requirements
- 0.75 oz of 0.7% capsaicinoids by weight - include a safety device to prevent unintentional damage - must be sold by RPh (or intern); no one else - must also include 1-800 number for self-defense - 2 canisters at once time to a single purchaser - purcahser must be 18+ and w/o convicted felony or assault crime in NYS
How many doses can methadone patients take home in months 1-3?
- 1 dose per week
Exact copies of advertisements must be kept for how long?
- 1 year after its last appearance - should be kept in the appropriate medium it was released in
"Clinical experience" for CDTM Requirement
- 1 year of clinical experience = 1680 hours w/i 1 calendar year = 15+ hours per week - consultation with physicians about drug therapy - must be documented by a supervisor or colaborative physician attesting this to be true
What is the BUD of unit dosed medications?
- 1 year or 50% of time left on manufacturers expirations, whichever is less
Pharmacy chains with how many stores have to participate in drug take back days?
- 10 or more stores
Narcotic addiction treatment programs must file a report summary of controlled substance activity in the presceeding month to the department of health by which day of the month?
- 10th of each month
Expiration date for repackaged in-house drugs
- 12 months or 50% of the time remaining to the manufacturers expiration date, whichever is less *from the date of repackaging*
CMS Short Cycle Dispensing Rule Medicare Part D Patients in LTCF
- 14-day filling cycle for NH patients - does not apply to antibiotics or drugs dispensed in original containers - does not apply to *generics* - does nt apply to drugs that are difficult to dispense - liquids - eye drops, ear drops, inhalation drugs, nasal sprays, parenteral drugs, or topical drugs
How old do you have to be to buy Sudafed?
- 18 in NY - DEA limits to 16 y/o?
DEA Number formula
- 1st + 3rd + 5th + 2(2nd + 4th + 6th) = 7th digit
How many unlicensed assistants (not techs) may assist a pharmacist?
- 2
What are the requirements for a patient less than 18 years old to get medical management?
- 2 documented attempts at short-term detox or psychosocial treatment within 12 months - parents must consent unless patient is emancipated
How many doses can methadone patients take home in months 4-6?
- 2 doses per week
The balance device in a pharmacy should not have less than how many grains of material weight to avoid errors of 5% or more?
- 2 grains
Immunizing children
- 2 to 18 years - for influenza, only - must update standing order for pediatrics - must be CPR-certified in pediatrics - must report to NYSIIS or CIR (NYS) - vaccines for Children program has specific guidelines
The number of unlicensed persons assisting a pharmacist allowed:
- 2 unlicensed persons - exeption: persons who are responsible tor the act of placing unit dose meds into carts in hospital ("cart filling") are exempt from the ratio (as long as they are not performing all the other tasks)
How many doses can methadone patients take home after 1 year?
- 2 weeks
How long must Sudafed records be kept?
- 2 years
Limit for refills on syringes and needles prescriptions
- 2 years
Needle prescriptions are good for how long?
- 2 years
CDTM Credentialing Requirements for PharmDs or MS in Clinical Pharmacy
- 2+ years of licensure AND - 1+ year of clinical experience AND - EITHER board certification OR residency
Nuclear pharmacy training
- 200 hours of didactic - 500 hours of experience
How long does a pharmacy have to report a patient picking up a controlled substance to the BNE?
- 24 hours
How many doses can methadone patients take home in months 7-9?
- 3 doses per week
How long do manufacturers have to keep records of practitioners requesting drug samples?
- 3 years
How long must methadone records be kept?
- 3 years
How long must transaction records of EPIC be kept?
- 3 years
CDTM Credentailing Requirements for BS in Pharmacy
- 3+ years of licensure AND - 1+ year of clinical experience AND - Either board certification OR residency
Sudafed limits
- 3.6 grams/individual/day - no more than 9 g in 30 day - no more than 7.5 g by mail order in 30 days - keep a logbook (of course)
EPIC coveres up to what day supply?
- 30 DS
*Reporting Requirements* change of name or address
- 30 days
*Reporting Requirements* change of stockholders
- 30 days
BOP mus be notified within how many days of change of name?
- 30 days
BOP must be notified of mailing address change in how many days?
- 30 days
How long do you have to notify the department of change of name or mailing address?
- 30 days
How long does a pharmacy have to give a patient their prescription records if they request them?
- 30 days
NYS BOP needs to be notified within how many days of change of officer in a pharmacy corporation?
- 30 days
How long do protocols between vendor pharmaceutical companies and hospitals have to be approved by the BOP within how many days of the start of the contract?
- 30 days - protocol must include a method for periodic reconciliation of pharmacy records filled and delivered prescriptions to the institution - list of steps to take to prevent diversion of drugs
How many doses can methadone patients take home after 2 years?
- 30 doses per month
Fax order for CIV
- 30-day or 100 dosage units (whichever is less) if the practitioner is an exception or waiver. (temporary technologic failure, veterinarian, certification) - if not, then 5-day supply
CE
- 45 hours every 3 years - 23 hours live - 3 hours MUST be on reducing prescription errors - initial CPR/BLS can count for 5 hours, recertification counts for 3 hours - need to keep record for 6 years from program
*Reporting Requirements* fire/flood
- 48 hours
How long do prescriber have to sign verbal orders for residents of nursing homes?
- 48 hours
For Medicaid, if the dr calls in an oral rx with a DAW, how many days does he have to send over a written prescription?
- 5 business days
Schedule 5 emergency supply can be for how long?
- 5 days
Within how many business days must a pharmacist communicate with the prescriber that a medication has been substituted with an FDA listed interchagable product when DAW is not on a prescription?
- 5 days - tell them drug name and manufacturer
How long after the most recent entry must patient medication profiles be kept retrievable form at a pharmacy?
- 5 years
National Association of Boards of Pharmacy CPE Monitor program
- CE monitor - collaboration between NABP, and ACPE - easier for state boards of pharmacy to monitor and authenticate CPE hours - CPEs automatically credited to your account - you are required to sign up for this system -__-
Institutional Dispenser Security Requirements for CS
- CI and CII must be kept in vault or safe - CIII-CV must be stored in locked cabinet approved by DOH BNE
anabolic steroid controlled scheduling
- CIII (federal) - CII (state)
CMS Final Rule for Nursing Homes (MEGARULE) Phase 3
- CMS is requiring facilities to develop an Infection Prevention and Control Program that includes an Antibiotic Stewardship Program and an Infection Preventionist
Pharmaceutical Alternatives
- Contain the same therapuetic agent but differ in their salts or esters, or different forms, or strengths - ex.) Micronase, Glynase
I-STOP Part D
- Continuing education for practitioners and pharmacists concerning prescription pain medication awareness
I-STOP Part C
- Controlled substance schedules
DEA 222 Form instructions
- Copy 1 (brown) goes to supplier - Copy 2 (green) goes to supplier, then supplier sends to DEA at the end of the month - Copy 3 (blue) retained by purchaser (x2 years, x6 years by state) - substances controlled by NYS, but not Feds do *not* have to be filed on DEA form - no anabolic steroids - no benzodiazepines
DEA form 222 triplacates
- Copy 1 (brown): supplier - Copy 2 (green): DEA - Copy 3 (blue): purchaser
When prescribing for controlled substances, what needs to be on the prescription?
- DEA of practitioner - DEA of institution (unless institution doesn't have DEA number)
Practitioners with Prescribing Privileges limited by the scope of practice
- Dentist - Veterinarian - Podiatrist
Who has jurisdiction of syringe prescribing?
- Department of Health
Electronic Prior Approval
- Directs the Commissioner of Financial Services to develop a standard prescription drug approval form in electronic form for all participants in the health care system
Mini-Clinics
- Doctors or other providers located within pharmacies - Mini-Clinic may not be part of pharmacy profit - Ownership may not be shared - any provider group in NYS that is listed as a "professional corporation" may not have any ownership in pharmacy
Waxman-Hatch Act
- Drug Price Competition and Patent Term Restoration Act - generic drugs without having to get approved again (ANDA)
REMS for CS
- ER/LA drug, *only* (hydromorphone, morphine, oxycodone, tapentadol, fentanyl, methadone [analgesic form]) - manufacturers *must* provide for their products - prescribers are *encouraged* to use them, but do not have to
Electronic prescription storage
- ERx data can be stored electronically as long as they are readily reteiveable, easily, readable, and rendered in a format that a person can read
Anaphylaxis recording
- Each certified pharmacist shall ensure that a record of all persons to whom such pharmacist has administered an anaphylaxis treatment agent - must maintain a record in the patient profile - each certified pharmacist shall contact the local emergency medical services and *follow up with provider*
Pharmacist Requirements for Licensure
- Education - Experience - Examination - 21 years of age - *Good moral character* - citizenship
HIPAA Update Breach Notification Rule
- Even if no harm comes to the patient, if HIPAA has been breached, *you must report it* unless you can show there is a low probability that PHI has been compromised
Clinical Laboratory Improvement Amendments (CLIA)
- FDA-approved home tests with low risk for error - an institution need not have a clinical lab if qualified health professional gives the test - per NY, pharmacies must have a medical director and a collaborative agreement with a lab
parempanel (Fucompa) scheduling
- Federal CIII - non-controlled in NYS (peculiar)
Price posting
- Federal Law does not require price posting - NYS price list must include drug's brand name, generic name, strength, dosage form, and price charged for that quantity - charge to patient must include cost of the drug, RPh's professional fee - handling fee - may list mailing or delivery cost separately - may list professional services
*Donation and Redispensing of Unused Prescription Drugs*: Enforcement
- Good faith compliance, subject only to professional liability - DOH work with donors, recipients and 3rd-party intermediaries
HITECH
- Health Information Technology for Economic and Clinical Health Act - violations against private practices, hospitals, outpatient facilities, health plans, pharmacies - incentive payments to professionals who are "meaningful" EHR users - you must safeguard PHI from intentional and unintentional uses or disclosures in violation of the privacy rule
Pharmacy Emergency Supply Worksheet
- If a prior auth. number has not been obtained by the prescriber and the pharmacist or recipient has attempted but is unable to reach the prescriber, the pharmacist may obtain a prior authorization for up to a 72-hour emergency supply of a brand-name or unpreferred drug
ACA and rescinding coverage
- Insurance companies may not rescind insurance coverage for mistakes on applications - may rescind for fraudulent mistakes - 30 days notice
When is drug take back day set by Drug Take-Back Act?
- July 10th
Practitioners with qualified prescribing privileges
- Physician's Assistant - Nurse practitioner - Midwife - Optomestrists (certified) - Pharmacists (CDTM)
Which prescriber DEA number must be on prescriptions for suboxone?
- X DEA number and regular DEA number
Laws vs. Regulations vs. Rules
- Laws are passed by a government body such as the legislature citing what is legal or illegal - Regulations are written by a gov't body to interpret these laws and put into "plain English" the do's and don'ts - Rules are made by government agencies to further fine tune the laws and regulations or to pass something STAT
*Donation and Redispensing of Unused Prescription Drugs*: Recipient entities
- Manufacturer - Wholesaler - Distributor - Pharmacy - Hospital note: a recipient entitiy may also be a donor entitiy
Medicare Part C
- Medicare Manged Care (Medicare Advantage Plans) - Possibly lower costs/more services
Medicare Part D
- Medicare prescription drug coverage - coverate through private insurance plans for prescription coverage only OR through regional managed care plans - deductibles and copays
Out-of-State Prescriptions
- NY law does not comment - for controlled substances, RPh may fill, but RPh takes responsibility for knowing that the practitioner is licensed/registered in the state where the Rx was written - call DEA?
NYS Regents Rules
- NYS has its own confidentiality law - Revealing of personally identifiable facts, data or information obtained in a professional capacity without the prior consent of the patient or client
Hospital adverse event reporting system...
- New York Patient Occurrance Reporting and Tracking System - department of health for serious harm or death
Domestic Chemical DIversion Control Act
- No employees whoh ave felony related to CS or listed chemical - no employees who have DEA registration denied - no past or present use of CS or criminal action from handling
I-STOP Part B
- ONYSRx forms - electronic prescriptions - language assitance
Oral prescriptions for Medicaid are not accepatable for what medications?
- OTC - schedule 2
substances excluded from the "orange book"
- OTC drugs - Diagnostic aids - Nutritional supplements - Devices
Drug Repository Program
- Overseen by NYS Board of Pharmacy - any person, drug manufacturer or health care facility may donate drugs to the repository - participation by pharmacies, hospitals, or nonprofit clinics is voluntary - ex.) Walgreens repository
Gag clause
- PBM may not prohibit or penalize a pharmacist or pharmacy from disclosing to an individual purchasing an Rx the cost or the availability of any therapeutically equivalent alternative medicaitions Or charge or collect from an individual a copayment that exceeds the total charges by the pharmacy for which the pharmacy is paid - if the individual pays a copayment the pharmacy shall retain the adjudicated costs and the PBM shall not redact or recoup the adjudicated cost (No "clawbacks")
Prescription Monitoring Program (PMP)
- Part of I-STOP - PR must check before providing any CS prescription (up to 24 hours in advance) - PR must document that they have - If the patient is consuming the drug on the same site it is dispensed (like a nursing home or hospital) the PR does *not* have to check
Pharmacies are covered uner LEP Law if...
- Part of a group of *8 or more* pharmacies - Located in NYS - same ownder or corporate entity - any pharmacy that dispenses most of its prescriptions through the USPS or other delivery services (mail order firms must also comply)
Requirements on a prescription (federal and state)
- Patient's name (NY +Feds) - Complete address (NY, only; not required if in profile) - Patient age (NY, only; Rph may add) - Date written (NY + Feds) - Drug name (NY + Feds) - Strength (NY + Feds; Rph may add) - Quantity (NY + Feds; RPh may add) - Directions for use (NY + Feds; PRh may add) - Prescriber's name (NY + Feds) - Prescriber's address (NY, only; not required if in profile) - Prescriber's telephone number (NY, only; not required if in profile) - Prescriber's profession (NY, only; not required if in profile) - Registration number (NY, only; not required if in profile) - Signature (NY + Feds)
Opioid Stewardship Payment
- Payments from each manufacturer and distributer licensed to sell or distribute opioids in NYS - not not include dispensing - includes intra-company transfers between divisions, affiliates, subsidiaries, parent or other entity under complete common ownership and control - $100,000,000 per year to suport programs operated by NYS office of substance abuse - manufacturer/distributor must provide detailed records to the state - does not include opioids sold outside of NYS
Medication Error CE Requirement
- Pharmacists must complete at least 3 hours of CE in understanding *medication error prevention and safety* - live or home study - 3 hours of medication error prevention and safety per 45 credits - it is unprofessional conduct to misrepresent your CE; professional misconduct to fail to complete CE
What books are required in a pharmacy to operate?
- Pharmacy Guide to Practice (Pharmacy Handbook) - Controlled Substance Stature (Article 33 of Public Health Law) - Rules and Regulations on Controlled Substances (part 80)
Information required on a presription label (even if dispensed by practitioner)
- Pharmacy information (name and address) - Patient information (name and address (w/ city and state) - Name of prescriber - date filled - prescription number - directions for use - any caution/warning statements - identification, strength, and manufacturer of the drug (unless prescriber explicity states that he/she does not want drug info; then just use NDC) - expiration date
The STARK law
- Physician Anti-referral law - prohibits a physician from referring MNY or Medicare patients to an entitiy that the provider has financial interest in (labs, pharmacies, radiology, physical therapy, etc)
Who can prescribe for addiction?
- X DEA numbers - NOT middlevel practitioners
Practitioners with Broad Prescribing Privileges
- Physicians and osteopaths - MD specialists (ophthalmologists, cardiologists) - MBBS (bachelor of medicine, bachelor of surgery) - MBChB (Medicinae Baccalaureus, Baccalaureus, Chirurgiae) - from England
What can the pharmacist add to a CS Rx if he/she can get the doctor on the phone?
- Prescriber's DEA number, suffix# - prescriber's name, telephone # - Drug strength, directions, MDD - drug Code
Who else can counsel?
- Prescribers (and they get paid for it) - R.N. may counsel at discharge at hospitals, but the hospital pharmacy is responsible for fulfilling this - pharmacies who "vendor" to nursing homes are exempt from counseling - Nursing home is caregive (nurse or consultant pharmacist)
Exceptions to Limitations of Practitioner Dispensing
- Prescribers whose practices are situated 10+ miles from the nearest pharmacy - the dispensing of drugs at no charge to the patient (samples) - persons practicing in hospitals - veterinarians (get away with everything) - the dispensing of drugs in a clinic, infirmary, or health service that is operated by or affiliated with a post-secondary institution - the dispensing of drugs in a medical emergency - the dispensing of drugs that are diluted, reconstituted, or compounded by a prescriber - the dispensing of allergenic extracts - the dispensing of drugs pursuant to oncological or AIDS protocol
Immunization Cost to Consumer
- Prior to giving the vaccination you must discuss cost with the patient - in the case that the immunization is not covered, there could be apossibility that the vaccine could be covered when administered by a PCP or practitioner
Pharmacist responsibilities when refilling a prescription
- RPH must indicate on the "reverse" of the original Rx the date of the refill, initials, and amount dispensed (if different than original quantity) - in the computer, no need to pull original paper Rx if you *scanned* and can see the original
RPhs and contact lenses
- RPh may dispense! - may maintain stock of contact lenses - may act as intermediatry distribution points for providing lenses to the public
Transferring Rxs (in general)
- RPh may transfer Rx info to, or accept a transfer from another pharamcy if expressly requested and approved by the patient or person authorized to act on behalf of patient - one fill at a time - not al at once - noncontrols - must be transferred directly from pharmacist to pharmacist - original Rx stays and refills are debited - does not apply to pharmacies with a shared database
What is a teaching hospital?
- Receives direct or indirect graduate medical education payment - pharmacist must be employed or be affiliated with the facility in order to perform CDTM
Mandatory Flu Vaccine Rule
- Requires such facilities to require that personnel who are not accinated against influenza to *wear a sugical mask or procedure mask* during the influenza season while working in areas where the patients may be present - these facilities must document the number and percentage of personnel vaccinated against influenza for the current season and provide these data to the DOH upon request - masks must be changed after leacing the room or completing care of a patient/resident on isolation precautions whether soiled or may have been soiled - "personnel" does not apply to visitors or family members of patients/residents - *does* apply to students and volunteers
Bar Codes for Prescription Products
- Requires that certain Rx drugs and biological products (vaccines, immunoglobulin) be bar-coded to decrease med. errors - OTC products that are commonly used in hospitals - not blood or blood components - Not medical devices
Counseling Regulations On-Premises delivery of Rx
- Rph or intern must counsel the patient or person picking up either face-to-face or by phone number - the counseling may *not* be given by unlicensed personnel - document patient refusal
I-STOP Part E
- Safe drug disposal of controlled substances
Medicaid pays only pays for certain drugs and DME found on a list:
- Section 505.3 (Drugs) - Section 505.5 (DME)
Physicians Assistants
- Supervision from a physician must be continuous, but does not require physical presence of SP at the time and place where services are being performed - Licensed PA may prescribe - Registered Specialist Assistant may not prescribe
Notice of Privacy Practices
- Tells how you are going to use PHI (in and out of your pharamcy) - describe your legal obligation under HIPAA to secure and protect the PHI - gives the patient the right to review and amend his/her PHI with the provider - must have this notice prominently displayed - tells patient his/her rights - inmates do not have a right to notice of privacy
Automatic dispensing machines
- The NYSDE considers these to be in violation of state law - ADMs may only be used for *emergency dispensing* in nursing homes per BNE letter
What if the patient wants a partial of a CII? (non-hospice)
- This counts as changing the quantity, so you must call the prescriber - the "remainder" doesn't exist, because the quantity has changed
Medicare Part D tiers
- Tier 1: generics - Tier 2: preferred brands - Tier 3: non-preferred brands - Tier 4: high costmeds - drug may move into other tiers *at any time*
Track and Trace "3 Ts"
- Transaction *information* (lot number, etc) - transaction *history* - transaction *statement* (received the product from a bonafide provider)
Sudafed ID
- US passport - alien registration receipt card - passport - for those under 18 (no age limit), may use school record or report card, daycare or nursery school record. (LOL!) - not responsibility of the pharmacist to investigate
Exceptions to Electronic Prescribing Rules
- Veterinarians (get out of everything) - out-of-state prescribers - waivers - The case of technologic or electronic failure - practitioners who prescribe <25 Rxs/year (radiologists?)
P-listed wastes
- Warfarin, nicotine
The "rule of thumb" regarding faxes and phones
- Written = electronic - verbal = fax - only fax-to-fax is allowed - Faxed Rxs must be on the blank of the prescriber and signed prior to faxing
Expansion of Immunization Privilege
- a NYS licensed physician or nurse practitioner may prescribe and order a patient-specific order or a *non-patient specific regimen* to a licensed pharmacist pursuant to regulations promulgated by the commissioner, and consistent with the public health wall for preventing: - influenza - pneumonia - Herpes Zoster - meningitis - Tetanus - Dipetheria - Pertussis - emergency treatment of anaphylaxis
Biosimilar
- a biological product may be demonstrated to be "biosimilar" if the product is "*highly similar*" to an already-approved biological product in terms of safety, purity, and potency of the product - different lots of the same product from the same company *may not be exact* - generics have to be exact
Uses and disclosures
- a covered entity may use or disclose PHI to another covered entity for payment activities - or to another health care provider for treatment activities
HIPAA Policy and Procedures
- a covered entity must implement policies and procedures with respect to protected health information that are designed to comply with HIPAA - you must have a policy and procedure for everything that HIPAA regulates
Bundling Payments
- a national pilot program to encourage hospitals, doctors, and other providers to work together to improve the coordination and quality of patient care - payments are bundled (flat fee) and shared among hospitals, doctors, and providers in the Medicare program
Copies of prescriptions
- a patient may have a copy of a non-controlled prescription, but may *not* have a copy of a controlled substance prescription - New York does *not* require any specific statement about the prescription copy
Business Associates
- a person who acts on behalf of the covered entity, but other than in the capacity of a member of the workforce of such covered entity - performs a function or activity involving the use of PHI (claims, data analysis, processing, quality assurance, etc) - they must list the PHI that they are allowed to use and disclose - must have a contract - must make assurances to covered entity on the safeguarding of the PHI - must return or destroy all PHI upon termination of the contract
Supplying schools
- a pharmacist may dispense drugs and devices to a registered professional nurse, and a registered professional nurse may possess and administer, drugs and devices, pursuant to a non-patient-specific regimen prescribed or ordered by a licensed physician or certified nurse practitioner, pursuant to regulations promulgated by the commissioner and the public health law - do ot need a wholesaler license to this
Computer crash
- a pharmacy shall have an auxiliary procedure to be used for documentation of all new and refilled prescriptions dispensed during system downtime - the procedure shall provide for the entry into the computer of *all data collected during downtime* and the RPh shall ensure that the maximum number of refills authorized on the original Rx has not been exceeded
Pharmacy Application (PHA)
- accepts an electronic prescription - must meet all electronic requirements set down by the DEA - must use the new ASAP 4.2 software (distinguishes when the Rx was filled and picked up) - must verify a practitioner's digital signature - must be able to download data into a database or spreadsheet
What if the prescriber dies?
- according to the FDA, the practitioner-patient relationship is broken. THe practitioner is no longer available to oversee the patient's use of the medication
CMS Durable Medical Equipment
- accredidation for DME products - includes *diabetic supplies* - quality service standards shall include consumer service standards
Medigap Medicare Supplemental Insurance
- additional insurance beneficiaries can buy to supplement what Medicare does not cover - may not sell any policies with *prescription drug coverage*
Controlled presciptions from RPAs must include:
- address and phone number of RPA and supervising - DEA number of RPA - handprinted, stamped, or imprinted name of supervising - imprinted or stamped name of RPA - signature of the RPA following by "RPA" - NYS registration number
Consent/Surrender Order
- agreement with licensee and his/her attorney - consent order (plea to charges and pay penalty) - application to surrender of license
What pharmacies must post te top 150 drug prices?
- all including institutional
Wholesale level recall
- all levels from manufacturer to wholesaler - may include pharmacies if manufacturer sells to pharmacy directly
Verbal Orders in Nursing Homes
- all mediactions must be in writing unless circumstances warrant a verbal order - must be countersigned by a prescriber w/i *48 hours* - If not signed w/i *48 hours*, order must be terminated and the facility shall ensure that the resident's medicaiton needs are promptly evaluated by the medical director or other legally authorized prescribing practitioner
Pharmacy reporting to PMP
- all pharmacies must report to PMP w/i *24 hours* of dispensing the drug - "zero" (did not dispense) reporting w/i 14 days
Discipline by State Boards
- all state boards required to report discipline to NABP, who in turn reports it to the National Practitioner Data Bank (NPDB)
Nurse Practitioner Modernization Act Collaborative Relationships
- allows experienced NPs to practice autonomously (w/o a protocol) - need *3600* hours experience - may practice and have collaborative relationships with a qualified physician or a DOH licensed health care facility
Condition Codes for CII
- allows for up to 3-month supply (or 6 months for steroids under code F) - A: Panic disorder - B: ADHD - C: Seizure disorder - D: Chronic Pain - E: Narcolepsy - F: Hormone deficiency in men and metastatic cancer in women - means patients *cannot* do a partial fill
Comprehensive Addiction and Recovery Act of 2016 (CARA)
- allows partial fills on CIIs on control level - allows up to a 90-day supply of a CII if each is issued on a separate Rx blank - this is *not allowed* in NYS
Who are exempt from controlled substance registration
- interns - residents - foreign-trained physicians
HIV Post Exposure Prophylasix (PEP)
- allows pharmacists to dispense a 7-day's suply of a started pack of an HIV PEP - via a physician's or NP's patient specific (Rx) or non-patient specific order (standing order) - must have referral w/i 3 days to a prescriber - no 7-day prepacks currently available
Expedited Partner Therapy (EPT)
- allows physicians and mid-level practitioners to provide Chlamydia patients with abx to be delievered to the sexual partner - usually 1 gm of azithromycin in a single dose - should *not* be used in patients cocurrently infected with gonorrhea or syphilis - *not* recommended in men having sex with men d/t high risk of HIV comorbidity - must have "EPT" written on Rx - no need for name, address, or DOB of sex partner - no liability or unprofessional conduct
Drug Addiction Treatment Act of 2000
- allows physicians to prescribe drugs in Schedules III-V for opioid addiction - only *buprenorphine* is approved by the FDA at this time - prior to DATA, only had methadone clinics
Community First Choice Option
- allows states to offer home and community-based servies to disabled individuals through Medicaid rather than institutional care in nursing homes
Class 3c license for CS
- ambulances, AEMT - "c" for "car"
Kefauver-Harris Amendment (1962)
- amemnded the Food Drug and Cosmetic Act - "drug efficacy amendment" - primarily against thalidomide - all new drugs marketed in US must be *safe and effective* - regulates drug advertising - informed consent for research subjects - Good Manufacturing Practices
Purpose of Issuing Prescriptions for CS
- an Rx *may not* be used by practitioner to obtain controlled substances for general dispensing to patients - an Rx *may not* be issued for dispensing of narcotic drugs (in any schedule) for "detoxification treatment" or "maintenance treatment"
Pharmacy Benefit Manager definition
- an entity that contracts with pharmacies or pharmacy contracting agencies (PCA)
Who must register for Controlled Substances
- any entity involved with manufacture, distribution, dipsensing of a controlled subtance - pay a fee every 3 years (federal) - DEA will notify you 60 days prior for renewal - Community pharmacies only need CS registration under federal law - hospital pharmacies per NY and Fed. law - license reflects what controlled substances you are allowed to work with
Prescription samples
- any practitioner authorized to prescribe in NYS may give prescription samples of that which they are allowed to prescribe - it is illegal to sell samples - no samples of Controlled Substances are allowed in NYS (but you can give out coupons)
Prescription imprints
- anyone who writes a prescription must have his/her name imprinted (stamped) on the blank - Imprinted name is not a substitute for a signature - Cannot be on the line reserved for the prescriber's signature - must be conspicuous - not required for computer-generated Rxs
What did the Food, Drug and Cosmetic Act of 1938 do with regards to cosmetics and definition of cosmetics?
- anything applied to human body - any component of cosmetics
What did the Food, Drug and Cosmetic Act of 1938 do with regards to food and definition of food?
- anything used for food/drinks by ppl or animals - anything that goes into food - chewing gum
NYS substitution law
- applies to outpatient prescriptions from clinics - does not aply to inpatient medication orders - does not apply to telephone orders (RPh must document that bit) - no form of the prescription is required by *federal* law
Buprenorphine rules (CIII drug)
- approved by FDA for use in opioid toxicity and addiction - may be used for pain - may have refills - may get partial fills - subutex (buprenorphine) should only be used for induction to avoid precipitating withdrawal symptoms - suboxone (buprenorphine and naloxone) should be used for maintenance therapy - physician or group practice can treat a max of 30 patients - physician must register every two years (no cost)
Therapeutic equivalent
- approved by the FDA as safe and effective - pharmaceutically equivalent *and* bioequivalent - adequately labeled - manufactured with current Good Manufacturing Practices - ex) Lasix and furosemide
Schedule A poisons
- arsenic - atropine - corrosive sublimate - potassium cyanide - chloral hydrate - hydrocyanic acid - strychnine and all other poisonous vegetable alkaloids and their salts - oil of bitter almond containing hydrocyanic acid
The number of interns allowed per pharmacist
- as many as you like (as long as supervision is appropriate)
Dispensing, counponding space of registered pharmacy must be how big?
- at least 100 square feet
How many hours per week does the SP have to work?
- at least 30 hours or more than half the hours open
Registered pharmacy how big?
- at least 300 square feet
How many drug tests must medical maintence patients received per year?
- at least 8 - no test for buprenorphine - testing for substance abuse, not compliance
less-common CIII agents
- barbital suppositories - ketamine (ketalar) - buprenorphine - embutramide (embutane) - oxybate (GHB) (Xyrem)
Durham-Humphrey Amendment (1951)
- because of *toxicity*, some drugs must be used under direction of a licensed practitioner - such drug shall be dispensed only on a prescription - seling the drug without a prescription is doing an act which causes the drug to be misbranded while being held for sale - defines "Legend" drugs and OTC drugs
Federal Food Drug and Cosmetic Act (1938)
- because people died in Europe from a manufacturer using diethylene glycol as a solvent in cough syrup - drug listed in USP as articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals - articles intened to affect the stucture or function of the body of a man or other animals - outlaws counterfeit drugs
Perpetual CII inventory
- is *not* required by law
Incidental Use and Disclosures (accidental)
- being overheard talking to a patient - you are not expected to guarantee a patient's PHI from all potential risks - you are not expected to guarantee a patient's PHI from all potential risks - are not expected to *retrofit* any pricacy device into your pharmacy (counseling booths) - you must have reasonable safeguards
LPAs: controlled substances and DEA numbers
- both priveleges are optional - to obtain a DEA number and to prescribed a controlled substance, an LPA *must be registered with the DEA*
Automated Dispensing Cabinets in Nursing Homes
- both the nursing home (class 3a) and ADM need a DEA number - pharmacy needs a record of what is in the machine - when you stock the machine, you must do a DEA222 form
What must be included on the drug price list?
- brand/generic drug name - strength - dosage form - quantity - price
When can drug samples be given to a pharmacy?
- can be given to a charitable organization that provides care to indigent or low income patients, but must be given to patients free of charge
Conditions legitimizing marijuana
- cancer - positive status for HIV or AIDS - ALS - Parkinson's - Multiple Sclerosis - Intractable spasticity: spinal cord damage - epilepsy - inflammatory bowel disease - neuropathies - Huntington's disease - any condition by the commissioner - *PLUS* - cachexia (wasting syndrome) - severe or chronic pain - severe nausea - seizures - severe or persistenst muscle spasms
What records can be stored centrally and what ones need to be retained at the pharmacy?
- centrally: shipping and financial records on controls - pharmacy: form 222, prescriptions, inventories
Young Adult Coverage
- children (dependent or not) until *age 26* (no matter what) are eligible to enroll in their parent's employer's plan.
U-listed wastes
- chloral hydrate - selenium sulfide (dandruff shampoo) - some chemotherapy drugs (but not most)
A quick list of CIV depressants
- chloral hydrate (Notec) - ethchlorvinyl (Placidyl) - meprobamate (Miltown, Equanil) - phenobarbital (what?!?) - zolpidem (Ambien) - eszopiclone (Lunesta) - Zaleplon (Sonata) - diethylpropion (Tenuate) - mazindol (Sanorex) - phentermine (lonamin, Fastin) - pentazocine (Talwin, Talacen) - Cathine - provigil (Modafinil) - Meridia (Sibutramine) - Stadol (Butorphanol) - Chloralphenazone (Midrin) - Tramadol (Ultram) - Fospropofol (Lusedra) - Carisoprodol (Soma)
Other than manufacurers and distributors, scheduale 2 medications can be filled how?
- closing pharmacy transfers medications - pharmacy that is not closing transfers C2 to another pharmacy - narcotic compounder fills scheduale 2 orders for an off-site registered narcotic treatment program - registered researchers authorized to have controlled substances are also able to distribute scheduale 2 medications to facilities authorized to distribute scheduale 2 medications
Durham-Humphrey Amendment
- created the OTC and prescription drug categories - "Caution: federal law prohibits dispensing without a prescription" - childproof containers unless waived
I-STOP Part A
- createds the "new" prescription monitoring program - Practitioner and pharmacist requirements
Pharmacy Application must backup prescriptions...
- daily
Medical Device Act of 1976
- dangerous and useless medical devices - testing and reporting requirements of the devices - divided devices into three classes - Class 1: needles, scissors, gloves, toothbrushes - Class 2: insulin pens, pumps, syringes, diagnostic tools, tampons, heating tools - Class 3: pacemarketing, soft contact lenses, replacement heart valves
When a brand name medication is dispensed in place of a generic in cases of an emergency what must be recorded on the prescription?
- date, hour, nature of emergency
Package insert components
- description of drug - clinical pharmacology - indications and contraindications - precautions, adverse reactions - dosage and products available
Medicaid Inspector General
- detects medicaid fraud, detection, and receovery - all supervising pharmacists must register separately with medicaid - SPs are not required to notify medicaid - pharmacies who bill Medicaid *> $5 million* per year attract the attention of the general - requires that Medicaid providers develop and implement compliance programs aimed at detecting fraud, waste, and abuse in the Medicaid program
Prescriptions for OTC Drugs
- determine whether the physician knows that the drug is available w/o prescription - prescriber may have reason for Rx on prescription - maybe dosage reginem requires supervision or possible interaction - handle as Rx, including any refills
Contents of each medication in emergency crash carts must be approved by who?
- director of nursing - medical doctor - pharmacist
Veterinary Rx Labeling misbranding violation
- dispening veterinary legend drug without Rx
If prescriber writes for a BRAND product with a DAW...
- dispense BRAND
If prescriber writes for a BRAND product w/o DAW...
- dispense the least expensive product
If prescriber writes for a manufacturer-specific generic product w/o DAW...
- dispense the least expensive product
If prescriber writes for a manufacturer-specific generic product with a DAW...
- dispense the manufacturer's generic
If prescriber writes for a generic medication w/o a manufacturer (with or without DAW)
- dispense whatever the heck you want
Narcotic Addict Treatment Act of 1974
- dispesning at clinics to addicts by specially trained physicians - only two drugs approved for use - methadone - levo-alpha-acetylmethadol (laam) - methadone given as 1 single dose at a time - cannot be filled at the pharmacy
LPAs: controlled prescriptions
- must have their own DEA number (starting with "M") - may use their own blanks, or the blank of the SP - must have name (mechanical imprint) of MD
Limitations to generic substitution law
- does not apply to prescriptions coming from out-of-state - nursing homes being served by a community pharmacy are *not* excused - does not apply to when practitioners dispense
Counseling for a drug is required if any of the following should change:
- dose - strength - route of administration - directions for use - NYS BOP recommends that counseling be made on drugs that have not been filled for *90 days*
What needs to be included on repackaged medications?
- drug name, strength, quantity - lot number - date of repackaging - number of packages prepared - number of dosage units in each package - name of manufacturer and/or distributor - signature of person repackaging and SP
Pure Food and Drug Act (1906)
- drugs cannot be distributed through interstate commerce if misbranded or adulterated
Medicaid Dispensing Limits
- drugs must be ordered in a quantity consistent with the health needs of the patient and sound medical practice - the quantity ordered or prescribed must be based on generally accepted medical practice - the ordering practitioner must be contacted if dispensing the supply specified in the prescription would result in the medical assistance recipient recieving a quantity of drugs wich exceeds the manufacturer's labeling instructions
Non-specific patient orders shall include a protocol:
- either include name and license # of pharmacist on protocol, or name of entity who employs pharmacists - the period of time for which protocol is valid (start and end dates) - the standards, procedures, and reporting requirements set forth by this law - specific immunization agents that the pharmacist is permitted to administer including dose, indication, and route - the name, license number, and signatre of licensed practitioner (or NP) who has issued the order
Acute phase
- eliminating the use of illicit opiods for at least 24 hours
Third Party Logistics Provider
- entity that provides or coordinates warehousing, or other logistics sergices of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the porudct, not have responsibility to direct the sale or siposition of the product - FedEx, USPS, UPS
Buprenorphine prior auth law
- every insurance policy must provice for prescription drugs for the treatment of a substance use disorder shall include immediate access, without prior authorization, to a *5-day emergency supply* of prescribed medication assocaited with the management of opioid withdrawal and/or stabilization
CS Education materials
- every patient dispensing for controlled substance the pharmacist must provide the patient with information about the dangers of misuse and potential risk for addiction to prescription controlled substances AND - the physical and behavior warning signs of addiction
"Failover Faxes"
- ex.) due to temporary network outages or failures, the originator's software cannot send you to electronically, but sends a computer-generated fax - *not allowed*
Safe Medical Devices Act
- first act to requires that the healthcare facility report malfunctions of medical devices that have contributed to patient injury, illness, and or death to the manufacturer - (FDA Modernization Act expanded on reporting of medical devices)
NDC meaning
- first set of 4-5 numbers: manufacturer - second set 4 numbers: drug - third set 2 numbers: package
What vaccines can pharmacists administer?
- flu - pneumococcal - *meningococcal* - shingles - diptheria, tetnus, pertusis
CE Conditional Registration
- for RPHs who have not met the CE requirement, but have shown competence - time period of registration is set by department but not >1 year - Extra fee (on top of triennial fee) - must complete deficiency - must complete regular requirement of 1.25 CE/month
FDA Approval type S
- for drugs *similar to those on the market*
FDA Approval type P
- for new innovative drugs *not on the market*
Drug Development: *Fast Track*
- for unmet medical needs - new drugs or enhanced therapy
Foreign Rxs
- from Canada, Mexico - if patient presents you the Rx, may be filled if Rx is the same drug, strength, and formulation as in US - you cannot substitute another product - you must verify the doctor - you may *not* mail to their country - warn patient that drugs may be seized at the border
Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) accredidation
- from NAPB 1.) verifiaction of licensure 2.) Confirmation of policies and procedures 3.) on-site survey of facility
What does HIPAA do (in general?)
- gives patients control of their PHI - empowers patients to control how their information is to be used, to whom it is sent, and to correct any misinformation - gives the patient the right to examine his/her medical information and receive a copy of it - FEDERAL LAW
Reasonable Safeguards for HIPAA
- glass between your counter and the front of the pharmacy - asking customers to stand back as you counsel - speak with a lowered tone of voice to patients/providers - avoid using patient's names in hallways - isolate or lock patient record files - use computer security - mailed refill reminders must be encrypted/enveloped
Medical marijuana patient certificaton card
- good for one year or patient's death, if terminally ill - *not* a prescription
What did the Food, Drug and Cosmetic Act of 1938 do with regards to drugs and their definition of drug?
- has to be listed in USP/NF - drug defined as intended for use in diagnosis, cure, treatment, prevention of disease in ppl or animals - drug further defined as intended to affect structure/fxn of the body of ppl or animals - counterfeit drugs addressed
Optometrists Phase One
- have a "U" in front of their license number
Limitations of Practitioner Dispensing
- no more than a 72-hours supply of drug can be dispensed by a practitioner
Optometrists Phase Two
- have a "V" in front of license number - must become certified to se Phase 2 agents w/i *3 years* of Phase One certification - beta-blockers, alpha-agonists, direct-acting cholinergic agents, prostaglandins, carbonic anhydrase inhibitors
General rule of waste
- hazardous waste must go to a permitted treatment, storage, and disposal facility
Preexisting conditions in ACA
- health plans cannot limit or deny benefits or deny coverage fora a child younger than age 19 simply because the child has a "preexisting condition" - insurers will be prohibited from denying coverage to *anyone* based on the state of their health
Drug Price Competition and Patient Term Restoration Act of 1984 ("Hatch-Waxman Amendment")
- helps bring generic drugs to market faster - only need to file an ANDA and not an NDA - extends some patient to "innovative drugs" - generics are relived of performing clinical studies to show safety and efficacy
Verbal orders
- highest area of med. errors - may be phoned in by an agent (employee) of the prescriber (as long as not controlled) - controlled drugs must be phoned in by the prescriber *in any venue* - Rx must be reduced to writing immediately (or w/i 72 hours, per federal law) - (*DAW*) RPh must document whether or not generic substitution is permitted (NYS law) - Must indicate with RPh received the Rx, the date, time, and prescription number
What conditions can steroids be issued more than a 30 day supply for?
- hormone def in males - metastatic breast cancer in females - gynecologic conditions responsive to treatment with steroids - angioedema - anemia
Medicare Part A
- hospitalization - mandatory upon retirement - *free*
what is medicare part A?
- hospitalization - mandatory upon retirement, free
Samples in a hospital
- hosptial pharmacies usually handle all the samples pursuant to an agreement with the PR or health care entity - the pharmacy must keep copies of a practitioner's written request for samples - must be stored away from other pharmacy stock - original packaging for the drug sample must be used for dispensing - the drug sample cannot be purchased by any individual or cannot be offered for sale by the pharmacy
Floor stocks of controlled substances
- if >72-hour supply, must be in stationary, double-key locked cabinet (CII-CIV); CV can just be in a stationary locked cabinet - if <72-hour supply, may be stored with the patinet's other meds in a securely locked med cart (not allowed in 3a facilities)
Misbranding (definition)
- if any word, statement, or other information required is not prominently placed on the labl, with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use - a drug shal be deemed misbranded if its labeling is *false* or *misleading* in any particular manner - it is misbranding to *not* list acive ingredient, precautions, adequate directions*
Can on-call docs order a CS for another doc?
- if he/she has direct access to the patient's records - if he/she has direct and adequate consultation with the initial prescriber - if he/she has no direct access to patient's records, the prescriber must document in his/her own record and transmit to the initial prescriber
Emergency Department CS
- if immediate dispensing is necessary and no alternative treatment available, may dispense no more than a *24-hr supply* - no Rx needed, but label is required
Adulteration (definition)
- if it is in whole or part, filthy, *putrid*, or decomposed substances - if it is packed under unsanitary conditions - if it is contaminated - if the container is unsanitary or has poisonous or deletrious substances - a color additive which is unsafe - if the drug has differing standards than the official compendia - if the product is combined with others that reduces its quality or strength
Discharging patients with meds
- if patient leaves the nursing home, those medications belong to the patient - if the patient leaves a *hospital*, those medications belong to the patient
Log Book Requirement
- if the system provides a hard copy printout of each day's CS prescription refils, each pharmacist who refilled those Rxs must verify his/her accuracy by signing and dating the printout - the printout must be provided to each pahrmacy that uses the computer system w/i 72 hours of the date on which the refill was dispensed - in lie of the printout, the pharmacy must maintain a bound logbook in which each pharmacist involved in the days dispensing signs a statement verifying that the refill information entered into the computer that the day has been reviewed him/her and is correct as shown - BNE wants the book kept for 5 years
Dispensing a CS for a patient transferring somewhere else
- if transfer is to exceed 3 hours, an institutional prescriber may dispense a single dose of CS
Nurse Practitioners: collaboration
- in order to write prescriptions, NPs must have a written practice *agreement and protocol* established with a collaborating physicion *or a collaborative relationship* (for experienced Nurse Practitioner) - may work for 2 or more providers at one facility (do not need to enter multiple collaborative agreements)
Supervising Physician limits to assistants
- in private practice, may not supervise more than 4 LPAs or more than 2 SPAs - in hospital, may not supervise more than 6 LPAs or RSAs in any combination
Labeling by Manufacturer
- information on bottle or pacakging of that box including the package insert - patient counseling information - federal caution statement
Class 3 license for CS
- institutional dispensers (hospitals) - all dispensing through registerd pharmacy - has DEA registration - has inpatient orders
ACA elminating lifetime limits
- insurance companies will be prohibited from imposing lifetime dollar limits on essential benefits, like hospital stays
Insurance for patients in clinical trials
- insurers will be prohibited from dropping or limiting coverage because an individual chooses to participate in a clinical trial
Hospital physicians can supervise how many PAs?
- up to 6
Drugs that may be returned and repackaged into blister packs for redispensing if...
- it has been NOT been 90 days since the repackaging - the expiration date and repackaging dates are clearly marked on the package - the lot number is marked on the package
Robinson Patman Act (1936)
- it is unlawful for a seller of a product to discriminate in price between purchasers of like products when the effect of the disctimination substantially injures competition unless the discrimintation is cost-justified (large quantity discounts)
Sending CS to Central Fill
- law allows CII-CV to be transmitted from retail to Central Fill facility, but NYS does not allow the transfer of controlled subtances ANYWHERE
Who "owns" the prescription?
- legal rights attached to prescription - patient has a right to have order refilled if authorized and according to law - patient has a right to a copy, with qualification - RPh has a duty *not* to disclose information and maintain confidentiality
Narrow Therapeutic Index Drugs
- less than 2 fold difference between median lethal dose and median effective dose
Administrative Warnings
- letter issued by the Proffesional Conduct Officer (director of OPD) - Issued for minor/technical misconduct - lists the misconduct and rule broken - wanrs licensee - not a disciplinary action - confidential
Class 3a license for CS
- limited institutional dispensers (nursing homes, prisons, developmental homes)- - may only store and administer CS to patients pursuant to prescriptions and filled by registered pharmacy - do *not* have DEA numbers - if facility is a physical and integral part of a Class 3 facility, may obtain CS as substocks
"Sealed" Emergency Medicine Kits
- limited suppies of *controlled substances* for use in emergency situations may be stocked in "sealed" emergency kits - each kit may contain up to a 24-r suply of a maximum of 10 different controlled substances in unit dose packaging, 3 of which may be injectable drugs - Controlled substances in the kit may be administered by authorized personnel pursuant to an order of authorized practitioner to meet the immediate need of a resident - order must immediately be reuced to writing and such order must be signed by the practitioner w/i 48 hours - elsewise, the order is terminated - record all controlled substances forever - a pharmacy may distribute a controlled substance to a practitioner in a Class 3a facility, soley for stocking in sealed emergency medication kits - facility must notify the pharmacy w/i 24 hours that the sealed EMK is broken - each EMK must be secured in a stationary, double-locked system
Nursing Home Emergency Kit
- limited to injectables, mostly - can also contain SL nitroglycerin - may have up to 5 noninjectable, prepackaged meds, not to exceed a 24-hour supply - the total number of noninjectables may not exceed 25 medicatios for the entire facility - each kit must be secured at or near the nurses station
negative formulary
- list of trade name drugs that pharmacists may not dispense as generic drugs - always substitute unless on the list
Purple book
- lists biological products, including any biosimilars and interchangeable biological products licensed by the FDA
What agencies do theft of controlled substances have to be reported to?
- local police - local or regional DEA - NYS Dep of Health
Counseling Regulations Off-premises delivery of Rx
- mail order, delivery services - RPh shall include a written offer to counsel - leave a telephone number where RPh can be reached - if mail order, phone number is toll-free - if patient accepts, RPh must contact person via telephone or in person
Daily Record of Rxs Filled/Refilled (log)
- maintain in ready form which indicates the Rx number, the ordering prescriber, the patient's name, signature/initials of pharmacist who filled/refilled - if you keep a daily file for new Rxs, this log is met - if you have a log of refilled prescriptions, you are good to go
When mail order sends an alternate drug due to physician consultation, the pharmacist is required to...
- make 2 documented call attempts to the patient within 48 hours of mailing/delivery
Midwifery
- management of normal preganancies, childbirth and pospartum care (up to 28 days), as well as the primary preventive reproductive health care of essentially healthy women - written collaborative agreement required b/t midwife and physician
DEA form 225
- manufacturer - distributor - labs - importer - exporter - need to renew every 3 years
A pharmacy compounds IBU suppositories and sells them to other pharmacies, what is this called?
- manufacturing
Emergency dispensing of CS in a Class 3 facility
- may be adminstered by oral order if... - emergency - order is immediately reduced to writing - notation is made of emergency condition - order is signed by a prescriber w/i *48 hours* - orders must be highly specific (drug, strength, dose *route of administration*) - time or dose ranges are not allowed (1 to 2 tablets, every 4 to 6 hours)
Dispensing naloxone
- may be dispensed to anyone who requests it - no prescription - standing order in NYS - you must have received training - must *label* the naloxone (name of recipient, not patient) - *must* tell recipients how to use it
Outpatient Pharmacy Security Requirements for CS
- may be locked in a cabinet, OR - dispered throughout stock to hide them (like at the Rite Aid I worked at)
Drug Quality and Security Act compounding rules
- may compound from FDA list - may not compound drugs pulled from the market - may not compound commercially available drug products (tamiflu suspension?) - may not compoud items that are diccicult to compound (inhalers) - may not compound products that are OTC or from OTC's w/o a prescription - exempts compounded drugs from new drug requirements, labeling requirements
Time limit on NYS prescriptions
- no real time limit - use good judgement - only limited by insurance or medicaid
Fax orders for controlled substances (any) for *hospice patients*
- may dispense up to a 30-day supply - pracitioner must note on Rx about the hospice patient - Still need an OSNYSRx in 72 hours - must report w/i 7 days
If DEA Rules Federal III only, NYS noncontrol....
- may dispense what the physician wrote for verbally or via fax - up to 5 refills in 6 months - must sign and date - practitioner may give samples - no phone limitations for federal CIII-CV substances - nurse may call Rxs into the pharmacy
*Donation and Redispensing of Unused Prescription Drugs*: Donor entities
- may donate unussed prescription drugs to a recipient entitiy securley - directly or through 3rd-party intermediary - must ensure privacy of patients whose drugs were initially dispensed - drugs must be inspected by a pharmacist or other health care professional - drugs must be in tamper-evident or unit-dose/multi-dose packaging
Optometrist priveleges
- may give samples - may NOT dispense needles - ARE issued a DEA number but are NOT permitted to prescribe controlled substances
Nurse Practitioner Rx Blanks
- may have *seperate* blanks from physician, or both - must include name of NP, designation, certification number ("F" followed by 6 digits and sepcialty code) - office address/telephone number
Standing Orders in a Class 3 facility
- may include "prn" notation - may be CS - expire every 7 days, unless patient has convulsions, ADHD, chronic spasticity, patient is in a class 3 residential health care facility, patients in prison with class 3 license; these orders are valid for 30 days and must be re-written every 30 days
Days Supply for CIII-CV drugs
- may not write for more than 30-day supply, unless there's a *diagnosis code* - if diagnosis code F, no refills allowed - for other diagnosis codes, a 90-day supply means *only 1 refill allowed* (to fit w/i 6 months) - diagnosis code means no partial fills
Copies of controlled subtance prescriptions
- may only be given by pharmacists to the practitioner who issued the original - a practitioner may print a copy of an eRx for a patient *after* the Pr transmits to the pharmacy
Optometrists prescribing
- may prescribe and use drugs for topical application to the surface of the eye w/i scope of practice - no injections, needles, or controlled drugs
PAs: inpatient rules
- medical orders shall be countersigned by a supervising physician *within 24 hours* - but not required prior to execution of the order - responsibility of the hospital
what is medicare part D?
- medicare rx drug coverage - rx coverage thru private insurance plans - thru managed care plans - deductibles and copays
Violation of Committee Proceeding
- more serious misconduct - consittutes disciplinary action - creates a disciplinary history - matter of public record, but not published on the website
What compounding devices does a pharmacy need to have?
- mortar and pestle - balance device (if needed metric balances) - graduate devices that measure volume (0.1 mL - 500 mL)
*State* laws for CII verbal order
- must be an emergency - must only be 5-day supply - must write "telephone order" - must have *written* prescription w/i 72 hours - must notify BNE in 7 days, notify DEA (soon)
Transfer of CS between pharmacies (CIII, CIV, CV)
- must be immidiate medical need - not for "stock balancing" - vendee gets *original* invoice and a copy of the request - vendor gets oroginal request and the *copy* of the invoice (the opposite) - may not exceed 5% of all CS dispensed or transferred - may not distribute to prescribers without a distributor's license
Customized packaging (multi-dose blister packs)
- must be performed by a pharmacist or other person under RPh supervision - labels on repacked drugs shall bear sufficient information for proper identification and safety - must keep a record of what was repacked - all information required by Education Law - must have permission of patient, patient's caregiver, or prescriber - medications shall not be repackaged for or reissued to any patient other than to the patient for whom they are originally dispensed - *no controlled substances*
Repackaging In-House Use Regents Rules
- must be repacked by a pharmacist or under his/her supervision - labels shal bear sufficient information for proper identification and safety - must have drug name and strength, lot number, quantity repackaged, manufacturer/distributor, date of repacking - keep repacking records for *5 years*
Faxed prescriptions
- must be signed by the prescriber - may be used for controlled and uncontrolled prescriptions - must come from an unblocked fax number at the top of one of the prescriptions
Internet pharmacies
- must exist a valid prescriber/patient relationship - face-to-face - internet questionnaires do not qualify
OSHA and Vaccines
- must follow federal guidelines for giving shots in any setting - must have policy and procedures for a sanitary area, exposure plan - determination of employee exposure - implementation of various methods of exposure control, including universal precaution - post-exposure and follow-up - communication of hazards to employees and training - Recordkeeping - Procedures for evaluating circumstances surrouding exposure invidents - using safety devices - comply with current CDC recommendations
Nursing Home Consultant Pharmacist
- must have a consultant pharmacist (registered RPh) - provides consultation on all aspects of pharmacy services - must provide for record of receipt distribution of all Controlled Substances - chart check once every 30 days
LPAs: noncontrolled prescriptions
- must have name, address, and phone of PA - must have name (mechanical imprint) of supervising physician - prescriptions do *not* need to be countersigned - must include registraiton number (6-digit)
Immunization patient consent
- must have the *patient's consent* after informing them of ADR's etc, and before giving the vaccination - consent may be acquired verbally - you may use your own language and consent form - a patient >19 may withdraw their consent by using the NYSIIS Withdrawal of Consent form (but why?) - must provide a copy of the Vaccine Information Statements (VIS) to the patient prior to adminstering the drug
Authorized Collector
- must have your DEA registration modified - may NOT peform take-back programs - voluntary - maintain collection receptables inside their registered location - may not take back illicit drugs - may not require identification of any ultimate user - must have a sign that clearly states CII-CV and non-controls
Midwife Rx Blanks
- must include name of midwife - office address/telephone number - "midwife", or "professional midwife" - certification number ("F" followed by 6 digits)
Receipt of Immunization
- must provide a receipt with: - patient's name - date of immunization - address of administration - administering pharmacist - immunization agent - manufacturer - lot #
*Federal* laws for CII verbal order
- must receive follow-up in *7 days* - must write "authorization for emergency dispensing" - must notify BNE in 7 days, notify DEA (soon) - out of state providers must follow-up with their own Rx blanks
HIPAA Breach response if information pertains to <500 people:
- must send an individual notice in written form via *1st-class* mail or via email if requested by the patient - must contact the patient within *60 days* of discovery of the breach - must notify the Secretary of HHS no later than *60* days after the end of the calendar year from when the breach was discovered
HIPAA Breach response if information pertains to >=500 people:
- must send individual notice - also must provide a media notice (prominent media outlet) - must notify the Secretary of HHS w/i *60* days of the discovery of the breach
Drug Development: *Accelerated approvals*
- must show long-term outcomes and benefits
What drug must you be abstinent from opiates before starting?
- naltrexone - 7 days for short acting opiates - 10 days for long acting opiates
Medications dispensed by the prescriber must have...
- name and address of dispenser - name and address of patient - delivery date - drug name and strength - directions
Veterinary Rx Labeling
- name and address of owner of animal - species of animal - name of veterinarian - directions for use - cautionary statements, if any
Important elements on label
- name, address, and phone number of the pharmacy - patient's address - name of prescriber - date of fill - prescription number - these must *not* be highlighted like the critical elements
Components of a NYS Medication profile (from Obra 90)
- name, address, phone number, gender, DOB - allergies - chronic diseases (NYS, only) - Disease states (Federal, only) - comprehensive list of medications (RX + OTC) for counseling - relative devices - pharmacist comments relevant to the individual's drug therapy - prospective drug use review (*DUR*) (NYS and Feds) before Rx is given - you may still dispense if patient refuses to give these
DEA form 363
- narcotic treatment programs or dispensing locations
What did the Food, Drug and Cosmetic Act of 1938 do with regards to devices and definition of devices?
- need to be listed in USP/NF - same definition as drug but DOES NOT ACHIEVE PRIMARY INTENDED PURPOSE THROUGH CHEMICAL ACTION
National Provider Identification Number (NPI)
- new identification number - HIPAA requires for all health providers - you may apply through an easy, web-based application process - everyone *must* have an NPI - NPIs with an "Entity type code" of 1 will be issued to health care providers who are individual human beings (pharmacists included)
Minimum Security Med Carts
- no CII allowed - Schedule CIII-CV need double-key locks - when the cart is not in use, must be anchored - locked drawer system - independent locking mechanism
Controlled Substance Prescription date
- no CS Rx ay be issued prior to the examination of the patient by the practitioner - practitioner may prescribe upon review of report of consulting practitioner or hospital - all CS prescriptions must be issued with the date of the practitioner saw and examined the patient (unless the patient develops a new symptom in an emergency situation)
Community samples
- no Rx samples may be given to retail pharmacies! - no samples of CS are allowed in NYS - coupons are alllowed to be taken for any controlled substance - any samples by prescribers must be labled and put in a suitable container (documented in the patient's record)
Plan B
- no age restrictions per federal gov't as of 2013 - MNY says that if you are under 17, you need a prescription to use Plan B
NYS Governor's Budget Update PBM audti
- no audits the first 3 days of calendar month (busiest time for pharmacies) - notify the pharmacy w/i 15 days prior to audit - 24 months look back - list of Rx numbers may not include last 2 digits - max of *100 rxs* - preliminary report to pharmacy w/i 45 days of audit - then pharmacy has 45 days to address discrepancies - final report 60 days from audit
Equivalence ratings
- no known or suspected bioequivalence problems (AA, AN, AO, AO, or AT) - Have been tested and proved problems between products have been resolved (AB) -*state* law allows substitutions w/o AB-rating, federal law does not
Fax-backs
- no longer allowed - pharmacists can *not* send a reminder to the physician and have the physician sends the same document back as a refill
CIII narcotic limits
- no more than 1.8 g of codeine (or dihydrocodeine) per 100 Mls or - not more than 90 mg per dosage unit with one or more active nonncarcotic ingredients - no more than 300 mg of ethylmorphine per 100 mL or not more than 15 mg per dosage unit - no more than 500 mg of opium per 100 mL or per 100 grams
Expiration dates on customized packaging
- no more than 60 days from date of package preparation - no longer than the shortest expiration date of any one drug
DEA Form 41
- use this form to record the destruction of all controlled substances
When/what type of drugs can be sold at the auction?
- non controlled - controlled - drugs in bulk - drugs in open containers (need to be inspected by the BOP and deemed appropriate for auction) - need proper registration and certifications - controls, bulk, and open drugs: auction place need to be registered with the BOP at least more than 7 days before auction and has supervision of licensed pharmacist - cannot sell drugs that are within *30 days* of expiration date
If the generic is out-of-stock...
- non-emergency: RPh may dispense the *Brand* drug at a price *not to exceed the generic, had it been available* - emergency: RPh may dispense the *Brand* drug at *Brand price* - "emergency" is up to clinical judgement - the RPh then records on the back of the Rx the date, time, and nature of emergency
*Donation and Redispensing of Unused Prescription Drugs*: 3rd-Party Intermediaries
- non-for-profit organization that facilitates the donation or transfer of prescription drugs, but *does not take possession or ownership of the prescription drugs* - does not need an RPh
How many people are on the board of pharmacy?
- not less than 9 pharmacists that have been licensed for at least 5 years - plus the executive secretary
Nicotine products
- not or sale to those <18 years old - proof of age required - not allowed for sale in vending machine (due to ID requirement) - anyone may sell these
Who do you have to tell if there is a HIPPA breach?
- notify affected individuals within 60 calendar days - fewer than 500 people: keep log, notify HHS annually - more than 500 people: Secretary of HHS and prominent local media
Items *not* required on a label
- number of refills remaining/authorized (curious...) - pharmacist's initials - MDD - Pharmacy's DEA number - prescriber's DEA number - lot numbers - zip codes
CDTM License Certification
- on NYSED website - "C" with license number
NYS Subsitution Law: form of the prescription
- one signature line - imprinted immediately below the line in 8-pt. upper-case type, the legen: THIS PRESCRIPTION WILL BE FILLED GENERICALLY UNLESS PRESCRIBER WRITES 'daw' IN THE BOX BELOW"
Medicaid Rules and Regulations
- only basic drugs are covered - 60 days from the date written - records must be kept for *6 years* - all orders are refillable up to 5x/6 months if allowed - medicaid has the power to contract with mail order at any time
White blanks
- only exception to Official New York State RX Blanks (ONYSRx) - for prescribers not practicing in NYS - for clinics/hospitals on federal land (VA, Indian reservations, Fort Drum)
Manufacturer or Distributor Rx Samples
- only practitioners licensed to prescribe such drugs may do samples (not allowed by manufacturers or distributors) - *may* distribute samples to pharmacies of hospitals or other health care entities at the request of a licensed prescriber - must be in response to a written request on a form indicating the name, address, professional designation, and signature of the practitioner making the request
Federal Prescription files
- only two files, must keep for 6 years per HIPAA and Medicaid - 1.) CII drugs - 2.) III, IV, V, if marked with a red C + uncontrolled
DEA CSOS
- order federal CII drug w/o a DEA 222 form - must enroll online - electronic 222 form is generated
Examples of misconduct
- outside scope of practice - fraud - gross negligence - conviction of crime - habitual user or impairment of drugs, alcohol - sexual abuse - maintain proper records - delegating duties to unauthorized persons - refusial to provide services based on national origin - practicing while license is suspended - serious matters
Who must notify the Department of a change in supervising pharmacist in a retail pharmacy?
- owner of the pharmacy
Biologics Price Competition and Innovation Act (BPCIA) 2010
- part of Affordable Care Act - allowed a pathway to introduce biosimilars to the US market
Patient options for sharing their prescriptions through shared data bases among pharmacies:
- patient can select which pharmacies can share information to have prescriptions dispensed - patient can allow prescription information to be shared through a data base to be dispensed at any pharmacy - patient can request prescriptions not be shared in a data base and a firewall will need to be placed to protect the information
Medical Maintenance Phase
- patient has been in treatment for 2 years - life is all good (housing, job, ect.)
When can a schedule 2 prescriptions be faxed?
- patient in a long term facility - hospice - home infusion therapy
Notice of Privacy Practices: logbook
- patient must sign an acknowledgement (logbook) - even if patient refuses to sign, you must still provide treatment - children <18 years do not have to sign - must keep all these records for *6 years*
What can the pharmacist add to a CS Rx if missing?
- patient's address - patient's sex - patient's age
Patient consent to CDTM
- patient's right to choose to not participate in CDTM shall be disclosed to any patient
Patient Rights to Access
- patients have the right to access their health records and obtain a copy except: - psychotherapy notes ("glass door") - inmates (have no rights at all) - information compiled in a reasonable anticipation of or use with civil, criminal, or administrative actions - patient has the right to file a complaint
HIPAA complaints
- patients or *non-patients* may file a complaint to the pharmacy about PHI issue, or they may complain directly to the HHS Office of Civil Rights - pharmacists must provide a process for documenting all such complaints - must have a complaint policy and develop a standardized complaint form - no time period with which you must notify complaintant
ACA Insurance Exchanges
- patients without insurance can apply direactly in an Affordable Insurance Exchange - an Exchange is a new transparent and competitive insurance marketplace where individuals and small business can buy affordable and qualified health care plan
Definition of CDTM
- performance of clinical services by a pharmacist relating to the review, evaluation and management of drug therapy to a patient treated by a physician in accordance with a written protocol - must refer to specific disease or associated disease states
NYS "age 29 law"
- permits eligible young adults through the age of 29 to continue or obtain coverage through a parent's group policy - employees or their eligible dependents may then elect the benefit and pay the premium, which cannot be more than 100% of the single premium rate - the young adult must be unmarried, not be insured by or eligible for comprehensive helath insurance through his/her own employer, live or reside in NYS, and not be covered by Medicare - does *not* have to live with parent, or be a student
CE Requirements
- phamacists must renew registrations triennially - to renew pharmacists must complete *45 CE hours (23 hours must be live*, where you can interact with an instructor) - if not, they may apply for *conditional registration* - 1 hour = 0.1 CEU = 50+ minutes - credits do not carry over - records must be kept for *6 years*
Rosiglitazone REMS
- pharamcy must be certified - Med Guide - prescriber must be certified - patients must be enrolled
Bioequivalent
- pharmaceutically equivalent products that display comparable bioavailability when studied under similar experimental conditions
Authorized Providers for the Expanded Syringe Access Program (ESAP)
- pharmacies - health care facilities - practitioners who are allowed to prescribe syringes/needles
If a written/verbal order comes to the pharmacy indicating it was originally sent electronically...
- pharmacist must check records to ensure that the electronic version *was not received and dispensed*
Persons authorized to dispense
- pharmacists (interns under supervision) - practitioners (anyone who is authorized to *prescribe* medications may dispense drugs including samples of those medications)
Oral authorization for refills
- pharmacists *may* take oral authorizations for refills for non-controlled drugs from a prescriber - no limit on the number of refills - RPH must indicate date, time, name of practitioner authorizing the refills, and the number of refills
Documentation of CDTM
- pharmacists *must document* any changes in the patient's record
CMS Final Rule for Nursing Homes (MEGARULE) Phase 1
- pharmacists are *not* licensed professinals - facilities must develop and implement a baseline care plan for each resident w/i 48 hours of admission - physicians *must* report on pharmacist recommendations - med. reconciliation is required as part of discharge - pharmacists required to perform a drug regimen review for each resident at least once monthly - must look for unnecessary drugs
Immunization laws
- pharmacists must notify the patient's PCP AND NYS registry AND annual pharmacist immunization survey - must complete APHA course - must complete CPR course (not online or virtual, either) - must pay a fee - must keep up with Blood Borne Pathogen training every year (federal) - puts an "i" next to your license number
Which phase of a clinical trial is the first to test for efficacy in a drug?
- phase 2
Immunization county rule
- physician or NP may be practicing in the county or adjoinging county
Medicare Part B
- physician services - *optional* for retirees - paid from SS checks
what is medicare part B?
- physician services - optional for retirees, paid from social security
Accountable Care Organizations
- physicians can join thse groups to coordinate patient care, improve quality, and reduce unnecessary hospital readmissions
Professional Corporation Law
- physicians cannot forwards patients to a specific pharmacy - they may not send an e-Rx to a specific pharmacy unless requested by a patient - Physicians may not own or have ownership in a pharmacy - However, physicians may form a business corporation which may have a pharmacy ownership, but MNY and Medicare will d/c the physicians as part of STARK law.
USP Chapter 795
- policies and practices for *non-sterile* compounding - expiration of compounded product *must not exceed 6 months or 25% of the expiration of any one of the products*
USP Chapter 797
- policies and practices for coumpounding *sterile* preparations safely and without contamination - examples include baths and soaks for live organs and issues, implants, inhalations, injeciotions, powder for injections, irrigations, metered sprays, and ophthalmic preparations - personnel must be adequately educated and trained in the providions - must have a plan to retain on a periodic basis - also includes adequate labing, sterilization methods, and wuality assuranec plan to spot deficiencies and remedy in a timely manner
Drug Disposal Environmental Law
- poster placed in the pharmacy - the important message about NOT FLUSHING!
Code AB in orange book
- potential equivalency issues but adequate scientific evidence exists to establish bioequivalence
Anabolic steroid rules
- practitioners must have informed consent of individual - do *not* require a DEA 222 (because Federal CIII) - all state schedule II requirements apply (no refills, emergency oral Rx, f/u requirements, 30 day/6 month supply requirements
Some CV substances
- pregabalin (Lyrica) - locasamide (Vimpat) - ezogabine (Potiga) - brivaracetam (Briviact) (not in NYS)
What must be *handwritten* on a hardcopy of a prescription?
- prescriber signature - DAW - instruction for drug name not to be included on the label
Not Child-Resistant Packaging
- prescriber's may direct dispensers to use EZ caps, but cannot issue a blanket statement - patients *can* request blanket rule
In order for MNY to cover Brand
- prescriber, in his/her own handwriting must write on the face of the Rx "brand necessary" or a DAW in the box on the Rx - abbreviations are not acceptable
Exceptions to Mandatory E-Prescribing: Waivers
- prescribers with waivers must notify the department when he/she receives the capability to issue prescriptions electronically - requires a practitioner who does not use e-prescribing to file information with DOH as soon as practicable - each exception requires filing information on controlled substances with the state
Scope of CDTM in NYS
- prescribing in order to adjust or manage a drug regimen of a patient (includes prescribing a new drug for the patient) - ordering disease state laboratory tests - ordering or performing routine patient monitoring functions - decision by treating physician shall prevail - no pain medications allowed
When can there be more than 1 medication on a prescription?
- prescription drugs + needles (medical devices)
New York State Prescription files
- prescriptions must be stored in one of three files: 1.) Non-controlled drugs 2.) Schedule II drugs 3.) Schedule III, IV, and V, controlled strugs - state law says you gotta keep records for 5 years
Immunization Requirements (general)
- prior to administering, the certified pharmacist must ensure that each potential recipient is properly assessed for contraindications that would preclude immunizations - must have emergency supplies ready (epinephrine and syringes/needles) - must provide written instructions to the recipient regarding appropriate course of action in the event of contraindications or aderse reactions - pharmacist must make him/herself available to discuss the outcome of the immunization with the attending PCP or the statewide immunization registry - must provide an area for immunization - the Recommended Adult Immunization schedule is *mandatory* - must keep a record of all persons immunized at the pharmacy for the life of the patient - must report administration to patient's PCP; if patient doesn't have a PCP, you must remark on the importance of a PCP
When do PPIs need to be given to nursing home patients when Med Guides are required?
- prior to the first administration and every 30 days thereafter
Pharmacist accepting the transfer:
- produces a hard copy or electronically - marks "refill transfer" on hard copy or electronically - keeps hard copy for *5 years* (HIPAA says *6 years*) - records the dates of original and most recent filling or transfer of the original Rx - transferring pharmacy's name, address, prescription number - name of transferring RPh - name of pharmacist receiving transfer
Class I recalls
- product causes serious, adverse health consequences or *death* - (Lidane in cough syrup let to a child's death)
Class II recalls
- product causes temporary or medically reversible consequences - (wrong strength labeled)
Class III recalls
- product not likely to cause any adverse health consequence - (unapproved dye use)
"A"-rated generics
- products that are considered *therapeutically equivalent* to each other - not considered as having any difference
Professional Assistance Program (PAP)
- professionals who are addicted to chemicals - voluntary and confidential - go into treatment programs under NYS BOP - may not harm patients - may times alternative to professional discipline - NYS BOP member will sit as "ex-officio" on your behalf - not an admisision of guilt
Sherman Antitrust Act (1890) Section #2
- prohibits monopolies, attempts to monopolize or conspiracy to monopolize
Pregnancy and Vaccinations
- prohibits the administration of vaccines containing more than trace amounts of thimerosal to: - women who know they are pregnant - children <3 years - influenza vaccine may contain no more than 0.625 mcg of mercury per 0.25 ML dose
CMS Final Rule for Nursing Homes (MEGARULE) Phase 2
- psychotropic drugs (changed from "antipsychotics") - given only if resident is being treated for a specific condition as diagnosed or documented in clinical record (no PRN orders unless indicated) - PRN orders may not be renewed beyond 14 days unless prescriber documents this in clinical record
FDA Amendments Act of 2007
- reauthorized/amended many drugs and medical device provisions set to expire - increased responsibility and authority to FDA to regulate drug safety - mandate label changes
Retail level recall
- recall to level immediately preceding the consumer - pharmacies, physicians, nursing homes, hospitals, varies with product
Opiod addiction patients must be addicted for 1 year or longer to receive medical management, except?
- recently released from prison - pregnant - patients previously treated up to 2 years after discharge
Pharmacist giving the transfer must:
- record the name of the patient - record the refill that was transferred - record the name, address, and telephone number of the pharmacy to which it was transferred - name of RPh transferring the prescription information - date of transfer - RPh receiving the transfer
CIII-CV orders (not benzoes)
- refills allowed - 30-day supply - up to 5 refills in 6 months (refills can not be added over the phone) - 7-day early refill applies, but earlier refilling *may* be authorized by the prescriber
Controlled Substance Classification 11 entity
- registered community pharmacy (individual stores even if part of franchise) - automated dispensing system
Nurse Practioners (general)
- registered professional nurse - mid-level practitioner - certified by the State Education Department - maximum of *4* NPs/physician at different locations - DEA number starts with "M" - *can* do controlled substances, give samples, and sign a protocol with a pharmacist
Rx Drug Marketing Act of 1987 (federal)
- regulates the sampling of Rx drugs and coupons distributed for Rx drugs - counterfeiting is prohibited - samples defined as "units of a drug that are intended to promote the sale of the drug and are *not intended to be sold*"
"AN" rated products
- solutions and powders for aerosolization - Proventil, Ventolin, and Proair
Prescription Drug Marketing Act
- regulations regarding the sale and distribution of medications revolving around the storage, distribution, and resale - required proper storage and distribution records - prohibits re-importation of drugs except by the manufacturer -prohibits the sale of samples at retail pharmacies -requires drug wholesalers to be licensed by the states - restricts resale of obtained by hospitals at discounted rates
Drug Retail Price List
- replaces the price poste - 150 most prescribed drugs - current selling price - if your selling price changes during the week, you can legally charge the new price - you must have a sign notifying people of the availability of the Drug Retail Price List - will receive update from BOP yearly (written and electronically) - the board shall make the compendium list available to each pharmacy free of charge - if pharmacy has a website, must be on that website - not *required* to give the list over the phone
Immunization Adverse Event Reporting
- report any adverse outcomes as required by Federal Law on the Vaccine Adverse Event Reporting System (VAERS) form of the *CDC*
Prescription Registration number
- required for all NYS prescriptions *not* written by a physician (so, like NPs, and Midwives) - 6-digits - all electronic prescriptions must have the prescriber's NPI number
Reporting to New York Statewide Immunization Information System
- required reporting for adults 19 yo or older upon the *consent of the patient* - must be reported to NYSIIS w/i 14 days
Hospital Readmissions Reduction Program
- requires CMS to reduce payments to IPPS hospitals with excess readmissions
Treatment of Heroin and Opioid Addictions Law
- requires all practitioners who treat *humans* (not vets) are allowed to prescribed CS and who have a DEA# - must complete 3 hours of mandatory coursework on pain management, palliative care, and addiction every 3 years
Kefauver-Harris Amendment
- requires drug manufacturers to prove drugs *effective*, as well as safe before being marketed - thalidomide birth defects
FDA and Tablet Labeling
- requires manufacturers to label solid oral dosage forms - unless impractical (very small pills)
Limited English Proficiency (LEP) Law
- requires pharmacies to provide access to free and competent oral interpretation serices - "meaningful" access to free language services - either face-to-face, verabally, or by phone - prescription should have an LEP on it - employees must be informed of this *free* language assistance service - must be given on an "immediate" basis - can be performed through 3rd party contractor - pharmacies must post a notice sign (only 1) - pharmacies are not liable for errors from contractors who interpret - pharmacies may be waived if they can show undue burden from these services
DEA form 224
- researchers - educational institutions - *pharmacies* - need to renew every 3 years
Privacy officer
- responsible for the development and implementation of the policies and procedure - there must be a contact person to handle complaints in the company
Drug Efficacy Study Implementation Program 1968
- resulting from the Kefauver-Harris Amendment of 1962 - Looked at drugs marketed prior to 1962 to see if they are safe and effective - Medicaid and insurance companies will not reimburse for DESI drugs
High risk expiration date
- room temp: 24 hours - refrigerator: 3 days
Medium risk expiration date:
- room temp: 30 hours - refrigerator: 7 days
Low risk expiration dates:
- room temp: 48 hours - refrigerator: 14 days
Pharmaceutical Equivalent (definition)
- same active ingredient - same dosage form - same strength - same route of administration - *differ* in size, shape, etc - different types of aspirin
What information needs to be on an electronic prescription?
- same as written prescription plus NPI number
Anabolic steroid scheduale in NY?
- scheduale 2
"Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" must be included on what prescriptions?
- scheduale 2-4
Tylenol w codiene elixer scheduale?
- scheduale 5 (tablets are scheduale 3)
When do you need to take an exact count on controlled substance during inventory?
- schedule 2 - bottles of 1,000 or more - containers are sealed
What is the appropriate way to file prescriptions?
- schedule 2 - schedule 3-5 - legend
What schedule are the -barbitals?
- schedule 2 - schedule 3: suppository or combined with other non-control drugs - phenobarbital: schedule 4
How should prescription records be stored?
- schedule 2, schedule 3-5, legend - schedule 2, schedule 3-5 with legend, but controls marked
What schedule is codeine?
- schedule 3: not more than 90 mg per dosage unit and with other medications (w/ APAP) - schedule 5: liquid formulations with no more than 200mg/100mL (cough syrups)
What schedule is opium?
- schedule 5: 100 mg/mL
What can pharmacy interns NOT do?
- sell self-defense spray - sign or initial a prescription
Prescription Drug User Fee Act of 1992
- shortens review time of new products coming to market - charges each pharmaceutical manufacturer a "fee" which is used to hire more reviewers - leads to more recalls
*Donation and Redispensing of Unused Prescription Drugs*: Drugs that may *not* be dispensed
- show evidence of adulteration or misbranding - show evidence of tampering - will expire prior to use by he patient - have been excluded from the program - part of REMS program or other registration with FDA
Drug Development: *Breakthrough Therapy*
- similar to Fast Track, but may skip steps in the approval process
Veterinary Drugs
- some veterinary legend drugs are human OTC (antihistamines) - some human legend drugs are veterinarian OTC (tetracycline for birds) - Drugs approved by FDA for veterinarian use are not intended for human use (and vice versa)
Drug Development: *Priority Reviews*
- speed approval process
4 Pharmacy Primary Languages as defined by LEP law
- spoken by >1% of the population - Italian - Russian - Chinese - Spanish
Who May Provide CE
- sponsor of CE must be approved by the Commissioner of the Dept. of Ed. - Currently aproved by ACPE as sponsors of CE - some are approved that are NOT ACPE providers
Medicare rules
- sponsors may not required beneficiaries to obtain from mail order - disallows brand manufacturers from filing 30-month stays against generic competition - allows generic companies a 180-day exclusivity if they file application on the first day of elligibility
FDA Modernization Act of 1997
- streamlined ADR reporting - revised compounding laws - regulates sunburn products - regulates medical devices and nutritional products - New Legend reads "Rx only" - misbranded if not present; manufacturer's responsibility - may use investigational drugs outside of controlled clinical studies to treat patients with serious or life-threatening diseases whih no comparable or satisfactory therapy is available
How can controlled substances be disposed of?
- surrender to the NY department of health - return to the supplier
Federal CIV drugs that are uncontrolled in NYS
- suvoresant (Belsomra) - lorcaserin (Belviq)
Where can CDTM be performed?
- teaching or general hospitals - diagnostic centers, treatment centers, outpatient departments - nursing homes (must have an onsite pharmacy staffed by a licensed pharmacist) - not dental clinics, dental dispensaries, RHCF, or rehabilitation centers
Practice of Pharmacy (definition)
- the *administering, preparing, compounding, preserving, or the dispensing*, of drugs, medicines, and therapeutic devices on the basis of prescriptions or other legal authority, and collaborative drug therapy management - only a person licensed or otherwise authorized under this article shall practice pharmacy or use the title "pharmacist"
Who does Medicaid help?
- the *poor* and the *disabled* - Medicare supports the elderly and those in ESRD; these are taken care of by federal gov't.
The scheduling of controlled substances at the federal level is performed by who?
- the US Attorney General, as head of the Justice Department (which the Drug Enforcement Administration is under), may add, delete, or reschedule substances - scientific and medical recommendation from the FDA is included in the decision
ACA eliminating annual limits
- the law prohibits new plans and existing group plans from imposing annual dollar limits on the amount of coverage an individual may receive
If the pharmacists receives written/verbal order that indicates an electronic version was sent to *another pharmacy*...
- the pharmacist must check with that pharmacy to determine if the Rx was filled
Pharmacist responsibility
- the pharmacist who deliberately ignores a questionable prescription when there is reason to believe it was not issued for a legitimate medical purpose may be persecuted along with the issuing practitioner for distributing controlled substances
*Donation and Redispensing of Unused Prescription Drugs*: Redispensing
- the recipient entity may repackage or prepackage the drugs after the drugs have passed inspection - priority to redispensing is given to indigent, uninsured, or under-insured - you may *not* resell the drug that is being redispensed, but may charge a reasonable processing fee
Midwife privileges
- the same as Nurse Practitioner's (seperate Rx blanks, controlled substances, samples), but limited to practice of midwifery
HIPAA and HITECH Enforcement
- through the State Attorney General Office - $100 to $50,000 per violation - Whistleblowers get a cut (25-30%) - certain violations are covered also under NYS General Business Law if breach involved SS number, Driver's License number, or credit card information
Rules for dispensing needles/syringes w/o an Rx
- to a person 18+ years - in quantities of 10 or fewer - no restrictions on types of hypodermic syringes/needles sold - must include a safety insert with each transaction of syringes/needles provided - pharmacies are *not allowed to advertise* this service - program is voluntary and demands registration - pharmacy must have sharps container and know how to dispose of it - *no record-keeping required* (astounding)
The Community Based Care Transitions Program (CCTP)
- to reduce hospital readmissions, test sustainablefunding streams for care transition services,maintain or improve quality of care, and document measurable savings to the Medicare program
"AT" rated products
- topical products - only products that have ratings w/i their dosage-form category are considered equivalent
Partially filling CIII-CV drugs
- totally allowed - get "okay" from MD - total quantity must be gone by 30 days from written date
Examples of unprofessional conduct
- undue influence on patient for financial gain (fee spliting, kickbacks, restriction of patient freedom) - filing false reports - moral unfitness (DWI) - not making copies of patient records upon request - revialing personal data of a patient without prior consent - misleading advertisement - patient abandonment - patient abuse (harassment, intimidation) - failure to maintain records - claiming "secret" formulas or cures - failure to pay child support
Sherman Antitrust Act (1890) Section #1
- unlawful any contract, combination or conspiracy in restraint of trade - prohibits competitors from getting into agreements to reduce competition - consipring to drop a third party plan or set prices
One Drug Per Blank
- unless verified by the prescriber issuing the RX - but never controlled substances!! - devices (like needles) do not count - does not apply to prescriptions coming from other states - does not apply to verbal orders being written down on one pharmacy blank (Rite Aid)
MNY-specific dules
- verbal Rxs need to include the *time of the call* - even noncontrolled drugs must be called in by the agent - controlled drugs *and* certain other drugs (growth hormone) must be called in by the provider
Thalomid (thalidomide) REMS
- verify negative pregnancy test - do not prescribe >4 weeks - send patient to a certified pharmacy
Exceptions to PMP system
- veterinarians - addicts or habitual users - PR administering a CS - out-of-state prescribers - PR prescribing in the ED of a general hospital (not an urgent care; maximum of 5 day supply) - hospice care - in an emergency - temporary technological failure - a designee (anyone *employed* by agency) can check PMP on behalf of PR
Exceptions to electronic prescribing
- waiver - out of state - *would not be dispensed in a timely manner* - technical difficulties
Unlicensed persons may *not*
- weigh, compound, or mix ingredients - sign, initial any dispensing records - counsel patients for any type of drug or device
Pharmacy requirements: measuring devices
- weighing device - metric weights - devices capable of measuring 0.1 mL to 500 mL
"Minimum necessary" rule
- when using or disclosing protected health information or when requesting protected health information from another covered entity, a covered entity must make reasonable efforts to limit PHI to the minimum neessary to accomplish the intended purpose, use, disclosure, or request - does not apply to other payment and health care operations (HMOs, 3rd parties)
"qui tam" lawsuits
- whistle-blowers who testify against their employers about Fraud, Waste, and Abuse
Prescription Drug Marketing Act of 1987 (PDMA)
- wholesalers licensed under state law - may not sell, trade or purchase samples or coupons - defines storage, handling, and record-keeping of samples - practitioners must file a written request for samples - prohibits resale of Rx drugs - prohibits re-importation of Rx drugs initially manufactured in the US - retail pharmacies may not have samples - regulates vouchers or coupons for samples
Ensuring Free Choice
- workers meeting certain requirements who cannot afford the coverage provided by their employwer may take whatever funds their employer might have contributed to their insurance and use these resources to help purchase a more affordable plan in the new health insurance exchanges
Specialists assistants may
- write prescriptions for outpatients - write med orders for inpatients - write prescriptions for non-controls - have DEA number and write for scheduale 3-5 - call in oral prescriptions - write prescriptions for needles - dispense medications within their scope
Must the patient information from prescriptions for pseudophed be added to the logbook?
- yes
Adding refills onto the dispensed quantity (STAR rating scenario)
- you *cannot* change the quantity of any Rx without contacting the prescriber, first - both controlled or uncontrolled
Power of attorney on DEA form
- you *must* have it! - owner authorizes order CII - signed by person who signed registration and by person authorized to order - good until revoked
Supervising Pharmacist
- you are responsible for everything, forever (24/7/52) - must be full time (30+ hours/week) or majority of the hours open (if pharmacy is open less than 30hours/week) - federal government does not license individuals, states do; feds do not dictate obligations of SP - if sick, disabled > 30 days, must assign different SP - SP may be liable for actions of others - must inform all personnel verbally *and* in writing - may only supervise one pharmacy
Individual access to PMP
- you can look yourself up in PMP or your legally authorized representatives - subpoena to PMP goes to BNE -> pharmacy does not *own* the BNE
Disposing of Controlled Substances
- you cannot take them back - this would mean the ultimate user is distributing them illegaly - However, an Attorney General may authorized LTC facilities to dispose of controlled substances on behalf of the ultimate user - and, if a person dies while lawfully in possession of a controlled substance, someone else is allowed to dispose of it
acceptable CE...
-contributes to professional practice of pharmacy -meet standards of regulations set by commishoner -may include specific areas in the future -may be in areas that can also contribute to health of public -sponsor of CE must be approved by commishoner
what is the usual EPT Rx written for?
1 gram azithromycin in a single dose
pharmacist CDTM credential requirements
1 year of clinical experience - 1680 hrs w/in 1 year - 15 or more hours per week experience is consultation w/phys. about drug therapy - documented by participating physician at same place as pharmacist
how many internship hours do you need to take part 3 early?
1040 - need to be outside APPE/school requirements - P3s only
when was the drug enforcement agency created?
1973
when did the tampering resistant packaging start and as a result of what?
1982 - tylenol scare
how long after APHA immunization training do you have to become certified?
3 years
when was the orphan drug act put into place and what did it do?
1983 - tax and licensing incentives for rare diseases - 200000 people or less with the disease
when was the comprehensive methamphetamine control act and what did it do?
1996 - 24g threshold for pseudoephedrine
Ratio of full time pharmacy intern to preceptor?
1:1
maximum NP to physician ratio at a location
1:4
two less-common CII drugs
1.) nabilone (Cesamet) [antiemetic] 2.) phenylacetone [precursor of amphetamine or CPC]
when do you get a conditional registration
1. RPHs who havent met requirement 2. RPH who have to show competency 3. conditional registration can not last longer than 1 year 4. cant be renewed or extended 5. extra money, greater than or equal to every 3 yr fee 6. must complete deficiency 7. must complete 1.25 CE/month 8. 6 and 7 need to be done in conditional time frame
A pharmacist may partially fill a CS Rx if:
1.) out of stock situtation (remainder must be supplied in 72 hours) 2.) terminally ill patient (hospice) 3.) Resident in a Residential Health Care Facility - partial fills must still be filled w/i 30 days of the date written - if a CII Rx is written >30 days for hospice patient, patient has *60* days to pick up the partial (yes, even if there is a condition code)= - if a CIII-CV Rx is written, hospice patient has up to 6 months to pick up
how long do you keep medicaid records?
10 yrs
What information *cannot* be modified on a CS Rx?
1.) practitioner's signature or address [address can be *changed*, but it cannot be *added*] 2.) Date 3.) CS name *or* quantity [quantity can be *changed*, but cannot be *added*] 4.) name of ultimate user
how long do you keep medicare part D records?
10 yrs
how long must prescription drug marketing records be kept for?
3 years
what kinds of subjects are used in phase 2 of the drug approval process?
100-300: efficacy - data on diff. doses - safety SEs, toxicity, DIs - pharmacologic effect and PK
what kinds of subjects are present for phase 3?
1000-3000, varied geographics, tested against standard if applicable
how do rxs need to be filed federally?
1. C2s 2. C3-5 (marked w/red C+) and non controls
To sign an eRx, an Electronic Prescribing application must require the prescriber to authenticate 2/3 of the following:
1.) something only the PR *knows* (password or challenge question) 2.) something the PR *is* (biometric data like fingerprint or iris) 3.) Something that the PR *has* (hard token separate from the computer) - the 2-factor system constitutes the signing of the prescription
USP standards categories
1. general notices - general chapters and basic definitions 2. general chapters - those under 1000 are minimum requirements, not goals/guidelines 3. monographs A. documents for bulk drug substances - standards for identity, quality, purity, strength B. documents for specific preparations
medicare part D tiers
1. generics 2. preferred brands 3. non preferred brands 4. high cost meds *drugs can move tiers anytime*
how do prescriptions in NYS need to be filed?
1. non controlled 2. schedule 2 3. schedule 3-5 and controlled
new pregnancy labeling in 3 categories
1. pregnancy 2. Lactation 3. females and males of reproductive potential
Drug Development: *IND*
1.) Investigational New Drug - application submitted to FDA - animal work - new drug/new dosage form
Critical elements on label
1.) Patient name 2.) Direcetions for use 3.) Drug name and strength - must be emphasized by color, bold type, or both and printed in a minimum 12-pt. font
New Pregancy Warnings
1.) Pregnancy: must include potential risk to fetus 2.) Lactation: risk summary 3.) Femals and Males of reproductive potential
Daily Record Requirements
1.) Provide adequate safeguards against improper manipulations or alterations of stored records 2.) arrangements shall be made which assure completeness and continuity of Rx records if the relationship between a pharmacy and a suplier of data processing services terminates for any reason 3.) the system shall provide retrieval of information regarding original dispensing and the refilling of prescriptions
Things unlicesned personnel in the pharmacy can do
1.) hand filled Rxs to the patient or someone acting on behalf of the patient (after counseling requirement) 2.) key prescription data into a computer 3.) receive written or ERxs (RPh or intern must deem ERx acceptable and initial it first) 4.) may get drugs from stock 5.) get Rx files and other records from storage 6.) Handle paper prescriptions 7.) count dosage units (measuring) 8.) affix Rx labels to containers 9.) prepare manual records of dispesing for the initials or signature of the pharmacist 10.) Reconstitution is *not* considered compounding
When receiving a written Rx, the RPh must:
1.) initial or signature the Rx 2.) Date 3.) Record the Rx number (serial number) 4.) Record the brand or generic name (manufacturer) 5.) Record quantity filled (if different than Rx) - may do these electronically - if intern, must be counter-signed by RPh
Graduates of a foreign college of pharmacy must complete how much internship to become licensed? None 3 months 6 months 12 months?
12
how long are patents on biogenerics?
12 years
how long is the exclusivity period for generic companies that make a patent challenge?
180 days
what year was the pure food and drugs act enacted and what does it do?
1906 recognition of USP/NF interstate commerce of adulterated/misbranded products - no regulation of cosmetics, medical devices - no labeling requirements
when was the FDA founded?
1906 - during the passage of the pure food and drug act
what year was the FDCA enacted and what did it do?
1938: creation of FDA drugs had to be proved safe for use regulation of cosmetics, medical devices, color additives proof of fraud no longer needed for false claims or misbranding warning labeling for all habit forming drugs directions for use factory inspections by FDA predistribution clearance FDA authority to obtain injunction for violatoins fast track for new drugs grandfathered drugs
what year was the amendment to the FDCA enacted? what did it do? what was it also known as?
1951: durham humphrey amendment - 2 classes: OTC + legend (cant dispense without an Rx) - oral transmission of rx - refils - minimal labeling requirements: no misleading info, not sold under name of other drugs, labeling for storage, childproof containers, labeling to compendium regulations
what year was the drug abuse control enacted and what did it do?
1965 strict control of abused drugs - stimulants, depressants, hallucinogens
what year was the fair packaging and labeling act enacted?
1966 consumer products need to list net contents, manufacturer, identification of type of product
what year was the FDA bureau of drug abuse control enacted?
1966 control of dangerous drugs
what year was the bureau of narcotics and dangerous drugs enacted and for what?
1968: BNDD stop illegal drug traffic
what year was the control substance act enacted? what did it do?
1970 established 5 schedules of controlled substances
when was the poison prevention packaging law enacted? what did it do?
1970 protection for children - applies to drug products, household substances, OTCs - child resistant - waiver for pharmacies
what year was the over the counter drug review enacted and what did it do?
1972 improved safety and effectiveness for OTCs
what authentication factors must an eRx application have to securely allow the prescriber to make an rx?
2 of the following: something only prescriber knows - password/answer to question something the PR is - biometrics something the PR has - device separate from computer that grants PR entry
LPAs controls rxs
2-5 only can have own DEA number - HAVE to register to prescribe controls
how long do other drugs have for an exclusivity period?
3 years IF criteria is met
hours SP has to work
30 or more hours per week if pharmacy operates less than 30 hours need majority of hours open
NP specialty codes range
30-43
how many and what kind of volunteers for phase 2?
300 have the disease being treated - no comorbidities - no other drugs
The minimum sized area that may be registered as a pharmacy in New York State is: 100 sq ft - this is the minimum size area for the behind the counter dispensing/compounding area 200 sq ft 300 sq ft 500 sq ft?
300 this is the minimum size area for behind the counter dispensing and compounding
refrigerator temps
36-47 F 2-8 C
how many hours do NPs need to practice autonomously?
3600
NYS total CE hours to renew
45 every 3 years
Drug Developement: *Phase 1*
2.) Phase 1 - Drug safety, primarily - 20-80 volunteers, usually *healthy* - find a safe dosage range for drug - pharmacokinetics/pharmacology of the drug
what does patent protection for new drugs consist of?
20 yrs from date of first filing - effective for less than 20 tho
how many and what kind of volunteers for phase 1?
20-80 healthy
what kinds of subjects are used in phase 1?
20-80 healthy ppl short time: less than 2 weeks watch for safety issues
when was the combat methamphetamine epidemic act and what did it do?
2005 - limit sales of PSE, phenylpropanolamine, ephedrine - 3.6 g per day and 9 g per month
when will the donut hole in medicare close?
2020 - seniors pay 25% copay until catastrophic coverage
NYS live CE requirement
23 or more live - teleconferencing - computer course - taped course but need to be interacting with instructor to be live
to what age are children covered until?
26 y/o
how many phases does the OTC review process have?
3
hours of CE required in medication error prevention and safety?
3 - live or home
in a pharmacy when do you need to report fire/flood?
48 hours
how many refills in 6 months are allowed on medicaid rxs?
5
Methadone long term detoxification treatment
30 - 180 days
in a pharmacy when do you need to report change of name or address?
30 days
in a pharmacy when do you need to report change of stockholders?
30 days
Drug Development: *Phase 2*
3.) Phase II - 300 volunteers who have the disease being treated (no co-morbidities, and no other drugs) - efficacy (general success) v effectiveness (what happens to each specific patient?) - dosage range
Methadone clinic after 3 years can take how many doses?
30
medicaid rxs have to be kept for how long?
6 yrs
how long do patients have a right to receive an accounting of PHI for?
6 yrs of disclosures
what requirements are the most extensive elements of the REMS program?
ETASU requirements - required medical interventions in order to prescribe or dispense a particular product
Drug Development: *Phase 3*
4.) Phase III - use dosage range recommended in Phase II to run longer studies - confirm safety and efficacy - discover and list adverse reactions - at the end of Phase III, a "new drug application" is submitted
Board members are appointed for terms of:
5 years
all inventory records are kept for how long?
5 years
how long of an exclusivity period do new chemicals have?
5 years
if a pharmacist is registered as a wholesaler/repacker, how long must records be kept?
5 years
how long do you need to keep hard copies of transferred rxs?
5 years HIPAA says 6 years
how long do you keep BNE records?
5 yrs
how long do you keep NYSBOP records?
5 yrs
how long do you keep rx records?
5 yrs
how long do rx records need to be kept?
5 yrs HIPAA and medicaid say 6 need to be made available for inspection and copying by appropriate authorities
Drug Development: *NDA*
5.) New Drug Application - for new drugs never on the market OR new dosage forms for an exisiting drug entry - must show exhaustive data on drugs, absorption, kinetics, excretion, elimination, effects, etc.
how many years after a pt dies does their PHI not fall under HIPAA?
50 or more
who supports medicaid?
50% federal 50% state
what license for pharmacists or providers is required to compound a drug product?
503A
how long do pediatric drugs have an exclusivity period for?
6 months
how long do you have to keep the notice of privacy pt records?
6 years
how long must all records for orders for drugs or medical supplies be kept for for medicaid?
6 years
length of time to keep CE credit documentation
6 years - need to have ready if SED does audit
how long do you keep HIPAA records?
6 yrs
in a pharmacy when do you need to report auction?
7 days before auction
how long of an exclusivity period do orphan drugs have?
7 years
what is the max amt of a medication that can be dispensed by a PR?
72 hours
What number of pharmacies results in a need to translate to Chinese, Italian, Spanish, and Russian? 2 commonly owned pharmacies 4 commonly owned pharmacies 8 commonly owned pharmacies 10 commonly owned pharmacies?
8
how often does the board of regents meet and what are most of their cases?
8 times/year 80% are consent/surrender orders
iPLEDGE
A drug restricted program dedicated to prevent fetal exposure drugs included in this list are: Claravis-Accutane, Amnesteen, Sotret, Absorica, Zenatane, and Myorisan
what are the pregnancy warnings for drugs?
A: safe for use w/good data B: animal studies: no known ADR, no controlled studies C: animal studies show ADR D: studies demonstrates risk - need risk Vs benefit X: contraindication
where is the application for an IND sent?
FDA
special label warning for alcohol
APAP - 3 or more drinks per day other drugs
what software must be used w/PHA?
ASAP 4.2
Drug Develpment: *ANDA*
Abbreviated New Drug Application - similar to NDA, but not as long or complete - show the drug works the same as the brand name (for generics, mostly)
Schedule B poisons
Aconite, belladonna, cantharides, colchicum, conium cotton root, digitalis, ergot, hellebore, henbane, phytolacca, strophanthus, oil of savin, oil of tansy, veratrum viride and their pharmaceutical preparations, arsenical solutions, carbolic acid, chloroform, creosote, croton oil, white precipitate, methyl or wood alcohol, mineral acids, oxalic acid, paris green, salts of lead, salts of zinc - any drug, chemical or preparation which is liable to be destructive to adult human life in quantities of sixty grains or less.
who regulates prescription items and their advertising?
FDA
what book contains therapeutic equivalency data?
FDA Orange book
internet pharmacies may only sell what kinds of drugs?
FDA approved - risk of counterfeit
Clinical Laboratory Improvement Amendments (CLIA)
FDA approved home tests - tests that have low risk for error dont have to have clinical lab if health professional gives test
what is the process for an investigational new drug?
IND phase 1 phase 2 phase 3 NDA studies market phase 4
where are recalls published?
FDA enforcement report index
midlevel practitioners DEA numbers always start with..
M
what is the reporting site Medwatch for?
FDA safety, information and ADE reporting, risk identification, collects information about marketed products safety alerts about all medical materials, class 1 recalls/withdrawals, drug shortages - dissemination of information to the public
what act did USP/NF come out of?
FDCA
what is anti tampering packaging regulated by?
FDCA
what act designated the USP-NF as the official compendia for drugs marketed in the US?
FDCA: food, drug, cosmetics act
phase 2 agents
BBs alpha agonists direct acting cholinergics prostaglandins carbonic anhydrase inhibitors
who needs to be notified when change in SP?
BOP office of medicaid inspector general
what will be added to RPH license number if CDTM certified?
C w/license number
LPA inpatient orders
C2-C5 and medical orders - employed by institution or extended privilege - care of phys.
if you keep your daily log electronic, what else must you have a log book for?
C3-C5
where do any adverse outcomes from immunizations get reported to?
CDC's vaccine adverse event reporting system
who sets security standards for PHAs?
DEA
what does a midwife certification number start with?
F
what did the generic initiative for value and efficiency do?
GIVE - modernize and streamline generic drug approval process
what is the federal confidentiality rules?
HIPAA
what is the official compendium for homeopathic drugs in the US?
HPUS: homeopathic pharmacopeia of the US
who is known as the founding father of the FDA?
Harvey Wiley - the forerunner
HITECH
Health Information Technology for Economic and Clinical Health Act
HIPAA
Health Insurance Portability and Accountability Act
The current RPh immunization law expires on:
July 1, 2020
when is free language assistance not required?
LEP refuses material already translated into preferred language less than 8 stores in a chain or owned by same person
midlevel practitioners
NP LPA midwives
what do all electronic rxs require of the PR?
NPI number
what does HIPAA require of all health providers?
NPI number
what is NYS confidentiality rules?
NYS regents rules
what are the treatment programs under professional assistance program supervised by?
NYSBOP
what systems do RNs and pharmacists need to access in NYS when immunizing?
NYSIIS CIR
what are exceptions to max 72 hour med supply dispensed by PR?
PRs whose practices are 10 or more miles away from pharmacy dispensing of samples at no charge to pt PRs in hospitals veterinarians dispensing drugs in clinic, infirmary, health service that is operated by a post secondary institution dispensing of drugs in medical emergency dispensing of drugs diluted, reconstituted, compounded by PR dispensing of allergenic extracts dispensing of drugs for oncological/AIDS protocol
who can counsel?
Pharmacist/intern PRs
broad privilege rx authority
Physicians Osteopaths MD specialists - ophthalmologists - MBBS: bachelors in medicine/surgery - MBChB: masters in medicine/surgery
what are the FDA approval types?
S and P
What schedule is soma?
Schedule IV
STEPS
System for Thalidomide Education and Prescribing Safety
what does the NYS substitution law require on NYS prescriptions from outpt. clinics etc?
THIS PRESCRIPTION WILL BE WILLED GENERICALLY UNLESS THE PRESCRIBER WRITES "daw" IN THE BOX BELOW - must be 8 point, uppercase type - immediately below signature line
Optometrists that are able to prescribe are identified by what letter in front of their 6 digit license?
U
optometrist license number certified in Phase 1
U
where are FDA laws enforced?
US DC puerto rico guam virgin islands american samoa US territories
what association monitors meat and poultry?
USDA
what is medmarx used for?
USP, medication error, ADE data, hospitals - voluntary
what is the official compendia?
USP-NF: for drugs marketed in the US
optometrist license number certified in Phase 1 and 2
V
what does HIPAA establish to protect the confidentiality of medical information?
a floor of safeguards
what is a pharmacy primary language?
a language spoken by 1% or more of the US population in a region - not more than 7 in one region
what must pharmacies post in regards to free language assistance program?
a notice that reads: point to your language. language assistance will be provided at no cost to you - in each of the pharmacy primary languages - placed where rxs are dropped off/picked up - near registers - 20 point, bold face arial type, bold font - needs to contrast w/background - each statement in box and 1/4 inch clear space between adjacent boxes
how must medicaid drugs be ordered?
a quantity consistent w/health needs of patient and sound medical practice
what must a pharmacy have in regards to retail price list?
a sign that notifies ppl of list conspicuously posted - drug retail price list available upon request - placed in area where rxs are presented, waiting area, or where rxs are delivered - needs to be on website if pharmacy has one w/toll free number - if mail order, need notice w/each rx and toll free number
open formulary
a system that allows a pharmacy to use an prescribed medications - doesn't have to be approved before it is ordered
who can transmit the rx once the PR has signed it?
agent or employee of the PR
Accreditation Council for Pharmacy Education (ACPE)
accredits: - pharmacy schools - continuing education programs - pharmacists - pharmacy techs
what needs to be on the rx label of a compounded rx?
active ingredient
what does the USP portion of USP-NF stand for?
active ingredients
what needs to be on OTC labels?
active ingredients uses warning inactive ingredients purpose/product category directions for use - age specific
Izzo vs. Manhattan medical group (N.Y 1990)
addict used fake prescription without doctors name on it to get drugs and died
Pregnancy Category A Drugs
adequate and well known studies no risk to fetus cannot rule out harm "use during pregnancy only if clearly needed"
A medication with an unapproved color additive is...
adulterated
when is a new drug application submitted?
after completion of phase 3
when does phase 4 take place?
after drug lands on market
Critical elements of prescription labels include which of the following: Drug name and strength Patient name Directions for use, in full sentences All of the above?
all
Unprofessional conduct also includes: Abandoning the premises of a registered establishment Failure by SP to provide adequate supervision of a pharmacy Aiding and abetting an unlicensed person to dispense drugs All of the above?
all
Unprofessional conduct for pharmacists includes which of the following: Providing MDs with Rx blanks with the pharmacy name Placing in stock a dispensed Rx returned by a patient Failing to make prescription price information available All of the above?
all
all rx drug labels shall contain what elements?
all critical elements all important elements
who must be informed of the free language assistance service?
all employees - given on immediate basis
what needs to be done in regard to employee training and PHI?
all entities must train workforce - in reasonable time frame keep record of training any changes to policies require employee notification/training
when is counseling required in NYS?
all new rxs new pt to pharmacy new dose new strength change in route or directions for use for existing med previously dispensed to pt - has not been treated w/this med in 90 days MATTERS RPH DEEMS SIGNIFICANT
Persons in which of the following professions may transmit an oral RX to a vendor pharmacy? Licensed Practical Nurses Registered Nurses Pharmacists All of the above - anyone licensed in the health profession is allowed to do so?
all of the above
Regarding prescriptions drug prices: The BOP must develop a list of the top 150 drugs every year Every pharmacy must update its current prices weekly Pharmacies must post a sign indicating access to a price list All of the above?
all of the above
Which of the following is not required on the label of a prescription? Pharmacy registration number Pharmacy DEA number Number of refills remaining All of the above?
all of the above
special label warning for sulfites
allergy
what did the NY public health law do?
allowed for EPT
what are authorized generics?
branded company licenses another company to sell generics under original patent
collaborative relationships for NPs
allows NPs to practice autonomously - need to have 3600 hours NP practice experience
what do you need to do when refilling controlled substances?
always go back to original and note refill info
when does impermissible use/disclosure of PHI need to be reported?
always, unless there is proof there is a low probability that PHI has been compromised - need to perform risk assessment
Kefauver-Harris Amendment of 1962
amended FDCA, drug efficacy amendment result of thalidomide given to pregnant women drugs marketed in US must be safe and effective - regulation of advertising - informed consent of research subjects - good manufacturing practices
what is a class 3 recall?
animal excrement or hair in product
what 3 broad areas of information must be included on an IND application?
animal pharmacology/toxicology studies - dont want subjects exposed to large risk manufacturing info - need consistent batches of drug clinical protocols and investigator info
pregnancy category B drugs
animal studies have failed to demonstrate a risk to fetus OR there are no animal reproductive studies and no adequate and well controlled studies in pregnant women "use during pregnancy only if clearly needed"
what constitutes and emergency in pharmacy?
any condition requiring alleviation of severe pain or which threatens to cause disability or take life if not promptly treated
what does FDA fast track do?
enhanced approval process for unmet medical needs - new drugs or enhanced therapy
on what condition can samples be given to hospital pharmacies or other health care entities?
at request of licensed prescriber
what is required of the SP?
awareness of all laws, rules, regs that affect pharmacy and practice within responsible 24/7/52 must have FULL control of pharmacy - employees - registrations - required licenses - ensure compliance - inventory current - pharmacy has all required mats - CS have to be licensed
required pharmacy devices
balance devices to measure 0.1 mL to 500 mL metric weights
when does a prospective drug use review need to be completed?
before rx given to patient - medicaid
what is the FDAs role in labeling?
black box warnings - drugs and medical devices
how is an rx endorsed on the rx form?
brand name of drug or manufacturer date RPH initials (non controlled) rx number
Hatch-Waxman Act of 1984/drug price competition and patent term restoration act
brings generic drugs to market faster - only need to file ANDA allows extension of patent by 5 years if innovative drug generics dont have to perform clinical studies for safety and efficacy
what are the REMS timetables for assessments?
by 18 months, 3 years, and after the 7th year it is approved
how can rx drug sampling be done?
by manufacturer by distributer by mail by representative
how must rxs for controlls be phoned in?
by prescriber directly, in any venue
how must controlled substances be phoned in?
by the prescriber in ANY venue
Regarding syringes and needles: Pharmacists can only dispense upon receipt of a prescription Prescriptions for needles and syringes are not refillable Prescriptions for syringes can be refilled NMT 1 year Can be sold up to 10 under Expanded Syringe Access Program?
can be sold up to 10 under expanded syringe access program
if fail NAPLEX 5 times...
can only retake if have remediation plan
PBM pharmacy audits
cant conduct audit in first 3 calendar days of any month give no later than 15 days notice of upcoming audit limit audit period to 24 months after claim submitted include in written advance of audit the rx numbers in question can use written and verifiable records of PR limit the number of rxs to 100 in a 12 month period except in cases of fraud provide pharmacy w/copy of audit w/in 45 days of audit completion
where are the drug approval applications submitted to ?
center for drug evaluation and research
what needs to be provided to the patient after immunization?
certificate of immunization: - patients name - date of immunization - address of administration - administering pharmacist - immunization - manufacturer - lot #
how do optometrists become certified in phase 2 agents?
certified in phase 1 certified in phase 2 w/in 3 years
what are patients rights w/PHI?
change what is wrong receive accounting of all disclosures from past 6 yrs right to additional privacy restrictions
what is iPledge for?
computer based risk management program for isotretinoin - pharmacies receive authorization from this to dispense to patient
what is a category 1 OTC medication?
condition under which OTC ingredients are generally recognized as safe and effective and are not misbranded
what is a category 2 OTC medication?
conditions under which OTC ingredients are not generally recognized as safe and effective or are misbranded
what is a category 3 OTC medication?
conditions under which the available data are insufficient to permit final classification at this time as category 1 or 2
what is looked for in phase 3?
confirmation of safety and efficacy discovery and list of adverse rxns
what must pharmacists give to pts before vaccinating?
consent form current vaccine information statements have emergency supplies ready have assessed pt for CIs to immunization must give written instructions in event of CIs or ADEs
in order to treat pts w/glaucoma or ocular HTN, optometrists must have had to...
consult w/ophthalmologist - for 3 yrs or - 75 consults
pharmaceutical alternatives
contain same therapeutic agent but differ in salts/esters/forms/strengths
when can a rx be communicated by an employee of the prescribing practitioner?
contemporaneously reduced to writing dispense in conformity with labeling requirements applicable to written Rx make good faith effort to verify employee's identity if unknown to RPH
what act does the DEA enforce controlled substances with?
controlled substance act 21
translation
conversion of written text from one language to pts preferred language by an individual competent to do so - still need to use pharmaceutical and health related terminology
where can patients file complaints?
covered entity - W/O RETALIATION office of civil rights
Durham-Humphrey Amendment
created OTC class and Rx (legend) class
how often must the PHA back up rxs?
daily
what is the federal register?
daily publication for rules, proposed rules and notices of federal agencies and organizations as well as executive orders and other presidential documents
Medical Device Act of 1976
dangerous or useless medical devices testing and reporting requirements of devices divided devices into 3 classes
CE records need to contain...
date + location provider name + ID # program title number of hours earned proof of attendance
when refilling what must an RPH indicate on the reverse of the original rx?
date of refill time of refill initials/signature of RPH amt. dispensed if different name of PR authorizing refill include number of refills
medicaid verbal rxs must be..
dated initialed/signed by RPH that took it at time of call initialed/signed by RPH that dispensed
broad privilege but w/in scope rx authority
dentist vet podiatrist
what department promulgates HIPAA?
department of health and human services
what department is the DEA associated with?
department of justice
when does the minimum necessary not apply?
disclosures made to or by request by another healthcare provider for the treatment of the patient to the patient for treatment, payment or healthcare operations pursuant to a patient authorization to HHS when required for compliance reasons as required by law
serial number "DDDD..."
dispensed as medically necessary in the pharmacy during state of emergency
what does ASAP 4.2 do?
distinguishes between when rx was filled and when it was picked up
what is the center for drug evaluation and research?
division of FDA determines if the product is suitable for use in clinical trials
what is the required CDTM documentation from pharmacists?
document in pt record any changes to pts therapy notify pts order treating PR
what do biogenerics need to have in order to be approved?
documentation of clinical proof and safety + efficacy - immunogenicity + post market pharmacovigilance
what should RPH do if generic is out of stock/unavailable?
dont fill order more/borrow some can dispense brand at a price that would not exceed price of generic had it been available
what is determined in phase 2?
dosage range efficacy vs effectiveness safety
what is required to be included on price posting?
drug brand name generic name strength dosage form price of a quantity all charges to pt - cost of drug - RPH fee - handling fee
what does OBRA 90 look at?
drug over/underutilization therapeutic appropriateness appropriate use of generics retrospective drug review after drug is dispensed
primary purpose of phase 1
drug safety - want safe dosage range
pure food and drug act of 1906
drugs could not be distributed through interstate commerce if misbranded or adulterated
what drugs are legend drugs?
drugs intended for human use that are: -hypnotic or habit forming -not safe for self medication - new drugs
Orphan Drug Act of 1983
drugs that treat diseases of few people - <200,000 ppl w/disease tax and licensing breaks for manufacturers
what is a tier 3 HIPAA violation and 2019 max fine?
due to willful neglect that is timely corrected $250,000
what is the purpose of a communication plan with REMS?
educates, informs, raises awareness of risk - healthcare providers - professional societies
what is ISMP for?
education of the healthcare community and consumers - error reporting - newsletters - resources: high alert med list + error prone abbreviations
pregnancy category C drugs
either animal studies have shown ADEs on fetus OR there are no animal reproductive studies and no adequate well controlled studies on pregnant women "use in pregnancy only if potential benefits justifies the potential risk to fetus"
Who does Medicare cover?
elderly end stage renal disease
serial number of "EEEE.."
electronic
LPA electronic rx
electronic signature of LPA name, address, phone of super. phys.
what needs to be done for an electronic daily log to ensure that it is an accurate record?
electronically sign or initial it
what can written Rxs not have as a signature?
electronically signed by prescriber - all need to be signed
how are all the critical elements shown on the drug label?
emphasized by color highlight, bolded or both printed in minimum 12 point font
what did the drug price competition and patent term restoration act do?
encourages development of generics - evergreening
what is the mission of the DEA?
enforce controlled substance laws and regulations bring to the criminal and civil justice system those who are involved in illicit trafficking of controlled substances recommend and support non enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets
USP chapters under 1000 are...
enforceable by regulators and accreditation organizations - NYS board PARTIAL COMPLIANCE IS NOT ACCEPTABLE
what does FDA accelerated approvals do?
enhanced approval process but requires long term outcomes and benefits
pharmacists can immunize for...
flu pneumococcal acute herpes zoster meningococcal tetanus diptheria pertussis
When a pharmacy in another state wishes to register in NYS, the pharmacy must: Follow NYS dispensing limits for controlled substances Require its supervising pharmacist to become licensed in NYS - this is required for outsourcing facilities not just regular pharmacies Is not required to offer patient counseling Is not required to have a toll-free telephone number?
follow NYS dispensing limits for controlled substances
medicaid and plan B non rx drugs
for 17 + no rx needed - prescriber can be left off and claim still processed up to 6 courses in 12 month period
medicaid and plan B rx
for less than 17 y/o need PRs license number serial number on rx must counsel if new
what can optometrists prescribe?
for topical application to surface of the eye only - w/in scope
how must rxs be transferred?
from RPH to RPH orally written electronically
class 2 medical device
general controls are not enough must meet specific safety, effectiveness, performance b4 marketing -insulin pens, pumps, syringes, diagnostic tools, tampons (toxic shock), heating pads
computer generated Rxs okay if...
generated at time rx is filled out by physician
what should be known about generics when patents for a certain drug are in place?
generics can only be marketed if a patent has expired or has never been patented - generic maker has to make sure that the patent is invalid or will not be infringed upon
all medications in nursing homes must be in writing unless...
given to licensed nurse or RPH must be countersigned by PR w/in 48 hours - if not then order must be terminated
what products are exempt from expiration dating?
homeopathic products
what does HIPAA allow pts do do with their shit?
how info is used who it is sent to pts can correct mistakes pts can look at the info pts can get a copy of the info
drugs approved for vet use by FDA are not approved for...
human use vice versa
when would a REMS be required before approval of a drug?
if FDA determines REMS is necessary to ensure the benefits outweigh risks of the drug
when do you not put all of the required items on the rx label?
if PR requests in handwriting not to
misbranding
if any word, statement or other info required is not prominent on label labeling is false or misleading does not list: active ingredient, precautions, adequate directions
Generic Drug Enforcement Act of 1992
if convicted of felony: - cant participate in drug approval process - individuals and entities severe penalties imposed for: - failing to disclose material facts - bribery - false statements
under what conditions can an rx be transferred?
if expressly requested and approved by pt or person authorized to act on behalf of pt. one at a time not all at once non controls only
adulteration
if in whole or part filthy, putrid, decomposed substances packed in unsanitary conditions contaminated container is unsanitary container has poisonous or deleterious substances unsafe color additive drug has differing standards than official compendia product combined w/others that reduces quality/strength
where do RPHs sign/initial Rx?
if intern, need both RPH and intern's initials/signature on FACE/front of Rx
medicaid emergency supply of brand name/non preferred drug and how much?
if prior auth. not obtained by PR and pharmacist or can't reach PR, pharmacist can dispense 72 hours worth of brand name or non preferred drug
can you fill foreign rxs?
if rx is for same drug, strength, formulation in US - no substitutions
when do you not need to pull paper rxs for refills?
if scanned in - if not, must pull
what must RPH document on an oral/verbal rx?
if substitution was permitted or not
when would a REMS be required for post-approval for a drug?
if the FDA becomes aware of new safety information and determines if REMS needed to ensure benefits are more than risks
when can you not use the alternative licensing option?
if you have already sat for the NYS part 3
when do you not need to pull the original paper rx?
if you scanned and can see the original
what were the reasons for implementing HIPAA HITECH
impermissible uses/disclosures lack of safeguards lack of pt access to PHI minimum necessary rule violations lack of valid authorization for use of PHI when one is required
what must the covered entity do when disclosing PHI?
implement policies and procedures that limit PHI disclosed to amt. reasonably necessary to achieve the purpose develop criteria to limit request of PHI to whats resonable
LPA written rx non controlled signing
imprinted/stamped name of supervising phys. imprinted LPA name signed LPA name - names w/P.A. or LPA behind it registration number
serial number "TTT..."
in need of a new Rx number
what must all drugs present to the FDA regardless of rating?
in vitro bioequivalence standards acceptable to FDA
what does the NF portion of USP-NF stand for?
inactive ingredients
what are the only options to write rxs with?
indelible pencil ink typewritten
what is the institutional review board?
independent ethics committee - approve, require modification, disapprove research, assures rights are protected
package insert from manufacturer contain what
index of contents patient counseling info high lights section - summary of indications, dosages, BBWs federal caution statement description of drug clinical pharmacology indications CIs precautions adverse rxns overdose info
NPIs w/entity type code 1...
individual healthcare providers - pharmacists
what needs to happen if there is a PHI breach affecting less than 500 ppl?
individuals sent notice in written form - 1st class mail or email if requested - description of type of info, steps to correct - needs to be w/in 60 days of breach discovery notify secretary of HHS no later than 60 days after the end of the calendar year from when the breach happened
labeling by manufacturer
info in bottle or packaging of bottle including package insert
what must a pharmacist do when receiving a written RX?
initial/signature - if intern, countersign by RPH date rx number/serial number brand/generic manufacturer quantity: if different from original
when does the NYS substitution law not apply?
inpatient med order phone order not required federally
Safe Medical Devices Act of 1990
institutions must report problems with devices to FDA
competent oral interpretation
interpreter understands the message and has to re-express it accurately using pharmaceutical and health related terminology
what is an IND?
investigational new drug
what is the pharmacopeial forum for?
journal for public review of revisions to published standards
the current immunization law expires...
july 1st, 2020
what does a pharmacist need to do with regards to anaphylaxis?
keep a record of all persons administered anaphylaxis treatment to keep info in pt profile contact 911 and PCP of patient
what must a hospital pharmacy do with PRs written requests for drug samples?
keep em
what act did good manufacturing practices come out of?
kefauver harris
what are administrative warnings?
letter issued by OPD for minor/technical misconduct not disciplinary action confidential, cant be divulged to anyone
in order to fill rx remotely/checking remotely...
licensed in NYS
NYS medicaid only enrolls...
licensed practitioners
when using or disclosing PHI a covered entity must make reasonable efforts to do what?
limit PHI usage to the minimum necessary to accomplish the task
if business associates use PHI what must they do?
list PHI allowed to use and disclose need a contract make assurances to covered entity on safeguarding of PHI must return/destroy all PHI upon termination of contract - or can extend provisions
Positive formulary
list of drugs that MAY be generically substituted based on bioavailability data - subsitution is limited to medications contained on a specific list
what is the FDA purple book?
lists biological products licensed by FDA - biosimilars - interchangeable biological products
rules
made by government agencies to further fine tune the laws and regulations or to pass something stat
what is the purpose of a prospective drug use review?
make sure all meds for medicaid pts are necessary, appropriate, and unlikely to result in ADE
expiration date on rxs dispensed in community pharmacy
manufacturer expiration or 1 year - whichever is less from date of dispensing
who has the authority to initiate a recall?
manufacturers only - if they dont then take legal action or seizure or injuction (prevention of manufacturing)
what is an abbreviated new drug application and the difference being?
me too drugs: encouragement of generics to be made - generics: same active ingredient, dose form, route of administration, strength, show bioequivalence clinical and efficacy studies are not required
what is medicare part C?
medicare managed care - possibly lower cost/more services
what is contained in a REMS for an NDA/BLA vs an ANDA?
medication guide/package insert, communication plan, ETASU, implementation system - NDA/BLA medication guide, ETASU, implementation system - ANDA
what products are included under the USP-NF?
medicines - generic drugs too medical devices excipients dietary supplements
midwifery
mgmt of normal pregnancies mgmt childbirth/postpartum care - up to 28 days after
violation of committee proceeding
more serious misconduct - several violations - severe violation constitutes disciplinary action creates disciplinary hx matter of public record but not published online
when deciding which law to abide by which do you pick? federal vs state?
more stringent - generally NYS
how many ppl vaccinated by pharmacists since 2009?
more than 1,000,000
what is a class 1 recall?
most serious - label mix up or defective product - notify all patients who received the product
what brand name drugs can be electronically transmitted w/medicaid
multi source, with an A rated generic
what if the pharmacist needs to add an annotation to an eRx?
must add it electronically - want a PHA that does this and retains the annotations
OSHA and vaccinations
must follow federal guidelines on giving shots in any setting must have policy and procedures - sanitary area - exposure plan - exposure control
medicaid eligible PRs
must have authority to prescribe in NYS must have NPI number - on file w/medicaid enrolled in medicaid fee for service programs, medicaid managed care, family health plan
patient immunization consent
must have pts. consent to immunize them after informing them about the vaccine - verbally - in existing consent form - consent form on NYSIIS - language from NYSIIS consent form
what if a pt doesnt have a PCP when immunized?
must provide info on why you should in a form developed by commissioner of health
what needs to be contained on a pts. medication profile in NYS?
name address phone # gender DOB allergies chronic diseases disease states comprehensive list of meds (RX + OTC) relavant devices
what needs to be on the documented request by the PR to get samples?
name address professional designation signature identity of drug sample quantity of drug sample name of manufacturer sample date of request recipient needs to execute written receipt
what needs to be included on optometrists written Rxs?
name license # U or V office address/phone
how is an rx endorsed on the rx label?
name strength manufacturer/distributer
what must rxs from midwives contain?
name of MW office address phone # needs to say midwife/midwifery certification number: starts w/F
what needs to be brought up during counseling?
name of drug dosage form dosage route duration of therapy refill info directions/precautions technique for self-monitoring storage missed dose info common/severe ADE interactions - CIs and what action needs to be taken
what does the RPH giving the transfer have to record?
name of pt the fact that refil of the rx has been transferred name/address/phone # of pharmacy to which it was transferred name of RPH transferring date of transfer RPH receving
manufacturers labels are misbranded if what is not present on label?
name of substance quantity
what doesnt need to be on an EPT Rx?
name, address, DOB of partner
what is required on a vet legend drug label?
name/address of owner species of animal name of vet directions for use caution statements
what is the US adopted names council and what is their criteria?
names new drugs names need to be: - short, distinctive - cant be confused w/others - provide for distinctive drug category
who does NABP report discipline to?
national practitioner data bank
what details need to be uncovered to determine if PHI has been compromised?
nature/extent of PHI - types of identifiers who received and accessed potential that PHI was viewed or acquired extent to which the risk was mitigated
if the SP is sick/disabled for more than 30 days what happens?
need new SP
how long are medicaid rxs good for?
need to be filled w/in 60 days
how are daily records of rxs filled/refilled maintained?
need to be in a ready retrievable form
CLIA in NYS in pharmacies
need to have medical director need to have collaborative agreement
restoration of revocated license
need to wait more than 3 years to apply for restoration
what is the IND application incorporated into?
new drug application
what constitutes an IND application?
new drug/new dosage form
what constitutes a new drug application?
new drugs never on market new dosage form for existing drug entity for brand name drugs
what is a supplemental new drug application?
new information about already approved products - change in formulation or new written information
FDA approval type P
new innovative drugs not on the market
when is communication w/PR not required w/biosimilars?
no FDA approved interchangeable biologic for one prescribed refill is not changed from the product previously dispensed
can drugs in the redispensing program be sold?
no but processing fees can be charged
how are all the important elements shown on the drug label?
no highlighting or bolding legible not presented in a fashion that will undermine the emphasis of critical elements
what does a rating of AA, AN, AO, AP, AT indicate?
no known or suspected bioequivalence probs
rx must be reduced to writing/electronic in how long?
no later than 72 hours
how many LPA and RSA can be employed/supervised in a private practice?
no more than 4 LPA no more than 2 RSA
how many LPA and RSA can be employed/supervised in hospital?
no more than 6 LPA or RSA
can 90 days supply be given upon pt request?
no unless PR authorizes
items not required on rx label
number of refills pharmacists initials MDD pharmacy's DEA prescriber's DEA lot numbers zip codes
how are rxs filed?
numerical form or another that allows ready retrieval
what is an investigator IND?
off label use that is physician initiated generally
unacceptable medicaid practice is contrary to...
official rules and regs of department published fees, rates, claims, procedures of department official rules and regs of department of health, education and mental hygiene regulations of federal department of health and human services under the federal social security act
When transmitting a prescription electronically, each prescription form may be for: One prescription Two prescriptions Three prescriptions The law is silent on this issue?
one Rx
each page of FAX or fiscal order w/medicaid can only include... with the exception of...
one drug nursing homes
A prescription for a non-controlled substance includes a refill instruction of "prn" allowing: No refills One refill Up to 5 refills in 6 months Sufficient refills for one year?
one refill
written rx requirements
patients name complete address - if not on file age - if not on file date written drug name strength quantity directions prescriber's name (stamp) prescriber's address prescriber's phone profession registration number prescriber's signature
who can file a complaint about PHI issues?
patients or non patients
what is a tier 1 HIPAA violation and 2019 max fine?
person didnt know that the person violated the provision $25,000
what defines a business associate?
person who acts on behalf of the covered entity but other than in the capacity of a member of the workforce of the entity
what is required during flu season at article 28 facilities?
personnel not vaccinated against flu wear surgical or procedure mask where pts are present - paid and unpaid staff - not family members of pts need to document % of personnel vaccinated - provide to DOH upon request
what must the covered entity must identify when using PHI?
persons in workforce who need to access it to carry out duties what categories of PHI they need to use under what conditions
bioequivalent
pharmaceutically equivalent products that display comparable bioavailability when studied under similar experimental conditions
what is the limited english proficiency requirement?
pharmacies need to provide access to free and competent oral interpretation services - face to face - verbally - phone who requests it or has rx for it in the LEP's preferred language - for counseling + filling rxs
who is responsible for info on rx blank?
pharmacist prescriber
Which of the following are not required to take courses in child abuse reporting? Pharmacists Chiropractors Registered Nurses Optometrists?
pharmacists
who is allowed to dispense medications?
pharmacists pharmacy interns under supervision anyone who is allowed to prescribe meds may dispense drugs - includes samples of those meds
what is required on a rx label?
pharmacy info - name - address patient info - name - address: city + state too name of PR date filled Rx number directions for use any caution/warnings identification of drug strength of drug manufacturer/distributer expiration date
what are the important elements of drug labels?
pharmacy info: - name - address - phone patient's address name of PR date of filling/refilling Rx number
when are control standards figured out in the drug approval process?
phase 2+3 - randomized clinical trials - single blind vs double blind
which phase (2 or 3) has longer studies?
phase 3
drug categories optometrists can be certified in
phase one phase two
special label warning for aspartame
phenylketonuria
serial number of "9999..."
phone stuff pharmacy dispensing
what providers can provide a specific order for flu vaccine?
physician NP PA ophthamologist
faxed rxs or fiscal order for medicaid must include...
physician stamp/signature on ONYSRx
who can use EPT?
physicians midwives PAs NPs
STARK law and pharmacies
physicians cant send pts to certain pharmacy unless pt requests it physicians cant own or have ownership in a pharmacy
consent/surrender order
plea to charges and pay penalty application to surrender license person is in inactive status cant practice ANYWHERE sent to board of regents - create public record
what must pharmacists have in place for patient complaints?
policy and procedure for documentation - complaint policy - complaint form - no time frame but if set in policy, need to abide by it
who does medicaid cover?
poor disabled
pregnancy category D drugs
positive evidence of fetal risk exists based on data from investigational/marketing experience/studies in humans - potential benefits in life threatening or serious diseases for which a safer drug cannot be used
what is encompassed within REMS?
post market drug safety drugs/biologics that have been identified to pose a risk medication guide: provided with each prescription communication plan for healthcare providers
only who can send rxs electronically?
practitioners
class 3 medical device
pre market approval b/c life supporting/sustaining may cause unreasonable risks - pacemakers, soft contact lenses, replacement heart valves
when was the medical device amendments created and what did they do?
pre market approval, recording, reporting
why is federal law taken over state? (which clause)
preemptive doctrine
special label warning for mineral oil
pregnancy
new pregnancy labeling category 1
pregnancy - provide info relevant to use of drug in pregnant women: dosing and potential risks to fetus - include if any registry exists and is maintaining data on use in pregnancy - sections on: risk summary, clinical considerations, data
what can CDTM pharmacists not do?
prescribe pain medication change pts. meds if PCP says no
medicaid brand requests requirements for all written rxs
prescriber writes in own handwriting on face of rx: - brand necessary - brand medically necessary - DAW in box on rx no pre printed statements no abbreviations
who can phone in non controlled rxs?
prescriber's agent
CDTM activities allowed by pharmacists w/in a protocol
prescribing in order to adjust or manage medication regimen ordering disease state lab tests ordering or performing routine patient monitoring fxns
what is the controlled substance act 21?
prevent diversion of controlled substances and drug abuse
STARK law
prevents physicians from referring medicaid/medicare patients to a medical service provider that has a financial interest
if dispensing brand drug due to unavailability of generic, at what price must it be dispensed at?
price that would not exceed price of generic had it been available
what are the FDA enhanced approval types?
priority reviews fast track breakthrough therapy accelerated approvals
what needs to be in place in the event of a computer crash in the pharmacy?
procedure for documentation of all new rxs and refilled rxs dispensed during downtime - shall provide for re-entering into computer when back up
what needs to be available for a patient to file a PHI complaint?
process to do it in a pharmacy process to file a complaint to OCR need to hand them out and be in plain language that patient can understand
what is a biosimilar?
product is biosimilar if it is "highly similar" to an already approved biologics product in terms of safety, purity, potency manufactured from cellular based technologies using gene expression interchangeable biological product - if deemed ok by FDA find these in purple book
what is the professional assistance program?
professionals who are addicted to chemicals often an alternative to professional discipline
what is the mission of the FDA regarding drugs?
promote and protect public health by helping safe and effective products reach the market in a timely manner, monitor products for continued safety after use and get the public accurate science based information - protect from products that are not safe, pure or ineffective
what does HIPAA do?
protects individually identifiable health info - protected health information sets sets limits on disclosure of PHI institutes safeguards to secure PHI holds all covered entities accountable and responsible for safeguarding PHI gives pts control of PHI - how their info is used - who it is sent to - correct mistakes - examine info and get copy
what requirements do daily rx records need to meet?
provide adequate safeguards against alterations of records arrangements to assure completeness/continuity of rx records if relationship between pharmacy and data supplier terminates system shall provide retrieval of info regarding original dispensing and refilling of rxs
what is EPT?
provides chlamydia trachomatis pts. w/ABX or ONYSRx for ABX to be delivered to partner
when do patients not have a right to access health records?
psychotherapy notes inmates information compiled in a criminal investigation/lawsuit
what patients should EPT not be used for?
pts w/co-infection of gonorrhea/syphilis
what will becoming a certified immunizer do to your license number?
put "I" next to it
what dosage range is used in phase 3?
range developed in phase 2
in what form does a pts. medication profile need to be kept in and for how long?
readily retrievable form 5 yrs after most recent entry
FDA Amendments Act of 2007
reauthorized/amended many drugs and devices provisions set to expire increased FDA responsibility to regulate drug safety - mandated label changes - clinical trial data reporting and registries - post market studies
FDA reauthorization act of 2017
reauthorizes FDAs authority to collect user fees from makers of Rx drugs, medical devices, generic drugs, biosimilars to support agency in review of new drugs, devices, biologicals - expedited review - supports guidance to biosimilar makers
what can unlicensed personnel NOT do?
receive oral Rxs from practitioners interpret rxs for therapeutic requirements determine therapeutic equivalency weigh, compound, mix ingredients sign or initial any dispensing records counsel pts for any type of drug/device
chemical diversion and control act 1988
record keeping on certain chemicals/precursors imported and exported
what must RPH do if dispensed substituted drug due to emergency?
record on back of Rx: date time nature of emergency
what are ETASU requirements intended for? and how is it applied?
reduce specific serious risk listed in the labeling of the drug - prescribers have specific training/experience/certifications - specially certified pharmacies - drugs dispensed with evidence of safe use conditions - each patient is subject to monitoring - each patient enrolled in registry
what needs to be done in order to refill written/oral rxs?
refilling has been authorized by PR in original Rx or oral order RPHs must not refill unless refills are indicated
NP need to be...
registered and currently licensed in NYS certified by state education dep.
what does the NYS medicaid inspector general require of supervising RPHs?
registration separately w/medicaid - notify medicaid
Nutrition Labeling and Education Act of 1990 (NLEA) dietary supplement act of 1992 (DSA) dietary supplement health and education act of 1993 (DSHEA)
regulate health claims for non drug - manufacturers need to have it classified as a drug OR - get approval for those claims OR - remove claims OR - take off market supplements diet supplements herbals foods defined drug same as before
drug marketing act of 1987
regulates sampling of rx drugs and coupons distributed for rx drugs prohibited counterfeiting of these
what are drug regulations and standards for?
regulation of: - food - drugs - medical devices - cosmetics - vaccines - blood - biologics - radiation emitting devices - animal/veterinary - tobacco
NP modernization act
removed required collaborative agreement and now allows for collaborative relationships for experienced NPs
drug retail price list
replaces price poster 150 most frequently prescribed drugs and their usual doses current selling price
DEA form 106
report of theft or loss of controlled substances
what should be done if there is a suspected fetal exposure to celgene?
report to MEDWATCH + celgene corporation
social service law
requires medicaid providers develop and implement compliance programs to detect fraud, waste, abuse in medicaid program
Physician Payment Sunshine Act
requires reporting of non trivial payments made by manufacturers to group organizations to department of health and human services - website lists names and payments
what is the federal caution statement for legend drugs?
requires: - "prescription legend" - "CAUTION: federal law prohibits dispensing w/o rx" or "Rx Only"
alternative licensing
residency program approved by NYSED/NYSBOP certificate of completion of pharmacy practice residency competencies
what is a privacy officer?
responsible for development and implementation of the policies and procedure contact person to handle complaints in the company well versed in HIPAA and other privacy shit must be at a lvl that can implement change
Drug Efficacy Study Implementation (DESI) 1968
resulted from kefauver harris looked at drugs marketed b4 1962 to see if safe and effective - ongoing - medicaid and insurance companies look at these for drug reimbursement
Federal Food, Drug, and Cosmetic Act of 1938
resulted from ppl dying in europe from diethylene glycol as solvent in cough syrup drug - has to be listed in USP/NF - drug defined as intended for use in diagnosis, cure, treatment, prevention of disease in ppl or animals - drug further defined as intended to affect structure/fxn of the body of ppl or animals counterfeit drugs: falsely claim to be another product on US market food - anything used for food/drinks by ppl or animals - anything that goes into food - chewing gum cosmetics - anything applied to human body - any component of cosmetics devices - need to be listed in USP/NF - same definition as drug but DOES NOT ACHIEVE PRIMARY INTENDED PURPOSE THROUGH CHEMICAL ACTION misbranding + adulteration - cosmetics, devices, drugs
what year was the kefauver harris amendment enacted and what did it do?
resulted from the thalidomide event in europe - birth defects safety and efficacy: drug efficacy amendment FDA jurisdiction over drug advertising clinical research informed consent CGMP
any rx that is created, signed, transmitted, received electronically, and all records related to that rx will be...
retained electronically readily retrievable easily readable in a format that is readable
what must the act of transmission be independent of?
review and signature process
special label warning for ASA
reyes syndrome
what is REMS?
risk evaluation and mitigation strategy: may be needed for approval of a new drug or even older drug from the manufacturer - provisions to assure that drug benefits outweigh the risk + manage known or potential serious risks with medications or biologic agents
unused prescription donation and redispensing program
rx drugs redispensed this way shall be inspected by licensed healthcare provider or pharmacist
what do the daily records of rxs need to clearly indicate?
rx number PR who ordered patient's name signature/initials of RPH who filled/refilled
when can white rx blanks be accepted?
rxs from out of state clinics/hospitals on federal land - VA - reservations - bases
what waivers allow PRs to write for non CS or CS rxs not electronically?
rxs w/complicated instructions - longer than 140 characters compounded rxs w/2 or more products - also infusions w/2 or more products rx requiring additional attachment by FDA approved protocols under EPT approved protocols under collaborative drug mgmt public health emergency that would allow non patient specific rx approved research protocol non patient specific rx for opioid antagonist PR to pharmacist serving as vendor for pts in nursing homes
what is phase 3 of drug approval process?
safety and effectiveness
what labeling requirements do dispensing practitioners have?
same
what needs to be the same to be considered a pharmaceutical equivalent?
same active ingredient same dosage form same strength same route
what needs to be recorded of all pts immunized at the pharmacy?
same as certificate handed to patients
how does a student pharmacist become an immunizer?
same but they will have intern permit
sherman antitrust act 1890
section 1 - unlawful contract, combination, conspiracy to restraint of trade - prohibits competitors from getting into agreements to reduce competition - conspiring to drop 3rd party plan or set prices section 2 - prohibits monopolies, attempts to, conspiracies to
what do rx forms and eRxs include in regards to LEP individuals?
section where PRs may indicate this
fax or fiscal order w/medicaid must originate from...
secure/unblocked fax #
what must computer type written rxs have?
security touch feature bar code serial number
robinson patman act
seller cant discriminate in price between purchasers of like products when the effect of discrimination injures the competition - unless cost justified w/large quantity discounts preferential or differential pricing
Durham-Humphrey Amendment of 1951
selling drug w/o Rx makes it misbranded two classes of drugs - legend: only w/Rx - drugs sold w/o rx: non legend, OTC, unrestricted legality of filling oral order to dispense meds legality of refilled rxs
what needs to happen if there is a PHI breach affecting more than 500 ppl?
send individual notice media notice: prominent ones notify secretary of HHS w/in 60 days of discovery of breach
accountability and recordkeeping of hospital pharmacy's outpatient and retail services must be kept...
separate
where do drug samples need to be kept in a hospital pharmacy?
separate from all other pharmacy stock
criteria for investigational drug use
serious or life threatening disease no comparable alternative drug is under investigation for that condition sponsor is actively pursuing approval serious disease: sufficient evidence of safety/effectiveness life threatening: there is reasonable basis that it may be effective and would not expose pts to unreasonable risk
what is a treatment IND?
serious or life threatening disease or condition - time is of the essence
what kinds of risks are REMS required for?
serious risks that are documented on a drug's label
prescription drug user fee act of 1992
shorten review time of new products coming to market charges manufacturers a fee which is used to hire more reviewers
when can drugs not be used in redispensing program?
show evidence of being misbranded/adulterated evidence of the packaging being tampered with will expire before use by the patient based on PR's directions for use excluded from the program under commissioner regulations REMS program drug
everything with a verbal rx is the same as written except...
signature of prescriber
what do RPHs need to do when receiving an oral/verbal Rx?
signature/initials of receiving RPH Rx number date time who phoned it in signature/initials of RPH who filled it substitution law requirements
anything handed to patient must be...
signed by practitioner
FDA approval type S
similar drugs to ones on market
what factors are considered when determining need for REMS?
size of population that will use the drug seriousness of the disease the drug is treating expected benefit of the drug expected duration of treatment seriousness of known/potential ADEs whether the drug is new
drugs rated "AN"
solutions and powders for aerosolization no known or suspected bioequivalence problems
caregiver identified as...
someone acting on behalf of the pt - be sure they understand this
what does the vaccines for children program do?
specific guidelines for reimbursement
what is required on all immunization orders?
specific immunization agents that pharmacist can administer, indication, dose, route name, license number, signature of who issued it
what is the difference between the sponsor and the investigator in a drug trial?
sponsor oversees process for safety and efficacy investigator is directly involved with the subject and gets informed consent - conducted according to plan, aligns with goals, protects welfare of patients and control of drug product - reports to sponsor
all rxs dispensed in NYS must include...
standardized patient centered data elements - critical - important
who enforces HIPAA and HITECH?
state attorney general offices
The body that determines disciplinary penalties is: The State Board of Pharmacy The State Board of Regents The Commissioner of Education The Office of the Professions?
state board of regents
oversight of the health profession rests w/which of the following authorities? The Governor's Office The State Health Department The State Education Department The State Attorney General
state education department
what determines if OBRA applies to all patients or just medicaid patients?
states determine this
who licenses individuals: federal or state?
states do
FDCA Rx writing
states have authority to determine which licenses can prescribe drugs
USP 797
sterile compounding
FDA Modernization Act of 1997
streamlined ADR reporting regulates suburban products regulates medical devices and nutritional products Rx only legend misbranded if not present or present and not required
dandamudi vs tisch
struck down law that prevented nonimmigrants from obtaining pharmacy licenses
Pregnancy Category X drugs
studies in animals or humans have demonstrated fetal risk and the risks outweigh any benefits "may cause fetal harm when given to a pregnant woman"
what is steps for?
system for thalidomide education and prescribing safety - celgene - registration: BC, pregnancy testing, informed consent
What is a Notice of Privacy Practices?
tells how entity is going to use PHI - in and out of pharmacy describe your legal obligation under HIPAA to secure and protect PHI gives pt the right to review and amend his/her PHI w/provider - ask for copy tells pt his/her rights
what is a class 2 recall?
temporary, generally reversible - not enough active ingredient in the product
only who can electronically sign and review an rx?
the PR
bioavailability
the rate and extent to which the active ingredient is absorbed from a drug product and becomes available at the site of drug action to produce its effect
obra 90 which includes screening, reviewing, evaluating rxs for potential drug problems due to
therapeutic duplication DDIs OTC interactions incorrect dose incorrect duplication of therapy drug allergy interactions clinical abuse/misuse
what kind of "equivalent" do drugs need to be in order to be substituted?
therapeutically equivalent
drugs rated "A"
therapeutically equivalent to each other not considered to have any difference
what does the NLEA/DSA/DSHEA require manufacturers to place on the label if a non drug?
this statement has not been evaluated by the FDA. this product is not intended to diagnose, treat, cure, or prevent any disease
what is the mission of the FDA regarding labeling?
truthful and usable information that assists consumers in making healthy, safe decisions when using the product
how often do temperature readings need to be taken of vaccine storage and where do they get reported?
twice daily NYSIIS temp log on biweekly basis
The NY Board of Pharmacy must have at least how many public members? 1, 2, 5, 7?
two
LEP individual
unable to speak, read, write english at a level that permits understanding of health-related pharmaceutical info communicated in english
rules for pharmacy intern immunization
under immediate supervision of certified pharmacist all records must be counter signed by certified pharmacist must ask pt if its ok for student to do it
what are the PHA application requirements?
verify PR's digital signature read + retain PR's full DEA read + retain institution's full DEA + PR's internal code allow addition of # of units/volume of dispensed drug allow addition of date dispensed name/initials of person who dispensed retrieve controlled Rxs by practitioner name, patient name, drug name, date dispensed able to download data into spreadsheet back up Rxs daily
what are the exceptions to electronic prescribing?
vets out of state federal institutions waivers technology/electrical failure PR determines patient wouldn't get meds fast enough to prevent impacted health if the PR prescribes less than 25 rxs/year
what is a tier 2 HIPAA violation and 2019 max fine?
violation was due to reasonable cause and not willful neglect $100,000
when do immunizations need to be reported to NYSIIS by?
w/in 14 days
LPA inpt. countersign by...
w/in 24 hours responsibility of hospital
when do you have to notify BOP w/SP change?
w/in 7 days - file form WPH
if found cheating...
wait 3 yrs b4 applying to next exam
when are the parents/guardians not the minors personal representative?
when NYS or other law does not require their consent and minor does give consent when a court decides who can make the decisions when parent agrees with confidential relationship between minor and physician
what is the minimum necessary?
when disclosing PHI, pharmacy must make reasonable effort to limit PHI to accomplish intended purpose
when can vets face criminal liability?
when dispensing vet legend drug w/o Rx
what is an emergency IND?
when the time allotment cant be met and the patients dont meet the protocol criteria - pandemic/epidemic
false claims act
whistle blowers can receive part of winnings in lawsuit if testify against employers for medicaid fraud, waste, abuse
Prescription Drug Marketing Act of 1987
wholesalers licensed under state law cant sell/trade/purchase coupons/samples - defines storage/recordkeeping of these too practitioners have to file written request for samples no samples for retail pharmacy no resale of rx drugs by hospitals or healthcare facilities no reimportation of rx drugs manufactured in US companies shipping product between states must be registered with those states
BOP and retail price list
will receive one yearly free of charge
what is a tier 4 HIPAA violation and 2019 max fine?
willful neglect that is not timely corrected $1,500,000
when do ppl need to be notified of breach?
within 60 days of breach
regulations
written by a government body to interpret these laws and put into plain english the do's and don'ts
what if RPH cant reach pt after 2 attempts and 48 hours?
written explanation
what does a midwife collaborative agreement require?
written guidelines written protocols address specific areas of practice
serial number "ONYSRx"
written in NY faxed
collaborative agreement
written protocols reflecting areas NP is certified to practice
serial number of "zzzz..."
written rx from out of state written rx from federal land PRs
can midwives have separate rx blanks?
ye
can pharmacists supply flu vaccines and syringes to NPs at schools without a wholesaler's license?
yea boi
if selling price changes during the week than whats contained on drug retail price list can you legally charge new price?
yea boi - nothing contained in retail price list prevents pharmacy from changing and charging current retail price at any time as long as the price list is UPDATED WEEKLY
is every pharmacy in NYS required to have an SP?
yeah
are SPs held responsible for errors of staff pharmacists?
yeah - assigns violation of drug laws to employer of establishment - can find SPs failing to supervise pharmacy or inadequately inform staff about problem areas
is a prospective drug use review required and for what patients?
yes and for medicaid patients
can you substitute a less expensive biological product than one prescribed?
yes if meets these conditions: - product is in fact interchangeable - prescriber does not say substitution not allowed - need to have name/strength/manu. on label unless PR doesnt want that
can you take oral refill authorizations?
yes, from a prescriber
do midwives need written collaborative agreements?
yes, needs to be with a phys.
do whistle blowers of HIPAA violations to state attorney general offices have incentive?
yes, they get a cut of fines
are hospital pharmacies responsible for counseling?
yes, when dispensing in outpt pharmacies or discharging pts
