PharmLaw 9

smoore020390's version from 2015-09-08 08:13


Question Answer
What required drugs to be proven safe prior to release onto market?FDCA of 1938
What drugs required drugs to be safe AND effective?Kefauver-Harris ammendment of 1962
What created categories of drugs Rx and OTC?Durham-Humphrey Amendment 1951
What required Rx drugs ads to be done by FDA?Kefauver-Harris Amendment of 1962
What streamlined the generic approval process?Waxman-Hatch Amendment or Drug Price Competition and Patent-Term Restoration Act
What first required labels for adequate directions for use and warnings about habit forming ingredient? FDCA of 1938
What created CGMPs? Kefauver-Harris Amendment of 1962
What first prohibited the adulteration and misbranding of drugs?Pure Food and Drug Act 1906
What allowed for refills?DHA of 1951
What required tighter restrictions on Rx samples and tried to prevent drugs from going to black market?Prescription Drug Marketing Act of 1987
What allowed for oral Rxs?DHA of 1951
What allowed FDA to charge fees to drug companies for reviewing NDAs?Prescription Drug User Fee Act (PDUFA) 1992
Which amendment allowed req informed consent for research subjects and reporting of ADRs?Kefauver-Harris Amendment of 1962
What did the waxman-hatch amendment do?AKA Drug Price Competition and Patent-Term Restoration Act. Streamlined generic approval process while extending patents for certain brand name products
FDA Modernization Act of 1997Expedited approval of certain drugs. P-status vs. S-status (FDAMA)
Food and Drug Administration Amendments Act of 2007 (FDAAA)Increased fees for NDA review. Established post-marketing studies and REMS requirements
What created Medicare Part D?Medicare Rx Drug Improvement and Modernization Act of 2003. Fed health insurance for age 65 and up.


Question Answer
How does Part D Work?Monthly premium, meet annual deductible. Then Part D pays 75% of annual drug costs until coverage gap is reached. Then pt pays all drug costs, following gap, plan resumes covg.
What does "any willing provider mean?"ALL rx benefit plans must participate with any willing pharmacy agreeing to terms and conditions of plan. Can receive > 30 days at local pharmacy (may still have preferred/non-preff pharmacies)
MTM and Part DPharmacists may receive fees for providing MTM services with multiple chronic diseases, take multiple covered drugs, likely to exceed annual drug costs
How long does Medicare require pharmacies to keep records?10 years!!!!
What requires use of child resistant packaging?Poison Prevention Packaging Act of 1970
Definition of child resistant container80% of kids <5 can't open but 90% of adults can
What fed law requires RPhs make reasonable effort to obtain, record, and maintain pt med recordsOBRA 90
How long does FDA have to respond to IND?30 days
When can drugs get fast tracked to approval? Or have "p-status"If new drug product that is intended to treat a serious life-threatening disease and addresses an unmet medical need
What is a Class I recall?Serious ADRs including death
Can pharamacies say that they specialize in compounding?YES! But not any specific product
When could a pharmacy be considered a manufacturer not a compounder?If selling to other pharmacies/3rd parties/MDs, if can get same product from manufacturer. Interstate distribution of compounded products can't be >5% total Rx volume
When recording CEs attended, need to documentTitle, #hrs, sponsor's name, verification, date and location
Are separate pharmacy registrations required for every location?YES!
What needs to be displayed on exterior of establishment?Name of owners. If owner not RPh, must bear name of supervising RPh.


Question Answer
Partition of pharmacy must beEnclosed permanently by a partition at least 9'6" unless the ceiling is less than 9'6". Must go from floor to ceiling
What is a non-resident establishment?Pharmacy, manufacturer or wholesaler located outside of NYS that ships, mails, or delivers Rx drugs to other establishments, authorized prescribers residing in NY. Including internet pharmacies
What is an agent of record?A designee for a nonresident establishment that resides in NYS
What must nonresident establishments provide regarding contact?Toll-free phone number available during normal business hours at least 40 hrs per week
To operate a radioactive pharmacy need what licenseappropriate license that is issued by NYS Dept. of health and labor.
To be a nuclear pharmacist (need one when nuclear pharmacy is open) mustHave submitted to state board either BPS nuclear RPh certification. Complete minimum 200 contact hrs of didactifc instruction in nuclear pharmacy and minimum of 500hrs training under supervision of board certified nuclear RPh in a certified nuclear residency/training program
How many pharmacies can an Rph be supervisor of?One!
What required RPhs to offer to counsel?OBRA 90!
Who is responsible for ensuring compliance of all rules and regulations in a pharmacy?Supervising RPh
Can a supervising Rph assign their responsibilities to others?NO!
What is the abbreviation for doc of dental surg?DDS
What is abbreviation for doc of dental med?DDM
What is abbreviation for doc of podiatric med?DPM
What does DVM meanDoc of vet med


Question Answer
What should be included in a prospective drug review?Drug therapy probs 2/2 therap duplication, drug-disease CI, drug-drug intxns (OTCs too), Incorrect dose or duration of therapy, drug-allergy intxn, clinical abuse/misuse for use
When must pts receive notice of privacy practices at pharmacy?When services first provided
How long should signatures documenting HIPAA be held?6 years from date received or from last date an Rx is dispensed
What must be included on an Rx?Date Rx issued, prescriber info including name(cant be written, imprint req.) and profession Full address and phone, NYS license #, signature. Patient info including pt name and full address and age. Name, strength, qty, directions
What can a RPh add to an Rx without authorization from MD?Pt address/age. Telephone, state lisence#, and profession of prescriber.
What can a RPh add to an Rx WITH authorization from MD?Strength of med, quantity, directions for use, refills.
What can a RPH NEVER add to an Rx?Patient name, date rx written, medication name, signature of provider
If Rx has PRN refills, how many times can be refilled?once! (per NYS)
What must be included on an Rx label?Name and address of pharmacy, Rx number, date filled, name and adress of pt, name and strength of drug, directoins for use, name of prescriber, name of manufacturer (and distributor if different). Controlled subs MUST have pharmacys phone number on label
AACan substitute
ABCan substitute
ANPowders and aerolized solns
AOInjectables in oil
Can medicaid refills be transferred?NO!
Can syringe refills be transferred?NO!
What must a transferring RPh record?pharmacy to which it is being transferred name address telephone. Name of RPh receiving. Name RPh transferring. Date of transfer. Which refill of Rx has been transferred
What must a receiving RPh record?Pt name, pharmacy from which it is being transferred name address, name of RPh receiving, name of RPh transferring. Date of original Rx and most recent fill. Original Rx number. ALSO indicate that this is a refill transfer on face of rx


Question Answer
What schedule is buprenorphine?CIII
What schedule is buprenorphine/naloxone?CIII
What schedule is butabarbital?CIII
What schedule is APAP with codeine?CIII
How much codeine to be considered CIII?less than or equal to 1.8g/100mL or less than or equal to 90mg
How many mg of morphine to be considered CIII?less than or equal to 50mg/100mL
How many mg of opium to be considered CIII?less than or equal to 500mg opium/100mL or less than orequal to 25 mg per dosage units
How much ethylmorphine to be a CIII?less than or equal to 300mg ethylmorphine per 100mL or less than or equal to 15 mg dosage unit.
How many mg of codeine to be CV?less/equal to 200mg/100 mL
How much ethylmorphine to be a CV?less/equal to 100mg/ 100mL or 100g
How much diphenoxylate to be a CV?less/equal to 2.5mg diphenoxylate and not less than 25mcg of atropine per dosage unit
How much opium to be a CV?Less/equal to 100mg/100mL or per 100g


Question Answer
Are directions "take as directed" allowed?No! need actual directions
If adding missing info to an Rx after authorized by MD RPh mustsign and date after receiving authorization to add info
If RPh adds missing info to Rx after speaking with providerRPh must record date of change, reason for cahnge and sign
Is writing an acceptable condition on a CS script instead of a code acceptable?YES!
How should BZDs be filedIn Rx file for CIII-CV!
What needs to be included on 222 form?In typewriter, pen, indelible pencil - one item per line. Need name and address of supplier and signed and dated by authorized person
When does pharmacy act as a distributor in terms of controlled substanes?If returning unused, partial, or full containers to manufactuerer or distributor. OR Distributing to another practitioner.
When RPh need to be licensed as CS distributor?If dispense more than 5% of total CS dosage units in 12 mos, then a distributor.
What is PMP for?Collect, monitor, report info concerning the prescribing and dispensing of controlled substances
Patient registr keeps pt info forNo less than 6 mos no more than 5 years
What is the PMP duty to consult?Consult prior to prescribing or dispensing CII-CIV
Is it mandatory for RPhs to consult the PMP?NO!
Who can access PMP in the pharmacy?RPh, intern, designee
RPh role in PMPReal time filing of CS Rx info to PMP - max 24 hrs after filling or with mail order, 72 hr after sending out.
Who can DOH provide dispensed CS info to?PRactitioner, RPhs, Attornery Gen Medicaid Fraud Control Unit. Local health dept. Medical examiners and coroners. Inidivdiuals