5644290
Description
Flashcards by Hayley Klein, updated more than 1 year ago
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Created by Hayley Klein
over 10 years ago
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| Question | Answer |
| Pure Food and Drug ACT | Drugs could not be adulterated or misbranded |
| FDCA | Had to be proven safe Adequate directions for use Warning about habit-forming drugs |
| Durham-Humphrey Amendment of 1951 | Legend drugs: Adequate directions for use “Caution: Federal law prohibits dispensing without a prescription |
| Kefauver-Harris Amendment of 1962 | Not only safe… but EFFECTIVE Created GMP and NDA Informed consent for clinical trials Reporting of ADR’s |
| Orphan Drug Act of 1983 | For rare diseases -- tax & licensing incentives; extends patent (by 7 years) Rare = affects < 200,000 persons in U.S. |
| Waxman-Hatch Amendment – 1984 | Established ANDA for generics Must prove bioequivaence Established patent restoration for brands (min. 5 year exclusive marketing regardless of patent years remaining from original 17 years after registration) If a generic challenges a patent, 6 months exclusive rights given |
| Prescription Drug Marketing Act - 1987 | Established controls for wholesaler distribution and record keeping Banned re-importation of Rx drugs back into the U.S. Pharmacies CANNOT stock samples |
| OBRA 90 | Requires PharmD to offer to counsel on all NEW Rx’s Required PharmD to perform PROSPECTIVE and RETROSPECTIVE DUR Maintain patient profile for 2 years |
| FDA Modernization Act of 1997 | Fast-track review of some NDA Clarification of pharmacy compounding Legend shortened to “Rx Only” Elimination of Habit-forming warning Supplemental NDA for new uses of existing drugs |
| Medicare Prescription Drug Improvements and Modernization Act – 2003 (MMA) | Established Medicare Part D Reimbursement basis -- changed from AWP to ASP (average sales price) Formula must contain 1 drug in each therapeutic class and most drugs for: |
| Part D Plan Requirements under MMA | can’t have exclusive deal w/ a chain mail order CANNOT be a requirement must inform if cheaper generic is available must offer MTM services PharmD may be reimbursed for MTM any pharmacy can participate |
| Drug classes in which most drugs are covered under Part.D | Anticonvulsants, Neoplastics, Antiretrovirals, Antidepressants, Psychotics, Immunosuppressants |
| 3 Requirements of DME | Can stand repeated use Primarily for medical purpose Appropriate for use in home |
| Medicare Tiers | Tier 1: least expensive generic drug Tier 2: preferred brand name drug Tier 3: non-preferred brand name drug Tier 4: rarer, high-cost drugs |
| When can Medicare part D formulary be changed? | Whenever! |
| When is the PArt.D enrollment period | 3 months before and 4 months after a patient's birthday month |
| Medicare D covers almost all drugs in which classes? | Anticonvulsants, Neoplastics, Antiretrovirals, Antidepressants, Psychotics, Immunosuppressants |
| Durable Medical Equipment (DME) -- i.e. wheelchairs, O2 tanks, walkers -- must meet these 3 requirements: | Can stand repeated use Primarily for medical purpose Appropriate for use in home |
| T/F: NDC is required on prescription drug bottles from the manufacturer | False |
| Compounding BUD for Non-aqueous liquids and solids using commercial products | NMT 25% of the time remaining on the commercial product OR max of 6 months, whichever is less |
| Compounding BUD for Aqueous solutions obtained from commercial product | 14 days when stored at a cold temp |
| Compounding BUD for all other compounds (not including non-aqueous liquids/solids & aqueous solutions contained from commercial product) | Not more than 30 days |
| HIPPA agreement must be kept for...... | 6 years from date signed or last date a prescription is dispensed (whichever is later) |
| T/F: Pharmacists can fill out of state prescriptions. | True. up to their discretion |
| What is considered short-term and long-term detox? | Short: <30 days Long: 30-180 days |
| All Rx’s for controls must contain: | Full name and address of the patient Drug name, strength, and dosage form Quantity prescribed Directions for use Name, address, and DEA # of the practitioner Practitioner signature and date written |
| What can be changed on a CII? | Drug strength Quantity Directions |
| How long does the FDA have to approve or deny and IND | 30 days |
| Phase I trials asses _____ | Safety |
| Phase 2 trials assess _______ | Efficacy |
| What happens in Phase 3 trials? | RCT. Compared to placebo/other drugs |
| After Phase 3 trials, NDA can be filed. How long does the FDA have to approve or deny an NDA? | No time limit |
| For an ANDA, the generic drug must prove __________ to the brand. | Bioequivalence |
| First 5 numbers of NDC? | manufacturer |
| Middle 4 numbers of NDC? | Drug |
| Last 2 numbers of NDC? | Package Size |
| T/F: Manufacturers must list inactive ingredients on bottle. | True |
| T/F: OTC labels must list the amounts of all inactive ingredients as well as active. | False. Only have to list active ingredients and CERTAIN other ingredients |
| Limit on Ipecac syrup | 30 mL |
| Size limit of sodium-phosphate laxatives? | 90 mL |
| Class 1 Recalls | serious, deaths remove stock, notify patients |
| Class 2 Recalls | temporary or potential remove stock |
| Class 3 recalls | unlikely to cause problems voluntary removal |
| Who can prescribe? | Physicians, Dentists, Podiatrists, Vets PAs and APRNs |
| Optometrists can prescribe if they complete ______ _________. | Additional pharmacology training |
| T/F: Chiropractors cannot prescribe. | True |
| Optometrists can prescribe a _____ day supply of narcotics and pain meds. | 3 day (72 hours) |
| T/F: Optometrists can prescribe oxycodone. | False. No CII's |
| O | 60 days |
| T/F: Optometrists can prescribe B-Blockers. | True. BUT certain conditions. |
| In emergency, may take oral order for a CII.. Written Rx must be delivered or mailed (post-marked) to pharmacy within ____ days. | 7 days |
| Faxed CII's can be used as originals in which 3 situations? | LTCF Hospice Terminally Ill **Reason (one of these 3 choices) needs to be documented on the Rx. |
| CII's can be partially filled in what scenario? | Don't have enough in stock NOT BY PATIENT REQUEST |
| If a CII is partially filled, how long does the pharmacy have to fill the remainder before it expires? | 72 hours |
| Pharmacists must put 3 things on a CII RX. What are they? Where should they be written? | Signature RX# Date of Fill **On Front OR Rear of RX** |
| T/F: The legal limit day supply of CII's is 30 days. | FALSE. No legal limit. Pharmacist should use discretion |
| A MD can write CII'S for future fills. What's the max day supply he can do this for? | 90 days |
| Future-Fill CII's prescription should be dated when? | On date it was WRITTEN! |
| What are the refill limits on CIII-CV Rxs? | 5 refills or 6 months |
| What must the pharmacist write on CIII-CV Prescriptions? | Initials Date of Fill RX# |
| T/F: A Rx for dangerous drug can be prepared by practitioner’s agent, but must be signed by practitioner | True |
| T/F: A PA Rx must contain delegating physician’s name, address, and phone for controls only. | FALSE. Must contain that info for all Rx's |
| T/F: A PA can prescribe CII-CV drugs ONLY if the delegating MD cosigns behind them. | False. If PA has their own DEA, no cosign needed. Otherwise, delegating MD must cosign |
| PAs and APRNs can prescribe refills for up to 24 months on which 3 drug classes? | Oral contraceptives Prenatal vitamins Hormone-Replacement Therapy |
| T/F: PA's and APRN's can prescribe CIIs. | False. PA's ONLY |
| T/F: When receiving a verbal RX in the hospital, you must obtain the name of the person transmitting the RX. | False. Only have to do that in the community setting. |
| If you cannot contact a prescriber for a refill, you can give the patient a ______ hr supply. | 72 hours CANNOT be a control Only if not having the medication would be detrimental to the patient |
| How long must you keep patient profiles? | 5 years |
| How long must you keep inventory and purchase logs (controls included)? | 2 years |
| T/F: It is legal to fill an out-of-state prescription written by a PA. | False. Do NOT fill out-of-state Rxs from APRNs and PAs |
| CV limits for OTC sale | 4 ozs or 32 dosage units / 48h |
| How long are DEA#'s valid for? | 36 months |
| How long must you keep transfer records for control substances? | 30 months |
| Sudafed logs must be kept for _____. | 2 years |
| Monthly and daily max for Sudafed purchase | 3.6g/day 9g/30 days |
| Form for purchasing CII's | Form 222 |
| Form for transferring CII's and Returning them | Form 222 |
| DEA form for destroying controls | Form 41 |
| What are the 3 ways in which controls can be destroyed? | Representatives of GDNA Agents of the U.S. DEA A reverse distributor holding a current permit issued by the GBOP |
| Form for reporting theft of Controls | Form 106 |
| How long do you have to fill out a form 106? | 10 days |
| Must notify GDNA AND DEA w/in ___ days of loss or theft of controls.. | 3 days |
| How often must you inventory control substances? | Every 2 years |
| T/F: If CIII-CV open bottles have >1000 count, you can estimate the amount. | FALSE. Open bottles >1000, must have an exact count. Open bottles <1000 you can estimate |
| Pharm.D license must be renewed every ___ years by ______ (date) of _____ (years). | 2 December 31st Even |
| If a pharmacist hasn't renewed their license after ______ (date), then it will be revoked | January 31st |
| When do you need to notify the Board after PIC change? | Immediately |
| Notice of any change of employment or business address shall be filed with the division director WITHIN ___ days after such change | 10 days |
| How long must you retain CE records? | for 2 years after renewal |
| How frequently must the PIC check for expired drugs? | at least every 6 months |
| T/F: Pharmacy Techs can sell hypodermic needles/syringes. | False. Only pharmacists and interns |
| If a prescription is electronically generated and printed out, it must meet 2 qualifications: | 1. Be on security paper 2. Be signed (not electronic) |
| How often does Drug Therapy Modification Certification need to be renewed? | Yearly |
| CE Requirements for DTM Pharamcists | 3 hours of CE must be related to DTM and one of those hours must be live |
| Who serves the GA Board of Pharmacy? | 7 pharmacists 1 consumer |
| How long is the term for a GBP member? | 5 years |
| What is the minimum size for a pharmacy? | 150 sq. ft |
| Hospital emergency/crash carts should be opened and inspected by a PharmD at least once every _____ days | 90 days |
| T/F: If a pharmacist substitutes a generic drug for a brand drug, the generic name is sufficient on the label. | False: Both names should be on the label with “generic for (insert name of brand name pre- scribed drug product)” or similar language to indicate substitution has occurred. |
| T/F: The words "Brand Necessary" must be stamped, written, or printed on the face of the Rx in order to dispense brand. | False Must be WRITTEN only! (unless the Rx is sent electronically) |
| What is the minimum time a patient must be around to be observed after a vaccine? | Minimum of 15 minutes |
| Under what age must a patient have a prescription for the flu vaccine? | <13 years old |
| Ketamine is a class C___ drugs | CIII |
| Xyrem is a class C___ drugs | CIII |
| Soma is a class C___ drugs | CIV |
| Synthetic cannabinoids are a class C___ drugs | CI |
| Pharmacists must pay a late fee, which is ___% of the renewal fee, if they are late for renewing their license. Late renewal is between which dates? | 50% of renewal fee + Renewal fee Late: Jan 1 - Jan 31 |
| If a pharmacist's license is inactive, how many CE hours do they need? | ZERO |
| Pharmacy licenses should be renewed by _____ (date) every ___ years on ____ years | June 30th 2 years Odd years |
| The pharmacist cannot be absent more than _____ hours at a time and more than ____ hours per day | 1.5 hr at a time 3 hours per day |
| If the pharmacist is absent for more than 3 hours, a sign must be present saying "Prescription Department Closed" and letters much be at least ____ inches in size | 3 inches |
| Drive-thru window must be what size? | at least 2' x 3' |
| How many drive thru lanes can a pharmacy have? And what's the furthest away the window can be? | 2 24 feet |
| When do you have to notify board for permanent closing of a pharmacy? | Immediately |
| When do you have to notify the Board for change of ownership or location of pharmacy? | Immediately |
| When does any theft/loss in a pharmacy need to be reported to the Board? | Immediately |
| When do you have to notify the Board after conviction of any employee of licensed pharmacy? | Immediately |
| When do you have to report significant ADRs to the Board? | Immediately |
| How long do you have to report a disaster or accident to the board? | Immediately |
| T/F: You cannot compound a product that has been removed from market. | False. You cannot compound a product that has been removed from market because of SAFETY issues. |
| How long must you keep records of compounding training? | 5 years |
| CE Requirements of Pharmacists in a specialty pharmacy | Need at least 10 hours of CE credit in the specialty area |
| Physical requirements of a hospital pharmacy | At least 10 sq.ft per bed |
| How quickly do you have to report damage by fire and/or water to a building to the GDNA? | written notice shall be forwarded to Director of GDNA at his office WITHIN 3 DAYS |
| Theft, Loss, or Unaccounted for CS should be reported to ____ and ____ within ____ days. Form used: ______ | DEA and GDNA 3 days Form 106 |
| What must you document for CV excepted sales? | Drug Name, Type, Quantity Patient Name, Address, DOB INTENDED USE! |
| 5 scenarios in which counseling is not required: | 1. Inpatient hospital 2. Inmates 3. Patients getting drugs from Public Health 4. REFILLS 5. If patient refuses |
| T/F: Pharmacists can fill controls "For Office Use" | False |
| Which act prohibited interstate commerce of adulterated food, drinks, drugs? | Food and Drug Act |
| What is required on an inpatient RX? | Patient name Patient room # Drug name Drug strength Drug directions for use Date Prescriber’s signature |
| Maintain all Rx records for 2 YEARS EXCEPT (4 exceptions): | Transferred CS x 30 MONTHS Poison records x 5 YEARS HIPAA records x 6 YEARS State payment program x 5 YEARS |
| Which act established Rx and Non-Rx Drugs? | 1951: Durham-Humphrey Amendment |
| Requirements for prescription LABEL (8 items) | Name/address/phone # of pharmacy Name of patient RX# Date of fill Name of prescriber Directions for use Expiration date of drug (typically 1 year) ID of dispensing RPh |
| Unit dose labels in the hospital must contain: | Brand or generic name Strength Lot # Expiration date |
| 4 products that cannot be mail-ordered | CII’s, refrigerated products, chemo, suppositories |
| In LTCFs, CII's can be partially filled for up to _____ days. | 60 days |
| In order to reuse medications dispensed in the LTCF, drugs must have at least ____ months left before expiration. | 6 months |
| IN LTCF, emergency kits should my inventoried every ______ months. | 1 month (30 days) |
| Emergency kits in LTCFs should contain the following info on the OUTSIDE of the kit: | 1. Drugs 2. Expiration date 3. Vendor pharmacy name/address/phone |
| Can you compound products that are commercially available? | No. |
| T/F: It is acceptable to compound products for other pharmacies. | False. Cannot re-sell compounded products. |
| T/F: It is acceptable to compound products for "Office Use Only" | True |
| A registered professional nurse who is employed by a licensed home health agency may possess ____, ____ and ____ for use as intravenous maintenance for use in a home health setting, | Sterile water Sterile saline Diluted Heparin |
| FDA requires MedGuides when: | Pt labeling could prevent serious adverse effects Product has serious risks relative to benefits Pt adherence to directions is crucial |
| Maintain Sudafed records for ____ yrs. | 2 years |
| Requirements of log for selling poisons: | Date of sale Purchaser name & address Poison name & qty Purpose of purchase Name of pharmacist |
| Must maintain logs of poison sales for ____ years. | 5 years |
| How long must you keep HIPAA records? | 6 years |
| In order to reactivate an "inactive" license after 4 or more years, one must complete: | (1) Retake MPJE, 30 hours CE, Completion of intern-like hours based on number of inactive years OR (2) 1000 hours & retake NAPLEX |
| In order to reactivate an "inactive" license after < 4 years, one must complete: | $500 fee 30 hours CE w/in past 2 years CV |
| If a CE audit occurs and you are deficient in hours, you must | Complete 2 CE hours for every 1 hour deficiency Pay a fine of up to $50 for every deficient hour |
| If doing DTM, patient profiles must be kept for ____ years. | 10 years |
| What is the max term for a DTM agreement with a physician? | 2 years |
| Max hours an intern can work per week? | 50 hours |
| Techs must notify the Board of change in address or employment address within ___ days. | 10 days |
| Pharmacy licenses are renewed every ___ years on _____ of _____ years. License lapses by ________. | 2 years June 30th Odd years Lapses by Sept. 1 |
| In the hospital, who can destroy drugs? | Pharmacist or Nurse and 1 witness |
| T/F: A pharmacy packaging donated drugs for indigent patients, can charge a repackaging fee. | True |
| Adulterated or Misbranded: Contains in whole/part any filthy, putrid, or decomposed substance | Adulterated |
| Adulterated or Misbranded: Has been prepared, packaged, or held under unsanitary conditions | Adulterated |
| Adulterated or Misbranded: Has been manufactured under conditions that do not meet GMP standards | Adulterated |
| Adulterated or Misbranded: Contains unapproved color additive | Adulterated |
| Adulterated or Misbranded: Missing name/location of manufacturer, packer, or distributor | Misbranded |
| Adulterated or Misbranded: Quantity of container contents is not present | Misbranded |
| Adulterated or Misbranded: Adequate directions for use/warnings (OTC) are not included | Misbranded |
| Adulterated or Misbranded: Multiple lot numbers are present in one bottle | Misbranded |
| Adulterated or Misbranded: Labeling Rx with brand but dispensing generic | Misbranded |
| Adulterated or Misbranded: Labeling Rx with one strength but dispensing another | Misbranded |
| The 7 pharmacists on the Georgia Board must meet | 1. Resident for at least 6 months 2. Licensed and in good standing 3. At least 5 years of experience 4. Actively practicing 5. Not employed by a school/COP |
| T/F: Board members only serve 5 years. | False. If they do not have a successor they stay on for however long |
| Who appoints the director of the GDNA? | BOP |
| Can patients import drugs? | Yes if the patient declares it's for personal use and NMT a 3 mo. supply |
| Pharmacy DEA Registration Form | Form 224 |
| Manufacturer/Researcher DEA Reigstration Form | Form 225 |
| Narcotic Tx Program DEA Registration Form | Form 363 |
| How long are DEA permits good for? | 36 months |
| DEA renewal forms are automatically sent ____ days prior to expiration. Contact DEA if form has not been received ____ days prior to expiration. | 60 days 45 days |
| Which color of the 222 form goes where? Brown Green Blue | Brown: Supplier Green: DEA Blue: Puchaser |
| If supplier cannot fill CII order in its entirety, supplier may supply the balance w/in ____ days | 60 days |
| Transferred prescriptions must be kept for _____ months. | 30 months |
| T/F: The pharmacist transferring a Rx, must write "VOID" on the face of the Rx. | True. The pharmacist receiving must write "Transfer" |
| 2 ways to store prescriptions. | 1. CII, CIII-CV, All others 2. CII, All others |
| How to verify a DEA number | Add digits 1 + 3 + 5 (Add digits 2 + 4 + 6) x 2 Add the above two results Last digit of result should match last digit of DEA number |
| What is a form 226? | DEA renewal form |
| What is a form 222a? | request for more 222 forms |
| What is a form 82? | Inform registrants of inspection |
| Physicians must have a "X" number assigned by the DEA in order to prescribe ________ | Buprenoprhine |
| Pharmacists can sell CII's to another pharmacy provided it does not exceed _____% of their total control sales during that year. | 5% Same thing goes for Doctor's office Use a 222 Form!!!!! |
| The pharmacist in charge of each day's dispensing must record a log of CII sales how frequently? | daily (Log book) |
| Pharmacies using a computerized system must be able to retrieve refill data within ____ hours. | 48 hours |
| If a drug becomes scheduled when do you have to inventory it? | The day it becomes schedules and the biennially |
| If an MD passes away, how long can you fill their scrips? | 6 months |
| IN a LTCF, if an emergency kit is used, must receive a RX for the drugs used within _____ hours. | 72 hours |
| T/F: In order to place an emergency kit in a LTCF, the pharmacy must submit an application but do not need to identify the contents. | False. Must apply and Must state what they plan to put in the kit |
| Chemo agents must be prepared in a _____ flow, Class ____ biological safety cabinet. | Vertical Class II |
| Contact DEA if amount of Sudafed sold is over _____ grams | 24 grams |
| Name the OTC insulins. | NPH and Regular (So Humulin N, R, and 70/30 Novolin N, R, and 70/30) |
| Adulterated/Misbranded: Smoke or water damage | Adulterated |
| Adulterated or Misbranded: OC does not come with PPI. | Misbranded |
| Adulterated or Misbranded: Product is missing "Keep away from children" wording. | Misbranded |
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