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A few exemptions from DEA registration
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Which form is used for new pharmacy and physician registration?
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ZFederal Law1
ZFederal Law
| Question | Answer |
|---|---|
| A few exemptions from DEA registration | Public Health Service Practitioners, Bureau of Prisons Practitioners, Military Service Practitioners (AG can deny) |
| Which form is used for new pharmacy and physician registration? | DEA 224 |
| Change of address requires new registration, T/F? | True |
| If there is a transfer of business how many days prior to the move must the DEA be notified? | 14 (name address, and DEA # of old business AND new business) |
| DEA # verification AB1357210 | 1+5+2=8; 3+7+1 =11x2=22 +8 =30; the zero at end is verified by the zero at end of DEA # |
| T/F Records for CII must be kept separate from other records | True |
| 3 types of records | Inventory, drugs received( invoices for C3-C5 and DEA222 for C2), and drugs dispersed |
| Which form is used if theft or loss occurs? | DEA 106 |
| Form for drugs surrendered for disposal | DEA 41 |
| Requires all OTC and prescription drugs be subject to special packing requirements | Poison prevention packaging |
| Established 2 classes of drug, prescription and OTC | Durham Humphrey |
| Required drugs be proven safe and effective | Kefauver harris |
| Mandates increased recordkeeping for physicians and pharmacists who dispense narcotics | harrison narcotic act |
| Individually identifiable health info addressed under the privacy rule | PHI |
| Established a formal definition of dietary supplements using several criteria | DSHEA |
| Official compendia of active ingredients | USP |
| Established a fast track approval process for srugs intended for serious life threatening diseases | FDAMA |
| A key component in OBRA 90 that pharmacists must offer counseling to patients | Prospective DUR |
| Act that provides storage, handling, and recordkeeping for drug samples | Prescription drug marketing |
| Act regarding safety and efficacy of medical devices according to their function | Medical devices |
| Intent was cost savings and better fiscal mgmt | of medicare/ Medicaid |
| Provide tax incentives for manufacturers to develop drugs for rare disease | Orphandrug |
| Established to ensure security and dprivacy of patients medical records when electronically transmitted | HIPPA |
| Authorized batch certification on insulin and penicillin | FDCA |
| Dept of health and human services is an example of what kind of agency? | Federal administrative; responsible for Health Care Financing Admin and FDA |
| Fair Trade Commission is what kind of agency? | Federal administrative; drug advertising |
| US Justice Department | Fed admin agency; DEA |
| State Board of Pharmacy puts in details for legislatures framework | No answer |
| 4 types of law | Criminal (person vsgov) ; civil (person vs person);administrative (created/ enforced by gov agencies); common law( no specific statute) |
| A pharmacist who unintentionallyharms a patient through inattentiveness or carelessness can be considered legally negligent “tort”; civil or criminal? | Civil |
| Failing to do something that a reasonable person would do | omission |
| doing something that a reasonable person would not do | Commission |
| a violation of the legal obligation to an individual; ex: misfilling a prescription | Breach of duty |
| a reasonable standard of care while performing any acts that could potentially harm others | Duty owed |
| Proof that pharmacists misconduct caused the alleged damage | Causation |
| Loss or injury to a person or property | Damage |
| 4 elements of negligence (all 4 needed to be legally liable) | Duty owed, breach of duty, causation, damage |
| Definition of “drug” | Habit forming OR not safe w/o supervision OR is limited by application to be used under supervision |
| cGMP | Current good manufacturing practices |
| Drugs recognized among experts to be safe and effective | OTC drugs; must contain adequate directions for use and comply with cGMP |
| Obtaining FDA Pre-marketing drug approval; new use for previously approved drugs | New Drug Application |
| once the patent on an approved parent drug product expires, the FDA allows manufacturers of generic products to submit a what? ANDA | ANDA |
| ANDA | Abbreviated New Drug Application; no safety or efficacy data required; have to prove it’s the same bioequivalence |
| Formulation change or change to written material of product goes thru what process? | SNDA (Supplemental New Drug Application) |
| OTC monograph | OTC’s broken down into categories instead of making each go thru FDA process; list of safe products that can be used in a new product |
| 11 digit, 3 segment number identifying all drug products | NDC (National Drug Code); required on all OTC AND prescription labels |
| First section of National Drug Code | manufacturer or distributor |
| Second section of NDC | “product” |
| Third section of NDC | “packaging” |
| Concerned with physical condition of drug or device | Adulteration; unsanitary, etc |
| Concerned with representation made by the manufacturer regarding drug or device | misbranding |
| False or misleading label, inadequate directions for use, doesn’t warn of possible habit forming | misbranding |
| Not in conformance with GMP, poisonous container, unsafe color additives, not tamper resistant | Adulteration |
| Insulin or antibiotic that is not batch certified is an example of what? | Misbranding; every batch tested for strength and quality |
| Label vs labeling | Label is attached to actual container and labeling refers to all accompanying info; package inserts etc |
| Patient information program ( 2 parts of program) | MedGuides and Consumer Medication Information (CMI) |
| Manufacturers are required to provide these for drugs that pose a “serious and significant” concern to the public, Requires FDA approval | MedGuides of Patient Info Program; Manufacturer provides to dispenser, dispenser provides to patient |
| Mandated that written information is provided to the patient for every drug every time a new prescription is dispensed | Consumer medication Information (CMI); Patient Information Program |
| Which class of product recall is most serious? | Class I, irreversible damage/ death; class II reversible damage; class III often mislabeling; FDA does tell public which class |
| T/F; Pharmacists have to know which products have been recalled? | True |
| Product recall withdrawal process | Manufacturer contacts seller; seller contacts consumer- manufacturer or FDA may initiate recall |
| set of regulations that establishes minimum requirements for the methods, facilities, or controls used in the manufacture, processing, packing, or holding of a drug product | GMP |
| The intent of the GMP is to do what? | Ensure safety of drug and that it meets quality and purity requirements; adulterated if not in accordance with GMP |
| Manufacturers are inspected by FDA how often? | Every 2 years |
| “Approved Drug Products with Therapeutic Equivalence Evaluations” | Orange book |
| Two-letter coding system for the therapeutic equivalence; first letter is either an A or a B | First letter=A; equivalent- first letter B; not equivalent |
| In the A/B equivalence coding system, the second letter means what? | Gives info about dosing- ex: oil or aerosol |
| MedWatch and VAERS (Vaccine Adverse Event Reporting System) are part of what? | Voluntary Reporting Programs |
| Pharmacists must provide: “Call your doctor for medical advice about side effects; You may report side effects to the FDA at 1-800-FDA-1088” | Voluntary Reporting Programs |
| Clinical trials Phase I | healthy patients; detect adverse side effects; doesn’t determine efficacy |
| Clinical trials phase II | Written consent from patients who have the disease; determine efficacy and dosage |
| Clinical trials phase III | Verbal consent; large studies; strict criteria; risk to benefit analysis |
| Clinical trials phase IV | Post marketing surveillance; FDA can rescind NDA approval |
| 1820 first group of physicians gathered info about drugs, created a compendia standard of drugs | US Pharmacopia |
| Monographs of inactive ingredients | NF (National Formulary) |
| USP and NF joined into 1 compendium for drug standards | USP/NF; meet every 5 years to review |
| HPUS is what? | Homeopathic pharmacopeia of the US; compendium for homeopathic (natural) products |
| Prohibited the adulteration/ misbranding of drugs; not required to list ingredients; no authority to ban drugs | Pure Food and Drug Act of 1906;misleading claims were not prevented; only prevented false statements about drugs identity |
| Required prescriptions for narcotics and mandated record keeping for physicians and pharmacists | Harrison Narcotic act of 1914 |
| Authorized batch certification AND required new drugs to be proven safe before marketed | Food, drug, and cosmetic act of 1938 |
| Established 2 classes of drugs; required drugs to be labeled | durham- Humphrey; must contain “ federal law prohibits dispensing without prescription |
| Adequate info vs adequate directions | OTC require adequate directions for use (clear and specific), prescription meds require adequate information in health care provider lingo |
| Required drugs to be SAFE and EFFECTIVE; established GMP | Kefauver- Harris |
| Established advertising procedures | Kefauver- Harris; legend (prescription drugs)=FDA ; OTC= Federal trade commission |
| Special packaging and child resistant packaging | Poison prevention packaging act (not required if patient request or physician prescribes) |
| Medical Devices Act: 3 classes according to function | Class I, low risk (bandaids, no testing); Class II,must be evaluated (hearing aids); Class III, life supporting devices(pacemaker) pre-market approval |
| Tax/ licensing incentives for manufacturers to develop and market drugs for rare diseases | Orphan drug act |
| Extended patent to 5 years after FDA approval; streamlined generic drug approval process | Drug Price Competition and Patent Term Restoration Act |
| Requirements for samples | Prescription Drug Marketing Act |
| Intent was cost saving/ better mgmt of Medicaid and medicare; required drug use review | OBRA 90 (Omnibus Budget Reconciliation Act) |
| 3 components of OBRA90 | Rebates, innovation, drug utilization review |
| 3 components of DUR | Screening prescriptions prior to dispense, patient counseling, and pharmacist documentation of relevant info (allergies etc) |
| Annual Fees on manufacturers; allowed more FDA employees and faster drug approval | Prescription Drug User Fee Act |
| Definition of dietary supplement | (Dietary Supplement Health and Education); product other than tobacco; vitamin, mineral, herb, amino acid orcombo of these |
| Required labels to say “This statement has not been evaluated by the FDA, not intended to diagnose etc | DSHEA |
| Fast track approval for life threatening disease; data base for clinical trials; panel review; “off-label”uses | FDAMA (Food and Drug Administration Modernization Act |
| Incentives for creating PEDIATRIC clinical studies | FDAMA; also regulates pharmacy coumpounding |
| Designed to stimulate additional research into pediatric data for pharmaceuticals | Best pharmaceuticals for children act |
| FDA requires research on certain drugs before licensing;ex:Pediatric studies prior to marketing | Pediatrics Research Equity Act |
| Gives FDA more authority to remove unsafe dietary supplements (DS) and OTC products | Dietary Supplement and nonprescription drug protection act; also requires manufacturer to submit reports of serious adverse effects |
| Examples of individually identifiable health info | Name, address, ss#, or a combo of things: zip code +DOB+unusual diagnosis |
| Organizations privy to patient PHI | covered entities |
| Covered entities: | health plans, clearing houses(billing etc), electronic transmission by health care provider |
| Enforces HIPPA | Office of Civil Rights; civil penalties 25k,criminal penalties 50k, intent to sell 250k and prison |
| CSA | Controlled Substance Act; enforces by DEA (agency of US dept of Justice) |
| Goal of this act is to trace controlled substances and prevent diversion | CSA |
| Controlled drugs/ scheduled drugs: | Potential for addiction and abuse |
| Narcotic controlled substance is defined as? | Natural or synthetic opium or opiate and any derivative, poppy straw, coca leaves, cocaine; narcotic CS and CS are regulated same way |
| Who has the authority to place a schedule on a drug? | US attorney general |
| Used in research; high potential for abuse; no current accepted medical use | C I (Schedule I) |
| Manufacturers and distributors register with the DEA how often? | Annually |
| Dispensers (doctors and pharmacies) are required to register with the DEA how often? | Determined by AG; 1-3 years. nevada is 2 years |
| Dispense: | to deliver a controlled substance to the ultimate user (patient) |
| Inventory of CII is required how often? | perpetual; actual physical count |
| inventory of CS's is done how? | initial and then every 2 years; doesn't need to be submitted to DEA but needs to be kept in records |
| Estimation can be made of CS inventory if? | opened bottle holds less than 1000 units; must be counted if bottle holds more than 1,000 units |
| Disposal of CS | DEA Form 41; DEA will instruct registrant how to dispose; transfer, deliver to DEA, destroy in presence of DEA, other DEA authorized means |
| If DEA allows, pharmacies can destroy outdated, damaged, unwanted CS; witnesses to destruction can be? | pharmacist, licensed physician, midlevel practitioner, nurse or state/ local law enforcement |
| New pharmacy initially registers to order CS with which form? | DEA form 224 |
| DEA form 222 | CI CII drugs, triplicate, serial #, states which schedules registrant is allowed to handle |
| Ordering CS | CI and CII- DEA 222; CIII-V- invoice or packing slip with drug name, dosage and strength, number of units/containers; supplier info |
| Form 222 copies | pharmacy keeps copy 3; forward copy 1 & 2 to supplier; supplier sends copy 2 to DEA; valid for 60 days |
| POA | power of attorney designated by person who signed DEA registration; can sign 222 on behalf of the signer (requires 2 witnesses) |
| Pharmacist needs to mark if something not received or can face huge fine | no answer |
| Can still use form 222 if minor error | misspelled drug name, no date, package size (if only 1 package size available), strength (if only 1 strength). Supplier cannot fill in "last line completed" |
| Electronic ordering of CI-CV is allowed if? | Digital certificate |
| CII must be hand written; III-V can be verbal or written | State law more detailed |
| Oral Emergency CII prescription | limited to unspecified period;must have written script from prescriber within 7 days or report dr. to DEA. Check State law |
| Fax requirements | III-V is original as fax |
| CII can be a faxed "original" under what conditions? | compounded for direct admin, LTCF, hospice |
| State Board determines if electronic prescribing is allowed | not allowed for CII |
| Labeling requirements for CII-V | date of dispense, pharmacy name/ address (phone not req), script #,patient/physician name, directions for use, cautionary statements |
| Partial filling: must be able to supply full amount within 72 hours or do what? | notify prescriber, write on script how many were dispensedno further quantity may be supplied w/o a new script |
| partial filling of CII for LTCF patient; script is good for how mong? | 60 days form date of issue |
| No refills allowed for CII | no expiration under Federal Law p.61 |
| CIII-IV expires? | 6 months, no more than 5 refills |
| CV expires? | 12 months, can prescribe as needed for refills |
| Multiple CII rx issued if? | not more than 90 day supply; if 3 separate scripts are written for 30 days each, they must have instructions on fill dates |
| CII-CV must be stored where in a pharmacy? In Dr. office? | pharmacy- locked cabinet or mixed in with other meds to deter theft. Dr office must have them in a locket cabinet |
| CII cannot be transferred; no refills | CIII-CV can be transferred 1 time |
| Can a CS be mailed? Which classes? | Any CS can be mailed as long as the package doesnt state whats in it |
| Can CS's be delivered or shipped out of country? | Not without DEA "exporter" registration and export permit |
| OTC ephedrine etc is limited to how much? | 3.6 g/ day or 9 g/ month; less if mail order |
Created by:
angieryx
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