Term
| What agency regulates prescription drug advertising? What about OTC drug advertising? |
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Definition
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Term
| What federal organization is responsible for administering medicare? |
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Definition
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Term
| Which federal department is responsible for the DEA? |
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Definition
| - The Department of Justice |
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Term
| What does each part of Medicare (A,B,C,D) cover? |
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Definition
A- Hospitilization insurance
B - Medical insurane for physician services
C - Medicare managed care
D - Medicare prescription drug program (income based premiums) |
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Term
| When can someone enroll in Medicare? |
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Definition
| Three months before and four months after the month of their birthday. |
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Term
| Name the substances contained in certain products which require a special warning... |
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Definition
- Yellow 5 (Tartrazine)
- Aspartame (phenylketonurics)
- Sulfites
- Mineral Oil (not in infants or pregnant women)
- Wintergree oil (methyl salicylate, if > 5%)
- Sodium Phosphate, max 90ml
- Isoproterenol (breathing difficulties)
- Ipecac - For emergency use, consult physician first, poison prevention center, or hospital emergency room, keep out of reach of kids, one dose is 15 ml, not sold in > 30 ml
- Acetophenetidin - Possible kidney damage
- Salicylates - Reyes
- Alcohol warning |
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Term
| Commercial oral tablets have codes that identify what about the tablets? |
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Definition
- Name of manufacturer
- Name and strength of drug |
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Term
| The Medicare Modernization Act of 2003 says that a pharmacy has to keep prescription records for how many years? |
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Definition
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Term
| Per federal guidelines, what should be included on each prescription LABEL? |
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Definition
- Name of patient
- Prescription number
- Date when prescription is written or dispensed
- Directions for use
- Name of prescriber
- Name/address of pharmacy
- Any cautionary statements |
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Term
| What are some of the drugs that must adhere to the Poison Prevention Packaging Act (PPPA)? |
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Definition
- Aspirin
- Methyl Salicylate
- Controlled Substances
- Prescription drugs
- Iron
- Acetaminophen
- Diphenhydramine
- Ibuprofen
- Loperamide
- Mouthwash
- Lidocaine
- Dibucaine
- Naproxen
- Ketoprofen
- Fluoride
- Minodoxidil
- Nonprescription drugs |
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Term
| What references contain information regarding the bioequivalence of drug products (and specifically what volumes?) |
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Definition
- Orange Book
- USP DI (Volume III) |
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Term
| If a patient refues to provide information for his prescription profile, what authority does the pharmacist have? |
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Definition
- Fill the presciption
- Refuse to fill the prescription |
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Term
| How long must a patient's signed HIPPA acknowledgement be kept for? |
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Definition
| Six year from the date of last dispensing, sucka |
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Term
| What are the specific DEA registration forms that must be used by different types of entities to register with the DEA? |
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Definition
Pharmacies - 224
Manufacturers or Researchers - 225
Narcotic Treatment Programs - 363
These forms followed by an "a" denote a registration renewal form, and are mailed to each registered entity 60 days before they're due. If they're not received at least 45 days before, contact the DEA office nearest you |
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Term
| How long is a DEA registration for controlled substances good for? |
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Definition
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Term
| Every location where controlled substances are manufactured, distribuuted, or dispensed must have its own DEA registration EXCEPT for the following.... |
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Definition
- Warehouses used by registrants to store controlled substances
- A practitioner's office where drugs are prescribed, but not administered or dispensed
- Common carriers
- An office where sales of controlled substances are solicited, made or supervised, but the location does not contain controlled substances |
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Term
| Ultimately what copy of the DEA Form 222 goes to the suplier? |
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Definition
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Term
Ultimately what copy of the DEA Form 222 goes to the supplier and then to the DEA?
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Definition
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Term
Ultimately what copy of the DEA Form 222 goes to the purchaser?
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Definition
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Term
| What happens if a DEA Form 222 cannot be filled for any reason? |
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Definition
- Supplier must return copies 1 and 2 to purchaser with statement as to the reason.
- Purchaser must staple this to copy 3 and retain.
- These orders cannot simply be corrected, a new form must be used |
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Term
| What happens if DEA Forms 222 are lost/stolen? |
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Definition
- Purchaser must prepare another form in triiplicate with a statement containing the serial number and date of lost form.
- Copy 3 of second form and a copy of the statement must be retained with copy 3 of the first form. Statement must be attached to copy 1 and 2 of second form sent to supplier. |
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Term
| In what instances is a pharmacist not considered a manufacturer? Or rather, does not need to REGISTER with the DEA as a manufacturer... |
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Definition
Pharmacist may compound "for office use" as long as the product.....
- Is compounded as an aqueous, oleaginous, or solid dosage form
- does not contain more than 20% controlled substance
- is only distributed to a practitioner who is authorized to dispense |
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Term
| In identity proofing for sending controlled prescriptions electronically, what is required? |
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Definition
- Practitioners must obtain two-factor authentication credential or digital certificates from federally approved credential service proviers or certification authorities.
- Something you know (knowledge factor), something you have (hard token of some kind?), and something you are (biometric information) |
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Term
| According to federal guidelines, when may a CII be faxed? |
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Definition
- To home infusion pharmacies receiving prescriptions intended for parenteral administration
- a resident of a Long Term Care Facility (LTCF)
- Hospice patients
- In the above situations the faxed script can serve as the original, in all others the prescription can not be dispensed until the original script is brought in. |
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Term
| If a blinded study is being conducted, what does not need to appear on a controlled prescription label? |
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Definition
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Term
| If a DEA Registrant is destroying controlled substances, what forms do they need to fill out? |
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Definition
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Term
| Prior authorization for destruction of controlled substances by the DEA is not required if who/what witnesses the destruction? |
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Definition
| An authorized member of state law enforcement or regulatory agency |
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Term
| When do do schedule III-V controls NOT need to have a red "C" no less than one inch high stamped in the bottom right hand corner of filed prescriptions? |
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Definition
| If computer records of these prescriptions are kept instead |
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Term
| Carfentanil, etorphine, and diprenorphine must be stored in what? |
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Definition
| A safe or steel cabinet equivalent to a US Government Class V security container |
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Term
| If controlled substances are lost or stolen, what needs to be filled out? |
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Definition
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Term
| What are the seven points of a nonprescription product label? |
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Definition
- Name of the product
- Name/address of mfg, packer, or distributor
- Net contents of package
- established name of all active ingredients and certain inactive ingredients
- name of any habit forming drugs
- cautions and warnings needed to protect the consumer
- adequate directions of use |
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Term
| What else is required on a nonprescription label besides the "seven points?" |
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Definition
- Statement of the intended use
- Dosage range appropriate for different ages
- How often the OTC may be safely taken
- Route or method of administration
- Other factors that make affect efficacy ("take before meals")
Note:New OTC regulations in 1999, must present "Drug Facts" in standard order
- Active ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients |
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Term
| What is the designation of sodium levels in OTC products? |
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Definition
Sodium free - < 0.5 mg of sodium per dosage unit
Very Low Sodium - <35mg Sodium per dosage unit
Low Sodium - <140mg Sodium per dosage unit (if more, must say "do not use if on a restricted diet blah blah) |
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Term
| A pharmacist may refill prescriptions written for nonprecription drugs without prescriber authorization unless..... |
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Definition
- The dose requested is greater than the recommended dose on the label of th commercial OTC product
- The prescrier has limited the number of refills on the original prescription
- The drug is a CV where the number of refills must be designated by the prescriber
- The individual state has a set time period lmit for refills |
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Term
| What agency regulates teh advertising and labeling of cosmetics? |
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Definition
The FTC
- Ingredients may be listed in descending order of predominance (so water may be first).
- Ingredients <1% may be listed at the bottom in random order
- Perfume and flavoring oils may simply be listed by name. Coloring agents must be thoe accepted for cosmetic use |
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Term
| What organization is responsible for establishing names for ingredients used in cosmetic formulations? |
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Definition
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Term
| What is NOT required to be listed on the label of a cosmetic product? |
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Definition
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Term
| Who is covered under the Americans with Disabilities Act? |
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Definition
- Epileptics
- Those with Paralysis
- HIV positive individuals
- AIDS patients
- The mentally retarded
- Alcoholics
- Pregnant women
NOT covered are those illegally using drugs
Any company employing 15 or more individuals is covered
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Term
| What reference source includes select law and regulations for controlled substances? |
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Definition
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Term
| What organization is responsible for overseeing the selection of a nonproprietary name for a new drug? |
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Definition
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Term
| How many years of exclusive marketing does the Marketing Act of 1987 guarantee a company? |
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Definition
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Term
| In terms of applying for a new DEA registration, what forms are used by pharmacies, mfg/researchers, and narcotic treatment programs? |
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Definition
Pharmacies - 224
Mfg/researchers - 225
Narcotic Treatment Programs - 363 |
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Term
| Primary souces for the names of ingredients include the following.... |
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Definition
- CTFA Cosmetic Ingredient Dictionary
- Food Chemicals Index
- USAN
- USP Dictionary of Names |
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Term
| Name four drugs that fall into the category of "grandfathered.." |
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Definition
- Thyroid - dessicated
- Ephedrine
- Epinephrine
- Phenobarbital |
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Term
| The statement "Caution: Federal law prohibits teh transfer of this drug to any person other than the patient for whom it was prescribed, is NOT required for... |
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Definition
- Substances used in blinded studies
- Dispensing CV's
- Dispensing controlled substances to be administered to a patient in an institution |
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Term
| To beadmitted to a comprehensive maintenance program, narc-dependent individuals must have physiologically dependent on narcs for at least.... |
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Definition
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Term
| The authority for determining the schedule of a new controlled substances is..... |
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Definition
| The Attorney General of the United States |
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Term
| What sources can be consulted for information concerning bioequivalence of drug products? |
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Definition
- Electronic Orange Book
- USP/DI
- Facts and Comparisons
- FDA Website |
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Term
| What is the BEST resource when determining the preferred name of an additive for a product label? |
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Definition
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Term
| Hippa forms must be kept on file for how many years? |
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Definition
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Term
| Excipients included in pharmaceutical dosage forms are usually found on which list? |
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Definition
| GRAS - Generally Recognized as Safe |
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Term
| What form is used by a hospital to order large quantities of tax-free grain alochol? |
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Definition
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Term
| Who is the regulatory agency that is responsible for OTC advertising? |
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Definition
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Term
| What two reference books are recognized as legal documents by the federal government? |
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Definition
- Homeopathic Pharmacopeia of the US
- USP/NF |
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Term
| Who is authorized to designate the "official" name for a new drug? |
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Definition
Secretary of HHS has the final burden
note: the USAN establishes nonproprietary names, and is sponsored by the AMA, apha, and USPC |
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Term
| The label of a parenteral product is not req. t list the presence of a.... |
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Definition
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Term
| Besides what they already have in stock in the pharmacy , what also must be included in a controlled substance inventory by a pharmacist? |
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Definition
Drugs stored in a warehouse for the registrant at a different location
Drugs ordered by a customer but not yet paid for |
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Term
| What is NOT required to be on the lael of a unit dose package prepared in a hospital? |
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Definition
- MFG expiration date.
- Beyond use expiration date IS required |
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Term
| Uses for tax free alcohol purchased by a hospital may include..... |
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Definition
- Only orders for inpatients
- Anything regarding outpatient orders or selling to it another pharmacy/hospital is FUCKING ILLEGAL
- Must maintain a running inventory as well |
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Term
| What two things apparently do not need to be on the labels of pharmaceutical products? |
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Definition
| - Flavoring oils and inert gasses. |
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Term
| Ephedra may no longer be included in what products in a community pharmacy? |
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Definition
- Dietary Supplements
Note: MAY be in herbal teas and nonprescription drug products, sucka |
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Term
| What kind of practitioners may administer/dispense drugs to patients as part of a narcotic treatment program? |
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Definition
- Pharmacists
- Registered Nurses
- Licensed Practical Nurses |
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