Pharmaceutical Regulations and Compounding Guidelines, Exams of Nursing

Download Pharmaceutical Regulations and Compounding Guidelines and more Exams Nursing in PDF only on Docsity! NHA:PHARMACY TECHNICIAN EXAM LATEST VERSION 2024 QUESTIONS AND ANSWERS DEA form 106 - ANSWER>>report of theft or loss of controlled substances DEA form 41 - ANSWER>>request permission to destroy exp C-2 DEA form 224 - ANSWER>>Apply for a DEA registration number (to disp control) DEA form 222 - ANSWER>>Order form for CI and CII substances. Must be kept for 2 years. Medicare part A - ANSWER>>hospital insurance Medicare part B - ANSWER>>-physicians services -diabetic services -specialty meds -medical equipment Medicare part C - ANSWER>>provides supplemental coverage allow patients to participate in HMO/PPO for extra cost Medicate part D - ANSWER>>Prescription drug coverage (insulin, vaccines..) DAW 0 - ANSWER>>no product selection indicated, generic ok, pt ok DAW 1 - ANSWER>>substitution not allowed by prescriber, fill exactly as written DAW 2 - ANSWER>>substitution ok, but pt request that brand be disp'd DAW 3 - ANSWER>>substitution ok, but pharmacy fills brand even though generic is available DAW 4 - ANSWER>>Substitution allowed - generic drug not in stock DAW 5 - ANSWER>>substitution allowed but pharmacy uses the brand DAW 6 - ANSWER>>override DAW 7 - ANSWER>>substitution not ok, brand mandated by state DAW 8 - ANSWER>>substitution ok, brand disp'd because generic is not manufactured DAW 9 - ANSWER>>other Drug Utilization Review (DUR) - ANSWER>>(pharmacist's job) reviewing the patient's profile with medication to ensure safety How many hours of CE are technicians required to complete? How often? - ANSWER>>20 hours every 2 years Adjudication - ANSWER>>submitting 3rd party insurance claim for payment How are legend and controlled prescriptions filed? - ANSWER>>legend are filed together, c-ii are filed separately, and c-iii to c-iv are filed together ad - ANSWER>>right ear as - ANSWER>>left ear au - ANSWER>>both ears bu - ANSWER>>buccal USP 800 - ANSWER>>handling hazardous drugs Who releases medication recalls? - ANSWER>>the FDA Class 1 medication recall - ANSWER>>serious adverse effects or death, customer level Class 2 medication recall - ANSWER>>temporary adverse effect or a small chance of an adverse effect Class 3 medication recall - ANSWER>>problem not likely to cause adverse effects Department of transportation (DOT) - ANSWER>>regulates how medication waste should be shipped P-listed - ANSWER>>acutely hazardous waste (epinephrine, nicotine, warfarin) D-listed - ANSWER>>toxic, ignitable, corrosive (benzoyl alcohol, albuterol inhaler) U-listed - ANSWER>>toxic (chemotherapy) What is on a patient profile - ANSWER>>(basic demographic info) name, address, DOB, phone#, email types of drug interactions - ANSWER>>drug-drug drug-age drug-health condition NKDA - ANSWER>>no known drug allergies to all drugs NKA - ANSWER>>no known allergies to anything Trissel's Handbook on Injectable Drugs - ANSWER>>Provides information on the stability and compatibility of injectable drugs post - ANSWER>>after, behind peri - ANSWER>>around, surrounding how to dispose of antibiotics - ANSWER>>mixed with coffee grounds or soaked in water how to dispose of warfarin - ANSWER>>hazardous, so meant to be placed in a specific bin for professional disposal how to dispose of chemotherapy - ANSWER>>yellow sharps container how to dispose of fentanyl patches - ANSWER>>flush down toilet USP - ANSWER>>United States Pharmacopeia: info about product, med quality standards, and info about legend + OTC Pink book - ANSWER>>provides info about vaccines and diseases The Merck Index - ANSWER>>lists chemical attributes of chemicals, meds, and biologicals barbiturates - ANSWER>>central nervous center depressant, used to treat seizures and anxiety medicaid - ANSWER>>health care coverage for low income children, adults, elderly, and people with disabilities National Formulary (NF) - ANSWER>>list of officially recognized names of drugs that have an established usefulness how often is the national formulary updated - ANSWER>>every 5 years PDR (Physician's Desk Reference) - ANSWER>>The most widely used refernces for drugs in current use. Who act created the FDA - ANSWER>>Pure Food and Drug Act of 1906 Pure Food and Drug Act of 1906 - ANSWER>>prevented the adulteration and mislabeling of foods and pharmaceuticals The Joint Commission - ANSWER>>Independent non-profit organization, sets healthcare quality standards and protects patients and visitors, conducts inspections of healthcare facilities. tort - ANSWER>>act that causes harm/injury to a person intentionally or negligently Harrison Narcotic Act of 1914 - ANSWER>>curb the recreational use of opium, established that opiums cannot be purchased without an rxs Federal Food, Drug, and Cosmetic Act of 1938 - ANSWER>>created because the pure food and drug act was not worded strictly enough, emphasized adulteration and misbranding Durham-Humphrey Amendment of 1951 - ANSWER>>required all rx drugs to be labeled "caution: federal law prohibits dispensing without an prescription", created the distinction between legend and OTC Kefauver-Harris Amendment of 1962 - ANSWER>>ensured that drugs be proven safe and effective, gave FDA authority to approve manufacturers marketing Safety Data Sheet (SDS) - ANSWER>>info on all potentially dangerous chemicals used in the workplace, enforced by OSHA required on a unit dose label - ANSWER>>drug name strength dosage form lot # manufacturer exp date Category A pregnancy risk - ANSWER>>controlled studies in humans show no risk to the fetus Category B pregnancy risk - ANSWER>>No controlled studies have been conducted in humans; animal studies show no risk to the fetus Category C pregnancy risk - ANSWER>>Risk in animals; little human data; most drugs are here Category D pregnancy risk - ANSWER>>Positive evidence of human fetal risk. Use only if no other choice Category X pregnancy drugs - ANSWER>>Bosentan (anti-endothelin, anti- pulmonary hypetensive) Statins Warfarin Category X pregnancy risk - ANSWER>>Risks involved in drug use clearly outweigh potential benefits, NEVER use by pregnant women Medwatch - ANSWER>>This is the FDA reporting service for adverse effects that occur from use of approved drugs. who can report to medwatch - ANSWER>>anyone National Provider Identifier (NPI) - ANSWER>>Unique 10-digit code for providers required by HIPAA. Yellow book - ANSWER>>CDC's standard resource on travel information Red book - ANSWER>>provides the latest pricing information, including nationally recognized AWP's and suggested retail prices for OTC products black box warning - ANSWER>>warning, required by FDA, to alert prescribers of serious adverse events that have occurred USP 797 - ANSWER>>Guidelines for sterile compounding USP 795 - ANSWER>>guidelines for non-sterile preparations what drugs should be dispensed in original packaging - ANSWER>>Nitrostat(nitroglycerin) Pradaxa, anticoagulant birth control NIOSH (National Institute for Occupational Safety and Health) - ANSWER>>created by OSHA to help develop work safety standard DEA 225 - ANSWER>>needed to manufacture or distribute controlled substances dosage forms - ANSWER>>solids, semisolids, solutions sublingual - ANSWER>>under the tongue buccal - ANSWER>>between the cheek and gum what are sublingual tablets meant to do - ANSWER>>dissolve fast, absorb directly into bloodstream w/out passing digestive tract what are buccal tablets meant to do - ANSWER>>dissolve slowly, absorb into bloodstream w/out passing digestive tract what are controlled release meds do - ANSWER>>med is released over extended amount of time to avoid concentrations in digestive tract/provides longer duration of action LA - ANSWER>>long action SA - ANSWER>>sustained action SR - ANSWER>>sustained release CR - ANSWER>>controlled release ER - ANSWER>>extended release TR - ANSWER>>time release effervescent tab - ANSWER>>dissolve into water, fizzy enteric coated tab - ANSWER>>protective out later so tab doesn't dissolve in stomach, dissolves in stomach emulsions - ANSWER>>liquid mixture of oil and water pastes - ANSWER>>stiff ointment that doesn't melt at body temp. syrups - ANSWER>>concentrated mix of sugar and water with active ingredients EXPECT - ANSWER>>expectorant (cough med used to help clear muccus) PULV - ANSWER>>powder SL - ANSWER>>sublingual AB rating - ANSWER>>rating from FDA stating there is adequate evidence supporting bioequivalence of brand and generic what insurance is typically billed first? - ANSWER>>Medicare Medicare - ANSWER>>for those who are: older than 65 disabled and unable to work have end-stage renal disease end-stage renal disease - ANSWER>>terminal disease what two parts of medicare does the pharmacy focus on most - ANSWER>>part B(DME) and D(drugs) DME - ANSWER>>durable medical equipment COB - ANSWER>>coordination of benefits proper sequence of COB - ANSWER>>medicare -> commercial insurance (BCBS, cigna etc) -> medicaid Medicaid - ANSWER>>for those with low income, or with mental or physical disabilities automated dispensing machines - ANSWER>>cabinets with various drawers for different medications Risk Evaluation and Mitigation Strategies (REMS) - ANSWER>>Program of the FDA, designed to monitor drugs that have a high risk compared to benefit ratio what medications should be dispensed in its original container - ANSWER>>- nitrostat(nitroglycerin) sublingual tab -pradaxa(dabigatran) disp to protect from degration and moisture -suspensions -zpak, medrol, accutane teratogenic - ANSWER>>producing malformations (in the developing embryo) insulin must be stored at (temp) - ANSWER>>36-46 degrees farenheit APAP - ANSWER>>Acetaminophen (Tylenol) medication guide - ANSWER>>consumer info on safe use of high risk meds antieoplastic - ANSWER>>chemotherapy (must use PPE to handle) antiretroviral - ANSWER>>used to manage HIV infections what is the first prescription # for a legend drug - ANSWER>>6 what is the first prescription # for an OTC drug - ANSWER>>7 1lb = ____ oz - ANSWER>>16 oz 1Tbsp = ___tsp - ANSWER>>3 tsp 1tbsp=____ml - ANSWER>>15 ml 1 fl oz = ___ mL - ANSWER>>30 ml 20 gtt = ___ml - ANSWER>>1 ml 1 cup = 8 oz = 1/2 pint = ___ml - ANSWER>>240 ml 1 oz = ___g - ANSWER>>30 g 2.2lbs = ____kg - ANSWER>>1kg 1 in = ____cm - ANSWER>>2.54 cm temperature conversion equation - ANSWER>>5F = 9C + 160 standard precations - ANSWER>>created by the CDC to protect healthcare workers Bloodborne Pathogen Standard - ANSWER>>federal law requiring that healthcare facilities protect employees from bloodborne health hazards Garbing order - ANSWER>>shoe cover, hair cover, beard cover, mask, gown, gloves how often should laminar hoods be cleaned - ANSWER>>-at the beginning of each shift -before each batch preparation -every 30 minutes during continuous compounding of a single CSP how often should the ceilings be cleaned in compounding areas - ANSWER>>monthly ISO 8 - ANSWER>>anteroom how often should HEPA filters be inspected and certified - ANSWER>>every 6 months HEPA filters - ANSWER>>remove bacteria from the air BUD date for nonsterile, semisolid prep with h2O - ANSWER>>30 days critical site on a syringe during sterile compounding - ANSWER>>syringe plunger what is used to dilute hydrocortisone ointment - ANSWER>>petroleum jelly what must unit dose systems include - ANSWER>>-product identification -environmental exposure -usability -handling what could be the reason that patients run out of medications faster than expected? (rf too soon) - ANSWER>>-prescriber has increased the dose but pt has not given the new prescription to the pharmacy -pt taking more than prescribed -pt misunderstands proper use of medicaiton -pt is diverting or abusing the med what could be the reason why patients may be taking less medication than they should? - ANSWER>>-they cannot afford it -they experience side effects they do not like -the prescriber has reduced the dose but the new prescription has not been given to the pharmacy -pt may be forgetting to take their medications why do SSRIs need to be dispensed with a medguide - ANSWER>>increased risk of suicidal thoughts in adolescents why do NSAIDs need to be disp w/ medguide - ANSWER>>risk of GI bleeding why does isotretinoin need to be disp w/ medguide - ANSWER>>risk of birth defects why do fluoroquinolones need to be disp w/ medguide - ANSWER>>risk of tendinitis why does eszopiclone need to be disp w/ medguide - ANSWER>>risk of sleep related activities you may not remember why does metoclopramide need to be disp w/ medguide - ANSWER>>risk of tardive dyskinesia (face/body making irregular movements that you cannot control) why does rosiglitazone need to be disp w/ medguide - ANSWER>>risk of heart failure layout of hospital pharmacy - ANSWER>>pu window, data entry area, disp area, nonsterile compounding area, sterile compounding area taking too much acetaminophen can result in - ANSWER>>liver toxicity, especially with alcohol intake how stable are multidose vials for after they're opened - ANSWER>>28 days where to report adverse affects to vaccines - ANSWER>>Vaccine Adverse Event Reporting System (VAERS) what do all antidepressants require - ANSWER>>a black box warning laminar flow air hoods should run for ____mins before compounding - ANSWER>>30 minutes what program sponsored by the FDA regulates the disp of isotretinoin(accutane) for severe adverse effects - ANSWER>>iPledge colace treats - ANSWER>>constipation immodium treats - ANSWER>>diarrhea mucinex treats - ANSWER>>congestion which insurance allows a pt to see a specialist without a referral - ANSWER>>PPO Examples of SSRIs - ANSWER>>fluoxetine (Prozac) sertraline (Zoloft) paroxetine (Paxil) fluvoxamine (Luvox) V - ANSWER>>5 X - ANSWER>>10 C - ANSWER>>100 L - ANSWER>>50 D - ANSWER>>500 M - ANSWER>>1000