Updated (2022) Comprehensive Exam for the Certification of Pharmacy Technicians/ Exam for the Certification of Pharmacy Technicians (ExCPT). Over 700 QnA.

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Federal Food and Drug Act FDA - Series of consumer protection laws - led to creation of the FDA - banned foreign and interstate traffic in adulterated or mislabeled food and drug products - Produ... cts had to be inspected and offenders where prosecuted - Active Ingredients had to be placed on labels of packaging - drugs can not fall below purity levels set by United states pharmacopoeia or national Formulary - Health Insurance Portability and Accountability Act - HIPAA - Provides the ability to transfer and continue health insurance coverage for millions of American workers and families when they change or lose jobs - reduces Health care fraud and abuse - Mandatory Industry Wide standards for health care information and electronic billing processes - requires the protections and confidential handling of protected health information Omnibus Budget Reconciliation Act OBRA - Allowed Workers and Families to keep their group coverage in cases of volentary or involentary job loss - in case of reduced hours worked - job transitions - give workers who lost their health benifits right to choose to continue plans under certain circumstances - required under businesses with 20+ employees - applies to both government and private sector - set period of time, maybe influenced by circumstances OBRA 90 - placed regulations on how to interact with patients - record keeping mandates, prospective drug reviews - counseling obligations - must review medicaid participants enire drug profile before prescribing medications Medicaid - Social Health care program for families and individuals with low income + recources - government insurance for people of all ages who can not afford sufficient health care - varies from state to state --> joint funded between state and federal - must be US citizens or legal permanent residents - Medicare - National Social Insurance Program - administered by US government - provides health insuracne for Americans aged 65+ - members must have worked and payed for the system - provides health insurance for younger people with disabilities - Disability - Form of Insurance that insures the beneficiaries income against the risk that disability creates a barrier for a worker to complete the core functions of their work - encompasses paid sick leave, short term disability benefits, and long term disability benifits - U.S. Social Security Act - Social Welfare Legislation Act - provides federal assistance to those who can not wotk - Combat Methamphetamine Epidemic Act - enacted to curb the growing problem of underground manufacture of illegal drugs - regulates over the counter products that can be used to make drugs - include daily sales limits and 30 day purchase limits - places products out of easy reach - sale logbooks - customer ID verification - training of employees and sellers - Sale of Ephedrin - sale is limited to behind the counter - must present photo ID - stores require to keep personal information on buyers for at least 2 years - sales allowed in drive through lanes U.S. Merck + co - An American pharmaceutical company - one of the largest in the world - publishes Merck Manuals --> a series of reference books for medical professionals - Merck Index -->list of chemical compounds --> lost Poison prevention Packaging Act PPPA - requires use of child resistant packaging for prescription drugs, OTC, household chemicals, and hazerdous materials - some drugs are exempt from child proof packaging --> OTC drugs with the proper labeling not for children and in big enough packages Kefauver - Harris Act - requires drug manufacturers to provide proof of their effectivness and safety before approval - requires drug advertisements to disclose side effects - stopped cheap generic drugs from being marketed as more expensive drugs and taking credit as breakthrough medications Controlled Substances Act CSA - federal US drug Policy - manufacture, importation, possession, use and distribution of certain substances is regulated - created 5 classifications of schedules - all controlled substances need to be inventoried Biannually Schedule I Drugs - High Potential for abuse - no potential medical use or treatment in US - lack of accepted safety for use of drug under medical supervision - No prescriptions may be written for drug - Crimes involving drugs can be quite serious Schedule II Drugs - Drugs have high potential for abuse - Drugs have currently accepted medical uses, although there may be serious restrictions - Abuse of drug may lead to severe psychological or physical dependence - may not be used unless directly dispensed by a practitioner - refills not allowed --> must write multiple prescriptions at once - must be stored in a safe, while other schedules can be stored throughout pharmacy Schedule III Drugs - has potential for abuse, but to a lesser degree than schedules I + II - drug has an accepted medical treatment - abuse of drug may lead to moderate or low physical dependency or high psychological dependence - may not be dispensed without a prescription - may not be dispensed six months after prescription written - may not be refilled more than 5 times - may be prescribed orally or over phone Schedule IV Drugs - low potential for abuse - has currently accepted medical use - abuse may lead to limited physical or psychological dependence - can be refilled up to five times after 6 months written or orally Schedule V Drugs - low potential for abuse - currently accepted medical use - limited dependence - may be dispensed without medical reason - orally or written DEA form 222 1 + 2 order form - Order Forms for Schedule 1 and 2 drugs - used to order from another registrant retail and hospital pharmacies - wholesaler or retailers use this form - forms need to be maintained for 2 years --> all forms Standard Invoice ... DEA form 69 ... DEA Form 41 form of controlled substances inventory and destruction - registers inventory of controlled substances - used to return drugs to DEA or acceptable recipients - documents surrender or destruction of controlled substances - forwarded to DEA for disposal DEA 82 form of inspection - Notice of Inspections of controlled premises - informs registrant an inspection will be made DEA form 104 surrender and close - Voluntary surrender of controlled substance privileges - used to surrender permit to the DEA on a voluntary basis - used to close pharmacys DEA 106/666 loss or theft - report loss or theft of controlled substances - Report discovered shortage of controlled substances DEA 222a - used to obtain DEA 222 form from DEA DEA 224 license form - institutions - new Application for registration of controlled substances act - Form used by retail pharmacies, clinics, hospitals, practitioners, and teaching institutions, - to get license to obtain or dispense controlled substances DEA 225 license form sellers New application for registration used by manufacturers, distributors , wholesalers, importers, exporters, researchers - to obtain and use controlled substances DEA 226 application for re-registration of controlled substances - privileged by retail pharmacies, hospitals, practitioners or teachers to obtain or dispense controlled meds DEA 363 narcotics for pharmacy programs - Registration for narcotic rx programs - used to obtain approval narcotic rx program using controlled substances Ordering and recipt of samples Only a practicioner who has been issued individual DEA numbers are authroized to recieve any controlled substances in a sample, starter pack, or any container - Only those with industrial prescribing authority are allowed to order / receive any dangerous drug sample/starter pack Insulin Storage - recommended temperature is 36 - 46 Farenheit --> unopened --> till expiration date - Vials and cartiridges should be 59 - 86 up to 28 days - if altered only two weeks - loses effectivness when exposed to extreme temperatures or sunlight - keep as cool as possible, but not frozen - Capsule sizes - size 5 is the smallest --> bigger numbers are smaller - su07 is the largest - length and diameter increase as number goes down - starts over again at 13 and goes down to 7 - four types of 0 in the middle - two 7s (su07) and 2 12s (12el) Capsule Information - both types of capsules made from aqueous gelling agents --> mainly gelatin but sometimes cellulose - Hard Shelled Capsules - made of gelatin - contain dry powdered ingredients - made in two halves --> lowered body is filled - then sealed by higher diameter cap Soft Shelled Capsules - primarily used for oils and active ingredients that are dissolved or suspended in oil - Single piece encapsulating method - sealed with a single drop of gelatin - DEA numbers - assigned to health care providers by the DEA allowing them to write prescriptions for controlled substances - legally used solely to track controlled substances - Also used by the Industry as general prescriber numbers -->unique identifier for anyone who can prescribe medications - DEA sections - Contains 2 letters and 6 numbers and 1 check digit - First Letter is code identifying type of registrant --> letters A - X depending on job type - Second Letter is the first letter of the registrants last name - seventh number is the checksum Seventh number, check sum - sum of digits 1, 3, 5 - then sum the digits of 2, 4, 6 and multiply by 2 - add the two sums together = CHECK - Right most digit of the CHECK number is the 7th digit MSDS material safety data sheet - material safety data sheet - component of product stewardship, occupational safety and health, and spill handling procedures - catalog information on chemicals, compounds, and mixtures - info on safe use and potential hazards - should be available for reference where chemicals are being stores - for work settings Drug Drug interactions - when ever two or more drugs are taken, there is a chance that there will be interactions - may increase or decrease the effects of intended uses and side effects - more drugs taken more likely interactions will occur - Ways drug drug interactions occur - absorption rate into the body - distribution of drug throughout the body - alteration made to drug in body --> metabolism - elimination of drug from the body Contraindicated - Never take these drugs together - high risk for dangerous interaction - contra bad Serious - Potential for serious interaction - regular monitoring by doctor is required - alternate medicine may be necessary - monitering by serious black Significant - Potential for significant interaction - monitoring by doctor likely required Minor - Interaction is unlikely, minor, or insignificant A - Depreciated - used by some older entities B Hospital/clinic C Practitioner D Teaching Institution E Manufacturer F Distributor G Researcher H Analytical Lab J Importer K Exporter L reverse Distributor M Mid level Practitioner P, R, S, T, U Narcotic Treatment Program X Suboxone/Subutex Prescribing Program First Shift 7am - 3pm - morning shift Second Shift 3pm - 11pm - afternoon shift - also called swing shift third shift 11pm - 1am - night shift Medication carts - distributed from pharmacy throughout the facility - 24 hours worth of medication included in each cart - FDA Class I Recall - Dangerous products that could cause serious health problems or death - contain toxins, allergens, label mix ups, defects FDA Class II Recall - for products that might cause a temporary health problem - pose slight threat of serious nature - FDA Class III Recall - For products unlikely to cause any adverse health reactions - still violate FDA labeling and manufacturing laws - container defects, lack of proper labeling, wrong color/taste FDA Class Recalls - company can call a recall on their own after discovering flaw - FDA can call a recall - if recall is not done FDA can call a seizure of product - must quickly remove products that are potentially dangerous from the market - Firms must take full responsibility for removal of dangerous products - Drug Expiration Guidelines - Final day the manufacturer guarantees the drug to perform at full potency and safety - exist on medication labels --> required by law - no recommendation about drug given after expiration - drugs typically last 12 - 60 months - after container is opened, expiration no longer reliable - shelf life may actually be longer than expiration date - If just the month and year are indicated --> drug can be used or dispensed until the last day of that month Strenght of solutions - need to be calculated in grams/ml Business days - do not include weekends - day an order arrives does not count as a business day - do not include federal holidays - AMA - American Medical Association - largest associations of physicians and medical students in US - promote art and science of medicine to better public health - advance interests of physicians and patients and lobby for favorable legistlation - raise money for medical education - Publishes JAMA, Largest circulation of any weekly medical journal PFC - Pharmacy Formulary commitee - lists all mediciens - annualy updates drugs and ingredients - standards must be met for strength, quality, and purity HPhA - Hospital Pharmacist Association - Professional organization that represents the interests of pharmacists who practice in hospitals, health maintanence, long term care facilities, home care - P&T - Pharmacy and Therapeutics commitee - comittee at a hospital or insurance plan that meets to decide what drugs will appear at that entities drug formulary - consists of physicians and pharmacists - weigh cost benifits of each drug and decide which to use NDC - National Drug Code - unique product identifier for drugs intended for human use - registered drug establishments must provide FDA with a current list of all drugs manufactured - 10 digit, 3 segment numeric identifier assigned to each medication - once an NDC is assigned to a product, it may not be reused - sometimes referred to as the drug listing act of 1972 - for coding NDC segment 1 - first segment is the labelor code - 4 or 5 digits - assigned by FDA upon submission of a labelers code request - labeler is any form that manufactures, repacks, or distributes a drug product Second segment - Product Code - 3 or 4 digits long - identifies a specific strength, dosage form, and formulation for a particular firm - assigned by the labeler third segment - Package code - 1 or 2 digits long - identifies package forms and sizes - assigned by the labeler Orange Book - Approved drug products with therapeutics equivalence evaluations - identifies drugs approved on basis of safety and effectiveness by FDA - lists patents Red Book - Multi volume treatise outlined fiscal law - pricing and product information for drugs - answers commonly asked question Therapeutic Equivalence Index - for generic drugs PDR Physicians Desk Reference - commercially published compilation of manufacturers prescribing information, package inserts on prescription drugs - provides physicians with list of fully mandated information for writing prescriptions - widely available in libraries and bookstores - Auxiliary labels For the X - easily identifiable stickers --> bright colors with easily identifiable graphics - available in Spanish and french - contains warnings, Instructions for route of admission, Dietary information - short to the point phrases PTCB Certification - every 2 years a minimum of 20 hours of continued education is neceassary - 1 hour must be on patient safety Min/Max inventory size - the min is the numerator --> once point is reached a new order is needed to be placed - max is denominator --> what the new order would reach up to PPPA exception - nitroglycerin SL - aspirin or acetaminophen -- powder or tablets isosorbid dinitrate - erythromycin ethyl succinate - potassium supplements - sodium flouride - betamethasone - oral contraceptives - pancrelipase - anhydrous cholestyramine - hormone replacement therapy - sucrase - estrogen tablets - https://quizlet.com/10156794/pppa-exemptions-flash-cards/ Medicare Part A - Hospital Insurance covers most medically necessary hospital care, skilled nursing facilities, home health and hospice care - Free if you have worked and paid social security for more than 10 years (40 calender quarters) - if less than montly premium will be paid Medicare Part B - Medical Insurance covers most medically necessary doctor, preventative care, medical equipment, hospital outpatient services, lab tests, mental health care, and home + ambulance - always pay montly premium Medicare Part C - Part of policy that allows private insurance companies to provide Medicare benifits - not a seperate benifit - include HMOs and PPOs - known as Medicare Advantage plans Medicare Part D - outpatient prescription drug insurance - provided only through private insurance companies that have contacts with the government - never directly provided by the government - must choose coverage that works with Medicare benifits Durham - Humphrey Amendment - Defined two specific kinds of medications - Legend drugs ( Prescriptions - Over the counter Drugs - legend drugs include drugs with habit forming or harmful side effects tall Man lettering Practice of writing part of a drugs name in upper case letters to help distinguish drugs that sound and look alike - to avoid errors - only for portion of drug name that are similar [Show More]

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