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VI - up to day 7

QuestionAnswer
Medication Therapy Management (MTM): counseling patients to choose, use, and monitor their drug use​ and aims to achieve optimum therapeutic outcomes and reduce adverse events in patients.
Medication Reconciliation: process of reviewing a patient's medication orders alongside all other medications a patient has been taking
American Association of Health-System Pharmacists (ASHP) accreditation organization - represents the interests of pharmacists and pharmacy technicians who practice in hospitals, health maintenance organizations (HMOs), long term care facilities, home care, and other components of healthcare.
EXCPT 100 Questions​ 20 Pretest Questions​ 130 minutes = 2 hour 10 min​ Passing Score: 390/490
PTCB 80 Scored Questions​ 10 Unscored Questions​ 2 hours for the exam (5-minute tutorial, 1 hour and 50-minute exam, and 5-minute post-exam survey).​ Passing Score: 1400/1600
Health Insurance Portability and Accountability Act (HIPAA) act to ensure protection of patient information and confidentiality
Statutes Passed by legislatures(federal & state) and approved by the chief executive 
Regulations Adopted by executive agencies such as FDA, DEA, OSHA, CMS, CDC and the state boards of pharmacy​ - maintains minimum public safety standards
Professional Standards  Requirements set forth by the profession but do not have the force of law.
Standards Sets of criteria used to measure product quality or professional performance against a norm.
Ethics  Standards of personal conduct and professional behavior adopted by the pharmacy profession and associations of pharmacists and pharmacy technicians
Pure Food and Drug Act of 1906  Prohibited the interstate transportation or sale of adulterated or misbranded medications and food.
Federal Food, Drug, and Cosmetic (FD&C) Act of 1938 Enacted to ensure that all medications are pure and safe.
Durham - Humphrey Amendment of 1951  Requires all products to have adequate directions for use unless they contain the federal legend "Caution: Federal law prohibits dispensing without a prescription." Or "RX Only"
Kefauver-Harris Amendment of 1962 Enacted to ensure all medications are pure, safe, and effective.
Comprehensive Drug Abuse Prevention and Control Act of 1970 regulates manufacturing, distribution, prescribing, and dispensing of controlled substances through the Drug Enforcement Administration (DEA). 
Poison Prevention Packaging Act of 1970 (PPPA) Requires most prescriptions for oral use to be dispensed in child-resistant containers unless the patient or prescribers request otherwise 
Drug Listing Act of 1972 All medications are assigned a specific 10-digit identification number known as the National Drug Code (NDC)
Orphan Drug Act of 1983 Provided an incentive for drug manufacturers to develop medications for the treatment, diagnosis, or prevention of rare diseases.
Omnibus Budget Reconciliation Act of 1990 (OBRA '90) Requires Pharmacists to keep patient profiles and records of all medications used by Medicaid patients.
Consolidated Omnibus Budget Reconciliation Act (COBRA) Gives workers and their families who lose their health benefits the right to choose to continue group health benefits provided by their group health plan for limited periods of time under certain circumstances -- such as voluntary or involuntary job loss 
Anabolic Steroid Act of 1990 Classified anabolic steroids as Schedue III controlled substances 
Medicare Modernization Act of 2003 Provides voluntary prescription medication benefits to Medicare benificiaries a.k.a Medicare Part D
Combat Methamphetamine Epidemic Act of 2005 Created a new category of products called Schedule Listed Chemical Product (SLCP) and placed limits on daily and monthly sales
Drug Supply Chain Security Act of 2013 Outlines the critical steps to build a system to identify and trace prescription medications as they are distributed throughout the U.S.
State Boards of Pharmacy Regulate the operation of pharmacy departments, the practice of pharmacy by pharmacists, and the performance of technical functions by pharmacy technicians.
United States Pharmacopeia (USP) Establishes standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements.
National Formulary contains standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements.
USP 795 non-sterile compounding
USP 797 sterile compounding
USP 800 hazardous drugs
The Joint Commission Organization that sets forth standards for hospitals, ambulatory healthcare, behavioral healthcare, critical access hospitals, home care, long-term care facilities, and laboratories.
The National Association of Boards of Pharmacy (NABP) Consists of representation from each state board of pharmacy, U.S. territories, the Bahamas, the 10 Canadian provinces, and Australia's.
Institute for Safe Medication Practices (ISMP) A nonprofit organization dedicated to preventing medication errors.
The Food and Drug Administration (FDA) Federal agency that supervises the development, testing, purity, safety, and effectiveness of prescription and OTC medication
Centers for Medicare and Medicaid Services (CMS) Regulates and administers Medicare, Medicaid, the State Children's Health Insurance Program, HIPAA, Clinical Laboratory Improvement Amendments, and several other programs.
Occupational Safety and Health Administration (OSHA) Ensures safe and healthful working conditions by establishing and enforcing standards.
Policy and Procedure Manual  Pharmacies have Policy and Procedure Manual to establish guidelines for running the facility
USP-NF United States Pharmacopeia (USP) and the National Formulary (NF)
United States Pharmacopeia – Drug Information (USP-DI) A publication available in two versions, patient and professional. Provides prescribing information, interactions, allergies, warnings, and side effects.
Approved Drug Products with Therapeutic Equivalence Evaluations - Orange Book List of all FDA-approved prescription and OTC medication products and rates them for safety and effectiveness, as well as bioequivalence.
American Hospital Formulary Services Drug Information (AHFS-DI) Collection of single-drug entity medication monographs available in print and online versions developed by the American Society of Hospital Pharmacists.
Drug Facts and Comparisons A drug information resource available in print or online versions that contains many facts about product group and individual products and makes Comparisions among them.
Physicians’ Desk Reference (PDR) Reference that lists brand-name and generic-name medications use, side effects, and other pertinent dispensing information; compilation of package inserts
Handbook on Injectable Drugs Lists safety and effectiveness of nonprescription medications, herbal remedies, homeopathic products, nutritional supplements.
Package insert Complete labeling & dispensing information provided by the product manufacturer that includes product description, indications for use, contraindications, warnings, precautions, adverse reactions, dosage and administration, contents, & storage,
Patient Package Insert info provided in package insert in a form that is easier for nonmedical persons to understand
Medication Guide A.K.A. monographs  Required by the FDA to provide vital information to prevent serious adverse effects, influence patient decision making regarding known serious side effects with the products, or patient adherence to directions for use of the products
Red Book provides formulary management and cost containment information
Micromedex application that addresses medication disease and toxicology management and formulary management.
Lexicomp Online comprehensive source of information that includes appropriate dosing and administration of a medication - "Facts and Comparison Off-Label"
Epocrates Online medication and disease information, medication interactions, a pill identifier, and guidelines in the treatment of various health conditions and diseases
Ident-A-Drug online lists tablet and capsule identifications. It includes more than 38,000 listings.
Micromedex's IDENTIDEX identifies medications by shape, color, and imprint. It is a useful resource for law enforcement to identify medication found in the field
Geriatric Dosage Handbook includes information on suggested current dosages for adult patients.
The Merck Manual includes information on diagnosing and treating medical conditions.
Pediatric and Neonatal Dosage Handbook contains information on suggested current dosages for pediatric patients.
CDC Health Information for International Travel - Yellow Book includes health recommendations for international travel published every 2 years.
List of Licensed Biological Products - Purple Book online database that contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products
Approved Animal Drug Products - Green Book list of FDA-approved animal drug products
Capsules Small, oblong, gelatin containers filled with medication.
Tablets Solid dosage forms that vary greatly in shape
Immediate Release active ingredient released in a short period of time, typically 30 minutes or less. ​
Controlled Release release medication over an extended time to avoid high concentrations in the digestive tract or to provide longer durations of action that are available through conventional dosage forms​
Effervescent tablets contain mixture of acids and sodium bicarbonate plus active ingredients
Enteric-coated tablets coated to prevent from dissolving in the stomach, where they may be rendered inactive by stomach acids; dissolve in intestines
Troches and lozenges held in the mouth while they dissolve. Keep medication in contact with the mouth and throat for an extended period
Buccal tablets placed in the area between the cheek and gums
Sublingual tablets placed under the tongue
Orally disintegrating tablets solid dosage designed to dissolve quickly on the tongue, usually in 60 seconds or less.
Films oral medication strip formulated with hydrophilic polymers that dissolve on or under the tongue.
Suspension solid medication particles suspended in a liquid.​ Always add on a "Shake Well" auxiliary label
Elixirs clear, hydroalcoholic (water + alcohol) medications for oral use. Contain flavoring substance
Fluid extracts and tinctures use alcohol, water, or combinations of the two as their base and usually contain plant extracts as active ingredients.
Spirits or essences alcoholic or hydroalcoholic solutions of volatile substances. Contain such a high percentage of alcohol that they require storage in tight containers to prevent evaporation loss
Syrups concentrated solutions of sugar in water with active ingredients. (can also contain alcohol)
Emulsion mixture of oil and water. 
Ointments greasy, usually petroleum jelly base – good for areas that require protection
Creams combinations of water, oil, and other substances.
Lotions are like creams, but they contain more liquid and are applied more easily over larger areas of the body
Liniments mixtures of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application.
Gels semisolid suspension of very small particles, usually in a water base
Collodions liquids that dry as flexible films on skin.
Transdermal Patches topical delivery systems designed for prolonged action. Skin absorbs constant amounts of medication over a time period ranging from 12 hours to several days
Suppositories topical dosage forms; made for insertion into the rectum, others into the vagina.
Vaginal Tablets dissolve in the vagina
Otic ear
Opthalmic: eye
Aerosols sprayable products that use pressurized gas and valve systems to deliver medications
Chewing gum used to administer medication to be absorbed through the mucous membranes of the mouth.
Parenteral medications absorbed outside the enteral or gastrointestinal system; injected directly into the bloodstream using syringes.
Created by: rgvcpharmtech
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