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1990 Omnibus Budget Reconciliation Act(OBRA)
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Drug rating X
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PTCB study I
take home review packet definitions
| Question | Answer |
|---|---|
| 1990 Omnibus Budget Reconciliation Act(OBRA) | Required Pharmacists to provide counseling to medicaid patients |
| Drug rating X | The drug is extremely harmful during pregnancy |
| First 5 numbers of National Drug Code (NDC) | Describes the manufacturer of the drug |
| Second set of numbers of National Drug Code (NDC) | Indicates the medication, its strength, and dosage form |
| Last set of numbers of National Drug Code (NDC) | Indicates the package size |
| Drug Facts and Comparisons | Most reliable refgerence book in most cases |
| C-1 | Drugs that have no recocnized medical us in the US |
| C-II | Drugs that have high abuse potential, but have currently accepted medical us in the US |
| NACDS | National Association of Chain Drug Stores |
| DEA | Drug enforcement agency |
| AphA | American Pharmaceutical Association |
| NDC | A national drug number that identifies drugs approved by the FDA |
| UPC Code | Tracking code on a product that is a barcode and can be scanned |
| COGS | Cost of goods sold |
| Wholesale price | The amount the pharmacy pays for an item |
| CE Units | Continuing education units required to maintain license |
| Perpetual inventory | Inventory which is continually tracked so that you always have a current record of product on hand |
| Allowable Charge | The maximum amount an insurane company will reimburse for a drug |
| Net Price | The list price minus any trade discount |
| MEC | Minimum effective concentration |
| MTC | Minimum toxic concentration |
| MAR | Medication Administration Record |
| ASHP | American Society of Health-system pharmacists |
| Absorption | Movement of drug from dosage formulation to blood |
| Active Transport | Movement of drug molecules across membranes by active means |
| Additive Effects | The increase in effect when two drugs of similar actions are taken |
| Admixture | The resulting solution when a drug is added to a parenteral solution |
| Agonist | Drugs that activate receptors to accelerate or slow normal cell function |
| Anhydrous | Without water molecules |
| Bioavailability | The relative amount of an administered dse that reaches the general circulation and the rate that this occurs |
| Bioequivalence | The comparison between bioavailability between two dosage forms |
| Closed formulary | A limited list of medications approved by the PBM |
| Duration of Action | The time a drug concentration is above the minimum effective concentration (MEC) |
| DEA Number | Required on all controlled drug prescriptions, identifies the prescriber |
| Enterohepatic cycling | The transfer of drugs and their metabolites from the liver to the bile in the gallbladder |
| First Pass Metabolism | The substantial degradation of a drug caused the the enzyme metabolism in the liver before the drug reaches the sytemic circulation |
| Geometric Dilution | Blood filtering process of the kidneys |
| HEPA filter | High effeciency particulate air filter |
| Hypertonic | A solution that has greater osmolarity than blood |
| Orange Book | The common name for the FDA's approved drug products |
| Teratogenecity | The ability of a substance to cause abnormal fetal development |
| TPN | Total parental nutrition |
| Adverse effect | An unintended side effect of a medication that is negative or in some way injurious to a patient |
| Alimentary tract | The organs from the mouth to the anus. |
| TRUE/False The GI tract is part of the alimentary tract | True |
| Ampule | Sealed glass container with an elongated neck that must be snapped off |
| Antagonist | A drug that binds with receptors but does not activate them. Prevents them from being activated |
| Antibiotic | A substance which harms or kills microorganisms like bacteria of fungi |
| Antidote | A drug that antagonizes the toxic effect of another drug |
| Aqueous | Water-Based |
| Aseptic Technique | Methods used to maintain the sterile conditions of a product |
| Automated Dispensing System | A system in which medications are dispensed from an automated unit at the point of use |
| Auxiliary label | A label which can be affixed to a prescription container which contains specific warnings to assist patient compliance with taking medications |
| Body surface area (BSA) | A measure used for medication dosing which takes into consideration a patient's height and weight. Measured in square meters. |
| Concentration | The strength of a solution |
| Diluent | A solvent that dilutes a freeze-dried substance or dilutes a solution |
| Extemporaneous compounding | The on-demand preparation of a product |
| Flow rate | The rate in ml/hr or ml/min at which a solution is administered to a patient |
| Gauge | A measure for needles; the higher the gauge the smaller the needle |
| Health Information Portability and Accountability Act (HIPAA) | A federal act that protects patients privacy |
| Hypotonic | A solution which has lower osmolarity than blood |
| Infusion | The gradual intravenous injection of a volume of fluid |
| Isotonic | A solution which has the same osmolarity of blood |
| Legend drug | Any drug which requires a prescription |
| Look-alikes | Drug names that have similar appearance, especially when in written form |
| Material Safety Data Sheets (MSDS) | Required notices for hazardous substances |
| Meniscus | The curved surface of a column of liquid |
| Milliequivalet (mEq) | A unit of measure for electrolytes in solution |
| Parental | A route of administration to any organ outside of the alimentary tract |
| Passive Diffusion | The movement of drugs from an area of higher concentration to lower concentration |
| Pharmaceutical alternative | Drug products that contain the same active ingredients, but not necessarily the same amount or same dosage form |
| Pharmaceutical equivalent | Drug products that contain identical amounts of the same active ingredients in the same dosage form |
| Signa | The directions for use on a prescription |
| Solvent | A liquid that dissolves another substance in it |
| Therapeutic equivalent | Pharmaceutical equivalents that produce the same effects in patients |
| False-Only a pharmacist may do this | True/False A pharmacy technician can take a new prescription order or refill order via the telephone. |
| True | True/False Only pharmacists may provide confidential information to other health professionals or insurance companies. |
| FDA | Public health agency charged with protecting American consumers by enforcing the federal, food, drug and cosmetic act along with several public health laws. |
| Adulterated | Presence of any decomposed substance, packaging under unsanitary conditions or if the products strength or purity is different from what is indicated on the label |
| Misbranding | When the label is false or misleading or when proper warnings and directions are absent |
| FDA | This agency approves new drug entities |
| FDA | This agency regulates drug package inserts |
| FDA | This agency regulates the advertising of drug entities |
| FDA | This agency issues recalls on affected medications and medical supplies |
| State Board of Pharmacy (BOP) | This agency issues licenses for a pharmacist to practice or for a new pharmacy to open |
| State Board of Pharmacy (BOP) | This agency is responsible for enforcing laws passed by state legislature and extracting penalties for violations |
| Pharmacy Practice Act (Practice Act) | Sets forth rules and definitions involved in the practice of pharmacy |
| Administrative Code (Disciplinary guideline) | Document that list the penalty associated with each violation of the practice act |
| State controlled substances act | Companion to the Federal Controlled Substances Act explaining what drug entities the State has designated as it's own controlled substances. |
| The federal food and drug act(1906) | Prohibited sale of misbranded or adulterated food, drinks, and drugs. Required government pre-approval of drugs before being released to the public for sale |
| 1911 Amendment to the federal food and drug act of 1906 | required manufacturers and distributers to provide scientific proof for the claims made on their products. |
| The Federal Food, Drug and Cosmetic Act (FDCA) 1938 | Legislation that replaced the 1906 federal food and drug act. added a statute requiring that all drugs must be proven safe before being sold |
| The Durham-Humphrey Amendment (1951) | Amendment to the FDCA requiring that instructions be printed clearly on the manufacturers label. created a class of legend drugs that we now know as prescription drugs. Required legend drugs to be labeled with RX only |
| The Kefauver-Harris Amendment (1962) | Amendment to the FDCA that Required proof of effectiveness and safety before a drug could go to market gave prescription drug advertising regulation to the FDA. Required tax stamps to help stop illegal trafficking |
| The drug abuse control amendment DACA (1965) | Amendment to the FDCA that required barbiturates and stimulant drugs to need a prescription. Also excluded the need for tax stamps because congress was now responsible for regulating interstate commerce |
| The controlled substance act (CSA) (1970) | Replaced the Harrison and DACA. Requires record keeping and registration requirements of sufficient detail to be able to track transactions between manufacturers, suppliers, practitioners, and consumers. Originated the concept of the DEA number |
| The poison prevention act (PPPA)(1970) | Intended to decrease accidental poisonings from prescription medications. Required locking caps on all prescriptions dispensed from the pharmacy |
| What are the 3 exceptions to the poison prevention act? | When a patient asks for a non-safety lid, when a prescriber asks for a non-safety lid, and when the drug dispensed is an exempted drug. |
| Joint Commission on accreditation of Healthcare Organizations (JCAHO) | Non governmental organization which conducts voluntary certification inspections on nearly 20,000 health care organizations |
| Third party audits | pharmacy system of check and balance that verifies that the claim submitted and paid was correct and reasonable |
| Employer Audits | Pharmacy's policy and procedure manual |
| Patient Package Inserts (PPI's)(Monographs) | insert explaining product description, side effects, interactions, contraindications, side effects, dosage time and frequency |
| Occupational and Safety Act of 1970 (OSHA) | requirements for workplace safety |
| How long must HIPAA documents be retained? | 6 years |
| FDA's reporting system for adverse events (founded in 1993) | MedWatch |
| Which class of recall does this fall into: There is a strong likelihood that the product will cause serious adverse effects or death | Class I |
| Which class of recall does this fall into: The product may cause temporary but reversible side effects; or in which there is little likelihood of serious adverse effects | Class II |
| Which class of recall does this fall into: The product is not likely to cause adverse effects | Class III |
| Phase I of the new drug application process | Which phase of the NDA has trials that involve a very small number os healthy volunteers to determine maximum tolerated dose. Not designed to address the efficacy of the drug. Usually takes place at a single research facility. |
| Phase II of the new drug application process | Which phase of the NDA has trials that are primarily concerned with the effectiveness of the drug. Uses volunteers from the intended disease group. Usually several hundred individuals. |
| Phase II of the new drug application process | Which phase of the NDA has trials that use several thousand individuals and is usually done in a double blind set up. Usually done all over the country and pits the new drug against another drug |
| What is the average length of time for the Pre-clinical phase of NDA approval | 6 to 7 years |
| What is the average length of time for the Phase I process of NDA approval | 1 to 2 years |
| What is the average length of time for the Phase II process of NDA approval | 2 to 3 years |
| What is the average length of time for the Phase III process of NDA approval | 3 to 4 years |
| What is the total average length of time for the NDA approval process | 12 to 16 years |
| What is the term of a new patent | 20 years from the date on which the patent was filed |
| Who is required to have a DEA number | any practitioner who is registered by the state in which they practice and is authorized by that state to prescribe, manufacture, or have possession of controlled substances |
| DEA form 224 | form used to register pharmacy with the DEA * this registration must be renewed every 3 years |
| DEA form 222 | form used to oder schedule II drugs. Valid for only 60 days and must be signed by DEA number holder. |
| DEA form 41 | form used to inform DEA of the destruction of any controlled substance. Must indicate the name, strength, quantity of controlled substance along with the date of destruction, method of destruction, and witnesses present for destruction |
| DEA form 106 | form used to inform the DEA of loss or theft of legend drugs |
| 50% Rule | Rule that dictates what expiration date to place on a repackaged item |
| Prescription Header | Doctor's name, address, phone number, license type, and DEA number. Patient's full name and address. Date written |
| Prescription Body | Drug name, Strength, dosage form, and quantity. Instructions for use (SIG) Refill Information |
| Prescription Signature | Must be in ink. No stamped or mimeographed signatures allowed. |
| True/False A prescription only needs to contain the name of the prescriber the prescriber's DEA number and the patients name. | False: The prescription must also contain the phone number, address, and license type of the prescriber along with the patients full address. |
| True/False A laminar flow hood should be in operation 24 hours a day | True: if this machine is turned off it must be allowed to run for 30 minutes prior to use |
| Pharmacology | the science of substances used to prevent, diagnose, and treat disease. (The study of drugs, medicine) |
| Toxicology | The branch of pharmacology which deals with undesirable effects of chemicals on living systems |
| Drug | Chemicals which are administered to achieve a beneficial therapeutic effect on some process within the patient, or for their toxic effect on a parasite within the patient |
| Receptor site | A site that plays some sort of regulatory role in the body process. This |
| Bond | The manner in which two chemicals adhere to each other |
| Agonist | A drug which CAUSES a biological process to occur |
| Antagonist | A drug which BLOCKS naturally occurring body chemicals from causing a biological process to occur. I.E blockers |
| Dose | The amount of drug which is administered |
| Potency | Concerns the required amount of drug to achieve a desired outcome. The lower the dose is that is required the higher this is. |
| Maximum Efficacy | Concerns the maximum response possible from the drug |
| Pharmacokinetics | The bodies action on a drug |
Created by:
toni9223