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Fundamentals of Phar
Study Stack Chapter 2
| Terms | Descriptions |
|---|---|
| OBRA'87 | set requirements for facilities participating in Medicare and Medicaid programs and addressed enforcement mechanisms. A minimum standard of care was required, and a change began to take place, transitioning nursing homes from uncomfortable institutions to comfortable, home-like environments providing higher quality care. However, the provisions of OBRA'87 did not address individual privacy rights. |
| FDA | Is the agency within the U.S. Department of Health and Human Services responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, the national food supply, cosmetics, and radioactive products. |
| OSHA | is a U.S. government-managed agency that created Safety Data Sheet (SDS) requirements. |
| Medicare | Is a federal- and state-managed insurance program that covers health care costs and prescription drugs for individuals 65 years of age and older, for persons younger than 65 years of age with long-term disabilities, or for those with end-stage renal disease. |
| OBRA 90 | Pharmacists must review drugs for appropriateness, possible drug interactions, contraindications, and correctness of drug dosage and duration of therapy to ensure patient safety. |
| OBRA | Omnibus Budget Reconcilliation Act |
| OHSA | Occupational Safety and Health Administration |
| HIPAA | Health Insurance Portability and Accountability Act |
| Heroin | Is a schedule C-I with no medicinal use. |
| isotretinoin (Accutane, Amnesteem, Claravis, Sotret) | The FDA regulates this medications under a special program , iPledge ,because of the severe adverse effects of the drug. |
| Methadone | Schedule C-II controlled substance and is used to treat persons addicted to opiates. Patients are to receive specialized treatment while taking this medication. No more than 1 day's supply may be filled by a pharmacy, and the medication must be taken in a physician's office or drug treatment center. |
| Suboxone and subutex | Schedule C-III controlled substances that require special consent forms to be completed by the patient. Under federal law, prescribers must meet certain criteria. When all conditions are met, the DEA issues a special number with an X identifying them as qualified prescribers. |
| Schedule II | Have medical use but possess a high abuse potential with severe psychological or physical dependency No refills Medications must be stored in a locked safe. Medications requiring refrigeration must be stored in a locked refrigerator. |
| Schedules C-III and C-IV | Prescriptions may be refilled up to five times within 6 months after the date the prescription was written, whichever occurs first. Medications may be dispersed throughout the pharmacy with other medications |
| The most stringent law | Many states have laws that differ from federal law; remember that the strictest law is the one you follow. |
| HIPAA | The right to have corrections added to their health information. The right to ask to see and obtain a copy of their health records. The right to obtain a report on when and why their health information was shared for certain purposes. |
| DEA | Drug Enforcement Administration. Created and placed under supervision of Department of Justice Controlled substances are placed in one of five schedules based on potential for abuse and accepted medical use in the United States |
| FDA | Food and Drug Administration |
| Type 1 Class Recall | Products that could cause serious harm or prove fatal. |
| Type 2 Class Recall | Products found to cause a temporary health problem or pose a slight threat of serious harm. |
| Type 3 ClassRecall | Recalls are the lowest level, which is used for products that may have a minor defect or other condition that would not harm the patient but that prevents the drugs from being resold. This level includes a drug container defect (e.g., a faulty cap), a product with a strange color or taste, or the lack of English labeling on retail food items |
| Medwatch | Is the program under the FDA that allows consumers and health care professionals to report discrepancies or adverse reactions with medications. |
| Box Warning | Encased in a bold border within the manufacturer's insert. Health care professionals often refer to a boxed warning as a "black box warning," although this labeling term is not official. This type of warning is required on medications and other products that carry a high risk potential to the consumer. |
| U.S. Attorney General | Has the authority to decide the schedule under which a drug should be placed. |
| What is the meaning of DUE ? | drug utilization evaluation |
| What is DUE all about ? | Is a process designed to ensure that prescribed drugs are appropriately used. The desired outcome is an increase in medication-related efficacy and safety. |
| Schedule C- V | Referred to as exempt controlled substances may be over-the-counter (OTC) in some states because of the low potential of abuse. |
| What are exceptions to the childproof cap requirement set into place by the Poison Prevention Packaging Act of 1970? | Physicians' requests for non-childproof caps for their patients, certain legend medications, patients who are hospitalized, or at the specific request of the patient. |
| Form 222 | Used in ordering C - II drugs. Must be filled out by the receiving pharmacy in pen, typewriter, or indelible pencil. Top copy and middle copy with carbon paper are sent to the supplier or manufacturer Top and middle copies with carbon paper are returned to distributor or wholesaler Filing electronically is also possible (but not for C-I or C-II drugs) Pharmacy retains bottom copy Invoice and form are retained for 7 years |
| controlled substances | Any drug or other substance that is scheduled I through V and regulated by the Drug Enforcement Administration. |
| narcotic | A nonspecific term used to describe a drug that in moderate doses dulls the senses, relieves pain, and induces profound sleep but in excessive doses causes stupor, coma, or convulsions and may lead to addiction. |
| BOP | Board of Pharmacy |
| DEA Form 106 | Form to fill for loss or theft of Controlled Substance. Should include the following information: Name and address of firm (pharmacy) DEA registration number Date of theft or loss Name and telephone number of local police Type of theft List of identifying marks, symbols, or price codes Listing of controlled substances missing Pharmacy must send original copy of DEA and retain one copy for its records. |
| REMS | Risk Evaluation and Mitigation Strategies Includes the following : Medication guides Paper handouts that come with many prescription medicines Communication plan Educates, informs, and raises awareness of risks Elements to Assure Safe Use (ETASU) Patient package inserts Informational leaflet written for lay public describing benefits and risks of medications |
| Thalidomide | Indicated for multiple myeloma, and certain conditions must be adhered to by patient System for Thalidomide Education and Prescribing Safety (STEPS) has been approved by FDA Patients must see doctors every month Women must use two acceptable forms of birth control for 4 weeks before beginning to take thalidomide |
| Combat Methamphetamine Epidemic Act (CMEA) of 2005 | Regulates the sale of Pseudoephedrine. |
| NDC ( National Drug Code) | First set = labeler code 2nd set = product code , set by the drug company 3rd set = package code , set by the drug comapny |
| Form 224 | Use to dispense controlled drugs , which must be renewed every 3 years using Form 224a. |
| Examples of drugs that require package inserts to be provided with the prescription. | Retinoids Fertility drugs Estrogens |
| Controlled I ( C-I) | The strongest levels of abuse potential are schedule C-I drugs. These drugs have been determined to have a high potential for abuse and to have no acceptable medicinal purpose; they are also deemed unsafe for use under medical supervision. Schedule C-I drugs include LSD and heroin. Because C-I drugs do not have any medicinal use in the United States, pharmacies do not stock them and physicians cannot prescribe them for their patients |
Created by:
mparcasio