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Federal Law
| Question | Answer |
|---|---|
| Federal law requires that all prescriptions expire ___ year from the date written. | one |
| PRN indicates "_______" within the one year requirements. | refills as needed |
| The Pure Food and Drug Act: | 1906, required all foods and drugs to meet a standard of purity and strength. |
| The Harrison Narcotic Act, created in 1914, regulated: | opium, marijuana, synthetic agents, derivatives |
| The Federal Food, Drug, and Cosmetic Act (FFDDCA) required that: | 1938, manufacturers proved their drugs/cosmetics were safe and medical devices were effective. |
| The Federal Food, Drug and Cosmetic Act gave the FDA: | limited authority to remove products that they found to be unsafe and ineffective. |
| The Durham-Humphrey Amendments to the FFDDCA: | clarified distinction between Rx and OTC based on whether they were habit-forming, narcotic, hypnotic, or harmful. |
| The Durham-Humphrey Amendments to the FFDDCA required: | a Rx to dispense refills, which created the legend "Caution: Federal law prohibits dispensing without a Rx" |
| The Poison Packing Prevention Act: | 1970, required child proof packging |
| The Controlled Substances Act: | 1970, classified drugs based on their potential for abuse (Sch. I-V), it also required that all controlled substances bear the label: "Federal law prohibits the transfer of this drug to any other person other than the patient for whom prescribed" |
| The Joint Commission's mission is to: | improve the quality of care provided to the genera public. |
| The JCHAO is responsible for: | accreditation of institutional settings |
| OSHA is responsible for: | safety in the workplace. |
| American Association of Pharmacy Tech. : | 1979, set forth 10 codes of ethics that details the responsibilities of the tech. while protecting their rights to due process. |
| Prescription Marketing Act of 1987: | enacted to address certain Rx drug marketing practices that have contributed to the diversion of drugs into a secondary gray market |
| Omnibus Budget Reconciliation Act (OBRA 90) required: | pharmacists to offer counseling to Medicaid patients |
| Anabolic Steroids Act of 1990: | places any drug or hormonal substance related to testosterone under regulation of the Controlled Substances Act |
| FDA Modernization Act of 1997; | changed labeling requirements to "Rx only" |
| Medicare Modernization Act (MMA): | 2003, produced largest overhaul of Medicare and created Medicare Part D |
| Combat Methamphetamine Epidemic Act of 2005 (CMEA) regulated: | ephedrine, pseudophedrine, and phenlypropanolamine |
| Patient Safety and Quality Improvement of 2005's goal is to: | encourage reporting of events that adversely affect patients |
| Schedule I drugs: | have the potential to be highly abused and are not accepted for medical use. |
| Schedule II drugs require: | a Rx and are not refillable. |
| When dispensing partial fillings of Sch. II drugs, the pharmacist needs to: | record the number dispensed and dispense the remainder within 72 hours. |
| Partials for patients in long term care is valid for ___ days. | 60 |
| In an emergency situation, a Sch. II Rx can be called via telephone only if: | - immediate administration is required - no alternatives are available - physician cannot reasonably provide a written Rx - pharmacy must receive hard copy of Rx within 7 days |
| Use DEA Form ___ to report theft of Sch. II drug. | 106 |
| All ____ products are now a Sch. II drug. | Hydrocodone |
| Schedule III drugs can be refilled up to: | five times within six months |
| Schedule IV drugs have: | the same dispensing rules as Sch. III |
| Benzodiapines are: | Schedule IV drugs |
| Schedule V drugs can be sold OTC only if: | - the customer is over 21 - the substance is sold by the pharmacist - not more than 240 oz of opoid containing substances or 120 ml of non-containing substances may be dispensed within 48 hours - must have a record book |
| All records of controlled substances must be kept for at least ____ years for inspection. | 2 |
| Sch. II records must be maintained _____ from Sch. III-V records. | seperately |
| DEA form ___ is used to order Sch. II substances, return to supplier, and send to the reverse distributor. | 222 |
| DEA form ___ is used to dispose of controlled substances. | 41 |
| A red "C" must be used and stamped _____ to identify Sch. III-V Rx. | an inch high |
| If there is a conflict between federal and state requirements for filing Rx: | you should use the stricter of the two. |
| The first letter of a DEA number identifies _______. | the type of prescriber. |
| The second letter a DEA number identifies ______. | the first letter of the prescriber's last name. |
| An inventory is defined as: | a complete and accurate list of controlled substances. |
| When recording the number of Sch. II drugs in possession, an ____ count or measure is required. | exact |
| When recording the number of Sch. III-V drugs: | an estimated count is required, unless the contents hold more than 1,000 |
| The pharmacy is required to do inventory check every __________. | two years |
| Sch. II drugs must be in a _________. | locked cabinet or distributed throughout general stock. |
| Sch III-V drugs can be ordered by calling the __________. | wholesaler |
| Investigational drugs go through _________ before being released to the general public. | 4 phases of testing |
| Phase I: | drug is introduced for public use and patients volunteer to participate. |
| Phase II: | establishes effectiveness and safety and patients are closely monitored. |
| Phase III: | specifies effective/indications and adverse effects are studied. |
| Phase IV: | Post marketing trials, no controlled involved, remaining drugs are returned. |
Created by:
Michelle Lee
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