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PTCB Review
PTCB Review of Federal Requirement and Patient Safety
| Term | Definition |
|---|---|
| DEA Form 222 | Used by pharmacists to order Schedule II drugs. Triplicate form (or electronic CSOS equivalent) Must be kept for 2 years Errors cannot be corrected; must void and redo. Used by a reverse distributor to handle the destruction of controlled substances. |
| DEA Form 106 | Used to report theft or significant loss of controlled substances Must notify DEA and local law enforcement |
| DEA Form 41 | Used to document the destruction of controlled substances Requires DEA authorization or reverse distributor. Must be submitted for any breakage or spillage of a controlled substances. |
| HIPAA | Governs disclosure of Protected Health Information (PHI). |
| Durham Humphrey Amendment | Also known as the Prescription Drug Amendment Required prescription drugs to bear the legend, “Caution: Federal law prohibits dispensing without a prescription.” Subsequent amendments replaced it with the legend, “Rx only.” |
| Kefauer- Harris Amendment -1962 | Requires all medications in the United States to be pure, safe, and effective. ■ Established procedures for both drug applications and investigational drugs. ■ Drug manufacturers are required to be responsible for good manufacturing process (GMP). |
| Pure food and drug act of 1906 | Enacted in 1906 to prohibit the interstate transportation or sale of adulterated and misbranded food or drugs. |
| Food, drug, and cosmetic act of 1938 (FDCA 1938) | The U.S. Food and Drug Administration (FDA) was created under FDCA 1938. ■ Requires that all new drug applications be filed with the FDA. ■ Clearly defined adulteration and misbranding of drugs and food products. |
| Poison prevention packaging act of 1970 | The Poison Prevention Packaging Act of 1970 was enacted to reduce accidental poisoning in children. The act requires that most OTC and legend drugs be packaged in child-resistant containers. A child-resistant container is one that cannot be opened by 80% |
| Occupational safety and health act of 1970 | ■ Ensures a safe and healthful workplace for all employees. ■ Requires a reporting system for job-related injuries and illness. ■ Attempts to reduce hazards in the workplace and conduct requires use of the Safety Data Sheet (SDS) |
| Omnibus budget reconciliation act (OBRA) of 1990 | required states to establish drug use review programs consisting of three essential components: (1) prospective drug use review, (2) retrospective drug use review, and (3) educational programs. |
| Ethics | A study of standards and moral judment; it is a moral philosophy that is influenced by a particular group, society, philosophy, region, or profession. |
| Which medication is within the exceptions from the Poison Prevention Packaging Act? | Nitroglycerine |
| GMP Good Manufacturing process set by the Kefauver-Harris Amendment | guidelines that pharmacy follow when compounding medication |
| Safety Data Sheet (SDS) | Contains information about Potential Hazards of Chemicals |
| section of the NDC will identify the Manufacturer of the medication | First section |
| DEA FORM 224 | Pharmacy submit to the DEA to be able to dispense controlled substances. Is used to register a pharmacy with DEA in order to purchase controlled substance. |
| Examples of Scheduled II drugs | Hydromorphone, oxycodone , Vicodin |
| Examples of Schedules III drugs | Tylenol with Codeine |
| What guidelines are correct from the Good Manufacturing Practices as far as repackaging medications? | Beyond use date is one year for repackaged medications or the manufacturers expiration date if its les |
| Which organization has stated the abbreviation "QOD" should not be used? | ISMP |
| Depakote and Depakote ER are examples of ________ published by the ISMP. | drugs with look alike/sound alike names |
| Who must adhere to the "Do Not Use" List? | Health care facilities accredited by The Joint Commission |
| examples of medications contained on the ISMP high-alert medications for a community pharmacy | metformin methotrexate carbamazepine |
| Which drug carries a black box warning ? | Irbesartan |
| What is the purpose of using "tall man" letters? | To draw attention to dissimilarities in drug names |
| Which organization establishes standards of care for hospitals and long-term care facilities? | TJC ( The joint Commission) |
| Examples of high- alert medication in an acute care facility. | amiodarone D20W insulin |
| While working in a long-term care pharmacy, one should be extremely careful when dispensing which classification? | Anticoagulants |
| Medication errors are tracked by all of the following organizations | CDC NCCMERP FDA |
| Nitroglycerin is an example of a ________. | drug found on the "Do Not Crush" |
| Medications that have look-alike/sound-alike names can be distinguished using which of the following? | Tall Man lettering |
| How many times C-II prescriptions can be transferred between pharmacies? | cannot be transferred from one pharmacy to another |
| Who is responsible for enforcing federal laws to controlled substance? | DEA |
| What informations are commonly included in patient profile? | Name and DOB health conditions medication list |
| Class I recall | High risk of serious health problems or death. There is a reasonable probability that use of the product will cause or lead to serious adverse events or death. |
| Class II recall | Is one in which the probability exists that the use of the product will cause adverse health events that are temporary or medically reversible. |
| Class III | Unlikely to cause health problems, but violates regulations. |
| REMS ( Risk Evaluation and Mitigation Strategy) | It is a safety program for medications with serious safety concerns . Is a strategy to manage a known or serious risk associated with a drug or biological product by the FDA. |
| What are the 2 forms of hazardous waste that may be found in pharmacy ? | P - waste ( example: Epinephrine ) U - Waste ( Examples: cyclophosphamide , chlorambucil , selenium sulfide) |
| P - waste | Acutely hazardous . These chemicals can cause death or serious illness in low doses . Examples : epinephrine |
| U - waste | They are toxic and hazardous chemicals but do not carry the same immediate high-risk warnings as P - waste. Examples: cyclophosphamide , chlorambucil , selenium sulfid |
| Examples of dosage forms that should not be crushed. | enteric-coated, film-coated, and liquid-filled dosage forms |
| Abbreviations found on The Joint Commission's "Do Not Use" | U, IU, Q.D., QD, q.d., qd, Q.O.D., QOD, q.o.d, qod, MS, MSO4, and MgSO4. |
| Personal management record (PMR) | Is a comprehensive medication record of the patient's prescription and nonprescription medication as well as herbal products and other dietary supplements. |
| Medication therapy review (MTR) | Is a systemic process of collecting patient-specific information, reviewing the patient's medication and medical history, and identifying possible medication-related problems with possible plans to resolve them. |
| Medication-related action plan (MAP) | is a patient-centered document designed to assist the patient in managing and tracking their progress toward the actions identified in an MTR. |
| Medication therapy management (MTM) | consists of the PMR, the MTR, and the MAP. |
| Examples of medication/drug classifications that have been identified as high-alert medications in a long- term-care facility. | Anticoagulants, parenteral and oral; chemotherapeutic agents, parenteral and oral (excluding hormonal agents); hypoglycemics, oral (including combination products with another drug); insulins, all formulations and strengths (e.g., U-100, U-200, U-300, U-5 |
| What procedures would be used to reduce prescription errors in a pharmacy? | Bar scanning of labels Being aware of look-alike names of medications Using digital imaging of the medication |
| According to MEDMARX, which of the following medications has been associated with a large number of medication errors? | insulin, morphine, potassium chloride, albuterol, heparin, vancomycin, cefazolin, acetaminophen, warfarin, and furosemide. |
Created by:
mparcasio