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PTCB Review
PTCB Review of Federal Requirement
| 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 |
| 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 |
| HIPAA Used to document the destruction of controlled substances Requires DEA authorization or reverse distributor | 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 |
| 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" l |
| 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 |
| Class II recall | High risk of serious health problems or death |
| Class III | Unlikely to cause health problems, but violates regulations |
Created by:
mparcasio