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Excpt 2
Laws & Regulations
| 1938 Food Drug & Cosmetic | Before any new drug can be marketed it must be proven safe when used according to instructions on the label |
| 1951 Durham-Humphrey Amendment | Established two classes of drugs LEGEND & OTC |
| 1962 Kefauver-Harris Amendment | Amendment to the FDC act - before any new drug can be marketed it must be proven safe --- also regulates prescription drug advertising |
| 1970 Controlled Substance Act (CSA) | Classifies five levels of controlled substances that have potential for abuse; established Drug Enforcement Administration (DEA) as division of the Justice Department |
| 1990 Omnibus Budget Reconciliation Act (OBRA) | Requires pharmacies to offer counselling to Medicare patients regarding medications |
| 2005 Combat Methamphetamine Epidemic Act | Established strict controls on OTC sales of pseudoephedrine, epinephrine, and phenylpropanolamine |
| 2009 Health Information Technology for Economic & Clinical Health (HITECH) Act | Stregthens HIPPA rules specifically in regard to health information technology |
| FDA | Food & Drug Administration |
| FDA: | Supervises the development, testing, purity, safety and effectiveness of prescription and OTC medications |
| PPI | Patient Package Inserts |
| PPI: | required for specific drug classes such as oral contraceptives, and estrogens and provide detailed information about the drugs risk and benefits |
| Med Guides | required for drugs with significant risks or safety concerns and provides information to prevent serious adverse effects or ensure patient adherence to drug directions |
| The FDA requires retail pharmacies to provide a Patient Package Insert to every patient who receives medication with _____________________ (special warnings where a pharmaceuticals has a high risk potential) | black box or boxed warning |
| MedWatch: | An FDA reporting program where manufacturers, healthcare professionals, and consumers can report defects, adverse effects, and any other errors related to medications and medical product |
| HIPPA: | primary federal law that directs pharmacy professionals in handling patients protected health information |
| PHI | Protected Health Information |
| PHI: | Information in a person's health files that can identify them and that was included in the record when completing a health care service, includes anything the pharmacy staff collects, creates, or stores about a patient's identity or health |
| Patients using a particular pharmacy for the first time must sign an acknowledgement that pharmacy staff has informed them of their ________________ | HIPPA privacy practices |
| The pharmacy must keep its privacy practices and policies stored for ___ years after their creation date or last effective date. | 6 years |
| Health Care Fraud and Abuse Control Program: | HIPPA program to detect and investigate fraudulent health care and insurance claims |
| Typical prescribers include: | Physicians, dentists, nurse practitioners, optometrists, physician's assistant, and in some states under specific circumstances ----- pharmacists. |
| Information that is generally mandatory on a prescription includes: | Prescriber information: name, address, phone #, (DEA # for controlled substance) Patients name, DOB, address, Date prescribed Medication information: name, strength, dosage form, route, frequency, quantity, # of refill Sigs Prescriber signature |
| Joint Commission and the Institute for Safe Medication Practices (ISMP): | Has a "Do Not Use" list of sig abbreviations that are not recommended for use: exp; HS (could be confused with bedtime and half strength) |
| How long is a prescription for a non-controlled substance valid assuming the prescription still has refills? | 12 months |
| The FDA requires that all prescription medication packaging labels contain: | Name & quantity of each active ingredient, dosage, federal legend/ "Rx only", route of administration, federal warnings, NDC, type of container required for dispensing, name & place of business of manufacturers, expiration date, ect |
| Labels on OTC medications: | Product name, name & address of manufacturers & distributors, established name of all active & inactive ingredients, indications for use, net contents, cautions & warnings, directions for use |
| Drug Listing Act of 1972 (Administrated through FDA): | Every medication is required to have a unique NDC |
| NDC: | Identifies the labeler, product, and package size. |
| NDC first set of #'s (usually 5) represents: | The labeler |
| NDC second set of digits, usually four, represents: | The drug name and dose |
| NDC third set of #'s, usually 2 represents: | The package size |
| The Drug Supply Chain Security Act (DSCSA): | Requires the FDA to develop a tracking system to uncover and address medications that are counterfeit, falsified, or substandard |
| Approved Drug Products With Therapeutic Equivalence Evaluations --- "Orange Book" | Primary reference for determining bioequivalence/therapeutic equivalence |
| 1970 Occupational Safety and Health Administration (OSHA): | Helps ensure safe and healthy working conditions by setting and enforcing standards and by providing training, outreach, education, and assistance for all workers. |
| Patient Profiles should include: | Name, address, #, DOB, sex, social security #, medication/prescription history, Medication allergies/intolerances, chronic conditions/diseases, insurance information |
| Controlled substances include: | opioids, narcotics, amphetamines, barbiturates |
| Scheduled 1 (C-1): | Drugs that have a high potential for abuse and have no generally accepted medical uses, they are ILLEGAL, provider DO NOT PRESCRIBE them |
| Scheduled 1 drugs include: | Heroin, mescaline, peyote, lysergic acid |
| Scheduled 2: | Includes medication that have both a medical use and a high potential for abuse |
| Scheduled 2 drugs include: | Morphine, methadone (Methadose), oxycodone, hydromorphone, hydrocodone, fentanyl |
| Scheduled 3: | Includes medications that have a medical use and have a lesser chance of abuse than those in scheduled 1 & 2, they have a moderate potential for dependence |
| Scheduled 3 drugs include: | Ketamine, acetaminophen with codeine, and anabolic steroids such as testosterone |
| Scheduled 4: | Include medications that have a medical use and low potential for abuse and dependence |
| Scheduled 4 drugs include: | Phenobarbital, eszopiclone (Lunesta), tramadol (Ultram), and benzodiazepines such as lorazepam (Ativan) |
| Scheduled 5: | Includes medications that have a medical use, contain limited quantities of opiates, and are used as antidiarrheals/antitussives , lowest amount for abuse |
| DEA first letter codes identify type of registrant and can be: | A, B, F, M, X |
| DEA second letter is: | First letter of registrant's last name |
| Scheduled 3 & 4 refills are allowed: | refills are allowed for these medications 5 times within 6 months |
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