Pharmacy Law 2 Flashcards
assessment of one’s characteristics, skills, and qualities, etc
personal inventory
made health-care providers responsible for the privacy and security of identifiable patient health information; also called Protected Health Information (PHI)
1996 Health Insurance Portability and Accountability Act (HIPPA)
leading association for pharmacists practicing in hospitals and other health care systems
American Society of Health System Pharmacists (ASHP)
pharmacists located in hospitals are required to follow regulations of this organization
TJC (The Joint Commission)
Drug with no accepted medical use in the United States
Schedule I
which size needle is the most likely to cause coring? (coring is caused by using a large needle)
Ex: 13G (the smaller the needle number the larger the gauge)
a solution of halperidol (haldol) contains 2mg/ml of active ingredient. How many grams would be in 473ml of this solution?
0.946g
You have a 70% solution of dextrose 1000ml. How many kg of dextrose is in 400ml of this solution?
0.28kg
which is the largest capsule size?
size 0
the leading enforcement agency at the federal level for these regulations
The Food and Drug Administration
prohibits interstate commerce in adulterated or misbranded food, drinks, and drugs
Food and Drug Act of 1906
establishes that manufacturers, pharmacists, importers, and phyicians prescribing narcotics should be licensed and required to pay a tax.
1914 Harrison Tax Act
requires new drugs be shown to be safe before marketing
1938 Food, Drug and Cosmetic (FDC) Act
defines which drug require a prescription by a licensed practitioner and requires them to include this legend on the label
1951 Durham-Humphrey Amendment
requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug
1962 Kefauver-Harris Amendment
requires child proof packaging on all controlled and most prescription drugs dispensed by pharmacies
1970 Poison Prevention Packaging Act
classified 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution; established The Drug Enforcement Administration (DEA) = Justice Dept
1970 Controlled Substances Act (CSA)
provides incentives to promote research, approval, and marketing of drugs needed for the treatment of rare diseases.
1983 Orphan Drug Act
allows for both the extension of drug patent terms and quicker introduction of lower-cost generic drugs
1984 Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman)
requires pharmacists to offer counseling to medicaid patients regarding medications
1990 Omnibus Budget Reconciliation Act (OBRA)
pharmaceutical equivalents that produce the same effects in patients.
therapeutic equivalent
required by FDA for some potentially dangerous drugs and have information for patients on how to safety use medication
patients package inserts (PPI)
requires pharmacists to keep all otc cold and allergy medications containing ephedrine, pseudoephedrine or phenylpropanolamine behind the counter.
Combat Methamphetamine Epidermic Act (CMEA)
medications that contain habit forming ingredients but can be sold by a pharmacist without a script to persons at least 8 years of age
exempt narcotics
identification number assigned by manufacturers to a drug product
NDC (National Drug Code)
drugs with high potential for abuse and no accepted medical use in the U.S. may not be prescribed. Heroin, various opium dervatives, and hallucinogenic substances.
Schedule I
drugs that have high potential for abuse which may lead to physical or psychological dependence but that also have currently accepted medical uses in the U.S. Amphetamines, opium, cocaine, methadone, and various opiates
Schedule II
drugs with potential for abuse less that those in Sch I and Sch II. Currently accepted in U.S., but their abuse may lead to moderate or low physical dependence or hish psychological dependence. Anabolic steroids and various compounds containing limited quantities of narcotics such as cocaine
Schedule III
low potential for abuse relative to Schedule III drugs
Schedule IV
low potential for abuse relative to Schedule IV drugs
Schedule V
What do all prescribers of controlled substances must be authorized by the DEA need?
DEA Number
used C-1 and C-11 substances filled in pen, typewriters, or indelible pencil and signed by an authorized person
DEA Form 222 (copy 1 retained by supplier, copy 2 forwarded to DEA, copy 3 retained by the purchaser)
encourages healthcare professional to report adverse effects that occurs from the use of an approved drug or other medical product
MedWatch
unintended side effect of a medication that is negative or in some way injurios to a patient’s health
adverse effect
action taken to remove a drug from the market and have it returned to the manufacturer
recall
What recall class has strong likelihood that the product will cause serious adverse effects or death?
Recall Class I
What recall class cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects?
Recall Class II
What recall class is not likely to cause adverse effects?
Recall Class III
independent non-profit organization that establishes standards and monitors compliance for nearly 20,000 healthcare programs in the U.S.
The Joint Commission (TJC)
original reports of clinical and other types of research projects and studies
primary literature
condensed worked based on primary literature, such as textbooks, monographs, etc
tertiary literature
the extra pharmacopeia containing international drug monographs
martindale
OSHA required information for handling hazardous chemicals
MSDS (Material Safety Data Sheets)
