Chapters 1-3 main points Flashcards
Pharmacology
The study of drugs-their properties, uses, application, and effects.
Materia Medica
Generally pharmacology, but also refers to the drugs in use
Pharmaceutics
Of or about drugs; also, a drug product
Omnibus Budget Reconciliation Act (OBRA)
Requires pharmacists to provide counseling services to Medicaid patients.
Pharmacogniosi
The study of physical, chemical, biochemcial and biological properties of drugs as well as the search for new drugs from natural sources
How often is certification renewed
Certification must be renewed every two years; contains 20 contact hours of pharmacy related training continuing education, which includes at least one hour in law
PTCE
Pharmacy Technician Certification Exam
PTCB
Pharmacy Technician Certification Board
ExCPT
Exam for the Certification of Pharmacy Technicians
NHA
National Healthcare Association
1938 Food, Drug and Cosmetic (FDC) Act
Requires new drugs be shown to be safe before marketing
1951 Durham-Humphrey Amendment
Defines which drugs require a prescription; including a legend on the label
1962 Kefauver-Harris Amendment
Requires drug manufacturers to provide proof of safety and effectiveness before marketing a drug
1970 Poison Prevention Packaging Act
Requires childproof packaging on all controlled and most prescriptions drugs dispense by pharmacies
1970 Controlled Substances Act (CSA)
Classifies 5 levels of controlled substances that have potential for abuse and therefore restricts their distribution
1990 Omnibus Budget Reconciliation Act (OBRA)
Requires the pharmacists to offer counseling to Medicaid patients regarding medications
1996 Health Insurance Portability and Accountability Act
This law defined the scope of health information that may and may not be shared among health-care providers without patient consent and provided for broad and stringent regulations to protect patients’ right to privacy.
Whose job is to prove safety and effectiveness of a new drug and to whom must they show proof to?
It is the responsibility of the drug manufacture to provide proof of safety and effectiveness to the FDA’s Center for Drug Evaluation and Research
What happens in the different phases of clinical Testing?
There are 3 phases of clinical testing; Phase 1: 20-100 patients and lasts several months, the purpose is mainly safety. In phase 2 there are up to several hundred patients, lasts several months to two years, the purpose of phase 2 is some safety but mainly effectiveness. Phase 3 contains several hundred to several thousand patients, will last between 1 to 4 years, the purpose of safety is safety, effectiveness, and dosage.
How long does a patent last past the date of filing
A patent will expire 20 years past the date of filing.
1984 Hatch-Waxman Act
Allows for both the extension of drug patent terms and quicker introduction of lower0cost generic drugs
What are the limits on ephedrine that can be sold per day/per month
A person can purchase 3.6 grams of pseudoephedrine per day and 7.6 per month
Exempt Narcotics
Medications with habit forming ingredients that could be dispensed by a pharmacist without a prescription by persons at least 18 yrs old
What are the minimum requirements on prescription labels for most drugs?
Name and address of pharmacy Prescription serial number date written expiration date name of prescriber
What do the number in the NDC stand for
1st set (5 numbers) indicate the manufacturer 2nd set (4 numbers) indicates the medication, strength, and dosage form 3rd set (2 numbers) indicate the package size
What is a schedule I control substance?
These are drugs with a high potential for abuse and have no accepted medical use in the US; Heroin, various opiums, and various Hallucinogenic substances
What is a schedule II control substance?
These are drugs that have a high potential for abuse, which can lead to physical or psychological dependence but that also have currently accepted medical uses in the US; Amphetamines, opium, cocaine, methadone, and various opiates
What is a schedule III control substance?
These are drugs with a potential for abuse less than those in Schedules I and II. Their abuse may lead to moderate or low physical dependence or high psychological dependences; anabolic steroids and various compounds containing limited quantities of narcotic substances such as codine
What is a schedule IV control substance?
These are drugs have a low potential for abuse relative to schedule III. Their abuse can lead to low physical or psychological dependence. Phenobarbital, chloral hydrate, anesthetic methohexital
What is a schedule V control substance?
These are drugs that have a low potential for abuse. Their abuse could lead to limited physical and psychological dependence
DEA Form-224
Application for New Registration
DEA Form-224a
Application for Renewal Application for registration
DEA Form-224b
Retail Pharmacy Registration Affidavit for Chain Renewal
DEA Form-222
US Official order form for Schedule I & II
DEA Form-41
Registrants Inventory of Drugs Surrendered
DEA Form-106
Report of theft or loss of Controlled Substances
DEA Form-363
New Application Narcotic Treatment Program
DEA Form-363a
Application for DEA Registration for NTP renewal registration
DEA Form-510
Chemical Registration
MedWatch
FDA reporting program for health-care professionals to report adverse effects that occur from the use of an approval drug or other medical product
What is the ASHP
The American Society of Health-System Pharmacists is an association for pharmacists practicing in hospitals, HMSOs, long-term care facilities, home care agencies, and some other health-care systems
What is the USP?
The United States Pharmacopeial Convention is a voluntary not-for-profit organization that sets standards for the manufacture and distribution of drugs and related products in the US
What is TJC?
The Joint Commission is an independent non-profit organization that establishes standards and monitors compliance for hospitals, health-care networks, HMOs, and nursing homes.
What is the ASCP
The American Society for Consultant Pharmacists sets standards for practice for pharmacists who provide medication distribution and consultant services to nursing homes
Pharmaceutically Equivalent
Drug products that contain identical amounts of the same active ingredients in the same dosage form
Therapeutic Equivalent
Pharmaceutical equivalents that produces the same effects in patients
What is the class 1 recall
In a class 1 recall there is a strong likelihood that the product will cause serious adverse effects or death
What is a class 2 recall
A class 2 recall is where a products may cause temporary but reversible adverse effects, or in which there is little likelihood of serious adverse effects
What is a class 3 recall
In a class 3 recall a product is not likely to cause adverse effects.
