PCTB

certification laws
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Food and drug administration
the leading enforcement agency at the federal level for regulations concerning drug products
drug enforcement administration
the agency that controls the distribution of drugs that may be easily abused
food and drug act of 1906
prohibited interstate commerce in adulterated or misbranded food, drinks, and drugs. Government preapproval of drugs is required
1938 food, drug and cosmetic (FDC) act
in response to the fatal poisoning of 107 people, primarily children, by an untested sulfanilamide concoction, this comprehensive law requires new drugs be shown to be safe before marketing
1951 Durham-Humphrey Amendment
this law defines what drugs require a prescription by a licensed practitioner and requires them to include this legend on this label: "Caution: Federal Law Prohibits dispensing without a prescription"
1962 Kefauver-Harris Amendments
requires drug manufactures to provide proof of both safety and effectiveness before marketing the drug
1970 poison prevention packaging act
requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies
1970 Controlled substances act
The CSA classifies drugs that may be easily abused and restricts their distribution. It is enforced by the Drug enforcement administration (DEA) within the justice department
1990 Omnibus budget reconciliation act
among other things, this act required pharmacists to offer counseling to Medicaid patients regarding medications, effectively putting the common practice into law
Schedule 1
Heroin, various opium derivatives, and hallucinogenic substances these are not allowed in the United States
Schedule 2
Amphetamines, opium, cocaine, methadone, and various opiates
schedule 3
Phenobarbital, the sedative chloral hydrate, and the anesthetic methohexital
schedule 4
compounds containing limiting amounts of narcotics such as codeine
class 1 recall
strong likelihood that the product will cause serious adverse effects or death
class 2 recall
product may cause temporary but reversible adverse effects
class 3 recall
when a product is not likely to cause adverse effects
patient care units
patient rooms are divided into groups called nursing units or patient care units, with patients having similar problems often located on the same unit
nurses station
the work station for medical personnel on a nursing unit called the nurses station. Various items required for care of patients are stored there, including patient medications
ancillary areas
areas such as the emergency room that also use medications and are serviced by the pharmacy department
central pharmacy
the main inpatient pharmaacy in a hospital that has pharmacy satellites
front counter
area near the entrance of the main pharmacy where pharmacy technicians help other health-care professionals, answer phone calls, fill first doses of oral medications, and perform other duties as needed
satellite pharmacy
a branch of the inpatient pharmacy responsible for preparing, dispensing, and monitoring medication for specific patient areas
delivery technician
a delivery technician is responsible for transporting medications and other pharmacy supplies form the pharmacy to the nursing units, ancillary areas of the hospital, and/or outpatient clinics
outpatient pharmacy
a pharmacy attached to a hospital servicing patients who have left the hospital or who are visiting doctors in a hospital outpatient clinic
order processing
entering written medication orders in the computer system
monitoring drug therapy
retrieving drug levels, lab values, or other patient specific information from patient charts or electronic records to assist a pharmacist
placebo
inactive substances not real medications that are used to test the effectiveness of drugs
clinical test
tests on proposed new drugs(investigational drugs) are "controlled" by comparing the effect of a proposed drug on one group of patients with the effect of a different treatment on other patients
blind test
patients in trial are always "blind" to the treatment, i.e., they are not told which control group they are in. In a "double-blind" test neither the patients nor the physicians know what the medication is
patent protection
a patent for a new drug gives its manufacturer an exclusive right to market the drug for a specific period of time under brand name. a drug patent is in effect for 17 years form the date of the drug's discovery. The Hatch-Waxman Act of 1984 provided for up to five year extensions of patent protection to the patent holders to make up for time lost while products went through the FDA approval process
generics
once a patent for a brand drug expires, other manufacturers may copy the drug and release it under its pharmaceutical or generic name
labels and product labeling
all drugs are required to have clear and accurate information for all labels, inserts, packaging, and so on, but there are different information requirements for various categories of drugs
prescription drug labels
the minimum requirements on prescription labels for most drugs are as follows: name and address of dispenser, prescription serial number, date of prescription or filling, name of prescriber, name of patient, direction for use, and cautionary statements
national drug code(NDC)
the number assigned by the manufacterer. each NDC number has three parts or sets of numbers: the first set indicates the manufacturerer; the next set indicates the medication, its strength, and dosage form; the last set indicates the package size
controlled substances
a drug which has the potential to be abused and for which distribution is controlled by one of five schedules
control classification
manufacturers must clearly label controlled drugs with their control classification
DEA number/formula
the number all prescribers of controlled substances are assigned and which must be used on all controlled drug prescription. it has two letters followed by seven single digits numbers e.g, Ab1234563. The formula for checking a DEA number on a prescription form is; if the sum of the first, third, and fifth digits added to twice the sum of the second, fourth, and sixth digits, the total should be a number whose last digit is the same as the last digit of the DEA number
risk of approved drugs
there is always the risk that an approved drug may produce adverse side effects when used on a larger population
Med Watch
FDA reporting program for health care professionals to report adverse effects that occur from the use of an approved drug or other medical product. the MEd watch online voluntary reporting form 3500 is used for FDA regulated drugs, biologics, medical devices, and special nutritional products and cosmetics
state regulation
state boards of pharmacy are responsible for licensing all prescribers and dispensers and adminstering regulations for the practice of pharmacy in the state
liability
legal liability means you can be prosecuted for misconduct
negligence
failing to do something that should or must be done
prescription
an instruction form a medical practioner that authorize a patient to be issued a drug or device
prescription verification
it is necessary to check with the pharmacist on potential forgeries on prescriptions that are more than a few days old, or on prescriptions that in any way appear questionable
online billing
a prescritpion is interpreted and confirmed by the prescritpion system. if third-party billing is involved, this is done online simultaneously
preparation
once the prescription and third party billing is confirmed the label receipt are printed and the prescription is prepared
label
the general purpose of the prescription label is to provide information to the patient regarding the dispensed medication and how to take it. additionally, the label includes information about the pharmacy, the patient, the prescriber, and the prescription or transaction number assiigned to the prescription. computer generated prescription labels must be placed on containers so they are easy to locate and easy tp read
directions for use
also known as signa. since the patient is expected to self adminster the medication, these must be clear and easily understood by the patient
pharmacist check
if a prescription has been prepared by a technician, there is a final check by the pharmacist to make sure that it is correct
judgement question
technicians must request the advice of the pharmacist whenever judgment is required
prescription origin code
additional prescription information a technician adds into the computer system
auxillary labels
many computerized prescription systems will automatically indicate which auxillary label to use with each drug
contolled substance label
"caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
institutional settings
there are different requirements for institutional prescription since nursing staff generally adminster medications to patients. rules for institutional pharmacy prescription labels vary by instituion but often do not contain much more than the name,stength, manufacturer, expiration date, and dosage form of the medication
formulations
drus are contained in products called formulations. there are many drug formulations and many different routes to adminster them
route of administration
routes are classified as enteral or parentral. enteral refers to anything involving the tract form the mouth to the rectum. there are three enteral routes: oral, sublingual, and rectal is considered a parenteral administration route. oral administration is the most frequently used route of administration
local and systemic effects
a local effect occurs when the drug activity is at the site of administration(e.g. eyes, ears, nose, skin). a systemic effect occurs when the drug is introduced into the circulatory system
oral adminstration
the stomach has a ph around 1-2. certain drugs cannot be taken orally because they are degraded or destroyed by stomach acid and intestinal enzymes. drugs adminstered by liquid dosage forms genrally reach the circulatory system faster than drugs formulated in solid dosage forms
oral formulations
oral formulations contain various ingredients besides the active drug. these inactive ingredients include binders, lubricants, fillers, diluents, and disntegrants
gastrointestinal action
the disintegration and dissolution of tablets, capsules, and powders generally begins in the stomach, but will continue to occur when the stomach empties into the intestine. modified-release formulations extend dissolution over a period of hours and provide a longer duration of effect compared to plain tablets. enteric coated tablets prevent the tablet from disintegrating until it reaches the higher pHs of the intestine
sublingual adminstration
these tablets are placed under the tongue. they are generally fast-dissolving, uncoated tablets that contain highly water soluble drugs. when the drugs is released from the tablet, it is quickly absorbed into the circulatory system since the membranes lining the mouth are very thin and there is a rich blood supply to the mouth
rectal adminstration
rectal adminstration may be used to acheive a variety of systemic effects, including: asthma control, antinausea, antimotion sickness, and anti-infective. However, absorption from rectal adminstration is erractic and unpredictable. the most common rectal adminstration forms are suppositories, solutions, and ointments
parenteral adminstration
parenteral routes are often perferred when oral adminstration causes drug degradation or when a rapid drug response is desired, as in an emergency situation. the parenteral routes requiring
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