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Minimum Necessary Standard
principle that requires pharmacy professionals to disclose only the information other parties require about a patient
How often must employers of pharmacy staff provide training about HIPAA’s privacy and security rules?
annually
Prescription
a legal document that conveys a prescriber’s medication treatment plan to a pharmacist
Inpatient
acquires care in a health care facility
Outpatient
acquires medication from a retail or other pharmacy
Omnibus Budget Reconciliation Act of 1990 (OBRA ‘90)
federal law that increases pharmacists’ professional responsibilities in two ways
requires pharmacists to keep records (patient profiles) for all medications that Medicaid recipients use
requires pharmacists to offer counseling to all Medicaid recipients about the correct use of their medications
now applies to all patients
Prospective
prior to dispensing drug utilization reviews (DUR)
retrospective
periodic drug utilization reviews (DUR)
Controlled Substances Act (CSA) 1970
regulates the manufacture, importation, possession, use, and distribution of medications and substances that have the potential for abuse
Drug Enforcement Agency (DEA)
classifies controlled substances
enforces CSA provisions
regulates the sale and use of specific medications
Health Insurance Portability and Accountability Act (HIPAA) 1996
primary federal law that directs pharmacy professionals in handling patients’ protected health information (PHI)
guards against any misuse or disclosure of patients’ PHI
National Provider Identifier (NPI)
unique 10-digit number for that pharmacy used on all HIPAA addressed transactions
Prescription mandatory
patient’s name, address, and date of birth
date the prescriber wrote the prescription
medication information (name, strength, dosage form, route, dose, frequency, amount to dispense, number of refills, and permission for generic substitution
sig code or directions for the patient
prescriber’s signature, address, telephone number, and DEA number
Prescription Medication Labels
brand or trade name
generic name
the medication’s strength
legend statement
storage requirements
the package’s quantity
dosage form
manufacturer’s name
controlled substance mark
lot number
expiration date
National Drug Code (NDC number)
The first 4 digits identify the manufacturer
The next 3 or 4 digits identify the name, strength, and dosage form
The last two digits identify the package size
Basic Medication Label requirements
name and address of the dispenser
prescription’s serial or identification number
date the pharmacy filled the medication
name of the prescriber, plus any of the following that appeared on the prescription
patient’s name
directions for use
cautionary statements (take with food, shake well, can cause drowsiness)
OTC Medication Label requirements
medication’s name
name and address of the manufacturer or distributor
list of all active and inactive ingredients
amount of the product
adequate warnings
directions for use
Occupational Safety and Health Administration (OSHA)
helps ensure safe and healthful working conditions by setting and enforcing standards and by providing training, outreach, education, and assistance for all workers.
Health care fraud
the deliberate attempt to accrue illicit gain from a health care benefit program
patients using someone else’s health insurance carb
forging or altering prescriptions
stealing and attempting to fill someone else’s prescription
selling prescription medications
When reviewing the quantity requested on a prescription for a controlled substance, what might be a sign of a forgery?
an unusually large quantity
Patient Profile information
demographics (name, address, telephone numbers, date of birth, gender)
medication or prescription history
medication allergies
chronic conditions or diseases
third-party information
Paper Record of new and refill prescription information
serial number
dispensing date
patient’s name
prescriber’s name
medication name, strength, and dosage form
quantity dispensed
initials or identification code of the pharmacist and/or technician
Daily printout information
patient’s address
prescriber’s address
prescriber’s DEA number (if the prescription is for a controlled substance
quantity prescribed (if different from quantity dispensed
date of issue
total number of refills dispensed to date
Schedule I (C-I)
drugs that have a high potential for abuse and have no generally accepted medical uses
illegal
providers do not prescribe them
pharmacies do not stock or dispense them
heroin, mescaline, peyote, and lysergic acid diethylamide (LSD)
Schedule II (C-II)
medications that have a high potential for abuse, are dangerous, and can lead to psychological and physical dependence
morphine, methadone, oxycodone, hydromorphone, hydrocodone, fentanyl, levorphanol, meperidine, methylphenidate, secobarbital, and methamphetamine
Schedule III (C=III)
medications that have a moderate to low potential for physical and psychological dependence
ketamine, acetaminophen with codeine, butabarbital, dronabinol, thiopental, anabolic steroids, and testosterone
Schedule IV (C-IV)
medications that have a low potential for abuse and dependence
phenobarbital, chloral hydrate, diazepam, zolpidem, eszopiclone, alprazolam, chlordiazepoxide, pentazocine, temazepam, triazolam, and clonazepam
Schedule V (C-V)
medications that contain limited quantities of some narcotics, usually for antidiarrheal, antitussive, and analgesic purposes.
diphenoxylate with atropine, pregabalin, lacosamide, guaifenesin with codeine, kaolin and pectin with belladonna
In which controlled substance schedule is the commonly prescribed sleep aid zolpidem?
Schedule IV (C-IV)
DEA Number
valid DEA numbers consist of 2 letters and 7 digits
1st letter = code identifies the type of registrant
2nd letter - first letter of the registrant’s last name
Verifying a DEA number
add the first, third, and fifth digits of the DEA number
add the second, fourth, and sixth digits and multiply the sum by 2
add together the results
check that the last digit of the sum is the same as the last digit of the DEA number
CSA required prescription components
patient’s full name and street address
prescriber’s name, address, telephone number, and DEA registry number
date the prescriber issued the prescription, number of refills (no refills for C-II medications)
prescriber’s signature
Schedule II (C-II) refills
refills not allowed on a C-II prescription
Schedule III (C-III) and IV (C-IV) refills
refilling allowed 5 times within 6 months after the date of issue
can transfer to another pharmacy but only once
Schedule V (C-V)
some are prescription only while some are OTC (over the counter)
refills allowed 5 times in 6 months
C-I substance
lysergic acid diethylamide (LSD)
C-I substance
marijuana
C-I substance
heroin
C-I substance
peyote
C-II substance
fentanyl
C-II substance
methadone
C-II substance
methylphenidate
C-II substance
hydrocodone with acetaminophen
C-III substance
acetaminophen with codeine
C-III substance
ketamine
C-III substance
butabarbital
C-III substance
thiopental
C-IV substance
zolpidem
C-IV substance
diazepam
C-IV substance
clonazepam
C-IV substance
pentazocine
C-V substance
pregabalin
C-V substance
kaolin and pectin with belladonna
C-V substance
diphenoxylate with atropine
C-V substance
guaifenesin with codeine
Combat Methamphetamine Epidemic Act of 2005
a federal law that regulates retail sales of OTC products that contain ephedrine, pseudoephedrine, or phenylpropanolamine
can be used to make methamphetamine
Besides presenting a written prescription, what other information must appear on a prescription for a controlled substance like morphine?
the prescriber’s DEA number
How long will the pharmacy have to keep the prescription a patient brings for a C-II drug on file?
2 years
A patient presents a pharmacy technician with a prescription for zolpidem (Ambien) that the prescriber wrote 6 weeks ago. What should the technician do?
Process the prescription for the pharmacy to fill
A pharmacy technician should recognize that which of the following information is mandatory for controlled substance prescriptions and unnecessary for noncontrolled substance prescriptions?
the prescriber’s DEA number
Which of the following processes should a pharmacy technician use to file prescription hard copies for controlled substances?
file controlled substance prescriptions separately from legend prescriptions
According to HIPAA guidelines, which documents should a pharmacy technician have a new patient sign?
acknowledgement of notice of privacy practices
A pharmacy technician is filling prescriptions for storage according to federal regulations. What is the minimum amount of time prescriptions for controlled substances be retained?
2 years
A pharmacy technician should recognize that anabolic steroids are included in which of the following controlled substance schedules?
Schedule III
Which of the following sublingual medications is an exception to mandate for child-resistant caps on prescription medication containers?
nitroglycerin
Which of the following organizations enforces guidelines concerning medication quality standards?
Food and Drug Administration (FDA)
According to HIPAA guidelines, which of the following patient information is considered protected health information (PHI)
email address
According to the DEA, how often should a pharmacy technician conduct an inventory check for controlled substances?
Every 2 years
A pharmacy technician receives a handwritten prescription from a patient. The technician should verify that the prescription contains which of the following information?
quantity of the medication
A pharmacy technician should recognize that exempt narcotics are included in which of the following controlled substance schedules?
Schedule V
A pharmacy technician should recognize that which of the following laws requires medication manufactures to place a label stating, “Caution: Federal law prohibits dispensing without a prescription” on medication stock bottles?
Durham-Humphrey Amendment
A pharmacy technician should identify that which of the following organizations issues a pharmacy’s National Provider Identifier (NPI)
Centers for Medicare and Medicaid Services (CMS)
A pharmacy technician is required to include a patient package insert (PPI) when filling a prescription for which of the following types of medication?
Contraceptives