Self Check questions Flashcards
- What legislation established the five schedules of drugs having the potential for addiction?
b. Controlled Substances Act of 1970
- What legislation made a distinction between prescription and nonprescription drugs?
d. Durham-Humphrey Amendment of 1952
- What legislation required that prescription medications be dispensed in childproof containers?
a. Poison Prevention Packaging Act of 1970
- What legislation specifically identified the FDA as the enforcement body that would officially
approve all new drugs?
c. Federal Food, Drug and Cosmetic Act of 1938
- What legislation distinguished between drugs having abuse potential and drugs having none?
b. Controlled Substances Act of 1970
- What is the approximate ratio of the number of chemical compounds tested for activity as new
drugs to the number of chemical compounds that actually make it to the clinical testing stage?
C. 10,000 to 1
- What phase of drug testing determines the lethal dose of the chemical compound in
laboratory mice?
d. Short-term toxicity testing
- What type of test determines the potential for a test drug to cause cancer?
c. Carcinogenicity
- What type of test determines the potential for a test drug to cause birth defects?
a. Teratogenicity
- The IND application review by the FDA takes
c. one to two years
- A(n) ________ must be approved by the FDA before a drug can undergo clinical testing.
d．investigational new drug application (IND)
- A(n) ________ can’t be submitted to the FDA until the first three phases of clinical testing are
completed.
a. New drug application (NDA)
- A Phase 4 clinical study
c. is conducted after the drug is approved and marketed.
- A Phase ________ clinical test of a new drug starts immediately after the approval of an IND.
a. 1
- The application for approval of a generic equivalent is called a(n)
b. abbreviated new drug application (ANDA)
- The average drug has ________ years of exclusive sales and marketing before its generic
equivalent can be marketed and sold.
b. 12
- Approximately ________ of the 4000 or more prescriptions drugs currently being sold in the
United States are orphan drugs.
b. 300
- An “orphan drug” is a(n)
c. drug that’s used to treat rare disease.
- Which of the following conditions would most likely be treated with an orphan drug?
b. Lou Gehrig’s disease
- Which of the criteria listed below classifies an investigational new drug for “treatment use”?
b. No comparable alternative drug to treat the disease
- Which of the criteria listed below classifies an investigational new drug for “treatment use”?
c. Too expensive for the consumer to purchase
- Which amendment to the Federal Food, Drug, and Cosmetic Act of 1938 required all over-the counter
drugs to be both safe and effective?
d. Kefauver-Harris Amendment of 1962
- Prior to 1962, if an over-the-counter product had false or misleading information on the label,
it was categorized as
c. misbranded
- The current FDA review procedure for drugs sold without a prescription ensures that the
drug is
c. both safe and effective
The series of steps put in place to carry out the policies of a pharmacy department are
called legalities.
False. They are called P and P Policies and Procedures
One of the main reasons for having a set of policies and procedures in place is to
document the department’s compliance with the rules set forth by regulatory agencies.
False, they are to ensure safe, effective, and consistent actions taken by its employees.
A hospital pharmacy department must be compliant with the rules set forth by JCAHO. (Joint
Commission on Accreditation of Healthcare Organizations)
True
To be of worth, a P & P manual must be both current and available to the general public.
False, it is only available to the Pharmacy’s employees.
It’s important to have a current P & P manual to help hospital staff members maintain
Joint Commission accreditation every five years.
False. The P & P manual includes procedures that help all hospital departments comply with the Joint Commission standards. The Joint Commission accredits healthcare organizations every three years.
Name all 9 (reg) information that needs to be listen on the Rx container. 12 for controlled substances. (schedule ll)
• Patient name
• Date the prescription was written
• Name of medication
• Strength of medication
• Quantity requested
• Directions for use, or signa (often written as “Sig:”)
• Number of refills allowed
• Name, address, telephone number, and signature of
prescriber. Prescriptions can be written by physicians,
physician assistants, certified nurse practitioners
(CRNPs), dentists, veterinarians, or in some cases,
pharmacists.
• National Provider Identifier (NPI). This unique ID number
is now required for all insurance claim submissions.
\+ for schedule ll Patient’s address • DEA number of the prescriber • Prescriber’s signature in ink, if a Schedule II drug (which you’ll learn about in the next section)
**SIMPLIFIED** • Patient name • Medication name • Medication strength • Quantity of medication • Directions for use • Number of refills remaining, if any • Name of prescriber • Prescription number assigned by the pharmacy • Name, address, and phone number of pharmacy • Date prescription was filled • Name/initials of dispensing pharmacist • The expiration, or discard date for the medication
List the eight pieces of information that must be included on a prescription order before it can
be filled by the pharmacy.
- Patient name; date the prescription was written; name of medication; strength of medication; quantity requested;
directions for use; number of refills allowed; and name,
address, telephone number, and signature of prescriber
According to the DEA, there are five schedules or classes of drugs. Which class of drug would not be dispensed from a pharmacy?
- Schedule I
Though some drugs are purchased by the pharmacy directly from the manufacturer,
medications are often purchased by the pharmacy through negotiated agreements with
_______.
- wholesalers
Return goods specialty companies are used by pharmacies to dispose of _______.
- expired drugs
Would the pharmacist or the pharmacy technician participate in one-on-one patient counseling
sessions to explain how medicinal therapies can control conditions such as diabetes?
- The pharmacist
The list of approved drugs for use in an institution is called a(n)
formulary
A drug that has been prescribed with the orders to be given PRN should be administered
only as needed.
A type of floor stock used in emergency situations is often kept in wheeled units called …
crash carts.
In most hospitals, enough drugs are sent from the pharmacy to the patient areas to supply
medications to the patient for…
24 hours
Certain medication orders contain a special instruction called a(n) ________, which
automatically stops the dispensing process after a predetermined length of time.
ASO - automatic
stop orders
If a patient has both Medicare and Medicaid coverage, which program should be billed as the
primary payor?
Medicare
Which insurance coverage is handled as a joint venture between the federal and state
governments?
Medicade
Which part of Medicare offers prescription insurance coverage?
Medicare Part D
What codes are used to bill for MTMS (medication therapy management service) provided by a pharmacist?
CPT (Current Procedural Terminology)
