PTCB PTCE Exam QUESTIONS AND
ANSWERS.
Pure Food and Drug Act -
\Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs,
poisoned or contaminated drugs
Adultered drugs -
\Any drug that is not pure
misbranded drug -
\Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) -
\drugs must comply with standards of safety and efficacy, more modern act than Pure
Food and Drug Act. Oversees safety of food, drugs and cosmetics
FDA (Food and Drug Administration) -
\a division of USDHHS responsible for regulating food and drug products sold to the
public. Handles drug approvals, sold, and recalls of drugs
3 types of Drug Recalls -
\1. Most severe: permanent health hazard or death
2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from drugs
MedWatch Program -
\Reports to FDA side effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System -
\Database that contains information on adverse event and medication error reports
submitted to the FDA; designed to support the FDA's post-marketing safety surveillance
program.
VAERS (Vaccine Adverse Event Reporting System) -
\keeps track of all adverse effects associated with vaccines
IND (Investigational New Drug) -
\A drug not yet approved for marketing by the FDA but available for use in experiments
to determine its safety and efficacy.
FDA drug approval process -
\1. Hypothesis: comes up with the drug and reports findings (dosage, research and
findings) to FDA
,2. Pre-phase: consists of animal testing then human testing to small population (reports
correct dosing and side effects)
3. Large Human Trial: tests on wider population with longer procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent
tall man lettering -
\medication names that have mixed case lettering in the description name, which helps
reduce errors between medication names that either look or sound alike
FAERS and VAERS -
\Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 -
\• Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
Kefauver-Harris Amendment of 1962 -
\• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Harrison Narcotic Act -
\a 1914 congressional act that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 -
\established schedules of controlled substances and moved enforcement to the Justice
Department (C-1 to C-5)
Established the DEA
DEA -
\Enforces the controlled substance act under the DOJ. Makes sure all controlled
substances are manufactured, distributed, and stored properly.
Control 1 (C-1) drugs -
\High abuse. Considered not medical use or street drugs. (Marijuana, ecstasy, heroin,
LSD)
Control 2 (C-II) drugs -
\Consists of narcotics, pain killers, ADHD drugs. Highly addicting (Percocet, Endocet,
Norco, Fentanyl, Morphine)
, Control 3 (C-III) drugs -
\Mild pain killers, anabolic steroids and caffeine pills, can be moderately abused
(Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)
Control 4 (C-IV) drugs -
\Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite suppressants,
Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax, Carisoprodol/soma,
clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)
Control 5 (C-V) Drugs -
\Low Codeine amounts in cough suppressants. Considered the least abusive
(phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory -
\exact count for schedule II and an estimated count for III-V drugs must be performed
every 2 years
C-II Supply -
\Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? -
\Yes, and there are exceptions: for patients in community care or in long term IV care
Expiration date for C-II? -
\No expiration date but just be filled in 1 month or in a 10 day period
Can doctor make a phone prescription for C-II? -
\Only for extreme emergencies. A hard copy must be sent to the pharmacy in 7 days or
pharmacy can report the doctor to DEA
DEA Form 222 -
\must be used whenever Sch II drugs are bought, sold or transferred between
pharmacies or qualified distributors, can only order 10 medications at a time
Form 222 triplicate forms? -
\1) Seller
2) DEA
3) Pharmacy
How long must form 222 be kept in file? -
\For 2 years
Can you make mistakes on form 222? -
\No, must be mistake free. If a mistake is made, it is kept on file
ANSWERS.
Pure Food and Drug Act -
\Prevents the manufacturing, sale/transportation of misbranded or adulturated drugs,
poisoned or contaminated drugs
Adultered drugs -
\Any drug that is not pure
misbranded drug -
\Not labeled correctly
FDCA (Federal Food, Drug, and Cosmetic act) -
\drugs must comply with standards of safety and efficacy, more modern act than Pure
Food and Drug Act. Oversees safety of food, drugs and cosmetics
FDA (Food and Drug Administration) -
\a division of USDHHS responsible for regulating food and drug products sold to the
public. Handles drug approvals, sold, and recalls of drugs
3 types of Drug Recalls -
\1. Most severe: permanent health hazard or death
2. Medium severity: temporary or reversible damage
3. Least severe: mislabeling or misbranded drugs, low damage from drugs
MedWatch Program -
\Reports to FDA side effects or adverse effects of any drugs
(FAERS) FDA Adverse Event Reporting System -
\Database that contains information on adverse event and medication error reports
submitted to the FDA; designed to support the FDA's post-marketing safety surveillance
program.
VAERS (Vaccine Adverse Event Reporting System) -
\keeps track of all adverse effects associated with vaccines
IND (Investigational New Drug) -
\A drug not yet approved for marketing by the FDA but available for use in experiments
to determine its safety and efficacy.
FDA drug approval process -
\1. Hypothesis: comes up with the drug and reports findings (dosage, research and
findings) to FDA
,2. Pre-phase: consists of animal testing then human testing to small population (reports
correct dosing and side effects)
3. Large Human Trial: tests on wider population with longer procedure
4. Post-surveillance: approval by FDA but is monitored. Given a 20 year patent
tall man lettering -
\medication names that have mixed case lettering in the description name, which helps
reduce errors between medication names that either look or sound alike
FAERS and VAERS -
\Reports to the CDC (centers of disease control) as well
Durham-Humphrey Amendment of 1951 -
\• Created a distinction between "OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription..
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
Kefauver-Harris Amendment of 1962 -
\• Also known as the "Drug Efficacy Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of their
drugs before approval .
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
Harrison Narcotic Act -
\a 1914 congressional act that criminalized the sale and use of narcotics
Comprehensive Drug Abuse Prevention and Control Act of 1970 -
\established schedules of controlled substances and moved enforcement to the Justice
Department (C-1 to C-5)
Established the DEA
DEA -
\Enforces the controlled substance act under the DOJ. Makes sure all controlled
substances are manufactured, distributed, and stored properly.
Control 1 (C-1) drugs -
\High abuse. Considered not medical use or street drugs. (Marijuana, ecstasy, heroin,
LSD)
Control 2 (C-II) drugs -
\Consists of narcotics, pain killers, ADHD drugs. Highly addicting (Percocet, Endocet,
Norco, Fentanyl, Morphine)
, Control 3 (C-III) drugs -
\Mild pain killers, anabolic steroids and caffeine pills, can be moderately abused
(Tylenol 2, 3, 4; Vicodin; Depo-Testosterone; Buprenorphine; Ketamine)
Control 4 (C-IV) drugs -
\Anti-anxiety, anti-depressants, anti-psychotics, sleep aids, appetite suppressants,
Tramadol/Ultram. Has moderate abuse (alpralozam/Xanax, Carisoprodol/soma,
clonazepam/klonopin, lorazepam/Ativan, temazepam/restoril)
Control 5 (C-V) Drugs -
\Low Codeine amounts in cough suppressants. Considered the least abusive
(phenergan w/Codeine, guaifenesin w/codeine)
Biennial Inventory -
\exact count for schedule II and an estimated count for III-V drugs must be performed
every 2 years
C-II Supply -
\Only for 30 days. No partial filling or given for 90 day supply
Does C-II must have a prescription hard copy? -
\Yes, and there are exceptions: for patients in community care or in long term IV care
Expiration date for C-II? -
\No expiration date but just be filled in 1 month or in a 10 day period
Can doctor make a phone prescription for C-II? -
\Only for extreme emergencies. A hard copy must be sent to the pharmacy in 7 days or
pharmacy can report the doctor to DEA
DEA Form 222 -
\must be used whenever Sch II drugs are bought, sold or transferred between
pharmacies or qualified distributors, can only order 10 medications at a time
Form 222 triplicate forms? -
\1) Seller
2) DEA
3) Pharmacy
How long must form 222 be kept in file? -
\For 2 years
Can you make mistakes on form 222? -
\No, must be mistake free. If a mistake is made, it is kept on file
