ESSENTIALS OF PHARMACOLOGY FOR
HEALTH PROFESSIONS 10TH EDITION
COMPREHENSIVE SCRIPT WITH SOLUTIONS
◉ Examples of Schedule V Drugs.
Answer: Cough suppressants with small amounts of codeine and
preparations containing small amounts of opium, used to treat
diarrhea.
◉ Drug Standards.
Answer: Rules set to assure consumers that they get what they pay
for. The law says all preparations called by the same drug name must
be of uniform strength, quality and purity.
◉ 1906 Pure Food and Drug Act.
Answer: First government attempt to establish consumer protection
in manufacture of drugs and foods.
(1) Require all drugs marketed in the US to meet minimal standards
of strength, purity and quality.
(2) Demands all drug preparations containing dangerous
ingredients have a label on their container indicating dangerous
ingredient. Originally there were 11 dangerous ingredients,
including morphine.
,(3) Established two references of officially approved drugs: USP/NF:
United States Pharmacopeia (USP) and National Formulary.
◉ 1938 Federal Food, Drug, and Cosmetic Act and Amendments of
1951 & 1962.
Answer: Established the FDA under the Dept. of HHS to enforce the
provisions of the act. Established more specific regulations to
prevent the adulteration (tampering) of drugs, foods and cosmetics.
(1) All labels must be accurate, include a listing of all active and
inactive ingredients.
(2) All new products must be approved by the FDA before public
release.
(3) Warning labels must be present on certain medications. "May
cause drowsiness" "May cause nervousness" "May be habit-forming"
= legend drugs.
(4) Prescription and nonprescription drugs must be shown to be
effective and safe.
◉ Over-the-counter (OTC) medications.
Answer: Medications available without a prescription
◉ Legend drugs.
Answer: Drugs that must be labeled with a legend (inscription):
"May cause drowsiness" "May cause nervousness" "May be habit-
forming" = legend drugs.
, ◉ 1970 Controlled Substances Act.
Answer: Established the DEA as the bureau of DOJ to enforce
provisions of act. Sets much tighter controls on a specific group of
drugs--drugs that were being abused by society=substances that
needed to be controlled. Include depressants, stimulants,
psychedelics, narcotics and anabolic steroids.
(1) Controlled drugs are in 5 schedules according to their medical
value, harmfulness and potential for abuse and addiction.
(2) Demands security and accountability of controlled substances;
anyone who dispenses, receives, sells or destroys controlled
substances must keep on hand special DEA forms, indicating the
exact current inventory and a two-year inventory of every controlled
substance transaction.
(3) Sets limitations on the use of prescriptions, guidelines were
established for each of the 5 schedules of controlled substances,
regulating the number of times a drug may be prescribed in a six-
month period, which schedules prescriptions may be phone into a
pharmacy.
(4) Demands each prescriber of controlled drugs register with DEA
and obtain DEA registration number, to be present on their
prescriptions of controlled substances. Drug manufacturers must be
registered and identified with their own DEA numbers, also
pharmacists, physicians, vets, etc.
◉ 1983 Orphan Drug Act.
HEALTH PROFESSIONS 10TH EDITION
COMPREHENSIVE SCRIPT WITH SOLUTIONS
◉ Examples of Schedule V Drugs.
Answer: Cough suppressants with small amounts of codeine and
preparations containing small amounts of opium, used to treat
diarrhea.
◉ Drug Standards.
Answer: Rules set to assure consumers that they get what they pay
for. The law says all preparations called by the same drug name must
be of uniform strength, quality and purity.
◉ 1906 Pure Food and Drug Act.
Answer: First government attempt to establish consumer protection
in manufacture of drugs and foods.
(1) Require all drugs marketed in the US to meet minimal standards
of strength, purity and quality.
(2) Demands all drug preparations containing dangerous
ingredients have a label on their container indicating dangerous
ingredient. Originally there were 11 dangerous ingredients,
including morphine.
,(3) Established two references of officially approved drugs: USP/NF:
United States Pharmacopeia (USP) and National Formulary.
◉ 1938 Federal Food, Drug, and Cosmetic Act and Amendments of
1951 & 1962.
Answer: Established the FDA under the Dept. of HHS to enforce the
provisions of the act. Established more specific regulations to
prevent the adulteration (tampering) of drugs, foods and cosmetics.
(1) All labels must be accurate, include a listing of all active and
inactive ingredients.
(2) All new products must be approved by the FDA before public
release.
(3) Warning labels must be present on certain medications. "May
cause drowsiness" "May cause nervousness" "May be habit-forming"
= legend drugs.
(4) Prescription and nonprescription drugs must be shown to be
effective and safe.
◉ Over-the-counter (OTC) medications.
Answer: Medications available without a prescription
◉ Legend drugs.
Answer: Drugs that must be labeled with a legend (inscription):
"May cause drowsiness" "May cause nervousness" "May be habit-
forming" = legend drugs.
, ◉ 1970 Controlled Substances Act.
Answer: Established the DEA as the bureau of DOJ to enforce
provisions of act. Sets much tighter controls on a specific group of
drugs--drugs that were being abused by society=substances that
needed to be controlled. Include depressants, stimulants,
psychedelics, narcotics and anabolic steroids.
(1) Controlled drugs are in 5 schedules according to their medical
value, harmfulness and potential for abuse and addiction.
(2) Demands security and accountability of controlled substances;
anyone who dispenses, receives, sells or destroys controlled
substances must keep on hand special DEA forms, indicating the
exact current inventory and a two-year inventory of every controlled
substance transaction.
(3) Sets limitations on the use of prescriptions, guidelines were
established for each of the 5 schedules of controlled substances,
regulating the number of times a drug may be prescribed in a six-
month period, which schedules prescriptions may be phone into a
pharmacy.
(4) Demands each prescriber of controlled drugs register with DEA
and obtain DEA registration number, to be present on their
prescriptions of controlled substances. Drug manufacturers must be
registered and identified with their own DEA numbers, also
pharmacists, physicians, vets, etc.
◉ 1983 Orphan Drug Act.
