MEDICATION CONCEPTS AND CONSIDERATIONS Flashcards
◦ Any chemical that affects the physiologic processes of a living organism
Key, Receptor, or Drug
Drug
▪ Describes the drug’s chemical composition & molecular structure (IUPAC)
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
▪CHEMICAL NAME
▪ This name is generally NOT used in the clinical/prescribing setting
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
▪CHEMICAL NAME
▪ Name given by the United States Adopted Names Council
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
▪GENERIC NAME
▪ Named by Active ingredient
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
▪GENERIC NAME
▪ The drug has a registered trademark
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
BRAND/TRADE NAME
▪ use of the name is restricted by the drug’s patent owner (usually the manufacturer)
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
BRAND/TRADE NAME
2-Acetoxybenzoic acid
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
CHEMICAL NAME
Aspirin (acetylsalicylic acid)
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
GENERIC NAME
Aspro Clear®
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
BRAND/TRADE NAME
? Name is a patent protected name, patents EXPIRE over time (~17 years)
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
BRAND/TRADE NAME
? names last FOREVER
GENERIC NAME, CHEMICAL NAME, BRAND/TRADE NAME
GENERIC NAME
The FDA says that generic drugs must be ? to brand name drugs
bioequivalent of biotransmited
bioequivalent
With NARROW THERAPEUTIC INDEX DRUGS such as seizure drugs the patient should have
a. Use the SAME manufacturer
b. Use a Different manufacturer
c. Not necessarily the BRAND
d. But a CONSISTENCY in the product they use
a. Use the SAME manufacturer
b. Not necessarily the BRAND
c. But a CONSISTENCY in the product they use
Examples of some drug classes where generally we do not change manufacturers?
a. Thyroid,
b. Epilepsy,
c. Transplant, and a few other conditions
d. None
e. All
e. All
Plants
a. Heparin
b. Digoxin
c. Penicillin
d. Zinc
e. Pancreas- insulin (originally)
g. Insulins
h. Morphine
i. Iron
b. Digoxin
h. Morphine
Animals
a. Heparin
b. Digoxin
c. Penicillin
d. Zinc
e. Pancreas- insulin (originally)
g. Insulins
h. Morphine
i. Iron
e. Pancreas- insulin (originally)
a. Heparin
Minerals
a. Heparin
b. Digoxin
c. Penicillin
d. Zinc
e. Pancreas- insulin (originally)
g. Insulins
h. Morphine
i. Iron
d. Zinc
i. Iron
Laboratory synthesis
a. Heparin
b. Digoxin
c. Penicillin
d. Zinc
e. Pancreas- insulin (originally)
g. Insulins
h. Morphine
i. Iron
g. Insulins
Microbiological
a. Heparin
b. Digoxin
c. Penicillin
d. Zinc
e. Pancreas- insulin (originally)
g. Insulins
h. Morphine
i. Iron
c. Penicillin
Controlled Substances (DEA Schedules) Non-Controlled
Over the Counter, RX (Prescription), Dietary Supplements
RX (Prescription)
Over the Counter (OTC)
Behind the Counter (BTC)
Over the Counter, RX (Prescription), Dietary Supplements
Over the Counter
Vitamins
Herbals
Homeopathic
Over the Counter, RX (Prescription), Dietary Supplements
Dietary Supplements
Homeopathic
Over the Counter, RX (Prescription), Dietary Supplements
Dietary Supplements
RX (Prescription)
a. REGULATION- FDA,
b. REGULATION - The supplement manufacturers and
distributors
a. REGULATION- FDA,
Over the Counter
a. REGULATION- FDA,
b. REGULATION - The supplement manufacturers and
distributors
a. REGULATION- FDA,
Dietary Supplements
a. REGULATION- FDA,
b. REGULATION - The supplement manufacturers and
distributors
b. REGULATION - The supplement manufacturers and
distributors
◦ Means that these drugs require periodic monitoring
Over the Counter, RX (Prescription), Dietary Supplements
RX (Prescription)
◦ They must be prescribed by a health care professional
Over the Counter, RX (Prescription), Dietary Supplements
RX (Prescription)
◦ Means that these are generally safe and don’t require periodic monitoring
Over the Counter, RX (Prescription), Dietary Supplements
Over the Counter
▪ Government Agency that reviews and approves drugs in U.S.A
DEA, FDA
FDA
▪ Clinical Trials Goal: Drug is SAFE AND EFFECTIVE
DEA, FDA
FDA
? - Categories A through X Pregnancy
New method or Old method
Old method
? - Labeling Pregnancy
New method or Old method
New method
Pregnancy Category B should be “safer” than Category C, but not always the case
New method or Old method
Old method
▪ Categories don’t give you any details-Drug is “category B”, ok so what do I tell the patient?
New method or Old method
Old method
New method
Registry, risk summary, clinical considerations, data
Lactation, Pregnancy, Females and Male of Reproductive Potential
Pregnancy
New method
Risk summary, clinical considerations, data
Lactation
New method
Pregnancy/Infertility
Females and Male of Reproductive Potential
No risk to human fetus
Cat.
B, A, D, X, C
Cat A
No risk to animal fetus, information for humans unavailable
Cat B
ADE to animal fetus, information for humans unavailable
Cat C
Possible fetal risk in humans have been reported, However in selected cases consideration of potential benefit vs risk may warrant use of these drugs in pregnant women
Cat D
Fetal abnormalities and risk in humans and animals. Should not be given to pregnant women
Cat X
Which method focus on labeling pregnancy risk
New method or Old method
New method
Risk Evaluation and Mitigation Strategies (REMS DRUGS)
Which is true
a. Benefits > Risk, but we monitor for risk
b. Pharmacy and Prescriber register
c. Monthly requirements and criteria
d. Teamwork between patient, pharmacy and prescriber
e. None
f. All
f. All
Which Rems Drug
Antipsychotic- lowers Absolute Neutrophil Count (ANC)
Clozapine- Clozaril®
Isotretinoin (Accutane®)
Clozapine- Clozaril®
Which Rems Drug
Used to Treat: Acne
Clozapine- Clozaril®
Isotretinoin (Accutane®)
Isotretinoin (Accutane®)
Which Rems Drug
◦ =increased risk for infection
Clozapine- Clozaril®
Isotretinoin (Accutane®)
Clozapine- Clozaril®
Which Rems Drug
◦ Pregnancy Category: X (highly teratogenic!)
Clozapine- Clozaril®
Isotretinoin (Accutane®)
Isotretinoin (Accutane®)
Called iPLEDGE ?
Rems Drugs
Isotretinoin (Accutane®)
a. Enroll patient into Clozapine registry
b. Patient, Pharmacy, Prescriber enroll together
c. Report labs to REMS Program
d. Pregnancy test PRIOR to start
e. Monitor ANC at baseline and periodically
f. DURING therapy (refills), and 1 month AFTER stopping the drug
g. Educate about signs/symptoms of Neutropenia (infection)
b. Patient, Pharmacy, Prescriber enroll together
d. Pregnancy test PRIOR to start
f. DURING therapy (refills), and 1 month AFTER stopping the drug
Clozapine- Clozaril®
a. Enroll patient into Clozapine registry
b. Patient, Pharmacy, Prescriber enroll together
c. Report labs to REMS Program
d. Pregnancy test PRIOR to start
e. Monitor ANC at baseline and periodically
f. DURING therapy (refills), and 1 month AFTER stopping the drug
g. Educate about signs/symptoms of Neutropenia (infection)
a. Enroll patient into Clozapine registry
c. Report labs to REMS Program
e. Monitor ANC at baseline and periodically
g. Educate about signs/symptoms of Neutropenia (infection)
(sold without prescription)
Over the Counter, RX (Prescription), Dietary Supplements
Over the Counter
(need prescription)
Over the Counter, RX (Prescription), Dietary Supplements
RX (Prescription)
▪If drugs are found to have any dependency or abuse potential,
they are grouped into “schedules”
FDA or DEA
DEA
The 5 schedules are categorized based on:
a. Abuse potential,
b. SUD, misuse
c. Medical use
d. Dependency potential
e. None
f. All
f. All
▪These drugs are commonly referred to as:
a. Controlled Substances,
b. Scheduled Drugs
c. Narcotics
d. None
e. All
e. All
Marijuana, Heroin, LSD
Schedule 1-5?
Abuse Potential?
Medical Use?
Dependency Potential?
Schedule 1
High
None
Severe
Codeine with APAP
(acetaminophen)
Schedule 1-5?
Abuse Potential?
Medical Use?
Dependency Potential?
Schedule 3
Less than 2
Accepted
Moderate to low
Codeine, oxycodone, cocaine, hydrocodone with APAP (acetaminophen)
Schedule 1-5?
Abuse Potential?
Medical Use?
Dependency Potential?
Schedule 2
High
Accepted
Severe
Benzodiazepines
Schedule 1-5?
Abuse Potential?
Medical Use?
Dependency Potential?
Schedule 4
Less than 3
Accepted
Limited
Most cough medications
containing an opioid
Schedule 1-5?
Abuse Potential?
Medical Use?
Dependency Potential?
Schedule 5
Less than 4
Accepted
Limited
If a prescriber wants to prescribe a controlled substance (II-V), they need a DEA license
True or False
True
Schedule III- (C III)- NO REFILLS
True or False
False
Schedule II (C II)
▪ Physician Assistants, Nurse Practitioners, Dentists, etc.
can prescribe Schedule drugs with DEA Liscense
T or F
True
Which is true about schedule drugs
▪ADMINISTRATION
a. Keep them in secure areas (locked)
b. Have another nurse witness the discarding of controlled substances
both
Increased risk of pediatric deaths due to Tramadol and Codeine
T or F
T
The study of how genetic differences in a single gene influence variability in drug response (PK and PD)
PHARMACOGENOMICS or PHARMACOGENETICS
▪PHARMACOGENETICS-
▪ Genetic Polymorphisms
PHARMACOGENOMICS or PHARMACOGENETICS
▪PHARMACOGENETICS-
▪ The Study of how genetic difference in multiple genes influence variability in drug response
PHARMACOGENOMICS or PHARMACOGENETICS
▪PHARMACOGENOMICS-
Codeine is a Pro-Drug
T or F
T
Which is true about Codeine
a. Genetic Polymorphisms
b. CYP2D6
c. More than 70 different alleles have been discovered
d. Patients can be:
e. “ultra-rapid” metabolizers
g. “poor” metabolizers
All
Pediatric deaths when prescribed Codeine
Indirect or Direct
Direct
Infant deaths when Mother is breastfeeding while taking Codeine
Indirect or Direct
Indirect