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PC 707-MODULE QUESTIONS AND ANSWERS
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PC 707-MODULE QUESTIONS AND ANSWERS
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PC 707-MODULE QUESTIONS AND ANSWERSFull prescriptive authority - Answers- Full prescriptive authority is the legal right to
prescribe independently and without limitation.
How is prescriptive authority determined? - Answers- -part of the affordable care act
-Prescriptive authority is determined by state laws -regulated by health professional
boards.
Two criteria that FDA looks at for approval of all drugs? - Answers- 1) safety and 2)
efficacy
Over the Counter medications - Answers- drugs sold directly to a consumer without a
prescription from a healthcare professional
Prescription (noncontrolled) - Answers- sold only to consumers possessing a valid
prescription from a healthcare prescriber who is authorized to prescribe.
Controlled (Scheduled) - Answers- Drugs are classified into five (5) distinct categories
or schedules depending upon the drug's acceptable medical use and the drug's abuse
or dependency potential
1. Why are some drugs controlled/scheduled? - Answers- Drugs are classified into five
(5) distinct categories or schedules depending upon the drug's acceptable medical use
and the drug's abuse or dependency potential.s
Schedule I drugs - Answers- Abuse potential: Highest
Drug examples: Heroin, LSD, cocaine
Effects (dependence): Unpredictable, psychological or physical dependence, death
Medical use: No accepted medical use
Rx writing: None- only researchers
Refills: Not applicable
Schedule II drugs - Answers- Abuse potential: High
Drug examples: Hydromorphone, methadone, meperidine, oxycodone, and
fentanylEffects (dependence): may lead to severe psychological or physical
dependence.
Medical use: yes
Rx writing: Must be typed or filled out in ink, signed by prescriber. Oral prescription can
be called in over the phone, only for emergencies, written script must follow within 72
hours.
Refills: new Rx must be written each time
Schedule III drugs - Answers- Abuse potential: Moderate
Drug examples: Tylenol with codeine & suboxone
, Effects (dependence): abuse may lead to moderate or low physical dependence or high
psychological dependence.
Medical use: yes
Rx writing: Oral, written, or electronic
Refills: Up to 5 refills
What is a DEA number required for? - Answers- DEA numbers are required for
prescribing controlled/scheduled drugs
elements that create a bona fide patient-provider relationship - Answers- Complete hx,
physical exam, and documentation
Is it legal to prescribe off-label? - Answers- -Off-label drug use occurs in situations
when a drug has been found useful for conditions other than those that are FDA
approved
-Often seen for pediatrics and pregnancy due to lack of drug-trial inclusion
Patient education -- Risks, benefits, alternatives. If considered experimental for off-label
use, this must be discussed with patient/caregivers.
-Providers must document the decision making processes when prescribing an off-label
medication in the patient's medical record. (Existing evidential support)
1. Is it acceptable to prescribe to friends and/or family? Are there specific medications
that you should not prescribe to self, friends, or family? - Answers- -Cannot write for
yourself. Some state boards and medical associations consider it unethical
-Usually considered justified in emergencies or for minor, acute problems.
-Most states FORRBID writing for controlled drugs for self/family/friends
What conditions must be met to ethically in order to prescribe for family or friends? -
Answers- -Most states require having a "bona fide" patient-provider relationship.
-Must provide a reasonable standard of care Patients are entitled to a "reasonable
standard of care" -- Health History, physical exam, and documentation.
FDA human trial phase 1 - Answers- Number of subjects: 40-50 healthy volunteers,
usually adult males take the drug to evaluate pharmacokinetics
Purpose:This phase is a trial run to evaluate safety.
FDA human trial phase 2 - Answers- Number of subjects: Drug given in increasing
doses to a small number of patients. 10-100 in controlled clinical trials with the target
disease or disorder.
Purpose:Drug evaluation proceeds to Phase III if there are no serious adverse side
effects. This phase is a trial run to evaluate efficacy.
FDA human trial phase 3 - Answers- Number of subjects: Clinical trials (controlled and
uncontrolled) in multiple centers with ideally double-blind studies, if possible, to
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