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Questions and Answers
A S2 license allows anyone to prescribe dangerous regulated drugs.
A S2 license allows anyone to prescribe dangerous regulated drugs.
False
As age increases, the functions of tissues and organs generally improve.
As age increases, the functions of tissues and organs generally improve.
False
Opium and cocaine are classified as regulated drugs.
Opium and cocaine are classified as regulated drugs.
False
Dietary supplements can impact the efficacy of medications.
Dietary supplements can impact the efficacy of medications.
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The largest person requires less medication than a smaller person for the same effect.
The largest person requires less medication than a smaller person for the same effect.
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The storage condition of a drug can influence its effectiveness.
The storage condition of a drug can influence its effectiveness.
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Combining medications with certain dietary supplements can have serious consequences.
Combining medications with certain dietary supplements can have serious consequences.
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Genetic make-up has no effect on how a drug is metabolized in the body.
Genetic make-up has no effect on how a drug is metabolized in the body.
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The pregnancy letter category must be removed by June 29, 2020.
The pregnancy letter category must be removed by June 29, 2020.
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The Inscription part of a medical prescription provides instructions for the patient on how to take the medication.
The Inscription part of a medical prescription provides instructions for the patient on how to take the medication.
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The symbol 'Rx' found in prescriptions is derived from a Latin word that means 'mark'.
The symbol 'Rx' found in prescriptions is derived from a Latin word that means 'mark'.
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The Generic Act of 1988 ensures that drugs must be identified by their generic names.
The Generic Act of 1988 ensures that drugs must be identified by their generic names.
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Administrative Order No. 62 S. 1989 implements prescribing requirements under the Dangerous Drug Act.
Administrative Order No. 62 S. 1989 implements prescribing requirements under the Dangerous Drug Act.
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Narcotics produce insensibility or stupor and may be habit forming as monitored by the Dangerous Drug Act.
Narcotics produce insensibility or stupor and may be habit forming as monitored by the Dangerous Drug Act.
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The Subscription component of a medical prescription provides the names and quantities of the drugs being prescribed.
The Subscription component of a medical prescription provides the names and quantities of the drugs being prescribed.
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Lactation considerations in drug prescriptions include the same risk summary as pregnancy.
Lactation considerations in drug prescriptions include the same risk summary as pregnancy.
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Phase III trials typically involve $1000-3000$ patients and take about $3$ years.
Phase III trials typically involve $1000-3000$ patients and take about $3$ years.
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Category C drugs have been proven to have no adverse effects in humans.
Category C drugs have been proven to have no adverse effects in humans.
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Pregnancy Category D drugs are considered safe to use during pregnancy as they have no known risks.
Pregnancy Category D drugs are considered safe to use during pregnancy as they have no known risks.
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The Prescription drugs approved after June 30, 2015, use the old labelling system.
The Prescription drugs approved after June 30, 2015, use the old labelling system.
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Levothyroxine is an example of a Category B pregnancy drug.
Levothyroxine is an example of a Category B pregnancy drug.
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The FDA approval process for a drug can involve more than 5 years to complete.
The FDA approval process for a drug can involve more than 5 years to complete.
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Animal studies in Category B drugs have shown evidence of risk to the fetus.
Animal studies in Category B drugs have shown evidence of risk to the fetus.
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Atorvastatin is classified as a Category X drug due to its teratogenic effects.
Atorvastatin is classified as a Category X drug due to its teratogenic effects.
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Study Notes
Pregnancy Letter Category Removal
- Pregnancy letter category abolished by June 29, 2018.
- Replacement includes narrative sections for pregnancy and lactation.
Relevant Drug Laws
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Generic Act of 1988 (RA 6675)
- Promotes the production and distribution of drugs identified by generic names.
- Ensures drug availability at low cost, with provisions for free access to indigent patients.
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Administrative Order No. 62 S. 1989
- Implements prescribing requirements under the Generic Act.
- Requires full generic names written after the Rx symbol in prescriptions.
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Parts of Medical Prescription
- Superscription: Contains the heading with the Rx symbol.
- Inscription: Lists drug names, quantities, dosages, and forms.
- Subscription: Special instructions for pharmacists on compounding.
- Signatura/Transcription: Directions for patients on dosage and schedule.
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Dangerous Drug Act (RA 6425)
- Monitors narcotics that can induce insensibility and may be habit-forming.
- Prohibits specific drugs like opium and cocaine; regulates sedatives and amphetamines.
- Requires an S2 license for prescribing regulated drugs.
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Comprehensive Dangerous Drugs Act (RA 9165)
- Repeals RA 6425 and outlines definitions for dispensing and manufacturing dangerous drugs.
Factors Affecting Drug Responses
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Genetic Make-Up
- Influences drug metabolism; variability can cause toxicity.
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Age
- Decreased organ function with aging affects drug handling and efficacy.
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Body Size/Weight
- Larger individuals require higher drug doses for similar effects compared to smaller individuals.
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Use of Other Drugs and Dietary Supplements
- Some supplements can enhance or inhibit medication effects; combinations may cause life-threatening interactions.
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Consumption of Food and Beverages
- Foods can delay or inhibit drug absorption; alcohol may exacerbate CNS depressant effects.
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Presence of Diseases
- Conditions like kidney or liver disease can impair drug excretion or metabolism.
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Drug Storage
- Improper storage can affect drug efficacy.
Drug Approval Phases
- Phase I: Safety and profile assessment in 20-80 healthy volunteers; ~1 year duration.
- Phase II: Effectiveness evaluation with 100-300 patient volunteers; ~2 years duration.
- Phase III: Extensive monitoring in 1000-3000 patients; takes about 3 years.
- Final FDA approval process can take approximately 2.5 years post-trials.
Pregnancy Categories (Established 1979)
- Category A: No risk shown in well-controlled studies; considered safe (e.g., Levothyroxine, Folic Acid).
- Category B: No adverse effects in animals, but no studies in humans (e.g., Metformin, Amlodipine).
- Category C: Adverse effects in animals; potential benefits may justify use in pregnancy (e.g., Tramadol).
- Category D: Adverse effects in humans, but benefits may outweigh risks (e.g., Losartan).
- Category X: Risks clearly outweigh benefits; can cause teratogenic effects (e.g., Atorvastatin).
New Labelling System
- Pregnancy and Lactation Labelling Final Rule (PLLR): Effective June 30, 2015; mandates new format for prescription drugs approved after this date.
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Description
This quiz covers essential aspects of drug regulations, including the Generic Act of 1988 and updates on pregnancy and lactation guidelines related to drug use. It highlights the importance of risk assessment and clinical considerations during pregnancy and nursing. Understand the implications for healthcare providers and patients.
