Podcast
Questions and Answers
What is the highest level of evidence in the Quality of Evidence Pyramid?
What is the highest level of evidence in the Quality of Evidence Pyramid?
Which of the following steps is NOT part of WHO’s 6 steps for Rational Prescribing?
Which of the following steps is NOT part of WHO’s 6 steps for Rational Prescribing?
Which question addresses the pharmacokinetics of a drug in the Eight Standard Questions for Safe & Effective Prescribing?
Which question addresses the pharmacokinetics of a drug in the Eight Standard Questions for Safe & Effective Prescribing?
Which of the following aspects is important when considering Rational Drug Selection?
Which of the following aspects is important when considering Rational Drug Selection?
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What aspect of off-label prescribing is considered legal?
What aspect of off-label prescribing is considered legal?
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What is the purpose of shared decision-making in prescribing?
What is the purpose of shared decision-making in prescribing?
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Which of the following study types provides a low level of evidence according to the Quality of Evidence Pyramid?
Which of the following study types provides a low level of evidence according to the Quality of Evidence Pyramid?
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What does the 'I' in the AVOID acronym stand for in patient history?
What does the 'I' in the AVOID acronym stand for in patient history?
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Which of the following elements is NOT required in a prescription?
Which of the following elements is NOT required in a prescription?
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How does medication reconciliation primarily enhance patient safety?
How does medication reconciliation primarily enhance patient safety?
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What is the main advantage of e-prescribing over traditional methods?
What is the main advantage of e-prescribing over traditional methods?
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What does bioavailability specifically refer to?
What does bioavailability specifically refer to?
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Which process is NOT part of pharmacokinetics?
Which process is NOT part of pharmacokinetics?
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Which scenario best exemplifies verbal prescribing?
Which scenario best exemplifies verbal prescribing?
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What should a healthcare provider do to maximize safety in verbal prescribing?
What should a healthcare provider do to maximize safety in verbal prescribing?
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Why is it essential to know bioavailability differences between brand and generic drugs?
Why is it essential to know bioavailability differences between brand and generic drugs?
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What defines an adverse effect in medication usage?
What defines an adverse effect in medication usage?
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What is the primary purpose of a Black Box Warning?
What is the primary purpose of a Black Box Warning?
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What defines absolute contraindications in medication prescription?
What defines absolute contraindications in medication prescription?
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How does an agonist function in pharmacology?
How does an agonist function in pharmacology?
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Which condition can lead to altered drug absorption due to changes in gastric pH?
Which condition can lead to altered drug absorption due to changes in gastric pH?
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What is the role of CYP inhibitors in drug metabolism?
What is the role of CYP inhibitors in drug metabolism?
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What is a characteristic of Type 1 allergic reactions?
What is a characteristic of Type 1 allergic reactions?
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Which of the following best describes relative contraindications?
Which of the following best describes relative contraindications?
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What symptoms may arise due to adverse effects of medications?
What symptoms may arise due to adverse effects of medications?
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What should be appropriately documented to ensure accurate risk stratification when assessing a drug reaction?
What should be appropriately documented to ensure accurate risk stratification when assessing a drug reaction?
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How do ultra-rapid metabolizers affect drug dosage requirements?
How do ultra-rapid metabolizers affect drug dosage requirements?
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Which population is at risk of polypharmacy due to decreased glomerular filtration and liver function?
Which population is at risk of polypharmacy due to decreased glomerular filtration and liver function?
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What is one consequence of genetic variants on drug metabolism?
What is one consequence of genetic variants on drug metabolism?
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What has historically impacted the understanding of drug safety and efficacy for women?
What has historically impacted the understanding of drug safety and efficacy for women?
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What primarily determines the absorption rate of a drug in the body?
What primarily determines the absorption rate of a drug in the body?
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Which statement regarding the blood-brain barrier is accurate?
Which statement regarding the blood-brain barrier is accurate?
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What is the main consequence of protein binding of drugs?
What is the main consequence of protein binding of drugs?
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What occurs during the first pass effect?
What occurs during the first pass effect?
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How does CYP induction affect drug metabolism?
How does CYP induction affect drug metabolism?
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Which statement about infants and drug metabolism is true?
Which statement about infants and drug metabolism is true?
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What characterizes a prodrug?
What characterizes a prodrug?
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What is the impact of genetic variations on drug metabolism?
What is the impact of genetic variations on drug metabolism?
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What is the function of PGP in relation to drug absorption?
What is the function of PGP in relation to drug absorption?
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Which medication design is intended to dissolve in an alkaline environment?
Which medication design is intended to dissolve in an alkaline environment?
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Study Notes
Full Prescriptive Authority
- The right to prescribe medications without limit.
- Determined by state law.
Food and Drug Administration (FDA)
- A federal agency regulating medications and medical devices.
- Ensures safety, efficacy, and security of drugs, biological products, and medical devices.
- Monitors the safety of these products.
FDA Drug Approval Criteria
- Safety: The drug must be safe for its intended use.
- Efficacy: The drug must be effective for its intended use.
Drug Enforcement Administration (DEA)
- A federal agency enforcing controlled substances laws and regulations.
- Prescription for controlled/scheduled drugs must include a valid DEA number.
FDA Phases of Human Drug Studies
- Phase 1: Evaluate safety; subjects: 40-50 healthy volunteers.
- Phase 2: Evaluate efficacy; subjects: 10-100 patients with the target disease/disorder.
- Phase 3: Test safety and efficacy; subjects: several hundred to several thousand patients; randomized and blind controlled and uncontrolled trials.
- Phase 4: Post-market surveillance; subjects: varies, continued monitoring.
Drug Classifications
-
Over-the-Counter (OTC) Medications: Sold directly to consumers without a prescription; used for self-diagnosed conditions.
-
Prescription (Noncontrolled) Medications: Require a valid prescription from a healthcare provider.
-
Controlled (Scheduled) Medications: Classified based on medical use and potential for abuse; 5 schedules.
- Schedule I: Highest abuse potential (e.g., heroin, LSD); no accepted medical use.
- Schedule II: High abuse potential; no refills allowed; new prescription required (e.g., Oxycodone)
- Schedule III: Moderate abuse potential; refills up to 5 times within 6 months (e.g., Tylenol with codeine)
- Schedule IV: Low abuse potential; refills up to 5 times within 6 months (e.g., Xanax)
- Schedule V: Lowest abuse potential; refills as authorized by the prescriber (e.g., cough medicines with a low dose of codeine).
Elements of a Bona Fide Patient-Provider Relationship
- Complete medical history.
- Physical examination.
- Documentation of findings and treatment plan.
- Off-label prescribing
Legal Considerations
- Legal if benefits the patient and is based on scientific evidence.
- Not illegal, contraindicated, or investigational.
Rational Drug Selection
- Clearly identify the medical issue (patient's problem).
- Determine therapeutic objective (e.g., curative, symptom relief, management).
- Consider allergies, drug/drug interactions, cost, and availability.
- Provide necessary information about medication and its use (patient education).
- Follow up to ensure treatment is working as intended.
WHO's 6 steps for Rational Prescribing
- Identify the patient's problem.
- Specify the therapeutic objective.
- Choose the appropriate drug.
- Start treatment.
- Provide instructions, warnings, and information.
- Monitor treatment and adjust as needed.
Shared Decision-Making and Prescribing
- Involves patient preferences that predict therapeutic alliance and treatment adherence, leading to better outcomes.
Eight standard Questions for Safe & Effective Prescribing
- [Questions not covered in the given text]
Patient History & Prescribing
- Patient history helps avoid polypharmacy and drug interactions (Remember the AVOID acronym: Allergies, Vitamins and herbs, Old or OTC medications, Interactions, Dependency, and Mendel (family history)).
Medication Reconciliation
- Creating an accurate list of all medications a patient is taking.
- Ensures patient safety by avoiding errors at every patient encounter.
- Reconciling medications must occur at every patient encounter.
Required Elements of a Prescription
- Patient's name, date of birth, and address.
- Drug name and concentration.
- Drug form (tablet, capsule, liquid).
- Medication strength.
- Instructions for use (e.g., SIG).
- Quantity of medication.
- Number of refills.
- Prescriber's signature, DEA number (if applicable), state license number or NPI.
- Office address and telephone number.
- E-prescribing, paper prescribing, and verbal prescribing safety.
Paper Prescribing, Verbal Prescribing, Bioavailability, Chemical Equivalence, & Brand vs. Generic Drugs
- Paper prescribing: Less common, requires tamper-resistant pads; clear handwriting is crucial.
- Verbal prescribing: Used for urgent needs; receiver must repeat back the order to avoid errors.
- Bioavailability: The rate and extent to which a drug is absorbed and available at the site of action.
- Chemical equivalence: Two drug preparations with the same amount of identical chemical compounds.
Pharmacokinetics
- The movement of a drug through the body.
- Four main processes: absorption, distribution, metabolism, and excretion.
- Absorption and distribution determine route of administration.
### Lipid Solubility
- Highly lipid-soluble drugs are absorbed more quickly than those with low lipid solubility because they easily cross membranes.
Blood-Brain Barrier
- Unique anatomy of CNS capillaries with tight junctions prevents drug passage.
- Only lipid-soluble drugs or those with a transport system can pass.
Placental Drug Transfer
- Placental membranes do not constitute an absolute barrier.
- Most drugs cross via simple diffusion.
Protein Binding
Drugs may form reversible bonds with proteins, primarily plasma albumin. This binding restricts drug distribution. Protein-bound drugs are inactive.
Oral Medications
- Need to be absorbed through the GI tract.
- Impacted by factors like pH levels.
Enteric-coated Medications
- Designed to dissolve in a higher pH after leaving the stomach.
Routes of Administration
Different routes (oral, rectal, sublingual, etc.) are chosen based on absorption and distribution needs.
Hepatic Drug Metabolizing Enzymes
- Most liver metabolism is performed by the hepatic microsomal enzyme system (P450).
- Prodrug is a compound pharmacologically inactive but metabolized to an active form.
Special Consideration in Age
- Infants have limited drug-metabolizing capacity, and the liver does not fully develop until 1 year old.
- CYP Induction and Inhibition: Increases/decreases the rate of hepatic metabolism.
- Substrate: The substance on which an enzyme acts.
- First Pass Effect: Rapid hepatic deactivation of certain oral drugs before they reach systemic circulation, altering the drug dose.
Genetic Variations
- Genetic differences can affect drug metabolism rates (poor, intermediate, extensive, ultra-rapid metabolizers).
Renal Drug Excretion
- Kidneys are the primary site for drug excretion.
- Limiting drug duration in healthy individuals and increasing duration and intensity in those with impaired renal function.
Glomerular Filtration
- Moves drugs from blood to urine.
- Drugs bound to albumin do not pass.
Passive Tubular Reabsorption
- Reabsorption of lipid-soluble drugs back into the blood.
Active Tubular Secretion
- Active transport of drugs into urine.
Nonrenal Excretion
- Includes excretion through breast milk, bile, lungs, sweat, and saliva; has minimal clinical significance.
Time Course of Drug Responses
- Plasma Drug Level: Amount of drug in the blood correlates with therapeutic and toxic responses.
- Minimum Concentration: The lowest plasma drug level at which therapeutic effects occur.
- Toxic Concentration: The plasma level at which toxic effects begin.
- Therapeutic Range: The plasma drug level range between the minimum concentration and toxic concentration.
Dose-Response
- Maximal Efficacy: The largest effect a drug can produce.
- Relative Potency: The amount of drug needed to elicit an effect.
Drug-Receptor Interactions
- Affinity: The strength of attraction between a drug and its receptor.
- Activation: The drug's ability to cause the receptor to activate after binding.
Agonist/Antagonist/Partial Agonist
- Agonist: Drugs that bind to the receptor and mimic the action of endogenous molecules.
- Antagonist: Drugs that block the action of endogenous molecules, preventing activation; no effect if no agonist is present.
- Partial Agonist: Drugs that bind to the receptor and have only a moderate expression of the endogenous molecule's action.
Therapeutic Index
- A measure of a drug's safety. - A wide therapeutic index indicates a relatively safe drug; a small therapeutic index indicates a relatively unsafe drug.
Terminology in Prescribing
- Side Effects: Nearly unavoidable secondary drug effects at therapeutic doses.
- Examples of side effects: headache, nausea, vomiting, diarrhea.
- Characteristics: Generally predictable and dose-dependent.
- Adverse Effects: Noxious; unintended; undesired effects at normal drug dosages.
- Examples of adverse effects: range from mild (e.g., nausea, headache) to severe (e.g., anaphylactic reaction).
- Serious adverse effects: include outcomes like death, life-threatening events, hospitalization, significant incapacity, or congenital anomalies.
Precautions
[Details not covered in the text]
Black Box Warning
- FDA's most stringent warning.
- Alerts to serious side effects (e.g., injury or death).
Relative Contraindications
- Risk of not using the medication may outweigh the risk of using it.
Absolute Contraindications
- Do not prescribe.
- Could cause severe or life-threatening conditions.
Drug Interactions
[Details not covered in the text]
Receptor Sites
- Agonist: Activates the receptor to produce a response.
CYP Induction and Inhibition
- Substrate, Inhibitor, Inducer: Terms relevant to cytochrome enzyme activity and drug metabolism.
Gastric pH and Drug Absorption
- Antacids can increase stomach pH, potentially causing enteric-coated medications to break down prematurely.
Allergic Reactions
- Type 1 (Immediate Hypersensitivity): IgE mediated; symptoms: anaphylaxis, angioedema, bronchospasm.
- Type 2 (Antibody-Dependent Cytotoxicity): IgG or IgM mediated; symptoms: hemolysis, thrombocytopenia.
- Type 3 (Immune Complex Hypersensitivity): Immune complexes; symptoms: serum sickness.
- Type 4 (Cell-Mediated or Delayed Hypersensitivity): T cell-mediated; symptoms: skin reactions ranging from rash to Stevens-Johnson Syndrome.
- Pseudo Allergies: Non-IgE mediated, likely mast cell degranulation.
Anticholinergic Reaction
- Antagonizes action of acetylcholine.
- Inhibits parasympathetic nerve impulses.
- Side effect in elderly.
- Long-term use can lead to dementia.
QT Prolongation
- Longer than normal interval between depolarization and repolarization.
- Can cause arrhythmias and torsades.
Non-modifiable Risk Factors/Modifiable Risk Factors for QT Prolongation
- Non-modifiable: Female, (genetic, hormonal, anatomical factors)
- Modifiable: Hypokalemia, hypomagnesemia, hypocalcemia, renal or hepatic issues, drug interactions (other QT prolonging drugs), CYP3A4 inhibitors (e.g., grapefruit juice).
Food-Drug Interactions
- [Details not covered in the text]
Prophylactic Use
- [Note not covered in the text]
Chelation
- Bonding of ions between molecules to metal ions.
- Example: Medications binding to metals like iron, magnesium, calcium, or aluminum for use in therapy.
Drug Allergy History
- How old was the patient when the reaction occurred?
- Describe the reaction.
- When did the reaction occur in relation to the medication?
- How was the drug administered?
- Were other medications taken at the same time?
- What happened when the drug was stopped?
- Have you taken the drug since the reaction?
Important Considerations for Drug Allergies
- Distinguish between true allergies and side effects.
- Document clearly for accurate risk stratification.
- Use history to determine the type of reaction.
- Use history to determine appropriate actions.
Metabolizer Differences
- Ultra-Rapid Metabolizers: Require higher dosages for effectiveness.
- Intermediate & Slow Metabolizers: Decrease drug metabolism, causing drug accumulation and potential toxicity; lower dosages are necessary.
Genetic Variants
- Genetic variants can alter enzyme activity.
- Example: Warfarin and clopidogrel require genotyping to guide dosages due to genetic variations in CYP2C9 and CYP2C19.
Drug-to-Drug Interactions
- Inducers: Increase metabolism of other drugs.
- Inhibitors: Decrease metabolism of other drugs.
- Substrates: Drugs metabolized by the same enzyme, leading to competition.
Genetic Alterations
- Poor Metabolizers: Slow drug metabolism.
- Extensive Metabolizers (Normal): Standard drug metabolism.
- Ultra-Rapid Metabolizers: Fast drug metabolism.
Pharmacotherapeutic Considerations by Population
- Children: Metabolism influenced by developmental kidney and liver stages. Infants have underdeveloped blood-brain barriers.
- Elderly: Decreased glomerular filtration, liver mass, and hepatic blood flow; risk of polypharmacy.
- Pregnancy & Lactation: Medication safety crucial for the fetus/baby; risk vs. benefit analysis necessary.
- Sex Differences: Women show higher risks of adverse drug reactions (75% higher than men). Differences in metabolism and volume of distribution affect drug efficacy and safety.
Drug Classification Systems
- Letter System (for OTC Medications): A, B, C, D, X - classification system based on risk to the fetus,
- PLLR (for prescription Drugs): A system to track the risks and considerations of drugs during pregnancy and lactation.
Key Terms
- Teratogen: Substance damaging fetal development
- Criteria for teratogenic drugs: Criteria are detailed.
- All or Nothing: High doses during preimplantation can cause death; sublethal doses can allow recovery of the conceptus.
- Organogenesis: Formation of organs; critical period.
- Congenital Malformation: Structural defects at birth due to genetic/environmental factors.
- Maternal Conditions Requiring Medication Despite Risks: Asthma & Seizure Disorder (Phenytoin).
Hypertension (ACE Inhibitors)
- Should be replaced with safer alternatives.
- Listed Teratogens: A list of medications with established teratogenic risks.
- BEERS List: Identifies drugs likely to cause adverse effects in older adults.
- Significance of the BEERS List: Provides guidance on reducing inappropriate medication use in the elderly (polypharmacy).
- Polypharmacy: The practice of using five or more medications concurrently. Common in geriatric patients, including OTC and herbal products.
User provided information on the drug classification, approval, and risk related considerations in the text for OTC medications.
###Recommended Daily Allowances (RDA) and Education
- RDAs: Guidelines for nutrient intake; essential for special populations for whom the specific supplement needs are critical.
- Important to know RDAs are for healthy individuals under normal conditions.
- Consideration in Supplements: Important to know the risks of overdosage when consuming unregulated supplements.
Vitamins and Implications
- Fat-soluble vitamins: Include A, D, E, and K.Stored in the liver and fatty tissues. Deficiency of Fat-soluble vitamins can occur after prolonged deprivation.
- Mega-doses can lead to hypervitaminosis more quickly than water-soluble vitamins. Excessive vitamin A intake is teratogenic, causing malformations in fetal development.
Potential for Contamination
- Herbal products and supplements: Exempt from FDA standards and do not require proof of safety or efficacy.
- Potency, efficacy, or purity of marketed herbal medicines: Not regulated
- Unregulated supplements: May contain unlabeled active pharmaceutical ingredients, leading to potential drug interactions and health risks.
Active Pharmaceutical Ingredients in supplements
- Active pharmaceutical ingredients (APIs): Substances in drugs that are biologically active.
- Unregulated supplements - may contain APIs without proper labeling.
- Companies add active ingredients, omitting them from the label to pose risks to consumers.
- Active drugs in unregulated supplements could cause interactions with other medications.
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Description
This quiz covers essential aspects of pharmaceutical regulations including full prescriptive authority, the role of the FDA, and the drug approval process. It delves into safety and efficacy criteria, DEA regulations, and the phases of human drug studies. Test your knowledge on these critical topics in the field of pharmaceuticals.
