LE1 Flashcards

Question

High plasma protein binding: A. Generally makes the drug long acting B. Increases the volume of distribution of the drug C. Minimizes drug interactions D. Facilitates glomerular filtration of the drug

Answer 1

A. Generally makes the drug long acting Rationale: High plasma protein binding typically results in a longer duration of action for the drug because the bound drug is not readily available for metabolism and excretion.

Answer 2

B. The indication for use and when to take it Rationale: For "as needed" medications, the indication for use and the specific circumstances or symptoms for when to take the medication should be clearly written to ensure proper usage and effectiveness.

Answer 3

A. Letter B Rationale: The area under the curve (AUC) for a drug administered orally typically represents the bioavailability of the drug, which is usually less than that of an intravenous (IV) administration due to factors such as first-pass metabolism and incomplete absorption. In the figure, Letter B represents a smaller AUC compared to the IV administration (likely represented by Letter D), indicating a lower bioavailability, which is consistent with oral administration.

Answer 4

D. Collection and analysis of highly specific efficacy endpoint data Rationale: Phase III clinical trials are primarily focused on gathering more detailed information on efficacy and safety by analyzing highly specific endpoints in a larger patient population.

Answer 5

C. All of the above Rationale: Pharmacodynamics encompasses the biological effects produced by chemicals, the sites and mechanisms of these effects, and factors affecting the safety and effectiveness of the agent.

Answer 6

C. Phase IV Rationale: Phase IV clinical trials are ongoing studies conducted after a drug has been approved for market, focusing on long-term safety, effectiveness, and other aspects of the drug in a larger population.

Answer 7

C. Apparent volume of distribution (VD) and desired drug concentration in plasma Rationale: The loading dose is calculated to rapidly achieve the desired plasma concentration of the drug and is based on the volume of distribution (VD) and the target concentration.

Answer 8

B. Filled in triplicate Rationale: SPFDDs are filled in triplicate to ensure proper documentation and control of the prescription of dangerous drugs.

Answer 9

D. Substandard Rationale: A substandard drug is one that does not meet quality specifications, including having too much or too little of an active ingredient.

Answer 10

B. Phase I Rationale: Phase I trials are the first stage of clinical testing in humans, typically involving 20-80 healthy volunteers to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug.

Answer 11

B. True Rationale: A prescription is indeed a medico-legal document that serves as an authoritative instruction from a healthcare provider to a pharmacist.

Answer 12

B. False Rationale: Fixed dose drug combinations are not outlawed by the FDA. They are regulated and must meet certain criteria for approval, but they are not prohibited.

Answer 13

B. Large scale tests in people with the target disease Rationale: Phase III trials involve large-scale testing in people with the target disease to confirm the drug's effectiveness, monitor side effects, and collect data to ensure the drug can be used safely.

Answer 14

A. Registration number Rationale: The main components of a prescription (the "meat" of the Rx) include the drug name, amount, dose frequency, and route of administration. The registration number is not part of this section.

Answer 15

B. Exacerbation of illness Rationale: Irrational use of drugs can lead to worsening of the illness, as well as other negative outcomes like resistance, increased side effects, and ineffective treatment.

Answer 16

C. Antibiotic B EC50 = 2 Rationale: The EC50 (effective concentration for 50% of the population) is a measure of drug potency. The lower the EC50, the more potent the drug. Antibiotic B with an EC50 of 2 is the most potent.

Answer 17

D. Animals Rationale: Pre-clinical testing involves studies in animals to gather preliminary efficacy, toxicity, and pharmacokinetic information before human trials.

Answer 18

B. Phase IV Rationale: Phase IV trials, also known as post-marketing surveillance, involve pharmacovigilance to monitor the long-term safety and effectiveness of a drug after it has been approved for market use.

Answer 19

B. The percentage of drug released from a formulation that becomes available for biological effect Rationale: Bioavailability refers to the proportion of the administered drug that reaches the systemic circulation and is available to have an active effect.

Answer 20

C. Its clearance value will remain constant Rationale: In first-order kinetics, the rate of drug elimination is proportional to the drug concentration, and the clearance rate remains constant regardless of the dose.

Answer 21

B. Agonist Rationale: An agonist is a substance that binds to a receptor and activates it, mimicking the action of an endogenous ligand.

Answer 22

B. The half-life is the same regardless of the plasma concentration Rationale: In first-order kinetics, the rate of drug elimination is proportional to the drug concentration, and the half-life remains constant regardless of the plasma concentration.

Answer 23

F. Ask Acquire Appraise Apply Assess Rationale: The correct sequence in Evidence-Based Medicine (EBM) is to first formulate a question (Ask), then gather information (Acquire), critically evaluate the evidence (Appraise), apply the findings to clinical practice (Apply), and finally assess the outcomes (Assess).

Answer 24

D. Drug A has a lower EC50 Rationale: The figure shows dose-response curves for two drugs. The EC50 is the concentration of the drug that produces 50% of its maximal effect. Drug A reaches 50% of its maximal effect at a lower concentration than Drug B, indicating that Drug A has a lower EC50 and is therefore more potent.

Answer 25

D. Impractical Rationale: Fixed-dose combinations can be impractical if doses need to be adjusted individually for the drugs involved, as it can limit flexibility in dosing.

Answer 26

B. False Rationale: An adverse event does not necessarily require a proven causal relationship with the suspect drug; it simply refers to any undesirable experience associated with the use of a medical product.

Answer 27

D. Fake medicine Rationale: A fake medicine is a mislabeled drug intended to deceive and appear as a legitimate medication, often lacking the proper active ingredients or containing incorrect ingredients.

Answer 28

B. Dr. Paul Martini Rationale: Dr. Paul Martini is credited with the first recorded use of therapeutic drug monitoring with bromides in 1927.

Answer 29

B. False Rationale: The responsibility of reporting a serious adverse reaction typically falls on healthcare providers, not the patient. Consent is not a requirement for reporting adverse reactions to regulatory authorities.

Answer 30

C. Subscription Rationale: The subscription section of a prescription includes instructions to the pharmacist on the quantity of the drug to be dispensed.

Answer 31

D. IND (Investigational New Drug) Rationale: An Investigational New Drug (IND) application requires animal data to support the initial testing of a new drug in humans.

Answer 32

A. Noncompetitive antagonist Rationale: A noncompetitive antagonist binds to a different site than the agonist and decreases the maximal response of the agonist without competing for the same binding site.

Answer 33

B. Plasma half-life Rationale: Plasma half-life is a derived pharmacokinetic parameter, dependent on primary parameters like clearance and volume of distribution.

Answer 34

B. Phase I and II Rationale: Phase I and II trials involve drug metabolism and safety assessment, with Phase I focusing on safety and pharmacokinetics, and Phase II focusing on efficacy and side effects.

Answer 35

A. Phase II Rationale: Phase II clinical trials are conducted on a limited scale to assess the efficacy and side effects of a drug in a small group of patients.

Answer 36

A. Dry mouth Rationale: Atropine is known to cause dry mouth as a side effect due to its anticholinergic properties.

Answer 37

A. Under investigation in clinical trial (usually Phase II) Rationale: Treatment INDs are for patients with serious or life-threatening conditions who cannot participate in ongoing clinical trials, and the drug is typically in Phase III or beyond, not usually Phase II.

Answer 38

A. The effects are compared with similar patients receiving different treatment Rationale: Phase II trials focus on the efficacy of the drug and involve 100-300 patients, but the effects are typically compared with a placebo or standard treatment in Phase III trials.

Answer 39

C. Doctor's organizational affiliations Rationale: A doctor's organizational affiliations are not typically required on a prescription, whereas the address, professional tax receipt number (for private practitioners), and license number are mandatory.

Answer 40

E. Phase II Rationale: Phase II clinical trials generally last about 3 years, and approximately 25-30% of drugs pass this phase to proceed to Phase III trials.

Answer 41

D. Valid and serious Rationale: This report is valid because it includes a known reporter, a patient, and a serious adverse event (hospitalization due to hypertension).

Answer 42

D. Placebo is a dummy medication Rationale: A placebo is an inert or dummy medication given to some participants in clinical trials to compare the effects of the actual drug.

Answer 43

C. All of the above Rationale: Determining the maintenance dose involves considering the elimination half-life, clearance, volume of distribution, and the principles of first-order kinetics.

Answer 44

B. Less lipid soluble Rationale: The primary goal of biotransformation is to make drugs less lipid-soluble (more water-soluble) to facilitate their excretion from the body.

Answer 45

D. All of the above Rationale: A yellow prescription for dangerous drugs includes the S2 license number, diagnosis, and the number of tablets written in word form, unlike an ordinary prescription.

Answer 46

C. Treatment IND Rationale: A Treatment IND allows patients who do not qualify for ongoing clinical trials to receive investigational drugs for serious or life-threatening conditions.

Answer 47

B. Delayed hypersensitivity reaction Rationale: A delayed hypersensitivity reaction occurs some time after the initial exposure to the allergen, often after the treatment has been stopped.

Answer 48

A. Post Marketing Surveillance Rationale: Phase 4 trials, also known as post-marketing surveillance, involve monitoring the drug's safety and efficacy after it has been approved for marketing.

Answer 49

C. Drug AB > Drug A + Drug B Rationale: Potentiation occurs when the combined effect of two drugs is greater than the sum of their individual effects, as exemplified by Drug AB > Drug A + Drug B.

Answer 50

C. New Drug Application Rationale: A New Drug Application (NDA) is submitted to the FDA to obtain approval to market a new drug for clinical use.

Answer 51

A. False Rationale: Special Prescription Forms for Dangerous Drugs (SPFDD) do not allow for drug refills to ensure controlled dispensing.

Answer 52

A. True Rationale: Reportable drug reactions can include both adverse (negative) and unexpected beneficial (positive) effects.

Answer 53

A. Ethics Rationale: Controlling biases in research primarily involves internal validity, sampling methods, and sample, while ethics is a broader concept related to the conduct of research.

Answer 54

B. False Rationale: Published literature reports are still reported to pharmacovigilance authorities to ensure all data is monitored and assessed for drug safety.

Answer 55

C. Generics Act of 1988 Rationale: The Generics Act of 1988 defines how drugs must be prescribed in the Philippines, promoting the use of generic names.

Answer 56

D. Orphan Drug Rationale: The Orphan Drug designation provides incentives to companies that develop drugs for rare or unusual diseases.

Answer 57

C. Phase III Rationale: After successful completion of Phase III trials, the data is presented to the FDA for approval to market the drug.

Answer 58

A. The study of absorption, distribution, metabolism, and excretion of drugs Rationale: Pharmacokinetics involves studying how the body absorbs, distributes, metabolizes, and excretes drugs.

Answer 59

D. Phase III Rationale: Phase III trials are large-scale studies that investigate the drug's efficacy and safety in different populations and dosages through well-controlled studies.