Basic Pharmacology: Part II - Pharmacotherapeutic Issues, Drug Regulations, and Prescription Writing

Which of the following statements is correct with respect to prescription writing? A. A prescription is a written, verbal, or electronic order (1) from a licensed practitioner, (2) to a pharmacist, (3) for a particular medication, (4) for a specific patient, (5) at a particular time. B. Orders for legend, Schedule III, Schedule IV, and Schedule V drugs may be issued either orally or in writing; for Schedule II drugs they must be written. C. A practitioner may call-in a Schedule II prescription to a pharmacist, but the amount must be limited for the emergency period and the oral order must be followed up by a written order within 72 hours. D. All of the above are correct.

All of the above

Pharmacotherapy _______________. A. is the "art and science" of applying drug-related didactic knowledge and making therapeutic decisions that are the most likely to benefit a specific patient B. deals with the design, implementation, monitoring, evaluating and adjusting drug therapy; and educating/motivating patients to adhere to therapeutic recommendations C. requires the gathering of patient-specific information, i.e., obtaining a complete and accurate medical history D. All of the above are correct.

All of the above are correct

Which of the following statements is correct with respect to the weight of a patient and drug dosing? A. The optimum therapeutic dose intended to produce a specific effect in an individual is generally determined in terms of the amount of drug per kilogram of body weight. B. Drug dosages may have to be altered in the presence of such factors as age and various disease states such as liver and kidney disease. C. If a patient weighs more than 165 lb. (i.e., ≥75 kg), the MRD should be exceeded with extreme caution. D. All of the above are correct.

All of the above are correct

Which of the following statements is correct with respect to DailyMed? A. DailyMed is the official provider of FDA label information (package inserts). B. The DailyMed Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts. C. The drug labeling information on the DailyMed Web site is the most recent submitted to the FDA, although these labels have been reformatted to make them easier to read and may include strengthened warnings undergoing FDA review. D. All of the above are correct.

All of the above are correct.

Information on a specific drug prescribed to a child or a geriatric patient can be found in the drug's labeling _______________. A. "Dosage and Administration" section B. "Contraindications," "Warning and Precautions" and "Adverse Effects" sections C. "Pediatric use" or "Geriatric use" subsection D. All of the above are correct.

All the above are correct

Which of the following statements is correct with respect to dosage modification for drugs metabolized primarily by the liver? In general, a Child-Pugh score of _______________. A. ≤7 requires no modification of drug therapy B. 8 to 9 is grounds for a moderate decrease (≈25%) in the daily dose C. ≥10 indicates a need for significant decrease (≈50%) in daily dosing D. All of the above are correct.

All the above are correct

Which of the following statements is correct with respect to the 2014 amendment to the FDA's regulations governing the content and format of labeling for human prescription drugs and biological products? The amendment requires the _______________. A. removal of the old pregnancy categories A, B, C, D, and X from all drug product labeling and the inclusion of a new "Pregnancy" subsection that provides consistent information about risks to the fetus B. inclusion of a "Lactation" subsection with a summary of the risks of using a drug during lactation C. inclusion of a "Females and Males of Reproductive Potential" subsection, which provides guidance when data suggest drug-associated fertility effects D. All of the above are correct.

All the above are correct

Which of the following statements is correct with respect to the body of the prescription? A. The body of the prescription includes the symbol RX followed by the name of the drug (generic or brand name), which must be written out in full. B. The strength of a drug's unit dose is to be written in the metric system, e.g., in grams (g) or milligrams (mg) for solid formulations and in milligram per milliliter (mg/ml) for liquid formulations. C. Under directions for the patient it may be necessary to convert milliliters to a convenient household measurement. D. All of the above are correct.

All the above are correct

Which of the following statements is correct with respect to the heading of a prescription? A. The prescriber's name, address, and phone number validate the prescription, provide contact information, and identify the practitioner's primary place of business. B. The patient's full first and last name are imperative, the middle initial may be helpful; gender and age is useful to the pharmacist in determining the appropriateness of the medication and/or the proper dosage to be dispensed. C. The date when a prescription was issued or written allows for a determination of the life of the prescription to validate refills. D. All of the above are correct.

All the above are correct

Which of the federal regulations collected all legislations related to drugs with abuse potential into a single legislation; created a "closed" system for legitimate manufacturing, distribution, and dispensing of drugs; and created the five schedules of controlled substances? A. Harrison Narcotic Act of 1914. B. Drug Abuse Control Amendments of 1965. C. Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act (CSA) of 1970. D. Diversion Control Amendments of 1984, part of the Comprehensive Crime Control Act of 1984.

Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act (CSA) of 1970.

An unusual, unpredictable reaction observed in a small number of individuals resulting from an interaction between a drug and some unique aspect of the patient's physiologic/biochemical makeup is a genetic polymorphism-related _______________. A. idiosyncratic effect B. alteration of pharmacokinetic variables C. alteration of pharmacodynamic variables D. All of the above are correct.

Idiosyncratitc effect

All of the following statements related to adverse effects associated with drugs and other medical products are correct EXCEPT which one? A. Healthcare providers must be actively involved in monitoring for and reporting ADEs. B. The FDA launched MEDWatch, an initiative to educate healthcare professionals about the critical importance of being aware of, monitoring for, and reporting ADEs. C. MEDWatch is designed for compulsory reporting of problems associated with medical products. D. Reporting problems associated with medical products does not require proof of causality; a suspected association constitutes sufficient reason to report.

MEDWatch is designed for compulsory reporting of problems associated with medical products.

All of the following statements are correct with respect to adherence/non-adherence of patients to their medication regimen as prescribed EXCEPT which one? A. Determinants of non-adherence include the disease, the patient, the practitioner, the treatment regimen, and economic factors. B. Non-adherence is invariably unintentional (e.g., passively inconsistent medication-taking behavior including forgetfulness or carelessness). C. In children the major reason for non-adherence is a dislike for the taste or smell of the medication. D. Difficulty in opening packages or swallowing pills, poor memory, visual or hearing impairment contribute to non-adherence by elderly patients.

Non-adherence is invariably unintentional (e.g., passively inconsistent medication-taking behavior including forgetfulness or carelessness).

All of the following statements are correct with respect to pharmacodynamics EXCEPT which one? Pharmacodynamics _______________. A. relates to the molecular interactions between body constituents and drugs B. is concerned with issues related to biochemical and physiological mechanisms of drug actions and are based on the concept of drug-receptor interactions C. relates to determinant of the dosing regimen required for a drug to reach and maintain therapeutic concentrations in the body for optimum efficacy without causing toxicity D. describes the effect of drugs quantitatively in order to determine potency, efficacy, and toxicity

Relates to determinant of the dosing regimen required for a drug to reach and maintain therapeutic concentrations in the body for optimum efficacy without causing toxicity.

All of the following statements are correct with respect to the closing of a prescription EXCEPT which one? A. The closing must exhibit not only the prescriber's signature, but it must include his/her and DEA # on all prescriptions for legend and controlled substances. B. The closing may also contain additional instructions to the pharmacist, e.g., whether generic substitution is allowed and/or to include warnings on container labels such as "May cause drowsiness," "Take with food" or "Do not take with grapefruit juice." C. A pharmacist cannot refill a prescription without authorization, to avoid interrupting maintenance therapy; in the closing the prescriber may authorize refills on a written prescription. D. An order for Schedule III, drugs may be refilled up to five times within six months after the date of issue; refilling an order for a Schedule II drug is prohibited.

The closing must exhibit not only the prescriber's signature, but it must include his/her and DEA # on all prescriptions for legend and controlled substances

All of the following statements are correct with respect to dosing recommendations for patients with chronic kidney disease or renal failure EXCEPT which one? A. The gold standard to measure kidney function is the estimated creatinine clearance (eCrCl). B. FDA-approved drug labels, which provide recommendations for adjustments of drug dosages for patients with impaired kidney function, are most commonly based on the eCrCl determined by the Cockcroft-Gault equation. C. The extent to which a drug is removed by dialysis is dependent on the drug's molecular weight, plasma protein binding, volume of distribution, water/lipid solubility, and plasma clearance; and technical aspects of the dialysis procedure. D. In general, if hemodialysis and peritoneal dialysis enhances plasma clearance of a drug by more than 30%, supplemental dosing may be required or dosing after dialysis should be considered.

The gold standard to measure kidney function is the estimated creatinine clearance (eCrCl)

All of the following statements are correct with respect to FDA requirements on content and format of labeling for human prescription drug and biological products EXCEPT which one? A. The labeling (also known as the "package insert") contains scientific information needed for the safe and effective use of drugs. B. The labels are written for consumers, i.e., for the patients, and are intended to educate and motivate them to adhere to therapeutic recommendations. C. Manufacturers are required to submit to the FDA prescription drug labeling information under specific headings and subheadings in a specified order. D. Labeling is updated when new information becomes available that causes the labeling to become inaccurate.

The labels are written for consumers, i.e., for the patients, and are intended to educate and motivate them to adhere to therapeutic recommendations- they are written because prescription drugs use requires professional supervision by a clinician licensed by law to administer such drugs.

All of the following statements are correct with respect to the body of a prescription EXCEPT which one? A. When writing dosage strength always use leading zeros, e.g., write 0.8 ml versus .8 ml (which can be mistaken for 8 ml); and avoid trailing zeroes, e.g., write 5 mg versus 5.0 mg (which can be mistaken for 50 mg). B. When writing dosage strength and the strength of a unit dose is 1 milligram or more, but less than 1 gram, it should be written in milligrams (e.g., write 200 mg, not 0.2 g); when the unit dose is 1 gram or more it should be written in grams (e.g., write 2 g, not 2000 mg). C. In order to discourage alterations in written prescription orders, when prescribing a controlled substance, in addition to writing the number of tablets or capsules to be dispensed, the amount must also be written-out longhand, e.g., Disp #20 (twenty). D. The use of abbreviations is highly encouraged because they save time and make alteration of a prescription by the patient more difficult.

The use of abbreviations is highly encouraged because they save time and make alteration of a prescription by the patient more difficult.

Based on existing federal regulations, drugs fall into two major categories: non-prescription and prescription drugs - prescription drugs are further divided into legend drugs and scheduled drugs. A. Ture B. False

True

Following the ten steps to good prescribing, along with ongoing self-directed learning, reflects an efficient and practical approach to prescription writing and avoiding errors. A. True B. False

True