Q1: Which of the following federal agencies administers the Medicare and Medicaid programs?
The Centers for Medicare & Medicaid Services (CMS) is the federal agency that administers the Medicare and Medicaid programs.
Q2: Which of the following organizations develops standards regarding the identity, strength, quality, and purity of medications and dietary supplements?
The United States Pharmacopeia (USP) develops standards regarding the identity, strength, quality, and purity of medications and dietary supplements. These standards help ensure the safety and effectiveness of these products.
Q3: Which organization evaluates and accredits health care organizations and programs in the United States?
The Joint Commission (TJC) evaluates and accredits health care organizations and programs in the United States. This accreditation is a mark of quality and safety in healthcare.
Q4: Which of the following regulatory agencies establishes guidelines for the disposal of hazardous waste?
The Environmental Protection Agency (EPA) establishes guidelines for the disposal of hazardous waste, ensuring environmental protection and public health safety.
Q5: Which of the following laws requires that new drugs must be proven safe and have FDA approval granted prior to marketing?
The Food, Drug, and Cosmetic Act of 1938 requires that new drugs must be proven safe and have FDA approval before they can be marketed. This law was enacted in response to concerns about drug safety and led to significant changes in the regulation of pharmaceuticals.
Q6: Which of the following laws separated drugs into prescription and over-the-counter categories?
The Durham-Humphrey Amendment of 1951 separated drugs into prescription and over-the-counter (OTC) categories, defining which drugs require a prescription and which can be sold without one.
Q7: Which of the following laws classified controlled substances into one of five categories based on their abuse potential and accepted medical use?
The Comprehensive Drug Abuse Prevention and Control Act of 1970 classified controlled substances into one of five categories based on their abuse potential and accepted medical use.
Q8: Which of the following laws established the provision that all patient medical records and other personal health information must be kept private?
The Health Insurance Portability and Accountability Act of 1996 established the provision that all patient medical records and other personal health information must be kept private.
Q9: Which of the following laws prohibits the re-importation of drugs into the United States and regulates the sale of samples?
The Prescription Drug Marketing Act of 1987 prohibits the re-importation of drugs into the United States and regulates the sale and distribution of drug samples to ensure drug safety and efficacy.
Q10: A drug label that does not contain adequate directions for use would be in violation of which of the following federal laws?
The Food, Drug, and Cosmetic Act of 1938 requires that drug labels include adequate directions for use. A drug label that fails to meet this requirement would be in violation of this federal law.
Q11: The law requiring pharmacists to perform a prospective drug review, provide patient counseling, and maintain patient records is the ______________?
The Omnibus Budget Reconciliation Act of 1990 requires pharmacists to perform a prospective drug review, provide patient counseling, and maintain patient records. This act aims to ensure safe and effective medication use and improve patient outcomes.
Q12: Pharmacy employees who handle a hazardous chemical should refer to which of the following resources to find information about the hazards of the product and advised safety precautions?
Pharmacy employees who handle a hazardous chemical should refer to the product’s Safety Data Sheet (SDS) to find information about the hazards of the product and advised safety precautions.
Q13: Information on the generic equivalence of drugs can be found in which of the following resources?
Information on the generic equivalence of drugs can be found in the Orange Book, officially known as Approved Drug Products with Therapeutic Equivalence Evaluations. This resource provides information on the therapeutic equivalence of generic drugs compared to their brand-name counterparts.
Q14: Which of the following is a DEA program that allows for electronic orders of controlled substances?
CSOS stands for Controlled Substances Ordering System, which is a DEA program that allows for electronic orders of controlled substances. This system helps streamline the ordering process for pharmacies and other entities authorized to handle controlled substances while maintaining strict security measures.
Q15: Which of the following reference books is required to be in every pharmacy?
The United States Pharmacopeia (USP) is a compendium of drug information and standards that provides guidance on the identity, strength, quality, purity, packaging, and labeling of medications. It is a required reference book in every pharmacy to ensure compliance with standards and regulations.
Q16: Which chapter of the United States Pharmacopeia provides guidance for the compounding of non-sterile formulations for human or animal administration?
USP provides guidance for the compounding of non-sterile formulations for human or animal administration. This chapter outlines procedures, standards, and best practices for compounding non-sterile medications in pharmacies.
Q17: Which of the following chapters of the United States Pharmacopeia provides guidance for the compounding of sterile products?
USP provides guidance for the compounding of sterile products. This chapter outlines procedures, standards, and best practices for compounding sterile medications in pharmacies, ensuring patient safety and product quality.
Q18: A drug recall in which the use or exposure of the violative substance is not likely to cause adverse health consequences would be in which of the following recall classes?
In the United States, drug recalls are classified into three classes based on the level of risk posed by the violative product:
• Class I recall: Involves a situation in which there is a reasonable probability that the use or exposure to a violative product will cause serious adverse health consequences or death.
• Class II recall: Involves a situation in which the use or exposure to a violative product may cause temporary or medically reversible adverse health consequences, but the probability of serious adverse health consequences is remote.
• Class III recall: Involves a situation in which the use or exposure to a violative product is not likely to cause adverse health consequences.
Therefore, a drug recall in which the use or exposure of the violative substance is not likely to cause adverse health consequences would be classified as a Class III recall.
Q19: Medications that have no currently accepted medical use and a high potential for abuse are in which of the following drug schedules?
Medications that have no currently accepted medical use and a high potential for abuse are classified under Schedule I of the Controlled Substances Act. These substances are considered the most dangerous and tightly controlled drugs due to their high potential for abuse and lack of accepted medical use.
Q20: In which of the following scenarios is partially filling a Schedule II controlled substance permitted?
A pharmacy is permitted to partially fill a Schedule II controlled substance if the particular medication is out of stock. Partially filling a Schedule II controlled substance is possible under federal law in specific situations, but state laws may have additional restrictions. It's always best for the pharmacist to consult with the prescribing doctor if there's any question about a partial fill.
Q21: Which of the following DEA forms is used to order Schedule II medications?
• Form 41: Used for the disposal or destruction of controlled substances.
• Form 106: Used to report the theft or loss of controlled substances.
• Form 224: Used to apply for a DEA registration to dispense controlled substances.
Therefore, the correct form for ordering Schedule II medications is Form 222.
Q22: Pharmacy records such as prescriptions, controlled substance inventory records, and invoices must be able to be retrieved within how long of a request?
Pharmacy records such as prescriptions, controlled substance inventory records, and invoices must be able to be retrieved within 72 hours of a request. This ensures that pharmacies can provide necessary documentation promptly in response to inquiries or audits by regulatory authorities.
Q23: The Combat Methamphetamine Epidemic Act of 2005 requires that the logbook of pseudoephedrine sales includes all but which of the following information?
The Combat Methamphetamine Epidemic Act of 2005 requires that the logbook of pseudoephedrine sales includes product name and quantity, purchaser name and address, and date and time of sale.
Q24: The Combat Methamphetamine Epidemic Act of 2005 regulates the sale of over-the-counter products containing all but which of the following?
The Combat Methamphetamine Epidemic Act of 2005 regulates the sale of over-the-counter products containing ephedrine, pseudoephedrine, and phenylpropanolamine, but not phentermine. Phentermine is a prescription medication used for weight loss, and it is not regulated under this act.
Q25: After the discovery of a theft of controlled substances, the pharmacy must notify the local DEA office in writing within ______________ business day(s)?
Federal regulations require pharmacies to notify their local DEA office in writing within one business day of discovering a theft of controlled substances. This means prompt action is necessary to report the incident.
Q26: According to federal law, a prescription for a Schedule II controlled substance must be filled within how many days or months after being signed by the prescriber?
According to federal law, there is no time limit within which a prescription for a Schedule II controlled substance must be filled after being signed by the prescriber.
Q27: No more than ______________ refills are permitted for a Schedule III-IV controlled substance prescription?
No more than five refills are permitted for a Schedule III-IV controlled substance prescription.
Q28: A prescriber who is authorized to prescribe Subutex or Suboxone for the treatment of opioid addiction must have a special DEA number that starts with which of the following letters?
A prescriber who is authorized to prescribe Subutex or Suboxone for the treatment of opioid addiction must have a special DEA number that starts with the letter “X.” This indicates that the prescriber is authorized to treat opioid addiction with certain controlled substances.
Q29: Which of the following is an example of a Schedule II controlled substance?
Acetaminophen-hydrocodone is a Schedule II controlled substance due to its high potential for abuse and dependence. The other options (acetaminophen-codeine, diazepam, phenobarbital) fall into lower schedules (III and IV) with less potential for abuse.
Q30: Which of the following is true regarding mailing controlled substances via the United States Postal Service?
According to federal law, Schedule II controlled substances cannot be mailedbecause these are the most addictive and tightly controlled substances, mailing them is generally prohibited due to high potential for abuse. However, Schedule III-V controlled substances can be mailed under certain conditions, such as compliance with DEA regulations and mailing restrictions. Therefore, option "a" is the correct statement regarding mailing controlled substances via the United States Postal Service.
Q31: The first segment of an NDC number identifies which of the following?
The National Drug Code (NDC) is a unique identifier for medications and consists of three segments:
1. First segment: Identifies the drug manufacturer (labeler).
2. Second segment: Identifies the strength, dosage form, and formulation (product code).
3. Third segment: Identifies the package size and type (package code).
Therefore, the first segment of an NDC number specifically identifies the drug manufacturer.
Q32: The second segment of an NDC number identifies which of the following?
The National Drug Code (NDC) is a unique identifier for medications and consists of three segments:
1. First segment: Identifies the drug manufacturer (labeler).
2. Second segment: Identifies the strength, dosage form, and formulation (product code).
3. Third segment: Identifies the package size and type (package code).
Therefore, the second segment of an NDC number specifically identifies the strength, dosage form, and formulation (product code).
Q33: The third segment of an NDC number identifies which of the following?
The National Drug Code (NDC) is a unique identifier for medications in the United States and consists of three segments:
1. First segment: Identifies the drug manufacturer (labeler).
2. Second segment: Identifies the strength, dosage form, and formulation (product code).
3. Third segment: Identifies the package size and type (package code).
So, the third segment of an NDC number specifically indicates the package size and type.
Q34: All but which of the following is true regarding the issuance of multiple prescriptions for a particular Schedule II controlled substance from a prescriber to a patient?
For the issuance of multiple prescriptions for a Schedule II controlled substance, the following are true:
• a. Each prescription must be issued on a separate prescription blank.
• b. The prescriber must indicate the earliest date each prescription can be filled.
• d. The issuance of multiple prescriptions must be permitted by applicable state laws.
However:
• c. The patient may receive up to a twelve month supply is not true. The maximum supply allowed is typically a 90-day supply (three 30-day prescriptions), not twelve months.
Q35: All but which of the following is true regarding the issuance of multiple prescriptions for a particular Schedule II controlled substance from a prescriber to a patient?
Schedule V controlled substances have the lowest potential for abuse and include medications with limited quantities of certain narcotics. Examples include:
• a. Lomotil: Contains diphenoxylate and atropine, and is classified as a Schedule V controlled substance.
• b. Robitussin AC: Contains codeine and is classified as a Schedule V controlled substance.
• d. Phenergan with codeine: Contains codeine and is classified as a Schedule V controlled substance.
However:
• c. Tylenol with codeine (usually Tylenol #3 or #4) is classified as a Schedule III controlled substance, not Schedule V.
Q36: All but which of the following are required for the over-the-counter sale of select Schedule V medications?
For the over-the-counter sale of select Schedule V medications, the following are true:
• b. The purchaser must complete the Exempt Narcotic Book.
• c. The product must be sold in the original manufacturer’s container.
• d. No more than one container can be sold to the same purchaser within a 48-hour period.
However:
• a. The purchaser must be at least 21 years of age is not true. The purchaser must be at least 18 years of age, not 21. Therefore, the incorrect statement is a. The purchaser must be at least 21 years of age.
Q37: How often must a pharmacy complete an inventory of controlled substances according to federal law?
According to federal law, a pharmacy must complete an inventory of controlled substances at least every two years. This biennial inventory is required to ensure accurate accounting and control of all controlled substances.
Q38: Prescribers must have a DEA number in order to write prescriptions for _____________?
Prescribers must have a DEA (Drug Enforcement Administration) number in order to write prescriptions for controlled substances. This number is required to track and regulate the prescribing of medications that have a potential for abuse and dependence. DEA numbers are not required for prescribing non-controlled prescription medications or pseudoephedrine-containing medications (though pseudoephedrine sales are regulated).
Q39: An oral order for a Schedule II controlled substance is permitted _____________?
An oral order for a Schedule II controlled substance is permitted only in an emergency situation. In such cases, the prescribing practitioner must provide a written and signed prescription to the pharmacy within 7 days of the oral order. The other scenarios do not allow for an oral order of Schedule II controlled substances.
Q40: According to USP , pharmacy personnel who compound low- and medium-risk level sterile products must have their aseptic technique evaluated how often?
According to USP , pharmacy personnel who compound low- and medium-risk level sterile products must have their aseptic technique evaluated at least semi-annually (every six months). This evaluation ensures that personnel maintain proper aseptic techniques to prevent contamination and ensure the safety of compounded sterile products.
Q41: Which of the following should be the last digit of Dr. Brent Cole’s DEA number if it begins with BC372514_?
The last digit of the DEA number should be 8.
BC372514_
Step 1: Add first, third, and fifth digits: 3 + 2 + 1 = 6.
Step 2: Add second, fourth, and sixth digits, then multiply by two: 7 + 5 + 4 = 16 × 2 = 32.
Step 3: Add these two answers: 6 + 32 = 38.
Step 4: The last digit of this sum will be the last digit of the DEA number.
Q42: A forged prescription may display which of the following characteristics?
A forged prescription may display several suspicious characteristics, including:
• Prescription is written in different color inks: This can indicate that the prescription has been altered.
• Prescription appears to be photocopied: Forgers often use photocopies to replicate prescriptions.
• The drug prescribed differs in quantity, directions, or dosage from typical medical usage: This can suggest that the prescription is not genuine and was not issued by a legitimate prescriber.
Therefore, all of these characteristics (d. All of the above) are indicators of a potentially forged prescription.
Q43: Generally, a generic substitution can be made for a drug if the generic product meets which of the following criteria?
For a generic substitution to be made, the generic product must:
• Have the same active ingredient(s)
• Be in the same dosage form (e.g., tablet, capsule)
• Have the same strength
• Use the same route of administration (e.g., oral, injectable)
While in active ingredients and slight variations in dosage form might differ, the critical factor is that the generic drug must have the same route of administration as the brand-name drug.
Q44: Prescriptions for drugs in Schedules III-V may be transferred between pharmacies how many times according to federal law?
According to federal law, prescriptions for drugs in Schedules III-V may be transferred between pharmacies only one time. After the initial transfer, no further transfers are permitted, ensuring controlled tracking and dispensing of these medications.
Q45: Chemotherapeutic agents should be prepared in which of the following types of environment?
Chemotherapeutic agents, which are hazardous drugs, should be prepared in a Class II Biological Safety Cabinet (Vertical Laminar Flow Hood) or a similar environment that provides personnel, product, and environmental protection. These cabinets are specifically designed to safely handle hazardous materials, including chemotherapeutic agents, by providing vertical laminar airflow to contain and remove contaminants.
Q46: iPledge is a Risk Evaluation and Mitigation Strategy (REMS) program that pertains to which of the following medications?
iPledge is a Risk Evaluation and Mitigation Strategy (REMS) program specifically designed for isotretinoin. The program is implemented to prevent fetal exposure to isotretinoin due to its high risk of causing severe birth defects. It ensures that patients, prescribers, and pharmacies follow strict guidelines to manage this risk effectively.
Q47: Which of the following medications are exempt from the requirements of the Poison Prevention Packaging Act of 1970?
Sublingual nitroglycerin tablets are exempt from the requirements of the Poison Prevention Packaging Act of 1970. This exemption is due to the need for patients, especially those with angina, to access the medication quickly in an emergency situation without the delay that child-resistant packaging might cause.
Q48: Which of the following regulations are included in the Occupational Safety and Health Act of 1970?
The Occupational Safety and Health Act of 1970 includes the following regulations:
• Sets standards to ensure that employers are providing safe and healthy workplaces: This is the primary purpose of the act.
• Requires that chemical manufacturers provide to the purchaser Safety Data Sheets for hazardous chemicals: This helps ensure that employers and employees are informed about the hazards associated with chemicals in the workplace.
• Gives employees the right to file a complaint with OSHA regarding safety and health conditions in their workplace: This empowers employees to report unsafe working conditions without fear of retaliation.
Thus, all of these regulations are included in the Occupational Safety and Health Act of 1970.
Q49: A prescription for a Schedule II controlled substance may be faxed to a pharmacy in all but which of the following scenarios?
A prescription for a Schedule II controlled substance can be faxed to a pharmacy in the following situations:
• a. The patient is in hospice care: Faxing is allowed to ensure timely access to pain management.
• b. The patient is a resident of a long-term care facility: Faxing facilitates medication administration in these settings.
• c. The prescription is for a Schedule II controlled substance to be compounded for direct patient administration via parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion: Faxing is allowed for immediate preparation and administration.
However:
• d. The patient is being discharged from a hospital: This situation does not fall under the allowed exceptions for faxing a Schedule II prescription. An original written prescription is typically required.
Therefore, the incorrect scenario is d. The patient is being discharged from a hospital.
Q50: If a patient requests that medication be dispensed in a “non-child-resistant” container, the pharmacy should do which of the following?
If a patient requests that medication be dispensed in a non-child-resistant container, the pharmacy should:
• Document the information in the patient’s record: This ensures there is a record of the patient’s request for future reference and legal protection.
Receiving authorization from the prescriber is not required, and refusing to dispense the medication or taking no further action would not be appropriate.