Ch1&2
Under the Combat Methamphetamine Epidemic Act (CMEA), what limits apply to the sale of pseudoephedrine products to a single individual? Name it least three things.
The Combat Methamphetamine Epidemic Act sets a daily limit of 3.6 grams, a 30-day limit of 9 grams, and a separate 30-day limit of 7.5 grams for mail-order purchases.
Which of the following conditions must be met for a pharmacy to be exempt from the FDA manufacturing provisions when compounding medications?
A) The pharmacy compounds medications pursuant to a valid prescription for an individual patient.
B) The pharmacy compounds drugs for office use without a prescription.
C) The pharmacy complies with USP standards for sterile compounding.
D) The pharmacy crosses state lines to distribute compounded medications.
Answer: A
Pharmacies are exempt from FDA manufacturing provisions when they compound pursuant to a valid prescription for an individual patient. Compounding without a prescription for office use would not be exempt and may be considered manufacturing.
Which of the following best describes the process and authority for placing a drug in a controlled substance schedule?
A) The Attorney General has sole authority to schedule a drug and may do so at any time without consultation.
B) The Attorney General must receive a binding recommendation from the Secretary of DHHS regarding the scientific and medical evaluation of the drug before scheduling.
C) The Secretary of DHHS has authority over the schedule of controlled substances, except in cases where the Attorney General determines the need to act due to an imminent hazard to public safety.
D) The Attorney General and the FDA jointly determine the scheduling based on abuse potential and recommendations from state pharmacy boards.
Answer: C) The Secretary of DHHS has authority over the schedule of controlled substances, except in cases where the Attorney General determines the need to act due to an imminent hazard to public safety.
Explanation: The Attorney General may act without the Secretary of DHHS only in cases of imminent danger (eliminating A and B). FDA and state boards do not directly schedule drugs (eliminating D).
When verifying a DEA number, which of the following is not considered part of the verification process?
A) Checking that the second letter matches the first letter of the prescriber’s last name
B) Adding the 1st, 3rd, and 5th digits and then adding this to the sum of the 2nd, 4th, and 6th digits, multiplied by 2
C) Ensuring the final digit matches the calculated check digit
D) Solely relying on the formula to verify a DEA number without any other checks
Answer: D
Explanation: Although verifying the DEA number involves a mathematical check, this method alone cannot be solely relied upon. Other checks, such as ensuring the prescriber is authorized and licensed, are required.
Which of the following statements accurately describe the responsibilities of the DEA under the Controlled Substances Act (CSA)? (select all that apply)
a) The DEA regulates the distribution of controlled substances to ensure a "closed system."
b) The DEA is responsible for the manufacturing of all pharmaceutical products.
c) The DEA enforces laws related to the import and export of controlled substances.
d) The DEA can directly sell controlled substances to pharmacies without oversight.
Select all that apply.
a) The DEA regulates the distribution of controlled substances to ensure a "closed system."
c) The DEA enforces laws related to the import and export of controlled substances.
(Select all that apply: a, c)
Which of the following is a true statement regarding OBRA '90 (Omnibus Budget Reconciliation Act of 1990)?
(Choose all that apply)
A) It mandates that pharmacists provide prospective drug use reviews for Medicaid patients.
B) It mandates that pharmacists offer patient counseling for all prescriptions filled.
C) It requires pharmacists to check for therapeutic duplications and drug interactions.
D) It applies to both Medicaid and Medicare patients equally.
Answer: A, B, C
OBRA '90 applies to Medicaid patients and mandates pharmacists conduct prospective drug use reviews, offer counseling, and check for drug interactions. However, it does not apply to Medicare patients.
Under the Prescription Drug Marketing Act of 1987, which of the following activities is prohibited?
A) Hospitals purchasing drugs at discounted prices and reselling them to community pharmacies.
B) Pharmacies distributing prescription samples to patients.
C) Wholesalers obtaining state licenses to sell prescription drugs.
D) Manufacturers providing free samples of drugs to physicians.
Answer: A
The Prescription Drug Marketing Act prohibits hospitals from purchasing drugs at discounted prices and reselling them to community pharmacies, which could lead to unfair pricing practices and potential drug diversion.
Under the Federal Controlled Substances Act, which of the following individuals is not required to register with the DEA?
A) A dentist who prescribes controlled substances as part of their practice.
B) A pharmacist who dispenses controlled substances in a community pharmacy.
C) An employee of a manufacturer who distributes controlled substances to registered practitioners.
D) A veterinarian who administers controlled substances for animal treatment.
Answer: C) An employee of a manufacturer who distributes controlled substances to registered practitioners.
Explanation: Employees acting under a registered employer do not need their own DEA registration (the practitioner, pharmacist, and veterinarian all require registration).
Which of the following is not a required element on a controlled substance prescription?
A) Patient's name and address
B) Drug name, strength, dosage form, and quantity
C) Patient's diagnosis and reason for the prescription
D) Prescriber’s DEA registration number
Answer: C
Explanation: A diagnosis or reason for the prescription is not required on a CS prescription, though it must be for a legitimate medical purpose.
Which of the following statements are true regarding the responsibilities of pharmacists in a central fill pharmacy? (Select all that apply)
a) Only the pharmacist who dispenses the prescription is responsible for ensuring the legitimacy of the prescription.
b) Both the pharmacist at the central fill pharmacy and the retail pharmacy must verify that the prescription was issued for a legitimate medical purpose.
c) Central fill pharmacies may prepare prescriptions that are directly provided by the patient.
d) A licensed pharmacist must fill the prescription prepared by the central fill pharmacy.
(Select all that apply: b, d)
Which of the following is an allowed activity for a pharmacist under the Drug Addiction Treatment Act (DATA) of 2000?
A) Dispense methadone for opioid addiction treatment from a retail pharmacy
B) Dispense buprenorphine for opioid addiction treatment under the supervision of a DATA-waived physician
C) Prescribe buprenorphine directly to patients for opioid addiction
D) Administer methadone for opioid withdrawal in any pharmacy setting
Answer: B
Under the DATA 2000, pharmacists can dispense buprenorphine for opioid addiction treatment, but only under the supervision of a DATA-waived physician. Methadone cannot be dispensed for addiction treatment in a retail pharmacy setting.
Which of the following are true about the Orange Book and generic substitution?
A) The Orange Book uses a two-letter rating system to evaluate bioequivalence.
B) Bioequivalent pharmaceutical equivalents are generally presumed therapeutically equivalent.
C) Pharmacists must always substitute B-rated products for branded drugs.
D) All states allow pharmacists to substitute generics without prescriber approval.
Answer: A, B
The Orange Book uses a two-letter rating system to evaluate bioequivalence, and bioequivalent products are generally presumed to be therapeutically equivalent. However, B-rated products are not considered interchangeable, and pharmacists must comply with state laws regarding substitution.
What is one of the key distinctions between a DEA inspection and a state pharmacy board inspection in terms of legal rights?
A) DEA inspectors must always have a search warrant, while state pharmacy board inspectors may conduct warrantless searches if authorized by state law.
B) Both DEA and state inspectors are required to have search warrants issued by federal courts before inspecting controlled substance records.
C) DEA inspectors do not need any consent from the pharmacy owner, while state pharmacy board inspectors must obtain written consent before entering.
D) DEA inspections are always limited to Schedule II substances, while state inspectors have broader authority over all controlled substances.
Answer: A) DEA inspectors must always have a search warrant, while state pharmacy board inspectors may conduct warrantless searches if authorized by state law.
Explanation: The DEA generally needs a search warrant unless they have consent (eliminating C). State inspectors often have broader authority for routine inspections (eliminating B and D).
Which of the following best describes the "corresponding responsibility" of a pharmacist when dispensing controlled substances?
A) Ensure the prescription is signed and dated correctly
B) Confirm that the prescription was written for a legitimate medical purpose
C) Verify the patient’s insurance coverage before dispensing
D) Double-check the math on the DEA number
Answer: B
Explanation: The pharmacist has a corresponding responsibility to ensure that the controlled substance prescription is for a legitimate medical purpose, beyond just verifying technical aspects of the prescription.
Which of the following statements are correct regarding long-term care facilities (LTCFs) and their handling of controlled substances? (select all that apply)
a) LTCFs are required to register with the DEA to handle controlled substances.
b) LTCFs must follow state regulations regarding the disposal of unused medications.
c) Unused medications in LTCFs can be disposed of without contacting the DEA.
d) Pharmacists should check state agency guidelines for handling controlled substances in LTCFs.
(Select all that apply: b, d)
Under federal law, how often must a pharmacy conduct an inventory of controlled substances?
A) Every month
B) Every 2 years
C) Every 3 years
D) Only when directed by the DEA
Answer: B
Federal law mandates that pharmacies conduct a full inventory of controlled substances every two years (biennially).
Under the Poison Prevention Packaging Act, which of the following drugs is exempt from the child-resistant container requirement?
A) Sublingual nitroglycerin
B) Extended-release metformin
C) Oxycodone tablets
D) Warfarin tablets
Answer: A
Sublingual nitroglycerin is one of the drugs specifically exempt from the child-resistant packaging requirement under the Poison Prevention Packaging Act because it is used in emergency situations.
Under the DEA’s security requirements for controlled substances, which of the following is not true regarding pharmacy practices?
A) Pharmacies may store controlled substances by dispersing them throughout their stock of non-controlled substances to prevent theft.
B) A practitioner cannot employ a person who has had their DEA registration revoked to work with controlled substances.
C) All controlled substances must be stored in a substantially constructed cabinet to meet DEA requirements.
D) Pharmacies are expected to implement security measures designed to detect suspicious orders of controlled substances.
Answer: C) All controlled substances must be stored in a substantially constructed cabinet to meet DEA requirements.
Explanation: Pharmacies may store controlled substances dispersed with non-controlled substances, which is also a common security practice (eliminating A). Pharmacies can't employ individuals with revoked DEA registrations (B), and must monitor for suspicious orders (D).
Which of the following acts allows pharmacies to provide partial fills of a CII medication if requested by a patient or prescriber?
A) Secure and Responsible Drug Disposal Act
B) Ryan Haight Act
C) Comprehensive Addiction and Recovery Act (CARA)
D) Drug Addiction Treatment Act
Answer: C
Explanation: The Comprehensive Addiction and Recovery Act (CARA) allows pharmacies to provide partial fills of CII medications up to 30 days if requested by the patient or prescriber.
What steps must a pharmacist take when transferring ownership of a pharmacy?
a) Notify the nearest DEA Registration Field Office at least 14 days in advance.
b) Prepare a complete controlled substances inventory before the transfer.
c) Submit a new DEA Form-224.
d) Indicate where controlled substance inventories will be stored after the transfer.
Select all that apply.
a) Notify the nearest DEA Registration Field Office at least 14 days in advance.
b) Prepare a complete controlled substances inventory before the transfer.
d) Indicate where controlled substance inventories will be stored after the transfer.
(Select all that apply: a, b, d)
Which of the following is true regarding the handling of Schedule II controlled substances?
(Choose all that apply)
A) Schedule II prescriptions may be faxed for a long-term care facility patient.
B) A pharmacist may partially fill a Schedule II prescription for up to 30 days if the patient is terminally ill.
C) Schedule II drugs can be transferred between pharmacies for refill purposes.
D) Written prescriptions are required, except in certain emergency situations.
Answer: A, B, D
Schedule II prescriptions can be faxed for patients in long-term care facilities, and partial fills are allowed for terminally ill patients. However, Schedule II drugs cannot be transferred between pharmacies.
The Drug Supply Chain Security Act (DSCSA) requires which of the following systems to be fully implemented by November 2023?
A) A paper-based tracking system for prescription drugs changing ownership.
B) A fully electronic system to track and trace prescription drugs across the supply chain.
C) A voluntary tracking system for wholesalers and manufacturers.
D) A regional licensing system for drug wholesalers and 3PL providers.
Answer: B
The DSCSA mandates the implementation of a fully electronic system by November 2023 to track and trace prescription drugs across the supply chain, ensuring drug authenticity and safety.
Which of the following drugs may only be administered as part of an Opioid Treatment Program (OTP) and cannot be prescribed for outpatient use?
A) Methadone for the treatment of opioid dependence
B) Buprenorphine-containing products for opioid dependence treatment
C) Methadone for the treatment of severe pain
D) Buprenorphine for the treatment of chronic pain
Answer: A) Methadone for the treatment of opioid dependence.
Explanation: Methadone for opioid dependence must be dispensed at an OTP, but methadone for pain can be prescribed (eliminating C). Buprenorphine can be prescribed for opioid dependence or pain (eliminating B and D).
Which DEA form must be completed to document the theft or loss of controlled substances, and how soon must the DEA be notified?
A) Form 41, within 24 hours
B) Form 222, within 7 days
C) Form 106, within 24 hours
D) Form 224, within 30 days
Answer: C
Explanation: DEA Form 106 is used to report the theft or loss of controlled substances, and the DEA must be notified within 24 hours.
Which of the following substances would likely be classified under Schedule V of controlled substances?
a) Cough preparations containing not more than 200 milligrams of codeine per 100 milliliters.
b) Phenergan with codeine.
c) Fentanyl patches.
d) Alprazolam (Xanax).
Select all that apply.
a) Cough preparations containing not more than 200 milligrams of codeine per 100 milliliters.
b) Phenergan with codeine.
(Select all that apply: a, b)