FREE Master of Pharmacy: Pharmacy Law and Ethics Questions and Answers

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What legal concept defines the maximum period within which a crime can be prosecuted?

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The correct answer is "Statute of limitations." This legal concept establishes the maximum period during which legal action can be taken to prosecute a crime. Once the statute of limitations has expired, the crime cannot be pursued through the legal system. It serves to ensure that cases are brought to trial within a reasonable time frame, preventing the possibility of unjust delays or stale evidence.

Which pregnancy classification signifies that animal trials uncovered fetal risk at elevated doses, yet comprehensive human studies with stringent control indicated no risk?

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Category B pregnancy classification indicates that animal studies have shown some risk to the fetus at high doses, but well-controlled human studies have not demonstrated any risk. It suggests that the medication can be relatively safe to use during pregnancy based on available evidence.

In 1962, the Food, Drug, and Cosmetic Act saw the introduction of the Kefauver-Harris Amendment, which declared that:

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The correct answer is: a. Extensive animal, pharmacological, and toxicological testing must occur prior to testing in humans. The Kefauver-Harris Amendment of 1962, as an amendment to the Food, Drug, and Cosmetic Act, mandated that before conducting human trials, thorough evaluations encompassing animal studies, pharmacological assessments, and toxicological examinations must be conducted on new drugs. This was aimed at enhancing safety and efficacy evaluations in the drug development process.

Which of these DEA number(s) is correct for Dr. I.P. Freeley, a licensed Medical Doctor practicing in Southeast New Hampshire?

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The correct answer is: NH 1246847. Among the provided DEA numbers, NH 1246847 is the valid one for Dr. I.P. Freeley, a licensed Medical Doctor practicing in Southeast New Hampshire. The DEA number serves as an identifier for healthcare professionals authorized to prescribe controlled substances, and the correct one for Dr. Freeley's location and licensure is NH 1246847.

Under what circumstances can a partial filling of a schedule II narcotic medication be done today, with the remaining portion being dispensed to the patient at a later date?

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A Schedule II narcotic medication can be partially filled today if the patient can only afford a portion of the prescription but intends to return within 72 hours to complete the remaining portion. This provision helps patients with financial constraints while ensuring that they receive necessary medications in a timely manner.

What are the obligations imposed by the iPledge program?

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The iPledge program requires that female patients undergo a pregnancy test before receiving a prescription for the medication. This is to ensure that women who are pregnant do not take the medication, as it can cause serious birth defects. The program aims to prevent pregnancies while on the medication and requires strict adherence to contraceptive measures.

What is the required form that needs to be completed and submitted to the wholesaler before obtaining Schedule III drugs?

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The correct form that needs to be filled out and sent to the wholesaler before receiving Schedule III drugs is DEA Form 222. This form is used to track and regulate the distribution of controlled substances and ensures proper documentation and accountability in the distribution process.

What information is required to be present on the packaging of a commercial medication container?

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All of the mentioned options—street address of the maker, date of medication packaging, and ingredient information—are required to be present on the packaging of a commercial medication container. This ensures that consumers have access to essential information about the medication's source, packaging date, and its ingredients, promoting transparency and safety.

At what frequency should a patient who has been using clozapine for a duration of seven months without experiencing any adverse effects undergo a complete blood count (CBC) test?

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The correct answer is: Every four weeks. For a patient who has been taking clozapine for seven months without encountering any negative effects, the recommended frequency for undergoing a complete blood count (CBC) test is every four weeks. This monitoring schedule helps ensure the patient's safety by detecting any potential blood-related complications that could arise due to the medication.

What among the options is a fundamental component in establishing a case of malpractice?

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The correct answer is: a. Breach of Duty. In the context of establishing a malpractice case, a fundamental element is the demonstration of a breach of duty by the responsible party. This means that the healthcare professional or provider failed to meet the standard of care expected in a similar situation, leading to potential harm or injury to the patient.

Transferring a prescription for a C-V medication is permissible only twice, and this exchange can occur solely between two pharmacies that do not have a shared database.

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The correct answer is: 2 times. When it comes to transferring a prescription for a C-V (Schedule V) medication, it is allowed to do so on a maximum of two occasions. However, this transfer can only take place between two pharmacies that lack a common database. This regulation helps maintain appropriate control over the distribution and dispensing of certain controlled medications while ensuring patient safety and accurate record-keeping.

What is a noncontrolled dangerous substance which by appearance would lead a reasonable person to believe that it is a controlled dangerous substance?

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An imitation controlled dangerous substance is a noncontrolled substance that looks like a controlled substance.

The purpose of the S.T.E.P.S program is to guarantee the secure and appropriate utilization of:

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The correct answer is: Thalidomide. The S.T.E.P.S program has been established to ensure the safe and appropriate usage of Thalidomide, a medication that was previously linked to severe birth defects. This program is designed to mitigate the risks associated with Thalidomide and to closely monitor its distribution and prescription to prevent harm to patients, particularly pregnant women.

In the context of joint or collective activities, vicarious liability refers to the legal concept where an individual can be held accountable for the actions performed by another person.

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The correct answer is: True. Vicarious liability is indeed a legal concept that holds an individual responsible for the actions of another person when they are engaged in joint or collective activities. This principle is commonly applied in various legal contexts, such as employer-employee relationships, where employers can be held liable for the actions of their employees performed within the scope of their duties.

Which of the following choices constitutes misbranding?

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The action that constitutes misbranding is "Putting 90 tablets in a bottle labeled 100 tablets." Misbranding refers to labeling or packaging a medication in a way that is deceptive or inaccurate, such as providing an incorrect count of tablets in the bottle. This can lead to confusion and potential harm to patients who rely on accurate dosing instructions.

Which one among the options is excluded from the category of practitioners as defined by the Controlled Substance Act?

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The correct answer is: Hospital. According to the Controlled Substance Act, hospitals are not classified as practitioners. Among the provided options, dentists, pharmacists, drug researchers using controlled substances in research trials, and physicians are considered practitioners under the Act.

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