Telepharmacy Regulations Quiz
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Questions and Answers

What is prohibited for an unlicensed person regarding a pharmacist's license?

  • Displaying the license in a public area
  • Having a licensed pharmacist’s name on a prescription
  • Claiming to be a pharmacist without a license (correct)
  • Using the license to practice pharmacy (correct)

What must happen if the telepharmacy technology malfunctions?

  • No distribution of CSP may occur until the pharmacist verifies the technician's work or technology is restored (correct)
  • A licensed pharmacist must immediately arrive on-site to take over all processes
  • The director of the pharmacy must get involved only if there are complaints
  • The distribution of compounded sterile products (CSP) must continue with a technician's oversight

How often must hospitals using telepharmacy conduct quality assurance evaluations?

  • Biannually
  • Monthly
  • At least once per calendar quarter (correct)
  • Every six months

Under what condition is advertising the price of a legend drug at retail acceptable?

<p>If the period for the advertised price is clearly stated (D)</p> Signup and view all the answers

Who is responsible for ensuring compliance with telepharmacy regulations in a hospital?

<p>The hospital's director of pharmacy (D)</p> Signup and view all the answers

What information is not required to be included in records for compliance packaging?

<p>Patient’s ID number (A)</p> Signup and view all the answers

How long must records of compliance packaging and redispensing be retained?

<p>3 years (B)</p> Signup and view all the answers

Which of the following must be documented when returning original compliance packaging?

<p>The name of the pharmacist who accepted the return (B)</p> Signup and view all the answers

What factor is essential for the disposal of drugs according to the procedures outlined?

<p>Lawfully available means for destruction (C)</p> Signup and view all the answers

Which statement about the opioid warning label is correct?

<p>It can only be placed on the compliance packaging once. (B)</p> Signup and view all the answers

What must a prescription record document when a drug is substituted?

<p>The brand name or generic name and manufacturer of the drug (A)</p> Signup and view all the answers

Under what condition may a pharmacist substitute a generic drug or interchangeable biologic product according to the regulations?

<p>If the generic product is therapeutically equivalent and meets strength and dosage requirements (B)</p> Signup and view all the answers

What must be included on the signage posted in the pharmacy regarding drug substitution?

<p>The pharmacy may substitute a less expensive drug unless the patient disapproves (B)</p> Signup and view all the answers

When can a pharmacist NOT substitute a medication?

<p>The prescription specifies 'Brand Medically Necessary' or 'No Substitution' (A)</p> Signup and view all the answers

What special procedures must be followed for epilepsy/seizure medications when substituting?

<p>The pharmacist must inform both the patient and prescriber and obtain consent (C)</p> Signup and view all the answers

What happens if the pharmacist cannot obtain consent from a prescriber for an epilepsy/seizure medication?

<p>The pharmacist can use professional judgment to refill it as an emergency (D)</p> Signup and view all the answers

When cannot generic substitution typically occur regarding Medicaid reimbursement?

<p>When the drug is on the preferred dispensing list (D)</p> Signup and view all the answers

What must be indicated on a telephoned prescription for it to allow no substitution?

<p>The time the prescription was received and the name of the person giving authorization (B)</p> Signup and view all the answers

Under what conditions can a pharmacist delegate the authority to administer COVID or influenza tests to an advanced pharmacy technician (APhT)?

<p>If the APhT completes DCP-required training and administers the test under direct supervision of the pharmacist. (A)</p> Signup and view all the answers

What is the minimum age requirement for a patient being tested for HIV by a hospital-employed pharmacist?

<p>18 years old, or 12-17 with consent of a parent or proof of emancipation. (A)</p> Signup and view all the answers

What must a pharmacist do after administering a test for COVID or influenza?

<p>Provide results to the patient, their primary care provider, and report to the health director and DPH. (B)</p> Signup and view all the answers

Which of the following is NOT a requirement for a retail pharmacy-employed pharmacist to administer HIV-related tests?

<p>The patient must be at least 21 years old. (C)</p> Signup and view all the answers

How long must a pharmacist maintain records of the test results for COVID, influenza, or HIV-related tests?

<p>Three years. (B)</p> Signup and view all the answers

What legal claim did the plaintiffs make regarding the refusal to fill prescriptions for COVID-19 treatments?

<p>Violation of common law right to self-determination (B)</p> Signup and view all the answers

What was one of the outcomes of the case regarding the refusal to fill the prescription for emergency contraception?

<p>The jury awarded damages for emotional distress (A)</p> Signup and view all the answers

According to Minnesota regulations, what is a pharmacist's obligation when refusing to fill a legitimate prescription for emergency contraception?

<p>To provide immediate access to alternative dispensation (B)</p> Signup and view all the answers

What was the plaintiffs' allegation against the pharmacists who refused to fill their prescriptions for COVID-19 medications?

<p>Intentional infliction of emotional distress (A)</p> Signup and view all the answers

What was the argument made by the pharmacist regarding the emergency contraception prescription?

<p>It was considered an abortifacient based on personal beliefs (D)</p> Signup and view all the answers

What potential legal consequence is discussed if a pharmacist makes a recommendation that is not accepted by the prescriber and an adverse outcome occurs?

<p>No liability if properly documented (A)</p> Signup and view all the answers

In which scenario might a pharmacist claim protection from liability during dispensing?

<p>When working within a collaborative practice (A)</p> Signup and view all the answers

What kind of distress was awarded to the patient in the case regarding emergency contraception?

<p>Emotional distress (C)</p> Signup and view all the answers

What must be done with a copy of the patient-specific protocol administered by the pharmacist?

<p>It must be filed in the patient’s medical record. (D)</p> Signup and view all the answers

Which of the following statements is true regarding the continuation of care when a pharmacist discontinues a medication?

<p>The pharmacist must inform the prescribing practitioner within 24 hours. (D)</p> Signup and view all the answers

Under what conditions can a pharmacist administer vaccines to minors aged 12-17?

<p>With the consent of the minor's parent, guardian, or proof of emancipation. (D)</p> Signup and view all the answers

What qualifications must a pharmacy technician have to administer vaccinations?

<p>Must be registered and certified and trained at the pharmacy. (A)</p> Signup and view all the answers

Which entity's guidelines must the training program for vaccination administration adhere to?

<p>Centers for Disease Control and Prevention. (A)</p> Signup and view all the answers

What specific information must the written protocol for pharmacist vaccination administration include?

<p>The types of vaccines to be administered. (C)</p> Signup and view all the answers

What is a requirement for a pharmacy technician to become an 'advanced pharmacy technician' (APhT) for vaccine administration?

<p>Must receive delegation of authority from a supervising pharmacist. (A)</p> Signup and view all the answers

What must a pharmacist do to ensure the safe administration of vaccines?

<p>Review the patient’s vaccination history. (D)</p> Signup and view all the answers

What is required if a pharmacist is not qualified to administer vaccines?

<p>They cannot oversee other vaccinators. (B)</p> Signup and view all the answers

What is the implication of the federal PREP Act in relation to state vaccination provisions?

<p>It overrides state vaccination provisions until December 31, 2024. (D)</p> Signup and view all the answers

Flashcards

Unlicensed Pharmacy Practice

It is illegal to practice pharmacy without a license in Connecticut.

Telepharmacy in Hospitals

Connecticut hospitals can use technology (telepharmacy) to have pharmacists supervise technicians dispensing sterile drugs.

Technology Malfunction (Telepharmacy)

If telepharmacy tech fails, no sterile drug dispensing by technician unless pharmacist verifies or confirms processing after tech fixes the issue.

Advertising Prescription Drug Prices

If advertising prices of prescription drugs, the duration the price will be available needs to be clearly stated.

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Hospital Pharmacy Director's Role

Hospital director of pharmacy is responsible for overseeing telepharmacy and ensuring quality assurance.

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Drug Disposal Instructions

Pharmacies must provide instructions for safe and lawful disposal of drugs, including procedures for destruction at home and the nearest location for drug drop-off (e.g., police station, pharmacy).

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Opioid Warning Label

The warning label required for opioids can be affixed to compliance packaging only once, not on each compartment of multi-dose packaging.

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Compliance Packaging Records

Pharmacies must keep detailed records about drugs dispensed in compliance packaging, including patient information, packaging details, and the pharmacist's initials.

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Redispensing Compliance Packaging

Pharmacies accepting returned compliance packaging for redispensing must maintain records including the patient's name, packaging ID, acceptance date, and details about the drugs returned.

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Compliance Packaging Record Retention

Records related to compliance packaging and redispensing must be kept for a minimum of 3 years.

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Generic Drug Substitution

Replacing a brand-name drug with its equivalent generic version if the purchaser doesn't object, and certain conditions are met.

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Substitution Conditions

Three requirements for generic substitution: same strength/dose/form/quantity, therapeutically equivalent (Orange/Purple Book), and cost savings.

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Brand Medically Necessary (BMN)

When the prescription explicitly requires the brand-name medication, restricting substitution.

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No Substitution (NS)

When the prescription states the brand name is the only acceptable medication, disallowing substitution.

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Special Epilepsy Rx

Specific procedures for substitutions involving epilepsy medications, requiring notification and written consent from the prescriber before substitution.

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Medicaid Reimbursement

Medicaid provider contracts often necessitate generic substitutions unless the drug is on a preferred dispensing list.

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Labeling Requirements

Drug containers must display the dispensed drug's name, including the generic name and manufacturer if no brand name is available.

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Sign Requirements

Pharmacies must display a visible sign disclosing the option to substitute less expensive, equivalent drugs.

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Pharmacist Drug Administration

Pharmacists can administer drugs if a patient-specific protocol exists, and the actions are documented.

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Discontinuing Drugs (Pharmacist Role)

Pharmacists must notify the prescriber within 24 hours if a patient's drug is discontinued or deprescribed.

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Pharmacist Vaccine Administration (General)

Pharmacists can order, prescribe, and administer FDA-approved vaccines for adults and minors with parental consent.

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Pharmacist Vaccine Administration (CDC Schedule)

Pharmacists can administer any vaccine listed on the CDC's age-appropriate immunization schedule to adults and minors with parental consent.

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Pharmacist Vaccine Administration (Off-Schedule)

Pharmacists can administer vaccines not on the CDC's Adult Immunization Schedule to adults, if the instructions are available online.

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Pharmacist Vaccine Administration (Prescription)

Pharmacists can administer any vaccine pursuant to a written or verbal prescription from a prescribing practitioner.

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Pharmacy Technician Vaccine Administration

Registered and certified pharmacy technicians can administer vaccines under supervision by a qualified pharmacist.

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Advanced Pharmacy Technician (APhT)

APhTs can only administer vaccines on the CDC's age-appropriate schedule with the direct supervision and delegation of a pharmacist.

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Vaccine Administration Protocol

A written protocol is required for pharmacist administration of vaccines, outlining procedures, emergency plans, and documentation requirements.

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Pharmacist Responsibilities (Vaccine History)

Pharmacists must make a reasonable effort to review a patient's vaccination history to prevent inappropriate vaccine use.

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Pharmacist's COVID Test Delegation

A pharmacist can authorize an APhT to administer COVID or influenza tests if the APhT completes required training and administers the test under the pharmacist's direct supervision.

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COVID Test Reporting

The pharmacist ordering the COVID or influenza test must report the results to the patient, their primary care provider (if provided), the municipality's health director, and the Department of Public Health (DPH).

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HIV Testing by Pharmacists

Licensed pharmacists can order and administer HIV-related tests. Hospital pharmacists only need patient consent (age 18 or older, or 12-17 with parental consent). Retail pharmacists must meet specific criteria: DPH-approved CLIA application for the tests, completed training, and patient consent (age 18 or older, or 12-17 with parental consent).

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Reporting HIV Test Results

Pharmacists must report HIV test results to the patient, their PCP (if provided), the patient's municipality health director, and the DPH. This reporting is similar to the COVID or influenza testing regulations.

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APhT's Role

An Advanced Pharmacy Technician (APhT) can administer COVID or influenza tests under a pharmacist's direction, but only if they have completed the required training and are under direct supervision.

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Professional Judgment in Dispensing

Pharmacists have a legal obligation to fill prescriptions, but they can refuse based on professional judgment. This is usually governed by pharmacy policies and ethical guidelines.

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Pharmacist's Refusal Based on Religious Beliefs

Pharmacists may refuse to fill prescriptions based on religious beliefs, but they must provide an alternative pharmacy or staff member to dispense the medication.

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Discrimination in Pharmacy?

The Minnesota Human Rights Act protects against discrimination, but a jury found no discrimination when a pharmacist refused to fill an emergency contraception prescription based on religious beliefs.

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Liability in Different Pharmacy Settings

The potential for liability varies depending on the specific activity pharmacists engage in, such as dispensing, compounding, consulting, drug administration, or collaborative practice.

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Pharmacist's Responsibility for Unaccepted Recommendations

Pharmacists are liable for their recommendations, even if the patient ultimately chooses not to follow them. Documentation is crucial.

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Handling Questionable Prescriptions

Pharmacists should contact the prescriber to clarify any concerns about the safety or appropriateness of a prescription.

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Documenting Prescription Concerns

Pharmacists should meticulously document their interactions with prescribers, including any questions, concerns, and the resolution reached.

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Patient Self-Determination vs. Pharmacist's Duty

Pharmacists must balance respecting patient self-determination regarding medication choices while fulfilling their professional duty to provide safe and appropriate pharmaceutical care.

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Study Notes

Week 14 - Part 2 - Prescription Records, Labels, and Packaging Requirements

  • Federal vs. State Rules: Federal rules may supersede state rules regarding electronic transmission of prescriptions. There may be additional state requirements regarding prescription information.
  • Unfilled CS Prescriptions: Unfilled controlled substance (CS) prescriptions can be relayed electronically or via fax between pharmacies (but electronic is preferred).
  • DEA Electronic Transmission ONLY: The Drug Enforcement Administration (DEA) regulations regarding electronic transmission for CS prescriptions are stricter than some states' laws. State regulations that permit faxing may or may not be superseded by DEA regulations.
  • Pharmacy Practice in Connecticut: A license is required, and the license must be available for review. The practice of pharmacy without a license is prohibited.
  • Hospital Use of Telepharmacy: Connecticut hospitals may allow pharmacist supervision of technicians in dispensing products via technology.
  • Telepharmacy Malfunctions: If telepharmacy technology malfunctions, a pharmacist must either confirm the technical steps taken or personally review the dispensed product.

Week 15 - Substitution of Drugs and Biological Products

  • Generic Drug or IBP Substitution: A pharmacist can substitute a less expensive generic drug or IBP if the product is therapeutically equivalent, and the cost is lower to the patient. No substitution if there is a specific request from the patient to avoid substitution.
  • Telephoned/oral orders: Requirements for “Brand Medically Necessary (BMN)” or "no substitution" order must be written on electronic/telephoned orders or in an authorized person's handwriting in the electronic record.
  • Special Epilepsy/Seizures Procedures: Special substitution procedures may apply to epilepsy and seizure medications.

Additional Notes

  • Advertising Prescription Drugs: Pharmacists must disclose prices of legend drugs upon request.
  • Drugs for Termination of Pregnancy: Pharmacies that distribute drugs for termination of pregnancy must provide a list of nearby pharmacies to the patient if they do not stock that drug.
  • Emergency Refills: Refills for non-controlled drugs may be dispensed without the prescriber's authorization, under certain circumstances, within a 72-hour supply. However, the pharmacist must promptly notify the prescriber about these refills later. This does not apply to vacations.
  • 90-Day Refills for Non-Controlled Drugs: A pharmacist may authorize a refill for 90 days of a drug, provided the dosage is not restricted according to the prescribing doctor. A copy of the additional notice should be sent to the prescriber. The drug must be non-controlled.
  • Adding Flavoring Agents: A pharmacist may add flavoring agents if directed to by the patient/patient's agent/physician where permitted.

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Description

Test your knowledge on telepharmacy regulations, including compliance requirements, quality assurance evaluations, and advertising standards. This quiz covers various aspects important for practicing pharmacy in a telepharmacy setting. Dive in to ensure you're well-informed about the standards and responsibilities involved.

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