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Questions and Answers
Which activities are NOT permissible under the Nonprofit Institutions Act (1938)?
What should pharmacies do within 30 days upon request for Protected Health Information (PHI)?
What is required for a breach notification under HIPAA involving more than 500 individuals?
Under HIPAA, which situation requires written authorization before using PHI for marketing?
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What happens if a healthcare provider fails to provide a cost estimate for nonemergency services upon request?
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What must a prescriber's care plan for drug therapy management include?
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Which of the following drugs can a pharmacist NOT prescribe?
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Under which condition can pharmacies advertise drugs?
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What does Section 1 of the antitrust laws prohibit?
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What distinguishes a violation of Section 2 of the antitrust laws?
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Which act prohibits sellers from discriminating in price between purchasers of like products?
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What characterizes a per se violation under antitrust laws?
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What type of arrangement might be illegal if it restrains competition?
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What is the penalty per violation for willful neglect that is not corrected within 30 days?
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Which of the following best describes 'caveat emptor'?
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What is required for an applicant to obtain a community permit?
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What is the purpose of the State Board of Pharmacy (BOP)?
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How often must a community permit holder check their stock for outdated drugs?
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What does 'fiduciary duty' refer to in a professional context?
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Which type of institutional permit is associated with nursing homes?
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What is required for a community pharmacy's signage regarding operation hours?
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Study Notes
Drug Therapy Management
- Prescriber care plans are written by physicians.
- Pharmacists require a permit and a private area with a transferable patient care record to dispense medications.
- Pharmacists may not dispense injectable products, medications for pregnant women, quantities exceeding 34 days, or drugs exceeding recommended dosage.
- Pharmacists must keep an Rx and patient profile for four years.
Antitrust Laws
- Section 1 of Sherman Antitrust Act prohibits contracts, conspiracies, and combinations in restraint of trade.
- Violation occurs only when there is a competitor agreement.
- Section 2 of Sherman Antitrust Act prohibits monopolies.
- Rule of Reason determines whether an action is unreasonably anticompetitive while considering the defendant’s actions, pro-competitive, and anti-competitive aspects.
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Per Se Rule determines specific actions as unreasonably anticompetitive.
- Price Fixing: Competitors agree to manipulate pricing.
- Boycotts: Pharmacies agree to accept or reject a third-party program.
- Tying Arrangements: One product purchase is conditional on another purchase.
- Exclusive Contracts: A seller agrees to sell exclusively to a specific buyer.
- Joint Ventures: Entity integration is illegal if its purpose is to restrict competition.
- PPOs must be open to any pharmacy seeking to join.
Price Discrimination Act
- Robinson-Patman Act (1936) prohibits sellers from price discrimination among purchasers of similar products.
- Plaintiffs must demonstrate that price discrimination caused injury to their profits.
Nonprofit Institution Act
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Nonprofit Institution Act (1938) exempts nonprofit schools and institutions using products for their own use.
- Permissible activities include on-premises patients, ER patients on discharge, outpatients for personal use, and employees.
- Impermissible activities include refills, resale, and walk-in customers.
Drug Pricing Program
- 340B Drug Pricing Program requires manufacturers to offer discounted drug prices to entities serving underserved and uninsured individuals.
Pt Safety
- Patient Safety and Quality Improvement Act of 2005 allows pharmacies to confidentially share information about patient safety events with patient safety organizations.
Medicaid and License Termination
- 456.0635 prohibits the issuance of a license to applicants convicted of a felony within the past 15 years.
- Individuals terminated from Medicaid must be in good standing for five years before eligibility.
Cost Estimates
- Pharmacies must provide good faith estimates of reasonably anticipated charges for non-emergency services upon request.
- Failure to provide estimates within 7 business days can result in a daily fine of $500.
HIPAA
- HIPAA focuses on transaction and code sets, national provider identities, security, and privacy.
- National Provider Identifier (NPI) use became mandatory in 2007 for all healthcare providers.
- Notice Provision: Pharmacies must provide a privacy practices notice to patients in paper form on the first day of services.
- PHI Request: Pharmacies are given 30 days to provide patient health information upon request.
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Breach Notification: Pharmacies must notify affected individuals within 60 days if a privacy breach occurs.
- If more than 10 individuals are impacted, the Department of Health and Human Services (DHHS) must be notified.
- If more than 500 individuals are impacted, media notification is required.
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Marketing Authorization: Marketing materials require written authorization before selling patient health information.
- Exceptions exist for treatment, face-to-face interactions, case management, health-related services, and refill reminders.
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HIPAA Violation Penalties:
- Unintentional: 100perviolation,maximum100 per violation, maximum 100perviolation,maximum25,000 yearly.
- Reasonable Cause, Not Willful Neglect: 1,000perviolation,maximum1,000 per violation, maximum 1,000perviolation,maximum50,000 yearly.
- Willful Neglect Corrected within 30 Days: 10,000perviolation,maximum10,000 per violation, maximum 10,000perviolation,maximum250,000 yearly.
- Willful Neglect Not Corrected Within 30 Days: 50,000perviolation,maximum50,000 per violation, maximum 50,000perviolation,maximum1.5 million yearly.
- Intentional: More severe penalties, including prison.
Pharmacy Profession
- Profession: Mastery of complex skills, service to others, adherence to a code of ethics, promotion of public good, monopoly of knowledge, autonomy of practice, and self-regulation.
- Fiduciary Duty: Pharmacists have a duty to act in the best interests of their patients.
- Caveat Emptor (Let the Buyer Beware): Customers are expected to look out for themselves.
- Caveat Venditor (Let the Seller Beware): Healthcare professionals are responsible for their patients' well-being.
State Board of Pharmacy
- State Boards of Pharmacy (BOP): Safeguard the public by overseeing licensure for pharmacy professionals.
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Community Pharmacy Permits:
- Location: All buildings must be within 1/2 mile of a central location.
- Policy and Procedures: Mechanisms to identify and prevent invalid practitioner-patient relationships, fraudulent prescription filling, and forged prescriptions.
- Fingerprints: Applicants must submit fingerprints for owners holding 5% ownership.
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Inspection: On-site inspection required before issuing a permit.
- Minimum of one inspection annually.
- Two inspections during the first year.
- Inspections occur every two years if the pharmacy passes three consecutive years of inspections.
- Equipment: Satisfactory sink, sufficient shelf space, proper storage and refrigeration, and sanitation.
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Operating Hours: Minimum of 20 hours per week.
- Open: Block letters >1” in height, indicating hours of operation.
- Closed: Bold letters >2” in width and height,
- Outdated Drugs: Must check stock every four months.
- Private Consultation: Accessible, appropriate distance, walls/barriers, counter space, and signage.
- Record-Keeping: Must have a data processing system to retain original prescriptions for four years.
Institutional Pharmacy Permits
- Class 1: Nursing homes, no stock on-site.
- Class 2: Hospitals.
- Class 3: Hospitals with clinics.
- Class 2, Type A: Restricted, alcohol detoxification.
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