Law Final Exam PDF

Law Final Exam Module 5 Drug Therapy Management: “Prescriber Care Plan”- assessment of a pt & orders for specific drugs, lab tests, and other services intended to be dispensed or executed by pharmacists. Shall be written by a physician. o Must have permit with transferable...

Law Final Exam Module 5 Drug Therapy Management: “Prescriber Care Plan”- assessment of a pt & orders for specific drugs, lab tests, and other services intended to be dispensed or executed by pharmacists. Shall be written by a physician. o Must have permit with transferable pt care record, care area that is private where pharmacists may sit down, & CQI program. Permits: pharmacies may advertise drugs (other than CSs) if it is not false, misleading, or deceptive. Pharmacist prescribing: may NOT order injectable products, meds for pregnant women, quantity exceeding 34 days, or any drug exceeding the recommended dosage. Must create a Rx AND pt profile that are kept for 4 years. o May dispense: oral analgesics, AZO not exceeding 2-day supply, otic analgesics (ear only), anti-nausea, antihistamines (must be 6yo), topical antifungals & anti-inflammatory, salicylic acid (>2yo), vitamins w fluoride, medicinal shampoos (4oz), Naphazoline 0.1%, H2 antagonists (14 days), benzoyl peroxide, acyclovir ointment, fluoride containing (only if drinking water 40% market share raises question of monopoly. o Section 1: prohibits contract/conspiracy in restraint of trade. Only violated if there is an agreement between competitors (single cannot violate). Chains considered one entity. o Section 2: prohibits monopolies. A single competitor CAN violate. o Rule of reason: court will balance pro & anticompetitive effects of defendant’s actions (behavior). o Per se rule: actions the supreme court has ruled to be unreasonably anticompetitive. ▪ Price fixing: agreement among competitors to affect price. ▪ Boycotting: one pharmacy asks another whether to accept or reject a third-party program. ▪ Tying arrangements: conditioning purchase of one product on the purchase of another. Exclusive contracts: seller agrees to sell product only to a specific buyer. Legal, problems arise if contract restrains competition. Market share is determining factor. Joint ventures: integration of entities. Illegal when purpose is to restrain competition. PPOs: combine to represent in third-party negotiation. PPO should be open to any pharmacy that wants to join.  Robinson-Patman Act (1936): unlawful for sellers to discriminate in price between purchasers of like products when effects may injure competition. Must show prices caused plaintiff to suffer injury in profits. Nonprofit Institutions Act (1938): exempts nonprofit schools/institutions when using product for “own use”. o Permissible activities: pts on premises, ER pts on discharge, outpts for personal use, employees. o Impermissible activities: refills, resale, walk in customers. 340B: drug mfrs must provide drugs at reduced prices to entities serving underserved/uninsured. Patient Safety & Quality Improvement Act of 2005: pharmacies share info related to pt safety events with pt safety organizations. Info is confidential. 456.0635: health care fraud- shall refuse to issue license if applicant convicted of a felony within last 15 years. o If terminated from Medicaid: must be in good standing for 5 years. Cost estimates: upon request, for nonemergency services, shall provide good faith estimate of reasonably anticipated charges within 7 business days. Failure results in daily fine of $500 until estimate provided. HIPAA HIPAA: DHHS targets 4 aspects- transaction & code sets, national provider identities, security, & privacy. o 2007: all healthcare providers receive & use NPI number. 2013: strengthened rules. Notice provision: pharmacy must provide notice of privacy practices to pt in paper form on first day of services. Must make a good faith effort to obtain written acknowledgment. PHI requested from pts: pharmacies have 30 days to provide. Breach: must notify affected individuals within 60 days. If >10 ppl, must notify DHHS. If >500 ppl, notify media. Marketing: make communication to individual about a product that encourages purchase. HIPAA requires written authorization before PHI sold for marketing. Exceptions: for tx of individual, face to face, for case management, health related services, and refill reminders. Violation Per violation Per year Unintentional $100 $25k Due to reasonable cause & not willful neglect $1000 $50k Willful neglect corrected within 30 days $10k $250k Willful neglect NOT corrected within 30 days $50k $1.5m Intentional More severe, including prison Module 7 Profession: occupation with mastery of complex skill, service to others, code of ethics, promotion of public good, monopoly of knowledge, autonomy of practice & self-regulation. Fiduciary duty: duty of trust to act on behalf of another in the best interest. Caveat emptor: let the buyer beware, consumer must look out for themselves. Caveat vendor: let the seller beware, healthcare looks out for the pts best interest. Regulation: protect public from unqualified providers, inc quality of care, dec cost, inhibit criminal abuse. State BOP: purpose to protect the public. Oversees licensure process. Permit types: community, institutional, nuclear, special. Community permit: o Location: must be contiguous area, all buildings within ½ mile of central location. o Policy & Procedures: identify & guard against invalid practitioner-pt relationships, filling fraudulent Rxs for CS, identify Rx transmitted legally, identify forged Rxs. o Applicants: must get fingerprints for owners of 5% (saved for 60mo). o Inspection: must pass an on-site inspection before permit will be issued. Minimum 1 inspection per year, 2 during 1st year. If pass 3 years straight: inspections every 2 years.  o Equipment: must have sink, sufficient shelf space, proper storage & refrigerator, sanitation. o Operation hours: must be open minimum 20 hours/week. ▪ Open: block letters >1” in height with hours of operation. ▪ Closed: bold letters >2” width & height. o Outdated drugs: must check stock every 4 months. o Private consultation: must be accessible, appropriate distance, walls/barriers, counter space, & sign. o Record maintenance: requires data processing system, retain original Rxs for 4 years. Institutional types: Class 1: nursing home, no stock on site. Class 2: hospital. Class 3: hospitals with clinics. o Class 2: Type A: restricted, alcohol detox. Type B: urgent care/ short term. Type C: long term/jail. Special pharmacy: o Limited Community: institutional class 2 that dispenses to employees, medical staff, ER pts, any other pts continuing therapy (not to exceed 3-days). Pt must be deemed competent to admin multi-dose drug. o Sterile Products & Special Parenteral/Enteral: IV/enteral services to outpatients. Must have 24h phone. o Closed System Pharmacy: Rxs individually prepped for nursing homes, jails, ALFs, intermediate care facilities. CAN’T provide meds to inpatients in a hospital. Shall provide 24h on-call service. o ESRD: dialysis products for self administration at home. Inspect pharmacy monthly. o Parenteral/Enteral Extended Scope: compounding pt specific parenteral preparations. o ALF: assisted living facilities that provide unit dose meds. Pharm must inspect & make report monthly. Selling pharmacy: new owner (change in FEIN) needs new application. Notify board within 15 days. Continue to maintain records for 4 years. Pharmacy permit is NOT transferable. o Provide BOP with inventory: exact count C2, exact count C3-5 >1000 tabs, estimate