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Study guide for PTCB exam

Pure Food and Drug Act of 1906 Prevents sale of misbranded or contaminated foods or drugs.
Food, Drug and Cosmetic Act of 1938 (FDCA 1938) FDA created. Defined contamination and misbranding food and drug products.
Durham-Humphrey Act of 1951 Created RX (legend) and OTC (nonlegend) drug categories. Labels needed directions for use unless they contained "Caution: Federal law prohibits dispensing without a prescriptions" Verbal prescriptions over phone legalized.
Kefauver-Harris Amendment of 1962 All medications need to be pure, safe and effective.
Comprehensive Drug Abuse Prevention and Control Act of 1970 DEA created. Controlled Substances placed in one of 5 categories
Schedule I No accepted medical use and posses extremely high potential for abuse.
Schedule II Has medical use but high abuse potential with severe psychological or physical dependency.
Schedule III Accepted medical use and abuse potential is less than with Schedule I and II drugs
Schedule IV Abuse potential is less than with Schedule III, but administration may lead to limited psychical or psychological dependence.
Schedule V Abuse potential is less than with Schedule IV dugs. Includes exempt narcotics.
Ordering Schedule II Ordered by completing DEA Form 222. Valid for 60 days. Maximum of 10 items per form. Receipts, invoice, shipping, package numbers must be kept for 2 years.
Ordering Schedule III and IV Ordered by any method (written, faxed or verbal). Packing slips/invoice must be signed, dated, and stamped with a red "C" and kept for 2 years
Initial inventory Complete and accurate inventory of all controlled substances before the opening of the first day of business
Biennial inventory Taken every 2 years. Exact count for Schedule II and estimated count for Schedule III to V.
Perpetual inventory Realtime inventory. Shows controlled substances received by the facility, supplied to other locations, returned to pharmacy and dispensed to patients.
Destruction of controlled substances DEA for 41. Retail has one per year. Hospitals have "blanket authorization"
Theft of controlled substances Notify DEA diversion office, local police and complete DEA Form 106
Filling Schedule II prescriptions Handwritten or computer generated. SIGNED IN INK. No allowable refills. Partial filling allowed if available within 72 hours.
Emergency filling of Schedule II Oral allowed under good faith effort to contact physician, limited to a one time dose, reduce order to writing, and receive written RX within 7 days of oral order
Schedule II in Long-Term Care Facilities Faxed Scheduled II RX allowed. Partial filling allowed for terminal patients. Filed for 60 days from date of issue. "Long-term care facility patient" or "terminally ill patient" noted on RX.
Schedule III and IV drugs 5 refills in 6 months. Partial fills allowed if refills ordered.
Exempt narcotics Select cough and antidiarrheal RX items can be purchased by individuals. Must be original container. Not exceed quantity established by law. Must be 18 or older. One container per 48 hours
Transferring Controlled Substances: Transferring Pharmacist responsibilities "VOID" written on the face of invalidated RX. Name, address, DEA number of receiving pharmacy, and pharmacist receiving prescription written on back of RX. Date of transfer and name of transferring pharmacist recorded.
Transferring Controlled Substances: Receiving Pharmacist responsibilities "Transfer" written on received prescription. Date of issue, Original number of refills, date of original dispensing, number of refills left, pharmacy name, address, DEA number, and RX number of previous pharmacy as well as pharmacist's name. (old and new)
Poison Prevention Packaging Act of 1970 Child resistant packing
Occupational Safety and Health Act of 1970 (OSHA) Ensures safe and healthful workplace. Maintain reporting system for job-related injuries/illnesses. Reduce workplace hazards. Conduct audits to ensure compliance. requires use of Material Safety Data Sheets (MSDS)
Drug Listing Act 1972 National Drug Code (NDC) given to every drug
National Drug Code 11 digits. First 5 identify manufacturer. Next 4 identify the drug product. Final 2 represent the package size and packaging.
Orphan Drug Act of 1983 Provides incentives for manufacturers to develop drugs to diseases/conditions to which there are less than 200,000 cases in the world
Drug Price Competition and Patent Term Restoration Act of 1984 Encouraged creation of generic and new medications by streamlining for generic drug approval and extending patent licenses
Omnibus Budget Reconciliation Act of 1987 (OBRA-87) Revisions to Medicare/Medicaid conditions of Participation in long-term care facilities
Anabolic Steroid Control Act of 1990 Harsher penalties for the abuse of anabolic steroids of athletes
Omnibus Budget Reconciliation Act of 1990 (OBRA-90) Manufacturers provide lowest price to Medicaid patient with rebating Medicaid state agencies the difference in price. Must offer patients "offer to counsel"
FDA Safe Medical Devices Act of 1990 Requires all medical devices be tracked and records be maintained.
American with Disabilities Act of 1990 (ADA) Prevents discrimination against possible employees who may have a disability. Businesses must make "reasonable accommodation"
Resource Conservation and Recovery Act EPA produced federal guidelines regarding disposal of hazardous waste.
FDA Modernization Act "Federal law prohibits the dispensing of this medication without a prescription" allowed to be represented on a container by RX
Dietary Supplement Health and Education Act of 1994 (DSHEA) Herbal products are allowed health claims but not disease claims.
Health Insurance Portability and Accountability Act of 1996 (HIPPA) Protects patient information.
HIPPA: Title I Insurance reform. Created things like COBRA for when employees lose their jobs
HIPPA: Title II Administrative Simplification. Established computerized ways of processing data while keeping patient privacy.
Anabolic Steroid Control Act of 2004 Increased number of steroids by removing the requirement to show muscle growth. Most Schedule III drugs.
Any Willing Provider Law Allow pharmacy to participate in a prescription drug benefit plan as long as the pharmacy agrees to the terms and conditions
Freedom of Choice Law Allows a member of a prescription drug plan to select any pharmacy for his or her pharmacy benefit as long as the pharmacy agrees to the terms and conditions of the plan.
Freedom of Choice with regard to Long-Term Care Residents may choose an outside pharmacy for their medications if the pharmaceutical service is not provided under their contract. The facility may refuse admission if the resident refuses to use their system.
Prescription Drug Equity Law Prohibits a prescription drug plan from requiring mail order prescription drug coverage without also providing non-mail order coverage.
Medicare Drug, Improvement and Modernization Act of 2003 (MPDIMA) Changed payments for outpatient Part B drugs. Part D allowed people to enroll in either regional- or national-based plans.
Combat Methamphetamine Epidemic Act of 2005 Put a limit on age of buyer and amount bought of ephedrine, pseudoephedrine, and phenylpropanolamine. 3.6g/day or 9g/30day
Medicaid Tamper-Resistant Prescription Act
Created by: hdwenk



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