PTCB Review LATEST UPDATE

PTCB Review LATEST UPDATEPure Food and Drug Act of 1906 All manufacturers are required to properly label a drug with truthful information, prove effectiveness, prohibited the adulteration and misbranding of food and drugs in interstate commerce. • Helped passed by chief chemist for the Bureau of Chemistry, Harvey Wiley. Harrison Narcotics Tax Act of 1914 Stop the recreational use of opium. Implemented to regulate and tax the distribution, importation, and production of opiates. Sulfanilamide Tragedy of 1937 Led to the passage of the Food, Drug, and Cosmetic Act of 1938, more than 100 people died after the use of sulfanilamide. Dissolved sulfanilamide into diethylene glycol (antifreeze). Food, Drug, and Cosmetic Act of 1938 Banned false claims, required package inserts with directions to be included with products, and required exact labeling on the product. Addictive substances to be labeled with the statement, Warning: May be Habit Forming. Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs". • Legend Drugs can only be dispensed with a valid Prescription. • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". • Most people refer to Legend drugs simply as "Prescription Drugs". • The emphasis on this act was to insure safety thru qualified medical supervision. Thalidomide Tragedy of 1962 10,000 children died from a Thalidomide side effect, was marketed as a sedative and hypnotic used for insomnia, anxiety and gastritis. Led to stricter drug research, development, and regulations. Kefauver-Harris Amendment of 1962 • Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . • Required drug advertising to be more closely regulated and disclose accurate information about side effects Comprehensive Drug Abuse Prevention and Control Act of 1970 or Controlled Substances Act (CSA) Strictly controls the manufacture, importation, possession, use, and distribution of certain controlled substances. Narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and other regulated chemicals. • The DEA and FDA oversee the CSA. • The CSA implemented a scheduled class of narcotics based on abuse potential and safety. • CI - CV Poison Prevention Packaging Act of 1970 Requires use of child-resistant containers for prescription and nonprescription drugs Occupational Safety and Health Act (OSHA) of 1970 Establishes mandatory workplace safety regulations. Drug Listing Act of 1972 Establish the NDC (National Drug Code) number 5 - 4 - 2 First 5: the manufacturer/labeler 2nd 4: the drug product/product code Final 2: package size and packaging Medical Device Amendment of 1976 Established three regulatory classes for medical devices. • Class III - the most regulated and pose high risks for human use; require premarket approval applications that are the equivalent to a new drug application. • Class II - are performance-standard devices that are considered moderate risk for human use. • Class I - are general controlled dives with low risk for human use. Resource Conservation and Recovery Act (RCRA) of 1976 Gives the Environmental Protection Agency (EPA) complete authority in the disposal of hazardous substances. Including their generation, transportation, treatment, storage, and disposal. Orphan Drug Act of 1983 Regulates orphan drugs, which are pharmaceuticals developed specifically for rare diseases. Incentive from the government to create orphan drug. Drug Price Competition and Patent Term Restoration Act of 1984 Encourages the manufacturing of generic drugs by drug companies and formed the modern system of generic drug regulation in the United States. • Outlines the process for drug companies to file an Abbreviated New Drug Application (ANDA) to receive approval of a generic drug. • First company that files an ANDA for a generic drug has 180 days of exclusive rights to market the generic alternative to the brand drug. Prescription Drug Marketing Act of 1987 Helps prevent counterfeit drugs by providing legal safeguards in the chain of distribution of pharmaceuticals. It was designed to prevent the sales of discontinued, counterfeit, misbranded, subpar, and expired prescription drugs. Omnibus Budget Reconciliation Act (OBRA) of 1990 Related to COBRA, allows for continuing coverage and benefits of group healthcare plans for an employee and family based upon certain qualifying issues and events when benefits would otherwise be terminated. FDA Safe Medical Devices Act of 1990 All medical devices are to be tracked and records maintained for durable medical equipment. Anabolic Steroids Control Act of 1990 This act places "any drug or hormonal substance chemically and pharmacologically related to testosterone" under regulatory provisions of the Controlled Substance Act. CIII controlled substances Americans with Disabilities Act of 1990 A law passed in 1990 that requires employers and public facilities to make "reasonable accommodations" for people with disabilities and prohibits discrimination against these individuals in employment. Dietary Supplement Health and Education Act of 1994 Defines and regulates dietary supplement under the FDA's Good Manufacturing Practices. Dietary supplements must have proper labeling. Health Insurance Portability and Accountability Act (HIPAA) of 1996 Established Protected Health Information (PHI). Privacy rules implemented by HIPAA are meant to protect certain health information, including the use and disclosure of a patient's PHI. FDA Modernization Act of 1997 updated the Food, Drug, and Cosmetic Act to include technological, trade, and public health issues more relevant to the 21st century. Medicare Prescription Drug Improvement and Modernization Act of 2003 Gave low-income patients who need assistance with increasing drug costs the option of a prescription drug discount card. • This act helps increase access to medical treatment and reduces unnecessary hospitalizations associated with noncompliance in taking prescription drugs. Dietary Supplement and Nonprescription Drug Act of 2006 Requires reporting of adverse events caused by dietary supplements and nonprescription drugs. Reporting includes; • abuse of the drug, withdrawals form the drug, overdose of the drug, and failure of expected pharmacological action of the drug. Patient Protection and Affordable Care Act of 2010 • Requires individuals not covered by employer or government health insurance to purchase insurance or pay a penalty. • Creates Pre-Existing Condition Insurance Plan for those individuals who had been denied coverage due to pre-existing conditions. • Allows parents to keep their children on their plan until age 26. • Creates insurance exchanges for individuals and employers. Drug Quality and Security Act of 2013 Outlines steps to build an electronic tracking system to identify and trace specific prescription drugs distributed in the US. Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) Federal organization within the US Department of Justice. The ATF combats terrorism, arson and violent crime; regulates alcohol, tobacco, firearms, arson, and explosives. State Boards of Pharmacy (BOP) • Regulatory state agency that oversees the practice of pharmacy in a given state. • Define regulations affecting pharmacy and the roles, duties, and expectations of pharmacists and pharmacy technicians in that state. • Establish criteria for continuing education for both pharmacists and possibly pharmacy technicians to remain credentialed for their profession. • Have the authority to discipline pharmacies, pharmacists, and possibly pharmacy technicians for improper behavior. Determines the regulations affecting generic substitution in state. National Association of Boards of Pharmacy (NABP) Assists the boards of pharmacy in each state to protect public health by developing uniform standards Centers for Medicare and Medicaid Services (CMS) Promotes Medicare, Medicaid, and government plans in regards to healthcare coverage. Environmental Protection Agency (EPA) The US federal agency with a mission to protect human health and the environment. Watch for bacteria and viruses in the environment that could become a risk to the human poplation. Medwatch FDA's safety and adverse event reporting program The Joint Commission a not-for-profit organization that evaluates and accredits different types of healthcare facilities. Accredits hospitals through yearly inspections for compliance and national patient safety goals. Respondeat Superior "Let the master answer" an employer is vicariously liable for the behavior of an employee working within his or her scope of employment. DEA Form 224 Application for New Registration DEA number formula (1st + 3rd + 5th) + 2 (2nd + 4th + 6th) = last digit is last digit of DEA # • First letter of the DEA number is the Registrant type. A - Deprecated (used by older entities) B - Hospital or clinic C - Practitioner M - Mid-level practitioner X - Suboxone/Subutex prescribing program DEA Form 222 Must be used whenever Sch I or II drugs are bought, sold or transferred between pharmacies or qualified distributors • DEA Form 222 includes: company name and address, order date, name of drug, order number of item, quantity of packages of the item ordered, package size of the item ordered, purchaser's (pharmacist's) signature, and pharmacist's DEA number. DEA Form 41 Documents disposal and destruction of scheduled drugs. Must be kept on file for two years, only needs to be submitted to the DEA if requested. DEA Form 106 To report theft of controlled substances. Copies of DEA Form 106 are sent to the BOP, local police, and the DEA. • DEA Form 106 includes: pharmacy name, address, and phone number, DEA number, date of loss or theft, list of items stolen or lost, local police department information, and details about the container or labels, including a description and costs. Prescription Drug Monitoring Programs (PDMP) A program used to identify possible abuse and diversion of controlled substances. The Combat Methamphetamine Epidemic Act of 2005 (CMEA) Regulates the over the counter sales of ephedrine and pseudoephedrine. Limited to 30 days. Daily supply = 3.6g Mail Order = 7.5g Retail = 9g American Drug Index Identifies and describes thousands of prescription drugs in a dictionary format. • Available in print and online. American Hospital Formulary Service Drug Information Provides drug information with therapeutic guidelines and off-label uses. • Written and published by pharmacists and available online. Drug Facts and Comparisons A book the compiles information on 22,000 prescription and 6,000 OTC products, it lists products by therapeutic categories. It includes actions of drugs, warnings and precautions, interactions, adverse reactions, administration and dosage, contraindications and indications, dosages, and brand and generic names. • Available online Geriatric Dosage Handbook Provides geriatric sensitive doing information as well as information about drug interactions and dosing in the elderly. It includes a risk assessment of drugs that should be avoided or used with caution in older adults. • Written by Todd P. Semla • Dictionary formatted, available in PDF format. Goodman and Gilman's The Pharmacological Basis of Therapeutics Emphasizes the relationship between pharmacotherapy and pharmacodynamics. • Nick named the Blue Bible • Published in 1941, available in PDF format Handbook of Nonprescription Drugs Contains information on nonprescription drugs and self-care. It includes pharmacotherapy, medical foods, nutritional supplements, nodrug and preventative measures, and therapies unrelated to the use of prescription drugs. • Available in PDF format. Ident-A-Drug Online and print pill identifier presents drugs by shape, imprints, and color. The site provides an illustration of the drug including the brand and generic name, manufacturer, and purpose. Martindale's The Complete Drug Reference An unbiased and evaluated resource book on drugs used internationally. Provides international disease reviews and drug preparations. Micromedex Healthcare Evidence and Clinical Xpert Includes evidence based, referenced information on drugs, diseases, acute care, toxicology, and alternative medicines for healthcare professionals. • Online database Orange Book: Approved Drug Topics with Therapeutic Equivalence Evaluations Identifies approved drug products along with evaluations of therapeutic equivalents (generic drugs). Approved by the FDA, updated daily, available online • Known as the List and the Orange Book Pediatric and Neonatal Dosage Handbook Gives Important dosing information and evaluations for the management of pediatric patients by healthcare professionals. • Written by Jane Hodding and Donna M. Kraus The Pharmacy Technician's Pocket Drug Reference Small, portable book provides brand and generic drug names, illustrations, therapeutic class, dosage forms and strengths, and therapeutic uses. The Physician's Desk Reference (PDR) A compilation of annually updated manufacturers' prescribing information (package inserts) on prescription drugs. • Available online