PharmPrac7e-Chapter2-WLpresentation

[Audio] Welcome to the Pharmacy Practice for Technicians Seventh Edition presentation..

[Audio] Chapter Two: Pharmacy Law, Regulations, and Standards.

[Audio] At the end of this chapter, you will be able to: Define the terms laws, regulations, standards, and professional ethics. Summarize how drug injuries and deaths lead to protective legislation. Describe significant federal drug laws in the 20th century and their effects on pharmacy practice in the United States. Outline the different roles of government regulatory agencies and professional organizations—such as the Food and Drug Administration, Drug Enforcement Administration, and US Pharmacopeial Convention—in creating standards and enforcing laws and regulations..

[Audio] Section 2 point 1: Oversight. Section 2.1 Pharmacy Oversight.

[Audio] During the 19th century, the manufacture of drugs in the United States was unregulated. Medicines did not have to be proven safe or effective to be marketed. Opium and many of its extracts—such as morphine, codeine, and even heroin—found their way into medicines and were widely touted as cure-alls. Not only were these medications addictive, but they occasionally caused injury or death. By the 20th century, there were major concerns about these rogue medicines and about the purity of drugs imported from other countries. As a result, laws, oversight agencies, and professional organizations evolved to protect the public..

[Audio] A number of government agencies and independent professional organizations were created to provide oversight in the creation, distribution, and manufacturing of drugs as a means of protecting the public. Federal and state regulatory agencies include: The Food and Drug Administration or F-D-A, created by the Food, Drug, and Cosmetic Act of 1938 to ensure that pharmaceutical manufacturers obtain approval before releasing any new drug. The Drug Enforcement Administration or D-E-A, the primary agency responsible for enforcing the laws regarding potentially addictive controlled substances, both illegal and legal. The Occupational Safety and Health Administration, or Oh-Shuh, an agency of the Department of Labor that works to ensure the safety and health of US workers. The Federal Trade Commission, or F-T-C, an agency that protects the US consumer from deceptive advertising practices in the marketplace and regulates the labeling and advertising claims of dietary supplements. The Centers for Disease Control and Prevention, or C-D-C, that works to fight infectious diseases, to stop epidemics ( or regionally widespread contagious diseases) and pandemics ( or globally widespread epidemics), sexually transmitted diseases, food-borne diseases, and other contagious illnesses. And also, various state boards of health and welfare agencies..

[Audio] Independent professional organizations that monitor quality and marketing include: The US Pharmacopeial Convention, or U-S-P, is a nonprofit, scientific organization that sets quality standards for prescription drugs, OTC drugs, and dietary supplements. The National Association of Boards of Pharmacy, or N-A-B-P, a group that has developed a model for state practice acts and regulations to help individual state boards of pharmacy build their own regulations . The American Pharmacists Association, or A-P-H-A, an organization that helped establish professional practice standards for drug ingredients, compounding, and dosages And the American Society of Health-System Pharmacists , or A-S-H-P, a group that represents the interests of pharmacists and pharmacy technicians who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of healthcare..

[Audio] Section 2 point 2: Types of Oversight. Section 2.2 Types of Oversight.

[Audio] To understand how these various oversight bodies function, one needs to recognize the different levels of legal and nonlegal influences, and how they work together. There are four primary types of oversight: Laws, regulations, standards and ethics..

[Audio] A law, also known as a statutory law, is an overall rule that is passed by the legislative branches of federal, state, and local governments to guide conduct. Combined, the multilevel system of laws establishes the minimum acceptable standards to protect the public. Regulations are a set of written rules and procedures that exist to carry out a law. For example, the FDA, a federal governmental agency, has published regulations on the drug approval process, generic drug substitution, patient counseling, and adverse reaction reporting systems..

[Audio] A standard is a a guideline, benchmark, or desired level of quality to serve as the expected norm for a product or professional performance. Standards exist for drug products, individual professional conduct, and both community and institutional pharmacies—including hospitals, HMOs, nursing homes, and mail-order warehouses. Whereas laws and the resulting regulations represent the minimum level of legal oversight to protect the public, and professional standards represent quality in practice, professional ethics encompasses the higher realm of ideals, values, and missions that are held by professions and individual practitioners..

[Audio] Section 2 point 3: History of US Statutory Pharmacy Law and Oversight.

[Audio] The Federal Food, Drug, and Cosmetic, also known as F-D and C, of 1938 was passed after more than 100 individuals died as the result of poisoning from a sulfa drug product that contained a toxic chemical. This legislation created the FDA to ensure that pharmaceutical manufacturers obtain approval before releasing any new drug. From this point on, manufacturers were required to file a new drug application with each new drug and provide study data to show that the product was safe for use by humans..

[Audio] The Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly referred to as the Controlled Substances Act (CSA), was created to combat and control drug abuse and to supersede previous federal laws regarding drug abuse. The act classified drugs with potential for abuse as controlled substances, or drugs that are restricted because of a risk for abuse and dependence. The controlled substances were then ranked into five levels of restriction, or schedules. The DEA classifies new drugs into the appropriate schedule (using data and input from the FDA and drug manufacturers). It also, at times, reevaluates drugs that have been on the market for some time to determine whether they should be changed to a scheduled drug. For example, there was concern about the overuse and abuse of the generic narcotic hydrocodone in combination products such as Lortab, Vicodin, and Norco. Consequently, the DEA reclassified these drug products from Schedule III to Schedule II in October 2014..

[Audio] To prevent accidental childhood drug poisonings, the Poison Prevention Packaging Act was passed in 1970. This act required that most over the counter and prescription drugs be packaged in child-resistant containers that cannot be opened by 80% of children under age 5, but can be opened by 90% of adults. Upon request from a patient, a drug may be dispensed in a normal container. In fact, the patient—not the prescriber—can make a blanket request that all drugs be dispensed to them without child-resistant containers. This blanket request is often made by older patients and those with severe rheumatoid arthritis. Medications commonly dispensed in non-child-resistant containers include the antibiotic azithromycin, birth control pills, sublingual nitroglycerin tablets, and metered-dose inhalers..

[Audio] Prior to the 1980s, drugs with brand names were the ones most prescribed, dispensed, and recognized by prescribers and patients. The proliferation of brand name drugs was the result of many state anti-substitution laws passed to combat similar but counterfeit drugs. However, by 1984, mounting pressure by lawmakers, pharmacists, and consumers to reduce healthcare costs led to the passing of the Drug Price Competition and Patent Term Restoration Act. Generic drugs are required to be comparable to their brand-name counterparts in intended use, quality, performance, safety, strength, route of administration, and dosage form. They must also demonstrate bioequivalence, or similar strength and outcomes),to the brand-name product..

[Audio] Section 2 point 4: National Oversight Agencies and Organizations.

[Audio] The laws, acts, and amendments previously discussed provide the minimum level of acceptable standards for a broad scope of issues, offering a basic structure for the safe use of drug products and for the practice of pharmacy. Federal and state government agencies, along with nongovernmental organizations, work to ensure that the regulations required to fulfill these laws are established, reviewed, updated as needed, and enforced. Some of these agencies include the Food and Drug Administration, or F-D-A, an office with several agencies pertinent to the practice of pharmacy; The US Pharmacopeial Convention, or U-S-P, an independent, nonprofit, scientific organization that sets quality standards for prescription drugs, OTC drugs, and dietary supplements; The Drug Enforcement Administration, or D-E-A, the primary agency responsible for enforcing the laws regarding potentially addictive controlled substances, both illegal and legal..

[Audio] The National Council for Prescription Drug Programs, a not-for-profit organization that issues six-digit Processor ID Numbers which pharmacies and pharmaceutical providers use for online electronic records transmissions; The National Association of Boards of Pharmacy, the only professional organization that represents all 50 state boards of pharmacy. And The Occupational Safety and Health Administration, known as OSHA), an agency of the Department of Labor dedicated to ensuring the safety and health of US workers..

[Audio] Section 2 point 5: Drug and Professional Standards.

[Audio] As discussed, many healthcare and pharmacy professional organizations are involved in setting professional standards. Some work hand in hand with legal and enforcement agencies, offering guidelines for practice to offer the best care and fulfill the laws. In addition to setting quality standards for drugs, the USP has also developed standards for practice by pharmacists and pharmacy technicians. Many standards relate to and affect compounding practices. For example, the USP–NF has General Chapters <795> (nonsterile) and <797> (sterile), which set standards involving the storage, packaging, and preparation of nonsterile and sterile compounded preparations..

[Audio] In addition, USP General Chapter <800> addresses the handling of hazardous substances in compounding, storage, shipping, and other handling methods. Hazardous substances include chemotherapy drugs but extend beyond them. The USP practices must be applied not only for the protection of the patients, but also for the technicians and other staff..

[Audio] Section 2 point 6: Legal Responsibilities of Pharmacy Personnel.

[Audio] Though all these laws and standards can seem overwhelming, procedures to adhere to them are built into the everyday practices of pharmacy, so the laws need not be difficult to remember and follow. Each facility manager is responsible for ensuring that the correct processes are established and personnel are trained. The pharmacists make judgments in the filling and dispensing of drugs, counseling patients, and overseeing the work of technicians and carry the majority of the burden of liability. As pharmacy technicians shift into greater roles of responsibility, elements of liability shift with them. They must feel confident asking questions when situations or processes seem amiss or neglected to prevent problems..

[Audio] Section 2 point 7: The Courts and Pharmacy Professionals.

[Audio] When a legal problem arises involving a pharmacy practice, the courts often become involved. The courts are separated between those established to resolve criminal law cases, or issues between the government and offending parties, and civil law cases, or issues between citizens..

[Audio] In both criminal and civil courts, the party ( also known as the person or group) filing the case is called the plaintiff. This is whoever alleges a law has been breached. The entity being sued, which again could be a person or group, is called the defendant. The case brought before the court is against the defendant..

[Audio] This concludes the Pharmacy Practice for Technicians Seventh Edition presentation for Chapter Two..