Module 7

[Audio] Welcome to the Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7: Law & Ethics presentation. This module provides an overview of key legislation that affects daily pharmacy practice. You will review the federal rules and regulations, including why they were created and how they influence pharmacy operations. You will also learn the relationship between pharmacy laws and ethical decision-making and behaviors in the practice setting. Pharmacy technician students learn the federal laws and regulations that govern pharmacy practice. These laws and regulations, coupled with state board of pharmacy regulations, lay the foundation for a facility's policies and procedures as well as guide your professional communications and behaviors with colleagues and patients. Your knowledge of federal and state legislation and its application to pharmacy practice is critical to fulfilling your work responsibilities. You must also learn federal laws and regulations to sit for a national certification exam for pharmacy technicians. The Pharmacy Technician Certification Exam (PTCE) and the Exam for the Certification of Pharmacy Technicians (ExCPT) contain questions that assess your knowledge of pharmacy law and its application in the field..

[Audio] In this module, you will: Understand the differences between state and federal laws and regulations. Learn the influence of state and federal regulatory agencies on pharmacy practice Identify legal requirements for pharmacy technicians to practice. Identify federal laws and regulations related to drug manufacturing. Identify federal laws and regulations related to drug packaging. Identify federal laws and regulations related to drug labeling, marketing, and advertising..

[Audio] Identify federal laws and regulations related to compounding. Identify federal laws and regulations related to dispensing. Identify federal laws and regulations related to medication safety. Identify federal laws and regulations related to insurance. Understand professional practice standards. Use codes of conduct and ethical standards in practice..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.1: Governmental Oversight of Pharmacy Practice presentation covers the general concept of governmental oversight within the pharmacy. Both US federal and state legislatures create laws and regulations for pharmacy practice. These laws and regulations ensure the safety and well-being of US citizens, which is one of the key responsibilities of our government. Federal laws dictate everything from patient confidentiality to dispensing practices to drug manufacturing guidelines. Consequently, it is important to remember the events that precipitated the establishment of these laws and the impact on facilities, pharmacy personnel, and patients if not adhering to these regulations..

[Audio] A law is a rule established by an authority to direct behavior. Federal laws govern the practice and operation of pharmacies and the creation and use of medications in the US. A regulation is a rule created to enforce a given law. Federal regulations provide the structure and guidance for pharmacy personnel to follow these laws..

[Audio] Recognize Federal Laws Related to Pharmacy Practice. Federal laws typically offer a minimum level of acceptable standards as they apply to pharmacy practice. The common mandate of federal laws is the protection of the public. This consumer protection, however, was not always in place. Before the start of the 20th century, the unregulated production and dispensing of medications led to health risks, injuries, and deaths. These events sparked the enactment of federal laws and regulations during the 20th century that addressed the safe manufacturing, labeling, distribution, storage, dispensing, and administration of medications. Today, the US federal laws related to pharmacy practice are some of the strictest regulations in the world. These tight drug controls have safeguarded the health of US citizens for more than a century..

[Audio] Table 7.1 offers a timeline of federal healthcare legislation and the impact of these laws on pharmacy practice. Take a moment to review this table..

[Audio] Recognize the Impact of Federal Regulatory Agencies. To provide oversight and enforcement of federal laws and regulations, the US government has established federal regulatory agencies. For example, the Centers for Medicare & Medicaid Services is a federal regulatory agency that implements the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. This agency, as well as other agencies related to pharmacy practice, are listed in Table 7.2..

[Audio] Table 7.2. lists other agencies related to pharmacy practice. Take a moment to review this table..

[Audio] Understanding State Laws and Regulations Related to Pharmacy Practice. Similar to the federal government, a state's House of Representatives and Senate pass legislation and rely on regulatory agencies to oversee and enforce laws and regulations within the state. State laws and regulations focus on specific aspects of pharmacy practice, such as distribution and administration of medications, the ratio of pharmacists to technicians that can practice in a setting, and so on. Recognize State Laws Related to Pharmacy Practice. Laws and their regulations relating to pharmacy practice differ from state to state. Many of these laws deal specifically with pharmacy technicians, including their education, registration or licensure, national certification requirements, and scope of practice. For example, while North Carolina has the option of being nationally certified, it is not mandatory, and there is an alternate route to licensure. Arizona, on the other hand, requires national certification as a prerequisite. While there are some similarities in many states, there are also clear differences regarding the laws governing many aspects of pharmacy practice. This difference is due to the composition of members of both the state boards and their respective state legislatures. These members can advocate for new regulations and laws, or they can advocate to not add new requirements or rules..

[Audio] Before 2006, Ohio did not have any regulations regarding the training of pharmacy technicians. One could apply for a position without any experience. Unfortunately, this lack of oversight came at a human cost: a tragic medication error made by a pharmacy technician. In 2006, two-year-old Emily Jerry was receiving intravenous (IV) chemotherapy for an abdominal tumor. During her final chemotherapy treatment, she received a fatal dose of sodium chloride in her IV bag. A pharmacy technician made a medication error when preparing her IV solution. To find a purpose for his daughter's death, Christopher Jerry established the Emily Jerry Foundation to raise awareness of medication errors and to ensure that pharmacy technicians receive proper education and training to practice. Part of the organization's initiative is to create public awareness of the variation in state laws and regulations governing pharmacy technician practice. To that end, the Emily Jerry Foundation, in cooperation with the American Society of Health- System Pharmacists, created an interactive map to show how your state's pharmacy technicians compare with other states in education and training, certification, registration and licensure, and continuing education. This map can be accessed at https:// SSPharm.ParadigmEducation.com/EmilyJerry..

[Audio] Recognize the Impact of State Regulatory Agencies. Regulations for pharmacy practice at the state level are established and enforced by that state's board of pharmacy (BOP). Inspectors who work for a state's BOP visit pharmacies to ensure that regulations are being followed by a practice site as well as by pharmacy personnel. These inspections are typically conducted on an annual basis but can be initiated by a complaint or request, either from the public or an employee. For example, Nevada has a regulation that a pharmacy must have a ratio of three pharmacy technicians to one pharmacist (3:1) during hours of operation. If an inspector were to enter a pharmacy where this ratio was not being followed, it would be a finding and potential citation. Other states have different ratios, and some have no ratios..

[Audio] The website for a state's BOP provides information on the state laws and regulations for pharmacy practice as well as the requirements for pharmacy technicians to work in that state. These laws and regulations should be reviewed before moving to a new state to work as a pharmacy technician. A breakdown of BOP roles is outlined in Table 7.3 (shown here)..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.2 Federal and State Laws Related to Pharmacy Personnel presentation covers federal and state laws that regulate the activities of pharmacy personnel. The overarching purpose of federal and state pharmacy laws is to promote patient safety. These laws address several practice domains, including who can dispense medications, what requirements these individuals must fulfill, and what duties these workers can perform. As mentioned earlier in this module, it is your responsibility to know the legal requirements for pharmacy technicians in your state of practice. These requirements address the licensure, registration, and/or certification of technicians as well as their scope of practice..

[Audio] The terms licensure and registration are often used interchangeably when discussing pharmacy technician practice, but these terms reflect different processes with distinct requirements. Licensure requires you to take a state exam and meet or exceed a predetermined passing rate, much like taking a state driver's test to be licensed to drive a car. Certification requires you to pass a national exam, such as the PTCE or ExCPT. Registration requires you to meet state requirements to be placed on a registry or list of pharmacy technicians. These state requirements may include passing a national certification exam, completing an approved training program, or fulfilling a certain number of on-the-job training hours. According to the National Association of Boards of Pharmacy, 12 states license pharmacy technicians, 34 states register technicians, and 21 states require technicians to earn national certification..

[Audio] At its core, a pharmacy technician's scope of practice is to assist the pharmacist with the preparation (selection, counting, and packaging) of medications and their subsequent dispensing to patients. How much a technician can assist and in what ways varies among states. For example, in Utah, a pharmacy technician (under the direction of the supervising pharmacist) may advise patients regarding over-the-counter (OTC) medications and dietary supplements. In Maryland, however, pharmacy technicians may not advise patients regarding OTC medications. One task that exceeds the scope of practice for pharmacy technicians in all states is offering advice or counsel to patients regarding their prescription medications. This task requires the professional expertise of a pharmacist. The scope of practice for pharmacists continues to evolve, which affects the scope of practice for pharmacy technicians. New duties and responsibilities that do not require the professional judgment of a pharmacist are being delegated to technicians in some states. For that reason, you must know the laws and regulations regarding pharmacy technicians in the state in which you practice..

[Audio] A Technician's Role in Vaccination. In 2017, Idaho drafted new legislation that allowed certified pharmacy technicians to administer immunization injections under the supervision of a pharmacist. This expanded scope of practice is an exciting glimpse into the future of the pharmacy technician profession..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.3 presentation covers Federal Laws and Regulations Related to Drug Manufacturing. Before the start of the 20th century, there were no US laws that governed the production and sale of medications. Many people and companies sold counterfeit, adulterated, and in some cases toxic chemicals for consumers to ingest. The snake oil salesmen who would come to a town and sell their magical "cure-all tonic" (which was mainly whiskey) is an example of this type of practice. The Pure Food and Drug Act of 1906 defined the terms adulterated and misbranded, which made it a criminal act for businesses to make false claims on their packaging and not listing their ingredients properly. It was a start for drug regulation but required further legislation for it to be enforced. The federal laws and regulations that helped promote safe drug manufacturing include the FD&C Act of 1938, the Kefauver-Harris Amendment, and the Dietary Supplement Health and Education Act of 1994..

[Audio] The federal Food, Drug, and Cosmetic (FD&C) Act of 1938 was a set of laws crafted to oversee the safety of food, drugs, medical devices, and cosmetics. Cosmetics were added because there were many instances of unsafe products that were causing harm to consumers just as severe as misbranded or adulterated food and drugs. It defined what constitutes food, drugs and devices, or cosmetics and established both civil and criminal penalties for violations. It also established the FDA as an agency that would enforce manufacturing and advertising regulations in the US. The FDA requires that pharmaceutical manufacturers obtain approval before the release of a new drug. This federal law also set quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States. This act is referenced in several areas of this module, as its laws apply to many areas of pharmacy practice. The FD&C Act and FDA as an agency are two of the reasons that medications are as safe and effective as they are currently. There have also been several amendments to the FD&C Act that have expanded its scope and further defined how pharmacy is practiced..

[Audio] The FD&C Act of 1938 also set standards for quality ingredients for medications. These standards included drug strength, quality, and purity. This act is where the phrase and standard "pharmacy grade" came to be used, which describes a substance that meets a high level of purity and quality..

[Audio] If a drug, food, or cosmetic is not certified by the FDA, its contents or purity are in doubt and not considered safe for use or consumption. If an approved substance falls into this category, the FDA has the authority to recall it from the US market..

[Audio] Understanding the Kefauver-Harris Amendment. The Kefauver-Harris Amendment of 1962 was an amendment to the FD&C Act. It requires that the manufacturer of any new drug provide evidence of its safety and effectiveness before the drug can enter the US market. The drug must be shown to be safe through an intensive testing process that is undertaken by a drug sponsor, which is usually a pharmaceutical company. A drug sponsor must obtain permission from the FDA before testing any new drugs..

[Audio] The FDA also requires a pharmaceutical manufacturer to file a new drug application (NDA) with each new drug and to undergo drug trials to obtain FDA approval before marketing. These drug trials take more than a year to complete and involve animal testing and human clinical studies. The lengthy and rigorous drug trial process is the reason that brand medications are so expensive. The company that paid millions of dollars for years of clinical testing is granted a right to sell the medication exclusively for a period, and the higher consumer cost helps to recoup those research costs. These drug trials also determine the possible side effects of the medication, which is the information that goes into the marketing and patient monographs printed and dispensed with the medication..

[Audio] Understanding the Dietary Supplement Health and Education Act of 1994. The Dietary Supplement Health and Education Act of 1994 provides guidelines on dietary supplements, including vitamins, minerals, herbs, and nutritional supplements. This legislation states that manufacturers of supplements are not required to provide proof of efficacy or standardization to the FDA. Manufacturers simply must prove consumer safety and make truthful claims about their product. Due to the requirements of this act, the language on packaging and marketing materials for these supplements cannot make any claims that they treat a specific disease or condition, as they do not undergo the rigorous testing that drug manufacturers who apply for an NDA do..

[Audio] Pharmacy personnel must be prepared to explain how dietary supplement regulation differs from other OTC drugs. Many patients do not understand this distinction and treat vitamins and supplements as if they were FDA-approved medications. These products are not held to the same standards as medications and may vary in quality and potency. It is important for pharmacy technicians to help identify if a patient is taking supplements, as they can interact with prescribed medications..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.4 Federal Laws and Regulations Related to Drug Packaging presentation covers the purpose and considerations surrounding drug packaging regulations. After laws were created regulating the manufacturing of medications themselves, further legislation was needed to govern the way medications were packaged. Until 1970, there were numerous instances of children poisoning themselves by ingesting or being exposed to household substances and chemicals. Pediatricians considered this to be the leading cause of injuries for children under five years of age. The Poison and Prevention Packaging Act of 1970 was enacted to reduce these injuries and fatalities..

[Audio] The Poison and Prevention Packaging Act required most OTC and prescription drugs to be packaged in child-resistant containers to prevent accidental ingestion by children. To qualify as child resistant, the packaging cannot be opened by 80% of children under age five but can be opened by 90% of adults in manufacturers' tests. This federal legislation dictates that pharmacy personnel must dispense all prescription medications, including investigational drugs, in child-resistant containers, unless a patient specifically requests a regular container. Many pharmacies include in their new patient intake form a question asking if they would like to opt out of the child-resistant container requirement. This section asks if patients want medication dispensed with "EZ open" lids. If they choose to opt out, the technician has them sign a written or electronic waiver for documentation purposes. Unit-dose packaging, including blister packs and pouches, must also be child resistant. An extra layer of backing on these medications must be peeled away before the medication can be accessed..

[Audio] A drug's packaging plays an important role in its safety and effectiveness. Packaging protects the drug from being exposed to the elements and being contaminated. FDA regulations state that pharmaceutical packaging should provide certain consumer protections..

[Audio] FDA regulations state that pharmaceutical packaging should provide certain consumer protections. For example, the FDA provides regulations that drug packaging must provide protection against light, moisture, and temperature variations, all of which can change a medication's quality. FDA regulations also state that drugs should be protected against damage during shipping, handling, and storage. The containers themselves should not interact with a medications' properties or allow leaks..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.5 covers the Federal Laws and Regulations Related to Drug Labeling, Advertising, and Marketing. In addition to regulating who can practice pharmacy and how drugs must be manufactured and packaged, laws and regulations define how medications must be labeled and advertised to patients and consumers. We often see advertisements on television for new medications and look at medication instructions before using them but may not realize the rules that govern their content. Federal laws and regulations relating to labeling, advertising, and marketing include the FD&C Act of 1938, the Durham-Humphrey Amendment of 1951, and the Drug Listing Act of 1972..

[Audio] In addition to manufacturing practices, the FDA must oversee the labeling, advertising, and marketing of pharmaceutical products by their manufacturers. For example, manufacturers may not make speculative or false claims about the potential of the product, and they must also disclose the side effects, adverse reactions, and contraindications for their manufactured medications..

[Audio] OTC medications also undergo scrutiny by the FDA. The labels of OTC products must conform to a preferred format to make all information understandable to the public. While pharmacy technicians are never allowed to provide counseling, identification of existing information on labels both for prescription and OTC medications is legal, as it is considered a statement of fact rather than a professional judgment. If patients cannot read the label, a technician is able to tell them what it says. The FD&C label requirements for OTC medications ensures that accurate information is available to the consumer..

[Audio] Problematic Drug Ads. The drug manufacturer Pfizer paid royalties to Queen for the use of the song "We Are the Champions" in one of its advertisements for Viagra. Despite the investment, it was missing certain FDA-required elements in its marketing. The only thing stated at the end was for patients to "talk to their doctor." This ad was pulled from US markets because it did not list the medication's side effects..

[Audio] The Durham-Humphrey Amendment of 1951 established the terms legend (prescription required) and over the counter regarding medications. The amendment also created provisions that allowed for prescriptions to have refills and for prescribers to be able to call in prescriptions and refills via telephone. Before this, prescriptions had to be handwritten and delivered in person to the pharmacy to be filled. The Durham-Humphrey Amendment is why labeling on all prescription medications says "Rx Only." These are the medications that must be stored behind the counter..

[Audio] The amendment also set the standards of what drugs can be sold over the counter. It required review by the FDA to determine if a substance could be used safely and effectively without the patient being under the care of a physician. The labeling requirements for each class are different, with OTC medications having all the required storage and dosing information printed on the bottle or included in the packaging. This information is like the monographs dispensed with prescription medications. The labels or packages must include possible side effects, precautions, dosing ranges, and instructions for use by the patient..

[Audio] The Drug Listing Act of 1972 gave the FDA the authority to compile a list of currently marketed drugs and assign them each a numbered code, called the national drug code (NDC) number. That way, the FDA can maintain a database of drugs by use, manufacturer, and active ingredients. With different medications that could have potential allergies, interactions, duplication of therapy, and contraindications, this list is an invaluable resource to healthcare professionals and patients alike..

[Audio] The NDC number is a unique 10-digit, 3-segment number that is present on all OTC drugs and prescription medication packages and inserts in the United States. The three segments identify the labeler (manufacturer, repackaged, or distributor), the product (specific strength, dosage form, and formulation), and the size and type of its packaging..

[Audio] Figure 7.1 illustrates an example of an NDC number. The NDC number is one of the primary means technicians use to select the proper medication for dispensing, avoid medication errors, and bill insurance. For billing purposes, the NDC number shows the insurance carrier exactly which medication was dispensed to the customer. For that reason, it is important that the NDC number submitted for payment corresponds with the NDC number of the product actually dispensed. While two different manufacturers may have the exact same medication that would be therapeutically equivalent, they may not be billed the same..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.6 covers the Federal Laws and Regulations Related to Pharmacy Compounding. Compounding was a fundamental component of the origin of pharmacy practice. From apothecaries to early pharmacy practice, the art and science of mixing compounds for medicinal purposes was the main method for dispensing medications. The advent of large manufacturers and mass-produced medications in the first half of the 20th century became the primary means of medication production. Compounding by pharmacy personnel became the exception rather than the norm. However, the practice of both sterile and nonsterile compounding is still practiced, and custom preparations are still prescribed and used today. Sterile compounding is a mainstay of hospital practice and numerous specialty pharmacies compound medications for their patients. There is still a need for specific doses of medication that are not available commercially. For nonsterile preparations, these can include hormone therapies, flavor modifications, and dose form changes. Sterile preparations, such as IVs, are by nature customized to modify doses when a patient is in the hospital. Weight-based doses and items, such as total parenteral nutrition, require a technician to compound daily. Federal laws and regulations related to pharmacy compounding include the FDA Modernization Act of 1997 and the United States Pharmacopeia (USP) Chapter <795>, <797>, and <800> Regulations..

[Audio] The United States Pharmacopeia (USP) is a compendium of drug information for the US that establishes the standards of quality and safety for medications for the entire country. The FDA Modernization Act is an amendment to the FD&C Act that allows pharmacy personnel to compound sterile and nonsterile medications for patients if these medications meet USP standards. The FDA Modernization Act sets a clear definition of what activities are reserved for each entity, which helps prevent a compounding pharmacy from straying into the realm of manufacturing. A pharmacy that compounds medications for patient-specific doses is different from a manufacturer, such as GlaxoSmithKline, which compounds non-patient-specific medications in bulk for sale..

[Audio] Compounding pharmacies and hospitals do not have to meet the same guidelines as those set for manufacturers. These pharmacies and hospitals mix existing medications into alternate dosages and dose forms for patient-specific prescriptions and orders but do not produce new or unique substances. While small batches can be made in anticipation of use by certain patients, these preparations are not mass produced, which would cross the legal boundary into manufacturing. Manufacturers have stricter guidelines on the sterility and production processes than a compounding pharmacy does..

[Audio] Unsafe Compounding Practices In 2012, there was an outbreak of fungal meningitis that led to the deaths of 76 patients. The outbreak was the result of contaminated compounded preparations from a compounding pharmacy in New England. The pharmacy was making batches of prednisolone epidural injections in bulk rather than patient-specific doses by prescription. The pharmacy was acting like a manufacturer, which broke the laws that regulate compounding pharmacies. The pharmacy was also compounding under unsanitary conditions and falsifying documentation. The 2012 outbreak led to stronger FDA oversight of compounding practices across the country..

[Audio] The USP is not a federal or state regulatory agency but is run by a nonprofit organization. USP works closely with government and regulatory agencies to set medication standards. More than 1,000 general chapters in the USP cover standards regarding strength, quality, and purity of all drugs and supplements used in the US. These standards are legally recognized in the US. Many of the USP chapters apply to manufacturers and distribution, but three are directly related to compounding in pharmacies. These chapters relate to nonsterile compounding (USP Chapter <795>), sterile compounding (USP Chapter <797>), and hazardous compounding (USP Chapter <800>). The design and maintenance of compounding areas, procedures of compounding personnel, and documentation protocols are covered in USP Chapters <795>, <797>, and <800>, depending on the type of compounding involved..

[Audio] Recognize USP Chapter <795>. USP Chapter <795> covers the policies and procedures for nonsterile compounding. Nonsterile compounding includes preparations such as ointments, creams, oral suspensions, and capsules. Some pharmacy practices that are a result of USP Chapter <795> include the following: • standards for expiration dates of compounded preparations (beyond use dating) • standardized recipes and procedures for compounded preparations in a master formulation record • continuing education requirements for compounding personnel to maintain competency in nonsterile compounding.

[Audio] Recognize USP Chapter <797> (Rev. 2019). USP Chapter <797> (rev. 2019) covers the policies and procedures for sterile compounding—preparations such as standard IV medications and ocular preparations. Compounded sterile preparations (CSPs), are typically large-volume IV solutions used for fluid replacement, small-volume preparations containing an antibiotic in a base solution, narcotic preparations for pain relief, total parenteral nutrition, or chemotherapy medications. Ocular preparations are rarer CSPs prepared by personnel. Because these medications are typically administered by IV or IM routes (less by ocular instillation), the drugs have systemic access via a patient's bloodstream and, consequently, circulate to all organs. For that reason, any breach in aseptic technique during the preparation of a CSP has the potential to contaminate the CSP. This contamination can lead to patient injury or death. Once a contaminated CSP is in a patient's bloodstream, it cannot be reversed. As a result, the guidelines for CSPs are very strict and use highly specialized equipment and environments. Some pharmacy practices that are a result of USP Chapter <797> (rev. 2019) include the following: • design characteristics of two types of sterile compounding environments: cleanroom suite (the ante-room and buffer room) and segregated compounding area • quality assurance procedures for sterile compounding environments: air quality, temperature, and humidity; microbial air and surface sampling • equipment used for the preparation of CSPs (laminar airflow systems in primary engineering controls, or hoods) • CSP quality assurance (risk categories, beyond-use dates, identification of sources of contamination) • sterile compounding personnel compliance with hand hygiene, garbing, cleaning and disinfection in ante-room and buffer room.

[Audio] Recognize USP Chapter <800> USP Chapter <800> covers the policies and procedures for compounding of hazardous drugs. These preparations can be harmful to the person preparing them. They can include chemotherapeutic agents, hormone preparations, or radiopharmaceuticals. Because of the risk factors involved, additional precautions and practices are outlined in USP <800>. Some pharmacy practices that are a result of USP Chapter <800> include the following: • design characteristics of a hazardous drug compounding environment: negative-pressure primary engineering control (Class I through Class III biological safety cabinets) in a negative-pressure room • quality assurance procedures for hazardous drug compounding environment: air quality, temperature, and humidity; microbial air and surface sampling • identification of hazardous drugs, their associated hazards, safe handling practices, spill management, storage, transport, and disposal • specific garbing standards for sterile compounding personnel: chemotherapy gown, second pair of shoe covers, chemotherapy gloves, eye and face protection • specialized equipment for handling hazardous drugs: plastic-backed preparation mat, closed-system transfer device, chemotherapy dispensing pin, and chemotherapy sharps container.

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.7 covers the Federal Laws and Regulations Related to Pharmacy Dispensing Federal laws and regulations pertaining to dispensing are some of the most relevant to pharmacy technicians, especially in the community setting. The main duty of a technician is to assist in the dispensing of medications, whether that entails completing a new patient intake, entering a prescription, preparing an order, or accepting payment. The Controlled Substances Act and OBRA further specified dispensing operations for pharmacy personnel. These acts delineated which medications technicians could handle for production, established protocols for entering controlled substance prescriptions, and created duties related to medication therapy management. Another important act related to dispensing is the Health Insurance Portability and Accountability Act (HIPAA) of 1996..

[Audio] The Controlled Substances Act of 1970 was created to combat and control drug abuse. This legislation classifies drugs that have the potential for abuse and dependence into schedules, based on their abuse potential. Schedule I (CI) substances are illegal and available only for research or experimental purposes. Schedule II–V (CII–CV) substances can be legally dispensed, with restrictions on the numbers of refills and their quantities. CII medications have the highest potential for abuse, while CV medications have the least. Examples of CII medications include hydrocodone, Ritalin, and morphine. Anabolic steroids and buprenorphine are examples of CIII medications. CIV medications include Valium, Soma, and Xanax. Medications in the CV class include Phenergan with codeine..

[Audio] According to different state regulations, various medications can be treated in the same manner as CV drugs even if they are not officially classified as such, such as pseudoephedrine. Much like the FD&C Act created the FDA, the Controlled Substances Act created the Drug Enforcement Administration (DEA), whose purpose is to enforce the laws and regulations specifically dealing with controlled substances. Because of the potential for abuse, the inventory and dispensing procedures for controlled substances are strictly regulated. As a technician, it is important to know which medications and medication classes fall into these categories. If you do not know that a medication is a CII, for example, you might be looking for it on the regular stock shelf when it would, in fact, be locked away..

[Audio] Consider Prescribers of Controlled Substances. All practitioners who prescribe controlled substances must register with the DEA. These practitioners are authorized to prescribe controlled substances by the jurisdiction in which they are licensed. Examples of practitioners include physicians, physician assistants, nurse practitioners, dentists, veterinarians, and podiatrists. Prescribing privileges for controlled substances also depend on state laws and regulations. Consider Prescriptions for Controlled Substances. Prescriptions for a controlled substance must be written for a legitimate medical purpose. Controlled substances in Schedules III–V may only be written, faxed, or communicated verbally. In most cases, prescriptions for Schedule II controlled substances may only be delivered as handwritten prescriptions. There are a few exceptions to this rule: in an emergency, a prescriber can call in a prescription for a Schedule II controlled substance if the prescriber follows up by sending a written prescription to the pharmacy within seven days. Generally, these are for only several days' worth of medication. The other exception is for patients in hospice care, for whom prescriptions for Schedule II medications may be faxed. Pharmacy technicians must be mindful of red f lags when receiving and handling prescriptions for controlled substances. Since there is such high abuse of these medications, there is a higher risk of forged or altered prescriptions..

[Audio] Consider Storage and Tracking of Controlled Substances. The DEA requires controlled substances to be kept in a securely locked location in the pharmacy. In addition to the procedures dictated by federal regulations, healthcare facilities may have additional procedures to ensure the tracking of controlled substances. In some facilities, pharmacy technicians routinely count the tablets of a controlled substance prescription twice to ensure accuracy, and a pharmacist counts the tablets a third time. Each filled prescription for a controlled substance is recorded, and Schedule II drugs are recorded in a perpetual inventory logbook. Consider the Prescription Drug Monitoring Program. All states have authorized their narcotic and controlled substances agencies to use a Prescription Drug Monitoring Program (PDMP). This program is an electronic database designed to offer healthcare professionals access to a regional, multistate database of controlled substance prescription data to help make decisions about dispensing controlled substances. This information helps healthcare professionals reduce overprescribing and duplication in controlled substance prescriptions, which helps to curb controlled substance abuse. Prescribers can review patients' prescribing histories, helping to prevent "doctor shopping," in which a patient goes to multiple doctors to get multiple prescriptions for the same medication. Pharmacy technicians can also check the PDMP when presented with a controlled substance prescription. If there are multiple prescriptions in the system for the same patient, the pharmacist can choose not to fill it..

[Audio] Consider DEA Oversight of Pharmacies. All pharmacies must be registered with the DEA to receive narcotics and other controlled substances from drug wholesalers. Wholesalers must also be registered with the DEA. These wholesalers, under federal law, are required to contact the DEA if they observe "unusual amounts, patterns, or frequency of drug shipments" to pharmacies. If fraudulent activity is occurring at a pharmacy, the DEA has the ability to inspect the facility. The DEA works closely with state drug and narcotic agencies that are responsible for annual physical inspections and local investigation of unsafe prescribing and dispensing of medications or forging of controlled drug prescriptions. The DEA has established an audit trail to allow the agency to track the flow of narcotics from manufacturer to warehouse to pharmacy to patient. Many pharmacies maintain a perpetual inventory record (or tablet-by-tablet records) for complete accountability of narcotic drugs. Because pharmacy technicians have access to controlled substance inventories, they should learn to recognize drug diversion tactics. Diversion describes theft of an item. Technicians who are responsible for maintaining accurate inventory records must report losses to the pharmacist in charge..

[Audio] The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) requires states to have a Drug Utilization Review (DUR) Board, which establishes a state Medicaid preferred drug list and sets standards for pharmacist-to-patient education and counseling. This act also requires pharmacy personnel to make reasonable efforts to collect, update, and record all pertinent information in a patient's medication history. A pharmacist must review the patient profile—known as a DUR review—before a prescription is filled and offer medication counseling. The offer must be documented, and the note must indicate whether the offer was accepted or refused. It is a technician's responsibility to follow established protocols in the dispensing and sale of a prescription to ensure that counseling was offered to the patient..

[Audio] The Health Insurance Portability and Accountability Act (HIPAA) of 1996 implemented safeguards to protect patient confidentiality and protected health information, which is a patient's private medical information. The law requires that every healthcare facility—including pharmacies—have a policy on patient confidentiality that must be provided to each patient. Pharmacy technicians typically have patients sign an acknowledgement to document the receipt of this information. More information on HIPAA can be found in Module 5. HIPAA also requires that all pharmacy personnel follow protocols for assembling and organizing patient profiles and, under penalty of law, must not reveal any information about any patient outside the pharmacy workplace. They may not discuss or transmit prescription information to anyone other than the patient, parents of children under age 18, and appropriate healthcare providers. HIPAA is also why there are specific trash receptacles for items that include patient information, such as vial labels, monographs, and faxes. The documents in these receptacles are shredded and not placed in regular waste bins. Pharmacies must conduct HIPAA training for personnel, appoint a privacy officer, and conduct risk analyses to comply with HIPAA..

[Audio] Conduct HIPAA Training for Personnel. All pharmacies must have a training program on patient data privacy for its employees, and training must be renewed annually. Training is usually written or delivered online. Such training provides technicians with examples of HIPAA violations, describes the protocols in place at the facility to protect patient information, and explains the consequences for violations. Appoint a Privacy Officer. A privacy officer ensures that proper privacy procedures are implemented, including documentation, filing, and patient requests. This individual also monitors any changes to HIPAA legislation. Much like a safety compliance or quality assurance officer, privacy officers are tasked with ensuring compliance with the most current iterations of HIPAA policies and procedures. Conduct Risk Analyses. A pharmacy manager is responsible for conducting risk analyses to identify any issues concerning patients' electronic protected health information (ePHI). These analyses must be ongoing because new technology or changes in procedures can affect privacy safeguards. The analysis reviews all existing policies, procedures, technologies, and practices used in a given setting and determines the security risk level for patient information. The manager then makes suggestions or creates action plans as necessary to ensure that ePHI is not compromised..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.8 covers the Federal Laws and Regulations Related to Medication Safety. Medications can have profound effects on the human body, and their use must be monitored diligently. Abuse and addiction, as well as manufacturing defects, can affect the safety of both prescription and OTC medications. When patients become addicted to a medication, their safety, as well as the safety of others affected by the abuse, becomes a critical issue. Manufacturing defects can cause adulteration or chemical impurities during a production run for a medication. FDA regulations regarding recalls are in place to deal with them as they occur. Some of the federal laws and regulations related to medication safety include the Combat Methamphetamine Epidemic Act of 2005 and the FDA's Drug Recall Program..

[Audio] Sudafed and other products containing pseudoephedrine and ephedrine were once completely available as OTC medications. They are very effective for decongestant purposes and seemed relatively safe for public use, much like allergy and cold medications. However, some people started to use these medications to make methamphetamine, also known as meth or speed. Illegal drug users and dealers started to buy enormous quantities of pseudoephedrine and ephedrine from pharmacies—hundreds of dollars' worth, in some cases. The Combat Methamphetamine Epidemic Act of 2005 reclassifies all products containing pseudoephedrine and ephedrine and restricts the amount that can be purchased at one time or in any 30-day period. The effect of this act is that pharmacy personnel must store these products behind the counter and keep a log of all sales. Personnel must also undergo training for the handling of products containing pseudoephedrine and ephedrine..

[Audio] State laws and regulations for enforcing the Combat Methamphetamine Epidemic Act vary. In most cases, consumers who purchase these products must present legal identification for purchase and are allowed to purchase only a specified quantity within a certain time frame. The DEA oversees pharmacy compliance with this legislation. Pharmacy technicians should understand the laws that apply in their states and know the process for verifying identification and recording the sale into the state's system. If there is a violation of these regulations, such as a patient coming into the same store multiple times, the technician must notify the pharmacist in charge to determine the next course of action..

[Audio] When manufacturers recall a medication, it is to remove a defective or harmful product from the market. The company may initiate the recall, or the FDA may request the recall. When it is initiated, notifications go out to all practicing pharmacies and those who may have the medication in stock..

[Audio] When manufacturers recall a medication, it is to remove a defective or harmful product from the market. The company may initiate the recall, or the FDA may request the recall. When it is initiated, notifications go out to all practicing pharmacies and those who may have the medication in stock. Pharmacy technicians check computerized inventory records and pull the affected products from inventory shelves, unit-dose carts, crash carts, automated dispensing cabinets, and robots. Technicians must compare the lot number of the recalled drug with the inventory. Often recalls do not involve the entire medication in circulation but only specific lots. Typically, the technician needs to complete a form for the wholesaler that indicates the drug, strength, amount, and lot number; the products are then typically returned to the manufacturer or wholesaler for credit. In rare cases, the FDA may issue a Class I recall, which seeks to not only remove the affected lot numbers from the market but also from the patients to whom it may have been dispensed. In such cases, pharmacy technicians might assist in collecting data and reaching out to patients with further instructions..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.9 covers the Federal Laws and Regulations Related to Insurance Processing. Submitting insurance claims is a regular part of the work of a pharmacy technician. The pharmacy submits an electronic claim to the insurance company, which then reviews the prescriptions and judges, based on the drug coverage plan the patient has, whether a payment should be made and how much it should be. Usually, the insurance company pays the pharmacy on behalf of the patient for part of the patient's prescription cost, and the patient pays a portion as well. Medicare is the federal government program that provides insurance for individuals older than 65, those who are under 65 and receiving disability insurance, and those under 65 with end-stage renal disease. Medicare is essentially a government insurance program, and the Medicare Modernization Act of 2003 relates specifically to pharmacy technicians..

[Audio] The Medicare Modernization Act (MMA) of 2003 updated the Medicare system and initiated the option of a prescription drug insurance program called Medicare Part D. This program is suited to patients with economic hardships or patients needing high-cost medications. This legislation also launched Medicare Part C, a program that provides a comprehensive healthcare insurance option..

[Audio] The MMA encourages pharmacists to provide annual in-depth reviews of the medication profiles of Medicare patients taking high-cost medications or experiencing certain chronic health conditions. The pharmacist can then look for drug interactions, adverse reactions, and ways to reduce medication costs— and get reimbursement for performing these reviews. Pharmacy technicians should be aware that Medicare Part D is a supplement to Medicare that patients pay for separately..

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.10 covers Professional Practice Standards. Professional practice standards, like legal guidelines, establish conduct for pharmacy personnel. For example, the National Association of Boards of Pharmacy published the "Model State Pharmacy Act." It includes standards and recommended language for state boards to use when crafting their own pharmacy legislation..

[Audio] The following is an example of a standard from the "Model State Pharmacy Act" regarding renewal of licenses: "Each Pharmacist, Pharmacy Intern, and Certified Pharmacy Technician shall apply for renewal of his or her license annually [or at such interval determined by the board]." While this standard is ideal, it is also a guideline, meaning it does not have to be used, unlike a state law that sets a mandatory renewal period that may differ in length. It is what may also be referred to as a best practice. These types of standards are set by professional pharmacy practice organizations. The standards help to identify best practices that follow legal and ethical guidelines..

[Audio] Many pharmacy organizations exist at both the state and national level, and their goal is to set the standard for the processes technicians use in a variety of practice settings. Some of the most well-known organizations include the following: • National Association of Boards of Pharmacy • American Pharmacists Association • Institute for Safe Medication Practices • United States Pharmacopeia (USP) • Joint Commission • American Society of Health-System Pharmacists (ASHP) • Pharmacy Technician Educators Council.

[Audio] Career Readiness & Externships: Soft Skills for Pharmacy Technician's Module 7, Section 7.11 covers Ethical Standards..

[Audio] Ethical standards provide a moral framework for professional behavior and actions. They work in conjunction with professional practice standards to guide the behaviors of pharmacy personnel and underscore doing the right thing. Pharmacy has long been considered one of the most trustworthy professions, and highly ethical practices are what help maintain this status among patients and consumers. Ethical behaviors include obeying the federal and state laws and regulations outlined in previous sections. Patients put their trust in the knowledge, competency, honesty, and integrity of pharmacy personnel to serve their unique healthcare needs and to ensure the safety of their health and well-being. For these reasons, pharmacy personnel must be held to high standards of professional behavior. Ethics play a role in guiding the decision-making and actions of pharmacy personnel. A code of ethics regarding professional behavior is often written as a formal document and supported by professional organizations. The statements that make up the code provide language to aid in the decision-making process when an ethical issue presents itself in the pharmacy..

[Audio] The American Association of Pharmacy Technicians (AAPT), the American Society of Health-System Pharmacists (ASHP), and the Pharmacy Technician Certification Board (PTCB) have published a code of ethics for pharmacy personnel. While the language may vary, these codes of conduct follow the same overarching principles and guidelines. Many of the codes are meant to help technicians follow the laws listed earlier in this chapter as well as guide professional conduct to ensure the best outcomes for patient care. Below are links to these codes of conduct. • AAPT Codes of Conduct: https://SSPharm.ParadigmEducation.com/AAPTConduct • ASHP Codes of Conduct: https://SSPharm.ParadigmEducation.com/ASHPConduct • PTCB Codes of Conduct: https://SSPharm.ParadigmEducation.com/PTCBConduct.

[Audio] Think It Through: Codes of Conduct Think about your current approach and mind-set when making decisions. Do you have a personal code of conduct that influences what decisions you make and how you behave? If you do, how well does it align with your career as a pharmacy technician?.

[Audio] Take a moment for self-reflection and ask yourself: Do You Behave Ethically? For each of the following statements, answer "always," "sometimes," or "rarely/never" to rate your ethical decision-making skills. Respond to statements as honestly as possible. When considering my own ethical decision-making skills, I… take time to consider situations before making a decision. gather information from multiple sources. consider the accuracy of various sources. know my employer's policies and procedures. follow my employer's policies and procedures. consider all parties involved in the decision. identify the positive consequences of potential decisions. identify the negative consequences of potential decisions. confidently choose a course of action. follow up on the outcomes of a decision. make necessary changes after reviewing a decision..

[Audio] There will be many times in your career when you will be faced with several options to choose from. There may not be a clear right or wrong answer in these cases—merely the best or most ethical option. Selecting the best option requires the ability to make distinctions between these competing options. There are seven steps to aid in making ethical choices: stop and think, determine the facts, follow facility regulations, consider all affected individuals, weigh the consequences, make the decision, and review the results of your decision..

[Audio] Consider the following hypothetical ethical scenario: A patient comes to the counter very agitated and needs to know if a drug he is currently taking will interact with an OTC medication he wants to purchase. The patient is late for a job interview, and the pharmacist has stepped out to use the restroom. You happen to know the answer to the question, and the pharmacist has told you to relay the information in the past to another patient. Do you tell the patient the information you remember from the last time?.

[Audio] Stop and Think This advice may seem obvious, but slowing down and taking time to stop and think through your options will prevent you from making snap or rash decisions. There is nothing wrong with saying, "I need time to think about this situation." In the example, asking the patient to wait while you go and see if the pharmacist is available (even though you know she is not) can buy you time to consider your options..

[Audio] Determine the Facts You should have all relevant and important information to support an intelligent decision. To determine whether you have all the facts, make a list of what is known and unknown to you. If needed, seek additional information and verify (or dismiss) assumptions and other uncertain information. Additionally, it is important to consider the reliability and credibility of the people providing this information. Knowing what the patient is purchasing and what it is used for, you can determine if the need is critical enough to relay what you already know without pharmacist direction or if the patient can wait or come back after his interview..

[Audio] Follow Facility Regulations Pharmacy personnel must follow their facility's policy and procedures manual to ensure the ethical operation of the pharmacy. If an option does not align with the policies and procedures, it should be discarded. While you can relay information to a patient upon pharmacist direction, doing so unaided is considered counseling and is against facility and legal regulations..

[Audio] Consider All Affected Individuals When deciding, you must think about all the individuals who will potentially be affected by the decision. Often there are more people that can be affected than initially considered. In the scenario, you would be affected by a potential reprimand or termination, but the patient could also be affected. In this case, he could either miss his job interview while having to wait or be given incorrect information that could lead to a medication error..

[Audio] Weigh the Consequences Often there will be outcomes both positive and negative in deciding a course of action. Filter your choices to determine if any of your options will violate any core ethical values, and then eliminate the unethical options. If you decide to help the patient, you may make his day easier and perform what could be perceived as good customer service, which could result in a repeat customer. However, you could also be terminated or cause a serious medication error from choosing to counsel him. If you choose not to assist him and ask him to wait or come back, you might lose him as a customer but would not face the other consequences..

[Audio] Make the Decision Ultimately, you must decide. If you are still struggling to see a clear choice, try talking with others who may be involved or affected to get their opinions. Seek the advice of individuals you respect and trust, including people you know who have a strong moral compass. Ask yourself, "If everyone found out about my decision, would I be proud and comfortable with it?" Review the Results of Your Decision Ethical decision-makers monitor the effects of their choices and learn from their mistakes. If your decision is not producing the intended results or is causing undesirable results, reassess the situation and make a new decision..

[Audio] 7.12 Module Summary.. 7.12 Module Summary.

[Audio] Laws are what guide our conduct and ensure safety and prosperity. This statement holds true for the practice of pharmacy as well. To effectively carry out our duties, we must understand the laws at both the state and federal levels that regulate our scope of practice. As pharmacy technicians assume more advanced responsibilities, they will have more legal liability..

[Audio] Pharmacy personnel must adhere to all federal and state laws and regulations or risk legal repercussions. Violations in laws may result in damages, fines, probation, loss of licensure, or—in extreme cases—incarceration. It is also necessary to follow an ethical framework in the interpretation and execution of these laws and regulations. By following a code of conduct, pharmacy technicians can conduct themselves with the highest level of professionalism..