Cert Exam 5e Chapter 3 Presentation

[Audio] Welcome to the Certification Exam Review Fifth Edition presentation for Chapter 3..

[Audio] Chapter 3: Patient Safety and Quality Assurance.

[Audio] At the end of this chapter, you will be able to: Identify various agencies involved with patient safety, including the US Consumer Product Safety Commission (CPSC), the US Food and Drug Administration (FDA), and the Institute for Safe Medication Practices (ISMP). Describe the three phases of the drug approval process. Describe procedures and processes for reporting issues that impact patient safety such as errors and adverse events. List types of prescription errors and strategies to prevent errors. Identify high-risk, high-alert, and look-alike sound-alike drugs. Recognize issues that require pharmacist intervention to protect patient safety. Elaborate on the process of continuous quality improvement. Access and use references and resources as needed to perform job duties..

[Audio] . Identify high-risk, high-alert, and look-alike sound-alike drugs. Recognize issues that require pharmacist intervention to protect patient safety. Elaborate on the process of continuous quality improvement. Access and use references and resources as needed to perform job duties..

[Audio] Section three point one. Medication safety systems..

[Audio] One of the first challenges about medication safety is to make sure that the drugs are safe for human use. The US Centers for Disease Control and Prevention , the Centers for Medicare and Medicaid Services , the Consumer Product Safety Commission , the US Drug Enforcement Agency, the US Food and Drug Administration, the Federal Trade Commission, and the Occupational Safety and Health Administration, are agencies set up by the federal government to enforce laws, conduct research, and establish prevention processes..

[Audio] The state boards of pharmacy also advocate for safety laws on the state level. The major nongovernmental agencies involved in medication safety efforts are the Institute for Safe Medication Practices, the National Coordinating Council for Medication Error Reporting and Prevention, The Joint Commission, which oversees healthcare institution accreditation, and the US Pharmacopeial Convention. Within each pharmacy and compounding facility, the policy and procedures manual lays out the safe procedure for pharmacy filling, dispensing, and compounding based on the laws, regulations, standards, and counsel from these organizations..

[Audio] The FDA is responsible for the review and approval of all prescription and over-the-counter medications, including generic drugs. Every new drug approved by the FDA has a chemical name, a generic or nonproprietary name, and the manufacturer's recommended brand or trade name. The chemical name describes the chemical structure of the particular drug molecule. The generic or nonproprietary name is developed to provide an identifier that is not protected by a patent. The brand name is owned by the company that develops the drug, gets FDA approval and first markets it. Once the original patent of the brand drug expires (usually 17 years or more after the patent is filed), any manufacturer can apply to the FDA with an Abbreviated New Drug Application or A-N-D-A to market a generic version, which usually sells for a reduced price.

[Audio] For all new brand-name drugs, manufacturers must file an Investigational New Drug Application or I-N-D with the results from in-depth animal studies before the new drug can be approved for testing on human subjects. The clinical studies must then be submitted and approved by the Institutional Review Board or I-R-B of the university or hospital where the research will be conducted before the human clinical studies can begin. The I-R-B, sometimes known as the Human Use Committee, is comprised of scientists and practitioners from various disciplines. After the I-N-D is approved by the F-D-A and the I-R-B, non-F-D-A scientists conduct three phases of human clinical studies as part of the drug approval process. Phase 1 is the initial study or trial of the new drug, usually completed on a small number of healthy volunteers. Phase 2 aims to evaluate the effectiveness and safety of a drug for a specific indication or disease state on a slightly larger number of unique patients. If the results of phase 1 and phase 2 studies are promising, phase 3 studies are conducted in larger clinical trials (larger groups) to better assess the overall benefits and risks of the investigational drug on patients..

[Audio] Once a drug is released and a larger population of patients is using it, the probability that problems will arise increases. The F-D-A tracks adverse drug reactions, which are harmful or negative effects of or reactions to a particular drug on a patient,—an appreciably harmful or negative consequence to a patient from taking a particular drug-- through different feedback processes. The Adverse Event Reporting System is a centralized database that stores information from two separate federally sponsored reporting programs: MedWatch and VAERS. MedWatch and VAERS have a variety of duties: · MedWatch is a voluntary program that offers healthcare professionals and consumers an avenue to anonymously report a serious adverse event associated with any specific drug, biological device, or dietary supplement. The Vaccine Adverse Event Reporting System is Cosponsored by the CDC. This is a safety surveillance program, collecting information from vaccination providers and from the public about adverse reactions (possible side effects) that occur after a patient has been given a vaccine approved for market release in the United States..

[Audio] There are five ways the F-D-A may respond to reports of a problematic drug? Issue safety alerts to healthcare professionals or consumers on the drugs (including drug recalls), biologicals, dietary supplements, and counterfeit drugs. Request medication labeling changes to the product package insert, including contraindications, warnings, boxed warnings, precautions, and adverse reactions. List the drug as a high-risk medication and require that it be dispensed with a Medication Guide for provider and patient education. (This action may also be required before market release because of the results of clinical studies.) Require Risk Evaluation and Mitigation Strategies (REMS). These, too, may be required before market release. Remove the product from the market in a drug recall..

[Audio] For some high-risk drugs, the FDA requires manufacturers develop Risk Evaluation and Mitigation Strategies or (R-E-M-S) for providers and patients to follow. In some cases, community and institutional pharmacies and prescribers must register with the drug manufacturer or federal REMS program for each drug they will be dispensing or wholesaling and receive drug-specific REMS training. The pharmacist must review any required Medication Guides with patients and do other required counseling and monitoring activities. REMS programs are individually designed to closely track patients on these high-risk drugs and make periodic assessment reports to the FDA on their statuses. Technicians must know common drugs that require REMS, such as Thalidomide Isotretinoin Fentanyl Buprenorphine Clozapine & Olanzapine And Flibanserin ..

[Audio] In 2013, Congress passed the Drug Quality and Security Act (DQSA), which includes the Drug Supply Chain Security Act (DSCSA) and the Compounding Quality Act (CQA). It aimed to establish a national database to track and trace drug products through the supply chain from the manufacturer to the pharmacy and to increase compounding safety guidelines. Requirements of the law include the following: · verification that all trading partners and practitioners are properly licensed · drug-tracking documentation to be completed by the compounder/manufacturer, wholesalers and distributers, pharmacies, and administering clinicians and kept on file for a minimum of six years; · inspection of all drugs upon receipt to remove any suspicious products for further investigation..

[Audio] Section three point two. Preventing Medication Errors.

[Audio] The pharmacy technician, as a member of the healthcare team, works to provide the right patient with the right drug, at the right strength, with the right route of administration (ROA) and in the right form, with the right documentation, and to deliver the right education material, all with 100% accuracy . However, 44% of 700 pharmacists surveyed in 2012 admitted making errors. Of these, 37% admitted that they did not report the errors they made. That shows that prescription errors are significantly underreported and underscores the need for effective checks and balances..

[Audio] A medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer." A medication error often results in an adverse drug reaction or A-D-R. It may be a short-term acute reaction, long-term injury, or even death. After a medication error has occurred, a root cause analysis or R-C-A can help to identify the factors that led to the error. To proactively prevent medication errors, many pharmacies use failure modes and effects analysis or F-M-E-A. Failure modes means the ways in which something can fail, and effects analysis looks at the results or consequences and analyzes prevention techniques..

[Audio] In addition to the FDA's MedWatch and VAERS, several nonprofit and professional agencies track and/or work to minimize medication errors. The Institute for Safe Medication Practices or I-S-M-P tracks, collects, and disseminates information to healthcare personnel regarding safe medication practices using the following tools (among others): The I-S-M-P seeks out trends and address causes with innovations and guidance. In a study of 26,604 reports, 60% of errors occurred in the dispensing process, and pharmacy technicians were involved in nearly 40% of these errors. Major contributing factors included inexperience, distraction in the workplace, and excessive workload. The I-S-M-P distributes lists of high-alert medications to dispense with great care in different settings: acute care, community and ambulatory healthcare, and long-term care. I-S-M-P also has assembled the List of Error-Prone Abbreviations, Symbols, and Dose Designations. The I-S-M-P National Medication Errors Reporting Program or I-S-M-P-M-E-R-P is a voluntary medication error reporting program. It allows healthcare providers who have made a medication error to self-report anonymously..

[Audio] Section three point three. Ways Technicians Can Reduce Errors.

[Audio] The pharmacist is ultimately responsible for the accuracy and dispensing of prescriptions, but the pharmacy technician plays an important role in ensuring safety. The pharmacy technician has a moral and ethical obligation to raise questions to protect patient safety. It is better to err on the side of caution than to make a hasty decision and risk harming or killing a patient. The work area should be uncluttered and well-lit, and drug stock bottles should be returned to inventory after dispensing. When dealing with look-alike sound-alike drugs, the pharmacy should separate the stock containers in the inventory so that similar sounding and similar-looking products are not next to each other on the shelf. Technicians must be focused—even while multitasking—to prevent errors. Personal calls or cell phones distract attention and compromise safety. Technicians need to know and follow the P&P manual and state and federal laws..

[Audio] All stock medication labels include a unique, product-specific National Drug Code (NDC) in both numeric and bar-code form. The first number set (4 to 5 digits) identifies the manufacturer, the second set (3 to 4 digits) indicates the product code, and the last set (2 digits) shows the packaging size and type. Technicians should verify all their drug selections with the listed National Drug Code or N-D-C number and by scanning the NDC bar code on the stock label. The NDC number plays a crucial role in the prevention of medication errors...

[Audio] Any time that a technician is unsure while filling a prescription, the pharmacist should be consulted. There are also key points in the processes for pharmacist verification: after entering the profile and prescription, during the Drug Utilization Reviews or D-U-R and online adjudication if there are any alerts, and after the prescription is filled but before applying the label. When alerts arise during the D-U-R, the technician should consult a pharmacist before proceeding. A patient's allergy list should be updated every time they presents a new prescription because new allergies may have occurred since the last update. The pharmacist will use their professional judgment to decide whether to contact the prescriber or to fill the prescription. Some alerts that happen during adjudication need to be addressed by the pharmacist. When prior authorization is required, it is up to the prescribing physician to justify the use of the more expensive drug. The technician or pharmacist will need to contact the prescriber for review and action; the pharmacist may be able to expedite the clarification process by telephone, particularly if a delay would harm the patient. At the dispensing of each prescription, the technician is bound by law to offer counseling from the pharmacist. A pharmacist should always be consulted if a patient requests counseling on a prescription or O-T-C product. If a patient ever reports an ADR, the technician must immediately notify the pharmacist. Adverse reactions will be assessed by the pharmacist who will determine if the reaction should be added to the patient's profile as an allergy and/or be reported to the MedWatch..

[Audio] When dispensing prescriptions, every patient must receive the follow information with the medication: Brand and generic name Medication's proper appearance Purpose of the medication and duration of treatment Correct dosage and frequency and the best time or circumstances to take a dose How to proceed if a dose is missed Medications or foods that interact with the prescribed medication Whether the prescription is in addition to or replaces a current medication Common side effects and how to handle them Special precautions necessary for each drug therapy Proper storage for the medication.

[Audio] When dispensing prescriptions, every patient must receive the follow information with the medication: Medications or foods that interact with the prescribed medication Whether the prescription is in addition to or replaces a current medication Common side effects and how to handle them Special precautions necessary for each drug therapy Proper storage for the medication.

[Audio] Section three point four. Quality Control and Assurance.

[Audio] Within pharmacies and healthcare facilities, medication errors are difficult to track because there are no national laws that require pharmacy personnel errors be reported. To encourage more medical- and medication error tracking and analysis, the federal government passed the 2005 Patient Safety and Quality Improvement Act or P-S-Q-I-A. The P-S-Q-I-A encourages the creation of patient safety organizations or P-S-O that can collect confidential information on medical and medicine errors to develop systematic changes for safety. Those who report errors are legally protected from being sued or being punished in the workplace by loss of responsibilities, pay, or promotions. In addition to PSOs to encourage confidential reporting of medical and medicine errors, pharmacies conduct their own quality assessments to ensure quality and accuracy. Quality assessments include examining product integrity and safety, as well as customer service, productivity, efficiency, and profitability..

[Audio] The quality of the workforce is an essential component of any high-quality business. To ensure that pharmacies and institutions employ the best qualified people, an employer will examine all potential employees' credentials and employment histories. Credentials are the education and licensing requirements to practice a particular job. For pharmacy technicians, national certification is one of the best credentials. An experienced technician might be given extra responsibility to ensure medication safety. The tech-check-tech system, where advanced technicians check the work of less experienced technicians before the pharmacist verifies a medication, has been found to greatly reduce medication errors. Technicians who serve as medication profile specialists or medication reconciliation specialists in hospitals have also reduced many of the errors and omissions in medication histories that admitting personnel do not have the knowledge base to catch or query..

[Audio] Pharmacies and healthcare institutions must protect the safety of their workers as well as their patients. That is why they follow O-S-H-A regulations. Pharmacies and healthcare institutions require hand-washing standards and personal protective equipment or P-P-E, sharps containers, medication disposal processes, and hazardous spill kits. They also encourage or require annual flu vaccinations and implement the CDC's universal precautions against the transmission of bloodborne pathogens..

[Audio] In a hospital, there are committees working on safety and quality control. These committees track medical and medication errors to find root causes and to improve hospital processes. A hospital Infection Control Committee or I-C-C specifically works on preventing inadvertent transmission of infection and disease. It also tracks healthcare-associated infections or H-A-I to help prevent them from happening to patients and staff in the future. The I-C-C ensures that hospital staff are trained in standard hygiene, infection controlling protocols, and universal precautions..

[Audio] Many hospital and healthcare institutions use surveys to measure patient satisfaction. Hospital pharmacies can also survey their customers—the physicians, surgeons, and nurses who order or administer the drugs. Survey results can identify trends, areas that work well, and areas that need improvement. Institutions can also use survey results to compare their own performance over time and compare their institution's performance against others". Such analysis can lead to improvements. In community pharmacies, satisfaction is less likely to be measured by a formal survey. Repeat business is one measure of satisfaction. Patients who return again and again are usually content with the level of service. Magazines and newspapers in many areas can offer another means of assessing consumer satisfaction through annual "Best of" contests and surveys. These offer positive reinforcement that the institution is satisfying its clientele..

[Audio] Section three point five. References and Resources.

[Audio] Accessing and analyzing information is critical to patient safety. A pharmacy technician is responsible to research and provide information to other members of the pharmacy team. There are many references and sources of information available, and it is critical to know which one to use in which situation. Knowledge of references and how to use them will increase your value as a pharmacy technician. It is important to be familiar with certain pharmacy law, including the federal Controlled Substances Act and state pharmacy laws and regulations. Other federal references to be aware of include the Orange Book, which is available as an online resource. The Orange Book is published by the F-D-A and documents drug products that have been approved by the F-D-A and information about which products are therapeutically equivalent to each other. The F-D-A's Purple Book lists biological products that are approved by the F-D-A, and references whether biological products are biosimilar to or interchangeable with other biological products. Requirements for substituting biological products for one another vary by state law, so always consult your pharmacist if you have doubts. Drug Facts and Comparisons is a reference of clinical information for both prescription and O-T-C products. It provides important clinical and practical information for pharmacists and pharmacy technicians and facilitates the provision of important information to patients. Micromedex is another pharmacy reference that provides information on pharmaceutical products, medication management, disease and condition management, pricing and product information, and patient education. Lexicomp is another comprehensive source of drug-related information. "Trissel's," is a comprehensive reference on the compatibility, stability, pH, storage, and preparation of parenteral drugs. Trissel's is a printed and online reference intended for use by professionals who prepare and deliver parenteral medications..

[Audio] This concludes the Certification Exam Review Fifth Edition presentation for chapter three..