Cert Exam 5e Chapter 2 Presentation

[Audio] Welcome to the Certification Exam Review Fifth Edition presentation for Chapter 2..

[Audio] Chapter Two: Federal Requirements.. Chapter 2 Federal Requirements.

[Audio] At the end of this chapter, you will be able to: Discuss landmark legislation important to the practice of pharmacy. Identify the names and duties of pharmacy oversight agencies. Identify advances in science and pharmacology and the impact they had on society..

[Audio] Section two point one: Pharmacy Oversight.

[Audio] Pharmacy technicians must practice within federal laws and the laws of their state, as recommended by their state's board of pharmacy, and passed by their state and municipal lawmakers. When federal and state laws are in conflict, the strictest law always prevails..

[Audio] Key federal laws that affect pharmacy procedures that could be mentioned in a certification exam include. The Poison Prevention Packaging Act of 1970, which required child-resistant containers for most prescription and O-T-C drugs to prevent accidental ingestion and poisoning. The Omnibus Budget Reconciliation Act of 1990, which required pharmacists to engage in drug utilization reviews and offer Medicaid patients the option of free prescription counseling. The Health Insurance Portability and Accountability Act of 1996, which addressed patient privacy concerns by requiring signing of a confidential annual HIPAA form outlining who has access to patient information. And the Combat Methamphetamine Epidemic Act of 2005, which restricted sales of OTC drugs used in making methamphetamines to limited amounts..

[Audio] Section two point two: Oversight and Abuse.

[Audio] Federal and state agencies were established to oversee the laws. Some of the key federal and state agencies that provide oversight include. The Food and Drug Administration, which is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The Drug Enforcement Administration, which is responsible for enforcing the laws regarding potentially addictive controlled substances, both illegal and legal. The Centers for Disease Control and Prevention, which works to fight infectious diseases to stop epidemics (regional widespread contagious diseases) and pandemics (globally widespread epidemics), sexually transmitted diseases, food-borne diseases, and other contagious illnesses. The Occupational Safety and Health Administration, which works to ensure the safety and health of US workers by establishing and enforcing workplace regulations and standards. And individual state boards of pharmacy that work to create and enforce regulations for their states..

[Audio] Healthcare fraud is a growing problem and a major target of government enforcement efforts. Waste and abuse are also targets. Their definitions are as follows. Fraud, which is knowingly submitting false or misrepresented claims to obtain a payment one is not otherwise entitled to. Waste, which includes practices that result in unnecessary costs to the Medicare program, such as prescribing and dispensing unnecessary quantities of medication. Abuse can also result in unnecessary costs to the Medicare, but the provider does not knowingly misrepresent facts to obtain payment. For example, if a pharmacy unknowingly bills for a brand name drug but dispenses a generic, this is abuse..

[Audio] Section two point three: Federal Requirements for Handling and Disposal of Hazardous Drugs, Nonhazardous Waste, and Hazardous Waste.

[Audio] Drugs may be identified as hazardous or potentially hazardous based on at least one the following criteria: Carcinogenicity, which is any agent that promotes the formation of cancer. Teratogenicity, which is any agent that can disrupt the development of an embryo or fetus. Reproductive toxicity, which is any agent that interferes with normal reproduction. Organ toxicity in low doses, which is any agent that damages organ structure or function. Genotoxicity, which is any agent that damages genetic information within a cell causing mutations. And new drugs that mimic existing hazardous drugs in structure or toxicity..

[Audio] Most pharmaceutical waste and medications are non-hazardous. Non-hazardous pharmaceutical waste includes over-the-counter medications, antibiotics, and other medications. Non-hazardous pharmaceutical waste can be disposed of in designated bins, or in the regular trash if it will be incinerated. Glass and used needles must be disposed of in appropriate sharps containers..

[Audio] Disposal of hazardous waste must occur in an appropriate manner. Discarded gloves, gowns, and other disposable materials should be contained in thick, leak-proof plastic bags that are colored differently than other hospital trash bags. There should be at least one receptacle in every area where hazardous wastes are generated, and the waste should not be moved from one location to another. All E-P-A, state, and local laws and regulations should be followed for the disposal of hazardous waste..

[Audio] Section two point four: F-D-A Drug Labels.

[Audio] The FDA has the authority to require manufacturers to adhere to labeling and other regulations or have their products pulled from the shelves. Some key labeling requirements include: A Unit Dose Label, which must include the drug name, dose, strength, manufacturer's name, lot number, expiration date, and barcode. The Repackaged Medication Label, which must include the patient's name, drug name, strength, dose, administration time, lot number, expiration date, and barcode. The Nonsterile Compounded Products Label, which must include the patient and physician names, name of preparation and date of compounding, internal ID or lot number, direction for use, storage requirements, pharmacist initials, and beyond use date..

[Audio] Section two point five: F-D-A Risk Evaluation and Mitigation Strategies.

[Audio] Risk Evaluation and Mitigation Strategies, or R-E-M-S, is a drug safety program that the F-D-A can require for certain medications with serious safety concerns. R-E-M-S are intended to reinforce medication-use behaviors and actions that support the safe use of a medication. R-E-M-S include a risk mitigation goal, and are made up of information and/or required activities to be carried out by those who prescribe, dispense, or take the medication. Elements of R-E-M-S can include one or more of the following. Communicating to patients. R-E-M-S may require the drug manufacturer to develop material for patients, such as medication guides, which are handouts for patients distributed with many prescription medications. Communicating to healthcare providers, pharmacists, and healthcare settings. R-E-M-S may require the drug manufacturer to communicate directly to various healthcare providers and provide information about a specific serious risk with the R-E-M-S medication and how to reduce that risk. Required activities or clinical interventions. R-E-M-S may also require participants to take certain steps that support the safe use of the R-E-M-S medication. Required certifications and actions. Some R-E-M-S require prescribers and pharmacists become certified in the specific R-E-M-S and agree to carry out a set of activities to reduce the risk of the drug. Required documentation of safe use condition. Other R-E-M-S may require documentation of a safe use condition before the drug can be dispensed to the patient. Required patient actions. Some R-E-M-S may require the patient take certain actions to remain on the treatment..

[Audio] Section two point six: Controlled Substances Regulations.

[Audio] The 1970 Controlled Substances Act established the classification system for drugs with great potential for abuse. It categorized them into schedules denoted by Roman numerals. The lower the schedule number, the higher the risk of abuse. The Schedules work like this. Schedule 1, which are drugs with the highest potential for abuse and are therefore, illegal. For research only..

[Audio] Schedule 2, which are drugs with a high possibility of abuse that can lead to psychological or physical dependence. Dispensing is severely restricted. They cannot be prescribed by telephone except in an emergency. There are no refills on prescriptions..

[Audio] Schedule 3, which have less potential for abuse than Schedule 2. Prescriptions can be refilled up to five times within six months..

[Audio] Schedule 4, which has lower abuse potential than schedule 2 and schedule 3. Prescriptions can be refilled up to five times within six months..

[Audio] Schedule 5, which has the lowest abuse potential. Some are sold without a prescription depending on state law..

[Audio] Section two point seven: State Laws. Section 2.7 State Laws.

[Audio] In addition to knowledge of federal laws affecting pharmacy practice, technicians must be cognizant of state laws and regulations. The pharmacy technician may be responsible for registering annually with the state board of pharmacy and fulfilling all continuing education requirements. In most states, the pharmacy technician may legally perform the following duties. dispensing medication, record keeping, pricing, and billing..

[Audio] preparing doses of a premanufactured product..

[Audio] compounding sterile and nonsterile medications according to protocols..

[Audio] customer service for prescriptions.. 2.8 State Laws.

[Audio] transporting medications to patient care units in the hospital..

[Audio] checking and replenishing drug inventory..

[Audio] This concludes the Certification Exam Review Fifth Edition presentation for Chapter Two..