Medication Development and Regulation: Key Insights and Resources
School
Pima Medical Institute**We aren't endorsed by this school
Course
PHARMACOLO 102
Subject
Nursing
Date
Dec 10, 2024
Pages
4
Uploaded by EarlPolarBear4746
Name: _Claudia Fregoso__ Chapter 2: Medication Development, Regulation, and Resources1TEXTBOOK EXERCISE ANSWERKEYReviewQuestions1.How does the federal government regulate medications? They established federal drug laws such as oPure food and Drug actoFederal Food Drug, and cosmetic Act (1938; amended in 1952 and 1965)oControlled Substances Act2.What is the significance of the Pure Food and Drug Act of 1906? It sets standards for quality and required the proper labeling of medications.Required all drugs marketed in the US to meet minimal standards of uniform strength, purity and qualityRequired preparations containing morphine be labeledEstablished two references of officially approved drugs3.What is the role of the FDA in drug regulation? Their role is medication regulation. They require that all drugs must undergo stringent testing and provide proof of safety and effectiveness before release. They consist of centers and offices.4.Why is the separation of some drugs into five schedules important? They are important so that we are able to determine the level of abuse and dependence potential, andappropriate medical uses for the medication.. 5.What are the roles of The Joint Commission (TJC), the Occupational Safety and Health Administration(OSHA), and the Centers for Disease Control and Prevention (CDC) in medication regulation? The Joint Commission:Evaluates and accredits more than 20,500 health care organizations and programs in the U.S. They are the predominant standards setting organization. Some of the standards arethe National Patient safety Goals which addresses issues like infection control, Implementation guide for Surgical Site Infections. They also expanded to include a list of dangerous abbreviations, acronyms, and symbols that should not be used in the clinical setting.The Occupational Safety and Health Administration (OSHA):Their mission is to ensure the safety and health of American workers by setting and enforcing standards. They established the Occupational Exposure to bloodborne pathogens standard, which states that each employer must have a plan that ensures immediate and confidential postexposure treatment and follow-up procedures in accordance with the current CDC guidelines.Centers for Disease Control (CDC): An agency under the US department of health and Human Services.They are the leading federal agency for protecting the health and safety of people and for providing credible information to enhance health decisions. In 1995 they issued a protocol for Emergency TEACH Lesson Plan SNYDER AND KEEGAN: Pharmacology for the Surgical Technologist, 4th Edition Copyright© 2017, Elsevier Inc. All Rights Reserved.
Name: _Claudia Fregoso__ Chapter 2: Medication Development, Regulation, and Resources2needlestick Information. This protocol recommends prophylactic medication treatment as soon as possibleafter a needlestick or sharps injury known as postexposure prophylaxis.Review Questions(Continued)6.Use at least two medication references to research the indications and the side effectsof the following medications. A. Heparin sodiumIndications:Treatment of deep venous thrombosis (DVT), pulmonary embolism (PE), and arterial thromboembolism. Side Effects: Bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use.ReferencesDrug summary “Heparin Sodium.”(n.d.). Physicians Drug Reference. Retrieved October 17, 2024, from https://www.pdr.net/drug-summary/?drugLabelId=1263#adverse-reactions Warnock LB, Huang D. Heparin. [Updated 2023 Jul 10]. “Heparin Sodium”Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK538247/B. Diazepam (Valium) Indications:For the treatment of anxiety disorders or for the short-term relief of the symptoms of anxiety, alcohol withdrawal, non-severe alcohol withdrawal. For the treatment of muscle spasm due to local pathology such as muscle or joint inflammationor trauma; athetosis; stiff-man syndrome; tetanus; or spasticity due to upper motor neuron diseases such as cerebral palsy. For the treatment of muscle spasm due to tetanus.For the treatment of intermittent, stereotypic, episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from usual seizure pattern.For anesthesia induction or for procedural sedation. For the treatment of benzodiazepine withdrawal.For the treatment of insomnia.Side Effects:Sedation, Fatigue, Confusion, Anterograde amnesiaDepression, Ataxia, Irritability, Disinhibition, Local injection site reaction, Headache, Tremor, Dystonia, Urinary retention, Incontinence, Nausea, Constipation, Diplopia, Libi,changes, Rash. Menstrual irregularities, ALT and/or AST elevationReferencesDhaliwal JS, Rosani A, Saadabadi A. Diazepam. [Updated 2023 Aug 28]. National library Of Medicine Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK537022/Drug summary Valium (Diazepam). (n.d.). Physicians Drug Reference. Retrieved October 17, 2024, from https://www.pdr.net/drug-summary/?drugLabelId=2100#common-brand-names C. Ancef Indications: Broad-spectrum antibiotic For the treatment of upper respiratory tract infections, moderate to severe urinary tract infection (UTI). For the treatment of infective endocarditis. For the treatment of native valve endocarditis, prosthetic valve endocarditis. For surgical infection prophylaxis, uncomplicated and complicated skin TEACH Lesson Plan SNYDER AND KEEGAN: Pharmacology for the Surgical Technologist, 4th Edition Copyright© 2017, Elsevier Inc. All Rights Reserved.
Name: _Claudia Fregoso__ Chapter 2: Medication Development, Regulation, and Resources3and skin structure infections, including cellulitis, erysipelas, skin abscesses, necrotizinginfections, pyomyositis, and surgical incision site infections. For ophthalmic surgical infection prophylaxis. For the treatment of bacteremia, mastitis.Side Effects: Diarrhea, oral candidiasis (oral thrush), mouth ulcers, vomiting, nausea, stomach cramps, epigastric pain, heartburn, flatus, anorexia and pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment ReferencesCefazolin (Ancef). (n.d.). Physicians Drug Reference. Retrieved October 20, 2024, from https://www.pdr.net/drug-summary/?drugLabelId=1193#adverse-reactions Patton, K. T., Bell, F. B., Thompson, T., & Williamson, P. L. (2023a). The human body inhealth & disease(8th ed., pp. 531–532). Elsevier Health Sciences. 7.Why is it important for the surgical technologist to have an understanding of medications, though he or she does not directly administer them to the patient? The ST is the last line of defense. We can also catch mistakes that possibly would be missed. We also have to reconstitute or draw up medications into a syringe from our sterile field and we need to be aware of the proper dosage depending on the strength. Patient safety is always first.CriticalThinking1.How does the DEA affect clinical practice?. They enforce the Controlled Substances Act. It makes sure that they are being documented, dispensed, and used appropriately. They set procedures as to how to handle them and they must comply with the DEA standards. 2.Name three medications the surgeon uses during a procedure that are prepared on the back table. The surgeon may use 0.9% sodium chloride, 0.5% lidocaine, cefazolin.3.How are medications for procedures obtained at your clinical site? The circulator obtains the medication and passes it to the sterile scrub tech to be placed into the sterile field. The circulator will first read the strength and name of the drug along with the expiration date and the ST will repeat when accepting the medication. The ST will then label each medication entering the sterile field immediately. Scenario The surgery is scheduled as an excision of a cyst from the right lower back. The surgeon requests Xylocaine 1% with epinephrine, Demerol, and Versed for the local procedure. TEACH Lesson Plan SNYDER AND KEEGAN: Pharmacology for the Surgical Technologist, 4th Edition Copyright© 2017, Elsevier Inc. All Rights Reserved.
Name: _Claudia Fregoso__ Chapter 2: Medication Development, Regulation, and Resources41.What are the generic names for these medications? The generic name for Xylocaine is Lidocaine hydrocholoride/epinephrineThe generic name for Demerol is Meperidine hydrochloride.The generic name for Versed is Midazolam.2.Xylocaine is available in what strengths? 0.4%, 0.5%, 0.8%, 1%, 1.5%, 2%, 4%, 5%Critical Thinking(Continued)3.Which of these medications is/are narcotics? What is/are the controlled substances schedules? Demerol is a schedule II controlled substance and a narcotic,Versed is a schedule IV controlled substance 4.Which of the medications would have red on the label? What does this signify? Demerol would have red on the label and it would indicate a high abuse potential. It has been accepted for medical use but can lead to physical and psychological dependency. It also has specific restrictions. TEACH Lesson Plan SNYDER AND KEEGAN: Pharmacology for the Surgical Technologist, 4th Edition Copyright© 2017, Elsevier Inc. All Rights Reserved.