...treatment 34 ‘‘Black box’’ 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk Shirley Murphy, MD, and Rosemary Roberts, MD Silver Spring, Md A prominently displayed boxed warning, the so-called ‘‘black box,’’ is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these ‘‘black box’’ warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. (J Allergy Clin Immunol 2006;117:34-9.) Key words: Food and Drug Administration, adverse drug reactions, MedWatch, ‘‘black box’’ warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development Abbreviations used AERS: Adverse Event Reporting System CDER: Center for...
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...December 2, 2013 RAFT Task 1 Executive Summary for Joint Commission Standards Compliance Nightingale Community Hospital is a 180-bed acute care hospital that is a not-for profit entity. The hospital is community based and provides leadership in quality health services in which they provide. Their vision is to be the hospital that people choose, the place employees, physicians and volunteers want to work and a hospital of choice for the community. They are committed to providing a healing environment to their patients with a compassionate commitment to healthcare excellence. The four main areas of focus for the Joint Commission for Nightingale Hospital include Communication, Information Management, Medication Management and Infection Control. The goal of these four focus areas is safety. The goal of safety is the most important because it allows for the best management and treatment of patients. This will guide the hospital’s focus toward the best protocols and policies which will reduce patient harm and errors. Each policy and protocol is specifically designed for each individual facility. Medication Management is the focus area in which I chose to discuss the existing compliance of the organization. The Joint Commission’s ethics for medication management address the critical processes involved and support compliance with the National Patient Safety Goals. “The medication management standards are geared to allow assessment of the organization’s eight essential medication...
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...be Joint Commission compliant for the given standard. Standard | Description | Joint Commission Compliance | MM.01.01.01 | The hospital plans its medication management processes. | MetNightingale PoliciesPatient Care Polices: 1. Medication Management, Patient Specific Information 2. Medication Administration | NPSG.03.04.01 | Label all medications, medication containers (for example, syringes, medicine cups, basins), or other solutions on and off the sterile field. | MetNightingale Hospital NPSG Data: * Average Hospital-Wide Medication Labeling of Containers over the last 12 months = 99.6%. | NPSG.03.05.01 | Reduce the likelihood of patient harm associated with the use of anticoagulant therapy. | Needs ImprovementAverage Adverse Drug Events related to Anticoagulation therapy per 1000 patients days over the last 12 months = 3.4. | There is an identified risk for...
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...medical products to respond to deliberate and naturally emerging public health threats. What does the FDA regulate? The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction Drugs, including: • prescription drugs (both brand-name and generic) • non-prescription (over-the-counter) drugs • vaccines • blood and blood products • cellular and gene therapy products • tissue and tissue products The Federal Drug Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world. The law is intended to assure the consumer that drugs and devices are safe and effective for their intended uses and that all labeling and packaging is truthful, informative, and not deceptive. Chris’ Part The Regulation of Drugs • The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe...
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...important alternative treatment options: diet and nutrition, and behavior modification therapy (Millichap, 2010). Diet and Nutrition According to Millichap (2010), “of all the alternative therapies proposed for the treatment of ADHD, diet and dietary supplements have demanded the most attention and invoked frequent controversy” (p. 144) . The controversy is largely due to the fact that there is minimal scientific studies around this type of ADHD intervention. However, there are two main dietary interventions that show potential benefits to the treatment of ADHD in children. First, restrictive elimination diets aim to remove the foods that the child show a hypersensitivity to. This can sometime be an allergic reactions or a significant observable change in the child’s behavior. The most commonly restricted foods and additives are sugars and artificial food color (Millichap, 2010; Kim & Chang, 2011). Second, medical professional often recommend supplementation with free fatty acids to children with ADHD. Children with ADHD have a deficiency of FFA as it helps with brain growth and health. According to Kim and Chang (2011), “increasing the amount of FFA in the diet would be expected to counter ant FFA deficit and thereby possibly improve brain functioning and behavior” (p.417). Behavior Modification Therapy As Hodgson, Hutchinson, and Denson (2014) explain, behavior modification therapy utilizes “the principles of learning theory and operant conditioning, utilizing techniques such...
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...Jennifer Bauman Teaching Plan NUR 232 Nursing Diagnosis Knowledge deficit regarding Warfarin R/T unfamiliarity with medication. Planning Learning objectives/Goals 1. On completion of the learning session, the client will verbalize what foods should be avoided or eaten in moderation while taking Warfarin. 2. On completion of the learning session, the client will be able to verbalize adverse signs and symptoms to look for when taking Warfarin. 3. On completion of the learning session, the client will be able to verbalize the importance of compliance and the need for regular monitoring. (Managing OAT: p.584) Content Outline 1. Identify foods to eat in moderation while on Warfarin. 2. Discuss the importance of compliance while taking Warfarin and adverse effects that can occur from taking Warfarin. 3. Identify adverse signs and symptoms that can occur while on Warfarin. Teaching Content The client will be taught that any major change in their diet could affect how the body responds to the medication (Q&A). Foods that are rich in Vitamin K should be eaten in moderation and if there should be an increase in the consumption of Vitamin K over a week, the client should have another INR test. Foods that are rich in Vitamin K include green leafy vegetables, chick peas, liver, egg yolks, cereals containing wheat bran and oats, mature cheese, blue cheese, avocado, and olive oil (Q&A). The client will be taught that compliance while on Warfarin is very important...
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...Cymbalta can be viewed on major and cable networks, during daytime and early evening hours. The television commercials are run during the broadcast of soap operas and other daytime programming. Advertisements also appear on home improvement channels such as Home and Garden (HGTV) and the Food Network. The commercials depict active, attractive women and men that appear to be in their mid-forties and fifties participating in enjoyable life activities. The emphasis of the message in the advertisement for major depression disorder is depression is treatable and manageable by the use of Cymbalta. Cymbalta commercials also advertise the treatment of Fibromyalgia pain. The television commercial briefly describes the major side effects of Cymbalta such as nausea, dry mouth and constipation. The commercial also states that Cymbalta should not be taken by patients that take monoamine oxidase inhibitor (MAOI) and in patients with uncontrolled narrow angle glaucoma. Even with air time being limited, I believe the television advertisement to be truthful however, the focus of the advertisement is on the benefits of the medication and they do not give adequate time to disclose side effects, adverse reactions or contraindications. Duloxetine (Cymbalta, Ariclaim, Xeristar, Yentreve, Duzela,Dulane) is a serotonin reuptake inhibitor (SNRI) manufactured and marketed by Eli Lilly. It is prescribed for major depressive disorder and generalized anxiety disorder. Duloxetine has also been approved for...
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...1 NUR 201 DRUG CARD Student: ________________________ Generic Name: Bupropion hydrobromide________ Trade Name(s): Wellbutrin, Aplenzin, Zyban_ Classification: Antidepressant – atypical (heterocyclic), Aminoketone_____________________________ Administration Routes: PO _√_ SQ ___ IM ___ IV ___ Transdermal ____ Ophth_____ Action: Mechanism of action is not known; the drug does not inhibit MAO, and it only weakly blocks neuronal uptake of epinephrine, serotonin, and dopamine. However, its action is believed to be mediated by noradrenergic and/or dopaminergic mechanisms. Exerts moderate anticholinergic and sedative effects, but only slight orthostatic hypotension. Indications: (1) Treatment of major depressive disorder (immediate-release and extended-release). (2) Major depressive episodes in those with a history of seasonal affective disorder (Wellbutrin XL only). (3) Aid to stop smoking (Zyban only); may be combined with a nicotine transdermal system. Contraindications: Hypersensitivity to bupropion or any ingredients. Seizure disorders; presence or history of bulimia or anorexia nervosa due to the higher incidence of seizures in such clients. Concomitant use of an MAOI. Use in clients undergoing abrupt discontinuation of alcohol and sedatives, including benzodiazepines. Use in clients who have shown an allergic response to bupropion or other components of the various products. Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban all contain bupropion; do not use together. Lactation...
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...One vital contraindication with Sinemet is the use of nonselective monoamine oxidase (MAO) inhibitors. MAOI’s have to be withdrawn for a minimum of two weeks prior to initiating therapy with Sinemet (Brenner & Stevens, 2013). Patients who are taking MAOI’s need to consult with their provider prior to starting Sinemet as harmful and life-threatening adverse events could occur when used in combination. Patient with narrow-angle glaucoma or have had a previous hypersensitivity to this drug or a similar compound should not use Sinemet in the treatment of their PD (WebMD, 2015). Additionally, patient with a history of melanoma or undiagnosed skin lesions should refrain from taking Sinemet as it have shown in studies to activate malignant...
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...Pharmatherapeutics Assignment Personal and Medical history Mr. JP is an 86 year old Caucasian male who leaves with his wife in an assistance leaving home and receives help from a home health aide, who usually is there every morning to assist him and his wife with all their needs. Mr. JP started experiencing severe pain around his shoulder although he usually experience pains in his joints because of arthritis, after the fourth day his pain escalated to the point where he could not hold it any longer and started having a temperature of 103, therefore he decided to go to the emergency room. Mr. JP arrived to the emergency room complaining of joint pain in his left shoulder region and fever. The ER Physician’s diagnosis was, “Pain joint, shoulder region, left septic arthritis, bacteremia.” The physician decided to admit him for a few days and treat his infection and avoid any further complication. Mr. JP was ordered to be in contact isolation for the protection of him and others. His past medical history are significant for Type II diabetes which he was diagnose at the age of 48, follow with hypertension, glaucoma, CHF, arthritis, Neurogenic bladder, Carotid artery disease, COPD, Urinary obstruction, Mixed hyperlipidemia, chronic anemia, Gangrene of toe and Gout. Analysis of the individual Variables’ influence on Medications There are many factors that can affect when prescribing a medication to a client such as age, sex, genetic diseases, culture, ethnicity, allergy,...
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...Financial permaculture, a close cousin ofthe Transition Initiative, has taken root in Hohnenwald, Tennessee. Organizers there have created a business plan designed to meet the local county's food, energy, and banking needs in a sustainable manner. Financial permaculture applies the principles of permaculture to economics. Instead of putting time, attention, and money into global investments, those same resources support local investments (particularly those tbat fit permaculture), cooperatives, and local currencies. I grant that permaculture seems idealistic. It may be a backlash to globalization, or it may be an old idea whose time has come (or merely returned after millennia). Nonetheless, these turbulent times may provide the compost needed for a more responsible, humane, sustainable system to take bold. Meanwhile, we can each support our local community, just as we need healthy cells to have healthy organs, we need healthy neighborhoods and towns. Eiinlish |, Piirn iple^ of Fiiwncidl Permatullure. Stiljri Real Channel websile. hltp://soldri.com/bloR/íp-1730. Accessed Oi:tober 20. 2008, t idl Permdcullure. Eironomits on our terms. www,financial()ermaculture.org/ definition. Aicessed December 2. 2008. Tran'.ition Towns WIKI. http://iransitiontown5.()rg. Accessed tiïecember 31, 2008. Shorts headaches or stomachaches, and other health problems. Caregivers need to take care of themselves before tbey become physically ill or exhausted. They need to make self-care a priority...
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... Unit 6 Capstone Project- Type 1 Diabetes Kaplan University 4/8/2013 | The testing for type 1 diabetes can be problematic even for the most experienced physician. There usually is not a reason to test for it unless there is some sort of family history, when testing is necessary there are normally 3 different tests that will be used to determine if it truly is type 1 diabetes. One of the first tests administered is the Fasting Blood Glucose (FBG) with this test a blood sample is drawn after the patient has fasted for at least 8 hours, meaning no food or drinks except water. If the test results show a glucose reading of 126 mg/dl or higher the patient has diabetes a normal reading is between 70-110 mg/dl. Random Blood Glucose (RBG) is another form and fasting is not required it is used especially in an emergency situation when they need to determine sugar levels for the patient (most often children) as quickly as possible so if needed they can administer insulin so the patient does not go into a diabetic coma. Oral Glucose Tolerance Test(OGTT) is another diagnostic test it differs from the other two because you have to drink a sugary beverage to measure how your pancreas can manage the glucose you take in, before drinking the beverage, a fasting blood glucose level is taken, then you...
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...MODIFIED FOOD Introduction Today we use food that come from plants and animal modified by human through breeding, undergoing genetic changes from many thousand years. Plants and animals which have desire characteristics were chosen for breeding new generation. Desired characteristics arose from naturally occurring variations in genes of plants and animals. Hence genetic modification occurs naturally and forms the base of evolution. Techniques used today to modify genes provide new ways to identify special characteristics and transfer them in plants and animals. For example, it is now easy to make copy gene of an organism and insert it another organism for desire characters. The resulting plants and animals has...
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...reduce the risk of disease onset if a multifactorial component exists? Question 2= Genetic screening has become widely available to the public including prenatal screening of the fetus in utero to screening adults for genetic disorders, such as Parkinson's disease and breast cancer. Share your thoughts on the legal, ethical, and social implications that may be related to genetic screening. How would you educate your patient that is considering having genetic screening? Week 2: Question 1= Choose an FDA-approved prescription medication and discuss the pharmacokinetics and pharmacodynamics of the medication, including any differences that would be expected based on the patient's age, a condition of pregnancy, or lactation. Address any adverse effects the medication may have based on age, pregnancy, or lactation. Question 2= Active acquired immunity can be achieved through the use of childhood immunizations. Many parents voice concerns regarding the safety of vaccinations. What is your opinion on the current use of vaccinations? How would you educate parents regarding the safety and effectiveness of vaccinations? Defend your answers with evidence-based research. Week 3: Question 1= Share a case study of an electrolyte imbalance from your practice or from the...
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...QUALITY ASSURANCE TEAM CMC Quality Assurance Team is committed to product quality and safety. Quality Assurance Team share the same objective: to satisfy the stellar taste and criteria in classifying a product that is made with the highest standards. In scheduling food safety audits, CMC Co has sought qualified guidance and support from recognized firms who understand food safety and possess the technical expertise to develop comprehensive solutions to secure our competitive advantage. Our vendors and/or suppliers are regulated with meticulous checks and strict verification processes. All incoming supplies and raw materials must meet FDA compliance regulations to ensure they are correctly branded, unadulterated and of food grade standards. Production processes from receipt of raw material, manufacturing, to shipment and closely inspected to ensure conformity to company and customer standards. Peking Noodle Company pledges to follow through on all processes to ensure our products are safe and of exceptional quality. FOOD SAFETY PROGRAMS STANDARD SANITATION OPERATING PROCEDURES is the common name give to the sanitation procedures in food production plants which are required by the Food Safety and Inspection Service of the USDA and regulated by 9 CFR part 416 in conjunction with 21 CFR part 178.1010. It is considered one of the prerequisite programs of HACCP. SSOP’s are generally documented steps that must be followed to ensure adequate cleaning of product contact and non-product...
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