please respond to each discussion post with apa references Thank you!
According to the FDA, the FDA Adverse Event Reporting System (FAERS), is an interactive web-based tool that allows for data to be accessed in a user-friendly manner. The tool allows for the general public to search for any and all human adverse reactions that have been reported to the FDA by healthcare providers, consumers, and the pharmaceutical industry. It also holds information on medication errors and quality complaints that then lead to any adverse reactions. Also, if any party reports anything to the manufacturer, the manufacturer is then responsible in reporting it to the FDA.
There are so many great benefits to FAERS. Probably one of the best ones would be how easy it is to access and how user-friendly the information is. Those that access it can view summarized reports that can date all the way back to 1968! Users can narrow their searches by a specific time frame, specific year and even a particular product.
The FDA uses the data reported to assist in the advancement of pharmaceuticals, allowing the daily evolution and the lessening of adverse cases day by day. The reports that are sent to FAERS are reviews and evaluated by clinical reviewers to monitor the safety of products after they’ve been approved by the FDA. If a safety concern is identified, further evaluation is done. Based not he potential safety concern, the FDA may take immediate action to update labels, restrict use of the drug, communicate safety information to the general public, or even remove the product from the market.
Questions and answers on FDA’s adverse event reporting system (FAERS). (2018, June 4). U.S. Food and Drug Administration. https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers
The Food and Drug Administration (FDA) has a system called MedWatch that allows health professionals, patients and consumers report safety concerns regarding FDA-regulated products (MedWatch, 2023). In addition to medications, the system also tracks safety issues of biologics, medical devices, combination products, special nutritional products, cosmetics and food (MedWatch, 2023). The form is readily available online allowing for digital submissions to allow processing and subsequent tracking by the FDA. The website also provides access and an option to subscribe to safety reports that allows medical professionals, patients and consumers to stay informed as new safety concerns as they are released by the FDA. Additionally, hospital facilities throughout the US have independent safety reporting systems that allow for tracking and reporting within the organization that are reviewed by safety committees.
The ultimate outcome of adverse report findings is improving patient safety and reducing the risk of harm with timely reporting and investigations of reports. Depending on the type of safety concern the manufacturing company may announce the recall per federal guidelines that the FDA distributes or if there is a specific reported risk, the FDA will provide a full report of the concerns and recommendations to change practice. For example, in November 2022 the osteoporosis medication Prolia (denosumab) was reported to cause severe hypocalcemia for dialysis patients (Office of the Commissioner, 2022). The FDA distributed the concern for the medication and preliminary guidance for prescribers, nurses and patients to mitigate safety concerns since the investigation is ongoing. As healthcare professionals, it is our responsibility to contribute the “just culture” to protect our patients for adverse events.
Am J Health-Syst Pharm, Lynee, M. Lee, Delia, C. Carias, Gosser, R., Ambra, H., Stephens, S., & Templeman, W. A. (2021). ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting. American Society of Health-System Pharmacists. https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines/adverse-drug-reaction-monitoring-reporting.ashx
MedWatch: The FDA Safety Information and Adverse Event Reporting Program. (2023, January 13). U.S. Food And Drug Administration. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Office of the Commissioner. (2022, November 22). Prolia (denosumab) by Amgen: Drug Safety Communication – FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis. U.S. Food And Drug Administration. https://www.fda.gov/safety/medical-product-safety-information/prolia-denosumab-amgen-drug-safety-communication-fda-investigating-risk-severe-hypocalcemia-patients
Three medication classes commonly used for asthma treatment:
Inhaled Corticosteroids: powerful anti-inflammatory drugs that deliver medications directly to the lung, keeping them from swelling, and leaving less room for air movement. This makes them effective long-term control medications.
Long-acting beta agonists (LABAs): these are bronchodilators, which open the airways to provide long-term control. These are used in correlation with inhaled corticosteroids because when used alone, it can increase the risk of life-threatening asthma attacks.
Short-acting beta agonists (SABAs): bronchodilators that are used as rescue medications because they act quickly to relax the airway. Due to their rescue mechanism, it can cause dizziness, shakiness and headaches.
I’ve chosen two types of medications to discuss and how to prevent side effects:
1. Omalizumab is an immunomodulator that is administered as an injection every 2-4 weeks, under the skin. This particular medication can often have side effects of flu-like symptoms, and injection site reactions such as pain, itching, and redness. Numbing the injection site and choosing a site with more fatty tissue may help with injection site reactions. Taking Acetaminophen could help put flu-like symptoms to rest (Dimov &Casale, 2010).
2. Beclomethasone is an inhaled corticosteroid that is used twice a day for long-term control of asthma. Common side effects include yeast infection in the mouth, sinus pain, sore throat or irritation in the nose. These side effects could be avoided by rinsing the most after use.
10 drugs commonly prescribed for asthma. (2020, February 13). Healthgrades. https://www.healthgrades.com/right-care/asthma/10-drugs-commonly-prescribed-for-asthma
Dimov, V. V., & Casale, T. B. (2010). Immunomodulators for asthma. Allergy, asthma & immunology research, 2(4), 228–234. https://doi.org/10.4168/aair.2010.2.4.228
Side effects of Qvar (Beclomethasone Dipropionate HFA), warnings, uses. (n.d.). RxList.
Asthma is treated with bronchodilators and anti-inflammatories. More specifically, drugs such as anticholergernics, corticosteroids, and short-acting beta-agonists, can be used as quick-relief medications. Long-acting medication examples include long-acting beta-agonists, methylxanthines, immunomodulators, and mast cell stabilizers. There is no cure for this disease, so the patient must be adequately educated about the medication they take and be wary of possible environmental triggers and/or stressors they may encounter.
Adams et al. state, “The goals of drug therapy are twofold: to terminate acute bronchospasms in progress and to reduce the frequency of asthma attacks (2017, pg. 660)”. With regard to the education about the medication, the patient should know that bronchodilators should be taken before the anti-inflammatories. The patient should know what medications to take during an asthma attack. Knowing that short-acting beta-agonists can cause tremors, aanticholergernics can dry you out, while corticosteroids can cause ‘oral candidiasis, headache, throat irritation, gastroenteritis (Sharma et al., 2022)’. Because of all these various drugs the patient may take, it is important the patient avoid potential triggers and maintain a strict regimen when taking their prescribed medication.
Adams, M. P., Holland, N., & Urban, C. Q. (2017).
Pharmacology for nurses. A pathophysiologic approach. (5th ed.). Pearson Education.
Sharma, S., Hashmi, M. F., & Chakraborty, R. K. (2022).
Asthma Medications. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK531455/