Show
Black Box Warnings: Just the words sound serious. And they are. The U.S. Food and Drug Administration (FDA) requires a Black Box Warning (also called a black label warning or boxed warning) to be placed on medications that carry critical safety risks. It’s the FDA’s strictest labeling requirements that the FDA can mandate for prescription drugs. The name comes from the black border surrounding the text of the warning that appears on the package insert, label, and other information, such as a magazine advertisement. A Black Box Warning must provide an accurate and concise summary of the drug’s adverse effects and the risks associated when taking the medication, even when taken as prescribed. All prescription medications must be approved by the FDA. Approval comes only after rigorous studies that can document safe and effective use. In a perfect world, all possible adverse reactions would already be known before being approved and prescribed. But once a drug is available to a wide population, unexpected serious side effects can occur. This is when the FDA requires a Black Box Warning. What situations require a Black Box Warning?Since 1979, the FDA has required Black Box Warning for these circumstances:
What does a Black Box Warning look like?
The FDA wants patients and healthcare providers to see any warnings right away. The box contains a summary of adverse effects and risks that have been associated with the drug.
Here is the wording for sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI) antidepressant: Suicidality in Children and AdolescentsAntidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Zoloft is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder (OCD). What medications get a Black Box Warning?Over 400 medications have Black Box Warnings. Usually, the boxed warning applies to a class of drug, rather than individual medications. Common medications that must include a Black Box Warning include:
What are the roles and responsibilities of a nurse?The National Council of State Boards of Nursing (NCSBN) is the organization that oversees the NCLEX-RN. In the Test Plan for the RN licensure examination, one of the responsibilities of a Registered Nurse is to “handle and administer high-risk medications.” The Nursing “Rights” of Medication Administration are always important, and with Black Box drugs, they are critical. The nurse is the FINAL person to verify that the patient is receiving the correct drug and dose. The traditional “Five Rs” are:
Although following the Rights of Medication Administration is essential, the nurse must also use critical thinking to avoid medication errors and keep patients safe. Every nurse should stay updated on the new medications that are most commonly prescribed for patients on their hospital unit or in their specialty. Reading the package insert is important, no matter the level of nursing experience. A Black Box Warning will be in a prominent place; other information regarding dosage, adverse effects, and contraindications will also be provided. Registered Nurses are also expected to be aware of possible drug interactions. If you’re unfamiliar with a medication, take time to find out if it’s compatible with any other medications that your patient is currently taking. Contact the pharmacist or look up the drug online. Don’t administer a medication without checking if it can harm the patient. If in doubt, notify the health care provider who wrote the prescription. Patient teaching for a Black Box Warning medicationWhenever possible, patients should always be included in their own health care. When they are able to understand the purpose of their medication, as well as possible side effects, they can become competent consumers who can participate in decision making. The nurse is often responsible for educating a patient about their medications at the time of hospital discharge or after an office/clinic appointment. It’s helpful is another person also receives the information to avoid future confusion. Teaching points to remember include:
Medications are always a team effortWhile the nurse is the final step in administering medications, each person on the interdisciplinary team has a responsibility. The prescriber should know their patient and the medication well enough to determine if a drug with a Black Box Warning is the best option. Pharmacists should take every precaution to ensure that the drug is properly prepared and labeled, with exact instructions and warnings. The nurse double-checks everything before administering or providing patient education. Even the patient has a responsibility to ask questions and demonstrate understanding before self-administration. About the AuthorWinona Suzanne Ball Nursing Adviser, RN | MHS, Governors State University, IL 100% of people found this test helpful. Click a star to add your vote 1 votes - average 5 out of 5 Which is an example of a black box warning by the Food and Drug Administration?For example, several kinds of combination birth control pills carry a black box warning related to cardiovascular risks associated with them. The warning also strongly advises that women who use them not smoke, as cigarette smoking is known to increase the risk of those side effects.
What is the purpose of a black box warning on a package insert quizlet?What is the purpose of a "black box warning" on a package insert? It is used to draw attention to potentially fatal, life threatening, or disabling adverse effects for different medications.
What are the primary roles of the Food and Drug Administration FDA select all that apply?The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Which drug possesses a high risk for abuse according to the controlled substance drug schedules?Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.
|