Adverse drug events (ADE)
ADEs are when a medication leads to a negative or harmful effect. ADEs are responsible for more than 1.5 million emergency room visits each year in the U.S.. Leading causes include anticoagulants (blood thinners), diabetes medications (like insulin), and antibiotics.
Biosimilar
A biosimilar is a biologic medicine that has been developed to closely match an existing FDA-approved biologic. Both biologics and biosimilars are products made from living cells, such as those derived from animals, plants, bacteria, or yeast, which makes them more complex than traditional drugs. Because of this complexity, a biosimilar cannot be an exact copy of an FDA-approved biologic, but it must be shown to work the same way and be just as safe and effective as the original product to receive its own FDA approval.
Box warning
Box warnings, commonly referred to as “black box warnings,” are the strongest warnings issued by the FDA, indicating that a medication may cause serious or life-threatening adverse reactions. These warnings are typically highlighted with a black border near the top of a drug’s package insert and may be added, changed, or removed following an FDA review of new or existing evidence.
Comorbidity
Comorbidity refers to the presence of one or more health conditions alongside a primary condition. For example, if someone has diabetes but also experiences high blood pressure and depression, the doctor treating the diabetes will consider those additional conditions to be “comorbidities.”
This term is related to multimorbidity, which means someone has more than one health problem, but all conditions are treated as equally important.
Contraindication
When a drug or medical procedure could harm a patient, the advice not to use it is called a contraindication.
There are two kinds of contraindications:
Relative contraindication means that a certain treatment is generally not recommended due to another procedure or medication a person is taking, but it may still be used if the benefits outweigh the risks. For example, most people taking warfarin (a blood thinner) are usually advised to avoid aspirin because it can increase the risk of major bleeding side effects. However, in patients with a high risk of stroke, using both medications might be appropriate under close medical supervision.
Absolute contraindication means that the risks would be so severe for the patient that the medication or procedure should not even be considered. For example, if someone is pregnant, it’s recommended they never take Isotretinoin (Accutane) as it can result in severe birth defects.
Deintensifying
Deintensifying is when you lower the dosage of a drug or stop taking it
Deprescribing
Deprescribing is when a physician reduces a medication to the lowest effective dose, or discontinues it altogether. This typically occurs when a patient’s condition changes and the potential risks of the drug outweigh its expected benefits.
Disease Mongering
Sometimes referred to as “selling sickness,” disease mongering is when pharmaceutical companies (sometimes working with healthcare professionals and patient groups) overstate the severity of minor conditions, expand the definition of existing diseases or emphasize the risk of “pre-diseases,” to increase drug sales and profits. One example is the promotion of female sexual dysfunction (FSD) in the early 2000s. While many doctors and researchers argue that this “disease” simply describes normal differences in sexual desire, pharma companies have been accused of promoting FSD as a serious and underdiagnosed condition in an effort to market drugs like flibanserin.
Drug Cascades
Also known as “prescribing cascades,” drug cascades occur when a medication is prescribed to treat the side effects of an original drug you are on.
For example, a person might be prescribed a nonsteroidal anti-inflammatory (NSAID) to help relieve arthritis pain. A common side effect of NSAIDs is acid reflux. The person is then prescribed a proton pump inhibitor like omeprazole to treat the refux.
While drug cascades are sometimes considered appropriate when the benefits outweigh the risks, they can also lead to compounded side effects, drug-to-drug interactions, and worsened conditions over time.
Generic Drugs
A generic drug is a medication designed to match an approved brand-name drug in almost every way: dosage form, safety, strength, route of administration, quality, and intended use. Unlike brand-name drugs, however, generics are not required to undergo large clinical trials to prove safety or effectiveness. Instead, manufacturers must only show that the generic releases its active ingredient into the body at a similar rate — a requirement called bioequivalence.
Off Label
Off label refers to the unapproved use of an approved drug, often to manage conditions for which no specific or adequate treatment exists. This practice is legal and common in the US; the FDA states that a drug may be prescribed for an unapproved use if a medical professional determines it is “medically appropriate.”
Overprescribing
Overprescribing means prescribing a drug (or drugs) when it’s not clinically necessary. This can lead to increased side effects and public health issues. A 2018 study published by the Infectious Diseases Society of America found that nearly half of all outpatient antibiotic prescriptions were given without an infection-related diagnosis. Many were written for viral illnesses like colds and flu, which do not respond to antibiotics. Overprescribing of antbiotics can lead to unnecessary side effects (rash, diarrhea, yeast infections, allergic reactions) and fuels the rise of antibiotic resistance for the patient and in the general population.
Pharmaceutical pollution
Drugs can get into our waterways through wastewater (in our urine) and improper disposal of unused drugs, causing pharmaceutical pollution. At trace amounts, pharmaceuticals have been detected in drinking water, which can cause harm to humans, and their existence in oceans, rivers, lakes, and soil can also disrupt natural ecosystems.
Pharmacovigilance
According to the World Health Organization (WHO), pharmacovigilance describes the science and efforts behind drug safety. This includes drug testing in clinical trials and the monitoring of side effects.
In the United States, the Food and Drug Administration (FDA) is the primary authority for pharmacovigilance, while the Centers for Disease Control and Prevention (CDC) monitors vaccine safety, and the National Institutes of Health (NIH) performs additional research on drug safety.
Polypharmacy
When someone is taking five or more medications on a regular basis, this is called polypharmacy. The United States has one of the highest rates of polypharmacy in the world, with as many as 65% of adults over age 65 falling in this category. Polypharmacy has been found to raise the risk of falls, weakness and even death. This is because multiple medications can interact or cause side effects like dizziness, confusion, and low blood pressure.
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