The physiological and psychological effects of pharmaceuticals can cause serious health problems and, with some drugs, eventual addiction. Injuries and damages can be related to physician prescribing habits, drug manufacturer misrepresentations, consumer abuse, drug recalls, generic drugs, or environmental pollution from discarded drugs.
Over-prescription and over-diagnosis
Over-prescription occurs when health professionals prescribe unnecessary medications or excessive dosages to patients to diagnose or treat a medical ailment. Research has shown that the U.S. consumes the majority of the world’s prescription drugs. Some industry critics argue that pressures from the pharmaceutical market and industry misinformation has created a culture in the United States of misdiagnosis and excessive pharmaceuticals use.
The widespread use of antibiotics, which some experts consider to be the most over-prescribed medication in the country, has led to the evolution of antibiotic-resistant bacterial strains called “superbugs.” Millions of people are infected with these superbugs each year, resulting in thousands of deaths annually. Also, some industry observers warn of over-prescribed psychiatric drugs, and note that most Americans with mental health disorders are treated solely with medication rather than psychiatric healing methods. Finally, the prescription of opioids has drawn considerable attention as overdoses and addiction increase at extraordinary rates nationwide.
Millions of children in the U.S. are diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and many use drugs to treat the disorder. While major medical groups, including the American Academy of Pediatrics, American Medical Association, American Psychiatric Association, and National Institutes of Health, recognize the existence of ADHD and youth behavioral disorders, there is controversy surrounding whether pharmaceutical prescriptions are too easily utilized as the primary form of treatment.
Industry misrepresentation of product
Conflicts in the industry can arise from relationships between physicians and pharmaceutical drug representatives. The industry spends millions annually on marketing to doctors, and some – including doctors – have questioned if this practice alters how they prescribe. Also, traditionally, a pharmaceutical firm advertises a drug to physicians and informs them of the benefits and dangers, then physicians prescribe the medication for patients. Industry watchers, however, note that while pharmaceutical companies have an obligation to inform health professionals of all pertinent information, misinformation from the drug companies has allegedly become one source of damage for patients. For example, pharmaceutical companies now produce commercials that provide information to potential consumers. While physicians used to serve as a liability buffer for pharmaceutical companies by acting as the “learned intermediary,” some charge that pharmaceutical companies are increasingly becoming the providers of drug information for potential patients, increasing company exposure to product and corporate liability if injuries and damage occur from the improper use or misinformation related to the drug.
Consumer addiction and overdose
The strong psychoactive and physical effects of certain classes of drugs can lead to high rates of dependency and misuse. The most commonly abused pharmaceutical drugs are opioids and narcotics for pain relief, central nervous system depressants for anxiety disorders and sleep problems, and stimulants for ADHD and narcolepsy.
Prescription medicine abusers usually report that they obtained their drugs legally from a doctor, friend or relative – or by stealing them. College campus drug abuse is extreme, and often revolves around “study drugs,” meaning stimulants that provide better focus. It has been reported that in the U.S., one person dies every 19 minutes from a drug overdose, most often involving painkillers. The Centers for Disease Control and Prevention (CDC) has officially declared prescription drug abuse in the U.S. to be an epidemic.
Pharmaceutical recalls/withdrawals
Over the years, the FDA has pulled dozens of previously approved drugs off the market because it was found that they posed a risk to consumers. These withdrawals are usually prompted by adverse effects that were not detected during clinical trials, because manufacturers sometimes conduct trials only on a few thousand subjects, choosing to rely heavily on survey data from consumers after regulatory approval, to determine side effects. Some drug companies press the FDA to approve drugs more quickly, accepting the risk that a drug might have an unexpected side effect.
Brand-name vs. generic drugs
Brand name pharmaceuticals are often particularly expensive because of high initial development, marketing, and distribution costs; generic equivalents can cost up to 85% less. Because some insurers do not cover brand name medications, patients are prescribed the generic equivalent. If there is no generic substitute, the patient may need to pay for the medication out of pocket.
Pharmaceutical companies file for a patent on developed brand-name drugs that prohibits outside manufacturing and distribution of identical generic drugs for a set period. By law, generic pharmaceuticals must have identical chemical composition and product labeling as the brand-name, a potentially harmful regulation if the generic developer identifies new safety concerns or side effects with the drug that it cannot disclose. The limits placed on generic drug manufacturers are matched by limited liability – patients who take generic drugs cannot sue the generic manufacturers for issues relating to the efficacy or labeling of the drug. These regulations were established by the Hatch-Waxman Amendments to the Drug Price Competition and Patent Term Restoration Act of 1984. In several cases, the substitution of ingredients with metabolic equivalents or the exclusion of active ingredients has prompted patent infringement claims between patentee pharmaceutical manufacturers and generic companies.
“Off-label” drug use
“Off-label” drug use refers to the use of a medication in any manner not specifically approved by the FDA and delineated on the label that was approved for the drug during the regulatory process. Off-label drugs can be used for different diseases or medical conditions than originally intended, given in a different way such as by a different route of administration, or given in a different dose than in the approved label. Drugs are most commonly used off-label for combating cancer, controlling extreme pain, and treating autoimmune diseases, psychiatric problems, and conditions of the central nervous system such as multiple sclerosis. Health insurance companies manage off-label drug usage in different ways.
Environmental contamination
Improperly disposed of pharmaceutical medications can negatively affect local ecosystems, posing a potential risk for illness and disease in humans. Significant amounts of medicinal products are dumped into sinks and toilets, introducing large quantities of pharmaceutical compounds into local water supplies. Pharmaceuticals including antibiotics, anticonvulsants, mood stabilizers, and synthesized hormones have been found in the drinking water of millions of American homes in major metropolitan areas. While the concentrations of these pharmaceuticals are still small enough to classify the water as still potable, scientists are worried about the long-term health consequences of pharmaceutical contamination because many pharmaceuticals, like synthetic hormones, function at very low concentrations in humans. Residues of both prescription and non-prescription drugs have been detected in ecosystems, raising the question of whether this creates a risk for exposed plants, animals and microbes, or for humans. Highly lipid-soluble drugs may accumulate in the fat of animals, meaning that meat products consumed by humans can carry these chemicals.