The United States is the world’s largest market for pharmaceuticals and the world leader in biopharmaceutical research. U.S. firms conduct 80 percent of the world’s research and development in biotechnology and hold the intellectual property rights to most new medicines. In 2010, the pharmaceutical sector employed approximately 272,000 people (source: Bureau of Labor Statistics), and according to the Pharmaceutical Research and Manufacturers of America (PhRMA), those manufacturers spent $67.4 billion on research and development in 2010.
As the population ages and as the transition of the large demographic of baby boomers to senior citizens occurs, these people will often be taking multiple medications prescribed often by different doctors and sometimes dispensed by different pharmacies. This doesn’t even factor in the over the counter drugs and/or herbal supplements they may also be taking.
As a result, the propensity of medical errors is likely to occur.
An Institute for Safe Medication Practices manual states “a typical pharmacy…may generate up to two clinically significant prescriptions errors every week.”
The Institute of Medicine has estimated that up to 98,000 hospital patients die each year as a result of medical errors, and medication errors alone account for an estimated 7,000 deaths annually. These errors are also expensive to our health system, costing between $17 billion and $29 billion a year, IOM reports.
One in three patients will face a mistake during a hospital stay. The most common are medication errors.
Discovering more about how and why medication errors occur is fundamental to improving medication safety. Whenever an adverse drug event or near miss occurs there is an opportunity for learning and improving care.
Sources of error in prescribing: Inadequate knowledge about drug indications, contraindications and drug interactions. This has become an increasing problem as the number of medicines in use has increased. It is not possible for a doctor to remember all the relevant details necessary for safe prescribing. Prescribing for the wrong patient, prescribing the wrong dose, prescribing the wrong drug-these errors can sometimes occur due to lack of knowledge, but more commonly are a result of a “silly mistake” or “simple mistake”, referred to as a slip or a lapse. Alternative ways of accessing drug information (such as electronic patient records from a central database) are required.
Brand Name vs Generic Drugs
As more patents expire, the proliferation of generic drugs will increase.
Jan Engle, a doctor of pharmacy at University of Illinois Chicago, says small changes in drug concentration can cause adverse reactions or change the way a drug works. Another problem area seems to be with extended-release generics. “It may have a different release time, and it may peak at a different time, meaning you get the maximum drug effect at a different time than the brand,” Engle says.
Generic drugs account for seven out of 10 prescriptions, according to industry analysis. In many cases insurance companies require patients to buy generic prescriptions over name brand drugs because they are cheaper. The FDA’s own website reassures patients that generics are equal to name brands.
While the active ingredients are the same, the so-called inactive ingredients also known as filler ingredients, are not the same, thus the drug’s intended effectiveness,allergic reactions and other side effects may occur.
Many of these generic drugs are manufactured overseas,where the standards and quality control may be inferior to North American drug manufacturing plants. A common source for cheaper generics is India.
This problem is further exacerbated by some patients by passing their physician and pharmacy entirely by buying prescription drugs from international unregulated drug stores over the internet from Who knows where?
From grapefruit to calcium to licorice, some foods and their nutrients can interfere with the way your medicines work. Concerns about the interactions between foods and drugs are not limited to prescription medications. Dietary supplements (which also include vitamins, minerals and herbs) can likewise interfere with how some medications work. "Often, people think that herbal supplements are benign and don't have interactions, and that's absolutely false," says Christine Gerbstadt, a registered dietitian and spokesperson for the Academy of Nutrition and Dietetics. "Most supplements have the exact same chemicals and ingredients as pharmaceutical drugs but simply in a naturally occurring form or lower dose," she says.
Medicines designed to treat one medical issue, but also doing good elsewhere in the body. Companies cannot market medicine beyond the purposes or labeling approved by the FDA, no matter how well it works for something different. However, doctors are allowed to prescribe medicines and treatments "off-label," using caution and taking responsibility. The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescriptions written in the U.S. are for off-label therapies.
While there can be benefits derived from off-label drugs-there is debate about off-label drug use. Doctors emphasize that off-label prescribing has its place in medical practice, but they also admit that using a drug off-label can raise the risk of lawsuits should a patient have unwanted or bad side effects.
"Off-label prescribing can expose patients to risky and ineffective treatments," medical ethics professor Rebecca Dresser and Joel Frader, MD, write in the fall 2009 issue of The Journal of Law, Medicine & Ethics.
The U.S. market is the world’s largest free-pricing market for pharmaceuticals and has a favorable patent and regulatory environment. Product success is largely based on competition in product quality, safety and efficacy, and price. U.S. government support of biomedical research, along with its unparalleled scientific and research base and innovative biotechnology sector, make the U.S. market the preferred home for growth in the pharmaceutical industry.
Medications can greatly improve health when used wisely and correctly. Nevertheless, medication error is common and is causing preventable human suffering and financial cost.