Overboard on Over-the-Counter
Many Americans have incomplete knowledge about over-the-counter medicines,
taking too much of a product or mixing medicines in dangerous combinations.
About 20 years ago, ibuprofen—the active ingredient found in both Advil and Motrin—was available to consumers only with a doctor’s prescription.
Deeming it safe and effective for minor aches and pains, the U.S. Food and
Drug Administration (FDA) made the drug accessible for over-the-counter purchase
in 1984.
Today, ibuprofen is used by millions of consumers to treat ailments such as headaches, muscle soreness and fever, without a physician’s consultation.
Over-the-counter (OTC) medications currently account for more than 100,000 drug products on the market. More than 700 of these products were still prescription-only drugs 30 years ago.
Within the last few years, several notable drugs have made the switch from prescription to OTC status, including Claritin, Pepcid AC and Zantac, giving consumers immediate access to effective medications. But with increased accessibility also comes an increased risk for drug interactions and side effects, particularly for individuals who require long-term use.
“OTC medications save the consumer time and money because they don’t have to go to the doctor every time they are sick,” says Kathy Johnson, Pharm.D., Ph.D., associate professor of clinical pharmacy and pharmaceutical economics and policy at the USC School of Pharmacy. “But, it is important to understand that non-prescription drugs should be used with the same amount of caution as prescription drugs.”
According to the National Council on Patient Information, some Americans have incomplete knowledge about OTC medicines and may take too much of a single product or mix drugs inappropriately. Despite widespread use, consumer polls show that only 34 percent of the public could correctly identify the active ingredient—or the therapeutic substance—in their brand of pain reliever.
“Some people don’t understand what is written on the label or know how to differentiate between the active ingredients in OTC medications, says May Mak, Pharm.D., USC assistant professor of clinical pharmacy. “Even seemingly benign drugs can cause health problems if they are used the wrong way.”
One of the more popular types of OTC medicines available today is the cold and cough combination, which generally consists of a pain reliever, antihistamine, nasal decongestant and cough suppressant.
“Many drug overdoses occur because people mix cold and cough combinations with additional OTCs, unintentionally doubling the recommended dose of an active ingredient,” Mak says. “This poses a significant risk for people with heart problems or high blood pressure, which can be exacerbated by too much pseudoephedrine, the active ingredient in some nasal decongestants.”
“People can become active participants in their health care by asking pharmacists for information about how to use OTC medications safely and effectively,” Johnson says. “It is also important for patients to read the label each time they take the medication since labels change as new information becomes available.”
To ensure safety, Mak suggests that patients get all of their medications at a single pharmacy location.
“When a patient fills a prescription for the first time, the pharmacy begins compiling a medical record and maintains it with updated information over time,” Mak says. “Because the pharmacist has a detailed medical record, they can watch for any potential problems with drug interactions and recommend OTCs that will complement a patient’s overall drug regimen.”
Until 1951, the FDA did not have regulations for determining whether a drug should be reclassified from prescription to OTC status—known as the Rx-to-OTC switch. Before that time, the decision was left up to drug manufacturers, who often had different ideas about the same drug formulation, leading to confusion within the medical community.
Today, a drug making the Rx-to-OTC switch goes through a careful review process to predict its safety for a person’s self-diagnosis and self-treatment.
“The drug manufacturer must confirm that the medication can be administered without the supervision of a practitioner,” says Fred Weissman, Pharm.D., J.D., associate dean for academics and clinical affairs at the USC School of Pharmacy. “Also, they must prove that consumers can interpret product labeling, adhere to instructions and continue therapy for the time needed to produce a therapeutic effect.”
Drugs that are habit-forming or have the potential for toxicity are automatically eliminated from an OTC review. Weissman adds that the FDA usually approves medications at a lower dosage strength than the original prescription strength.
“To ensure both safety and efficacy, the idea is to have patients start at the lowest therapeutic dose possible in order to reduce side effects and potential drug interactions,” he says.
Since 1995, several notable drug categories have successfully made the Rx-to-OTC switch: heartburn medications, anti-fungal medications to combat yeast infections and non-sedating antihistamines. Although they provide increased access for consumers, pharmacists caution that these OTC medications may not be a cure-all.
In the healthcare arena, it is a well-known fact that often-disparate illnesses have overlapping symptoms. Unfortunately, many consumers are unaware of this phenomenon, Mak says.
“People should be able to tell if their symptoms are serious or not,” Mak says. “They need to know when they can treat themselves with OTC medications, and when they need medical attention.”
Heartburn medications are known as H2 blockers, which refers to the histamine 2 receptor that controls acid. By blocking this specific receptor, these drugs eliminate acid reflux that contributes to the feeling of heartburn.
“People who have an overproduction of acid in their stomach can alleviate heartburn symptoms through short-term use of H2 blockers,” Mak says. “But heartburn-like symptoms can merely be the result of sour stomach, which can be alleviated by an antacid. Or, it could be something as serious as an impending heart attack.”
Mak adds, “If people postpone a physician’s evaluation and self-medicate, they can be covering up serious and potentially life-threatening conditions.”
A drug category on the verge of an Rx-to-OTC switch has a similar predicament when it comes to a person’s self-diagnosis. The proton pump inhibitors, such as Prilosec, are effective for individuals with gastro-esophageal reflux disease, or GERD. They work by curbing the gastrointestinal tract’s proton pump, a system responsible for the formation of acid.
“GERD is a chronic condition for some people, causing permanent damage to the lining of the esophagus,” Mak explains. “My concern is that individuals will self-medicate with Prilosec for heartburn and other types of stomach upset, which may mask other serious symptoms that require an evaluation by a physician.”
The Rx-to-OTC switch of drug categories such as H2 blockers and proton pump inhibitors has created a group of medications on which pharmacists can focus their pharmaceutical care services, Mak says.
“Pharmacists can differentiate between benign symptoms and more serious ones,” she says. “They can recommend a standard course of treatment, as well as assess if the patient is at risk for a life-threatening condition.”
In 1998, WellPoint Health Networks made history by becoming the first managed care company to facilitate an Rx-to-OTC switch of all non-sedating antihistamines. The non-sedating, or second-generation, antihistamines include Claritin, Zyrtec and Allegra.
All antihistamines block the action of histamine in the receptors, which are responsible for causing allergic reactions including runny nose, watery eyes and sneezing. Prior to the switch, only first-generation antihistamines were available over-the-counter. These antihistamines are active ingredients in the brand-name products Benadryl and Tavist and often cause sedation and dizziness.
Second-generation antihistamines were designed to avoid blocking additional receptors, which elminates sedation and dizziness, so they are much safer to use.
After filing a Citizen’s Petition with the FDA, WellPoint was successful in transitioning Claritin to OTC status in December 2002. Since the switch, the drug has claimed 30.1 percent of the market share at an estimated total sale of $1.4 billion.
Claritin’s patent was about to expire when it was switched to OTC status. “Once a prescription drug loses patent protection, which typically happens anywhere between 17 and 22 years on the market, the manufacturer reviews the drug and if it meets the criteria, it is recommended for OTC status,” Weissman notes.
With the Rx-to-OTC switch, non-prescription Claritin became much more expensive for insured patients who were used to a low co-pay for an entire month’s supply. Meanwhile, the switch gave uninsured patients increased access to the non-sedating antihistamine at considerable cost savings.
“Health-care plans do not want to pay for certain drug categories, which is why they promote the use of some OTCs,” Weissman says. “When a drug makes the Rx-to-OTC switch, the financial burden is placed on the consumer because OTCs are not covered under the prescription benefit.”
Johnson says, “This fiscal dilemma is common for people today, but increased access to safe and effective medications is beneficial for all consumers.
Static on Statins Since July 2000, manufacturers of cholesterol-lowering medications—known
as statins—have petitioned the U.S. Food and Drug Administration
to switch the drug category from prescription to over-the-counter (Rx-to-OTC)
status. |
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