Over-The-Counter Drugs and Dietary Supplements & Herbs

Over-The-Counter (OTC) Drugs

OTC (over-the-counter) drugs are extremely important in the U.S. healthcare system because they provide the tremendous benefit of allowing consumers to take a more active role in their personal healthcare. This is especially important as the population of the United States ages, and more senior citizens are required to assess their own basic health care needs without the benefit of having a doctor available for every decision.

As with prescription drugs, the manufacture, oversight, and sale of over-the-counter (OTC) drugs are regulated by the FDA’s Center for Drug Evaluation and Research (CDER). However, the FDA has determined for several reasons that OTC drugs are safe for use without the supervision of a doctor or healthcare worker.

OTC drugs must meet several criteria that make them suitable for self-diagnosis in the general population. Normally, the potential for drug abuse in OTC drugs is extremely low. OTC drugs can also be easily labeled for direction and use, and doctors typically aren’t necessary for safe and effective administration.

OTC drug labels have a specific and formulaic layout: first, listing the product name, then the drug’s active ingredients, the purpose or principal use of the drug, any warnings for the drug, directions for taking the medicine, and inactive ingredients. In principle, an over-the-counter drug must be one designated to treat a condition that does not demand direct supervision of a doctor or healthcare worker.

OTC Drug Abuse & Misuse

While the FDA has the authority to oversee whether a drug can be safely sold to consumers without a prescription, the regulatory agency has increasingly had to fight an onslaught of abuse and misuse of OTC drugs in recent years. Two of the primary examples of this are the case of OTC drug pseudoephedrine and dextromethorphan, both used in cough and cold medicines.

The drug pseudoephedrine has been implicated in hundreds of illegal methamphetamine lab arrests around the country. It has since been relegated to “behind-the-counter” OTC drug status because of widespread abuse. Dextromethorphan is a cough suppressant and is widely abused among teens for its sedative and hallucinogenic properties.

Amid growing complaints from consumer groups about the efficacy and dangers of child cough and cold medicines, pharmaceutical companies pulled 14 pediatric cold and cough formulations from drug store shelves in late summer 2007. Public interest groups insisted that these drugs for children had caused hallucinations, arrhythmias, and even death in some cases, and represented a genuine danger to the public. The manufacturers’ trade group agreed in FDA hearings later during the year, and supported a complete withdrawal of pediatric cold formulations.

Staying Safe with OTC Drugs

Even though the FDA has made the determination that OTC drugs are safe enough for self-diagnosis, many patients fail to mention that they are taking OTC medications when they list their medications to their primary care physician. Always tell your doctor about any medication you are taking. This is best way to avoid drug injury. Very frequently patients ignore this vital advice and cause organ damage because their doctor is unaware of other meds they are on.

OTC medications are capable of interacting with other medications that your physician has prescribed, which underscores the importance of telling your doctor all the drugs you are taking so he will know what to avoid. Many OTC drugs can interact with drugs you are already on. Alcohol, for example, will intensify the sedative properties of cough and cold medications or antihistamines. It is very important to read the label when using OTC drugs. Remember, you are self-diagnosing when taking OTC drugs, so you need to act as your own drug injury safeguard.

Dietary Supplements and Herbs 

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined dietary supplements as food ingredients. Unlike drugs that must undergo rigid formal review before being introduced into the marketplace, a dietary supplement manufacturer must not prove that its product is effective for its intended purpose. The FDA can only raise alarm bells once it can be demonstrated that the supplement is actively harming the public.

Supplements are defined by DSHEA as a vitamin, mineral, a botanical herb, or some other dietary substance to supplement the diet. It must be in pill, capsule, tablet, powder, or liquid form, and it must be labeled as a “dietary supplement.”

Dietary supplement manufacturers cannot make any claims to cure a specific ailment - period. Supplement makers can make broad claims, however, about the product function or support mechanism. Broad claims about how a product “supports restful sleep” are permitted, whereas specific claims such as “cures depression,” are not allowed. The FDA only allows the manufacturers of dietary supplements and herbs to make what are termed “structure/function” claims- meaning thereby very broad claims about the product’s application for treating body function.

One of the major problems with herbs and dietary supplements is their lack of oversight. The manufacturer is responsible for ensuring the highest quality product reaches the marketplace. With the FDA’s limited resources, it is ultimately the manufacturer’s responsibility to ensure that the product does not become adulterated. The FDA does not investigate where these supplements are manufactured; often times they are produced under filthy, unthinkable conditions.

From a consumer standpoint, one of the worst problems about supplements is the adverse events reporting mechanism. If there are any serious adverse events concerning an herb or supplement reported to a supplements company, the company is not required by law to forward a MedWatch report to the FDA. Only once sick consumers have begun to report problem symptoms with a particular supplement to their doctors do MedWatch reports begin to be submitted about a particular problem herb/supplement. By then the damage has already mushroomed into a significant health crisis.

There are many ways that medications you are on can interact with dietary supplements and herbs that you are taking. It is important that you tell your doctor about all the herbs and dietary supplements that you take. Dietary supplements and herbs are not regulated like FDA drugs, but can have similar problematic drug interactions. In recent years the FDA issued a warning about the use of the herb Kava and problems with liver toxicity. Dietary supplements and herbs are powerful substances despite their largely unregulated industry, and must be reckoned with accordingly.

Read the first article: Drug Injury, Drug Safety, and Drug Accident Prevention