From prescription pad to store shelf

Why and how some drugs get OK’d for over-the-counter use.

Any consumer looking for the allergy medicine Claritin can readily find it on the shelves of nearly any retail pharmacy in the United States. But before 2002, allergy sufferers could obtain this drug only with a doctor’s prescription.¹ It is one of hundreds of medicines that have switched from prescription to over-the-counter (OTC) status.²

OTC medicines save the U.S. health care system nearly $146 billion annually, according to a 2019 study by the Consumer Healthcare Products Association.³ They are popular with consumers who want to participate more fully in their own care while saving money.⁴

When consumers get more engaged with their health, good things happen. The study that attributed savings to the lower cost of OTC versus prescription drugs also found that people used fewer doctor visits and had less time away from work when taking OTC rather than seeking treatment or a prescription.⁵

Making the switch from prescription to OTC also pays off for pharmaceutical companies. They can reap the benefits of wider sales and, sometimes, extended commercial life of the drugs.

Prescription versus OTC: What is the difference?

Since 1951, U.S. law has divided drugs into two different classifications: prescription and nonprescription.⁶

Prescription drugs are regulated by the Federal Drug Administration (FDA) through the New Drug Application Process for approval for marketing in the United States. The FDA regulates OTC drugs through a drug monograph containing acceptable ingredients, doses, formulations and labeling requirements.⁷

The prescription classification is in place to minimize the risk of patients misusing habit-forming or dangerous drugs, including drugs for difficult-to-diagnose medical conditions.

Experts advise patients to consult a doctor before taking any new OTC drug.⁸ Some people are allergic to certain OTC medicines, and others are not safe for pregnant women. Certain cold and flu, pain and other OTC medications can raise blood pressure or interfere with prescribed blood pressure medication.⁹

The Rx to OTC switch

Since 1976, at least 106 ingredients, indications or dosage strengths have made the switch from the prescription pad to the pharmacy aisle. As a result, more than 700 medicines are available over the counter that once required a prescription.¹⁰

To get FDA approval to change a prescription drug’s classification to OTC, the product’s manufacturer must prove its medication’s safety and efficacy.¹¹ Generally drugs can become OTC if:

·         They have low potential for misuse and abuse.

·         They are used for self-diagnosed conditions.

·         They can be used safely and effectively without a health care provider’s instruction.

·         They can be adequately labeled.

Precautions still needed

In the interest of consumer safety, the FDA has stringent labeling requirements for OTC drugs. A consumer reading the drug facts label of an OTC medicine should be able to determine whether the drug is right for them, follow usage directions and understand any warnings.¹²

Over-the-counter drugs are still subject to misuse, however. For example, poisoning related to acetaminophen (Tylenol) is one of the most common causes of poisoning and death caused by medications.¹³

Similarly, users of ibuprofen may experience ulcers and intestinal bleeding and are at higher risk for heart attack or stroke.¹⁴

·         RX to OTC 

·         Finally, there are a few financial considerations regarding OTC drugs to keep in mind:

·         The consumer’s cost for certain over-the-counter drugs can sometimes be higher than if they were purchased with a prescription, depending on an individual’s coverage and whether they have a coupon or qualify for a discount.

·         In addition, buying the prescription product allows a consumer to use their pre-tax flexible spending account or health savings account to pay for the medication. The IRS does not allow those monies to be spent on over-the-counter medicines. 

As more and more drugs make the transition from prescription to OTC, consumers and their doctors do need to exercise due caution. But overall, these medications can represent a substantial advantage, both financially and in terms of better health. 

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