From Pharmacy Counter to Aisle 4: The Prescription to Over-the-Counter Journey

By Barbara Young, PharmD

Some medications that used to require a prescription are now available without one.

Prescription medications can be changed to nonprescription (over-the-counter; OTC) status if there is enough evidence that it can be used safely without direct oversight by a healthcare provider. To date, 106 drug ingredients and about 700 products have been switched to OTC status from prescription. A recent example of this is the class of proton pump inhibitors (PPIs) such as omeprazole (Prilosec®) and esomeprazole (Nexium®) used to treat acid reflux.

What criteria are used to reclassify drug products from prescription to OTC?
To reassign a medication from prescription to OTC status, the FDA requires that the product must be shown to be safe and effective and include instructions that are easily understood by people using the medication.

There are 3 factors that the FDA evaluates:

1. The ability of patients to self-diagnose the condition the medication is intended to treat.
2. The risks of toxicity, abuse potential, drug interactions, and side effects when used without medical supervision and monitoring.
3. The ability of the medication to be used without supervision by a healthcare professional and people can understand instructions of when to contact a healthcare professional when the condition does not resolve or other issues arise.

What are the advantages of moving drug products to OTC for consumers?
Advantages include easier access to medication, ability to obtain treatment without going to a medical office or clinic, and lower costs of the product.
However, some costs may increase with this switch because few health insurance companies provide reimbursement for OTC products. But this may be offset by the elimination of a doctor’s office visit, time away from work, or costs associated with prescription medications. For people without insurance, this may be a more affordable option.

What are the advantages of moving drug products to OTC for manufacturers?
When a product is moved from prescription to OTC status for all or a portion of approved uses, a manufacturer can maintain patent for the product and avoid competing generic products from being approved. The broader availability to the public may also increase sales of the product.

What should you be aware of if using these types of OTC drugs?
When using OTC drugs, it is really important to read all the included labeling information carefully. If you have questions, ask your pharmacist or healthcare professional for more guidance. This is important to avoid adverse effects, drug interactions, or ineffective treatment.

Another concern with reclassified products is that using them may delay more effective treatment. This may happen when symptoms are improved or relieved by OTC medications. Delay can also occur when the diagnosis is not accurate or if it is masking another condition.

Summary
Moving certain prescription products from prescription status to OTC has been well received by consumers. However, to use these products safely, you must carefully read all information contained in and on the package. If you have any questions, ask your pharmacist for more information. Never continue to use the medication beyond the recommended time frame or if your condition has not resolved.