When you’re feeling under the weather or dealing with a minor injury, it’s natural to want relief as quickly as possible. Over-the-counter (OTC) and prescription drugs offer different paths to that relief, each with its own advantages and disadvantages. In this article, Let’s explore the key differences between OTC and prescription drugs with GOL to help you make informed decisions about your health care.

What are OTC (over-the-counter) drugs?

Over-the-counter (OTC) medicines are medications that you can buy without a prescription from a healthcare professional . They are designed to treat a variety of minor ailments and conditions, such as pain, fever, allergies, coughs, colds, constipation, diarrhea, heartburn, and acne.

OTC medicines are generally safe for most people to use as directed. However, it is important to read and follow the label instructions carefully. Taking too much of an OTC medicine or taking it for too long can be dangerous. You should also talk to your doctor before taking OTC medicine if you are pregnant, breastfeeding, or have a chronic medical condition.

How do people use and misuse OTC medicines?

People use over-the-counter (OTC) medicines for a variety of common health issues, ranging from headaches and minor aches to allergies and cold symptoms. These medications are easily accessible without the need for a prescription, allowing individuals to address their health concerns promptly. OTC medicines are available in various forms such as tablets, capsules, liquids, creams, and nasal sprays, providing options for different preferences and needs.

When used as directed, OTC drugs can effectively alleviate symptoms and improve well-being. For instance, pain relievers like ibuprofen and acetaminophen can help manage mild to moderate pain, while antihistamines can provide relief from allergy symptoms such as sneezing and itching. Cough and cold remedies may contain ingredients to suppress coughs or alleviate nasal congestion, offering relief from common respiratory ailments.

However, misuse of OTC drugs can occur in several ways, posing potential risks to individuals’ health:

• Taking medicine in a way or dose other than directed: Some individuals may deviate from the recommended dosage instructions provided on the package or by a healthcare professional. This could involve taking more than the recommended dose, taking doses too frequently, or using the medication for longer than advised. Such misuse can lead to adverse effects or complications, including overdose, allergic reactions, or other health issues.
• Taking medicine for the effect it causes: In certain cases, individuals may misuse OTC medicines for non-medical purposes, seeking to experience effects beyond their intended therapeutic use. For example, some may misuse medications containing ingredients such as dextromethorphan (DXM) found in cough suppressants to achieve a euphoric or hallucinogenic effect. This misuse can be dangerous and may result in serious health consequences, including addiction, overdose, and even death.
• Mixing OTC medicines together to create new products: Another form of misuse involves combining different OTC medicines to create new formulations or products. While some may do this with the intention of enhancing the desired effects or treating multiple symptoms simultaneously, it can be risky due to potential interactions between ingredients. Mixing medicines without proper knowledge or guidance from a healthcare professional can increase the risk of adverse reactions or unintended consequences.

To minimize the risk of misuse, it’s essential for individuals to use OTC medicines responsibly and according to the instructions provided. This includes adhering to recommended dosages, avoiding non-medical use, and seeking guidance from healthcare professionals if unsure about proper usage or potential interactions. Additionally, it’s crucial to store OTC medicines securely and out of reach of children to prevent accidental ingestion. Overall, informed and cautious use of OTC medicines can help ensure their safe and effective use in managing minor health concerns.

Additional details on Over-The-Counter (OTC) products

Could you shed some light on what an Rx-to-OTC switch entails?

Numerous OTC medications have undergone what is termed an “Rx-to-OTC switch,” formerly requiring a prescription but now accessible without one. This shift broadens consumer access to certain products. For instance, medications such as esomeprazole (Nexium 24HR) and famotidine (Pepcid AC), typically used to manage heartburn, exemplify this transition. Moreover, Nasonex 24HR Allergy, previously a prescription nasal spray for hay fever symptoms, became available OTC in 2022. Notably, Plan B One Step, an emergency contraceptive pill, is now readily available without age restrictions, prominently displayed in numerous U.S. pharmacies.

In the year 2023, several medications received approval for OTC utilization. These include Narcan and RiVive, both naloxone nasal sprays designated for the emergency treatment of opioid overdoses. Additionally, Opill, the first progestin-only oral contraceptive available without a prescription in the United States, was among the medications greenlit for OTC distribution.

Which medications are stored behind the pharmacy counter?

A subset of OTC medications falls under stricter control measures. These products, classified as OTC, are nonetheless stored behind the pharmacy counter and dispensed under the supervision of a pharmacist.

Certain products, like pseudoephedrine (Sudafed), an oral decongestant prone to misuse, may necessitate presenting proper identification and signing for the purchase, or in some cases, a prescription as per state regulations. Some states permit the sale of codeine-containing cough syrup, categorized as a schedule 5 controlled substance, from behind the counter, although many states mandate a prescription.

Phenylephrine, another oral decongestant not kept behind the counter, was deemed ineffective at the current OTC dose by the FDA during a September 2023 assembly. Despite no safety concerns associated with the active ingredient, phenylephrine remains on the U.S. market. Notably, CVS, a national pharmacy chain, has opted to discontinue the sale of products containing phenylephrine as the sole ingredient.

Certain insulin types, such as Novolin N (insulin isophane) and Humulin R (insulin regular), are also accessible from a pharmacist behind the pharmacy counter to ensure proper counseling on their usage. Despite being vital for managing diabetes, insulin can pose risks if used incorrectly, leading to fluctuations in blood sugar levels.

Before making any changes to your insulin regimen, always consult with your physician.

Regulations regarding behind-the-counter medications often vary based on state or local mandates, encompassing criteria like age, proof of identity, or quantity limitations. Your pharmacist can provide insights into the specific regulations governing your area.

Read more: A Guide to Drug Master Files

How does the FDA review OTC drugs?

The U.S. Food and Drug Administration (FDA) oversees the review of over-the-counter (OTC) medications through a dedicated process involving several key divisions and committees. This process is anchored by the FDA’s Center for Drug Evaluation and Research (CDER), specifically the Division of Drug Information, alongside the Office of Drug Evaluation and the Nonprescription Drug Advisory Committee. Together, these entities are responsible for scrutinizing the components and labeling of OTC drugs.

For each category of OTC product, there’s a specific OTC drug monograph in place. These monographs detail the approved ingredients, dosages, formulations, and labeling requirements for that category. If a new product aligns with an existing monograph, it can be introduced to the market directly, bypassing any additional scrutiny from the FDA. However, if a product doesn’t fit within an established monograph, it must seek approval through the FDA’s New Drug Approval System before it can be sold.

Are over-the-counter (OTC) drugs safe to use?

Over-the-counter (OTC) drugs are generally safe to use when you adhere to the instructions on the packaging. However, it’s important to remember that they can still pose risks, such as possible side effects, interactions with other drugs, or issues from taking too much.

It’s crucial to carefully read the “Drug Facts” label on all OTC products or inside the packaging and follow the provided guidelines. If you have any doubts or questions about an OTC medication, a herbal remedy, or a dietary supplement, it’s a good idea to consult with a healthcare professional like a doctor or pharmacist. Additionally, pregnant women should always consult their doctor before taking any form of medication, vitamins, or herbal supplements, even if they are available over the counter.

What are 7 items that must be on OTC medication labels?

Every over-the-counter (OTC) medication comes with a label that provides detailed instructions and cautionary advice, ensuring users can make informed choices and use the products safely.

Here’s 7 items that must be on OTC drug labels:

• Active Ingredient: This section lists the active substance in the medication and its quantity per unit, indicating what’s actually treating your symptoms.
• Uses: Describes what conditions or symptoms the medication is intended to treat or prevent.
• Warnings: Important information on when not to use the medication, situations that might require a doctor’s consultation before use, potential side effects or interactions with other drugs, advice on when to halt usage and consult a healthcare professional, and special precautions for pregnant or breastfeeding individuals. It also includes a reminder to keep the medication away from children.
• Inactive Ingredients: Details on non-active components, like colors or flavors, that are part of the formula.
• Purpose: Clarifies the action or category of the product, such as whether it’s an antihistamine, antacid, or cough suppressant.
• Directions: Provides guidance on the correct dosage, how and when to take the medication, tailored to specific age groups.
• Other Information: Offers advice on proper storage and may include details about certain ingredients, like the amount of essential minerals (calcium, potassium, or sodium) contained in the product.

Why are some medications OTC while others are only available by prescription?

Prescription medications typically exhibit higher potency and may pose risks of interactions with specific foods or other drugs. Consequently, they’re usually recommended to be administered under healthcare provider supervision.

On the other hand, OTC treatments are characterized by lower toxicity levels, and the FDA has concluded that their benefits outweigh any associated risks or side effects. These medications are designed for self-administration for commonly self-diagnosed conditions. They feature clear labeling encompassing usage directions, indications, and precautions. Additionally, OTC medications are often less potent compared to their prescription counterparts.

8 differences between OTC and Prescription

Here are eight key factors to consider when navigating medication decisions:

1. Safety

The classification of a medication as OTC or prescription hinges on the safety profile of its active ingredients. OTC products adhere to FDA standards for safety, quality, and effectiveness.

2. FDA Approval Process

While both OTC and prescription drugs are regulated by the FDA, they undergo distinct approval pathways. Prescription drugs undergo the rigorous New Drug Application (NDA) process, involving the submission of comprehensive clinical trial data and manufacturing information. This includes details on the drug’s mechanism of action, dosage guidelines, and safety and side effect profiles.

OTC medications, however, are governed by FDA-monitored OTC drug monographs. These monographs outline criteria for acceptable ingredients, dosages, formulations, and labeling requirements. If a drug complies with an OTC monograph, it can be marketed and sold without further FDA review or approval.

To meet OTC standards, medications must:

• Demonstrate benefits outweighing risks
• Pose low potential for misuse or abuse
• Be suitable for self-diagnosed conditions
• Feature clear and comprehensible labeling

Drugs transitioning from prescription to OTC status must still undergo the NDA process for FDA approval. This is because they fall outside the parameters outlined by existing OTC monographs.

Importantly, it’s worth noting that OTC versions of medications may sometimes target different symptoms than their prescription counterparts. Additionally, their efficacy and suitability for individual patients may vary. For example, while prescription Xyzal (levocetirizine) addresses allergy symptoms and chronic hives, OTC versions are solely approved for allergy relief.

Read more: What is biosimilar medicine? FDA Review and Approval Process

3. Usage

Prescriptions are intended solely for the individual they’re prescribed to, whereas OTC medications are often shared among family members, kept accessible in the household for communal use.

While OTC medications in tablet or topical forms are generally deemed safe for sharing, certain OTC treatments, such as nasal sprays, eye drops, and ear drops, are best kept for individual use due to hygiene considerations.

4. Cost

The cost of prescription and OTC medications can vary significantly.

Prescription drug costs are contingent on factors such as insurance coverage, deductible status, copay requirements, and available manufacturer discounts. Without insurance, expenses may fluctuate based on access to patient assistance programs or potential savings with discount coupons like GoodRx.

Additionally, the necessity of an in-person or virtual consultation with a healthcare provider adds to the cost of prescription medications.

While OTC medications don’t necessitate a prescription, they may still vary in price. Savings can be achieved through coupons or by opting for generic (store-brand) alternatives.

5. Accessibility

Prescription medications require a healthcare provider’s prescription and can only be dispensed by licensed pharmacists from pharmacies during operating hours.

In contrast, OTC medicines are available without a prescription and can be obtained from various retailers, ensuring easy accessibility at any time. However, certain OTC treatments, such as those containing pseudoephedrine for cold or allergy relief, must be acquired from pharmacy counters due to quantity limits, age restrictions, and identification requirements, owing to their potential misuse in illicit drug production.

6. Labeling

Labeling requirements differ for prescription and OTC drugs. While healthcare providers determine prescription dosage and usage instructions, OTC medications must feature consumer-friendly labeling for self-diagnosis and symptom management. OTC labeling includes information on the medication’s purpose, directions for use, and warnings regarding potential side effects or interactions.

7. Potency

Prescription medications typically possess higher potency than OTC treatments, necessitating professional guidance for safe usage. OTC medications, on the other hand, boast wider safety margins and are primarily utilized for minor ailments like allergies or mild pain relief.

Some OTC medications may be available at higher potencies with a prescription, such as hydrocortisone cream. While OTC versions typically come in 1% potency or lower, stronger formulations require a doctor’s prescription.

8. Disposal Protocol

Due to potential harm if improperly consumed, certain prescription medications necessitate safe disposal. The FDA advises utilizing drug take-back programs whenever possible for disposal. For medications not eligible for flushing, such as OTC and prescription drugs, proper disposal entails mixing them with undesirable substances like coffee grounds or cat litter before disposing of them in sealed containers in household trash. Personal information should be obscured from prescription packaging before disposal.

We hope the above article has provided you with useful information about the differences between OTC and prescription drugs. Understanding these differences will help you make informed choices when addressing health issues. GOL will continue to regularly update information related to the FDA, including new regulations regarding OTC and prescription drugs. Follow GOL to stay up-to-date with the latest and most accurate information in this field.

References: 

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Understanding Over-the-Counter Medicines