How A Prescription Drug Becomes Available Over the Counter
Considering the recent efforts to make oral contraceptives available over the counter, understanding the FDA guidelines on how a drug becomes available over the counter is essential for the industry.
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- The FDA approval process is complex and involves multiple steps. Understanding how a prescription drug becomes available over the counter (OTC) is essential for healthcare professionals, members of the pharmaceutical industry, and patients.
According to the Consumer Healthcare Products Association (CHPA), the switch from a prescription drug to medication available OTC is “a scientifically rigorous and highly regulated process that allows consumers to have OTC access to a growing range of medicines. For a medicine to be granted OTC status, it must have a wide safety margin, be effective, and bear understandable labeling to ensure proper use.”
Certain drugs, such as Nasonex 24 HR Allergy Nasal Spray, make it through the approval process and become available OTC. Meanwhile, others don’t quite fit into the criteria. One notable switch from prescription to over-the-counter happened for allergy medication in 2015. The percentage of OTC allergy medications increased by 9% from 2009 to 2015.
Pathways for Approval
In the United States, over-the-counter distribution of medications is regulated by the Food and Drug Administration (FDA). According to the FDA, two primary regulatory pathways are used to approve OTC drugs: the new drug application process and the OTC drug review process — sometimes called the OTC monograph process.
OTC Drug Monograph
The FDA states that “an OTC drug monograph establishes conditions, such as active ingredients, uses (indications), doses, routes of administration, labeling, and testing, under which an OTC drug in a given therapeutic category (e.g., sunscreen, antacid) is generally recognized as safe and effective (GRASE) for its intended use.”
Adding, removing, or changing a monograph can be initiated by either side: the industry, such as the manufacturer or developer of the product, or the FDA.
An industry member can file an OTC monograph order request (OMOR). After the submission, the OMOR undergoes FDA review, and the public will have 45 days to comment on the order. At this point, the FDA will review the comments and make a final ruling.
Similarly, if the FDA issues the order, the public again gets 45 days to make comments, and the process proceeds as previously mentioned. Unlike an industry-initiated order, an FDA-initiated order can be expedited in case of a public health concern or risk of adverse reaction. In this instance, an interim final order is issued, and before the 45 days, the public will have to comment on the decision. After 45 days, the FDA will review and issue a final order.
Factors to Consider
According to the Journal of Research in Pharmacy Practice, multiple factors are considered when a drug goes from prescription to OTC:
- benefit-risk comparison
- consumer-friendly labeling
- how the drug is a good alternative to prescription medication
The first factor to consider for the switch, benefit-risk comparison, refers to whether the drug can be safely used over the counter and still allow the patients to reach the intended goal.
Clinicians in the Journal of Research in Pharmacy Practice state, “if the drug is highly toxic or addictive, the medication status will remain as ‘prescription-only.’ However, if the drug has labels that consumers can understand and adhere to and if patients are capable of properly diagnosing their condition, then the medication may make the switch to OTC.”
Simply put, this means that drugs that are exceptionally dangerous, such as opioids and other addictive substances, are unlikely to be approved for OTC sale. Drugs approved for OTC distribution are easy to use, have minimal addiction risk, and have minimal adverse side effects.
Despite that, some drugs available for OTC sale will be restricted to certain ages or quantities to help minimize any remaining risk of addiction or fatality.
Appropriate labeling is also essential for a drug to be approved for OTC use. A good candidate for OTC distribution includes safety and instructional information that is easy to understand and can be followed appropriately by the consumer. The Journal of Research in Pharmacy Practice indicates that proper OTC drug labeling includes active and inactive ingredients, uses, warnings, indications, directions, and any additional information that may alter the product’s use, storage, or efficacy.
Finally, researchers in the publication explain that “the drug indications for the new OTC release must be comparable to the indication for the prescription drug while still allowing the patient to accurately and easily self-diagnose. The OTC drug should also be relatively safe in regard to toxicity, drug–drug interactions (DDIs), and side effects as well as a minimized potential for abuse.”
Marketing and Other Considerations
Other rules and regulations for over-the-counter drugs differ from prescription drugs, especially in the marketing realm. Pharmaceutical companies seeking an OTC transition must provide patients with the necessary information to manage their health conditions conveniently and successfully.
Investigators in the Journal of Research in Pharmacy Practice explain, “conditions that are commonly treated OTC often include acute diseases such as headaches and common cold that can be easily identified by a patient without medical training. A recent example of such medication is Flonase that transitioned from prescription-only to OTC and is available to consumers without a prescription starting 2015.”
Researchers also advised that “allowing patients access to more information on the medications is also vital to the success of OTC drugs. Making sure that there is proper labeling (with appropriate font size) that is clear and straightforward is important for proper medication adherence. Patients still need to have pharmacists available to consult if they need guidance on how to use medication and for what conditions. Keeping the standards high is the best way to ensure that OTC medications will be safe and effective for patients.”
Benefits to OTC Transition
When a drug transitions from prescription to OTC, there are significant benefits.
Access to Care: Patients
The CHPA believes switching from prescription to OTC can widen accessibility to different medications: “When nicotine replacement therapies went OTC, there was a 150–200% increase in their purchase and use in the first year after the switch. Increased access enabled tens of thousands of smokers to use these products to help quit smoking. That’s a $2 billion social benefit every year.”
Regarding widening access, researchers in the Journal of Research in Pharmacy Practice shared that the OTC switch makes medications more affordable and less time-consuming. Rather than seeing a healthcare provider and getting a script, patients can go to the pharmacy and pick it up without the additional step.
Timesaving: Providers
In addition to saving time for patients, the OTC switch can also save time for providers. With the current physician shortage, providers must make the most of their available time.
The OTC switch reduces the time examining the patient, writing a prescription, explaining the medication, and filling the prescription. Saving time can allow providers to allocate more to pressing issues and other, more complex patients.
Payer Benefits
Like the savings it provides patients, the switch from Rx to OTC saves money for insurance companies as the drug itself does not cost as much. “An example of health insurance is Medicare Part D, which is meant to help cover prescription medications. When medications are switched to OTC, it means a drop in costs for insurance companies because they don’t have to cover OTC medications in their plans,” noted the Journal of Research in Pharmacy Practice.
Drawbacks to OTC Transition
Conversely, there are some drawbacks to the OTC transition. Most notably, reduced patient monitoring can be a concern. Since patients are getting the medications independently, their providers cannot monitor them for any side effects or overuse.
An additional concern may be reduced patient comfort. Some patients will experience anxiety taking medications without the direction of the provider. To some, this comfort reduction is insignificant compared to the potential benefits.
Many healthcare professionals are watching as oral contraceptive manufacturers apply for OTC approval. As the healthcare industry progresses and more drugs come to market, a well-rounded understanding of prescription drugs and OTC approvals may prove beneficial.
