Preventing Unintentional OTC Medication Misuse

Description of the Public Health Program

            Medication misuse occurs when a drug is taken in a way or at a dose other than what is directed on the packaging. The U.S. Food and Drug Administration (FDA) and individual states closely regulate prescription medications that are dispensed to the public such as with the iSTOP program in NYS and DEA licensure, but there is more leniency when it comes to over-the-counter drugs (OTC) and less regulation on what is being advertised to the public. The majority of OTC medications are generally safe to use, but some products such as Dextromethorphan (DMX), a cough suppressant, and Loperamide, an anti-diarrheal, contain active ingredients that can be accidentally misused if directions are not followed correctly (Department of Justice, 2020).

In 2005, the FDA issued online warnings about DMX use, following increased reports of teen deaths. Although the warning included consequences of abuse such as brain damage, seizures, loss of consciousness, irregular heartbeat, and death – unintentional misuse still remains an issue. According to the 2020 National Survey on Drug Use and Health, 0.9% (2.4 million people) of adolescents aged 12 to 17, 1.2% of young adults ages 18 to 25, and 0.8% of adults ages 26 and older misused OTC cough and cold medicines within the year. While the percentages seem insignificant at first glance, there is a significant increase in drug misuse numbers compared to the year prior which only consisted of 223,000 adolescents, 389,000 young adults, and 1.8 million adults aged 26 or older (SAMHSA, 2020). 

Our proposed public health program targets the gap in drug education, with a focus on individuals purchasing and/or taking drugs with potentially high risks, but are often overlooked due to their OTC status. These individuals consist of adolescents and adults, including parents and caregivers of young children. While there are many stakeholders, we believe that the pharmaceutical industry (consisting of pharmacists, pharmacies, pharmaceuticals) as well as drug advertisement companies will play a major role in successfully carrying out such a program and ultimately further commit to protecting the safety of the public. 

Development & Dissemination of Interventions

            There are many possible interventions that can help prevent accidental OTC medication misuse. The most beneficial interventions focus on patient and parent education, reinforcement by pharmacies, and proper advertisement of the benefits and adverse side effects of medications by pharmaceuticals.

1. Patient & Parent Education

Patient education is arguably one of the most beneficial ways to empower patients in taking control of their health and achieving better health outcomes. There are many different OTC medications that treat the same symptoms, often making it confusing and overwhelming for the patient. Patients do not have immediate access to their providers, nor do they think of utilizing the pharmacist for help. Therefore, we need to make sure there are available resources at the hands of the patient located on the shelves of medications. Resources should outline the differences between each drug treating that particular symptom and clearly state drug interactions or any adverse effects. This is especially important for once-prescribed drugs that have now become OTC, as there still may be active ingredients that could harm the patient.

• If young adults or children are unintentionally abusing OTC drugs, they may be obtaining them from their medicine cabinets. Hence, we encourage parents to keep medication bottles capped and out of reach from young children, especially if they are not needed on a daily basis.
• We also encourage parents to appropriately dose OTC medications when their children are sick. It is understandable that parents may not know the exact dosing of childhood medications, so it is important to educate parents on readily available resources such as the FDA’s Division of Drug Information, where pharmacists are readily available to respond to questions about drugs for the U.S. public.
• Patients may unintentionally combine multiple medications at the same time, unaware of adverse health consequences. For example, if a patient has a cough they may take NyQuil (Acetaminophen, Doxylamine Succinate, DXM) along with an additional Acetaminophen pill or an additional antihistamine pill. The patient believes they are simply treating their symptoms, however, many medications can have additive or synergistic effects leading to toxicity. In an effort to educate our patients, placing large-print, colored labels on medication bottles and providing workshops for community members about the different ways OTC medications can be misused will prevent patients from overdosing. Lastly, due to the diverse communities we serve, having instructions in multiple languages will be beneficial to those whose first language is not English.

2. Reinforcement by Pharmacy/Drug Stores

According to FDA public health expert Mary E. Kremzner, pharmacists “help people get the maximum benefit from the drugs they need to take, with the least amount of risk” (FDA, 2022). Agreeing with this sentiment, incorporating pharmacy staff to our public health program is essential, as they are the first point of contact for individuals during the purchase of OTC medications. Proper training and reinforcement by pharmacies and pharmacists could serve as an avenue to decrease OTC misuse.

• Pharmacists should provide brief education on the instructions and side effects of drugs patients are purchasing. Within a hospital setting, pharmacy technicians have demonstrated positive impacts by obtaining medication history and conducting medication reconciliation for patients (Sansgiry et al, 2016). By expanding the role of pharmacists and pharmacy technicians to be more proactive in managing OTC medications, providing oral and written medication information, and further developing trust with all patients, we can ensure patients will not misuse OTC medications.
• Pharmacies can also reinforce patients from misusing OTC drugs by having a shared patient record. For instance, implementing a system that allows for the patient to be “carded” for every OTC drug purchase they make allows for increased awareness by the patient and detection of whether they have made similar purchases in the past. This could also potentially reduce “pharmacy shopping” because pharmacists will be able to view patients who have purchased several of the same drugs. Once implemented, pharmacists or pharmacies who fail to comply with these standards should be fined.
• Lastly, another step pharmacies can take to raise awareness on OTC medication abuse, with the help of pharmaceutical and advertisement companies, is to place “quick facts” pamphlets next to the drugs or posters at the pharmacy counters and in waiting areas.

3. Pharmaceuticals & Proper Advertising

Consumer advertisement of drugs allows for greater awareness of available treatment and better discussions between patients and healthcare professionals (FDA, 2015). In order to ensure consumers are acquainted with the various safety concerns of OTC drugs, drugs must be properly advertised and geared towards the literacy of the general public. People who have low health literacy and limited English proficiency are twice as likely to report poor health status (Agency for Healthcare Research and Quality, 2020). Thus, the way OTC drugs are currently advertised should be revised.

• Currently, the advertisements for OTC drugs are much less regulated than prescription drugs. This difference is likely due to the federal agency in charge of respective advertisements. The FDA regulates advertisements for prescription drugs, whereas OTC drugs are regulated by the US Federal Trade Commission (FTC). As such, the FTC presents with fewer regulations, where they hold drug advertisements to the same standard as other consumer products. We suggest that OTC drug advertisements should equally focus on the safety concerns and drug contraindications, along with the benefits. This is crucial because OTC drug advertisements are the driving factor in how patients make their medication selection.
• Since the FTC regulates non-prescription drug advertisements, we also recommend more regulation on what information is included; paying close attention to medication indications, adverse effects, and contraindications. In preparing advertisements, we also recommend the use of larger fonts and language that is easy to understand on all drug labels to make it easier for people in the general population who may have poor health literacy. Further steps may also include labeling of dosing information and instructions in different languages.

Evaluation & Maintenance

We expect pharmacies to provide us with bi-yearly reports as well as updates on educating their community members on adverse side effects including potentially life-threatening effects that can occur when consuming high doses of OTC drugs. If pharmacies fail to comply with these standards, then they will be fined and will receive additional training. We hope to translate these bi-yearly reports into quantitative data, in which we can determine the effectiveness and success of the interventions outlined above. We also hope to use these reports to determine which communities may require additional support. If these interventions are a success, we hope to continue their practice and assess their effectiveness via yearly reports over the next five years.

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