Izabela Sadej, MSW, is a policy analyst at Boston University School of Public Health. She tweets at @IzzySadej. Research for this article was supported by Arnold Ventures.
This post is the second in a series that examines pharmaceutical drug distribution in the United States. The first post described the FDA drug classification process [prescription or over-the-counter (OTC)] and how drugs can switch classifications, while this piece focuses on the costs and benefits associated with both. The next and final post will explore alternative approaches to drug distribution, with a particular focus on the role of pharmacists.
The primary purpose for prescription drug requirements is concern for patient safety and well-being. Prescription requirements allow health care professionals to provide education, oversight, and care management when patients need pharmaceutical care, especially for drugs that can be particularly harmful if not properly managed. A person’s medical history and current health status are considered before prescriptions are filled, allowing for appropriate course of treatment and dosage.
Consumers cannot always accurately self-diagnose and self-medicate when purchasing their own medicine, which highlights the importance of access to health care professionals when pharmaceutical drugs are involved. Concerns for drug misuse and abuse are valid; even with access hurdles, prescription drugs are among the most misused and abused substances.
However, while prescription drugs are essential to millions of people, particularly those who suffer from chronic illness, they have become increasingly expensive. A 2021 report found that three in ten adults did not take their prescriptions due to costs. Consumer drug expenditure heavily depends on health insurance coverage, if one has insurance at all, and can fluctuate depending on branding.
OTC classification allows for easier, universal access to important medicines. It is estimated that OTC drugs are used by 81 percent of adults as a first response to minor ailments and have provided symptomatic relief to 60 million people who probably wouldn’t otherwise seek medical treatment.
Barriers – such as cost, lack of insurance, stigma, etc. – limit under-served communities from accessing pharmaceutical care directly from a doctor. The CDC found that 30.4 million people were uninsured in the beginning of 2020 and nearly half of adults reported that they or someone in their household deferred medical care due to COVID-19. OTC approval has the potential to alleviate some of this burden.
For example, OTC approval could increase access to Naloxone, a largely unavailable medicine that rapidly reverses an opioid overdose. While several states have created laws that allow pharmacists to distribute the drug without a prescription, access barriers continue to exist that have resulted in advocacy to approve Naloxone for OTC use. Some of these barriers include negative stigma about carrying Naloxone, health care provider discomfort in distributing Naloxone, its high cost, and the prevalence of medicine and pharmacy deserts. OTC distribution won’t address all of these, but could address some. In addition, structural racism disproportionately increases the risk of overdose and death in communities of color, causing opioid-related overdoses to continue to rise. Greater access to Naloxone could also address this issue.
OTC drug availability also promotes patient autonomy and comfort when needing certain medicines. For instance, when the Plan B One-Step medication became available OTC, it allowed individuals to access emergency contraception in a timely and discreet manner. Confidentiality is an important consideration for medication access, particularly for women’s health and pregnancy-related care.
Although consumers normally pay out-of-pocket for OTC drugs, which can be a barrier to their use, prescription to OTC drug switches have been found to save both time and costs. This benefits consumers, providers, and insurers alike by limiting unnecessary clinic visits and reducing overall drug prices.
The classification system of prescription and OTC drugs creates both opportunities and barriers for several stakeholders, but especially consumers. It is important to remember that the end goal should always be providing people with access to the medicines they need.