Many nasal decongestant products used by millions of American consumers to relieve cold and allergy symptoms contain pseudoephedrine (PSE), a sympathomimetic drug, which can be used to manufacture methamphetamine, an abused and illegal psychostimulant. Currently, the federal government has instituted several sales constraints to prevent illicit use of PSE, including behind-the-counter (BTC) or secured storage, compliance with specific daily purchase limits, customer age or identity verification, and inscription of all sales into a record book.
In efforts to further prevent the use of illicit methamphetamine, many states have taken additional steps. Thirty-two states have adopted a real-time, statewide electronic tracking system to monitor purchasing patterns of PSE. Two states, Oregon and Mississippi, have restricted access to PSE by making the chemical a Schedule III controlled substance, which requires a physician’s prescription to obtain. While making PSE a prescription-only medication has the potential to control access to the drug for off-label uses, it also restricts access for the majority of users who intend to use the drug properly.
Fifty-seven million Americans live in regions that lack adequate access to primary healthcare due to a shortage of physicians in their communities. Although providers of all types are needed, the majority of the shortage can be attributed to a primary care physician shortage. Recent projections indicate that the U.S. health system will fall short of meeting primary care provider demands by around 52,000 doctors in 2025. Adding the additional responsibility for physicians to see patients to prescribe PSE has the potential to further increase the cost, time, and difficultly associated with obtaining the treatment.
Primary care providers are, and will remain, the main source of care for people with undiagnosed health concerns. These providers are the first contact for most people looking to receive treatment for symptoms that can be relieved by PSE-containing products. However, for those living in a region experiencing primary care shortages, often hospital emergency rooms or urgent care centers become the primary site-of-care. Therefore, an increase in demand and utilization of both primary care and emergency care providers could occur with a prescription-only requirement for PSE. While reducing illicit access, a prescription-only requirement for PSE-containing products compounded with the shortage of physicians will create access restrictions for legitimate users, prolonging the timeline to symptom relief. As consumers are forced to obtain a prescription from their provider, the number of physician visits will increase. This influx in patients will increase provider workload and administrative burdens, stressing an already strained system. As wait times increase and access to primary care physicians decreases, consumers may turn to alternative settings of care like emergency departments and urgent care clinics. However, these settings are often more costly and are not always available in areas most impacted by the shortage of primary care physicians.
Our model indicates approximately 1.2 million new provider visits for consumers in the first year of a nationwide PSE prescription-only policy. These new visits would significantly increase stakeholder costs. Consumers could expect new out-of-pocket costs for provider visits totaling $44.5 million. Similarly, public and private payers would pay an additional $198.9 million in combined costs associated with new provider visits and coverage of PSE-containing products. Furthermore, these visits only represent a fraction of the demand for PSE-containing products from affected individuals who forgo a physician visit due to the time, cost, or limited access they have to care providers.
A prescription requirement may reduce PSE access for prohibited uses and curb methamphetamine production. However, the impact on illegal production of methamphetamine resulting from a nationwide prescription-only policy must be weighed against the estimated costs and implications to key stakeholders of legitimate use of PSE-containing products. Given the growing shortage of primary care physicians, these burdens and expenses may increase. As policymakers continue to explore options for reducing the illicit purchase of PSE, it will be important to consider various implications of a prescription-only policy and how the current physician shortage may affect stakeholders. Ultimately, to successfully address the methamphetamine issue, a multifaceted strategy that balances the need for consumers to access necessary medications while curbing illicit production and use of methamphetamine will be required.
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The Consumer Healthcare Products Association provided funding for this research. Avalere maintained full editorial control.