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 third in a series that examines pharmaceutical drug distribution in the United States (US). The first post described the Food and Drug Administration’s (FDA) drug classification process [prescription or over-the-counter (OTC)] and how drugs can switch classifications, while the second post focused on the costs and benefits associated with both classification types. This final post will explore expanding the role of pharmacists as an alternative method in drug distribution and access to care.
Pharmacists in the US Today
Pharmacists have a specific set of responsibilities across the US health care system, primarily in the distribution of medications prescribed by health care providers. They are also a source of information on medication usage for patients and advise other health practitioners on the selection, dosage, interactions, and side effects. While a large portion of pharmacists work in community pharmacies (drug stores), many also work in hospitals, outpatient care centers, and other settings that handle medication.
The role of pharmacists has expanded over time, particularly when it comes to patient care services. For instance, take Medication Therapy Management (MTM), which first arose through Medicare Part D and has since expanded across several states. MTM allows pharmacists to provide direct patient services to optimize therapeutic medication outcomes and prevent unnecessary costs. This includes reviewing a patient’s entire medication list (both prescribed and OTC products) to address any potential issues, such as incorrect medication usage, duplicates or unnecessary medication, or the need for additional medication. MTM encourages a patient-centered approach to pharmaceutical care through increased direct patient education and more intensive collaboration with other health care providers.
Beyond MTM, other ways to broaden the responsibilities of pharmacists have been considered, such as granting prescribing privileges and provider status, as well as creating a “third class” of drugs that would be distributed by pharmacists themselves.
Proposed Changes
Prescribing and Provider Privileges
Providing pharmacists with prescribing privileges and/or provider status has been greatly contested in the US. While all states allow pharmacists to prescribe medication in some capacity, most prescribing regulations are restrictive and only apply to specific medications (such as naloxone, hormonal contraceptives, and smoking cessation products). Expanding these privileges has become especially relevant during the COVID-19 pandemic, as pharmacists have become a key access point to health care services.
However, many health systems do not recognize pharmacists as health care providers, which prevents pharmacists from being able to bill for services provided. In 2021, the Pharmacy and Medically Underserved Areas Enhancement Act was introduced, which if passed would amend the Social Security Act to include pharmacists on the list of recognized providers under Medicare Part B. This would increase access to services for recipients and set a precedent to grant pharmacists with provider status.
While expanding pharmacists’ prescribing and provider privileges may alleviate some burden on health systems, these additional responsibilities are contested by some. Some pharmacists do not want the greater responsibility that come with these privileges. Physician groups have also historically opposed pharmacist provider status over concerns like the change it would have on a pharmacist’s scope of practice, essentially allowing them to “practice medicine” similar to physicians. Additionally, granting provider status causes hesitation about the associated increase in costs with providing reimbursement payments for services.
A Third Class of Drugs
As previously discussed, the US follows a two-class drug distribution system (prescription or OTC). However, an alternative approach that would increase pharmacist involvement would be the introduction of an official “third class” of drugs. The US has a single non-prescription category (OTC), with some exceptions as mentioned above, while there are several nations (that are considered “equally developed” as the US) that have two or more non-prescription classifications.
For instance, through a model that promotes self-care, the United Kingdom has two non-prescription classifications, OTC and pharmacy-only (drugs that can only be sold from a registered pharmacy). New Zealand and Australia have three non-prescription classifications including pharmacist-only (for medicines that require professional advice from a pharmacist but do not require a prescription from a doctor), pharmacy-only (for medicines that are available in pharmacies but do not require consultation with a pharmacist), and general sales (for medicines that can be sold in places not classified as pharmacies). Japan restricts all non-prescription medicine sales to pharmacy staff-only (pharmacist or other registered persons).
While some non-prescription medications have restrictions for purchase in the US (like age limits or requiring proof of identification), the FDA and American Medical Association have historically rejected the creation of an additional classification that would serve as pharmacist-only, or behind the counter (BTC), access. In 2009, the US Government Accountability Office released a report stating that there are several issues that need to be addressed before BTC could be established, including concerns that it would become the default for prescription to OTC drug switches, thus reducing patient access to medicine that would otherwise become OTC.
Series Conclusion
As examined in this series, pharmaceutical drug distribution in the US is a heavily regulated process with both benefits and drawbacks. These include:
- Multiple methods in achieving FDA drug approval, which also allows drugs to switch from prescription to OTC (Part 1/3).
- Costs and benefits to both the prescription and OTC classifications, including concerns for patient autonomy, access to care, and cost (Part 2/3).
- Hesitancy around alternative methods to pharmaceutical drug distribution, such as expanding the role of pharmacists (Part 3/3).
While alternative approaches to pharmaceutical drug distribution exist, many of these methods would require drastic changes to the US’ system. It’s important to first understand how this system currently works and keep patient access and affordability at the forefront of future conversations.
