ACNU: Changing everything about non-prescription medication
By: Dan Frey and Todd Greenwood
What is ACNU?
ACNU is the acronym for the new rule from the United States Food and Drug Administration (FDA) that will dramatically alter the landscape for non-prescription medication. It stands for “Additional Conditions for Non-Prescription Use” and with the preliminary rule published in October 2022 the final rule may be complete as early as next spring. With ACNU, chronic care medications and medications that until now were unavailable without a doctor’s prescription (Rx) will be made available to consumers. These may include statins for cholesterol lowering, ace inhibitors for hypertension, triptans for treating migraines and tadalafil for erectile dysfunction.
To be clear, medications available under ACNU will be non-prescription, but they will not be sitting on an open store shelf like an over the counter (OTC) medication. Instead, consumers will need to complete the “additional conditions,” which will be to objectively verify that they meet the conditions for both initial use of a drug and through ongoing digital oversight that they continue to meet conditions as they seek refills. This objective verification and digital oversight will be managed through what we term a “digital care platform,” and this platform, which will be surfaced to consumers on a smart phone application, through a website, or in an in-store kiosk, is core to ACNU. The digital care platform will guide consumers through questions that will objectively verify, through available databases of medication history and health history as well as self-reports, that a consumer who requests a medication meets the conditions for safe use of that medication. In this way, there is reasonable assurance that consumers both understand the intended use of the medication and those who are granted access are deemed appropriate to use it.
Why ACNU and why now?
Over the past few decades, healthcare in the U.S. has changed dramatically from acute care to chronic condition management, and with it an increase in the use of chronic treatments. There has been an emergence of patient-centered healthcare and a growing sentiment that healthcare just ought to be more convenient, mirroring the conveniences of other consumer sectors. Indeed, dissatisfaction with healthcare-related convenience and accessibility was one of the top concerns of people in the U.S. in the 2024 ZS Future of Health Report. Another mega-trend is the steady decline in the percentage of consumers who have a regular doctor, something likely to continue with looming provider shortages and the rise of alternative retail-based primary care settings. As a result, the role of a single primary care physician as the coordinator and gatekeeper for one’s medication is becoming outdated.
Core to the FDA’s mandate is to reduce the barriers to access for drugs deemed safe and effective with the aim of addressing underserved areas of public health need. However, slow action has resulted in a marketplace response that undermines the FDA’s mission. For example, cross border pharmacy utilization and alternative online pharmacy channels have grown, especially since the start of the pandemic.
The historical route for expanding access to medication in the public good has been to take safe and effective classes of prescription drugs and make them available over the counter through a pathway called Rx-to-OTC switch. A 2013 study by the Consumer Healthcare Products Association (CHPA) on trust in OTC medication concluded that most consumers prefer OTC medications over Rx ones, with two thirds choosing an OTC when available. However, the number of drugs allowed by FDA for Rx-to-OTC switch has declined over the last decade. For a drug to be successfully switched, it needs a label comprehension study, showing that the major elements of a Drug Facts Label are understandable and a self-selection study, which proves that a consumer who may be considering a drug sitting on an open store shelf will be able to understand and make a correct and appropriate decision about the use of that drug for themselves or a family member.
One of the biggest barriers to bringing chronic care drugs through Rx-to-OTC switch is that consumers fail the self-selection test. For example, manufacturers of statins have tried on numerous occasions without success to design a Drug Facts Label that will deliver the critical information necessary for an ordinary consumer to be able to make a correct and appropriate self-use decision. The conditions and limitations for safe use and the restrictions that consumers need to consider with statins are simply too complicated to be communicated in a simple, clear and readable format on the rear panel of a box.
What is termed “labeling” is critically important to ensuring that consumers can use their drugs safely. Indeed, even with Rx medications, the FDA has been listening to patients who find it difficult to read the instructions for safe use or wade through confusing and sometimes contradictory language for Rx medication — which may be delivered in package inserts, medication guides or stapled to the top of a paper bag at retail. To that end, another rule called the Patient Medication Information (PMI) — currently in proposal — would reduce these duplicative vehicles for prescription medication and would move towards mandatory electronic distribution of a singular, standardized medication guide. In a diverse society, where different languages are spoken and with varying levels of health literacy, the agency wants to ensure that appropriate Conditions of Use, Instructions for Use and safety information are standardized and made accessible for consumers and patients when, how and where they need it. With ACNU and PMI, the agency is recognizing that digital tools should be a standard component of labeling. This will lead to safer medication use of both non-prescription and Rx drugs, as well-designed and standardized digital information will be available — on demand — long after printed materials have been put into the recycling bin.
Objective verification
The ACNU rule will spell a new way for consumers to receive medication. Imagine a consumer who has been experiencing migraines and may have successfully tried triptans in the past but is currently not treated. The consumer might see an ad for a migraine medication brand, possibly on an instore ad or online, and it might be accompanied with the words, “now available without a prescription.” If they were in a store, they could use their smartphone and an associated QR code to learn more about the medication, and if they thought that the med might be effective for them, they would engage through a chatbot dialogue in a self-selection process.
This self-selection process would of course be different for every medication, and would be designed, tested and regulated according to the label, contraindications and conditions for appropriate use. But it would be far more than a simple health and medication history questionnaire, as the process would be required to use available data to objectively verify — to the extent possible — the answers provided by the consumer.
With acute migraine for example, triptans are contraindicated for patients who have coronary artery disease, a history of stroke or uncontrolled hypertension. While consumers seeking a triptan would be asked to self-report if they had any of these preexisting conditions, the digital care platform would be designed to objectively verify the conditions for safe use by checking the prospective consumer’s previous prescriptions. For those consumers who appeared to have a contraindication for use, they would be given instruction to speak with their doctor or indeed given the opportunity to have an immediate online telemedicine visit. For consumers who meet the requirements for use, they could receive their medicine through instore or ecommerce channels. Then, as they use their medication, they could consult their ACNU app to review the label.
Creating a consumer journey through ACNU that will both satisfy the need for assuring patient safety and create an experience that will be deemed easy to use and seamless for a broad and diverse consumer population will require a digital care platform purpose built for the task.
Coming up
In the following blogs we will discuss how the ACNU rule will affect physicians, pharmacies and pharmaceutical manufacturers. We will consider some of the unknown factors regarding pricing and payers and we will start to unpack the simultaneous-marketing provision of ACNU — which allows pharmaceutical manufacturers to offer patients and consumers both an Rx version and an ACNU version of the same product.
