Oregon Publishes Final Rule Requiring Pharmacies to Provide Prescription Label Readers

Continuing the national trend of increased focus on accessibility in health care, the Oregon Board of Pharmacy recently published 855-041-1131 (Rule), requiring pharmacies to notify patients that prescription label readers are available, and to provide the readers to the patients who request one. In order for the readers to work, the pharmacy also must have compatible labels that can be read by the reader. Effective June 23, 2020, the Rule applies to all dispensing drug outlets, including nonresident pharmacies.

The Rule implements legislation that was enacted last year. Effective January 1, 2020, the Oregon Governor signed HB2935, requiring pharmacies to provide visually impaired patients with a prescription label reader. The reader is a device that is programmed to read the prescription label out loud. A chip encoded with the information printed on the label is embedded in the label, and the prescription reader audibly conveys relevant information about dosage, side effects, and other important information, making it possible for visually impaired individuals to discern what the medication is, which prescription bottle they are holding, and other details critical to successful adherence.

Skimpy on the Details, Maximizing Flexibility
The Rule is a single regulation, and mainly reiterates language from the statute without amplifying how pharmacies can comply. Specifically, the Rule states:

A pharmacy shall notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information. A pharmacy that provides a prescription reader shall make it available to the person for at least the duration of the prescription, shall confirm it is appropriate to address the person's visual impairment, and shall ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider. Or. Admin. R. 855-041-1131.

The Rule does not state, and so far there is no guidance from the Board addressing, how pharmacies are supposed to implement this. For example:

• What format must the notice be in?
• Is it acceptable for the notice to be electronic or verbal?
• Must notice be provided with each fill?
• If a patient requests a reader, is it acceptable for the pharmacy to contact the patient's prescriber to confirm the person has a visual impairment?
• Are pharmacies allowed to charge patients for the reader or bill for the replacement cost if the patient does not return it?

This leaves a significant amount of discretion up to the pharmacies. Overall, the cost of providing the readers, tracking who has which reader, and getting them back from patients at the end of a course of medication is expected to be a practical, logistical difficulty for many pharmacy providers if they don't already make readers available to their patients. There is also a risk that some prescription readers may not be returned to the pharmacy, for example, when a patient is no longer receiving medications from the pharmacy, is admitted to a hospital, or dies.

Oregon Focus on Accessibility in Other Areas as Well
In addition to legislation intended to improve access for visually impaired patients, Oregon has also enacted SB698, though it is not effective until January 1, 2021. This statute requires, among other things, prescription labels to contain English plus an additional language, upon request. There are no implementing regulations yet. The Board anticipates starting the rulemaking process for this language accessibility requirement next month. Quarles & Brady will send an alert when the Board releases for public comment a draft of the proposed rules.

Part of a Larger Trend
Over the past several years, states and the federal government have increased focus on ensuring patient accessibility to prescription information and health care services in languages that the patient can understand, and through assistive devices to help people control and manage their own treatment. Health care providers, including pharmacies, can be the target of complaints, enforcement action or, when it comes websites in particular, litigation, due to noncompliance with the growing body of accessibility requirements.

At the federal level, requirements stem from the Americans with Disabilities Act (ADA) and the Affordable Care Act (ACA), among others. For example, the US Department of Justice, through enforcement of the ADA, requires websites be accessible and, in several states, particularly under human rights laws in California and New York, companies have been the target of lawsuits based on accessibility issues with websites or apps. In addition, Section 1557 of the ACA prohibits health care providers from discriminating on the ground of race, color, national origin, sex, age, or disability in certain health programs and activities, and requires providers to have policies and procedures delineating how the provider makes care accessible (such as through the availability of translation services, telephone relay service, and other strategies).

At the state level, pharmacy boards have been focused primarily on language assistance for several years, and the trend is now expanding to assistive devices, such as the prescription label readers. California, New York, and others have requirements in place related to translation or interpretation services, including providing label information in multiple languages and notices to patients about the availability of pharmacy services in their preferred language. Many contracts or accreditations will also require provision of translation and interpretation services.

Technology is making strides to increase accessibility for patients in new ways. Regulations requiring implementation of the technology, to bring it to bear in a mass way, offer benefits and challenges. The benefits of such requirements include increased medication effectiveness and patient safety through ensuring people understand what their medication is for and how to take it correctly. The expanding requirements also increase the regulatory burden, compliance risk, and cost for pharmacies. The challenge of some of them, such as with products like the label readers, may be difficult to implement in a practical, cost-effective way without also generating inefficiency or other operational challenges. Cooperation among regulators, pharmacies, and patients may be necessary to ensure the best outcomes possible as technology continues to make strides in improving accessibility and the industry learns how to incorporate the new technology into patient care.

For more information about how the Rule could affect your business, or questions regarding prescription labeling and accessibility requirements, please contact your Quarles & Brady attorney or:

• Katea Ravega: (317) 399-2849 / katea.ravega@quarles.com
• Shamika Mazyck: (317) 299-2835 / shamika.mazyck@quarles.com