Virginia HB 516 Heads to Floor Vote

Virginia HB 516 Passes Subcommittee and Committee and Heads to Floor Vote

February 8, 2024 

A contingent of eight pharmacists were present representing the Virginia Pharmacy Association, Kaiser Permanente, Virginia Association of Chain Drug Stores, Epic Pharmacies (community pharmacy advocacy group), Virginia Food Industry Association, and the Virginia Society of Health System Pharmacists who all opposed accessible prescription labeling legislation. A few proposed alternatives including a Board of Pharmacy work group and wording that would allow the Board of Pharmacy to decide on the parameters of the regulations rather than codifying them.

Bonnie O'Day, legislative chair of the National Federation of the Blind of Virginia along with Stewart Prost and Shannon Britt of the Tidewater chapter, testified in support of the bill and demonstrated how talking prescription labels work.  Bonnie concluded her remarks saying, "I am extremely disappointed that the Board of Pharmacy and all of the pharmacists have come out against this bill with the very low cost it will take to implement it. I also oppose the substitute amendment that has been proposed. It is obvious that the Board of Pharmacy and all the pharmacists that have spoken today oppose the bill and think every thing is fine the way it is, so if you so establish some kind of study group, which I hope you do not, please find an independent body to conduct the research."

Several references were made throughout the hearing to the Virginia Board of Pharmacy HB2147 work group on translated and accessible prescription labeling in which no stakeholders or affected community members were included in the discussion.  The exact wording of HB2147 tasked them with identifying the "barriers" to providing translation and interpretation services, and that is exactly and only what they did. The resulting report from that discussion can be found here:  https://rga.lis.virginia.gov/Published/2023/RD719/PDF

Delegate Price, who was chairing the conversation offered the following comment: "I would just say, if you are in a work group and you find yourself around a table that does not have the affected community, then you know the room is not complete--this is something that we need to accept as the norm; folks need to be--and end the conversation."

Delegate Hope, sponsor of the bill concluded his remarks saying: "...This is about saving people's lives. I think that was demonstrated with the two different pill bottles [eye drops] that look exactly the same. Mistakes can be made. And we need to move on this.  I know there is a substitute that the staff attorney has, I don't know what the committee's will is.  I'd like to have a bill. I'd like to have the bill that is before you; but if the subcommittee wants to go a different route--I will say this--if we go the substitute option, we have to watch what comes out of this process. Because we will - I disagree with the comments that were said that we don't need to clutter up the statues with this.  Clearly there is a need.  Clearly someone needs to be told that we have to have this accessibility option for people who are vision impaired.  It's clear the need has been expressed. Either way, we act on this bill, or if we do the substitute, we have to come back here and make sure that this actually happens."

The original bill language was recommended to be reported out of committee 5-2 and passed the full committee on February 8, 2024 with 17 yea to 5 nay

Link to view the full Subcommittee Testimony:

https://sg001-harmony.sliq.net/00304/Harmony/en/PowerBrowser/PowerBrowserV2?fk=16132&viewMode=2#agenda_

Alce su Voz Builds Community Coalition for Mayan Language Speakers

Alce su Voz Builds Ark City Community Coalition with Speakers of Four Mayan Languages

By Rachel Showstack 

Nov 9, 2023

Ark City KS --Kansas residents from Guatemala who speak the Mayan languages K’iche’, Akateko, Q’anjob’al, and Aguacateko spoke with Alce su Voz on Saturday about what their communities need to attain health equity. The conversation occurred at our first Mayan community meeting in Arkansas City, a town in rural south-central Kansas close to Oklahoma. Not surprising to our team, one of the most salient themes in the conversation was the need for staff and providers within healthcare entities to understand that Mayan community members do not necessarily speak Spanish. Their languages, which are part of the Mayan language family, were spoken for thousands of years before the Spanish colonization, and yet many Kansans mistakenly believe that they are dialects of Spanish.

Read the full blog post here: https://www.alcesuvoz.com/post/alce-su-voz-builds-ark-city-community-coalition-with-speakers-of-four-mayan-languages

Medical Device Nonvisual Accessibility Act, H.R. 1328 / S. 3621

Issue—Inaccessible digital interfaces prevent blind individuals from independently and safely operating medical devices that are essential to blind people’s daily healthcare needs. 

Medical devices with a digital interface are becoming more prevalent and less accessible for blind Americans. The rapid proliferation of advanced technology is undeniable. Most new models of medical devices, such as glucose, oxygen, and blood pressure monitors, along with the emergence of in-home devices that offer medical care options, such as chemotherapy treatments and dialysis, require consumers to interact with digital displays or other interfaces. This new technology is constantly being developed and deployed without nonvisual accessibility as an integral part of the design phase, which creates a modern-day barrier. The inaccessibility of these medical devices is not a mere inconvenience; when accessibility for blind consumers is omitted from the medical technology landscape, the health, safety, and independence of blind Americans are in imminent danger.

According to the Center for Connected Medicine, telehealth currently makes up 20 percent of all medical visits, and more healthcare providers are looking to expand telemedicine services.[1] According to the Pew Research Center, Rural Americans live an average of 10.5 miles from the nearest hospital.[2] According to the Journal of the American Pharmacists Association, across the United States, 8.3% of counties had at least 50% of residents with a distance greater than 10 miles from the closest pharmacy.[3] Unfortunately,  these visits assume that a person has easy access to accessible medical devices to take their own vital signs. As a result of inaccessibility, blind and low-vision Americans are at a distinct disadvantage when it comes to receiving the same virtual healthcare as our sighted counterparts.

Nonvisual access is achievable, as demonstrated by several mainstream products. Apple has incorporated VoiceOver (a screen reading function) into all of its products, making iPhones, Macbooks and Mac desktops, and iPads fully accessible to blind people right out of the box. Virtually all ATMs manufactured in the United States are accessible, and every polling place is required to have a nonvisually accessible voting machine. Frequently, a simple audio output or tactile feature can make a product accessible at little to no additional cost for manufacturers.

Current disability laws have not been able to keep up with advancements due to the expeditious evolution of medical technology and its incorporation into medical devices. Although the Americans with Disabilities Act and other laws require physical accessibility for people with disabilities (e.g., wheelchair ramps, Braille in public buildings), no laws protect a blind consumer’s right to access medical devices. The National Council on Disability concluded that accessibility standards lag behind the rapid pace of technology, which can interfere with technology access.[4] This trend of inaccessibility will continue if accessibility solutions are ignored. Only a fraction of medical device manufacturers have incorporated nonvisual access standards into their product design, while others continue to resist these solutions.

Solution—Medical Device Nonvisual Accessibility Act:

Calls on the Food and Drug Administration (FDA) to promulgate nonvisual accessibility regulations for Class II and Class III medical devices with digital interfaces. The FDA will consult with stakeholders with disabilities and manufacturers and issue a notice of proposed rulemaking no later than twelve months after the date of enactment of the act. No later than twenty-four months after the date of enactment of the act, the FDA will publish the final rule including the nonvisual accessibility requirements.

 

Requires manufacturers of Class II and Class III medical devices with digital interfaces to make their products nonvisually accessible. Manufacturers will have twelve months following the publication of the final rule to ensure that all the Class II and Class III medical devices with digital interfaces they produce are nonvisually accessible.

 

Authorizes the FDA to enforce the nonvisual access requirements for Class II and Class III medical devices with digital interfaces. Any manufactured device found to be out of compliance, whether by a public complaint to the FDA or by an independent FDA investigation, will be considered an adulterated product under the Federal Food, Drug, and Cosmetic Act. Manufacturers may file for an exemption for one of two reasons: clear and convincing evidence that making the medical device nonvisually accessible would fundamentally alter the use of the product; or proof that modifying the medical device would create an undue hardship for the company.

 For more information, contact:

Justin Young, Government Affairs Specialist, National Federation of the Blind

Phone: 410-659-9314, extension 2210, Email: jyoung@nfb.org or visit www.nfb.org

 

 

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[1] See Center for Connected Medicine, Telehealth utilization settles in at 20% or less of medical appointments, available at https://connectedmed.com/resources/post-pandemic-telehealth-utilization-settles-in-at-20-or-less-of-medical-appointments/

[2] See Pew Research Center, How far Americans live from the closest hospital differs by community type, available at https://www.pewresearch.org/short-reads/2018/12/12/how-far-americans-live-from-the-closest-hospital-differs-by-community-type/

[3] See Journal of the American Pharmacists Association, Access to community pharmacies: A nationwide geographic information systems cross-sectional analysis available at https://www.japha.org/article/S1544-3191(22)00233-3/fulltext

[4] See NATIONAL COUNCIL ON DISABILITIES, National Disability Policy Progress Report: Technology that enables access to the full opportunities of citizenship under the Constitution is a right at 19 (October 7, 2016), available at https://ncd.gov/progressreport/2016/progress-report-october-2016