New law will allow pharmacists to administer HIV prevention medication without prescription
Nevada will become one of the first states to allow pharmacists to prescribe human immunodeficiency virus (HIV) prevention drugs to patients at risk of contracting the virus, as the state works to combat one of the highest rates of HIV diagnoses in the country.
A bill signed by Gov. Steve Sisolak on June 6 authorizes pharmacists with sufficient liability coverage to prescribe, dispense and administer HIV prevention drugs — including post-exposure prophylaxis (PEP) to people who may have come into contact with HIV and pre-exposure prophylaxis (PrEP) for people at risk — without a prescription from a practitioner starting as early as Oct. 1, in accordance with protocols to be developed by the State Board of Pharmacy over the next several months.
“One of the biggest obstacles, across the globe, and specifically here in Nevada is access,” said Rob Phoenix, a family nurse practitioner who runs Huntridge Family Clinic, a LGBTQ-centric medical clinic in Las Vegas focused on HIV prevention and treatment. “It's hopefully going to bring an access point where patients can literally walk in, talk to the pharmacist about HIV and their risk and reduction in a culturally competent and sex-positive way.”
Since the beginning of the HIV and AIDS epidemic in the 1980s, significant advancements in the treatment of HIV have been made. Certain contraceptives, such as condoms, have long been and remain a commonly used and effective prevention method, but within the past 10 years, the Food and Drug Administration (FDA) has approved drug therapies for those who live at risk of being infected.
In 2012, the administration approved Truvada, a PrEP drug that can reduce the risk of contracting HIV by 99 percent and is recommended for all adults and adolescents at risk for HIV through sex or injection drug use, including people who have a sexual partner with HIV. In 2019, the FDA approved a second PrEP drug, Descovy, though the medication is recommended for a smaller group of people that only includes gay and bisexual cisgender men and transgender women because the drug’s effectiveness for preventing infection through vaginal sex has not been evaluated.
Despite the effectiveness of those drugs, there were only 1,535 PrEP users in Nevada in 2019, while there were more than 10,000 Nevadans living with HIV in 2018, according to data from AIDSVu, an online tool from Emory University’s Rollins School of Public Health that visualizes the impact of the HIV epidemic.
Phoenix explained that limited access to prevention options can create problems in Nevada, which had the fifth highest rate of new HIV diagnoses in 2018, behind Washington D.C., Georgia, Florida and Louisiana.
“Patients are coming in to providers, they're asking for HIV prevention and they're either being told, ‘we don't know what that is’ or ‘you shouldn't be having that kind of sex’ or ‘I don't prescribe that kind of medicine,’” Phoenix said.
Expanding access to prevention options is also especially important for the LGBTQ community. More than 80 percent of Nevada men living with HIV in 2018 contracted the virus during male-to-male sexual contact, and that year, gay and bisexual men made up 69 percent of the 37,968 new HIV diagnoses in the country.
Sisolak signed SB325, which was sponsored by Senate Minority Leader James Settelmeyer (R-Minden), into law during an event on June 6 focused on support of the LGBTQ community.
“In our state, we celebrate our diversity,” Sisolak said in a statement. “I am so grateful to sign legislation to ensure that our LGBTQ+ community feels safe, protected and can continue to grow and flourish in the Silver State.”
Settelmeyer did not respond to requests for comment from The Nevada Independent about the legislation, but the senator based out of rural, conservative Douglas County was joined during presentations of the bill by Elizabeth MacMenamin, vice president of government affairs for the Retail Association of Nevada, where he noted the need for expanding health care access in the state.
“We all know that this health crisis has shown us, without a doubt, that we do not have enough doctors out there to help individuals,” Settelmeyer said during a hearing of the bill in May. “What this bill seeks to do is allow pharmacists to kind of step in and help out, especially in the realm of dealing with pre-exposure to immunodeficiency and also to post-exposure.”
The measure received no opposition during its initial hearing and was voted unanimously out of the Senate, before passing 40-2 in the Assembly, with Andy Matthews (R-Las Vegas) and Annie Black (R-Mesquite) as the only opponents to the bill.
Preventing more cases
Advocates of SB325 have framed the measure as a wide-reaching public health effort that can both decrease the state’s high transmission rate and decrease stigma around HIV.
André Wade, who chairs the state’s HIV modernization task force and serves as the state director for Silver State Equality, an LGBTQ+ civil rights organization, explained that getting medication directly from a neighborhood pharmacy can be much easier than having to first go to a primary care provider.
“Someone can just go to the pharmacy and request PrEP or PEP and not have to go to their doctor, if they even have one, and have insurance, if they even have insurance,” Wade said. “So, it just takes away that barrier.”
Phoenix also said that some people may simply be more comfortable with going to the pharmacy because “the pharmacy is a pretty stigma-free zone,” where people already pick up other kinds of medication, such as antibiotics or blood pressure medicines.
One other bill, SB190, which was approved by the governor on June 8, expands access to medication in a similar way by allowing women to receive birth control through a pharmacy without a doctor’s visit.
The prevalence of other sexually transmitted diseases in Nevada also creates a greater need for more prevention options, Phoenix said. People who have a sexually transmitted disease typically have a greater risk of contracting HIV, according to the CDC, with syphilis and gonorrhea more closely linked to HIV than some other diseases. In 2018, Nevada had the highest rate of syphilis cases and the 12th highest rate of gonorrhea cases in the country.
As the state attempts to get more people at risk of HIV transmission on PrEP, Phoenix said the tools already in place through pharmacies can also help people adhere to prevention treatments.
“There's a significant drop off in persistence with PrEP over time,” he said. “One of the advantages of the pharmacy-based model is they're already getting reminders about other prescriptions, and the pharmacies have built-in processes for auto reminders and things like that.”
PrEP medications are typically administered on a 30-day basis, with one pill meant to be taken daily. The medication reduces the risk of getting HIV from sex by about 99 percent when taken as prescribed, according to the CDC.
The ease of access provided by pharmacies also could help prevent new HIV cases through the administration of PEP for people exposed to the virus because PEP must be taken within 72 hours after a possible exposure to HIV. Treatment using PEP then continues every day for 28 days.
Phoenix said that having pharmacists administer the drug can help deliver more treatments within that crucial 72-hour window, as many primary care providers are closed during the weekend.
“I can tell you dozens of examples of patients here in Las Vegas that have presented to urgent cares and quick cares and ERs and freestanding ERs, and they're denied PEP,” Phoenix said. “I see probably two or three patients a week for PEP, and the majority of them have been somewhere and they've been told, ‘we don't do that here’ or ‘we don't know what that is.’”
Wade also noted that people living in rural areas of Nevada will be able to access prevention drugs through neighborhood pharmacies, rather than through primary care providers that are more sparsely located in certain parts of the state.
As SB325 passed through the Legislature, proponents of the bill stressed that prevention does not happen in a bubble. Testing is also a vital part of limiting the number of new HIV diagnoses.
“People are less likely to transmit the virus if they know their status,” Wade said. “So all these efforts, public health efforts, to help people better understand and know what HIV is — the transmission, trying to increase testing so people can know their status and just decreasing the rate of transmission overall — eventually, it just has the potential to have the numbers go down and down.”
The bill requires the State Board of Pharmacy to develop protocols for pharmacists to not only prescribe and administer prevention drugs, but also to order or conduct the laboratory tests necessary to find out whether such medication is appropriate for the patient.
Phoenix said that the testing component of the bill could potentially lead to a quicker turnaround time for patients to receive PrEP.
“Ideally, they'll be able to do same-day PrEP,” he said. “The pharmacist will be able to just get them set up with a lab [test], so that they send them to the lab to get their blood drawn. But they get [the patient] their medicine to go.”
Increased testing is also a key goal of UNAIDS, a joint United Nations effort to end the global HIV and AIDS pandemic. UNAIDS is working towards a 90-90-90 target, which aims to have 90 percent of all people living with HIV know their status, 90 percent of all people diagnosed with HIV to receive sustained treatment and 90 percent of all people receiving treatment to experience viral load suppression.
Nevada lags behind those goals. In 2018, 19.1 percent of the new HIV cases in the state were diagnosed late, which is defined as receiving an AIDS diagnosis within three months of an initial HIV diagnosis. Other CDC data from that year suggests one in five Nevadans are unaware of their status.
Another bill, SB211, which was signed by the governor on June 4, also would help ensure more people know their HIV status, Wade said.
The measure requires medical providers who provide emergency medical services in hospital and primary care settings to offer STD testing, including tests for HIV, to anyone age 15 and older.
“We need all the tools from our toolbox to address this issue,” Wade said. “Testing is a tool, so people can know their status. Medication, like PrEP and PEP, is another tool.”
Even as the testing and prevention options become more widespread, the high costs of HIV medication remain a barrier to reducing new cases.
Truvada and Descovy, the two federally approved PrEP medications, each cost roughly $2,000 for a 30-day supply of tablets. A full, month-long course of PEP treatment can cost $600 to $1,000 for people without insurance.
However, insurance coverage and certain federal and state programs can help reduce costs.
SB325 requires private and public health plans, including Medicaid and plans for government employees, to provide coverage for the costs of HIV prevention drugs, as well as the costs of any associated laboratory or diagnostic procedures. Under the bill, those insurers are also required to reimburse pharmacists for testing and prescribing in the same manner that primary care providers would be reimbursed for the same services.
Gilead, a biopharmaceutical company that makes both Truvada and Descovy, has a program called Advancing Access, which provides copay coupon cards to certain eligible patients who need financial assistance with their copays. In 2019, the company also announced plans to donate 2.4 million bottles of Truvada annually to the CDC for uninsured Americans at risk for HIV, with donations running through 2030.
At the federal level, the Department of Health and Human Services runs a program called Ready, Set, PrEP which helps people who lack prescription drug coverage gain access to PrEP at no cost. In connection with that program, there is a federal HIV services locator available online that can connect people to the closest testing and prevention services in their area.
Phoenix said that few Nevadans are aware of the program and federal support available for people at risk of HIV.
“In Nevada, we've done a really poor job of advocating for Ready, Set, PrEP,” he said. “We only have about 25 people that are on that program, and it's been out for about three or four years.”
He added that even pharmacists may be unaware of the options for support.
“I can tell you my personal stories, the pharmacists don't know this,” Phoenix said. “I went to CVS and tried to get Ready, Set, PrEP, and they're like, ‘what's that?’ And they wanted to charge me $5,000 for a 90-day supply of medicine.”
People who have contracted HIV also have support options at the federal level through the Ryan White HIV/AIDS Program, which provides HIV information resources and helps connect people living with HIV who are uninsured or underinsured to treatment services.
Phoenix noted that new HIV treatment and prevention options could help with expanding access for patients at risk as more drugs are given approval over the coming years. In January, the FDA approved the first injectable, complete regimen for adults living with HIV that is administered once a month, and Phoenix noted similar options could eventually be available for PrEP.
“There are some new mechanisms for PrEP that are coming out that are probably going to be injectable, so this bill will allow the pharmacists to do the injections as well,” Phoenix said.
The remaining work
Following the passage of SB325 in early June, the State Board of Pharmacy has a maximum of two years to develop protocols to allow Nevada pharmacists to become some of the first in the nation to directly prescribe and administer HIV prevention drugs. The board is aiming to implement those protocols as early as Oct. 1.
In the past two years, California and Colorado have passed similar laws allowing pharmacists to administer HIV prevention drugs directly to patients, and an Oregon bill allowing pharmacists to administer PrEP and PEP was signed by the state’s governor on June 23.
As the regulations for Nevada’s pharmacists are developed, Phoenix said it will be important for the protocols to not create hurdles for pharmacists, noting that some laws in other states have included some limitations. In California, for example, pharmacists are not allowed to furnish a 60-day supply of PrEP to a single patient more than once every two years.
The state’s pharmacy board will be holding public meetings in the coming months to gather feedback on the regulations, including protocols for the administration of the drugs and rules on what level of liability insurance is sufficient for a pharmacist to engage in those protocols.
Though the timeline for enacting those regulations remains uncertain, proponents of the measure have stressed that the passage of SB325 is a significant step for the state.
“The idea of pharmacists being able to prescribe PrEP and PEP has been something folks have been talking about from a research and policy perspective for years,” Wade said. “So, I’m glad it's being implemented in Nevada … It is something that they needed for a very long time.”