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SB 159 Frequently Answered Questions Can PrEP be provided to a patient for 30 days or 60 days? A PrEP/PEP certified pharmacist can provide no more than a 60-day supply, either as a 30-day prescription only (no refills) or 30-day prescription with one refill in order to give time to link to care. How many days do I have to take the end-of-session quiz? You have up to 60 days after the program to receive ACPE-accredited CE credit. Contact CSHP for more information on the certificate portion of the program. I did not pass the quiz on my first attempt. What do I do? You can re-take the quiz in order to receive a passing score. Is there a list of testing types available for use? How often do false-positive or false-negative results occur? The oral test has a higher rate of false-positive results (although still very low) in comparison to the serology test. The 4th generation RAPID test is very accurate and has a low chance of false-positive results. Is there a checklist to identify patients who are not eligible for PrEP/PEP? Any patient who is sexually active and does not know the status of their partners could benefit from PrEP. For PEP, if the patient has had an exposure to someone of unknown status then they have 72 hours in order to seek PEP care. If they are outside that window, they would not be eligible. Are there risks on current medications for male patients if they have future childbearing plans? There is currently no data showing negative side effects/results from anti-retroviral medications with the male reproductive organs. Do you recommend a very in-depth sexual history intake at the pharmacy (community) level? Yes, it is recommended to record a detailed sexual history of your patient if possible. The sexual history intake should be facilitated in a private space for counseling. If a patient says they are currently experiencing “intimate partner violence”, am I obligated as a pharmacist to report this to the police? Should I get patient consent prior to reporting? In California, healthcare practitioners (including pharmacists) have a mandatory requirement to report to the police if they suspect the patient is experiencing domestic violence. Have the domestic violence hotline available for quick access If the patient does not feel safe in their home, ensure to provide resources for where to access assistance Helpful link: Can PrEP/PEP be given to a pregnant female patient? For PEP, there are regimens that would not be recommended in pregnant women because of teratogenic side effects (i.e. dolutegravir) during the first trimester. An agent safe to use during pregnancy is raltegravir. For PrEP agents is not known to be teratogenic; however, it is recommended to consider the risks/benefits and establish your patient’s risk is in addition to other harm reduction strategies. Depending how far along the patient is in her pregnancy, a PrEP/PEP certified pharmacist will be able to make safe and effective recommendations. The Tsepamo study shows that the risk of neural tube defect incidence associated with dolutegravir is lower (0.003% incidence) than initially reported (0.3% of all deliveries), but there is still a risk especially in the first trimester of pregnancy. The neural tube generally develops between 2-8 weeks of gestation. If the patient needs PEP and is in her first trimester taking folate supplementation, then it is recommended to use raltegravir. If the patient is in her second or third trimester, then a dolutegravir-based regimen is recommended for PEP. What data, if any, are available for patients who use THC or CBD products and are interested in PrEP? Although legalized in California, there is limited information due to lack of legalization of THC or CBD products at the federal level allowing for specific robust clinical trials testing PrEP/PEP agents. Substance use by the patient is documented despite any evidence of drug-drug interactions with PrEP therapy, including most of the newer cannabinoid products. Will CSHP be making a toolkit or screener to help PrEP/PEP certified pharmacists set up their own programs? Does the Board of Pharmacy (BoP) have specific guidelines for setting up and maintaining PrEP/PEP competencies? CSHP is committed to seeing the full implementation of pharmacist-led HIV prevention services for all pharmacists who what t provide such services to their patient population. The webinar is CSHP’s first step in seeing this process through. It includes great resources such as a questionnaire, table of regimens based on screening, resources for domestic violence agencies, and contact information for organizations (i.e. Planned Parenthood) and healthcare practitioners to report domestic violence. Is there a resource of recommended physicians that pharmacists can refer to in the event that patients do not have a PCP? Resources are provided at the end of the webinar. When maintaining documentation of providing PrEP, is there or will there be an electronic database to ensure safety and efficacy of drug use? For example, the CURES program lets pharmacists know whether a patient is “shopping around” for drugs at pharmacies without following up with their PCP. The intent is to drive patients into primary care for their long-term PrEP; however, patients may find loot poles to obtaining PrEP/PEP medications. The discussions at BoP have not included such as listing as of yet. Does liver function pose a concern in PrEP/PEP use? Not specifically for PrEP. We are more concerned about renal function when agents such as tenofovir are being utilized in patient care. Do the days of use differ in anal versus vaginal tissue? Yes, tissue absorption varies at the two sites. The drug is absorbed quicker in anal tissue than vaginal tissue. The rate of tissue absorption also varies based on anti-retroviral agent and dosage. Is furnishing Descovy by a pharmacist covered by SB 159 despite not yet being incorporated into CDC guidelines? Although not yet in CDC guidelines, SB 159 allows for pharmacists to furnish Descovy for PrEP patients. Please note that Descovy is only approved for specified patient populations (i.e. MSM, transgender women). It has not been approved for furnishing use in heterosexual women and transgender men. Therefore, it is not approved in patients who have vaginal sex at this time. What happens if a patient has known pre-exposure to HIV before the maximum PrEP efficacy point (i.e. 7 days for anal receptive sex)? Recommendations do depend if the sexual encounter was with or without condom use, status of partner’s sexual history, etc. If the answers are unknown, PEP can be provided if sexual encounter took place within a 72-hour timeframe. Seriously consider risk versus benefit use in each patient prior to PEP furnishing. Is a PrEP/PEP certified pharmacist allowed to furnish additional refills for continuation of care? A pharmacist is allowed to furnish a 60-day supply maximum in a two-year period for PrEP. Advocating for linkage between patient and PCP is important for continued HIV protection. Is there a maximum benefit of co-pay card per fill for Descovy or Truvada? Yes, but this may change when Truvada goes generic at the end of 2020. As of now, insurance covers most of the cost allowing patients a low to no cost co-pay. More information about co-pays: Gilead’s Advancing Access program includes all of our patient assistance options including copay cards, insurance investigations, prior authorization assistance, and patient assistance for those that are uninsured or under insured. There is an income qualification which is set at 500% of the poverty level.You can find more information at the website: Gilead’s Advancing Access program includes all of our patient assistance options including copay cards, insurance investigations, prior authorization assistance, and patient assistance for those that are uninsured or under insured. There is an income qualification which is set at 500% of the poverty level. More information can be found at: *3A*2F*2F*2F&data=02*7C01*7Cjlam*40chapman.edu*7C4a0ed340784140829d5808d7c9bae309*7C809929af2d2545bf983Does the 60-day supply of PrEP need to be divided into two 30-day supply prescriptions or can we give the 60-day supply at once? It depends on the patient’s insurance plan. Currently, the regulations do not specify. If PrEP has already been furnished to a patient for a 60-day supply over the two-year period, how are we able to track patient history? There is no electronic record that keeps track of patient history at this time. The reason behind the 60-day supply is to help patients establish follow-up care with their PCP. Do we need to notify BoP that we have passed the SB 159 PrEP/PEP webinar training in order to begin furnishing? Completion of the training webinar and certification is sufficient.My pharmacy does not have an electronic medical record (i.e. EHR). Is there a location of documents in the pharmacy that we need to collect, store and use in order to log history and other related documentation? As of right now, there are no specific forms required to use for documentation. Some PrEP programs have been established through collaborative practice programs have used paper documentation/files. Is the CLIA waiver for SB 159 for oral swab only? Is the finger stick also waived? Both oral swab and finger stick are CLIA waived. Do pharmacy students need to claim CE credit in order to participate in PrEP/PEP medication management? Although CE credit are not necessary, pharmacy students are required to complete the online training webinar, quiz and certification in order to be PrEP/PEP certified. Discuss any PrEP/PEP practice opportunities with your APPE preceptor prior to any patient encounter.Do you recommend having a P&P in the pharmacy for furnishing PrEP/PEP? It is strongly recommended to have P&P in your pharmacy setting. It is good clinical practice to document and outline practices that are followed in your specific setting as well as on-site training that has been completed. Instructions for Claiming CPE CreditDo Not Skip Step 1:?This process ensures all CPE credit obtained from CSHP will be transferred to NABP’s CPE Monitor which is what state Boards of Pharmacy use for re-licensures and audits.?Creating an AccountStep 1:?Your?CSHP?account profile must include your, correct, NABP e-Profile ID and NABP e-Profile birthday (MMDD, no spaces) to successfully claim credits with CPE Monitor.?To do so, go to?.?If you already have an account:? Sign in to your CSHP account. ?Upon login, you will be taken to your “My Profile” page. To check/edit your NABP information in your profile, click the “Manage Profile” link on the right of the screen then click “Edit Bio”. View or update your NABP information in the “Professional Information” section. If you make any changes in your profile, make sure you click?SAVE CHANGES?at the bottom of the page. Proceed to Step 2 below.?If you have a lapsed/expired CSHP membership and just want to claim credit: Follow the instructions below for “If you do not have an account.”?If you do not have an account: ?Go to the top of the page and click “Join CSHP”.? If you wish to join CSHP select the appropriate member type.? If you do not wish to join CSHP and just want to process your CE, choose “Non-member CE Account” from the member type ($0 amount). Follow the steps. Make sure you enter your NABP e-Profile ID and NABP e-Profile birthday.NOTE: Once you have an account, you won’t need to repeat this process when you claim CPE in the future with CSHP.?Claiming Your CreditStep 2: Go to the?NEW?CSHP Online Continuing Education Portal at? 3: Once logged on to the CSHP Online Continuing Education Portal page,?, see “Claim your CE Credit for a Live Activity,” then type your session code (secret code provided at the end of your session) into the box and then click the “Now Click Here” button.?If you are completing an online activity, such as a?CJHP?CE article, go to "List of all available Online Activities" and make your selection (You must be a member to view?CJHP?articles).? INCLUDEPICTURE "" \* MERGEFORMATINET Step 4: Complete an evaluation for the session and submit. The system will send you an email acknowledging your attendance.? If there is an error with CPE Monitor and your submission, you will receive a second email within 24 hours.?Step 5: To ensure successful processing of your CE credit, please log into CPE Monitor. Go to?, click on NABP e-Profile Login, at the top of the page. If you have questions about logging onto NABP, you will need to contact NABP directly.More information about CPE Monitor?Contact CSHP if you have questions or issues claiming credit.?education@?or 916-447-1033 ................
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