RxCe - HIV-AIDS and Florida Prevention Programs Materials

HIV/AIDS AND FLORIDA PREVENTION PROGRAMS

JEFF GOLDBERG, PharmD, BCPP

Jeff Goldberg is a graduate of the University of Montana, Skaggs School of Pharmacy Doctor of Pharmacy program. He has clinical experience working in inpatient acute care and psychiatric hospitals and is a board-certified psychiatric pharmacist. He has also worked in community pharmacy settings. Jeff spends most of his free time exploring with his wife and kids and enjoys attending concerts and sports events.

Topic Overview

The human immunodeficiency virus (HIV) is a retrovirus that causes acquired immunodeficiency syndrome (AIDS). HIV can significantly depress immune system function, leading progressively to AIDS. Antiretroviral therapy (ART) has reduced the morbidity and mortality associated with HIV-1 infection and AIDS, enabling HIV-infected individuals to live longer and have an improved quality of life. Advancements in ART have allowed many patients with HIV to achieve viral suppression. Nevertheless, HIV and AIDS are still serious health problems requiring federal and state resources. The Omnibus AIDS Act, Florida, as amended, guides and mandates Florida healthcare clinicians in the areas of screening, diagnosing, and reporting HIV/AIDS under A Brief Legal Guide For Health Care Professionals. Florida law reflects existing recommendations by the Centers for Disease Control and Prevention and other national organizations concerned with HIV testing and methods to avoid disease transmission through voluntary testing.

Accreditation Statement:

RxCe.com LLC is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Universal Activity Number (UAN): The ACPE Universal Activity Number assigned to this activity is

Pharmacist 0669-0000-24-125-H02-P

Pharmacy Technician 0669-0000-24-126-H02-T

Credits: 1 hour(s) (0.1 CEU(s)) of continuing education credit

Type of Activity: Knowledge

Media: Computer-Based Training (online course) Fee Information: $4.99

Estimated time to complete activity: 1 hour(s) (0.1 CEU(s)), including Course Test and course evaluation

Release Date: September 8, 2024 Expiration Date: September 1, 2025

Target Audience: This educational activity is for pharmacists and pharmacy technicians

How to Earn Credit: From September 8, 2024, through September 1, 2025, participants must:

Read the “learning objectives” and “author and planning team disclosures;”

Study the section entitled “educational activity;” and

Complete the Course Test and Evaluation form. The Course Test will be graded automatically. Following successful completion of the Course Test with a score of 70% or higher, a statement of participation will be made available immediately. (No partial credit will be given.)

Credit for this course will be uploaded to CPE Monitor®.

Learning Objectives: Upon completion of this educational activity, participants should be able to:

Meet the continuing education requirements of the Florida Administrative Code, Rule 64B16-26.103(1)(a)

Identify how HIV/AIDS is transmitted

Identify methods of prevention and precaution for HIV/AIDS transmission

Describe the types of co-occurring disorders that may be seen in patients diagnosed with HIV/AIDS

Describe the State of Florida law on HIV/AIDS and its impact on testing, including the offering of HIV testing to pregnant women

Describe the State of Florida law on reporting HIV/AIDS and partner notification

Disclosures

The following individuals were involved in developing this activity: Jeff Goldberg, PharmD, BCPP, and Pamela Sardo, PharmD, BS. Pamela Sardo was an employee of Rhythm Pharmaceuticals until March 2022 and has no conflicts of interest or relationships regarding the subject matter discussed. There are no financial relationships relevant to this activity to report or disclose by any of the individuals involved in the development of this activity.

Educational Activity

HIV/AIDS and Florida Prevention Programs Introduction

The human immunodeficiency virus (HIV) is a retrovirus that causes acquired immunodeficiency syndrome (AIDS). HIV can significantly depress immune system function, leading progressively to AIDS. Antiretroviral therapy (ART) has reduced the morbidity and mortality associated with HIV-1 infection and AIDS, enabling HIV-infected individuals to live longer and have an improved quality of life, but there is no cure. Nevertheless, HIV and AIDS remain serious health problems requiring federal and state resources. Florida’s Omnibus AIDS Act, as amended, guides Florida clinicians in the areas of screening, diagnosing, and reporting HIV/AIDS under the publication known as “A Brief Legal Guide For Health Care Professionals.” As amended, the Florida Act reflects existing recommendations by the Centers for Disease Control and Prevention (CDC) and other national organizations concerned with HIV testing and methods to avoid disease transmission through voluntary testing. Pharmacy professionals’ understanding of transmission, progression, treatment of HIV and AIDS, and Florida regulations provides opportunities to mitigate transmission and support patients and healthcare colleagues at risk for, or presenting with, infection.

Prevalence of HIV/AIDS

The human immunodeficiency virus remains prevalent among specific population groups.1,2 Approximately 1.2 million people live with HIV infection.3 In 2022, about 31,800 people acquired HIV in the U.S.3 It is estimated that 13% of new HIV infection cases are undiagnosed, which may lead to unknowingly infecting partners.3 Infections with HIV and the development of AIDS in the U.S. disproportionately affect racial and ethnic minorities and homosexuals/bisexuals, particularly men who have sex with men (MSM).4,5 Black females are disproportionately affected by HIV compared to women of other races or ethnicities.5 Men who have sex with men (MSM) account for

70% of the new diagnoses.5 In addition, more than 1 million people in the United States identify as transgender. In 2021, adult and adolescent transgender people and people with other gender identities made up 2.5% of new HIV diagnoses in the United States and territories.5 Most new HIV diagnoses were among Black/African American transgender women.5

Takeaway:

About 13% of people with HIV, or 1 in 7, are not aware they have HIV. This part of the population does not receive the care and treatment they need to stay healthy and prevent transmitting the virus to their partners.6

Types and Stages of HIV Infection

The human immunodeficiency virus is a retrovirus.7,8 An infection with HIV is a process of viral entry into the body, attachment of HIV to the cell membrane of CD4+ T-cells in the immune system, entry of HIV into those cells, and subsequently, viral replication.8 Replication is the process by which HIV releases its RNA into the cell, allowing viral DNA to be integrated into the host’s DNA, leading to the production of multiple copies of HIV.9

HIV-1 and HIV-2

There are two types of HIV: HIV-1 and HIV-2.5 In the U.S., HIV-1 is the most common type of HIV infection. HIV-1 and HIV-2 can progress to AIDS.10

Stages of HIV Infection

When a person becomes infected with HIV, the progression of the infection may be described in stages. The National Institute of Health (NIH) describes the stages as (1) acute HIV infection, (2) chronic HIV infection, and

(3) acquired immunodeficiency syndrome (AIDS).11

The Acute HIV Infection Stage

The stage immediately following an HIV infection is the acute HIV infection stage, developing within 2 to 4 weeks after infection and may last for months. Seroconversion occurs, and antibodies can be detected in the blood. The patient will test positive for HIV.12,13 At this point, the blood levels of HIV are very high, which increases the risk of transmission.

The Chronic HIV Infection Stage

The second stage of HIV infection is the chronic HIV infection stage, characterized by clinical latency and few (if any) symptoms.14 During this stage, there is a consistent decline in CD4 cell count and relatively stable viral load.14,15 Chronic HIV infection generally lasts several years, even without treatment, before progressing to AIDS.14

During this stage, the virus becomes established in the CD4 cells of the immune system. The infected patient is generally asymptomatic because the immune system can still combat most infections until the CD4 count drops to critical levels (<200 cells/µL), signifying the development of AIDS.14 HIV can replicate and mutate rapidly. In addition, the viral reservoirs cannot be eliminated. It is still possible to transmit HIV in this stage (even if the patient is taking ART).13

AIDS

Once the CD4 cell count falls below 200 cells/µL or the patient develops an AIDS-associated opportunistic infection, the patient is diagnosed with AIDS. Patients with AIDS have very low levels of CD4 cells, severely impaired immune function, and are at risk for the development of opportunistic infections and neoplasms.11

The CD4 cells infected with HIV reproduce the virus and are subsequently destroyed. This leads to fewer CD4 cells able to activate an

immune response and predisposes the patient to opportunistic infections, very high viral load, and increased risk of virus transmission.16

HIV Transmission and Prevention

Transmission of HIV occurs primarily by contact with infected blood and by sexual contact.17,18 HIV can also be transmitted perinatally from a mother to a child during the pregnancy, delivery, and even through breast milk (which accounts for nearly 50% of pediatric HIV infections each year).19 HIV can be found in essentially any type of body fluid or secretion, but the risk of transmission from contact with body fluids/secretions other than blood, semen, or vaginal fluids tends to be remote.18 Feces, gastric secretions, sputum, and body fluids other than blood, semen, and vaginal fluids may contain HIV, but they are not considered infectious unless they are visibly contaminated with blood.18

Sexual Transmission

Most HIV infections happen from sexual activity with an infected person. The sexual transmission of HIV depends on multiple factors, such as circumcision, genetic factors, viral load, sexual behaviors, other sexually transmitted diseases, and ART administration.17,20-22 Circumcision decreases HIV infection significantly;21 however, it does not appear to decrease the risk of male-to-female transmission.23

Sexual behaviors that influence HIV transmission may include the type of sexual activity (with MSM having the highest risk), number of sexual partners, use or non-use of condoms, and sexual activity corresponding with alcohol or drug use.17 The risk of HIV transmission during one act of unprotected intercourse is an estimated 0.04% female-to-male and 0.08% male-to-female.24,25 The presence of a sexually transmitted disease increases the risk for HIV transmission.21,22

Sexual Transmission Prevention Strategies

Prevention strategies for sexually transmitted diseases include medical interventions (such as ART) and preventative behaviors (such as avoiding high-risk behavior).2,17 Pharmacists can counsel patients on behavioral changes, which may include a change in the type of sexual activity, a reduction in the number of sexual partners, the use of condoms, and an understanding of the role alcohol or drug use during sex may play in leading to more risky behavior.17,26

Blood Transfusion Transmission

HIV can be transmitted by transfusion with donated blood or blood products, such as packed red blood cells, fresh frozen plasma, platelets, whole blood, etc.27 Potential donors are screened for HIV infection, and donated blood is tested for antibodies to HIV-1 and HIV-2, as well as HIV-1 nucleic acid.28 As a result, the risk has been reported as low.27 The reported risk of HIV transmission following a contaminated blood transfusion is approximately 88% to 100%.29

Needle Sharing

The risk of HIV transmission from using an HIV-contaminated needle has been estimated to be one infection per 150 exposures to needle or syringe sharing.29,30 Needle sharing should never occur.

Clinical Pearl

Counsel patients to always dispose of needles or syringes safely after use.

Occupational Exposure

Blood is the most common source of HIV transmission to healthcare workers. Other body fluids, such as amniotic fluid, cerebrospinal fluid, pericardial fluid, pleural fluid, and synovial fluid, are also considered potentially infectious.31 Feces, gastric secretions, nasal secretions, saliva, sputum, sweat, tears, and urine may contain low amounts of HIV but are not considered infectious unless they are visibly contaminated with blood.31

Percutaneous Inoculation (Needlestick)

An exposure that places healthcare workers, including pharmacists, at the most risk for infection with HIV is percutaneous inoculation (needlestick) with blood from a patient with an HIV infection, accompanied by the presence of a detectable viral load in the patient and/or the patient is not on suppressive antiretroviral therapy.31,32

The CDC estimates that hospital-based healthcare personnel sustain 385,000 needlesticks and other sharps-related injuries annually. This is an average of 1,000 sharps injuries per day.33-35 Wyżgowski, et al. (2016) stated that the probability of HIV infection caused by needle injury ranges between 0.3% to 0.03%, based on risk factors such as the depth of injury and volume of blood the person was exposed to.36 The risk of HIV infection is greater if the viral load is high, the amount of blood injected or splashed is high, a large bore or hollow needle was involved,36 as well as a deep injury or an injury from a visibly contaminated device.29 An injury with a needle that had been placed in a vein or artery of a terminally ill, infected patient will raise the risk of an actual infection.29

Risky behaviors are estimated to cause 95% of HIV infections contracted in an occupational setting.36 Wyżgowski, et al. (2016) evaluated the daily routine of surgeons and anesthetists to determine whether they treated every patient as being potentially HIV-positive or whether they engaged in risky behavior by not doing so.36 They found that these medical professionals only

took precautions if the patient was from a known high-risk group, such as male homosexuals, bisexuals, intravenous drug abusers, etc.36

Needlestick Prevention for Healthcare Workers

When handling any blood or other bodily fluid, healthcare providers should always take the same precautions and assume that it could potentially be infected with a bloodborne pathogen (such as HIV). Safety rules to prevent HIV transmission need to be observed daily.33,36,37

Post-exposure Prophylaxis

The CDC published recommendations for managing occupational exposures. After a healthcare worker is exposed to HIV (especially the first 6 to 12 weeks, when most infected persons are expected to show signs of infection), the exposed healthcare worker should follow standard recommendations for preventing transmission of HIV. These include not donating blood, semen, or organs and not having unprotected sexual intercourse.32 If someone chooses to have sexual intercourse, using a condom consistently and correctly may reduce the risk of HIV transmission.32 In addition, women should consider not breastfeeding infants during the follow- up period to prevent exposing their infants to HIV in breast milk.

Guidelines for healthcare workers who have been exposed to HIV include the following precautions and steps:32,38

Eyes and affected mucous membranes should be flushed with water.

Wounds should be washed with soap and water

Healthcare workers should notify their department handling occupational exposures to bloodborne pathogens

Seek medical attention immediately

If possible, conduct rapid HIV testing on the source patient (as well as testing for bloodborne pathogens, such as hepatitis B and C)

Test for the presence of HIV with follow-up testing at 6 weeks, 12 weeks, and 6 months

Start post-exposure prophylaxis (PEP), preferably within 72 hours of exposure. Do not delay while awaiting HIV test results

Possible Exposure Risks for Pharmacists and Technicians

All healthcare workers should be cautious of bodily fluid exposure. All needles and syringes should be disposed of properly in a sharps container, and needles should never be recapped after use to avoid an accidental stick. For pharmacists who do point-of-care testing, proper use of gloves and immediate disposal of testing supplies can greatly decrease the risk of needlesticks and bloodborne pathogens. Pharmacists in hospital settings should wear appropriate garb for the setting they are entering. All pharmacy staff should be aware of bodily fluids that may be on bottles and supplies that patients may bring in and be cautious and diligent when handling a patient’s supplies.

Case Study: Accidental needlesticks reported by a retail pharmacy chain

A study reviewed needlestick injury reports from 2000 to 2011 in a nationwide retail pharmacy chain. Thirty-three likely preventable needlestick injuries were reported,39 of which 73% occurred during the peak influenza vaccine administration months, from September through January. The injuries most commonly occurred (58%) after use and before needle disposal when

putting the sharp into the disposal container while disassembling the sharp and when the sharp was left in an inappropriate place.39

SHEA Guidelines and the HIV-infected Healthcare Worker

The Society for Healthcare Epidemiology of America (SHEA) recommends that healthcare workers infected with hepatitis B, C, and/or HIV routinely double-glove for all invasive procedures.40 The goal is to prevent contact with mucous membranes or non-intact skin. These recommendations include receiving advice from an expert review panel and having routine follow-up, which includes viral load testing twice each year to document appropriate viral suppression (less than 200 copies/mL). The healthcare worker must agree, in writing, to comply with oversight and agree to allow their physician to disclose their health information to the review panel. Appropriate infection control procedures in SHEA guidelines reduce patient exposure to blood.

OSHA Bloodborne Pathogen Standards

Adherence to the bloodborne pathogen standard established by the Occupational Safety and Health Administration (OSHA) is mandatory for all hospitals and healthcare facilities. To comply, employers must establish a written plan for controlling exposure to bloodborne pathogens.41-43 This plan should include an assessment of risk situations, which employees are at risk and when they are at risk, and specific employer actions to control and manage exposure to bloodborne pathogens.41-43

Pharmacy personnel should remain vigilant regarding the annual plan, which includes the following:41-43

Implementing standard precautions and ensure that employees know how to use them

Provide personal protective equipment (PPE) at no cost and educate when PPE should be donned

Provide initial and annual training on bloodborne pathogens to all employees.

Use engineering controls to control the risk of exposure to bloodborne pathogens41-43

Using work practice controls for the proper handling and disposal of blood, specimens, contaminated waste, and the proper cleaning and decontamination of equipment and patient rooms

Offer vaccination against hepatitis B to all employees with exposure risk

Action plan for employee exposure occurrence

Disposable gloves must be discarded as soon as possible after they have become contaminated, punctured, or torn. Employees must wash their hands immediately or as soon as possible after removing gloves. Employees must wash their hands after contact with blood or other potentially infectious material and before and after performing patient care.41-43

PEPline Hotline

The National Clinicians Consultation Center PEPline is a consultation service for occupational post-exposure prophylaxis. The PEPline has trained physicians to give information, counseling, and treatment recommendations for needle stick injuries.44

Healthcare Worker-to-Patient HIV Transmission

CDC Guidelines

After a cluster of HIV infections of patients by a Florida dentist, these cases led to the publication of CDC guidelines entitled “Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures.”45-47

Mother-to-Infant Transmission

HIV can be transmitted from a mother to a child during pregnancy, labor, and after birth via breast milk. The most important factor for mother- to-child HIV transmission is the viral load, which applies to prenatal transmission, transmission during birth, and transmission via breast milk.48-50

The risk of HIV transmission in the absence of prenatal ART has been estimated to be approximately 25%.48 If a mother and infant receive prophylactic ART and the infant is not breastfed, this risk is approximately 0.1%.48 The American Academy of Pediatrics has advised that regardless of viral load and/or the use of ART, HIV-positive mothers should not breastfeed.49,50

Clinical Pearl

The Perinatal HIV Hotline (888-448-8765) and the PEPline (888-448-4911)

are both available 24 hours, 7 days per week

Pre-Exposure Prophylaxis, ART, and Other Preventions

Prevention is key.51,52 ART, sexual abstinence, the use of condoms, avoidance of sharing drug-injection equipment, and pre-exposure prophylaxis are all effective means of prevention.53 For couples who are serodiscordant, ART significantly reduces the viral load and helps to prevent the transmission of HIV.22,54,55 The effectiveness of condoms in preventing the transmission of HIV, if used properly, has been estimated to be 90-95%.22,56 Lambskin condoms are ineffective.57 A dental dam (a thin square of latex) or condoms can be used to help prevent the transmission of HIV from oral sex.54,55

Pre-Exposure Prophylaxis

Providing intravenous drug users with sterile syringes aims to reduce needle sharing and can help to decrease the incidence of HIV infections.58 Intravenous drug users with an HIV-positive partner, people who share injection equipment, and those who have recently undergone drug treatment but are not currently injecting drugs may benefit from pre-procedure prophylaxis.59 The CDC recommends two oral medications, emtricitabine and tenofovir disoproxil fumarate (Truvada®), and emtricitabine and tenofovir alafenamide Descovy®.60 They are approved for daily use as HIV PrEP.60 In addition to the oral medications, the FDA has approved cabotegravir extended-release injectable for intramuscular use as HIV PrEP.60 Emtricitabine and tenofovir alafenamide may be used as PrEP in men and transgender women. 60

There is a significant reduction in HIV transmission when PrEP is used in at-risk populations.59 PrEP is recommended for those at substantial risk for acquiring HIV, including those who have recently had a bacterial STD, have a high number of sexual partners, have a history of inconsistent or no condom use, or are sex workers.59

Case Study: Pre-Exposure Prophylaxis

The following case study highlights the importance of considering a patient’s comorbidities, labs, and other factors before prescribing PrEP. In this case, a 56-year-old European MSM and recreational drug user moved to Bangkok. He started taking tenofovir disoproxil fumarate in combination with emtricitabine (Truvada®) as pre-exposure prophylaxis.61 He had intercourse with an average of two male partners per week, often unprotected.61 Eleven months after starting the PrEP, he stopped taking PrEP on medical advice due to his suboptimal renal function. He was diagnosed with secondary syphilis (rashes to the palm and sole) and treated.61 Later, due to impaired renal function, he was denied PrEP (Cr 1.53 mg/dL and eGFR of 50).61

For reference, the package insert for emtricitabine and tenofovir disoproxil fumarate allows the continued use of the medication if the creatinine clearance is greater than 30 mL/min, so the patient possibly could have remained on the medication with an adjusted dosing schedule.62 While not on PrEP, he continued to have unprotected sex and was diagnosed with HIV.61 The lesson is that there remains a need for clinicians to consider alternative HIV prevention plans for patients who discontinue PrEP.61

HIV Screening

The CDC recommends screening to detect HIV for everyone aged 13 to 64 years of age, women who are pregnant or may become pregnant, anyone who is in a high-risk group, anyone who seeks treatment for an STD, and all patients who are diagnosed with hepatitis B or tuberculosis.63

Blood Test for Antibodies to HIV and HIV Antigen

Screening uses blood tests that look for antibodies to HIV, the HIV antigen, and/or HIV.63,64 Antibodies can take up to 90 days to appear following infection.65 For most people, an antibody response to HIV will be detected within three months of infection. Alternatively, a person who tests negative but has been involved in high-risk behavior within three months of the test could still have an HIV infection.63

The CDC guidelines discuss the laboratory testing and criteria to detect HIV in adults and children two years of age and older:66-68

A combination test that detects antibodies to HIV-1 and HIV-2 and

p24Ag (an HIV antigen)

If any part of the combination test is positive or indeterminate, then nucleic acid testing should be performed to verify the positive result. A nucleic acid test checks for target sequences of specific HIV genes

If the nucleic acid testing is positive, there is an HIV infection

Home Screening Tests

The Food and Drug Administration (FDA) has approved two home screening tests to detect HIV: OraQuick® and Home Access HIV-1 Test System.69-71 OraQuick® uses an oral swab and a test liquid, and the results are ready in 20-40 minutes.70

Pharmacy technicians should know where home tests are located if stocked in the pharmacy. Pharmacists should also be prepared to give patients information on where testing may be available, direct patients to their primary care provider for laboratory testing if there is a significant concern, and steps to take if a home test comes back positive.

State Regulations for HIV/AIDS Testing

Florida reported one of the highest rates of HIV infection, so the state passed the Omnibus AIDS Act of 1988.72 Florida’s Omnibus AIDS Act, as amended, guides and mandates healthcare clinicians regarding screening, diagnosing, and reporting HIV/AIDS under the publication known as “A Brief Legal Guide For Health Care Professionals.”72 The Florida Act, as amended, reflects existing recommendations from the CDC and other national organizations.72

In Florida, specific licensed healthcare providers must complete a course on HIV/AIDS that conforms to their professional roles.73 Also, all licensed healthcare facilities must educate employed healthcare workers about HIV infection.74,75

The Department of Health also enacted legislation to “develop and implement a statewide HIV and AIDS prevention campaign to strengthen HIV and AIDS prevention programs and early intervention and treatment efforts in the state’s black, Hispanic, and other minority communities.”72,76 The goal was to create a healthcare environment where people needing HIV testing would consent to the test with the reassurance of receiving proper informed consent and privacy. Patient rights to confidentiality under the Florida statute

also prohibits discrimination against patients who are confirmed positive for HIV/AIDS.72

The Targeted Outreach for Pregnant Women Act (TOPWA) was passed in 1999 “to reach pregnant women who have HIV and high-risk pregnant women who are not receiving services.”77 TOPWA focuses on the needs of under-served women to help them obtain medical or social services with a treatment goal to reduce their risk for HIV infection as well as co-occurring disorders such as substance use.77

Through services offered by TOPWA, women of childbearing age with a history of HIV infection or substance use or who are at risk of being infected with HIV can receive assistance for access to prenatal care. Additionally, pregnant women enrolled in TOPWA are provided HIV testing, family planning services, and other HIV prevention and education.77

Healthcare professionals, including pharmacists and nurses, must complete education on the State of Florida HIV testing protocol that outlines procedures that must be in place “for securing patient consent, testing samples, and informing patients of test results.”72 Florida's Omnibus AIDS Act requires, with few exceptions, health care providers ordering HIV tests to (A) obtain the "informed consent" of the test subject, (B) confirm positive preliminary test results through corroborating tests before informing the test subject of the result and (C) take "all reasonable efforts" to notify the test subject about the test results.”72

Provisions were also added regarding notification of persons other than the patient who may have been exposed to HIV and for mandatory reporting of positive HIV test results to Florida public health offices.72

When a patient tests positive for HIV, the healthcare provider (or their designee) who orders the HIV test is required under Florida law to advise the patient of the importance of notifying sexual or needle-sharing partners who may have been exposed. Providers should also inform the patient of voluntary and confidential partner notification services provided by the Florida

Department of Health and county health departments. When notifying partners who may have been exposed, health department employees are required to keep the identity of the original patient who tested positive for HIV confidential. Providers are required to report positive HIV tests to their local county health department within two weeks of the positive test.72

An important source of information for Florida pharmacists is the Florida Department of Health Division of Medical Quality Assurance BOARD OF PHARMACY (2020), which outlines requirements for maintaining patient confidentiality and State of Florida Statutes pertaining to required education for all healthcare professionals on HIV/AIDS testing requirements in Florida.78 All pharmacists, upon their first renewal of licensure, must complete one hour of board-approved continuing education on HIV/AIDS. More information regarding required education for pharmacists in Florida is available online.78 Continuing education requirements related to HIV/AIDS education for professional licensees, including pharmacists, are listed in Section 456.033, Florida Statutes.72,74

AIDS and Co-occurring Disorders

Once a patient with HIV progresses to AIDS, several different organ systems can be affected.79 Comorbidities, such as endocrine conditions, liver disease, cardiovascular disease, neurologic disease, oral lesions, and pulmonary disease, can indicate that a patient with HIV has progressed to AIDS.79,80

Pulmonary Disease

Pulmonary disease is a typical complication of AIDS. Sinus infections, bacterial and fungal pneumonia, and tuberculosis are common in people with AIDS.81,82 There is a high incidence of chronic pulmonary disease and respiratory symptoms in HIV-infected individuals.82

Tuberculosis is a leading cause of infectious disease death globally.83 According to Al Abri, et al. (2020), TB surpassed HIV/AIDS in terms of morbidity/mortality rates, and in 2018, an estimated 1.5 million deaths worldwide resulted from a TB infection, of which 251,000 deaths involved HIV- positive individuals.83

The CDC guidelines recognize that “TB disease can be difficult to diagnose in persons with HIV infection because of nonclassical or normal radiographic presentation or the simultaneous occurrence of other pulmonary infections. HIV-infected patients are also at greater risk for extrapulmonary TB.”84 Healthcare workers exposed to suspected or confirmed infectious TB should consider an N95 disposable respirator.85

Additional infections and neoplasms, considered to be AIDS-defining diseases, may include bacterial infections, candidiasis, cervical cancer, cytomegalovirus, Kaposi sarcoma, Burkitt lymphoma, or myobacterium avium complex, among others.86-88

Brief Overview of Antiretroviral Therapy

Even with advances in treatment and prevention, there is no cure.1 ART is the recommended treatment for HIV. Some sources use the term HAART, or highly active ART when referring to ART.2,90-92 Treatment reduces the morbidity and mortality associated with AIDS. It has also enabled HIV-infected individuals to live longer, improve their quality of life, and decrease HIV transmission.2,90-92

In the U.S., the recommendation is to begin ART for all patients who have an infection with HIV.2,91,92 Treatment is focused on three goals:

1) Managing the infection with ART, 2) Monitoring and treating complications, and 3) Preventing transmission of HIV.2,91,92 Reaching these goals can restore and preserve immunologic function, reduce HIV-associated morbidity, and prolong the duration and quality of survival.

There are nine classes of ART drugs that can be used and include:

1) non-nucleoside reverse transcriptase inhibitors (NNRTIs), 2) nucleoside reverse transcriptase inhibitors (NRTIs), 3) protease inhibitors (PIs), 4) fusion inhibitors, 5) chemokine receptor antagonists (CCR5 antagonists),

6) integrase strand transfer inhibitors (INSTIs), 7) post attachment inhibitors,

8) attachment inhibitors, and 9) capsid inhibitors.90,91

Different ART regimens are used for children, pregnant women, people who have been previously treated with ART, and people who have specific medical problems. Prior to beginning ART, a patient’s medical, psychological, and surgical history should be reviewed, and the prescription, over-the- counter, and supplements the patient is taking should be reviewed.92,93 The patient should receive vaccinations for influenza, hepatitis A, hepatitis B, pneumonia, and varicella.92,93

Despite the effectiveness of ARTs, HIV/AIDS remains a US and global public health issue.94 As such, monitoring laboratory values is needed to evaluate the effectiveness of ART and monitor for adverse drug effects.2,92-95

Treatment failures are partly driven by the emergence of resistant viral strains resulting from poor treatment adherence, leading to virologic failure associated with rebound viremia, worsening immune function, and increased morbidity and mortality.94 In addition to the emergence of drug-resistant strains, virologic failure can be caused by drug resistance, suboptimal drug concentrations, and drug interactions. Pharmacy teams can address these failures by recommending genotypic resistance testing to the interdisciplinary team, considering that failure may be caused by poor adherence versus failure caused by drug resistance, understanding that poor adherence and failure caused by drug resistance can coexist, and using treatment regimens consisting of at least three medications from two or more drug classes.94 The objective of therapy after treatment failure is to choose a regimen that is well- tolerated, affordable, minimally burdensome, and capable of rapidly and consistently achieving virologic suppression.94

Summary

Pharmacists and pharmacy technicians need to remain current regarding diagnosis and major improvements in the medical treatment and prognosis for individuals with HIV/AIDS. HIV/AIDS transmission, including mother-to-infant transmission, sexual transmission, occupational exposure, and potential risk factors affecting disease outcomes, results in increased morbidity, mortality, and risk to healthcare teams. All healthcare professionals should emphasize the importance of risk reduction processes and adherence to ART. Healthcare professionals should complete continuing education courses on HIV/AIDS that conform to their professional roles to stay up to date with the latest recommendations to optimize healthcare worker safety and patient outcomes.

Course Test

HIV is primarily transmitted through

sexual activity with an infected person.

casual social contact with an infected person.

insect bites.

blood transfusion from HIV-contaminated blood.

People who are infected with HIV will generally have a detectable antibody response to HIV

three months after infection.

after the sixth month following an infection.

only when AIDS symptoms are present.

one month after a positive HIV test

Healthcare workers are at the greatest risk for a workplace infection with HIV

through aerosol transmission of HIV from an infected patient.

from a needlestick with blood from an HIV-infected patient.

from contact with linen from an HIV-infected patient.

when caring for a patient with AIDS.

The CDC recommends pre-exposure prophylaxis (PrEP) with

hepatitis B vaccination

dolutegravir

abacavir and lamivudine

emtricitabine and tenofovir disoproxil fumarate (Truvada®)

Post-exposure drug prophylaxis for occupational HIV exposure by a healthcare worker should be started

only if the healthcare worker tests positive for HIV.

only if the patient who is the suspected source of the potential exposure tests positive for HIV.

as soon as possible, preferably within 72 hours after the exposure.

within 10 days of exposure.

is the most common source of HIV transmission to healthcare professionals.

Amniotic fluid

Pericardial fluid

Pleural fluid

Blood

Tuberculosis (TB) can be difficult to diagnose in persons who have HIV because

HIV-infected persons are at a reduced risk for extrapulmonary TB.

TB, like HIV, is a retrovirus.

of the simultaneous occurrence of other pulmonary infections.

radiographic presentations of TB are always normal.

Which of the following best describes who benefits from services offered by TOPWA in Florida?

Women with HIV/AIDS

Women of childbearing age with a prior HIV infection, substance use, or high risk of HIV infection

Men who have sex with men

Adolescent males or females

Which of the following statements best expresses when safety precautions should be followed by a healthcare professional when handling any blood or other bodily fluid?

Safety precautions should be followed only when a healthcare professional knows the patient is HIV positive

Safety precautions should be followed only when a healthcare professional knows the patient is in a high-risk group for HIV infection

Safety precautions should be followed only when a healthcare professional knows the patient is an intravenous drug user

A healthcare professional should follow safety precautions for all patients.

When a patient tests positive for HIV, the healthcare provider (or their designee) who orders the HIV test is required under Florida law to

let the HIV patient’s partners know that the patient exposed them to HIV.

report positive HIV tests to their local county health department one month after the positive test to ensure the test was not a false positive.

inform the patient that the Florida Department of Health requires mandatory partner notification.

advise the patient of the importance of notifying sexual or needle- sharing partners who may have been exposed.

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DISCLAIMER

The information provided in this course is general in nature, and it is solely designed to provide participants with continuing education credit(s). This course and materials are not meant to substitute for the independent, professional judgment of any participant regarding that participant’s professional practice, including but not limited to patient assessment, diagnosis, treatment, and/or health management. Medical and pharmacy practices, rules, and laws vary from state to state, and this course does not cover the laws of each state; therefore, participants must consult the laws of their state as they relate to their professional practice.

Healthcare professionals, including pharmacists and pharmacy technicians, must consult with their employer, healthcare facility, hospital, or other organization, for guidelines, protocols, and procedures they are to follow. The information provided in this course does not replace those guidelines, protocols, and procedures but is for academic purposes only, and this course’s limited purpose is for the completion of continuing education credits.

Participants are advised and acknowledge that information related to medications, their administration, dosing, contraindications, adverse reactions, interactions, warnings, precautions, or accepted uses are constantly changing, and any person taking this course understands that such person must make an independent review of medication information prior to any patient assessment, diagnosis, treatment and/or health management. Any discussion of off-label use of any medication, device, or procedure is informational only, and such uses are not endorsed hereby.

Nothing contained in this course represents the opinions, views, judgments, or conclusions of RxCe.com LLC. RxCe.com LLC is not liable or responsible to any person for any inaccuracy, error, or omission with respect to this course, or course material.

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