The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Appropriations Committee on Health and Human Services
BILL: CS/CS/SB 1320
INTRODUCER: Appropriations Committee on Health and Human Services; Health Policy Committee;
and Senator Calatayud
SUBJECT: HIV Infection Prevention Drugs
DATE: February 12, 2024
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Rossitto-Van
Winkle
Brown
HP
Fav/CS
2. Gerbrandt McKnight AHS Fav/CS
3. RC
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/CS/SB 1320 creates s. 465.1861, F.S., to establish a process under which a pharmacist may
order and dispense certain HIV drugs. The bill defines the following terms: HIV, HIV infection
prevention drug, HIV postexposure prophylaxis drug, and HIV preexposure prophylaxis drug.
The bill authorizes a pharmacist to screen an adult for HIV exposure and provide the results to
that adult, with the advice that the patient should seek further medical consultation or treatment
from a physician, regardless of the test results.
The bill requires all pharmacies that provide adult HIV screenings have an access-to-care plan
for assisting patients in gaining access to appropriate care settings when they present to the
pharmacy for HIV screening and indicate that they lack regular access to primary care.
The bill does not have a fiscal impact on state expenditures.
The bill takes effect July 1, 2024.
REVISED: BILL: CS/CS/SB 1320 Page 2
II. Present Situation:
Pharmacist Licensure
Pharmacy is the third largest health profession behind nursing and medicine.
1
The Board of
Pharmacy (BOP), in conjunction with the Department of Health (DOH), regulates the practice of
pharmacists under ch. 465, F.S.
2
To be licensed as a pharmacist, a person must:
3
Complete an application and remit an examination fee;
Be at least 18 years of age;
Hold a degree from an accredited and approved school or college of pharmacy;
4
Have completed a BOP-approved internship; and
Complete the BOP-approved examination.
A pharmacist must complete at least 30 hours of BOP-approved continuing education during
each biennial renewal period.
5
Pharmacists who are certified to administer vaccines or
epinephrine auto-injections must complete a three-hour continuing education course on the safe
and effective administration of vaccines and epinephrine auto-injections as a part of the biennial
licensure renewal.
6
Pharmacists who administer long-acting antipsychotic medications must
complete an approved eight-hour continuing education course as a part of the continuing
education.
7
Pharmacist Scope of Practice
In Florida, the practice of the profession of pharmacy includes:
8
Compounding, dispensing, and consulting concerning the contents, therapeutic values, and
uses of any medicinal drug;
Consulting concerning therapeutic values and interactions of patent or proprietary
preparations;
Monitoring a patient’s drug therapy and assisting the patient in the management of his or her
drug therapy, including the review of the patient’s drug therapy and communication with the
patient’s prescribing health care provider or other persons specifically authorized by the
patient;
Transmitting information from prescribers to their patients;
1
American Association of Colleges of Pharmacy, About AACP, available at https://www.aacp.org/about-aacp (last visited
Jan. 24, 2024).
2
Sections 465.004 and 465.005, F.S.
3
Section 465.007, F.S. The DOH may also issue a license by endorsement to a pharmacist who is licensed in another state
upon meeting the applicable requirements set forth in law and rule. See s. 465.0075, F.S.
4
If the applicant has graduated from a 4-year undergraduate pharmacy program of a school or college of pharmacy located
outside the U.S., the applicant must demonstrate proficiency in English, pass the board-approved Foreign Pharmacy Graduate
Equivalency Examination, and complete a minimum of 500 hours in a supervised work activity program within Florida under
the supervision of a DOH licensed pharmacist.
5
Section 465.009, F.S.
6
Section 465.009(6), F.S.
7
Section 465.1893, F.S.
8
Section 465.003(13), F.S. BILL: CS/CS/SB 1320 Page 3
Administering specified vaccines to adults and influenza vaccines to persons seven years of
age or older;
9
Administering epinephrine autoinjections;
10
and
Administering antipsychotic medications by injection.
11
A pharmacist may not alter a prescriber’s directions, diagnose or treat any disease, initiate any
drug therapy, or practice medicine or osteopathic medicine, unless permitted by law.
12
Pharmacists may order and dispense drugs that are included in a formulary developed by a
committee composed of members of the Board of Medicine (BOM), the Board of Osteopathic
Medicine (BOOM), and the BOP.
13
The formulary may only include:
Any medicinal drug of single or multiple active ingredients in any strength when such active
ingredients have been approved individually or in combination for over-the-counter sale by
the U.S. Food and Drug Administration (FDA);
Any medicinal drug recommended by the FDA Advisory Panel for transfer to over-the-
counter status pending approval by the FDA;
Any medicinal drug containing any antihistamine or decongestant as a single active
ingredient or in combination;
Any medicinal drug containing fluoride in any strength;
Any medicinal drug containing lindane in any strength;
Any over-the-counter proprietary drug under federal law that has been approved for
reimbursement by the Florida Medicaid Program; and
Any topical anti-infective, excluding eye and ear topical anti-infective.
14
A pharmacist may order the following, within his or her professional judgment and subject to the
following conditions:
Certain oral analgesics for mild to moderate pain. The pharmacist may order these drugs for
minor pain and menstrual cramps for patients with no history of peptic ulcer disease. The
prescription is limited to a six-day supply for one treatment of:
o Magnesium salicylate/phenyltoloxamine citrate;
o Acetylsalicylic acid (zero order release, long-acting tablets);
o Choline salicylate and magnesium salicylate;
o Naproxen sodium;
o Naproxen;
o Ibuprofen;
o Phenazopyridine, for urinary pain; and
o Antipyrine 5.4 percent, benzocaine 1.4 percent, glycerin, for ear pain if clinical signs or
symptoms of tympanic membrane perforation are not present;
Anti-nausea preparations;
Certain antihistamines and decongestants;
9
See s. 465.189, F.S.
10
Id.
11
Section 465.1893, F.S.
12
Section 465.003(13), F.S.
13
Section 465.186, F.S.
14
Id. BILL: CS/CS/SB 1320 Page 4
Certain topical antifungals/antibacterials;
Topical anti-inflammatory preparations containing hydrocortisone not exceeding 2.5 percent;
Certain otic antifungal/antibacterial;
Salicylic acid 16.7 percent and lactic acid 16.7 percent in flexible collodion, to be applied to
warts, except for patients under 2 years of age, and those with diabetes or impaired
circulation;
Vitamins with fluoride, excluding vitamins with folic acid over 0.9 mg.;
Medicinal drug shampoos containing lindane for the treatment of head lice;
Ophthalmic. Naphazoline 0.1 percent ophthalmic solution;
Certain histamine H2 antagonists;
Acne products; and
Topical antiviral for herpes simplex infections of the lips.
15
Collaborative Pharmacy Practice Agreements
Under s. 465.1865, F.S., a collaborative pharmacy practice agreement (CPPA) is a formal
agreement in which a physician licensed under ch. 458, F.S., or ch. 459, F.S., makes a diagnosis,
supervises patient care, and refers patients to a pharmacist under a protocol that allows the
pharmacist to provide specified patient care services for certain chronic medical conditions. A
CPPA specifies what functions beyond the pharmacist’s typical scope of practice can be
delegated to the pharmacist by the collaborating physician.
16
Common tasks include initiating,
modifying, or discontinuing medication therapy and ordering and evaluating tests.
17
Pharmacist Training for Collaborative Practice
To provide services under a CPPA, a pharmacist must be certified by the BOP. To obtain
certification a pharmacist must complete a 20-hour course approved by the BOP, in consultation
with the BOM and the BOOM, and:
Hold an active and unencumbered license to practice pharmacy;
Have a Ph.D. in pharmacy or have five years of experience as a licensed pharmacist;
Have completed the BOP-approved, 20-hour course, eight hours of which must be live or live
video conference that includes instruction in:
o Performance of patient assessments;
o Ordering, performing, and interpreting clinical and laboratory tests;
o Evaluating and managing diseases and health conditions in collaboration with other
health care practitioners; and
o Writing and entering into a CPPA.
Maintains at least $250,000 of professional liability insurance coverage; and
Has established a system to maintain patient records of patients receiving services under a
CPPA for five years from the patient’s most recent service.
18
15
Fla. Admin. Code R. 64B16-27.220 (2023).
16
U.S. Center for Disease Control and Prevention, Advancing Team-Based Care Through Collaborative Practice
Agreements: A Resource and Implementation Guide for Adding Pharmacists to the Care Team, (2017), available at
https://www.cdc.gov/dhdsp/pubs/docs/CPA-Team-Based-Care.pdf (last visited Jan. 25, 2024).
17
Id.
18
Section 465.1865(2), F.S. and Fla. Admin. Code R. 64B-31.007 (2023). BILL: CS/CS/SB 1320 Page 5
Required Contents of CPPA
The terms and conditions of the CPPA must be appropriate to the pharmacist’s training, and the
services delegated to the pharmacist must be within the collaborating physician’s scope of
practice. A copy of the certification received from the BOP must be included as an attachment to
the CPPA. A CPPA must include the following:
The name of the collaborating physician’s patient(s) for whom a pharmacist may provide
services;
Each chronic health condition to be collaboratively managed;
The specific medicinal drug(s) to be managed for each patient;
Material terms defined as those terms enumerated in s. 465.1865(3)(a), F.S.;
Circumstances under which the pharmacist may order or perform and evaluate laboratory or
clinical tests;
Conditions and events in which the pharmacist must notify the collaborating physician and
the manner and timeframe in which notification must occur;
The start and end dates of the CPPA and termination procedures, including procedures for
patient notification and medical records transfers;
A statement that the CPPA may be terminated, in writing, by either party at any time; and
In the event of an addendum to the material terms of an existing CPPA, a copy of the
addendum and the initial agreement.
A CPPA will automatically terminate two years after execution if not renewed. The pharmacist,
along with the collaborating physician, must maintain the CPPA on file at his or her practice
location and must make the CPPA available to the DOH or BOP upon request or inspection. A
pharmacist who enters into a CPPA must submit a copy of the signed agreement to the BOP
before the agreement may be implemented.
19
Allowable Chronic Health Conditions for Pharmacist CPPAs
CPPAs in Florida allow a pharmacist to provide specific patient care services for the following
chronic health conditions:
Anti-coagulation management;
Arthritis;
Asthma;
Chronic obstructive pulmonary disease (COPD);
HIV or acquired immune deficiency syndrome (AIDS);
Hyperlipidemia;
Hypertension;
Nicotine dependence;
Obesity;
Opioid use disorder;
Type 2 diabetes;
Hepatitis C; and
19
Section 465.1865(3), F.S. and Fla. Admin. Code R. 64B-31.003 (2023). BILL: CS/CS/SB 1320 Page 6
Any other chronic condition adopted in rule by the BOP, in consultation with the BOM and
the BOOM.
20
Prohibited Acts Regarding a CPPA
A pharmacist may not:
Modify or discontinue medicinal drugs prescribed by a health care practitioner with whom he
or she does not have a CPPA; or
Enter into a CPPA while acting as a pharmacy employee without the written approval of the
owner of the pharmacy.
A physician may not delegate the authority to initiate or prescribe a controlled substance listed in
s. 893.03, F.S. or 21 U.S.C. s. 812, to a pharmacist.
Continuing Education
A pharmacist who practices under a CPPA must complete an eight-hour continuing education
(CE) course approved by the BOP that addresses CPPA-related issues each biennial licensure
renewal, in addition to the CE requirements under s. 465.009, F.S. A pharmacist wishing to
maintain CPPA certification must submit confirmation of having completed such course when
applying for licensure renewal. A pharmacist who fails to complete this CE is prohibited from
practicing under a CPPA.
CPPAs in Effect
According to the DOH 2022 - 2023 Annual Report there are 39,337 licensed pharmacists in
Florida.
21
There are 120 pharmacists certified to provide care under a CPPA. There are 37
pharmacists and 37 physicians actively engaged in collaborative practice. The BOP has received
97 CPPAs, 47 of which contain more than one chronic health condition that can be
collaboratively managed.
22
The chart below illustrates the composition of chronic conditions
treated by CPPA as of March 31, 2023.
23
20
Section 465.1865, F.S. and Fla. Admin. Code R. 64B-31.005 (2023). The statute provides for arthritis, asthma, COPD,
Type 2 diabetes, HIV/AIDS, and obesity. The other items in the list (anti-coagulation management, hyperlipidemia,
hypertension, nicotine dependence, opioid use disorder, and hepatitis C) were added under BOP rule.
21
Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long-Range Plan, Fiscal Year
2022-2023, at pg. 4, available at https://www.floridahealth.gov/licensing-and-regulation/reports-and-publications/annual-
reports.html (last visited Jan. 26, 2024).
22
Florida Department of Health, Division of Medical Quality Assurance, Pharmacy Collaborative Practice Agreements,
Report to Senate Health Policy Committee, Aug, 1, 2023, (on file with the senate Committee on Health Policy). While the
number of participating pharmacists and physicians are identical, this does not represent a one-to-one ratio; a pharmacist may
have multiple agreements with more than one physician just as multiple physicians may have multiple agreements with more
than one pharmacist.
23
Id. BILL: CS/CS/SB 1320 Page 7
Condition Count
Anti-Coagulation Management 48
Arthritis 46
Asthma 46
COPD 46
HIV/AIDS 85
Hyperlipidemia 45
Hypertension 50
Nicotine Dependence 44
Obesity 48
Opioid Use Disorder 1
Type 2 Diabetes 48
Human Immunodeficiency Virus (HIV)
The HIV attacks and destroys the infection-fighting CD4 cells (CD4 T lymphocyte) of the
immune system. The loss of CD4 cells makes it difficult for the body to fight off infections,
illnesses, and certain cancers. Without treatment, HIV can gradually destroy the immune system,
causing health decline and the onset of AIDS. With treatment, the immune system can recover.
24
If untreated, an HIV infection may cause acquired immunodeficiency syndrome (AIDS), the
most advanced stage of HIV infection. People with HIV who are not on medication and do not
have consistent control of their HIV can transmit HIV through bodily fluids exchanged via sex,
sharing of needles, pregnancy, and/or breastfeeding. If HIV is controlled, the risk of transmission
can be close to zero.
25
For people without HIV, there are several ways to reduce the risk of becoming infected with
HIV. Using condoms correctly with every sexual encounter, particularly with partners who are
HIV positive with a detectable viral load or with partners whose HIV status is unknown, can
reduce the risk of acquiring HIV. Reducing HIV risk also involves limiting and reducing sexual
partners and avoiding sharing needles.
26
Pre-exposure Prophylaxis (PrEP)
PrEP is an HIV prevention option for people who do not have HIV but who are at risk of
becoming infected. PrEP involves taking a specific HIV medicine every day or a long-acting
injection.
27
24
U.S. National Institute of Health, Understanding HIV, available at https://hivinfo.nih.gov/understanding-hiv/fact-
sheets/hiv-and-aids-basics (last visited Jan. 25, 2024).
25
Id.
26
Id.
27
Id. BILL: CS/CS/SB 1320 Page 8
Post-exposure Prophylaxis (PEP)
PEP means taking HIV medicines within 72 hours after a possible exposure to HIV to prevent
HIV infection. PEP should be used only in emergencies. It is not meant for regular use by people
who may be exposed to HIV frequently. The sooner PEP is started after a possible HIV
exposure, the better. Persons who are treated with PEP are directed to take the drug every day for
28 days.
28
HIV Testing
Certain healthcare providers can give an HIV test. HIV testing is also available at many
hospitals, medical clinics, substance abuse programs, and community health centers. Getting
tested through a professional healthcare provider is recommended; however, there are HIV self-
testing kits available.
29
A rapid self-test is an oral fluid test done entirely at home or in private. A mail-in self-test
requires a person to provide a blood sample from a finger-stick, which is then sent to a lab for
testing.
30
The federal Centers for Disease Control and Prevention (CDC) recommends that everyone age
13 to 64 get tested for HIV at least once as part of routine health care and that people at higher
risk for HIV get tested more often. HIV testing can detect if a person has an HIV infection, but it
cannot tell how long the person has had the infection or if the person has AIDS.
31
There are three types of tests used to diagnose HIV infection: antibody tests, antigen/antibody
tests, and nucleic acid tests:
Antibody tests check for HIV antibodies in blood or oral fluid. HIV antibodies are disease-
fighting proteins that the body produces in response to HIV infection. Most rapid tests and
home-use tests are antibody tests;
Antigen/antibody tests can detect both HIV antibodies and HIV antigens (a part of the virus)
in the blood; and
Nucleic acid tests look for HIV in the blood.
How soon each test can detect HIV infection differs, because each test has a different window
period. The window period is the time between when a person may have been exposed to HIV
and when a test can accurately detect HIV infection. A person’s initial HIV test will usually be
either an antibody test or an antigen/antibody test. Nucleic acid tests are very expensive and not
routinely used for HIV screening unless the person had a high-risk exposure or a possible
exposure with early symptoms of HIV infection.
28
U.S. National Institute of Health, HIV Prevention: Post-exposure Prophylaxis (PEP), available at
https://hivinfo.nih.gov/understanding-hiv/fact-sheets/post-exposure-prophylaxis-pep (last visited Jan. 31, 2024).
29
U.S. National Institute of Health, HIV Testing, Where can someone get tested for HIV?,
https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-testing (last visited Jan. 25, 2024).
30
Id.
31
U.S. National Institute of Health, HIV Testing, available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-testing
(last visited Jan. 25, 2024). BILL: CS/CS/SB 1320 Page 9
When an HIV test is positive, a follow-up test will be conducted. Sometimes people will need to
visit a health care provider to take a follow-up test. Other times, the follow-up test may be
performed in a lab using the same blood sample that was provided for the first test. A positive
follow-up test confirms that a person has HIV.
HIV Treatment
People with HIV should start taking HIV medicines as soon as possible after HIV is diagnosed.
For people with HIV who have the following conditions, it is especially important to start taking
HIV medicines right away:
32
Pregnancy;
AIDS-defining conditions; and
Early HIV infection.
33
Antiretroviral therapy (ART) is the use of HIV medicines that reduce the level of HIV in the
blood (called viral load). ART is recommended for everyone who has HIV. ART cannot cure
HIV infection, but HIV medicines help people with HIV have about the same life expectancy as
people without HIV. ART can eliminate the risk of HIV transmission. For mothers with HIV
who want to breastfeed, the risk of transmitting HIV through breast milk is less than one percent
with the consistent use of ART and an undetectable viral load. People on ART take a
combination of medicines (called an HIV treatment regimen) every day (pills) or by schedule
(injections). In many cases oral medicines may be combined into a single pill or capsule. There
are newer long-acting medicines given by an injection every two months that may be used for
some people.
34
FDA Approved HIV Medications
The following is a list HIV medicines, by category, recommended for the treatment of HIV
infection in the U.S., based on the U.S. Department of Health and Human Services (HHS)
HIV/AIDS medical practice guidelines:
35
Nucleoside Reverse Transcriptase Inhibitors (NRTIs): These drugs block reverse-
transcriptase, an enzyme HIV needs to make copies of itself.
o Abacavir;
o Emtricitabine;
o Lamivudine;
o Tenofovir disoproxil;
o Fumarate; and
o Zidovudine.
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs): These drugs bind to and
later alter reverse-transcriptase.
o Doravirine;
32
U.S. National Institute of Health, When to Start HIV Medicines (rev, Aug. 16, 2021) available at
https://hivinfo.nih.gov/understanding-hiv/fact-sheets/when-start-hiv-medicines (last visited Jan. 25, 2024).
33
Id. Early HIV infection, also known as acute HIV infection, is the period up to six months after a person is infection with
HIV.
34
Id.
35
U.S. National Institute of Health, FDA-Approved HIV Medicines, available at https://hivinfo.nih.gov/understanding-
hiv/fact-sheets/fda-approved-hiv-medicines (last visited Jan. 25, 2024). BILL: CS/CS/SB 1320 Page 10
o Efavirenz;
o Etravirine;
o Nevirapine; and
o Rilpivirine.
Protease Inhibitors (PIs): These drugs block HIV protease, an enzyme HIV needs to make
copies of itself.
o Atazanavir;
o Darunavir;
o Tosamprenavir;
o Ritonavir; and
o Tipranavir.
Fusion Inhibitors: These drugs block HIV from entering the CD4 T lymphocytes (CD4
cells) of the immune system.
o Enfuvirtide.
CCR5 Antagonists: These drugs block the CCR5 co-receptor on the surface of certain
immune cells that HIV utilizes to enter the cells.
o Maraviroc.
Integrase Strand Transfer Inhibitor (INSTIs): These drugs block HIV integrase, an
enzyme HIV needs to make copies of itself.
o Cabotegravir;
o Dolutegravir; and
o Raltegravir.
Attachment Inhibitors: These drugs bind to the gp120 protein on the outer surface of HIV,
preventing HIV from entering CD4 cells.
o Fostemsavir.
Post-attachment inhibitors: These drugs block CD4 receptors on the surface of certain
immune cells that HIV utilizes to enter the cells.
o Ibalizumab-uiyk.
Capsid Inhibitors: These drugs interfere with the HIV capsid, a protein shell that protects
HIV's genetic material and enzymes needed for replication.
o Lenacapavir.
Pharmacokinetic Enhancers: These drugs are used in HIV treatment to increase the
effectiveness of an HIV medicine included in an HIV treatment regimen.
o Cobicistat.
Combination HIV Medicines: These medicines contain two or more HIV medicines from
one or more drug classes.
Side Effects of HIV Medication
Adverse effects have been reported with all ART antiretroviral (ARV) drugs. As ART is
recommended for all patients regardless of CD4 T lymphocyte (CD4) cell count, and because
therapy must be continued indefinitely, the focus of patient management has evolved from
identifying and managing early ARV-related toxicities to individualizing therapy to avoid long-
term adverse effects, including:
Diabetes and other metabolic complications;
Atherosclerotic cardiovascular disease;
Kidney dysfunction; BILL: CS/CS/SB 1320 Page 11
Bone loss; and
Weight gain.
To achieve and sustain viral suppression over a lifetime, both long-term and short-term ART
toxicities must be anticipated and managed. When selecting an ARV regimen, clinicians should
consider potential adverse effects, as well as the patient’s comorbidities, concomitant
medications, and prior history of drug intolerances.
36
HIV and Opportunistic Infections, Coinfections, and Conditions
Opportunistic infections (OIs) are infections that occur more often or are more severe in people
with weakened immune systems than in people with healthy immune systems. People with
weakened immune systems include people living with HIV, as HIV damages the immune
system. A weakened immune system makes it harder for the body to fight off OIs. HIV-related
OIs include:
Pneumonia;
Salmonella infection;
Candidiasis;
Toxoplasmosis; and
Tuberculosis.
For people with HIV, the best protection against OIs is to take HIV medicines every day. HIV
medicines prevent HIV from damaging the immune system. Because HIV medicines are now
widely used in the United States, fewer people with HIV get OIs.
37
III. Effect of Proposed Changes:
The bill creates s. 465.1861, F.S., to establish a process under which a pharmacist may order and
dispense preexposure and postexposure HIV drugs.
The bill defines the following terms as follows:
“HIV” means the human immunodeficiency virus.
“HIV infection prevention drug” means preexposure prophylaxis, postexposure prophylaxis,
and any other drug approved by the U.S. Food and Drug Administration for the prevention of
HIV infection as of March 8, 2024.
“HIV Postexposure prophylaxis drug” means a drug or drug combination that meets the
clinical eligibility recommendations of Centers for Disease Control and Prevention (CDC)
guidelines for antiretroviral treatment following potential exposure to HIV issued as of
March 8, 2024.
36
U.S. National Institute of Health, Do all HIV medicines cause the same side effects?, Limitations to Treatment Safety and
Efficacy, Adverse Effects of Antiretroviral Agents, available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-
medicines-and-side-effects (last visited Jan. 26, 2024).
37
U.S. National Institute of Health, HIV and Opportunistic Infections, Coinfections and Conditions, What is an Opportunistic
Infection? available at https://hivinfo.nih.gov/understanding-hiv/fact-sheets/what-opportunistic-infection (last visited Jan. 25,
2024). BILL: CS/CS/SB 1320 Page 12
“HIV Preexposure prophylaxis drug” means a drug or drug combination that meets the
clinical eligibility recommendations of CDC guidelines for antiretroviral treatment for the
prevention of HIV transmission issued as of March 8, 2024.
The bill authorizes a pharmacist to screen an adult for HIV and provide the results to that adult,
with the advice that the patient should seek further medical consultation or treatment from a
physician.
The bill provides that a pharmacist may dispense HIV preexposure drugs only under a valid
prescription issued by a licensed health care practitioner authorized by law to prescribe such
drugs.
The bill authorizes a pharmacist to order and dispense HIV postexposure drugs only under a
written collaborative practice agreement (CPA) with a medical or osteopathic physician in the
same geographic area as the pharmacist. Under the bill the term “geographic area,” is the county
or counties, or any portion of the county or counties, within which the pharmacist and the
physician provide health care services.
The CPA must contain particular terms and conditions imposed by the supervising physician
relating to the screening for HIV and the ordering and dispensing of HIV postexposure drugs.
The CPA must include:
Specific categories of patients the pharmacist is authorized to screen for HIV and for whom
the pharmacist may order and dispense HIV postexposure drugs;
The physician’s instructions for obtaining relevant patient medical history to identify
disqualifying health conditions, adverse reactions, and contraindications to the use of HIV
postexposure drugs;
A requirement that the pharmacist maintain records for any HIV postexposure drugs ordered
and dispensed under the CPA;
A process and schedule for the physician to review the pharmacist’s records and actions
under the CPA; and
Any additional requirements established by the Board of Pharmacy (BOP), and approved by
the BOM and the BOOM.
A pharmacist who enters into a CPA with a supervising physician must submit the agreement to
the BOP.
If a pharmacist orders and dispenses HIV postexposure drugs under the CPA, he or she must
provide the patient with written information advising the patient to seek follow-up care from his
or her primary care physician. If the patient indicates that he or she lacks regular access to
primary care, the pharmacist must comply with the procedures set out in the pharmacy’s
approved access-to-care plan (ACP).
A pharmacist must be certified by the BOP before ordering or dispensing HIV postexposure
drugs. To be certified, a pharmacist must meet all of the following:
Hold an active and unencumbered license to practice pharmacy;
Be engaged in the active practice of pharmacy; BILL: CS/CS/SB 1320 Page 13
Have a Ph.D. degree in pharmacy or have completed at least three years of experience as a
licensed pharmacist;
Maintain at least $250,000 of liability coverage;
Complete a course approved by the BOP, in consultation with the Board of Medicine and the
Board of Osteopathic Medicine, which includes, at a minimum, instruction on all of the
following, but with no required number of hours:
o Performance of patient assessments.
o Point-of-care testing procedures.
o Safe and effective treatment of HIV exposure with HIV infection prevention drugs,
including, but not limited to:
Consideration of the side effects.
The patient’s diet and activity levels.
o Identification of contraindications;
o Identification of comorbidities in individuals with HIV requiring further medical
evaluation and treatment, including:
Cardiovascular disease;
Lung and liver cancer;
Chronic obstructive lung disease; and
Diabetes.
A pharmacist authorized to order and dispense HIV postexposure drugs under a CPA must
provide his or her supervising physician with evidence of current certification.
The bill requires that all pharmacies that provide adult HIV screenings have an access-to-care
plan (ACP) for assisting patients in gaining access to appropriate care settings when they present
to the pharmacy for HIV screening and indicate that they lack regular access to primary care.
An ACP must include:
Procedures to educate patients about care that would be best provided in a primary care
setting and the importance of receiving regular primary care;
A collaborative partnership with one or more nearby federally qualified health centers
(FQHC), county health departments (CHD), or other primary care settings. The goals of such
partnership must include, but need not be limited to:
o Identifying patients who have presented to the pharmacy for HIV screening or access to
HIV infection prevention drugs; and
o If such a patient indicates that he or she lacks regular access to primary care, proactively
seeking to establish a relationship between the patient and an FQHC, CHD, or other
primary care setting so that the patient develops a medical home at such setting for
primary health care services.
The bill provides that a pharmacy that establishes one or more collaborative partnerships may not
enter into an arrangement relating to such partnership which would prevent an FQHC, CHD, or
other primary care setting from establishing collaborative partnerships with other pharmacies.
Under the bill, as of July 1, 2025, a pharmacy’s ACP must be approved by the DOH before the
pharmacy may receive initial licensure or licensure renewal occurring after that date. A
pharmacy with an approved ACP must submit data to the DOH regarding the implementation BILL: CS/CS/SB 1320 Page 14
and results of its plan as part of the licensure renewal process, or as directed by the DOH, before
each licensure renewal.
The bill requires the BOP to adopt rules to implement s. 465.1861, F.S.
The bill takes effect July 1, 2024.
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
The following language in the bill: “the board shall adopt by rule reasonable and fair
minimum standards to ensure that all pharmacies that provide adult screening for HIV
exposure submit to the department for approval an access-to-care plan (ACP) for
assisting patients to gain access to appropriate care settings when they present to the
pharmacy for HIV screening and indicate that they lack regular access to primary care”
may present an unconstitutional delegation under Article II, Section 3 of the Florida
Constitution. Askew v. Cross Key Waterways, 372 So. 2d 913, 925 (Fla. 1978); see also
Avatar Dev. Corp. v. State; 723 So. 2d 199, 202 (Fla. 1998) (citing Askew with
approval). “…fundamental and primary policy decisions must be made by members of
the legislature who are elected to perform those tasks, and administration of legislative
programs must be pursuant to some minimal standards and guidelines ascertainable by
reference to the enactment establishing the program.”
Section 465.1861(7), F.S., as created by the bill, could be interpreted to violate Article
III, Section 6 of the Florida Constitution, the single subject rule. The Florida Supreme
Court has held that the single subject clause contains three requirements: first, each law
must embrace only one subject; second, the law may include any matter that properly
connected with the subject; and third, the subject must be briefly expressed in the title.
38
The subject matter to consider when determining whether a bill embraces a single subject
38
Franklin v. State, 887 So. 1063, 1072 (Fla. 2004). BILL: CS/CS/SB 1320 Page 15
is the bill’s title's subject, and the test is whether the bill is designed to accomplish
separate objectives with no natural or logical connection to each other.
39
The bill’s title indicates it is an act relating to HIV infection prevention drugs. However,
the bill’s provisions under s. 465.1861(7), F.S., relate to pharmacies that provide adult
screening for HIV exposure and the requirement for an ACP, without addressing the
subject of HIV infection prevention drugs that are dispensed by pharmacists under the
bill’s other provisions. Subsection (7) requires pharmacies, not pharmacists, to submit to
the DOH for approval an access-to-care plan (ACP), with standards set by the BOP, for
assisting patients to gain access to appropriate care settings when they present to the
pharmacy for HIV screening and indicate that they lack regular access to primary care,
regardless of whether HIV infection prevention drugs are ordered or dispensed.
In State vs. Lee, 356 So. 2d 276 (Fla. 1978), citing with approval E.g., Colonial Inv. Co.
v. Nolan, 100 Fla. 1349, 131 So. 178 (1930), the Florida Supreme Court stated that [The
purpose of the constitutional prohibition against a plurality of subjects in a single
legislative act is to prevent a single enactment from becoming a "cloak" for dissimilar
legislation having no necessary or appropriate connection with the subject matter.]
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
To the extent that pharmacists provide HIV testing or become certified and enter into
collaborative practice agreements with physicians under the bill, HIV testing and
treatment might become more accessible.
C. Government Sector Impact:
The bill does not have a fiscal impact on state expenditures.
VI. Technical Deficiencies:
None.
VII. Related Issues:
Unlike the current statutory provisions for a “collaborative pharmacy practice agreement”
(CPPA) relating to treatment of chronic conditions found in s. 465.1865, F.S., the bill does not
define a “collaborative practice agreement” nor provide the level of detail regarding
requirements for what the agreement must contain or what form it must take as is required of a
CPPA. Notable differences can be found between the two agreements in the following examples
39
See Ex parte Knight, 41 So. 786, 788 (Fla. 1906); Bd. of Pub. Instruction v. Doran, 224 So. 2d 693, 699 (Fla. 1969). BILL: CS/CS/SB 1320 Page 16
of requirements for a CPPA that are not required for a collaborative practice agreement (CPA)
created under the bill:
Must be signed by both practitioners.
Pharmacist certification must be attached to CPPA;
Applies only to the collaborating physician’s patients who are named in the agreement.
Specific drugs to be managed for each patient must be listed in the agreement;
Triggers for the pharmacist to notify the collaborating physician and the manner and
timeframe in which notification must occur must be included in the agreement;
Duration limitations.
Provisions for termination of the agreement.
Certain actions prohibited.
Employer permission (if applicable).
Continuing education.
Record-keeping.
Lines 69-72 provide that a pharmacist may dispense HIV preexposure drugs only pursuant to a
valid prescription issued by a licensed health care practitioner authorized by law to prescribe
such drugs. Lines 73-81 provide that a pharmacist may order and dispense HIV postexposure
drugs only pursuant to a written CPA with a physician who practices in the same geographic
region as the pharmacist. These provisions appear to conflict with existing law in s. 465.1861,
F.S., relating to authority for pharmacists to enter into a CPPA with a physician to treat chronic
conditions, including HIV/AIDS. By use of the word “only” in the two instances cited above, the
bill may conflict with a pharmacist’s authority to order and dispense such drugs under the
existing CPPA provisions, which are separate from the bill’s CPA provisions.
Lines 115-119 provide that if a patient for whom a pharmacist has ordered and dispensed
postexposure HIV drugs indicates that he or she lacks regular access to primary care, the
pharmacist must comply with the procedures of the pharmacy’s approved ACP as provided
under s. 465.1861(7), F.S., which is created later in the bill. However, the bill’s provisions for
the contents of an ACP include no procedures relating to such a case and only pertain to persons
who receive HIV screening at the pharmacy.
Lines 179-182 require a pharmacy’s ACP to be approved by the Department of Health (DOH)`
before the pharmacy may receive initial licensure or licensure renewal after July 1, 2025.
However, because a pharmacy may not establish an ACP until after it has been licensed, the
bill’s reference to “initial licensure” is not applicable. An amendment to remove the concept of
initial licensure from this provision is advisable.
VIII. Statutes Affected:
This bill creates section 465.1861 of the Florida Statutes. BILL: CS/CS/SB 1320 Page 17
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS/CS by Appropriations Committee on Health and Human Services on February
8, 2024:
The committee substitute:
Revises the requirement that a collaborative practice agreement (CPA) include any
other requirements established by the Board of Pharmacy (BOP) in consultation with
the Board of Medicine (BOM) and the Board of Osteopathic Medicine (BOOM), and
instead requires that the CPA include any other requirements established by the BOP,
and approved the BOM and BOOM.
Revises the requirement that the CPA include a process and schedule for the
physician to review the pharmacist’s actions under the CPA and instead requires the
CPA to include a process and schedule to review the pharmacist’s records and actions
under the CPA.
Revises a requirement that a pharmacist must be certified by the BOP, according to
the rules adopted by the BOP, and in consultation with the BOM and BOOM, to
order and dispense certain HIV drugs, and instead requires the rules adopted by the
BOP to be approved by the BOM and BOOM.
Requires a pharmacist to maintain records for any postexposure drugs ordered and
dispensed under the CPA.
CS by Health Policy on January 30, 2024:
The committee substitute:
Deletes the terms “postexposure prophylaxis” and “preexposure prophylaxis;” and
replaces them with the terms, “HIV postexposure prophylaxis drug” and “HIV
preexposure prophylaxis drug,” but the language of the definitions does not change;
Requires the CPA to require particular terms and conditions imposed by the
supervising physician, and include:
o Specific categories of patients the pharmacist is authorized to screen for HIV and
for whom the pharmacist may order and dispense HIV postexposure prophylaxis
drugs;
o The physician’s instructions for obtaining relevant patient medical history for the
purpose of identifying disqualifying health conditions, adverse reactions, and
contraindications to the use of HIV postexposure prophylaxis drugs;
o A process and schedule for the physician to review the pharmacist’s actions under
the CPA; and
o Any other requirements as established by the BOP in consultation with the BOM
and the BOOM.
Requires a pharmacist who screens an adult patient for HIV exposure to advise the
patient to seek further medical consultation or treatment from a physician, regardless
of the test results;
Requires the BOP to adopt rules to create standards for pharmacies doing adult
screening for HIV exposure to submit to the DOH for approval an ACP to assist BILL: CS/CS/SB 1320 Page 18
patients to gain access to appropriate care settings when the patient indicate that they
lack regular access to primary care;
Requires a pharmacy’s ACP to include patient educational procedures, a collaborative
partnership with one or more FQHCs, CHDs, or other primary care settings, and have
DOH approval of the ACP before the pharmacy may receive an initial license or
renewal; and
Requires a pharmacy that establishes one or more collaborative partnerships may not
enter into an arrangement relating to these partnerships which would prevent an
FQHC, CHD, or other primary care setting from establishing collaborative
partnerships with other pharmacies.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.