HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: CS/HB 201 Emergency Refills of Insulin and Insulin-related Supplies or Equipment SPONSOR(S): Healthcare Regulation Subcommittee, Bell TIED BILLS: IDEN./SIM. BILLS: REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Healthcare Regulation Subcommittee 18 Y, 0 N, As CS DesRochers McElroy 2) Health & Human Services Committee 14 Y, 0 N DesRochers Calamas SUMMARY ANALYSIS There are 38 million people in the United States diagnosed with diabetes, including more than 2 million people in Florida. Diabetes occurs when blood glucose, also called blood sugar, is too high due to an individual’s inability to effectively produce or process insulin. Over time, high blood glucose leads to problems such as: heart disease, stroke, kidney disease, eye problems, dental disease, nerve damage, foot problems, depression, sleep apnea, and sexual and bladder problems. Diabetics must take insulin to reduce their blood glucose levels. Different types of insulin start to work at different speeds, and the effects of each last a different length of time. Insulin can be taken in several ways; common options include a syringe, insulin pen, insulin pump and insulin inhaler. A pharmacist may only dispense controlled substances, including insulin, upon a written, oral, or electronic prescription. Current law contains limited exceptions to this requirement for emergency prescription refills which include authority for a pharmacist to dispense a one-time refill of one vial of insulin to treat diabetes, if the pharmacist is unable to readily obtain refill authorization from a prescriber. Current law however, does not authorize pharmacists to dispense insulin-related supplies or equipment as part of an emergency prescription refill. CS/HB 201 expands current law on emergency prescription refills to authorize a pharmacist to dispense an emergency refill of insulin and insulin-related supplies or equipment to treat diabetes up to three nonconsecutive times per calendar year, if the pharmacist is unable to readily obtain refill authorization from a prescriber. The bill has no fiscal impact on state or local government. The bill provides an effective date of July 1, 2024. This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives . STORAGE NAME: h0201c.HHS DATE: 1/16/2024 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOSED CHANGES: Present Situation Diabetes Diabetes occurs when blood glucose, also called blood sugar, is too high. 1 Blood glucose is the body’s main source of energy and comes mainly from one’s diet. 2 Over time, high blood glucose leads to problems such as: 3 Heart disease Stroke Kidney disease Eye problems Dental disease Nerve damage Foot problems Depression Sleep apnea Sexual and bladder problems There are two primary types of diabetes: type 1 and type 2. Type 1 Diabetes In most people with type 1 diabetes, the body’s immune system, which normally fights infection, attacks and destroys the cells in the pancreas that make insulin. 4 As a result, the pancreas stops making insulin. Without insulin, glucose cannot get into the cells and blood glucose rises above normal. People with type 1 diabetes need to take insulin every day to stay alive. Type 1 diabetes typically occurs in children and young adults, although it can appear at any age. Having a parent or sibling with the disease may increase the chance of developing type 1 diabetes.5 Symptoms of type 1 diabetes are serious and usually happen quickly, over a few days to weeks, and can include: Increased thirst and urination Increased hunger Blurred vision Fatigue Unexplained weight loss 1 U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Type 1 Diab etes, (last reviewed July 2017) https://www.niddk.nih.gov/health-information/diabetes/overview/what-is- diabetes/type-1-diabetes/ (last visited Nov. 17, 2023). 2 Id . 3 Mayo Clinic, Patient Care & Health Information, Disease & Conditions, Diabetic Ketoacidosis, (Oct. 6, 2022) https://www.mayoclinic.org/diseases-conditions/diabetic-ketoacidosis/symptoms-causes/syc-20371551 (last visited Nov. 17, 2023); U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidn ey Diseases, Type 2 Diab etes, (last reviewed May 2017) https://www.niddk.nih.gov/health-information/diabetes/overview/what-is- diabetes/type-2-diabetes (last visited Nov. 17, 2023). 4 Insulin, a hormone made by the pancreas, helps the glucose in the blood get into the cells to be used for energy. Another hormone, glucagon, works with insulin to control blood glucose levels. 5 Id . STORAGE NAME: h0201c.HHS PAGE: 2 DATE: 1/16/2024 Sometimes the first symptoms of type 1 diabetes are signs of a life-threatening condition called diabetic ketoacidosis (DKA).6 The condition develops when the body cannot produce enough insulin. Without enough insulin, the body begins to break down fat as fuel. This causes a buildup of acids in the bloodstream called ketones; if left untreated, the buildup can lead to DKA. Symptoms of DKA include:7 Breath that smells fruity Dry or flushed skin Nausea or vomiting Stomach pain Trouble breathing Trouble paying attention or feeling confused Type 1 diabetics must take insulin because the body no longer makes it on its own. Different types of insulin start to work at different speeds, and the effects of each last a different length of time. Insulin can be taken in several ways; common options include a needle and syringe, insulin pen, or insulin pump.8 Some people who have difficulty reaching their blood glucose targets with insulin alone also might need to take another type of diabetes medicine that works with insulin, such as pramlintide. Pramlintide, given by injection, helps keep blood glucose levels from going too high after eating. Few people with type 1 diabetes take pramlintide, however. Another diabetes medicine, metformin, may help decrease the amount of insulin necessary.9 Type 2 Diabetes Type 2 diabetes, the most common type of diabetes, occurs when blood glucose is too high. In type 2 diabetes, the body does not make enough insulin or does not use insulin well enough. Too much glucose then stays in the blood, and not enough reaches the cells.10 Type 2 diabetes can develop at any age, even during childhood. However, type 2 diabetes occurs most often in middle-aged and older people. A person is more likely to develop type 2 diabetes if he or she is aged 45 or older, has a family history of diabetes, or is overweight or has obesity. Diabetes is more common in people who are African American, Hispanic/Latino, American Indian, Asian American, or Pacific Islander.11 Physical inactivity and certain health problems such as high blood pressure affects a person’s chances of developing type 2 diabetes. A person is also more likely to develop type 2 diabetes if they have prediabetes or had gestational diabetes when they were pregnant. Symptoms of type 2 diabetes include:12 Increased thirst and urination Increased hunger Feeling tired Blurred vision Numbness or tingling in the feet or hands Sores that do not heal Unexplained weight loss 6 Id. 7 Supra, FN 3. 8 Supra, FN 1. 9 Id. 10 Supra, FN 3. 11 Id. 12 Id. STORAGE NAME: h0201c.HHS PAGE: 3 DATE: 1/16/2024 Symptoms of type 2 diabetes often develop slowly, usually over the course of several years, and can be so mild as to not be noticed. Many people have no symptoms. Some people do not find out they have the disease until they have diabetes-related health problems.13 Type 2 diabetes is caused by several factors, including: 14 Overweight and obesity Not being physically active Insulin resistance Genes Many people with type 2 diabetes also have nonalcoholic fatty liver disease, a disease in which fat appears inside the liver that can, over time, affect liver function and cause liver injury. 15 Diabetes is also linked to other health problems such as sleep apnea, depression, some types of cancer, and dementia.16 Treatment of Diabetes Diabetics must take insulin to reduce their blood glucose levels. Different types of insulin start to work at different speeds, and the effects of each last a different length of time. Insulin can be taken in several ways; common options include a syringe, insulin pen, insulin pump and insulin inhaler. Syringe A syringe delivers insulin through a needle. The patient’s physician determines the amount of insulin required per dose, and the patient acquires a syringe with sufficient dosage capacity. 17 Insulin Pen An insulin pen also delivers insulin through a needle. Insulin pens offer greater portability and are more user-friendly than syringes. Needles in these pens are small, thin, and more comfortable. Some insulin pens use cartridges inserted into the pen while others are pre-filled. The insulin dose is dialed on the pen, and the insulin is injected through the needle.18 Insulin Pump An insulin pump delivers insulin through a thin plastic tube placed semi-permanently into the fatty layer under the patient’s skin – usually in the stomach area or back of the upper arm. Insulin pumps eliminate unpredictable effects of intermediate or long-acting insulin, and deliver short or rapid acting insulin taken at or before mealtimes to control blood sugar levels. Training is necessary to use the insulin pump, and there are risks of side-effects (e.g., weight gain, infection, and DKA).19 Insulin Inhaler An oral insulin inhaler delivers ultra-rapid acting insulin at the beginning of meals. The inhaler device is small and is as effective as injectable rapid-acting insulins. Inhaler devices still must be used in conjunction with injections or a pump for intermediate- or long-acting insulin taken to keep blood sugar 13 Id. 14 Id. 15 Johns Hopkins Medicine, Health, Conditions and Diseases, Nonalcoholic Fatty Liver Disease, available at https://hopkinsmedicine.org/health/conditions-and-diseases/nonalcoholic-fatty-liver-disease (last visited Nov. 17, 2023). 16 Supra, FN 3. 17 Centers for Disease and Control and Prevention, 4 Ways to Take Insulin (last reviewed April 18, 2023) https://www.cdc.gov/diabetes/basics/type-1-4-ways-to-take-insulin.html (last visited Dec. 5, 2023). 18 Id. 19 Id. STORAGE NAME: h0201c.HHS PAGE: 4 DATE: 1/16/2024 levels steady between meals and overnight. Inhaler device dosages are not as precise as other insulin administration devices.20 Impact of Diabetes Diabetes is the eighth leading cause of death in the United States.21 Below is a snapshot of diabetes prevalence and health care costs in the U.S.22 In Florida, diabetes is the seventh leading cause of death, claiming 7,550 lives in 2022.23 The Florida Department of Health calculates an age-adjusted rate to measure deaths per 100,000. An age-adjusted rate is a weighted average where the crude each for each age group is multiplied by its representative 20 Id. 21 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, What is Diab etes, (last reviewed Sept. 5, 2023), https://www.cdc.gov/diabetes/basics/diabetes.html (last visited Nov. 27, 2023). 22 Centers for Disease Control and Prevention, A Snapshot: Diab etes in the United States, available at https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html (last visited Nov. 27, 2023). 23 Florida Department of Health, Leading Causes of Death Profile, Bureau of Community Health Assessment, Division of Public Health Statistics and Performance Management, Florida Department of Health, https://www.flhealthcharts.gov/ChartsReports/rdPage.aspx?rdReport=ChartsProfiles.LeadingCausesOfDeathProfile (last visited Jan. 13, 2024). STORAGE NAME: h0201c.HHS PAGE: 5 DATE: 1/16/2024 proportion in the standard population before being summed together.24 In 2022, the age-adjusted deaths from diabetes rate per 100,000 population in Florida was 22.8.25 Florida Age-adjusted Deaths from Diabetes, Rate Per 100,000 Population, 2022 26 The American Diabetes Association estimates that 2,071,045 Floridians, or 11.6% of the adult population, have diagnosed diabetes. People with diabetes have medical expenses about 2.3 times higher than those without diabetes, and diagnosed diabetes costs approximately $25 billion in Florida each year.27 Pharmacists Pharmacist Licensure 24 Florida Department of Health, Age-Adjusted Rate, FLHEALTH Charts, Florida Department of Health, https://www.flhealthcharts.gov/Charts/documents/AARDescription.pdf (last visited Nov. 27, 2023). 25 Florida Department of Health, Deaths from Diab etes, FLHEALTH Charts, Florida Department of Health, https://www.flhealthcharts.gov/ChartsDashboards/rdPage.aspx?rdReport=Death.DataViewer&cid=0090 (last visited Jan. 13, 2024). 26 Id. 27 American Diabetes Association, The Burden of Diab etes in Florida, (last reviewed Mar. 2023), https://diabetes.org/sites/default/files/2023-09/ADV_2023_State_Fact_sheets_all_rev_Florida.pdf (last visited Nov. 27, 2023). STORAGE NAME: h0201c.HHS PAGE: 6 DATE: 1/16/2024 Pharmacy is the third largest health profession behind nursing and medicine. 28 The Board of Pharmacy (Board), in conjunction with the Department of Health (DOH), regulates the practice of pharmacy under ch. 465, F.S.29 To be licensed as a pharmacist in Florida, a person must: 30 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; 31 Have completed a board-approved internship; and Successfully complete the board-approved examination. Pharmacist Scope of Practice In Florida, the practice of the pharmacy profession includes:32 Compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of a 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, regarding the drug therapy; Transmitting information from prescribers to their patients; Preparing prepackaged drug products in facilities holding Class III institutional facility permits; 33 Administering vaccines to adults;34 Administering epinephrine injections;35 and Administering antipsychotic medications by injection. 36 A pharmacist may only dispense controlled substances, including insulin, upon a written, oral, or electronic prescription.37 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.38 Pharmacists may order and dispense drugs that are included in a formulary developed by a committee composed of members of the Boards of Medicine, Osteopathic Medicine, and Pharmacy. The formulary may only include:39 Medicinal drugs of single or multiple active ingredients in any strengths when such active ingredients have been approved individually or in combination for over-the-counter sale by the United States Food and Drug Administration; 28 American Association of Colleges of Pharmacy, Ab out AACP, available at https://www.aacp.org/about-aacp (last visited Nov. 27, 2023). 29 ss. 465.004 and 465.005, F.S. 30 s. 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. 31