SPONSOR:

Rep. Bennett & Rep. K. Johnson & Sen. Pinkney

Reps. Baumbach, Dorsey Walker, Morrison, Osienski, K. Williams; Sen. Mantzavinos

HOUSE OF REPRESENTATIVES

151st GENERAL ASSEMBLY

HOUSE BILL NO. 399

AN ACT TO AMEND TITLE 24 OF THE DELAWARE CODE RELATING TO PRACTICE OF PHARMACY.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend Chapter 25, Title 24 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underlines as follows and by redesignating accordingly:

§ 2502. Definitions.

For purposes of this chapter:

(21) “Practice of pharmacy” means the interpreting, evaluating, and dispensing of a practitioner’s or prescriber’s order. The “practice of pharmacy” includes the proper compounding, labeling, packaging, and dispensing of a drug to a patient or the patient’s agent, and administering a drug to a patient. The “practice of pharmacy” includes the application of the pharmacist’s knowledge of pharmaceutics, pharmacology, pharmacokinetics, drug and food interactions, drug product selection, and patient counseling. The “practice of pharmacy” also includes all of the following:

a. Participation in drug utilization and/or drug regimen reviews; reviews.

b. Participation in therapeutic drug selection, substitution of therapeutically equivalent drug products; products.

c. Advising practitioners and other health-care professionals, as well as patients, regarding the total scope of drug therapy, so as to deliver the best care possible; possible.

d. Monitoring drug therapy; therapy.

e. Performing and interpreting capillary blood tests to screen and monitor disease risk factors or facilitate patient education, the results of which must be reported to the patient’s health-care practitioner; screening results to be reported only if outside normal limits; limits.

( ) Ordering, performing, and interpreting tests authorized by the Food and Drug Administration, and waived under the federal Clinical Laboratory Improvement Amendments of 1988.

f. Conducting or managing a pharmacy or other business establishment where drugs are compounded or dispensed; dispensed.

( ) Initiating drug therapy for health conditions in accordance with § 2525 of this title.

g. [Repealed.]

h. Administration of injectable medications, biologicals and adult immunizations pursuant to a valid prescription or physician-approved protocol approved by a physician duly licensed in the State under subchapter III of Chapter 17 of this title. Pharmacists shall request which physician or physicians and notify the physician or physicians as designated by the patient of such administration within 24 72 hours. The notice shall include the patient’s name, the name of the immunizations, inoculations or vaccinations administered, and the date of administration and may be submitted by phone, fax, post or electronically. Upon request a copy of the protocol will be made available to the designated physician or physicians without costs; costs.

i. Dispensing contraceptives or dispensing and administering injectable hormonal contraceptives under Chapter 30O of Title 16.

§ 2525. Testing, screening, and treatment of health conditions.

(a) Pursuant to a statewide written protocol, a pharmacist may order, test, screen, and treat health conditions that include all of the following:

(1) Influenza.

(2) Group A Streptococcus Pharyngitis.

(3) SARS-COV-2 or other respiratory illness, condition, or disease.

(4) Lice.

(5) Urinary tract infection.

(6) Skin conditions, including ringworm and athlete’s foot.

(7) Minor, uncomplicated infections.

(8) HIV.

(9) Other emerging and existing public health threats identified by the Department of Public Health including preventative health, mental health, substance abuse disorders, and infectious disease prevention if permitted by an order, rule, or regulation.

(b) A pharmacist who orders, tests, screens, or treats health conditions under this section may use any test that may guide clinical decision making that is waived under the federal Clinical Laboratory Improvement Amendments of 1988, or the federal rules adopted thereunder, or any established screening procedure that can safely be performed by a pharmacist.

(c) A pharmacist may delegate the administrative and technical tasks of performing a test waived by the federal Clinical Laboratory Improvement Amendments of 1988 to an intern or pharmacy technician acting under the supervision of the pharmacist.

(d) Prohibit the denial of reimbursement under health benefit plans for services and procedures performed by a pharmacist that are within the scope of the pharmacist’s license and would be covered if the services or procedures were performed by a physician, an advanced practice nurse, or physicians assistant.

SYNOPSIS

All human laboratory testing is regulated under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”). CLIA-waived tests are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. Common CLIA-waived tests include Influenza, HIV, COVID-19, and lipid-panel tests. Amid COVID-19 pandemic, the need for immediate diagnostic services that are close to home became vital. This bill authorizes pharmacists to order and perform tests authorized by the FDA and CLIA-waived and provide treatment for such health conditions.