Chapter 12. Therapeutic Pharmaceutical Agents
Regulation .01 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
“Adverse drug reaction” means a physical or psychological reaction experienced by a patient which:
(a)
Results from the administration of diagnostic or therapeutic pharmaceutical agents;
(b)
Poses a threat to the health of the patient; and
(c)
Requires treatment or medical intervention.
(2)
“Adverse reaction” means the unintended or unexpected effect of treatment on a patient caused by or resulting from:
(a)
An adverse drug reaction;
(b)
The removal of a superficial foreign body from the eye; or
(c)
The ordering of a laboratory test.
(3)
“Board” means the Board of Examiners in Optometry.
(4)
“Diagnostic pharmaceutical agent (DPA)” means a medication that:
(a)
Directly or indirectly affects the pupil of the eye as defined in COMAR 10.28.11;
(b)
Directly or indirectly affects the sensitivity of the cornea as defined in COMAR 10.28.11; or
(c)
Stains the ocular surface.
(5)
“Ophthalmologist” means a physician who practices in the specialty of ophthalmology and who is licensed by the Maryland Board of Physicians.
(6)
“Primary open angle glaucoma” means glaucomatous changes characterized by:
(a)
Adult onset;
(b)
The presence of open, normal appearing angles as demonstrated by gonioscopy, and not otherwise explained; and
(c)
One or more of the following:
(i)
The appearance of optic disc damage or optic nerve fiber layer damage as evidenced by the size or shape of the optic disc cup, thinning or notching of the optic disc rim, progressive changes in the appearance of the optic disc cup, optic disc hemorrhage, or nerve fiber layer defects, seen clinically or via imaging;
(ii)
The presence of abnormalities in the visual field including arcuate defect, nasal step, paracentral scotoma, or general depression, in the absence of other causes or explanations for a visual field defect; or
(iii)
Intraocular pressure that is thought to pose a threat to the health of the optic nerve.
(7)
“Secretary” means the Secretary of Health.
(8)
“Therapeutic pharmaceutical agent (TPA)” means a medication used for the treatment of a disease or condition of the eye as specified in Health Occupations Article, §11-404.2, Annotated Code of Maryland.
(9)
“Therapeutically certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use therapeutic pharmaceutical agents in the practice of optometry and provides therapeutic services to patients in Maryland.
(10)
“TPA record” means the optometrist's documentation of a patient's visit, the result of which involved the prescribing of medication or the performance of a procedure for treatment of a medical eye condition by a therapeutically certified optometrist.
(11)
“Universal precautions” has the meaning stated in COMAR 10.06.01.02B(10).
Regulation .02 Requirements for Certification.LinkCopy Citation
A.
Except for an optometrist who qualifies under §C or D of this regulation, the Board shall certify an optometrist licensed to practice in Maryland as qualified to use TPAs if the licensed optometrist submits to the Board evidence satisfactory to the Board that the optometrist:
(1)
Has successfully completed at least 110 hours of Board-approved TPA education before applying for certification to use TPAs;
(2)
Has successfully passed the National Board of Examiners in Optometry's (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections; and
(3)
Is currently certified by the Board to administer topical ocular DPAs.
B.
The Board may consider pharmacology courses that an optometrist successfully completed during a course of study at an accredited school of optometry recognized by the Board when calculating the 110 hours of Board-approved TPA education required under §§A(1) and D(1) of this regulation. If accepted by the Board, then each:
(1)
Semester credit hour will equal 15 hours of TPA education; and
(2)
Quarter credit hour will equal 10 hours of TPA education.
C.
The Board shall certify an optometrist who has graduated from an accredited school of optometry within 3 years before applying for certification to use TPAs if the optometrist:
(1)
Submits proof of current certification in cardiopulmonary resuscitation (CPR) to the Board; and
(2)
Completes the process to become certified to use TPAs within 3 years of the date of graduation from an accredited school of optometry.
D.
If an optometrist who has graduated on or after July 1, 2005, from an accredited school of optometry recognized by the Board, is not certified within 3 years of graduation, the Board shall certify the optometrist to use TPAs if the optometrist:
(1)
Has successfully completed at least 110 hours of Board-approved TPA education before applying for certification to use TPAs;
(2)
Has successfully passed the National Board of Examiners in Optometry's (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections; and
(3)
Submits proof of current certification in cardiopulmonary resuscitation (CPR) to the Board.
E.
The credit hours taken for initial certification in TPAs may be included as part of the hours of continuing education required for biennial license renewal.
Regulation .03 Requirements for Renewal of Certification.LinkCopy Citation
A.
An optometrist certified by the Board under this chapter shall complete 50 hours of continuing education during the 2 year licensure period in order to renew the optometrist's license.
B.
An optometrist certified by the Board under this chapter shall complete 30 hours of continuing education in the use and management of TPAs, during the 2-year licensure period.
C.
The Board shall count the 30 hours of continuing education in TPAs toward the 50 hours of continuing education required for biennial renewal.
D.
A therapeutically certified optometrist shall be certified in CPR and shall verify this certification on request by the Board.
E.
Unless there are extenuating circumstances acceptable to the Board, the Board shall revoke the TPA certification of an optometrist who does not fulfill the requirements for renewal of the TPA certification.
F.
TPA Self-Assessment. At the time of license renewal, the therapeutically certified optometrist shall complete a self-assessment checklist provided by the Board to evaluate the following aspects of the optometrist’s practice utilizing TPAs, including but not limited to:
(1)
Legibility and completeness of TPA records;
(2)
Documentation of patient visits, services rendered, and communications;
(3)
Documentation of subjective complaints, objective findings, clinical assessments relating to the findings of the diagnosis, and the plan;
(4)
A written office plan for handling emergencies;
(5)
A system for patients to reach the optometrist, or to access care, in the event of an ocular emergency;
(6)
A systematic discarding of expired medications;
(7)
Documentation of current CPR certification;
(8)
An infection control policy;
(9)
Patient confidentiality;
(10)
A patient tracking system that enables identification and follow-up to ensure treatment of patients who:
(a)
Are being followed or referred out for emergency sight or life-threatening conditions; or
(b)
Fail to keep appointments;
(11)
Procedures for appropriate termination of the doctor-patient relationship when necessary;
(12)
Satisfactory explanation of the treatment plan so that the patient knows and understands the nature of the patient’s problem or problems and the goals of the treatment regimen; and
(13)
Advice to patients regarding the importance of progress examinations and follow-up care.
Regulation .04 Standards of Quality for Therapeutically Certified Optometrists and Optometric Care.LinkCopy Citation
A.
The therapeutically certified optometrist shall provide clinical therapeutic eye care consistent with published, universally accepted practice or clinical guidelines and standards of care.
B.
The therapeutically certified optometrist shall adhere to the additional guidelines and standards of care given in §§C—T of this regulation.
C.
The therapeutically certified optometrist shall ensure that:
(1)
TPA records are consistent with the Subjective, Objective, Assessment, and Plan (SOAP) format;
(2)
Assessment and plans are consistent with the patient's subjective and clinical findings; and
(3)
TPA records are complete and legible.
D.
The therapeutically certified optometrist shall document the following data, if applicable, for each TPA patient visit or communication:
(1)
Date of service;
(2)
Current Procedural Terminology (CPT) Code, most recent edition;
(3)
International Classification of Diseases (ICD) Code, most recent edition;
(4)
Medication/treatment provided; and
(5)
Follow-up recommendation.
E.
The therapeutically certified optometrist shall document the following data as part of the patient's permanent file:
(1)
Name;
(2)
Date of birth;
(3)
Name of the doctor to whom the patient is referred, appointment date, and documentation that the patient or guardian preferred to schedule the referral appointment on their own;
(4)
Record of tests administered and the results of the tests;
(5)
Written reports of other consultations, referrals received, or both; and
(6)
Documentation of the occurrence of any adverse reaction.
F.
The therapeutically certified optometrist shall provide for 24-hour emergency coverage.
G.
The therapeutically certified optometrist shall have a medical kit for treating anaphylactic emergencies available at each location where patients are seen.
H.
The therapeutically certified optometrist shall be certified in CPR.
I.
The therapeutically certified optometrist shall have a written plan for responding to emergencies, including specific plans for referral to hospital emergency rooms, emergency ambulatory centers, ophthalmologists, or other appropriate medical doctors when necessary at each location where patients are seen.
J.
The therapeutically certified optometrist shall comply with:
(1)
Applicable national and State standards of infection control at each office; and
(2)
Principles of universal precautions as defined in COMAR 10.06.01.02B(10).
K.
The therapeutically certified optometrist shall maintain a written tracking system to identify patients who are being followed or referred for emergency sight or life-threatening conditions and who fail to keep appointments.
L.
The therapeutically certified optometrist shall document that a patient who fails to keep an appointment for an emergency sight or life-threatening condition was contacted by:
(1)
Telephone;
(2)
Electronic mail or other electronic means;
(3)
Text message; or
(4)
Mail.
M.
The therapeutically certified optometrist shall report all adverse reactions to the Board. An adverse drug reaction may be indicated by symptoms which include, but are not limited to, painful eye, pruritus, urticarial lesions, wheals, skin rash of periorbital tissues, nausea, vomiting, fainting, confusion, cessation of respiration, wheezing, clinically significant change in heart rate, or chest pain.
N.
The therapeutically certified optometrist shall prescribe and administer all therapeutic pharmaceutical agents in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland.
O.
The therapeutically certified optometrist shall remove superficial foreign bodies from the eye in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland.
P.
A therapeutically certified optometrist may not prescribe or administer a therapeutic pharmaceutical agent unless specifically authorized by law or these regulations.
Q.
The therapeutically certified optometrist shall report to the Board, on the form provided by the Board, within 10 working days of the occurrence, an adverse reaction. The therapeutically certified optometrist shall include in the report, at a minimum, the following:
(1)
The optometrist's name, address, and license number;
(2)
Patient information including:
(a)
Presenting problem;
(b)
Diagnosis;
(c)
Agent administered; and
(d)
Method of administration;
(3)
The adverse reaction; and
(4)
Subsequent action taken.
R.
Glaucoma Management.
(1)
In accordance with Health Occupations Article, §11-404.2, Annotated Code of Maryland, a therapeutically certified optometrist shall perform the procedures and tests necessary to diagnose primary open angle glaucoma appropriately.
(2)
A therapeutically certified optometrist may administer and prescribe topical pharmaceutical agents for glaucoma only as authorized by law.
S.
In developing a glaucoma treatment plan that ensures the maximum effectiveness for the patient, the therapeutically certified optometrist shall consider the following:
(1)
Types of agents to be administered and potential side effects;
(2)
Status of the optic nerve structure, function, and its relationship to intraocular pressure;
(3)
Identification of a target intraocular pressure at or below the target level in which further optic nerve damage is unlikely to occur;
(4)
Maintenance of intraocular pressure at or below the target level by initiating appropriate therapeutic intervention;
(5)
Monitoring of the optic nerve and resetting the target intraocular pressure if deterioration occurs;
(6)
Minimization of the side effects of treatment and their impact on the patient's vision, general health, and quality of life;
(7)
Education of the patient in the management of primary open angle glaucoma disease;
(8)
Reference to accepted clinical guidelines for glaucoma follow-up management; and
(9)
Criteria for surgical intervention.
T.
Laboratory Tests. Laboratory tests shall be ordered by a therapeutically certified optometrist only as provided by law.
Regulation .05 Monitoring of Complaint Investigation.LinkCopy Citation
A.
The Board shall review complaints against optometrists relating to ocular therapeutics, management of primary open angle glaucoma, removal of superficial foreign bodies, and other aspects of practice by a therapeutically certified optometrist.
B.
The Board's procedures for handling complaints are governed by Health Occupations Article, Title 11, Annotated Code of Maryland, COMAR 10.28.04, and State Government Article, §§10-201—10-227, Annotated Code of Maryland.
Chapter annotations
Authority: Health Occupations Article, §§11-101, 11-205, 11-302—11-309, 11-401.1, 11-404, and 11-404.1, Annotated Code of Maryland
History: Effective date:
History: Regulations .01—.08 adopted as an emergency provision effective May 17, 1996 (23:12 Md. R. 867); adopted permanently effective October 21, 1996 (23:21 Md. R. 1467)
History: Regulation .01B amended effective October 19, 2009 (36:21 Md. R. 1591)
History: Regulations .02 amended as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); amended permanently effective March 4, 2002 (29:4 Md. R. 417)
History: Regulation .02 amended effective October 19, 2009 (36:21 Md. R. 1591); May 20, 2019 (46:10 Md. R. 488)
History: Regulations .06 amended effective October 15, 2001 (28:20 Md. R. 1783)
History: Regulation .06A, C amended effective October 19, 2009 (36:21 Md. R. 1591)
History: Regulations .08 repealed effective October 15, 2001 (28:20 Md. R. 1783)
History: Chapter revised effective November 15, 2021 (48:23 Md. R. 980)
History: Regulation .02 amended effective July 7, 2025 (52:13 Md. R. 656)