64B15-18.003: Medicinal Drugs Which May be Ordered by Pharmacists
PURPOSE AND EFFECT: The proposed rule amendments are intended to update language in the rule addressing specific medications which may be ordered by pharmacists.
SUMMARY: The proposed rule amendments update the list of specific medicinal drugs which may be ordered by a pharmacist.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared. The Board has determined that the proposed rule amendments will not have an impact on small business.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.186(2) FS.
LAW IMPLEMENTED: 465.186 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Anthony Jusevitch, Executive Director, Board of Osteopathic Medicine/MQA, 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256
THE FULL TEXT OF THE PROPOSED RULE IS:
64B15-18.003 Medicinal Drugs Which May be Ordered by Pharmacists.
A Pharmacist may order and dispense from the following formulary within the pharmacists professional judgment, subject to the stated conditions:
(1) 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 shall be limited to a six (6) day supply for one treatment. If The following may be ordered for mild to moderate pain: magnesium salicylate/phenyltoloxamine citrate, acetylsalicylic acid (Zero order release, long acting tablets), choline salicylate and magnesium salicylate, IBUPROFEN (no more than 400 mg per dosage unit for minor pain and menstrual cramps limited to a six (6) day supply for one treatment). When appropriate, such prescriptions shall be labeled to be taken with food or milk.
(a) Magnesium salicylate/phenyltoloxamine citrate.
(b) Acetylsalicylic acid (Zero order release, long acting tablets).
(c) Choline salicylate and magnesium salicylate.
(d) Naproxen sodium.
(e) Naproxen.
(f) Ibuprofen.
(2) Urinary analgesics. Phenazopyridine, The following may be ordered: phenazopyridine not exceeding a two (2) day supply. The Such prescriptions shall be labeled about as to the tendency to discolor urine. If and when appropriate, the prescription shall be labeled to be taken after meals.
(3) Otic analgesics. Antipyrine The following may be dispensed: antipyrine 5.4%, benzocaine 1.4%, glycerin, if clinical signs and symptoms of tympanic membrane perforation do not exist. The product which shall be labeled for use in the ear only.
(4) Hemorrhoid medications. The following may be dispensed: 0.5% hydrocortisone acetate and 0.5% dibucaine ointments and creams, limited to a seven (7) day supply.
(5) Leg cramps. The following may be ordered: quinine sulfate tablets, except to patients with cardiac arrhythmias, and not to patients currently using anticoagulant or digitalis containing drugs. When appropriate, such prescriptions shall be labeled to be taken with or after meals.
(4)(6) Anti-nausea preparations. The following may be dispensed:
(a) Meclizine up to 25 mg., except for a patient currently using a central nervous system (CNS) depressant. The prescription shall be labeled to advise of drowsiness side effect and caution against concomitant use with alcohol or other depressants.
(b) Scopolamine not exceeding 1.5 mg. per dermal patch. Patient shall be warned to seek appropriate medical attention if eye pain, redness or decreased vision develops.
(5)(7) Antihistamines and decongestants. The following, including their salts, either as a single ingredient product or in combination including nasal decongestants, may be ordered for a patients above (6) years of age:
(a) Antihistamines. The pharmacist shall warn the patient that an antihistamine should not be used by patients with bronchial asthma or other lower respiratory symptoms, glaucoma, cardiovascular disorders, hypertension, prostate conditions and urinary retention. An antihistamine shall be labeled to advise the patient of drowsiness and caution against the concomitant use with alcohol or other depressants.
1. Diphenhydramine.
2.(b) Carbinoxamine.
(c) Loratadine (maximum 14 days supply only).
3.(d) Pyrilamine.
(e) Azelastine.
4.(f) Dexchlorpheniramine.
5.(g) Brompheniramine.
(h) Fexofenadine.
(b) Decongestants. The pharmacist shall not order an oral decongestant for use by a patient with coronary artery disease, angina, hyperthyroidism, diabetes, glaucoma, prostate conditions, hypertension, or a patient currently using a monoamine oxidase inhibitor.
1. Phenylephrine.
2. Azatadine.
The patient should be warned that antihistamines should not be used by patients with bronchial asthma or other lower respiratory symptoms, glaucoma, cardiovascular disorders, hypertension, prostate conditions and urinary retention. Antihistamines shall be labeled to advise of drowsiness side effects and caution against use with alcohol or other depressants.
(i) Ephedrine.
(j) Phenylephrine.
(k) Phenyltoloxamine.
(l) Azatadine.
(m) Diphenylpyraline.
Oral decongestants shall not be ordered for use by patients with coronary artery disease, angina, hyperthyroidism, diabetes, glaucoma, prostate conditions, hypertension, or patients currently using monoamine oxidase inhibitors.
(6) Topical antifungal/antibacterials.
(a) Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams).
(b) Haloprogin 1%.
(c) Clotrimazole topical cream and lotion.
(d) Erythromycin topical.
(8) Anthelmintic. The following may be ordered: Pyrantel pamoate. The drug product may only be ordered for use by patients over 2 years of age.
(9) Topical antifungal/antibacterials. The following may be ordered: Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams), Haloprogin 1%, Clotrimazole topical cream and lotion. The patient shall be warned that all of the above products should not be used near deep or puncture wounds, and Iodochlorhydroxyquin preparations shall be labeled as to the staining potential.
(7)(10) Topical anti-inflammatory. The pharmacist shall warn the patient that hydrocortisone should not be used on bacterial infections, viral infections, fungal infections, or by patients with impaired circulation. The prescription shall be labeled to advise the patient to avoid contact with eyes, mucous membranes or broken skin. Preparations containing hydrocortisone not exceeding 2.5%.
The following may be ordered: Preparations containing hydrocortisone not exceeding 0.5%. The patient shall be warned that hydrocortisone should not be used on bacterial or fungal infections or by patients with impaired circulation. Such prescriptions shall be labeled to avoid contact with eyes and broken skin.
(8)(11) Otic antifungal/antibacterial. Acetic The following may be ordered: acetic acid 2% in aluminum acetate solution, which shall be labeled for use in ears only.
(9)(12) Keratolytics. Salicylic The following may be ordered: salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be applied to warts, except for patients under two (2) years of age, and those with diabetes or impaired circulation. Prescriptions shall be labeled to avoid contact with normal skin, eyes and mucous membranes.
(10)(13) Vitamins with fluoride (This does not include vitamins with folic acid in excess of 0.9 mg.).
(11)(14) Medicinal drug shampoos containing Lindane. The pharmacist shall: may be ordered pursuant to the following conditions:
(a) Limit The pharmacist shall limit the order to the treatment of head lice only;
(b) Order no more than four (4) ounces per person; and
(c) Provide provide the patient with the appropriate instructions and precautions for use.
(b) The amount allowed per person shall be four ounces.
(12) Ophthalmics: Naphazoline 0.1% ophthalmic solution.
(13) Histamine H2 antagonists. The pharmacist shall advise the patient to seek medical attention if symptoms persist longer than 14 days while using the medication or if stools darken or contain blood.
(a) Cimetidine.
(b) Famotidine.
(c) Ranitidine HCL.
(14) Acne products. Benzoyl Peroxide. The prescription shall be labeled to advise the patient to avoid use on the eye, eyelid, or mucous membranes.
(15) Topical Antiviral.
(a) Acyclovir ointment may be ordered for the treatment of herpes simplex infections of the lips.
(b) Penciclovir.
Rulemaking Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History–New 5-1-86, Formerly 21R-18.003, 61F9-18.003, 59W-18.003, Amended 10-16-01,________.