The proposed rule amendments are intended bring the rule into compliance with the proposed Board of Pharmacy Rule 61B16-27.220, F.A.C., with regard to medicinal drugs which may be appropriately ordered by pharmacists.

 

DEPARTMENT OF HEALTH
Board of Medicine

RULE NO: RULE TITLE
64B8-36.003: Medicinal Drugs Which May Be Ordered by Pharmacists
PURPOSE AND EFFECT: The proposed rule amendments are intended bring the rule into compliance with the proposed Board of Pharmacy Rule 61B16-27.220, F.A.C., with regard to medicinal drugs which may be appropriately ordered by pharmacists.
SUMMARY: The proposed rule amendments set forth the various medicinal drugs which may appropriately be ordered by pharmacists.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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: Larry McPherson, Jr., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B8-36.003 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 appropriate, the prescription shall be labeled to be taken with food or milk.

(a) Magnesium magnesium salicylate/phenyltoloxamine citrate.,

(b) Acetylsalicylic acetylsalicylic acid (Zero order release, long acting tablets).,

(c) Choline choline salicylate and magnesium salicylate.,

(d) Naproxen naproxen sodium.,

(e) Naproxen. naproxen, and

(f) Ibuprofen. ibuprofen for minor pain and menstrual cramps for patients with no history of peptic ulcer disease; limited to a six (6) day supply for one treatment. When appropriate, such prescriptions shall be labeled to be taken with food or milk.

(2) Urinary analgesics.; Phenazopyridine phenazopyridine, not exceeding a two (2) day supply. The Such prescriptions shall be labeled about as to the tendency to discolor urine. If appropriate, the prescription and when appropriate shall be labeled to be taken after meals.

(3) Otic analgesics.; Antipyrine 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) Anti-nausea preparations.;

(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 and caution against concomitant use with alcohol or other depressants.

(b) Scopolamine not exceeding 1.5 mg. per dermal patch. Patient shall to be warned to seek appropriate medical attention if eye pain, redness or decreased vision develops. “if eye pain develops, seek appropriate medical attention.”

(5) 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 patient 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.(a) Diphenhydramine.

2.(b) Carbinoxamine.

3.(c) Pyrilamine.

4.(d) Dexchlorpheniramine.

5.(e) Brompheniramine.

(f) Loratadine (maximum 14 days supply only).

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 and caution against the concomitant use with alcohol or other depressants.

(g) Fexofenadine.

(h) Azelastine.

(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.

(i) Ephedrine.

1.(j) Phenylephrine.

(k) Phenyltoloxamine.

2.(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) Anthelmintic; Pyrantel pamoate. The drug product may only be ordered for use by patients over 2 years of age.

(6)(7) Topical antifungal/antibacterials.;

(a) Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams).,

(b) Haloprogin 1%.,

(c) Clotrimazole topical cream and lotion., Nystatin topical cream, ointment, lotion or powder, miconazole nitrate topical cream,

(d) Erythromycin erythromycin topical. 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)(8) 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 preparations containing hydrocortisone not exceeding 2.5%. The patient shall be warned that hydrocortisone should not be used on bacterial infections, viral infections, fungal infections or by patients with impaired circulation. Such prescriptions shall be labeled to avoid contact with eyes and broken skin.

(8)(9) Otic antifungal/antibacterial.; Acetic acetic acid 2% in aluminum acetate solution, which shall be labeled for use in ears only.

(9)(10) Keratolytics.; Salicylic 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)(11) Vitamins with fluoride. (This does not include vitamins with folic acid in excess of 0.9 mg.)

(11)(12) Medicinal drug shampoos containing Lindane. may be ordered pursuant to the following conditions:

(a) The pharmacist shall:

(a) Limit 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.

(13) Antidiarrheal: Loperamide 2mg. per dosage unit. No more that a two day supply may be dispensed.

(14) Smoking cessation products: Nicotine transdermal systems.

(a) Before prescribing, the pharmacist:

1. Must have successfully completed a comprehensive smoking cessation training program such as the American Cancer Society Physician Training Program or other ACPE approved certification program.

2. Must insure patient involvement in a behavior modification program.

3. Must insure that there are no medical contraindications for patient participation including pregnancy or breastfeeding, cardiovascular disease (postinfarction, arrhythmias, hypertension, peripheral vascular disease), pheochromocytoma, hyperthyroidism, or insulin dependent diabetes mellitus.

4. Must inform patients of all contraindications and hazards of drug therapy including drug, food, and nutritional interactions.

5. Must counsel patients on proper drug use of prescribed product.

(b) After prescribing, the pharmacist:

1. May dispense no more than a 14 day supply of nicotine transdermal patches.

2. May dispense smoking cessation products for no more than 24 consecutive weeks of drug therapy.

3. May prescribe these products for nicotine replacement only.

4. Must perform and document follow-up counseling during therapy.

(12)(15) Ophthalmics.: Naphazoline 0.1% ophthalmic solution.

(16) Cough suppressants:

(a) Guaifenesin.

(b) Dextromethorophan.

(17) Vaginal antifungals: Miconazole nitrate suppositories and/or miconazole nitrate cream.

(13)(18) 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) Famotiding.

(c) Ranitidine HCL.

Pharmacists shall advise patients that these agents may mask serious disorders.

(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)(19) Topical Antiviral.:

(a) Acyclovir ointment may be ordered for the treatment of herpes simplex infections of the lips.

(b) Penciclovir.

(20) Acne product: Benzoyl peroxide.

Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History–New 5-1-86, Formerly 21M-39.003, 61F6-39.003, 59R-36.003, Amended 8-19-99,__________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Joint Committee, Board of Pharmacy/Board of Medicine; Rules Committee of the Board of Medicine
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 06, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: August 31, 2007