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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEA unique state law and a seven member regulatory board (two Board of Pharmacy representatives, two Board of Medicine representatives, two Board of Osteopathy representatives, and one member from the public) currently authorize pharmacists to directly prescribe about 20 categories of prescription medications covering approximately 50 products listed on a state formulary. The pharmacy community in Florida is interested in creating a new category of “time sensitive drugs” for a number of medications and placing EC under that special category for future legislation attempts. In 2001 a pharmacist introduced a resolution to support EC into the Florida Pharmacists Association House of Delegates. Community pharmacy faculty at Nova Southeastern University, College of Pharmacy surveyed pharmacists and pharmacy students on EC access in Broward and Dade Counties. A clinical pharmacist has been providing EC to patients at Jackson Memorial Hospital under a protocol with the hospital’s Gynecology Department. Florida’s EC Workgroup, made up of eight Planned Parenthood affiliates in Florida, has undertaken an initiative to increase access to EC, especially on college campuses. In 2002 the workgroup conducted a nonscientific survey (DOC-24K) of 321 pharmacies statewide and provided them with a feedback letter summarizing results (DOC-88K). Dr. Rob Hemmick, an emergency room physician, also conducts research on access to EC. The Florida Medical Association passed a resolution (DOC-316K) about increasing EC awareness. The Miami ACLU has also been active on increasing EC on college campuses. In 2002 Florida introduced EC in the ER legislations — Emergency Treatment for Survivors of Rape, authored by the Florida Council Against Sexual Assault. The House bill (HB125) died in committee and the Senate bill (SB 2246) died on the Senate calendar. Planned Parenthood of South Palm Beach and Broward Counties, Inc. conducted a mystery shopper survey of local pharmacies in South Palm Beach and Broward Counties regarding the availability of Plan B (Emergency Contraception) over a two-week period ending February 14, 2006. The results (PDF-44K) revealed that 51.9% of pharmacies surveyed had Plan B available; 24.3% of pharmacies surveyed did not have Plan B but offered to special order; and 23.8% of pharmacies surveyed did not have Plan B and did not offer to special order. This is an active period for coalition building in Florida. Efforts are underway to form a coalition to improve education about EC, to improve EC access for survivors of rape and sexual assault, and to lower the barriers to EC access in pharmacies.
CONTACTSMichael Jackson, R.Ph. Joy Marcus, RPh, CPh, MS, BS Maria Maniscalco, Pharm D Linh Vuong, Pharm D Karen Daniel, Pharm D, CDE Rob Hemmick, MD
USEFUL LINKSFlorida Board of Pharmacy Florida Pharmacy Association Florida Legislature Planned Parenthood of South Palm Beach & Broward Counties, Inc. Planned Parenthood of North Central Florida Planned Parenthood of Northeast Florida Planned Parenthood of Collier County Planned Parenthood of Southwest and Central Florida Planned Parenthood of the Palm Beach and Treasure Coast Area Florida Association of Planned Parenthood Affiliates Florida Department of Health
PROTOCOL ENVIRONMENTPossible Environment: Revision to Existing Authority Required This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community. Pharmacist initiation of EC would require:
PHARMACY PRACTICE ACTPharmacy Practice Act Regulatory and Statutory Authority Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003. FLORIDA Pharmacists in any practice setting may engage in drug therapy management pursuant to a patient-specific Prescriber Care Plan written by a physician. This plan may include “orders for specific drugs . . . and other pharmaceutical services,” and must specify the drug therapy to be dispensed, the “conditions under which a pharmacist shall . . execute drug therapy orders,” and the conditions for contacting the physician. Drug Therapy Management is broadly defined to include “any act or service” provided by a pharmacist pursuant to a physician order which may include oral emergency contraceptives; however, the statutory definitions of “dispense” and “administration” appear to preclude pharmacists from administering injectable medications such as immunizations or the injectable contraceptive to individual patients pursuant to a Prescriber Care Plan. To deliver drug therapy services, the “pharmacy permit” must provide for :
A separate, unique state law and accompanying Board regulations authorize pharmacists to directly prescribe 20 categories of prescription medications, covering about 50 products, listed on a state-established formulary. The products range from oral analgesics and antihistamines to antidiarrheal and smoking cessation products. Numerous restrictions and requirements govern pharmacist prescribing, most notably:
Contraceptives, immunizations and vaccines are not on the state’s formulary. Statutory authority: Provided in definition of “practice of the profession of pharmacy,” and Pharmacists Order of Medicinal Drugs, 23 Fla. Stat. Ann. § 465.003 , § 465.186 Regulatory authority: Provided in Pharmacy Practice regulations governing Ordering and Dispensing Approved Medicinal Drug Products, and Medicinal Drugs Which May Be Ordered by Pharmacists, Fla. Admin. Code Ann. 64B16-27.200-.220, and Standards of Practice – Drug Therapy Management, Fla. Admin. Code Ann. r. 64B16-27.830
FLORIDA STATUTE Title XXXII Chapter 465 465.003 Definitions. (1) “Administration” means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption … (13) “Practice of the profession of pharmacy” includes compounding, dispensing, and consulting concerning contents, therapeutic values, and uses of any medicinal drug; consulting concerning therapeutic values and interactions of patent or proprietary preparations, whether pursuant to prescriptions or in the absence and entirely independent of such prescriptions or orders; and other pharmaceutical services. For purposes of this subsection, “other pharmaceutical services” means the monitoring of the patient's drug therapy and assisting the patient in the management of his or her drug therapy, and includes review of the patient's drug therapy and communication with the patient's prescribing health care provider as licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or similar statutory provision in another jurisdiction, or such provider's agent or such other persons as specifically authorized by the patient, regarding the drug therapy. However, nothing in this subsection may be interpreted to permit an alteration of a prescriber's directions, the diagnosis or treatment of any disease, the initiation of any drug therapy, the practice of medicine, or the practice of osteopathic medicine, unless otherwise permitted by law. “Practice of the profession of pharmacy” also includes any other act, service, operation, research, or transaction incidental to, or forming a part of, any of the foregoing acts, requiring, involving, or employing the science or art of any branch of the pharmaceutical profession, study, or training, and shall expressly permit a pharmacist to transmit information from persons authorized to prescribe medicinal drugs to their patients. 465.186 Pharmacist's order for medicinal drugs; dispensing procedure; development of formulary (1) There is hereby created a committee composed of two members of the Board of Medicine licensed under chapter 458 chosen by said board, one member of the Board of Osteopathic Medicine licensed under chapter 459 chosen by said board, three members of the Board of Pharmacy licensed under this chapter and chosen by said board, and one additional person with a background in health care or pharmacology chosen by the committee. The committee shall establish a formulary of medicinal drug products and dispensing procedures which shall be used by a pharmacist when ordering and dispensing such drug products to the public. Dispensing procedures may include matters related to reception of patient, description of his or her condition, patient interview, patient physician referral, product selection, and dispensing and use limitations. In developing the formulary of medicinal drug products, the committee may include products falling within the following categories:
(2) The Board of Pharmacy, the Board of Medicine, and the Board of Osteopathic Medicine shall adopt by rule a formulary of medicinal drugs and dispensing procedures as established by the committee. A pharmacist may order and dispense a product from the formulary pursuant to the established dispensing procedure, as adopted by the boards, for each drug in conjunction with its inclusion in the formulary. Any drug product ordered by a pharmacist shall be selected and dispensed only by the pharmacist so ordering, and said order shall not be refilled, nor shall another medicinal drug be ordered for the same condition unless such act is consistent with dispensing procedures established by the committee. Appropriate referral to another health care provider is indicated under such circumstances. On each occasion of such dispensing, the pharmacist shall create and maintain a prescription record in the form required by law. (3) Affixed to the container containing a medicinal drug dispensed pursuant to this section shall be a label bearing the following information:
(4) Any pharmacist performing the services authorized by this section shall be eligible for reimbursement by third party prescription programs when so provided by contract or when otherwise provided by such program. (5) Any person ordering or dispensing medicinal drugs in violation of this section shall be guilty of a misdemeanor of the first degree, and such violation shall be punishable as provided in s. 775.082 or s. 775.083
FLORIDA REGULATIONS CHAPTER 64B16-27 PHARMACY PRACTICE 64B16-27.200 Purpose and Effect. The purpose of this rule chapter is to set forth pursuant to the requirements of Section 465.186, F.S., the medicinal drug products which may be ordered and dispensed by pharmacists to the public and to set forth the terms and conditions under which such ordering and dispensing by the pharmacist may take place. The list of drugs set forth below and the conditions under which said drugs may be ordered and dispensed have been determined pursuant to a joint committee of medical, osteopathic and pharmacy professionals as created by Section 465.186, F.S. Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History-New 5-1-86, Formerly 21S-18.001, 21S-27.200, 61F10-27.200, 59X-27.200. 64B16-27.210 General Terms and Conditions to Be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products. Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations: (1) Injectable products shall not be ordered by the pharmacist. (2) No oral medicinal drugs shall be ordered by a pharmacist for a pregnant patient or nursing mother. (3) In any case of dispensing hereunder, the amount or quantity of drug dispensed shall not exceed a 34-day supply or standard course of treatment unless subject to the specific limitations in this rule. Patients shall be advised that they should seek the advice of an appropriate health care provider if their present condition, symptom, or complaint does not improve upon the completion of the drug regimen. (4) The directions for use of all prescribed medicinal drugs shall not exceed the manufacturer’s recommended dosage. (5) The pharmacist may only perform the acts of ordering and dispensing in a pharmacy which has been issued a permit by the Board of Pharmacy. (6) The pharmacist shall create a prescription when ordering and dispensing medicinal drug products which shall be maintained in the prescription files of the pharmacy. The pharmacist shall place the trade or generic name and the quantity dispensed on the prescription label, in addition to all other label requirements. (7) The pharmacist shall maintain patient profiles, separate from the prescription order, for all patients for whom the pharmacist orders and dispenses medicinal drug products and shall initial and date each profile entry. Such profiles shall be maintained at the pharmacy wherein the ordering and dispensing originated for a period of seven (7) years. (8) In the patient profiles, the pharmacist shall record as a minimum the following information if a medicinal drug product is ordered and dispensed.
(9) A medicinal drug product may be ordered, and dispensed only by the pharmacist so ordering. (10) Only legend medicinal drugs may be prescribed by a pharmacist. Over-the-counter drugs are exempt from the requirements of this rule and shall be recommended as over-the-counter products. (11) Pharmacy interns and supportive personnel may not be involved in the ordering of the medicinal drugs permitted in this Rule. Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History-New 5-1-86, Formerly 21S-18.002, 21S-27.210, 61F10-27.210, 59X-27.210. 64B16-27.220 Medicinal Drugs Which May Be Ordered by Pharmacists. A Pharmacist may order and dispense from the following formulary, subject to the stated conditions: (1) Oral analgesics for mild to moderate pain: magnesium salicylate/phenyltoloxamine citrate, acetylsalicylic acid (Zero order release, long acting tablets), choline salicylate and magnesium salicylate, naproxen sodium, naproxen, and 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, not exceeding a two (2) day supply. Such prescriptions shall be labeled as to the tendency to discolor urine and when appropriate shall be labeled to be taken after meals. (3) Otic analgesics; antipyrine 5.4%, benzocaine 1.4%, glycerin, which shall be labeled for use in the ear only. (4) Anti-nausea preparations; Medicine up to 25 mg., except for a patient currently using a central nervous system (CNS) depressant. The prescription shall be labeled to advise the patient of drowsiness and to caution against concomitant use with alcohol or other depressants. Scopolamine not exceeding 1.5 mg. per dermal patch. Patient to be warned “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 patients above 6 years of age:
(6) Anthelmintic: Pyrantel pamoate. The drug product may only be ordered for use by patients over 2 years of age. (7) Topical antifungal/antibacterials; Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams), Haloprogin 1%, Clotrimazole topical cream and lotion. Nystatin topical cream, ointment, lotion or powder, miconazole nitrate topical cream, 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. (8) Topical anti-inflammatory; 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. (9) Otic antifungal/antibacterial; acetic acid 2% in aluminum acetate solution which shall be labeled for use in ears only. (10) Keratolytics; 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. (11) Vitamins with fluoride (This does not include vitamins with folic acid in excess of 0.9 mg.) (12) Medicinal drug shampoos containing Lindane may be ordered pursuant to the following conditions:
(13) Antidiarrheal: Loperamide 2 mg per dosage unit. No more than a two day supply may be dispensed. (14) Smoking cessation products: Nicotine transdermal systems.
(15) Ophthalmics: Naphazoline 0.1% ophthalmic solution. (16) Cough suppressants:
(17) Vaginal antifungals: Miconazole nitrate suppositories and/or miconazole nitrate cream. (18) Histamine H2 antagonists:
(19) Topical Antiviral:
(20) Acne product: Benzoyl peroxide. 64B16-27.830 Standards of Practice - Drug Therapy Management. (1) “Prescriber Care Plan” means an individualized assessment of a patient and orders for specific drugs, laboratory tests, and other pharmaceutical services intended to be dispensed or executed by a pharmacist. The Prescriber Care Plan shall be written by a physician licensed pursuant to Chapter 458, 459, 461, or 466, F.S., or similar statutory provision in another jurisdiction, and may be transmitted by any means of communication. The Prescriber Care Plan shall specify the conditions under which a pharmacist shall order laboratory tests, interpret laboratory values ordered for a patient, execute drug therapy orders for a patient, and notify the physician. (2) “Drug Therapy Management” means any act or service by a pharmacist in compliance with orders in a Prescriber Care Plan. (3) A pharmacist may provide Drug Therapy Management services for a patient, incidental to the dispensing of medicinal drugs or as a part of consulting concerning therapeutic values of medicinal drugs or as part of managing and monitoring the patient’s drug therapy. A pharmacist who provides Drug Therapy Management services for a patient shall comply with orders in a Prescriber Care Plan, insofar as they specify:
(4) A pharmacist who provides Drug Therapy Management services shall do so only under the auspices of a pharmacy permit that provides the following:
Specific Authority 465.005, 465.0155 FS. Law Implemented 465.003(13), 465.0155, 465.022(1)(b) FS. History-New 4-4-00.
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