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| Helping pharmacy & health communities improve access to Emergency Contraception (EC) |
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EC PHARMACY UPDATEThere is currently no known activity promoting direct pharmacy access to EC. Indiana is a conservative state. Many pharmacies do not carry dedicated EC products, but the Family Planning Council purchases EC and provides it to their delegates. Furthermore, per the medical standards for Title X in Indiana, all Title X family planning programs must educate every patient receiving initial medical services about EC and offer pills to take home in case of contraceptive failure. Despite these efforts, EC is still widely misunderstood to be an abortifacient. Planned Parenthood of Indiana makes EC available at all 37 of its health centers (free to sexual assault survivors). Women can also obtain EC at a Planned Parenthood clinic or pharmacy of choice. Planned Parenthood also has various campaigns to increase awareness and access. The Health Access and Privacy Alliance, representing 23 Indiana organizations, is dedicated to reproductive health and guaranteed access to contraception.
CONTACTSJennifer Jorczak Michael McKillip Gayla Winston
USEFUL LINKSIndiana State Board of Pharmacy Indiana Pharmacists Alliance Indiana General Assembly Planned Parenthood of Indiana Indiana Family Health Council
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. INDIANA Only pharmacists practicing in a hospital or private mental institution setting may provide certain drug therapy management services, including the administration of drugs, covering any designated diseases and medications listed in a patient-specific order from a practitioner or in a facility-approved protocol. While the protocols should be developed by a team of professionals, the hospital or institutional governing board has authority regarding terms, implementation, revision and renewal of the protocol. The protocol must be reviewed at least annually. The scope of practice is outlined in the protocol, and the law allows a pharmacist, under a physician’s supervision, to:
The procedures performed must relate to the condition for which the patient first saw the practitioner, and all decisions and adjustments must be entered immediately into patient medical records, which must be available for review by the authorizing practitioner. The protocol must ensure that the patient’s medical records are available, and it must be reviewed annually. Finally, the pharmacist must communicate with the admitting practitioner prior to implementing a protocol involving parenteral nutrition. Current law also authorizes pharmacists in community and institutional settings to administer any drug, such as contraceptives and immunizations, via any route of delivery, pursuant to a patient-specific prescription. Statutory authority: Provided in the definition of “Practice of Pharmacy,” Ind. Code §§ 25-26-13-2, and the chapter governing “Drug Regimes” and adjustments, Ind. Code 25-26-16. Regulatory authority: Provided in regulatory definitions, 856 Ind. Admin. Code 1-1.1, and the updated section governing “Institutional Pharmacies and Pharmacy Services,” 856 Ind. Admin. Code 28.1
INDIANA STATUTE PHARMACY PRACTICE ACT IC 25-26 Pharmacists, Pharmacies, Drug Stores Chapter 13. Regulation of Pharmacists and Pharmacies - Creation of Board. 25-26-13-2 Definitions Sec. 2. “The practice of pharmacy” or “the practice of the profession of pharmacy” means a patient oriented health care profession in which pharmacists interact with and counsel patients and with other health care professionals concerning drugs and devices used to enhance patients' wellness, prevent illness, and optimize the outcome of a drug or device, by accepting responsibility for performing or supervising a pharmacist intern, a pharmacist extern, or an unlicensed person under section 18(a)(4) of this chapter to do the following acts, services, and operations:
As added by Acts 1977, P.L.276, Sec.1. Amended by P.L.149-1987, Sec.72; P.L.2-1993, Sec.144; P.L.1887-1999, Sec.1. IC16-18-2-161 Sec. 161. (a) “Health care facility” includes:
IC 16-18-2-167
As added by P.L.2-1993, SEC.1. Amended by P.L.61-1993, SEC.62; P.L.111-1996, SEC.2; P.L.58-2000, SEC.1. Chapter 16. Drug Regimens IC 25-26-16-1 “Protocol” defined Sec. 1. As used in this chapter, “protocol” means the policies, procedures, and protocols of a hospital listed in IC 16-18-2-161(1) concerning the adjustment of a patient's drug regimen by a pharmacist. IC 25-26-16-2 Adjustment Sec. 2. For purposes of this chapter, a pharmacist adjusts a drug regimen if the pharmacist:
IC 25-26-16-3 Protocol upon hospital admission Sec.3. (a) at the time of admission to a hospital that has adopted a protocol under this chapter, the following apply:
The pharmacist shall review the appropriate medical records of the patient to determine whether the admitting practitioner has authorized the use of a specific protocol before adjusting the patient's drug therapy regimen. The admitting practitioner may at any time modify or cancel a protocol by entering the modification or cancellation in the patient's medical record. (b) Not withstanding subsection (a)(2), if a protocol involves parenteral nutrition of the patient, the pharmacist shall communicate with the admitting practitioner to receive approval to begin the protocol. The authorization of the admitting practitioner to use the protocol shall be entered immediately in the patient's medical record. IC 25-26-16-4 Minimum protocol requirements Sec.4. (a) This section applies to a pharmacist practicing in a hospital listed in IC 16-18-2- 161(1), in which the pharmacist is supervised by a physician as required under the protocols of the facility that are developed by health care professionals, including physicians, pharmacists, and registered nurses. (b) The protocols developed under this chapter must at a minimum require that the medical records of the patient are available to both the patient's practitioner and the pharmacist and that the procedures performed by the pharmacist relate to a condition for which the patient has first seen a physician or other licensed practitioner. IC 25-26-16-5 Implementation, revision, or renewal of protocol Sec. 5. If a hospital or private mental health institution elects to implement, revise, or renew a protocol under this chapter, the governing board of the hospital of private mental health institution shall consult with that facility's medical staff, pharmacists, and other health care providers selected by the governing board. However, the governing board is the ultimate authority regarding the terms, implementation, revision, and renewal of the protocol. IC 25-26-16-6 Modification of written protocol Sec. 6. Except for the addition or deletion of authorized practitioners and pharmacists, a modification to written protocols requires the initiation of a new protocol. IC 25-26-16-7 Annual review Sec. 7. A protocol of a health care facility developed under this chapter must be reviewed at least annually. IC 25-26-16-8 Documentation Sec. 8. Documentation of protocols must be maintained in a current, consistent, and readily retrievable manner. A pharmacist is required to document decisions made under this chapter in a manner that shows adequate, consistent, and regular communication with an authorizing practitioner. After making an adjustment or a change to the drug regimen of a patient, the pharmacist shall immediately enter the change in the patient's medical record. 25-26-16-9 Confidentiality; liability Sec.9. (a) This chapter does not modify the requirements of other statutes relating to the confidentiality of medical records. (b) This chapter does not make any other licensed health care provider liable for the actions of a pharmacist carried out under this section.
INDIANA REGULATIONS INDIANA BOARD OF PHARMACY REGULATIONS TITLE 856 Pharmacies and Pharmacists RULE 1.1. Definitions ARTICLE 1. PHARMACIES AND PHARMACISTS Rule 1.1. Definitions 856 IAC 1-1.1-1 Adoption of definitions Authority: IC 25-26-13-4 Affected: IC 25-26-13-2; IC 35-48-1-1 Sec. 1. All terms which are defined in IC 25-26-13-2 shall have the same meanings as they are so defined when used in the rules and regulations of the Indiana board of pharmacy found in Article 1 of Title 856 of the Indiana Administrative Code. (Indiana Board of Pharmacy; 856 IAC 1-1.1-1; filed Dec 3, 1985, 3:02 pm: 9 IR 767; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; errata filed Jan 9, 2002, 4:20 p.m.: 25 IR 1645) 856 IAC 1-1.1-2 “Pharmacy Practice Act” defined Authority: IC 25-26-13-4 Affected: IC 25-26-13 Sec. 2. The term “Pharmacy Practice Act” when used in these regulations is in reference to Acts 1977, Public Law codified at IC 25-26-13 as amended from time to time. (Indiana Board of Pharmacy; 856 IAC 1-1.1-2; filed Dec 3, 1985, 3:02 pm: 9 IR 767; readopted filed Nov 13, 2001, 3:55 p.m.: 25 IR 1330; errata filed Jan 9, 2002, 4:20 p.m.: 25 IR 1645) Rule 28. Institutional Pharmacies (Repealed) (Repealed by Indiana Board of Pharmacy; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1643) Rule 28.1. Institutional Pharmacies and Pharmacy Services 856 IAC 1-28.1-1 Definitions Authority: IC 25-26-13-4 Affected: IC 16-42-19-5; IC 25-6-3-7; IC 25-26-13 * * * (6) “Institutional facility” means any health care facility whose primary purpose is to provide a physical environment for patients to obtain health care services, except those places where practitioners, as defined by IC 16-42-19-5, who are duly licensed, engage in private practice and pharmacies licensed under IC 25-26-13-17. 856 IAC 1-28.1-2 Purpose Authority: IC 25-26-13-4 Affected: IC 25-26-13-17 Sec. 2. The purpose of this rule is to set forth the responsibilities of pharmacists and pharmacies serving institutional and home health care patients. (Indiana Board of Pharmacy; 856 IAC 1-28.1-2; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1637) 856 IAC 1-28.1-3 Applicability Authority: IC 25-26-13-4 Affected: IC 25-26-13-17 Sec. 3. This rule is applicable to pharmacies located: (1) within institutional facilities as defined in section 1 of this rule and classified as Type II pharmacies in IC 25-26-13-17; and (2) outside institutional facilities that serve institutionalized patients who are classified as Type III and Type VI pharmacies as in IC 25-26-13-17. (Indiana Board of Pharmacy; 856 IAC 1-28.1-3; filed Dec 26, 2001, 2:44 p.m.: 25 IR 1637) 856 IAC 1-28.1-7 Pharmacist’s duties Authority: IC 25-26-13-4 Affected: IC 16-42-19-3; IC 25-26-13-2; IC 25-26-13-31; IC 25-26-16 Sec. 7. * * * (b) The pharmacist practicing in an institutional pharmacy shall, at a minimum, do the following: (1) Obtain and maintain patient drug histories and drug profiles. (2) Perform drug evaluations, drug utilization review, drug regimen review, and drug therapy management under protocol approved by the medical staff of the institution and authorized by IC 25-26-16. * * * (9) Compound, label, administer, and dispense drugs or devices. (10) Assess, record, and report quality related events as defined in this rule. * * *
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