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EC PHARMACY UPDATE

The Iowa Pharmacy Association (IPA) adopted a policy in 2001 (DOC-20K) that supports patient access to emergency contraception products and the voluntary involvement of pharmacists in emergency contraception programs.

The Iowa Board of Pharmacy and the Iowa Board of Medical Examiners are working to establish a framework to facilitate collaborative initiatives under the Iowa Pharmacy Act. Currently, pharmacists work with physicians to develop protocols to administer immunizations.

IPA recently hosted a presentation on the Pharmacists Role in Emergency Contraception. Representatives from the Iowa Family Planning Association and Planned Parenthood were invited to attend.

The “Healthy Iowan 2010” (HI2K10) approved the action to: “Provide by 2003 practicing Iowa pharmacists with authorization to provide emergency contraceptive pills for women who request them — according to a preexisting protocol — and require insurance plans to provide payment for this medication when other drugs are covered by the plan.” This document was developed by the Iowa Department of Public Health in consultation with other organizations in the state. (The intent of this goal has not been met just yet.)

The Iowa Family Health Bureau is providing training on EC targeted to Title X providers, but this training can include other health care professionals. The Family Planning Council and Planned Parenthood of Greater Iowa have received some support to develop materials and ads to increase awareness about EC.

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CONTACTS

Jennifer Moulten, R.Ph.
Senior Vice President, Educational Affairs
Iowa Pharmacy Association
8515 Douglas Ave., Suite 16
Des Moines, IA 50322
515-270-0713
Fax: 515-270-2979
www.iarx.org

Thomas Temple, R.Ph., M.S.
Executive Vice President & CEO
Iowa Pharmacy Association
8515 Douglas Ave., Suite 16
Des Moines, IA 50322
515-270-0713
Fax: 515-270-2979
ttemple@iarx.org
www.iarx.org

Jodi Tomlonovic
Executive Director
Family Planning Council of Iowa
108 3rd Street, Suite 220
Des Moines, IA 50309
515-288-9028
Fax: 515-288-4048
jtomlonovic@fpcouncil.com

Kathy Widelski
Coordinator, Family Planning Bureau
Iowa Department of Public Health
321 East 12th Street, Lucas State Office Building
Des Moines, IA 50319-0075
515-281-4907
Fax: 515-242-6384
kwidelsk@idph.state.ia.us

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USEFUL LINKS

Iowa State Board of Pharmacy
www.state.ia.us/ibpe

Iowa Pharmacy Association
www.iarx.org

The Iowa Legislature
www.legis.state.ia.us

Planned Parenthood of Greater Iowa
www.ppgi.org

Family Planning Council of Iowa
www.fpcouncil.com

NARAL Pro-Choice Iowa
www.iowanaral.org

Iowa Department of Public Health
www.idph.state.ia.us

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PROTOCOL ENVIRONMENT

Possible 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:

• Confirmation and/or approval from the Board of Pharmacy that collaborative practice agreements may be used to provide EC
• Modifying the requirement for patient-specific protocols

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PHARMACY PRACTICE ACT

Pharmacy 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.

IOWA

Iowa has not formally authorized collaborative practice agreements beyond those described below for immunizations. The Board has, however, identified the formal establishment of such authority in its Proposed Regulatory Plan for Fiscal Year 2003 (dated 7/24/02):

II. Regulatory Plan

The Board of Pharmacy Examiners has identified the following subjects currently under active consideration or development and on which the Board expects to issue proposed or final rules during the current fiscal year or thereafter.

* * *

B. Drug therapy management/collaborative practice

The need to improve patient care by coordinating the activities of the various health care providers has become a major topic in the nations' health care community and Iowa is not immune. Practitioners from the various health care disciplines can make significant contributions to patient care by utilizing their specialized training and skills in a collaborative manner as members of an interdisciplinary team. Pharmacists, for example, can provide the team with expertise needed to improve a patient's drug therapy and self-care skills.

Many states have some statute or regulation addressing collaborative drug therapy management and many include requirements or provisions for formal collaborative practice agreements between pharmacists and physicians. Collaborative practice agreements must be based on trust and a successful working relationship between a pharmacist or group of pharmacists and a physician or group of physicians.

Any provisions defining or authorizing collaborative practice between pharmacists and physicians will need to be approved by both the pharmacy and medical communities and regulators. The Pharmacy Examiners Board anticipates initiating discussion, during fiscal year 2003, with the Medical Examiners Board to explore the possibility of pursuing rule making and/or legislative change to permit a level of collaborative practice among Iowa physicians and pharmacists. The Board anticipates that any proposals addressed in these discussions may generate controversy within the health professional communities.

As of June 15, however, the Board did not have Collaborative Practice listed on its Rulemaking Docket.

One or more pharmacists practicing in any setting may administer influenza and pneumoccocus immunizations to adults pursuant to a written protocol by one or more physicians that need not be patient-specific, but must identify the dosages, route of administration, and procedures for record keeping and long-term record storage. The pharmacist must receive specified training and continuing education. Administration of any other immunizations requires a patient-specific protocol.

Statutory Authority: Iowa Code § 155A.3

Regulatory Authority: Iowa Admin. Code r. 657-8.5(5), r. 657-8.7, r. 8.21, r. 8.22, r. 8.33

IOWA STATUTES

Iowa Code

155A.3 Definitions.

As used in this chapter, unless the context otherwise requires:

1. “Administer” means the direct application of a prescription drug, whether by injection, inhalation, ingestion, or any other means, to the body of a patient or research subject by one of the following:

a. A practitioner or the practitioner's authorized agent.

b. The patient or research subject at the direction of a practitioner.

2. “Authorized agent” means an individual designated by a practitioner who is under the supervision of the practitioner and for whom the practitioner assumes legal responsibility.

…

20. “Medication order” means a written order from a practitioner or an oral order from a practitioner or the practitioner's authorized agent for administration of a drug or device.

…

27. “Practice of pharmacy” is a dynamic patient-oriented health service profession that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use and related drug therapy.

…

31. “Prescription drug order” means a written order from a practitioner or an oral order from a practitioner or the practitioner's authorized agent who communicates the practitioner's instructions, to a pharmacist for a prescription drug or device to be dispensed.

IOWA REGULATIONS

Iowa Administrative Code

PHARMACY EXAMINERS BOARD[657] (GNA)

CHAPTER 8

MINIMUM STANDARDS FOR THE

PRACTICE OF PHARMACY

[Prior to 2/10/88, see Pharmacy Examiners[620] Ch 6]

8.5(5) Confidentiality. In the absence of express consent from the patient or order or direction of a court, except where the best interests of the patient require, a pharmacist shall not divulge or reveal to any person other than the patient or the patient’s authorized representative, the prescriber or other licensed practitioner then caring for the patient, another licensed pharmacist, or a person duly authorized by law to receive such information, any of the following:

a. The contents of any prescription or the therapeutic effect thereof or the nature of professional pharmaceutical services rendered to a patient;

b. The nature, extent, or degree of illness suffered by any patient; or

c. Any medical information furnished by the prescriber.

This shall not prevent pharmacists from transferring a prescription to another pharmacy, providing a copy of a nonrefillable prescription to the person for whom the prescription was issued which copy is marked “For Information Purposes Only,” providing drug therapy information to physicians for their patients, or providing information to the board or its representative. Disposal of any materials containing or including patient-specific or confidential information shall be conducted in a manner to preserve patient confidentiality.

657-8.7(272C) Continuing education requirements as a condition for license renewal.

8.7(1) Continuing education program attendance. Continuing education programs that carry the seal of the American Council on Pharmaceutical Education (ACPE) approved provider will automatically qualify for continuing education credit. Program attendance is mandated in order to receive credit unless it is a correspondence course ACPE approved. Non-ACPE provider programs must be submitted to the board office for consideration no later than the date of the program. The request shall be made on forms provided by the board office. Pharmacists who are continuing their formal education in health-related graduate programs may be exempted from meeting the continuing education requirements during the period of such enrollment. Applicants for this exemption must petition the board on forms provided by the board office. This regulation does not preclude the future possibility of relicensure examination.

8.7(2) Continuing education unit required. The nationally accepted measurement of continuing education is referred to as CEU (Continuing Education Unit) and will be the measurement employed by the board of pharmacy examiners. Ten contact hours of approved continuing education are equivalent to one CEU. The board of pharmacy examiners will require 3.0 CEU each renewal period.

8.7(3) Continuing education program attendance certificate.

a. An approved provider will be required to make available to individual pharmacists certificates that indicate successful completion and participation in a continuing education program.

The certificate will carry the following information:

1. Pharmacist’s full name.

2. Pharmacist’s license number.

3. Number of contact hours for program attended.

4. Date and place of continuing education program.

5. Name of the program provider.

6. An indicator of the type or category of continuing education program completed.

b. Pharmacists must retain certificates in their own personal files for four years.

8.7(4) Continuing education program topics. Effective July 1, 1991, all pharmacists are required to obtain a minimum of 50 percent of their required 3.0 continuing education units (CEUs) in ACPE-approved courses dealing with drug therapy including, but not limited to, topics such as adverse drug reactions, biotechnology, clinical monitoring and drug utilization review, disease state, drug delivery systems, drug information, drug interactions, drug product selection, drugs, medical compliance, new drugs, nuclear pharmacy, OTC therapeutics, pharmacology, pharmacokinetics, substance abuse, and general therapeutics.

8.7(5) New license holders registered by examination. After the initial license is issued, the new license holder is exempt from meeting CE requirements for the first license renewal. Regardless of when license is first issued, the new license holder will be required to obtain 30 contact hours (3.0 CEU) of CE credits prior to the second renewal.

8.7(6) Reporting continuing education credits:

a. Pharmacists are required to submit documentation on the renewal application form that the continuing education requirements prescribed by the board have been met. Documentation will include the total number of credits accumulated for the renewal period and a listing of the individual programs attended, dates of participation, credits awarded and approved providers.

b. The board may require pharmacists to submit the program attendance certificates for the programs stated on the renewal application.

c. Failure to receive the renewal application shall not relieve the pharmacist of the responsibility of meeting continuing education requirements.

657-8.21(155A) Skin puncture for patient training. A licensed pharmacist may perform skin puncture for purposes of training patients to withdraw their blood in order to perform self-assessment tests to monitor medical conditions including, but not limited to, diabetes. This does not preclude a pharmacist from performing venipuncture as authorized by institutional or clinic privileges.

657-8.22(155A) Blood pressure measurement. A licensed pharmacist may take a person’s blood pressure and may inform the person of the results, render an opinion as to whether the reading is within a high, low, or normal range, and may advise the person to consult a physician of the person’s choice.

..

657-8.33(147,155A) Supervision of pharmacists who administer adult immunizations. A physician may prescribe via written protocol adult immunizations for influenza and pneumococcal vaccines for administration by an authorized pharmacist if the physician meets these requirements for supervising the pharmacist.

8.33(1) Definitions.

a. “Authorized pharmacist” means an Iowa-licensed pharmacist who has documented that the pharmacist has successfully completed an educational program meeting the training standards on vaccine administration as provided by an American Council on Pharmaceutical Education (ACPE)-approved provider of continuing pharmaceutical education that:

(1) Requires documentation by the pharmacist of current certification in the American Heart Association

or the Red Cross Basic Cardiac Life Support Protocol for health care providers;

(2) Is an evidence-based course that includes study material and hands-on training and techniques for administering vaccines, requires testing with a passing score, complies with current Centers for Disease Control and Prevention guidelines, and provides instruction and experiential training in the following content areas:

1. Standards for immunization practices;

2. Basic immunology and vaccine protection;

3. Vaccine-preventable diseases;

4. Recommended immunization schedules;

5. Vaccine storage and management;

6. Informed consent;

7. Physiology and techniques for vaccine administration;

8. Pre- and post-vaccine assessment and counseling;

9. Immunization record management; and

10. Management of adverse events, including identification, appropriate response, documentation, and reporting.

b. “Vaccine” means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

c. “Written protocol” means a physician’s order for one or more patients that contains, at a minimum, the following:

(1) A statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of administration of adult immunizations for influenza and pneumococcus;

(2) A statement identifying the individual authorized pharmacists;

(3) A statement that forbids an authorized pharmacist from delegating the administration of adult immunizations to anyone other than another authorized pharmacist or a registered nurse;

(4) A statement identifying the vaccines that may be administered by an authorized pharmacist, the dosages, and the route of administration;

(5) A statement identifying the activities an authorized pharmacist shall follow in the course of administering adult immunizations, including:

1. Procedures for determining if a patient is eligible to receive the vaccine;

2. Procedures for determining the appropriate scheduling and frequency of drug administration in accordance with applicable guidelines;

3. Procedures for record keeping and long-term record storage including batch or identification numbers;

4. Procedures to follow in case of life-threatening reactions; and

5. Procedures for the pharmacist and patient to follow in case of reactions following administration;

(6) A statement that describes how the authorized pharmacist shall report the administration of adult immunizations, within 30 days, to the physician issuing the written protocols and to the patient’s primary care physician if one has been designated by the patient. In case of serious complications, the authorized pharmacist shall notify the physicians within 24 hours and submit a VAERS report to the bureau of immunizations, Iowa department of public health. (VAERS is the Vaccine Advisory Event Reporting System.) A serious complication is one that requires further medical or therapeutic intervention to effectively protect the patient from further risk, morbidity, or mortality.

8.33(2) Supervision. A physician who prescribes adult immunizations to an authorized pharmacist for administration shall adequately supervise that pharmacist. Physician supervision shall be considered adequate if the delegating physician:

a. Ensures that the authorized pharmacist is prepared as described in subrule 8.33(1), paragraph “a”;

b. Provides a written protocol that is updated at least annually;

c. Is available through direct telecommunication for consultation, assistance, and direction, or provides physician backup to provide these services when the physician supervisor is not available;

d. Is an Iowa-licensed physician who has a working relationship with an authorized pharmacist within the physician’s local provider service area.

8.33(3) Administration of other adult immunizations by pharmacists. A physician may prescribe, for an individual patient by prescription or medication order, other adult immunizations to be administered by an authorized pharmacist.

This rule is intended to implement Iowa Code sections 147.76, 155A.3, 155A.4, and 272C.3.

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The state comparison information above was adapted from a study conducted by the American Pharmacists Association and commissioned by the Pharmacy Access Partnership.

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