Hearing: Freedom of Conscience for Small Pharmacies
House Small Business Committee, Washington, D.C. 25 July, 2005

Prepared Remarks of Ms. Sheila Nix

Senior Policy Advisor, Governor Blagojevich

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Governor Blagojevich is a leader in fighting for and removing the barriers to accessible, affordable health care. In particular, women's health is a top priority. The Governor's commitment to health care is based on his belief that health care is a right and is vital to successful families and communities in Illinois.

The Governor has supported many different health programs aimed at women, including programs that address breast and cervical cancer, cardiovascular disease, and osteoporosis. Governor Blagojevich has also improved women's access to contraceptives by signing legislation to require private insurance to cover birth control and launching a public awareness campaign about the coverage in 2005. The Governor's decision to champion a woman's right to get her prescription for birth control filled without delay, without hassle and without a lecture is based on the knowledge that birth control is a fundamental health care issue for women. Birth control pills can be used to treat a variety of health problems. Pharmacies in the business of filling contraceptives should respect the decisions a woman has made with her doctor. The U.S. Food and Drug Administration (FDA) identifies both birth control pills and emergency contraceptives as preventing pregnancy, and the American Medical Association, American Medical Women's Association, and the American Nurses Association all agree that patient's valid prescription, based on a decision made between a woman and her doctor, should be filled without hassle and without delay.

Background on Governor Blagojevich's health care initiatives

The Governor has improved the lives of Illinoisans in several important ways, including providing health care to people who need it, ensuring people have access to affordable prescription drugs, and actively addressing health care access and availability for women.

Providing health care to people who need it

Governor Blagojevich has provided 313,000 more men, women, and children with health care through Illinois' KidCare and FamilyCare programs. The Kaiser Foundation has ranked Illinois the best state in the nation for providing health care to people who need it. The Governor has taken steps to reduce the nursing shortage in Illinois by eliminating the nurses' registration backlog and giving new grants for training.

Ensuring access to affordable prescription drugs

The Governor signed legislation that ensures that seniors do not suffer gaps in coverage because of the problems with the federal Medicare prescription drug benefit. Illinois' response to the federal program is the most generous and comprehensive of any state in the nation. Governor Blagojevich has also started I-SaveRx to provide people with access to more affordable prescription drugs from Canada and Europe.

Supporting important women's health care initiatives

The Governor created the Illinois Healthy Women Initiative. This has helped provide up to 120,000 women leaving Medicaid with basic health care and reproductive education as well as comprehensive reproductive health care coverage (annual physicals, pap smears, mammograms, contraceptives, and treatment for sexually transmitted diseases).The Governor has supported several programs that help women battle cancer. For example, the Stand Against Cancer Initiative encourages early detection of breast and cervical cancer. It has resulted in 7,500 screenings and targets the hardest to reach minority women in Illinois. In addition, the Illinois Breast Cancer and Cervical Cancer Program provided nearly 19,000 women with free screenings in fiscal year 2004 and offers free mammograms, breast exams, pap tests, and pelvic exams to low-income women between 35-64 years old with no health insurance. The Governor has also addressed major health care concerns of women, cardiovascular disease and osteoporosis, by providing funding to local health departments and community-based agencies. Lastly, Governor Blagojevich has taken a leadership role in supporting women's right to birth control. He has supported and signed legislation that required private insurance providers cover all FDA-approved contraceptive services and prescriptions. The Governor has also supported the Family Planning Program, which provides a range of medical services and education to more than 175,000 low-income women and adolescents of reproductive age. His emergency rule ensuring that women have the right to get birth control prescriptions filled is another step in making sure women's health care needs are taken seriously.

Women's Right to Get Prescriptions Filled

A woman's access to health care should never be denied or delayed. Yet, in the state of Illinois and around this nation, pharmacies are interfering with the decision women and their doctors make to obtain contraception.¹ In the last few months, several Illinois women have been subjected to this kind of refusal to fill a contraceptive prescription.

Complaints prompt rule

In February of this year, the Illinois Department of Financial and Professional Regulation (IDFPR) received two complaints from a doctor's office.² In each complaint, it is alleged that a pharmacist employed by a Chicago-area pharmacy had refused to fill two prescriptions for emergency contraception that the doctor's office had called in earlier that day. The complainant further alleged that, in response to the call from the doctor's office, the pharmacist stated, "I don't fill those." The pharmacist then advised the caller to call back several hours later when a different pharmacist would be on duty. This could present a problem because the effectiveness of the medication is dependent on when it is taken.

After investigation of these allegations, the Department filed a formal complaint against the pharmacy. The Department alleged that this pharmacy had failed to provide pharmaceutical care and had engaged in unprofessional conduct. The complaint remains pending within the agency. No action has been taken against the individual pharmacist.

Responding to these cases, Governor Blagojevich directed the Illinois Department of Financial and Professional Regulation ("IDFPR" or "Department") to promulgate a rule to ensure that women of this state are not denied access to basic health care. The rule is designed to ensure that all Illinois pharmacies dispense prescriptions for contraceptive medication without hassle, without lecture and without delay.

Since that time, the Governor's Office and the IDFPR have taken additional complaints from other women who have presented prescriptions for emergency contraception to Illinois pharmacists who have refused to fill those prescriptions. For example, a pharmacist employed by a pharmacy in St. Charles, Illinois recently refused to fill a prescription for emergency contraception for a 29-year-old, married mother of one child. The woman had run out of her birth control pills over the weekend. She was filling the emergency contraception prescription out an abundance of caution.³

Emergency and Permanent Rule

The Governor's rule clarified a retail pharmacy's duty to dispense contraceptive medication without delay. The rule does not apply to individual pharmacists; it applies to pharmacies. This rule was not intended to - nor does it - pertain to health care right of conscious legislation or encroach on an individual pharmacist exercising his or her beliefs. Instead, the rule applies to pharmacies, and it directs pharmacies in the business of dispensing contraceptive medication to fill valid, lawful prescriptions for contraception without delay.

The language of the emergency rule was amended as the Department responded to concerns raised by Illinois pharmacist associations and Catholic health care organizations. On June 2, 2005, the Department held a public hearing to collect comments on the rule. In response to comments received, the Department further examined the rule and amended it. The full text of the final proposed rule is as follows:

Section 1330.91

j) Duty of Division I Pharmacy to Dispense Contraceptives

1) Upon receipt of a valid, lawful prescription for a contraceptive, a pharmacy must dispense the contraceptive, or a suitable alternative permitted by the prescriber, to the patient or the patient's agent without delay, consistent with the normal timeframe for filling any other prescription. If the contraceptive, or a suitable alternative, is not in stock, the pharmacy must obtain the contraceptive under the pharmacy's standard procedures for ordering contraceptive drugs not in stock, including the procedures of any entity that is affiliated with, owns, or franchises the pharmacy. However, if the patient prefers, the prescription must be transferred to a local pharmacy of the patient's choice under the pharmacy's standard procedures for transferring prescriptions for contraceptive drugs, including the procedures of any entity that is affiliated with, owns, or franchises the pharmacy. Under any circumstances an unfilled prescription for contraceptive drugs must be returned to the patient if the patient so directs.

2) For the purposes of this subsection (j), the term "contraceptive" shall refer to all FDA-approved drugs or devices that prevent pregnancy.

3) Nothing in this subsection (j) shall interfere with a pharmacist's screening for potential drug therapy problems due to therapeutic duplication, drug-disease contraindications, drug-drug interactions (including serious interactions with nonprescription or over-the-counter drugs), drug-food interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions, or clinical abuse or misuse, pursuant to 225 ILCS 85/3(q).

Some important points from the rule bear emphasizing:

Women should have access to basic health care. A small number of pharmacists in the state of Illinois have expressed religious objections to filling certain contraceptive prescriptions. This rule takes a balanced approach to these two important interests. Pharmacies that stock contraceptive medications must fill valid, lawful prescriptions for all contraception without delay. However, if a pharmacy is not in the business of selling contraceptive prescriptions, it is not subject to the requirements of this rule. If a pharmacy sells contraceptives, but an individual pharmacist makes a conscientious objection, a pharmacy can make alternate arrangements to fill the prescription. The state leaves it up to the pharmacy to adopt an appropriate protocol. A pharmacy may fill a prescription for contraception with a suitable alternative in consultation with the customer's physician. If the prescribed contraceptive medication (or a suitable alternative) is not in stock, the pharmacy must obtain the medication through its regular procedures for ordering contraception. For chain pharmacies with numerous locations, the medication might be obtained from another store. Alternatively, if the pharmacy does not have the contraception in stock, the pharmacy must return the prescription to the patient or transfer the prescription, as the patient directs and as pharmacy practices allow. For Catholic-affiliated pharmacies, there is no pharmacy protocol for transferring contraceptive prescriptions because Catholic-affiliated pharmacies do not stock contraceptives or fill such prescriptions. Therefore, this language allows a Catholic-affiliated pharmacy to "opt out" of transferring the prescription. The rule does not interfere with a pharmacist's professional obligation to engage in drug therapy review and screening. For example, where a pharmacist sees that the customer is taking another medication that is contra-indicated for this prescription, the pharmacist is still expected to call the doctor and confirm that this prescription is appropriate and should be filled. This is part of the definition of the "practice of pharmacy" in the state of Illinois. See 225 ILCS 85/3 (d).At the Governor's direction, the Department filed this rule originally as an emergency rule. Emergency rules have the force and effect of law the moment they are filed, and they are effective for 150 days if not suspended. The Department also filed a proposed permanent rule. A hearing will be held on this rule on August 16, 2005. Unless the rule is objected to by the Joint Committee on Administrative Rules (JCAR), the proposed permanent rule will become effective before the emergency rule expires at the end of August.

Impact of the Rule

The emergency and permanent rules filed by the Department address a major concern regarding women's access to health care - that a woman's decision made with her doctor about her health must be respected. After consulting with their doctors, women make decisions about their health care. For example, after talking to her doctor, a woman may choose to take cholesterol-lowering medication, if she and her doctor together decide she cannot control her condition through diet and exercise. In the same way, prescriptions for contraceptive medications are written after the same kind of personal, confidential medical analysis and discussion between the patient and her doctor.

Contraceptives may be prescribed in a monthly or emergency form. The reason for the medication and the most appropriate form of the medication are matters between the doctor and patient. For example, contraceptives are prescribed to treat a number of conditions, above and beyond preventing pregnancy. Women may choose to take contraceptives to lower the risk of fibroadenomas or dysmenorrhea; to address the symptoms of endometriosis and Polycystic Ovary Syndrome; and to treat acne.

The rule applies to only contraceptives and not to RU-486. It does apply to all forms of pregnancy prevention, as identified by the FDA. This includes emergency contraceptives, which the FDA found to act in the same way as monthly birth control pills. The National Institutes of Health, the FDA, and the American College of Obstetricians and Gynecologists, state that emergency contraception will not terminate a pregnancy.⁴

Further, even emergency contraceptives may be prescribed to address various health issues. For example, at a public hearing, Dr. Lauren Streicher, MD, testified as follows:

A patient I currently treat bleeds so heavily during menstruation that she has required blood transfusions on two separate occasions. She is scheduled for surgery to correct the problem, but last week she had an unexpected episode of extremely heavy bleeding. Her husband called me, terrified, and described the blood pouring out of his wife. They live in a small town in Southern Illinois - two hours away from the nearest hospital. I instructed him to go to the nearest pharmacy and pick up a prescription of birth control pills to be taken at a higher dose to temporarily decrease the bleeding while they drove to the hospital. Time was obviously of the essence.

The husband told me he was worried that their local pharmacy would not fill the prescription because their pharmacist was known to disapprove of birth control pills. Fortunately, a different pharmacist was on duty, and he received the medication for his wife.⁵

If a pharmacist had attempted to interfere with filling this prescription, the results could have been deadly for this woman. The pharmacist would have interfered with the woman receiving medication she needed - as determined by a physician who had been treating her condition. The rule ensures that women have the access they deserve to health care and their relationship with their doctor is respected.

No one should interfere with a woman's right to have access to medications, including contraceptives, which her doctor has prescribed. It is a step backwards from the goal of ensuring all people in Illinois, especially women, have access to the health care they need. Access to birth control is a fundamental health care issue for women. Ensuring that women have the right to their birth control without delay, without hassle, and without a lecture is an important aspect of Governor Blagojevich's commitment to health care. Along with this effort, the Governor will continue to tackle other important issues in women's health, such as addressing cardiovascular diseases and osteoporosis as well as cancer screenings. He has made efforts to ensure families, children, and Illinois citizens have the access to health care and prescription drugs that they need. Governor Blagojevich's decision to ensure women can obtain their contraceptive prescriptions is a critical component in building strong families and communities in Illinois.