Issues in Depth
-Legal Commentaries-
 

Service or Servitude:
 Reflections on
 Freedom of Conscience
for Health Care Workers

Freedom of Conscience
and the Needs
of the Patient

Establishment Bioethics

Referral:
A False Compromise

Opening Statement of Chairman Manzullo

Good morning.  It is my pleasure to welcome everyone to today’s Small Business Committee hearing on the impact that “duty-to-fill” laws have on small pharmacies.

The subject before this Committee today deals with the negative impact on small pharmacies that operate under the strict law that requires pharmacists to fill all prescriptions – even if doing so violates their moral and professional beliefs.  I also want to discuss alternatives that will ensure that women who want a certain prescription have access to it, while preserving the integrity of the pharmacist.

Many individuals become physicians, nurses, pharmacists, or other healthcare workers based on a deeply-held conviction of service to others. 

Each of these individuals has a developed sense of conscience based on personal experience, individual ideology, religious beliefs, or cultural influences.

The primary debate surrounding this issue relates to a pharmacist’s moral opposition to filling prescriptions for emergency contraception, also known as the “morning-after-pill.”  On April 1, 2005, Illinois Governor Rod Blagojevich issued an emergency rule that requires pharmacies in the state that sell contraceptives to fill all prescriptions for FDA-approved contraceptives “without delay.”  That rule is currently before the Joint Committee on Administrative Rules to determine whether it should become permanent.  Several pharmacists have filed lawsuits challenging the rule, and one of those individuals is here today.

The right to refuse to participate in acts that conflict with an ethical or religious conviction is accepted as an essential element of a free society.  But what happens when the government forces a business to violate those beliefs?

Many pharmacies in small communities may not have another pharmacist who can simply fill the prescription for the pharmacist with a moral objection.  Nor can they easily transfer the prescription to another pharmacy nearby.  Under the Illinois rule and proposed federal legislation, such pharmacy would be forced to order the product under their standard procedures for ordering other out-of-stock drugs, even if it violates their personal beliefs or professional standards.

This will not only violate the pharmacist’s conscience, but may also be extremely costly for the business.  Pharmacies do not stock every drug that is currently on the market for economic reasons. This rule could become very expensive for pharmacies that are forced to order the morning-after pill when they otherwise would not have.

So what happens if a pharmacy owner refuses to fill a prescription despite these new mandates?  Many of the “duty-to-fill” requirements impose stiff penalties on pharmacies who continue to allow their pharmacists to exercise their conscience. 

Pharmacies could be subject to fines or even suspension of their licenses.  If a pharmacy shuts down, especially in a small community, such as Morrison, IL, and in many of the other rural areas I represent, other businesses will also be affected.  If people have to go to the next town to pick up their prescriptions, they may fill up their gas tanks or buy groceries, as well.  The entire community is affected if a pharmacy is forced to close its doors.

No one, least of all a health care provider, should be required to violate his or her conscience by participating in procedures that he or she deems harmful.  The government should never force anyone to choose between his business or beliefs.

The purpose of this hearing is to explore the impacts that extreme “duty to fill” legislation will have on small pharmacies.  I also hope to discuss alternatives that will ensure that women have access to medicine while preserving the beliefs of the pharmacist. 

I look forward to the testimony of all of the witnesses this morning, and I turn to my colleague, the Ranking Member for her opening statement.

Prepared Remarks of Mr. Luke Vander Bleek, R.Ph.
Pharmacist/President  Fitzgerald and Eggleston Pharmacies

Thank you Chairman Manzullo for the invitation to testify to the honorable members of this committee. I would also like to thank you, the members, in advance for the courtesy of your presence in receiving my testimony this morning.  

On April 1, 2005, Governor Blagojevich, issued an emergency executive rule in the State of Illinois requiring community pharmacies licensed in Illinois, pursuant to a valid legal prescription, to procure and dispense all forms of contraceptives without delay. This order includes the requirement that pharmacies that offer birth control therapy for sale, to also offer emergency contraceptives for sale in the same manner.

I object that any private business should be required by government to offer for sale any particular product or service. Additionally, I have strong professional and moral objections to this executive requirement being placed on my business. 

Professionally, as a pharmacist, I find the published scientific data concerning the actual mechanism of action of emergency contraceptives to be lacking.  Therefore, I regard the use of these products by women who are potentially hosting a live human embryo to be unsafe.  I find no published evidence for me to conclude that this therapy does not jeopardize a live human embryo. 

 Morally, I regard my involvement in therapies intended to terminate human life to be wrong. Additionally, I believe the Illinois Rights of Conscience Act grants me protection to operate my business as I have in the past

 My Governor’s order creates an environment in Illinois whereby a person holding deep moral convictions concerning the unborn cannot own and operate a licensed pharmacy.

 This environment creates an issue for small business, especially small business in small rural underserved markets.

 Many small communities are served by only one pharmacy, which is independently owned and operated. Other small communities are without and would benefit from the convenience and access of a pharmacy.

 In an environment where government requires business to be conducted in an amoral manner, the opportunity for moral business owners diminishes, as does the access to services and the economic activity these entrepreneurs may provide. 

Currently the governor’s rule is temporary with plans to become permanent. It is my position that I will not own and operate pharmacies in Illinois in the event that this temporary emergency rule becomes permanent. 

I do not have to tell this committee of the existence of only a finite number of investors that are able and willing to invest in underserved markets. What I am here to point out is that the business of pharmacy is not different in this way.

 In 1997, following 5 years of active management, my wife, Joan, and I became the owners of Fitzgerald Pharmacy in the small town of Morrison, Illinois, population 4200. We work, live, and raise our family this beautiful Midwest town. At the time of our purchase, there existed two successful independently owned pharmacies in Morrison.  In 2000, we purchased the other to grow our business and facilitate the retirement of the owner. 

 In 1998, Joan and I purchased a pharmacy from the Eggleston family, a retiring couple, in Sycamore, Illinois, population 9,500. This pharmacy business had been actively marketed for sale for nearly 3 years. As I now know, we were the only seriously interested buyers of this 38-year-old practice. Absent our interest the doors would have been closed forever.

 In 2001, we opened a pharmacy in Prophetstown, Illinois. This town of 1,800 residents had been without a pharmacy for nearly 6 months. The previous pharmacy operator, finding no one to succeed him, liquidated his business. Joan and I made our final decision to invest and locate a pharmacy in Prophetstown in large part to the very active solicitation by the town’s residents and its mayor.

In 2004, Joan, a young partner, and I opened a pharmacy in Genoa, Illinois. This town of 4,200 residents had been without a pharmacy for more than 8 years. Again, our decision to expand into Genoa was due in large part to local government making its case as to the unmet need for pharmacy services. 

In every residential market, large and small, pharmacies are a vital part of the community.  In small markets, pharmacies serve as anchor businesses creating opportunities for complimentary businesses. Indeed, when a resident of a small community must leave town to access a pharmacist and have a prescription filled, the resident also purchases goods and services from other vendors in the neighboring community satisfying many consumer needs.  This causes the businesses located in the resident’s community to suffer and eventually close. This deepens the demise of Main Street all across the country.

Pharmacists are the most accessible health care practitioners. It is commonplace for citizens to seek and receive free counsel from these primary care community pharmacists in all 50 states.  Pharmacists, like other professionals, carry with them their professional judgment. Science, education, law, ethics, and morality act as a guide. Patients benefit from their guidance.

Limiting the number of pharmacy owners to only those willing to operate in an amoral environment, clearly puts pressure on underserved markets in the U.S.

Joan and I, the parents of four school age daughters, have already decided that we will not continue to pursue ownership in pharmacies in Illinois in an environment where pharmacy licensure requires us to stock and dispense products we believe to be harmful to human life. I have spent my entire profession in pharmacy committed to easing suffering, curing and diagnosing disease, and improving the quality of human life. Though it has required significant sacrifice of time and effort, Joan and I have also enjoyed the opportunity to own and operate a small business in Illinois. Even so, we have resolved that we will not invest, and I will not practice in an environment, which we are legally obligated to be involved in the destruction of human life.

Prepared Remarks of Ms. Sheila Nix
Senior Policy Advisor  Governor Blagojevich  

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. 

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.  

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.

Prepared Remarks of Mr. J. Michael Patton, M.S., CAE
Executive Director  Illinois Pharmacists Association  

Good Morning and thank you to Committee Chair Congressman Manzullo for inviting me to speak today before this committee on the issue of Freedom of Conscience for Small Pharmacies.

Ladies and Gentleman of the House Committee on Small Business!

On April 1^st Illinois’ Governor Rod Blagojevich invoked an emergency rule requiring all Illinois licensed pharmacies to provide contraceptives based on a valid, lawful prescription without delay.  As initially implemented, this emergency rule posed a substantial risk to patient care and created a substantial challenge for pharmacists licensed in our State.

Since that time, the emergency ruling has been modified and proposed language will be reviewed by our Joint Committee on Administrative Rules on August 16^th.  The language as now being promulgated is as follows: 

“ 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 either be transferred to a local pharmacy of the patient’s choice or returned to the patient, as the patient 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 ILCS85/3 (q).”

As the ruling is now being enforced, the Illinois Pharmacists Association has taken a formal position that we can accept and support these modifications.  However, we feel it is imperative that the reference to “health care personnel” as cited in the Illinois Health Right of Conscience Act must be amended to specifically include pharmacists by reference rather than just by inference as “health care personnel”.

The initial impact of this edict was harrowing for Illinois pharmacists as many of the small, rural communities did not carry emergency contraceptive indication referred to as Plan B.  These pharmacies did not stock this item because of any personal or religious beliefs but rather the simple principles of supply and demand.  If there is no demand there is no reason to inventory this product.  The reality of many of these small pharmacies in these remote communities is that if a woman has unprotected sex and determines with the advice of her physician that pregnancy could be eminent, then she will seek out a pharmacy in a nearby metropolitan area to preserve and protect her privacy and anonymity.

Now these pharmacies are being challenged as to how to respond to the new ruling of the Governor.  Most still do not carry this product, but have established a relationship for a personal referral with a nearby “chain store” who now will typically stock this product due to the new mandate and the corporate requirement for compliance.  The ruling provides for the ability for the pharmacist, with the patient’s permission, to transfer the prescription to a local pharmacy of the patient’s choice or return the prescription to the patient.

Unfortunately, what we are now finding is that some individuals are now testing select pharmacies to discern the willingness of the pharmacy to fill their prescription.  A case in point is a woman who would drive over 100 miles to a very small rural pharmacy to get her prescription filled when she had passed multiple metropolitan areas.  This initiative has been utilized now at several pharmacies that happen to be owned by Illinois legislators.  This has caused concern and fear of many rural pharmacies that they may also be targeted in this “plot” to coerce pharmacies into compliance;  thereby creating the need for many pharmacies to now “inventory” this product in the event they might be “tested”!

This situation has caused many pharmacists to examine their own profession and dedication. They feel they no longer have the right to determine their own fate in the dilemma of dispensing.  Should they or shouldn’t they dispense?  Pharmacists are now beginning to question their rights under this new mandate.  Irrespective of their own personal beliefs, many pharmacists are now facing the reality if it is oral contraceptives today, what might the prescription be that will be mandated tomorrow?

Pharmacists are health care professionals, as defined in Illinois statute, and expect to be treated as the professionals that they are trained to be.  The commitment of the pharmacist is to serve and protect the health and safety of their patients.  This can quite easily be met by allowing pharmacists to do as they always have; if a medicine is not in stock, they may offer to order it for the patient or in the event of a time sensitive prescription like “Plan B”, they may make a referral to a local fellow professional.

This ruling has created limited economic hardship on many small pharmacists, but the threat of a noncompliance complaint for legitimately not having this product in stock has created a much greater burden on all pharmacists.  As a result, some pharmacists are questioning the viability of maintaining their practice in the State of Illinois.  Some with whom I have spoken, are contemplating relocating into other nearby States that will allow them to practice without fear of intervention. This consideration, will undoubtedly have significant impact on the availability, affordability and access to quality healthcare in many remote rural areas, rendering those patients in greatest need to drive greater distances to have their prescriptions filled.  Only time will tell the true cost implications of these decisions.  Pharmacists by nature are quite diligent in their efforts to comply, but the outside influences of certain “activists groups” testing selected pharmacists has created a noose of fear that is greater than any inventory item. 

These pharmacists fear their license may be in jeopardy if they fail to comply with a mandate such as this irrespective of their personal beliefs.  The cost of compliance has become an emotional, as well as an economic burden.

The Illinois Pharmacists Association has also urged the Governor to give further consideration, to recognize the right of conscience for pharmacists, but for those choosing to be trained to do so; we suggest allowing properly trained pharmacists to dispense “Plan B” without a prescription under the formal protocols of a licensed physician.  This is now being done in at least 6 other states.  This would allow pharmacists to be properly trained to counsel and dispense, and pharmacies to publicly advocate their willingness to dispense emergency contraception without a prescription.  This we feel addresses the availability of emergency contraception, and also provides the potential for savings as well.

Thank you ladies and gentlemen for the privilege and opportunity to be with you today, and I will be happy to try and address any questions that you might have.

Good morning.  Thank you for the opportunity to appear before you today and present the views of the American Pharmacists Association (APhA).  I am Linda Garrelts MacLean, a pharmacist and active member of APhA.  I have been in practice for 27 years and am the former co-owner of two community pharmacies in Spokane and Deer Park, Washington.  Founded in 1852 as the American Pharmaceutical Association, APhA is the first-established and largest national pharmacist organization in the United States, representing more than 53,000 practicing pharmacists, pharmaceutical scientists, student pharmacists and pharmacy technicians.  APhA members practice in virtually every area of pharmacy practice, including independent and chain community pharmacy, hospital pharmacy, nuclear pharmacy, long term care pharmacy, home health care and hospice. 

Let me first commend the Committee for holding today’s hearing to address the effects that the Governor of Illinois’ emergency order requiring pharmacies to provide contraceptives based on a valid, legal prescription ‘without delay’ will have on small pharmacies.  We greatly appreciate the opportunity to provide the pharmacist’s perspective on this important topic.  As you can see from the chart provided as Attachment A, pharmacists are the most accessible health care providers on the health care team.  Pharmacists fulfill a vital role in rural communities and other communities suffering from a shortage of health care providers.  This role must be taken into account when considering proposals that may affect pharmacists in rural areas.  For some of these patients, the pharmacist may be the only access point into our health care system.

Recent activity at the state and federal level on the issue of pharmacist conscience clauses has had and will have a direct impact on the ability of pharmacists and pharmacies to provide care to their patients.  This activity has also magnified the issue to a degree which does not accurately reflect the scope of the issue.  The vast majority of pharmacists dispense the vast majority of prescriptions. Regardless, pharmacists want to retain the ability to opt out of providing services to which they personally object.  My testimony will focus on the actual professional side, the provision of pharmacist services.  Pharmacist services are a business.  Intruding on how and what I choose to provide my patients is an intrusion into how I run my small business.  To that end, I appreciate the Committee recognizing the business aspect of a health care issue.

My comments today will discuss the pharmacist conscience clause, pharmacists’ activities to increase appropriate access to emergency contraceptives, the impact of ‘duty to fill’ legislation has on the pharmacist’s clinical role, the scope of the problem, and potential next steps.  Whether expanding the pharmacist’s role in improving medication use, working to successfully implement the Medicare prescription drug benefit, seeking adequate reimbursement in the Medicaid program, or enacting laws to allow pharmacists to immunize patients, pharmacists are stepping up to the plate to help ensure patients have access to medications and know how to make the best use of those medications.

Pharmacist Conscience Clause
The ability of health professionals to opt out of providing services they find personally objectionable is an important component of our health care system.  The pharmacy profession officially addressed this situation in 1998 through the APhA’s policy-making process, our House of Delegates.  Stimulated in part by the legalization of physician assisted suicide in Oregon, the policy applies to any situation where a pharmacist objects to dispensing a medication for personal (religious or moral) reasons. APhA’s policy states:

APhA recognizes the individual pharmacist’s right to exercise conscientious refusal and supports the establishment of systems to ensure [the] patient’s access to legally prescribed therapy without compromising the pharmacist’s right of conscientious refusal.

APhA’s policy supports the ability of a pharmacist to opt out of dispensing a prescription or providing a service for personal reasons and also supports the establishment of systems so that the patient’s access to appropriate health care is not disrupted.  In sum, our policy supports a pharmacist ‘stepping away’ from participating but not ‘stepping in the way’ of the patient accessing the therapy. 

Pharmacists, like physicians and nurses, should not be forced to participate in procedures to which they have moral objections.  However, recognizing pharmacists’ unique role in the health care system, there should also be systems in place to make sure that the patient’s health care needs are served.    It is possible to address the rights of patients and the ability of pharmacists to step away from an activity to which they object. Real world experience has proven this to be true.  And it does not require a confrontation with the patient.

Types of Systems
Because APhA’s policy supports the establishment of systems to ensure patients receive access to their care, it is worthwhile to take a moment to discuss these various types of systems.  The first of several potential systems begins when a pharmacist chooses where to practice.  A pharmacist who objects to physician assisted suicide would choose a practice outside the State of Oregon, or outside a practice that participates.  A pharmacist with personal objections to dispensing hormonal contraceptives would avoid practicing in a Title X clinic.  Even when a pharmacist makes a thoughtful decision about where to practice, the pharmacist may be faced with a prescription to which they have moral or religious objections.  Common systems that are used to balance a pharmacist’s moral or religious objections and a patient’s needs include staffing the pharmacy so that another pharmacist in the same pharmacy can dispense the prescription, and referring a new prescription or transferring a refill prescription to a different pharmacy.

An active communication plan can also help navigate these situations.  When prescribers and patients are directed proactively to pharmacies that carry certain drugs, such as emergency contraceptives, patients can be directed to those pharmacies.  The Association of Reproductive Health Professionals operates a national hotline (1-888-not-2-late) that allows patients to find a listing of providers who provide emergency contraception services.  The same group, in collaboration with Princeton University’s Office of Population Research, also operates a website (http://not-2-late.com) that can help patients identify a provider of emergency contraceptives in their area.  This concept can be applied more informally at the local level by proactive communications between pharmacists and prescribers.

Enacting pharmacist prescriptive authority for emergency contraceptives is another system that I will discuss in greater length.  Where these programs are in place, patients are directed to the pharmacists who prescribe and dispense emergency contraceptives and away from those who do not.  For example, in rural Washington State, potential patients are directed to pharmacists who participate in the emergency contraceptive care program, streamlining the process for the patient. Finally, in areas where no pharmacist will dispense a medication it may be the prescriber who chooses to dispense the product.  What each of these systems has in common is better communication between pharmacists and prescribers — a concept with broader benefits than navigating these rare situations.

An important underlying concept of our proposed systems is that they are established proactively — before a pharmacist is presented with a prescription to which they object.  The system should be seamless, with a pharmacist – patient interaction that is very similar to the interaction that occurs with any other prescription.  Similar to the situation where a medication is simply out of stock on any given day, if the pharmacist is unable to dispense the prescription, then the patient must be made aware of the options available to them to fulfill his or her medication needs.  The pharmacist should not use their position of power to berate the patient, to share their own personal beliefs, or obstruct patient access to therapy—such as refusing to return a patient’s legally valid, clinically appropriate prescription. In most states this activity is prohibited by law.   When alternative systems are established proactively, the patient is unaware of the pharmacist’s actions and both the patient’s right to care and the pharmacist’s need to step away from certain activity are accommodated.

Ongoing Activities; Opportunities for the Future
As professionals, pharmacists continually strive to provide the best patient care possible, including continuous review of practices and taking steps to improve medication use and advance patient care.  Unfortunately, the press has highlighted a few negative situations rather than focusing on the more broad reality of a significant number of pharmacists working to increase access to therapy such as emergency contraception. 

Because of the short timeframe involved in effective use of emergency contraceptives, the opportunities for pharmacist involvement in expanding patient access are many.  APhA supports the voluntary involvement of pharmacists, in collaboration with other health care providers, in emergency contraceptive care programs that include patient evaluation, patient education, and direct provision of emergency contraceptive medications.¹

Pharmacists in Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington have legal authority to prescribe and dispense emergency contraceptives under collaborative agreements with doctors and other prescribers.  Legislation to establish similar programs was introduced this year in Illinois, Kentucky, Maryland, Massachusetts, New Jersey, New York (it is waiting for the Governor’s signature), Oregon, Texas, and Vermont.

In the states where pharmacists have this authority, patients do not need to go to their physician first — something that could be difficult to accomplish in the short time period of effectiveness.  Instead, patients may go directly to a participating pharmacist to receive their prescription for emergency contraceptives.  Participating pharmacists receive training and work in collaboration with physicians and other prescribers through a pre-established protocol detailing the situations where emergency contraception should be used.  Patients are first interviewed and counseled by the pharmacist.  If the pharmacist agrees that the patient meets the clinical criteria for the medication, then the pharmacist will write the prescription and dispense the medication.  Patients who need additional clinical care are referred to their physician. 

While serving as President and President-elect for the Washington State Pharmacist’s Association, I was instrumental in helping enact emergency contraceptive prescriptive authority in my home State of Washington, which was the first state to enact this type of law.  Pharmacists began providing emergency contraception services in 1997.  Since then, hundreds of pharmacists and student pharmacists have been trained annually.  Approximately 1,200 emergency contraception interventions are done quarterly by pharmacists in local, Washington chain pharmacies in forty-three locations.  Clearly the system is working well in Washington. 

The states that have more recently adopted pharmacist emergency contraception prescriptive authority laws appear to have strong support from their pharmacists as well.  Two to three times more pharmacists than expected have attended emergency contraception prescriptive authority training programs.  These numbers and the experience of Washington State reflect the growing movement in pharmacy to make better use of pharmacists’ clinical expertise while also helping to improve access to medications, including emergency contraceptives.  It is a reality that negates the perception the media has created of pharmacists as obstructionists.

Pharmacists’ Clinical Role
Another consequence of ‘duty to fill’ legislation is its impact on the clinical role of pharmacists.  (‘Duty to fill’ legislation would require pharmacies or pharmacists to dispense ‘legal’ prescriptions.  When poorly crafted, such a requirement conflicts with the pharmacist’s legal responsibility to assess the clinical safety and appropriateness of the prescription.)  Much of the media coverage and the discussion around some of the legislative proposals portray pharmacists as simply robots—transforming individuals from thinking health care professionals into automatons forbidden from having personal beliefs, and from exercising their considerable professional judgment gained during years of education and practice.  Serving our patients and helping them make the best use of their medication is our priority.

If the pharmacist’s role were merely to dispense lawfully prescribed medicines, that robot or automaton would fit the bill. But pharmacists are professionals whose role on the health care team is to collaborate with physicians and patients to help medications do what they should—and nothing they shouldn’t. The profession exists to help patients access medications that will help them, and that means going beyond a ‘lawful’ prescription.

• A prescription calling for a 10-fold overdose is ‘lawful’, but likely fatal to the patient.
• A prescription calling for the antibiotic amoxicillin for a patient allergic to penicillin is ‘lawful’, but again, potentially fatal to the patient.
• A prescription calling for an oral contraceptive for a patient with a history of thromboembolic disease is ‘lawful’, but may result in patient harm.

‘Duty to fill’ legislation can cause problems for pharmacists and our patients.  Under Illinois Governor Blagojevich’s original April 1^st order, for example, pharmacies that sell contraceptives are required to fill valid, legal prescriptions for these medications without delay.  As written, the rule did not appear to permit pharmacists to protect patients from medications contraindicated because of allergy or drug-related interactions or to correct potential dosing errors. Nor did the rule permit pharmacists to transfer prescriptions if they had any objections to filling the prescriptions. According to the Governor, he was prompted to issue the order by reports to state health authorities that two women were unable to have prescriptions filled for emergency contraceptives at a chain pharmacy in Chicago.

Pharmacy’s reaction to Governor Blagojevich highlighted the reality that the emergency order, as originally written, would conflict with provisions in the Illinois Pharmacy Practice Act that require pharmacists to conduct prospective drug utilization review. The profession stated, “The requirement to dispense a valid, lawful prescription ‘without delay’ could require a pharmacist to dispense a valid, lawful-but clinically inappropriate-medication ‘without delay.”²

In response, on April 11^th, the Illinois Department of Financial and Professional Regulation published an open letter to Illinois pharmacists in which it clarified that the April 1^st emergency rule was not intended to “interfere in any way with a pharmacist’s responsibility to conduct prospective drug utilization review.”  Governor Blagojevich and the Department have pursued a permanent rule through the regulatory process to replace the emergency amendment.  Patients in Illinois will be well served if the Illinois Pharmacist Association’s efforts to include pharmacist prescriptive authority for emergency contraception is successful as it is one of the mechanisms to expand access.

As stated previously, pharmacists are professionals whose role on the health care team is to collaborate with physicians and patients to help medications do what they should – and nothing they shouldn’t.  To take away their clinical judgment is a draconian step backwards in an era when we are seeking to reduce the number of medication-related errors.

Impact on the Business of Pharmacy
‘Duty to fill’ legislation can also affect the business side of pharmacy.  As noted previously, it is a reality that health care is a business, and pharmacy practice a component of that business.  ’Duty to fill’ legislation affects business—and specifically small businesses—by dictating how a business must accommodate its staff, in this situation, its pharmacists.³  For example, some proposals have defined the type of system a pharmacy must implement in order to assure patients may access necessary medications, such as requiring a pharmacy to order a product if the medication is not in stock.  With more than 10,000 medications on the market today, it is impossible for a typical pharmacy to carry all medications—and unnecessary as well.  Decisions about which drugs to stock are based on the patient population served, the health plans in which the pharmacy participates, and the prescribing patterns of the physicians and other prescribers in the community.  Medications that are widely used in some geographic areas may be used only infrequently in others.  In some cases, a pharmacy may be willing to order a drug that is typically not available at the practice.  But depending on the patient’s needs, how quickly the pharmacy can receive the drug, and how much more the drug may cost the pharmacy (special orders may cost the pharmacy more — and the pharmacy may not receive any payment to cover those additional costs), special-ordering the drug may not be a viable option. In these situations, patients would typically be referred to other pharmacy practices or alternative arrangements would be made.

In trying to address an issue that to some may be a legitimate access issue and to others may be an issue of convenience, ‘duty to fill’ proposals would compel health care providers and businesses to provide certain services.  Decisions about what services to provide and by whom should be left up to individual health care providers.  Decisions about which systems to implement and how to implement them should be left up to pharmacy managers and pharmacists.  Patients will choose the pharmacy and pharmacists who best serve their needs, and market forces will dictate what services the pharmacies provide.

Is Legislation Necessary?
As with any policy discussion, it is critical to examine the situation in context and to carefully review the potential impact — positive and negative — of a legislative or regulatory proposal.  With most, if not all, ‘duty to fill’ proposals, both health care and small businesses are negatively impacted. 

The first challenge with such proposals is that they use a broad approach to a statistically minor problem.  While any instance of a pharmacist obstructing access to medications must be addressed, such situations are very rare.  Nearly 3.3 billion prescriptions are dispensed each year in the outpatient setting,⁴ averaging about 9 million prescriptions per day.  Proponents of ‘duty to fill’ laws document approximately twelve examples of refusals to fill since 1996.  One must question the need for new laws or regulations to address a handful of situations that may have been avoided through better communication and alternative systems.

Additionally, APhA strongly objects to creating federal oversight of the practice of pharmacy.  The practice of pharmacy, both the profession and the business, are regulated at the state level, just as all other health care providers.  We would oppose federal legislation to regulate the practice of pharmacy at the federal level.  Health care should be regulated at the local level to reflect local needs.  State Boards of Pharmacy should remain the leader in regulating the practice, not state or federal legislators who may not understand or appreciate a proposal’s impact on local patient care, local health care, or local pharmacies and physician offices. 

It is not unusual for a good policy to have unintended consequences.  Some of the proposals that would create a ‘duty to fill’ could result in a pharmacy choosing not to stock a certain product to avoid the situation of forcing their pharmacists to dispense.  Other pharmacies could decide to rescind the conscience clause protections they had had in place, and which were working well, because they do not believe that they can allow pharmacists to ‘step away’ and still meet the law’s requirements.  And a seemingly simple law, depending on how it is written, could compel pharmacists to participate in current ‘opt-in’ programs such as Oregon’s physician assisted suicide program.

Next Steps
One individual’s rights should not outweigh another’s.  Our policy balances the needs of the patient and the individual needs of the pharmacist, as well as the pharmacist’s professional responsibility.  Implemented well, patients will receive care and pharmacists will not be forced to ignore their personal moral beliefs.  With planning, there are no winners or losers – both persons are accommodated.  Rather than designating a profession as robots or automatons that ascribe to one set of beliefs, a different approach is available. And it works. It takes more time, and proactive implementation, but then, many of the best solutions do.

As a portion of the recently adopted American Medical Association (AMA) pharmacist conscience clause resolution indicates, pharmacists and physicians agree. Patients should receive their medications without harassment and interference, but pharmacists should not be compelled to participate in activity they find objectionable. The resolution directs the AMA to have a dialogue with APhA on this issue.  We welcome a dialogue that will ensure this continued recognition of the need to serve patients and recognize the individual beliefs of pharmacists and physicians. Just like physicians, pharmacists abide by a Code of Ethics for the delivery of health care.  Just as physicians are not required to provide all medical services, pharmacists should not be required to provide all pharmacy services.

Physicians and pharmacists collaborate every day to improve medication use and advance patient care—including navigating issues of conscience. We look forward to working with the AMA on this issue, much as our individual members are working together with physicians today and everyday in your districts.  It is a great opportunity for the profession to lead the efforts to address an issue facing health care professionals and patients.

Additionally, APhA will continue to help state pharmacy associations enact legislation that would provide pharmacists the legal authority to increase access to emergency contraception.   These programs support the clinical role of pharmacists in counseling and educating patients and also increase the awareness among consumers and prescribers about these drug products.  Lack of patient and prescriber awareness is a significant barrier to care.

Thank you for the opportunity to provide pharmacists’ perspective on this important issue.   APhA offers our assistance to the Committee as you continue your valuable work on this important issue and would welcome the opportunity to facilitate communications with state pharmacy associations so that Members of Congress can better assess the situation in their districts.

My name is Megan Kelly. I live in Geneva, Illinois. I’m 29 years old, married, a mother, and a high school art teacher.

Recently, in trying to make a responsible decision about my health and family planning, I was humiliated and discriminated against by a pharmacist who refused to fill my prescriptions for birth control pills and emergency contraception based on her own personal views. This pharmacist put my health in danger by refusing to fill my prescription and imposing a delay in my ability to access my legally prescribed medication.

On Sunday of 4th of July weekend I went to get my BC prescription filled and found out I had no more refills left.  When my usual pharmacist tried to contact my doctor she was told that I had to make my annual appointment before I could get my prescription filled.  My doctor was also out of town due to the fact that it was 4th of July.  After not being able to use my birth control pills for 3 days my doctor recommended that I use the EC pill as a precautionary measure.  That is why I tried to get both the birth control pill and the EC pill prescription filled.

My doctor’s office called in my prescriptions to a local Jewel-Osco pharmacy in St. Charles and was told my medication was available. When I went to pick up my medication, the pharmacist on duty said she would not fill my prescriptions because of her beliefs, and that I would have to get my prescriptions filled elsewhere.  I was shocked.  I asked for the store manager, who said he could not force his pharmacists to fill my prescriptions if they are willing to transfer the prescriptions to another location. I called the pharmacy district manager for Albertson’s Inc., who operates Jewel-Osco, and he confirmed this company policy.

The nearest Osco they wanted to transfer my prescription to is located on the other side of town. I had to get home to my child and a dinner party that was starting at my house in twenty minutes and I did not have time to drive across town.  I was finally able to get my medication hours later at a Walgreen’s pharmacy.

As a patient, I consult with my doctor about the best course of treatment. In writing a prescription, my doctor is doing his job and acting in my best interest. I do not expect a pharmacist to breach the relationship I have with my doctor and endanger my health. When pharmacists refuse to dispense medicine, they are not doing their job. Their job is to dispense medication, not moral judgment. A pharmacist’s personal views do not belong in my healthcare.

As a consumer, I have a right to walk in to any pharmacy in America and expect to have my prescription filled without unnecessary delays or discrimination. It is completely unacceptable for this store to refer customers to another provider at a different location. As in my case, this practice can result in humiliation and - based on the nature of the medication - poses a health risk when the prescription is not filled in a timely manner. Birth control pills must be taken every day at the same time to be effective, and the effectiveness of emergency contraception diminishes dramatically as time goes on.

I have since learned that what I suspected at the time is true: the Jewel-Osco pharmacy in St. Charles is in violation of an emergency rule that Illinois Governor Blagojevich signed on April 1, which states that pharmacies in Illinois that sell contraceptives must accept and fill prescriptions for contraceptives without delay. The Joint Committee on Administrative Rules is expected to make a decision about whether to make the rule permanent in August.

It is the responsibility of pharmacies to ensure that all individuals’ needs are met, and that no one becomes a target of discrimination. The Jewel-Osco pharmacy in St. Charles currently employs a pharmacist who is jeopardizing women’s health by refusing to fill legal, physician-prescribed family planning medication.

The bottom line is this: if a woman and her doctor have already discussed the need for contraception, she should be able to walk in to any pharmacy in America and expect to have her prescription filled without unnecessary delays or discrimination. Women should never be denied basic health care services by pharmacists who choose to impose their own beliefs on others.