I. Background and Need for the Policy
The American Public Health Association (APHA) has long endorsed universal access to reproductive health care, including contraception, as an important public health measure.1-8 Indeed, the Centers for Disease Control and Prevention has declared family planning to be one of the 10 most significant public health achievements of the 20th century.9 This position paper concerns a specific emerging obstacle to contraceptive access not previously addressed by APHA policy.
Access to contraceptive information and services is critical to preventing unintended pregnancies and to enabling women to control the timing and spacing of their pregnancies.10 Use of contraceptives is widely accepted in the United States. The typical American woman, who wants to have only two children, uses contraceptives for about three decades. Research shows that 62 percent of American women ages 15 to 44 are using a contraceptive method, and 32 percent of those are using hormonal contraceptive pills.11
According to the Institute of Medicine, unintended pregnancy can have serious consequences for both women and infants, including late prenatal care, greater risks for the woman of depression and physical abuse, and increased incidence of low birthweight babies leading to higher risks of serious illness and even death in the first year of life.10 For some women, pregnancy can entail great health risks and even life endangerment, making access to contraception essential. Contraceptives often are prescribed for a range of medical purposes in addition to birth control, such as amenorrhea, dysmenorrhea and endometriosis.12
Accordingly, APHA notes with concern a number of reports of women being unable to fill prescriptions for hormonal contraceptives, including emergency contraception (EC), because of objections to contraception by individual pharmacists or pharmacies.13 In some instances, women have reported that pharmacists berated them about the use of contraceptives and/or refused to transfer the prescription to another pharmacy.14 The reason most often stated by objecting pharmacists for refusing to dispense contraceptives is the religious or moral belief that contraception (especially emergency contraception) is equivalent to "early abortion." Research indicates that this belief sometimes is based on pharmacists' confusion of emergency contraception with RU 486 (mifepristone, sometimes referred to as the "abortion pill"),15 and in other cases, is based on a conservative religious view of when pregnancy begins,16 which is at odds with the mainstream medical definition,17 and on an unproven hypotheses of contraceptives' mechanism of action.18;
While reports indicate only a minority of pharmacists are refusing to dispense contraceptives for religious or moral reasons, their actions nonetheless represent interference with patients' rights and the prescriber-patient relationship. This interference is especially harmful given the time sensitivity of all contraceptives, especially emergency contraception, and the fact that birth control pills are available only by prescription in the United States and emergency contraception is approved to be sold over-the-counter for people 18 and older with proper age identification.19 Birth control must be used on a regular schedule, and delayed or skipped doses can lead to unintended pregnancy. Emergency contraception is most effective when taken within the first 24 hours after unprotected intercourse, and has no demonstrated efficacy after 120 hours.20
Because of the time-sensitive nature of emergency contraception, APHA is among the more than 60 medical, public health and women's health organizations that had urged the U.S. Food and Drug Administration (FDA) to switch emergency contraception from a prescription-only medication to over-the-counter status.21 After a three-year regulatory review process, the FDA in August of 2006 approved the sale of Plan B emergency contraception without a prescription to people 18 and over who present required forms of identification with proof of age. This action will improve ease of access to emergency contraception for many women. However, women under 18 still will be required to present a prescription.19 Women with Medicaid coverage also currently need prescriptions, depending on state Medicaid regulations. This is because Medicaid coverage of over-the-counter drugs are at state option and, even when covered requires a prescription.22 The FDA action restricts sale of EC to pharmacies, and does not permit it in convenience stores or other locations where over-the-counter medications often are sold.19 Prior to the FDA's action, the APHA had supported interim efforts to make emergency contraception more readily available, such as through the adoption of state laws that permit pharmacists to directly dispense the medication to patients under collaborative practice agreements with physicians.21
APHA has also urged health systems to establish protocols to ensure that a patient is not denied timely access to emergency contraception based on the moral or religious objections of a health care provider.23 That position is at odds with public policies being sought in a number of states that would protect objecting pharmacists from any liability for refusing to fill contraceptive prescriptions based on pharmacists' personal beliefs, not medical judgment, and without provisions to ensure that patients are able to obtain needed medications in a timely manner.24 Four states, Arkansas, Georgia, Mississippi, and South Dakota permit pharmacists to refuse to dispense contraceptives, including emergency contraception. Other states are introducing bills or proposing regulations that permit pharmacists or pharmacies to refuse to fill prescriptions with inadequate or no patient protections.25,26
APHA has recognized the professional expertise of pharmacists and the important role pharmacists play in promoting public health, including ensuring safe medication use.27 The patient's welfare should be paramount in the performance of the pharmacist's professional responsibilities. As such, the Code of Ethics for Pharmacists adopted by the 53,000-member American Pharmacists Association (APhA) states that "a pharmacist places concern for the well-being of the patient at the center of professional practice" and "respects the autonomy and dignity of each patient."28
However, the APhA also supports an objecting pharmacist's refusal to dispense a medication for religious or moral reasons and the establishment of systems to ensure patient access in cases of such refusal.29 Some examples cited by the APhA of "systems" that could be used to ensure that patients receive needed medication include staffing the pharmacy so that another pharmacist in the same store can step in to fill the prescription, and referring or transferring a prescription to a different pharmacy. The APhA recommends that these systems be established "proactively- before a pharmacist is presented with a prescription to which they object," and should be seamless to the patient.29 In situations in which no local pharmacist is willing to dispense the medication, APhA further recommends that prescribers directly dispense the product and that prescribing health professionals proactively direct their patients to pharmacies that are known to carry the prescribed drugs.29
The patient's ability to obtain prescribed contraceptives promptly could nevertheless be compromised under such suggested systems. Some pharmacies do not have more than one pharmacist available at all times so there may be no alternative pharmacist available to step in for an objecting pharmacist when a prescription for contraceptives is presented. Referrals to other pharmacies may not be viable for women who must obtain their prescriptions from certain pharmacies that have contracted with their private or public health insurance plans.
Access to contraceptives for women in rural areas can be especially problematic if the only local pharmacy will not stock the medication, or if an objecting pharmacist is on duty alone for portions of the day. Overall, there are fewer health resources in rural communities, with almost 75 percent of rural counties having areas within them designated as Medically Under-served Areas.30 Pharmacists serving rural communities may be among the few available health care providers in a community, but they too can be scarce.31 Pharmacists are less available in rural areas, with a ratio of 66 pharmacists per 100,000 people in rural areas, compared with 78 pharmacists per 100,000 people nationwide in 1999.32 Rural area residents face additional challenges in obtaining health care, including higher poverty rates, geographic isolation, and lack of both public and personal modes of transportation.33 Until recently, Wal-Mart, which is the only pharmacy in some communities, refused to stock EC.34 Thus, the nearest alternative pharmacy to which a patient could be referred to fill an EC prescription (if under age 18 or on Medicaid) or to purchase EC may be located a considerable distance away, proving to be an insurmountable barrier for those with no ready access to transportation.
While it is possible for a woman in a rural area to contact a contraceptive prescriber over the Internet or by telephone, in most states, that prescriber still needs to phone the prescription into a pharmacy located near the patient, or ask the patient to pick up the medication at the prescribing clinic, which may be located hundreds of miles away. Moreover, most of these clinics do not operate 24 hours a day, or over the weekend, thus introducing delay into the process. One Planned Parenthood affiliate is shipping contraceptives to patients who have filled out assessment forms online or through a telephone interview. However, the administrator of that clinic stated this service is limited to residents of the same state and one neighboring state because of state regulations. In addition, the cost to the patient of obtaining the contraceptives is increased by the overnight shipping fees and the assessment of an on-line prescribing fee, and third-party payors (such as insurance plans) do not always cover these costs.35
Reproductive health and public health professionals, allied pharmacists and policy-makers have responded to the public health concerns raised by pharmacist refusals with a variety of approaches, including contacting state pharmacy oversight boards and seeking legislative or regulatory action. As a result of their refusals, pharmacies or pharmacists could be susceptible to disciplinary action under pharmacy oversight board complaint procedures. For example, the California Board of Pharmacy in June 2006 issued a citation and fined a pharmacist for violating California law when he obstructed a patient's access to emergency contraception by refusing to fill or transfer her prescription. The pharmacy board found that the violation constituted unprofessional conduct.36 The Wisconsin Pharmacy Examining Board reprimanded and limited the license of a pharmacist who failed to inform a young woman of her options for having her prescription for oral contraceptives refilled after he refused to dispense the contraceptive and also refused to transfer it to another pharmacy.36 A state court has upheld the pharmacy board's action.37
State pharmacy boards also have begun to issue policy statements to address this issue. For example, in May 2004 the Massachusetts Board of Registration in Pharmacy stated that Massachusetts licensed pharmacists are required to fill a prescription that has been determined by the pharmacist to be a valid prescription under state and federal laws and which has been subjected to a prospective drug review to determine issues such as drug allergy interactions. The Board noted that there are no statutory or regulatory exceptions for this requirement for any particular drug or class of drugs.38 Acting on this policy, the Board later required Wal-Mart to stock emergency contraception in all of its 44 stores in the state.39 Other states, such as North Carolina and Oregon, also have articulated policies to protect patient access.40,41
State legislative and regulatory bodies are weighing in on pharmacy refusals and patient access. For example, California adopted legislation that imposes a duty on pharmacists to fill all prescriptions, and permits pharmacist refusals based on ethical, moral or religious grounds only if the pharmacist has given advance notice in writing to his/her employer and if the pharmacy can accommodate that pharmacist's objections without undue hardship to the employer.42 In Illinois, the governor issued a regulation requiring pharmacies to ensure that prescriptions for contraception are filled without delay.43 On the federal level, Congress has introduced measures to require pharmacies to fill or order prescriptions for all medications, including contraceptives.44
The education of pharmacists about emergency contraception, particularly its time frame of effectiveness and mechanism of action, has also been identified as a critical need. Pharmacist confusion about the difference between emergency contraception and medication abortion (mifepristone) has been reported in several surveys.45,46,47,48,49,50 By contrast, pharmacists who have undergone training about emergency contraception have, as in the states of Washington and California, been more likely to work to expand women's access to that medication.51
Several national medical and health organizations have issued statements or policies addressing pharmacist refusals. The American Medical Association (AMA), for example, has a policy, "Preserving Patients' Ability to Have Legally Valid Prescriptions Filled."52 AMA trustee Peter W. Carmel, MD, issued a statement asserting that "Patients need reliable access to medications prescribed by their physicians without unnecessary delay or interference. The AMA will work with the pharmacists associations and state legislators so that neither patients' health, nor the patient-physician relationship, is harmed by pharmacists' refusal to fill prescribed medications."53
II. The Role of Pharmacists in Meeting Patients' Need for Contraceptives
When a health professional such as a physician or nurse practitioner has prescribed contraception,54 the patient must be able to obtain the contraceptive in a timely manner at a pharmacy, without interference from those pharmacists who have personal objections to contraception. Similarly, patients need timely access to non-prescription emergency contraception. Any delay in access can endanger the patient's health by increasing the risk of unintended pregnancy or exacerbating the other medical conditions for which contraceptives are sometimes prescribed.55,56
In a number of states, pharmacists have played an active role in improving patients' access to contraceptives. Pharmacists have worked with advocates to pass laws in nine states thus far -Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington- allowing participating pharmacists to dispense emergency contraception to women without a prior prescription under a collaborative practice arrangement with a physician or independent prescribing ability.57 In these states, the FDA's prescription requirement for females under 18 or patients without the required form of identification will not pose an obstacle because these patients will be able to obtain both the prescription and the medication at participating pharmacies. These arrangements can also be a way for women on Medicaid to obtain easier access to EC.
APHA recognizes pharmacists' professional responsibilities, and patients trust pharmacists to evaluate prescriptions for contraindications. APHA notes the objections of pharmacists and pharmacies to any mandate that they maintain all prescribed medications in stock.58 APHA also notes that while the vast majority of pharmacists have no objection to dispensing contraception, some pharmacists do profess deeply held personal objections, especially to the dispensing of emergency contraceptives. Those beliefs should be accommodated to the extent possible. However, the patient's right to timely access to contraceptives must not be sacrificed in order to accommodate such beliefs.
The practice of pharmacy is regulated by each state for the purpose of protecting public health. Accordingly, any public policies or professional standards that allow for individual pharmacists to refuse to dispense contraception must require pharmacies to protect the patients' ability to obtain prescribed contraceptives in a timely manner at their pharmacy.
III. APHA Recommendations
As the nation's oldest and largest public health organization, APHA has the responsibility and expertise to address this critical health access issue from the perspective of public health protection. Thus, APHA takes the position that the patient's health and well-being must come first in health care delivery and in the formulation of health policy. Therefore, APHA recommends that any policies or standards to address the desire of some pharmacists or pharmacy employees to refuse to dispense contraceptives should advance the following three principles:
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